On March 4, 2011, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed to list four chemicals as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) under the “Labor Code mechanism” for listing contained in Health and Safety Code Section 25249.8(a). The four substances are: Chemical CAS No. Endpoint Reference Cyclopenta[cd]pyrene 27208-37-3 Cancer (2010a; 2010b) Ethanol in alcoholic beverages —...
March 1, 2011, is the deadline for owners or operators of facilities covered under Section 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) to file annual “Tier II” reporting forms to the appropriate state and local agencies. Under EPCRA Section 312, any facility required under Occupational Safety and Health Administration (OSHA) regulations to maintain material safety data sheets (MSDS) for hazardous chemicals and that stores these chemicals on-site during the...
February 11, 2011
Respondents to House Committee Identify FIFRA and TSCA Regulatory Actions as Impediments to Job Growth
On February 10, 2011, during a hearing on “Regulatory Impediments to Job Creation,” the House Committee on Oversight and Government Reform released a preliminary staff report entitled Assessing Regulatory Impediments to Job Creation. In December 2010, Committee Chair Darrell Issa (R-CA) sent letters to over 150 businesses, industry organizations, and think tanks asking for examples of existing and proposed regulations that have negatively impacted job growth, as well as...
Both Turkey and South Korea are working to implement chemical management programs to comply with broader international initiatives. In December 2009, Turkey implemented new legislation concerning the classification, labeling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations. South Korea has initiated a process for the management of chemicals, with the objective of minimizing the harmful effects...
February 3, 2011
Senate Subcommittee Holds Hearing on Assessing the Effectiveness of U.S. Chemical Safety Laws
On February 3, 2011, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled “Assessing the Effectiveness of U.S. Chemical Safety Laws.” Subcommittee Chair Frank Lautenberg (D-NJ) last year introduced the Safe Chemicals Act of 2010, a bill that would have reformed the Toxic Substances Control Act (TSCA) by shifting the burden of proof to industry to show chemicals are safe, rather than the U.S....
On January 18, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a proposed rule that would revise EPA’s February 6, 2006, final rule concerning protections for subjects in human research. According to EPA, the proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The proposed amendments would also disallow participation in third-party pesticide...
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a “plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.” See FDA News Release, “FDA to improve most common review path for medical devices” (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of...
January 10, 2011
CPSC Will Hold Web Conferences on the Publicly Available Consumer Product Safety Information Database
On January 7, 2011, the U.S. Consumer Product Safety Commission (CPSC) announced that it will hold two live web conferences on the publicly available consumer product safety information database. During the first web conference, scheduled for January 11, 2011, CPSC will demonstrate key functions of the database, such as how a consumer will be able to use the new online reporting form to submit a report of harm related to the use of a consumer product...
Thank you for participating in Bergeson & Campbell, P.C.’s webinar on endocrine disruptors Monday, December 20, 2010. We are delighted that you were able to participate, and hope that you found the information and format useful and convenient. Request the materials from this webinar....
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...
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...
December 14, 2010
Korea Publishes List of Potential GHS Classifications and Plans to Issue New Material Safety Data Sheet Rules
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...
December 13, 2010
CPSC Promulgates Final Rule Regarding Publicly Available Consumer Product Safety Information Database
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...
December 10, 2010
EPA Will Hold Public Information Exchange on Nanomaterial Case Studies and Workshop on Nanoscale Silver
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 studies as part of an ongoing...
Monday, December 20, 2010 1:30 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, 2011 1:00 – 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: More details to follow....
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...
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,...
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...
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,...
November 19, 2010
California Releases Revised Safer Consumer Product Alternatives Regulations for Comment
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...
November 18, 2010
EPA Proposes EDSP Policies and Procedures for SDWA Chemicals and Issues Second List of Chemicals for EDSP Tier 1 Screening
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...
November 17, 2010
EPA Announces Second List of Chemicals for EDSP Screening and Publication of Proposed Policies and Procedures
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...
November 8, 2010
EPA Proposes Revisions to FIFRA Procedures to Ensure Protection of Data Submitters’ Rights
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...
October 28, 2010
CPSC Posts Draft Final Rule Regarding Publicly Available Consumer Product Safety Information Database
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...
October 19, 2010
OSHA Proposes Interpretation of Its Provisions for Feasible Administrative or Engineering Controls of Occupational Noise
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...
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...
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. Request the materials from this webinar....
August 24, 2010
DOT Proposes to Harmonize Air and Marine Transport Regulations with International Standards
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...
August 23, 2010
OSHA Hosting Internet Forum to Identify Hazardous Chemicals That Warrant Exposure Reduction Strategies
The Occupational Safety and Health Administration (OSHA) is hosting an Internet forum that began on August 16 and runs through August 27 to seek stakeholder input in identifying hazardous chemicals for which OSHA should develop exposure reduction strategies. The forum expressly solicits stakeholders’ views on “harmful chemicals” and reasons why OSHA should focus on them in reducing worker exposures. The notice announcing the forum expresses OSHA’s recognition...
August 20, 2010
EPA Announces Action Plans for Chemicals Used in Dyes, Flame Retardants, and Industrial Detergents
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...
Charlie Auer submitted testimony today on H.R. 5820, the Toxic Chemicals Safety Act of 2010. As many of you know, Charlie is affiliated with Bergeson & Campbell, P.C. (B&C), and we are pleased to share the copy of Charlie’s testimony for your information. The testimony Charlie prepared is offered strictly on his own behalf, and does not reflect anyone’s views other than Charlie’s. That said, given Charlie’s intimate understanding of the Toxic Substances Control Act and...
July 30, 2010
Subcommittee on Commerce, Trade, and Consumer Protection Convenes a Legislative Hearing on TCSA
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...