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The State of California now has over 900 chemical substances for which warning and labeling is required under Proposition 65 (Prop 65). Recently added to this list are soluble nickel compounds. Given the potential ubiquity of the substance, this could have big implications.

On November 26, 2018, Inside EPA included information from Bergeson & Campbell, P.C.’s (B&C®) memorandum “EPA Publishes First Draft TSCA Chemical Risk Evaluation” in the article “EPA's PV29 Assessment Likely to Test Reformed TSCA's Data Standards.” In a Nov. 16 memo on the draft's release, the law firm Bergeson and Campbell suggests that there may be little reason to challenge the agency's finding though it leaves the door open to questioning the data EPA...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29...

Download transcript. This week, I sat down with Michael Wenk, one of our senior regulatory consultants, to discuss his new book Chemical Regulation in the Middle East. Michael’s book focuses on eight countries in the Middle East that have a combination of well developed and emerging chemical regulatory schemes. His book provides a comprehensive examination of the main chemical management laws in force for each particular country, and summarizes general trends and issues facing the region as a...

On November 14, 2018, Inside EPA spoke with Christopher R. Bryant, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), for the article “EPA Eases RCRA For Airbag Removals But Keeps Hazardous Waste Status.” [W]hile dealers and others removing the airbags will be conditionally exempt under the new rule, others further down the waste stream will not, says Chris Bryant, a former EPA waste official who is now a senior regulatory consultant with Bergeson...

On November 13, 2018, Charles M. Auer, Senior Regulatory and Policy Advisor, Bergeson & Campbell, P.C. (B&C®), was quoted by Inside EPA regarding Congress’ plan to oversee the U.S. Environmental Protection Agency’s (EPA) implementation of the revised Toxic Substances Control Act (TSCA). “There may be some bipartisan oversight on nuts and bolts questions. But my guess is that each side will generally focus questions on 'their' issues and concerns,” says Charles...

On November 12, 2018, Richard E. Engler, Ph.D., Director of Chemistry for Bergeson & Campbell, P.C. (B&C®), was featured on National Public Radio’s (NPR) morning news program “Morning Edition” during a segment on the chemical methylene chloride.  Reporter Rebecca Hersher asked Dr. Engler, a 17-year veteran of the US Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) and leader of EPA's Green Chemistry Program, about EPA’s review...

Compliance & Risks presented a complimentary webinar “Proposition 65 Warning Requirements and Compliance Strategies.” Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) and Lisa R. Burchi, Of Counsel, B&C, presented an overview of California’s Office of Environmental Health Hazard Assessment new Prop 65 warning label requirements that took effect on August 30, 2018. 

On November 6, 2018, Bloomberg Environment quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding new chemical rules. Before 2016, the EPA took regulatory action on 10-15 percent of new chemicals, clearing the way for 85-90 percent of new compounds to proceed without restrictions, Richard Engler, Bergeson and Campbell PC’s director of chemistry, said. But since the amendments to the nation’s primary chemicals law passed in...

On November 5, 2018, Bloomberg Environment quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), in the article “More Sales, Broader Safeguards May Follow Chemical Rule Deluge.” The rules broaden sales opportunities for both the companies that designed these chemicals and ones that want to make or use them, Richard Engler, who was a chemist at the Environmental Protection Agency for 17 years, told Bloomberg Environment. […] The...

In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published a Proposed Rule Stage item titled “Update to the Hazard Communication Standard,” RIN 1218-AC93, and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March 2019. The full description of the item is: OSHA and other U.S. agencies have been...

Washington, D.C. (November 1, 2018):  Bergeson & Campbell, P.C. (B&C®) is launching a podcast today.  It is called All Things Chemical™ and it will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic...

Download transcript. This week, I got to have a roundtable discussion with several of my colleagues about a Strategic Research Plan released by the EPA earlier this summer, outlining their approach to reduce and replace “vertebrate” testing. What we’re really talking about, of course, is animal testing. In keeping with the commitment outlined in 2016’s Toxic Substances Control Act (TSCA), the EPA proposes several so-called New Approach Methodologies, or NAMs, which they hope will be able...

Effective October 26, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) added nickel (soluble compounds) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65 (Prop 65).  Importantly, “soluble” is not defined in the listing.  On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts”...

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued a final fees rule under the Toxic Substances Control Act (TSCA). The final rule largely tracks the proposed rule. The EPA will host a series of webinars focusing on TSCA submissions and fee payments under the final rule. The agency has posted a pre-publication version of the final rule, as well as its response to public comments on the proposed rule.

Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), directs that “[n]ot later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish” (Environmental Protection Agency [EPA], 2018a, p. 30056) an inventory of mercury or mercury-added products or uses of mercury in a manufacturing process. On June 27, 2018, the U.S. Environmental Protection Agency...

Hi, this is Lynn Bergeson of Bergeson & Campbell in Washington, D.C. I'm here to announce that we have launched a podcast. It's called All Things Chemical. And whether you are a lawyer in the chemical space, a scientist or a manager, or a CEO of a Fortune 50 chemical company, you will want to listen up. Starting November 1st we will be releasing a podcast every other week. We're going to be dealing with a whole host of really interesting issues including animal testing and alternatives to...

On October 17, 2018, Bergeson & Campbell, P.C. (B&C®) presented a complimentary webinar regarding pending implementation dates of key U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) rules. “Keeping up with FSMA – Rules, Obligations, and Key Compliance Dates” was presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, and...

On October 18, 2018, Inside EPA quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding the B&C memorandum “EPA Proposes SNURs that Break New Ground under Amended TSCA.” Industry attorneys are welcoming the agency's approach, suggesting it sets a precedent for future agency action. “The proposed SNUR is interesting, important, and controversial, as this is the first time under the new law for which EPA is proposing to...

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those acted on since entry into force of amended TSCA), the 13 chemical substances are not also subject...

With the pending implementation dates of several core elements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), many manufacturers are challenged in addressing efficiently and smartly supply chain complexities. This webinar, presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, showed...

Inside EPA Quotes B&C’s “EPA Issues Final TSCA Fees Rule” Memorandum On October 16, 2018, Inside EPA quoted Bergeson & Campbell P.C.'s (B&C®) memorandum “EPA Issues Final TSCA Fees Rule” in the article “EPA finalizes TSCA fees rule but legal challenges possible.” A Sept. 28 memo from the law firm Bergeson & Campbell notes that “the final rule will apply to all submissions that are received starting October 1, 2018. EPA stated that it will...

As part of Amazon’s commitment to responsible sourcing, Amazon has posted its chemicals policy, which includes its first Restricted Substance List (RSL). Amazon states that it defines chemicals of concern as those chemicals that: (1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or (2) are persistent, bioaccumulative, and toxic. Amazon “strategically prioritize[s] which chemicals of concern to focus on based on product...

Now more than ever, chemical industry stakeholders with shared business and advocacy interests are urged to consider collaborating on regulatory, testing, and related advocacy opportunities. Two years post-passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act means the U.S. Environmental Protection Agency (EPA) is well underway with implementation of the amended Toxic Substances Control Act (TSCA).    Industry groups that are already established and...

On October 8, 2018, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), moderated “Sustainable Investment in Agriculture: Improving Agricultural Land Investment Contracts and the Contracting Process” at the legal profession’s largest international event, the International Bar Association (IBA) Annual Conference held this year in Rome, Italy. Ms. Bergeson is Vice Chairman of IBA’s Agricultural Law Committee. Panelists Katherine Cook, Matrix...

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) released the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under the Toxic Substances Control Act (TSCA). EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be...

On September 29, 2018, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and President-Elect of the Product Stewardship Society (PSS) moderated the closing session, “Drivers of Product Stewardship: The Role of Regulations, Private Governance, and Managing,” at the 2018 Product Stewardship Conference in Washington D.C. This conference addressed global safety, environmental, and regulatory challenges by bringing together prominent professionals to present and...

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued a final fees rule under the Toxic Substances Control Act (TSCA). The final rule largely tracks the proposed rule. In its press release, EPA states that the fees collected from chemical manufacturers “will go toward developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and making...

On September 24, 2018, Bloomberg Environment quoted Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), regarding the U.S. Environmental Protection Agency’s (EPA) plan to expand the list of fluorochemicals on the ChemView database. Companies making new fluorochemicals had to generate more than $25 million worth of health, environmental fate, degradation data, and other information under agreements they made, the agency told Bloomberg...

Wednesday, October 17, 2018 1:00 p.m. - 2:00 p.m. (EDT)  Complimentary Registration Available Online  Speakers: ■ Karin F. Baron, MSPHSenior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®)■ Lynn L. BergesonManaging Partner, B&C; President, Acta■ Scott J. Burya, Ph.D.Regulatory Chemist, B&C and Acta With key implementation dates of several core elements of the U.S. Food and Drug Administration’s (FDA) Food...

On September 18, 2018, Bergeson & Campbell, P.C. (B&C®) and Bloomberg BNA presented “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules,” the fourth webinar in the 2018 Chemical Policy Summit Series. The presenters noted that protecting confidential business information (CBI), including chemical identity, has never been easy but remains an essential component of a successful commercial chemical strategy, and cautioned that amended Toxic...

On September 19, 2018, Kathleen M. Roberts, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), was quoted by Bloomberg Environment in the article “U.S. Chemical Makers’ Sharing of Use Data Stirs Debate.” TSCA and REACH also are different laws in different stages of implementation, which explains some of the divergent responses of U.S. and European manufacturers, said Kathleen M. Roberts, a senior regulatory consultant in Bergeson & Campbell, PC’s...

This summer, the U.S. Environmental Protection Agency’s Office of Inspector General (OIG) issued a report titled “EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.” The OIG conducted an audit to determine how the EPA is ensuring companies are compliant with the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA), and whether the EPA uses CDR data to prioritize chemicals for the purpose of identifying...

Bergeson & Campbell, P.C. (B&C®) and Bloomberg BNA were pleased to present “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules,” the fourth webinar in the 2018 Chemical Policy Summit Series. Protecting confidential business information (CBI), including chemical identity, has never been easy but remains an essential component of a successful commercial chemical strategy.  New Toxic Substances Control Act (TSCA) Section 14 is much more...

On September 12, 2018, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) presented “Chemical Regulation in the Middle East.” This complimentary webinar was developed in conjunction with the recently released book “Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S., Senior Regulatory Consultant with B&C and Acta. Mr. Wenk presented an overview of chemical substance regulation in the Middle East with a focus on key chemical control...

Bergeson & Campbell has written extensively about the U.S. Environmental Protection Agency’s implementation of the 2016 Amendments to the Toxic Substances Control Act occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). On the whole, EPA implementation efforts have been timely, balanced, and defensible. Implementation of Section 5 (new chemicals) revisions has been less successful. To date, the EPA’s approach has impeded the...

This article reviews the Trump Administration’s engagement, to date, in key industrial chemical matters, domestically and internationally.  Topics include the Toxic Substances Control Act (TSCA), the UN’s Strategic Approach to International Chemicals Management (SAICM) and 2030 Agenda for Sustainable Development, and Ratification of the Stockholm Convention on Persistent Organic Pollutants.

On September 4, 2018, Bloomberg Environment quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®) regarding a shortage of 1,2-benzisothiazol-3(2H)-one. An ongoing global shortage of a chemical used in inks, disinfectants, cleaning, and many other products shows why manufacturers need backup plans to ensure they can meet their commercial obligations, an attorney told Bloomberg Environment. “This may well be an illustration of the new normal,” Lynn...

Complimentary webinar on September 12, 2018, 12:00 p.m. - 1:00 p.m. (EDT) Register online The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the publication of “Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S. This first of its kind handbook offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in the countries of the Middle East....

The Acta Group (Acta®) and Bergeson & Campbell, P.C. (B&C®) are pleased to announce the publication of “Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S., Senior Regulatory Consultant with Acta and B&C. This first of its kind handbook offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in the countries of the Middle East. It also explores the...

As a candidate and now as president, President Trump has been uncharacteristically predictable in systematically dismantling signature environmental policies of prior administrations and ceding the United States’ leadership in combating climate change to other global powers. The administration’s industrial chemicals management policy has been less transparent and predictable, however. Some may have interpreted candidate Trump’s notable silence on the campaign trail as support for Toxic...

On August 21, 2018, Susan Bodine, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA), issued a memorandum to EPA Regional Administrators ordering a shift in OECA’s activities from enforcement to compliance.  This column reports on this important shift in Agency focus. Background For over two decades, EPA has strategically focused its enforcement and compliance resources on priorities it deems the...

The release of the Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for a new polymer, P-16-0510, represents a positive step in implementing the New Chemicals Program under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The new chemical is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays and other consumer products. This column explains why this is a significant development.

On August 21, 2018, Christopher R. Bryant, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), was quoted by Bloomberg Environment regarding the U.S. Court of Appeals for the District of Columbia Circuit’s recent order for the U.S. Environmental Protection Agency (EPA) to reconsider multiple parts of a 2015 regulation determining “how coal-fired energy utilities could dispose of coal ash, a byproduct of burning coal to generate electricity.” The decision...

On August 10, 2018, Inside EPA’s article “Industry Backs EPA Chemical Approval But Seeks Clarity On TSCA Process” included comments from TSCAblog’s August 6, 2018, post “EPA Adds Clarity to Interpretation of “Reasonably Foreseeable Conditions of Use”.”  Industry attorneys are welcoming EPA's recent approval of a new chemical that took a narrow view of the substance's “reasonably foreseen uses” that the agency is required to consider, but are urging officials to...

The ‘right-to-know’ has been a foundational element of U.S. environmental law and policy for decades. As more information becomes known about the potential health and environmental impacts of chemical substances in industrial, commercial, and especially consumer products, the public’s interest in product ingredients has sharply increased. Recently this interest has taken a new direction, one targeting consumer cleaning products. Two state initiatives, originating in opposite sides of the...

On July 27, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.  OIG conducted an audit to determine how EPA is ensuring that companies are compliant with the Chemical Data Reporting (CDR) Rule requirements under the Toxic Substances Control Act (TSCA) and whether EPA is using CDR data to prioritize chemicals for the...

On August 2, 2018, Kathleen M. Roberts, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®) and Vice President, B&C Consortia Management (BCCM), was quoted by Bloomberg Environment in the article “Manufacturers’ Core Questions Remain on EPA’s New Chemical Controls.” Some potential customers won’t purchase any compound regulated by a new use rule, even if the new chemical is better for the environment and safer than alternatives, Kathleen M....

On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture...

On July 20, 2018, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program.  The PGCCA Program is sponsored by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry...