Memoranda

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

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

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

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...

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

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

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

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...

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

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...

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,...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

In a February 18, 2010, Politics Daily article, Lynn L. Bergeson commented on regulations being developed by the U.S. Environmental Protection Agency (EPA) that would increase reporting of nanomaterial products. Bergeson stated that she expects EPA to propose that businesses provide data only for new products, and that those on the market would be grandfathered in....

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...

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...

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...

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...

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 safety study to EPA under TSCA Section 8(e) for that...

The Acta Group, L.L.C. (Acta) 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...

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...

January 7, 2010 As is our custom, The Acta Group, L.L.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...

The January 5, 2010, issue of BNA Daily Environment Report quotes Charles Auer and Bergeson & Campbell, P.C.’s (B&C) December 31, 2009, memorandum regarding the action plans announced by the U.S. Environmental Protection Agency (EPA) on December 30, 2009. Auer described the action plans as “very ambitious” and noted that it remains to be seen whether EPA will have the staff and other resources to be as ambitious as it wants to be. In its...

...

...

...

...

...

...

...

...

...

...

...

...

...

...

...