Brexit is a moving target from a political viewpoint, but many matters for regulatory compliance and product stewardship teams globally appear clearer than before. This article suggests timely REACH compliance strategies companies should adopt and implement that account for wide-ranging Brexit repercussions.

Big retailers strive to source products responsibly. This typically includes recognition of chemicals in the products they market. As part of its commitment to responsible sourcing, Amazon recently posted its Chemicals Policy, which includes its first Restricted Substance List (RSL). This column discusses this milestone.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).

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 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 (EPA) published a final rule responding to this legislative mandate. The rule requires certain entities to provide information to assist in the preparation of this inventory. This column outlines the final rule and discusses its implications.

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 their potential risks to human health and the environment. The OIG found that implementing policies for data quality checks will help tailor the information reported to meet the EPA’s needs. This column discusses the report.

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 commercialization of more sustainable new chemical technologies and thus has, ironically, extended the market presence of often less- sustainable legacy chemicals. This article was originally published as a three part series analyzing the implementation of TSCA Section 5 and its impact on chemical innovation.

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.

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 Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment on June 22, 2016. Others may have assumed that candidate Trump was simply unaware of the enactment of the most sweeping legislative changes to our domestic chemical management law in four decades and the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). President Trump has kept his TSCA cards close to his vest, and the administration’s broader engagement in chemicals management on the world stage is similarly unclear. Some trends can be discerned, or at least inferred, as discussed in this article.

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.

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 country, reflect different approaches to compelling product ingredient disclosure, and portend similar state measures elsewhere. Consumer product manufacturers are bracing for renewed challenges in preserving consistent product labeling and maintaining confidential business information (CBI). Information-saturated consumers likely do not know what to think as they sort through ever more detailed product information. How these state measures might impact European manufacturers and trade and commerce in general remain to be seen. Here is an overview of the new measures and their implications.

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available (https://www.epa.gov/tsca-inventory/ how-access-tsca-inventory). For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance to assist companies in creating structurally descriptive chemical names for substances whose specific chemical identities are claimed confidential and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. Because the need to retain chemical identity confidentiality is critical, this guidance is an essential read.

Reducing childhood lead exposure has long been a focus of the U.S. Environmental Protection Agency (EPA). The Flint, Mich., water crisis has inspired renewed concerns with lead exposure and heightened attention on the hazards occasioned by exposure to dust and dust-lead, especially exposure to children. On July 2, 2018, EPA proposed to lower the dust-lead hazard standards for homes with dust-lead issues. This column summarizes the proposal.

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. 

The U.S. Environmental Protection Agency (EPA) expanded on June 12, 2018, the list of chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). The list now includes a category containing 13 nonylphenol ethoxylates (NPE). NPEs are nonionic surfactants used in a variety of industrial applications and consumer products including adhesives, wetting agents, emulsifiers, stabilizers, dispersants, defoamers, cleaners, paints and coatings. The final rule will apply for the reporting year beginning January 1, 2019, with the first reporting forms due July 1, 2020. This development will impact chemical stakeholders in a range of commercial applications, as explained below.

On March 16, 2018, the U.S. Environmental Protection Agency (EPA) proposed to add hazardous waste aerosol cans to the category of “universal wastes” regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations, codified at Title 40 of the C.F.R., Part 273. 83 Fed. Reg. 11654. According to EPA, this action would benefit the many manufacturing facilities and others that generate and manage large quantities of hazardous waste aerosol cans.

On May 4, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) proposed a rule to establish the first ever National Bioengineered Food Disclosure Standard (NBFDS) mandated by Congress in 2016. This column discusses the proposal, what it intends to achieve, and its implications.

On May 2, 2018, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing publication of its Final 2016 Effluent Guidelines Program Plan. The Plan describes EPA's Clean Water Act rulemakings and other actions intended to control industrial wastewater pollution. 

Changes to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act have fundamentally changed the way the US Environmental Protection Agency (EPA) reviews new and assesses existing chemical substances in surprising and subtle ways. Our 26-professionals TSCA practice in Washington, D.C. has been “doing TSCA” for a very long time. We offer our European colleagues practical insights into the new law and EPA’s implementation efforts. As we represent many European companies that have business interests in the U.S., our views are offered from a practical perspective.

The U.S. Occupational Safety and Health Administration (OSHA) announced on March 2, 2018, that it will begin enforcing certain requirements of the 2017 final rule on occupational exposure to beryllium in general industry, construction, and shipyards on May 11, 2018, and that it will delay enforcement of certain other standards. This column discusses the final rule and OSHA’s recent enforcement policy. 

We all knew it was coming, and the proposal has finally arrived. On February 8, 2018, the US Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides the EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law” (EPA, 2018a, p. 1). This column summarizes the proposal and explains why it is significant.

A downloadable and printable version of this article is available here. 

In just a few short months, on August 30, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations will come into force. By then, companies must be compliant with the revised regulations for consumer product, occupational and environmental exposures.

The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials.

A petition filed under Section 21 of the Toxic Substances Control Act (TSCA) was one of the first actions reviewed by a federal district court since TSCA was substantially rewritten in June 2016.The rulings described below pose interesting and potentially formidable challenges for TSCA stakeholders.

In December 2017, the U.S. Environmental Protection Agency (EPA) issued a final rule prohibiting entities from asserting claims of confidential business information (CBI) for certain documents related to the export, import, and transit of hazardous waste. Manufacturers that have historically relied on assertions of CBI should be aware of this change. 

When the Toxic Substances Control Act (TSCA) was legislatively ‘modernised’ in June 2016, no one in the legal community doubted litigation was in our collective future. We have not been disappointed.

The US Environmental Protection Agency (EPA) and its legal counsel for these purposes, the US Department of Justice (DoJ), are facing multiple lawsuits in several federal appeals courts and the very real possibility of more litigation deriving from TSCA Section 21 citizen petitions in the light of a recent decision. While none of this is especially unexpected, it is nonetheless disquieting. This article is a quick summary of where the cases stand and a discussion of what is at stake.

The cost of compliance with the Toxic Substances Control Act (TSCA) will soon rise. On February 8, 2018, the U.S. Environmental Protection Agency (EPA) signed off on proposed TSCA user fees. As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA authorizes the EPA to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” This column summarizes the proposal and its significance.

Big changes are in store for regulated entities subject to Prop 65 based on a rule implemented in August 2016, but with a fast-approaching enforcement date of Aug. 30, 2018.

The new year promises to be a busy one in the chemical area. The U.S. Environmental Protection Agency (EPA) hit all of its new Toxic Substances Control Act (TSCA) marks in timely promulgating rules or taking other steps required by the new TSCA. 

On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled "WHO Guidelines to Protect Workers from Nanomaterials." As reported in our December 13, 2017, blog item (see https://nanotech.lawbc.com/2017/12/who-publishes-guidelines-on-protecting-workers-from-potential-risks-of-manufactured-nanomaterials/), the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.

The U.S. Environmental Protection Agency (EPA) continues to implement reporting requirements pertinent to the supply, use and trade of mercury in the United States. This column provides more information and a closer look into the EPA’s October 2017 proposed rule.

Proposition 65 (Prop 65) is very much a part of the “right-to-know” landscape in California and, as we all know, Prop 65 warnings are especially visible in that state. This much is clear. What may be less clear are the sweeping changes in the “clear and reasonable warning” requirements now scheduled to take effect from August 30, 2018. This date may seem like a long way off, but it is right around the corner in terms of coming into compliance with these dramatic changes. This Washington Watch column summarizes the new warning requirements and the reasons why companies need to focus now on these changes.

On 23 June 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should ‘Leave’ or ‘Remain’ in the European Union (EU). The referendum turnout was 71.8 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry.

Between then and now, there have been significant developments in case law and statute, culminating in the triggering of Article 50 of the Lisbon Treaty and the issuing of a White Paper setting out the UK’s strategy for repealing the European Communities Act 1972 (ECA 1972) and ending the supremacy of EU law. The Brexit process and potential outcomes, including ‘knowns and unknowns’, are subject to change and are evolving at an exceptionally rapid pace, and will likely continue to do so. Terminology utilised for important documents and events has changed since the start of the Brexit story in June 2016. Many Brexit-related issues depend significantly or entirely on outcomes of political negotiations, and making any predictions has become a challenging endeavour. The global chemicals industry is well advised, as part of an effort to support regulatory and legal compliance, to monitor regularly news and consultations regarding Brexit

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements (EPA, 2017). This final rule is now in effect. This Washington Watch column explains why the rule is important, and what stakeholders should be doing to protect their interests.

California’s Proposition 65 (Prop 65) has been a keen area of client interest for years. One question repeatedly asked is “what is a clear and reasonable warning?” The California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document specifically covering “clear and reasonable warnings” requirements. The Q&A aims to help companies comply with new Prop 65 notice requirements that become effective next August. This column explains the significance of this Q&A document.

After a decade of trying, the U.S. Environmental Protection Agency (EPA) now has in effect a final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule focusing on nanoscale materials. This article explains the final rule, what stakeholders are required to do, and by when.

The Toxic Substances Control Act (TSCA) is the federal gap-filling chemical control law regulating chemical substances used in applications other than food, drugs, cosmetics, and pesticides, and other uses that are regulated by other federal authorities. Chemical product innovators need to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae), intermediates, and commercial products, and build TSCA compliance into business timelines and budgets. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

On October 15, 2017, California governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017. The law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020, while the product label disclosure requirements cover products sold in California on or after January 1, 2021.

Products that embody tried, true, and especially cutting-edge technologies are generally embraced by retailers as sure-fire pathways to marketing success. What’s not to like about best sellers and newer, faster, cleaner, or otherwise improved products? Sometimes overlooked is what is hidden behind the technology curtain -- what is the secret sauce that makes the product faster, cleaner, or better? In marketing products with new modes of action and spiffy new attributes, retailers are part of a product liability chain of which they need to be aware. This paper provides an overview of emerging legal and practical issues pertinent to the inclusion of technologies supporting products marketed to the public.

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.

On June 22, 2017, the U.S. Environmental Protection Agency (EPA) issued the final inventory notification rule under the amended Toxic Substances Control Act (TSCA). The rule establishes an electronic notification of chemical substances listed on the TSCA Inventory that were manufactured/imported for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow processor notification. These notifications will be used to distinguish "active" from "inactive" substances. A summary of this rule follows.

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is now in effect. Here is why the rule is important, and what stakeholders should be doing to protect their interests.

NIEHS is developing a plan to guide its next five years and seeks broad input. NIEHS has created an online survey, "Trends & Insights: Next Steps for NIEHS," through which stakeholders can provide feedback on the existing Strategic Plan, as well as offer any other relevant comments.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amended the Toxic Substances Control Act. The act, which has been in force for just over a year, made substantive changes to multiple sections of TSCA that are proving to be even more consequential than anticipated (new TSCA is identified as Pub. L. No. 114-182 and old TSCA was identified as Pub. L. No. 94-469).

This paper, authored principally by former EPA officials and a practicing TSCA lawyer, all with long experience under old TSCA, provides suggestions for new approaches or ‘‘fixes’’ that could assist the agency and interested groups in moving toward smoother implementation of the new law, achieving policy goals, and ensuring greater transparency. These suggestions are presented in no particular order and in the spirit of urging other stakeholders to also think of creative ways to ensure that new TSCA fulfills Congress’s mandate to develop an effective domestic chemical management program.

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a nanosilver pesticide product and vacated that conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC), the Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver containing antimicrobial pesticide product named NSPW-L30SWS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW was in the public interest.”

Among the many legal, regulatory, and policy issues being watched closely by pesticide registrants as the U.S. Environmental Protection Agency’s (EPA) long and contentious review of chlorpyrifos registrations continues is the controversy concerning when EPA may appropriately apply a tenfold uncertainty factor pursuant to the Food Quality Protection Act (FQPA 10X). This issue centers around EPA’s novel and unprecedented use of epidemiological data and the statutory requirements that govern EPA’s determination that sufficient uncertainty exists to warrant applying the FQPA 10X, not only to chlorpyrifos itself, but to all organophosphate (OP) pesticide products. This issue has drawn much attention and concern from pesticide registrants, and from other interested parties. The issues directly affecting chlorpyrifos have played out not only in EPA’s registration review process for chlorpyrifos, but also in a court challenge to EPA’s decision.

Climate change watchers know that October, 15, 2016, was a historic day for international climate action. On that day, nearly 200 countries reached an agreement to phase down use of hydrofluorocarbons (HFCs) at the 28th Meeting of the Parties to the Montreal Protocol in Kigali, Rwanda. The meeting to discuss the Amendment took place from July 15-23, 2016. This seemingly impossible alignment of international interests reflects years of effort. This column summarizes this historic event and its implications.