All Knowledge & Insights By Date

On February 24, 2017, President Trump issued Executive Order (EO) 13777, “Enforcing the Regulatory Reform Agenda.” Issuance of the EO, and the subsequent measures undertaken by U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt offer unique opportunities for chemical stakeholders.  This memorandum summarizes EPA’s efforts to date in this regard, and identifies opportunities that stakeholders may wish to pursue to eliminate or amend regulatory...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning substantiation of confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. 82 Fed, Reg. 7562. The process would not consider costs or other non-risk factors. Risk evaluation is the second step, after prioritization, in a new...

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances Control Act (TSCA) as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. 82 Fed. Reg. 4825. The proposed rule describes the processes for identifying potential candidates for...

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing.  The proposed rule has not yet been published in the Federal Register, but a pre-publication version of the proposed rule is available on EPA’s website, along with a fact sheet and other...

After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish in the December 21, 2016, Federal Register a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA).  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates...

On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016. According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals...

On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the "not likely to present an unreasonable risk" determination at Section 5(a)(3)(C). It is notable that all...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA's plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182, and copies are expected to be available from the U.S. Government Publishing...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the new law, landmark legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). EPA's web page includes links for users to access: The text of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act); ...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to the Toxic Substances Control Act (TSCA). Lautenberg results in fundamental shifts in the requirements and approach under TSCA, while introducing important new concepts and approaches. It is our view that the body of changes, including the careful balancing of competing needs and interests and the deft and assiduous drafting, yield a...

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well...

In preparation for the opening of the reporting period for the U.S. Environmental Protection Agency's (EPA) 2016 Chemical Data Reporting (CDR) rule, Bergeson & Campbell, P.C. (B&C®) conducted a review of recent enforcement actions taken by EPA under the CDR rule. B&C reviewed enforcement action data from May 2007 through September 2014 and found 37 different cases involving an allegation of a violation of the CDR rule. Based on the data collected, B&C highlighted a number of...

As we are poised to witness the reauthorization of the Toxic Substances Control Act (TSCA) -- the first revision of our domestic chemical management law in 40 years -- stakeholders will need immediately to understand what the "new TSCA" means for their industrial operations and strategically adjust their global operations to the new law. Bergeson & Campbell, P.C. (B&C®) convened a summit to examine generally the anticipated changes to TSCA, the process and implementation issues that the...

Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the "legacy" issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the short list of notable achievements that will have some remaining work to...

What the implementation of new TSCA will look like, along with the general environmental program and emphasis of the new Trump Administration, is very unclear this early in the New Year (the new President will not arrive until January 20). What is more predictable is that the operating environment of OCSPP will change significantly, with uncertain impacts on both the U.S. Environmental Protection Agency’s (EPA) pesticide and toxic chemical regulatory programs. EPA institutionally may never be...

This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the House of Representatives on...

The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the...

The U.S. Environmental Protection Agency (EPA) released on September 17, 2015, a signed final significant new use rule (SNUR) for hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). Under the final rule, persons who intend to manufacture (including import) or process HBCD for use in consumer textiles (other than for use in motor vehicles) must notify EPA at least 90 days before commencing that activity. EPA notes that in this SNUR, the exemption for persons importing or...

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the...

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae...

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this bill as it works to improve the protection of human health and...

On June 11, 2015, the U.S. Environmental Protection Agency (EPA) held a meeting on its Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT Chemical Control Division, provided further insight into EPA's goals, directives, and...

The House is scheduled to vote late today, June 23, 2015 (around 6:30 p.m. or 7:00 p.m.), on the TSCA Modernization Act of 2015 (H.R. 2576). The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this...

The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum, the House Committee passed the marked up bill. The House Energy and Commerce Subcommittee on Environment and the Economy had considered and passed an earlier discussion draft version of the TSCA Modernization Act (TMA2 DD) in May 2015, while an initial discussion draft...

On June 2-3, 2015, the House Committee on Energy and Commerce held a markup hearing on the TSCA Modernization Act of 2015 (H.R. 2576). Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, formally introduced the bill on May 26, 2015. On June 2, 2015, the Committee heard opening statements only. Energy and Commerce Committee Vice Chair Marsha Blackburn (R-TN) made the first statement, noting the broad bipartisan support...

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April, Shimkus released an initial discussion draft of the TSCA Modernization Act of 2015 (TMA1); our memorandum on TMA1 is available online. In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a...

On May 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a markup of a revised discussion draft of the TSCA Modernization Act of 2015, prepared by Subcommittee Chair John Shimkus (R-IL) and released on May 12, 2015. The May 12, 2015, press release announcing the revised discussion draft and markup emphasizes the bipartisan nature of the bill, which is supported by Shimkus, Subcommittee Ranking Member Paul Tonko (D-NY), Committee Chair...

Background A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. The revised version, which we identify here as Lautenberg2, includes changes that appear to be intended to address issues and concerns identified by Senators with the previous version of the bill (Lautenberg1). Our review of Lautenberg1 is available online. We reviewed the...

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider several bills, including the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Prior to the hearing, on April 27, 2015, Senators Tom Udall (D-NM), Sheldon Whitehouse (D-RI), Jeff Merkley (D-OR), and Cory Booker (D-NJ) announced a bipartisan compromise agreement intended to strengthen protections under S. 697, while expanding states' authority. During the...

On April 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on the discussion draft of the TSCA Modernization Act of 2015 (TMA DD) introduced by Subcommittee Chair John Shimkus (R-IL) on April 7, 2015. As noted in our April 9, 2015, memorandum, "Shimkus Releases Discussion Draft of TSCA Reform Legislation," in the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a revised...

On April 7, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a Discussion Draft of the "TSCA Modernization Act of 2015" (TMA DD). In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a revised discussion draft of the bill, CICA2. In addition, Shimkus held "countless" hearings concerning reform of the Toxic Substances Control Act...

The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity,...

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) issued a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods...

As noted in our recent memorandum on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, Lautenberg), Senators Barbara Boxer (D-CA) and Ed Markey (D-MA) recently introduced the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act (S. 725, Boxer-Markey), which presents their approach to revising the Toxic Substances Control Act (TSCA). We had committed to preparing a review comparing Lautenberg with the new Boxer-Markey bill, and that...

On March 18, 2015, the Senate Environment and Public Works Committee held a hearing on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). A detailed analysis of S. 697 is available in our March 13, 2015, memorandum. There were a number of references to the late Senator Frank R. Lautenberg (D-NJ), who introduced several bills intended to reform the Toxic Substances Control Act (TSCA), and whether the current bill would accomplish his goals. Throughout the...

Background The Senate over the past several years has considered a number of legislative texts to amend the Toxic Substances Control Act (TSCA). These include the Safer Chemicals Act, several versions of which were introduced by Senator Frank Lautenberg (D-NJ), with the most recent in 2013, and the Chemical Safety Improvement Act (S. 1009, CSIA) introduced by Senators Lautenberg and David Vitter (R-LA) in 2013. Senator Lautenberg died shortly after CSIA's introduction and over...

New York Times (March 6, 2015)" data-title="TSCA Reform: "Tom Udall's Unlikely Alliance With the Chemical Industry" New York Times (March 6, 2015)"> Headlines in The New York Times (NYT) describing a cozy relationship between a liberal Democratic Senator from New Mexico and the chemical industry is not a common occurrence. In this case, understanding the coverage reveals the story of an even more sordid and murky world of political infighting, nasty and...

On January 21, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposed amendment to a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals. According to EPA's January 15, 2015, press release, EPA intends the proposed amendment "to ensure that perfluorinated chemicals that have been phased out do not re-enter the marketplace without review." The proposed amendment would require anyone who intends to import these perfluorinated...

Click here for a PDF version of the memorandum. 2015 will be a very interesting year. There are two overarching considerations that will make the year more difficult to predict than merely assuming most of this year's issues will simply be extensions of past issues, with a few new initiatives sprinkled in. First, the new Republican majority in the Senate will change the dynamic between the Executive and Legislative branches. Second, the Obama Administration will begin its lame duck status as it...

On December 17, 2014, the U.S. Environmental Protection Agency (EPA) announced that it is taking action to protect the public from certain chemicals that it states have the potential to cause a range of health effects from cancer to reproductive and developmental harm to people and aquatic organisms. EPA's press release, "EPA Prevents Harmful Chemicals from Entering the Marketplace," includes a quote from Jim Jones, Assistant Administrator for the Office of Chemical Safety and Pollution...

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2014, that it has updated its Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. According to EPA, the updated TSCA Work Plan reflects updated data submitted to EPA on chemical releases and potential exposures that EPA received as part of the Chemical Data Reporting (CDR) Rule and the Toxics Release Inventory (TRI) Program. EPA removed or consolidated 16 chemicals, most of which are believed to be...

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a "significant new use," and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use." Persons subject to the SNURs would be...

Following the release last week of our Firm Clients and Friends Memorandum "Summary of Changes in the Chemical Safety Improvement Act (CSIA, S. 1009) and the Boxer TSCA Version Released September 18, 2014," Bergeson & Campbell, P.C. (B&C®) received copies of a number of documents relating to what is now described as the "Udall-Vitter Discussion Draft" (U-V DD) of the original CSIA (CSIA1). The documents obtained include: A version of the clean, revised text of U-V DD, which is...

This analysis reviews the changes made to the original version of the Chemical Safety Improvement Act (CSIA) (identified as CSIA1 in this memorandum) based on Senator Barbara Boxer's (D-CA) version of the Toxic Substances Control Act (TSCA) reform legislation released on September 18, 2014 (Boxer TSCA). This analysis attempts to analyze both the interim changes made to the bill and the changes that appear as underlined text in Boxer TSCA. Boxer TSCA was reportedly created by Senator Boxer by a...

The U.S. Environmental Protection Agency (EPA) released on August 28, 2014, final risk assessments for three Toxic Substances Control Act (TSCA) Work Plan chemicals -- methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The much anticipated release of these assessments marks a real milestone for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), and EPA is to be commended for...