Overview of Manufacturer-Requested Risk Evaluations
The Toxic Substances Control Act (TSCA) allows a manufacturer of a chemical substance (or category of chemical substances) to request an EPA-conducted risk evaluation on the chemical substance (or category of chemical substances) for conditions of use of interest to the manufacturer. TSCA required EPA to develop the form and manner under which these requests must be made, and the criteria EPA will use to determine whether to grant a request.
- Read about the entire process in the Risk Evaluation rule.
- Find a list of manufacturer-requested risk evaluations.
On this page:
- Submitting a Request
- General Process and Timeline
- Meeting Scientific Standards in Requests
- Criteria for Granting a Request
- Fees Associated with a Request
- Confidential Business Information (CBI) Concerns
- Public Participation Opportunities
One or more manufacturers of a chemical substance (or category of chemical substances) may request that EPA conduct a risk evaluation of that chemical substance (or category of chemical substances). A third-party entity may submit the request on behalf of one or more manufacturers, provided the contact information is provided for all requesting manufacturers.
If EPA grants the manufacturer request, then the risk evaluation will be conducted in the same manner, and using the same criteria, as EPA uses in all TSCA risk evaluations. The entire process for a manufacturer-requested risk evaluation is outlined in the Risk Evaluation rule.
If EPA determines that the chemical substance (or category of chemical substances) presents an unreasonable risk of injury to health or the environment under any of the conditions of use covered in the risk evaluation, the Agency will initiate action under TSCA Section 6(a) to ensure that the chemical substance (or category of chemical substances) no longer presents such risk. Manufacturers (including importers) of chemicals submitted for manufacturer requested risk evaluation may be impacted if EPA determines that a condition of use of the chemical substance (or category of chemical substances) presents unreasonable risk that necessitates risk management.
Manufacturers must submit a request for a risk evaluation using EPA’s Central Data Exchange (CDX). The request must include: manufacturer name and contact information; chemical identity information; circumstances of interest to the requester and rationale for why the listed circumstances constitute conditions of use under TSCA; and all information necessary for EPA to conduct the risk evaluation on the conditions of use of interest to the manufacturer (e.g., hazard, exposure, potentially exposed or susceptible subpopulations).
Once EPA receives a manufacturer request, the general process and timeline is as follows:
- EPA will determine if the request is facially complete (i.e., appears to include all the necessary information).
- Within 15 days of receipt of a facially complete manufacturer request, EPA will notify the public of the receipt of the request.
- Within 60 business days of receipt of a facially complete manufacturer request, EPA will publish the request in the Federal Register, along with identification of the additional conditions of use EPA believes should be included in the evaluation, and the basis for these proposed conditions of use. EPA will open a docket for no less than a 45-day public comment period to accept comment on the request and the additional conditions of use EPA is considering for inclusion.
- Within 60 calendar days of the end of the public comment period, EPA will make a decision to grant or deny the manufacturer request.
Any scientific information submitted by a manufacturer must be consistent with the scientific standards set forth in TSCA Section 26(h) (15 U.S.C. 2625(h)). Although the judgment of consistency is ultimately EPA's, holding the requester to the statutory standard helps to ensure that, if EPA grants the request, then the Agency can effectively utilize the information provided.
For those circumstances submitted in the request, the manufacturer must provide or reference all of the information EPA needs to conduct the risk evaluation. While the requesting manufacturer does not need to supply copies of information that is publicly available, they must provide a list of full bibliographic citations for all submitted references.
For information that is only publicly available in a foreign language, please provide an English-translated copy. EPA’s systematic review document indicates that EPA will use papers written in English for the risk evaluations, and foreign-language papers will only be used on a case-by-case basis.
A manufacturer request for risk evaluation must include all of the information outlined in 40 CFR 702.37(b) of the risk evaluation rule, including:
- Chemical Identity, all known names, CAS number, and molecular structure;
- If the request is for a category of chemical substances, an explanation of why the category is appropriate for TSCA risk evaluation under 15 U.S.C. § 2625(c);
- Circumstances under which a risk evaluation is requested;
- Rationale for why these circumstances constitute “conditions of use,” as defined under 40 CFR § 702.33; and
- A list of all existing information that is relevant to determining whether the chemical substance (or category of chemical substances), under the circumstances identified by the manufacturer(s), presents an unreasonable risk of injury to health or the environment; an explanation as to why the information is adequate to permit EPA to conduct a risk evaluation addressing the circumstances identified by the manufacturer(s); and all available information on relevant health and environmental hazards and exposures and exposed populations, as relevant to the circumstances identified in the request, including, at a minimum:
- The chemical substance’s hazard and exposure potential;
- The chemical substance’s persistence and bioaccumulation;
- Any relevant potentially exposed or susceptible subpopulations;
- Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage facility location and nearby water source(s);
- The chemical substance’s production volume or significant changes in production volume; and
- Any additional information relevant to the potential risks of the chemical substance under the circumstances identified in the request.
After receiving a request, EPA will follow the process/timeline described above.
All of the following criteria must be met for EPA to grant the request:
- The circumstances identified in a request constitute conditions of use that warrant inclusion in the risk evaluation for the chemical substance (or category of chemical substances);
- EPA has all of the information needed to conduct a risk evaluation on the conditions of use that were the subject of the request; and
- All other criteria and requirements of EPA’s regulations on submission of manufacturer requests for risk evaluations under 40 CFR § 702.37 have been met.
Manufacturers must pay fees to support requests for risk evaluations granted by EPA, as authorized by Congress under TSCA Sections 6(b)(4)(E)(ii) and 26(b)(4)(D), and required by EPA under 40 C.F.R. § 702.37(e)(11) and the TSCA fees rule.
If EPA grants a manufacturer request for risk evaluation, the requester(s) has 30 days to withdraw the request. The initial fee payment is due within 30 days of EPA granting the manufacturer request, as per the TSCA fees rule. If the requester decides not to go forward, then the chemical substance will not move into risk evaluation.
You may claim information as CBI pursuant to TSCA Section 14 when submitting a manufacturer request for risk evaluation via EPA’s Central Data Exchange (CDX). Please submit any information that is claimed as CBI, including attachments, accompanied by a redacted version of the information. Manufacturers must supply a structurally descriptive generic name if specific chemical identity is claimed as CBI. Instructions for claiming information as CBI are included in 40 CFR § 702.37(d) of the risk evaluation rule. The rule requires upfront substantiation of submitted CBI, pursuant to TSCA Section 14 (15 USC § 2613), except for information described in TSCA Section 14(c)(2).
Note that once EPA has found a request for risk evaluation to be facially complete, EPA is required to open a docket for the request. If you submit a request for risk evaluation via CDX that includes attachments containing CBI, the redacted versions of the attachments will be included in the public docket for that chemical substance.
Once a manufacturer request has been determined by the Agency to be facially complete, EPA is required to notify the public within 15 business days of its receipt. Within 60 business days of receiving a facially complete manufacturer request, EPA will open a public docket for the request and provide no less than a 45-calendar day public comment period.
During the comment period, the public may submit comments and information relevant to the requested risk evaluation to the public docket. Commenters are encouraged to identify any information not included in the request commenters believe would be needed to conduct a risk evaluation, and to provide any information relevant to EPA’s proposed additional the conditions of use.