Memoranda

In a stunning bipartisan show of support for reform of the Toxic Substances Control Act (TSCA) that few saw coming, Senators David Vitter (R-LA) and Frank Lautenberg (D-NJ) (among bipartisan others) introduced on May 22, 2013, the Chemical Safety Improvement Act (CSIA), later designated S. 1009, available online. CSIA provides a new and streamlined approach to reform TSCA that stakeholders may view favorably when compared to prior legislative templates that have been...

Senator David Vitter (R-LA) announced today that he and Senator Frank Lautenberg (D-NJ) are the lead co-sponsors on a bill to reauthorize and amend the Toxic Substances Control Act (TSCA). The bill, entitled the Chemical Safety Improvement Act (CSIA), is co-sponsored by the following Senators: Kirsten Gillibrand (D-NY)Mike Crapo (R-ID)Dick Durbin (D-IL)Lamar Alexander (R-TN)Charles Schumer (D-NY)James Inhofe (R-OK)Tom Udall (D-NM)Susan Collins (R-ME)Joe Manchin (D-WV)Marco...

As reported in our May 17, 2022, memorandum, on May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new...

On April 24, 2013, the South Korea National Assembly Environmental and Labor Committee passed the Act on Registration and Evaluation, Authorization and Restriction of Chemical Substances, commonly known as Korea REACH or K-REACH. On April 30, 2013, the National Assembly enacted K-REACH, and it is now scheduled to come into force on January 1, 2015. Information on K-REACH is not yet available on the Ministry of Environment's website. A translation of the Act is...

On May 8, 2013, the U.S. Environmental Protection Agency (EPA) issued a long-awaited final rule revising the data requirements for antimicrobial pesticide products. EPA states the revisions "reflect current scientific and regulatory practice, and [] provide the regulated community with clearer and transparent information about the data needed to support pesticide registration decisions for antimicrobial products." The final rule revises and updates the data requirements for antimicrobial...

The European Union (EU) voted April 29, 2013, on a proposal to restrict the use of three neonicotinoid substances for agricultural uses. The substances are clothianidin, imidacloprid, and thiamethoxam. The proposal failed to gain sufficient support from the 27 EU Member States Appeal Committee and was passed to the European Commission (EC), which has confirmed that the proposal will be adopted in the coming weeks. Restriction upon the agricultural use of the three neonicotinoid substances will...

On April 22-23, 2013, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) Pesticide Operations Management (POM) Working Committee (WC) held its semi-annual full committee meeting in U.S. Environmental Protection Agency (EPA) offices in Crystal City, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to...

In a widely anticipated and potentially influential report released on April 30, 2013, a committee of the National Research Council of the National Academy of Sciences (NAS) made detailed recommendations concerning potential revisions to the process by which the U.S. Environmental Protection Agency (EPA) and the Fish and Wildlife Service or the National Marine Fisheries Service (the Services) assess risk during consultation under Section 7(a)(2) of the Endangered Species Act (ESA) for specific...

On April 29, 2013, the U.S. Government Accountability Office (GAO) released a report entitled Toxic Substances: EPA Has Increased Efforts to Assess and Control Chemicals but Could Strengthen Its Approach, which provides the results of a performance audit conducted by GAO from December 2011 to March 2013. GAO reviewed the extent to which: (1) the U.S. Environmental Protection Agency (EPA) has made progress implementing its new approach for managing toxic chemicals with the goal of...

As reported in our April 11, 2013, memorandum, on April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act of 2013 (S. 696) (SCA 2013), which would reform the Toxic Substances Control Act (TSCA). Senator Lautenberg's press release noted that the bill is identical to the Safe Chemicals Act of 2011 (S. 847) (SCA 2011), which was reported favorably out of the Senate Environment and Public Works (EPW) Committee on a party-line vote in the 112th Congress on July 25,...

The European Commission (EC) published Regulation 348/2013 on April 17, 2013, that adds eight substances to Annex XIV of EU Regulation 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), commonly referred to as the Authorization List. The notice can be found online. The substances are: Chemical NameCAS NumberEC NumberLast Application DateSunset...

In a decision with enormous implications for pesticide registrants, on April 22, 2013, the U.S. District Court for the Northern District of California dismissed a complaint in Center for Biological Diversity, et al. v. EPA, a case often referred to as the "Mega-ESA" case. In this suit, the plaintiffs asserted that the U.S. Environmental Protection Agency (EPA) improperly failed to initiate or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) for 382...

On April 18, 2013, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for eight chemical substances that were the subject of premanufacture notices (PMN) P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, P-11-332, P-12-298, and P-12-299, the first six of which are renewable, biobased chemical substances manufactured by KiOR, Inc. This memorandum explains why the proposed SNURs for the biobased chemical...

On April 17, 2013, the United Kingdom's (UK) Department for Business, Innovation and Skills launched a public consultation on the implementation of the recast Waste Electrical and Electronic Equipment (WEEE) Directive. The consultation focuses on how the government should amend the existing WEEE regulations to ensure compliance with the recast WEEE Directive published on July 24, 2012, and on how to respond to concerns from UK producers of electrical and electronic equipment under the...

In its April 30, 2012, publication, FY 2013 Office of Enforcement and Compliance Assurance (OECA) National Program Manager (NPM) Guidance, OECA discusses its enforcement objectives and program priorities for fiscal year (FY) 2013. In discussing notable changes for FY 2013 from FY 2012, OECA lists budget challenges and states that it must cut resources in certain areas: "Anticipating tight budgets in FY 2013 and beyond, EPA's enforcement program needs to focus its limited resources...

On April 10, 2013, the California Department of Toxic Substances Control (DTSC) released what many believe to be the last revisions to the proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 15-day comment period, ending April 25, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online. In summary, DTSC has not made many...

On April 10, 2013, Senator Frank R. Lautenberg (D-NJ) reintroduced the Safe Chemicals Act (S. 696), which would reform the Toxic Substances Control Act (TSCA) and is identical to legislation (S. 847) reported favorably out of the Senate Environment and Public Works (EPW) Committee on a party-line vote in the 112th Congress. In his April 10, 2013, press release, Senator Lautenberg states that, compared to earlier versions of the legislation, the Safe Chemicals Act of 2013 "includes a number of...

On March 27, 2013, as part of the Toxic Substances Control Act (TSCA) Work Plan, the U.S. Environmental Protection Agency (EPA) announced that it will begin assessments on 23 chemicals, with a specific focus on flame retardant chemicals. According to EPA's press release, EPA will evaluate 20 flame retardant chemicals, conducting full risk assessments for four of the flame retardants, three of which are on the TSCA Work Plan, and one of which was the subject of an Action Plan. In addition to the...

The U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) convened an in-person and on-line public forum today to discuss OPPT's ongoing efforts to develop an interactive public website. The website would integrate a wide range of chemical data collected and EPA assessments conducted under Toxic Substances Control Act (TSCA) programs, as supplemented by additional EPA resources such as the Integrated Risk Information System (IRIS) and the Toxics Release...

Rosemarie Kelley, Director, Waste and Chemical Enforcement Division, U.S. Environmental Protection Agency's (EPA) Office of Enforcement and Compliance Assurance, announced during a recent industry meeting that one of EPA's enforcement priorities will be to look at how manufacturers are naming and listing fractions of existing chemicals for Toxic Substances Control Act (TSCA) Inventory purposes. Kelley stated that fractions or "slices" of existing substances could be new chemical substances for...

On March 5, 2013, the U.S. Environmental Protection Agency (EPA) published in the Federal Register an important final rule certifying additional fuel pathways that meet the biomass-based diesel, advanced biofuel, or cellulosic biofuel lifecycle greenhouse gas (GHG) reduction requirements under the Renewable Fuel Standard (RFS) Program. The final rule describes EPA's evaluation of advanced biofuels produced from camelina (Camelina sativa) oil and energy cane plants,...

On February 25, 2013, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances that were the subject of premanufacture notices (PMN). In addition, 17 of the chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. If issued in final, the SNURs would require persons who intend to manufacture, import, or process the chemical substances for an activity that is...

On February 21, 2013, a three judge panel of the Fourth Circuit Court of Appeals issued a unanimous landmark decision in Dow Agrosciences v. National Marine Fisheries Service setting aside a Biological Opinion (BiOp) prepared by the National Marine Fisheries Service (NMFS) that found that use of the pesticides chlorpyrifos, diazinon, and malathion could jeopardize the viability of certain species of salmon and their habitat. The decision will have significant implications for...

The U.S. Environmental Protection Agency (EPA) published in the February 20, 2013, Federal Register a notice announcing its intent to extend an Information Collection Request (ICR) concerning "Registration of Fuels and Fuel Additives -- Health-Effects Research Requirements for Manufacturers." Manufacturers (including importers) of fuels and additives designated by EPA, including motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels, are required to...

Warm spring-like weather welcomed participants to the 4th Annual Next Generation Bio-Based Chemicals Summit at the Hilton San Diego/Del Mar. As a Platinum Sponsor of this premier event, Bergeson & Campbell, P.C. (B&C) professionals participated in four major events at the Summit. Attendees from many countries enjoyed the opportunity to become updated on the latest technologies and business developments in a well-organized program consisting of two days of concurrent pre-summit...

The U.S. Environmental Protection Agency (EPA) released on February 6, 2013, its preliminary volatilization assessment for the registration review of chlorpyrifos. 76 Fed. Reg. 8522. In a letter to the Natural Resources Defense Council (NRDC) and to the Pesticide Action Network North America (PANNA) dated January 25, 2013, updating these groups on EPA's response to their September 12, 2007, joint petition regarding chlorpyrifos, EPA stated that "[t]his assessment represents a significant...

On January 30, 2013, the California Department of Toxic Substances Control (DTSC) released revised proposed Safer Consumer Products Regulations (Revised Proposed Regulations). The Revised Proposed Regulations are subject to a 30-day comment period, ending February 28, 2013. Memoranda providing background information are available online. The Revised Proposed Regulations are available online. Below is a summary of the core elements of the Revised Proposed...

The U.S. Environmental Protection Agency (EPA) announced on January 30, 2013, that it will issue a final notice of intent to cancel the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrations for the 12 D-Con mouse and rat control products produced by Reckitt Benckiser Inc. (Reckitt). This notice is intended to effectuate a Risk Mitigation Decision for rodenticides issued by EPA on May 28, 2008. EPA contends that these cancellations are necessary because "these products fail to...

On January 18, 2013, the U.S. Environmental Protection Agency (EPA) promulgated a final rule revising the regulations on the labeling of pesticide products and devices intended solely for export. EPA states that the final rule restructures the current regulations to clarify which provisions apply under various circumstances. The final rule also provides increased specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments...

The U.S. Environmental Protection Agency (EPA) published on January 16, 2013, a Federal Register notice announcing the availability of and seeking public comment on a draft Pesticide Registration (PR) Notice entitled "Web-Distributed Labeling for Pesticide Products." EPA states that the draft PR Notice provides "guidance concerning the process by which registrants can make legally valid versions of pesticide labeling available through the Internet." According to EPA,...

On December 20, 2012, U.S. Environmental Protection Agency (EPA) Administrator Jackson signed a much-anticipated rulemaking package revising the emission standards for commercial and industrial solid waste incineration units (CISWI). The rule has not yet been published in the Federal Register. The final rule accomplishes two broad goals: it revises the Clean Air Act (CAA) emission limits for CISWIs, and it revises the definition under the Resource Conservation and Recovery Act...

The U.S. Environmental Protection Agency (EPA) announced on January 4, 2013, the availability of the first draft risk assessments developed under the Toxic Substances Control Act (TSCA) Work Plan. The draft risk assessments are for particular uses of five chemicals found in household products: methylene chloride or dichloromethane (DCM) and N-methylpyrrolidone (NMP) in paint stripper products; trichloroethylene (TCE) as a degreaser and a spray-on protective coating; antimony trioxide (ATO) as a...

On December 12, 2012, the U.S. Environmental Protection Agency (EPA) announced in a Federal Register notice the availability of a draft Pesticide Registration (PR) Notice entitled "Guidance for Antimicrobial Pesticide Products with Mold-Related Label Claims (Draft PR Notice). 77 Fed. Reg. 74003. The Draft PR Notice has some potentially alarming implications regarding the continued use of certain claims under the treated articles exemption that any registrants of active...

The Acta Group's (Acta) thoughts are below on what may be headed our way in 2013 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Although the 2012 Presidential Election is over, environmental issues will continue to be used to make distinctions between the two parties (or between the House and Senate). Speculation is currently rife with what directions a re-elected Obama Administration might take: seek a middle-ground approach to...

The U.S. Environmental Protection Agency (EPA) proposed on December 31, 2012, a new rule intended to address a long-standing enforcement issue that has vexed federal and state inspectors for years. 77 Fed. Reg. 76979. The proposed rule would require that active and inert ingredients permitted in products eligible for the exemption from registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b)(2) for minimum risk pesticides be described more clearly on...

This is the first in a series of updates concerning compliance initiatives underway by the U.S. Food and Drug Administration (FDA) that affect various segments of the regulated industry. This issue focuses on court actions, Warning Letters, recalls, and other matters pertaining to dietary supplements. We will periodically outline actions and issues affecting prescription and over-the-counter (OTC) drugs, medical device and diagnostic products, food, cosmetics, animal drugs, and biologics....

Today, Office of Pollution Prevention and Toxics (OPPT) Director Wendy Cleland-Hamnett announced the U.S. Environmental Protection Agency's (EPA) decision to withdraw the Toxic Substances Control Act (TSCA) Section 8(d) immediate final rule published on December 3, 2012. According to EPA's letter responding to various entities' request for either withdrawal or an extension of time within which to persuade EPA to remove the listing of cadmium and cadmium compounds from the model 8(d) rule, it...

On May 3-4, 2012, the Pesticide Program Dialogue Committee (PPDC) convened its semiannual meeting in the U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. This memorandum summarizes the presentations and topics discussed during the meeting, which were organized into 12 sessions: Update Regarding Strategic Plans, Budget, and PRIA 3  Pollinator Protection  Integrated Pest Management  Endocrine Disruptor Screening Program  PPDC Workgroup and OPP Program...

On November 27, 2012, the U.S. Environmental Protection Agency (EPA) released a document entitled The EDSP Universe of Chemicals and General Validation Principles, as well as the list of approximately 10,000 chemicals. According to EPA, the document is a supplement to the June 2012 EDSP Comprehensive Management Plan, which EPA intends to provide strategic guidance and outline critical activities that are planned for the Endocrine Disruptor Screening Program (EDSP) for...

On November 20, 2012, the U.S. Environmental Protection Agency (EPA) signed off on a direct final rule adding cadmium and cadmium compounds to the Toxic Substances Control Act (TSCA) Section 8(d) model rule thus requiring manufactures and importers of cadmium and cadmium compounds, including use as part of an article, that have been or are reasonably likely to be incorporated into consumer products, to report health and safety studies to EPA. The prepublication copy of the rule is...

November 14, 20121:30 – 3:30 p.m. (EST) Bergeson & Campbell, P.C. (B&C) is hosting a complimentary webinar on the implications of the election results on federal environmental law and policy. This webinar will focus on the implications of President Obama's reelection and yesterday's Congressional election results, including what policies and initiatives can be expected in the next four years, and how any likely regulatory directions may affect our clients. Speakers include:James V....

On October 31, 2012, the Court of Appeals of the State of California, Third Appellate District, issued a decision affirming the decision of the trial court, which found that the California Office of Environmental Health Hazard Assessment (OEHHA) had failed to provide sufficient evidence that styrene and vinyl acetate are "known" to cause cancer and thus these substances could not be listed as carcinogens under Proposition 65. The decision, which is available online, has important...

On October 1, 2012, the Federal Trade Commission (FTC) released the long-awaited revised Guides for the Use of Environmental Marketing Claims (Green Guides). This is a very important development and clients and friends marketing products in the "green" space need to be fully aware of the significant marketing, business, and legal implications of this document. FTC intends the Green Guides to help marketers ensure that the claims they make about the environmental attributes of...

On September 17-18, 2012, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) Pesticide Operations Management (POM) Working Committee (WC) held its semi-annual full committee meeting in U.S. Environmental Protection Agency (EPA) offices in Crystal City, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to...

The National Research Council (NRC) Committee to Review the Integrated Risk Information System (IRIS) Process held its first meeting on September 17-18, 2012, opening with a public session on September 17, 2012. The U.S. Environmental Protection Agency (EPA) has asked NRC to review the IRIS process and changes being implemented or planned by EPA, and recommend modifications or additional changes as appropriate to improve the scientific and technical performance of the IRIS Program. According to...

On September 6, 2012, the California Department of Toxic Substances Control (DTSC) Director Debbie Raphael spoke during the Safer Consumer Products Summit regarding the proposed Safer Consumer Products Regulations (Proposed Regulations). Memoranda providing background information on the Proposed Regulations are available online. The Proposed Regulations are available online. Points raised during the Summit include: Timing: DTSC will hold a public hearing on the...

On August 22, 2012, a divided Securities and Exchange Commission (SEC) voted three-to-two in favor of adopting a final rule regarding disclosure and reporting obligations with respect to the use of conflict minerals to implement the requirements of Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank). Not surprisingly, the vote was along party lines with Chairwoman Shapiro and Commissioners Aguilar and Walter voting in favor and Commissioners Paredes and...

The U.S. Environmental Protection Agency (EPA) released a pre-publication version of a proposed amendment to the significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances (available at 40 C.F.R. § 721.9582) to add seven PFAS chemical substances that have completed the new chemical review process under the Toxic Substances Control Act (TSCA), but have not yet commenced production or import, and to designate (for all listed PFAS chemical substances) processing as a...

On August 3, 2012, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), the National Marine Fisheries Service (NMFS), and the U.S. Fish and Wildlife Service (FWS) (together, the Services) announced the availability of proposed revisions to the Endangered Species Act (ESA) consultation process as it is conducted within the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Registration Review process. The written proposal is available online....

On July 27, 2012, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products Regulations (Proposed Regulations). The Proposed Regulations, subject to a 45-day comment period, are the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative. The Proposed Regulations have been through several iterations, including an "informal draft" that was released in October 2011, and other drafts released on June...