Memoranda

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...

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 (RCRA) of...

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...

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...

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: Copies of most slides and handouts from the meeting are available on the PPDC website. Session I. Update Regarding Strategic Plans, Budget, and PRIA 3 Steve Bradbury, Director, Office of...

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 the remainder of...

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...

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...

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...

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...

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 Proposed...

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...

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...

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...

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...

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 available online. Pesticides in the...

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...

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...

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...

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...

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 report current data on the...

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...

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 in 2012. The chemicals span the...

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...

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...

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: Copies of most slides and handouts from the meeting are available on the PPDC website. Session I. Update Regarding Strategic Plans, Budget, and PRIA 3 Steve Bradbury, Director, Office of...

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 commitments supportive of...

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...

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...

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...

On April 18, 2012, the George Washington University Regulatory Studies Center convened a panel discussion entitled Moving Forward With IRIS Reform: Implementing National Academies’ Roadmap for Revisions. Panelists included Dr. Lynn R. Goldman, Dean of the School of Public Health and Health Services and former Assistant Administrator for Toxic Substances at the U.S. Environmental Protection Agency (EPA); Rebecca Clark, M.P.H., Acting Director of EPA’s National Center for...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on April 20, 2012, a Federal Register notice announcing the availability of Pesticide Registration Notice (PR Notice) 2012-1, entitled “Material Safety Data Sheets as Pesticide Labeling.” EPA issued the PR Notice on April 9, 2012, and EPA intends it to provide guidance to registrants concerning the relationship between EPA-approved labels for pesticides registered under the Federal Insecticide,...

Since the establishment of the Endocrine Disruptor Screening Program (EDSP) and the U.S. Environmental Protection Agency’s (EPA) issuance of EDSP test rules for pesticide active ingredients and pesticide inert ingredients, questions have been raised regarding the procedures for addressing the compensability of data on inert ingredients. For example, on March 14, 2012, EPA published a Federal Register notice concerning the results from the EDSP inert ingredient test orders, in...

In light of the European Chemicals Agency’s (ECHA) recent release of Version 2.0 of its Guidance on Data Sharing, which provides assistance to companies placing substances onto the European Union (EU) market under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation (EC regulation 1907/2006), and other developments, Bergeson & Campbell, P.C. has updated its memorandum on EU and international data compensation and sharing mechanisms. This...

On March 29, 2012, India’s Department of Chemicals and Petrochemicals (DCPC), located within the Ministry of Chemicals and Fertilizers, announced the availability of a draft National Chemical Policy, 2012. The draft Policy is intended to facilitate the growth and development of the chemical sector in India. DCPC states that the policy “accords high importance” to research and development (R&D), technology up-gradation, safety and sustainability, pollution and environmental...

On April 3, 2012, the European Chemicals Agency (ECHA) released Version 2.0 of its Guidance on Data Sharing to provide further assistance to companies placing substances onto the European Union (EU) market under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (EC regulation 1907/2006). The revised Guidance, available online, is a must read for entities wishing to optimize and protect their investment in chemical testing data. The original version...

The U.S. Occupational Safety and Health Administration (OSHA) announced on March 20, 2012, that it has revised the Hazard Communication Standard (HCS), aligning it with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The final HCS rule will be implemented in various phases with full implementation by 2016 and, according to OSHA, will benefit workers by reducing confusion about chemical hazards in the workplace, facilitating safety...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2012, proposed significant new use rules (SNUR) that would require companies to report all new uses of five groups of chemicals, including in domestic and imported products and articles, to give EPA the opportunity, if warranted, to prohibit or limit the activity. The chemicals, which were part of the existing chemical action plans that EPA released in 2009 through 2011, are polybrominated diphenylethers (PBDE),...