Memoranda

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...

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, Fungicide,...

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 aspects,...

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,...

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),...

On March 16, 2012, the U.S. Environmental Protection Agency (EPA) announced the availability of the long-awaited final test guidelines for Series 810 -- Product Performance Test Guidelines, specifically public health uses of antimicrobial agents (OCSPP 810.2000), sterilants (OCSPP 810.2100), disinfectants (OCSPP 810.2200), and sanitizers (OCSPP 810.2300). These test guidelines are part of a series established by EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing...

On March 1, 2012, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced a work plan of 83 chemicals for further review under the Toxic Substances Control Act (TSCA). EPA identified seven chemicals for risk assessment in 2012, and intends to complete some of these assessments this year and initiate new assessments from the work plan in the coming years. EPA stated that, this Spring, it plans to identify specific chemicals...

President Obama signed a February 21, 2012, memorandum entitled "Driving Innovation and Creating Jobs in Rural America through Biobased and Sustainable Product Procurement." The BioPreferred Program, which was established by the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) and amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill), is intended to increase federal procurement of biobased products, which will promote rural economic development, create new...

If anyone is thinking big penalties under the Toxic Substances Control Act (TSCA) are a thing of the past, think again. On February 7, 2012, the U.S. Environmental Protection Agency (EPA) announced that Dover Chemical Corporation has agreed to pay a $1.4 million civil penalty for the unauthorized manufacture of chemical substances at facilities in Dover, Ohio, and Hammond, Indiana. The settlement resolves alleged violations of TSCA premanufacture notice (PMN) obligations for the production of...

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On January 19, 2012, Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM) convened a workshop at which invited U.S. Environmental Protection Agency (EPA) staff reviewed case studies on reporting obligations for byproduct and recycled materials under the Chemical Data Reporting rule. For those of you who were unable to listen in, the recorded audio for the workshop is available on B&C's website....

On January 18, 2012, the California Office of Environmental Health Hazard Assessment (OEHHA) issued final regulations that "specify the hazard traits, toxicological and environmental endpoints and other relevant data to be included" in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (DTSC) will develop. The Clearinghouse will be used, in part, to help DTSC identify chemicals of concern in consumer products as part of its Green Chemistry...

In a January 13, 2012, letter to U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson, Representatives Fred Upton (R-MI), Chair of the House Energy and Commerce Committee, and John Shimkus (R-IL), Chair of the Energy and Commerce Subcommittee on Environment and the Economy, asked EPA to postpone the Chemical Data Reporting (CDR) implementation and compliance deadlines from February 1, 2012, to align it with the future CDR submission periods...

On January 9, 2012, the U.S. Government Accountability Office (GAO) released a report entitled Challenges Remain with EPA's Integrated Risk Information System Program, which evaluates the U.S. Environmental Protection Agency's (EPA) progress in completing Integrated Risk Information System (IRIS) assessments under the May 2009 process. EPA revised its IRIS assessment process in May 2009 in response to a March 2008 GAO report on the IRIS program. EPA most recently revised the IRIS...

Thursday, January 19, 2012 9:00 a.m. - 2:00 p.m. (EST) Bergeson & Campbell, P.C. (B&C) and B&C Consortia Management, L.L.C. (BCCM), affiliates of The Acta Group, L.L.C., have organized a workshop with the U.S. Environmental Protection Agency (EPA) to review reporting obligations for byproducts and recycled materials under the Chemical Data Reporting (CDR) rule. The workshop will focus on specific case studies previously submitted to EPA related to the reporting of byproducts or...

The Acta Group, L.L.C.'s (Acta) thoughts are below on what may be headed our way in 2012 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). The 2012 Presidential Election cycle will influence any activity by either party or the Administration over the next year. We also offer a few thoughts on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Food and Drug Administration (FDA), and Asian chemical...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). According to EPA, 15 of the substances are subject to consent orders under Section 5(e) of the Toxic Substances Control Act (TSCA). Persons who intend to manufacture, import, or process any of the 17 substances for an activity that is designated as a significant new use by the...

On November 23, 2011, the European Union (EU) Council's committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for "problematic"...

On December 5-6, 2011, the Association of American Pesticide Control Officials (AAPCO)/State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research and Evaluation Group (SFIREG) held its semi-annual full committee meeting in U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and AAPCO created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the states and...

On December 5, 2011, the California Department of Toxic Substances Control (DTSC) held a workshop to review DTSC's "informal draft" Safer Consumer Products Regulations (SCPR) released on October 31, 2011. The Acta Group, L.L.C.'s (Acta) memoranda providing background information on SCPR are available online. DTSC began by reviewing the elements of the regulation -- the Chemicals of Concern (COC) List; the prioritization of products; the quality assurance of alternative assessments (AA); and...

The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it granted a conditional registration for a pesticide product containing nanosilver as a new active ingredient. This memorandum provides additional information regarding this momentous regulatory achievement. HeiQ AGS-20 is a silver-based antimicrobial pesticide product that will be incorporated into textiles to suppress the growth of bacteria, which EPA states in its December 1, 2011, Decision Document "cause...

On November 29, 2011, the National Toxicology Program (NTP) held a listening session on its proposed revisions to the review process for the Report on Carcinogens (RoC). According to NTP, its proposed changes are intended to "enhance transparency and efficiency and to enable the NTP to publish the RoC in a timelier manner. The NTP also seeks to maintain critical elements of the existing process including external scientific and public involvement, scientific rigor, and...

Guidelines for Selecting Product-Related Environmental Sustainability Standards and/or Ecolabeling Programs The American National Standards Institute (ANSI) hosted on November 22, 2011, a webinar delivered by the U.S. Environmental Protection Agency (EPA) and the General Services Administration (GSA) titled Guidelines for Selecting Product-Related Environmental Sustainability Standards and/or Ecolabeling Programs. The webinar provided an update on ongoing...

On November 14-15, 2011, the California Department of Toxic Substances Control's (DTSC) Green Ribbon Science Panel (GRSP) met to review DTSC's "informal draft" Safer Consumer Products Regulations (SCPR) released on October 31, 2011. Memoranda providing background information are available online. Information about the meeting can be found online. During the meeting, DTSC provided an explanation for how the regulations were developed and then set forth questions for discussion on three...

On November 17, 2011, the Senate Environment and Public Works Committee and the Committee's Superfund, Toxics, and Environmental Health Subcommittee held a hearing on legislation intended to reform the Toxic Substances Control Act (TSCA), the Safe Chemicals Act of 2011 (S. 847). Senator Frank Lautenberg (D-NJ), who introduced the legislation on April 14, 2011, and is Chair of the Subcommittee, chaired the hearing. The Safe Chemicals Act is intended to modernize TSCA to require chemical companies...

On November 15, 2011, the Congressional Nanotechnology Caucus hosted a briefing on the impact of nanotechnology on job creation. Topics addressed included the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers included: Hilary Flynn, Lux Research;  Doug Jamison, Chief Executive Office, Harris & Harris; and  Robert D. "Skip" Rung, President and...

Responses to questions raised by stakeholders during the September 15, 2011, Chemical Data Reporting (CDR) rule webinar, hosted by Bergeson & Campbell, P.C. (B&C), are provided below. During the September 15, 2011, webinar, which was attended by more than 300 participants, numerous issues, questions, and requests for clarification were addressed during the Q&A portion of the webinar. Many of the questions submitted, however, could not be addressed during the time allotted. In...