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. Environmental Protection Agency (EPA) published a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards. 85 Fed. Reg. 16334. EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals, furthering outstanding or innovative source reduction. All Safer Choice stakeholders and program participants in good standing are eligible for recognition. Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2019. EPA notes that there is no form associated with this year’s application. EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony that is being planned for fall 2020. Submissions are due May 31, 2020.
Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle. As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical space.
ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). EPA states that some of the key revisions include:
Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.
Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods. EPA notes that as it highlights chemical safety during the month of March, “these grants support that goal by providing information, training, and tools to improve public health and the surrounding environment, reduce pollutants, and decrease resource use (e.g., water and energy).” EPA anticipates awarding individual grants in the range of $20,000 - $200,000 for a two-year funding period (or between $10,000 - $100,000 per year), though award amounts may vary based on EPA region. EPA anticipates awarding 20 grants in total. EPA states that grant applications should focus on at least one of the following P2 priority areas, also referred to as National Emphasis Areas (NEA) that support several of the EPA’s Smart Sectors. Through these grants, technical assistance and projects should encourage businesses to identify, develop, and adopt P2 practices and reduce waste in the following sectors:
Food and Beverage Manufacturing and Processing (NEA #1);
Chemical Manufacturing, Processing, and Formulation (NEA #2);
Automotive Manufacturing and Maintenance (NEA #3);
Aerospace Product and Parts Manufacturing and Maintenance (NEA #4); and
Metal Manufacturing and Fabrication (NEA #5).
Proposals are due by April 30, 2020. Additional information is available on www.grants.gov, under Funding Opportunity Announcement EPA-HQ-OPPT-2020-002.
On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020. Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first two or three years after enactment, really through 2019, setting up the bones of the program, the regulations, the structure, the fees rule, and now we’ve begun the deep process of looking at each chemical [for risk evaluation].” The conversation continued with discussion regarding how chemicals are selected for evaluation, surprises EPA encountered while making low-priority determinations, and what can be expected through the remainder of 2020. Ms. Dunn and Ms. Bergeson agreed that as more chemicals go through this review process, the quantity and type of information needed will standardize, leading to more predictability for all stakeholders. Now that a system is evolving, EPA plans to identify data gaps early to provide time to strategize how to acquire as much information as is required to evaluate properly a chemical on schedule and with minimal additional costs.
A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.
As reported in our October 1, 2019, blog item, on September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review. According to OMB’s website, OMB completed its review on February 14, 2020. EPA has not yet publicly released the proposed rule.
According to the item on the rulemaking in EPA’s fall 2019 Unified Agenda, EPA is developing a supplemental proposal to its 2015 proposed LCPFAC SNUR amendments. EPA states that the supplemental proposal would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles. According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in Section 5(a)(5) of the Toxic Substances Control Act (TSCA) that was added with the 2016 amendments to TSCA. Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification. Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.
The U.S. Environmental Protection Agency (EPA) Pollution Prevention (P2) Grant Program has announced the availability of funds to provide technical assistance (e.g., information, training, tools) to businesses to encourage the development and implementation of source reduction practices. EPA states that source reduction practices can help businesses save money by reducing resource use, expenditures, waste, and liability costs, while at the same time reducing their environmental footprint and helping to protect human health and the environment. Applications for fiscal years (FY) 2020 and 2021 are due March 31, 2020.
EPA states that it anticipates awarding approximately $9.38 million in total federal pollution prevention grant funding over a two-year funding cycle ($4.69 million in FY 2020 funds and approximately $4.69 million in FY 2021 funds). According to EPA, P2 grants are expected to be awarded in each EPA region and will be funded in the form of grants or cooperative agreements. EPA provides the following “quick facts” for P2 grants:
Eligibility: State governments, colleges, and universities (recognized as instrumentalities of the state), federally recognized tribes, and intertribal consortia;
Match requirement: 50 percent match; for tribal governments that place P2 grant activities into a performance partnership grant (PPG) agreement, the match for the tribe is reduced to five percent;
Review of applications: Along with other requirements that are noted in the Request for Applications (RFA), applications must address one of the following statutory/regulatory criteria to merit further review:
Provide technical assistance and/or training to businesses/facilities about source reduction techniques to help them adopt and implement source reduction approaches and to increase the development, adoption, and market penetration of greener products and sustainable manufacturing practices; and
Identify, develop, document, and share P2 best management practices and innovations so this information may inform future technical assistance and these P2 approaches and outcomes may be replicated by others;
Range of awards: Individual grant awards may potentially be in the range of $40,000-$500,000 for the two-year funding period (between $20,000 and $250,000 incrementally funded per year). Some EPA regions may have lower award caps, however; and
The New York State Department of Environmental Conservation (NYSDEC) will hold a public meeting on February 24, 2020, at 1 p.m. (EST) in Albany, New York, “to discuss amendments to the household cleansing product rules that are being considered for adoption.” According to NYSDEC, amendments include specifying what information must be reported about covered products and their ingredients, how information should be shared with NYSDEC for the public record, the type of studies that must be reported, and how confidential business information (CBI) should be handled. NYSDEC states that during the meeting, it “is looking for input on disclosure of nonfunctional ingredients, issues around confidential information, and how to disclose when a product’s formulation temporarily changes, as well as other regulatory concerns.” Registration is required to attend the meeting. NYSDEC notes that it “will hold a formal public comment period at a later date once it officially proposes the regulations.”
As reported in our September 4, 2019, blog item, on August 27, 2019, the State of New York Supreme Court invalidated the Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYSDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here. The court found that the Disclosure Program was established in violation of the State Administrative Procedure Act (SAPA) and the New York State Constitution. In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYSDEC. A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’”
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
TSCA Tutor™ online training courses include:
Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
TSCA Tutor -- Curriculum
An Overview of TSCA (Course number T101)
New TSCA at a Glance (Course number T102)
Import Requirements, TSCA Section 13 (Course number T103)
Export Requirements, TSCA Section 12 (Course number T104)
Confidential Business Information (CBI) (Course number T105)
Reporting and Retention of Information, TSCA Section 8 (Course number T106)
Inspections and Audits (Course number T201)
Preparing for a TSCA Audit
TSCA Penalties/Overview of Self-Confession Policy
TSCA Section 5, Part 1: TSCA Chemical Inventory, Exemptions (Course number T202)
TSCA Section 5, Part 2: New Chemicals/New Use (Course number T203)
New Chemicals/New Use
Chemical Data Reporting (CDR) (Course number T204)
Byproduct Reporting under CDR
Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
The U.S. Environmental Protection Agency (EPA) announced on December 2, 2019, that it granted the first two manufacturer requests for risk evaluations for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production. EPA states that if the requests are not withdrawn within 30 days, both DIDP and DINP will enter the risk evaluation process under the Toxic Substances Control Act (TSCA). Manufacturer-requested risk evaluations are conducted in the same manner as other risk evaluations conducted under TSCA Section 6(b)(4)(A). EPA received the manufacturer requests from ExxonMobil Chemical Company (for DIDP) and from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex (for DINP), both through the American Chemistry Council’s High Phthalates Panel. Both chemicals were identified in the 2014 Update to the TSCA Work Plan. As reported in our August 17, 2019, blog item, EPA held a public comment period on the requests, as well as additional conditions of use that EPA identified to include in the risk evaluations. More information is available in our August 19, 2019, memorandum, “EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use.”
Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, product defense, and associated business issues.