Memoranda

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...

In a largely symbolic vote along party lines, on July 25, 2012, the Senate Environment and Public Works Committee by a 10-8 vote passed an amended version of Senator Frank Lautenberg's (D-NJ) Safe Chemicals Act of 2011 (S. 847). Despite the Committee's passage of the bill, the legislation faces a headwind of opposition from Senate Republicans and the chemical industry and is unlikely to be passed this year. Republicans criticized the scheduled markup of the Safe Chemicals Act, particularly in...

On July 11, 2012, China's State Administration of Work Safety (SAWS) published Order Number 53, Measures for the Administration of Registration of Hazardous Chemicals, which replaces its 2002 predecessor. Order Number 53 extends the chemical registration requirements to importers and manufacturers/producers. An increase in the number of substances defined as "hazardous chemicals" in China is also expected. The Order will enter into force on August 1, 2012, and the chemicals...

The Senate Committee on Environment and Public Works and Subcommittee on Superfund, Toxics, and Environmental Health held a joint hearing yesterday entitled "Oversight of EPA Authorities and Actions to Control Exposures to Toxic Chemicals." The hearing examined current initiatives related to flame retardant chemicals as a means of exploring the U.S. Environmental Protection Agency's (EPA) authority over chemical safety under the Toxic Substances Control Act (TSCA). During the July 24, 2012,...

On May 22, 2012, the European Union (EU) adopted the Biocidal Products Regulation (EC Regulation 528/2012) (BPR), which will replace and repeal the Biocidal Products Directive (BPD) (98/8/EC) currently in effect for regulating biocidal active substances and biocidal products. The BPR entered into force on July 17, 2012, with many new provisions going into effect on September 1, 2013, with a transitional period for certain provisions. The BPR is...

The U.S. Environmental Protection Agency (EPA) released on June 28, 2012, an Endocrine Disruptor Screening Program (EDSP) "Comprehensive Management Plan," that EPA states is intended to provide strategic guidance and outline critical activities that are planned for the EDSP for the remainder of fiscal year (FY) 2012 and through FY 2017. EPA states that although the plan is intended as an internal planning document, it made the Plan available to the public to be consistent with EPA's stated...

On June 27, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of two sets of final test guidelines: Series 810 -- Product Performance Test Guidelines, specifically public health uses of disinfectants and sanitizers for use on fabrics and textiles (OCSPP 810.2400), air sanitizers (OCSPP 810.2500), and disinfectants and sanitizers for use in water (OCSPP 810.2600); and Series 850 -- Ecological Effects Test Guidelines (Groups B, C, D, and F). These guidelines are...

On April 16, 2012, the Natural Resources Defense Council (NRDC) filed its brief in its lawsuit against the U.S. Environmental Protection Agency (EPA) concerning EPA's conditional registration for HeiQ AGS-20, an end-use product containing nanosilver. NRDC filed suit on January 26, 2012, in the U.S. Court of Appeals for the Ninth Circuit (California) against EPA, seeking to limit public exposure to the nanosilver's use in clothing, baby blankets, and other textiles and prevent EPA "from allowing...

The Chinese Ministry of Industry and Information Technology (MIIT) proposed amending the Restriction on the use of Hazardous Substances in electrical and electronic equipment (RoHS) on June 4, 2012. The proposed revisions would align the definition of electrical and electronic equipment (EEE) with the European Union's (EU) RoHS Directive; clarify the definition of hazardous substances; provide MIIT more authority to implement RoHS; and create a voluntary certification process for EEE in China....

On May 30-31, 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) Region 5 offices in Chicago, Illinois. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to...

On June 11, 2012, the U.S. Environmental Protection Agency (EPA) signed a Federal Register notice extending the deadline for Chemical Data Reporting (CDR) submissions from June 30, 2012, to August 13, 2012. According to the pre-publication notice, this is a "one-time extension" only. The CDR regulations require manufacturers and importers of certain chemical substances included on the Toxic Substances Control Act (TSCA) Inventory to...

On June 1, 2012, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced an additional 18 chemicals to be assessed under its Toxic Substances Control Act (TSCA) Work Plan initiative. These additional assessments are scheduled to occur in 2013 and 2014, although it is not clear from EPA's announcement which chemicals would be assessed in which year. EPA did announce, however, that it "would welcome the submission of additional relevant information...

Exactly three months from the date the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its Toxic Substances Control Act (TSCA) Work Plan initiative, EPA on June 1 announced an additional 18 chemicals scheduled for assessment during 2013 and 2014. EPA states that it selected the chemicals for a variety of reasons, similar to those it used to identify the seven Work Plan chemicals to assess...

At the request of California Governor Jerry Brown (D), the California Department of Toxic Substances Control (DTSC) withdrew its October 31, 2011, informal draft Safer Consumer Products regulations, as well as a revised formal draft scheduled for release in April. Brown reportedly had concerns regarding the scope of the regulations, the treatment of confidential business information, and duplication of existing federal and state regulations. Brown asked DTSC to issue new informal draft...

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed revised recommendations on permissible exposure limits (PEL) from FACOSH's Emerging Issues Subcommittee. FACOSH is authorized by the Occupational Safety and Health Act and Executive Order (EO) 11,612, as amended, "to advise the Secretary [of Labor] on all matters relating to the occupational safety and health of federal employees," including providing advice on how to reduce the...

The Federal Advisory Council on Occupational Safety and Health (FACOSH) met on May 3, 2012, during which it discussed revised recommendations on permissible exposure limits (PEL) from FACOSH's Emerging Issues Subcommittee. FACOSH is authorized by the Occupational Safety and Health Act and Executive Order (EO) 11,612, as amended, "to advise the Secretary [of Labor] on all matters relating to the occupational safety and health of federal employees," including providing advice on how to reduce the...

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 April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy, and the environment. In coordination with the release of the National Bioeconomy Blueprint, the Secretary of Health and Human Services Kathleen Sebelius and the Secretary of Agriculture Tom Vilsack announced...

On April 27, 2012, the President's Council of Advisors on Science and Technology (PCAST) released the Report to the President and Congress on the Fourth Assessment of the National Nanotechnology Initiative, which is a Congressionally mandated biennial review of the National Nanotechnology Initiative (NNI). PCAST found that the NNI, which has provided $16 billion to date in investments by 26 federal agencies, "has had a 'catalytic and substantial impact' on the growth of the U.S....

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) hosted a webinar today concerning a web-based tool that EPA plans to make available to allow submission of Toxic Substances Control Act (TSCA) Section 8(e) notices via the Internet through EPA's Central Data Exchange (CDX) portal. EPA plans to make slides from today's webinar available online. EPA increasingly is seeking submission of notices and reports electronically through the CDX...

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, including Food Ingredients that are Color Additives," which is available online, and "Guidance for Industry: Safety of...