June 22, 2010

EPA Issues Interim Guidance for Employee Participation in Risk Management Program Inspections

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...
June 21, 2010

EPA Settles Case Concerning Human Subjects Protections Rule

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...
June 18, 2010

ECHA Publishes Technical Manual for Including Nanoforms in an IUCLID Dossier

On June 11, 2010, the European Chemicals Agency (ECHA) announced the availability of a technical manual for including nanoforms in an International Uniform Chemical Information Database (IUCLID) dossier. The Nanomaterials in IUCLID 5.2 Industry User Manual “gives practical instruction to [Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)] registrants on how to include information on different forms of a substance in a IUCLID 5.2 dossier.” The...
June 10, 2010

CDTSC Holds Alternatives Assessment Symposium

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...
June 8, 2010

ECHA Clarifies the Definition of Intermediates

In a June 1, 2010, press release, the European Chemicals Agency (ECHA) announced that Member States have alerted ECHA and the European Commission (EC) “to industry positions on intermediates, which appear not to be in line with the definition of intermediates in [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation] and the guidance on intermediates.” The purpose of the guidance document, agreed among all authorities, is to explain to industry...
June 7, 2010

EP Committee Votes on Proposed Recast of the RoHS Directive

On June 2, 2010, the European Parliament (EP) Committee on the Environment, Public Health, and Food Safety approved the proposed recast of the Directive on the Restrictions of Hazardous Substances (RoHS) in Electrical and Electronic Equipment, with 55 votes in favor, one against, and two abstentions. Although the proposal by rapporteur Jill Evans would have added all brominated and chlorinated flame retardants, polyvinyl chloride, chlorinated plasticizers, and three phthalates — butyl...
June 1, 2010

EPA Will Begin Reviewing TSCA CBI Claims

On May 27, 2010, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing that it will begin a general practice of reviewing confidentiality claims for chemical identities in health and safety studies submitted under the Toxic Substances Control Act (TSCA). 75 Fed. Reg. 29754, available online. EPA states that TSCA Section 14(b) “does not extend confidential treatment to health and safety studies, or data from health and safety studies,...
May 28, 2010

ECHA Summarizes Details and Location of Information Regarding CLP Notification

In a recent European Chemicals Agency (ECHA) e-News release, dated May 19, 2010, ECHA provides a brief summary and Internet links to several important press releases to assist notifiers. The release provides a brief overview of the duties that are required to be met under notification along with access to documents and web pages that provide assistance on performing Classification, Labelling and Packaging (CLP) notifications in association with the CLP Regulation (1272/2008). This memorandum...
May 27, 2010

EPA Regions Will Propose Draft NPDES General Permit

According to a prepublication copy of a forthcoming Federal Register notice, all U.S. Environmental Protection Agency (EPA) regions will propose a draft National Pollutant Discharge Elimination System (NPDES) general permit for point source discharges from the application of certain pesticides to U.S. waters. Once final, the permit will be available to operators in those areas where EPA is the NPDES permitting authority. According to the notice, this action is in response to the Sixth...
May 26, 2010

CPSC Proposes Requirements for Testing Component Parts in Consumer Products

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...
May 25, 2010

Walking-Working Surfaces and Fall Protection Systems

According to the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA), a potentially lethal workplace hazard lurks at the feet of millions of workers in the U.S. The floors and other surfaces that American workers walk on during our daily work routines can be the cause of serious injuries. Slips, trips and falls — particularly falls from elevated heights — for decades have been a leading cause of workplace fatalities in the U.S....
May 19, 2010

EPA Announces Draft PR Notice Concerning False or Misleading Pesticide Product Brand Names

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...
May 13, 2010

EPA Issues Final “Tailoring” GHG Permitting Rule

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...
May 13, 2010

TSCA Reform Webinar Follow-up

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...
May 4, 2010

New York Sustainability and Green Procurement Advisory Council Drafting Recommendations for FY 2010-11

The Sustainability and Green Procurement Advisory Council (Advisory Council) of the New York Interagency Committee on Sustainability and Green Procurement (Interagency Committee) is in the process of drafting recommendations for inclusion in the annual report required under Governor David Paterson’s 2008 Executive Order (EO) directing state agencies, public authorities, and public benefit corporations to buy environmentally friendly products. In September 2009, the Advisory Council voted...
May 3, 2010

TSCA Reform Webinar Invitation

Monday, May 10, 2010 11:00 a.m. – 1:00 p.m. (EDT) Bergeson & Campbell, P.C. (B&C) is hosting a free webinar on TSCA Reform Legislative Initiatives on May 10, 2010. On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA), which is intended to address the “core failings” of TSCA. Also on April 15, 2010, Representatives Bobby Rush (D-IL), Chairman of the Subcommittee on Commerce,...
April 30, 2010

PPDC Discusses Nanotechnology and Pesticides

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)...
April 27, 2010

Summary and Comparison of the TSCA Reform Legislation

Bergeson & Campbell. P.C. is 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 are available here. On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA), which is intended to address...
April 21, 2010

ECHA Publishes List of Substances Identified for Registration in 2010

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...
April 15, 2010

Senate and House TSCA Reform Legislation Released Today

Today Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, which is intended to address the “core failings” of TSCA.  Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) released a discussion draft of their legislation, the Toxics Chemicals Safety Act of 2010, and announced an aggressive schedule that seeks to complete action by “mid-summer.” Lautenberg’s Safe Chemicals Act would: Links to the bills, summaries, and other related materials...
April 12, 2010

DOT Considering Changes to Regulations Governing Transportation of Combustible Materials

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...
April 9, 2010

EPA Posts Fact Sheet on Determining If a Cleaning Product Is a Pesticide

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...
April 8, 2010

EPA Reassessing Authorizations for PCB Use and Distribution in Commerce

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,...
March 30, 2010

EPA Announces BPA Action Plan

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...
March 19, 2010

EPA Planning to Release More Chemical Action Plans

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...
March 18, 2010

ECHA Board of Appeals Issues Guidance for Appealing ECHA Decisions

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 parties...
March 16, 2010

China MEP Adopts Amended New Chemical Notification Scheme

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 other leading regulatory...
March 11, 2010

GAO Recommends FDA Strengthen Its Oversight of GRAS Food Ingredients

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 and Drug...
March 10, 2010

Senate Subcommittee Holds Hearing to Obtain Business Perspectives on TSCA Reform

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...
March 9, 2010

ECHA Announces New Public Consultation on Eight Potential Substances of Very High Concern

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 substances as SVHCs. ECHA...
March 9, 2010

DOT Eases Requirements for Security Plans

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 associated with security...
March 4, 2010

House Subcommittee Holds Hearing on TSCA and PBTs

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...
March 3, 2010

Health Canada Adopts Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials

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...
March 1, 2010

House Subcommittee Holds Hearing on Endocrine Disrupting Chemicals in Drinking Water

On February 25, 2010, the House Committee on Energy and Commerce Subcommittee on Energy and Environment held a hearing entitled “Endocrine Disrupting Chemicals in Drinking Water: Risks to Human Health and the Environment.” The Subcommittee intended the hearing to examine the science and regulation of endocrine disruptors that may be found in sources of drinking water. Witnesses included: The witness testimony is available online. Subcommittee members criticized the slow pace of...
February 24, 2010

EPA Publishes Final Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes

Today the U.S. Environmental Protection Agency (EPA) published its final clarification under which certain activated phosphors that are not on the Toxic Substances Control Act (TSCA) Section 8(b) Chemical Substance Inventory (TSCA Inventory) will be considered to be “new” chemical substances under TSCA Section 5, and thus will be subject to applicable notification requirements under TSCA Section 5. According to EPA, the clarification is necessary because EPA’s statements in...
February 23, 2010

OIG Report Concludes EPA Needs Coordinated Plan to Oversee Its TSCA Responsibilities

On February 18, 2010, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities, urging EPA to coordinate better risk assessment and oversight activities by establishing a management plan that contains new goals and measures that demonstrate the results of Office of Pollution Prevention and Toxics (OPPT) and Office of Enforcement and Compliance...
February 22, 2010

EPA Proposes Amendments to TSCA Section 4 Enforceable Consent Agreement Procedures

On February 19, 2010, the U.S. Environmental Protection Agency (EPA) proposed important revisions to the procedures for development of enforceable consent agreements (ECA) to generate test data under Section 4 of the Toxic Substances Control Act (TSCA). 75 Fed. Reg. 7428 (Feb. 19, 2010). The proposed rule includes some sweeping changes for when and how negotiations will be initiated, conducted, and concluded, and limits the timeframe within which these activities will take place. Companies that...
February 17, 2010

New York Advisory Council Green Procurement Chemical Avoidance List Released Publicly

As we reported last month, the Sustainability and Green Procurement Advisory Council (Advisory Council) of the New York Interagency Committee on Sustainability and Green Procurement (Interagency Committee) voted 9-1 to recommend creating a “chemical avoidance list” that would be a list of chemicals that New York government agencies should avoid buying. The list would comply with Governor David Paterson’s 2008 Executive Order directing state agencies, public authorities, and...
February 8, 2010

EPA SAP Releases Report on Nanosilver and Other Nanometal Pesticide Products

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products. Before summarizing the SAP’s primary conclusions and recommendations, we note a few general observations. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of “nanometal...
February 4, 2010

Senate Subcommittee Holds Hearing Regarding Current Science on Public Exposure to Toxic Chemicals

Today the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health held a hearing entitled “Current Science on Public Exposures to Toxic Chemicals.” Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, criticized the Toxic Substances Control Act (TSCA) for failing to provide the U.S. Environmental Protection Agency (EPA) the necessary authority to protect the public from unsafe chemicals. Lautenberg stated that he intends...
January 28, 2010

EPA Announces Intent to Issue Cancellation Order for Spirotetramat

On January 26, 2010, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) announced that it intends to issue a cancellation order for the pesticide spirotetramat pursuant to Section 6(a)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A comment period is now open on the existing stocks provisions of the planned cancellation order. Comments are due February 8, 2010. EPA states that, on December 23, 2009, the U.S. District Court for the...
January 27, 2010

Final Rule Amends PMN Exemption for Polymers

Today the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the polymer exemption rule, which provides an exemption from the premanufacture notification (PMN) requirements of the Toxic Substances Control Act (TSCA). The amendment excludes from eligibility polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. This exclusion includes polymers that contain any one or...
January 25, 2010

EPA Revises TSCA Section 8(e) CBI Policy and Holds ePMN CDX Registration Webinar

EPA Limits CBI Claims in TSCA Section 8(e) Submissions On January 21, 2010, the U.S. Environmental Protection Agency (EPA) announced a new practice concerning confidential business information (CBI) claims for substantial risk information submitted to EPA under Toxic Substances Control Act (TSCA) Section 8(e). 75 Fed. Reg. 3462. According to EPA’s announcement, if a chemical substance is listed on the public portion of the TSCA Inventory, EPA expects a company submitting a health and...
January 22, 2010

Senate Expected to Schedule TSCA Hearing

Bergeson & Campbell, P.C. (B&C) has learned that the Senate is preparing to schedule a hearing on the Toxic Substances Control Act (TSCA) in early February, most likely on February 4, 2010. As noted in our 2010 Predictions memorandum, a new and significantly revised Kid-Safe Chemicals Act (KSCA) has not yet surfaced. The fact that the Senate is scheduling a hearing indicates that a revised Senate proposal is expected soon. There are also indications that if new...
January 13, 2010

EPA Revises TSCA Section 5 PMN and SNUN Electronic Reporting Requirements

On January 6, 2010, the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the electronic reporting requirements under Section 5 of the Toxic Substances Control Act (TSCA) (available online). According to EPA, the amendments are intended to streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA by establishing standards and requirements for the use of EPA’s Central Data Exchange (CDX) to encrypt and...
January 12, 2010

Additional Information on New York “Chemical Avoidance List”

In our memorandum dated January 6, 2010, we alerted you to a recent activity in New York in connection with the development of a “chemical avoidance list.” The list, which reportedly consists of approximately 85 chemicals, would include chemicals that New York government agencies should avoid buying. By way of background, last May the Advisory Council of the New York Interagency Committee on Sustainability and Green Procurement voted 9-1 to recommend adoption of the not-yet...
January 7, 2010

2010 Predictions

As is our custom, Bergeson & Campbell, P.C. is pleased to forward our thoughts on what may be in store this year from the U.S. Environmental Protection Agency’s Office of Prevention, Pesticides, and Toxic Substances. In light of the significant chemical management developments underway in the European Union, we are pleased that Ruxandra Cana and Koen Van Maldegem from the Brussels office of Field Fisher Waterhouse LLP have contributed their thoughts on what may be...
January 6, 2010

New York Considers Listing Chemicals that Agencies Should Avoid Buying

The New York Interagency Committee on Sustainability and Green Procurement has voted 9-1 to recommend a “chemical avoidance list,” which would be a list of 85 chemicals that New York government agencies should avoid buying. Listed chemicals would not be banned, but industry representatives have criticized the proposal, noting that the list would not address the actual risk from exposure. The Committee intends the list to comply with Governor David Paterson’s 2008 Executive...
December 31, 2009

EPA Announces Action Plans For Existing Chemicals

True to her word, yesterday U.S. Environmental Protection Agency (EPA) Administrator Lisa P. Jackson announced action plans on phthalates, long-chain perfluorinated chemicals (PFC), polybrominated diphenyl ethers (PBDE) in products, and short-chain chlorinated paraffins (SCCP).  This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents — and possibly shape future...
December 10, 2009

CDC Releases Fourth National Report on Human Exposure to Environmental Chemicals

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