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October 1, 2010

Monthly Update for October 2010

Bergeson & Campbell, P.C.

TSCA/FIFRA/NTP/EPCRA

EPA Denies TSCA Section 21 Petition On Lead In Ammunition And Fishing Sinkers: On September 24, 2010, the U.S. Environmental Protection Agency (EPA) announced its decision to deny a petition submitted under the Toxic Substances Control Act (TSCA) Section 21 requesting that EPA prohibit under TSCA Section 6(a) the manufacture, processing, and distribution in commerce of (1) lead bullets and shot; and (2) lead fishing sinkers. 75 Fed. Reg. 58377. EPA denied the first request due to a lack of authority to regulate lead in bullets and shot under TSCA. EPA’s decision is based on the exclusion of shells and cartridges from the definition of “chemical substance” in TSCA Section 3(2)(B)(v). EPA is still considering the second request and will respond to that portion of the petition within the 90-day period provided in TSCA Section 21. This notice explains EPA’s reasons for the denial of the request specific to lead bullets and shot.

EPA Issues Final Rule Amending Enforceable Consent Agreement Procedural Rules: On September 16, 2010, EPA issued a final rule revising the procedures for developing Enforceable Consent Agreements (ECA) to generate test data under TSCA. 75 Fed. Reg. 56472. The main features of the ECA process that EPA is changing include when and how to initiate negotiations and inserting a firm deadline at which negotiations will terminate. EPA also deleted, modified, or consolidated several sections of 40 C.F.R. Part 790 to place the ECA provisions in one section and the Interagency Testing Committee (ITC) provisions in a separate section, to make it clearer that there is one ECA negotiation procedure applicable to all circumstances when an ECA would be appropriate, and to make conforming changes in other sections that reference the ECA procedures. The final rule follows the proposal closely. The final rule is effective October 18, 2010.

Investor Organizations Support TSCA Reform: On September 27, 2010, the Investor Environmental Health Network and the American Sustainable Business Council submitted a letter urging Congress to pass House and Senate bills that would revise TSCA and require chemical manufacturers to provide more information about their products. The letter is available online.

EPA Pesticide Database To Aid Consumers In Controlling Bed Bugs: EPA has announced a new database listing all pesticides registered for bed bag control. The new tool allows consumers to choose an EPA-registered bed bug product that is safe if properly used according to label instructions. According to EPA, there are more than 300 different EPA-registered products for use against bed bugs. More information is available online.

EPA Extends Compliance Date On Containment Rule: On October 10, 2010, EPA amended the pesticide container and containment regulations to provide an 8-month extension of the labeling compliance date from December 16, 2010, to August 16, 2011. 75 Fed. Reg. 62323. This change is being made to provide additional time for pesticide registrants to revise labels to bring them into compliance with the regulations and for EPA and states to review and approve the revised labels. This final rule is effective December 7, 2010.

EPA Publishes Brochure On Children’s Health: On October 7, 2010, EPA released a brochure, Protecting Children’s Health The National Pesticide Program, to educate readers about the ways EPA believes its pesticide program protects children. The document is available online.

Transatlantic Chemical Toxicity Testing Agreement Signed: On October 11, 2010, the Institute for Health and Consumer Protection (IHCP), a part of the European Commission’s (EC) Joint Research Center, announced it has signed an agreement with EPA’s National Center for Computational Toxicology (NCCT) to exchange research materials and results that are believed useful for predicting chemical toxicity. The IHCP states NCCT’s ToxCast program fits well with its efforts to design and evaluate integrated testing strategies — which combine chemical-grouping approaches, computational modeling, and in vitro testing — for predicting chemical toxicity. Launched in 2007, ToxCast aims to use data from high throughput screening assays to build statistical and computational models for predicting potential chemical toxicity in people and prioritize chemicals for more in-depth toxicity testing.

EPA Sends Draft Revisions To Human Research Rule To Secretary Of Agriculture: On October 13, 2010, 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. 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 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 Organizing Committee, AFL-CIO, and Migrant Clinicians Network. According to the Federal Register notice, the draft proposed amendments “would clarify the applicability of the rules to human testing for pesticides submitted to EPA under any statute, would disallow consent by a legally authorized representative of participants in pesticide studies who cannot consent for themselves, and would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based on the recommendations of the National Academy of Sciences and on the Nuremberg Code.” A more detailed memorandum is available online.

RCRA/CERCLA

EPA Extends By One Year The Compliance Date On Spill Prevention Rule: On October 14, 2010, EPA extended the compliance date by one year for certain facilities subject to amendments to the Spill Prevention, Control, and Countermeasure (SPCC) rule. 75 Fed. Reg. 63093. EPA also announced that some facilities will not be eligible for the one year extension and must comply by the current date of November 10, 2010. Last year, EPA amended the SPCC rule. Regulated facilities are required to amend and implement these changes as part of their overall SPCC plans. The purpose of the SPCC rule, which was issued in 1973, is to establish requirements for facilities to prevent a discharge of oil into navigable waters or adjoining shorelines. EPA has no SPCC jurisdiction over drilling, production, or workover facilities seaward of the coastline. Facilities that must comply by November 10, 2010, include: drilling, production or workover facilities that are offshore or that have an offshore component, or onshore facilities required to have and submit Facility Response Plans (FRP), due to the threats these facilities could pose of significant oil spills to navigable waters or adjoining shorelines. Types of facilities eligible for the one year extension include: onshore oil production, farms, electric utility plants, petroleum refining and related industries, chemical manufacturing, food manufacturing, manufacturing facilities using and storing animal fats and vegetable oils, metal and other manufacturing, real estate rental and leasing, retail trade, contract construction, wholesale trade, other commercial, transportation, arts entertainment and recreation, other services (except public administration), petroleum bulk stations and terminals, education, hospitals and other health care, accommodation and food services, fuel oil dealers, gasoline stations, information finance and insurance, mining, warehousing and storage, religious organizations, military installations, pipelines, and government facilities. These amendments do not remove the regulatory requirement for owners or operators of facilities in operation before August 16, 2002, to maintain and continue implementing an SPCC plan in accordance with the SPCC regulations then in effect. More information on the rule is available online.

CAA/CWA

EPA Issues Rule Regarding Mandatory Reporting Of Greenhouse Gases: On September 22, 2010, EPA issued a final rule amending the Final Mandatory Reporting of Greenhouse Gases Rule. 75 Fed. Reg. 57669. The rule requires reporters subject to the rule to provide: the name, address, and percentage ownership of their U.S. parent company(s); their primary North American Industry Classification System (NAICS) code(s) as well as all additional applicable NAICS code(s); and an indication of whether or not any of their reported emissions are from a cogeneration unit. This final action also corrects an editorial error in revisions made to the General Provisions published earlier this year. The final rule is effective on November 22, 2010.

EPA Proposes Guidelines Establishing Test Procedures For Pollutant Analysis: On September 23, 2010, EPA proposed changes to analysis and sampling test procedures in wastewater regulations. 75 Fed. Reg. 58024. The changes are designed to increase flexibility to the regulated community and laboratories in their selection of analytical methods (test procedures) for use in Clean Water Act (CWA) programs. The changes include proposal of EPA methods and methods published by voluntary consensus standard bodies, such as ASTM International and the Standard Methods Committee, and updated versions of currently approved methods. EPA also proposed to add certain methods reviewed under the alternate test procedures program. Further, EPA proposed changes to the current regulations to clarify the process for EPA approval for use of alternate procedures for nationwide and Regional use. EPA proposed minimum quality control requirements to improve consistency across method versions; corrections to previously approved methods; and changes to sample collection, preservation, and holding time requirements. Finally, EPA proposed changes to how EPA cites methods in three effluent guideline regulations. EPA must receive comments on this proposal on or before November 22, 2010.

White House Issues Guidance On Greenhouse Gas Emissions Reporting: On October 6, 2010, the White House Council on Environmental Quality (CEQ) issued guidance for federal agencies and departments that have been directed by President Obama to begin reporting their annual greenhouse gas (GHG) emissions. Executive Order 13514 covers carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride. The protocol directs federal departments and agencies to report emissions beginning in January 2011, including emissions directly linked to agency activities such as energy use and indirect emissions stemming from vendor services, fuel consumed through commuting by agency employees, and other sources. The White House Council on Environmental Quality Guidance on Federal Greenhouse Gas Accounting and Reporting is available online.

EPA Issues Sewage Sludge Air Emissions Rule: On October 14, 2010, EPA issued a proposed rule regulating emissions of mercury from sewage sludge incinerators. 75 Fed. Reg. 63260. EPA proposed new source performance standards for new and existing sewage sludge incinerators. The proposal seeks to amend 40 C.F.R. Part 60 subparts LLLL and MMMM, requiring the incinerators to control emissions of mercury, lead, cadmium, hydrogen chloride, particulate matter, carbon monoxide, dioxins and furans, nitrogen oxides, and sulfur dioxide. Comments are due by November 15, 2010.

NANOTECHNOLOGY

EPA Issues Final SNURs For Carbon Nanotubes: On September 17, 2010, EPA issued final significant new use rules (SNUR) for two chemical substances that were the subject of premanufacture notices (PMN). 75 Fed. Reg. 56880. The two chemical substances are identified generically as multi-walled carbon nanotubes (CNT) (PMN P-08-177) and single-walled CNTs (PMN P-08-328). Persons who intend to manufacture, import, or process either of these substances for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. EPA states that it believes the SNURs are necessary because these chemical substances may be hazardous to human health and the environment. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule is effective October 18, 2010.

EPA issued direct final SNURs on these two substances on June 24, 2009. EPA withdrew the notices on August 21, 2009, after receiving notices of intent to submit adverse comments on the SNURs. EPA issued proposed SNURs on November 6, 2009. In response to comments on the applicability of the SNURs for these chemicals, EPA has included clarifying language for those forms of the subject PMN substances that are exempt from the provisions of the SNURs. These exemptions apply to quantities of the PMN substances: after they have been completely reacted (cured); incorporated or embedded into a polymer matrix that itself has been reacted (cured); or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing. In response to comments on the basis for the SNURs, EPA developed revised human health effects and environmental effects summaries for CNTs.

NIOSH Announces Formal Partnership On Nanotechnology Research And Guidance: The National Institute for Occupational Safety and Health (NIOSH) announced on September 22, 2010, that it entered into a formal partnership with the National Science Foundation (NSF) Center for High-Rate Nanomanufacturing (CHN) that is intended to provide companies with practical research and guidance to promote occupational health and safety in nanotechnology. Through the new partnership, University of Massachusetts (UMass) Lowell, CHN, and NIOSH will “address safety issues so that discoveries can quickly turn into commercially available products.” NIOSH and UMass Lowell research teams will evaluate potential exposure to nanomaterials and recommend solutions at small- to medium-sized companies and research laboratories. NIOSH will publish best practices developed by UMass Lowell and CHN. UMass Lowell will host and NIOSH will co-sponsor the 5th International Symposium on Nanotechnology, Occupational, and Environmental Health on August 9-12, 2011, in Boston. More information about the partnership is available online. Details regarding the conference are available online.

OPP Considering Labeling Of Nanopesticides: 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, EPA Office of Pesticide Programs (OPP), provided an update on EPA’s regulation of pesticides containing nanoscale materials. McLain’s presentation includes two previously unreported OPP regulatory activities. First, according to McLain, OPP intends to require that nanoproducts be labeled in the same way as other pesticide products. Ingredients would be listed as “nano-X,” and OPP would evaluate the claims on a case-by-case basis. Second, OPP apparently is considering issuing data call-ins (DCI) to obtain information EPA may need to evaluate the registerability under FIFRA of nanoscale materials. Using its FIFRA DCI authority is, of course, an option several industry groups have been urging in lieu of repurposing FIFRA Section 6(a)(2). McLain’s slides are available online.

NIH And FDA Will Fund Research On Nanoparticles: In a September 27, 2010, press release, the National Institutes of Health (NIH) announced that it will award $9.4 million over three years to support four research projects in regulatory science. NIH will make the awards in partnership with the U.S. Food and Drug Administration (FDA), which will contribute approximately $950,000. According to the press release, the projects include research on nanoparticles and their characterization. NIH states that the projects were chosen “because they were the most meritorious proposals for addressing high priority areas in cutting-edge biomedical research and regulatory science.” Dennis E. Hourcade, Ph.D., Washington University, St. Louis, will receive funding for “Characterization/Bioinformatics-Modeling of Nanoparticle: Complement Interactions.” NIH defines regulatory science as “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency, and performance.” More information is available online.

ASTM Nanotechnology Committee Creates Subcommittee On Nano-Enabled Consumer Products: Last month, the ASTM International Committee E56 on Nanotechnology announced the creation of Subcommittee E56.06 on Nano-Enabled Consumer Products. According to ASTM, the Subcommittee will develop standards for determining the presence of engineered nanomaterials in consumer products and understanding the potential for exposure from the use of these consumer products. The Subcommittee will focus its initial efforts on the identification and evaluation of engineered nanomaterials in consumer products. Projects under consideration include:

  • Standards for measurement of silver in textiles and liquids (including atomic spectroscopy to assess mass);
  • Standards for evaluating the form of silver in textiles and liquids (including electron microscopy to evaluate size, shape, and chemical composition; and ultraviolet-visible spectrophotometry to evaluate size using surface plasmon resonance absorbance); and
  • Standards for assessment of nanosilver exposure potential from use of textile and liquid consumer products (including release from consumer products in biological fluids [skin surface, lung, gastrointestinal tract]; release from consumer products in environmental matrices [air, water, soil] throughout a product lifecycle).

The Subcommittee is seeking expertise for participation from the following areas:

  • Analytical chemistry, including atomic spectroscopy;
  • Scanning or transmission electron microscopy and analytical techniques such as energy dispersive X-ray analysis or auger spectroscopy;
  • Ultraviolet-visible spectroscopy;
  • Materials characterization, including crystallinity and surface area;
  • Textiles;
  • Consumer product safety;
  • Exposure assessment; and
  • Environmental chemistry (air, water, soil).

More information is available online.

CDTSC And EPA Hold Public Workshop On State And Federal Nanomaterial Activities: On September 22, 2010, the California Department of Toxic Substances Control (CDTSC) and EPA held a public workshop on state and federal nanomaterial activities. During the workshop, CDTSC and EPA discussed the results of California’s DCI for CNTs, 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 CDTSC’s second DCI, which it intends to issue this Fall, include nanosilver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. CDTSC may also include in the DCI a request for more information concerning CNTs incorporated in nanometals. According to CDTSC, the DCI will focus its initial questions on analytical test methods for the respective nanomaterial chemical, as well as its metabolites and breakdown products, in various matrices. The meeting presentations for each of the DCI candidates include more specific information regarding applications, production, human health and environmental concerns, why CDTSC is interested, and possible DCI questions. A more detailed memorandum is available online.

OECD Releases Report On Current Developments And Activities On The Safety Of Manufactured Nanomaterials: In a September 22, 2010, report entitled Current Developments/Activities on the Safety of Manufactured Nanomaterials, the Organization for Economic Cooperation and Development (OECD) provides information on current and planned activities related to the safety of manufactured nanomaterials in OECD member and non-member countries that attended the seventh meeting of OECD’s Working Party on Manufactured Nanomaterials (WPMN) on July 7-9, 2010, in Paris, France. The document also includes reports on relevant current activities in other international organizations such as the International Organization for Standardization (ISO) and the World Health Organization (WHO). The report is available online.

REACH DEVELOPMENT

Belgium Minister Calls For REACH Register To Ensure Traceability Of Nanomaterials: During a September 14, 2010, conference on nanomaterials management, Paul Magnette, the Belgian Minister for Energy, Environment, Sustainable Development, and Consumer Protection, proposed to create a specific register for nanomaterials under the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) program and to implement mandatory labeling for nanomaterials used in consumer products. According to Magnette, the next European Environment and Health Action Plan is expected to address the challenge of nanomaterials among its priority areas. In 2011, the EC must also respond to the April 2009 European Parliament (EP) resolution on the regulatory aspects of nanomaterials. The resolution calls for various “ambitious” measures to ensure safety with regard to nanomaterials and nanotechnology. Magnette put forward five proposals from the Belgian Presidency of the European Union (EU) that are intended to respond to consumer needs while ensuring their safety: define the obligation to inform the consumer of the presence of nanomaterials in consumer products; ensure the traceability of the chain so as to be able to return to the source, if necessary (regarding this aspect, it would be obligatory to maintain a register of nanomaterials); identify the most appropriate regulatory path at the EU level for risk evaluation and management; encourage member states, during this transitory period, to take up the responsibility and draw up integrated national strategies and concrete measures in favor of risk management, information, and monitoring; and regulate the claims made on labels of products containing nanomaterials.

ECHA Expects To Add 40 Substances To Candidate List Of SVHCs: European Chemicals Agency (ECHA) Executive Director Geert Dancet stated on October 4, 2010, that, in 2011, ECHA expects to add 40 substances to the candidate list of substances of very high concern (SVHC) for authorization under the REACH program. Beginning in 2011, ECHA will oversee new listings twice a year, with consultations on member state or EC proposals in the Spring and Fall, and an update to the candidate list completed each June and December. The EC stated in March 2010 that more than 100 substances should be listed as candidates for restrictions or bans by 2012. Once substances are included on the candidate list, substance bans can be imposed after further consultations and assessments, with limited authorizations allowed only for specific uses. The first substances were added to the candidate list in October 2008, and the EU REACH Committee provisionally approved the first set of bans for six substances — 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene), 4,4′-diaminodiphenylmethane, hexabromocyclododecane (and all major diastereoisomers), di(2-ethylhexyl) phthalate, benzyl butyl phthalate, and dibutyl phthalate — on September 21, 2010. The approval could still be blocked by EU member states or the EP. Trade unions and non-governmental organizations have criticized the process as too slow, claiming that workers and the environment continue to be exposed to substances that are known to be hazardous. While Spain’s Union Institute of Work, Environment, and Health has urged adding approximately 1,500 substances already classified as category 1 or 2 carcinogenic, mutagenic, or reprotoxic (CMR) to the candidate list, ECHA has rejected this approach. An ECHA spokesperson stated that it was “most important that the right substances [are] enter[ed] on the candidate list,” and that the aim should be a “useful regulatory outcome.” More information on the candidate list is available on the Internet

ECHA Expects Companies To Meet Registration Deadline For Most Substances: An ECHA spokesperson stated on October 4, 2010, that ECHA has received and accepted for evaluation dossiers for about half the chemical substances used in the EU that must be registered by November 30, 2010. Several ECHA officials said they were satisfied with the volume of registrations. According to ECHA Executive Director Geert Dancet, ECHA remains concerned about the registration of substances imported into, but not manufactured in, the EU. Dancet also stated that companies were progressing slowly with substance classification and labeling notifications. Under REACH, approximately 5,000 substances produced in or imported into the EU must be registered by November 30, 2010, or their supply on the EU market will be illegal. Under the classification, labeling, and packaging regulation, companies have until December 1, 2010, to bring their inventories in line with the United Nations Globally Harmonized System of Classification and Labeling, and submit to ECHA a notification of updated substance information by January 3, 2011. The November 30, 2010, REACH deadline apples to substances produced or imported in annual volumes of 1,000 metric tons or more, and to the most hazardous classes of CMR substances in volumes of one metric ton or more. ECHA expects about 3,000 substances to fall into the high-volume category, and between 1,500 and 2,000 to fall into the lower-volume hazardous categories. By September 30, 2010, ECHA had received and processed 4,185 dossiers covering 2,265 substances, and expects to receive 38,000 dossiers covering up to 5,000 substances. Once a lead company has submitted a registration dossier, other companies manufacturing or importing the same substance must submit supplementary dossiers, leading to a higher number of dossiers submitted than the number of substances registered. Before the end of October 2010, ECHA will publish a list of registered substances, which it will update weekly, so that companies using chemicals in their products can check on the status of the materials they need.

LEGISLATIVE DEVELOPMENTS

Effort To Halt EPA Emissions Rules Stalled: A move by Senator Christopher Bond (R-MO) to force EPA to delay the present January 2011 effective date for GHG regulations was sidetracked by the Senate Majority Whip, Richard Durbin (D-IL). Senator Bond requested unanimous consent for an amendment to bring up for consideration by the full Senate of a bill sponsored by Senator Jay Rockefeller (D-WVA). That measure, S. 3072, The Stationary Source Regulations Delay Act, would prohibit the Administrator of EPA, during the two-year period beginning after enactment, from taking any action under Clean Air Act (CAA) with respect to any stationary source permitting requirement or requirement concerning standards of performance for new stationary sources relating to carbon dioxide or methane. The Rockfeller bill would also provide that no action taken by the Administrator during the two-year period after enactment could be considered to make carbon dioxide or methane a pollutant subject to regulation under the CAA for any source other than a new motor vehicle or new motor vehicle engine.

The Stationary Source Regulation Delay Act contains a number of exemptions. One such exclusion is any action under the CAA relating to the vehicle emissions standards contained in current specified EPA Dockets. Also exempted is any action relating to the preparation of a report or the enforcement of a reporting requirement; or any action relating to the provision of technical support at a state’s request. Trade press reports quote Senator Rockefeller as saying that he is on the way to the 60 votes needed to bring the bill up on the floor. Other reports quote the number of present supporters of the Rockefeller measure at 12.

Senator Bond attempted to use another piece of legislation, the Defense Authorization Bill, as a means to bring up his proposed bar to EPA action to regulate GHG emissions from stationary sources, such as power plants. He made a motion to bring up the bill, which motion, if passed, would have given him the vehicle to spur debate on EPA actions. The motion to bring up the Authorization measure failed by a vote of 56 to 43.

President Obama Signs Continuing Appropriations Act 2011: On September 30, 2010, the President signed a continuing resolution to fund operations of the government into the new fiscal year that commenced October 1, 2010. The resolution was needed since none of the appropriations bills for the several departments and agencies had passed by September 30, 2010. Those measures will be taken up in the so-called lame-duck session of Congress after the mid-term elections in early November.

Measure Directs Multi-faceted Study Of Controlled Drug Disposal: On September 22, 2010, the House of Representatives passed H.R. 5809, the Safe Drug Disposal Act of 2010, a bill authored by Representative Jay Inslee (D-WA). The measure would amend the Controlled Substances Act to allow an ultimate user who has lawfully obtained a controlled substance or anyone authorized to dispose of the ultimate user’s property to deliver that substance to another person for disposal if: (1) the person receiving the controlled substance is authorized to receive and dispose of the substance; and (2) the delivery and disposal take place in accordance with regulations issued by the United States Attorney General to prevent diversion of controlled substances.

The Safe Drug Disposal Act also directs: the Attorney General to authorize long-term care facilities to deliver for disposal controlled substances on behalf of ultimate users and authorizes the Director of National Drug Control Policy to carry out a public education and outreach campaign to increase awareness of safe drug disposal. Furthermore, the Comptroller General is directed to collect data on the delivery, transfer, and disposal of controlled substances under the Safe Drug Disposal Act and to submit findings and recommendations to Congress on the use, effectiveness, and accessibility of disposal programs. Finally, the EPA Administrator is to study the environmental impacts from the ultimate disposal of controlled substances and the ease and cost of implementation of drug take-back programs.

Senator Boxer Introduces Bill To Address Effects Of Disease Clusters: On September 28, Senator Barbara Boxer (D-CA) introduced a long-awaited bill to investigate disease clusters. H.R. 3861, the Strengthening Protection for Children and Communities from Disease Clusters Act, seeks to provide the EPA Administrator the authority to help conduct investigations into the potential for environmental pollutants or toxic substances to cause disease clusters; to ensure that the Administrator has the authority to undertake actions to help address existing and potential environmental pollution and toxic substances that may contribute to the creation of disease clusters; and to enable the Administrator to integrate and work in conjunction with other federal, state, and local agencies, institutions of higher education, and the public in investigating and helping to address the possible causes of disease clusters. Co-sponsors include Senators Amy Kobuchar (D-MN), Frank Lautenberg (D-NJ), and Bill Nelson (D-FL). The bill was referred to the Environment and Public Works Committee (EPW).

H.R. 3861 is designed to protect and assist pregnant women, infants, children, and other individuals who have been, are, or could be harmed by, and become part of, a disease cluster; to enhance federal resources, expertise, outreach, transparency, and accountability in responding to public and state and local government inquiries about the potential causes of a disease cluster; and to strengthen Federal analytical capacity and coordination, including with state and local authorities, in the investigation of the potential causes of disease clusters.

MISCELLANEOUS

FTC Releases Proposed Revisions To The “Green Guides”: 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 result of three public workshops exploring emerging issues, along with consumer perception research, and significant public comment. A copy of the proposed changes is available online. The FTC also provides a summary online. A more detailed memorandum is available online.

EPA Soliciting Comments On Its Role In Advancing Sustainable Products: On September 16, 2010, 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 products.” A more detailed memorandum is available online. Comments are due October 19, 2010.

California Releases Proposed Regulations For Safer Consumer Products: 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 would be required to perform an “alternatives assessment” to determine if a viable safer alternative is available. CDTSC will hold a public hearing on November 1, 2010, and comments on the proposed regulations are due November 1, 2010, as well. CDTSC intends to complete the formal process to adopt the proposed regulations by the end of 2010. More information is available online. A more detailed memorandum is available online.

EPA Marks 20th Anniversary Of The Pollution Prevention Act Of 1990: EPA marked the 20th anniversary of the Pollution Prevention Act of 1990 during Pollution Prevention Week, September 19-25, 2010. The Act laid the groundwork for reducing pollution at its source and reducing the amount of contaminants released into the environment. EPA is focused on integrating of pollution prevention goals into all its programs and has already achieved results in many Agency programs: in 2009 alone, Americans with the help of Energy Star saved $17 billion dollars on their energy bills and reduced GHG emissions equivalent to those of 29 million cars; WasteWise celebrated 15 years of environmental results in 2009, with 2,860 members contributing to the prevention and recycling of more than 160 million tons of waste (or 320 billion pounds); since the program began in 2003, Plug-In To eCycling partners have recycled more than 360 million pounds of electronics, including televisions, computers, and cell phones; WaterSense has helped consumers save 46 billion gallons of water and $343 million in water and sewer bills since the program’s inception in 2006; and Green electronics, Green Chemistry and Green Engineering, and the Design for the Environment (DfE) programs have reduced the use of toxic materials in everyday items like computers and household cleaners and give consumers the choice to use safer products since the programs began in 2006, 1995, and 1992, respectively. More than 2,000 products carry the DfE label. EPA has also been working with states, local governments, international organizations, environmental groups, and industry to identify pollution prevention opportunities.

USDA Issues Final Auditing Standard For Genetically Modified Plants: On October 5, 2010, the U.S. Department of Agriculture (USDA) issued a final auditing standard for use by companies and university researchers to assess the risks of growing or transporting genetically modified organisms. 75 Fed. Reg. 61413. USDA’s Animal and Plant Health Inspection Service (APHIS) has been developing the auditing standard to encourage best management practices for agricultural, biotechnology, and other companies and researchers that engineer such organisms. The practices are designed to protect against the release of organisms that can threaten the ability of plants and various agricultural crops to resist pests. The APHIS auditing standard was designed to assist companies and researchers comply with broader APHIS regulations governing the import, interstate movement, and environmental release of the organisms. The auditing standard addresses containment procedures for storing organisms; methods of identifying regulated organisms that are in storage or are being moved; and procedures for monitoring for the accidental release of regulated organisms, according to the agency. The revised APHIS audit standard and other information about the Biotechnology Quality Management System (BQMS) audit programs are available online.

EPA Lays Out Five-Year Plan On Agency Priorities: EPA issued recently its fiscal year (FY) 2011 to 2015 strategic plan, which provides a blueprint for advancing EPA’s mission and Administrator Jackson’s priorities. This plan presents five strategic goals for advancing the Agency’s environmental and human-health mission, accompanied by five cross-cutting fundamental strategies that seek to adapt the EPA’s work inside and outside of the Agency to meet the growing environmental protection needs of the day. The five-year plan includes new benchmarks that track progress against Administrator Jackson’s seven priorities such as taking action to reduce emissions of GHGs and adapt to climate change; protecting America’s waters; increasing the use of smart growth and sustainable development strategies in communities; building and maintaining strong state and tribal partnerships; working for environmental justice; and ensuring that chemical health and safety information is available to the public. The five strategic goals for advancing EPA’s environmental and human-health mission are: taking action on climate change and improving air quality; protecting America’s waters; cleaning up communities and advancing sustainable development; ensuring the safety of chemicals and preventing pollution; and enforcing environmental laws. The Administrator has committed the Agency to pursuing these priorities in the years ahead to fulfill EPA’s mission to protect human health and the environment. In addressing these priorities, EPA will continue to affirm the core values of science, transparency, and the rule of law. EPA sent notification letters to more than 800 organizations and individuals requesting comment on the draft plan. Congress requires all federal agencies to develop a strategic plan covering a five-year period, which is updated every three years. EPA developed the FY 2011-2015 strategic plan after receiving extensive comments from stakeholders and the public. The plan is prepared in accordance with the Government Performance and Results Act of 1993. More information on the strategic plan is available online.