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Monthly Federal Developments Memorandum
August 1, 2010

Monthly Update for August 2010

Bergeson & Campbell, P.C.

TSCA/FIFRA/NTP/EPCRA

EPA And Other Federal Agencies Collaborate To Improve Chemical Screening: On July 19, 2010, the U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center (NCGC) announced the addition of the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration enables federal agencies to develop ways to predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to predict better how chemicals may affect humans. FDA will provide additional expertise and chemical safety information to improve current chemical testing methods. FDA will collaborate with other Tox21 members to prioritize chemicals that need more extensive toxicological evaluation, and develop models that can better predict human response to chemicals. EPA contributes to Tox21 through the ToxCast program and by providing chemicals and additional fast, automated tests to NCGC. ToxCast currently includes 500 chemical screening tests that have assessed over 300 environmental chemicals. A major part of the Tox21 partnership is the robotic screening and informatics platform at NCGC that uses fast, automated tests to screen thousands of chemicals a day for toxicological activity in cells. More information on the Tox21 collaboration is available online; ToxCast is available online; NTP is available online; NCGC is available online; and FDA is available online.

Elemental Mercury Used In Flow Meters, Natural Gas Manometers, And Pyrometers; Significant New Use Rule: On July 21, 2010, EPA issued a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for elemental mercury for use in flow meters, natural gas manometers, and pyrometers, except for use in these articles when they are in service as of September 11, 2009. 75 Fed. Reg. 42330. EPA believes the use of mercury in this application has ceased. The rule requires persons who intend to manufacture, including import, or process elemental mercury for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. Persons subject to the provisions of this rule will not be exempt from significant new use reporting if they import into the United States or process elemental mercury as part of an article. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule is effective August 20, 2010.

EPA Issues Sixty-Sixth Report Of The TSCA Interagency Testing: On July 21, 2010, EPA announced that the TSCA Interagency Testing Committee (ITC) transmitted its Sixty-Sixth Report to the Administrator of EPA on June 3, 2010. 75 Fed. Reg. 42441. In the Sixty-Sixth ITC Report, the ITC did not make any changes to the TSCA Section 4(e) Priority Testing List. Comments must be received on or before August 20, 2010.

NTP Announces Appointment Of Dr. Christopher Portier: On July 22, 2010, NTP announced the appointment of Dr. Christopher Portier as Director of the Centers for Disease Control and Prevention (CDC) National Center for Environmental Health and Administrator of the Agency for Toxic Substances and Disease Registry (NCEH/ATSDR). Dr. Portier began his new position at CDC effective August 1, 2010. The NCEH/ATSDR is an NTP-participating agency with membership on the NTP Executive Committee. More information about Dr. Portier is available online.

D.C. Court Announces Decision In NCGA v. EPA: The D.C. Circuit issued in National Corn Growers Ass’n. v. EPA its decision regarding EPA’s revocation of the tolerances for carbofuran. Petitioners challenged EPA’s denial of a hearing under the Federal Food, Drug, and Cosmetic Act (FFDCA) on factual issues arising in connection with the revocation of tolerance and import tolerances. The court concurred with petitioners that EPA’s revocation of the import tolerances was arbitrary and capricious, and ordered EPA to reinstate the import tolerances for rice, bananas, coffee, and sugar cane. Importantly, the court upheld EPA’s decision to deny a hearing on the tolerance revocation on the ground that petitioners were not permitted to raise arguments in their objections and hearing request that had the court considered new and not been raised during the informal rulemaking stage of the tolerance revocation process. Petitioners have not yet determined whether to seek rehearing or certiorari.

EPA Publishes Latest Data On Industrial And Toxics Release Inventory: EPA released the latest data on industrial releases and transfers of toxic chemicals in the United States between January 1 and December 31, 2009, on July 28, 2010. EPA made the Toxics Release Inventory (TRI) data available within weeks of the reporting deadline through its website, TRI Explorer and Envirofacts. The database contains environmental release and transfer data on nearly 650 chemicals and chemical categories reported to EPA by more than 21,000 industrial and other facilities. TRI includes manufacturing, metal mining, electric utilities, and commercial hazardous waste treatment facilities, among others. Facilities must report their data by July 1 of each year. The preliminary dataset includes more than 80 percent of the data expected to be reported for 2009. EPA intends to update the dataset in August and again in September. More information on the data is available online.

Court Finds EPA’s Position That It May Use Misbranding Actions To Enforce Reregistration Determinations To Be Final And Ripe For Review: On July 16, 2010, a three judge panel for the U.S. Court of Appeals for the District of Columbia Circuit issued a unanimous decision in Reckitt Benckiser v. EPA (No. 09-1314), finding that the EPA’s May 28, 2008, threat to implement its final risk mitigation decision for ten rodenticides (RMD) by enforcement actions for “misbranding” is “sufficiently final agency action ripe for review.” The court states that the U.S. District Court for the District of Columbia, where the case originated, has jurisdiction concerning the EPA misbranding threat pursuant to Section 16(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and reversed and remanded the lower court’s decision. Lynn L. Bergeson and Timothy D. Backstrom were on the brief for amici curiae in support of Reckitt Benckiser (Reckitt). The court’s decision is available online. A more detailed discussion of the decision is available online.

EPA Issues Final Test Guidelines For Skin-Applied Insect Repellents: On August 6, 2010, EPA announced the availability of the final test guidelines for Product Performance of Skin-applied Insect Repellents of Insect and Other Arthropods, Test Guidelines OPPTS No. 810.3700. 75 Fed. Reg. 47592. Among other additions, the guidelines contain a section addressing the ethical considerations affecting the design and conduct of repellent studies when human subjects are involved.

EPA Adjusts Pesticide Registration Improvement Act (PRIA) Fees: In accordance with FIFRA Section 33, EPA published a revised list of pesticide registration service fees applicable to specified pesticide registration applications and tolerance actions. The new fees become effective on October 1, 2010. Registration service fees for applications received on or after October 1, 2010, increase by 5 percent (rounding up to the nearest dollar) from the fees published for fiscal year (FY) 2009 and 2010. The review times, or the amount of time that EPA has to make a decision on an application, will be the same as FY 2010.

EPA Issues Proposed IUR Modifications Rule: On August 13, 2010, EPA published a proposed Inventory Update Reporting (IUR) rule, which would require electronic reporting and expanded manufacturing, processing, and use information. 75 Fed. Reg. 49655. According to EPA, the electronic reporting requirement would make reporting easier and more accessible to all potential reporters. EPA has also proposed changes to specific data elements, including the addition of other production-volume data that would require production volume for all years since the 2006 reporting year. The proposed rule would also require a greater amount of substantiation for confidential business information (CBI) claims. Under the proposed rule, inorganic chemicals would no longer be partially exempt. EPA states that the partial exemption “was a one-time exemption for 2006 reporting only.” EPA intends to issue a final rule in time for the next reporting period, which is scheduled for June 1-September 30, 2011. Comments on the proposed rule are due October 12, 2010. More information is available online.

RCRA/CERCLA

EPA Publishes Notice Regarding Export Of Certain Wastes: On July 30, 2010, EPA published a Federal Register notice to inform “affected businesses” about Freedom of Information Act (FOIA) requests received by EPA for documentation received or issued by EPA or data contained in EPA database systems pertaining to the export and import of Resource Conservation and Recovery Act (RCRA) hazardous waste from/to the United States, the export of cathode ray tubes (CRT) and Spent Lead Acid Batteries (SLAB) from the United States, and the export and import of RCRA universal waste from/to the United States. 75 Fed. Reg. 44951. EPA notes that these documents and data may identify or reference multiple parties, and describe transactions involving the movement of specified materials in which the parties propose to participate or have participated. EPA states that the purpose of its notice is to provide the affected businesses with the opportunity to assert claims that any of the information sought that pertains to them is entitled to treatment as CBI, and to send comments to EPA supporting their claims for such treatment. Comments are due August 30, 2010.

Court Affirms EPA’s Interpretation That Used Solvent Is RCRA Waste: On August 6, 2010, the U.S. Court of Appeals for the D.C. Circuit determined that solutions of liquid potassium hydroxide (KOH) used by Howmet Corporation to clean metal casings qualify as “spent material” under RCRA Subtitle C, and are subject to hazardous waste regulations. Howmet Corp. v. EPA, D.C. Cir., No. 09-5360 (Aug. 6, 2010). Howmet argued that liquid KOH did not have one “purpose” as defined by RCRA and could be used as a solvent and a fertilizer ingredient without qualifying as a spent material. The court disagreed, and upheld a 2009 ruling by the U.S. District Court for the District of Columbia that granted summary judgment in favor of EPA. Though the phrase “purpose for which it is produced” is not adequately defined in EPA regulations, the D.C. Circuit decision agreed with EPA’s interpretation of the statute as referring to the “original use” of a product. In a dissenting opinion, Judge Brett Kavanaugh stated EPA’s interpretation of “purpose” as the original use only “mangles the language” of RCRA and is “flatly inconsistent” with the law. The liquid KOH could have multiple purposes as argued by Howmet. The U.S. Court of Appeals for the District of Columbia Circuit’s decision in Howmet Corp. is available online.

CAA/CWA

Obama Administration Adopts New Policy To Protect Oceans: On July 19, 2010, the Obama Administration adopted recommendations by a federal task force for protecting the nation’s oceans, coasts, and the Great Lakes and created a national council to implement a new oceans policy. According to the Council on Environmental Quality (CEQ), the national policy identifies coastal and marine spatial planning as a priority. It would be regional in scope, developed cooperatively among federal, tribal, and local authorities, and include substantial stakeholder, scientific, and public input. “Spatial planning” refers to the process of deciding what activities are suitable for specific areas along the nation’s oceans, coasts, and Great Lakes. The policy was recommended by the Interagency Ocean Policy Task Force. The policy is intended to provide a framework for providing high-level direction and policy guidance from a clearly designated and identifiable authority, according to CEQ. The new U.S. policy is intended to: protect, maintain, and restore the health and biological diversity of ocean, coastal, and Great Lakes ecosystems and resources, as well as to improve their resiliency; bolster conservation and sustainable uses of land in ways that will improve the health of ocean, coastal, and Great Lakes ecosystems; use the best available science and technology to inform decisions; and improve understanding and awareness of changing environmental conditions, trends, and their causes and of human activities in ocean, coastal, and Great Lakes waters.

The National Ocean Council is charged with developing action plans for each objective. The heads of CEQ and the White House Office of Science and Technology Policy are co-chairs of the Council, which includes representatives from more than a dozen federal agencies. Under the framework, which articulates goals and principles, the United States will be subdivided into nine regional planning areas. Each region will have a corresponding regional planning body consisting of federal, state, and tribal representatives to develop regional goals, objectives, and ultimately regional coastal and marine spatial plans. The framework describes an implementation approach that maximizes flexibility among the regions, addresses capacity, and aims to have coastal and marine spatial plans for all regions by 2015, the task force recommendations said. The recommendations were outlined in the report entitled Final Recommendations of the Interagency Ocean Policy Task Force, released by CEQ. The White House Executive Order establishing an oceans policy is available online. Final Recommendations of the Interagency Ocean Policy Task Force is available online. The recommendations are not designed to establish new regulations, but rather to outline how coordination can be improved, Nancy Sutley, Chair of the CEQ, stated, noting that they were developed following an extensive public comment process. The final recommendations come at a time when national concern over conserving ocean and coastal resources has heightened in the wake of the Gulf of Mexico oil spill.

EPA Issues Notice Of Proposed Rulemaking For Regulation Of Fuels And Fuel Additives: On July 20, 2010, EPA issued notice of its intent proposing annual standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and renewable fuels that apply to all gasoline and diesel produced or imported in FY 2011. 75 Fed. Reg. 42238. Under Clean Air Act (CAA) Section 211(o), as amended by the Energy Independence and Security Act of 2007 (EISA), EPA is required to set the renewable fuel standards each November for the following year based on gasoline and diesel projections from the Energy Information Administration (EIA). Additionally, EPA is required to set the cellulosic biofuel standard each year based on the volume projected to be available during the following year, using EIA projections and assessments of production capability from industry. The action also presents two proposed changes to the Renewable Fuel Standard (RFS2) regulations. The first would create a temporary and limited means for certain renewable fuel producers to generate delayed Renewable Identification Numbers (RIN) after they have produced and sold renewable fuel. This proposed provision would apply only to those producers who use canola oil, grain sorghum, pulpwood, or palm oil to produce renewable fuel. The second proposed regulatory provision would establish criteria for foreign countries to adopt an aggregate approach to compliance with the renewable biomass provision akin to that applicable to the U.S. Comments must be received on or before August 19, 2010.

EPA Agrees To Modify Reporting Rule For Chemicals, Fertilizer, Refining Sectors: On July 20, 2010, petitioners and EPA reached a settlement of a lawsuit filed in the U.S. Court of Appeals for the District of Columbia Circuit challenging EPA’s reporting requirements pertinent to greenhouse gas (GHG) emissions reporting in October 2009. 75 Fed. Reg. 42085. The rule applies to sources that emit more than 25,000 metric tons of carbon dioxide-equivalent GHGs. Facilities covered by that rule had to begin measuring emissions January 1, 2010, and must file their first reports by March 31, 2011. Eight lawsuits were filed challenging the rule. All were consolidated under a suit filed by the American Chemistry Council (ACC). Under the settlement, the cases will be largely dismissed, and EPA will make changes to monitoring and reporting requirements as described in the notice. Comments on the settlement are due by August 19, 2010.

EPA Proposes Spill Prevention, Control, And Countermeasure Rule Amendments: On August 3, 2010, EPA proposed to amend the date by which certain facilities must prepare or amend their Spill Prevention, Control, and Countermeasure (SPCC) Plans, and implement those Plans. 75 Fed. Reg. 45572. The action would allow additional time for those affected in the regulated community to understand the revisions to the SPCC rule finalized in December 2008 and November 2009. In light of the recent uncertainty surrounding EPA’s review of the final amendments to the December 2008 rule and the delay of that rule’s effective date, EPA proposed to provide an additional year for certain facilities, with a new compliance date of November 10, 2011. EPA is not proposing to extend the compliance date for drilling, production, and workover facilities that are offshore or that have an offshore component, or for onshore facilities required to submit Facility Response Plans (FRP). Comments on the proposed rule must be received by August 18, 2010.

EPA Proposes Mandatory Reporting Of GHGs: On August 11, 2010, EPA proposed to amend specific provisions in the GHG reporting rule to clarify certain provisions, to correct technical and editorial errors, and to address certain questions and issues that have arisen since promulgation. 75 Fed. Reg. 48744. The proposed changes include providing additional information and clarity on existing requirements, allowing greater flexibility or simplified calculation methods for certain sources in a facility, amending data reporting requirements to provide additional clarity on when different types of GHG emissions need to be calculated and reported, clarifying terms and definitions in certain equations, and technical corrections. Comments must be received on or before September 27, 2010.

EPA Proposes Rules On CAA Permitting For GHG Emissions: On August 12, 2010, EPA announced two proposed rules to which it intends to ensure that businesses planning to build new, large facilities or make major expansions to existing ones will be able to obtain CAA permits that address their GHG emissions. EPA promulgated its final GHG tailoring rule on June 3, 2010, which specifies that beginning in 2011, projects that will increase GHG emissions substantially will require an air permit. EPA states that its proposed rules “will help ensure that these sources will be able to get those permits regardless of where they are located.” Under the CAA, states must develop EPA-approved implementation plans that include requirements for issuing air permits. When federal permitting requirements change, as they did after EPA promulgated the final GHG tailoring rule, states may need to modify these plans. In the first proposed rule, EPA would require permitting programs in 13 states to make changes to their implementation plans to ensure that GHG emissions will be covered. All other states that implement an EPA-approved air permitting program must review their existing permitting authority and inform EPA if their programs do not address GHG emissions. Because some states may not be able to develop and submit revisions to their plans before the tailoring rule becomes effective in 2011, in the second rule, EPA is proposing a federal implementation plan, which would allow EPA to issue permits for large GHG emitters located in these states. EPA states that this “would be a temporary measure that is in place until the state can revise its own plan and resume responsibility for GHG permitting.” The proposed rules have not yet been published in the Federal Register. The first proposed rule will have a 30-day comment period that will begin upon publication. EPA has scheduled a hearing on the second proposed rule on August 25, 2010, and will accept comment for 30 days after that hearing. EPA is working to promulgate final rules prior to January 2, 2011, the earliest GHG permitting requirements will be effective. The prepublication copies of the proposed rules and more information regarding the public hearing are available online.

EPA Denies Petitions To Reconsider The Endangerment And Cause Or Contribute Findings For GHGs: On August 13, 2010, EPA announced that it is denying the petitions to reconsider the endangerment and cause or contribute findings for GHGs under CAA Section 202(a). 75 Fed. Reg. 49555. EPA states that it “carefully reviewed all of the petitions and revisited both the scientific record and the Administrator’s decision process underlying the Findings in light of these petitions.” According to EPA, its analysis of the petitions reveals that the petitioners “have provided inadequate and generally unscientific arguments and evidence that the underlying science supporting the Findings is flawed, misinterpreted or inappropriately applied by EPA.” EPA described the science supporting the finding that elevated concentrations of GHGs in the atmosphere may reasonably be anticipated to endanger the public health and welfare as “robust, voluminous, and compelling, and has been strongly affirmed by the recent science assessment of the U.S. National Academy of Sciences.” EPA’s denial was effective July 29, 2010.

NANOTECHNOLOGY

EPA Reopens Comment Period For Multi-Walled Carbon Nanotube SNUR: On July 28, 2010, the EPA published a Federal Register notice announcing that it is reopening the comment period for its February 3, 2010, proposed SNUR for the chemical substance identified generically as multi-walled carbon nanotubes (P-08-199). 75 Fed. Reg. 44198. According to the July 28, 2010, notice, a commenter noted that neither the proposed rule nor the docket contained specific carbon nanotube data or data supporting the nature of the dermal concern for carbon nanotubes. The commenter stated it was not possible to assess EPA’s evaluation and determination based on the current record. Another commenter noted that EPA’s subsequent reviews and concerns for carbon nanotubes have expanded, and that the proposed SNUR should reflect those updated data. EPA states that it has added additional explanation and references of its health and environmental concerns for carbon nanotubes to the public docket for consideration, and is reopening the comment period for 30 days. Comments are due August 27, 2010.

NIEHS Begins Intramural NanoHealth Signature Program: The August 2010 issue of the NIEHS Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with NTP, labs in the NIEHS intramural program, and EPA as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere. The team will study the effects in cell tissues, animals, and human subjects. The research team will test the hypothesis that selected ENMs induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:

  • Exposing human bronchial epithelia and alveolar macrophages — native lung cells donated by healthy volunteers — to ENMs ex vivo to evaluate inflammation and cell toxicity;
  • Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
  • Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.

More information is available online.

RTI International To Develop Nanomaterials Registry: RTI International announced August 3, 2010, that it has received a three-year federal contract worth nearly $3 million to develop a web-based database with information about biological and environmental interactions with well-characterized nanomaterials. The registry is being funded by agencies within the National Institutes of Health, including the National Heart, Lung, and Blood Institute; the National Institute of Biomedical Imaging and Bioengineering; NIEHS; and the National Cancer Institute. Information in the database will be reviewed by scientists to increase its reliability and encourage its widespread use. More information is available online.

Massachusetts Releases Nanotechnology Guidance Document: The Massachusetts Office of Technical Assistance (MOTA) will post a Technology Guidance Document entitled “Nanotechnology — Considerations for Safe Development,” which includes recommendations intended to enhance the safety of nanotechnology. According to MOTA, it is providing the Guidance for “the express purpose of assisting in the development of this technology, as failure to prevent exposures or releases will not just risk harm to health or the environment — it will also impede the common interest in realizing the benefits that nanotechnology can provide.” The Guidance is available online.

The Guidance notes that several organizations have developed recommendations for good management practices for facilities (companies, public and private research institutions, including educational facilities) handling engineered nanoparticles (ENP). According to the Guidance, facilities that handle ENPs should develop a risk reduction program with the goal of preventing exposures and releases that may cause harm, even though that risk may not be fully understood now. MOTA states that risk reduction plans can be thought of as having two contextual levels: one, the direct and immediate, which protects personnel in the workplace where ENPs are handled, and prevents the release of ENPs from the workplace into the environment; and two, the eventual potential impact of ENPs, after they have left the facility, considering possible releases during transport, use, and disposal. MOTA suggests that risk reduction plans address both contexts. At the facility, safety measures could include preventive materials selection and process design; containment; and proper personal protective equipment. To reduce risks outside the facility, MOTA recommends making preventing facility releases an integral part of the program. Risk reduction plans should also address cleanup, storage, and transfer; waste shipments; and employee involvement.

MOTA also suggests evaluation of the impacts of use and post-use disposition, to protect consumers and others, as well as the organization itself from potential product, contract, tort, or other liability. MOTA notes that the British Standards Institute recommends providing labeling when “any different handling, maintenance, cleaning, storage or disposal of the product is advised as a consequence of nanoparticle content.” Facilities should consider potentially affected entities, including consumers, workers who use materials containing ENPs, and workers who will come in contact with wastes containing ENPs; practice proactive compliance, through communication with agencies that have regulatory authority over the risks the product could cause; maintain an open and transparent program for testing; recognize the value of preventing harm; and realize the value of nanotechnology.

EPA Announces Availability Of Nanomaterial Case Study For Nanoscale Silver In Disinfectant Spray: On August 13, 2010, EPA announced the availability of a draft document entitled Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray, which EPA intends to serve as part of a process to help identify and prioritize scientific and technical information that could be used in conducting comprehensive environmental assessments of selected nanomaterials. 75 Fed. Reg. 49487. EPA states that the Case Study does not attempt to draw conclusions regarding potential environmental risks of nanoscale silver, but instead aims to identify what is known and unknown about nanoscale silver to support EPA’s future assessment efforts. EPA states that it is releasing the draft Case Study “solely for the purpose of pre-dissemination review under applicable information quality guidelines.” The draft Case Study “has not been formally disseminated by EPA,” and it “does not represent and should not be construed to represent any Agency policy or determination.” When preparing the final Case Study, EPA intends to consider any public comments received by September 27, 2010. The draft Case Study is available online.

LEGISLATIVE DEVELOPMENTS

House Introduces TSCA Reform Legislation: On July 22, 2010, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (TCSA), which is intended to strengthen TSCA. The bill is different in key respects from the House Discussion Draft circulated by Representatives Rush and Waxman on April 15, 2010 — better in some instances and worse in others. On balance, the bill poses considerable and perhaps insurmountable challenges for the chemical community and its downstream customers.

More information is available online. A detailed summary and comparison of the House and Senate bills and House discussion draft is available online.

Subcommittee On Commerce, Trade, And Consumer Protection Convenes A Legislative Hearing On TCSA: On Thursday, July 29, 2010, at 10:00 a.m. (EDT), the Subcommittee on Commerce, Trade, and Consumer Protection held a legislative hearing on H.R. 5820, TCSA. Witnesses at the hearing were (in order of testimony):

  • Steve Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
  • Richard Denison, Ph.D., Senior Scientist, Environmental Defense Fund;
  • Calvin M. Dooley, President and Chief Executive Officer, ACC;
  • Ken Cook, President, Environmental Working Group;
  • Howard Williams, Vice President, Construction Specialties, Inc.;
  • Mark Mitchell, M.D., M.P.H., President, Connecticut Coalition for Environmental Justice; and
  • Beth Bosley, Society of Chemical Manufacturers and Affiliates, Inc.

Subcommittee Chairman Bobby Rush (D-IL) provided opening remarks. He referred to the stakeholder discussion that was conducted prior to the bill being introduced on July 22, 2010. He acknowledged that the bill was not something that all sides would love, but hopefully would be something all could live with. Ranking Minority member Whitfield (R-KY) commented on concerns related to adverse impact of the proposed legislation on jobs in America. Other Subcommittee members provided comments, including Waxman (D-CA), Pitts (R-PA), Pallone (D-NJ), Latta (R-OH), Dingell (D-MI), Barton (R-TX), Green (D-TX), Gingrey (R-GA), DeGette (D-CO), Scalise (R-LA), Castor (D-FL), Murphy (R-PA), Schakowsky (D-IL), Space (D-OH), Sutton (D-OH), and Sarbanes (D-MD). A summary of the hearing is available online.

Safe Cosmetics Act Would Allow FDA To Require Labeling Of Nanomaterial: On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend FFDCA “to ensure the safe use of cosmetics.” Under the bill, the FDA Secretary would: (1) monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and (2) consider scale-specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients. Regarding cosmetic and ingredient statements, the bill would require manufacturers to submit electronically a statement containing certain information, including “the ingredient list as it appears on the cosmetic label or insert, including the particle size of any nanoscale cosmetic ingredients.” The bill would also allow the FDA Secretary to require that: (1) minerals and other particulate ingredients be labeled as “nano-scale” on a cosmetic ingredient label or list if not less than one dimension is 100 nanometers (nm) or smaller for not less than one percent of the ingredient particles in the cosmetic; and (2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties. The bill was referred to the Committee on Energy and Commerce, as well as the Committee on Education and Labor.

House Authorizes Increased Funds For Safe Drinking Water Act Compliance: The House of Representatives approved by voice vote and sent to the Senate the Assistance, Quality and Affordability Act of 2010 (H.R. 5320). The measure amends the Safe Drinking Water Act to increase funding for state revolving funds and to provide a variety of assistance to small water systems to improve performance Funding in FY 2011 would be set at $1.4 billion, and that would increase in FY 2012 to $1.6 billion and to $1.8 billion in 2013. The bill also provides that prohibitions on the use of lead pipes, solder, and flux do not apply to pipes, pipe and plumbing fittings, and fixtures (pipes) that are used exclusively for nonpotable services, and revises the definition of “lead free” to mean not containing more than 0.2 percent lead when used with respect to solder and flux and no more than a weighted average of 0.25 percent when used with respect to the wetted surfaces of pipes. H.R. 5320 requires EPA’s Administrator, in carrying out the Estrogenic Substances Screening Program not later than one year after enactment of the Endocrine Disruptor Screening Enhancement Act of 2010, to publish a list of at least 100 substances for testing of endocrine disrupting substances that may be in drinking water, giving priority in selecting substances for listing to substances that pose the greatest public health concern. The Act also contains provisions for testing new protocols and establishing a searchable public database with information on the testing program.

House Subcommittee Approves Decreased Funding For EPA: The House Appropriations Subcommittee on the Department of Interior, Environment and related agencies on July 22, 2010, approved a measure providing funding of approximately $10 billion for EPA for FY 2011. That figure is $271 million less than was appropriated for 2010 and $2 million under the amount requested by the Administration. The Subcommittee bill would see decreases in the funding levels for state and tribal assistance grants, and for clean water state revolving funds. Similarly, drinking water revolving funds and the hazardous substance Superfund monies would be reduced. The Subcommittee refused to approve an amendment that would have forestalled EPA regulations on GHG emissions from stationary sources. In a related matter, Senator Lisa Murkowski (R-AK) is reported to have proposed an amendment to a tax relief measure for small business that would prevent the imposition of the GHG regulations for a period of two years.

Legislation Introduced Regarding Stormwater Runoff From Federally Funded Highways: Senator Benjamin Cardin (D-MD) introduced S. 3602, the Safe Treatment of Polluted Stormwater Runoff Act on July 15, 2010. The measure provides that steps have to be taken to minimize or eliminate stormwater runoff from highways and other roadways built with federal funds. Receipt of such funds would be contingent on the state providing assurances that a highway project would be constructed in accordance with minimum standards enumerated in the bill. Those standards include avoiding and minimizing alteration of natural features and hydrology and maximizing use of pollution source control measures that utilize existing terrain and natural features and reduce chemical introduction to reduce creation of pollution on the project site. Also, the project should be designed to maximize capture of highway runoff pollution on site through pretreatment and treatment, including environmental site design techniques and other control measures that promote evapotransporation and infiltration.

Senate Passes Federal Buildings Personnel Training Act: On July 20, 2010, the Senate passed the Federal Buildings Personnel Training Act by unanimous consent. It requires the Administrator of General Services to identify annually the core competencies necessary for federal personnel performing building operations and maintenance, energy management, safety, and design functions to comply with requirements under federal law, including competencies relating to sustainability, water efficiency, electrical safety, and building performance measures; and also to identify a course, certification, degree, license, or registration to demonstrate, and for ongoing training in, each core competency for the appropriate category of personnel. The Act further requires individuals in each category to demonstrate each core competency identified for the category within one year. The measure also requires the Administrator to develop or identify comprehensive continuing education courses to ensure the operation of federal buildings in accordance with industry best practices and standards; and makes training requirements under this Act applicable to non-federal personnel performing building operations and maintenance, energy management, safety, and design functions under contract with a federal agency. A contractor must provide training to, and certify the demonstration of core competencies for, non-federal personnel in a manner that is approved by the Administrator.

Support For Use Of Recycled Materials: Legislation introduced by Senators Olympia Snowe (R-ME) and Thomas Carper (D-DE) on July 22 is designed to encourage procurement personnel for federal agencies to purchase more recycled goods. Doing so would be made easier by ending confusion over when it is appropriate to buy recycled materials under the Solid Waste Disposal Act. That Act does not define what a reasonable purchase would be. As provided in S. 3633, it now would be reasonable for a purchasing agent to buy recycled goods if those goods contain at least 25 percent recovered materials and the cost is no more than 110 percent of the bid price of the highest ranked competing product that contains zero or de minimus recovered materials.

Senate Committee Votes To Extend Chemical Security Measure: On July 28, 2010, the Senate Homeland Security and Governmental Affairs Committee voted unanimously to extend the existing chemical security law for a three-year period. The action taken fell short of the actions taken earlier by the House of Representatives. The House had voted to extend the scope of the chemical security legislation to wastewater and drinking water facilities, since they often handle large quantities of high risk chemicals. The Senate also failed to adopt a provision known as IST, or Inherently Safer Technology, that would call for a consideration of a switch of chemicals and the institution of safer technology and processes to limit risk from such as terrorist attacks. The Committee chair, Joseph Lieberman (ID-CT), had supported the provisions that were not adopted. The Senate is expected to consider the matter further after the August recess. The present law is set to expire on October 4, 2010.

Legislation Would Amend FIFRA To Clarify CWA Permit Requirements: On August 5, 2010, Senators Blanche Lincoln (D-AR), Chair of the Committee on Agriculture, Nutrition, and Forestry, and Ranking Member Saxby Chambliss (R-GA) introduced legislation that would amend FIFRA to clarify that the Clean Water Act (CWA) permits are not required for pesticide application in accordance with FIFRA (S. 3735). The Senate legislation is prompted by EPA’s June 4, 2010, notice proposing a draft National Pollutant Discharge Elimination System (NPDES) pesticide general permit for point source discharges from the application of certain pesticides. 75 Fed. Reg. 31755. More information regarding the Senate legislation is available online. Representative Frank Lucas (R-OK), Ranking Member of the House Agriculture Committee, has introduced companion legislation in the House.

EPA issued on June 4, 2010, a notice in response to the Sixth Circuit Court’s ruling that vacated an EPA regulation that excluded discharges from the application of pesticides to or over, including near, U.S. waters from the need to obtain an NPDES permit if the application was done in accordance with other laws. EPA requested and was granted a two-year stay of the court’s mandate to provide time to draft and implement the permit. The stay of the mandate expires on April 9, 2011; where after, NPDES permits will be required for all point source discharges to U.S. waters of biological pesticides, and chemical pesticides that leave a residue. The draft general permit would regulate discharges to U.S. waters from the application of biological pesticides, and chemical pesticides that leave a residue for the following pesticide use patterns:

  • Mosquito and Other Flying Insect Pest Control — To control public health/nuisance and other flying insect pests that develop or are present during a portion of their life cycle in or above standing or flowing water. Public health/nuisance pests in this use category include but are not limited to mosquitoes and black flies;
  • Aquatic Weed and Algae Control — To control weeds and algae in water and at water’s edge;
  • Aquatic Nuisance Animal Control — To control invasive or other nuisance species in water and at water’s edge. Aquatic nuisance animals in this use category include, but are not limited to fish, lampreys, and mollusks; and
  • Forest Canopy Pest Control — Aerial application of a pesticide over a forest canopy to control the population of a pest species (e.g., insect or pathogen) where, to target the pest effectively, a portion of the pesticide unavoidably will be applied over and deposited to water.

President Signs Manufacturing Enhancement Act: President Obama signed H.R. 4380, the United States Manufacturing Enhancement Act of 2010, into law. The law amends the Harmonized Tariff Schedule of the United States to provide for duty suspensions and reductions through December 31, 2012, for specified chemicals and other products, including various staple fibers, imaging colorants, and various chemicals. H.R. 4380 also extends existing suspensions and reductions of duties through December 31, 2012, for other specified chemicals and products and imposes, suspends, and increases and/or decreases additional duties on certain chemicals through December 31, 2012.

MISCELLANEOUS

OMB Issues Memorandum On Science Priorities: On July 21, 2010, the White House Office of Management and Budget (OMB) issued a memorandum to all federal departments and agencies asking each to prioritize science and technology in their upcoming FY 2012 budget submissions. Agencies were asked to explain in their budget submissions how they will redirect available resources, as appropriate, and consistent with their mission, from lower-priority areas to science and technology activities that address six challenges. Three of the challenges are relevant to environmental issues: moving toward a clean energy future to reduce dependence on energy imports while curbing GHG emissions; understanding, adapting to, and mitigating the impacts of global climate change; and managing the competing demands on land, fresh water, and the oceans for the production of food, fiber, biofuels, and ecosystem services based on sustainability and biodiversity. The other three challenges are to promote sustainable economic growth and job creation; defeating the most dangerous diseases and achieving better health outcomes for all while reducing health care costs; and developing the technologies to protect our troops, citizens, and national interests. The memorandum, Science and Technology Priorities for the FY 2012 Budget, is available online.

EPA Releases Rulemaking Guidance On Environmental Justice: On July 26, 2010, EPA released an interim guidance document to assist EPA staff incorporate environmental justice into EPA’s rulemaking process. The rulemaking guidance is regarded as an important step toward meeting EPA Administrator Jackson’s priority to work for environmental justice and protect the health and safety of communities who have been disproportionally impacted by pollution. The document, Interim Guidance on Considering Environmental Justice During the Development of an Action, seeks to advance environmental justice for low-income, minority, and indigenous communities and tribal governments that have been historically underrepresented in the regulatory decision-making process. The guidance also outlines the multiple steps that every EPA program office can take to incorporate the needs of overburdened neighborhoods into the EPA’s decision-making, scientific analysis, and rule development. EPA seeks public feedback on how to best implement and improve the guide for EPA staff to further advance efforts toward environmental justice. To view the interim guidance and submit feedback, go online. More information on environmental justice is available online.

CDC Updates Data On Human Levels Of Chemicals: On July 29, 2010, CDC updated information on the levels of 51 chemicals reported in the Fourth Report on Human Exposure to Environmental Chemicals, which was released in December 2009. The chemicals included phenols, metals, perfluorinated compounds, and phthalates. The nationally representative data on biomonitoring data that CDC added came from the 2005-2006 survey cycle of the National Health and Nutrition Examination Survey (NHANES). The updated tables are cumulative, and contain results from previous survey cycles or information from 1999 through 2006. CDC also reported human levels of six new chemicals: four parabens (butyl, ethyl, methyl, and n-propyl parabens) and two phthalate metabolites (mono-[carboxynonyl] phthalate and mono-[carboxyoctyl] phthalate). The updated information is available online.

OEHHA Announces Comment Period For 27 Chemicals: On July 9, 2010, the Office of Environmental Health Hazard Assessment (OEHHA) announced the beginning of the public comment period on 27 chemicals. The 27 chemicals are:

  • Acephate;
  • Alpha-methyl styrene (1-methyl-1-phenylethylene);
  • Amitraz;
  • Atrazine;
  • 2-Biphenylamine and its salts;
  • Budesonide;
  • 4-Chloro-m-phenylenediamine;
  • C.I. Acid Orange 3;
  • Ciprofibrate;
  • Clomiphene and its salts;
  • Decabromodiphenyl ether (DecaBDE; decabromobiphenyl oxide);
  • Decalin;
  • 2,6-Dichloro-p-phenylenediamine;
  • Furfural;
  • Gentian Violet;
  • 4-Hydroxymethyl, 4-Methyl, and 4-Hydroxy Benzenediazonium and their salts;
  • Isoniazid;
  • Malathion;
  • 7-Methylbenz[a]anthracene;
  • N-Methyl-N-formylhydrazine;
  • Methylphenidate and its salts;
  • Omeprazole and its salts;
  • Pantoprazole and its salts;
  • Perfluorooctane sulfonate (PFOS) and its salts and transformation and degradation precursors;
  • Phosmet;
  • Quinoxaline-1,4-dioxide compounds and Desoxycarbadox; and
  • Rabeprozole and its salts.

The Carcinogen Identification Committee (CIC) meeting will be held in Sacramento, California, on September 21-22, 2010 .

Nine Chemicals Added To POPs Convention: The Secretariat to the Stockholm Convention on Persistent Organic Pollutants (POPs) announced on August 10, 2010, that nine chemicals or chemical groups will be added to the international chemicals treaty on August 26, 2010. As of August 26, parties to the Convention must take steps to ban, restrict, or properly manage the chemicals and chemical groups added to the treaty. The nine chemicals or chemical groups are:

  • Alpha hexachlorocyclohexane (CAS No. 319-84-6);
  • Beta hexachlorocyclohexane (CAS No. 319-85-7);
  • Chlordecone (CAS No. 143-50-0);
  • Hexabromobiphenyl (CAS No. 36355-91-8);
  • Hexabromodiphenyl (CAS Nos. 68631-49-2, 207122-15-4, 446255-22-7, and 207122-16-5);
  • Lindane (CAS No. 58-89-9);
  • Pentachlorobenzene (CAS No. 608-93-5);
  • Perfluorooctane sulfonic acid along with its salts (CAS Nos. include 1763-23-1, 70225-14-8, 2795-39-3, 29081-56-9, and 29457-72-5) and perfluorooactane sulfonyl fluoride (CAS No: 307-35-7); and
  • Tetrabromodiphenyl ether (CAS No: 40088-47-9) and pentabromodiphenyl ether (CAS No: 32534-81-9).

Revision Of Freedom Of Information Act Regulations: On August 11, 2010, the CEQ issued a revised rule governing the disclosure of information pursuant to the requests made under FOIA. 75 Fed. Reg. 48585. The revisions reflect the principles established by President Obama’s Presidential Memoranda on “Transparency and Open Government” and “Freedom of Information Act” issued on January 21, 2009, and Attorney General Holder’s Memorandum on “The Freedom of Information Act (FOIA)” issued on March 19, 2009. The regulations provide for an online FOIA Requester Service Center and Reading Room; electronic FOIA requests; access to records published or released under FOIA in electronic format, provided the record is readily reproducible in that form or format; designation of a Chief FOIA Officer and FOIA Public Liaison; referral of requests to appropriate federal agencies or consultation with another agency, if appropriate; review of requests in order of receipt; multi-tracking of FOIA requests based on the amount of time and work involved in processing requests; revision of CEQ’s initial determination period from 10 days to 20 days, beginning on the date CEQ receives a written request; assignment of individualized tracking numbers for certain requests; tolling of the time limit for CEQ to act on a request; expedited processing of FOIA requests upon showing a showing of compelling need; CEQ consultations with a requester to determine if a FOIA request may be modified to allow for a more timely response, or to arrange an alternative time frame for a response; informing the requester of the volume of requested material withheld and the extent of deletions in records released in response to a FOIA request; increase in time for appeal from 45 to 60 days from the date of denial of a request; extension of the time limit to respond to a request in “unusual circumstances,” and aggregation of clearly related requests by a single requester or group of requesters. Further, CEQ’s fee structure is revised to include a method for computing fees based upon the classification of the requester and the base pay of the employee making the search, an increase of copying costs from $0.10 to $0.15 per page, and a provision for waiving fees. Additional administrative changes include reorganizing, renumbering, and renaming of the FOIA subsections and updating addresses and telephone numbers. The final rule is effective September 10, 2010.

OECD Adds EPA Chemical Database To eChemPortal: On August 11, 2010, the Organization for Economic Cooperation and Development (OECD) announced that the EPA Aggregated Computational Toxicology Resource (ACToR) is now available through eChemPortal, OECD’s website for information on chemical substances. ACToR links to more than 400 sources of publicly available data on environmental chemicals, and includes information on chemical structure, physico-chemical values, in vitro assay data, and in vivo toxicology data. The database contains both tabular, quantitative data, and links to text reports at other sites. The eChemPortal is a collaboration between OECD, the European Commission, the United States, Canada, Japan, the International Council of Chemical Associations, the Business and Industry Advisory Committee, the World Health Organization’s International Program on Chemical Safety, the United Nations Environment Program on Chemicals, and environmental nongovernmental organizations. The eChemPortal is available online.

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