By Lynn L. Bergeson and Carla N. Hutton
As reported in our March 14, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. EPA has since submitted the ICR to the Office of Management and Budget (OMB) for review and approval. EPA published a notice on August 30, 2022, allowing for an additional 30 days for public comment. 87 Fed. Reg. 52967. Comments are due September 29, 2022.
The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it is consolidating the existing ICRs to streamline the presentation of the paperwork burden estimates, thereby reducing the administrative burden for both the public and EPA and allowing a better assessment of the burden and costs for reporting and recordkeeping activities under TSCA Section 8. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:
- TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR): Under TSCA Section 8(a), persons who manufacture or import chemical substances listed at 40 C.F.R. Section 712.30 are subject to the Section 8(a) PAIR requirements. These manufacturers and importers must submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under 40 C.F.R. Part 766 Subpart B that are very similar to the PAIR requirements are also covered within this information collection activity.
- Chemical-Specific Rules, TSCA Section 8(a): Under TSCA Section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA Section 8(a). A chemical-specific Section 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. Any chemical covered by TSCA for which the Office of Pollution Prevention and Toxics (OPPT), other EPA offices, or another federal agency has a reasonable need for information, and that cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical-specific TSCA Section 8(a) rulemaking.
- Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment: Under TSCA Section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA Section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
- Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies: Under TSCA Section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of health and safety studies in their possession that relate health and/or environmental effects of the chemical substances and mixtures.
By Lynn L. Bergeson and Carla N. Hutton
On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal of an existing ICR that is currently approved through October 31, 2022. Before submitting the ICR to OMB for review and approval under the Paperwork Reduction Act (PRA), EPA is soliciting comments on specific aspects of the information collection activities and burden estimates. Comments are due April 11, 2022.
Under TSCA Section 8(e), any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment is required to inform EPA immediately of such information unless they have actual knowledge that EPA has been adequately informed of such information. There is also an option for those who wish to submit voluntarily “For Your Information” (FYI) notices. More information on TSCA Section 8(e) requirements is available in our TSCA frequently asked questions (FAQ).
EPA estimates that the total estimated number of potential respondents is 51 and that the total estimated average number of responses for each respondent is 343. There is a decrease of 3,847 hours from the last approval (from 21,412 to 17,565 hours). According to EPA, this reflects an overall decrease in the number of Section 8(e) and FYI submissions, which decreased from 408 to 343 Section 8(e) submissions and 13 to six FYI submissions, respectively. EPA has also increased the total annual costs due to an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead).
EPA notes that in addition, OMB has requested that it move toward using the 18-question format for ICR Supporting Statements used by other federal agencies and departments that is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA states that it does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs.
By Lynn L. Bergeson and Carla N. Hutton
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.
EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”
According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years. It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.
The final rule will be effective 30 days after publication in the Federal Register.
By Lynn L. Bergeson
On July 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register soliciting a second round of comments on the burdens and value of information it periodically collects addressing significant new use rules (SNUR) for existing chemicals. Specifically, EPA submitted a request to renew the approval of an existing information collection request (ICR), Toxic Substances Control Act (TSCA) Section 5(a)(2) SNURs for Existing Chemicals, to the Office of Management and Budget (OMB). This notice provides chemical manufacturers and other interested parties a second opportunity to comment on certain questions, specifically: whether the agency accurately estimated the burden of responding to SNURs that it issues for chemicals in commerce; whether the agency could minimize the burden; and whether the information it collects is necessary.
The first ICR was issued on September 2, 2015, and comments were due November 2, 2015. Only two comments were filed in response to the initial ICR, by the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA), two trade associations. ACC and SOCMA stated in their comments that EPA underestimated the burdens its SNURs impose on chemical manufacturers and their customers.
This renewed ICR states that EPA estimated that six companies would be affected by its new use rules for existing chemicals, creating an estimated total burden of 1,025 hours per year and a cost of $100,595.
Comments are due August 25, 2016.
SNURs are deeply unpopular to some in the chemical community and welcomed outcomes of the premanufacture notice (PMN) or significant new use notification (SNUN) process to others. Most would agree that the cost of compliance with a SNUR can be difficult to estimate with any degree of precision. Some of us are also of the view that TSCA, as recently amended, may result in many more SNURs given the new “determination” requirements under TSCA Section 5(a). The comment period opened by today’s Federal Register notice provides an excellent opportunity to provide comment to EPA and thus help to ensure that EPA has an accurate and current basis upon which to estimate the cost.