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September 1, 2010

Monthly Update for September 2010

Bergeson & Campbell, P.C.


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 listing under the Toxics Release Inventory (TRI). More information is available online. A more detailed memorandum is available online.

EPA To Convene Public Meeting On HPV Chemicals: On August 23, 2010, EPA announced that it will hold a public meeting to give members of the public an opportunity to comment on a proposed rule under TSCA Section 4(a)(1)(B) entitled “Testing of Certain High Production Volume Chemicals; Third Group of Chemicals.” 75 Fed. Reg. 51734. The proposed rule, when finalized, would require manufacturers, importers, and processors of certain high production volume (HPV) chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate. Opportunity to present oral comment was provided in the proposed rule and in response to that opportunity, a request to present oral comments was received. The meeting will be held on September 9, 2010, from 1:00 p.m. to 4:00 p.m. Please consult the Federal Register for details.

Nine Chemicals Now Subject To New Restrictions Under Amendments To Stockholm Convention: On August 26, 2010, amendments to the Stockholm Convention on Persistent Organic Pollutants (POPs) entered into force and impose new restrictions on the production, trade, and use of nine chemicals. Eight of the chemicals are listed under Annex A of the POPs Convention, and include chlordecone, hexabromobiphenyl, lindane, alpha hexachlorocyclohexane, beta hexachlorocyclohexane, pentachlorobenzene, hexabromodiphenyl ether/ heptabromodiphenyl ether, and tetrabromodiphenyl ether/pentabromodiphenyl ether. Annex A bans the substances for use, import, and export among treaty members. The ninth chemical — perfluorooctane sulfonic acid (PFOS), its salts, and perfluorooctane sulfonyl fluoride — has been added to Annex B of the Convention, subjecting it to restrictions on production and use.

EPA Responds To TSCA Section 21 Petition On Cadmium: On August 30, 2010, EPA agreed to issue a TSCA Section 8(d) rule regarding cadmium and cadmium compounds used in consumer products, especially metal toy jewelry, granting a petition filed by a coalition of environmental groups. In a letter from Assistant Administrator Steve Owens, EPA stated that it is prepared to consider banning or restricting the metal if the Consumer Product Safety Commission (CPSC) does not address consumer uses of cadmium. The letter to the Sierra Club responds to a petition filed on May 28, 2010, by the Sierra Club, the Center for Environmental Health, the Empire State Consumer Project, and Rochesterians Against the Misuse of Pesticides.

EPA Proposes Conditional Registration Of Nanosilver Pesticide Product: 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 hosiery, and outdoor use articles such as sailcloth, tarps, tents, and awnings. According to the August 12, 2010, Decision Document, EPA “views a ‘nanoscale material’ as an active or inert ingredient and any component parts thereof intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.” EPA is proposing to grant a four-year conditional registration under Section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Comments on the proposed conditional registration were due September 11, 2010. A more detailed analysis can be found online.

EPA Denies Petition Calling For Lead Ammunition Ban: On August 27, 2010, EPA denied a petition calling for a ban on the production and distribution of lead hunting ammunition. EPA sent a letter to the petitioners explaining the rejection. The letter is available online. EPA claimed that it is taking action on many fronts to address major sources of lead, however, it was not and is not considering taking action on whether the lead content in hunting ammunition poses an undue threat to wildlife. According to EPA, “[a]s there are no similar jurisdictional issues relating to the agency’s authority over fishing sinkers, EPA — as required by law — will continue formally reviewing a second part of the petition related to lead fishing sinkers.” EPA will consider comments on the fishing tackle issue that are submitted by September 15, 2010.

EPA Announces Web-Distributed Labeling User Acceptance Pilot: On August 18, 2010, EPA’s Office of Pesticide Programs (OPP) announced that it is exploring a new initiative called “web-distributed labeling” that would make the most current version of some pesticide labeling available to users via the Internet. 75 Fed. Reg. 51058. OPP announced its intention to conduct a web-distributed labeling “User Acceptance Pilot” and solicited interest from entities potentially willing to participate in this pilot program. Through the User Acceptance Pilot, EPA intends to demonstrate how users could access labeling information using the Internet, thereby helping EPA determine whether the benefits of web-distributed labeling would be sufficiently appealing to users that they would be willing to visit a website to download and use labeling. The notice provides a brief description of a pilot website and invites participation in developing a pilot web-distributed labeling website by interested parties. Comments must be received on or before September 17, 2010.

EPA Withdraws Two Section 4 Test Rule Proposals: On September 14, 2009, EPA withdrew two proposed rules for which it no longer intends to issue a final rule. 75 Fed. Reg. 55728. EPA published the “Proposed Test Rule for Certain Chemicals on the ATSDR/EPA CERCLA Priority List of Hazardous Substances” for the consideration of testing for four chemicals (chloroethane, hydrogen cyanide, methylene chloride, and sodium cyanide). The chemicals are listed on the Agency for Toxic Substances and Disease Registry (ATSDR)/EPA priority list of hazardous substances which is compiled under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In its proposal, EPA explained that the reason EPA proposed to use its authority under TSCA Section 4 was to support ATSDR’s Substance Specific Applied Research Program, a program for collecting data and other information needed for developing health assessments pursuant to CERCLA. ATSDR had referred the chemicals subject to the proposed rule to EPA under authority of CERCLA Section 104(i). Since then, ATSDR has informed EPA that it no longer needs EPA to finalize this proposed rule. The Office of Pollution Prevention and Toxics (OPPT) withdrew this proposed test rule and removed it from the EPA Semi-Annual Regulatory Agenda.

EPA also withdrew the “Proposed Test Rule for Hazardous Air Pollutants” proposed on June 26, 1996. This document proposed using EPA’s authority under TSCA Section 4 for testing 21 chemicals that are listed as hazardous air pollutants (HAP) under Section 112 of the Clean Air Act (CAA) and solicited proposals for enforceable consent agreements (ECA). EPA’s Office of Air and Radiation (OAR), along with EPA’s Office of Research and Development (ORD), referred the chemicals subject to this proposed rule to OPPT for obtaining certain health effects data to assess the risk remaining after the imposition of technology-based emissions standards required by CAA Section 112(d). OPPT explained that the reason it proposed to use EPA’s authority under TSCA Section 4 was to support OAR and ORD in meeting EPA’s statutory obligation under CAA Section 112(f). After the proposal was issued in 1996, OAR and ORD informed OPPT that they no longer support the need for a final rule. Additionally, OPPT has determined that the record does not address scientific information developed since the original proposal was issued in 1996. OPPT thus withdrew the proposed test rule and removed it from the EPA Semi-Annual Regulatory Agenda.

EPA Launches New Online Discussion Forum For Pesticide Labeling: On September 8, 2010, EPA’s OPP unveiled Enable the Label, an online discussion forum established to facilitate the exchange of information and ideas related to the labeling of pesticides. Initially, it will be used to facilitate a monthly discussion focusing on one or two chapters of the Label Review Manual. Each month several questions will be posed for discussion and participants are welcome to post their thoughts and ideas on the topics and provide feedback on any other subject covered in that month’s chapter. The goal is to improve the clarity and usefulness of the Manual for its users — primarily people who draft, review, or enforce labels in the field. Pesticide manufacturers and their representatives, state pesticide regulators, and pesticide users are expected to be interested in participating in EPA’s new Enable the Label online discussion forum. The inaugural Enable the Label discussion will solicit ideas related to Chapters 1 and 2 of the Manual. Discussion threads covering these chapters will be open for comment and discussion for 30 days. Subsequently, EPA will move through the Manual by individual chapter or small groups of chapters, each open for comment for 30 days. OPP will review comments received and incorporate useful ones into future revisions of the Label Review Manual. For this discussion focusing on the Label Review Manual, EPA is not asking for general discussions on pesticide policy issues. Enable the Label will provide informal comment opportunities to everyone interested in improving the Label Review Manual, and encourage creative solutions to complex pesticide label challenges in an open and transparent environment. To submit comments and comment on others’ ideas, visit EPA’s website online.RCRA/CERCLA

EPA Agrees To Revise Further The RCRA Definition Of Solid Waste: On September 10, 2010, EPA reached agreement with the Sierra Club to propose revisions to the Definition of Solid Waste (DSW) under the Resource Conservation and Recovery Act (RCRA) by June 30, 2011, and to issue a final rule by December 31, 2012Sierra Club v. EPA, D.C. Cir., No. 09-1041. The Sierra Club filed suit in the U.S. Court of Appeals for the District of Columbia Circuit, seeking judicial review of EPA’s October 30, 2008, final rule. The Sierra Club alleged the exemptions in the final rule exceeded EPA’s authority and likely would lead to “sham” recycling at facilities located disproportionately near low-income and minority communities.

How EPA regulates when a recycled material is a hazardous waste under RCRA has been a hotly debated issue for decades. EPA first promulgated its regulatory program for determining when a recycled material is a solid (and thus, potentially hazardous) waste under RCRA in 1985. The DSW provisions are complex, controversial, and carry significant regulatory impact. In the more than two decades since EPA issued the DSW rule, EPA has revised the rule several times and the regulations have been the subject of numerous suits.

This attention and scrutiny given the rule by the regulated community, environmentalists, and other stakeholders underscore the rule’s importance. A material that is recycled in a manner that is excluded by EPA is not a solid waste and thus cannot be a hazardous waste under RCRA. By contrast, a material that is recycled in a way that is not excluded is a solid waste and thus may be subject to RCRA’s stringent and costly controls. The DSW provisions thus impact tens of thousands of businesses that generate hazardous waste or that recycle potentially hazardous waste.

EPA last revised the DSW rule on October 30, 2008, in the waning days of the Bush Administration. 73 Fed. Reg. 64668. That rule excludes from the RCRA DSW materials that are:

  • Generated and legitimately reclaimed under the control of the generator (“generator-controlled exclusion”);
  • Generated and transferred to another company for legitimate reclamation under specific conditions (“transfer-based exclusion”); or
  • Determined by EPA or an authorized state to be non-wastes on a case-by-case basis via a petition process.

The rule also contains a provision to determine whether recycling activities are legitimate under the new exclusions and non-waste determinations. To be excluded under the revised DSW, hazardous secondary materials must be legitimately reclaimed and must meet the conditions of the exclusions. Certain of these conditions require the recycled material to be contained properly, although the rule does not specify containment units or practices.

This rule generated significant controversy. Environmental groups were particularly concerned about the rule’s provisions that would exclude certain materials destined for recycling and that are contained in units that do not meet RCRA’s stringent standards for release prevention. Shortly after EPA promulgated the rule, Earthjustice, on behalf of the Sierra Club, filed suit over the rule in the U.S. Court of Appeals for the District of Columbia Circuit, alleging the exemptions exceeded EPA’s authority and likely would lead to “sham” recycling at facilities located disproportionately near low-income and minority communities. Several industry groups also filed suit over the rule’s provisions, although their arguments generally centered on EPA’s failure to exclude a broader universe of materials. The court eventually consolidated these cases in Sierra Club v. EPA, Case No. 09-1041.

After the Obama Administration came into office, EPA announced its intent to review the DSW’s provisions governing how regulated entities should contain recyclable materials. EPA also issued a draft methodology on environmental justice to determine how the rule would impact low-income and minority communities. But EPA did not commit to initiating a formal rulemaking on the rule. Environmentalists thus continued to pressure the Agency on what they deemed as necessary changes to the rule.

EPA and environmentalists now have reached agreement that the Agency will issue proposed changes to the rule. On September 10, 2010, EPA and the Sierra Club filed a joint brief asking the court to sever the Sierra Club from the case. The industry groups involved in the case have either taken no position on the settlement or opposed it.

Under the settlement, EPA has agreed to issue a notice of proposed rulemaking (NPRM) that will address the issues raised in the Sierra Club’s lawsuit by June 30, 2011. These include issues raised by EPA in a May 27, 2009, Federal Register notice. 74 Fed. Reg. 25200. Specifically, the NPRM will address the definition of “contained,” notification requirements for entities claiming that they are recycling their wastes in an excluded manner, the definition of legitimate recycling, and the merits and legality of the transfer-based exclusion. The settlement states that EPA will issue a final rule by December 31, 2012.

This settlement will not quiet the dispute and controversy surrounding the DSW. As noted above, the settlement does not resolve the pending industry suits over the October 2008 rule. The industry groups that are still involved in the litigation over the rule include the American Petroleum Institute (API), the Environmental Technology Council, Inc., the Metals Industry Recycling Coalition, the Alliance of Automobile Manufacturers, the American Chemistry Council, the American Coke and Coal Chemicals Institute, the American Forest and Paper Association Inc., the American Coatings Association (formerly the National Paint & Coatings Association), the Society of Chemical Manufacturers and Affiliates (formerly the Synthetic Organic Chemical Manufacturers Association, Inc.), the Treated Wood Council, the Utility Solid Waste Activities Group, the Edison Electric Institute, the National Rural Electric Cooperative Association, the American Gas Association, and the National Mining Association.

Moreover, this settlement is expected to exacerbate the uncertainty within the regulated community regarding when a recycled material is a solid and potentially hazardous waste under RCRA. Under RCRA, states are authorized to implement the program in lieu of EPA, and only a handful of states lack this authority. Few RCRA-authorized states have adopted the provisions of the October 2008 rule, largely because of the likelihood that the legal challenges against the rule would yield additional changes. Those businesses that thus would benefit from the rule’s changes must continue to wait and see how the debate is decided. Twenty-five years after the DSW was first issued, controversy and confusion continue to reign over whether a recycled material is a waste.CAA/CWA

EPA Releases Draft Strategy For Clean Water: On August 20, 2010, EPA invited the public to comment on its draft strategy to protect and restore the nation’s lakes, streams, and coastal waters. The strategy, Coming Together for Clean Water: EPA’s Strategy for Achieving Clean Water, is designed to chart EPA’s path in protecting America’s waters. The strategy was developed by considering the input and ideas generated at the April “Coming Together for Clean Water” forum as well as comments received through the online discussion forum. Participants shared their perspectives on how to advance EPA’s clean water agenda focusing on the Agency’s two priority areas: healthy watersheds and sustainable communities. Public comments on the draft strategy are due by September 17, 2010. More information on the draft strategy and to comment is available online.

EPA Requests Information From Companies About Chemicals Used In Natural Gas Extraction: On September 9, 2010, EPA announced that it has issued voluntary information requests to nine natural gas service companies regarding the process known as hydraulic fracturing. The data requested are part of a broad scientific study now underway by EPA, to determine whether hydraulic fracturing has an impact on drinking water and the public health. EPA seeks information on the chemical composition of fluids used in the hydraulic fracturing process, data on the impacts of the chemicals on human health and the environment, standard operating procedures at their hydraulic fracturing sites and the locations of sites where fracturing has been conducted. EPA is also holding a series of public meetings in major oil and gas production regions to hear from the public, independent experts, and industry. The initial results of the study will be announced in late 2012. EPA will identify additional information for industry to provide — including information on fluid disposal practices and geological features — that will help EPA carry out the study. EPA has requested the information be provided on a voluntary basis within 30 days, and has asked the companies to respond within seven days to inform EPA whether they will provide all of the information sought. The data being sought by EPA are similar to information that has already been provided separately to Congress by the industry. The letter on the voluntary information request is available online.REACH

Chemical Names May Be Kept Confidential In The C&L Inventory: The European Chemicals Agency (ECHA) issued an August 13, 2010, a news alert regarding the confidentiality of the International Union of Pure and Applied Chemistry (IUPAC) names in the Classification and Labeling (C&L) Inventory. For all hazardous substances and all non-hazardous substances subject to registration that are placed on the market on or after December 1, 2010, notifications to the C&L Inventory are due January 3, 2011, or one month after placing the substance on the market. For each substance, information on the classification and labeling will be published. According to ECHA, the IUPAC name can be considered confidential, and thus not be published in the C&L Inventory, in the following cases:

  • Non-phase in substances; or
  • Substances only used as one or more of the following:
    • As intermediates;
    • In scientific research and development; or
    • In product and process oriented research and development.

More information is available online.

ECHA Requests That Notifiers Include Analytical Information And Spectral Data In Their Updated Registration Dossiers: ECHA requested in an August 25, 2010, news alert that companies who notified substances under Directive 67/548/EEC include in any updated registration dossier, submitted in accordance with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), “the appropriate analytical information and spectral data necessary to identify the substance.” Under Directive 67/548/EEC, notifications were made using the Summary Notification Interchange Format, which did not allow for the inclusion of attachments such as analytical information and spectral data, and thus this information could not be migrated into the International Uniform Chemical Information Database (IUCLID) format. Consequently, ECHA is inviting former notifiers under Directive 67/548/EEC to attach manually the analytical information and spectral data into Section 1.4 of their IUCLID substance dataset when they update the registration dossier. Such information is necessary to allow for the verification of substance identity. More information is available online.

ECHA Holds Webinar To Help Companies Prepare REACH-IT Dossiers: ECHA held a webinar on September 8, 2010, on how to be more effective when working with REACH-IT, in particular how to pass the “business rules.” ECHA provided advice on how to register successfully, using examples of common mistakes and how these can be avoided. ECHA has provided a recording of the webinar on its website. More information is available online.

EU Agency Seeks Comment On Ten Chemicals, One Group For “Very High Concern” Listing: On August 30, 2010, ECHA requested comments on whether ten industrial chemicals and one group of chemicals nominated by Austria, Germany, and the Netherlands should be considered potential substances of very high concern. The chemicals are: 1,2,3-trichlorobenzene; 1,2,4-trichlorobenzene; 1,3,5-trichlorobenzene; cobalt(II) sulfate; cobalt(II) dinitrate; cobalt(II) carbonate; cobalt(II) diacetate; 2-methoxyethanol; 2-ethoxyethanol, chromium trioxide; and a family of acids generated from chromium trioxide and their oligomers. Additional information about the nominated chemicals is available online, which has a link to comment on whether they should be placed on the Candidate List.NANOTECHNOLOGY

ISO Issues Report Describing Nanomaterials Classification: On August 17, 2010, the International Organization for Standardization (ISO) published a technical report describing a way to classify nanomaterials according to their size, chemical nature, properties, and characteristics. The document, Nanotechnologies – Methodology for the Classification and Categorization of Nanomaterials (ISO/TR 11360), was spearheaded by Iran’s Nanotechnology Standardization Committee through ISO’s Committee on Nanotechnologies (TC 229). The classification system called the “nano-tree” distinguishes nanomaterials based on different structures or properties. For example, nanomaterials could be classified based on their optical, electrical, and magnetic properties. A description of the report is available online, which has links to purchase the document.

FDA Will Hold Public Workshop On Medical Devices And Nanotechnology: On September 23, 2010, the U.S. Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these topics and requests comments on a number of related questions. The workshop is open to the public, and the deadline for registration is September 15, 2010. Space availability permitting, on-site registration will be available on a first come first serve basis. Comments must be submitted by September 15, 2010, to be considered for the workshop discussion. All other comments are due October 22, 2010.LEGISLATIVE DEVELOPMENTS

The Restoration Of The Chesapeake Bay And Tributaries: Congress, the Executive Branch of the federal government, state governments, and farmer/constituents are all becoming involved in the effort to act on the strategy of the Obama Administration to restore the Chesapeake Bay and its tributaries. The federal and state agencies are working on plans to comply with federal water quality standards by first 2017, and then by 2025. EPA has indicated that 60% of the actions needed to be compliant should be in place by 2017, with the final needed reductions in the annual nutrient pollution levels achieved by 2025. EPA is presently developing a total maximum daily load (TMDL) for the Bay and its tributaries, and determining the share of the load to be borne by each state. That determination is expected in draft form by September 24, and in final by year-end. Six states and the District of Columbia combine to form the Chesapeake Bay Watershed. All but the State of Virginia submitted draft plans on or before the deadline of September 1, 2010, that EPA had set for achieving the needed reductions. The plans, however, differed in many respects, according to published sources. For example, Pennsylvania indicated that it was working toward the 2025 goal and was making significant progress in reducing nitrogen and phosphorus levels in Pennsylvania waters, while still needing to make additional reductions of almost 30 million pounds for nitrogen and 1.2 million pounds for phosphorus. Millions of pounds of reductions in sediment are also needed. Maryland said it hoped to meet the standards set by EPA five years early, in 2020. New York argued about the treatment being accorded each of the states, claiming that the allocations to each state lacked fundamental fairness and assigned a disproportionate share of the needed reductions to the Empire state.

Actions in the Senate and the House of Representatives mirror the lack of agreement on how to proceed to restore the watershed. Senator Ben Cardin (D-MD) has offered a substitute for the bill that was reported out of the Environment and Public Works Committee. The substitute is intended to answer objections raised with the measure and help ensure passage of a bill that would broaden EPA authority to regulate the watershed. Critics of the compromise, such as Riverkeeper chapters, point to the perceived weakening of the Clean Water Act (CWA) by creating a category of pollution that would be considered de minimis and not needing a discharge permit. Bearing on what EPA is already doing, the Cardin measure would drop the term TMDL and replace it with a new description, waste load and load allocation, said by opponents to be a non-specific concept difficult to enforce. The bill, the amended Chesapeake Clean Water and Ecosystem Restoration Act, would also eliminate a concept in the original bill borrowed from the CAA, in the form of a provision authorizing EPA to take over a state plan if the state repeatedly failed to meet water quality goals. Even with the several key changes from the measure reported out of Committee, farmers, developers, builders and some state agencies still oppose the bill as reposing unlimited new authority in EPA. One of the strongest opponents is the farm bloc, which is supporting legislation in the House of Representatives sponsored by Representatives Bob Goodlette (R-VA) and Tim Holden (D-PA). Their bill would supplant EPA regulation of agricultural activities in the watershed by setting up, among other provisions, an Independent Evaluation and Technical Advisory Committee for Chesapeake Bay Program, with the Department of Agriculture serving as the administering agency for the Committee.

Measure Would Provide Incentives For Purchase Of Plug-In Vehicles: Senator Debbie Stabenow (D-MI) on August 5 introduced S. 3715, a measure to amend the Internal Revenue Code of 1986 to modify certain tax incentives for alternative vehicles by extending and increasing the so-called new qualified hybrid motor vehicle credit and increasing the alternative fuel vehicle refueling property credit for charging devices designed to recharge a motor vehicle propelled by electricity. Among other provisions, the bill would also establish a battery insurance program within the Department of Energy.MISCELLANEOUS

DOT Amends Drug Testing Requirements: On August 16, 2010, the U.S. Department of Transportation (DOT) issued a final rule amending the procedures for transportation workplace drug and alcohol testing programs. 75 Fed. Reg. 49850. The final rule amends 49 C.F.R. Part 40, which establishes regulations and procedures for any entity required to conduct drug tests under DOT’s regulatory programs. The changes, which are effective on October 1, 2010, amend DOT’s drug testing procedures dealing with laboratory testing of urine specimens. Some of the changes will also affect the training of and procedures used by Medical Review Officers (MRO). Under the Omnibus Transportation Employees Testing Act (Omnibus Act), DOT is required to follow the Health and Human Services (HHS) requirements for drug testing procedures and protocols. The August 16 final rule changes are intended to bring DOT’s testing requirements in line with those of HHS. Among other things, the rule will require testing for the drug Ecstasy, lower cutoff levels for cocaine and amphetamines, and require mandatory initial testing for heroin. The rule also requires each MRO to be re-qualified — including passing an examination given by an MRO training organization — every five years.

DOT Proposes To Harmonize Air And Marine Transport Regulations With International Standards: On August 24, 2010, DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a proposed rule seeking to harmonize the Hazardous Materials Regulations (HMR) with international standards. 75 Fed. Reg. 52069. The proposal revises several proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. PHMSA states that these revisions are necessary for the HMRs to be consistent with recent changes made to the International Maritime Dangerous Goods Code (IMDG), the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI), and the United Nations Recommendations on the Transport of Dangerous Goods — Model Regulations. Comments on the proposed changes must be submitted to PHMSA by October 25, 2010. A more detailed memorandum is available online.

OSHA Hosting Internet Forum To Identify Hazardous Chemicals That Warrant Exposure Reduction Strategies: The Occupational Safety and Health Administration (OSHA) hosted an Internet forum that began on August 16 and ran 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 that many of the Permissible Exposure Limits (PEL) currently in effect for workplace chemicals have remained unchanged for years. During its first two years of existence, OSHA established approximately 400 PELs, but has only developed 29 since then. OSHA said that it “realizes the inadequacy of many of its PELs and is seeking creative solutions, both long term and short term, to address this inadequacy.” The forum thus is OSHA’s initial step for addressing these “inadequacies.” OSHA is soliciting input from the regulated community and other stakeholders to identify the chemicals of concern on which OSHA can focus its initial efforts beyond those which OSHA is already addressing through ongoing rulemaking. OSHA is asking interested parties to nominate those chemicals for which the existing PEL is particularly inadequate or for which OSHA has no standard at all, and “that are putting workers at risk for occupational illness.” Interested parties are asked to complete a nomination form online. Nominations were accepted until August 27. OSHA asks that when nominating a particular chemical, parties should include the criteria used for selecting that chemical for nomination (e.g., the OSHA PEL is inadequate, there is widespread use of the chemical and potential worker exposure). This forum is a significant and innovative step in the revision of existing PELs or creation of new PELs, and reflects the Administration’s commitment to diminishing worker exposure to chemicals that has been so evident in measures related to reform of TSCA (see online). Through this forum, OSHA is asking interested parties to, at least in part, help set its regulatory agenda. OSHA intends to use the chemicals nominated through this Internet forum as its list of chemicals upon which it will prioritize its actions. Clients and friends should monitor the forum closely, paying particular attention to the nomination of chemicals that are routinely used in the workplace or otherwise of interest.

Public Consultations Begin On Proposals For Harmonization Of The Classification And Labeling Of Four Substances: On August 20, 2010, the public consultations on Germany’s proposals for harmonization of the classification and labeling began for 2-ethoxyethanol; reaction mass of 2,4,4-trimethylpent-1-ene and 2,4,4-trimethylpent-2-ene; and vinyl acetate. Comments on these substances are due October 4, 2010. On August 27, 2010, the public consultation began for the United Kingdom (UK) and the Netherlands’ proposal for indoxacarb and indoxacarb (enantiomeric reaction mass S.R. 75:25), and comments are due October 11, 2010. Under the Classification, Labeling, and Packaging (CLP) regulation, individual European Union (EU) member states and industry may propose harmonization of the classification and labeling of substances. ECHA publishes the proposals for comment. The proposals are available online.

ATSDR Announces Availability Of Draft Toxicological Profile: On August 26, 2010, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability for review and comment of a new draft toxicological profile on unregulated hazardous substances that was prepared for the Department of Defense (DOD). 75 Fed. Reg. 52535. All toxicological profiles issued as “Drafts for Public Comment” represent ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. ATSDR seeks public comment and additional information or reports on studies about the health effects of royal demolition explosive (RDX), chemical name hexahydro-1,3,5-trinitro-1,3,5-triazine, also known as cyclonite, for review and potential inclusion in the profile. Comments on this draft toxicological profile must be received no later than November 19, 2010.

UK Advisors Release Guidance On Substitution Of Chemicals: On August 26, 2010, a British government advisory group issued guidance for companies seeking to replace a chemical, a manufacturing process, or a product with an equivalent that is better for human health or the environment. The UK Chemicals Stakeholder Forum, which advises the Department of Environment, Food, and Rural Affairs (DEFRA) on ways manufacturers can reduce risks from hazardous chemicals, published the A Guide to Substitution. The guide takes a broad view of substitution. It discusses not only “substance for substance” substitution, in which a less toxic chemical serves as alternative to a more toxic one, but also alternative manufacturing processes, product designs, and “service for product” approaches to encourage sustainable business operations. Specific examples of each type of substitution are provided. A Guide to Substitution is available online.

President Obama Appoints EPA Region 4 Administrator: On September 1, 2010, the White House announced the President’s appointment of Gwen Keyes Fleming as the Administrator for EPA’s Region 4. Keyes Fleming has more than 15 years experience as a prosecutor and administrator. For the past five years, she has served as the district attorney in Georgia’s Stone Mountain Judicial Circuit, which encompasses DeKalb County, according to EPA. She is the first African American and the first woman to have held this position. Prior to serving as district attorney, Keyes Fleming was the county’s elected solicitor-general, where she handled misdemeanors and implemented domestic violence-prevention initiatives.

EPA Issues Draft Guidance For Medical Professionals: On September 8, 2010, EPA issued draft guidance for medical professionals on the handling of unused pharmaceuticals. 75 Fed. Reg. 54627. The guidance, Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, is targeted at hospitals, medical clinics, doctors’ offices, long-term care facilities, and veterinary facilities and aims to keep the drugs from being discharged into water bodies. The guidance describes techniques for reducing or avoiding pharmaceutical waste; practices for identifying and managing types of unused pharmaceuticals; and applicable disposal regulations. EPA has been studying unused pharmaceutical disposal practices at health care facilities, prompted by the concern that large amounts of pharmaceuticals are being flushed or disposed down the drain, ultimately ending up in rivers, streams, and coastal waters. EPA stated it hopes that the guidance document will help reduce the amount of pharmaceuticals discharged to water bodies. In August 2009, the National Association of Counties passed a resolution that says pharmaceuticals are an emerging environmental contaminant that can be detected in surface waters around the United States and in the drinking water of 24 major metropolitan areas affecting 41 million Americans. Some of the pharmaceuticals may enter the environment by passing through human bodies, the resolution says, but disposal of medicines “by flushing into wastewater or disposal in the solid waste stream contributes to contamination.” The guidance document Best Management Practices for Unused Pharmaceuticals at Health Care Facilities is available online. Comments are due by November 8, 2010.

National Conversation Draft Work Group Reports Available For Comment: On September 7, 2010, the Centers for Disease Control and Prevention (CDC) announced that the National Conversation on Public Health and Chemical Exposures draft Work Group reports are available for public comment. The National Conversation is a collaborative initiative supported by CDC and ATSDR through which many organizations and individuals are “helping develop an action agenda for strengthening the nation’s approach to protecting the public’s health from harmful chemical exposures.” Six Work Group reports are posted, one on each of the following “cross-cutting public health and chemical exposures topics”:

  • Monitoring — The Monitoring Work Group is focused on facilitating the collection, analysis, and interpretation of information on chemicals, including their sources, uses, exposure, and associated health outcomes.
  • Scientific Understanding — The Scientific Understanding Work Group is focused on filling knowledge gaps on the health effects of chemicals.
  • Policies and Practices — The Policies and Practices Work Group is focused on “reducing harmful chemical exposures and adverse health outcomes, eliminating inequities, and spurring the development and use of safer alternatives.”
  • Chemical Emergencies — The Chemical Emergencies Work Group is focused on preventing, preparing for, responding to, and recovering from acute chemical incidents.
  • Serving Communities — The Serving Communities Work Group is focused on addressing local chemical exposure concerns to promote environmental justice and improve health.
  • Education and Communication — The Education and Communication Work Group is focused on ensuring a well-informed public and a competent network of health care providers.

Comments on the draft Work Group reports are due September 20, 2010. Following the public comment period, National Conversation Work Groups will prepare their final reports. The National Conversation Leadership Council will draw on Work Group reports, as well as the results of public input received through other forums in authoring the action agenda. The Leadership Council’s draft action agenda will be available for public comment in December 2010. Final Work Group reports, including recommendations, will be appended to the action agenda. The draft Work Group reports are available online.