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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...
February 23, 2012
Presidential Memorandum Calls for Increased Federal Procurement of Biobased Products
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,...
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...
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...
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 — June...
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...
January 4, 2012
Chemical Data Reporting (CDR) Workshop to Review Case Studies on Reporting Byproducts/Recycled Materials
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...
January 3, 2012
Predictions for EPA’s Office of Chemical Safety and Pollution Prevention, and Beyond
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...
December 27, 2011
EPA Scheduled to Publish Proposed SNURs for 17 Chemicals, Including CNTs
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...
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...
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...
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...
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 external...
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 federal efforts to develop...
November 21, 2011
DTSC GRSP Meets to Review Revised “Informal Draft” Safer Consumer Products Regulations
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...
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...
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: As noted in Jamison and Flynn’s slides, the discussion reinforced the view that nanotechnology is creating jobs and helping grow the...
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...
On November 15, 2011, the Congressional Nanotechnology Caucus will host a briefing on the impact of nanotechnology on job creation. Topics to be addressed include 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 will include: The briefing will begin at 3:00 p.m. in Room 385 of the Russell Senate Office Building. To RSVP, please contact Matt Bormet...
The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled “Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of ‘Nanomaterials.'” The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU)...
On November 17, 2011, the Senate Environment and Public Works Committee and the Committee’s Superfund, Toxics, and Environmental Health Subcommittee will hold 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, will chair the hearing. The Safe Chemicals Act is intended to modernize TSCA to require...
On November 8, 2011, CropLife America and the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) Pesticides, Chemical Regulation, and Right-to-Know Committee convened a program entitled “What’s New, What’s Hot in Pesticide Law and Policy.” Rosemarie Kelley, Director of the U.S. Environmental Protection Agency’s (EPA) Office of Civil Enforcement’s Waste and Chemical Enforcement Division, gave a presentation concerning...
On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an “informal draft” Safer Consumer Products Regulations (SCPR). DTSC proposed these regulations after ten months of meetings following the California Secretary for Environmental Protection’s instructions to DTSC to stop working on issuing proposed regulations and instead “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”...
The National Toxicology Program (NTP) published an October 31, 2011, Federal Register notice inviting written comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. 76 Fed. Reg. 67200. The RoC is a Congressionally mandated, biennial document that identifies agents, substances, mixtures, or exposure circumstances that may pose a hazard to human health by virtue of their carcinogenicity. Substances...
October 31, 2011
SAB Announces Initiatives Intended to Enhance Public Involvement in Advisory Activities
The U.S. Environmental Protection Agency (EPA) Science Advisory Board (SAB) recently posted a list of fiscal year (FY) 2012 initiatives intended to enhance public involvement in advisory activities. According to the SAB website, in response to suggestions received at a June 1, 2011, session on public involvement, the SAB Staff Office developed additional practices to enhance public involvement in activities of the SAB, Clean Air Scientific Advisory Committee (CASAC), and Advisory...
On October 25, 2011, Office of Chemical Safety and Pollution Prevention (OCSPP) Assistant Administrator Stephen A. Owens announced his resignation from the U.S. Environmental Protection Agency (EPA). In his message to EPA staff, Mr. Owens stated: I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the...
The October 21, 2011, Federal Register includes two test rules concerning high production volume (HPV) chemicals: a final test rule for certain chemicals from the third group, and a proposed test rule and proposed significant new use rule (SNUR) for the fourth group of chemicals. See 76 Fed. Reg. 65385 and 65580, respectively. The proposed “SNUR plus test rule” represents a novel approach for the U.S. Environmental Protection Agency (EPA) in handling HPV chemicals...
On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2) human...
The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation “invites” member states, European Union agencies, and economic operators to use the following definition of nanomaterial “in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies”: The Recommendation states that, by December 2014, the EC will review the definition...
October 6, 2011
House Subcommittee Holds Hearing on Environmental Regulation and Its Impact on the Economy
On October 6, 2011, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on “Chemical Risk Assessment: What Works for Jobs and the Economy?” According to the background memorandum, the hearing was intended to explore the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS), and the relationship between IRIS and EPA’s regulatory requirements, “specifically whether IRIS is producing high quality...
On September 28, 2011, the U.S. Environmental Protection Agency (EPA) issued its final guidance on the weight-of-evidence (WoE) (Final WoE Guidance) analysis that it will use to evaluate the results of data submitted in response to test orders issued for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). This WoE analysis, in turn, will be used to determine what substances merit further study under Tier 2 as substances that have the potential to...
The House Energy and Commerce Subcommittee on Environment and the Economy will hold a hearing on October 6, 2011, on “Chemical Risk Assessment: What Works for Jobs and the Economy?” The hearing will begin at 9:00 a.m. The witness list is not yet publicly available. We understand the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) process will be a subject of discussion....
On September 19-20, 2011, the Pesticide Operations Management (POM) Working Committee (WC) of the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) met in U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (AAPCO) created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and...
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SEPTEMBER 15, 2011 — SAVE THE DATE Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C will host a complimentary webinar on the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule on Thursday, September 15, 2011, from 1:30 p.m. to 3:30 p.m. (EDT). This webinar will provide an overview of the new rule,...
August 23, 2011
EPA Invites Public Input on Its Planned Process for Identifying Priority Chemicals under TSCA
Embracing new social media tools, the U.S. Environmental Protection Agency (EPA) on August 18, 2011, invited stakeholders to provide feedback on its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). Noting that EPA’s online discussion forum will remain open until 5:00 p.m. (EDT) on September 14, 2011, EPA invited public input on its “Discussion Guide: Background and Discussion Questions for Identifying...
August 16, 2011
Chemical Data Reporting Rule Analysis: Announcement of Webinar on Chemical Data Reporting Rule
The U.S. Environmental Protection Agency (EPA) released on August 2, 2011, the pre-publication copy of the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The rule was published on August 16, 2011. 76 Fed. Reg. 50816. Bergeson & Campbell, P.C. will host a webinar on the CDR Rule in mid to late September and will provide under separate cover webinar registration details....
August 3, 2011
EPA Announces Chemical Data Reporting Rule, Which Replaces the IUR Modifications Rule
The U.S. Environmental Protection Agency (EPA) announced on August 2, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The CDR is intended to enable EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory (TSCA Inventory). This includes current information on...
July 29, 2011
OECD Releases Guidance and Surveys Regarding Minor Use Pesticide Registration Incentives
The Organization for Economic Cooperation and Development (OECD) recently released three documents on pesticide minor uses: (1) Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses (Minor Use Guidance); (2) OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results; and (3) OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses: Survey...
On July 26, 2011, the Office of the Secretary of the Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), issued an advance notice of proposed rulemaking (ANPR) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. The ANPR seeks comment on how to protect better human subjects who are involved...
The U.S. Environmental Protection Agency (EPA) is currently scheduled to publish on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). EPA will request comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA will also seek comments on requiring environmental testing consisting of sampling and monitoring for BPA...
July 18, 2011
Green Ribbon Science Panel Meets to Discuss Safer Consumer Product Alternatives Regulations
The Green Ribbon Science Panel (Panel) met on July 14-15, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations, as required by AB 1879. Under AB 1879 and Health and Safety Code (HSC) 25253, DTSC is required to adopt regulations “that establish a process for evaluating chemicals of concern in consumer products, and their potential alternatives, to determine how best to limit...
July 14, 2011
Senate Science and Space Subcommittee Holds Hearing on National Nanotechnology Investment
On July, 14, 2011, the Senate Committee on Commerce, Science, and Transportation’s Science and Space Subcommittee held a hearing on national nanotechnology investment. The hearing was held to examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments as the Committee works on drafting a...
On July 14, 2011, the House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program. According to the hearing charter, the hearing was prompted in part by the recent National Academy of Sciences (NAS) report on EPA’s formaldehyde assessment, which focused on the process EPA uses to develop initially draft IRIS assessments and which is separate from...
On July 11, 2011, the U.S. Environmental Protection Agency (EPA) announced a proposed significant new use rule (SNUR) for 14 glymes, a class of chemicals structurally related to glycol ethers. According to EPA, the proposed rule, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), would require persons who intend to manufacture, import, or process the glymes for an activity that is designated as a significant new use to notify EPA at least...
On July 1, 2010, the Minnesota Department of Health (MDH) released its list of “chemicals of high concern.” Under the 2009 Toxic Free Kids Act, a “chemical of high concern” is a chemical “identified on the basis of credible scientific evidence by a state, federal, or international agency as being known or suspected with a high degree of probability to”: The Act instructs MDH to “consider chemicals listed as a suspected carcinogen, reproductive...