Memoranda

The State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Research and Evaluation Group (SFIREG) Pesticide Operations and Management (POM) Committee held a meeting on September 20, 2010. During the meeting, Jennifer McLain, Associate Director of the Antimicrobials Division, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP), provided an update on EPA's regulation of pesticides containing nanoscale materials. McLain's slides are available online. Much...

On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and the U.S. Environmental Protection Agency (EPA) held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California's data call-in (DCI) for carbon nanotubes (CNT), its plans for future DCIs, and EPA's efforts related to CNTs. More information, including the meeting presentations, is available online. The candidate chemicals for...

Bergeson & Campbell, P.C. (B&C) and the American Chemistry Council are hosting a free webinar on recent proposed changes to the TSCA Inventory Update Reporting (IUR) obligations on September 28, 2010. In addition to providing a comprehensive overview of the proposed changes, this webinar will also focus on past industry efforts in reporting use and exposure information on Form U, Part III in an effort to assist those companies new to such reporting requirements....

The California Department of Toxic Substances Control (CDTSC) has released its proposed regulations for safer consumer product alternatives. Under the proposed regulations, CDTSC would create a list of chemicals that it deems toxic and believes could harm people or the environment. CDTSC would prioritize products containing those chemicals based upon such factors as the volume in commerce, the extent of public exposure, and how the product is eventually disposed. Manufacturers of those products...

Today the U.S. Environmental Protection Agency (EPA) published a Federal Register notice seeking individual stakeholder input regarding EPA's role in the "green" or sustainable products movement. 75 Fed. Reg. 56528. EPA will consider the information gathered from the notice and other sources as it works to define its role and develop a strategy that identifies how EPA "can make a meaningful contribution to the development, manufacture, designation, and use of sustainable...

The U.S. Environmental Protection Agency (EPA) proposed on August 13, 2010, that it will conditionally register a pesticide product containing nanosilver as an active ingredient. According to EPA, the nanosilver active ingredient is intended for use as a preservative in textile products, including those made from natural and synthetic fibers and which are used to manufacture indoor use articles such as sheets, blankets, towels, napkins, outerwear, sportswear, sleepwear, undergarments, socks and...

On August 24, 2010, the U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a proposed rule seeking to harmonize the Hazardous Materials Regulations (HMRs) with international standards. 75 Fed. Reg. 52069. The proposal revises several proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. PHMSA states that these revisions are...

Bergeson & Campbell, P.C. is hosting a webinar on TSCA Reform Legislative Initiatives on September 22, 2010, at 1:30 p.m. (EDT). This webinar will focus on recent developments and as such builds on the May 22, 2010, webinar, which focused on developments to that time. Please save the date -- details will be sent under separate cover....

On August 18, 2010, the U.S. Environmental Protection Agency (EPA) announced action plans for benzidine dyes, hexabromocyclododecane (HBCD), and nonylphenol (NP) and nonylphenol ethoxylates (NPE). According to EPA, the chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively. The action plans identify a range of actions EPA is considering under the Toxic Substances Control Act (TSCA), as well as...

On August 13, 2010, the U.S. Environmental Protection Agency (EPA) proposed its Inventory Update Reporting (IUR) Modifications Rule. 75 Fed. Reg. 49655. As highlighted below, the proposal includes important changes to the IUR reporting obligations that will have a significant impact on industry. These include, among others, requiring process and use information for substances over 25,000 pounds, requiring electronic submission of IUR reports; replacing the "readily obtainable" reporting...

On August 5, 2010, Senators Blanche Lincoln (D-AR), Chair of the Committee on Agriculture, Nutrition, and Forestry, and Ranking Member Saxby Chambliss (R-GA) introduced legislation that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to clarify that Clean Water Act (CWA) permits are not required for pesticide application in accordance with FIFRA (S. 3735). The Senate legislation is prompted by the U.S. Environmental Protection Agency's (EPA) June 4, 2010, notice...

The Massachusetts Office of Technical Assistance (MOTA) will post this week a Technology Guidance Document entitled "Nanotechnology -- Considerations for Safe Development," which includes recommendations intended to enhance the safety of nanotechnology. According to MOTA, it is providing the Guidance for "the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment -- it will also impede...

On Thursday, July 29, 2010, at 10:00 a.m. (EDT), the Subcommittee on Commerce, Trade, and Consumer Protection held a legislative hearing on H.R. 5820, the Toxic Chemicals Safety Act of 2010 (TCSA). Witnesses at the hearing were (in order of testimony): Steve Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA);  Richard Denison, Ph.D., Senior Scientist, Environmental Defense Fund;  Calvin M. Dooley, President and...

On July 22, 2010, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (TCSA), which is intended to strengthen the Toxic Substances Control Act (TSCA). On July 27, 2010, the House Committee on Energy and Commerce issued a briefing memo announcing a Subcommittee on Commerce, Trade, and Consumer Protection...

Last evening, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (TCSA), which is intended to strengthen the Toxic Substances Control Act (TSCA). The bill is different in key respects from the House Discussion Draft circulated by Representatives Rush and Waxman on April 15, 2010 -- better in some instances and...

On July 16, 2010, a three judge panel for the U.S. Court of Appeals for the District of Columbia Circuit issued a unanimous decision in Reckitt Benckiser v. EPA (No. 09-1314), finding that the U.S. Environmental Protection Agency's (EPA) May 28, 2008, threat to implement its final risk mitigation decision for ten rodenticides (RMD) by enforcement actions for "misbranding" is "sufficiently final agency action ripe for review." The court states that the U.S. District Court for...

In the July 13, 2010, Federal Register, the U.S. Environmental Protection Agency (EPA) provides guidance on various reporting options that states and local agencies may choose in implementing Sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA). In addition, EPA also provides some new interpretations and revises some existing ones "to help facilities comply with certain of the requirements under EPCRA." The effective date of the guidance...

On Wednesday, June 23, 2010, the U.S. Environmental Protection Agency (EPA) held a public hearing on the draft National Pollutant Discharge Elimination System (NPDES) Pesticides General Permit (PGP). This hearing, along with three previous public meetings, was held during the 45-day public comment period (through July 19, 2010) on the draft PGP for point source discharges from the application of pesticides to waters of the U.S. EPA proposed the PGP in response to the 2009 decision by the Sixth...

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On June 23, 2010, Health Canada issued final regulations to set forth new "rules on how the scientific data used to support a pesticide registration is protected from reliance by another applicant or registrant." The regulations are available online. Health Canada states: "These Regulations are designed to provide a legally enforceable and fair process of pesticide data protection. They are intended to benefit pesticide users, particularly in the agricultural sector, by encouraging the...

Taiwan's Council of Labor Affairs of the Executive Yuan (CLA) has developed and released operational guidelines for nominating existing chemical substances for listing on a national Inventory. Through creation of a national Inventory, Taiwan intends to strengthen its control over the manufacture, import, and use of chemicals in Taiwan, thus improving its national chemical management. It is a preparatory process for establishing the National Existing Chemical Substance Inventory. Once completed,...

The California Department of Toxic Substances Control (CDTSC) released on June 23, 2010, the draft regulations for safer consumer product alternatives. CDTSC states that the draft regulations "would prioritize toxic chemicals and products, require manufacturers to seek safer alternatives to toxic chemicals in their products, and create tough governmental responses for lack of compliance." Under the draft regulations, CDTSC would create a list of chemicals that it deems toxic and believes could...

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On June 22, 2010, the European Chemicals Agency (ECHA) announced that a new practical guide makes clear that inorganic substances with the same chemical composition but different crystalline forms are regarded as different substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation (EC No. 1907/2006). Practical guide 11: How to address specific substance identification issues (Practical Guide) is available online. The...

On June 21, 2010, the Supreme Court issued a decision in Monsanto, et al v. Geertson Seed Farms, et al. In the 7-1 decision, the Court reversed a decision by the 9th Circuit Court of Appeals. The Court held that the District Court that reviewed a decision by the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture abused its discretion when it issued an injunction precluding APHIS from allowing any sale or use of Roundup Ready Alfalfa (RRA), a...

On June 22, 2010, the U.S. Environmental Protection Agency (EPA) announced that employees at facilities regulated under Section 112(r) of the Clean Air Act (CAA) will be invited to participate in government inspections of their worksites. Interim guidance issued by EPA and referenced in its announcement states that "[e]ffective immediately, EPA staff conducting CAA section 112(r) on-site compliance evaluations should offer facility employees and employee representatives the opportunity to...

On June 18, 2010, the U.S. Environmental Protection Agency (EPA) announced that it has settled a lawsuit over its 2006 final rule regarding protections for subjects in human research. Under the settlement, EPA agrees to propose amendments to the rule consistent with language negotiated by the groups who challenged it -- Natural Resources Defense Council, Pesticide Action Network North America, Pineros y Campesinos Unidos Del Noroeste, Physicians for Social Responsibility, Farm Labor Organizing...

On June 9, 2010, the California Department of Toxic Substances Control (CDTSC) held a conference entitled "Alternatives Analysis Symposium I: Issues and Evolution, Capitalizing on Success." CDTSC states that the alternatives analysis process for chemicals used in consumer products is a "core element" of California's Green Chemistry Initiative, and that identifying alternatives is a complex process, involving an analysis of a chemical's impact on human health and the environment. According to...

On May 20, 2010, the U.S. Consumer Product Safety Commission (CPSC) issued a proposed rule regarding the conditions and requirements for testing component parts of consumer products to demonstrate compliance of a consumer product with all applicable rules, bans, standards, and regulations to support a general conformity certificate or a certificate for a children's product pursuant to Section 14(a) of the Consumer Product Safety Act (CPSA); as part of a reasonable testing program pursuant to...

We are pleased to announce that Kevin N. Goulden and Leslie S. MacDougall of The Acta Group EU, Ltd (Acta EU) will address technical and regulatory issues at the June 1, 2010, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) seminar entitled "Outstanding Issues Before the 1st December 2010 Registration Deadline." The seminar, which will be held at Field Fisher Waterhouse LLP, in Brussels, Belgium, will address questions related to...

Today the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of, and seeking public comment on, a draft Pesticide Registration (PR) Notice entitled "False or Misleading Pesticide Product Brand Names." According to EPA, the draft PR Notice is intended to provide guidance to applicants, registrants, and distributors concerning pesticide product brand names that may be false or misleading, either by themselves or in...

Today the U.S. Environmental Protection Agency (EPA) issued what it describes as a "common sense" approach to addressing greenhouse gas (GHG) emissions from stationary sources under the Clean Air Act (CAA) by phasing-in the deadlines by which facilities must obtain permits for GHG emissions. Specifically, this controversial final rule sets thresholds for GHG emissions that define when permits under the New Source Review (NSR) Prevention of Significant Deterioration (PSD) and Title V Operating...

Thank you for participating in Bergeson & Campbell, P.C.'s webinar on TSCA Reform on Monday, May 10, 2010. We are delighted that you were able to participate, and hope that you found the information and format useful and convenient. Apropos of our recent webinar, we thought we would use this occasion to share Charlie Auer's response to a recent blog posting by Dr. Richard Denison regarding the reasons why Charlie believes some aspects of the current legislative initiatives to amend TSCA may...

The U.S. Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on April 5, 2010, issued an Advance Notice of Proposed Rulemaking (ANPRM) stating that it is considering revising the hazardous materials regulations (HMRs) governing the transportation of combustible materials. 75 Fed. Reg. 17111. Specifically, PHMSA is seeking to harmonize the domestic regulations applicable to the transportation of combustible liquids with international...

At yesterday's U.S. Environmental Protection Agency's (EPA) Pesticide Program Dialogue Committee (PPDC) meeting, William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP's recent consultation with EPA's Scientific Advisory Panel (SAP) concerning nanosilver and...

The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) are pleased to provide the summary and comparison of the Toxic Substances Control Act (TSCA) reform measures recently circulated and invites you to participate in a webinar on Monday, May 10, 2010, at 11:00 a.m. - 1:00 p.m. (EDT). Details regarding the webinar will be sent under separate cover. On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209...

On April 16, 2010, the European Chemicals Agency (ECHA) published a list of substances that companies intend to register under the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation by the November 30, 2010, deadline. The list is based on feedback received from companies and registrations already submitted via the authorized channels. One reason that this exercise is likely being undertaken now by ECHA is to enable ECHA to identify which...

Companies located in European Union (EU) countries have expressed relief at news that they may have won more time to comply with a significant new chemicals control law adopted by the Turkish government. This memorandum explains why. Meeting of Interested Parties A delegation of EU chemicals manufacturers and exporters organized by the European Chemical Industry Council (CEFIC) visited the Turkish Ministry of Environment and Forestry (MOEF) in February to ask for more time to...

In a March 2010 fact sheet, the U.S. Environmental Protection Agency (EPA) describes how to determine whether a cleaning product is a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, pesticide products must be registered if they are considered to be intended for a pesticidal purpose. EPA states that products are considered to be for a pesticidal purpose "if the person who distributes or sells them claims, states or implies that they can or should be...

More than 30 years have passed since the U.S. Environmental Protection Agency (EPA) issued its initial set of regulations on the use and distribution in commerce of polychlorinated biphenyls (PCBs) and PCB items. Now with three decades of experience and information on PCBs and PCB items, EPA has decided to exercise its authority under the Toxic Substances Control Act (TSCA) and reassess the regulations governing PCB use authorizations and distribution in commerce. On April 7, 2010, EPA issued an...

On March 29, 2010, the U.S. Environmental Protection Agency (EPA) announced its action plan on bisphenol A (BPA). In its press release, EPA states that the BPA action plan "focuses on the environmental impacts of BPA and will look to add BPA to EPA's list of chemicals of concern and require testing related to environmental effects." EPA notes that, in January 2010, the Food and Drug Administration (FDA) announced that it had some concerns about the potential human health impacts of BPA, and...

On March 17, 2010, the U.S. Environmental Protection Agency (EPA) announced that it is preparing action plans for nonylphenol/nonylphenol ethoxylate (NP/NPE), hexabromocyclododecane (HBCD), siloxanes, and diisocyanates. EPA is also preparing final action plans for the chemicals remaining on EPA's initial list -- bisphenol A and benzidine dyes. EPA chose the chemicals based on a range of criteria, including identification as persistent, bioaccumulative, and toxic; high production volume...

On March 10, 2010, the European Chemicals Agency (ECHA) Board of Appeals (Board) issued a document, Practice Directions to Parties to Appeal Proceedings Before the Board of Appeal of the European Chemicals Agency (Practice Directions), to provide guidance on various aspects of the appeals proceedings, including communications with the Board, procedures for lodging a notice of appeal and other pleading documents, the rights of parties to confidentiality, and procedures for...

On December 30, 2009, the Chinese Ministry of Environmental Protection (MEP) adopted the newly amended new chemical notification scheme "Measures on Environmental Management of New Chemical Substances" (新化学物质环境管理办法), Order 7. The new program enters into force on October 15, 2010. This memorandum provides a general overview of this critically important new program. Background The new regulation is intended in part to align China with...

On March 5, 2010, the U.S. Government Accountability Office (GAO) released a report entitled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). The Federal Food, Drug, and Cosmetic Act (FFDCA) exempts generally recognized as safe (GRAS) substances, which include spices, artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives, from the general requirement that companies obtain Food...

On March 9, 2010, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled "Business Perspectives on Reforming U.S. Chemical Safety Laws." Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, convened the hearing with leaders of businesses that manufacture or use chemicals to examine their business perspectives on reforming the Toxic Substances Control Act (TSCA). Only two other Senators participated in the...

Today the U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a final rule narrowing the list of hazardous materials (hazmats) that require security plans when transported in commerce. 75 Fed. Reg. 10974. The rule is effective on October 1, 2010, although voluntary compliance is authorized as of April 8, 2010. The final rule also revises the regulations applicable to the content of and training...

Today the European Chemicals Agency (ECHA) proposed to identify eight chemicals as substances of very high concern (SVHC) and possible candidates for authorization under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The detailed proposals are available on the ECHA website online. Comments are due April 22, 2010. Potential Additions to the SVHC Listing Denmark, France, and Germany proposed identifying eight...

On March 4, 2010, the House Committee on Energy and Commerce Subcommittee on Commerce, Trade, and Consumer Protection held a hearing entitled "TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions." The Subcommittee held the hearing to examine U.S. and international efforts to protect public health and the environment from persistent, bioaccumulative, and toxic (PBT) chemicals, how the Toxic Substances Control Act (TSCA) is currently being used...

On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy "is effective immediately." In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and other...