Memoranda

The Acta Group, L.L.C.'s (Acta) thoughts are below on what may be headed our way in 2011 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). In short, the general trends established by the Obama Administration during the past two years are expected to continue notwithstanding the 2010 election results. At the same time, the impact of the election results, notably with the new Republican majority in the House of Representatives, will...

The California Department of Toxic Substances Control (DTSC) released a December 23, 2010, letter from Linda S. Adams, California's Secretary for Environmental Protection to Assembly Member Mike Feuer, the author of the 2008 law (A.B. 1879) that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer's letter outlining his concerns about the DTSC's November 16, 2010, release of revisions to its "Safer...

On December 6-7, 2010, the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) held its semi-annual full committee meeting at the U.S. Environmental Protection Agency's (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 cooperation between the...

On December 17, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued proposed regulations that would specify hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (CDTSC) will develop. CDTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of...

Korea has taken a major step toward achieving full compliance with the United Nations Globally Harmonized System (GHS) for the classification and labeling of chemicals by identifying 151 substances as "hazardous" for consultation. The Ministry of the Environment (MoE) in Korea also is placing more responsibilities on manufacturers and importers by introducing new rules regarding updating and content of material safety data sheets (MSDS). The MoE has given companies just ten days to comment on...

On December 9, 2010, the U.S. Consumer Product Safety Commission (CPSC) promulgated the final rule establishing a publicly available consumer product safety information database, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The database must be publicly available, searchable, and accessible through CPSC's website. CPSC's final rule interprets various statutory requirements pertaining to the information to include in the database, and establishes...

The U.S. Environmental Protection Agency (EPA) will announce in a Federal Register notice scheduled for publication on December 13, 2010, that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the...

Monday, December 20, 20101:30 p.m. - 3:30 p.m. (EST) Bergeson & Campbell, P.C. (B&C) is hosting a free webinar on endocrine disruptors on December 20, 2010. This webinar will provide an introduction to the issues associated with endocrine disruptors and testing strategies under the U.S. Environmental Protection Agency's (EPA) Endocrine Disruptor Screening Program (EDSP), while focusing on recent EPA developments that expand the regulatory scope beyond pesticide...

SAVE THE DATE January 27, 20111:00 - 5:30 p.m. (EST) NANO GOVERNANCE: THE CURRENT STATE OF FEDERAL, STATE, AND INTERNATIONAL REGULATION Please mark January 27, 2011, on your calendar for an exciting teleconference under development by the American Bar Association, Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-to-Know Committee. Program Overview: The Federal Regulatory Outlook  Beyond the Feds: International/State...

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...

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 significant impact on...

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 for Tier 1...

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, International Food...

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 groups: those that are...

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, ranging...

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 providers,...

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 general...

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 believes...

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 Environmental...

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 2008...

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 controls, rather...

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...

...

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...

...

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...