Background on the Low Releases and Low Exposures (LoREX) Exemption
On this page:
- Who is eligible for the exemption?
- Why did EPA provide an exemption for new chemicals with low environmental releases and human exposures?
- How do I apply for a LoRex exemption?
- What other information should I know about LoREX exemptions?
- What happens after a LoREX exemption application is approved?
- How do I submit a modification to a LoREX?
Pursuant to section 5(h)(4) and section 26 of the Toxic Substances Control Act (TSCA), EPA established a section 5(h)(4) exemption category for certain chemical substances with low environmental releases and human exposures.
- Read the rule establishing this exemption (60 FR 16336-16351, March 29, 1995).
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.
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 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.
Why did EPA provide an exemption for new chemicals with low environmental releases and human exposures?
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. (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).
Pre-notice consultation with the Agency can help the potential submitter make this determination. Find Sources of Assistance and Information.
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 40 CFR 723.50(d) or if there are issues concerning exposure or toxicity that require further review beyond 30 days under section 40 CFR 723.50(h)(1).
Note: You must mark the certification statements on PMN page 2 and 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:
- Fill in the applicable fields in the PMN pages 4-13;
- Enter the modification information in the cover letter; or
- Enter the modification information as an attachment.
It should be noted that for modifications, the new e-PMN software does not validate any data beyond PMN page 3.