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July 1, 2011

Monthly Update for July 2011

Bergeson & Campbell, P.C.


EPA Schedules IRIS Workshop On Methanol: On June 22, 2011, the U.S. Environmental Protection Agency (EPA) scheduled a workshop on and released a proposed addendum to the external peer review draft human health assessment titled Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS) for public comment. 76 Fed. Reg. 36534. The purpose of the addendum is to provide the public with several recent studies that were published between the initial release of the methanol assessment in January 2010 and the recent re-release of the non-cancer portion of that assessment in April 2011. Due to the “unusual step of placing the methanol assessment on hold,” according to EPA, and the length of time that elapsed since the initial release of the assessment, EPA decided to issue the addendum addressing additional studies. EPA also announced that Eastern Research Group, Inc. (ERG), an EPA contractor for external scientific peer review, will convene an independent panel of experts and organize and conduct an external peer review workshop to review the draft Toxicological Review of Methanol (Non-Cancer), including the addendum. The peer review panel workshop will be held on July 22, 2011.

EPA Releases Draft Toxicological Review Of Acrylonitrile And Schedules Listening Session: On June 30, 2011, EPA announced a 60-day public comment period and a public listening session for the external review draft human health assessment titled Toxicological Review of Acrylonitrile: In Support of Summary Information on the Integrated Risk Information System (IRIS). 76 Fed. Reg. 38387. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD). EPA released the draft assessment for purposes of peer review and public comment. The public comment period ends August 29, 2011.

Expansion Of Industry Sectors Covered By The TRI Program: On June 23, 2011, EPA initiated a rulemaking to expand the industry sectors subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), also known as the Toxics Release Inventory (TRI). As originally enacted, EPCRA Section 313 applied only to the manufacturing industry sectors. The statute, however, allows EPA to add sectors to TRI to the extent that doing so is relevant to the purposes of EPCRA Section 313. Under this authority, EPA has begun a rulemaking that seeks to subject seven additional industry sectors to TRI reporting. The rule would expand coverage to the following industry sectors: Iron Ore Mining, Phosphate Mining, Municipal Waste Incineration, Industrial Dry Cleaning, Petroleum Bulk Storage, and Steam-Only Production from Fossil Fuels. EPA anticipates issuing a proposed rule in December 2012 that would add these new sectors to EPCRA Section 313 reporting.

EPA Announces Proposed SNUR For 14 Glymes: On July 12, 2011, EPA issued a proposed significant new use rule (SNUR) for 14 glymes, a class of chemicals structurally related to glycol ethers. According to EPA, the proposed rule, issued under Toxic Substances Control Act (TSCA) Section 5(a)(2), would require persons who intend to manufacture, import, or process the glymes for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. 76 Fed. Reg. 40850. The notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments are due September 12, 2011. EPA states that the docket will be available online under Docket ID EPA-HQ-OPPT-2009-0767.

OCSPP Announced Principal Deputy Assistant Administrator: EPA announced on July 13, 2011, that Louise Wise will be joining the Office of Chemical Safety and Pollution Prevention (OCSPP) as Principal Deputy Assistant Administrator, effective July 20, 2011. Wise graduated from Vanderbilt University and Georgetown Law Center, Wise joined EPA in 1984. During her 27 years with EPA, Wise has held senior positions in the Office of General Counsel (OGC), the Office of Solid Waste and Emergency Response (OSWER), the Office of the Administrator (OA), the Office of Water (OW), and the Office of Policy (OP), where she has worked since 2003.

EPA Extends Comment Period On Nanoscale Materials In Pesticide Products: On July 13, 2011, EPA extended the comment period concerning possible approaches for obtaining information about what nanoscale materials are present in registered pesticide products until August. 76 Fed. Reg. 41178. Comments are now due on August 17, 2011.


EPA Proposes Hazardous Waste Manifest Printing Specifications Correction Rule: On June 22, 2011, EPA proposed a minor change to the Resource Conservation and Recovery Act (RCRA) hazardous waste manifest regulations that affects entities that print the hazardous waste manifest form in accordance with EPA’s specifications. 76 Fed. Reg. 36480. Specifically, EPA proposed to amend the current printing specification regulation to indicate that red ink, as well as other distinct colors, or other methods to distinguish the copy distribution notations from the rest of the printed form and data entries are permissible. This proposed change would, according to EPA, afford authorized manifest form printers greater flexibility in complying with the federal hazardous waste manifest printing specifications. Written comments must be received by July 22, 2011.

EPA Proposes Revisions To RCRA Definition Of Solid Waste: On June 30, 2011, EPA Administrator Lisa Jackson signed a proposed rule seeking to narrow certain recycling exemptions under RCRA’s “Definition of Solid Waste” (DSW) provisions. A pre-publication copy of the rule and related information can be accessed online. EPA will accept comments on the rule for 60 days after it is published in the Federal Register. More information is available online.

ASTM Issues Guidance On Continuing Obligations For Contaminated Properties: On July 8, 2011, ASTM International published a new standard that provides guidance on continuing obligations for contaminated property. The Standard Guide for Identifying and Complying With Continuing Obligations (E2790-11) informs property purchasers of activities they must undertake to protect against liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The standard begins where guidance for the Phase I standard ends. The Phase I environmental site assessment is a preliminary look at a possible brownfields site. The guide focuses only on certain continuing obligations, namely those pertaining to land use restrictions, institutional controls, and taking reasonable steps with respect to releases of chemicals of concern. The guide uses a four-step process to help a prospective purchaser identify and organize the continuing obligations, take any initial steps after purchasing the property, and monitor and maintain these obligations through the term of ownership. More information on ASTM’s Standard Guide for Identifying and Complying With Continuing Obligations (E2790-11) is available online. Information on how to purchase the guide is available online.


EC Intends To Issue Regulatory Definition Of Nanomaterial This Summer: A European Commission (EC) spokesperson stated on June 15, 2011, that the EC intends to adopt a regulatory definition for nanomaterials this summer. According to the spokesperson, the definition would take the form of a recommendation, which would be a nonbinding guideline that can be used by European Union (EU) member states and regulatory bodies. In March 2011, the EC stated that it was working on a flexible definition that could be used in different sectors and different regulatory contexts. During a June 8-10, 2011, meeting of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Competent Authorities, a letter from the EC to the Dutch Environment Ministry was circulated in which the EC said that the nanomaterial definition would be ready by the end of June. When asked about the letter, the EC spokesperson stated: “We’re still working on the definition.”

Netherlands Delegation Notes Risks Associated With Nanomaterials: The Netherlands delegation submitted a paper entitled “Risks associated with nanomaterials” for discussion during the June 21, 2011, meeting of the Environment Council of the EU. The paper states that, under current EU legislation and the precautionary principle, “industry bears primary responsibility for the safety of its products for workers and consumers.” The current legislation is intended, however, “to assess the hazards of chemical substances used in products, such as cosmetics, but is not geared to evaluating the specific hazards related to nanoengineered particles.” According to the delegation, a key problem is the lack of a generally accepted definition of what constitutes a nanomaterial. The paper calls on the EC to take three steps to regulate nanomaterials: (1) reach agreement on a broadly applicable definition of nanomaterials that covers as many materials with nanospecific risks as possible; (2) ensure traceability and enable a fast and adequate response should a specific nanomaterial ever be found to be hazardous; and (3) develop an adequate risk assessment system for nanomaterials and for products with nanoscale features, and, where necessary, of risk control measures. The paper urges the EU to take action, rather than member states, to prevent industry from facing non-harmonized definitions of nanomaterials, different substance databases, additional administrative costs, and possible market restrictions for certain materials or products. The paper notes that, in the absence of such measures, however, member state initiatives “may be necessary to protect health and the environment.” The paper is available online.

Final Recast Of The RoHS Directive Published: The recast of the Directive on the Restriction of Hazardous Substances (RoHS) was published in the July 1, 2011, Official Journal of the European Union. The notice calls for the restriction of other hazardous substances and their substitution by more “environmentally friendly alternatives” as soon as scientific evidence is available, and taking into account the precautionary principle. The notice specifically states that these “other hazardous substances” include “any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure.” Proposed restrictions on additional substances, including nanosilver and long multi-walled carbon nanotubes, were not supported by the EU Council and were not included in the version of the legislation passed by both the EU Council and European Parliament (EP). The notice is available online.


EPA Rule Would Consolidate NESHAP Standards For Chemical Industry Sectors: EPA on June 16, 2011, began a rulemaking that would consolidate several chemical industry National Emission Standards for Hazardous Air Pollutants (NESHAP) into a single chemical sector NESHAP. The chemical sector is currently subject to 14 separate NESHAPs and six New Source Performance Standards (NSPS). Under this rule, EPA is seeking to consolidate these rules into a single chemical sector NESHAP that will address air toxics and a single chemical sector NSPS that will address criteria pollutants. Uniform standards (for heat exchangers, equipment leaks, storage vessels and transfer operations, control devices and closed-vent systems, and wastewater) are being developed in separate actions and will specify the work practices, equipment standards, and proper monitoring, recordkeeping, and reporting requirements. The regulatory text for the chemical sector NESHAP and NSPS is expected to reference the uniform standards, which will ensure that requirements are consistent, to the extent appropriate, across the chemical sector. EPA states that it will consolidate the NESHAP for Hazardous Organic Chemicals (HON), Miscellaneous Organic Chemicals (MON), Ethylene, Organic Liquids Distribution (OLD), Pesticide Active Ingredients (PAI), Polyether Polyols (PEPO), Group IV Polymers and Resins (P&R IV), and Vinyl Chloride and revise these rules to address unregulated and under-regulated emission points under Maximum Achievable Control Technology (MACT) or technology review for these categories. At the same time, EPA says that it will also perform a residual risk review for the MON, Ethylene, OLD, PAI, PEPOs, and P&R IV. Additionally, EPA is evaluating emissions from Vinyl Chloride facilities (currently covered by the HON and the Vinyl Chloride NESHAP) to see if additional emissions limitations are needed for combustion of chlorinated organic compounds. Similarly, EPA plans to review the six chemical sector NSPS and consolidate these requirements into a single sector NSPS and expand the scope of the rule, as necessary, to include additional emissions sources and limitations. The proposed rule is scheduled to be issued by EPA in December 2011.

EPA Issues Cross-State Air Pollution Rule: On July 6, 2011, EPA prepared in final a rule replacing EPA’s 2005 Clean Air Interstate Rule (CAIR). The so-called Cross-State Air Pollution Rule seeks to address the problem of air pollution that is transported across state boundaries. A December 2008 court decision found flaws in CAIR, but kept CAIR requirements in place while directing EPA to issue a replacement rule. To replace CAIR quickly, EPA adopted federal implementation plans (FIP) for each of the states covered by the rule. The Cross-State Air Pollution Rule requires 27 states in the eastern half of the U.S. to take measures that should reduce emissions of several criteria pollutants, namely sulfur dioxide (SO2) and nitrogen oxides (NOX). The rule targets power plant emissions that cross state lines and contribute to ground-level ozone and fine particle pollution in other states. EPA also issued a supplemental notice of proposed rulemaking (SNPR) that would require six states — Iowa, Kansas, Michigan, Missouri, Oklahoma, and Wisconsin — to make summertime NOX reductions under the Cross-State Air Pollution Rule ozone-season control program. 76 Fed. Reg. 40662. Five of those states are already covered in the final rule for interstate fine particle pollution (PM2.5). Comments on the SNPR are due by August 22, 2011.

EPA claims that the final rule will significantly cut emissions of SO2 and NOX from power plants in the eastern half of the U.S. The first phase of compliance begins January 1, 2012, for SO2 and annual NOX reductions and May 1, 2012, for ozone season NOX reductions. The second phase of SO2 reductions begins January 1, 2014. By 2014, the Cross-State Air Pollution Rule and other final state and EPA actions will reduce power plant SO2 emissions by 73 percent from 2005 levels, according to EPA estimates. EPA also believes that the rule will cut power plant NOX emissions by 54 percent. The final rule also establishes a process for determining each upwind state’s responsibility to protect downwind air quality. Under the rule, each time EPA revises the National Ambient Air Quality Standards (NAAQS), EPA can apply this process and determine if interstate pollution transport contributes to exceedances of the new NAAQS and whether new emission reductions should be required from upwind states. For example, additional emission reductions from power plants or other sources in upwind states, in addition to actions taken in downwind states, may be needed for many areas to meet future ozone or PM2.5 standards.


OSHA Proposes Changes To Recordkeeping And Reporting Requirements For Work-Related Injuries And Illnesses: The Occupational Safety and Health Administration (OSHA) on June 22, 2011, issued a proposed rule revising two aspects of OSHA’s recordkeeping and reporting requirements for work-related injuries and illnesses. 76 Fed. Reg. 36414. Under existing regulations, employers must report to OSHA, within eight hours, all work-related fatalities and in-patient hospitalizations of three or more employees. Under the proposal, employers would be required to report to OSHA all work-related fatalities and in-patient hospitalizations within eight hours, and work-related amputations within 24 hours. Reporting amputations is not required under the current regulation. OSHA is also proposing to update Appendix A of the recordkeeping rule (29 C.F.R. Part 1904 Subpart B) that lists industries partially exempt from the requirements to maintain work-related injury or illness logs. These industries received partial exemption because of their relatively low injury and illness rates. The current list of industries is based on the Standard Industrial Classification (SIC) system. The North American Industry Classification System (NAICS) was introduced in 1997 to replace the SIC system for classifying establishments by industry. When OSHA issued the recordkeeping rule in 2001, it used the old SIC code system because injury and illness data were not yet available based on the NAICS. The comment period on the proposed rule closes on September 20, 2011.


European Chemicals Agency Seeks Comment On Possible Substance Bans And Restrictions: On June 15, 2011, the European Chemicals Agency (ECHA) opened a series of public consultations on substances that could be banned or have limitations placed on their uses under the EU’s REACH legislation. In 13 cases, ECHA invited comments on chemicals that are listed on the so-called REACH candidate list of substances considered to be of very high concern. The 13 substances are chromium trioxide; chromic acid; sodium dichromate; potassium dichromate; ammonium dichromate; potassium chromate; sodium chromate; trichloroethylene; and the cobalt compounds cobalt (II) sulphate; cobalt dichloride; cobalt (II) dinitrate; cobalt (II) carbonate; and cobalt (II) diacetate. ECHA also stated that depending on the outcome of the public consultations, it would recommend to the EC that the substances be included in Annex XIV of REACH, which lists chemicals that are either prohibited or can only be used for specified applications. The EC would take the final decision on the inclusion of substances in Annex XIV, ECHA stated. To date, six substances have been banned under REACH, under a Commission decision in February 2011. A total of 53 substances have been listed on the candidate list for potential bans. ECHA also called for comments on possible restrictions on mercury in specialized measuring devices and on the mercury-based compounds phenylmercury acetate, phenylmercury propionate, phenylmercury 2-ethylhexanoate, phenylmercuric octanoate, and phenylmercury neodecanoate, which are used in the production of polyurethane coatings and adhesives. The Annex XIV consultations are open until September 14, 2011, and the consultations on possible restrictions of the uses of mercury and certain compounds are open until August 16, 2011. ECHA consultation documents are available online.

EU Chemicals Agency Formalizes Listing Of Seven Substances Of Very High Concern: On June 20, 2011, ECHA formally added seven hazardous chemicals to the EU’s candidate list of substances of very high concern, meaning they could be banned unless specific uses are authorized under the REACH legislation. The substances are 1,2,3-trichloropropane; 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (known as DIHP); 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (known as DHNUP); 1-methyl-2-pyrrolidone; 2-ethoxyethyl acetate; hydrazine; and strontium chromate. The listing was decided on by a committee of experts from EU member states that met May 25-27, 2011. The addition of the substances brings the number of hazardous chemicals on the candidate list to 53. Under REACH, inclusion in the candidate list is a signal that a substance could be prioritized for an eventual ban. Decisions on bans are made by the EC. Manufacturers or importers of products containing listed substances are required to provide safety data sheets to their customers, provide safe-use information on request, and submit a notification to ECHA within six months of the listing. More information is available online.

RoHS Directive Issued On July 1, 2011: The new RoHS Directive was published on July 1, 2011. A copy is available online. The expected future transportation timetable is: Directive entry into force — July 21, 2011 (20 days after publication); UK Consultation — Autumn/Winter 2011; New UK Regulations published — October/November 2012; UK RoHS Guidance — October/November 2012; and Transportation deadline and UK Regulations enter into force — January 2, 2013.

ECHA Issues Article 117 Report: On June 30, 2011, ECHA issued a report required under REACH Article 117(2), reporting on the operation of REACH and the Classification, Labeling, and Packaging of Substances (CLP) regulation. According to ECHA, REACH generally is working well and most shortcomings can be improved by more efficient implementation of the regulation. ECHA stated that the EC should propose amendments to prevent companies from grouping different substances into the same registration dossiers, and to punish companies that persistently file substandard registration dossiers that do not meet the information requirements set out under REACH. ECHA also concluded that to date the main challenge presented by REACH — the obligation by December 1, 2010, to register with ECHA substances manufactured or imported in volumes of 1,000 metric tons or more, and some hazardous substances at lower volumes — had been successfully managed despite “huge workloads.” The report notes other areas for improvement. The ECHA report on the operation of REACH and the CLP regulation is available online.


FDA Publishes Notices Concerning Sunscreens: On June 17, 2011, the Food and Drug Administration (FDA) published several Federal Register notices concerning sunscreens:

  • Final Rule on Sunscreen Testing and Labeling: Establishes standards for testing ultraviolet A (UVA) and ultraviolet B (UVB) protection, requirements for proper labeling of a product’s sun protection factor (SPF) and use of the claim “broad spectrum,” prohibits use of the claims “sunblock,” “waterproof,” and “sweatproof,” and mandates use of the Drug Facts labeling format. 76 Fed. Reg. 35620. The final rule will become effective June 18, 2012. The compliance date for all products subject to the final rule with annual sales less than $25,000 is June 17, 2013. The compliance date for all other products subject to the final rule is June 18, 2012.
  • Proposed Rule to Limit SPF Claims: Proposes an upper limit of SPF 50+ in the absence of data demonstrating the effectiveness of a higher SPF. 76 Fed. Reg. 35672. Comments on the proposed rule are due by September 15, 2011. Comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) must be submitted by July 18, 2011.
  • Advance Notice of Proposed Rulemaking (ANPR) on Sunscreen Dosage Forms: Solicits public comment and data on the safety and effectiveness of different dosage forms of sunscreen (e.g., gels, sticks, aerosols, wipes, etc.). 76 Fed. Reg. 35669. FDA has indicated a particular interest in receiving data on demonstrating the effectiveness of spray formulations and on the safety of inhaled aerosolized sunscreen ingredients. Data and information must be submitted by September 15, 2011.
  • Proposed Information Collection Request on SPF Labeling and Testing Requirements and Drug Facts Labeling for OTC Sunscreen Drug Products: Announces an opportunity for public comment on the proposed collection of certain information. 76 Fed. Reg. 35678. FDA requests comments on information collection requests concerning SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products. Comments are due August 16, 2011.
  • Draft Guidance for Industry: The Draft Guidance, entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application,” outlines FDA’s enforcement policy regarding sunscreen products in light of the Agency’s new final rule on testing and labeling and the tentative final monograph for sunscreen products. 76 Fed. Reg. 35665. Significantly, FDA will allow labeling of specific SPF values above 50 until the proposed rule limiting such claims is prepared in final as long as the claims are supported by data in accord with the current monograph standards. The Draft Guidance also notes that FDA intends to NOT include spray formulations in any final monograph proposal unless sufficient data are submitted in response to the ANPR request. Combination sunscreen-insect repellant products will continue to enjoy enforcement discretion as long as the products contain sunscreen ingredients listed in the current monograph and an insect repellant registered with the U.S. Environmental Protection Agency (EPA). The Draft Guidance is available online. Comments on the Draft Guidance are due by August 16, 2011. Written comments on the proposed collection of information are due by August 16, 2011.


House Subcommittee On Investigations And Oversight Holds Hearing On IRIS Program: On July 14, 2011, the House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on EPA’s Integrated Risk Information System (IRIS) Program. According to the hearing charter, the hearing was prompted in part by the recent National Academy of Sciences (NAS) report on EPA’s formaldehyde assessment, which focused on the process EPA uses to develop initially draft IRIS assessments and which is separate from the overall process that includes multiple layers of review. The charter states that, in light of those criticisms, and recognizing that this is not the first time NAS has articulated them, the Committee’s goal is to better understand the process behind the development of IRIS assessments, whether EPA plans on adopting NAS’s recommendations, and whether EPA assessments are based on the best available evidence and evaluated in accordance with established protocols. A more detailed memorandum is available online.

Senate Science And Space Subcommittee Holds Hearing On National Nanotechnology Investment: On July, 14, 2011, the Senate Committee on Commerce, Science, and Transportation’s Science and Space Subcommittee held a hearing on national nanotechnology investment. The hearing was held to examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments as the Committee works on drafting a reauthorization bill for the National Nanotechnology Initiative (NNI). The hearing was well attended and portrayed nanotechnology in a positive and constructive light. While no legislative initiative to reauthorize the NNI was discussed or introduced, we understand Committee staff is considering such legislation. A more detailed memorandum is available online.

Regulatory Reform And Small Business: The House of Representatives Judiciary Committee, voting along party lines, on July 7, 2011, passed H.R. 527, the Regulatory Flexibility Improvements Act (RFIA). The Act would require initial and final regulatory flexibility analyses to describe alternatives to any rule proposed by a federal agency that would minimize any adverse significant economic impact or maximize the beneficial significant economic impact on small business entities. The measure, sponsored by Representative Lamar Smith (R-TX), would also expand elements of initial and final regulatory flexibility analyses under the original Regulatory Flexibility Act (RFA) to include estimates and descriptions of the cumulative economic impact of a proposed rule on a small entity. Each agency would also be required to publish in the Federal Register a plan for the periodic review of existing and new rules that have a significant impact on a substantial number of small entities to determine whether such rules should be continued, changed, or rescinded. Finally, the RFIA would provide for judicial review of an agency final rule for compliance with RFA requirements after the publication of such rule. Federal Courts of Appeal would be granted jurisdiction to review all final rules issued in accordance with RFA.

Debate Is Continuing On Chemical Security: Debate is continuing on Capitol Hill on the extension of the Chemical Facility Anti-Terrorism Standards (CFATS) program. The Republican controlled House Homeland Security Committee passed on June 22, 2011, a proposal for a seven-year extension of the CFATS program, while the Democratic controlled Senate Homeland Security and Affairs Committee approved a three-year extension one week later. Democrats are concerned about gaps in the coverage of the program that should be closed before any lengthy extension, such as seven years, is enacted. These gaps include wastewater and drinking water plants and also inherently safer technology (IST). If there is an impasse as the October date for the program to expire nears, Congress may simply extend the program for one year, as has been done previously.

EPA Faces Reduction In Funding And Activities: The Subcommittee on Interior, Environment and Related Agencies of the House of Representatives Appropriations Committee voted on July 7, 2011, to reduce the funding for EPA for fiscal 2012 and also to restrict the jurisdiction of the Agency in certain program areas. Funding would be set at $7.1 billion, or $1.6 billion less than for 2011. There would be a variety of restrictions on programs relating to, among others, drinking water and wastewater, stationary sources of greenhouse gases, and pesticide spraying. The vote was along party lines, with Democrats criticizing the extent of the cuts in both spending and programs. On July 12, 2011, the full Appropriations Committee reported the bill to the House floor. In the process, the Committee brought forward the prohibition the Subcommittee had put on the work of the EPA, and added a prohibition on the regulation of mobile sources of greenhouse gas emissions, hazardous air pollutants from cement kilns, fine particulate matter, and nutrients in Florida waters. The Republicans on the Committee rebuffed efforts by Democrats to add back in funds for such projects as Superfund and brownfields.

Safe Cosmetic Legislation Re-introduced: Representatives Jan Scharkowsky (D-IL), Ed Markey (D-MA), and Tommy Baldwin (D-WI) re-introduced the Safe Cosmetics Act on June 24, 2011. The bill, H.R. 2859, is similar to legislation considered in past sessions, with added safeguards to protect small companies. According to Rep. Scharkowsky, the measure is intended to close what the sponsors perceive to be major loopholes in federal law that allow companies to use ingredients in cosmetics and personal products known to damage human health and the environment. In a press release, the sponsors went on to say that FDA does not regulate cosmetics the same way it does food and drugs to ensure safety. The growing number of reports of serious health problems the sponsors cite from the use of cosmetics shows a need to update the laws. H.R. 2859 would seek to do that in a variety of ways. Random annual sample tests for pathogens or contaminants would be conducted by FDA. Cosmetic companies would have to register and pay a fee based on gross sales. (Companies with sales of $2 million or less would be exempt from registration and companies with sales under $10 million would not have to pay the fee.) Ingredients would have to be listed on the label for cosmetics and a list of ingredients that would be prohibited would be established by FDA. The bill highlights carcinogens and reproductive toxins as principal candidates for exclusion. FDA would have recall authority for violative products in the marketplace and there would have to be reporting of adverse health effects. States would be allowed to set more stringent standards.

House Challenges EPA Authority To Block Grants: The House of Representatives passed H.R. 2018 and sent the measure to the Senate. H.R. 2018, styled the Clean Water Cooperative Federalism Act of 2011, would amend the Federal Water Pollution Control Act (commonly known as the Clean Water Act) to prohibit the Administrator of EPA from taking a variety of actions, among them: (1) promulgating a revised or new water quality standard for a pollutant when the Administrator has approved a state water quality standard for such pollutant unless the state concurs with the Administrator’s determination that the revised or new standard is necessary to meet the requirements of such Act; (2) taking action to supersede a state’s determination that a discharge will comply with effluent limitations, water quality standards, controls on the discharge of pollutants, and toxic and pretreatment effluent standards under such Act; (3) withdrawing approval of a state program under the National Pollution Discharge Elimination System (NPDES), limiting federal financial assistance for a state NPDES program, or objecting to the issuance of a NPDES permit by a state on the basis that the Administrator disagrees with the state regarding the implementation of an approved water quality standard or the implementation of any federal guidance that directs the interpretation of such standard; and (4) prohibiting the specification of any defined area as a disposal site for the discharge of dredged or fill material into navigable waters and denying or restricting the use of such area as a disposal site in a permit if the state where the discharge originates does not concur with the Administrator’s determination that the discharge will result in an unacceptable adverse effect on municipal water supplies, shellfish beds, and fishery areas.

Moran Plans To Address Endocrine Disrupting Chemicals: Representative James Moran (D-VA) has indicated that he will introduce legislation at some point to address what he says is a growing concern with the public health implications of endocrine disrupting chemicals. Senator John Kerry (D-MA) has indicated that he will join in sponsoring the measure. A draft copy of the proposed legislative language has been circulating, but there is no assurance that the bill language will not change prior to introduction. As presently written, the Moran legislation would focus research activities first on the National Toxicology Program (NTP) and its Board of Scientific Counselors with the goal of strengthening the scientific basis of information used by federal agencies to understand the effects of endocrine disrupting chemicals and reduce human exposure to them, and then on the National Institute of Environmental Health Sciences (NIEHS). Initially, a panel of NTP experts would consider and report to the director of NTP on research and issues relating to the identification, classification, or evaluation of such chemicals. Within three years after the bill passes, an up-to-date list would have to be provided to the NTP Director specifying chemicals that are actual or potential endocrine disrupting chemicals and identifying the level of evidence that the chemical disrupts the human endocrine system, the level of concern that causes, and the pathways of exposure for humans and animals. The panel would also report on the possible need for additional data to determine the level of concern. The Director of NIEHS would conduct a research program designed to develop information for federal agencies to understand the chemical disruption of the endocrine system and how to reduce such exposure. The lists developed would be used by the agencies to prepare and publish a response evaluating the findings and determinations of the NTP for each chemical subject to their jurisdiction. If the Director finds at least a minimum level of concern that a chemical may be a disruptor, each agency must develop a strategy for reducing human exposure, and make it available with methods to promote voluntary actions by industry to reduce exposure. If the Director of NIEHS makes a finding that a chemical is a high level of concern as a disruptor, it would be unlawful to use the chemical in a manner affecting interstate commerce unless the pathway to human exposure is mitigated. The several agencies that might be involved have 24 months to establish regulations or take other actions to implement the prohibition against use for chemicals found to create a high level of concern. The NIEHS Director could move to “ban” up to ten endocrine disruptor chemicals per year.

House Subcommittee Clears TRAIN Measure: The Subcommittee on Energy and Power of the House Energy and Commerce Committee approved a bill written by Representative John Sullivan (R-OK) and Jim Mathieson (D-UT) that creates a panel of agency heads or their designees to analyze the effect of regulations promulgated by EPA relating to air quality in one way or another. In each analysis, the legislation mandates that it include the impact on the global economic competitiveness of the United States, especially as it relates to energy intensive and trade sensitive industries. The analysis also has to cover other cumulative costs and benefits and resulting changes in electrical and fuel prices. A study on the effect on employment over a five-year period is also included, and the effect on the bulk power supply. The bill calls for a study of the cumulative effect on consumers, small businesses, regional economies, state, local, and tribal governments, local and industry specific labor markets, and agriculture. A first report would be due in August 2012 and would include projections of the effect in 20122020, and 2030.


EPA Research Office Plans To Launch Chemical Safety For Sustainability Initiative: On June 17, 2011, EPA’s ORD announced that it will launch a Chemical Safety for Sustainability research initiative by October 1, 2011. The Chemical Safety for Sustainability effort will seek to gather information that may be helpful in understanding “real-world risks” about people’s aggregate exposure to particular chemicals from multiple sources, the cumulative risks that come from human and ecological exposures to different chemicals that affect the body in similar ways, and the risks to populations that are more susceptible to chemicals across the life cycle of those compounds, according to Jeff Morris, EPA ORD. EPA also could develop predictive computer models to assist companies or other interested parties determine when a chemical being researched for possible development has either problematic or positive attributes. Information on the Committee on Science for EPA’s Future is available online.

Three Chemicals Added To Rotterdam List For Prior Consent: At the June 20-24, 2011, meeting of the Fifth Conference of the Parties to the Rotterdam Convention on Prior Informed Consent Procedures for Certain Hazardous Chemicals and Pesticides, representatives from the convention’s 143 member governments agreed to add alachlor, aldicarb, and endosulfan to the prior informed consent (PIC) list. Adopted in 1998, the Rotterdam Convention requires countries exporting chemicals or pesticides listed in Annex III that are banned or severely restricted at home to notify the importing country and receive approval before the shipment is sent, a process known as prior informed consent. Parties to the Stockholm Convention on Persistent Organic Pollutants (POPs) decided in April to add endosulfan to its list of banned chemicals, with some limited exceptions. Endosulfan is banned in at least 60 countries, with other nations such as Brazil, China, and the United States phasing out the pesticide. Under the convention rules, a hazardous chemical or pesticide is to be listed in Annex III if governments in at least two regions have taken action to restrict or ban the substance and have notified the convention of their actions. In reviewing the notifications, the Chemical Review Committee must confirm that the final regulatory action was taken to protect human health or the environment and as a consequence of a risk evaluation based on a review of scientific data in the context of prevailing conditions in the country in question. The debate over chrysotile asbestos continues as no consensus was reached. More information on the Fifth Conference of the Parties to the Rotterdam Convention on Prior Informed Consent Procedures for Certain Hazardous Chemicals and Pesticides is available online.