Memoranda

On September 21, 2010, the U.S. Food and Drug Administration (FDA) held a public hearing on the issue of labeling food made from the genetically engineered (GE) fish AquAdvantage Salmon, an Atlantic salmon produced by AquaBounty Technologies, Inc. The purpose of this hearing was to present the relevant legal principles for food naming and labeling, and describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition and...

We are pleased to announce that the NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such “hot” topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency’s (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and...

Bergeson & Campbell, P.C. is hosting a webinar on endocrine disruptors on December 20, 2010, at 1:30 p.m. (EST). This webinar will focus on recent developments in the area of endocrine disruptors, including the U.S. Environmental Protection Agency’s (EPA) recent issuance of the second list of chemicals for Tier 1 screening, implications of the draft “weight-of evidence” and policies and procedures guidance documents, lessons learned from the first list of chemicals selected...

On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The RoHS Directive currently lists six materials as being restricted: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenylethers. The EP passed by a vote of 640 to 3, with 12 abstentions,...

On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on “Moving Beyond Nanogeneralities — Providing Focus to Nanopolicy Progress.” Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere,...

On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. The proposed regulations pertain to the identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and regulatory responses for selected alternatives. CDTSC held a public hearing on November 1, 2010, during which it accepted written and oral testimony. In...

On November 17, 2010, the U.S. Environmental Protection Agency (EPA) published draft policies and procedures for screening Safe Drinking Water Act (SDWA) chemicals under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70558. “SDWA chemicals” are substances which “may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed” (SDWA Section 1457). In the notice, EPA divided SDWA chemicals into two...

On November 17, 2010, the U.S. Environmental Protection Agency (EPA) announced the second list of chemicals and substances for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). 75 Fed. Reg. 70248. EPA states that the list of 134 chemicals “includes a large number of pesticides, two perfluorocarbon compounds (PFCs), and three pharmaceuticals (erythromycin, nitroglycerin, and quinoline). This list also consists of an array of other chemicals,...

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) recently announced new administrative processes for the notification and assessment of industrial nanomaterials that are considered new chemicals, which will be of interest to companies introducing nanomaterials as new chemicals in Australia. NICNAS is the governmental, industrial chemical notification system in Australia and is responsible for the management of the Australian Inventory of Chemical Substances. After...

The U.S. Environmental Protection Agency (EPA) subpoenaed Halliburton Co. on November 10, 2010, for hydraulic fracturing data citing, among others, authority under Section 11(c) of the Toxic Substances Control Act (TSCA). In response to a request from Congress to study hydraulic fracturing’s potential impact on drinking water, human health, and the environment, on September 9, 2010, EPA issued voluntary information requests to nine national and regional hydraulic fracturing service...

On November 5, 2010, the U.S. Environmental Protection Agency (EPA) proposed revisions to the regulations at 40 C.F.R. Part 152, governing the procedures for the satisfaction of data requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 75 Fed. Reg. 68297 (online). EPA states that these regulations have not been revised since they were first issued in 1984, so many of the proposed revisions accommodate statutory and procedural changes that have occurred since then...

This memorandum provides a summary outlook on possible implications of the 2010 Congressional mid-term elections on policy and legislative developments in the U.S. Environmental Protection Agency’s (EPA) regulation of chemicals and pesticides. The dramatic decline in the number of elected Democratic members, especially the loss of the majority in the House of Representatives, will make for some significant differences in the prospects for EPA’s budget, legislative proposals, and...

The U.S. Environmental Protection Agency (EPA) announced in a November 4, 2010, Federal Register notice the availability for public review and comment of a draft guidance document entitled, “Weight-of-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening to Identify Candidate Chemicals for Tier 2 Testing.” According to EPA, the purpose of the draft guidance document is “to set forth some general principles, criteria, and considerations EPA generally...

We are pleased to announced that Lynn L. Bergeson will moderate a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled “Selling Green: A Concise Overview of the FTC’s Proposed Guides for the Use of Environmental Marketing Claims.” The November 16, 2010, teleconference will explore the Federal Trade Commission’s (FTC) proposed revisions to its Guides for the Use of...

On Monday, July 20, 2010, the U.S. Occupational Safety and Health Administration (OSHA) held the fourth of five scheduled Injury and Illness Prevention Program (I2P2) stakeholder meetings. OSHA held the informal, information-gathering meeting for all interested parties as part of its development of a rule intended to reduce injuries and illnesses in the workplace by proactively addressing workplace safety and health hazards in a systematic way. The stakeholder meeting attendees included...

The Consumer Product Safety Commission (CPSC) released an October 14, 2010, memorandum that includes its draft final rule concerning the publicly available, searchable database on the safety of consumer products, and other substances the CPSC regulates. The database is intended to provide a single point of access to reports of harm involving consumer products, manufacturer’s comments on the reports, and recall information. Under Section 212 of the Consumer Product Safety Improvement Act of...

On October 20, 2010, the U.S. Patent and Trademark Office (USPTO) announced that it is seeking comment on its expansion of the Green Technology Pilot Program. 75 Fed. Reg. 64692. USPTO implemented the Pilot Program on December 8, 2009, permitting patent applications pertaining to green technologies, including greenhouse gas reduction, to be advanced out of turn for examination and reviewed earlier. USPTO intends the Program to promote the development of green technologies, which could include...

On October 19, 2010, the Occupational Safety and Health Administration (OSHA) proposed to alter significantly its interpretation of the term “feasible administrative or engineering controls” as that term is used in the applicable sections of OSHA’s General Industry and Construction Occupational Noise Exposure standards. 75 Fed. Reg. 64216. Under the standard, which is codified at 29 C.F.R. Sections 1910.95(b)(1) and 1926.52(b), employers must use administrative or engineering...

Today the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it has forwarded to the Secretary of Agriculture, a draft proposed rule that would revise EPA’s 2006 rule on protections for subjects in human research involving pesticides. 75 Fed. Reg. 62738 (found online). EPA announced on June 18, 2010, that it settled a lawsuit over its 2006 final rule. Under the settlement, EPA agreed to propose amendments to the rule...

On October 6, 2010, the U.S. Federal Trade Commission (FTC) released for public comment revisions to its Guides for the Use of Environmental Marketing Claims (Green Guides), which the FTC contends is designed to assist product marketers avoid making false and misleading environmental claims. The proposed changes, released in a pre-publication Federal Register notice, are designed to update the Green Guides and make them easier for companies to use and understand. They are the...

...

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...

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...

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. Background. On...

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...

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...

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”...

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...

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): Subcommittee Chairman Bobby Rush (D-IL) provided opening remarks. He referred to the stakeholder discussion that was conducted prior to the bill being introduced on July 22, 2010. He acknowledged that the bill was not...

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...

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....

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...

...

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...

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...

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...

...

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 assessment of...

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...

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...

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...

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...