By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Richard E. Engler, Ph.D.
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452. The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule. The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials. More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.” EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.” Comments are due June 15, 2017.
The 14-page draft guidance, in the form of questions and answers, addresses questions within the following categories: what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality. While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply. Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported. More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”
By Lynn L. Bergeson and Margaret R. Graham
On May 9, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a notice stating that it was reopening the comment period regarding whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted. 82 Fed. Reg. 21542. EPA is opening the comment period for another 15 days, until May 24, 2017, to provide adequate opportunity for the public to consider the results of EPA’s consultation with the Small Business Administration (SBA). EPA’s initial request for comments was published on December 15, 2016, and comments on its initial notice were due by January 17, 2017.
The reopening of the comment period allows for public review and comment on EPA’s December 7, 2016, consultation request to the SBA on the adequacy of the current standards, as well as the SBA Administrator’s April 5, 2017, feedback on EPA’s consultation request. In the notice, EPA states that it had intended to add SBA’s response to the docket to give the public an opportunity to review the response to inform their comments on EPA’s preliminary determination; EPA is providing that opportunity now.
By Christopher R. Bryant, Lynn L. Bergeson, and Margaret R. Graham
Facing a government shutdown, late on April 30, 2017, lawmakers reached agreement on a spending bill that funds the federal government through September 2017, which is the end of Fiscal Year (FY) 2017.
President Trump’s budget blueprint sought to slash EPA’s coffers by some 31 percent (and more if certain programs were eliminated from the base). The deal reached by lawmakers, however, would essentially fund EPA at its current levels and retain current staff levels. The bill appropriates $8.058 billion for EPA, paring a little over $80 million -- about one percent -- from EPA’s FY 2016 budget.
Programs targeted for elimination by President Trump remain funded, at least through September, when Congress will face another budget showdown. For example, the bill funds the Great Lakes Restoration Initiative, the Chesapeake Bay Program, and lead elimination programs.
While EPA’s budget is generally unchanged, the bill does contain several policy riders. It would require EPA to treat air emissions from forest biomass as carbon neutral. EPA also would not be allowed to regulate manure and similar agricultural byproducts as wastes under the Resource Conservation and Recovery Act (RCRA), and the bill would bar EPA from requiring Clean Water Act (CWA) permits for certain agricultural practices. The legislation also prohibits funding to regulate lead content of ammunition, ammunition components, and fishing tackle under the Toxic Substances Control Act (TSCA) or any other law.
Senate Report No. 114-281 on the pending FY 2017 budget deal and an accompanying explanatory statement also address specifically TSCA, the Integrated Risk Information System (IRIS), and nanomaterials. The specific language is below.
- Toxic Substances Control Act Modernization -- The Committee notes that legislation to modernize the Toxic Substances Control Act [TSCA] was recently approved by both the Senate and the House of Representatives. This bill includes language that will enable the EPA to collect and spend new fees to conduct additional chemical reviews, consistent with TSCA modernization legislation. Those fees are expected to be $25,000,000 per year once the program is fully implemented. The Congressional Budget Office estimates that in fiscal year 2017, fee collections will begin several months after the beginning of the fiscal year and will total $4,000,000. This bill also includes language ensuring that new fee collections will supplement, not supplant, appropriated resources for these activities.
- Integrated Risk Information System -- The Committee is aware of efforts by the Agency to implement the 2011 National Academy of Science’s [NAS] Chapter 7 and 2014 NAS report recommendations for the Integrated Risk Information System [IRIS] but remains concerned that the recommendations have not been fully implemented. In published appendices that accompany final IRIS assessments, EPA has detailed some of the Agency’s deficiencies in meeting the NAS high-priority reforms. The Committee directs the Agency to convene an interagency working group to be Co-Chaired with the Office of Information and Regulatory Affairs and to include relevant executive branch stakeholders to review compliance with the NAS recommendations in IRIS assessments issued since the 2014 NAS report. The working group shall focus specifically on transition from the use of single point estimates of hazard and exposure to presenting more complete information on the distribution of estimated hazards, exposures, and/or risks, including central tendency values; on processes for evaluating study quality, relevance, and risk of bias; the use of a transparent and reproducible weight-of-evidence process for applying scientific findings; the selection of an adverse outcome; and the use of default linear low-dose extrapolation and other default modeling approaches to hazard determinations. The Committee directs the Agency to issue a report to the Committees of Appropriations of the House and Senate on the findings of the working group and the implementation plans of its findings within 180 days of enactment of this act. The working group report shall also include a timetable for EPA’s full implementation of the NAS recommendations for all IRIS assessments issued since the 2014 NAS report.
- Nanomaterials Research -- The Committee notes the increased capabilities that the Food and Drug Administration [FDA] has developed to study environment, health, and safety of nanomaterials [nanoEHS] within FDA’s Jefferson Laboratory Campus, including the National Center for Toxicological Research, and its consolidated headquarters at White Oak, Maryland. The FDA can and should be more involved in nanoEHS research with other agencies, particularly in activities involving human health. Out of the amounts appropriated, the [EPA} Administrator shall seek to involve the FDA in nanoEHS research to the maximum extent possible, including participation in EPA funded research.
By Lynn L. Bergeson and Margaret R. Graham
The amended Toxic Substances Control Act (TSCA) has ushered in new developments in testing strategies. In March 2017, Andre E. Nel, Ph.D. (Division of NanoMedicine, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, California (UCLA); California NanoSystems Institute, UCLA (CNSI)) and Timothy F. Malloy (CNSI; UCLA School of Law; UCLA Center on Environmental and Occupational Health) published Policy reforms to update chemical safety testing: TSCA reform empowers EPA to use modernized safety testing in the United States, in the Journal Science. This article discusses this new “paradigm” in testing, which it states relies “largely on nonanimal, alternative testing strategies (ATS), uses mechanism-based in vitro assays and in silico predictive tools for testing chemicals at considerably less cost.” There are technological and institutional challenges, however, that the article addresses, but the authors state they hope to provide a “cautious but hopeful assessment of this intersection of law and science.”
The article describes five iterative components that make up the elements of ATS: conceptual pathways; biomolecular events; screening and modeling; integrating evidence; and regulatory applications. These components work together to inform four types of regulatory decisions: “screening to identify chemicals and nanomaterials for more extensive testing and evaluation; ranking or prioritization for further action; qualitative or quantitative risk management in support of risk management; and comparative evaluation of the hazards and risks of different substances in support of safer design.”
Amended TSCA Section 4(h)(2) implements alternative testing methods to “promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals,” and Section 4(h)(2)(A) directs EPA, by June 2018, to develop a strategic plan that will promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures….”
The article states that while the amended statute seems to be only “procedural in nature” in terms of the implementation of ATS, as the statute compels EPA to facilitate development of ATS but does not obligate the agency to adopt it, two factors bode well for ATS implementation: (1) various EPA offices as well as its partner entities are “already engaged in bringing ATS into the regulatory context”; and (2) as amended TSCA mandates EPA to prioritize chemicals already in the marketplace for safety evaluations, by “specified enforceable deadlines,” which incentivizes the broader EPA chemical regulatory program to “adopt ATS for prioritization and subsequent risk evaluation of chemicals deemed high priority.” The article references EPA’s Office of Research and Development (ORD), the Office of Science Coordination and Policy (OSCP), the new chemical review program, and EPA’s partner entity the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods as those entities engaged in ATS implementation.
By Lynn L. Bergeson and Margaret R. Graham
On March 29, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notice releasing its initial inventory report of mercury supply, use, and trade in the United States pursuant to Section 8(b)(9)(10) of the amended Toxic Substances Control Act (TSCA). Specifically, the report is a “compilation of readily available, previously published data on the supply, use and trade elementary mercury and mercury compounds,” and its purpose is to “identify any manufacturing processes or products that intentionally add mercury.” The report itself is available in Docket ID EPA-HQ-OPPT-2017-0127-002 on http://www.regulations.gov. The notice states that EPA is not soliciting comments on this report.
The report states that it is focused on commodity mercury, as opposed to mercury that is handled and discarded as waste, and that in some cases the information is outdated. The report is organized in three parts:
- Introduction, which includes U.S. laws affecting supply and trade of Mercury; and sources of information;
- Elemental mercury, which includes supply of elemental mercury, sources of supply, use of elemental mercury (including mercury-added products and manufacturing processes), and trade of elemental mercury; and
- Mercury compounds, which includes supply, use, and trade of Mercury compounds.
By Lynn L. Bergeson and Margaret R. Graham
On March 8, 2017, Senator James Lankford (R-OK) introduced S. 578, the “Better Evaluation of Science and Technology Act” or “BEST Act,” a bill that would amend title 5 of the United States Code, commonly referred to as the Administrative Procedure Act (APA), to “provide requirements for agency decision making based on science.” Although the BEST Act does not refer to the recently amended Toxic Substances Control Act (TSCA), it is apparent that it plans to implement the same science standards stipulated in amended TSCA, for all federal agencies that use “scientific information” (which the bill does not define) in their rulemakings, including the U.S. Environmental Protection Agency (EPA). Section 2 of the BEST Act uses language quoted verbatim from TSCA Section 26, subsections (h) Scientific Standards, (i) Weight of Scientific Evidence, and (j) Availability of Information.
S. 578 was one in a package of regulatory improvement bills that Lankford introduced on March 8, 2017, which his press release stated were “aimed at improving the federal rulemaking process so the final regulations work better for the American people.” Lankford is a vocal critic of some agencies’ practices regarding scientific integrity, stating that “agencies occasionally use hidden science to support their regulatory decisions instead of transparent conclusions, data, and methods,” and that, instead, “Agencies should use the best available science that has been peer-reviewed by an independent third-party, make sure conclusions are verifiable and reproducible, and assure the data is transparent and publically available.”
By Lynn L. Bergeson
On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017. On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.” EPA is accepting comments in Docket ID EPA-HQ-OPPT-2016-0426 on the www.regulations.gov website. More information on this proposed rule is available in our memorandum EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive).
By Lynn L. Bergeson and Margaret R. Graham
In January, the U.S. Environmental Protection Agency (EPA) issued its initial report to Congress on its capacity to implement certain provisions of the amended Toxic Substances Control Act (TSCA). The report, prepared by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for the Committees on Energy and Commerce, and appropriations of the U.S. House of Representatives, and the Committees on Environment and Public Works, and Appropriations of the U.S. Senate, was directed to be provided within six months of enactment under Section 26(m)(1) of amended TSCA. In the report, EPA states that it anticipates “ramping up from 10 risk evaluations in FY2017 to 15 in FY2018, reaching 20 by the end of FY2019,” which is necessary “to accomplish an ongoing pace of at least 20 EPA-initiated risk evaluations underway” by the end of calendar year (CY) 2019. EPA also provides a table on page five, Table 1: TSCA Risk Evaluations, Numbers Underway and Resources Estimates, which presents estimates for its annual costs, calculated by dividing the average lifecycle costs of the actions by the number of years the statute provides for the agency to complete those actions, and then multiplying the result by the numbers of actions required/anticipated to be underway each year. The total annual costs range from $12.3 million for FY2017 to $35.8 million for FY2021. The report refers to the rule to implement the fee collection provisions, stating it is “currently under development,” but does not provide any more details on when it will be issued.
On January 30, 2017, President Trump issued a Memorandum for the Heads of Executive Departments and Agencies in the Federal Register which directs federal agencies to “support the expansion of manufacturing in the United States through expedited reviews of and approvals for proposals to construct or expand manufacturing facilities and through reductions in regulatory burdens affecting domestic manufacturing.” 82 Fed. Reg. 8667. The memo will require the Secretary of the Department of Commerce (DOC) to conduct outreach to stakeholders concerning the impact of federal regulations on domestic manufacturing and to solicit comments for 60 days concerning “Federal actions to streamline permitting and reduce regulatory burdens for domestic manufacturers.” DOC is also instructed to coordinate this process with the Secretaries of EPA, the U.S. Department of Agriculture (USDA), the U.S. Department of Energy (DOE), and the Administrator of the Small Business Administration (SBA), among others, and within 60 days after the process is completed, to submit a report setting forth a plan to streamline federal permitting processes for domestic manufacturing and “to reduce regulatory burdens affecting domestic manufacturers,” identifying “priority actions as well as recommended deadlines for completing actions.”
Also on January 30, 2017, President Trump issued an Executive Order on reducing regulation and controlling regulatory costs casually referred to as the “one in, two out” order which states that when executive departments and agencies “publicly propos[e] for notice and comment or otherwise promulgat[e] a new regulation, [they] shall identify at least two existing regulations to be repealed.” The order also states that no incremental costs can be accrued for any new regulations unless required by law or advised in writing by the Director of the Office of Management and Budget (OMB). For any costs that are accrued, it is directed for them to be “offset by the elimination of existing costs associated with at least two prior regulations.” In the order, the OMB Director is tasked with providing guidance on implementation, as well as identifying the total amount of costs allowed for each agency “in issuing new regulations and repealing regulations for the next fiscal year.” The regulations exempt from this order are: regulations issued with respect to a military, national security, or foreign affairs function; regulations related to agency organization, management, or personnel; and other categories exempted by the OMB Director.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
On January 27, 2017, the U.S. Customs and Border Protection (CBP) issued in the Federal Register a notice of delay of an effective date of a final rule issued on December 27, 2016 (81 Fed. Reg. 94980). The final rule announced amendments to CBP regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture. 82 Fed. Reg. 8590. Specifically, the final rule amends CBP’s regulations under 19 C.F.R. Parts 12 and 127 to establish an electronic option for importers to file the required U.S. Environmental Protection Agency (EPA) TSCA certifications, to clarify and add certain definitions, and to eliminate the paper-based blanket certification process.
The effective date of the final rule was initially set at January 26, 2017, but is now delayed until March 21, 2017, in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017, directing heads of executive departments and agencies temporarily to postpone the effective date for 60 days from the date of the memorandum, of all regulations that had been published in the Federal Register, but had not taken effect. In the notice, CBP states that this additional time is not unwelcome, as it will allow affected entities more time to “become familiar with the increased flexibilities and new processes of the final regulations.”
By Lynn L. Bergeson and Margaret R. Graham
On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing it will be holding a public meeting to receive public input and information on uses and conditions of use for the initial ten chemicals to be evaluated under Section 6(b)(2)(A) of the amended Toxic Substances Control Act (TSCA) on February 14, 2017, from 9:00 a.m. to 3:00 p.m. (EST), at the Ronald Reagan Building and International Trade Center, Polaris Room, 1300 Pennsylvania Avenue Northwest, Washington, DC 20004. 82 Fed. Reg. 6545. EPA states that the information it gathers on uses and the conditions of use will assist it in identifying potential exposure scenarios for the ten chemicals.
Registration is available online and remote access will be available for registered participants. Public dockets for each chemical have been established. Written comments and materials will also be accepted in these dockets on www.regulations.gov. EPA requests for them to be submitted by March 1, 2017.
Additional information, including links to the public dockets, is available on EPA’s website and in our blog item EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.