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Background on the LoREX Exemption

Section 5(h)(4) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2604(h)(4)) allows the EPA, by rule, to grant an exemption from any or all of the requirements of section 5 if EPA determines that the manufacture, processing, distribution in commerce, use, or disposal of a substance will not present an unreasonable risk of injury to health or the environment. Section 26(c) of the TSCA provides that any action authorized under the TSCA for an individual chemical substance may be taken for a category of such substances. The Agency has established a section 5(h)(4) exemption category for certain chemical substances with low environmental releases and human exposures. The language establishing this exemption was published in the Federal Register on March 29, 1995 (60 FR 16336-16351). To ensure that these chemical substances will not present an unreasonable risk, EPA has included procedural safeguards, including a 30-day review and other conditions in the exemption.

All manufacturers and importers of new chemical substances subject to premanufacture notice (PMN) requirements and meeting the stated release and exposure criteria are eligible to apply for this low release and exposure (LoREX) exemption, regardless of production volume. The LoREX exemption is intended to encourage companies to develop manufacturing, processing, use, and disposal techniques which minimize exposures to workers, consumers, the general public, and the environment. Eligibility is independent of production volume level.

The Agency determined that the concept of basing an exemption on low release and exposure taken together offered several potential advantages. First, an exposure-driven exemption can generally provide a more direct gauge of the magnitude of risk which will be presented by a given new chemical substance. Production volume alone is only an indirect indicator of exposures and releases. Secondly, EPA believes that the existence of a LoREX exemption will encourage pollution prevention techniques by rewarding manufacturers able to meet the low release and exposure criteria with more timely regulatory decisions, and, in many cases, with less burdensome regulatory controls. Such a result would entail substantial time and resource savings for both EPA and industry. The same form (7710-25) is used for requesting LoREX as for other section 5 submissions.

As with the low volume exemption, the uses of the new chemical substance are restricted to those approved in the exemption notice, and submitters must maintain any exposure or release controls throughout the period of the exemption. Manufacturing sites identified in the exemption notice are binding unless specified conditions are satisfied. EPA believes that these binding provisions of the LoREX exemption can be an effective substitute for regulation under section 5(e) of the TSCA.

Prospective submitters should be mindful that the principal focus of the LoREX exemption is on release and exposure, not toxicity. EPA will generally be unable to conduct a thorough review of any submitted test data within the allotted review period. To the extent that the Agency must undertake extensive detailed examination of the inherent toxicity of a given chemical substance, submission of a PMN may be more appropriate. Prenotice consultation Sources of Assistance and Information with the Agency can help the potential submitter make this determination (Of course, any toxicity data on the new chemical substance in the possession or control of the manufacturer must accompany the submission whether it is necessary for exemption approval or not).

To satisfy the Agency that the submitted material can be a member of the LoREX class, which meets the required section 5(h)(4) findings of no unreasonable risk, the exemption notice submitter must first meet the eligibility criteria listed in paragraph (c) of the rule indicating that exposure to the new substance, and hence the risk presented by the substance, is low. Except as provided under the surface water and ambient air criteria, the human exposure side of the eligibility criteria requires the submitter to show that there are no exposures to consumers or the general public inherent in the proposed manufacturing, processing, or uses of the substance, and that any worker exposure which is likely to occur will be adequately controlled through use of engineering controls, work practices, and/or personal protective equipment.

LoREX eligibility criteria for releases to three environmental media are listed. In assessing the potential for environmental release, the submitter is required to consider all routine releases from manufacture, processing and use, including releases associated with cleaning of equipment and from disposal or cleaning of containers and packaging. For ambient surface water, submitters must either (1) prevent all direct and indirect releases of the exempted substance to surface waters; or (2) demonstrate that any releases to water that may occur will result in surface water concentrations of the substance that are no greater than 1 part per billion (ppb) using the surface water concentration calculation method described in 40 CFR section 721.90 and 721.91. The Agency encourages potential submitters to consult with the Agency prior to the initiation of any testing. Such consultation frequently results in more relevant data and can often lower the submitters' test costs.

The rule excludes from eligibility all chemical substances which will be disposed of via landfill unless the submitter demonstrates to EPA in the notice that the exempted substance has negligible ground-water migration potential. The rule establishes procedures for revocation of the exemption if EPA later determines that the substance may cause serious acute or chronic human effects or environmental effects. In addition, EPA has the authority to require documents relevant to an exemption from the manufacturer (in addition to the information provided in the exemption notice), and the manufacturer would be required to submit promptly to EPA any new data indicating that a substance is ineligible. These provisions will ensure that eligibility for and continuation of the exemption will be determined on the basis of the best available information, regardless of when the information becomes available.

Upon approval of a LoREX exemption, the submitter is bound to the uses and the exposure and release controls described in the approved exemption. The submitter is also bound to the listed manufacturing sites unless the conditions described in the exemption are met. The Agency will deny an exemption application despite satisfaction of the LoREX exemption criteria if EPA makes the findings in section 723.50(d) or if there are issues concerning exposure or toxicity that require further review beyond 30 days under section 723.50(h)(1).

If you submit a LoREX to EPA, you are required to use the electronic-PMN ("e-PMN") software as discussed in the "e-PMN" final rule (75 FR 773) (PDF) (18 pp, 110K, about PDF). You must use the PMN module within the e-PMN software to submit your LVE. On page 1 of the PMN module, be sure to check the box stating the type of notice you are submitting is a LoREX.

During the first year following the effective date of the final rule, LoREX submissions will be permitted via Central Data Exchange (CDX), optical disc or paper. One year after the rule's effective date, i.e., as of April 6, 2010, paper submissions will not be accepted. Two years after the final rule's effective date, i.e., as of April 6, 2011, all submissions will be required to be submitted electronically via CDX. Refer to www.epa.gov/cdx, the CDX Registration Guide (PDF) (44 pp, 8.6MB, about PDF), or the CDX Helpful Hints (PDF) (10 pp, 41K, about PDF) for directions on how to register and submit notices via CDX.

You must also submit LoREX modifications using the PMN module. Mark the modification type on PMN page 1 (continued) and the certification statements on PMN page 2. Fill out the contact information on PMN page 3. You can enter the rest of the modification information into the form in one of three ways:

  1. fill in the applicable fields in the PMN pages 4-13;
  2. enter the modification information in the cover letter; or
  3. enter the modification information as an attachment.

It should be noted that for modifications, the e-TSCA/e-PMN software does not validate any data beyond PMN page 3.


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