All Knowledge & Insights By Date

In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420. See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”...

The U.S. Environmental Protection Agency (EPA) announced on July 15, 2019, that it will cease sending notices of deficiency to businesses that submit procedurally flawed confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). This is a significant change from the interpretation EPA announced in January 2017, and a company’s failure to appreciate its consequences could prove damaging. Effective August 15, 2019, EPA will provide written...

The U.S. Environmental Protection Agency (EPA) published on July 1, 2019, a Federal Register notice announcing the availability of the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA). 84 Fed. Reg. 31315. EPA states that the purpose of the risk evaluations is to determine whether a chemical substance presents an unreasonable risk to...

The U.S. Environmental Protection Agency released on June 21, 2019, a proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT). EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA): decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP);...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder...

On April 17, 2019, the U.S. Environmental Protection Agency (EPA) released a final significant new use rule (SNUR) for asbestos using the definition in Title II, Section 202 of the Toxic Substances Control Act (TSCA), which defines asbestos as the “asbestiform varieties of six fiber types -- chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.”  EPA states that it is promulgating the SNUR “to ensure...

On April 12, 2019, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every...

On April 10, 2019, the U.S. Environmental Protection Agency (EPA) released a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in...

On March 27, 2019, the U.S. Environmental Protection Agency (EPA) posted a signed final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as...

On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program:  Reviewing its Progress and Roadblocks Ahead.”  The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 40 chemicals for which EPA is initiating the prioritization process for risk evaluation. Section 6(b)(2)(B) of the Toxic Substances Control Act (TSCA) requires that, as of three and a half years after enactment (by December 22, 2019), at least 20 high-priority chemicals be undergoing risk evaluations and at least 20 low-priority chemicals be designated by EPA. In a March 21,...

On March 15, 2019, the U.S. Environmental Protection Agency (EPA) published a signed final rule that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. EPA states that it “determined that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality.” Under the final rule, paint removal products containing...

On March 18, 2019, the U.S. Environmental Protection Agency (EPA) released new tools intended to help companies, organizations, and individuals fulfill their reporting requirements under the mercury reporting requirements rule. Those required to report under the mercury rule can now do so online through the Mercury Electronic Reporting (MER) application accessed through EPA’s Central Data Exchange (CDX). EPA states that it designed this reporting tool “to be user-friendly, with drop-down...

On March 13, 2019, the House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on “Mismanaging Chemical Risks:  EPA’s Failure to Protect Workers.”  The hearing examined the U.S. Environmental Protection Agency’s (EPA) assessment and management of risks to workers from toxic chemicals under the Toxic Substances Control Act (TSCA) and other laws.  The Subcommittee focused on EPA’s implementation of the Frank R. Lautenberg Chemical Safety for...

The U.S. Government Accountability Office (GAO) released on March 6, 2019, a report entitled High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas. GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges. GAO’s report describes the status of high-risk areas and outlines actions necessary...

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has...

The U.S. Environmental Protection Agency (EPA) released on February 19, 2019, an update of the Toxic Substances Control Act (TSCA) Chemical Inventory (TSCA Inventory), which lists chemicals that are “active” versus “inactive” in commerce in the U.S.  EPA’s News Release states that a “key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce.”...

On January 28, 2019, the U.S. Environmental Protection Agency (EPA) published its Year in Review: 2018 (YIR). The YIR lists the following accomplishments: Issued major proposals, including the Affordable Clean Energy Rule, the Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule, and the new waters of the U.S. definition;  Provided greater regulatory certainty to states, tribes, localities, and the regulated community;  Streamlined the effectiveness and efficiency of...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2019. In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in the New Year. Our unique business platform and growing...

On December 21, 2018, the U.S. Environmental Protection Agency (EPA) denied a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA initiate rulemaking to amend the TSCA Chemical Data Reporting (CDR) rule to increase reporting of asbestos. EPA denied the September 27, 2018, petition on the grounds that the petitioners, the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental...

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...

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...

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 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 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...

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...

Available On-Demand - TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of...

Bergeson & Campbell P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next. On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act...

The U.S. Environmental Protection Agency (EPA) issued on June 20, 2018, guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications (Points to Consider Guidance), “promotes early engagement and communication, and enhances overall understanding of...

In somewhat of a surprise announcement, the New York State Department of Environmental Conservation (NYSDEC) on June 6, 2018, released its final policy and form for manufacturer disclosures under the Household Cleansing Product Information Disclosure Program. The Disclosure Program is similar to the recently enacted California Cleaning Product Right to Know Act of 2017 which requires the disclosure of cleaning product ingredients by way of website or product label. The Household...

On June 1, 2018, the U.S. Environmental Protection Agency (EPA) announced that it took “three important steps” intended to ensure chemical safety under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended the Toxic Substances Control Act (TSCA).  EPA released the following for public comment:  (1) the first ten problem formulation documents, (2) EPA’s systemic review approach document, and (3) a significant new use rule (SNUR)...

On May 10, 2018, the U.S. Environmental Protection Agency (EPA) announced several upcoming actions on methylene chloride. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA is required to perform risk evaluations on the uses of ten specific chemicals, including methylene chloride. According to EPA, it is nearing completion of problem formulations for these first ten chemicals. EPA’s announcement states that it will send a final methylene chloride rule to the...

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization. The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions. OPPT’s other functions are proposed to be distributed into a...

On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced that the compliance date for emission standards, recordkeeping, and labeling (the manufactured-by date or import-by date) under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as Title VI of the Toxic Substances Control Act (TSCA) has been set for June 1, 2018, instead of December 12, 2018, per order of the U.S. District Court for...

On February 8, 2018, the U.S. 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 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...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2018. The document distills key trends in U.S. and global chemical law and regulation, and provides a sneak preview of what our legal, scientific, and regulatory professionals believe we are likely to see in the New Year. Our unique business platform and global team of highly skilled professionals are perfectly suited...

As previously reported in our blog item on October 26, 2017, the U.S. Environmental Protection Agency (EPA) proposed triennial electronic reporting requirements pertinent to the supply, use, and trade of mercury in the United States. 82 Fed. Reg. 49564. This memorandum provides more information and an in-depth look into EPA’s proposed rule. The 2016 amendments to the Toxic Substances Control Act (TSCA) require EPA to establish periodic mercury reporting requirements for any...

As Toxic Substances Control Act (TSCA) aficionados know well, September 19, 2017, is a banner date.  By then, information that was submitted and claimed as Confidential Business Information (CBI) between June 22, 2016, and March 21, 2017, must be substantiated.  If you have not already done so, the September 19th deadline looms large. Background On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on August 3, 2017, providing the names and affiliations of additional candidates currently under consideration for appointment to the Science Advisory Committee on Chemicals (SACC). The notice states that the purpose of the SACC is to provide independent advice and expert consultation at the request of the EPA Administrator with respect to the scientific and technical aspects of risk...

Bergeson & Campbell, P.C. (B&C®) appreciates the efforts being made by the U.S. Environmental Protection Agency (EPA) to upgrade and update several of the category documents in the New Chemicals Program, encourage EPA’s continued activity in this area, and encourage EPA to engage in a broader effort to solicit public comments.  We recognize the critical role that the new chemicals categories have played in the implementation of the New Chemicals Program.  Over time, however, we...

The U.S. Environmental Protection Agency (EPA) released on June 22, 2017, the pre-publication Federal Register notices of the final framework actions under the Toxic Substances Control Act (TSCA), as revised by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals...

On May 23, 2017, the White House unveiled the full version of President Trump’s proposed budget for fiscal year (FY) 2018 entitled “A New Foundation for American Greatness.”  As signaled in the President’s “skinny budget” released earlier this year, the proposed budget would fund the U.S. Environmental Protection Agency (EPA) at $5.7 billion -- a more than 30 percent decrease from the current funding of nearly eight billion.  EPA’s...

With the recent release of the 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of active substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory (Inventory), the magnitude of effort that will be needed for the Section 8(b)(4) Inventory Reset is becoming clear.  Stakeholders should waste no time in preparing to meet their obligations. Non-confidential Portion of the Inventory Bergeson & Campbell, P.C....

One of the consequences of the new Toxic Substances Control Act (TSCA) is the need for the U.S. Environmental Protection Agency (EPA) to review and make determinations under Section 5(a)(3)(B) on premanufacture notification (PMN) chemicals submitted to EPA, and then to take required actions.  These requirements raise particular and sometimes challenging issues for new chemical polymers because the way polymers are identified allows for multiple different forms of the polymer to be...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or...

On May 8, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notification stating that a public meeting will be held to elicit public input on approaches for assigning and applying Unique Identifiers (UID) that are now required whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance.  82 Fed. Reg. 21386.  The meeting will be held on May 24, 2017,...