Jump to main content.


 
Vol. 58 No.  27 Thursday, February 11, 1993  p 8136 (Rule)         
    1/4377  

ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Part 82 

[FRL-4557-1] 

RIN 2060-AD47 

Protection of Stratospheric Ozone; Labeling 

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule. 

컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴컴

SUMMARY: This final rule establishes labeling requirements for 
products manufactured with, containers of, and products containing 
specific ozone-depleting substances pursuant to section 611 
of the Clean Air Act, as amended. Specifically, the regulations 
require products that are manufactured with a process using 
a class I substance currently defined as chlorofluorocarbons 
(CFCs), halons, carbon tetrachloride, methyl chloroform, products 
containing a class I substance and containers of a class I or 
class II substance (hydrochlorofluorocarbons (HCFCs)) or mixture 
to bear a "clearly legible and conspicuous" warning statement. 
The substances affected by today's final rule are class I
substances 
and class II substances, as defined in 40 CFR part 82, appendix 
A to subpart A and in any later rulemaking.

EFFECTIVE DATE: The final regulation is effective on March 15, 
1993. The information collection requirements contained in 40 
CFR 82.122 have not been approved by the Office of Management 
and Budget (OMB) and are not effective until OMB has approved 
them. An announcement of the effective date of 40 CFR 82.122 
will be published in the Federal Register.

ADDRESSES: Comments and materials supporting this rulemaking 
are contained in Public Docket No. A-91-60 in room M-1500,
Waterside 
Mall (Ground Floor), U.S. Environmental Protection Agency, 401 
M Street, SW., Washington, DC 20460. Dockets may be inspected 
from 8:30 a.m. until 12 noon, and from 1:30 p.m. until 3 p.m., 
Monday through Friday. A reasonable fee may be charged for copying 
docket materials.

FOR FURTHER INFORMATION CONTACT: Kate Van Slyck, Stratospheric 
Ozone Protection Branch, Stratospheric Protection Division, 
Office of Atmospheric Programs, Office of Air and Radiation 
(6202-J), 401 M Street, SW., Washington, DC 20460. (202) 233-
9742. The Stratospheric Ozone Information Hotline at 1-800-296-
1996 can also be contacted for further information.

SUPPLEMENTARY INFORMATION: The contents of today's preamble 
are listed in the following outline:

I. Background 
A. Ozone Depletion
B. Montreal Protocol 
C. Excise Tax 
D. London Amendments to the Montreal Protocol 
E. Clean Air Act Amendments of 1990, Title VI 
F. Requirements of Section 611 
II. The May 4, 1992 Notice of Proposed Rulemaking 
III. Accelerated Phaseout 
1. New Scientific Data Regarding Ozone Depletion 
2. Copenhagen Revisions to the Montreal Protocol 
3. The Proposed Accelerated Phaseout Regulation 
4. Effect of Accelerated Phaseout on Labeling Regulation 
IV. Summary of Public Participation 
V. Response to Significant Comments 
A. Definition of Interstate Commerce and Introduction into
Interstate 
    Commerce 
B. Products Manufactured Before May 15, 1993 
C. Products Manufactured With Controlled Substances 
1. Changes to the Label Pass-Through Requirement 
a. Resin Producers and the Use of One Label 
2. Incidental Uses 
3. Transformation 
4. Destruction 
5. Use Reduction Exemption for CFC-113 and Methyl Chloroform 
    Used as Solvents 
D. Products Containing and Containers Containing 
1. Distinction Between "Products Containing" and "Containers 
    Containing" and Label Requirement 
2. Label Pass-through Requirement for "Products Containing" 
    and "Containers Containing" 
3. Containers of Recaptured Substances and Waste 
4. Trace Quantities of Unintended Residues or Impurities 
E. Use of Controlled Substances for Repairs and Used Products 
F. Label Placement and Alternative Labeling Options 
1. Label Placement 
a. Clearly legible and conspicuous 
2. Alternative Labeling Options 
a. Alternative Labels 
b. Supplemental Printed Material 
c. Products not Viewed by the Purchaser Prior to or at the Same 
    Time of Purchase 
d. Competing Information. 
e. Parallel to Existing Information 
G. Products Manufactured for Export Only 
H. Imports 
I. Medical Products 
J. Packaging 
K. Research and Development 
L. Warning Statement Text and Requirement 
M. Recoverable Substances Label 
N. Symbol 
O. Petition Process 
VI. Summary of the Final Rule and Changes from the Proposed 
    Rule 
VII. Effective Date 
VIII. Summary of Supporting Analyses 
A. Regulatory Impact Analysis 
B. Regulatory Flexibility Analysis 
C. Paperwork Reduction Act 
IX. References 

I. Background 


A. Ozone Depletion 

   The stratospheric ozone layer protects the earth from
ultraviolet 
(UV-B) radiation. Research begun in the 1970s indicated that 
when certain industrially produced halocarbons (including
chlorofluorocarbons 
(CFCs), halons, carbon tetrachloride and methyl chloroform) 
are released into the environment, they migrate into the
stratosphere, 
where they contribute to the depletion of the ozone layer. To 
the extent depletion occurs, penetration of the atmosphere by 
UV-B radiation increases. Increased exposure to UV-B radiation 
produces health and environmental damage, including increased 
incidence of skin cancer and cataracts, suppression of the immune 
system, damage to crops and aquatic organisms, increased formation 
of ground-level ozone and increased weathering of outdoor plastics.

B. Montreal Protocol 

   In response to growing evidence that chlorine and bromine 
could destroy stratospheric ozone on a global basis and the 
discovery of the ozone hole over Antarctica, many members of 
the international community came to the conclusion that an
international 
agreement to reduce global production of ozone-depleting substances

was needed. Because releases of CFCs from all areas mix in the 
atmosphere to affect stratospheric ozone globally, efforts to 
reduce emissions from specific products by only a few nations 
could quickly be offset by increases in emissions from other 
nations, leaving the risks to the ozone layer unchanged. EPA 
evaluated the risks of ozone depletion in Assessing the Risks 
of Trace Gases That Can Modify the Stratosphere (1987) and
concluded 
that an international approach was necessary to effectively 
safeguard the ozone layer. 
   EPA participated in negotiations organized by the United 
Nations Environment Programme (UNEP) to achieve an international 
agreement to protect the ozone layer. In September 1987, the 
United States and 22 other countries signed the Montreal Protocol 
on Substances that Deplete the Ozone Layer. The 1987 Protocol 
called for a freeze in the production and consumption (defined 
as production plus imports minus exports of bulk chemicals) 
of CFC-11, -12, -113, -114, -115, and halon 1211, 1301 and 2402 
at 1986 levels, and a phased reduction of the CFCs to 50 percent 
of 1986 levels by 1998. Currently, over 90 nations representing 
well over 90 percent of the world's consumption are parties 
to the Protocol. 
   In an August 12, 1988 final rulemaking (53 FR 30566) EPA 
promulgated regulations implementing the requirements of the 
1987 Protocol through a system of tradable allowances. EPA
apportioned 
these allowances to producers and importers of these "controlled 
substances" based on their 1986 levels. To monitor industry's 
compliance with the production and consumption limits, EPA required

recordkeeping and quarterly reporting and conducted periodic 
compliance reviews and inspections. 

C. Excise Tax 

   As part of the Omnibus Budget Reconciliation Act of 1989, 
Internal Revenue Code of Ozone-Depleting Substances, section 
506A of Public Law 101-239, the United States Congress levied 
an excise tax on the sale of CFCs and other chemicals which 
deplete the ozone layer, with specific exemptions for exports 
and recycling. The tax went into effect on January 1, 1990, 
and increases annually. The original excise tax was amended 
by the Omnibus Budget Reconciliation Act of 1991 to include 
methyl chloroform, carbon tetrachloride and the other CFCs
regulated 
by the amended Montreal Protocol and Title VI of the Clean Air 
Act, as amended in 1990. The Energy Policy Act of 1992, section 
1931 of Public Law 102-486, revised and further increased the 
excise tax, effective January 1, 1993. By raising the cost of 
virgin controlled substances, the tax has created an additional 
incentive for industry to shift out of these substances and 
increase recycling activities, and it has encouraged the
development 
of a market for alternative chemicals and processes. 

D. London Amendments to the Montreal Protocol 

   Under Article 6 of the Montreal Protocol, the Parties are 
required to assess the science, economics and alternative
technologies 
related to protection of the ozone layer every two years. In 
response to this requirement, the Parties issued their first 
scientific assessment in 1989 (Scientific Assessment of Ozone 
Depletion, which has been placed in the docket for this
rulemaking.) 
During this assessment, scientists examined the data from land-
based monitoring stations and the total ozone mapping spectometer 
(TOMS) satellite and found that there had been global ozone 
depletion over the northern hemisphere as well as over the southern

hemisphere. The scientific assessment also reported that a three 
to five percent decrease in stratospheric ozone levels had occurred

between 1969-1986 in the northern hemisphere in the winter months 
that could not be attributed to known natural processes. 
   At the Second Meeting of the Protocol Parties, held in London 
on June 29, 1990, the Parties responded to this new evidence 
by tightening the restrictions placed on these chemicals. The 
Parties to the Protocol passed amendments and adjustments which 
called for a full phaseout of the already regulated CFCs and 
halons by 2000, a phaseout of carbon tetrachloride and "other 
CFCs" by 2000 and a phaseout of methyl chloroform by 2004. The 
Parties also passed a non-binding resolution regarding the use 
of hydrochlorofluorocarbons (HCFCs) as interim substitutes for 
CFCs. Partially halogenated HCFCs add much less chlorine to 
the stratosphere than the fully halogenated CFCs, but still 
pose a significant threat to the ozone layer, (See 56 FR 2420 
January 22, 1991 for more information on the relative effects 
of different ozone-depleting substances). 

E. Clean Air Act Amendments of 1990, Title VI 

   On November 15, 1990, the Clean Air Act Amendments of 1990 
were signed into law. The requirements in Title VI of the amended 
act include phaseout controls similar to those in the London 
Amendments, although the interim targets are more stringent 
and the phaseout date of methyl chloroform is earlier (section 
604). Other Title VI provisions require EPA to promulgate
additional 
controls pertaining to the protection of the stratospheric ozone. 
These provisions: (1) Restrict production and consumption of 
HCFCs (section 605); (2) restrict the uses of controlled ozone-
depleting substances, including provisions to reduce emissions 
of controlled substances to the "lowest achievable level" in 
all use sectors (section 608); (3) require the recovery and 
recycling of refrigerant when servicing motor vehicle air
conditioners 
(section 609); (4) ban nonessential products (section 610); 
(5) mandate warning labels (section 611); (6) establish a safe 
alternatives program (section 612); and (7) require revision 
of federal procurement policies to minimize government use of 
ozone-depleting substances. EPA has already promulgated regulations

implementing the phaseout provisions contained in section 604 
of the Act (57 FR 33754) and the section 610 ban on nonessential 
uses. EPA is currently in the process of promulgating regulations 
under several other sections of Title VI. 
   One of the provisions of the Act which complements the labeling 
requirement is the Significant New Alternatives Program (SNAP) 
established under section 612. The Advance Notice of Proposed 
Rulemaking for SNAP was published in the Federal Register on 
January 16, 1992 (57 FR 1984); the Notice of Proposed Rulemaking 
is currently being prepared for publication. The SNAP program 
has been established to evaluate the overall effects on human 
health and the environment of the potential substitutes for 
ozone-depleting substances. Rules promulgated under SNAP will 
render it unlawful to replace an ozone-depleting substance with 
a substitute chemical or technology that may present adverse 
effects to human health and the environment if the Administrator 
determines that some other alternative is commercially available 
and that this alternative poses a lower overall threat to human 
health and the environment. The SNAP program is a powerful tool 
for ensuring that "safe" alternatives are developed.

F. Requirements of Section 611 

   The rule being promulgated today implements section 611 which 
prohibits, effective May 15, 1993, the introduction into interstate

commerce of any container containing class I and class II
substances, 
product containing class I substances and product manufactured 
with class I substances, unless it bears a warning statement 
indicating that the product contains or is manufactured with 
ozone-depleting substance(s). The section extends the prohibition 
after May 15, 1993, and before January 1, 2015, to any products 
containing, or manufactured with class II substances if the 
Administrator determines that safe alternatives are available. 
Beginning January 1, 2015, all products containing or manufactured 
with class I or class II substances must also be labeled. While 
the label provisions have different effective dates for products 
containing and manufactured with class I substances, as compared 
to products containing and manufactured with class II substances, 
the requirements in the regulation are the same for products 
"manufactured with" and products "containing" such substances 
unless otherwise indicated. The term "controlled substance," 
defined in the regulation, will be used to refer to both class 
I and class II substances where the labeling requirements apply 
to both substances. 

II. The May 4, 1992 Notice of Proposed Rulemaking 

   In a notice of proposed rulemaking published on May 4, 1992 
(57 FR 19166), EPA proposed regulations to implement section 
611. (It should be noted that EPA considers section 611 to be 
self-implementing except for those prohibitions that require 
an EPA determination to be triggered (see, e.g., section
611(c)(1)). 
Consequently, products covered by section 611 would have to 
be labeled even if EPA did not promulgate implementing regulations.

Specifically, EPA proposed that effective May 15, 1993, labels 
be required on containers of class I and class II substances 
and products containing or manufactured with class I substances. 
The proposal also called for labels on all products containing 
or manufactured with class I or class II substances, beginning 
on January 1, 2015. 
   EPA proposed definitions for the terms "class I substance 
and class II substance," "container," "containing or contains," 
"incidental uses," "manufactured with," "potentially available," 
"principal display panel," "product," "recoverable substance," 
"supplemental printed information," "transform," "ultimate
consumer," 
"type size," and "warning label." While many of the proposed 
definitions were consistent with definitions in regulations 
under other sections of Title VI, the definitions also included 
some that apply only to the regulations promulgated pursuant 
to section 611. In describing these definitions, EPA discussed 
the legal and policy aspects of the options considered in the 
proposal. 
   With respect to products "manufactured with" ozone-depleting 
substances, EPA proposed that a product is "manufactured with" 
a class I or class II substance if a class I or class II substance 
is used in the product's manufacturing process, including the 
manufacture of component parts, but the class I or class II 
substance is not contained in the product at the point of sale 
to the ultimate consumer. Examples of products "manufactured 
with" under the proposed definition included products cleaned 
with solvents, products with adhesives or coatings using solvents, 
open celled flexible foam products, and certain food and tobacco 
products. Excluded from the definition were incidental uses, 
those uses where no physical contact occurs between the product 
and the controlled substance. Examples of incidental uses provided 
in the proposal were are produce stored in a warehouse that 
is refrigerated by a CFC system, or clothes that are manufactured 
by machinery which requires routine maintenance with a controlled 
substance like methyl chloroform, but that the clothes do not 
come into contact with the substance directly. Also excluded 
from the proposed definition of "manufactured with" were products 
manufactured with ozone-depleting substances that are transformed 
into non-ozone-depleting substances during the manufacturing 
process and therefore do not pose a threat to the ozone layer. 
Appendix A of the proposal, parts 1 and 2, consisted of a partial 
list of products that were considered "manufactured with" and 
those considered "containing." 
   In the proposal, EPA indicated that it would not narrow its 
definition of "manufactured with" through establishment of a 
"de minimis" level because though many CFCs and other ozone-
depleting substances were typically used in small quantities 
by individual users, the aggregate use of these substances over 
an entire market segment was large. 
   Under the proposal, EPA defined "product containing" ozone-
depleting substances to be products that hold a controlled
substance 
within their structure, or that are intended to be charged with 
a controlled substance, at the point of sale to the ultimate 
consumer, consistent with Appendix B of the Montreal Protocol 
on Substances That Deplete the Ozone Layer (UNEP Memo June 21, 
1991). (In the Appendix, the Protocol Parties listed "products 
containing" controlled substances for purposes of a trade provision

in Article 4 of the Protocol.) Examples cited were truck air 
conditioning units, domestic and commercial refrigeration
equipment, 
aerosol products and fire extinguishers. 
   The proposal contained a discussion regarding the appropriate 
placement of labels on products. The definition section of the 
proposed rule contained definitions of "principal display panel" 
(PDP) and "supplemental printed information" which were relevant 
to the discussion of label placement. Since section 611 requires 
that a label be "clearly legible and conspicuous," EPA proposed 
that the label appear on the product or its container/packaging, 
whichever the ultimate consumer would view first when making 
the purchase. EPA proposed that placement of the label on the 
PDP would be one way in which to ensure that the label was "clearly

legible and conspicuous," since it is generally large enough 
to accommodate a label and it is usually where the consumer 
is likely to look for product information. However, the proposal 
also stated that placement of the label on another display panel 
that is normally viewed by the consumer at the time of purchase 
could also be "clearly legible and conspicuous." 
   In addition to display panels, the proposal discussed
alternative 
label placement for those products that are not normally viewed 
at the time of the purchase decision. It suggested that for 
such products, manufacturers include the warning statement in 
supplemental printed materials. For products that are normally 
viewed at the time of the purchase decision, but are irregularly 
shaped or small and cannot therefore accommodate a label on 
a display panel, the proposed rule indicated that hang tags, 
cards, stickers, tape and other options of label placement could 
be used for placement of the label. 
   EPA also proposed that a product be considered to have been 
introduced into interstate commerce either at the warehouse 
from which the manufacturer releases the product for distribution 
or sale, or at the site of U.S. Customs clearance for imported 
products. EPA proposed that the warning statement be passed 
through the stream of commerce to the ultimate consumer in order 
to inform the ultimate consumer of any controlled substances 
used and thereby maximize manufacturers' incentive to switch 
to substitutes. Specifically, EPA proposed that for products 
incorporating other products as components the label information 
on the final product include any information regarding use of 
controlled substance(s) in the manufacturing of the component 
products. EPA indicated that under such requirements, a
manufacturer 
could rely on its reasonable belief that the purchased component 
products were not manufactured with controlled substances if 
a label did not accompany the product and that independent
investigations 
through the stream of commerce were unnecessary. Manufacturers 
could also employ contractual specifications which would declare 
to their suppliers their unwillingness to purchase products 
manufactured with any controlled substance. 
   For manufacturers in need of temporary exemptions from the 
labeling requirement (under section 611(e)(5), effective January 
1, 2015, that all products containing or manufactured with a 
controlled substance must bear a label), EPA proposed a petition 
process with specific format and data requirements. Those
manufacturers 
that demonstrated, to the satisfaction of the Administrator, 
that no alternative substitutes were currently or potentially 
available for their specific use of class I substances could 
obtain an exemption. The proposed petition process sought to 
implement section 611(e)(1), which allows persons to request 
EPA to apply the labeling requirements to a product containing 
or manufactured with a class II substance earlier than the statute 
otherwise provided. The Agency also proposed a petition process 
for persons to request an exemption for their products manufactured

with a class I substance. The Agency would have 180 days to 
review such petitions. 
   Also proposed was the application of a permanent label on 
products containing class I substances indicating how to recover 
the substances. The intent of the additional label was to provide 
clarification to servicers of the products and recyclers of 
the substances contained in the product to facilitate appropriate 
handling. Under section 608, EPA is required to promulgate
regulations 
to maximize the recycling of such substances and to reduce
emissions 
of such substances to the lowest possible levels. 
   EPA also requested comments on whether a symbol should accompany

the warning text as a means of more effectively communicating 
the intent of the warning statement. However, EPA was concerned 
that the cost of such a symbol would outweigh the benefits of 
using the symbol. EPA did not propose a symbol. 
   In developing the rule, the Agency received guidance from 
a Subcommittee on Labeling of the Stratospheric Ozone Protection 
Advisory Committee (STOPAC) in accordance with the Federal Advisory

Committee Act, 5 U.S.C. App. section 9(c). Additionally, small 
"use-sector" groups convened to discuss application of the labeling

requirement throughout various sectors of industry. The Agency 
wishes to acknowledge their valuable technical expertise and 
assistance in the development of the proposal. 

III. Accelerated Phaseout 

   Based on new scientific evidence developed since the passage 
of section 611 and development of the proposed implementing 
regulations, the international community, led by the United 
States, has agreed to further accelerate the phaseout of already 
regulated ozone-depleting substances and control such substances 
pursuant to this agreement. Virtually all class I substances 
will be phased out in less than three (3) years and some of 
those with the highest ozone depletion factors will be phased 
out in less than one year. EPA believes that its decisions in 
this rulemaking should take into account the significantly
shortened 
life span of ozone-depleting substances and the correspondingly 
diminished impact labeling would be expected to have. The following

section describes the most recent scientific and international 
developments regarding ozone depletion to provide the relevant 
context for EPA decisions regarding the labeling rule. 

1. New Scientific Data Regarding Ozone Depletion 

   Significant scientific advances have occurred since the 1989 
Protocol assessments. Several subsequent reports since that 
time have indicated a more rapid rate of ozone depletion than 
previously believed. The most recent Montreal Protocol Scientific 
Assessment, issued December 17, 1991, contains information from 
ground-based monitoring instruments, as well as from satellite 
instruments, from the years 1979-1991. The data indicate
significant 
decreases in total-column ozone have occurred in winter, and 
for the first time several similar decreases in spring and summer, 
in both the northern and southern hemispheres at middle and 
high latitudes. The data further show no significant depletion 
has occurred in the tropics. TOMS data indicate that for the 
period 1979 to 1991, decreases in total ozone at 45 degrees 
south latitude ranged between 4.4 percent in the fall to as 
much as 6.2 percent in the summer, while depletion at 45 degrees 
north latitude ranged between 1.7 percent in the fall to 5.6 
percent in the winter. Data from the ground-based Dobson network 
confirm these losses in total column ozone during the thirteen-
year period. These findings show almost twice as much depletion 
as the average rate measured by the ground-based network over 
a twenty-year period. Based on this new data, scientists have 
concluded that the ozone in the stratosphere during the 1980s 
disappeared at a much faster rate than experienced in the previous 
decade. 
   The recent UNEP Science Assessment also includes new data 
on the estimated ozone depletion potentials (ODPs) of ozone-
depleting substances. The assessment places the ODP of methyl 
bromide, a chemical previously thought to have an insignificant 
effect on stratospheric ozone, at 0.6, with a range of uncertainty 
between 0.44-0.69. The Executive Summary of the Assessment states 
that, "if the anthropogenic sources of methyl bromide are
significant 
and their emissions can be reduced, then each ten percent reduction

in methyl bromide would rapidly result in a decrease in
stratospheric 
bromine of 1.5 pptv (parts per trillion by volume), which is 
equivalent to a reduction in chlorine of 0.045 to 0.18 ppbv 
(parts per billion by volume). This gain is comparable to that 
of a three-year acceleration of the scheduled phaseout of the 
CFCs." On November 25, 1992, the Parties to the Montreal Protocol 
agreed to assign methyl bromide with an ODP of 0.7 and freeze 
its production and consumption at 1991 levels. See subsection 
4 below in this section for further information regarding this 
issue. 
   On February 3, 1992, NASA released preliminary data acquired 
by the ongoing Arctic Airborne Stratospheric Experiment-II (AASE-
II), a series of high-altitude instrument-laden plane flights 
over the northern hemisphere (see Interim Findings: Second Airborne

Arctic Stratospheric Expedition). Additional data were also 
obtained from the initial observations by NASA's Upper Atmosphere 
Research Satellite (UARS), launched in September 1991. The
measurements 
show higher levels of chlorine monoxide (ClO) (the key agent 
responsible for stratospheric ozone depletion) over Canada and 
New England than were observed during any previous series of 
aircraft flights. In fact, the ClO levels over the United States 
and Canada and as far south as the Caribbean were many times 
greater than gas phase models had predicted. These levels are 
only partially explainable by enhanced aerosol surface reactions 
due to emissions from the volcanic eruptions of Mount Pinatubo. 
The expedition also found that the levels of hydrogen chloride 
(HCl), a chemical species that stores atmospheric chlorine, 
to be low, providing new evidence for the existence of chemical 
processes that convert stable forms of chlorine into
ozone-destroying 
species. The Montreal Protocol Scientific Assessment document 
includes studies on the Antarctic ozone hole which implicate 
chlorine as the main cause of ozone depletion over the Antarctic, 
and link high chlorine concentrations to CFCs and other chlorinated

and brominated compounds. The high ClO and bromine monoxide 
(BrO) levels observed in these studies indicate that human-induced 
rates of ozone destruction were as high as one to two percent 
per day for short periods of time beginning in late January. 
   In addition, the levels of nitrogen oxides (NOx) were also 
observed to be low, providing evidence of reactions that take 
place on the surface of aerosols that diminish the ability of 
the atmosphere to control the buildup of chlorine radicals. 
New observations of HCl and nitrogen oxide (NO) imply that chlorine

and bromine are more effective in destroying ozone than previously 
believed. 
   The NASA findings indicate that in late January of 1992, 
the Arctic air was chemically "primed" for the potential formation 
of a springtime ozone "hole" similar to that formed each spring 
over Antarctica. These findings also are consistent with theories 
that ozone depletion may occur at an accelerated rate on aerosol 
surfaces in the stratosphere anywhere around the globe, and 
not only on polar stratospheric clouds as was previously believed. 
   After collecting more data, NASA released an April 30, 1992 
"End of Mission Statement," which indicated that while a rise 
in stratospheric temperatures in late January apparently prevented 
severe ozone depletion from occurring in the Arctic this year, 
observed ozone levels were nonetheless lower than had previously 
been recorded for this time of year. This information has further 
increased the Agency's concern that significant ozone loss may 
occur over populated regions of the earth, thus exposing humans, 
plants and animals to harmful levels of UV-B radiation, and 
adds support to the need for further efforts to limit emissions 
of anthropogenic chlorine and bromine.
   In response to these findings, President Bush announced on 
February 11, 1992, that the United States would unilaterally 
accelerate the phaseout schedule for ozone-depleting substances, 
and he called upon other nations to agree to an accelerated 
phaseout schedule as well. The President also asked U.S. producers 
to voluntarily reduce 1992 output of class I substances to half 
of the 1986 baseline levels. In addition, the President directed 
EPA to re-evaluate the phaseout schedule for HCFCs, and to consider

the phaseout of methyl bromide. 
   The Agency has also received two petitions to accelerate 
the phaseout of these chemicals. One petition was submitted 
by three environmental groups, the Natural Resources Defense 
Council (NRDC), the Environmental Defense Fund (EDF), and Friends 
of the Earth (FOE). This petition further requested that EPA 
add methyl bromide to the list of class I substances. The other 
petition was submitted by the Alliance for Responsible CFC Policy, 
an industry group of producers and users of the chemicals. 

2. Copenhagen Revisions to the Montreal Protocol 

   On November 25, 1992, the Fourth Meeting of the Montreal 
Protocol was convened. 
   In this meeting, the Parties took a number of actions, including

accelerating the phaseout schedule of CFCs, halons, carbon
tetrachloride, 
and methyl chloroform and added HCFCs and methyl bromide to 
the list of chemicals to be controlled under the Montreal Protocol.

   The following changes to the previously proposed phaseout 
schedules were reached at the Copenhagen meeting: 
   (1) Adjusting the phaseout schedule for CFCs (class I, group 
I substances) to a 75% reduction in production and consumption 
(production plus imports minus exports) from 1986 baseline levels 
for 1994 and 1995, and a complete phaseout by 1996; 
   (2) Adjusting the schedule for Halons (class I, group II 
substances) to a complete phaseout in production and consumption 
by 1994: 
   (3) Adjusting the phaseout schedule for other fully halogenated 
CFCs (class I, group III substances) to a reduction from 1989 
levels, 75% in 1994 and 1995, and a complete phaseout of production

and consumption by 1996; 
   (4) Phasing out of carbon tetrachloride (class I, group IV) 
by a reduction from 1989 levels of 85% in 1995, and a complete 
phaseout in 1996; 
   (5) Adjusting the phaseout schedule for methyl chloroform 
(class I, group V) by reducing the production and consumption 
of 1989 levels by 50% in 1994, and phasing out completely by 
1996. 
   (6) Establishing criteria for identifying essential uses 
and a process for excepting limited production and consumption 
of the above chemicals following their phaseout (see below). 
   These adjustments go into effect in approximately six months. 
In addition, the Parties adopted the following amendments to 
the Protocol: 
   (1) Freezing consumption of HCFCs (class II substances)
beginning 
in 1996 to a baseline ceiling of: 100% of 1989 the ozone depletion 
potential (ODP) weighted level of HCFC consumption plus 3.1% 
of the ODP weighted 1989 CFC 2004, 65% by 2010, 90% by 2015, 
and 99.5% by 2020; and completely phasing out consumption by 
2030; 
   (2) Adding Hydrobromoflourocarbons (HBFCs) to the list of 
class II controlled substances, specifying their ozone depletion 
potential, and phasing their consumption out completely by 1996; 
   (3) Listing methyl bromide as a controlled substance with 
an ozone depletion potential of 0.7, and freezing consumption 
beginning in 1995 to 1991 consumption levels; (the calculated 
levels of consumption shall not include quarantine and preshipment 
uses); 
   (4) Establishing a procedure for the approval by the Parties 
for continued production and consumption after phaseout to meet 
essential use requirements; essential uses are defined as those 
necessary for health or safety, or critical to the functioning 
of society, and where there are no available alternatives or 
existing stocks of banked or recycled material; 
   (5) Establishing reporting requirements for HCFCs, HBFCs, 
and methyl bromide; 
   (6) Establishing reporting requirements for imports and exports 
of controlled substances to and from non-parties to the Protocol; 
   The Amendments will enter into force under the Protocol
following 
their ratification by at least twenty Parties. This is projected 
to be accomplished by January 1, 1994.
   The Parties also made a number of procedural and definitional 
changes that affect implementation of the Protocol and that 
are included in the proposed accelerated phaseout regulation. 
The changes include: 
   (1) The approval of destruction technologies and the requirement

that Parties that plan to operate destruction facilities do 
so in accordance with Good Housekeeping Procedures developed 
by the Parties or their equivalent; 
   (2) Clarification of the definition of controlled substances 
to exclude insignificant quantities under defined circumstances, 
and to encourage Parties to minimize emissions of such substances; 
   (3) Clarification of the reporting requirements and treatment 
of international transshipment; 
   (4) Modification of definition of controlled substance to 
exclude import and export of recycled and used controlled
substances 
from the calculation of consumption, but to require reporting 
of data concerning these imports and exports. 
   The Parties also adopted a procedure under which the Parties 
can approve the continued production and consumption of ozone-
depleting substances after the phaseout to meet essential uses. 
Such uses are defined as necessary for health, safety, or critical 
to the functioning of society, but are to be permitted only 
in cases when no alternatives exist or when existing stocks 
of banked or recycled material are not available. The definition 
of "controlled substance" was also clarified to exclude
insignificant 
quantities resulting from inadvertent production and unreacted 
feedstock.

3. The Proposed Accelerated Phaseout Regulation

   In July 1992, EPA issued its final rule and regulatory program 
implementing section 604 of the Clean Air Act Amendments. The 
section limits the production and consumption of ozone-depleting 
chemicals. EPA controls production and consumption by issuing 
allowances or permits that are expended in the production or 
importation of these chemicals. Trading of these allowances 
is permitted.
   The regulation requires producers of class I substances to 
gradually reduce their production of these chemicals and to 
phase them out completely as of January 1, 2000 (2002 for methyl 
chloroform). In addition to the production limits, the rule 
requires a similar reduction in consumption.
   In February 1992, the President requested that U.S. producers 
voluntarily reduce their production by half of the baseline 
year levels. He also announced that the U.S. would revisit the 
phaseout schedule for HCFCs and progress towards an accelerated 
phaseout of class I substances from 2000 to the end of 1995.
   At the same time, EPA received a petition from the Natural 
Resources Defence Council (NRDC), the Environmental Defense 
Fund (EDF) and Friends of the Earth (FOE), requesting that EPA 
add methyl bromide to the list of class I substances. Another 
petition was submitted by the Alliance for Responsible CFC Policy. 
The Fourth Meeting of the Parties to the Protocol, discussed 
above, further supported the movement towards an agreed upon 
accelerated phaseout by the Parties.
   Based on these new developments, EPA is proposing to accelerate 
the phaseout of CFCs, methyl chloroform, carbon tetrachloride, 
halons, HCFC-141b, HCFC-142b, and HCFC-22. The Agency is also 
proposing to add methyl bromide and HBFCs to the list of major 
class I substances. In addition to these new listings, the proposal

implements various trade provisions required by the Montreal 
Protocol to encourage countries to join the Protocol by prohibiting

the trade of bulk substances and products containing controlled 
substances with non-parties. 

4. Effect of Accelerated Phaseout on the Labeling Regulation 

   The accelerated phaseout will have a significant impact upon 
manufacturing processes that use class I substances affected 
by today's rulemaking. The combined effects of the excise tax 
and the original phaseout schedule have already created strong 
economic incentives for industry to find substitutes for class 
I substances. In fact, according to EPA's database on producers 
of these chemicals, current U.S. production of CFCs are about 
50 percent below the 1986 baseline levels set by the Montreal 
Protocol. The accelerated phaseout will significantly increase 
the economic incentives for all class I substance users to switch 
to alternatives. Consequently, even where a particular process 
that uses a class I substance is exempted from the labeling 
requirement through the petition process outlined below, the 
substance in question will rapidly become scarce and expensive, 
and industry will be encouraged to find alternative chemicals 
or processes.
   When Congress passed the Clean Air Act Amendments of 1990, 
it required the production and consumption of class I substances 
to be phased out by the year 2000 (2002 for methyl chloroform 
(MCF)) and warning labels to be applied to containers containing 
class I and class II substances, and products containing and 
manufactured with class I substances beginning on May 15, 1993. 
The section 611 labeling provisions related to class I substances 
thus had six and a half years (eight and a half years for MCF) 
to have an effect on the use of class I substances before they 
were phased out. However, the decision to end production of 
class I substances by January 1, 1996 (January 1, 1994 in the 
case of halons) means that the labeling of products manufactured 
with class I substances per section 611(d) and products containing 
and containers containing class I substances per section 611(b) 
will be in effect for less than three years before the complete 
phaseout takes effect. As a result, EPA has streamlined some 
of the proposed requirements related to class I substances in 
recognition that manufacturers will be phasing out their uses 
of these substances at a much earlier date. This is further 
addressed below in the Response to Significant Comments section 
(V). 

IV. Summary of Public Participation 

   A hearing on the proposed labeling rule was held on May 18, 
1992. Nine groups presented oral comments to the proposed
requirements 
and submitted written testimony to the Agency. A transcript 
of the testimony is contained in the public, No. A-91-60.
   The Agency received a total of 162 comments on the proposed 
rule. Six commenters supported the proposal that labels supply 
ultimate consumers with information at the point of purchase 
decision. Other commenters recognized the impact that labeling 
will have as a market incentive for elimination of class I
substances 
and in the development of alternative substances and processes 
that use such substances.
   Many comments addressed EPA's proposal that manufacturers 
that do not manufacture with a process using a class I substance, 
but use component products which were manufactured using a class 
I substance, would have to label their products (the "pass-through 
requirement"). Commenters requested that EPA consider the
significant 
financial and administrative burden on manufacturers who may 
have well over 1,500 suppliers of components. Many commenters 
also addressed the issue of products manufactured and stored 
in inventory prior to the effective date of the rule. Commenters 
stated that the burden of pulling back all such products from 
inventories, warehouses, distributors and retailers for purposes 
of applying a label would be an onerous task with little, if 
any, environmental benefit. The issue of products manufactured 
for export only was discussed by many commenters who were concerned

that U.S. manufacturers would be at an economic disadvantage 
in a global market if American-made products for export were 
required to bear a warning statement, because other countries 
do not have similar requirements.
   Other comments addressed the use of a symbol with the warning 
statement. Most commenters argued against the symbol, indicating 
that it could distract consumers from the warning statement 
itself, as well as from other important information on a product's 
label. Another issue raised frequently in comments concerned 
the recoverable substances label. Many commenters did not support 
the label since section 608 covers such products containing 
recoverable substances and promotes training for servicers handling

and disposing of such substances. Many commenters requested 
clarification of the alternative label placement options. They 
indicated that there was no clear distinction among the proposed 
options. Finally, the Agency received numerous comments regarding 
the definition of incidental uses of class I substances and 
the need for a de minimis exemption.
   EPA addresses the significant comments that it received in 
section V. below. EPA addresses other comments received in a 
separate Response to Comments document available in the docket. 

V. Response to Significant Comments 


A. Definition of Interstate Commerce and Introduction Into
Interstate 
Commerce 

   Some of the commenters indicated that EPA should include 
a definition of interstate commerce in the final rule and specify 
at which point a product enters into interstate commerce. EPA 
defines interstate commerce as the distribution or transportation 
of any product or container between one state, territory,
possession 
or the District of Columbia and another state, territory,
possession, 
or the District of Columbia. It is further defined as the sale, 
use or manufacture of any product in more than one state,
territory, 
possession or the District of Columbia. For a product or container 
in the United States to avoid coverage as being in intrastate 
commerce, an affected party must provide adequate documentation 
that the product not only was or will be manufactured, distributed,

sold or used without ever crossing state lines, but that none 
of the components that went into, or will go into, the manufacture,

distribution, sale or use of such product originated, or will 
originate, in another state. 
   A product is first introduced into interstate commerce either 
when it is released from the facility in which it was manufactured,

when it enters the warehouse from which a domestic manufacturer 
releases the product or container for shipment, or for imported 
products, when they are at the site of U.S. Customs clearance. 
The inclusion of the facility in which a product was manufactured 
as a point of introduction responds to comments indicating that 
some manufacturers do not inventory their products, but sell 
them directly to separate warehouse facilities. In this case, 
the manufacturer of the product is required to apply the label 
before the product leaves its facility. A manufacturer that 
stores its product in its own warehouse introduces that product 
into interstate commerce when the product enters its warehouse. 
The manufacturer in this case is required to apply the label 
prior to or contemporaneous with, the product's entrance into 
the warehouse. This provision differs from the proposal in that 
the introduction of a product into interstate commerce occurs 
when the product enters the warehouse, not when the product 
leaves the warehouse. As discussed below in part V.B., several 
commenters stated that manufacturers often store products at 
warehouses for extended periods of time before the products 
finally leave the warehouse. This change to the regulation will 
ease enforcement by requiring that all products that are stored 
in warehouses be labeled by the time they enter storage. This 
revision also allows manufacturers to avoid having to label 
products manufactured prior to May 15, 1993 but still in inventory 
on that date. 
   Containers containing ozone-depleting substances become subject 
to these regulations at the time they are charged with an ozone-
depleting substance. At the point of charge, they are defined 
as containers containing ozone-depleting substances which have 
been introduced into interstate commerce. Application of a warning 
statement therefore would be required upon completion of the 
charging activity. 

B. Products Manufactured Before May 15, 1993 

   Many commenters addressed the impact of the labeling rule 
on products in inventory and in production up until the effective 
date. The commenters all expressed concern that requiring a 
label on products that were manufactured before the effective 
date, but are still in the manufacturer's inventory as of the 
effective date, would impose significant economic and logistic 
burdens on the affected manufacturers, distributors, wholesalers 
and retailers. Consequently, the commenters argued that EPA 
should not require a label on products manufactured before May 
15, 1993, even if the products have not left the warehouse from 
where the manufacturer releases the product for distribution 
or sale. Some comments indicated that EPA should allow a grace 
period for those products that are manufactured and warehoused 
prior to the effective date, if an exemption of such products 
from labeling altogether is not possible. 
   EPA agrees with these commenters that requiring a label on 
products already manufactured prior to the effective date would 
adversely affect a number of businesses without providing any 
appreciable environmental benefits. There are many manufacturers 
that maintain large stocks of products to support high or
conditional 
consumer demand. If EPA were to apply these regulations to such 
products, manufacturers would be required to retain those products,

remove their packaging in order to label them appropriately, 
and resume normal commercial distribution. An additional problem 
for some products is that the stream of commerce for such products 
is strictly regulated (e.g., limited shelf life of metered dose 
inhalers) in which case any deviation from a product's regulated 
commercial mobility would require regulatory complications and 
delays in the distribution of such products. Other manufacturers 
may have products stored in warehouses across the United States 
and on foreign territory, in which case labeling such products 
according to the proposed requirements would require significant 
time and expense. One major electronics company indicated that 
it currently has approximately 2,500 suppliers world-wide and 
purchases about 70,000 component products from these suppliers. 
For this company, labeling all of its inventoried products prior 
to the effective date would involve tremendous costs and time. 
In addition, manufacturing processes for many products manufactured

with class I substances prior to May 15, 1993 would have already 
released the substance during manufacture except for those
processes 
where recovery and recycling occur. Therefore, the final product 
poses no further threat to the stratospheric ozone layer when 
it is inventoried or later sold. 
   EPA believes that its clarification of the term "introduction 
into interstate commerce" (see section V.A.) should ease most 
of the concern of commenters on this point. If a product has 
been introduced into interstate commerce before May 15, 1993, 
then it is not subject to these regulations. Only a small number 
of products will have been manufactured before May 15, 1993 
but will not have left the facility of manufacture or have entered 
the manufacturer's warehouse by the effective date. Therefore, 
for the vast majority of products manufactured before May 15, 
1993, the rulemaking is inapplicable on its face, given EPA's 
definition of the term "introduction into interstate commerce." 
   For those small number of products that are manufactured 
before May 15, 1993, but which have not left the place of
manufacture 
or have not entered the manufacturer's warehouse before May 
15, 1993, or that are manufactured in foreign countries before 
May 15, 1993, EPA is allowing such products to be "grandfathered." 
EPA believes that requiring manufacturers to label these products 
would adversely affect numerous businesses, because the labeling 
process for many manufacturers occurs during the actual
manufacturing 
process. Thus, if EPA did not grandfather these products,
manufacturers 
would have to undergo a onetime cost to retrieve and label products

already manufactured but not yet introduced into interstate 
commerce before May 15, 1993. EPA believes that little if any 
appreciable environmental benefits would be gained from requiring 
such products to be labeled. 
   EPA believes that sufficient precedent exists for this decision.

The United States Court of Appeals for the District of Columbia 
Circuit has established a four-part test to judge the
appropriateness 
of Agency grandfathering (see Sierra Club v. EPA, 719 F.2d 436 
(D.C. Cir. 1983)). This test involves balancing the result of 
four analyses, including whether the new rule represents an 
abrupt departure from previously established practice, the extent 
to which a party relied on the previous rule, the degree of 
burden that application of the new rule would impose on the 
regulated parties, and the statutory interest in applying the 
new rule immediately. 
   EPA believes that the labeling requirements represent an 
abrupt departure from previous practice. Prior to the effective 
date of the labeling requirements, manufacturers in general 
were not required to provide any labeling information regarding 
whether controlled substances were contained in, or used in 
the manufacture of, a product; moreover, until today's publication 
of these regulations, manufacturers could not know for certain 
the specific labeling provisions that they would be required 
to implement. As discussed above, requiring labeling on products 
manufactured before May 15, 1993 would impose an unreasonable 
burden on numerous affected parties while providing no significant 
environmental benefits. For these reasons, EPA believes that 
its grandfathering of products manufactured before May 15, 1993 
is consistent with the requirements of Sierra Club v. EPA. 
   Today's final rule also provides for grandfathering products 
containing class I or class II substances. Such products face 
problems like these described above for products "manufactured 
with," in that they can be stored for distribution throughout 
the world. To require them to be labeled before distribution 
in order to apply the warning statement would result in significant

costs with little or no environmental benefit. 
   Therefore, given the large onetime cost to label inventoried 
products, and limited environmental benefit of labeling these 
products, this regulation provides that all products manufactured 
before May 15, 1993 are not subject to the requirements of section 
611(d). This decision is also based on the fact that industry 
will have significantly less time to implement the labeling 
requirement than the statute envisioned because the Agency did 
not promulgate implementing regulations within eighteen months 
following enactment of the Act's amendments, as required by 
the statute. Had EPA promulgated such regulation at the proper 
time, manufacturers would have had one year from the time of 
publication of the regulation to the law's effective date to 
comply. Because of these delays, manufacturers have substantially 
less time to comply after the promulgation of these regulations. 
Therefore, EPA acknowledges the difficulty that manufacturers 
with inventories of products would have without such a
"grandfathering" 
exemption. 
   EPA is requiring that for products manufactured before the 
effective date to be exempt from the labeling requirement,
manufacturers 
must be able to show within twenty-four (24) hours of receiving 
a request by EPA that such products were manufactured prior 
to May 15, 1993. Although EPA is not requiring new recordkeeping 
requirements or specific tracking systems today, manufacturers 
must have an accountable system in place on site so that EPA 
can verify that unlabeled products were manufactured or containers 
were filled prior to the effective date. The burden thus falls 
upon the manufacturer to show that unlabeled products are exempt 
from the labeling provision. If a manufacturer is unable to 
verify such information, then that person will be deemed out 
of compliance and subject to penalties, pursuant to Title I, 
section 113 of the Clean Air Act. Importers of products that 
can show at the site of U.S. Customs (Customs) clearance that 
such products were manufactured prior to the effective date 
are also exempted from the labeling requirement. In the absence 
of such proof, products containing or manufactured with a class 
I substance will need to bear the appropriate label, regardless 
of the manufacture date. 

C. Products Manufactured With Controlled Substances{1} 

      {1}  This labeling regulation applies to products
manufactured 
      퀇ith class I and class II substances. However, it
should 
      쿫e noted that products manufactured with class II
substances 
      쿪re not regulated by this regulation until January 1, 
      2015, or until the Administrator finds, after notice 
      쿪nd opportunity for comment, that for a particular
product 
      퀂ubstitute products or processes are potentially or
currently 
      쿪vailable. 

1. Changes to the Label Pass-Through Requirement 

   In the proposed rule, EPA required that products manufactured 
with and containing controlled substances be labeled throughout 
the stream of commerce. Its definition of "manufactured with" 
exempted transformation and non-contact uses of controlled
substances. 
The proposal indicated that by allowing these exemptions, the 
requirements would not result in universal labeling. Additionally, 
EPA indicated that the labeling requirements should apply across 
all use sectors since Congress did not restrict applicability 
of the law. 
   EPA further proposed that in order to inform the ultimate 
consumer that a controlled substance had been used in the
manufacture 
of any part of a finished product, any manufacturer that
incorporates 
a labeled component into its product, would be required to label 
its product, even if no ozone-depleting substances are used 
by the manufacturer in the subsequent manufacturing process. 
EPA stated in the proposal that manufacturers could rely on 
the label information they received from their suppliers, as 
long as they reasonably believed that the information was accurate.

EPA suggested that manufacturers could show reasonable belief 
by using contract provisions requiring accurate labeling by 
their suppliers. 
   One commenter supported EPA's definition of "manufactured 
with," stating that it would not necessarily culminate in universal

labeling, and that EPA's proposal to pass the label through 
the stream of commerce to the ultimate consumer is fair and 
appropriate, as long as there are clear penalties to discourage 
noncompliance. However, many responded that EPA's proposed
definition 
of "manufactured with" was extremely broad, covering a significant 
number of products, including component products, and that such 
a requirement would in fact result in universal labeling with 
an onerous and expensive tracking burden. These commenters argued 
that tracking components was unavoidable and that all products 
would have to be labeled. Such universal labeling, it was argued, 
would reduce the effectiveness of the requirement, with little 
environmental benefit and possible confusion for consumers. 
Other comments expressed doubt as to whether the proposal reflected

congressional intent. 
   Several also commented that the proposal would disadvantage 
downstream manufacturers that do not use controlled substances 
in their own manufacturing processes, but that depend upon a 
multitude of suppliers who may use controlled substances in 
their manufacturing processes. 
   According to these commenters some manufacturers may have 
more than 1,500 suppliers for a given manufacturing process. 
As a result, tracking the source of supply, determining whether 
that source used a controlled substance, and determining whether 
that source's component was used in a specific final product, 
could be extremely difficult and prohibitively costly to implement.

As discussed below, the commenters also stated that manufacturers 
cannot use contract provisions to ensure accurate labeling for 
all their components. 
   The difficulties in tracking the use of controlled substances 
throughout the stream of commerce are illustrated by the case 
of a major electronics manufacturer. This firm purchases about 
70,000 component products from about 2,500 domestic and foreign 
suppliers. The company has phased out completely its use of 
class I substances in its own manufacturing processes, but because 
it buys from suppliers it must determine and track their use 
of class I substances. To do so, it has undertaken an outreach 
program to learn the extent to which class I substances are 
being used throughout its supply chain. The company contends, 
however, that surveys, letters, follow-up letters, data entry 
of the information received, data analysis and subsequent outreach 
to those vendors using class I substances are time-consuming 
and cannot assume the degree of certainty required by the approach 
outlined in the proposal.
   Tracking is made more difficult by the fact that many products, 
especially electronic products, are comprised of thousands of 
components that may come into contact with ozone-depleting
substances. 
Therefore, a manufacturer would have to label its products unless 
it has a reasonable belief that all of its component products 
in a final product were not manufactured with ozone-depleting 
substances. Moreover, as the proposed warning statement would 
have to list every controlled substance used by any manufacturer's 
suppliers, a manufacturer would have to have a reasonable belief 
regarding the uses of controlled substances by any of its
suppliers. 
The company discussed above learned that tracking by their
suppliers 
of their uses of class I substances was very poor overall. Of 
its 2,500 world-wide suppliers, only one was found to have an 
outreach program that targeted more than one level of suppliers. 
Therefore, it would be extremely difficult for this manufacturer 
to be reasonably confident that the products it purchases are 
free of ozone-depleting substances, because the vendors throughout 
its supply chain lack the necessary information about their 
own products, as well as the components that they purchase from 
their suppliers. In addition, regulations vary among countries 
and tracking of class I substance use abroad is poor. Thus, 
many commenters stated that it would be impossible to be reasonably

confident that a purchased product does not require a warning 
statement. According to commenters, this would lead to universal 
labeling of all final products in several industries, especially 
the electronics industry. Universal labeling, these commenters 
agreed, would not fulfill the intent of the law, since ultimate 
consumers would be unable to distinguish among any of these 
products on the basis of controlled substance use.
   While the proposed rule did not require a company to conduct 
independent investigations throughout its stream of commerce 
in order to form a reasonable belief, subsequent to the proposal, 
many manufacturers and their suppliers initiated such
investigations 
in order to be assured that their final products did not require 
the warning statement. Several commenters stated that a
manufacturer 
must perform investigations in order to satisfy the reasonable 
belief requirement that their suppliers are accurately labeling. 
They explained that EPA's suggestion that contract provisions 
be used to establish a reasonable belief was not practical. 
As discussed above, many products rely on numerous parts
manufactured 
by many suppliers and that revisions of all the contracts involved,

where they exist, would be an enormous undertaking. These
commenters 
indicated that many of the components incorporated into their 
products are purchased without contracts. Such products are 
either purchased "off the shelf" or from various suppliers at 
different times, depending on one's inventory and the market 
situation. These commenters stated that they cannot control 
the manufacturing processes of these products through contract 
specification provisions. Thus, aside from using independent 
investigations, manufacturers have no way of ensuring that
component 
manufacturers are not using ozone-depleting substances or are 
accurately labeling their products.
   Commenters further explain that the problem is further
exacerbated 
by the fact that many components are purchased with little lead 
time between purchase and incorporation into a new product. 
As a result, the packaging information for the final product, 
including any labeling information, is often completed before 
the components are purchased. Under such circumstances it is 
impossible for manufacturers to know whether to label the package. 
If EPA requires labeling of a product based on a component
manufacturer's 
use of ozone-depleting substances, then the manufacturer of 
the final product may have to expend significant costs to
restructure 
its packaging and labeling processes in order to account for 
incorporation of last minute information.
   It is evident to EPA that given the difficulty of tracking 
the use of controlled substances throughout the stream of commerce,

the "reasonable belief" provision as proposed was too vague 
to define or determine liability and was therefore unworkable.
   For products manufactured with controlled substances, EPA 
has given considerable thought to the concerns raised in the 
comments on passing labels through the stream of commerce. As 
a result, EPA is revising its definition of "manufactured with" 
to state that a product is "manufactured with" an ozone-depleting 
substance if the manufacturer of the product itself used an 
ozone-depleting substance in manufacturing that product. Thus, 
the inclusion of component products manufactured using controlled 
substances in the manufacture of another product, that does 
not otherwise involve the use of controlled substances does 
not constitute "manufacturing with an ozone-depleting substance." 
Each item manufactured and introduced into interstate commerce 
is considered a product, necessitating a label if manufactured 
with a controlled substance. The incorporation of that product 
into another, however, does not necessitate a label.
   EPA believes that the revision to the label pass-through 
requirement for products "manufactured with" ozone-depleting 
substances is consistent with the statute. EPA believes that 
the phrase "manufactured with a process that uses" an ozone-
depleting substance can reasonably be interpreted to refer only 
to the manufacturing process of the company that introduces 
the product into commerce and not also to the manufacturing 
of any component parts made by another company. Thus, a product 
"manufactured with a process that uses" an ozone-depleting
substance 
means only a product that was manufactured using such substances 
by the company that introduces the product into commerce (i.e., 
the manufacturer of the final product). To illustrate, a television

would be a product manufactured with a process using
ozone-depleting 
substances only if the manufacturer of the final product used 
such substances in its manufacturing process. Use of component 
parts made by a supplier using ozone-depleting substances would 
not constitute "manufacturing with a process" using those
substances. 
Thus, the television would have to be labeled only if that company 
that introduces it into commerce itself used ozone-depleting 
substances to make the television. The component parts, on the 
other hand, would be products "manufactured with a process using 
ozone-depleting substances" since their supplier made them using 
ozone-depleting substances in its manufacturing process. The 
labeling requirement would accordingly apply to the component 
parts, but the label would not have to be incorporated by the 
manufacturer of the final product.
   Section 611 does not define "products manufactured with a 
process that uses" ozone-depleting substances. EPA believes 
that the approach it implicitly took to the phrase in its proposed 
rule is consistent with, but not compelled by, the statute. 
As a conceptual matter, it would advance the purpose of the 
labeling provision to require that any product be labeled through 
the stream of commerce so long as any part of it, no matter 
how small a fraction of the whole, was made using ozone-depleting 
substances. However, to the extent that such a requirement proved 
unworkable and resulted in inaccurate information, it could 
actually undermine the integrity and thus the effectiveness 
of the labeling program.
   The purpose of the labeling provision is also served if the 
buyer of any product is made aware of whether the product's 
maker itself used ozone-depleting substances. Under the definition 
described above, wherever in the stream of commerce class I 
or class II substances are used, the buyer at the next point 
in the stream of commerce would be made aware of their use. 
While this approach would result in many labels reaching only 
other manufacturers, EPA believes that many manufacturers can 
be expected to have an incentive at least as great as that of 
downstream consumers to respond to the warning statement.
Manufacturers 
that rely on component parts made by other companies can ill 
afford to rely on suppliers to use alternative substances or 
find other suppliers that do. Thus, labels attached to products 
as defined above would promote the switch to substitutes that 
Congress sought to encourage through the labeling provision.
   While labeling products through the stream of commerce could 
add to the incentive effect of the program, EPA is persuaded 
by the comments summarized above that the proposed pass-through 
requirement is impracticable and would probably not result in 
accurate information reaching the retail consumers. The proposed 
"reasonable belief" standard for determining whether to label 
would also be difficult to enforce.
   In addition, the recent decision of the Protocol Parties 
to significantly accelerate the phaseout of the listed ozone-
depleting substances (a decision which EPA must implement under 
section 606(a)(3) of the CAA) reduces the importance of the 
labeling program. Congress enacted section 611 when class I 
substances were expected to be phased out by the year 2000. 
The labeling requirement thus provided an incentive for
manufacturers 
to move away from their use of such substances before 2000 in 
order to avoid the negative market reaction. With the acceleration 
of the phaseout to 1996 for most class I substances (and 1994 
for others), requiring products to be labeled is unlikely to 
significantly add to manufacturers' incentive to switch to
alternative 
substances.
   In light of the substantial burden and questionable
effectiveness 
of the proposed pass-through requirement, EPA is not requiring 
it in today's rule for products manufactured with controlled 
substances. The Agency is instead adopting the definition of 
"products manufactured using" ozone-depleting substances described 
above so that a manufacturer need only label its product if 
the manufacturer itself used ozone-depleting substances in
producing 
it.
   For the purpose of applying the definition described above, 
divisions of a company, wholly-owned subsidiaries and parent 
corporations are considered to be a single manufacturer. Therefore,

where one division of a company, for example, incorporates a 
component manufactured with an ozone-depleting substance and 
that component was manufactured by another division of the same 
company, the final product must contain a warning statement 
upon its introduction into interstate commerce, even where the 
product may be finished by other divisions without the use of 
ozone-depleting substances. If a manufacturing process of a 
product takes place in more than one facility, the label
information 
must accompany the product, but not necessarily in the form 
of a label. Upon the final point of manufacture, a label must 
then be applied. EPA believes that this will facilitate the 
labeling process and reduce the burden in the overall manufacturing

process of a product where the process involves more than one 
site of operation.
   EPA believes that the tracking problems associated with the 
pass-through requirement are to a great extent eliminated if 
manufacturers are only required to track the use of ozone-depleting

substances by the divisions within a subsidiary of the same 
company.
   In contrast to manufacturers that use a component manufactured 
with a controlled substance, the rule promulgated today prohibits 
distributors, wholesalers and retailers that receive a product 
with a label indicating that it was manufactured with a process 
that uses a controlled substance from removing the label. They 
must leave the label on a product they purchase or distribute, 
including products they re-package,{2} and are subject to
penalties. 
Since the purpose of the labeling program would obviously be 
frustrated if labels could be removed by downstream sellers, 
EPA is exercising its authority under section 301 of the CAA 
to establish the prohibitions described above.
      {2}  EPA considers the assembly of component products 
      퀃o be a manufacturing process only when the assembly 
      쿬reates an entirely new product. Manufacturers,
distributors, 
      퀇holesalers and retailers that simply repackage a
product 
      쿪nd/or do not substantially change it, are not
manufacturing 
      쿪 product and must pass the warning statement through 
      퀃he stream of commerce.
   Rules governing labeling by importers also differ from the 
general rules described above. Importers must have a "reasonable 
belief" that a "product manufactured" or "product containing" 
does not require a label at the time it enters the site of U.S. 
Customs clearance, or its introduction into interstate commerce. 
With no similar labeling requirements abroad, foreign manufacturers

will not likely impart the information required of domestic 
products without an inquiry made by the U.S. importer of record. 
It is therefore the responsibility of the importer to investigate 
at least one step back into the manufacturing process of the 
product to determine whether it is manufactured with a class 
I substance. An importer may use specifications in its contracts 
with its suppliers under which the suppliers are required to 
certify whether the product being exported to the United States 
was or was not manufactured using a controlled substance, in 
order to show that the importer has a reasonable belief that 
the product was not manufactured using controlled substances. 
Importers are not required to investigate whether a component 
incorporated into the product they are importing was manufactured 
with a class I substance. 
   a. Resin producers and the use of one label. One commenter, 
noting the difficulty and cost of determining which class I 
substances are used in the manufacturing process of a product, 
stated that resin producers who purchase one or more pigments 
manufactured with class I substances would have great difficulty 
in determining which and how many class I substances were used 
in the manufacturing process of the pigments. The commenter 
noted that several different labels for the same type of products 
would be required as a result. It suggested that EPA's final 
regulation enable resin producers to forego labeling since they 
do not use the class I substances themselves and would be unable 
to determine how many and which ones were used in the manufacturing

of the pigments. 
   Under the definition of product "manufactured with" being 
adopted today, EPA would not require resin producers to label 
if they, in fact, do not use a controlled substance in their 
manufacturing process. If they do use such substances, they 
would be required to label their products. The label would have 
to list substances used in the producer's own manufacturing 
process. One label listing the substances by their standard 
chemical names could be used instead of multiple labels for 
a single product. EPA believes that by dropping the pass-through 
requirement for products manufactured with controlled substances, 
it is addressing the issue of liability for all manufacturers 
concerned with products they purchase upstream. 

2. Incidental Uses 

   Many commenters supported EPA's determination in the proposed 
rulemaking that incidental uses of controlled substances should 
not trigger the labeling requirement. However, commenters argued 
that EPA's definition of incidental use was too narrow and should 
include "contact" incidental use as well. Some of the uses of 
controlled substances that commenters sought exemptions for 
as an "incidental use" were the following: use as reactive atoms 
that are not integral to the manufacturing process; use in making 
food packaging; use as incidental additives such as those found 
in the manufacturing of spices which are then added to other 
foods; use as cleaners of plates used to print product information 
and labels; use to clean reaction vessels in the manufacture 
of silicone products; use as degreasers in the production of 
industrial diamonds; and use as mold release agents used to 
prevent the adhesion of products to a mold. Other commenters 
recommended that EPA include "non-routine" and "unintentional 
physical contact" situations as incidental uses. 
   In the final rule, EPA expands incidental uses to include 
"contact" uses in which a class I or class II substance is used 
intermittently, on a non-routine basis, and not as an integral 
part of the manufacturing process of the product. Some examples 
would be an intermittent application of a controlled substance, 
such as methyl chloroform as a spot cleaner for textiles, or 
an occasional cleaning of an ink plate with a solvent as part 
of routine maintenance, as long as the use is not a part of 
the manufacturing process itself. Another example would be the 
infrequent performance of leak detection tests on a cooling 
system and condenser, using CFCs or substances containing CFCs. 
EPA believes that such incidental "contact" uses, though they 
potentially could involve a brief initial physical contact between 
the controlled substance and the product, occur so infrequently 
(e.g., typically as part of the maintenance process), that labeling

would not be appropriate. This exemption would also likely cover 
most situations where a physical contact occurred unintentionally. 
   In contrast, mold release agents that are applied on a regular 
and systematic basis in a manufacture process would not be
considered 
an incidental use of a class I substance. Further, the defluxing 
of printed circuit boards during a continuous production process 
would not be considered an incidental use. EPA also cannot exempt 
food processing applications in which a spice, for example, 
is manufactured with a controlled substance. However, where 
foods are prepared with such spices, such foods are not required 
to bear a label, based on the definition of a product "manufactured

with" discussed above. Again, products that incorporate other 
products which were manufactured with controlled substances 
are not required to pass through the label unless both sets 
of products were manufactured by the same company. 
   One commenter argued that plasma etching in the manufacturing 
process of semiconductors is an incidental use of controlled 
substances. (Plasma etching uses controlled substances in a 
sealed chamber in which radio frequency energy is applied to 
excite the chemicals and break them down to create an "ion-plasma."

The plasma is used to etch certain parts of a silicon wafer 
upon which semiconductors are created.) The manufacturer states 
that the use of a controlled substance to supply ions to the 
plasma is terminated once the chemicals are "broken down" in 
the sealed chamber. Another commenter indicated that a direct 
contact use that is closed-loop (the controlled substance is 
not emitted and/or destroyed) or employs recovery and recycling 
systems should be considered an incidental use. Finally, another 
commented that use of methyl chloroform as a solvent carrier 
which eventually evaporates (except for trace quantities) should 
be considered as an incidental use. 
   EPA does not consider the use of controlled substances in 
the process of plasma etching an incidental use since the
controlled 
substances are integral to that process. However, as plasma 
etching falls under the transformation exemption discussed below, 
products involving this use would be exempt from the labeling 
requirements. The use of closed-loop or recovery and recycling 
systems as part of a process does not qualify that use as an 
incidental use. Finally, a process in which methyl chloroform 
serves as a solvent carrier cannot be considered incidental. 
The evaporated methyl chloroform could be emitted into the
atmosphere, 
thus contributing to the destruction of the ozone layer. 

3. Transformation 

   In the Notice of Proposed Rulemaking, EPA proposed exempting 
products that are manufactured with a process using a controlled 
substance in which that substance is not emitted but instead 
transformed (i.e., completely consumed into a non-ozone-depleting 
substance during the manufacturing process) and therefore no 
longer poses a threat to the ozone layer. EPA reasoned that 
since Congress exempted transformed controlled substances from 
the definition of production for purposes of the phaseout
provisions, 
it would not have intended to require labels on products
manufactured 
using a process that transforms controlled substances. Under 
the statute definition of production, after all, transformed 
controlled substances are treated as though they never existed. 
The definition of transformation, for purposes of section 611, 
was proposed to be "to use and entirely consume a controlled 
substance by changing it into one or more substances that are 
not subject to this subpart in the manufacturing process of 
a product or chemical" (57 FR 19166, 19198). 
   Several comments addressed the need for a clearer definition 
of transformation, especially one that took into account of 
the physical law that chemical reactions are never 100% efficient 
and thus leave "trace quantities" of controlled unreacted
substances. 
One commenter requested that EPA exempt certain transformation 
processes, such as plasma etching (described above) from the 
labeling requirement. 
   EPA has promulgated regulations for the phaseout of production 
and consumption of class I substances by 2000 (57 FR 33754, 
July 30, 1992). Those regulations define, transformation as 
"to use and entirely consume (except for trace quantities) a 
controlled substance in the manufacture of other chemicals for 
commercial purposes." That definition reflects that transformation 
results in "trace quantities." Today, EPA adopts that definition 
for the labeling rule. The trace quantities exception acknowledges 
that transformation unavoidably leaves insignificant amounts 
of controlled substances that are not intended for commercial 
use. Plasma etching is considered a process that entails
transformation, 
and thus products manufactured using plasma etching need not 
be labeled, unless they are otherwise subject to the regulations. 
   Several commenters urged that methyl chloroform (MCF) used 
as a source of chlorine molecules in an oxidation process of 
semiconductor manufacturing should be considered to be transformed 
during such manufacture, because the MCF breaks down to provide 
a source of chlorine and therefore does not contribute to ozone 
depletion. One large manufacturer indicated that at high
temperatures 
and where there is an excess of oxygen, no MCF will remain or 
be emitted. If in the oxidation process of semiconductor
manufacturing, 
MCF is transformed, except for trace quantities, EPA would not 
require that resulting product to be labeled. 
   One commenter suggested that a process in which a class I 
substance has been generated as a coincidental, unavoidable 
by-product (CUBP) be considered transformed and consequently 
exempted from the requirement{3}. EPA agrees that use of such 
a process should not require the resulting product to be labeled, 
but for different reasons than the comments give. CUBP does 
not entail the use of a controlled substance, rather it involves 
the unavoidable production of such a substance. Since a process 
that results in CUBP does not use controlled substances, it 
does not fall under the definition of "manufactured with a process 
using" ozone-depleting substances for purposes of triggering 
the labeling requirements. Since CUBP is unavoidable, moreover, 
little purpose would be served by requiring manufacturers using 
such a process to label their products. EPA therefore finds 
that the labeling requirements do not apply to products
manufactured 
using a process EPA has determined meets the CUBP exemptions 
criteria under the regulations implementing section 604 (57 
FR 33754-33765, July 30, 1992). Additionally, EPA addresses 
trace quantities of unintended residues or impurities below 
in section D.3. 
      {3}  A CUBP is a coincidental unavoidable by-product 
      쿽f a manufacturing process that is immediately
contained 
      쿪nd destroyed by the producer, using a maximum
available 
      쿬ontrol technology with a destruction efficiency of
99.99%. 
   It is important to note that the destruction of a controlled 
substance in a manufacturing process other than the process 
in which the product itself is manufactured is not regarded 
as transformation. For example, if in a production process a 
company uses a controlled substance and then removes it from 
the process for incineration in a separate destruction process 
within the same facility, that substance is not transformed; 
it is destroyed. Even though the destruction of the substance 
will prevent the risk of release into the stratosphere, it is 
not transformation and will not be dealt as such for the purposes 
of this rule. 

4. Destruction 

   At the Fourth Meeting of the Parties to the Montreal Protocol 
(the Parties), which took place November 23-25, 1992 in Copenhagen,

the Parties approved five destruction technologies to be used 
for destroying class I substances. Under the existing Protocol, 
"production" of controlled substances is defined as "the amount 
of controlled substances produced, minus the amount destroyed 
by technologies to be approved by the Parties." These approved 
five destruction technologies (liquid injection incineration, 
reactor cracking, gaseous/fume oxidation, rotary kiln incinerators,

and cement kilns), enable the Parties to subtract from the
definition 
of production that amount of ozone-depleting substance(s) which 
is destroyed by these means. EPA is currently revising its draft 
proposal of the regulation accelerating the phaseout of class 
I and class II substances to address this issue among others 
raised in Copenhagen. 
   EPA seeks comment on whether it could and should provide 
an exemption from the labeling requirements for the use of
controlled 
substances that are destroyed using one of the above-mentioned 
approved technologies. The destruction technology procedures 
would have to be consistent with regulations under the Resource 
Conservation and Recovery Act and other applicable acts, and 
meet, at a minimum, standards set forth in Table 5-1 of the 
United Nations Environmental Programme (UNEP) report entitled, 
Ad-Hoc Technical Advisory Committee on ODS Destruction
Technologies, 
and the code of Good Housekeeping Procedures for destruction 
setforth in section 5.5 of the UNEP Report. Destruction
technologies 
would also have to be operated, at a minimum, in accordance 
with the UNEP report.
   Since the ultimate goal of Title VI is to minimize depletion 
of stratospheric ozone, such an exemption that would recognize, 
and provide an incentive for, the elimination of emissions of 
controlled substances through the use of approved destruction 
technologies is one method of reducing risks of ozone depletion. 

5. Use Reduction Exemption for CFC-113 and Methyl Chloroform 
Used as Solvents 

   In the proposed rulemaking, EPA did not propose excluding 
a "de minimis level" of use of a controlled substance from its 
definition of products "manufactured using," but requested comments

on how a "de minimis" exemption could be implemented. EPA's 
rationale against such an exemption was that though an individual 
use of a controlled substance may be small, such uses in the 
aggregate over an entire use sector could pose a significant 
threat to the ozone in the upper atmosphere. 
   EPA received many comments regarding the Agency's decision 
not to propose a "de minimis" level, particularly in the case 
of products manufactured with class I substances. One commenter 
stated that EPA's proposed determination that aggregate use 
levels over an entire market segment can be large and thus pose 
a threat to the ozone layer should not preclude granting exemptions

from the labeling requirement in cases where a company can show 
that its use of a class I substance is nonetheless de minimis. 
Many commenters provided options for an aggregate "de minimis" 
level. Some suggested that where a firm has achieved a 90% to 
95% reduction in the use of class I substances from a specified 
baseline level, that EPA should find that manufacturer's remaining 
uses of class I substances to be "de minimis." Other commenters 
suggested defining a de minimis level as a specified amount 
of a class I substance that could be used per product on an 
annual basis. However, in evaluating this particular approach, 
the Agency has concluded that it cannot possibly investigate 
use of class I substances in the manufacture of all individual 
products. 
   Some commenters suggested a de minimis exemption for specific 
applications using "small quantities" of class I substances, 
including degreasers for steel products. Another proposal was 
simply to set a de minimis level for carbon tetrachloride (CCL4) 
at 0.1% by weight, or 1,000 ppm in a final product. 
   EPA does not find any of the proposals suggested above to 
be practical or lawful. However, EPA does recognize that
manufacturers 
who are attempting to eliminate the use of ozone-depleting
substances 
may be unable at this time to completely eliminate such use, 
because potential substitutes may not be available for all uses. 
The Clean Air Act provides exemptions from the labeling requirement

for products manufactured with class I substances, if the
"Administrator 
determines that there are no substitute products or manufacturing 
processes that: (a) Do not rely on the use of such class I
substance, 
(b) reduce the overall risk to human health and the environment, 
and (c) are currently or potentially available." Given the wide 
range of uses of class I substances, EPA will not be able to 
assess the availability of substitutes for all substances and 
uses in all manufacturing processes in the short amount of time 
before the labeling regulation takes effect. The petition process, 
discussed in section V.P below, accommodates requests for specific 
exemptions, but exclusive reliance on this process would be 
administratively impractical in view of the relevant timeframe 
and EPA's limited resources. 
   The United Nations Environment Programme (UNEP) "Report of 
the Solvents, Coatings and Adhesives Technical Options
Subcommittee, 
1991 Assessment," states that potential substitutes other than 
HCFCs may not be available for approximately 2% to 8% of the 
current uses of class I substances as solvents in the solvent-
cleaning, adhesives, coatings and inks end-use sectors across 
industry{4}. The class I substances used in these solvent sectors 
are CFC-113 and methyl chloroform (MCF). The specific HCFC
alternatives 
are problematic because they are either relatively high in ozone 
depletion potential, less technologically feasible for the specific

uses required, or not economically viable for many of these 
uses. EPA believes that those products "manufactured with" the 
uses of CFC-113 and MCF for which no long term adequate substitutes

currently appear to be technologically or economically feasible 
would be eligible for the exemption described above. While the 
statute conditions the availability on a determination of a 
potentially available substitute, EPA notes that it must base 
its determination on currently available evidence. If current 
evidence indicates that potential substitutes are not
technologically 
and economically feasible, EPA believes it should make the required

determination and provide an exemption. 
      {4}  In contrast, the UNEP reports covering other end-
      퀅se sectors, such as refrigerated appliances, halon
extinguishers, 
      쿪ir conditioners and foams, do not indicate a similar 
      쿭ifficulty in finding long-term substitutes. 
   However, it is administratively impossible for EPA to identify 
and describe all uses or types of uses of CFC-113 and MCF in 
the solvent-cleaning, adhesives and coatings sector which may 
warrant an exemption. The UNEP report speaks to broad applications 
of CFC-113 and MCF in the solvent sector and does not attempt 
to identify the specific uses for which there are no
technologically, 
environmentally and economically viable alternatives. Although 
it is possible to describe certain applications where it has 
been difficult to find substitutes, a comprehensive list of 
such applications would be extremely difficult to compile due 
to the many diverse and specialized uses for these ozone-depleting 
solvents. 
   One gains a better understanding of the difficulty of listing 
all the applications for CFC-113 and methyl chloroform by comparing

some of their solvent uses to uses of CFCs as refrigerants. 
In refrigeration, an application is defined by the refrigerant 
(e.g., CFC-11 or CFC-12) and the equipment (e.g., centrifugal 
building chiller or household refrigerator). In contrast, solvent 
use itself is broken down into multiple use categories ranging 
from large uses such as solvent cleaning or aerosols to much 
smaller uses such as lubricant carriers or book preservation. 
Each of these use categories is then further defined by a variety 
of factors. Use of solvents as cleaning agents alone is defined 
by: 
-Equipment-Cleaning equipment can vary in size and throughput 
  capacity from a vapor degreasing system designed to clean 
  airplane wings to a small spray can used for cleaning electrical 
  locks 
-Chemical-CFC-113 or methyl chloroform 
-Geometry of the part-Part configurations range from
high-performance 
  instrumentation such as accelerometers and medical pacemakers 
  to parts as simple as nuts and bolts 
-Substrate-Parts can be made from materials varying from basic 
  carbon steel to magnesium to ceramic to plastics for contact 
  lenses 
-Cleanliness-Even for the same part, cleanliness standards vary 
  greatly so that, for instance, a transmitter in a fighter 
  aircraft is cleaned to a different standard than one in a 
  child's walkie-talkie.
   These parameters turn the listing of substitutes for each 
application into a complex undertaking. If one of the variables 
changes even slightly, the substitute must change, too. For 
example, gyroscopes (instruments designed to detect movement) 
with silicon fill fluids are cleaned with different substitutes 
than those filled with fluorinated compounds. 
   Generating a list of all solvent applications for which
substitution 
is difficult would involve splitting out innumerable
sub-applications 
within the solvent use sector. While the Agency is aware that 
certain applications may have few satisfactory substitutes, 
it cannot in the time available compile a comprehensive list 
of solvent uses of CFC-113 and MCF for which no potential
substitutions 
exist; nor can the Agency make such a determination for individual 
solvent uses without the data that it expects to receive under 
the petition process. 
   Under these circumstances, EPA believes that manufacturers 
who use CFC-113 or MCF as solvents should not be required to 
label their products where such manufacturers have made good 
faith efforts to eliminate their uses of such substances, but 
have been unable to completely eliminate them due to the remaining 
small uses for which substitution is particularly difficult. 
The Agency believes that it is therefore appropriate to exempt 
products "manufactured with" CFC-113 or MCF from the labeling 
provisions where the products' manufacturer can show that it 
has reduced its use to that percentage for which the UNEP report 
estimates substitutes are not available. Therefore, taking the 
mid-point of the UNEP estimate, or 5%, EPA believes that it 
is appropriate and consistent with the provisions of section 
611(d)(2) to exempt a company from the labeling requirements 
if the company is able to prove that it has reduced its use 
of CFC-113 and MCF as solvents to 5% of its 1990 use. 
   This exemption applies only to products "manufactured with" 
CFC-113 and MCF used as solvents. The uses of these and other 
class I substances in products containing or in containers of 
such substances would not be covered by this provision. These 
categories constitute a much more limited number of applications 
and therefore do not entail the administrative burdens of
evaluating 
the availability of substitutes across a wide array of small 
uses. 
   By allowing this exemption, EPA recognizes that where a company 
has reduced its use of CFC-113 and MCF as solvents for its products

by 95% or greater since 1990, the remaining use of such substances 
is likely due to the lack of technologically and economically 
feasible long-term substitutes for such use as discussed in 
the 1991 UNEP Report. EPA is using 1990 as a baseline because 
it is the first full year of control on CFCs under the Montreal 
Protocol and the year in which the Clean Air Act Amendments 
were enacted. As a result, many companies began maintaining 
adequate records on their overall use levels of these compounds 
at that time. 
   EPA recognizes that this approach cannot exactly duplicate 
the usage results that would have occurred had EPA been able 
to make individual determinations as to which uses had no currently

or potentially available alternatives and thus which specific 
uses should be exempt. This exemption may benefit certain
manufacturers 
that would not have otherwise been able to take advantage of 
an exemption, and may not adequately cover those manufacturers 
who still require greater than 5% of their 1990 use for
applications 
where there are no potentially available substitutes. These 
manufacturers can, however, still use the petition process to 
request an exemption for such uses. Nevertheless, EPA believes 
that given the extreme administrative difficulty of evaluating 
exemption requests for the many small uses of CFC-113 and MCF 
as solvents, and the likelihood that remaining solvent uses 
will require further research and development before satisfactory 
substitutes can be brought to market, its approach is an
appropriate 
and workable surrogate. Such a provision will allow companies 
to focus their efforts on the search for substitutes, rather 
than face the burden of documenting their use and of petitioning 
EPA for such exemptions. 
   EPA believes that this approach will also encourage early 
reductions of class I substances by users seeking to reach the 
95% level to avoid the labeling requirement. Such reductions 
could lead to significant early environmental benefits which 
would outweigh any environmental damage that may result from 
providing an exemption for products manufactured with the remaining

5%, for the limited period prior to the January 1, 1996 production 
phaseout. EPA believes that without this use reduction exemption, 
in some instances manufacturers would have less of an incentive 
to reduce their use of CFC-113 and MCF as solvents prior to 
the required production phaseout. Without this exemption, if 
a product is manufactured using any amount of CFC-113 or MCF 
as a solvent, it would have to be labeled. If the manufacturer 
is required to label its product because of a single remaining 
use in its manufacturing process, it would be less likely to 
reduce any other uses of CFC-113 or MCF because the product 
would still require a warning statement. However, if a manufacturer

can avoid the labeling requirement by reducing its use by 95%, 
the manufacturer will be more likely to make such a reduction 
in order to avoid the labeling requirements. 
   To utilize this reduced use exemption, a company must certify 
in writing to EPA that it (including its divisions, branches 
or facilities) has achieved a reduction in its total use of 
CFC-113 and MCF as solvents by 95% or greater from its calendar 
year 1990 use of such substances as solvents. The company must 
show that it has reduced its use from its 1990 levels by 95% 
during a twelve-month period which can be calculated either 
as the twelve-month period ending within sixty (60) days of 
the date the certification was received, or as the most recent 
calendar year. 
   The Agency is limiting this exemption to those companies 
that can certify their reduction by May 15, 1994 in order to 
encourage early reductions of such substances. There would be 
negligible environmental benefit to allowing certification beyond 
May 15, 1994, given the January 1996 phaseout date. Companies 
unable to meet this deadline may still petition EPA for an
individual 
exemption, although the petition process is likely to be time-
consuming. Once a company has received an exemption from labeling, 
the exemption from labeling is assured beyond May 15, 1994; 
however, if at any time a company increases its use of CFC-113 
or MCF as solvents such that its use is greater over a twelve-
month period than 5% of its 1990 usage, it must notify the EPA 
within thirty (30) days and must begin labeling. 
   In calculating the baseline, a company may subtract from 
both the baseline and total use calculations uses of CFC-113 
or MCF where the chemicals were transformed, because such uses 
are themselves the basis for an exemption (described above). 
If purchase orders of MCF or CFC-113 are used as the basis for 
calculating the baseline or reduction levels, adjustments for 
changes in inventories must be made to reflect actual use. 
   Records (or legible copies) supporting a company's assertion 
that it has reduced its use must be maintained at a single facility

within the company. The certification to EPA must specify the 
facility where the records supporting a company's reduction 
are located. The certification must include a description of 
the records (purchase orders, inventoried stock records) maintained

at that location, and the type of system used to track company-
wide use. All certifications must provide the name of a contact 
person, address and telephone number for that contact person. 
Certifications should be sent to the Labeling Program Manager, 
Stratospheric Protection Division, Office of Atmospheric Programs, 
U.S. Environmental Protection Agency, 6202-J, 401 M Street, 
SW., Washington, DC 20460. One copy should be submitted to the 
Agency and one must be retained by the company. 
   During a field inspection, EPA may require verification of 
a company's use in 1990 of CFC-113 and MCF as solvents that 
year and of its 95% reduced use during a subsequent twelve month 
period. A company must therefore make the appropriate adjustments 
to its records to account for the use of inventoried CFC-113 
and MCF solvents in 1990 and in the subsequent twelve month 
period showing the 95% reduced use. If a company subtracts use 
associated with transformation in its formulation, data showing 
a clear association of quantities of use with provable
transformation 
must also be accessible with the above records upon request 
by EPA. 
   The Agency understands that many companies have available 
the information outlined above for tracking company-wide use 
of CFC-113 and MCF, as well as its use of other class I substances.

The pending acceleration of the phaseout and the Clean Air Act 
regulations have prompted many companies to track their uses 
of class I substances in their efforts to comply and to anticipate 
elimination of the substances. Other companies may have to upgrade 
their tracking systems in order to utilize the reduced use
exemption 
provision. 
   Companies seeking to qualify for this exemption by the time 
the labeling regulations take effect on May 15, 1993, must certify 
to EPA by May 15, 1993 that they have met the reduction
requirements 
outlined above, in order for the Agency to review such
certifications. 
Companies seeking to qualify for this exemption following the 
effective date of the labeling requirement must certify to EPA 
their total reduced use of CFC-113 and MCF as solvents for a 
twelve month period ending within sixty (60) days of the date 
the certification was received, or the last calendar year. A 
company may then cease to label its products fourteen (14) days 
following the Agency's receipt of the certification. If a company 
decides not to label its products manufactured with CFC-113 
or MCF based on this reduced use exemption, the burden of proof 
is on the company to show, upon request by EPA, adequate data 
outlined above demonstrating that it is legally eligible to 
use this provision. 

D. "Products Containing" and "Containers Containing" 


1. Distinction Between "Products Containing" and "Containers 
Containing" and Label Requirement 

   In the proposed rule, EPA defined containers of class I or 
class II substances as "the immediate vessel of any size in 
which that substance is stored or transported." EPA further 
stated that this definition included cans, drums, trucks and 
isotanks of class I or class II substances alone or in mixtures" 
(57 FR 19166-19167). 
   One commenter inquired whether containers such as degreasing 
units or large empty tanks, which may be used to hold such
substances, 
should be labeled at the time of manufacture. Another commenter 
stated that confusion existed between when a product was a
controlled 
substance contained in a container and when it was a product 
containing a controlled substance. 
   To further clarify the distinction between a controlled
substance 
in a container and a product containing a controlled substance, 
EPA is incorporating in its final rule today a further elaboration 
of what would be covered by the requirement to label containers 
of class I or class II substances. This clarification is drawn 
from EPA's existing definition of bulk controlled substance 
in its current phaseout regulations (July 30, 1992, 57 FR 33754, 
33788). This definition states that, "If a listed substance 
or mixture must first be transferred from a bulk container to 
another container, vessel, or piece of equipment in order to 
realize the intended use, the listed substances or mixture is 
a controlled substance." 
   Drawing from this definition of what constitutes a "bulk" 
controlled substance, EPA is revising the definition of "container 
containing" for section 611 to limit the phrase to containers 
holding a controlled substance: "If a class I or class II substance

that is intended to be transferred to another container, vessel 
or piece of equipment in order to realize its intended use. 
If the controlled substance is used in a container, vessel or 
piece of equipment without being transferred, then that container 
would be deemed a "product containing" and would be labeled 
accordingly. 
   For example, CFCs in a small can sold to recharge refrigeration 
equipment would be used only after being transferred to an air 
conditioning system. The can would thus be labeled as a "container 
containing." A large tank of halon attached to a total flooding 
fire protection system on the other hand, would be labeled as 
a "product containing," because the halon is used directly from 
the tank itself. 
   In the case of a tank holding a solvent which is used as 
degreasing equipment, the equipment itself is typically sold 
without the controlled substance and therefore would not qualify 
as either a container or a product containing for purposes of 
this rule. This would hold true even though, at a later point 
in time, a class I or class II substance was contained in the 
tank during the use of this equipment. Thus, for equipment from 
which a controlled substance is used without being transferred, 
the applicable criteria is whether the equipment contains the 
controlled substance at the time of sale. It would not be logical 
to require labeling after the point of sale when consumer decisions

are made. At the same time, to require labeling of all products 
that could be "used with" a controlled substance would be overly 
broad and discourage the sale of equipment that could be used 
with either a controlled substance or an alternative. However, 
for containers containing controlled substances, the container 
must be labeled whenever it contains a controlled substance, 
whether or not it contained a controlled substance at the time 
it was originally purchased. 

2. Label Pass-Through Requirement for "Products Containing" 
and "Containers Containing" 

   As discussed in section V.C. above, if a component product 
that was "manufactured with" a controlled substance is incorporated

into another product, these regulations do not require the
manufacturer 
of the final product to pass the labeling information accompanying 
the component product through the stream of commerce. However, 
EPA is requiring that a warning statement for products and
containers 
containing controlled substances be passed through the stream 
of commerce. There are several significant distinctions between 
"products and containers containing" and "products manufactured 
with" that indicate that the pass-through requirement should 
be retained for "products and containers containing." First, 
whereas a manufacturing process can be reasonably defined as 
not including the manufacture of components, the term "product 
containing" cannot be read to exclude components that are
themselves 
contained within the structure of the product. If a component 
part contains controlled substances, the final product still 
contains the controlled substance at the point of sale. 
   Moreover, unlike products manufactured with controlled
substances, 
it is much less onerous for a manufacturer to determine whether 
or not a product or container purchased from a supplier contains 
an ozone-depleting substance since the substance is held within 
the product's physical structure. Also, because the controlled 
substance is held within a product or container's structure, 
the release of the controlled substance into the atmosphere 
has not yet occurred. The consumer will generally release the 
substance through the use of the product, since the substance 
is likely an active ingredient of the product itself or a
propellant. 
Informed by a label that indicates the controlled substances' 
effect on the ozone layer, the consumer may, in many cases where 
possible, take precautions to minimize or avoid the release 
of the substance into the environment. A manufacturer that
purchases 
products without a label must have a reasonable belief that 
the product does not in fact contain a controlled substance 
before incorporating it into its final product. Manufacturers 
must also have a reasonable belief that a "container containing" 
is accurately labeled. Finally, importers must have a reasonable 
belief that information about "products containing" or "containers 
containing" is accurate, as the importer is required to ensure 
proper labeling at the site of U.S. Customs clearance. 

3. Containers of Recaptured Substances and Waste

   One commenter suggested that EPA should not require a label 
on containers for storing and transporting recaptured class 
I and class II substances, since such containers are reused 
and may contain a number of different substances at different 
times. In addition, the commenter stated that a label on such 
containers has no legitimate role in that it does not assist 
consumers in making purchase decisions. 
   EPA disagrees with this comment; a person handling such
containers 
would benefit from the specific chemical information on the 
label and the label would, in such case, act as a precaution 
for handling procedures. Though the label does not specifically 
address handling practices of such substances, it would inform 
those handling these containers of the chemicals contained in 
them and would encourage them to dispose of them or recycle 
them correctly. 
   Another commenter indicated that containers of class I or 
class II substance waste or waste containing trace amounts of 
such substances, intended for incineration, should not require 
a label since the substances will be destroyed. EPA believes 
that such containers require a label, since the waste contains 
a class I or class II substance which will require handling 
and proper precautions prior to its incineration, and since 
the waste enters into interstate commerce. Further, EPA believes 
that containers of class I or class II substances to be recycled 
or reclaimed must bear the warning statement, to ensure that 
the technician of a reclamation facility is aware of the substances

contained in order to exercise the proper caution. Reclaimed 
substances are also resold by the reclaimer, and thus should 
be labeled upon introduction into interstate commerce. 
   Some commenters suggested that containers that once contained 
an ozone-depleting substance but are later recycled through 
melt down or scrapping and incorporated into another product, 
should not require a label. EPA agrees that if the new product 
no longer contains a class I or class II substance, it does 
not require a label. 
   One commenter argued that for containers in which military 
products "manufactured with" or "containing" class I or class 
II substances are transported and then returned empty to the 
originator, the label should be permitted to be "covered" by 
the originator of the products so that the container may be 
reused for other purposes. EPA accepts that at the point of 
their return, as long as the containers are emptied of their 
contents of the class I or class II substances, the label may 
be covered or removed. If such container subsequently is charged 
with a class I or class II substance, a label would be required 
at that time. EPA also would not require that a container or 
vessel for transport of a "product containing" or "container 
containing" be labeled; only the immediate container that holds 
the ozone-depleting substance must be labeled. 

4. Trace Quantities of Unintended Residues or Impurities 

   One commenter raised the issue whether any chlorination process 
in which carbon tetrachloride (CCL4) is inadvertently produced 
would require a label under the proposed rulemaking, including 
such processes as the chlorination of drinking water. The comment 
is based on the fact that EPA made no exception in the proposed 
rulemaking for products containing unintended residual amounts 
of trace quantities of a controlled substance. Such trace
quantities 
are not introduced intentionally into the manufacturing process; 
they are the result of a chemical reaction by which impurities 
are produced and retained in the final product. They may also 
be the remainder of a controlled substance that has been added 
and then removed, either, for example, as a solvent or explosion 
suppressant. Another commenter offered the example of the
production 
of chlorine. Water and brine are combined in the process in 
which the hydrocarbons contained in the water are chlorinated 
during the chlorine production process. As a result, trace
quantities 
of CCL4 are created. Most of these trace quantities remain in 
the chlorine, which is then used in the production of other 
products. 
   Upon reviewing numerous comments on this issue and discussions 
with various segments of industry, EPA has determined that products

with trace quantities of unintended residues or impurities
resulting 
from a chemical reaction in its manufacturing process, are exempt 
from coverage under this rule. In these cases, the residual 
controlled substance is neither intended nor serves a function 
in the final product itself, and therefore EPA does not consider 
the product to be a product "containing" a class I substance. 
Therefore, the product falls outside these labeling requirements 
for "products containing." 
   This position is further supported by the recent Fourth Meeting 
of the Montreal Protocol Parties in Copenhagen. The Parties 
approved a decision stating that insignificant quantities of 
controlled substances derived from inadvertent production in 
a manufacturing process or from an unreacted feedstock, or used 
as a process agent, such as an explosion suppressant, which 
is present in a substance as trace residues or impurities, may 
be excluded from the definition of "controlled substance" under 
the Protocol. EPA will soon be proposing to modify its regulations 
for the phaseout of class I and class II substances to reflect 
this clarification of the definition of controlled substances. 
   In the 2000 phaseout rule implementing section 604 (57 FR 
33754), the Agency determined that where CCL4 of a controlled 
substance is produced as a coincidental unintended by-product 
(CUBP) of a manufacturing process and then immediately contained 
or destroyed, that process need not be considered "product" 
of a controlled substance. The Agency exempted CUBP production 
of controlled substances listed in Groups IV and V from the 
production restrictions. Because the Protocol's proposed change 
to the definition of controlled substance adopted in Copenhagen 
encompasses situations also covered by the CUBP, EPA will soon 
be proposing to eliminate this provision from its existing
regulations. 
The adoption of the Protocol's recent interpretation of controlled 
substance further supports the exemption from the labeling
requirements 
outlined in the trace quantities exemption in the paragraph 
above. Those products containing insignificant quantities, or 
trace quantities, of controlled substances present as unreacted 
feedstock, from incidental or inadvertent production, or used 
as a process agent, are exempted from the labeling provision. 
   Despite some comments on exemption of specific uses of CCL4, 
the Agency believes that a product containing a controlled
substance 
cannot be exempt from the labeling rule where the controlled 
substance is essential to the manufacture of that product, such 
as with CCL4 as an explosion prevention measure in the manufacture 
of chlorine. Where such substance is intentionally introduced 
to the manufacturing process, it is not inadvertent and
uncontrollable. 
Only those trace quantities associated with the inadvertent 
production or unintended residues are exempted from today's 
rule. However, the use of CCL4 as an explosion prevention measure 
does not result in the product "containing" the controlled
substance, 
rather it is considered by EPA to be a product "manufactured 
with" a controlled substance and would require a warning statement.

Furthermore, evaporation of a controlled substance is an emission 
and cannot therefore be exempt from the requirement. 

E. Use of Controlled Substances for Repairs and Used Products

   In the proposed rulemaking, EPA did not discuss the use of 
class I substances in the repair of products or in the reuse 
of products. Comments regarding these uses indicated that class 
I substances may be used as solvents in the repair of a product. 
EPA believes that a product undergoing repair is not being
introduced 
into interstate commerce. The ultimate consumer already owns 
the product and therefore, the warning statement is unwarranted. 
   In a similar manner, products that are resold for reuse are 
products that have already been introduced into interstate
commerce. 
Subsequent use or sale is not covered by today's rulemaking 
(except for the prohibition on the removal of labels by
distributors, 
wholesalers and retailers, discussed earlier) and therefore 
the labeling requirements do not apply. In contrast, products 
"manufactured with" or "containing" controlled substances that 
are used by service technicians for repair or recycling purposes 
should be labeled according to the label requirements applicable 
to their manufacture. Such products or containers may be
manufactured 
solely for use in repair or recycling applications, but are 
required to be labeled pursuant to section 611. 
   However, EPA believes that recycled or reclaimed products 
containing controlled substances, such as some solvent-cleaning 
and adhesive products, are introduced into interstate commerce 
as new products when they are recycled or reclaimed. Such products 
must be labeled accordingly. On the other hand, EPA is aware 
that some recycled products, such as packaging materials or 
chemicals may inadvertently come into physical contact with 
a controlled substance in which it is possible for trace quantities

to remain in the products themselves. Consistent with the exemption

in today's final rule for unintended trace quantities of residues 
or impurities, EPA does not require such products where the 
manufacturers are not intentionally introducing a controlled 
substance into a recycling or reclamation process to be labeled. 

F. Label Placement and Alternative Labeling Options 


1. Label Placement 

   a. Clearly legible and conspicuous. In the Notice of Proposed 
Rulemaking, EPA proposed to require that the warning statement 
be placed on any display panel on the product's surface or
packaging 
where the label will be "clearly legible and conspicuous." EPA 
did not propose that the label appear on a product's principle 
display panel (PDP), though EPA did request comments regarding 
whether such a requirement would be appropriate. EPA also proposed 
to allow alternative placement of the warning label (for example, 
on hang tags, cards, or stickers) where placement on a display 
panel is not feasible. One commenter supported EPA's proposed 
use of hang tags, cards or stickers as alternative labeling 
options. Two commenters stated that the warning statement should 
appear on the product's display panel when available and, in 
particular, on the PDP, where one exists, because the PDP is 
conspicuous to the ultimate consumer. One of these commenters 
indicated that this approach would promote equality among companies

in label placement and would satisfy the requirement that the 
label be "clearly legible and conspicuous." In contrast, several 
commenters indicated that the Congress did not mandate that 
the label be applied to the product's PDP and that EPA should 
therefore not specify the meaning of "clearly legible and
conspicuous" 
in terms of prescribed label placement. Another commenter contended

that the back and side panels of a container or product could 
satisfy the requirement. One commenter requested clarification 
on what EPA meant by its suggestion that the label be placed 
where "normally" viewed by the consumer, as opposed to where 
the label is "easily or readily viewed." 
   After considering the comments received on label placement, 
EPA has decided that the warning statement may appear on a display 
panel other than the PDP as long as that label can be readily 
seen and understood by the consumer at the time of purchase. 
Although requiring all labels to appear on the PDP would promote 
uniformity among manufacturers' labeling practices, uniformity 
would come at the expense of the manufacturers' flexibility. 
In view of the broad diversity of products, potentially affected 
by the labeling requirements, EPA believes manufacturers will 
need some latitude as to where to place the labels. If a
manufacturer 
includes the warning statement on a product's PDP, this would 
satisfy the requirement that the label be "clearly legible and 
conspicuous," but placement in this manner is not required. 
The label may be placed on any display panel as long as it is 
conspicuous and clearly legible. A display panel may include 
any side of a product, package or container, excluding any location

where the warning label would not be "conspicuous and clearly 
legible." A display panel may include the bottom side of a product 
package or container where the bottom side is normally used 
to convey consumer information and is likely to be viewed by 
the consumer at the time of purchase. For example, a label on 
the bottom of a refrigerator or its shipping carton would not 
be readily available to the ultimate consumer; however, a label 
on the bottom of a portable radio would be appropriately placed 
because a purchaser is likely to examine the whole product prior 
to buying the product and additional information regarding the 
radio telephone would normally be found on its underside. Products 
that are sold in containers should be labeled directly on the 
container or display, rather than on the product itself, such 
as an electronic game. Finally, EPA is also permitting a number 
of alternative labeling options as discussed below. 

2. Alternative labeling options 

   a. Alternative labels. The proposed rule indicated that for 
products that are irregularly shaped or small, alternative
labeling, 
such as hang tags, tape, cards, stickers or similar overlabeling 
could be used so long as the label or warning statement was 
securely attached to the container, product, outer packaging 
or display case. These alternatives are included in the final 
rule. An alternative label must be clearly legible and conspicuous.

As long as the warning statement is at least as conspicuous 
on an alternative label as it would be on a product itself, 
the manufacturer has the discretion as to which of these labeling 
methods is used for irregularly shaped or small products. Such 
alternative labels must themselves be clearly legible and
conspicuous. 
   b. Supplemental printed material. While EPA prefers that 
manufacturers place the warning label on a display panel on 
the product or its outer packaging, or use overlabeling where 
alternative labeling is necessary, labeling using supplemental 
printed material could also satisfy the section 611 requirement. 
EPA defines supplemental printed material as information which 
accompanies a product and which the consumer is likely to read 
at the time of purchase. (Supplemental printed material that 
is only available to the consumer after the time of purchase 
of the product would not satisfy the labeling requirements.) 
Examples of these options include, but are not limited to, warnings

included on invoices, bills of lading, package inserts and Material

Safety Data Sheets (MSDS), so long as they are likely to be 
read before the purchase is completed. Supplemental printed 
material would be most appropriate if a product has no PDP or 
display panel area, or if the warning statement would be as 
conspicuous to the consumer on such printed material as it would 
be on the product. It would also be appropriate to include a 
warning statement on supplemental printed material such as an 
invoice, for a shipment of products sold in large quantities 
(e.g., nuts and bolts), rather than labeling individual items. 
Where supplemental printed material is used, the warning statement 
would have to be clearly legible and conspicuous to the consumer 
at the time of purchase.
   Two commenters asked EPA to clarify that additional labeling 
(on a product or in advertising about the product) is not required 
when the label appears on supplemental printed material. In 
response, EPA confirms that should a manufacturer choose to 
implement the labeling requirement using supplemental printed 
information, additional labeling is not required. Again, the 
governing principle is that the purchaser be able to read and 
understand the label at the time of purchase. 
   Another example of where supplemental printed material would 
be appropriate is in the case of medical devices that are purchased

directly by a hospital or clinic and not by the patient. For 
example, EPA realizes that some medical products are administered 
directly by hospital or clinic personnel to a patient, without 
necessarily informing that patient of whether the medication 
or medical device was made with a controlled substance. The 
patient is less likely to be adequately informed about the product 
or to make a choice regarding the product due to hospital
procedures 
and the circumstances under which the patient receives treatment. 
In such cases, EPA believes that the ultimate consumer is the 
person making the immediate purchasing decision of that product 
on behalf of and for the use by a patient. Supplemental information

must accompany the products to the point at which the purchaser 
accepts the products and need not be communicated directly to 
the patient. 
   Labeling of supplemental printed material may also be
appropriate 
for prescription drug products containing controlled substances 
that are deemed "essential" by the Food and Drug Administration 
(FDA), such as metered dose inhalers. (See discussion on medical 
products in section V.I. below.) 
   While supplemental printed material may be a label placement 
option for most products, containers of class I or class II 
substances that are smaller than 55 gallon drums must be labeled 
directly on their PDPs or display panel areas. Containers of 
controlled substances that are larger than 55 gallon drums may 
apply the warning statement on supplemental printed information 
to convey the warning statement, as long as it is clearly legible 
and conspicuous to the purchaser either at the time of purchase 
or time of delivery provided the purchase is not complete until 
delivery is accepted. EPA believes that containers larger than 
55 gallon drums, such as railcars, trucks and aircraft need 
not bear a label directly on them since they carry other containers

and products as well, and information regarding the contents 
is usually viewed in supplemental information by the consumer 
upon delivery. 
   c. Products not viewed by the purchaser prior to or at the 
same time of purchase. Several commenters stated that some products

are typically sold over the phone or through the mail, so that 
labeling the product itself would not provide the information 
to the purchaser until after the point of purchase.
   In the NPRM, EPA discussed the use of supplemental printed 
material as an alternative to placing the labels directly on 
the a product, its display or packaging. Supplemental printed 
material was defined in terms of printed or graphic informational 
or promotional material. In order to address the issues described 
above, EPA has distinguished between supplemental and promotional 
printed material in the rule promulgated today. Supplemental 
material accompanies the product and is available for the consumer 
to read at the time of purchase. Promotional printed material, 
by contrast, does not accompany a product and is available prior 
to the point of purchase by appearing in or on newspapers,
journals, 
catalogues and displays, for example. 
   Congress' purpose in requiring products to be labeled was 
to provide consumers with information regarding the use of ozone-
depleting substances so that they can use the information in 
making their purchasing decisions. To accomplish this purpose 
in the case of products normally purchased sight-unseen,
manufacturers 
or sellers may use either of two approaches. First, promotional 
printed material may be used to inform consumers of the use 
of ozone-depleting substances. The required information must 
appear on the promotional printed material in a clearly legible 
and conspicuous manner. 
   Second, a company may place the label on a product or its 
packaging, or use alternative labeling as described above, so 
that the requisite information is clearly legible and conspicuous 
to the purchaser at the time of product delivery. However, this 
option requires that either the purchase not be completed until 
delivery is accepted (e.g., COD orders) or the purchaser be 
permitted to return the product following its delivery. For 
the labeling requirement to serve Congress' purpose, where
information 
is not made available when the purchase order is placed, customers 
must at least be allowed to refuse delivery or to return the 
product after that information is made available. 
   d. Competing information. Several commenters argued that 
the label would compete with other labeling information on
restricted 
package space and that overcrowding the existing PDP would make 
the information difficult to read and inhibit the consumer from 
reading it. EPA does not agree, especially given EPA's acceptance 
of alternative label placement options which provide manufacturers 
with flexibility to address circumstances where applying a label 
directly on a product may not be appropriate or viable. In
addition, 
EPA is not directing companies to increase the size of their 
products' packaging to accommodate the label bearing the warning 
statement, as some commenters inferred. In any case, section 
611 specifically requires that the label be "clearly legible 
and conspicuous." 
   e. Parallel to existing information. EPA proposed that the 
warning statement must appear parallel to any base on which 
the product or container is being displayed. Some commenters 
recommended that EPA instead prescribe that the label be parallel 
and aligned with all other labeling information on the product. 
EPA agrees with this recommendation. Further, if the warning 
statement is on supplemental printed material, the statement 
must also be parallel and aligned with other labeling information 
in the printed material. 

G. Products Manufactured for Export Only 

   The proposed rule did not specifically address the issue 
of whether labeling is required for products manufactured for 
export only. Several commenters urged EPA not to require that 
products manufactured for export meet the labeling requirements. 
Commenters indicated that a requirement for labels bearing the 
warning statement on exports would put products manufactured 
in the United States at a competitive disadvantage in the world 
marketplace, compared to products manufactured in countries 
where labeling is not required. Moreover, commenters noted that 
EPA could not enforce the labeling requirement beyond U.S.
boundaries; 
therefore, labels on exported products could be removed after 
they leave United States territory but before they reach consumers.
   EPA does not believe that products manufactured for export 
only should be subject to section 611's labeling requirements. 
Section 611 applies to products that are "introduced into
interstate 
commerce," but makes no reference to foreign commerce. The Clean 
Air Act does not define "interstate commerce." However, EPA 
believes that section 611's use of interstate commerce does 
not include "foreign commerce" (i.e. commerce outside the United 
States). See Border Pipe Line v. Federal Power Commission, 171 
F.2d 149 (D.C. Cir. 1948) (interstate commerce does not generally 
include foreign commerce); Distrigas Corporation v. Federal 
Power Commission, 495 F.2d 1057 (D.C. Cir. 1974). See, also 
e.g., 18 U.S.C. 10, which defines interstate commerce and foreign 
commerce separately. 
   Exports primarily affect foreign commerce. Although it may 
be argued that exports are introduced into interstate commerce 
when they are transported from the manufacturer within the United 
States to the place of export, EPA does not believe that products 
manufactured for export only should be covered by section 611. 
EPA has considerable discretion in determining the scope of 
the term "introduced into interstate commerce" for purposes 
of these regulations. As the Supreme Court noted, the term
"interstate 
commerce" cannot be subjected to any single definition for every 
federal statute regulating commerce.{5} Court decisions have 
not been uniform regarding the point at which a product destined 
for foreign commerce should be considered as being in "foreign 
commerce" when it is traveling to port.{6} Courts have looked 
to the essential purpose of statutory provisions in determining 
the scope of the term "interstate commerce."{7} EPA therefore 
believes that its determination of whether exports should be 
included within the scope of the labeling requirement should 
be based on the intent of section 611 and EPA's ability to pursue 
its enforcement responsibilities under section 611. Based on 
this analysis, EPA does not believe that the term "introduced 
into interstate commerce" should be extended to include products 
manufactured for export only. 
      {5}  McLeod v. Threlkeld, 319 U.S. 491, 495, 63 S. Ct. 
      1248, 1250 (1943); see also United States v. Auguello, 
      452 F.2d 1135, 1141 (2d Cir. 1971) (in determining the 
      퀂cope of the term interstate commerce in a criminal
statute, 
      퀃he court noted that cases from other areas of the law 
      쿪re an unreliable guide to the interpretation of the 
      퀂tatute at issue). 
      {6}  See, e.g., Japan line, Ltd. v. County of Los
Angeles, 
      441 U.S. 434, 437, 99 S. Ct. 1813, 1815 (containers are

      쿯ound to be instrumentalities of foreign commerce where

      퀃hey "engage in no intrastate or interstate
transportation 
      쿮xcept as continuations of international voyages");
Connell 
      쿝ice & Sugar Co. v. County of Yalo, 569 F.2d 514
(9th 
      쿎ir. 1978) (products in storage that were bound for
export 
      퀇ere subject to local taxation because they had not
actually 
      쿮ntered the export stream); Southern Pacific
Transportation 
      쿎o. v. I.C.C., 565 F.2d 625 (9th Cir. 1978)(whether
transportation 
      쿶s interstate or intrastate "is determined by the
essential 
      쿬haracter of the commerce, manifested by the shipper's 
      쿯ixed and persisting transportation intent at the time 
      쿽f shipment"); Carson Petroleum v. Vial, 279 U.S. 95, 
      107, 49 S.Ct. 292, 295 (1020) (the essential character 
      쿽f the commerce, not the various steps in its
transportation, 
      퀂hould determine whether it is interstate, intrastate, 
      쿽r foreign); Wentz v. U.S., 244 F.2d 172, 176 (9th Cir.

      1957) (court found that where telegram from California 
      퀃o Mexico was initially transmitted to Texas and then 
      퀁etransmitted to Mexico, the initial transmittal was 
      쿶n interstate commerce). 
      {7}  See United States v. Castro, 837 F.2d 441 (11th 
      쿎ir. 1988) (failure of Congress to specifically include

      쿶mports in statute does not mean that imports are
excluded 
      퀇here legislative history and essential purpose of the 
      퀂tatute indicate that imports should be included);
Distrigas 
      쿎orporation v. Federal Power Commission, 495 F.2d 1057,

      1064 (D.C. Cir. 1974) (legislative history of Natural 
      쿒as Act indicates that imports and exports were meant 
      퀃o be excluded; nonetheless, the court would include 
      쿶mports and exports within the scope if exclusion would

      쿫e contrary to the purpose of the statute). 
   As discussed above, the labeling requirements are designed 
to alert consumers to the fact that ozone-depleting substances 
are contained in a product or were used to manufacture it. However,

during the period that the exports are traveling to port, they 
can have no effect on the purchasing decisions of consumers, 
as no consumers will see the product until after it has left 
the United States. Moreover, as the labels will be in English, 
many of the products that are labeled will be sent to countries 
where the labels will not be understood. In addition, once a 
product has left the United States, EPA cannot prevent labels 
from being removed from the product. Therefore, EPA cannot ensure 
that products exported from the United States will be labeled 
when they are viewed by the consumer, which would defeat the 
purpose of the labeling requirement. 
   Unlike products sold in the United States, products produced 
and sold abroad do not have to meet the labeling requirements 
of section 611. EPA recognizes the competitive disadvantage 
that U.S. manufacturers would have in the foreign marketplace 
as a result of having to label. Consumers in the foreign
marketplace, 
when faced with two otherwise identical products, one which 
is labeled and the other which is not, would likely choose the 
unlabeled product even though the unlabeled product may also 
contain or be manufactured with ozone-depleting substances. 
If U.S. regulations were to require domestic products manufactured 
only for export to be labeled while products manufactured and 
sold in other countries were not, U.S. products would be placed 
at an unfair disadvantage in the foreign marketplace with no 
compensating benefit to consumer choice, since foreign consumers 
would incorrectly infer that non-U.S. products did not contain 
or involve the use of ozone-depleting substances. 
   Agencies have excluded exports from similar requirements 
on other occasions. For example, the Consumer Product Safety 
Commission has exempted products from requirements of the Consumer 
Product Safety Act, 15 U.S.C. 2015 et. seq., where the products 
are never distributed in commerce for use in the United States, 
and exempted from the Federal Hazardous Substances Act, 15 U.S.C. 
1261 et. seq., where the products are never sold or offered 
in domestic commerce. See 16 CFR 1010.1 (b). 
   To avoid application of this rule, products manufactured 
solely for export may not be sold within the United States. 
EPA is requiring that products and containers manufactured for 
export be clearly identified as such at the warehouse or facility 
from where the export will be transported and that any additional 
documentation for such products or containers be readily available 
on site. This is to enable Federal enforcers to distinguish 
between products or containers for domestic sale, which require 
labels, and those intended only for export, which do not. 

H. Imports 

   EPA proposed that imports be covered by the labeling
requirements 
and regarded imports as having entered interstate commerce at 
the site of U.S. Customs (Customs) clearance. 
   Several commenters asked whether the Agency plans to inform 
Customs of the new labeling requirements. EPA has agreements 
with Customs under other existing regulations to inspect imports 
and will work further with Customs to ensure that products and 
containers entering the U.S. meet the requirements of section 
611. 
   The definition of "import" in today's final rule is consistent 
with the definition promulgated under regulations implementing 
section 604 of the Act (57 FR 33754, 33788, July 30, 1992). 
There are two situations described in the section 604 rule that 
are excluded from the definition of "import" also adopted here. 
One pertains to the off-loading of class I or class II substances 
from ships during servicing. EPA believes that temporary off-
loading containers or products containing or manufactured with 
controlled substances should not be considered importation since 
the products are not being introduced into interstate commerce. 
Therefore, they should not fall under the labeling provision. 
   The other case involves products or containers introduced 
in bond at the Mexico border. Under the Maquiladora Agreement, 
the United States and Mexico established a free-trade zone along 
a segment of the U.S./Mexico border. Essentially, products are 
permitted to be transported across that zone without any U.S. 
Customs restrictions being imposed. Products manufactured with 
or containing controlled substances or containers charged with 
controlled substances within this zone established by the
Maquiladora 
Agreement are not considered to be imported products. At the 
same time, such products or containers are being introduced 
into United States interstate commerce, and are therefore subject 
to the labeling requirements. 
   Some commenters argued that if they purchase foreign products 
manufactured with a class I substance from other companies and 
incorporate them into their own products, their final products 
should be exempt from the labeling requirement. As discussed 
above, the final rule eliminates the requirement that a
manufacturer 
must label its product if a component product was manufactured 
with a controlled substance. Thus, if a manufacturer incorporates 
a component product manufactured with a controlled substance 
into its product without using a controlled substance in its 
own manufacturing process, under today's rule, its product is 
not required to bear a warning statement. Manufacturers
incorporating 
component products into their products need not investigate 
whether such products were manufactured with a controlled
substance. 
However, U.S. parent companies that purchase products manufactured 
with controlled substances from their foreign subsidiaries would 
be required to label their subsequent products in the same manner 
required of any U.S. company using components from a domestic 
subsidiary. 
   Importers of foreign products are still obligated to label 
foreign products if the manufacturer of that product used a 
controlled substance in its manufacturing process. If importers 
were not so obligated, then imported products would have an 
unfair competitive advantage over domestic products. However, 
consistent with EPA's decision to eliminate the label "pass-
through" provision, an importer need only investigate whether 
the final product being imported was manufactured with a controlled

substance in determining whether a warning statement is required. 
The importer is not required to investigate whether component 
parts of the final product were manufactured with controlled 
substances. 
   All imported products containing and containers containing 
controlled substances must be labeled at the site of U.S. Customs 
clearance and must remain labeled throughout the stream of
commerce. 
As discussed above, manufacturers of "products and containers 
containing" controlled substances are not exempt from the
requirements 
to pass information through the stream of commerce indicating 
that the product or container contains an ozone-depleting
substance. 

I. Medical Products 

   Several commenters argued that certain prescription products, 
such as some metered dose inhalers (MDIs), should be exempt 
from the labeling requirements because they are essential to 
the health of patients. These commenters feared that the warning 
statement could result in patients not using medication despite 
the advice of their physicians, because the patients would be 
concerned about damage to the ozone layer or would be alarmed 
by the inclusion of the words "warning" and "harms public health 
and environment" in the warning statement. These commenters, 
which included the Food and Drug Administration, voiced concern 
about the possible ill effects on the health of asthma patients 
if such patients discontinued the use of MDIs as a result of 
the warning statement. The commenters argued that the label 
should not appear on prescription drugs, since the decision 
to buy the drug is based on the physician's advice and, therefore, 
the physician should be considered the "ultimate consumer" in 
this case. Other commenters noted that pharmacists often receive 
medical products in bulk packaging and repackage the products 
for consumer purchase. In these cases, the patient would not 
see the package prior to purchase, negating the purpose of the 
label. 
   EPA understands the importance of medical products like MDIs 
to many patients' health and believes it appropriate to tailor 
the labeling requirement to avoid unduly alarming patients. 
At the same time, section 611 does not provide the Agency with 
authority to exempt any products containing class I substances 
from the labeling requirement, even if such products are considered

essential. That section specifically provides that no product 
containing a class I or class II substance may be introduced 
into interstate commerce after the effective date without the 
warning statement. Congress clearly gave EPA authority to exempt 
production of class I substances needed for medical products 
from the phaseout requirements of section 604 of the Act and 
authority to exempt certain products "manufactured with" class 
I substances from the labeling requirements of section 611 if 
appropriate substitutes are available. By contrast, Congress 
gave the EPA no similar authority to exempt medical products 
containing class I substances from the labeling rule. 
   Contrary to the assertion of some commenters, there is no 
basis for believing that section 611 does not apply to medical 
products subject to FDA labeling rules. FDA's labeling regulations 
were in effect when the Clean Air Act Amendments were enacted, 
and Congress could have indicated that the labeling provisions 
of section 611 do not apply to the products covered by FDA
regulations. 
It did not do so, however, and since section 611 was passed 
after FDA's rules and statute authorizing them, section 611 
would govern in the case of any conflicts. 
   Within these legal constraints, however, EPA wishes to avoid 
any adverse impact labels might have. As detailed above, a number 
of commenters voiced concern that patients might not use medical 
products essential to their health if confronted by the required 
labeling information. The commenters presented no evidence
supporting 
their concerns, however. EPA considers it highly unlikely that 
patients would not use a medical product vital to their health 
because it bore a label notifying them of the products' use 
of ozone-depleting substances. Patients would more likely react, 
if at all, by asking their physician or pharmacist what they 
should do in view of the label's information. Such inquiries 
could help create the kind of market pressure Congress sought 
as a means of prodding industry to find and use alternatives. 
   However, as discussed earlier, EPA does allow the warning 
statement to appear on supplemental printed material. In the 
case of prescription products deemed essential by FDA, such 
as MDIs, EPA believes that, given the concerns expressed by 
commenters, it is appropriate for the statutory warning statement 
to appear on supplemental printed material intended for the 
prescribing physician, rather than for the patient, as long 
as the supplementary printed material intended for the patient 
contains language that informs the patient that the product 
contains an ozone-depleting substance. EPA agrees with commenters 
that the inclusion of the words "warning" and "harms public 
health" on the information provided to the patient might cause 
undue alarm. Therefore, if the statutory warning statement appears 
on the printed material intended for the physician, then the 
product or printed material intended for the patient need only 
state the following: "This product contains [name of substance], 
a substance which harms the environment by depleting ozone in 
the upper atmosphere." Manufacturers could supplement this
information, 
if they wish, with instructions for the patient to consult with 
his or her physician before discontinuing use of the product. 
EPA expects that FDA will provide at a later date such additional 
language in the Federal Register. 
   EPA believes these provisions address the concerns regarding 
potential adverse health effects in a manner consistent with 
section 611(c), since the full warning statement will be provided 
to the prescribing physician and the information that the product 
contains an ozone-depleting substance will be provided to the 
patient. To the extent this approach represents a partial exemption

from the statutory requirement, EPA may grant it as an exercise 
of the type of administrative authority described in Alabama 
Power Co. v. Costle, 636 F.2d 323 (D.C. Cir. 1979). The change 
to the statutory language is minimal and the environmental
consequence 
is probably non-existent. Removing the words "warning" and "harms 
public health," however, avoids unduly and perhaps dangerously 
alarming patients. 
   EPA received other comments noting the impact of FDA's labeling 
regulations on the time needed for compliance with today's
rulemaking. 
Based on discussions with FDA, there appear to be three ways 
to implement the changes in labeling for FDA-regulated medical 
products (21 CFR 314.70) manufactured with or containing class 
I substances in time to meet the statutory deadline of May 15, 
1993: (1) Notify FDA through the company's annual report of 
the changes made to the label-such changes would be considered 
"minor or editorial;" (2) partake in a supplemental process 
that FDA uses to grant pre-approval for such modifications to 
the existing labeling; or, (3) through "supplemental changes 
being effected" or changes that may be made prior to FDA approval, 
make the necessary changes and inform FDA afterwards. FDA has 
informed EPA that companies should, to the extent possible, 
implement section 611 labeling changes using the third option, 
"supplemental changes being effected" (21 CFR 314.70 (c)2(i)). 
EPA believes that it is FDA's intention to provide at a later 
date specific additional language to accompany the warning
statement 
for drug products containing class I substances, such as MDIs, 
which would inform the patient to further consult with his or 
her physician when considering the implications on their overall 
health of the section 611 warning statement. 
   One commenter also indicated that contact lenses that are 
manufactured with class I substances would be difficult to label, 
because consumers generally purchase contact lenses without 
packaging and the label obviously cannot be placed directly 
on the lenses themselves. Manufacturers of ophthalmic devices, 
such as contact lenses, may include the warning statement on 
supplemental information, as long as the label appears on
information 
that the ultimate consumer receives by the time of purchase. 
In this context, FDA indicated that it may be notified of such 
changes to a company's existing labeling information through 
a manufacturer's annual report, thus requiring no pre-approval. 

J. Packaging 

   Some commenters indicated that it would be misleading for 
the warning statement to appear on a wrapper or packaging that 
itself contains or is manufactured with controlled substances, 
when the product inside does not contain or was not manufactured 
with such substances. Packaging materials may be used for
transportation 
or display purposes for products that do not contain or were 
not manufactured with a controlled substance. The commenters 
inquired as to whether this packaging would necessitate a label. 
Such labeling, the commenters argue, could mislead consumers 
into believing that the contents are themselves ozone-depleters. 
   In the final rule, EPA is requiring that packaging materials 
manufactured with a controlled substance be labeled to inform 
purchasers of such materials of the use of controlled substances 
in the manufacturing of those materials. EPA believes that
packaging 
materials when sold as such are products in and of themselves 
and should therefore be subject to the labeling requirements. 
However, consistent with the pass-through discussion in V.C.1 
above, purchasers of such packaging materials are not required 
to subsequently label their product based on the labeling
information 
pertaining to the packaging materials. 
   Manufacturers that manufacture their own packaging materials 
using controlled substances, or that use controlled substances 
to attach the packaging to its contents, must label their product, 
even if the package contents were not made with ozone-depleting 
substances. In this case, the packaging is part of the product, 
and if the packaging is made with controlled substances, it 
must be labeled. Otherwise the anomalous result would be that 
all uses of ozone-depleting substances would require labeling 
except packaging. So long as the company introduces the product 
into commerce using ozone-depleting substances to make any aspect 
of it-including packaging-it must label the product. 

K. Research and Development 

   In the proposed rulemaking, EPA did not specifically address 
whether research and development (R&D) activities, including 
R&D to find alternative substances for class I or class II
substances, 
should be subject to the labeling requirements. A few commenters 
stated that R&D activities should be exempt from the labeling 
requirement since the products being developed are not being 
introduced into the stream of commerce. EPA agrees that a product 
undergoing research is not introduced into interstate commerce 
and, therefore, need not be labeled. Upon conclusion of R&D 
activities, any product containing or manufactured with a
controlled 
substance will require a warning statement upon its introduction 
into interstate commerce. 

L. Warning Statement Text and Requirement 

   Some commenters supported the text of the warning statement, 
bearing the standard chemical name. However, several commented 
that there was little environmental benefit to naming the specific 
chemicals used in a manufacturing process. Suggested alternatives 
to the chemical name included the terms "class I substances" 
and "CFCs and other substances." A commenter indicated that 
the Clean Air Act's reference to "class I," should be sufficient 
for the label. These commenters did not believe that stating 
the specific substances used on the label was valuable to
consumers, 
who do not tend to differentiate between ozone-depleting chemicals.

Therefore, according to the commenters, simply the statement 
that an "ozone-depleting substance" was used in the manufacture 
of a product would be sufficient for purposes of informing
consumers. 
Other commenters argued that the label would detract from other 
important warning hazard labels and requested that the Agency 
remove the word "WARNING" from the statement. 
   When Congress mandated the use of labels under section 611, 
it specified the exact language that should be used. This language 
includes the name of the substance that is subject to the labeling 
requirement and contained in or used to manufacture a product. 
EPA does not believe that the use of terms such as "class I 
substance" or "CFCs and other such substances" would be adequate 
to meet the requirements of section 611. Furthermore, such terms 
would not provide consumers with the ability to distinguish 
the ozone-depleting potential of one substance relative to another,

which can vary by a factor of ten among class I substances. 
The ability to distinguish allows consumers to differentiate 
in making their purchasing decisions between substances with 
significantly different ozone depletion potentials. As an
additional 
benefit, labels containing specific chemical names facilitate 
efforts related to handling, disposal, recovery and recycling 
under sections 608 and 609 of the Act. Such information is
potentially 
beneficial to service technicians. Therefore, EPA is not amending 
its requirement that the exact name of the ozone-depleting
substance 
be used in the warning statement. 
   Additionally, the final regulations continue to require that 
the word "warning" be used to begin the warning statement. EPA 
is not authorized to remove the word "warning" from the text 
of the statement, since that wording is prescribed by Congress 
in section 611. EPA also disagrees with the comment that the 
warning statement will discourage consumers from reading a
product's 
PDP or other display panel area, especially given the options 
available for label placement. 
   Some commenters indicated that labeling relative to human 
health hazards and product use and handling should be regarded 
as more important and suggested eliminating the requirement 
for the section 611 label in the case of these products. The 
Clean Air Act mandates the warning statement and provides no 
such exceptions. EPA has an obligation to implement the law 
and to ensure compliance among the regulated community. 

M. Recoverable Substances Label 

   Comments received stated that labels indicating that ozone-
depleting substances are recoverable and not mandated under 
section 611 and that section 608 (recovery and recycling) does 
not itself require such labels. Some comments affirmed that 
many products containing class I and class II substances already 
have permanent labels identifying the relevant substances they 
contain. They claim that labeling for recovery purposes would 
add little value to current information provided on existing 
labels. 
   After consideration of the comments received, EPA believes 
that recycling and recovery of class I substances are sufficiently 
addressed under sections 608 and 609. Therefore, EPA is not 
requiring a separate labeling requirement under section 611 
for recoverable substances; the warning statement as specified 
in that section will be the only required label for products 
and containers, as outlined in today's rulemaking. 

N. Symbol 

   In the proposal, EPA stated that it was considering, but 
not proposing, the requirement of a symbol to accompany the 
warning statement. EPA requested comments on the appropriateness 
of such a symbol. One commenter strongly favored the use of 
a symbol as discussed in EPA's proposal. However, EPA also received

numerous comments that indicated that warning statements without 
corresponding symbols have been as effective as those with symbols.

These commenters further stated that symbols can be misleading 
to the consumer at times. Several commented that symbols do 
not provide consumers with any information in addition to what 
is communicated in the warning statement. Other commenters implied 
that a symbol can distract consumers from reading other important 
labels on a product or container. 
   Some commenters indicated that incorporating the graphic 
symbol would be costly, given inherent limitations in existing 
printing equipment. For example, some small businesses that 
print labels and supplemental information may be unable to
replicate 
the graphic using existing equipment. Such businesses would 
be forced to invest in new printing equipment in order to comply. 
Other commenters indicated that to add the symbol would result 
in altering the colors used on existing labels on products. 
This could cause problems in the existing arrangement of other 
printed information on the products, therefore requiring the 
manufacturer to relabel all of its products. The subsequent 
cost could be up to $1,000 per product label. In addition to 
these economic concerns, commenters indicated that it made little 
sense to make such changes and investment for substances that 
will be phased out shortly. 
   EPA has decided to forego the use of a symbol. The Agency 
believes that the 1996 phaseout of class I substances (1994 
for halons) diminishes the overall utility of a symbol thus 
substantially reducing the potential benefits from the use of 
a symbol without reducing costs. The Agency also agrees with 
commenters that the warning text would significantly increase 
the cost of labeling, with little or no environmental benefit. 

O. Petition Process 

   Four commenters supported the petition process as described 
in the proposed rulemaking, citing that a process is necessary 
to exempt from the labeling requirement those products for which 
alternative substances and manufacturing processes are not
available. 
Others supported EPA's proposed provision allowing "class action" 
petitions, claiming that petitions allowing one petition for 
multiple manufacturers of the same product or for similar products,

would simplify the process for companies with the same end-uses 
of a class I substance. 
   Several commenters indicated that the rulemaking should shift 
the statutory prescription and exempt all products manufactured 
with class I substances unless the Agency makes a determination 
that substitutes are currently or potentially available. They 
argued that because of the accelerated phaseout date of 1996, 
EPA could determine now that substitutes are not currently
available, 
they would also not be potentially available, since the timeframe 
from the effective date of this rule to the phaseout is
considerably 
shorter than what it was at the time the law was written. 
   The language of section 611 clearly does not allow EPA to 
exempt products manufactured with class I substances from the 
labeling requirements unless EPA makes an affirmative
determination. 
The law explicitly states that products manufactured with class 
I substances must be labeled, unless the Administrator makes 
an affirmative determination that no substitute chemicals or 
processes exist that do not rely on a class I substance, that 
reduce the overall risk to human health and the environment, 
and that are currently or potentially available. EPA continues 
to believe that the most appropriate way to provide exemptions 
for specific products manufactured with class I substances is 
through case-by-case evaluation of specific products or
manufacturing 
processes through the petition process described in the proposed 
rulemaking. This process allows EPA to make a sound decision 
whether to exempt a product or process from labeling based upon 
the specific facts provided by the petitioner. However, to avoid 
being overwhelmed with individual petitions reflecting the myriad 
MCF and CFC-113 used as solvents, EPA has adopted the "reduced 
use exemption" described above. This exemption does not, however, 
prevent any firm from applying for a specific exemption for 
a product, regardless of reductions in use made by that firm, 
if the criteria for an exemption contained in the regulations 
are satisfied. 
   One commenter stated that the Agency should grant temporary 
exemptions to those manufacturers that petition the Administrator 
until a determination on the petition has been made. However, 
EPA does not believe such an exemption is appropriate, because 
it would enable manufacturers who wanted to avoid or postpone 
complying with the labeling requirements to initiate the petition 
process with little or no likelihood of success on the merits 
of the petition. EPA wants to avoid creating such an incentive 
and, therefore, is requiring that products be labeled pending 
the Agency's decision on a petition. 
   Another commenter indicated that the EPA should expedite 
the review process for petitions whenever possible. EPA agrees 
and will make every possible effort to expedite the review process.

The reduced use exemption, as well as the revised pass-through 
requirement and other provisions of this rule, should dramatically 
reduce the number of petitions received by EPA.
   One commenter inquired about the treatment of confidential 
business information (CBI) included in a petition and inquired 
about the Agency's ability to guarantee confidentiality. Under 
the Clean Air Act, anyone submitting information for which CBI 
status is requested must assert a claim of confidentiality at 
the time of submission. Failure to assert a claim of
confidentiality 
at the time of submission may result in the disclosure of the 
information by the Agency without further notice. Further, it 
should be noted that information which is publicly available 
(e.g., in journals, trade magazines, product literature, etc.) 
cannot be claimed as CBI. EPA will treat all claims of business 
confidentiality in a manner consistent with 40 CFR part 2, subpart 
B. These procedures offer petitioners significant protection 
from disclosure of CBI. Though the Agency cannot guarantee that 
it will be able in all circumstances to justify granting or 
denying a petition without public disclosure of confidential 
information, EPA will endeavor not to use confidential information 
in the public participation process wherever possible. There 
are situations in which the Agency has contractors "cleared" 
for handling confidential information. Before the Agency uses 
such contractors, it will notify any petitioner of the potential 
use of such a contractor in the petition review. 
   One commenter indicated that EPA's description of a substance 
as "currently available" did not indicate that the substitute 
is widely available. The commenter urged that a substance be 
considered currently available when it is marketed in "commercial 
quantities." EPA agrees with this point if commercial quantities 
means that they are available, but not necessarily in market-
wide quantities, and affordable. An example of such a circumstance 
would be where a single company is producing and marketing an 
alternative for more than one end-use; because the product is 
not manufactured by more than one company, the product may not 
be considered "widely available." EPA, however, believes that 
substitutes that are commercially available are currently
available. 
   One commenter indicated that the definition of potentially 
available should convey that a substitute is technologically 
feasible, environmentally acceptable, and economically viable 
"for a particular application," rather than for a sector-wide 
or end-use-wide application. EPA agrees that for the purpose 
of section 611, companies will be submitting petitions for their 
individual class I substance use and that its evaluation should, 
to the extent possible, be directed at that use and not at a 
sector-wide review. 

VI. Summary of the Final Rule and Changes from the Proposed 
Rule 

   This section briefly describes the amendments to the proposed 
rule. Any changes made to the rule language as a result of the 
public comments are conveyed. A new section has been added to 
reflect that position adopted today regarding companies using, 
or importers introducing, products manufactured with a process 
using class I substances. Various changes to the final rule 
that have been made for purposes of clarification are also
described 
herein. Labeling provisions discussed in the proposed rule that 
are not addressed or amended in today's final rule remain unchanged

and are thus applicable in the final rulemaking. 

A. Authority 

   The authority citation has been revised to reflect the most 
recent authority citation adopted by EPA for 40 CFR part 82. 

B. Purpose (Section 82.100) 

   This section states that the purpose of the rulemaking is 
to require warning statements on containers of, and products 
containing or manufactured with, certain ozone-depleting
substances. 

C. Applicability (Section 82.102) 

   This section defines those products that are subject to the 
labeling requirements of 40 CFR part 82. Paragraph (c) of this 
section, pertaining to the recoverable substances label, is 
deleted to reflect the Agency's determination that the handling 
of recoverable and recyclable substances is sufficiently covered 
in sections 608 and 609 of the Act. Products and containers 
using such substances, however, are required to bear the warning 
statement under paragraph (a) or (b) of this section. 
   Paragraph (a) of this section has been revised to indicate 
that for substances added to the lists of controlled substances 
after the publication of this rulemaking, the labeling regulations 
shall apply to the listed products and containers one year after 
such addition or earlier, if indicated in the rulemaking for 
such listing. A new paragraph (c) is added to this section to 
indicate that "products manufactured with" and "products
containing" 
class I substances that are products manufactured prior to May 
15, 1993 do not need to be labeled. 

D. Definitions (Section 82.104) 

   This section in the proposed rulemaking contains the definitions

of the terms "class I substance," "class II substance,"
"container," 
"containing or contains," "controlled substance," "manufactured 
with," "potentially available," "principal display panel,"
"product," 
"recoverable substance," "supplemental printed material,"
"transform," 
"type size," "ultimate consumer," and "warning label." The final 
rule includes new definitions for "consumer," "containers
containing," 
"distributor," "export," "import," "importer," "interstate
commerce," 
"product containing," "promotional printed material," "retailer," 
and "wholesaler" in an effort to incorporate the relevant comments 
into today's final rulemaking. 
   The definitions for a class I substance and class II substance 
remain unchanged. The definition of container also remains
unchanged, 
but EPA duly notes a comment regarding the word "immediate" 
in the definition. A comment indicated that the proposed definition

of container could imply that the label should be applied to 
the container before the introduction of a class I or class 
II substance. EPA requires that upon the point of filling a 
container with such a substance, the manufacturer in charge 
of filling the container must label the container, and not the 
manufacturer of the container itself. 
   The definition of "containing or contains" has been deleted; 
"containing or contains" is covered now in the new definitions 
of "product containing" and "container containing." 
   The term "controlled substance" is retained and refers to 
"class I" and "class II" substances. As discussed above, it 
is important to note that the effective date of specific provisions

in today's rule varies between class I and class II substances. 
   The definition of "manufactured with" is amended to require 
manufacturers of products manufactured with controlled substances 
to label according to their direct manufacturing processes and 
not those related to products purchased upstream. Given this 
determination, EPA considers each manufactured good a product. 
EPA also changes the definition of "manufactured with" by expanding

incidental uses to include contact use, a class I or class II 
substance is used intermittently in a manufacturing process; 
and by adding the exception for trace quantities in the definition 
of transformation. The expanded incidental use exemption was 
incorporated as a result of the several comments that explained 
numerous situations in which a class I or class II substance 
is applied for intermittent maintenance purposes and not routinely 
with the production of each product. 
   The definition for "potentially available" remains unchanged. 
The definition for "principal display panel" is amended to delete 
the guidance for determining the proper type size for the warning 
statement on a PDP. Placement of the warning statement on the 
PDP would clearly meet the requirements of section 611, but 
there are alternative options for label placement discussed 
below in part VI.F. (Section 82.108). 
   The definition of "product" is expanded to include products 
that incorporate component products. The term "recoverable
substance" 
is deleted because EPA no longer is requiring a recoverable 
substances label on containers or products containing such
substances. 
The "supplemental printed material" definition is amended to 
include "invoices" as a means for label placement. The revised 
definition also excludes the terms "written advertisements, 
brochures, circulars". Such terms are categorized as "promotional 
printed material" later in this section, defined as informational 
material that does not accompany a product to the consumer. 
   The definition of "transform" is amended to incorporate the 
phrase "except for trace quantities." The Agency received several 
comments that argued that the definition of transformation should 
remain consistent with that in the rule (57 FR 33754) implementing 
section 604 of the Act. The EPA agrees with those comments. 
   The definition of "type size" remains unchanged. "Ultimate 
consumer" remains unchanged. The definition of "warning label" 
is modified to exclude the reference to the symbol in 82.106 
of the regulation. 
   The final rule adds the following definitions to this section: 
"consumer," "container containing," "distributor," "export," 
"import," "importer," "interstate commerce," "product containing," 
"promotional printed material," "retailer" and "wholesaler." 
   The definition for consumer is differentiated from "ultimate 
consumer," in that "consumer" merely means a purchaser of a 
product that has been introduced into interstate commerce. The 
definition of "container containing" is added to this final 
rule. As discussed in V.D.1 above, a "container containing" 
is a container that holds a controlled substance until the
substance 
can be transferred into the "container, vessel, or piece of 
equipment" from which the use of the controlled substance will 
be realized. Examples of such "containers, vessels or pieces 
of equipment" are degreasing machines. These "containers, vessels, 
or pieces of equipment" are defined to be products containing 
as discussed earlier.
   In addition, the definition of "container containing" does 
not reference the time of purchase by the consumer, because 
containers containing controlled substances must be labeled 
whenever they contain such substances, regardless of whether 
they contained such substances at the time of their original 
purchase. 
   The definitions for "export," "exporter" and "import" are 
consistent with the definitions in the regulations promulgated 
to implement section 604 (57 FR 33754, 33788, July 30, 1992). 
The term "import" excludes two situations. First, where ships 
temporarily off-load containers and products that would otherwise 
be subject to this rule, no import is considered to have occurred. 
Containers containing class I or class II substances that originate

from the United States, are temporarily held in Mexico in bond 
and are returned to the United States are also not included 
in the definition of import. The term "importer" is consistent 
with the definition in the proposed rule for the accelerated 
phaseout of controlled substances, pursuant to section 606 of 
the Act, which is being published concurrently with this
rulemaking. 
"Interstate commerce" is defined as the distribution, or
transportation 
of any product between one state, territory, possession, territory 
or the District of Columbia and another state, territory,
possession 
or the District of Columbia, or the sale, use or manufacture 
of any product in more than one state, territory, possession 
or the District of Columbia. The entry points into interstate 
commerce for products that are in interstate commerce or will 
enter into interstate commerce have been revised to include 
the manufacturer's facility (where a manufacturer has no warehouse)

from which a product is released for distribution, sale or use. 
The definition is also revised to specify that the entry of 
a product into the warehouse owned by the manufacturer of that 
product is an "introduction into interstate commerce." EPA received

extensive comments regarding the economic and logistical burden 
of labeling all products in inventory made prior to this date. 
EPA has revised its definition of "introduction into interstate 
commerce," for "products manufactured with" and "products
containing" 
controlled substances, EPA defines "introduction into interstate 
commerce" to be either the entry of such products into the
warehouse 
from which a domestic manufacturer releases the product for 
shipment, the release of such products or containers by the 
manufacturer from its manufacturing facility where the manufacturer

does not own a warehouse, and in the case of imports, at the 
site of U.S. Customs clearance. This change in the definition 
of "introduction into interstate commerce" should significantly 
lessen the need to label products in inventory as of May 15, 
1993. The reasons and justifications for this "grandfather" 
provision are discussed in section V.B above. Paragraph (a) 
of this section has been revised to reflect the "grandfathering" 
of these products. 
   The definitions for "distributor," "wholesaler" and "retailer" 
below convey those commercial entities required to pass a warning 
statement on all such labeled products through the stream of 
commerce to the ultimate consumer. The proposed rule did not 
define these entities; however, they are covered under the
regulation. 
The definition of "distributor" is consistent with the definition 
promulgated in regulations implementing section 610 of the Act. 
The definitions for "retailer" and "wholesaler" have been defined 
in order to clarify the entities responsible for compliance 
with the regulations promulgated in this rulemaking. 
   The term "product containing" has been added to the regulation 
to mean a product, which includes containers, vessels, and pieces 
of equipment, that physically holds a class I substance at the 
point of sale to the ultimate consumer remains within the product 
for its intended use. 
   As discussed above, EPA has defined a second category of 
printed information on products in addition to "supplemental 
printed material." The second category is "promotional printed 
materials," and includes brochures, flyers, written advertisements,

catalogues, circulars, desk references, fact sheets, and similar 
materials. These materials typically do not accompany the product 
through to the sale to the consumer or ultimate consumer.
Supplemental 
printed material was revised to exclude promotional printed 
materials from its definition; supplemental information is
information 
that accompanies a product at the time of purchase. Promotional 
printed material is suggested as a final option in the case 
where the alternative labeling placement options discussed earlier 
are not appropriate because a product is available through ordering

systems only. The options for placement in these circumstances 
are discussed further in 82.108 of the regulation. 

E. Warning Statement Requirements (Section 82.106) 

   This section contains the warning statement, which by law, 
must be applied to those products or containers identified in 
82.102 (a) or (b) of the regulation. It also emphasizes that 
the label must not detract from, interfere with or mar existing 
labels required on a product's PDP. This section is amended 
to exempt from the labeling requirements: (1) Products containing 
trace quantities of unintended residues or impurities of controlled

substances; (2) products covered by the use reduction exemption; 
(3) products manufactured for export only; (4) products undergoing 
repair; and, (5) products or processes undergoing research and 
development. 

F. Placement of Warning Statement (Section 82.108) 

   This section describes the various locations where the label 
may appear in order to satisfy the requirement. The options 
for labeling and label placement in the proposed rulemaking 
were unclear to many commenters. It is EPA's intention today 
to clarify the options for label placement. The overriding
requirement 
is for the warning statement to be "conspicuous and clearly 
legible" by consumers at the time of purchase. A manufacturer 
may clearly comply with the requirement by placing the label 
on its product's principle display panel (PDP). Other means 
of complying would be to label the outer packaging of the product 
if the consumer could clearly view the label on such packaging. 
Alternative placement options such as alternative labels (hang 
tags, cards, tape, etc.) and supplemental printed materials 
(invoices, bills of lading, MSDS', etc.) may also fulfill the 
requirements. When a product is not viewed at the time of purchase,

such as a product purchased through mail or telephone orders, 
use of promotional printed materials is another option. An
alternative 
to using promotional printed information for products which 
are not viewed at the time of purchase is the direct labeling 
of a product or its accompanying printed information, defined 
as supplemental printed information above, so that the consumer 
views the warning statement at the time of product delivery. 
This alternative is only available where a product can be returned 
after delivery or if the purchase is not complete until the 
time of delivery. 
   In paragraph (a) of this section, EPA defines the PDP as 
a placement option that meets the requirements of the law; however,

a company may choose to label the packaging on any display panel 
so long as the label is clearly legible and conspicuous at the 
time of purchase; to apply the label on outer packaging under 
paragraph (b) of this section; or to use the alternative labeling 
options indicated in paragraph (c) of this section. In paragraph 
(b) "Outer packaging" of this section, the regulatory text is 
amended to include "warning statement" rather than "warning 
label," due to the fact that some manufacturers may choose to 
have the warning text printed directly on the packaging rather 
than on a label. 
   Paragraph (c) "Alternative placement" of this section, is 
amended to include the term "supplemental printed material," 
which is information that accompanies the product and that the 
consumer, or ultimate consumer views at the time of purchase. 
The text is amended to read "warning statement" rather than 
"warning label," in recognition that manufacturers may choose 
to include the warning text in the product's literature with 
the other product information instead of applying an actual 
label. The addition of the phrase "or accompanies the product 
or container" enables companies to meet the requirements without 
having to attach the label to the product when options discussed 
in paragraph (c) of this section are used. Containers larger 
than 55 gallon drums are given the option of using supplemental 
printed material for label placement, since consumers usually 
view supplemental information rather than the actual vessel 
itself, at the time of purchase. 
   Finally, paragraph (d) of this section cites two new methods 
that companies may use if they are unable to meet the labeling 
requirements in the other paragraphs of 82.108, because they 
distribute or sell their products through a phone or mail ordering 
system. Under the first option, a company may include the warning 
statement on promotional printed material. Under the second 
option, a company may place the warning statement such that 
it is conspicuous and clearly legible at the time of product 
delivery as long as the product may be returned after delivery 
or the purchase is not completed until delivery is accepted 
(e.g., COD orders). Under this option, the company may meet 
the requirement that the warning statement be conspicuous and 
clearly legible by placing the statement on a display panel, 
or outer packaging or by using the options for alternative
placement 
as described in paragraphs (a), (b), or (c). This paragraph 
replaces the paragraph on "supplemental printed material,"
indicated 
in the proposed rulemaking. 

G. Form of Label Bearing the Warning Statement (Section 82.110) 

   This section indicates the criteria by which a label is judged 
to be "clearly legible." EPA retains paragraphs (a)(1) and (a)(2) 
as they appeared in the proposed rulemaking. They specify the 
typography, layout, and color combination guidelines. Paragraph 
(b) "Name of Substance," remains unchanged. Paragraph (c) "Combined

statement for multiple class I substances," also remains unchanged 
in this section. 
   In paragraph (d) "Format," the reference to the symbol, which 
was not proposed, is deleted. Also in this section, the appearance 
of the label text is amended so that the text appears parallel 
to the surrounding text on the product's PDP, display panel, 
or in the supplemental or promotional printed material, or on 
other alternative placements rather than parallel to the base 
on which the product rests. The remainder of this section is 
unchanged. 
   The proposed rulemaking defined, in Table 1, the type sizes 
in relation to the area of the PDP. In paragraph (f)(1) of this 
section, a minor change is made to include the display panel 
as the source upon which type size is based, which would include 
the PDP, rather than apply solely to the PDP. 

H. Removal of Label Bearing the Warning Statement (Section 82.112) 

   Section 82.112 of the proposal prohibited the removal of 
a label bearing the warning statement except by the ultimate 
consumer. The proposed section required that the label follow 
a product through the stream of commerce and not be removed, 
unless a manufacturer incorporated the name of a substance from 
a label on a component product into the label for the
manufacturer's 
final product. Paragraph (a) of this section remains unchanged 
except that it now references a new paragraph (c) in this section. 
Paragraph (b) is amended to clarify that a warning statement 
on a product that is being incorporated into another product 
may be removed by the purchasing manufacturer if that information 
is then incorporated into the warning statement accompanying 
the subsequent product or if the exemption under paragraph (c) 
applies. In a new paragraph (c) of this section, an exemption 
is permitted for a manufacturer who incorporates into its own 
product a labeled product manufactured by another company using 
controlled substances. If the manufacturer uses a controlled 
substance in the manufacturing of its final product or in the 
manufacturing of component parts it makes, a label must accompany 
the product reflecting those substances it used. 

I. Compliance by Manufacturers and Importers With Requirements 
for Labeling of Containers of Controlled Substances, or Products 
Containing Controlled Substances (Section 82.114) 

   This section is added to the final rule to distinguish the 
revised pass-through requirement applicable to "products
containing" 
controlled substances and "containers containing" controlled 
substances from that applicable to products manufactured with 
such substances. The proposed rule did not make a distinction 
because the warning statement was required to be passed through 
the stream of commerce to the ultimate consumer for all products 
manufactured with controlled substances, products containing 
controlled substances, or containers containing controlled
substances. 
Labels on a product being incorporated into an final product 
were required to be incorporated into the new label accompanying 
the product to the ultimate consumer. 
   In today's final rule, this section requires that for all 
products containing controlled substances and containers containing

controlled substances, a label must still be passed through 
the stream of commerce to the ultimate consumer. If a "product 
containing" a controlled substance is incorporated into another 
product, the final product must bear a new warning statement 
incorporating the information on the incorporated products' 
warning statement. Paragraph (b), "Reliance on Reasonable Belief," 
is changed to clarify the responsibilities of importers that 
import products that are incorporated into their own products. 
Importers that introduce foreign products into interstate commerce 
must have a reasonable belief that the import is properly labeled 
or does not require a warning statement at the site of Customs 
clearance. Under no circumstances may an importer remove a label 
from a container of a controlled substance or a product containing 
controlled substances, unless the container or product is
incorporated 
into a new container or product and the label information
accompanying 
the first container or product is then incorporated into a new 
label on the final product. Paragraph (c), "Contractual
obligations," 
states that importers may use contractual obligations to show 
evidence of reasonable belief in determining whether the products 
manufactured abroad are accurately labeled. 

J. Compliance by Manufacturers of Products Manufactured With 
Controlled Substances (Section 82.116) 

   This section has been changed to describe the revised pass-
through requirement for products manufactured with controlled 
substances as discussed earlier. It also clarifies the treatment 
of imports. Any importer that introduces foreign products into 
interstate commerce must ensure that the product is properly 
labeled, unless the importer has a reasonable belief that the 
import does not require a warning statement pursuant to 82.102 
of the regulation at the site of Customs clearance. Products 
of foreign incorporated companies manufacturing products
"manufactured 
with" controlled substances are subject to the requirements 
of this subpart if they are imported as defined above. Paragraph 
(c), "Contractual obligations," states that importers may use 
contractual obligations to show evidence of reasonable belief 
that the products manufactured by foreign manufacturers and 
suppliers are properly labeled. 

K. Compliance by Wholesalers, Distributors and Retailers (Section 
82.118) 

   This section describes the responsibilities of distributors, 
wholesalers and retailers who must pass the label through from 
their suppliers of products or containers containing or products 
manufactured with controlled substances to the ultimate consumer. 
The section remains unchanged. 

L. Recoverable Substances Label (Section 82.120) 

   This section is deleted. 

M. Petitions (Section 82.120) 

   This new 82.120 describes in detail the process by which 
a petitioner may submit a petition to exempt a product manufactured

with a class I substance from the labeling requirements, or 
to apply the labeling requirements to a product containing or 
manufactured with a class II substance. It also explains the 
procedures by which the Agency will review and evaluate the 
petitions and the criteria upon which the Agency will base its 
final determinations. The section remains unchanged.

N. Certification, Recordkeeping and Notice Requirements (Section 
82.122) 

   This section has been added to indicate what procedures are 
required for persons wishing to claim an exemption from labeling 
of products manufactured with CFC-113 and methyl chloroform 
based on the "reduced use exemption," as provided in 82.106(b)(2). 

O. Prohibitions (Section 82.124) 

   Paragraph (a)(1)(i) of this section states that, effective 
May 15, 1993, no product or container identified in 82.102(a) 
may enter into interstate commerce unless it bears a warning 
statement that is consistent with 82.106, or unless the product 
is temporarily exempted from the labeling requirements as having 
no potential substitutes pursuant to 82.120. Paragraph (a)(1)(i) 
has been amended to note that the following products or containers 
do not require labeling: products manufactured before May 15, 
1993, which are "grandfathered" under 82.102(c); products
containing 
only trace quantities of a controlled substance, which are exempted

from the labeling requirements under 82.106(b)(1); products 
that fall under the reduced use exemption of 82.106(b)(2); 
products intended for export only, which are exempted under 
82.106(b)(3); products that are under repair, which are exempted 
under 82.106(b)(4); products undergoing research and development, 
which are exempted under 82.106(b)(5). This section has also 
been amended to indicate: (1) That manufacturers who incorporate 
products purchased from other manufacturers, where such
incorporated 
products have been manufactured with controlled substances, 
are exempt from the prohibition on removal of the warning
statement, 
under 82.112(c); and (2) that manufacturers and importers are 
not required to pass through and incorporate the information 
that accompanies the incorporated products, pursuant to 82.116(a). 
   The placement of the label for products identified in 82.102(a) 
must comply with 82.108, unless the product is temporarily 
exempted pursuant to 82.120. Paragraph (a)(2)(1) has been amended 
to indicate the exclusions under 82.102(c), 82.106(b), 82.112(c), 
and 82.116(a) discussed above. Such products must bear the warning 
statement pursuant to 82.110, unless the label is temporarily 
exempted pursuant to 82.120. Paragraph (a)(3)(i) has been amended 
to indicate that such labeling is not required if the product 
is not required to bear a label pursuant to 82.102(c), 82.106(b), 
82.112(c) or 82.116(a). 
   Similar provisions apply to products manufactured with or 
containing class II substances, as indicated in 82.102(b), 
except that the effective date of the rules as they apply to 
such products is January 1, 2015, or at any time after May 15, 
1993 that the Administrator finds for a certain product that 
substitute products or processes are potentially available. 
Also, the exclusions discussed above under 82.102(c), 82.106(b)(2) 
and 82.120 are inapplicable to such products. 
   A new paragraph (a)(5) has been added to this section to 
indicate the effective date of these prohibitions for effected 
"products manufactured with" and "products and containers
containing" 
newly listed substances. 
   Paragraph (b), which referred to the recoverable substances 
label, is deleted from this section, as that label is no longer 
required. 

VII. Effective Date 

   The effective date for the labeling requirements in the final 
rule remains unchanged; section 611 of the Clean Air Act
specifically 
states that the labeling requirements for products manufactured 
with class I substances, products containing class I substances, 
and containers containing class I or class II substances are 
effective 30 months following the enactment of the law, or May 
15, 1993. The labeling of products "manufactured with" and
"containing" 
class II substances is required beginning January 1, 2015.
(Labeling 
of particular products manufactured with or containing class 
II substances may be required before January 1, 2015, if the 
Administrator determines, after notice and opportunity for comment,

that adequate substitutes are available. This rulemaking does 
not include any such determinations.) EPA does not have the 
authority under section 611 to revise the effective dates. 
   EPA recognizes the practical problems the regulated community 
will have in meeting the May 15, 1993 deadline for labeling 
of products and containers containing class I substances, products 
manufactured with class I substances and containers of class 
II substances, given the late publication of this rule. The 
Agency recognizes that Congress intended in section 611 that 
there be one year between promulgation of these regulations 
and the effective date of the labeling requirements, and that 
these final regulations have been promulgated over eight months 
later than Congress intended. The Agency also realizes, based 
on the comments it has received and its own information relating 
to the complexity of implementing these labeling requirements, 
that most manufacturers will need as long as nine months after 
the date of publication of this rule to comply with these
requirements. 
As a result of these concerns, it is the Agency's policy to 
take no enforcement action for matters occurring during the 
first nine months following the publication of these regulations. 
   The applicability section of the regulations also provides 
that the effective date of the labeling requirements as they 
apply to substances listed as class I or class II substances 
after the promulgation of the regulation will be as provided 
in the final rule listing the substances, but will in no case 
be longer than one year after listing. EPA believes that
manufacturers 
will need some amount of lead time after a substance is newly 
listed before it can comply with the labeling regulations. However,

section 611 appears to indicate that the labeling requirements 
must become applicable one year after listing, at the latest. 
   Section 611 does not, on its face, address the treatment 
of newly listed substances. However, its provision for one year 
of lead time between the date of promulgation of these regulations 
and the effective date of the labeling requirements, and in 
the case of products manufactured subject to the labeling
requirements 
through the petition process indicates that Congress intended 
manufacturers to have some lead time before the requirements 
took effect. EPA will therefore determine the appropriate effective

date for newly listed substances upon listing them. 

VIII. Summary of Supporting Analyses 


A. Regulatory Impact Analysis 

   Executive Order No. 12291 requires the preparation of a
regulatory 
impact analysis for major rules, defined by the order as those 
likely to result in: 
   (1) An annual effect on the economy of $100 million or more; 
   (2) A major increase in costs or prices for consumers,
individual 
industries, Federal, state or local government agencies, or 
geographic industries; or 
   (3) Significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of the 
United States-based enterprises to compete with foreign-based 
enterprises in domestic or export markets. 
   The Agency has determined that this regulation does not meet 
the definition of a major rule under E.O. 12291 and has therefore 
not prepared a formal regulatory impact analysis. EPA has instead 
prepared a detailed background economic analysis which estimates 
and compares the costs and benefits of the regulation, using 
the accelerated phaseout as a baseline. There is also a discussion 
of the latest developments of the Montreal Protocol based on 
the Fourth Meeting of the Parties in Copenhagen in November 
1992. 
   Based on many revisions to the proposed rule, labeling costs 
have significantly been reduced, such as the revised label pass-
through requirement, which greatly affects the solvent-cleaning 
sector, a broadening of label placement options, exemptions 
for expanded incidental uses of ozone-depleting substances and 
a 95% reduced use exemption provision.
   In the background economic analysis document, the Agency 
provides estimates of the potential costs and benefits in monetary 
terms; however, these may not represent all of the potential 
costs and benefits of the labeling regulation. The costs and 
benefits are expected to correspond relative to one another; 
in other words, the higher the benefits, the higher the costs. 
For example, if consumers choose not to purchase products with 
warning statements, there could be a corresponding decrease 
in the use of ozone-depleting substances. If manufacturers
anticipate 
a significant decline in profits due to labeling, they may choose 
to reformulate or redesign their products in order to eliminate 
their use of ozone-depleting substances in their manufacturing 
processes. They would therefore avoid having to label their 
products. In this case, costs associated with reformulation 
or redesigning will increase, while costs of labeling will
decrease. 
If manufacturers decide to label their products, only the costs 
of labeling will be incurred. Benefits will occur when companies 
reformulate their products or manufacturing processes to avoid 
labeling due to the reduction in use of ozone-depleting substances.

   The Agency estimates that the total cost of labeling products 
to be $179.3 million per year (see docket, "Regulatory Impact 
Analysis of the Rule Requiring Labeling of Products Containing 
or Manufactured with Ozone-Depleting Substances," Chapter 5, 
"Comparison of Costs and Benefits"), based on 1992 dollars. 
It further estimated that the costs of reformulation or redesigning

will total $292.8 million at a 7% discount rate, and $351.7 
million at a 2% discount rate. The total costs in 1992 dollars, 
applying both discount rates, would be $472.1 million and $531 
million respectively. 
   The total annualized costs at the 7% discount rate would 
total $180 million over three years and, $184 million at the 
2% discount rate. 
   The benefits for labeling are based on a per kilogram value 
of $1.00 per year through the year 2075, as established in the 
Phaseout RIA for the regulation implementing section 604 of 
the Act (57 FR 33788, July 31, 1992). The benefits of reducing 
the emissions of methyl chloroform attributed to product
reformulations 
are estimated to entail a value range of $27.2 million to $180.9 
million, at a 7% discount rate, and $190.5 million to $720.2 
million at a 2% discount rate. The annualized benefits associated 
with the reduced emissions of ozone-depleting substances as 
a result of decreased sales of labeled products are estimated, 
using both discount rates, at $41.55 million and $273.8 million 
respectively. 
   The total annualized benefits are estimated therefore to 
range from $5 million to $11 million over about 75 years at 
a 7% discount rate, and $12 million to $25 million over the 
same period of time at a 2% discount rate. 

B. Regulatory Flexibility Analysis 

   The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires 
that Federal agencies examine the impacts of their regulations 
on small entities. Under 5 U.S.C. 604(a), whenever the Agency 
is required to publish a general notice of proposed rulemaking, 
it must prepare and make available for public comment an initial 
Regulatory Flexibility Analysis (RFA). Such an analysis is not 
required if the head of an Agency certifies that a rule will 
not have a significant economic impact on a substantial number 
of small entities, pursuant to 5 U.S.C. 605(b). 
   The Agency believes that the regulation will not have a
significant 
impact on a substantial number of small entities and has concluded,

as a result, that a formal RFA is not necessary. Instead, EPA 
has prepared an informal analysis of the impact on small entities 
in the background economic document (see docket). The Agency 
considered an across-the-board exemption for small entities, 
but made the final determination that section 611 does not
authorize 
an exemption since Congress made no indication of such. In
addition, 
the Agency considered an extension of one year for small entities; 
however, the final determination was made that Congress prescribed 
an effective date of May 15, 1993 which is inflexible to
extensions. 
Nevertheless, despite these decisions, EPA believes that all 
businesses will find the costs of the rule minimized due to 
several key amendments to the labeling requirements described 
above. The "grandfather" provision for inventory, the revised 
label pass-through requirement for products manufactured with 
class I substances, and several exemptions related to ozone-
depleting substance use are some of the key changes to the proposed

rule which will reduce the tracking, time and cost burdens
associated 
with the proposal that small businesses would otherwise face. 
   EPA concludes that these changes to the labeling requirements 
do not warrant a formal regulatory flexibility analysis for 
the final rule. Similar to the draft RIA for the NPRM, this 
document analyzes the impacts on companies based on their size 
of annual sales. 

C. Paperwork Reduction Act 

   The information collection requirements in this rule have 
been submitted for approval to the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 
et seq. These requirements are not effective until OMB approves 
them and a technical amendment to that effect is published in 
the Federal Register. 
   Public reporting burden for this collection of information 
is estimated to vary from 5 to 12 hours per response with an 
average of 8 hours per response, including time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing the collection of 
information. 
   Send comments regarding the burden estimate or any other 
aspect of this collection of information, including suggestions 
for reducing this burden to Chief, Information Policy Branch, 
PM-223Y, US EPA, 401 M Street, SW., Washington, DC 20460; and 
to the Office of Information and Regulatory Affairs, Office 
of Management and Budget, Washington, DC 20503, marked "Attention: 
Desk Officer for EPA." The Agency will respond to any OMB or 
public comments on the information collection request. 

IX. References 

   Federal Trade Commission. Staff Report on the Cigarette
Advertising 
Investigation (1981)
   Rudd, Joel. "Aiding Consumer Nutrition Decisions with the 
Simple Graphic Label Format." Home Economics Research Journal 
(March, 1986). 
   The Green Report: Findings and Preliminary Recommendations 
for Responsible Environmental Advertising. Ten State Task Force 
of Attorneys General (November, 1990). 
   The Green Report II: Recommendations for Responsible
Environmental 
Advertising. Ten-State Task Force of Attorneys General (May, 
1991). 
   United Nations Environmental Programme. Ad-Hoc Technical 
Advisory Committee on ODS Destruction Technologies. 
   United Nations Environmental Programme. Electronics, Degreasing 
and Dry Cleaning Solvents: Technical Options Report (June 30, 
1989). 
   United Nations Environmental Programme. Report of the Fourth 
Meeting of the Parties to the Montreal Protocol on Substances 
that Deplete the Ozone Layer (November 25, 1992). 
   United Nations Environmental Programme. Solvents, Coatings 
and Adhesives: Technical Options Committee Report (December, 
1991). 
   United Nations Environmental Programme. Scientific Assessment 
of Ozone Depletion: 1991 December 17, 1991). 
   United Nations Environmental Programme. Third Meetings of 
the Parties to the Montreal Protocol on Substances that Deplete 
the Ozone Layer: UNEP/OzL.Pro.3/L.4/Add.4 (Nairobi, 19-21 June, 
1991). 
   United States Department of Commerce, National Bureau of 
Standards. The Development of Effective Symbol Signs (1982). 
   United States Department of Health and Human Service, Food 
and Drug Administration. Compliance Costs of Food Labeling
Regulations 
(1991). 
   United States Environmental Protection Agency. Manual of 
Practices to Reduce and Eliminate CFC-113 Use in the Electronics 
Industry (March, 1990). 

List of Subjects in 40 CFR Part 82 Administrative practice and 
procedure

   Air pollution control, Chemicals, Chloroflourocarbons, Exports, 
Imports, Interstate commerce, Pass-through requirement, Reporting 
and recordkeeping requirements, Stratospheric ozone layer.

   Dated: January 19, 1993.

William K. Reilly, 
Administrator. 
   Title 40, Code of Federal Regulations, part 82, is amended 
to read as follows: 

PART 82-PROTECTION OF STRATOSPHERIC OZONE 

   1.The authority citation for part 82 continues to read as 
follows:

   Authority: 42 U.S.C. 7414, 7601, 7671-7671(q). 
   2.A new subpart E is added to read as follows: 

Subpart E-The Labeling of Products Using Ozone-Depleting Substances

Sec. 
82.100 Purpose. 
82.102 Applicability. 
82.104 Definitions. 
82.106 Warning statement requirements. 
82.108 Placement of warning statement. 
82.110 Form of label bearing warning statement. 
82.112 Removal of label bearing warning statement. 
82.114 Compliance by manufacturers and importers with requirements 
    for labeling of containers of controlled substances, or 
    products containing, controlled substances. 
82.116 Compliance by manufacturers or importers incorporating 
    products manufactured with controlled substances. 
82.118 Compliance by wholesalers, distributors and retailers. 
82.120 Petitions. 
82.122 Certification, recordkeeping, and notice requirements. 
82.124 Prohibitions. 

Subpart E-The Labeling of Products Using Ozone-Depleting Substances


82.100   Purpose. 

   The purpose of this subpart is to require warning statements 
on containers of, and products containing or manufactured with, 
certain ozone-depleting substances, pursuant to section 611 
of the Clean Air Act, as amended. 

82.102   Applicability. 

   (a) In the case of substances designated as class I or class 
II substances as of February 11, 1993, the requirements in this 
paragraph are applicable beginning on May 15, 1993. In the case 
of any substance designated as a class I or class II substance 
after February 11, 1993, the requirements in this paragraph 
of this section are applicable beginning either one year after 
the effective date of such designation or the date provided 
in the rulemaking designating such substance as a class I or 
class II substance, whichever comes first. On the applicability 
date indicated above, the requirements of this subpart shall 
apply to the following containers and products except as exempted 
under paragraph (c) of this section: 
   (1) All containers in which a class I or class II substance 
is stored or transported. 
   (2) All products containing a class I substance. 
   (3) All products directly manufactured with a process that 
uses a class I substance, unless otherwise exempted by this 
subpart or, unless the Administrator determines for a particular 
product that there are no substitute products or manufacturing 
processes for such product that do not rely on the use of a 
class I substance, that reduce overall risk to human health 
and the environment, and that are currently or potentially
available. 
If the Administrator makes such a determination for a particular 
product, then the requirements of this subpart are applicable 
for such product no later than January 1, 2015. 
   (b) Beginning on January 1, 2015 in any case, or one year 
after any determination between May 15, 1993 and January 1, 
2015, by the Administrator for a particular product that there 
are substitute products or manufacturing processes for such 
product that do not rely on the use of a class I or class II 
substance, that reduce the overall risk to human health and 
the environment, and that are currently or potentially available, 
the requirements of this subpart shall apply to the following: 
   (1) All products containing a class II substance. 
   (2) All products manufactured with a process that uses a 
class II substance. 
   (c) The requirements of this subpart shall not apply to products

manufactured prior to May 15, 1993, provided that the manufacturer 
submits documentation to EPA upon request showing that the product 
was manufactured prior to that date. 

82.104   Definitions. 

   (a) Class I substance means any substance designated as class 
I in 40 CFR part 82, appendix A to subpart A, including
chlorofluorocarbons, 
halons, carbon tetrachloride and methyl chloroform and any other 
substance so designated by the Agency at a later date. 
   (b) Class II substance means any substance designated as 
class II in 40 CFR part 82, appendix A to subpart A, including 
hydrochlorofluorocarbons and any other substance so designated 
by the Agency at a later date. 
   (c) Consumer means a commercial or non-commercial purchaser 
of a product or container that has been introduced into interstate 
commerce. 
   (d) Container means the immediate vessel in which a controlled 
substance is stored or transported. 
   (e) Container containing means a container that physically 
holds a controlled substance within its structure that is intended 
to be transferred to another container, vessel or piece of
equipment 
in order to realize its intended use. 
   (f) Controlled substance means a class I or class II ozone-
depleting substance. 
   (g) Distributor means a person to whom a product is delivered 
or sold for purposes of subsequent resale, delivery or export. 
   (h) Export means the transport of virgin, used, or recycled 
class I or class II substances or products manufactured or
containing 
class I or class II substances from inside the United States 
or its territories to persons outside the United States or its 
territories, excluding United States military bases and ships 
for on-board use. 
   (i) Exporter means the person who contracts to sell class 
I or class II substances or products manufactured with or
containing 
class I or class II substances for export or transfers such 
substances or products to his affiliate in another country. 
   (j) Import means to land on, bring into, or introduce into, 
or attempt to land on, bring into, or introduce into any place 
subject to the jurisdiction of the United States whether or 
not such landing, bringing, or introduction constitutes an
importation 
within the meaning of the customs laws of the United States, 
with the following exceptions: 
   (1) Temporary off-loading of products manufactured with or 
containers containing class I or class II substances from a 
ship are used for servicing of that ship, and 
   (2) Bringing containers of class I or class II substances 
or products containing or manufactured with class I or class 
II substances into the U.S. from Mexico where the class I or 
class II substance or container or product had been admitted 
into Mexico in bond and is of U.S. origin. 
   (k) Importer means any person who imports a controlled
substance, 
a product containing a controlled substance, or any other chemical 
substance (including a chemical substance shipped as part of 
a mixture or article), into the United States. "Importer" includes 
the person primarily liable for the payment of any duties on 
the merchandise or an authorized agent acting on his or her 
behalf. The term also includes, as appropriate: 
   (1) The consignee, 
   (2) The importer of record listed on U.S. Customs Service 
forms for the import, 
   (3) The actual owner if an actual owner's declaration and 
superseding bond has been filed; or 
   (4) The transferee, if the right to draw merchandise in a 
bonded warehouse has been transferred. 
   (l) Interstate commerce means the distribution or transportation

of any product between one state, territory, possession or the 
District of Columbia, and another state, territory, possession 
or the District of Columbia, or the sale, use or manufacture 
of any product in more than one state, territory, possession 
or District of Columbia. The entry points for which a product 
is introduced into interstate commerce are the release of a 
product from the facility in which the product was manufactured, 
the entry into a warehouse from which the domestic manufacturer 
releases the product for sale or distribution, and at the site 
of United States Customs clearance. 
   (m) Manufactured with a controlled substance means that the 
manufacturer of the product itself used a controlled substance 
directly in the product's manufacturing, but the product itself 
does not contain the controlled substance at the point of
introduction 
into interstate commerce. The following situations are excluded 
from the meaning of the phrase "manufactured with" a controlled 
substance: 
   (1) Where a product has not had physical contact with the 
controlled substance; or 
   (2) Where the manufacturing equipment has had physical contact 
with a controlled substance in an intermittent manner, not as 
a routine part of the direct manufacturing process; or 
   (3) Where the controlled substance has been transformed, 
except for trace quantities. 
   (n) Potentially available means that adequate information 
exists to make a determination that the substitute is
technologically 
feasible, environmentally acceptable and economically viable. 
   (o) Principal display panel (PDP) means the entire portion 
of the surface of a product, container or its outer packaging 
that is most likely to be displayed, shown, presented, or examined 
under customary conditions of retail sale. The area of the PDP 
is not limited to the portion of the surface covered with existing 
labeling; rather it includes the entire surface, excluding flanges,

shoulders, handles, or necks. 
   (p) Product means an item or category of items manufactured 
from raw or recycled materials, or other products, which is 
used to perform a function or task. 
   (q) Product containing means a product including, but not 
limited to, containers, vessels, or pieces of equipment, that 
physically holds a controlled substance at the point of sale 
to the ultimate consumer which remains within the product. 
   (r) Promotional printed material means any informational 
or advertising material (including, but not limited to, written 
advertisements, brochures, circulars, desk references and fact 
sheets) that is prepared by the manufacturer for display or 
promotion concerning a product or container, and that does not 
accompany the product to the consumer. 
   (s) Retailer means a person to whom a product is delivered 
or sold, if such delivery or sale is for purposes of sale or 
distribution in commerce to consumers who buy such product for 
purposes other than resale. 
   (t) Supplemental printed material means any informational 
material (including, but not limited to, package inserts, fact 
sheets, invoices, material safety data sheets, procurement and 
specification sheets, or other material) which accompanies a 
product or container to the consumer at the time of purchase. 
   (u) Transform means to use and entirely consume a class I 
or class II substance, except for trace quantities, by changing 
it into one or more substances not subject to this subpart in 
the manufacturing process of a product or chemical. 
   (v) Type size means the actual height of the printed image 
of each capital letter as it appears on a label. 
   (w) Ultimate consumer means the first commercial or
non-commercial 
purchaser of a container or product that is not intended for 
re-introduction into interstate commerce as a final product 
or as part of another product. 
   (x) Warning label means the warning statement required by 
section 611 of the Act. The term warning statement shall be 
synonymous with warning label for purposes of this subpart. 
   (y) Wholesaler means a person to whom a product is delivered 
or sold, if such delivery or sale is for purposes of sale or 
distribution to retailers who buy such product for purposes 
of resale. 

82.106   Warning statement requirements. 

   (a) Required warning statements. Unless otherwise exempted 
by this subpart, each container or product identified in 82.102(a) 
or (b) shall bear the following warning statement, meeting the 
requirements of this subpart for placement and form: 

   WARNING: Contains [or Manufactured with, if applicable] [insert 
name of substance], a substance which harms public health and 
environment by destroying ozone in the upper atmosphere.

   (b) Exemptions from warning label requirement. 
   The following products need not bear a warning label: 
   (1) Products in which trace quantities of a controlled substance

remain as a residue or impurity due to a chemical reaction, 
and where the controlled substance serves no useful purpose 
in or for the product itself. 
   (2) Products manufactured using methyl chloroform or CFC-
113 by persons who can demonstrate and certify a 95% reduction 
in overall usage from their 1990 calendar year usage of methyl 
chloroform or CFC-113 as solvents during a twelve (12) month 
period ending within sixty (60) days of such certification or 
during the most recently completed calendar year. In calculating 
such reduction, persons may subtract from quantities used those 
quantities for which they possess accessible data that establishes 
the amount of methyl chloroform or CFC-113 transformed. Such 
subtraction must be performed for both the applicable twelve 
month period and the 1990 calendar year. If at any time future 
usage exceeds the 95% reduction, all products manufactured with 
methyl chloroform or CFC-113 as solvents by that person must 
be labeled immediately. No person may qualify for this exemption 
after May 15, 1994. 
   (3) Products intended only for export outside of the United 
States shall not be considered "products introduced into interstate

commerce" provided such products are clearly designated as intended

for export only. 
   (4) Products that are otherwise not subject to the requirements 
of this subpart that are being repaired, using a process that 
uses a controlled substance. 
   (5) Products, processes, or substitute chemicals undergoing 
research and development, by which a controlled substance is 
used. Such products must be labeled when they are introduced 
into interstate commerce. 
   (c) Interference with other required labeling information. 
The warning statement shall not interfere with, detract from, 
or mar any labeling information required on the labeling by 
federal or state law. 

82.108   Placement of warning statement. 

   The warning statement shall be placed so as to satisfy the 
requirement of the Act that the warning statement be "clearly 
legible and conspicuous." The warning statement is clearly legible 
and conspicuous if it appears with such prominence and
conspicuousness 
as to render it likely to be read and understood by consumers 
under normal conditions of purchase. Such placement includes, 
but is not limited to, the following: 
   (a) Display panel placement. For any affected product or 
container that has a display panel that is normally viewed by 
the purchaser at the time of the purchase, the warning statement 
described in 82.106 may appear on any such display panel of 
the affected product or container such that it is "clearly legible 
and conspicuous" at the time of the purchase. If the warning 
statement appears on the principal display panel or outer packaging

of any such affected product or container, the warning statement 
shall qualify as "clearly legible and conspicuous," as long 
as the label also fulfills all other requirements of this subpart 
and is not obscured by any outer packaging, as required by
paragraph 
(b) of this section. The warning statement need not appear on 
such display panel if either: 
   (1) The warning statement appears on the outer packaging 
of the product or container, consistent with paragraph (b) of 
this section, and is clearly legible and conspicuous; or 
   (2) The warning statement is placed in a manner consistent 
with paragraph (c) of this section.
   (b) Outer packaging. If the product or container is normally 
packaged, wrapped, or otherwise covered when viewed by the
purchaser 
at the time of the purchase the warning statement described 
in 82.106 shall appear on any outer packaging, wrapping or 
other covering used in the retail display of the product or 
container, such that the warning statement is clearly legible 
and conspicuous at the time of the purchase. If the outer packaging

has a display panel that is normally viewed by the purchaser 
at the time of the purchase, the warning statement shall appear 
on such display panel. If the warning statement so appears on 
such product's or container's outer packaging, it need not appear 
on the surface of the product or container, as long as the
statement 
also fulfills all other requirements of this subpart. The warning 
statement need not appear on such outer packaging if either: 
   (1) The warning statement appears on the surface of the product 
or container, consistent with paragraph (a) of this section, 
and is clearly legible and conspicuous through any outer packaging,

wrapping or other covering used in display; or 
   (2) The warning statement is placed in a manner consistent 
with paragraph (c) of this section. 
   (c) Alternative placement. The warning statement may be placed 
on a hang tag, tape, card, sticker, invoice, bill of lading, 
supplemental printed material, or similar overlabeling that 
is securely attached to the container, product, outer packaging 
or display case, or accompanies the product containing or
manufactured 
with a controlled substance or a container containing class 
I or class II substances larger than a 55 gallon drum through 
its sale to the consumer or ultimate consumer. For prescription 
medical products that have been found to be essential for patient 
health by the Food and Drug Administration, the warning statement 
may be placed in supplemental printed material intended to be 
read by the prescribing physician, as long as the following 
statement is placed on the product, its packaging, or supplemental 
printed material intended to be read by the patient: "This product 
contains [insert name of substance], a substance which harms 
the environment by depleting ozone in the upper atmosphere." 
In any case, the warning statement must be clearly legible and 
conspicuous at the time of the purchase. 
   (d) Products not viewed by the purchaser at the time of
purchase. 
Where the purchaser of a product cannot view a product, its 
packaging or alternative labeling such that the warning statement 
is clearly legible and conspicuous at the time of purchase, 
as specified under paragraphs (a), (b), or (c) of this section, 
the warning statement may be placed in the following manner: 
   (1) Where promotional printed material is prepared for display 
or distribution, the warning statement may be placed on such 
promotional printed material such that it is clearly legible 
and conspicuous at the time of purchase; or 
   (2) The warning statement may be placed on the product, on 
its outer packaging, or on alternative labeling, consistent 
with paragraphs (a), (b), or (c) of this section, such that 
the warning statement is clearly legible and conspicuous at 
the time of product delivery, if the product may be returned 
by the purchaser at or after the time of delivery or if the 
purchase is not complete until the time of delivery (e.g., products

delivered C.O.D.). 

82.110   Form of label bearing warning statement. 

   (a) Conspicuousness and contrast. (1) The warning statement 
shall appear in conspicuous and legible type by typography, 
layout, and color with other printed matter on the label. (2) 
The warning statement shall appear in sharp contrast to any 
background upon which it appears. Examples of combinations of 
colors which may not satisfy the proposed requirement for sharp 
contrast are: black letters on a dark blue or dark green
background, 
dark red letters on a light red background, light red letters 
on a reflective silver background, and white letters on a light 
gray or tan background. 
   (b) Name of substance. The name of the class I or class II 
substance to be inserted into the warning statement shall be 
the standard chemical name of the substance as listed in 40 
CFR part 82, appendix A to subpart A, except that: 
   (1) The acronym "CFC" may be substituted for
"chlorofluorocarbon." 
   (2) The acronym "HCFC" may be substituted for
"hydrochlorofluorocarbon." 
   (3) The term "1,1,1-trichloroethane" may be substituted for 
"methyl chloroform." 
   (c) Combined statement for multiple class I substances. If 
a container containing or a product contains or is manufactured 
with, more than one class I or class II substance, the warning 
statement may include the names of all of the substances in 
a single warning statement, provided that the combined statement 
clearly distinguishes which substances the container or product 
contains and which were used in the manufacturing process. 
   (d) Format. (1) The warning statement shall be blocked within 
a square or rectangular area, with or without a border. 
   (2) The warning statement shall appear in lines that are 
parallel to the surrounding text on the product's PDP, display 
panel, supplemental printed material or promotional printed 
material. 
   (e) Type style. (1) The ratio of the height of a capital 
letter to its width shall be such that the height of the letter 
is no more than 3 times its width. 
   (2) The signal word "WARNING" shall appear in all capital 
letters.
   (f) Type size. The warning statement shall appear at least 
as large as the type sizes prescribed by this paragraph. The 
type size refers to the height of the capital letters. A larger 
type size materially enhances the legibility of the statement 
and is desirable. 
   (1) Display panel or outer packaging. Minimum type size
requirements 
for the warning statement are given in Table 1 and are based 
upon the area of the display panel of the product or container. 
Where the statement is on outer packaging, as well as the display 
panel area, the statement shall appear in the same minimum type 
size as on the display panel. 


                                        Table 1                    
                   
                                                                   
                   
컴컴컴컴컴컴컴컴컴컫컴컴컴컴컴쩡컴컴컴컴컫컴컴컴컴컴쩡컴컴컴컴컫컴컴컴컴컴쩡컴컴컴컴컴
  Area of display      0-2      >2-5     
>5-10    >10-15    >15-30      >30   
 
  panel (sq.in.)                                
                                
컴컴컴컴컴컴컴컴컴컵컴컴컴컴컴탠컴컴컴컴컵컴컴컴컴컴탠컴컴컴컴컵컴컴컴컴컴탠컴컴컴컴컴
                                                
                                
Type size (in.){1}                              
                                
 :                                              
                                
 Signal word .....      3/64      1/16      3/32
     7/64       1/8      5/32   
 Statement........      3/64      3/64      1/16
     3/32      3/32      7/64   
컴컴컴컴컴컴컴컴컴컨컴컴컴컴컴좔컴컴컴컴컨컴컴컴컴컴좔컴컴컴컴컨컴컴컴컴컴좔컴컴컴컴컴
  > means greater than                                          
                      
  {1} minimum height of printed image of letters                   
                   


   (2) Alternative placement. The minimum type size for the 
warning statement on any alternative placement which meets the 
requirements of 82.108(c) is 3/32 inches for the signal word 
and 1/16 of an inch for the statement. 
   (3) Promotional printed material. The minimum type size for 
the warning statement on promotional printed material is 3/32 
inches for the signal word and 1/16 of an inch for the statement, 
or the type size of any surrounding text, whichever is larger. 

82.112  Removal of label bearing warning statement.

   (a) Prohibition on removal. Except as described in paragraph 
(b) or (c) of this section, any warning statement that accompanies 
a product or container introduced into interstate commerce, 
as required by this subpart, must remain with the product or 
container and any product incorporating such product or container, 
up to and including the point of sale to the ultimate consumer. 
   (b) Incorporation of warning statement by subsequent
manufacturers. 
A manufacturer of a product that incorporates a product that 
is accompanied by a label bearing the warning statement may 
remove such label from the incorporated product if the information 
on such label is incorporated into a warning statement accompanying

the manufacturer's product, or if, pursuant to paragraph (c) 
of this section, the manufacturer of the product is not required 
to pass through the information contained on or incorporated 
in the product's label. 
   (c) Manufacturers that incorporate products manufactured 
with controlled substances. A manufacturer that incorporates 
into its own product a component product that: 
   (1) Was purchased from another manufacturer; 
   (2) Was manufactured with a process that uses a controlled 
substance(s); but 
   (3) Does not contain such substance(s), may remove such label 
from the incorporated product and need not apply a warning
statement 
to its own product, if the manufacturer does not use a controlled 
substance in its own manufacturing process. 
   A manufacturer that uses controlled substances in its own 
manufacturing process, and is otherwise subject to the regulations 
of this subpart, must label pursuant to 82.106, but need not 
include information regrading the incorporated product on the 
required label. 

82.114   Compliance by manufacturers and importers with
requirements 
for labeling of containers of controlled substances, or products 
containing controlled substances. 

   (a) Compliance by manufacturers and importers with requirements 
for labeling of containers of controlled substances, or products 
containing controlled substances. Each manufacturer of a product 
incorporating another product or container containing a controlled 
substance, to which 82.102 (a)(1), or, (a)(2) or (b)(1) applies, 
that is purchased or obtained from another manufacturer or
supplier, 
is required to pass through and incorporate the labeling
information 
that accompanies such incorporated product in a warning statement 
accompanying the manufacturer's finished product. Each importer 
of a product, or container containing a controlled substance, 
to which 82.102 (a)(1), (a)(2), or (b)(1) applies, including 
a component product or container incorporated into the product, 
that is purchased from a foreign manufacturer or supplier, is 
required to apply a label, or to ensure that a label has been 
properly applied, at the site of U.S. Customs clearance. 
   (b) Reliance on reasonable belief. The manufacturer or importer 
of a product that incorporates another product containing from 
another manufacturer or supplier may rely on the labeling
information 
(or lack thereof) that it receives with the product, and is 
not required to independently investigate whether the requirements 
of this subpart are applicable to such purchased product or 
container, as long as the manufacturer reasonably believes that 
the supplier or foreign manufacturer is reliably and accurately 
complying with the requirements of this subpart. 
   (c) Contractual obligations. A manufacturer's or importer's 
contractual relationship with its supplier under which the supplier

is required to accurately label, consistent with the requirements 
of this subpart, any products containing a controlled substance 
or containers of a controlled substance that are supplied to 
the manufacturer or importer, is evidence of reasonable belief. 

82.116   Compliance by manufacturers or importers incorporating 
products manufactured with controlled substances. 

   (a) Compliance by manufacturers or importers incorporating 
products manufactured with controlled substances, or importing 
products manufactured with controlled substances. Each manufacturer

or importer of a product incorporating another product to which 
82.102 (a)(3), or, (b)(2) applies, that is purchased from another 
manufacturer or supplier, is not required to pass through and 
incorporate the labeling information that accompanies such
incorporated 
product in a warning statement accompanying the manufacturer's 
or importer's finished product. Importers of products to which 
82.102 (a)(3) or (b)(2) applies are required to apply a label, 
or to ensure that a label has been properly applied at the site 
of U.S. Customs clearance. 
   (b) Reliance on reasonable belief. The importer of a product 
purchased or obtained from a foreign manufacturer or supplier, 
which product may have been manufactured with a controlled
substance, 
may rely on the information that it receives with the purchased 
product, and is not required to independently investigate whether 
the requirements of this subpart are applicable to the purchased 
or obtained product, as long as the importer reasonably believes 
that there was no use of controlled substances by the final 
manufacturer of the product being imported. 
   (c) Contractual obligations. An importer's contractual
relationship 
with its supplier under which the supplier is required to
accurately 
label, consistent with the requirements of this subpart, any 
products manufactured with a controlled substance that are supplied

to the importer, or to certify to the importer whether a product 
was or was not manufactured with a controlled substance is evidence

of reasonable belief. 

82.118   Compliance by wholesalers, distributors and retailers. 

   (a) Requirement of compliance by wholesalers, distributors 
and retailers. All wholesalers, distributors and retailers of 
products or containers to which this subpart applies are required 
to pass through the labeling information that accompanies the 
product. 
   (b) Reliance on reasonable belief. The wholesaler, distributor 
or retailer of a product may rely on the labeling information 
that it receives with the product or container, and is not required

to independently investigate whether the requirements of this 
subpart are applicable to the product or container, as long 
as the wholesaler, distributor or retailer reasonably believes 
that the supplier of the product or container is reliably and 
accurately complying with the requirements of this subpart. 
   (c) Contractual obligations. A wholesaler, distributor or 
retailer's contractual relationship with its supplier under 
which the supplier is required to accurately label, consistent 
with the requirements of this subpart, any products manufactured 
with a controlled substance that are supplied to the wholesaler, 
distributor or retailer is evidence of reasonable belief. 

82.120   Petitions. 

   (a) Requirements for procedure and timing. Persons seeking 
to apply the requirements of this regulation to a product
containing 
a class II substance or a product manufactured with a class 
I or a class II substance which is not otherwise subject to 
the requirements, or to temporarily exempt a product manufactured 
with a class I substance, based on a showing of a lack of currently

or potentially available alternatives, from the requirements 
of this regulation may submit petitions to: Labeling Program 
Manager, Stratospheric Protection Division, Office of Atmospheric 
Programs, U.S. Environmental Protection Agency, 6202-J, 401 
M Street, SW., Washington, DC 20460. Such persons must label 
their products while such petitions are under review by the 
Agency. 
   (b) Requirement for adequate data. Any petition submitted 
under paragraph (a) of this section shall be accompanied by 
adequate data, as defined in 82.120(c). If adequate data are 
not included by the petitioner, the Agency may return the petition 
and request specific additional information. 
   (c) Adequate data. A petition shall be considered by the 
Agency to be supported by adequate data if it includes all of 
the following: 
   (1) A part clearly labeled "Section I.A." which contains 
the petitioner's full name, company or organization name, address 
and telephone number, the product that is the subject of the 
petition, and, in the case of a petition to temporarily exempt 
a product manufactured with a class I substance from the labeling 
requirement, the manufacturer or manufacturers of that product. 
   (2) For petitions to temporarily exempt a product manufactured 
with a class I substance only, a part clearly labeled "Section 
I.A.T." which states the length of time for which an exemption 
is requested. 
   (3) A part clearly labeled "Section I.B." which includes 
the following statement, signed by the petitioner or an authorized 
representative:

   I certify under penalty of law that I have personally examined 
and am familiar with the information submitted in this petition 
and all attached documents, and that, based on my inquiry of 
those individuals immediately responsible for obtaining the 
information, I believe that the submitted information is true, 
accurate, and complete. I am aware that there are significant 
penalties for submitting false information. 

   (4) A part clearly labeled "Section I.C." which fully explains 
the basis for the petitioner's request that EPA add the labeling 
requirements to or remove them from the product which is the 
subject of the petition, based specifically upon the technical 
facility or laboratory tests, literature, or economic analysis 
described in paragraphs (c)(5), (6) and (7) of this section. 
   (5) A part clearly labeled "Section II.A." which fully describes

any technical facility or laboratory tests used to support the 
petitioner's claim. 
   (6) A part clearly labeled "Section II.B." which fully explains 
any values taken from literature or estimated on the basis of 
known information that are used to support the petitioner's 
claim. 
   (7) A part clearly labeled "Section II.C." which fully explains 
any economic analysis used to support the petitioner's claim. 
   (d) Criteria for evaluating petitions. Adequate data in support 
of any petition to the Agency to add a product to the labeling 
requirement or temporarily remove a product from the labeling 
requirement will be evaluated based upon a showing of sufficient 
quality and scope by the petitioner of whether there are or 
are not substitute products or manufacturing processes for such 
product: 
   (1) That do not rely on the use of such class I or class 
II substance; 
   (2) That reduce the overall risk to human health and the 
environment; and 
   (3) That are currently or potentially available. 
   (e) Procedure for acceptance or denial of petition. (1) If 
a petition submitted under this section contains adequate data, 
as defined under paragraph (c) of this section, the Agency shall 
within 180 days after receiving the complete petition either 
accept the petition or deny the petition. 
   (2) If the Agency makes a decision to accept a petition to 
apply the requirements of this regulation to a product containing 
or manufactured with a class II substance, the Agency will notify 
the petitioner and publish a proposed rule in the Federal Register 
to apply the labeling requirements to the product. 
   (3) If the Agency makes a decision to deny a petition to 
apply the requirements of this regulation to a product containing 
or manufactured with a class II substance, the Agency will notify 
the petitioner and publish an explanation of the petition denial 
in the Federal Register. 
   (4) If the Agency makes a decision to accept a petition to 
temporarily exempt a product manufactured with a class I substance 
from the requirements of this regulation, the Agency will notify 
the petitioner and publish a proposed rule in the Federal Register 
to temporarily exempt the product from the labeling requirements. 
Upon notification by the Agency, such manufacturer may immediately 
cease its labeling process for such exempted products. 
   (5) If the Agency makes a decision to deny a petition to 
temporarily exempt a product manufactured with a class I substance 
from the requirements of this regulation, the Agency will notify 
the petitioner and may, in appropriate circumstances, publish 
an explanation of the petition denial in the Federal Register. 

82.122   Certification, recordkeeping, and notice requirements.

   (a) Certification. (1) Persons claiming the exemption provided 
in 82.106 (b)(2) must submit a written certification to the 
following address: 

Labeling Program Manager, Stratospheric Protection Division, 
   Office of Atmospheric Programs, 6202-J, 401 M Street, SW., 
   Washington, DC 20460 

   (2) The certification must contain the following information: 
   (i) The exact location of documents verifying calendar year 
1990 usage and the 95% reduced usage during a twelve month period; 
   (ii) A description of the records maintained at that location; 
   (iii) A description of the type of system used to track usage; 
   (iv) An indication of which 12 month period reflects the 
95% reduced usage; and 
   (v) Name, address, and telephone number of a contact person. 
   (3) Persons who submit certifications postmarked on or before 
May 15, 1993, need not place warning labels on their products 
manufactured using CFC-113 or methyl chloroform as a solvent. 
Persons who submit certifications postmarked after May 15, 1993, 
must label their products manufactured using CFC-113 or methyl 
chloroform as a solvent for 14 days following such submittal 
of the certification. 
   (4) Persons certifying must also include a statement that 
indicates that their future annual use will not at no time exceed 
95% of their 1990 usage. 
   (5) Certifications must be signed by the owner or a responsible 
corporate officer. 
   (6) If the Administrator determines that a person's
certification 
is incomplete or that information supporting the exemption is 
inadequate, then products manufactured using CFC-113 or methyl 
chloroform as a solvent by such person must be labeled pursuant 
to 82.106(a). 
   (b) Recordkeeping. Persons claiming the exemption under
82.106(b)(2) 
must retain supporting documentation at one of their facilities. 
   (c) Notice Requirements. Persons who claim an exemption under 
82.106(b)(2) must submit a notice to the address in paragraph 
(a)(1) of this section within 30 days of the end of any 12 month 
period in which their usage of CFC-113 or methyl chloroform 
used as a solvent exceeds the 95% reduction from calendar year 
1990. 

82.124   Prohibitions. 

   (a) Warning statement. (1) Absence or presence of warning 
statement. (i) On or after May 15, 1993, except as indicated 
in paragraph (a)(5) of this section, no container or product 
identified in 82.102(a) may be introduced into interstate commerce 
unless it bears a warning statement that complies with the
requirements 
of 82.106(a) of this subpart, unless such labeling is not required 
under 82.102(c), 82.106(b), 82.112(c), 82.116(a), or temporarily 
exempted pursuant to 82.120. 
   (ii) On or after January 1, 2015, or any time between May 
15, 1993 and January 1, 2015 that the Administrator determines 
for a particular product manufactured with or containing a class 
II substance that there are substitute products or manufacturing 
processes for such product that do not rely on the use of a 
class I or class II substance, that reduce the overall risk 
to human health and the environment, and that are currently 
or potentially available, no product identified in 82.102(b) 
may be introduced into interstate commerce unless it bears a 
warning statement that complies with the requirements of 82.106 
of this subpart, unless such labeling is not required under 
82.106(b), 82.112(c) or 82.116(a). 
   (2) Placement of warning statement. (i) On or after May 15, 
1993, except as indicated in paragraph (a)(5) of this section, 
no container or product identified in 82.102(a) may be introduced 
into interstate commerce unless it bears a warning statement 
that complies with the requirements of 82.108 of this subpart, 
unless such labeling is not required under 82.102(c), 82.106(b), 
82.112(c), 82.116(a), or temporarily exempted pursuant to 
82.120. 
   (ii) On or after January 1, 2015, or any time between May 
15, 1993 and January 1, 2015 that the Administrator determines 
for a particular product manufactured with or containing a class 
II substance that there are substitute products or manufacturing 
processes for such product that do not rely on the use of a 
class I or class II substance, that reduce the overall risk 
to human health and the environment, and that are currently 
or potentially available, no product identified in 82.102(b) 
may be introduced into interstate commerce unless it bears a 
warning statement that complies with the requirements of 82.108 
of this subpart, unless such labeling is not required under 
82.106(b), 82.112 (c), or 82.116 (a).
   (3) Form of label bearing warning statement. (i) On or after 
May 15, 1993, except as indicated in paragraph (a)(5) of this 
section, no container or product identified in 82.102(a) may 
be introduced into interstate commerce unless it bears a warning 
statement that complies with the requirements of 82.110 of 
this subpart, unless such labeling is not required pursuant 
to 82.102(c), 82.106(b), 82.112(c), 82.116(a), or temporarily 
exempted pursuant to 82.120. 
   (ii) On or after January 1, 2015, or any time between May 
15, 1993 and January 1, 2015 that the Agency determines for 
a particular product manufactured with or containing a class 
II substance, that there are substitute products or manufacturing 
processes that do not rely on the use of a class I or class 
II substance, that reduce the overall risk to human health and 
the environment, and that are currently or potentially available, 
no product identified in 82.102(b) may be introduced into
interstate 
commerce unless it bears a warning statement that complies with 
the requirements of 82.110 of this subpart, unless such labeling 
is not required pursuant to 82.106(b), 82.112(c), or 82.116(a). 
   (4) On or after May 15, 1993, no person may modify, remove 
or interfere with any warning statement required by this subpart, 
except as described in 82.112 of this subpart. 
   (5) In the case of any substance designated as a class I 
or class II substance after [insert date of publication], the 
prohibitions in paragraphs (a)(1)(i), (a)(2)(i), and (a)(3)(i) 
of this section shall be applicable beginning one year after 
the effective date of designation of such substance as a class 
I or class II substance or shall be applicable beginning on 
the date provided in the rulemaking designating such substance 
as a class I or class II substance, whichever comes first.

[FR Doc. 93-2704 Filed 2-10-93; 8:45 am]
BILLING CODE 6560-50-P

Top of page


Local Navigation




Jump to main content.