Memoranda

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products. Before summarizing the SAP's primary conclusions and recommendations, we note a few general observations. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of "nanometal pesticide products."...

Today the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health held a hearing entitled "Current Science on Public Exposures to Toxic Chemicals." Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, criticized the Toxic Substances Control Act (TSCA) for failing to provide the U.S. Environmental Protection Agency (EPA) the necessary authority to protect the public from unsafe chemicals. Lautenberg stated that he intends to introduce...

On January 26, 2010, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it intends to issue a cancellation order for the pesticide spirotetramat pursuant to Section 6(a)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A comment period is now open on the existing stocks provisions of the planned cancellation order. Comments are due February 8, 2010. EPA states that, on December 23, 2009, the U.S. District Court for the...

Today the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the polymer exemption rule, which provides an exemption from the premanufacture notification (PMN) requirements of the Toxic Substances Control Act (TSCA). The amendment excludes from eligibility polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. This exclusion includes polymers that contain any one or...

EPA Limits CBI Claims in TSCA Section 8(e) Submissions On January 21, 2010, the U.S. Environmental Protection Agency (EPA) announced a new practice concerning confidential business information (CBI) claims for substantial risk information submitted to EPA under Toxic Substances Control Act (TSCA) Section 8(e). 75 Fed. Reg. 3462. According to EPA's announcement, if a chemical substance is listed on the public portion of the TSCA Inventory, EPA expects a company submitting a health and safety...

Bergeson & Campbell, P.C. (B&C) has learned that the Senate is preparing to schedule a hearing on the Toxic Substances Control Act (TSCA) in early February, most likely on February 4, 2010. As noted in our 2010 Predictions memorandum, a new and significantly revised Kid-Safe Chemicals Act (KSCA) has not yet surfaced. The fact that the Senate is scheduling a hearing indicates that a revised Senate proposal is expected soon. There are also indications that if new legislation in...

On January 6, 2010, the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the electronic reporting requirements under Section 5 of the Toxic Substances Control Act (TSCA) (available online). According to EPA, the amendments are intended to streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA by establishing standards and requirements for the use of EPA's Central Data Exchange (CDX) to encrypt and submit...

In our memorandum dated January 6, 2010, we alerted you to a recent activity in New York in connection with the development of a "chemical avoidance list." The list, which reportedly consists of approximately 85 chemicals, would include chemicals that New York government agencies should avoid buying. By way of background, last May the Advisory Council of the New York Interagency Committee on Sustainability and Green Procurement voted 9-1 to recommend adoption of the not-yet published...

As is our custom, Bergeson & Campbell, P.C. is pleased to forward our thoughts on what may be in store this year from the U.S. Environmental Protection Agency's Office of Prevention, Pesticides, and Toxic Substances. In light of the significant chemical management developments underway in the European Union, we are pleased that Ruxandra Cana and Koen Van Maldegem from the Brussels office of Field Fisher Waterhouse LLP have contributed their thoughts on what may be headed our way in the EU....

The New York Interagency Committee on Sustainability and Green Procurement has voted 9-1 to recommend a "chemical avoidance list," which would be a list of 85 chemicals that New York government agencies should avoid buying. Listed chemicals would not be banned, but industry representatives have criticized the proposal, noting that the list would not address the actual risk from exposure. The Committee intends the list to comply with Governor David Paterson's 2008 Executive Order directing state...

True to her word, yesterday U.S. Environmental Protection Agency (EPA) Administrator Lisa P. Jackson announced action plans on phthalates, long-chain perfluorinated chemicals (PFC), polybrominated diphenyl ethers (PBDE) in products, and short-chain chlorinated paraffins (SCCP).  This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents -- and possibly shape future...

Today the Centers for Disease Control and Prevention (CDC) released the Fourth National Report on Human Exposure to Environmental Chemicals (Fourth Report), which provides an ongoing assessment of the exposure of the U.S. population to environmental chemicals using biomonitoring.  The Fourth Report presents data for the U.S. population for 212 environmental chemicals over the period 2003-2004, updating CDC’s 2005 Third National Report on Human Exposure to Environmental...

Today the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced the development of two voluntary pilot programs for antimicrobial pesticide products.  Working collaboratively with the Pesticide Program Dialogue Committee (PPDC), OPP explored the different types of label statements and logos for antimicrobial pesticide product labels.  OPP developed the Factual Label Statement Pilot Program and the OPP-Design for the Environment (DfE) Logo Pilot...

Earlier today the U.S. Environmental Protection Agency (EPA) announced the availability of a policy paper entitled Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural Fields, and Pesticides with No Food Uses, which describes how EPA plans to use revised methods in conducting risk assessments for pesticide uses and exposures not governed by the Federal Food, Drug, and Cosmetic Act (FFDCA).  According to EPA, implementing this policy will increase...

During the European Chemicals Agency (ECHA) Member State Committee’s December 2-4, 2009, meeting, the Committee unanimously agreed that 15 new substances of very high concern (SVHC) would be added to the Candidate List.  The Committee also unanimously agreed on a testing proposal from ECHA that was submitted under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  More information on these actions is provided below. 15 SVHCs to Be Added to...

Today the full Senate Committee on Environment and Public Works and Subcommittee on Superfund, Toxics and Environmental Health held a joint hearing entitled “Oversight Hearing on the Federal Toxic Substances Control Act.”  During the hearing, Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, stated that he is preparing legislation to reform the Toxic Substances Control Act (TSCA).  In 2005 and 2008, Lautenberg introduced the Kid-Safe Chemicals Act, which...

On November 20, 2009, the European Union (EU) Council approved an updated cosmetics regulation that would require cosmetic products that contain nanoscale ingredients to be labeled as such.  The regulation would also require the manufacturers of new cosmetic products containing nanomaterials to notify the European Commission (EC) and provide certain information six months before the product is placed on the European market.  If the EC has concerns regarding the safety of the...

Today, the U.S. Environmental Protection Agency (EPA) released and requested comment on a draft document titled, “A Framework for Categorizing the Relative Vulnerability of Threatened and Endangered Species to Climate Change” (EPA/600/R-09/011).  74 Fed. Reg. 61671.  The document was prepared by the National Center for Environmental Assessment within EPA’s Office of Research and Development.  The draft document describes an evaluative framework to categorize the relative...

On September 16, 2009, Field Fisher Waterhouse (FFW), with and relying on the advice and assistance of The Acta Group EU, Ltd (Acta EU), an affiliate of Bergeson & Campbell, P.C., submitted the first appeal against a decision of the European Chemicals Agency (ECHA or the Agency) with the ECHA Board of Appeal, on behalf of the registrant. On the basis of this submission, on October 14, 2009, the Executive Director of ECHA rectified the contested decision pursuant to Article 93(1) of the...

Today the House Committee on Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection held a hearing entitled “Prioritizing Chemicals for Safety Determination.”  The hearing was intended to examine the options for prioritizing chemicals for safety determinations in the event that Congress passes legislation amending the Toxic Substances Control Act (TSCA) and reflects Congress’s sustained interest in chemical management reform legislation. The hearing, which was...

Today the European Chemicals Agency (ECHA) announced the online availability of a webinar regarding preparing and submitting a registration dossier.  ECHA held the webinar on November 4, 2009, for lead registrants.  The objective of the webinar was to provide lead registrants with an understanding of the main technical concepts required to be able to prepare and submit a registration dossier.  ECHA covered the following topics:  exporting information as an IUCLID 5...

On October 29, 2009, the European Commission (EC) adopted a Communication entitled Nanosciences and Nanotechnologies: An Action Plan for Europe 2005-2009. Second Implementation Report 2007-2009. The Communication outlines the key developments during 2007-2009 in each policy area of the Nanotechnology Action Plan 2005-2009, identifies current challenges, and draws conclusions relevant to the future European nanotechnology policy. According to the Communication, the EC has made significant...

Today the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances that were the subject of premanufacture notices (PMN). EPA identified the substances generically as multi-walled carbon nanotubes and single-walled carbon nanotubes. According to the notice, these substances are subject to TSCA Section 5(e) consent orders issued by EPA. The consent orders require protective...

On October 27-28, 2009, the Ninth Antimicrobial Workshop was held in Arlington, Virginia. The American Chemistry Council (ACC) Biocides Panel, the Consumer Specialty Products Association (CSPA), and ISSA sponsored the Workshop, which was conducted in coordination with the U.S. Environmental Protection Agency (EPA) Antimicrobials Division. The Workshop included presentations on the following topics: Eco-Claims for Disinfectants and Sanitizers; Current Activities/Future Directions for the EPA...

Today the U.S. Environmental Protection Agency (EPA) announced the availability of a Pesticide Registration (PR) Notice entitled "Pesticide Drift Labeling" (2009-X) and a draft explanatory document entitled "Pesticide Drift Labeling Interpretation."  In a separate Federal Register notice, EPA announced that, on October 13, 2009, Earthjustice and Farmworker Justice, on behalf of several other organizations, filed a petition requesting that EPA "systematically evaluate children's...

Today the European Chemicals Agency (ECHA) announced the availability of its Guidance in a Nutshell:  Chemical Safety Assessment, which is intended to assist industry in understanding the general provisions for conducting a Chemical Safety Assessment (CSA).  ECHA states that the Guidance is aimed at non-experts who would like to understand the legal requirements under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation regarding substance...

On October 14 and 15, 2009, the Pesticide Program Dialogue Committee (PPDC) held 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 seven sessions: National Permit Discharge Elimination System (NPDES) permit development for pesticides; Status of litigation-mandated endangered species biological opinions and their...

This memorandum outlines research being sponsored, conducted, or planned by the U.S. Food and Drug Administration (FDA) regarding nanoscale materials. FDA has indicated repeatedly that it needs additional information on the characterization of such materials to make informal decisions regarding the safety of regulated products that incorporate nanotechnology.1 While those decisions are for the most part in the future, there is at least one use of nanotechnology in drug and cosmetic products...

The U.S. Environmental Protection Agency (EPA) has posted two prepublication Federal Register notices concerning its Endocrine Disruptor Screening Program (EDSP).  In the first notice, EPA announces the EDSP Tier 1 battery of assays and availability of test guidelines for conducting the assays included in the battery.  In the second notice, EPA announces the issuance of the initial EDSP screening orders and the schedule of issuance.  EPA expects both notices to be...

Earlier this year, the United States Department of Agriculture (USDA) proposed a voluntary labeling program for biobased products and solicited comment on its approach.  Under the proposed labeling program, manufacturers and vendors could, after obtaining certification from USDA, market the certified biobased product using the “USDA Certified Biobased Product” label.  The proposed program would also apply to other entities, such as trade associations, that wish to use the label to...

At yesterday’s Pesticide Program Dialogue Committee meeting, Steven Bradbury, Deputy Office Director for Programs, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, announced that Steve Owens, Assistant Administrator of the EPA Office of Prevention, Pesticides and Toxic Substances, would be signing later in the day the Federal Register notice concerning the schedule for sending out test orders for the final list of chemicals for initial Tier 1 Screening...

On October 6, 2009, environmental, consumer, and industry associations hosted a conference entitled “The Future of U.S. Chemicals Policy.”  Sponsors included the Environmental Working Group, Rachel’s Network, The Pew Health Group, Community Against Pollution, The Louisiana Bucket Brigade, American Chemistry Council, Grocery Manufacturers Association (GMA), Turner Foundation, Soap and Detergent Association (SDA), and Consumer Specialty Products Association (CSPA).  U.S....

On October 1, 2009, the U.S. Environmental Protection Agency (EPA) announced the establishment of “a new transparent process” intended to allow the public to review and comment on risk assessments and proposed registration decisions for pesticides.  According to EPA, this expanded process will apply to all new pesticide active ingredients and first food uses, first outdoor uses, and first residential uses.  Starting October 1, 2009, for certain registration actions, EPA will add...

On September 30, 2009, the U.S. Environmental Protection Agency (EPA) announced the availability of the Nanomaterial Research Strategy (Strategy), which EPA describes as its new research strategy to understand better how manufactured nanomaterials may harm human health and the environment. The Strategy outlines what research EPA intends to support over the next several years to generate information about the safe use of nanotechnology and products that contain nanoscale materials. The...

Yesterday the Occupational Safety and Health Administration (OSHA) issued a proposed rule that would align the Hazard Communication Standard (HCS) with provisions of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  The HCS requires chemical manufacturers and importers to evaluate chemical hazards and provide information to subsequent users.  According to OSHA, it made a preliminary determination that the proposed HCS modifications...

Last night, in a speech at the Commonwealth Club in San Francisco, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson announced the Obama Administration’s core principles for legislative reform of the Toxic Substances Control Act (TSCA).  In parallel with the legislative initiative, Jackson also announced EPA’s plans to strengthen its current chemical management program and increase the pace of its efforts to address chemicals that pose a risk to the public. ...

Today the American Chemical Society (ACS) held a briefing intended to provide a forum to explore the perspectives, roles, and activities of various stakeholders regarding reform of the Toxic Substances Control Act (TSCA).  E. Donald Elliott, Willkie Farr & Gallagher LLP, moderated the panel, which included Andy Ingrejas, Safer Chemicals, Healthy Families; Sarah Brozena, American Chemistry Council (ACC); Roger McFadden, Staples; Kenneth Zarker, Washington State Department of Ecology; and...

Yesterday the Woodrow Wilson International Center for Scholars Project on Emerging Technologies (PEN) hosted a meeting on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies.” The program is part of a collaborative research project involving experts from the London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and PEN. The project is funded by a grant from the European Commission to support pilot projects on “Transatlantic...

Today the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Lisa Jackson signed a final rule that would require reporting of greenhouse gas (GHG) emissions from all sectors of the economy.  The prepublication version of the final rule states that it applies to fossil fuel suppliers and industrial gas suppliers, direct GHG emitters, and manufacturers of heavy-duty and off-road vehicles and engines.  The rule does not require control of GHG, “rather it...

On September 18, 2009, the United States Environmental Protection Agency (EPA) issued a Federal Register notice promulgating direct final significant new use rules (SNUR) for 12 chemical substances under Section 5(a)(2) of the Toxic Substances Control Act (TSCA).1 For two of the 12 substances, EPA issued final SNURs that set forth the same exposure controls that were negotiated with the initial premanufacture notice (PMN) submitter through “risk-based” TSCA Section 5(e)...

The U.S. Environmental Protection Agency (EPA) announced in a September 16, 2009, Federal Register notice that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) will meet November 3-6, 2009, “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” Nominations of candidates to serve as ad hoc SAP members for this meeting are...

Yesterday the European Chemicals Agency (ECHA) issued two press releases, one announcing that over 500 companies met to share best practice, and another regarding a clarification to avoid unnecessary animal tests.  This memorandum briefly summarizes the press releases, which are available online, and here. The European Commission and ECHA organized a meeting for lead registrants and candidate lead registrants to share their experience on taking the lead in developing joint...

On September 1, 2009, the United Kingdom Health and Safety Executive (HSE) announced proposed revisions to the Biocidal Product Regulations 2001, which implement the European Union’s Biocidal Products Directive 98/8/EC concerning the harmonization of the European market for biocidal products.  The revisions would keep biocides on the market after May 14, 2010; update references in the 2001 regulations; and adjust the 2001 regulations.  According to HSE, the proposed revisions do...

Today the European Chemicals Agency (ECHA) published Annex XV dossiers for the identification of 15 chemicals as substances of very high concern (SVHC) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The substances were proposed by European Union member states and the European Commission, and are identified as carcinogenic, mutagenic, or toxic to reproduction (CMR), or persistent, bioaccumulative, and toxic (PBT).  ECHA asks that...

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