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May 1, 2011

Monthly Update for May 2011

Bergeson & Campbell, P.C.


EPA Announces Listening Session On IRIS Draft Toxicological Review Of Methanol: On April 18, 2011, the U.S. Environmental Protection Agency (EPA) announced a 60-day public comment period and listening session on May 26, 2011, for the external review draft human health assessment entitled “Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-11/001). 76 Fed. Reg. 21736. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. Comments should be in writing and must be received by EPA by June 17, 2011.

EPA Will Suspend Next IUR Reporting Period: On May 11, 2011, EPA amended the Toxic Substances Control Act (TSCA) Section 8(a) Inventory Update Reporting (IUR) regulations by suspending the next IUR submission period, which would otherwise run from June 1, 2011, to September 30, 2011. 76 Fed. Reg. 27271. The IUR requires manufacturers, including importers, of certain chemical substances included on the TSCA Inventory to report current data on the manufacturing, processing, and use of the chemical substances. On August 13, 2010, EPA published a proposed rule that would modify the IUR regulations. The notice states that EPA is suspending the next submission period “to allow additional time to finalize the proposed modifications to the IUR regulations, and to avoid finalizing changes to the reporting requirements in the midst of the 2011 submission period. EPA expects to finalize, in the near future, changes to the IUR reporting requirements which will supersede this action.”

EPA Schedules SFIREG Working Committee Meeting: On April 19, 2011, EPA announced the Association of American Pesticide Control Officials (AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG), Pesticide Operations and Management (POM) Working Committee will convene a two-day meeting beginning on May 16, 2011, and ending May 17, 2011. 76 Fed. Reg. 21892. The meeting will be held in Seattle, Washington. Please consult the Federal Register for more information.

EPA Forwards Data Requirements For Antimicrobial Pesticides To USDA And HHS: On April 20, 2011, EPA notified the public that it has forwarded to the Secretary of the U.S. Department of Agriculture (USDA) and the Secretary of Health and Human Services (HHS) a draft final rule under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 76 Fed. Reg. 22044. EPA is codifying a separate listing of data requirements in the Code of Federal Regulations for the registration of antimicrobial pesticide products. These data requirements are intended to reflect current scientific knowledge and current EPA regulatory practices. Besides providing the regulated community with clearer and more transparent information, the updated data requirements further enhance EPA’s ability to make regulatory decisions about the human health and environmental fate and effects of antimicrobial pesticide products.

EPA Releases New Website On FIFRA Conditional Registrations: On April 25, 2011, EPA released a website regarding conditional registrations granted under FIFRA Section 3(c)(7). The website, entitled “Conditional Registration,” is available online. A related press release is available online. As discussed in a more detailed memorandum available online, the new website appears to raise as many questions as it seeks to answer.

EPA Inspector General Addresses Endocrine Program: EPA’s Office of Inspector General stated in a report released on May 4, 2011, that EPA needs policies and procedures to ensure timely evaluation and regulation of endocrine-disrupting chemicals and pesticides. The report, EPA’s Endocrine Disruptor Screening Program Should Establish Management Controls to Ensure More Timely Results, concluded that EPA “has not determined whether any chemical is a potential endocrine disruptor.” The report listed six specific recommendations:

  • Define the scope of the program by identifying pesticides and chemicals that could be subject to screening (relatively quick tests) or more comprehensive tests;
  • Develop a method to determine which chemicals and pesticides would be screened and tested first;
  • Complete specific criteria describing how it will evaluate the results obtained through the screening tests and the more comprehensive battery of tests;
  • Develop short-, intermediate-, and long-term measurements to gauge the progress and results of the program;
  • Issue a comprehensive management plan that includes an estimated five-year budget for the Endocrine Disruptor Screening Program, priorities, goals, and key activities; and
  • Annually review program results explaining reasons for any missed milestones or targets.

EPA has stated it will issue a comprehensive management plan by the end of June 2012. The EPA Office of Inspector General’s report is available online.

Brazil Joins OECD Agreement To Share Data: On May 9, 2011, the Organization for Economic Cooperation and Development (OECD) announced that Brazil has joined a multilateral agreement that allows governments and industry to save money and reduce the risk of trade disputes by sharing and accepting each other’s non-clinical data on environmental health and safety testing of chemical products and pesticides. The OECD system for Mutual Acceptance of Data (MAD) in the Assessment of Chemicals allows governments and chemical manufacturers to save resources by allowing chemical producers to complete a single study, where possible, to market products in all participating countries.


Green Ribbon Science Panel Meets To Discuss Safer Consumer Product Alternatives Regulations: On May 5-6, 2011, the Green Ribbon Science Panel (Panel) met to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations. The Panel had previously divided itself into three subcommittees and scheduled several teleconferences between April 4 and April 19, 2011, to discuss specific issues related to: (1) Chemical Identification and Prioritization; (2) Product Identification and Prioritization; and (3) De Minimis and Unintentionally-Added Chemicals. During the May 5-6, 2011, meetings, the Panel commented on various regulatory options on these issues prepared by DTSC based on comments provided during the subcommittee teleconferences.

For example, with regard to chemical identification and prioritization, the Panel debated different options regarding the development of a “Chemicals of Concern” (COC) list, ranging from specifically listing chemicals in the regulation if they met certain criteria; not listing chemicals per se but instead providing criteria and a process from which a COC list could be developed; or not developing a COC list at all, and instead focusing only on a “Priority Chemical” (PC) list that would include only those substances for which product identification and potentially alternative assessments would be conducted. While several Panel members advocated against a “List of Lists” approach, other Panel members noted that developing a flexible, comprehensive COC list would give a “heads up” to industry and consumers as to the universe of substances that could be selected as a PC. If there are two lists, Panel members discussed the possibility of developing the COC and PC lists concurrently, not sequentially, or otherwise providing a “fast track” to identify PCs with “known problems” to move the initiative forward.

With regard to the PC list, DTSC noted that it is likely to be small, perhaps between 10 and 50 chemicals, both because of restrained resources and an acknowledgment that this is a new, complex regulation that DTSC will hopefully learn from and improve over time. Panel members discussed a variety of criteria that could be used to identify and prioritize PCs and also those products containing PCs. These included hazard-related factors (e.g., physical state, type of hazard trait, toxicity, affect on sensitive subpopulations) and exposure-related factors (e.g., evidence of exposure to the PC, type of products containing the PC, frequency and duration of use of the products containing the PC, potential exposure scenarios and pathways). There also was discussion about whether this kind of information was known to DTSC, available publicly, or if it could be obtained by DTSC issuing a data call-in.

Other topics related to the criteria and process for providing an exemption from the alternatives assessment requirements for priority products that contained a PC that is (1) only present at or below a de minimis level; and/or (2) is an unintentionally added or unknown chemical. Many Panel members advocated against a de minimis level, noting that while some regulations (i.e., Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Prop 65) contain de minimis exemptions, in those cases the exemption determines whether a substance is broadly subject to the regulation or not. In this case, when a substance has already been identified as a PC and products containing the PC have already been prioritized for an alternatives assessment, Panel members argued that the purpose of these regulations — to motivate innovation and find safer alternatives — is not advanced if PCs are allowed in products even at small concentrations. If a de minimis exemption was included in the regulations, many of the Panel members also seemed to advocate against a default de minimis level of 0.1 percent. Although it was noted that a 0.1 percent de minimis level has been accepted and used in other regulatory contexts, it was also argued that this level is arbitrary and not scientifically defensible.

DTSC discussed developing new subcommittees that would focus on issues related to the alternatives assessment process and scheduling teleconferences in advance of the next full Panel meeting, which is expected to occur in July 2011 in Sacramento.

The agenda, meeting notice, subcommittee reports, regulatory concept option papers, and other meeting materials are available online.

California Governor Brown Announces Appointment Of New DTSC Director: On May 2, 2011, Governor Edmund G. Brown, Jr. (D) announced several appointments, including Deborah Raphael as Director of the California DTSC. Raphael has been the Program Director for Toxics Reduction, Green Business, and Green Building at the San Francisco Department of the Environment since 1999. Previously, she was a Senior Environmental Program Manager at the City of Santa Monica from 1993 to 1999. Raphael is a Co-Chair of the DTSC’s Green Ribbon Science Panel. Raphael’s Panel biography notes that, as the Program Manager for the San Francisco Department of Environment, she was responsible for working with stakeholders to implement the city’s Integrated Pest Management, Environmentally Preferable Purchasing, Green Business Certification, and Green Building Programs. The biography states that Raphael was part of the team of city staff and community members that “crafted San Francisco’s Precautionary Principle Ordinance and is helping to lead the effort to implement the principle within City government.” The biography notes that Raphael “has represented the City on numerous statewide committees to craft policy and implement programs around extended producer responsibility and green chemistry.” The DTSC position requires Senate confirmation.


BfR Cautions Against Broad Use Of Nanosilver In Consumer Products: On April 12, 2011, the German Federal Institute for Risk Assessment (BfR) issued a statement entitled “Safety of Nano Silver in Consumer Products: Many Questions Remain Open,” which reports BfR’s conclusions from a February 2011 workshop discussing existing risks and possible options for comprehensive consumer protection from nanosilver. According to BfR, “the situation continues to be characterized by the fact that not enough secured scientific findings about the specific effects of nano-sized silver particles are available.” BfR states: “Articles of daily use and consumer products may not constitute any health risk based on statutory provisions during proper use or foreseeable misuse. Since no final safety assessment for man and the environment is available so far for nanoscale forms of silver due to the missing data, BfR continues to advise against a broad use of nano silver in consumer products.” The statement is available online.

UK FSA Publishes Report Of Consumers’ Views On Nano In Food And Food Packaging: On April 21, 2011, the United Kingdom’s (UK) Food Standards Agency (FSA) published a report of consumers’ views on the use of nanotechnology in food and food packaging. FSA convened a focus group in late 2010 and early 2011, and asked participants about their views on nanotechnology. According to FSA, the main findings are that:

  • Participants’ reactions to nanotechnology and food reflected a variety of concerns. These included whether this was a necessary development, whose interests it would serve, and whether the benefits outweighed the perceived risks;
  • Acceptance around the use of nanotechnology was conditional. For instance, participants were more positive about the use of nanotechnology to reduce the salt or fat content of foods without adversely affecting the taste or texture. Participants were negative towards the use of nanotechnology for what they perceived to be “trivial” purposes, however, such as using nanotechnology to develop new flavors and textures;
  • Participants were relatively more open to the use of nanotechnology in food packaging and readily identified the potential benefits of extended shelf life and waste reduction. Participants questioned, however, whether consumers would receive the benefits of nanotechnology or whether these developments would be of most benefit to the food industry;
  • The current way of regulating nanotechnologies in foods, the European Novel Foods Regulation, provided participants with a degree of confidence that the framework in place ensured the safety of nanotechnology in foods. Questions were raised, however, about the ability to predict long-term health effects of nanotechnology in food and whether wider social and environmental implications would be taken into account; and
  • To provide further confidence in the use of nanotechnology in foods, participants wanted transparency about the developments, including providing them with more information. A register of foods that use nanotechnology, established by a body independent from industry and government, was received positively. The introduction of an “n” label for nanotech foods was also proposed, although participants recognized that consumers might not use or understand this information without complementary education and awareness raising.

The report is available online.

EPA Issues Final SNUR For Certain Multi-Walled Carbon Nanotubes: On May 6, 2011, EPA promulgated a final significant new use rule (SNUR) under TSCA Section 5(a)(2) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. 76 Fed. Reg. 26186. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule must notify EPA at least 90 days before commencing that activity. The EPA states that it believes the final rule is necessary “because the chemical substance may be hazardous to human health,” and the required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The final rule will be effective June 6, 2011. More information is available online.

ITA Seeks Comments Concerning Regulatory Cooperation Between The U.S. And EU: In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports. 76 Fed. Reg. 24860. Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to greater trade and investment between the U.S. and EU “are not tariffs or quotas, but rather differences in regulatory measures.” The ITA seeks public input to help identify divergences in regulatory measures in the transatlantic marketplace, “so that the U.S. Government can work cooperatively with the European Union to address them.” This notice offers an important opportunity to educate the ITA on subtle, yet significant trade impacts that are derivative of regulatory and/or competitive issues. ITA also seeks recommendations for existing or emerging industry or product sectors that may benefit from regulatory cooperation between the U.S. and the EU. ITA asks that submitters be as specific as possible in describing the relevant product or product sector in which they believe there is an opportunity to facilitate trade without undermining U.S. public health, safety, environmental, and other legitimate policy objectives. ITA states that it is interested in receiving recommendations concerning any product sector that, due to the volume of trade between the U.S. and EU, “is a justifiable focus of enhanced regulatory cooperation.” Comments are due June 2, 2011. A more detailed memorandum is available online.

EC JRC Posts Report Of Workshop On “Early Harvest Of Research Results On Nanosafety”: The European Commission (EC) Joint Research Centre (JRC) has posted its report on a two-day April 2010 workshop entitled “Early Harvest of Research Results on Nanosafety,” which was aimed at informing stakeholders of the latest scientific progress in the field of nanomaterials risk assessment. The report is available online. Participants included scientists, small- and medium-sized enterprises, nanotechnology industry, representatives of EU national authorities, the EC, and the OECD. Breakout sessions discussed three cornerstones of the current research regarding nanomaterials: (1) measurement, characterization, and categorization; (2) exposure measurement and mitigation; and (3) toxicity and ecotoxicity.

UCSF’s Program On Reproductive Health And The Environment Publishes Recommendations For Addressing Health Risks From Nanomaterials In California: Last week, the University of California, San Francisco’s (UCSF) Program on Reproductive Health and the Environment announced the publication of its “Recommendations for Addressing Potential Health Risks from Nanomaterials in California,” which provides recommendations for addressing potential health risks from nanomaterials to the Office of Environmental Health Hazard Assessment (OEHHA) and to the State of California. The report is available online. OEHHA contracted with UCSF to prepare the report, which provides an overview of nanotechnology materials, potential exposures, and human-health risks, and recommendations for addressing potential health hazards and risks from nanotechnology. Recommendations include those that can be implemented under the existing regulatory structure of OEHHA, such as establishing a publicly accessible clearinghouse and inventory of nanomaterial sources and products. The report also includes recommendations that are outside the scope of OEHHA, many of which may require legislative changes, such as requiring testing of release and exposure potential for nanomaterials in existing and new consumer products, and implementing a labeling system that requires labeling of products that contain nanomaterials. According to UCSF, the recommendations primarily focus on requiring information on potential exposures and health hazards for nanomaterials used in the marketplace.

Recommendations for OEHHA to address health risks from nanomaterials that can be achieved under the existing regulatory structure:

  • Develop a definition of nanomaterials that can be used to identify them;
  • Identify and define priority properties for risk characterization and collect information about them for each nanomaterial;
  • Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties;
  • Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products;
  • Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring;
  • Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media;
  • As for other chemicals, focus on identifying and addressing nanomaterials that are persistent, bioaccumulative, and toxic (PBT);
  • Use existing hazard traits from other chemicals and toxicological and environmental-health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure;
  • Evaluate existing risk-assessment guidelines to determine whether they sufficiently cover nanomaterials, adjusting or incorporating nano-specific approaches as needed;
  • Integrate nanomaterials into current efforts to modernize toxicity testing;
  • Develop and maintain relationships with other governments and researchers to share relevant data and information on nanotechnology and nanomaterials’ use, applications, and toxicity;
  • Improve coordination and monitor communication among federal and state agencies, other countries’ governments, businesses, and non-governmental organizations; and
  • Continue to include opportunities for public input and comment during decision-making processes.

Recommendations to support successful approaches to address potential health risks from nanomaterials that are currently outside the scope of OEHHA:

  • Require disclosure of where and what nanomaterials are manufactured, in what quantities, and for what new or existing products;
  • Require reporting of properties that can identify nanomaterials that are PBTs. Phase out uses consistent with approaches for other PBTs;
  • Develop a framework for making policy and regulatory decisions that balances the uses and benefits of nanomaterials with their toxicity and exposure potential;
  • Require testing of release and exposure potential for nanomaterials in consumer products for both existing and new products;
  • Increase efforts to protect and educate workers, researchers, and downstream users of nanomaterials;
  • Require sufficient toxicological testing — preferably pre-market and also post-market as necessary — to assess risks to manufacturing and other workers and to downstream users, including consumers and susceptible subpopulations such as infants;
  • Implement a labeling system that requires labeling of products that contain nanomaterials;
  • Increase funding and support for targeted, nano-specific research to fill data gaps; and
  • Conduct targeted research on the biological fate, transport, and distribution of nanomaterials, including sources, exposure routes, and internal distributions. Integrate this research with information gathered on exposure potential.

Nanodermatology Society Issues 2011 Position Statement On Sunscreens: In its 2011 position statement on sunscreens, the Nanodermatology Society states that it “believes that nano-based sunscreens do not pose serious health risks to consumers,” and agrees with the Environmental Working Group (EWG) that “[z]inc and titanium-based formulations are among the safest, most effective, sunscreens on the market.” According to the position statement, which is available online, this is based on the current evidence showing:

  • Consumers using zinc and titanium sunscreen products are exposed to 20 percent less UVA radiation than those using sunscreens without these products;
  • Nano-titanium and zinc do not penetrate the outer layer of human skin, even through hair follicles; and
  • Nano-titanium and zinc do not reach living cells, and therefore pose no risk of toxicity.


EPA Scales Back Scope Of CWA Jurisdiction Guidance: On April 27, 2011, EPA issued a draft national clean water framework document that is intended to reflect the Administration’s commitment to clean water. The document contains changes in the scope of the Agency’s interpretation of its authority under the Clean Water Act (CWA), reportedly made in response to pressure from lawmakers and industry critics. The new proposal eliminates language from an earlier draft version that claimed the new policy would “increase significantly” the number of waterbodies subject to the federal law, while also substantially raising the bar to assert jurisdiction over isolated waterbodies. Language expanding jurisdiction over tributaries to traditionally navigable waters (TNW) and wetlands adjacent to those tributaries remains largely unchanged, however. EPA and the Army Corps of Engineers, which issues most CWA dredge-and-fill permits, have also agreed to wide-ranging calls to undertake a new rulemaking aimed to providing more certainty in implementing their broad new view of the water act’s scope, although officials could not provide any estimate on how soon the rulemaking would begin.

EPA Proposes Revised Standard For Secondary Lead Smelters: EPA is proposing a rule revising air toxics emissions from secondary lead smelters. The proposal would reduce lead and arsenic from the facilities by 63 percent, according to EPA. EPA’s proposed revisions would set more stringent national emissions standards for hazardous air pollutants (NESHAP) from the smelting operations, updating the standards originally set in 1997. The proposed rule would require secondary lead smelters to enclose all operations within a building with a venting system to ensure concentrations of lead stay below 0.15 micrograms per cubic meter. The proposed rule would also set a lead emissions limit of 0.2 milligram per dry standard cubic meter, ten times lower than the current standard, and require the facilities to control emissions of dioxins. Comments are due 45 days after publication in the Federal Register. The fact sheet for the Proposed Amendments to the Air Toxics Standards for the Secondary Lead Smelting Industry is available online.


EU Chemicals Agency States It Will Publish Names Of Hazardous Chemicals Producers: On May 11, 2011, the European Chemicals Agency (ECHA) stated that it would publish the names of producers of dangerous chemicals, absent “valid justification” for not doing so. The announcement apparently responds to criticism from several environmental groups that ECHA was withholding information on hazardous substances registered under the EU’s REACH law. The ECHA decision came two days after two environmental groups, Client Earth and ChemSec’s Substitute It Now! (SIN), threatened to bring legal action against ECHA at the General Court of the EU over the withholding of the names of REACH registrants involved in the production of some hazardous substances. Access to information collected as a consequence of REACH is covered by Article 118 of the regulation. The article does not explicitly prohibit the publication of names of producers, but states that publication of information can be refused if it could be considered to reveal “links between a manufacturer or importer, and his distributors or downstream users.” More information on substances registered under REACH is available online.


Congress Continues To Focus On Spending Legislation: The need to pass a spending bill for the federal government for fiscal 2012, coupled with the pressure being applied by the Administration to raise the debt ceiling before the federal government is forced to default on any of its obligations (May 16, or some date prior to August 2 if emergency accounting measures are utilized to extend the time) continue to preoccupy Members. At this writing, Republicans in the majority in the House are looking radically to reduce federal spending in return for support to raise the federal debt. For example, in a speech at the Executive Club in New York on May 9, Representative John Boehner (R-OH), Speaker of the House of Representatives, stated that federal budget cuts had to be larger than the amount that the Administration proposed to increase the borrowing limit — at least $2 trillion. Against this backdrop, Congressmen who have repeatedly attempted to strip EPA’s authority to regulate greenhouse gas emissions are renewing that fight as one way to cut allegedly wasteful spending and protect jobs. On the other hand, the Administration, and the Democratic leadership in the Senate, are looking to raise revenue by enacting tax hikes on higher income brackets and eliminating or reducing tax breaks for companies in lieu of reducing entitlement programs such as Social Security, Medicare, and Medicaid. The budget deficit/debt ceiling debate is projected to extend to July or August.

House Subcommittees Approve Chemical Security Measures: On May 5, 2011, the House Energy and Commerce Subcommittee on Environment and the Economy approved by voice vote H.R. 908, a measure sponsored by Representatives Timothy Murphy (R-PA) and Gene Green (D-TX) to amend the Department of Homeland Security Appropriations Act, 2007 to extend until October 4, 2017, the authority of the Secretary of the Department of Homeland Security (DHS) to issue interim final regulations establishing risk-based performance standards (chemical facility antiterrorism standards or CFAS) for security of chemical facilities and requiring vulnerability assessments and the development and implementation of site security plans for such facilities. On April 14, the House Homeland Security Subcommittee on Cybersecurity, Infrastructure Protection and Security Technologies voted 6-4 to approve a similar extension. (The two House Subcommittees have concurrent jurisdiction over matters dealing with chemical security.) The two measures being considered in the House do nothing regarding the exemption of public drinking water and wastewater facilities from CFAS standards. Those facilities would be made subject to CFAS under provisions of S. 711, introduced in the Senate by Senator Lautenberg (D-NJ). The Lautenberg bill would also mandate that facilities utilize inherently safer technology in complying with applicable standards. There has been no recent action in the Senate.

President Obama Signs 2011 Spending Bill: President Obama signed H.R. 1473 on April 15, 2011, which will fund the federal government for the balance of fiscal 2011. H.R. 1473 represents a compromise between Democrats and Republicans involving reductions in the federal deficit. One such compromise involves cuts amounting to $1.6 billion in the budget for EPA. That compromise measure omitted any of the “riders” that Republicans had advocated, including diminishing EPA’s authority to regulate greenhouse gases. These rider provisions are expected to be brought up again as Congress moves to consider the federal spending bill for 2012.

Members Of Congress Question EPA Authority And Actions: As this session of Congress moves forward, EPA is coming under enhanced scrutiny for a number of actions, including two controversial guidance documents. One is a proposed guidance (discussed above) that would restate which bodies of water are subject to the CWA. On April 14, 2011, 170 Members of Congress signed a letter to the EPA and the U.S. Army Corps of Engineers expressing concerns that the agencies were attempting to circumvent the proper regulatory process and utilize a guidance to expand EPA’s jurisdiction. According to the letter, in December 2010, EPA and the Corps sent the draft “Clean Water Protection Guidance” to the Office of Management and Budget (OMB) for regulatory review. By the agencies’ own admission, this “Guidance” would substantively change federal policy with respect to which waters fall under the jurisdiction of the CWA and significantly increase the scope of the federal government’s power to regulate waters. EPA did not wait for any response from OMB, however, but rather moved forward to implement the guidance.

According to Water Resources and Environment Subcommittee Chair Bob Gibbs (R-OH), “It is intolerable and irresponsible of the EPA to address such a fundamental issue through an informal, procedurally easier-to-issue guidance document… This is a thinly-veiled attempt to bypass formal rulemaking procedures and force implementation of the Administration’s radical agenda. This so-called ‘Guidance’ is not merely clarifying which waters are currently subject to the Clean Water Act, it is a vast expansion of the federal government’s jurisdiction and ability to impose its will on the states and the regulated community.”

Similar sentiments echoed from a hearing on May 5, 2011, into the actions of EPA that have had the effect of stalling the issuance of permits for coal mining. On April 10, 2010, EPA issued an interim guidance regarding the necessary contents of a permit application. The guidance has not been issued in final, but according to reports from the hearing, the guidance is being cited as the reason for rejecting the applications. Several court actions have been commenced challenging EPA’s use of the process it is employing.

Bill Introduced To Combine EPA, Energy Department: On May 5, 2011, Senator Richard Burr (R-NC) introduced a bill to combine the Department of Energy (DOE) and EPA into a single DOE and the Environment. At introduction, the measure had 15 co-sponsors. In a press release, Senator Burr stated that a major benefit of the legislation would be cost savings due to the elimination of duplicative effort. He indicated that savings of $3 billion could be realized in the next year if the new department secured and followed recommendations of the General Accountability Office (GAO) and OMB, and also combined support and administrative offices. A report in the Washington Post said that the Obama Administration “unequivocally” opposed the Burr bill.


U.S. Department Of Transportation Launches Pipeline Safety Awareness Website: On April 18, 2011, the U.S. Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA) launched a new Pipeline Safety Awareness website that will provide the public, community planners, and developers accessible information and guidance on locating area pipelines. The website includes safety advisories on specific pipelines, as well as maps, reports, research, frequently asked questions, and other resources to help inform the public on their local pipeline infrastructure. PHMSA will continue to update and add new information to the website as it becomes available. The new website is part of the Department’s pipeline safety action plan to address immediate concerns in pipeline safety, such as ensuring pipeline operators know the age and condition of their pipelines; and proposing new regulations to strengthen reporting and inspection requirements. The website is

DfE Issues Standard For Safer Cleaning Products: As part of its salute to Earth Day 2011, EPA announced on April 21, 2011, that more than 2,500 products are now authorized by EPA under its Design for the Environment (DfE) Safer Product Labeling Program to carry the DfE label. DfE-labeled products do not contain known chemicals of potential concern, including carcinogens, reproductive, or developmental toxicants. All product components, including dyes and fragrances, are screened for safety under the program. EPA also announced that it soon will require manufacturers with products that bear the DfE logo to disclose their ingredients to consumers. Before allowing the DfE logo to be used on a product label, EPA conducts a scientific evaluation to ensure that candidate products are formulated from the safest possible ingredients. The DfE label means that EPA has screened each ingredient for potential human health and environmental effects and that the product contains only ingredients that, in EPA’s scientific opinion, pose the least concern among chemicals in their class. EPA is also implementing a requirement effective immediately that new DfE-labeled products list all ingredients (other than trade secrets) on the product label or in another easily accessible location (such as a website, for example). New DfE-approved products also will have to meet additional life-cycle requirements such as sustainable packaging and limits on volatile organic compounds. The new disclosure and life-cycle requirements will be phased in for existing DfE products. More information on the DfE Safer Product Labeling Program and Standard for Safer Products is available online.

POPs Convention Delegates Agree To Ban Endosulfan With Some Exemptions: On April 29, 2011, delegates to the Fifth Conference of the Parties (COP-5) to the Stockholm Convention on Persistent Organic Pollutants (POPs) agreed to a global ban of endosulfan, an insecticide. According to press accounts, the ban comes with significant concessions to win support from India, the world’s largest user of endosulfan. In India, endosulfan will be allowed for as long as 11 years to fight pests on certain crops. The Stockholm Convention restricts the use of 21 pesticides or industrial chemicals, with 19 substances listed under Annex A, which bans production or use, with certain exemptions. Two chemicals — dichlorodiphenyltrichloroethane (DDT) and perfluorooctane sulfanate (PFOS) — are listed under the Convention’s Annex B, which restricts production or use of the chemicals. Endosulfan was the only product proposed for addition to the convention’s Annex A for the COP-5 meeting. In October 2010, the Convention’s POPs Review Committee of experts recommended banning the substance, with possible exemptions to ease the transition. India argued against adding the pesticide to the list, disputing risk studies and other data. More information on the Fifth Meeting of the Conference of the Parties to the Stockholm Convention, held in Geneva April 25-29, 2011, is available online.

22 Endocrine Disruptors Added To SIN List: On May 3, 2011, the International Chemical Secretariat published an updated version of its Substitute It Now! (SIN) list under the EU REACH law, adding 22 chemicals that it said have endocrine-disrupting properties. ChemSec stated the substances on the SIN list meet REACH criteria for being banned unless authorizations for specific uses are granted. It stated the EC and EU countries should “prioritize these substances for regulatory control through REACH.” Iain Brunning of British cosmetics retailer Boots said REACH and related laws were complex and “we look to organizations such as ChemSec and the SIN list to help us understand.” The identification of hazardous substances via the SIN list help companies “plan for strategic substitution,” Brunning stated. The 22 endocrine-disrupting substances ChemSec added to the SIN list are: 3-benzylidene camphor, 4-methylbenzylidene camphor, 4-nitrophenol, p-nitrophenol, benzophenone-1, benzophenone-2, benzophenone-3, butylparaben, dicyclohexyl phthalate, diethyl phthalate, dihexyl phthalate, ethylhexyl methoxycinnamate, metam natrium, methyl tertiary butyl ether (MTBE), pentachlorophenol, perchloroethylene, propylparaben, quadrosilan, resorcinol, tert-butylhydroxyanisole (BHA), thiram, and zineb. ChemSec said it added the 22 substances to the list because they are “as worrisome as other SVHCs [substances of very high concern]”; persist in the environment; have complex effects, especially when present in combination; and are “increasingly linked to a range of health problems.” More information on the ChemSec SIN list is available online.

NIOSH Issues Epidemiologic Resource: The eChartbook is a descriptive epidemiologic reference on occupational morbidity and mortality in the United States. A web-based resource for agencies, organizations, employers, researchers, workers, and others who need to know about occupational injuries and illnesses, the eChartbook includes more than 8,000 figures and tables describing the magnitude, distribution, and trends of the Nation’s occupational injuries, illnesses, and fatalities. To access the guide, go online.

DOD Minimizes Use Of Hexavalent Chromium: On May 5, 2011, the U.S. Department of Defense (DOD) issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the requirements for minimizing the use of materials containing hexavalent chromium in items acquired by DOD (deliverables and construction materials hereafter referred to as deliverables). 76 Fed. Reg. 25569. Hexavalent chromium is a chemical that has been used in numerous DOD weapons systems and platforms due to its corrosion protection properties. The rule codifies a DOD policy for addressing the human health and environmental risks related to the use of hexavalent chromium. The rule prohibits the delivery of items containing more than 0.1 percent by weight hexavalent chromium in any homogeneous material under DOD contracts unless there is no acceptable alternative to the use of hexavalent chromium. The rule was immediately effective.

EPA Schedules Public Meeting On EPA Advisory Activities Supported By SAB Staff Office: On May 11, 2011, EPA Science Advisory Board (SAB) Staff Office announced a public session on public involvement in activities related to the Advisory Council on Clean Air Compliance Analysis (the Council), Clean Air Scientific Advisory Committee (CASAC), and the SAB. 76 Fed. Reg. 27315. The SAB Staff Office provides management and technical support to the Council, CASAC, and the SAB and their committees and panels. The SAB Staff also provides information to the public about committee activities and how the public can provide input into the science advice process. As part of its effort to continuously strengthen policies and procedures for informing the public and involving them in advisory processes, the SAB Staff Office is holding a public session to receive public input and feedback on current processes. The SAB Staff Office will consider this feedback as it develops additional policies and procedures to support Council, CASAC, and SAB advisory activities. The meeting is on June 1, 2011.