Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
The U.S. Small Business Administration’s (SBA) Office of Advocacy (Advocacy) has announced that it will be hosting regional small business roundtables “to hear firsthand from small businesses facing regulatory burdens [on] … which federal agency regulations should be considered for reform or elimination,” and “which regulations are problematic for your business,” as a result of the recent Executive Orders 13771 and 13777 on regulatory reform.
The first two roundtables in this series will be held on June 7, 2017, and June 8, 2017, in Baton Rouge and New Orleans, Louisiana, respectively. Several more are expected to be scheduled soon for Boise, Idaho, Phoenix, Arizona, and St. Louis, Missouri, among others.
The Advocacy website states that the purpose of regional regulatory roundtables is to:
Registration for the first two roundtables is available online: Baton Rouge registration; New Orleans registration. Advocacy is also accepting comments regarding regulatory reform via an online form. More information on the Executive Orders and their implementation is available on our blog.
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published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed.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 EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.”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.”
EPA Reopens Comment Period on Standards for Small Manufacturers and Processors for TSCA Reporting for Review of SBA Consultation Documents
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.
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.
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.
On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts. The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB).
On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act. 81 Fed. Reg. 90843. The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.” EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”
Information about attending this meeting and its agenda will be posted to the NRC website. More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA.
EPA Extends Comment Date for Proposed Rules Banning Certain Uses of TCE, NMP, and Methylene Chloride
On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules: (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping (issued January 19, 2017); and (2) to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N-methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping (issued January 19, 2017). 82 Fed. Reg. 20310.
This is the second extension of the comment period for the proposed rule to ban TCE use in vapor degreasing and the first extension of the comment period for the proposed rule to ban the uses of NMP and methylene chloride for consumer and most types of commercial paint and coating removal. Comments on both proposed rules are now due on May 19, 2017.
“TSCA Reform: Key Provisions and Implications” Published In Environmental Quality Management Journal
On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management. On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing processes. This article summarizes key changes to TSCA and explains their likely impacts on the manufacturing sector.
On April 25, 2017, the U.S. Environmental Protection Agency (EPA) issued two notices in the Federal Register expressing its determination that 28 new chemical notifications are “not likely to present an unreasonable risk of injury to health or the environment.” 82 Fed Reg. 19044 (Statement of Findings for December 2016); 82 Fed. Reg. 19046 (Statements of Findings for February 2017). The statements of findings list premanufacture notices (PMN) and microbial commercial activity notices (MCAN) regarding new polymer and biodegradable chemicals submitted to EPA under Section 5 of the Toxic Substances Control Act (TSCA). The notices listed in the December 2016 statement of findings are:
The notices listed in the February 2017 statement of findings are:
The publication of these two notices fulfills EPA’s obligation under TSCA Section 5(g) to publish its findings; all of these determinations had previously been posted to the EPA website. It is to EPA’s credit that EPA has made its determinations public as soon as practicable by posting those determinations on its website. We recognize that publication in the Federal Register often lags behind EPA’s decisions because of resource constraints and competition with other Federal Register notices. We are pleased to see new chemicals cleared for production.
Nevertheless, EPA’s pace of approving new chemicals for the marketplace has slowed tremendously since enactment of TSCA reform. Furthermore, these notices do not provide any line of sight on the reasons contributing to the delays, or EPA’s resolution of these issues. To date, EPA has only published its final determinations for substances with low concerns for heath and ecological hazards. With only 28 new chemicals approved from the time period of December 1, 2016, to February 28, 2017, EPA will need to work much faster to even come close to its annual average number of 700-800 PMN reviews and keep the backlog of cases under review from continuing to grow.
According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Dr. Beck holds a doctorate in environmental health from the University of Washington. For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC). For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).
Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders. Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS). President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA). Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes.
A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise to educate senior EPA officials to help them understand the benefits of those programs or regulations, and save them from elimination. These internal memoranda demonstrate that the regulatory dismantling of EPA’s programs is being robustly carried out by EPA. Those stakeholders who wish to save a program benefitting their interests should act immediately to educate EPA. The three memoranda are:
More information on these memoranda are available in our full memorandum Internal EPA Memoranda Outline Approach for Regulatory Deconstruction; Stakeholders Have the Opportunity to Seek to Protect Programs at Risk.
On Wednesday, April 12, 2017, from 11:00 a.m. to 12:30 p.m. (EDT), the American Bar Association’s Section of Environment, Energy, and Resources will be hosting a teleconference on this very topic, entitled “What Happens Now at EPA: Assessing the Executive Orders and Upcoming Regulatory Reform.” Registration is available online.
On March 28, 2017, Senators Chris Coons (D-DE), Shelley Moore Capito (R-WV), Steve Daines (R-MT), and Gary Peters (D-MI) announced that they will serve as co-chairs of the newly formed Senate Chemistry Caucus. Senators John Boozman (R-AR), Joe Donnelly (D-IN), John Neely Kennedy (R-LA) and Joe Manchin (D-WV) have also agreed to join the Caucus. Senator Coons’ press release states that the Senate Chemistry Caucus will provide “a bipartisan forum for Senators to work together on issues dealing with the science of chemistry, the nation’s chemical business sector and their importance to our economy and the central role they play in the creation of innovative products vital to everyday life,” and that the group will work with their colleagues in the Senate to “underscore the importance of employing sound science to create effective public policy and to promote initiatives that encourage the development of chemical manufacturing and a new generation of chemists in the U.S. through world-class education and research programs.”
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:
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.”
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).