Pesticide Labeling Questions & Answers - General Labeling

• When active ingredients, manufacturing-use products or end-use products are being imported into the United States and the proper U.S. labeling is present, are these products allowed to have other country or international labeling on the product container as well? (LC06-0034)
  
  
• Generally, to be sold or distributed in the United States, a pesticide must be registered and must be labeled in accordance with the requirements of 40 CFR part 156.  The label (all written, printed or graphic matter on, or attached to, the pesticide) and any other labeling (written, printed or graphic material which accompanies the product or is referenced to on the label) may not be misbranded (e.g. false or misleading) as set forth in FIFRA section 2(q)(1)(A) and 40 CFR part 156.  Labeling language that is in addition to that required by FIFRA and its implementing regulations may be allowed if it is not false or misleading.  Therefore, so long as the international labeling is not false or misleading, or otherwise causes the pesticide to be misbranded, it may be allowed on a product container (or accompanying the product) in addition to the U.S.-required labeling.  Determining whether specific international labeling would be allowed requires a case-by-case comparison of the U.S. label and the international label.
  
• Some pesticide products have a container label and a booklet containing the directions for use attached to the container.  The EPA Label Review Manual spells out the requirements for the container label but it does not specify requirements for the booklet.  What are the minimum requirements for booklet labels?  Do they need to have the EPA registration number?  What other information must be included in these booklets?  LC06-0068

  The booklet is considered “labeling,” defined in part as:  “all labels and all other written, printed, or graphic matter (A) accompanying the pesticide or device at any time; or (B) to which reference is made on the label or in literature accompanying the pesticide or device.”  FIFRA § 2(p)(2).  Labeling must meet the requirements of 40 CFR Part 156 and must not be false or misleading.  Most of Part 156 speaks directly to what must be on the affixed label, however, EPA allows in 40 CFR 156.10(i)(1)(ii) for directions for use to be printed on labeling other than the affixed label such as in booklets, at the Agency’s discretion.  EPA has not set forth minimum label requirements for accompanying literature (booklets).  However, when directions for use will appear in accompanying literature such as a booklet, EPA will work with the registrant to determine what other labeling elements must also appear in the booklet so that the labeling as a whole is not false or misleading and ensures proper usage of the product.

• Does the Label Review Manual (LRM) Chapter 3 section entitled "Container Label Contents When Booklets are Used" also apply when a product is attached to a "blister card" for sale?  That is, does minimum labeling on the bottle need to include the eleven listed items and the rest of the information can be on the card that holds it?  Where should the First Aid Statement appear? (LCO6-0069)

   FIFRA and the Agency's implementing regulations establish the applicable requirements for which statements must be on the product label itself.  In particular,  40 CFR 156.10(a) requires certain items to be included on the affixed label while 40 CFR 156.10(i)(1)(ii)(B) allows limited flexibility by allowing the directions for use to appear elsewhere if properly referenced on the affixed label.  The affixed label must be "securely attached," meaning it can reasonably be expected to remain affixed during "the foreseeable conditions and period of use of the product."  Generally, it is not acceptable to print the required label items only on the "blister card" because the blister card is a part of the packaging that is usually discarded as the product is opened and therefore could well be discarded even before the user first begins to actually use the pesticide product (and is almost certain to be discarded before additional applications if the product is used more than once). 

• An antimicrobial product formulated as a strip is sold in a package containing 12 and 24 strips. At the present, the label is placed only on the outer package and not on the individual units.  Do the individual units also require a label? (LC06-0071)
  
  Because the strips themselves are the pesticide product, they do not need to be individually labeled because 40 CFR 156.10(a)(4) requires labels to be securely attached to the immediate container of the product and not the product itself.  If the strips were sold or distributed individually, then the individual package for each strip would need to be labeled.  To ensure that the strips are not sold or distributed individually, one might consider adding to the label(s) a statement such as “Individual strips are not for resale.”  With today's technologies, it may be difficult to determine what is the immediate container and whether your product is correctly labeled.  We encourage applicants and registrants to discuss your packaging options when discussing labeling in order to avoid possible misbranding violations once the product is sold or distributed.
  
  
• What is OPP’s policy with respect to embossed labeling?  (LC07-0099; 09/11/2007)

  Embossed labeling must meet the requirements of 40 CFR Part 156.10(a)(2)(i) and (ii).  These sections require that: 

  “(i) All words, statements, graphic representations, designs or other information required on the labeling by the Act or the regulations in this part must be clearly legible to a person with normal vision, and must be placed with such conspicuousness (as compared with other words, statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. 
  (ii) All required text must: 
  be set in 6–point or larger type;
  Appear on a clear contrasting background; and
   Not be obscured or crowded.” 

  In general, our preference is that the lettering be adequately raised to be seen clearly and be colored in a pastel color.  In the past OPP has found that pastel colors work best for making the label clearly legible and other colors may not be legible and therefore not allowed.  OPP also prefers that registrants remove use site language which is not needed on the distributed label if the product is actually being sold or distributed for just a subset of all of its registered uses, so that all label language can be set at a type size greater than 6 point if possible (i.e., If a product is being marketed just for swimming pool use, the cooling tower use language could be left off that label.).  40 CFR 152.130(b) allows distribution under a subset of approved labeling provided no changes would be necessary in precautionary statements, use classification or packaging. 

• For rodenticides in particular, when the label reads "product may be used to control rats in and around home, buildings, etc.", what is the maximum distance from a home, building etc. that the product may be used? (LC07-0121: 11/1/07)

  The term in or around home, buildings, etc., has not been defined from the standpoint of a maximum distance.  However, the Agency’s current view is that rodenticide baits intended for use by the general public should only be used indoors and against the outside walls of buildings.  EPA intends to require rodenticide registrants to amend those labels that currently allow placement of rat and mouse baits “in and around buildings” to delete that phrase and add language limiting use to “indoors and against the outside walls of buildings.”  See 1998 Rodenticide Cluster RED, pp. vii, 106 and 119.

• In the label review manual, Section 3, regarding Final Printed label/labeling. Please clarify. Would submission of a pdf that is sent to the printer constitute a Final Printed Label or would this still be considered draft?  Does a registrant have to take a 2- step approach with the Agency to accommodate state submissions such that a pdf is submitted as an FPL with 2 copies of the actual printed version sent at a later time when available? If a pdf is considered draft labeling, how is the registrant notified that it has been provisionally accepted and within what timeframe? How long does the registrant have to submit the actual printed material? Thank you. LC08-0129; 12/13/07

Since the promulgation of EPA's regulatory labeling requirements for pesticides in 1975, technology to produce true and accurate representations of final printed labeling has significantly advanced.  To that end, true and accurate representations of final printed labeling for each pesticide product as marketed will be acceptable to meet the requirements of 40 CFR 156.10(a)(6).  Generally a provisional draft master label will be reviewed and stamped accepted prior to the submission of final printed labeling.  OPP strongly encourages applicants and registrants to submit draft labeling electronically.  See http://www.epa.gov/oppfead1/eds/edsgoals.htm for more information.  Final printed labeling is not stamped approved by the Agency but is filed in the jacket of each pesticide as a record of the label with which the product is being marketed.

• RE: Chapter 3 General Label Requirements II.B. Container Label Contents When Booklets are Used: Many products are in small package sizes, i.e. gal, pt, qt, 250 ml and all of the text cannot fit on the base label (even with a front and back bottle label) Could you define EXACTLY what information is required to be on the base label. (LC08-0130; 11/29/07)

  As described in Chapter 3.II of the Label Review Manual, the following must be on the label which is on or “securely attached” to the container.

  1. Name and address of the producer, registrant, or person for whom produced
  2. Restricted Use Statement (if required)
  3. Product Name, Brand or Trademark

  4    Ingredient Statement
  5   Signal Word, including Skull & Crossbones, if either are required
  6   "Keep Out Of Reach Of Children" (KOOROC)
  7   Precautionary Statements, including Hazards to Humans & Domestic Animals and Environmental Hazards
  8   EPA Registration Number and EPA Establishment Number
  9   Either Directions for Use or a Referral Statement to Directions for Use in booklet,  if any  
       10  Net weight or measure of contents

  Other parts of the label may be placed in a booklet or other “pull off” type labeling.  This would include C2-.Directions for Use, which includes C3- Storage and Disposal, and  C5-Worker Protection Labeling [see 40 CFR 156.206(b)(3) for information on placement and required referral statements], and C4- Warranty Statement .

• In addition to the boilerplate surface water label advisories found in the label review manual, numerous other surface water label advisories can be found on labels.  Is the language found in the label review manual just guidance to be modified on a case-by-case basis, and if so, is there any other criteria used to determine which language will be used? (LC08-0196)
  
  The boilerplate surface water advisory language found in the Label Review Manual is an example of a warning statement that has historically been required on pesticide labels based on:  their tendency to run-off and drift; and their potential surface water impacts associated with the use pattern, environmental fate properties of the pesticide, and eco- or human health risks.  These environmental fate and risk issues are typically identified during the pesticide risk assessment process.  Beyond the boilerplate statement in the label review manual, label advisories may be modified on a case-by-case basis to reduce risk to humans and the environment based on the specifics of the pesticide being reviewed.
  
  
• I would like to know how closely a pesticide product technical bulletin needs to follow the associated EPA approved label. For example, our pesticide product has all the language in the EPA label. For the technical bulletin used to market the product can we leave, for instance, the first aid instructions off of the technical bulletin? I understand that false or misleading statements cannot be made on the technical bulletin. (LC08-0215; 11/13/08)

  "Technical bulletin" is not a defined regulatory term under FIFRA and therefore it is important to understand the nature of the bulletin described in order to answer.  Upon clarification, it was found that the technical bulletin described in the question is a marketing brochure to sell the product and to provide information to customers and is not labeling as defined by FIFRA § 2(p).  It would not accompany the product and there is not a reference to the bulletin on the product label.  EPA does not have requirements for statements included on such a technical bulletin that is not a part of the labeling.  However, it must not have claims that differ from the product label.  See FIFRA § 12(a)(1)(B).  If a registrant wishes to include additional claims in non-labeling marketing materials, such claims must be submitted as part of the statement of claims to be made that is required for registration under FIFRA § 3(c)(1)(C).

• In PR 2000-5, EPA states that label advisory statements can only be added or changed by amendment.  It is silent on how to delete advisory statements.  A previous PR Notice, 95-2, states that advisory statements can be deleted by notification.  Is this still the case? (LC08-0175; 5/15/08)

  PR Notice 2000-5 states that label advisory statements can only be added or changed by amendment, but does not specifically mention deletion of advisory statements.  An earlier PR Notice, 95-2, states that adding, revising or deleting advisory statements may be accomplished by notification.  However, a later PR Notice, 98-10, modified PRN 95-2 by stating that any advisory statements required by EPA may not be deleted by notification.  With regard to deleting advisory statements the questioner is correct that the latest PR Notice, 2000-5, is silent on the issue and therefore we conclude that the earlier PR Notices 95-2 and 98-10 are both still applicable.  Registrants may continue deleting non-required advisory statements by notification.  However, PR Notice 98-10 is also still applicable in that advisory statements required by EPA (for example, a ground water advisory) may not be deleted by notification and therefore may only be deleted by amendment.

1. Use Classification
   
   
• Must the statement “Restricted Use Pesticide" appear at the very top of a section 3 supplemental or SLN label?  Can other wording or symbols appear above the RUP statement? (LC08-0219; 11/20/08)
  
  Under the regulations (40 CFR 156.10(j)(2)(i)), restricted use products must bear  statements of restricted use classification at the top of the front panel.  The Label Review Manual  (Chapter 6. III.B.1) and PR Notice 93-1 both reflect this regulatory requirement that the statement must be at the very top of the label's front panel and also state that no other wording or symbols should appear above the RUP statement.   This applies to all labels including section 3 supplemental and 24c Special Local Needs (SLN) labeling.



2. Product Name
   
   
• Regarding pesticide product names, does the EPA consider use of the term "Expert" such as in "Expert's Choice" in a brand name to be false and misleading? If so, why? LC09-0289; 9/30/09
  

  The Agency considers the use of "expert" such as in the name "Expert's Choice" to be potentially false or misleading because the term has no objective established meaning. "Expert" appears to refer to some individual or some sort of group of people, neither of which are further defined or identified. 40 CFR 156.10(b)(2) states that “No name, brand or trademark may appear on the label which: (I) Is false or misleading, …..” If pesticide labeling is false or misleading in any particular, the product is misbranded and it is a violation of FIFRA to sell or distribute a misbranded pesticide. See FIFRA 2(q)(1)(A); 12(a)(1)(E). Unless an applicant can prove otherwise to the Agency, for instance through consumer surveys, or can provide some objective meaning that is supported by evidence to "expert" on the label, the Agency considers the term “expert” (in any context) to be false and misleading.

• The following company is listed on the EPA official company name list as follows:
  ABC CHEM CO dba XYZ COMPANY. On the label, how must the company name be declared?  In other words, is it acceptable to list either of the company names, or must both company names be declared as listed in the EPA database? (LC06-0003)

  40 CFR 156.10(c) requires that the name and address of producer, registrant, or person for whom produced be included on a pesticide's label.  The name on the label should be a correct reflection of the company name in our Name & Address file, which in this case would be ABC Chem. Co. dba XYZ Company.  Please see chapter 15 of the Label Review Manual.

• A question about the appropriate name and address used on a pesticide label:  An international company holds the registration for a product and are the manufacturer.  Their USA subsidiary acts as their agent in registration activity.  Is it acceptable to indicate the name and address of the USA company with the qualifier of "Manufactured by [name of registrant]" for: [USA subsidiary]".  The USA subsidiary would also like to show their logo on the label. (LC06-0031)

   40 CFR 156.10(c) requires that the name of the producer, registrants, or person for whom the product was produced be indicated on the label.  Names of non-producers may be included if they are qualified by phrases such as "Packed for," "Distributed by," or "Sold by."  More information is available in the Label Review Manual, Chapter 15.  In the case presented in the question, the name and address of the registrant would be the foreign company.  The US agent may be indicated if properly qualified.  In addition, there would be no problem with the use of the US subsidiary's logo as long as it was not misleading or otherwise inconsistent with FIFRA or its implementing regulations.

• Regarding product names, page 12-4 of the Label Review Manual says "Exact same name cannot be used for different products registered by any one registrant."  In the case of registration transfer (purchase/merger) where supplemental distributor registrations must be reestablished under a new EPA registration number, must the same product (with the new registration number) have a new name when the supplemental distributor form is submitted? In effect, does a new EPA registration number as a result of a transfer constitute a "different product"? (LC06-0043)

  40 CFR 156.10(b) requires the name, brand, or trademark under which a pesticide product is sold to appear on the front panel of the pesticide's label.  It is acceptable for a product distributed under supplemental distribution (40 CFR 152.132), as distributor product, to use the same name as the "parent" product.  That product name would be reflected on the supplemental distribution form.  In the case of a purchase/merger of two companies, the original supplemental distribution registrations go away and new supplemental distribution registrations are created with the filing of new distributor forms.

  If a company acquires a FIFRA section 3 registered product with the same name as one of their existing products, one of the two product names must be altered to some degree so that no two products of the registrant have the exact same name. 

• The California Department of Pesticide Regulation would like confirmation on the following issue: U.S. EPA does not allow for the words "total" or "complete" as part of a product's name, unless it is part of the brand name - such as "Safer Brand" or "Total Killer Brand...." (LC07-0098)

  It has been the agency's policy not to allow the use of terms such as "total" or "complete" as part of product names because such use may be false or misleading.  Use of terms such as "total" or "complete" may be allowed as part of a brand name so long as the brand name is presented in a non-misleading way.  The Agency will work with registrants to fit potentially misleading brand names into the context of a label so that they are not misleading.

• The LRM states a registrant cannot have two products registered under the same brand name. What if the registrant is issued more than one firm number under the same company?  Does "registrant" encompass all firm numbers issued to the company under one name or would a "registrant" with multiple firm numbers be allowed to sell two products with the same name, if the only distinguishing factor is the EPA Reg. Numbers? (LC08-0198;  8/28/08)
  
  40 CFR 156.10(b) states that the name of a product must appear on the front panel of the label and it cannot be false or misleading.   The name may be considered to be false or misleading unless it is sufficiently different to enable a user to distinguish one product from another and the exact same name cannot be used by any one registrant for different registered products.  See Label Review Manual Chapter 12 (   http://www.epa.gov/oppfead1/labeling/lrm/chap-12.htm ).  The Agency would consider the same name for two different products under the same company name to be misleading regardless of whether the registration numbers are different due to multiple company numbers.  A similar question was previously answered, LC 08-0157.
  
• Can EPA register a product for one company with the same name of a product already registered by another company? (LC08-0157; 2/28/08)

  Section 2(q)(1)(C) of  the Federal  Insecticide, Fungicide and Rodenticide Act (FIFRA) states that a product is misbranded if  “ it is an imitation of, or is offered for sale under the name of another pesticide.”  Further, 40 CFR 156.10(b) states the names may not be false or misleading.  We believe the best reading of the statute and regulations is that each product must have a unique name taking into account the name, brand or trademark in context. Thus, a company could not have two products with the same name but two different companies could potentially have a product with the same name because they would be distinguishable based on their company name.  This interpretation stems from what is allowed under FIFRA and 40 CFR 156.10(b); it does not take into account any limitations on having the same name based on copyright or trademark laws.

• The label for a registered product using an alternate brand name (ABN) includes only one set of usage directions from the approved master label. If additional use sites/directions (already approved on the master label) are added to the label of the ABN product, does a notification to EPA need to be filed? (LC08-0205; 9/22/08)

  Already-approved use sites and use directions can be incorporated onto an alternate brand name label without notification to the agency.  Before any new use sites or new use directions can be incorporated on the alternate brand name label, they must first be approved and stamped accepted on the product’s master label.   

  An alternative brand name product label is an example of a “split label” (a label that bears claims and directions for only a portion of the approved uses under a given master label, but is a complete label in itself, containing all the required labeling elements).  Agency regulations allow a registrant to distribute or sell a product under a “split label” provided that in limiting the uses identified on the label, no changes would be necessary to the precautionary statements, use classification, or packaging of the product as stated in 40 CFR § 152.130(b).  Furthermore, since split labels only contain labeling text contained in the already approved master label, the split labels are not stamped “accepted” separately and don’t require notification.   

3. Name and Address of Producer/Registrant
   
   
• Is it acceptable to have the statement "Produced For" (or similar appropriate wording) on the label to qualify the registrant's name when the registrant is the manufacturer? For example, some of Registrant X's product is produced by the registrant and some is produced by another producer.  The registrant would like the label to read "Produced For X" in both instances.  (LC08-0154, 1/24/08)

  40 CFR Part 156.10(c) addresses how the name and address of a producer must be represented on the label.  The regulations are clear that an unqualified name and address is considered the name and address of the producer.  If the producer is not the registrant and the name of the registrant appears on the label, the registrant's name and address must be qualified by terms such as “Packed for,” “Distributed by,” or “Sold by."  The regulations are silent on whether the registrant could have the term “Produced For” or similar qualifier preceding their name and address on the label even when they are the producer of the product.  Therefore, in a situation where the registrant is the producer of the product, the registrant’s name and address may appear either unqualified or qualified by an appropriate term such as “Distributed by” or "Produced for" so long as they qualification is not false or misleading.  See FIFRA sec. 2(q)(1)(A)

• The Agency states that a street address or P.O. Box, in addition to the city and state, are necessary for the proper delivery of mail.   Does the Agency agree that in certain cases, where a facility-specific zip code exists, a zip code plus extension which is unique to a registrant may meet the standard of including an address necessary for proper delivery of the mail without including a full street address on the product label? (LC08-0133 and LC08-0135: 11/1/07)

  The agency agrees that a zip code that is unique to a given registrant and adequate for the delivery of mail  would meet the requirement of "address" as discussed in 40 CFR 156.10(a)(ii) and 40 CFR 152.50(b)(2).

• Must the label of a registered pesticide set forth the actual "street" address of the company or may the address be set forth as follows:  ABC Company, Albany, New York 12203? (LC07-0087)

  In accordance with the regulations at 40 CFR 156.10(a)(ii)  the label must show clearly and prominently  the name and address of the  producer, registrant or person for whom produced.  40 CFR 152.50(b)(2) also discusses an "address" requirement.  That regulation states that a registrant must provide EPA with a current address that will be used by the Agency for corresponding with the registrant.  A street address or post office box, in addition to the city and state, are necessary for the proper delivery of mail.  We believe that "address" as discussed in 40 CFR 156.10(a)(ii) and 40 CFR 152.50(b)(2) includes a street address or post office box. 

4. Product Registration
   
   
• I would like to know or have someone define the term  EPA File Symbol number on a section 18 product.  Why does the product not have an EPA Registration number? (LC08-0183)
  
  An EPA file symbol (a registrant’s company number followed by a sequence of letters) is a symbol that the Agency uses to identify a pending new product registration action.  Once the agency completes action on an application for registration of a new pesticide product and registers the product, the file symbol is changed to a registration number (a registrant’s company number followed by a set of numbers).
  
  Under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act the Administrator may authorize the use of an unregistered pesticide or unregistered use of a registered pesticide (including an unregistered pesticide product) if an emergency condition exists as described under
  40 CFR Part 166.  Some products authorized for use under section 18 have been submitted for registration and have therefore received an EPA file symbol.  The agency has not taken final action with respect to registering the product but has authorized its use under section 18.
  These products could have an EPA file symbol assigned to them and that symbol may be included on a label, however, the product may only be used in accordance with a section 18 exemption granted by the Agency.
  
  
5. Establishment
   
   
• Does the establishment number have to be on the master label before EPA will stamp the label? (LC07-0108; 09/11/2007)

  No.  40 CFR 156.10(f) states:  The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the product was produced may appear in any suitable location on the label or immediate container.  Since the establishment number does not have to be on the printed label, but may be placed on, printed on, or embossed onto the container itself, it is not necessary for the establishment number to be on the master label.

• Does changing of an EPA Establishment Number appearing on an approved label require notification or may the EPA Establishment Number be changed without notification? (LC97-0093)

  The EPA Establishment number can be placed on either the label or the product container.  PR Notice 98-10 allows under Non-Notification, factual statements about where the product is made, which could include the Establishment Number. Therefore, the number can be changed without notification.  The product must indicate the Establishment Number of the final establishment at which the product was produced.

• Pesticides are often stored at a terminal facility in large stationary bulk tanks prior to shipment to a customer.  Is an EPA establishment number required if the terminal transfers pesticide product from one tank to another?  What establishment number would go on the tank, the formulator’s or the terminal’s? (LC06 – 0077)

  If the terminal is transferring pesticides as part of the distribution of the product, it is not required to register as an establishment.  The transfer is considered part of the process of shipping the pesticide to the retailer and ultimately the end-user.  If, however, the terminal is transferring the pesticide to another container acting as a refilling establishment, the terminal must register as an establishment and put it’s establishment number on the refilled container.

• We ink jet lot numbers on the primary container and master case.   Also, registration and establishment numbers are printed on the primary label as well as the master case label.  Do the registration and establishment numbers need to appear on the master case? (LC06 - 0075)
  
  The registration and establishment number are not required to appear on the master case if the pesticide product is removed from the master case before being sold to the end-user.  If the master case is the outer container as customarily distributed or sold to the user, 40 CFR 156.10(a)(4)(i) requires that the full label must appear on the master case, including the registration and establishment numbers.  As a matter of general practice, EPA recommends that the master (outer) case bear identification of the product within to allow quick identification of the product in the case of an accident or spill.  In addition, the person shipping the pesticide must ensure that the shipment meets all applicable Department of Transportation (DOT) regulations.
  
  
6. Ingredient Statement
   
   
• Many registrants list ATCC numbers in parentheses after a specific bacteria.  If the ATCC number is present on the EPA stamped "accepted" label, must it also be present on the final marketplace label or may the registrant omit the ATCC numbers from their final product labeling? (LC08-0152; 2-21-08)

  In the past, EPA requested that American Type Culture Collection (ATCC) numbers appear on the final printed labels of products.  However, after further consideration, EPA determined that while the ATCC numbers are necessary for the Agency microbiology reviewers as identifiers for the microorganisms tested and listed on product labels, they may not have the same level of significance to the end-users of the products.  Therefore, the Agency now allows a company to list ATCC numbers in one of the following locations:

              On the data matrix provided to the Agency
              On the master label (as optional text) with the listing of the organisms claimed, or
              As the final page of the master label (as optional text).

  Thus, ATCC numbers do not have to appear on the final product labeling since the ATCC numbers may be placed on the label as optional text.

7. Precautionary
   
   
• In what size font must precautionary statements such as "Don't use with oil" be? LC09-0272; 6.26.09

  All words, statements, graphic representations, designs or other information required on pesticide labeling must be set in no smaller than 6 point font. 40 CFR 156.10(a)(2). In addition, required content must appear on a clear contrasting background, not be obscured or crowded and be rendered so that it is likely to be read and understood by the ordinary individual under customary conditions of purchase or use. Precautionary statements must abide by the same 6-point font minimum, except when larger fonts are required for front panel precautionary statements such as signal words and child hazard warnings. 40 CFR 156.60(b) provides a table indicating the minimum required font size for front panel precautionary statements, which increases with the size of the label.

• This question is in regard to placement of the First Aid statements on a Category I (Danger) product. Our understanding is that if the signal word is "Danger" the First Aid statement must be on the front panel unless EPA grants an exception. If EPA stamps accepted on a label that includes the sentence "See side [back] panels for first aid and additional precautionary statements" under the signal word, is that considered permission by the agency to move the First Aid section off the front panel? (LC09-0250; 5.27.09)

  Yes. According to 40 CFR 156.68(d), first aid statements must appear on the front panel for all Toxicity Category I products, but the regulation allows for variation upon review if the proper reference statement is on the front panel. To request variation from the standard requirement, a registrant must explain to EPA why they believe it would be more practical for the information to appear elsewhere. EPA’s approval of the label with the variation is evidence of its acceptance.

• What is the difference between the label signal words "dermal sensitizer" and "dermal irritant"? I understand the fact that there are four categories for dermal irritation, whereas there is only one for dermal sensitization, either the product is or is not a dermal sensitizer. Dermal irritants can cause erythema and edema, whereas dermal sensitizers have the potential for allergic contact dermatitis. However, contact dermatitis can be characterized by erythema (redness of the skin) and edema (essentially swelling). I could use some clarification. Thank you much. (LC07-0119; 9/24/07)

  First, "dermal sensitizer" and "dermal irritant" are not signal words.  Signal words are described in 40 CFR 156.64 and are limited to "Danger," "Warning," and "Caution."  Signal words are associated with four numbered EPA toxicity categories.  These numbered toxicity categories correspond to the following tests:  oral and dermal LD50, inhalation LC50, eye and dermal irritation.  These tests are based on a single exposure to a substance.  In contrast, dermal sensitization is an immunologically mediated cutaneous reaction to repeat exposures to a substance.  Dermal sensitization is not part of the numbered toxicity categorization scheme.  Pesticides either are or are not dermal sensitizers.  Whether a pesticide is a dermal sensitizer is based on tests as described in OPPTS 870.2600.  You are correct that the two endpoints (dermal irritant and dermal sensitization) correlate; and that is why the OPPTS 870.2600 skin sensitization procedures state the highest nonirritating dose be used for the Beuhler and GPMT tests.  While no signal word is associated with dermal sensitization, products that test positive for dermal sensitization may be required to bear precautionary label language for this endpoint such as: "Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals."  See 40 CFR 156.70. 

• Will the Agency allow the use of the GHS explosiveness symbol and the GHS flammability symbol on pesticide labeling?  Is use of these symbols limited to NAFTA labels?  (LC08-0162; 5/15/08)

  The Agency will allow the use of the GHS (Globally Harmonized System for Hazard Communication) explosiveness symbol and the GHS flammability symbol on pesticide labeling and it is not limited to NAFTA labels.  40 CFR 156.78 requires warning statements on the flammability or explosive characteristics of pesticide products meeting listed criteria.  These statements, as applicable, must remain on labels that choose to in addition use the GHS symbols.  Further, 40 CFR 156.78(d)(3) requires a flammability symbol specifically for total release fogger products and offers an example symbol.  The GHS flammability symbol is equivalent and may replace the example provided.  GHS symbols may be added by a label amendment and may not be added through notification.  The GHS symbols allowed are:

  

8. Environmental Hazards Statement
   
   
• Chapter 8. II. D. 4 of the Label Review Manual indicates when Ground Water Advisories are "generally" required.  However many labels for outdoor use meeting the specified thresholds do not have such advisories.  Imidacloprid meets the specified thresholds for the advisories and has been detected in ground water in Long Island, NY.  The labeling for the agricultural product has the ground water advisory, but the label for the termiticide product does not.  Why the inconsistency? LC08-0143; 1/10/08
  
  As pointed out in the Chapter 8.II.D.4, Ground Water Advisories are “generally” required. The ground water advisory is a case-by-case basis determination depending on the use site and available data.  Termiticides uses are generally considered indoor uses because applications involve injection through drilled holes in slabs of constructed houses, or for pre-construction, the soil is sprayed just before the foundation is poured.  Under such circumstances, OPP has not generally required ground water advisories.
  
  
9. Directions for Use
   
   
• When a label specifically states, “Not for sale or use after the expiration date,” is it a violation of FIFRA for an individual consumer to use the product after that date? LC09-0282; 9/24/09

  Section 12(a)(2)(G) of FIFRA states that “it shall be unlawful for any person to use any registered pesticide in a manner inconsistent with its labeling.” Use after the expiration date is inconsistent with the label directions and would be a violation regardless of the reason the date appears on the label.

• Is the February 6, 1991 policy decision from the Office of Compliance Monitoring's Policy and Grants Division regarding greenhouse application still current? This policy indicates "that a label must specify greenhouse in order for the product to be applied in a greenhouse". I thought EPA revised this policy, but I was told by another state that this is still EPA's current view. (LC08-0170; 5/15/08)

  The Agency’s current position on greenhouse application is that in accordance with FIFRA section 2(ee) a label does not have to specify greenhouse as a site, provided the crop is on the label, in order to use the product in a greenhouse. 

• Labels with non-agricultural use requirements often have statements such as “Do not allow people or pets on treatment area during application.  Do not enter treatment areas until sprays have dried…”

  Regarding the second sentence of that statement, is it directed at all people or just workers that the applicator has control over?  Is it the responsibility of the applicator to make sure that no one enters the treated area until sprays have dried, and if so, how can the applicator accomplish that when applying to roadside right-of –ways and other areas that they cannot realistically control? LC07-0123; 11/15/07

  The label language cited (or similar labeling) appears on many labels with non-agricultural uses and must be read carefully in the context of the entire labeling of the product. There are many variations of the statements cited above and based on the wording of the statements they may have different meanings.  On some labels the prohibitions against entry are specific to certain uses.  On other labels the prohibitions are expressed in such a way that the prohibition applies to a broad array of uses. 

  The prohibition in the language cited above applies specifically to the applicator of the pesticide.  The first sentence requires the applicator to keep people or pets from entering the treatment area during application.  While the applicator may not be able to control the movement of people or pets into the area, the applicator can and must stop applying the pesticide if people or pets enter the area being treated.  The second sentence prohibits the applicator from entering the treated area until sprays have dried.  Neither sentence would require the applicator to have a continuing obligation to keep people or pets out of the treated area after application of the pesticide. 

• Would EPA regulate fertilizer and soil amendment products marketed by company “F” as pesticide products under the following conditions: contains a known synthetic plant growth regulator (e.g NAA and IBA), intends to market these products on food crops or, does not declare the synthetic plant growth regulator ingredients on the label. (LCO6-0074)

  The Federal Insecticide Fungicide and Rodenticide Act, as amended, defines a pesticide in part as “1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pests, 2) any substance or mixture of substances intended or used as a plant regulator, defoliant, desiccant, and 3) any nitrogen stabilizer …” FIFRA § 2(u)(emphasis added).

  Regulations established under FIFRA  state, in part:  “A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
              * * *
  “b) The substance contains one or more active ingredients and has no significant commercial value as distributed or sold other than
  (1) use for a pesticidal purpose (by itself or in combination with any other substance), (2) use for       manufacture of a pesticide;”  40 CFR part 152.15 (emphasis added)

  Under 40 CFR 152.15(b), products containing NAA and IBA may be pesticides even if no claims were made on the label. 

  Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product’s label claims.  If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs.

• What is the Agency's policy in the event a registrant or manufacturer wants to remove pesticidal claims from a product label in order to avoid the obligation to register the product?

  The lack of pesticidal claims on a product does not necessarily mean the product does not need to be registered.  The Federal Insecticide Fungicide and Rodenticide Act defines a pesticide in part as "1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pests, 2) any substance or mixture of substances intendedor used as a plant regulator, defoliant, desiccant, and 3) any nitrogen stabilizer ." FIFRA § 2(u)(emphasis added).

  Regulations established under FIFRA  state, in part:  "A substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if:
              * * *
  "b) The substance contains one or more active ingredients and has no significant commercial value as distributed or sold other than
  (1) use for a pesticidal purpose (by itself or in combination with any other substance),
  (2) use for manufacture of a pesticide;"  40 CFR part 152.15 (emphasis added)
  
  Intent for a pesticidal purpose is considered on a case-by-case basis and the Agency may determine a product is a pesticide, and therefore requires a registration, regardless of the product's label claims.  If you are unsure whether your product is a pesticide, it would be prudent to contact the Office of Pesticide Programs.

• What is the official EPA definition of an "orchard" in respect to the boundaries?  Is it the outside drip line of the trees, or number of feet beyond the drip line, or another criterion?  Some do not have fence lines and are part of a larger field.  (LC06-0028)
  
  EPA has not established an "official" definition of "orchards" as used on product labels.  An orchard is considered a distinct use site.  Generally, one would take a common sense approach to determining where a product labeled for use in an orchard might end.  Normally, one would determine that the orchard would end at the outer edge of the drip line of the last row of trees. 
  
  
• What is the statutory or regulatory authority that the word "should" used on pesticide labels is non-mandatory language.  (LC06-0032)

  Neither the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA") nor its implementing regulations contain a definition of the term "should."  The Office of Pesticide Programs (OPP) recognized the need for clarification of whether the term "should" on pesticide labels is considered mandatory or advisory and issued a Pesticide Registration Notice (PR notice) in 2000 (see PR notice 2000-5 at http://www.epa.gov/PR_Notices/pr2000-5.htm).   The statutory basis for this PR notice is section 2(ee) of FIFRA, which defines the term "to use any registered pesticide in a manner inconsistent with its labeling" (i.e., misuse) as use of "...any registered pesticide in a manner not permitted by the labeling...." The following excerpt from PR notice 2000-5 explains OPP's interpretation of terms such as "should", "may," and "must" as used on pesticide labels.

  PR notice 2000-5 states, in pertinent part:

  Mandatory statements, which commonly use imperative verbs such as "must" or "shall," either require action or prohibit the user from taking certain action. Advisory statements generally provide information, either in support of the mandatory statements or about the product in general. To ensure that the intent of each labeling statement is clear, mandatory statements need to be clearly distinguishable from advisory statements.
  Currently, labeling provisions are enforced by taking into consideration all of the information presented on the label and by reading advisory statements in the context of the entire label. Problems can arise when advisory statements are either vague or ambiguous in meaning, or are inconsistent with mandatory labeling statements. In the past, advisory statements have commonly used suggestive verbs such as "should," "may" or "recommend" to encourage the user to achieve the directed behavior, but often these statements can be unclear as to whether they are mandatory or advisory.
  Advisory language using terms such as "should," "may" and "recommend" can create ambiguities as to the intent of the direction or precaution. Too often, common everyday speech using the word "should" creeps into mandatory label statements where the imperative tense is needed to communicate that certain action is required. Another problem is contradictory headings and statements. A set of mandatory directions preceded by an advisory heading such as "Use Recommendations" potentially conflicts with the nature of the intended action. Lastly, the use of words such as "should" in advisory language can mistakenly imply that an unaccepted use is permissible. For example, the direction "you should remove all food articles prior to use" on a product that is not registered for any food uses could be mistakenly read to suggest that it is not mandatory to remove all food from the area to be treated. Consequently, such a statement would not be acceptable.
  The Agency seeks to improve mandatory and advisory labeling statements by providing guidance (see Appendix) on how they can best be written. Mandatory statements are generally written in imperative or directive terms (such as "shall," "must," "do this," "do not") so that a typical user will understand that these statements direct the user to take or avoid certain actions, and that failure to follow these instructions is a misuse of the product. Advisory statements are generally best written in descriptive or nondirective terms to support the mandatory statements or provide information. Suggestive terms such as "should," "may" or "recommend" may be confusing or ambiguous, or potentially conflict with mandatory labeling statements; thus, they are to be avoided. EPA realizes that the use of descriptive terms for advisory statements is not appropriate for every situation and that there are times where it may be necessary to use "should," "may," "recommend" or similar words.

• What does a 7-day restriction mean? Is it 7 days from time treatment ended (7/24) or does the treatment day count as Day 1 and from then out to Day 7? (LC06-0014)
  
  Traditionally the Agency considers the day of treatment to be Day 0. The 7-day restriction (pre-harvest interval) would start with Day 1 which is the day after the initial treatment with subsequent days to follow in order. The Agency has not required the exact time of treatment to be recorded but if someone were to appropriately document treatment ending at, for example 11:00 a.m. on Day 0, then Day 1 would end at 11:00 a.m. the next day and so forth.
  
  
• What is the minimum labeling required on the outside shipping container that is used to transport several individually labeled containers to be sold/distributed separately? (LC06-0002)
  
  Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) there is no minimum labeling required for shipping containers unless the shipping container is the unit customarily sold to the end user, in which case full labeling is required. The Agency suggests that at a minimum, shipping containers bear enough information to identify the contents of the container in the event of an accident or spill; usually product name, active ingredient(s), EPA Registration Number, and any pertinent precautionary labeling. Other regulatory agencies, such as the Department of Transportation, may have requirements concerning the labeling of shipping containers generally, which may apply to the shipping of pesticide products.
  
  
• If a label contains the statement, "For Industrial/Institutional/Commercial Use Only", does this prohibit its sale to consumers for household use? (LC06-0021)

  The language "For Industrial/Institutional/Commercial Use Only" does not prohibit a product's sale to consumers for household use. All products are classified as General Use or Restricted Use as described in 40 CFR 152.160 . General Use products may be sold to any person without restriction. Products classified for Restricted Use may only be sold to and used by certified applicators or persons under their direct supervision and are therefore prohibited from sale to the general public. The Agency has in certain cases limited the use of products to certain groups of users without classifying the product for Restricted Use. Three examples where this occurs are use by veterinarians, mosquito control officials and persons licensed or certified by a state to apply termiticide products. In these cases, the users are individuals identifiable either by a state credential or by being employed by certain public agencies. Individuals who are not members of these groups may still purchase these products but they are prohibited from using such products. The Agency believes the language "For Industrial/Institutional/Commercial Use Only" is too vague to clearly identify a discrete set of users and therefore would not be an enforceable means of limiting sale or use.

• Is the sentence "Use of this product where soils are permeable, particularly where the water table is shallow, may result in leaching to groundwater" advisory only? (EX1)

  The statement is advisory and is intended for informational/advisory purposes. The expectation is that the user will read this section of the label, be made aware that this product can move into groundwater, and will carefully follow label directions when using the product to prevent groundwater contamination.

• Does "unused product" refer to both opened and unopened packages? (EX2)

  Yes. The phrase "unused product" should be interpreted as opened product containers as well as unopened containers.

• What specifically is meant by the phrase "Do not apply to institutions in the immediate area when occupants are present"? (EX3)

  Institutional use is defined in 40 Code of Federal Regulations 152.3, to include hospitals, nursing homes, schools other than preschools and daycare centers, museums, libraries, sports facilities, and office buildings. The product can't be applied if one or more occupants are present in the immediate area where the product is to be applied.
  

• What is the EPA's definition of "shallow ground water"? (EX4)

  EPA has not established a standard depth to define shallow ground water. Hydrologic characteristics differ between regions of the country so shallow ground water is usually defined on a local or regional basis.

• Questions and Answers on pesticides labeled for use on commercially grown tree fruits (LC06-0004):
  
  
  1. Can pesticides that are labeled only for use on commercially grown tree fruit (such as apples) and are not Federal Restricted Use Products (RUPs) be applied by homeowners to control pests in backyard (noncommercial) apple orchards?
     
     A homeowner could legally apply the pesticides if they intended to make a profit from the fruit. Since the word "commercial" is commonly defined as engaged in commerce or intending to make a profit, the home owner would only have to show he or she intended to make a profit from the fruit in order to be within the bounds of the uses allowed on the label. Use in a noncommercial orchard would be inconsistent with the product's labeling and a violation of FIFRA.
     
     
  2. If the homeowner can apply these pesticides, then are any of the WPS requirements (such as PPE and REI) applicable?
     
     If the label carries WPS requirements such as PPE or REI and use is limited to commercial applications all applicators including homeowners would have to comply with them. The homeowner and his or her immediate family would be exempt from certain WPS requirements such as posting notifications because they are the "Owners of [an] agricultural establishment" as described in 40 CFR 170.104(a). Specific WPS requirements from which the homeowner would be exempt are listed in 40 CFR 170.104(a) (1).
     
     
  3. If the homeowner cannot apply these pesticides, then could they hire a commercial applicator to treat their apple orchard with these products?
     
     The homeowner could always hire a commercial applicator, but the answers to questions 1 and 2 apply since the labeling deals with pesticides labeled for use on commercially grown tree fruits versus a restriction requiring a commercial applicator to apply the product. The hired commercial applicator could only apply the pesticide to the homeowner orchard if the fruit it is intended for commerce and the commercial applicator would need to follow WPS requirements. The homeowner as "owner of [an] agricultural establishment" would be required to follow all WPS requirements if the commercial applicator is not a member of the homeowner's immediate family.
     
     
• What is the difference between a guideline and requirement in regards to use directions of common restricted-use termiticides? I have seen conflicting reports on whether "Directions for Use" on the label are considered a requirement (which are not subject to interpretation) or whether they guidelines (which are subject to the interpretation.) (LC06-0006)
  
  A guideline (a, principle, or piece of advice) is neither mandatory nor enforceable but rather is included on the label for the user's guidance. A requirement (e.g. something required through a regulation or adjudication like the act of registering a pesticide) is both mandatory and enforceable. Directions for Use are required to be on all pesticide labels. Certain statements in the Directions for Use section may be advisory and others are mandatory. Requirements or mandatory statements are written in a directive manner. The following are examples of language used in the Directions for Use to alert the user to a mandatory duty: such as (1) "Do not use ...," (2) "Users must...," and (3) "Apply at a maximum rate of ." Other statements may appear in the Directions for Use in an advisory manner e.g., descriptive or nondirective terms, such as "should," "may" or "recommend." See PR Notice 2000-5 concerning advisory versus mandatory language (http://www.epa.gov/PR_Notices/pr2000-5.htm). It is important to note that if any requirement under the Directions for Use is not followed, the user is using the product in a manner inconsistent with its labeling and is in a violation of FIFRA. See FIFRA section 2(ee).
  
  
• Questions and Answers on EPA PR Notice 96-7(LC06-0025):
  
  
1. As used in EPA PR Notice 96-7 and appearing on termiticide labels, what is the meaning of "do not apply at a lower dosage and/or concentration than specified on this label for applications prior to the installation of the finished grade"? In particular, does this refer specifically to the concentration of termiticide in the spray mix and volume of spray mix applied per unit area?
   
   It refers to either. There is no reason for applying a lower concentration of termiticide active ingredient in the spray mix or a lower dosage than is specified by the label. Less volume of the end-use dilution may be applied as directed by the label. PR Notice 96-7 makes reference to soils that cannot accept the label prescribed volume of end-use dilution and includes language for labeling to address this condition. This language is found on the labels of all soil applied termiticide products.
   
   At the finished grade, soil movement and manipulation is completed on the site and the house is build. As you know, sub-slab treatments take place according to label instructions before the "interior slab" is poured but after all interior grading is completed. Exterior perimeter applications should take place after final grading of the soil outside the foundation to insure that treated soil, hence the barrier or treated zone, is not disturbed. However, EPA has not defined the term "finished grade" on the label.
   
   
• Can a fungicide be applied to an ornamental species not listed on the label to control a target disease listed on the label? Can a fungicide be applied to a food crop species not listed on the label to control a target disease listed on the label? (LC06-0061)
  
  1) If the product label lists only specific ornamental species, then only those species are the labeled use sites (crops).  If however, a label should state:  "For use on ornamentals, such as [listing of several specific species].", then the product could be used on all ornamentals.
  

  2) Regarding food crops, we must consider established tolerances for the active ingredient pesticide.  A pesticide label will only list food crops for which a tolerance or an exemption from the requirement of a tolerance has been established.  Sometimes, if a crop grouping has an established tolerance or exemption from tolerance, the label might list the crop group, for example, "For use on stone fruits, such as cherries, nectarines, peaches and plums."  This would allow for the product's use on all crops in the stone fruit crop group for which a tolerance or exemption had been established.  Therefore, if the label does not list a crop group, then application of the pesticide product is limited to only those food crop species listed on the label.

• Is an apparatus of a pump connected to a bottle of concentrated pesticide, which in turn is hooked into a residential lawn irrigation system (sprinkler system) considered a chemigation device?  Can chemigation be referred to in a residential setting?  The pesticide used in this case is a 25(b) exempt product.  Could other registered conventional pesticides be used? (LC06-0064)

  The apparatus in question is application equipment that turns a residential lawn irrigation system into a chemigation system by introducing the pesticide into the irrigation system. Chemigation is defined in 40 CFR 170.3 as “the application of pesticides through irrigation systems.”  While this regulatory definition is exclusive to agricultural settings, it is reasonable for the Agency to apply it to similar situations outside of agricultural settings such as in residential lawn irrigation systems.  Thus the Agency would consider use of the apparatus described above as a chemigation application.   To the extent that a label prohibits the use of a product in a chemigation system, the label prohibition must be followed. 

  Chemigation has also been addressed in the agricultural setting through PR Notice 87.1, but this notice specially states that it does not apply to any pesticide product intended solely for residential setting.  However, the scope of the PR Notice was limited based on the information the Agency had on the extent of chemigation as a practice at the time.  The agency is currently reviewing PR Notice 87.1 to update in accordance with changing practices and will be putting a draft out for public comment.

• If no restrictions are mentioned in a product label, can it be assumed that there aren't any rotational or planting restrictions?  Or is there a standard default when no specifics are given? LC08-0151; 1/17/08

  If a pesticide is registered on an agricultural crop(s) and there are no restrictions on the product label concerning when rotational crops may be planted or any other planting restriction intervals, such as crop failure, then it would not be a violation of FIFRA to plant new crops at any time.

• Cleanout and disinfection of crawl spaces (area underneath houses) is a new service being provided by a number of PCO companies.  We are having difficulty determining whether disinfectants can legally be used in crawl spaces.  Often the sites on disinfectant labels are very broad and seem to allow treatment in any area of a structure (including the crawl space), but then the specific directions only cover areas with non-porous surfaces inside of a structure.  It would be helpful for EPA to address this new use pattern and in the meantime we would appreciate some guidance on when disinfectants with current labels can be used in crawl spaces. (LC08-0176; 10/18/08)

  The Agency does not have a standard definition for crawl spaces.  As a result, the user must refer to the label of the disinfectant product to determine whether the product can be used to treat crawl spaces.  Typical components of a crawl space include ground and bare wood.  The Agency considers these surfaces to be porous surfaces.  These types of surfaces cannot be treated unless the label contains directions that would allow the product to be used to disinfectant porous surfaces.  If the label has language limiting applications to hard non-porous surfaces, application to a crawl space with porous surfaces would not be permitted.  

• A Do-It-Yourself retail store offers for sale a general-use termiticide product with the statement “For sale to, use and storage only by individuals/firms licensed or registered by the state to apply termiticide and/or general pest-control products."  Is it "use inconsistent with the label” for a non-licensed home-owner to purchase and use the product?  (LC08-0186)

  It is not a Federal violation for an unlicensed individual to purchase a registered general-use product that bears the labeling referenced.  It is a violation of FIFRA 12(a)(2)(G) for an individual who is not licensed by the state to use a product that bears the labeling referenced.  In addition, it may be a violation of state law for an unlicensed individual to purchase products that include that labeling. 

  Note that for termiticide products, PR Notice 96-7 includes the preferred statement that should be used on termiticide labels:

  “For use by individuals/firms licensed or registered by the state to apply termiticide products. States may have more restrictive requirements regarding qualifications of persons using this product. Consult the structural pest control regulatory agency of your state prior to use of this product." 

• Specifically in regards to use sites that are going to be eliminated through amendment to terminate a use or uses due to a Data Call-In (DCI) or other EPA mandate; do you have to wait until the label is formally amended at the EPA and stamped approved before you begin removing these use sites from your marketing label? (LC08-0207; 9/22/08)

  A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in the precautionary statements, use classification or packaging.  [40 CFR 152.130(b)]  If a registrant intends to amend its registration to terminate a use in response to a DCI, the use could be removed from the marketing label at any time in advance of the use termination amendment as long as the removal doesn't trigger any requirements to change precautionary statements, use classification or packaging.

10. Worker Protection Statement
    
    
• From the EPA Chemical Resistance Category Chart (in reference to the Worker Protection Standards) what do the letters A-H Represent? (LCO6-0066)

  The letters A - H in the Chemical Resistance Category Chart contained in Chapter 10 of the Label Review Manual (LRM) refer to solvents categorized as to the chemical reaction to certain chemical resistant material, i.e., nitrile rubber, laminate barrier, viton..  These solvents are used in pesticide products subject to the Worker Protection Standard (WPS).  The lettered groups are used by pesticide users to select the appropriate type Personal Protective Material from the chart.

  A list of solvents and which category they fall in can be found in Supplement Three, the Main Labeling Guidance of PR Notice 93-7, issued by the Agency on April 20, 1993.

11. Storage and Disposal
    
    
• As follow-up to the EPA answer regarding Existing Stocks which states "If labeling is amended on the initiative of the registrant, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after the approval of the revision."(see LC07-0094)  Would you please clarify if this 18-month provision is applicable to label amendments that results in an EPA stamped approved label only - i.e., excludes label notification changes submitted by registrant? (LC07-0125; 11/1/07)

  Label notification changes submitted by the registrant are label amendments and subject to the same 18-month provision for existing stocks.  The 18-month period for changes made by notification begins upon the Agency’s receipt of a valid notification with the exception of changes made by notification for antimicrobials.   In the case of a notification of a change to an antimicrobial label, the 18-month period begins upon acceptance of the notification.  See FIFRA § 9(C)(i).  In either case, if the Agency finds that the change could not appropriately be made through notification then the label change must be resubmitted as an amendment and the 18-month period would begin upon EPA’s acceptance of the amendment.

• 40 CFR 152.130 and the Existing Stocks Policy (56 FR 29362) create a general 18-month period to distribute or sell products with existing labeling following approval of a voluntarily amended label.  Frequently EPA’s approval of the voluntarily amended label will direct the registrant to use this newer language at the next production or within 18 months.  New production after the 18-month window requires that labels use the newer text.   However, in many instances certain states (CA/NY) may take significantly longer to approve the newer text.  (LC07-0094)

  1) Can registrants continue printing older version label language (at the next production but within the 18-month window) until the newer label text is approved by CA and/or NY?  

  2) Can registrants continue printing older version label language after the 18-month window if the newer label text has not yet been approved by CA and/or NY. 

  3) Does the term "new production" refer to the production of the label or the production of the pesticide product.

  40 CFR 152.130 discusses distribution under approved labeling.  The Existing Stocks Policy further elaborates on the requirements of 40 CFR 152.130.  If labeling is amended on the initiative of the registrant, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after the approval of the revision.  The Agency may alter the time period for distribution or sale under the approved labeling in which case the registrant must comply with the EPA mandated time frames. 

  1) A registrant may distribute or sell a pesticide under previously approved labeling until the 18-month time period has expired.  After 18 months the pesticide must bear the newly registered labeling.  The 18-month time frame is independent of state registration status of a product.
   
  2) Registrants may not continue to label products with old labels after the 18-month period regardless of the registration status of the product in a particular state.

  3) The term “new production” generally refers to production of the pesticide product.  If the new label cannot be printed in time to coincide with new production of the pesticide product and the production is within the 18-month time period, old labels may be used, however supplemental or sticker labeling bearing the newly approved labeling must be used after the 18-month date to bring the product into compliance.      

• 40 CFR 152.30 and the Existing Stocks Policy (56 FR 29362) create a general 18-month period to distribute or sell products with existing labeling following approval of a voluntarily amended label.  New production after the 18-month window requires that labels use the newer text.  Must the new label text be employed at retail bulk sites after 18 months, even if the manufacturer has not implemented the new label for non-refillable packages because no new manufacturing of the formulation has occurred since approval? (LC06-0060)
  
  Regardless of whether the registrant has engaged in new production during the 18 months, any new production after 18 months must bear the new amended labeling.  Repackaging is considered production therefore pesticide product repackaged into refillable containers must bear the new amended labeling.
  
  
• Are there alternative "Container Disposal" instructions for antifouling paint products?  The paint labels that I have reviewed bear the following instructions: Triple rinse (or equivalent).  Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or by other procedures approved by State or local authorities.
  
  This instructs people to triple rinse the paint cans prior to disposal.  Since the vast majority of these products are not water soluble, are these directions prudent? (LC08-0189; 10/30/08)

  There are no standard alternative "Container Disposal" statements specific to antifouling paint products.  If the products in question are not intended to be diluted before use, EPA does not require rinsing instructions on the label (See EPA's August 2006 Pesticide Container-Containment Rule, 40 CFR 156.140 - 156.159 and the FAQ at http://www.epa.gov/pesticides/regulating/containerquestions.htm for more details.)  EPA agrees that it may not be prudent to triple rinse containers that hold pesticides that are ready-to-use products.  In those cases, the rinsate cannot be incorporated into the pesticide application because there is no pesticide mixture.  Therefore, rinsing the container would require the end user to properly dispose of the rinsate in addition to properly disposing of or recycling the container.  Accordingly, §156.146 and §156.156 of the container-containment rule require detailed rinsing instructions only for dilutable pesticide products' containers. 

  For dilutable products that cannot be effectively rinsed with water, §156.146(d) also allows registrants to propose alternative rinsing instructions.  Likewise, PR Notice 83-3 also provided that registrants might propose alternative container disposal statements if the statements recommended in the PR Notice and Chapter 13 of the Label Review Manual were not appropriate.  Registrants may revise the container disposal statement for a specific product by submitting an amendment to EPA with the revised container disposal instruction.

  Please note that there may be additional residue removal requirements under the Resource Conservation and Recovery Act (RCRA) regulations if the product is classified as a RCRA hazardous waste when it is disposed of.

• PR Notice 83-3 states that products intended solely for household use need not include the heading "STORAGE AND DISPOSAL."  Is this guidance still true? (LC97-0103)

  No. 40 CFR 156.10(i)(2)(ix) requires the heading "Storage and Disposal," which must be set in the type of the same minimum sizes as required for the child hazard warning.  In addition, subsequent  PR Notices, like 84-1 and 2001-6, came out to clarify Storage & Disposal guidance for residential use – household use products.

• Some labels state under the STORAGE DISPOSAL - and PESTICIDE DISPOSAL sections that, "Wastes resulting from the use of these pesticides may be disposed of on site or at an approved waste disposal facility."  How would one dispose of pesticides which include this label statement on site?  It is not clear if one puts the waste pesticide in the trash or buries it, etc....  This wording shows up under Chapter 13-V.B.2.b.(3) of the Label Review Manual.  (LC07-0095)

  The best method for using up opened and unused pesticides or unused diluted spray is use according to label directions.  Oftentimes, the unused product or diluted spray can be applied to another site listed on the label.  The Agency does not recommend pesticide disposal in the trash or by burying.  Additional guidance on pesticide storage and disposal can be found at:  http://www.epa.gov/pesticides/regulating/storage.htm

• Can aerosol cans containing pesticides be punctured by a disposal facility if the label states "do not puncture or incinerate"? LC08-0146; 12-13-07

  A pesticide container, even empty, is still a “pesticide product” as defined at 40 C.F.R. §152.3, and is therefore still subject to FIFRA.  As part of its process for approving registration of a pesticide product, EPA considers the applicant’s proposed disposal instructions.  See 40 C.F.R. §156.10(i)(2)(ix) (“The directions for use shall include the following, under the headings ‘Directions for Use’: ... Specific directions concerning the storage and disposal of the pesticide and its container, meeting the requirements of 40 CFR part 165.”).  Disposal is thus a “use,” and use of a registered pesticide in a manner inconsistent with its labeling is a violation of FIFRA section 12(a)(2)(G).

  FIFRA section 2(ee)(6), however, authorizes the Administrator to permit a “use inconsistent with the label” if he determines that the use of the pesticide is “consistent with the purposes of [FIFRA].”  These purposes may be broadly summarized as “to provide for the protection of man and his environment....” [ S. Rep. No. 92-838, at 3 (1972)].

  EPA’s regulations in 40 C.F.R. §156.78(b) require the labels of pressurized pesticide containers to include the statement “Do not puncture or incinerate container.” [EPA has issued guidance authorizing pesticide registrants to amend existing labels in order to expressly allow recycling of empty aerosol pesticide containers.   See Pesticide Registration Notice 94-2 (May 16, 1994)]  This requirement predates [See 36 Fed.Reg. 22496 (Nov. 25, 1971), promulgating the “Do not puncture or incinerate” requirement for pressurized pesticide containers, then codified at 40 C.F.R. §166.113(f)(3)] the enactment of the Federal Environmental Pesticide Control Act of 1972 which dramatically amended FIFRA, as well as the federal regulatory program for hazardous wastes, the Resource Conservation and Recovery Act of 1976.  Although the regulation originally may have been intended to protect users in their largely unregulated disposal of pressurized containers, such disposal practices have been replaced by a more centralized and highly regulated waste management industry. 

  EPA’s view is that the present purpose of the “Do not puncture or incinerate” instruction is to protect the ordinary users of pesticides from the hazards of pressurized containers.  EPA believes that the hazards associated with recycling aerosol pesticide containers are adequately, and more appropriately, addressed under federal, state and local laws concerning solid and hazardous wastes and occupational safety and health.  While EPA believes that these hazards are already adequately addressed through other authorities, EPA believes that any remaining risk that might arguably be subject to FIFRA is small and outweighed by the benefits of recycling the aerosol containers.  Therefore, EPA has determined that the puncturing of disposed aerosol pesticide containers for recycling is consistent with the purposes of FIFRA, provided that:

1. The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
2. The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and contain the residual contents; and
3. The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations. 

Failure to comply with all these conditions when puncturing aerosol pesticide containers would constitute use of a pesticide product in a manner inconsistent with its labeling and may result in the imposition of penalties under FIFRA.

• Are there alternative "Container Disposal" instructions for antifouling paint products?  The paint labels that I have reviewed bear the following instructions: Triple rinse (or equivalent).  Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or by other procedures approved by State or local authorities.
  This instructs people to triple rinse the paint cans prior to disposal.  Since the vast majority of these products are not water soluble, are these directions prudent? (LC08-0189; 10/30/08)

There are no standard alternative "Container Disposal" statements specific to antifouling paint products.  If the products in question are not intended to be diluted before use, EPA does not require rinsing instructions on the label (See EPA's August 2006 Pesticide Container-Containment Rule, 40 CFR 156.140 - 156.159 and the FAQ at http://www.epa.gov/pesticides/regulating/containerquestions.htm for more details.)  EPA agrees that it may not be prudent to triple rinse containers that hold pesticides that are ready-to-use products.  In those cases, the rinsate cannot be incorporated into the pesticide application because there is no pesticide mixture.  Therefore, rinsing the container would require the end user to properly dispose of the rinsate in addition to properly disposing of or recycling the container.  Accordingly, §156.146 and §156.156 of the container-containment rule require detailed rinsing instructions only for dilutable pesticide products' containers. 

For dilutable products that cannot be effectively rinsed with water, §156.146(d) also allows registrants to propose alternative rinsing instructions.  Likewise, PR Notice 83-3 also provided that registrants might propose alternative container disposal statements if the statements recommended in the PR Notice and Chapter 13 of the Label Review Manual were not appropriate.  Registrants may revise the container disposal statement for a specific product by submitting an amendment to EPA with the revised container disposal instruction.

Please note that there may be additional residue removal requirements under the Resource Conservation and Recovery Act (RCRA) regulations if the product is classified as a RCRA hazardous waste when it is disposed of.

12. Unattached Labeling
    
    
• When a "booklet" is used to place information that cannot fit and is not required to be on the "securely attached" label, must that "booklet" be attached to EVERY container (such as by a "pull off" adhesive). Or can the "booklet" be distributed by other means, such as attached to shipping papers, e-mailed to customer with every shipment, etc. Where to get the booklet or information contained in the booklet would be clearly written on the "securely attached" label. LC09-0294; 11/4/09

  A booklet that contains information required by 40 CFR Part 156 to be part of the product labeling must either accompany the product or be referenced on the label or in literature accompanying the pesticide. See FIFRA 2(p)(2). If the booklet is not referenced on the container label or accompanying literature, the booklet must accompany the product at the time of sale and may be distributed to dealers by attaching it to the shipping papers so long as there are an equal number of booklets and containers so that a booklet accompanies each container that is sold. If the labeling information is referenced on the container it need not be provided in equal numbers so long as the user can obtain the information in some format.