Monthly Update for July 2013
ChemCon Asia 2013 with its unique global approach and comprehensive review of global chemical issues will take place in Seoul, South Korea, from September 9-13, 2013, with an accompanying exhibition and two pre-conference seminars — Korea and Global Survey of Regulated Lists of Chemicals. Bergeson & Campbell, P.C. is a proud sponsor.
ChemCon is a global platform that brings together more than 200 experts representing companies, authorities, and international organizations from over 25 countries. Presentations given by more than 35 speakers from governments and industry will focus on the field of chemical legislation all over the world. Conference sessions will cover global chemical control, including current and emerging legislation, reporting and testing of new chemicals, chemical inventories, evaluation of existing chemicals, classification and labeling, risk management, hazard communication, and product registration. ChemCon Asia 2013 also enables attendees to learn from experiences from the legislative approach of others by presenting some interesting business cases.
The ChemCon advisory committee includes:
- Volker J. Soballa, Vice President Product Stewardship, Evonik Industries AG;
- Robert Donkers, Adviser DG Environment, Delegation of the European Union (EU) to India and Bhutan;
- Karon E. Armstrong, International Technical Operations, 3M;
- Robert Feierl, Feierl Herzele GmbH;
- Lynn L. Bergeson, Bergeson & Campbell, P.C.; and
- David Nelissen, Accenture.
Exhibition — In addition to the conference sessions of ChemCon Asia 2013, an exhibition will be organized on the same premises to provide up-to-date information about all kinds of technical or commercial services linked with the chemical industry.
More information is available online.
CRS Publishes Report Comparing TSCA Reform Legislation And Current Law: The Congressional Research Service (CRS) published a July 8, 2013, report entitled Proposed Reform of the Toxic Substances Control Act (TSCA) in the 113th Congress: S. 1009 Compared with S. 696 and Current Law. The report states that the Safe Chemicals Act (SCA) (S. 696) would amend TSCA to require chemical manufacturers and processors to submit specified information about the toxicity and usage of chemicals in commerce to the U.S. Environmental Protection Agency (EPA). EPA would use the information to determine whether a chemical would meet the safety standard of “a reasonable certainty of no harm from aggregate exposure,” given the imposition of any needed restrictions on manufacture, processing, distribution, use, or disposal. The SCA would prohibit uses of evaluated chemical substances unless they were determined by EPA to meet the safety standard. It would also increase public access to information about EPA’s decisions and to some information about chemicals that currently is treated as confidential business information (CBI). The report notes that the bill “would rarely preempt state and local laws.” More information regarding the SCA is available in our April 29, 2013, memorandum, which is available online. The Chemical Safety Improvement Act (CSIA) (S. 1009) would authorize EPA to require manufacturers to develop new information if EPA can show need in the context of an evaluative framework for chemical risk assessment and management. The bill would require EPA to screen all chemicals in commerce and assign each a high or low priority for risk assessment or, if necessary, require manufacturers to produce additional information. It would require EPA regulation ensuring “no unreasonable risk of harm from exposure” to a chemical under the intended conditions of use. The CSIA would preempt new state and local laws for chemicals identified as high or low priority. More information regarding the CSIA is available in our May 29, 2013, memorandum. The report states that both bills would evaluate the TSCA Inventory to allow prioritization of the estimated 9,000 chemicals currently produced and used in the U.S. In addition, both bills would explicitly require manufacturers to substantiate some requests for protection of CBI from public disclosure. The CRS report is available online.
EPA Responds To TSCA Petition On Oil And Gas Exploration And Production: On July 11, 2013, EPA responded to a petition submitted on August 4, 2011, by Earthjustice and 114 other organizations under Section 21 of TSCA. 78 Fed. Reg. 41768. The petition asked EPA to use: TSCA Section 8(a) to require manufacturers and processors of oil and gas exploration and production (E&P) chemical substances and mixtures to maintain certain records and submit reports on those records; TSCA Section 8(d) to require manufacturers, processors, and distributors to submit to EPA existing health and safety studies related to E&P chemical substances and mixtures; TSCA Section 8(c) to request submission of copies of any information related to significant adverse reactions to human health or the environment alleged to have been caused by E&P chemical substances and mixtures; and TSCA Section 4 to require manufacturers and processors of E&P chemical substances and mixtures to conduct toxicity testing of E&P chemical substances and mixtures. In a letter dated November 2, 2011, EPA informed petitioners that it denied the TSCA Section 4 request and in a letter dated November 23, 2011, EPA informed petitioners that it granted in part the TSCA Sections 8(a) and 8(d) requests. Because EPA partially granted the TSCA Sections 8(a) and 8(d) requests, EPA noted its plans to initiate rulemaking under TSCA Sections 8(a) and 8(d) to obtain data on chemical substances and mixtures used in hydraulic fracturing. Although EPA partially granted the TSCA Sections 8(a) and 8(d) requests, EPA stated that it is not committing to a specific rulemaking outcome. EPA plans first to develop an Advance Notice of Proposed Rulemaking (ANPRM) and initiate a stakeholder process to provide input on the design and scope of the TSCA reporting requirements that would be included in a proposed rule. EPA anticipates that states, industry, public interest groups, and members of the public will be participants in the process. The stakeholder process will bring stakeholders together to discuss the information needs and help EPA to ensure any reporting burdens and costs are minimized, ensuring information already available is considered to avoid duplication of efforts. The dialogue will also assist EPA in determining how information that is claimed CBI could be aggregated and disclosed to maximize transparency and public understanding.
EPA Launches FIFRA Online Training Tool: On June 18, 2013, EPA launched an online training tool on emergency exemption requests issued under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The online tool is intended to aid federal and state agencies in determining whether it is appropriate to request an emergency exemption for pesticide use and to help agencies correctly submit applications. The online training website includes a description of application requirements, overview of EPA’s process for reviewing exemption requests, and alternative options for handling a significant pest problem. The online training tool is available online.
EPA Proposes To Add Nonylphenol Category To TRI Reporting Requirements: On June 20, 2013, EPA proposed to add a nonylphenol category to the list of toxic chemicals subject to annual reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 78 Fed. Reg. 37176. EPA is adding this category to the list of chemicals under EPCRA’s Toxics Release Inventory (TRI) because it believes this category meets the EPCRA Section 313(d)(2)(C) toxicity criterion and warrants inclusion on the TRI. Nonylphenol is an organic chemical used in the manufacture of nonylphenol ethoxylates, which are nonionic surfactants used in a wide variety of industrial applications and consumer products. Because there is no one Chemical Abstracts Service Registry Number (CASRN) that adequately captures what is referred to as nonylphenol, and because of the apparent confusion that has resulted from the use of multiple CASRNs, EPA is proposing to add nonylphenol as a category defined by a structure. This category definition covers the chemicals that are included in CASRN 84852-15-3 as well as those 4 position isomers covered by CASRN 25154-52- 3. Any nonylphenol that meets the above category definition would be reportable regardless of its assigned CASRN. Comments on the proposed addition of the nonylphenol category to the TRI list of regulated chemicals must be submitted to EPA by August 19, 2013.
EPA Schedules Workshop On Chemically-Induced Mouse Lung Tumors: On June 18, 2013, EPA announced the scheduling of a workshop on October 24-25, 2013, that will cover a broad range of evidence from human, animal, and in vitro (test tube) studies with a focus on specific chemicals (ethylbenzene, naphthalene, and styrene) causing tumors in mice and implicated in a proposed species-specific mode of action based on metabolic and physiological susceptibility. The goal of the workshop is to inform Integrated Risk Information System (IRIS) assessments for chemicals with similar mouse lung tumor evidence. The workshop is being sponsored and organized by EPA with input from a volunteer committee of outside experts (including representatives from academic institutions, state agencies, other federal organizations, non-governmental organizations (NGO), and industry), and an internal working group of EPA experts and other federal partners. The workshop will include four separate sessions that will examine individual topic areas in detail, beginning with and continually referring back to the human relevance of data from animal and in vitro studies. Follow-on meetings may occur after the workshop to continue discussions related to the goal of the workshop.
EPA Decommissions eDisclosure Tool: As of July 1, 2013, EPA decommissioned eDisclosure, its web-based system that allowed companies to electronically self-disclose certain violations under EPA’s Audit Policy. Although EPA is taking eDisclosure off-line, regulated entities can still make voluntary disclosures under the Audit Policy. Instructions on how to submit disclosures are available online.
EPA Releases Draft Paper On Endocrine Disruptors: On June 19, 2013, EPA posted a draft paper on endocrine disruptors. The paper, State of the Science Evaluation: Nonmonotonic Dose Responses as They Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures, concludes that EPA’s current testing strategy is unlikely to miss problems that chemicals believed to pose endocrine disruptor issues would present to people or the environment. Information about EPA’s draft science paper on nonmonotonic dose responses along with links to the paper and related documents are available online.
OSHA Announces New National Emphasis Program For Occupational Exposure To Isocyanates: On June 25, 2013, the Occupational Safety and Health Administration (OSHA) announced a new National Emphasis Program (NEP) to protect workers from the health effects from occupational exposure to isocyanates. OSHA develops NEPs to focus outreach efforts and inspections on specific hazards in an industry for a three-year period. Through this NEP, OSHA intends to focus on workplaces in general, construction, and maritime industries that use isocyanate compounds in an effort to reduce occupational illnesses and deaths. More information is available online.
EPA Proposes To Lower Lead Reporting Threshold Under Air Emissions Reporting Requirements Rule: On June 20, 2013, EPA proposed to revise EPA emission inventory reporting requirements for state, local, and tribal agencies in the current Air Emissions Reporting Requirements Rule (AERR). 78 Fed. Reg. 37164. EPA proposed to lower the threshold for reporting lead sources as point sources. EPA issued the AERR on December 17, 2008, and the current AERR threshold for determining if a stationary source of lead emissions must be reported as an individual point source rather than as part of a county-aggregate nonpoint source is 5 tons per year (tpy). In 2010, however, EPA issued revisions to lead ambient air monitoring requirements, which required monitoring agencies to install and operate source-oriented ambient monitors near lead sources emitting 0.50 tpy or more by December 27, 2011. EPA proposed to lower the AERR emissions threshold for reporting lead emitters to match the 0.50 tpy threshold in the revised ambient air monitoring requirements. This would allow EPA to evaluate and provide proper oversight of the ambient monitoring network design finalized in the revised ambient air monitoring requirements. Comments on the proposed rule must be submitted by August 19, 2013.
EPA Sued For Missing Deadline To Review Ozone NAAQS: The Sierra Club, American Lung Association, Environmental Defense Fund, and Natural Resources Defense Council on June 19, 2013, filed a Complaint for Declaratory and Injunctive Relief against EPA for its failure to meet a statutory deadline for reviewing the ozone National Ambient Air Quality Standard (NAAQS). The complaint, filed by Earthjustice on behalf of the plaintiffs, seeks to force EPA to complete the review by September 30, 2014. The Clean Air Act (CAA) requires EPA to review and consider revising its NAAQS every five years. EPA last revised the ozone NAAQS in March 2008, but missed the March 2013 deadline for completing the review of the standard.
OECD Publishes Report On Nanotechnology For Green Innovation: On June 13, 2013, the Organization for Economic Cooperation and Development (OECD) Working Party on Nanotechnology (WPN) published the final report Nanotechnology for Green Innovation. The report summarizes information collected from various projects undertaken by the WPN regarding the use of nanotechnology for green innovation. It also draws on results and conclusions from the March 2012 symposium on “Assessing the Economic Impact of Nanotechnology,” which was organized by the OECD WPN and the U.S. National Nanotechnology Initiative (NNI). The report focuses on an introduction to “green nanotechnology,” strategies for green innovation through nanotechnology, and the impacts of green nanotechnology. The report also highlights investments in nanotechnology, priorities of selected countries, and opportunities for public-private collaboration. The full report is available online.
EC Begins Consultation On The REACH Annexes On Nanomaterials: On June 21, 2013, the European Commission (EC) began a consultation on the modification of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed. The EC states that REACH must ensure a high level of health, safety, and environmental protection, while also permitting access to innovative products and promoting innovation and competitiveness. The EC intends to provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with REACH Article 1(1). The EC expects to propose a possible amendment of the REACH annexes in 2013. Any proposed amendment would be accompanied by an impact assessment. Comments are due September 13, 2013. More information is available online.
NNI Posts FAQs For Small And Medium Businesses: NNI posted frequently asked questions (FAQ) for small and medium business and industry. According to NNI, the FAQs provide answers to some of the most common questions from the nanotechnology business community. The FAQs provide links to sites where a nanotechnology start-up company can obtain information about government funding opportunities; resources intended to help a small company focusing on research and development of nanotechnology-enabled products or services; and ways for a small nanotechnology business to protect intellectual property. The FAQs list U.S. government regulatory agencies that play a role in nanotechnology commercialization; links for information on meetings or workshops related to nanotechnology; ways for small nanotechnology companies to find out what the federal government is interested in buying; and a link to the Department of Commerce Bureau of Industry and Security, which is charged with the development, implementation, and interpretation “of U.S. export control policy for dual-use commodities, software, and technology.” The FAQs state that the Bureau maintains a webpage “devoted to guidance on how to comply with export control laws and regulations.” The FAQs are available online.
EPA Issues Final SNURs For Nanoscale Materials: On June 26, 2013, EPA issued final significant new use rules (SNUR) for 17 substances, including 14 fullerenes and three carbon nanotubes. 78 Fed. Reg. 38210. EPA proposed the submission December 2011. The SNURs require persons who intend to manufacture or process any of these 17 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The final rule includes EPA’s response to comments. EPA encourages any manufacturers or processors who intend to conduct testing or submit a significant new use notification (SNUN) to contact EPA prior to commencing testing to avoid duplicative testing, to identify alternative testing, and to discuss protocols and testing strategies. A commenter suggested that EPA provide mandatory nano-specific ingredient and warning labeling requirements. In response, EPA states that the SNURs and consent orders that are the basis for the SNURs do not require nano-specific labeling or warnings because: “(1) the basis for the consent orders and SNURs is not that they are nanomaterials per se, but rather is based on their specific properties and potential risks, and (2) companies that manufacture, process, and use chemical substances that are carbon nanotubes and fullerenes already clearly identify those chemical substances as nanomaterials.” The proposed SNURs would allow the submission of data in support of a new chemical exposure limit (NCEL) under 40 C.F.R. Section 721.30. EPA notes that, because of the uncertainty surrounding the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of 1 microgram per cubic meter (µg/m3), it “will not adopt the NIOSH REL as a NCEL at this time because EPA cannot determine that at the REL the potential exposures may not present an unreasonable risk.” EPA states that it will consider the final NIOSH REL, or other alternative exposure controls for carbon nanotubes, if a submission requesting such is made under 40 C.F.R. Section 721.30. EPA states that, despite uncertainties cited by a commenter, it “believes that its assessment and risk management of nanomaterials, although sometimes hampered by a lack of submitted data, is adequate to identify and prevent potential unreasonable risks to human health or the environment from manufacturing processing, and using nanomaterials including risks to workers.” The final rule will be effective on August 26, 2013.
EPA Regulatory Agenda Includes Notice Concerning Nanoscale Materials: On July 3, 2013, EPA posted its 2013 Regulatory Agenda, which includes the following item concerning nanoscale materials:
Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule: EPA is developing a proposal to establish reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA) for chemical substances when manufactured (defined by statute to include import) or processed as nanoscale materials. Specifically, EPA is developing a significant new use rule (SNUR) under TSCA section 5(a)(2) that would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by the proposed rule to notify EPA at least 90 days before commencing that activity. 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 to prevent unreasonable risk to human health or the environment. In addition, EPA is developing a proposal to require reporting and recordkeeping under TSCA section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.
According to the Regulatory Agenda item, EPA intends to issue a notice of proposed rulemaking in August 2013. The item is available online.
Denmark Begins Public Consultation On Nanomaterials Register: On July 4, 2013, the Danish Environmental Protection Agency began a public consultation on a draft order for a nanomaterials register. The draft order would impose annual reporting requirements on manufacturers and importers concerning mixtures and products containing nanomaterials. The reporting requirements would apply to nanomaterials released during use of the product or if the nanomaterial is the reason hazardous substances are released from the product. The order would take effect January 1, 2014, and the first reports would be due no later than January 31, 2015. Comments are due August 16, 2013. More information is available online.
Belgium Notifies EC Of Draft Decree Creating Nanomaterials Register: On July 4, 2013, the Belgian Federal Public Service for Health, Food Chain Safety, and Environment notified the EC of a draft decree that would create a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market. Under the draft decree, substances manufactured at the nanoscale, and preparations containing them, would be declared if more than 100 grams of these substances are placed on the market per year. If Belgium believes that a substance could present a risk to human health or the environment, it could ask registrants to provide information on potential dangers, exposure, and risks. The draft decree would apply to: substances manufactured at the nanoscale; preparations containing such substances; and articles incorporating these substances. Substances manufactured at the nanoscale included within the scope of the draft decree would encompass nanomaterials as defined in the EC’s October 2011 recommendation on the definition of nanomaterials, “including the assimilation of fullerenes, graphene flakes and carbon nanotubes, but with the exception of non-chemically-modified natural substances, substances produced accidentally and substances whose fraction between one nanometer and one hundred nanomet[er]s is a by-product of human activity.” Pigments and — concerning the declaration of articles — carbon black, synthetic amorphous silica, and precipitated calcium carbonate used as fillers would be excluded from the scope of the draft decree. Products already subject to regulations concerning nanomaterials, such as biocides, would also be excluded. The draft decree would apply from January 1, 2015, for nanomaterials and substances containing nanomaterials, and from January 1, 2016, for articles or complex objects that contain a substance in a nanoparticle state. EU Member States have until October 7, 2013, to submit comments on the draft decree. Belgium could then pass the draft decree, revising it as necessary based on any comments received. More information is available online.
ECHA Adds Six Substances To SVHC List: On June 20, 2013, the European Chemicals Agency (ECHA) added six chemicals to the REACH list of substances of very high concern (SVHC), making each eligible for phase out unless specific authorizations for continued uses in the EU are granted. The substances are cadmium, cadmium oxide, ammonium pentadecafluorooctanoate (APFO), pentadecafluorooctanoic acid (PFOA), dipentyl phthalate (DPP), and 4-nonylphenol, branched and linear, etoxylated. The REACH list of SVHCs is available online.
ECHA Launches Public Consultation On Six Substances: On June 24, 2013, ECHA launched a public consultation on its draft recommendation of six new substances to be included in the Authorization List. ECHA regularly recommends substances from the Candidate List for inclusion in the Authorization List (Annex XIV of REACH) to the EC. Based on an assessment of the available information and initial consultation of the Member State Committee, ECHA currently plans to recommend the following substances: N,N-dimethylformamide (DMF); diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA); aluminosilicate refractory ceramic fibers (Al-RCF); zirconia aluminosilicate refractory ceramic fibers (Zr-RCF); bis(pentabromophenyl) ether (decabromodiphenyl ether) (DecaBDE); and 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-Octylphenol ethoxylates) (4-tert-OPnEO). The recommendation also specifies the proposed conditions to the authorization requirement for each substance. These conditions particularly include the latest application and sunset dates and any specific exemptions of uses from the authorization requirement. More information is available online. Interested parties are invited to submit comments by September 23, 2013.
ECHA Outlines Plans To Expand Checks For REACH Compliance: On June 27, 2013, ECHA announced that it is deploying screening techniques and will extend checks to more than five percent of dossiers to iron out data quality problems that have dogged the implementation of REACH. ECHA and advocacy groups urging for greater safety of chemicals have highlighted on a number of occasions that the quality of REACH dossiers has sometimes been poor, with missing information or lack of clarity on issues such as substance identity. Compliance checks verify that dossiers provide sufficient information to meet the requirements of REACH. If dossiers are found to be noncompliant, ECHA can send binding requests to companies for updates. If these are not acted on, ECHA can ultimately revoke companies’ REACH registration numbers. Information on registration dossier compliance checks under REACH is available online.
FDA To Host Webinar On How FDA “Protects” Consumers From Pesticides: On July 2, 2013, the U.S. Food and Drug Administration (FDA) announced a webinar on how it “protects” consumers from pesticide. The notice states that FDA monitors residue levels for all foods except for meat and poultry products, and that 75 percent of the foods FDA monitors are fruits and vegetables. The webinar will explain how FDA’s monitoring program helps protect the consumer from traces of pesticides in foods. An opportunity to ask questions will follow the presentation. The webinar will take place on August 30, 2013, at 2:00 p.m. (EDT). To join the webinar, see the instructions. This webinar is part of a series of online sessions hosted by different FDA centers and offices.
EPA Approves Two Plant Species For Renewable Fuel Standard: On July 11, 2013, EPA announced its approval of imported strains of giant reed and napier grass as approved feedstocks for renewable fuels satisfying federal requirements for greenhouse gas reductions. 78 Fed. Reg. 41703. The rule was immediately effective.
USDA Makes Important Announcements To Further Biobased Products: On Thursday, July 11, 2013, the U.S. Department of Agriculture (USDA) made two important announcements that will help promote biobased products. First, USDA announced that it has designated the following eight new biobased product categories for preferred federal procurement under the BioPreferred Program: aircraft and boat cleaners; automotive care products; engine crankcase oil; gasoline fuel additives; metal cleaners and corrosion removers; microbial cleaning products; paint removers; and water turbine bearing oils. A full list was published in the June 11, 2013, Federal Register. Second, USDA announced that its BioPreferred Program also has reopened the web portal for companies to apply for the voluntary USDA Certified Biobased Product label. Thus far, about 900 individual products have received the USDA Certified Biobased Product label. USDA’s press release on these important announcements is available online.
EPW Chair Boxer States TSCA Reform Bill Needs Overhaul: On June 19, 2013, Senate Environment and Public Works (EPW) Committee Chair Barbara Boxer (D-CA) held a press conference arguing that the CSIA (S. 1009) — a bipartisan bill reforming TSCA and co-sponsored by Senator David Vitter (R-LA) and the late Senator Frank Lautenberg (D-NJ) — has little chance of passage without a significant overhaul. Boxer claimed that the bill faces stiff opposition from environmental and health advocates as well as California officials. These groups generally oppose the bill due to concerns that it would pre-empt state chemical and product safety regulations. Boxer noted that she would not support the pre-emption language and instead favors the SCA (S. 696), a TSCA reform bill she co-sponsored in April with Lautenberg. Boxer’s comments cast doubt on the CSIA’s passage, as she needs to give her consent for the bill to move forward in the EPW Committee. She plans to amend S. 1009 by grafting into it provisions from S. 696 and from other bills, including the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 50) and the BPA in Food Packaging Right to Know Act (S. 1124). Senator Boxer also noted that she plans to introduce a Chair’s markup after a scheduled July 31, 2013, hearing on TSCA reform.
Energy And Commerce Committee Approves Environmental Bills: On June 18 and 19, 2013, the House Energy and Commerce Committee marked up and passed four bills: the Coal Residuals Reuse and Management Act of 2013 (H.R. 2218), the Reducing Excessive Deadline Obligations Act of 2013 (H.R. 2279), the Federal and State Partnership for Environmental Protection Act of 2013 (H.R. 2226), and the Federal Facility Accountability Act of 2013 (H.R. 2318). The Coal Residuals Reuse and Management Act of 2013 is intended to encourage recovery and beneficial use of coal combustion residuals by removing the option for EPA to regulate coal combustion residuals under Subtitle C of the Resource Conservation and Recovery Act (RCRA )as a hazardous waste. The bill also establishes requirements for the management and disposal of coal combustion residuals that are protective of human health and the environment. The bill also sets out specific criteria for EPA to make a determination regarding whether a state permit program is deficient. The bill requires an implementing agency to require owners or operators of sites that will use coal combustion residues to apply for and obtain permits that incorporate the minimum requirements. The minimum requirements include certain criteria set out in 40 C.F.R. Part 258 for managing municipal waste and other requirements that would apply specifically to the management and disposal of coal combustion residues. The requirements include provisions for structural integrity, wind dispersal, public availability of information, design requirements, groundwater monitoring and corrective action, closure and post-closure, air quality, financial assurance, surface water, run-on and run-off for land based structures, run-off for surface impoundments, and location restrictions for structures established after enactment. The House of Representatives is expected to vote the week of July 15 on the Coal Residuals Reuse and Management Act of 2013.
Senate Bill Would Require Cost-Benefit Analysis Of Independent Agencies’ Rules: On June 18, 2013, a trio of Senators co-sponsored legislation (S. 1173) that would subject independent federal agencies to the same cost-benefit analysis requirements that govern executive agencies. The independent agencies targeted by the bill include the Securities and Exchange Commission, the National Labor Relations Board, the Small Business Administration, the Consumer Products Safety Commission, and others. These agencies now are largely exempt from the requirements in Executive Order (EO) 12866 and EO 13563 to conduct formal cost-benefit analyses during rulemaking. The Independent Agency Regulatory Analysis Act would change this by requiring independent agencies to conduct a cost-benefit analysis on their regulations and to adopt the least burdensome regulatory approach. Senators Rob Portman (R-OH), Mark Warner (D-VA), and Susan Collins (R-ME) co-sponsored the bill. Under the measure, independent agencies would also be required to submit significant regulatory proposals (those with an estimated economic impact of $100 million or more on the economy) to the White House Office of Management and Budget for review.
House Appropriations Subcommittee Restores Funding To PHMSA: The House Appropriations Subcommittee on Transportation, Housing and Urban Development on June 19, 2013, passed legislation that would restore pre-sequester funding to the Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA). The bill would provide PHMSA with $203 million in funding for fiscal year 2014 operations. The legislation includes funding for the Department of Transportation, the Department of Housing and Urban Development, and other related agencies. In total, the bill provides $44.1 billion in discretionary spending — a reduction of $7.7 billion below the fiscal year 2013 enacted level and $13.9 billion below the President’s budget request.
House Bill Would Repeal Fossil Fuel Consumption Reduction Mandate For Federal Buildings: On June 14, 2013, Representative Edward Whitfield (R-KY) introduced a bill that would eliminate the requirement that federal buildings phase out the use of energy generated by fossil fuels. The Energy Conservation and Production Act (42 U.S.C. 6834) requires that buildings owned or operated by the federal government completely wean themselves off the use of fossil fuel by 2030. Mr. Whitfield’s legislation would repeal that requirement.
Senators’ Bill Provides Climate Adaptation Tools Called For In GAO Report: On June 20, 2013, Senators Max Baucus (D-MT) and Sheldon Whitehouse (D-RI) introduced legislation to provide local communities with better tools to prepare for extreme weather and require federal agencies to work more efficiently by implementing a single, coordinated strategy for protecting, restoring, and conserving the natural resources that American tourism and recreation jobs and local economies depend on. The bill, the Safeguarding America’s Future and the Environment (SAFE) Act (S. 1202), comes on the heels of a new Government Accountability Office (GAO) report that notes “recreation and tourism generate billions of dollars for regional economies through activities such as fishing, hunting, skiing, hiking, and diving and some of these economic benefits could be reduced or lost as a result of the impacts from climate change.” The report highlights the need for additional tools provided in the SAFE Act, including grant funding for local communities and a central clearinghouse for climate science, so communities and agencies do not have to reinvent the wheel and have access to a single source for good science. The SAFE Act would specifically require federal agencies that manage natural resources to adopt climate change adaptation plans that are consistent with the National Fish, Wildlife, and Plants Climate Adaptation Strategy, released by the Obama Administration this year. This coordinated approach will reduce costs by preventing redundancies and by directing investment toward the most effective resiliency measures. The GAO report is entitled Climate Change: Various Adaptation Efforts Are Under Way at Key Natural Resource Management Agencies and is available online. The report explains that America’s environment and associated resources will likely be damaged by climate change, including “increases in air and water temperatures, wildfires, and drought; forests stressed by drought becoming more vulnerable to insect infestations; rising sea levels; and reduced snow cover and retreating glaciers.”
Senate Bill Would Repeal Renewable Fuel Standard: Senators from both sides of the aisle on June 20, 2013, co-sponsored a bill that would repeal the Renewable Fuel Standard (RFS). The Renewable Fuel Standard Repeal Act (S. 1195), introduced by Senator John Barrasso (R-WY), would repeal the statutory authorization for the RFS as well as the regulations implementing it. Calling the standard “fundamentally broken and beyond repair,” Barrasso stated that the standard would only drive up fuel and food costs without providing any meaningful environmental benefit. The RFS was created by the Energy Policy Act of 2005 (Pub. L. No. 109-58) and established the first renewable fuel volume mandate in the United States. The original program required 7.5 billion gallons of renewable fuel to be blended into gasoline by 2012. The RFS program was expanded by the Energy Independence and Security Act of 2007 (EISA) (Pub. L. No. 110-140) in several key ways. It expanded the RFS program to include diesel, in addition to gasoline and also increased the volume of renewable fuel required to be blended into transportation fuel from 9 billion gallons in 2008 to 36 billion gallons by 2022. The EISA also established new categories of renewable fuel, and set separate volume requirements for each one and required EPA to apply lifecycle greenhouse gas performance threshold standards to ensure that each category of renewable fuel emits fewer greenhouse gases than the petroleum fuel it replaces.
Senate Hearing Blasts EPA On Oversight Of Risk Management Program: EPA was criticized at a June 27, 2013, Senate EPW Committee hearing on its oversight of facilities that manage potentially explosive chemicals. The hearing was held in the wake of the fatal blast at a West, Texas, fertilizer distributor and other recent plant explosions. Committee Chair Barbara Boxer (D-CA) blasted EPA for not acting on a 2002 recommendation by the Chemical Safety Board (CSB) to regulate substances such as ammonium nitrate — the culprit in the West, Texas, explosion — under EPA’s Risk Management Program (RMP). “Unfortunately, EPA has not yet acted on CSB’s 2002 recommendation,” Boxer stated, adding that “Today I am calling on EPA to adopt this crucial safeguard and report back to me on this request within the next two weeks.” Senator David Vitter (R-LA), the Committee’s Ranking Member, also chafed at EPA’s seeming inaction on these issues and at its apparent disregard for CSB requests for information.
Senate Bill Would Create New Agency For Managing Radioactive Waste: A bi-partisan cadre of Senators introduced legislation on June 27, 2013, that seeks to end a 25 year old deadlock on the issue of federal management of nuclear waste. The bill — the Nuclear Waste Administration Act of 2013 (S. 1240) — would create a new federal agency to manage radioactive waste and a consent-based process for identifying and building radioactive waste storage and repository facilities. Introduced by Senator Ron Wyden (D-OR) and co-sponsored by Senators Lisa Murkowski (R-AK), Dianne Feinstein (D-CA), and Lamar Alexander (R-TN), the bill would establish a Nuclear Waste Administration, headed by an administrator and overseen by a five-member board. The bill would also require the agency to build a pilot fuel storage facility, to build one or more temporary consolidated storage facilities for spent fuel, and to link storage facility siting to progress on selecting a site and constructing a repository. For over 25 years the federal government has been unable to take custody of radioactive waste because the only project for a permanent geologic repository under consideration, Yucca Mountain in Nevada, was effectively terminated in 2009 when President Obama cut its budget. The government also has been unable to site interim storage facilities.
House Bill Would Require Opportunity For Comment On Regulatory Cost-Benefit Analyses: Legislation introduced in the House on June 28, 2013, by Representatives Duncan Hunter (R-CA) and Nick Rahall (D-WV) would require that any cost-benefit analysis the federal government uses to justify the promulgation of regulations be offered for 60 days of public comment and review. The Cost-Benefit and Regulatory Transparency Enhancement Act (H.R. 2593) was referred to the Committee on Oversight and Government Reform and to the Committee on the Judiciary.
Preserving Rural Resources Act: Representative Robert Hurt (R-VA) on June 28, 2013, introduced the Preserving Rural Resources Act (H.R. 2581), a bill that would allow farmers and foresters to preserve the natural resources they depend upon for their normal farming, forestry, ranching, and rural economic activities “by protecting them from federal regulatory overreach” by EPA and the U.S. Army Corps of Engineers. Representative Jim Costa (D-CA) is the lead co-sponsor on the bill. The bill is intended to codify exemptions from Clean Water Act (CWA) permitting for normal farming, forestry, and ranching activities.
Senate Likely To Vote On McCarthy Nomination Week Of July 15: Senate Majority Leader Harry Reid (D-NV) on July 11, 2013, filed a cloture motion and scheduled a July 16, 2013, vote on the nomination of Gina McCarthy as EPA Administrator. Reid has also threatened the so-called “nuclear option” for the vote, where the Senate rules would be altered to require only 51 votes instead of the normal 60 to approve the nomination.
House Energy And Commerce Subcommittee Passes Bills On Pipelines And Costs Of Environmental Regulations: The House Energy and Commerce Subcommittee on Energy and Power on July 10, 2013, passed on a 17-10 vote the Energy Consumers Relief Act (H.R. 1582). The bill would prohibit EPA from promulgating any final rule estimated to cost more than $1 billion if the Secretary of the Department of Energy (DOE) determines that the rule would cause significant adverse effects to the economy, such as raising energy prices. The Subcommittee also approved on a 17-9 vote the Natural Gas Pipeline Permitting Reform Act (H.R. 1900), which is intended to accelerate the federal approval process for natural gas pipelines. The bill would require the Federal Energy Regulatory Commission to approve or deny a permit application for the siting, construction, expansion, or operation of any natural gas pipeline not later than 12 months after public notice of the application. Both bills now head to the full Committee for consideration.
House Judiciary Subcommittee Approves Two Bills On Federal Regulatory Process: On July 10, 2013, the House Judiciary Subcommittee on Regulatory Reform approved the Sunshine for Regulatory Decrees and Settlements Act (H.R. 1493), a bill intended to put an end to “sue-and-settle” tactics attributed to EPA. The chief provisions of the legislation would require an agency against which a civil action is brought to publish the notice of intent to sue and the complaint in a readily accessible manner complaint. Agencies would also be required to publish consent decrees or settlement agreements in the Federal Register and online not later than 60 days before it is filed with the court. The public would then be allowed to comment on these decrees or agreements. The Subcommittee also approved by voice vote with no amendments the Regulatory Flexibility Improvements Act (H.R. 2542), which would require federal agencies to consider the indirect costs of rules on small businesses. The two bills now advance to the full Judiciary Committee for a vote.
House Subcommittee Holds Second TSCA Hearing: On July 11, 2013, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on “Regulation of New Chemicals, Protection of Confidential Business Information, and Innovation.” The Subcommittee held a June 13, 2013, oversight hearing on Title I of TSCA. The July 11, 2013, hearing was intended to provide the Subcommittee an opportunity to examine the regulatory implementation and “real world” implications of TSCA Section 5, which concerns the manufacture and processing of new chemicals, and TSCA Section 14, which limits public disclosure of data submitted to EPA on existing and new chemical substances and mixtures. The Subcommittee has previously stated it intends to hold additional hearings concerning TSCA. An archived webcast of the hearing is available online. A copy of our memorandum on the June 13, 2013, hearing is available online.
The Subcommittee’s background memorandum for the July 11, 2013, hearing, which is available online, includes the following issues for consideration:
- How TSCA Section 5, premanufacture notices (PMN) and SNUNs, and TSCA Section 14, protection of confidential information, affect innovation;
- Strengths and weaknesses of the PMN Program, significant new use regulations, and SNUNs under Section 5;
- Adequacy of EPA’s tools to make informed decisions under Section 5;
- Whether the protection provided to CBI under Section 14 is appropriate; and
- How other countries treat new chemical production and information protection.
The Subcommittee heard testimony from the following witnesses, whose statements are available online:
- Mr. Craig Morrison, Chief Executive Officer of Momentive Performance Materials Holding, LLC, and Chairman of the Executive Committee, American Chemistry Council;
- Mr. Len Sauers, Vice President, Global Sustainability, Procter and Gamble;
- Mr. David Isaacs, Vice President, Government Affairs, Semiconductor Industry Association;
- Dr. Rainer Lohmann, Professor of Oceanography, University of Rhode Island; and
- Ms. Heather White, Executive Director, Environmental Working Group.
Morrison, Sauers, and Isaacs described how TSCA allows companies to innovate while also protecting the environment and public health. According to Sauers, one of the strengths of how new chemicals are regulated under TSCA is the ability to custom tailor the safety data and information in a PMN submission to the specific new chemical in question and its potential exposures, rather than being required to provide a minimum safety data set that could include too little data or information that is not relevant. Isaacs stated that the new chemicals program employs an appropriate risk-based approach that is tailored to consider factors such as the conditions of use and exposure scenarios.
Sauers expressed concern with EPA’s recent decision to require the disclosure of confidential chemical identities for which health and safety studies are provided. Sauers testified that a specific, confidential chemical identity is not needed to evaluate a health and safety study or communicate its health effects and conclusions. According to Isaacs, TSCA’s current CBI provisions generally work well in providing information to the public while protecting a company’s trade secrets.
Lohmann testified that TSCA reform should include limiting the time during which information will be protected as CBI. According to Lohmann, efforts to understand issues such as the effects of persistent chemicals are hampered by the lack of publicly available information. Lohmann also suggested that if a company will be marketing a chemical mixture, then it should be required to study the health effects from the mixture as it will be used. He used the example of Firemaster 550, a flame retardant, to highlight these points and TSCA’s claimed failures. Firemaster 550 contains four ingredients, two of which were grandfathered in under TSCA and therefore were not subject to the new chemical requirements. White stated that TSCA’s provisions concerning new chemicals allow most new chemicals to reach the market without an adequate review of their safety, and that TSCA allows companies to make unwarranted CBI claims.
The witnesses’ testimony and the subsequent questions and answers focused on whether TSCA sufficiently protects the public health and environment while allowing for innovation. Sauers testified that TSCA allows companies to get chemicals into commerce within a reasonable timeframe. He repeatedly noted EPA’s willingness to meet before a PMN submission is submitted to discuss concerns and ensure that EPA has what it believes are the necessary safety data for its review. Lohmann and White, however, stated that new chemicals reach the market without adequate review from EPA. Lohmann also called for a stronger Section 5, similar to the EU’s regulation on REACH. White suggested that minimum safety data sets be provided with the chemical for the review process. Morrison countered that this would “swamp” EPA and industry with unnecessary and costly testing and would “kill” innovation.
Middle ground was possibly found during Representative Gene Green’s (D-TX) questioning regarding CBI. Green, representing an industry-intensive district, recognized the need to protect CBI, and proposed a provision be added that would require more validation for CBI claims. This would prevent abuse of CBI. The panel all seemed to agree with such a provision.
House Passes $30.4 Billion Energy And Water Appropriations Bill: In a largely partisan move, on July 10, 2013, the House passed a $30.4 billion fiscal year 2014 energy and water appropriations bill by a vote of 227-198. Only eight Democrats voted for the bill. The White House has threatened to veto the bill, as it slashes funding for renewable energy programs. The funding cuts are unlikely to be passed as is by the Democratic-controlled Senate. The Energy and Water Development and Related Agencies Appropriations Act of 2014 (H.R. 2609) would appropriate $24.6 billion for DOE, a $2.1 billion cut from current enacted levels, and it effectively would cut in half DOE spending on renewables and energy efficiency. The bill would provide $746 million for the Office of Energy Efficiency and Renewable Energy (OEERE), the lowest level in the program’s history, according to the July 8 White House statement of administration policy threatening to veto the legislation, which is available online. In addition, the bill would combine OEERE, which funds research and development of renewables, energy efficiency, and alternative vehicle technology, with the Office of Electricity Delivery and Reliability and fund the combined program at $983 million.
TEST Act Would Gather Information On Clinical Usage: Representative Edward J. Markey (D-MA) in May introduced the Trial and Experimental Studies Transparency Act (TEST). TEST (H.R. 2031) would amend the Public Health Service Act to add interventional studies of a drug, device, or biological product conducted outside of the United States that are submitted to the Secretary of Health and Human Services (HHS) to support approval of a marketing application. It also would add results of post-market surveillance of a Class II or Class III device that involves data collection from human subjects, to the clinical trials that have to be reported to the clinical trials data bank. Study directors would be required to submit supporting documents, including protocol documents and consent documents used to enroll subjects into the trial. The information would be required before the first patient is enrolled in the trial. After the data are submitted, the Director of the National Institutes of Health (NIH) would have to post the information within 30 days after the submission is determined to meet the quality criteria established by the Director. In a final step, the Director and the Commissioner of Food and Drugs (FDA) would be required to report on the number of clinical trials with information submitted to the registry and steps taken to enforce compliance with such reporting requirements.
SCRAP Act Would Stop FDA Standards For Growing Food: Representative Dan Benishek (R-MI) authored legislation to defund new regulations being put forward by the FDA that he claims have the potential to impact negatively Northern Michigan farmers. Companion legislation was introduced in the Senate by Mike Crapo (R-ID) and Jim Risch (R-ID). “These new regulations are just another example of Washington bureaucrats hurting families and farmers here in Northern Michigan,” stated Representative Benishek. Benishek’s legislation, the Stopping Costly Regulations Against Produce (SCRAP Act), would defund an FDA proposed rule for growing, harvesting, packing, and holding fresh produce on domestic and foreign farms. The proposed rule was issued pursuant to the Food Safety Modernization Act, which Congress passed in December 2010. It would require weekly testing of all agricultural water at a cost of $35 to $40 per week. The FDA estimates that the cost of implementation will cost a producer roughly $5,000 to $30,600 per farm, depending on size, and with a total industry price tag of $460 million.
EPA Reports On How Development Can Impact Public Health And Environment: On June 17, 2003, EPA released a report, Our Built and Natural Environments: A Technical Review of the Interactions Among Land Use, Transportation, and Environmental Quality, that offers evidence that certain kinds of land use and transportation strategies can reduce the environmental and human health impacts of development. The report is available online. The report, the second edition of a document published in 2001, summarizes trends in land use, buildings, travel behavior, population growth, and the expansion of developed land. It discusses the environmental consequences of these trends, such as habitat loss, degradation of water resources and air quality, urban heat islands, greenhouse gas emissions and global climate change, and other health and safety effects.
EPA Announces National Enforcement Initiatives For Fiscal Years 2014-2016: EPA has identified six multi-year national enforcement initiatives intended to address specific environmental problems, risks, or patterns of noncompliance. EPA reevaluates the initiatives every three years “to assure that federal enforcement resources are focused on the most important environmental problems where noncompliance is a significant contributing factor, and where federal enforcement attention can have a significant impact.” The current set of fiscal year 2011-2013 National Enforcement Initiatives will continue for fiscal years 2014-2016. These initiatives focus on:
- Keeping Raw Sewage and Contaminated Stormwater Out of Our Nation’s Waters: EPA will continue its enforcement focus on reducing discharges of raw sewage and contaminated stormwater into rivers, streams, and lakes. This National Enforcement Initiative focuses on reducing discharges from combined sewer overflows, sanitary sewer overflows, and municipal separate storm sewer systems by obtaining cities’ commitments to implement timely, affordable solutions to these problems;
- Preventing Animal Waste from Contaminating Surface and Ground Waters: Concentrated animal feeding operations (CAFO) are a subset of livestock and poultry animal feeding operations (AFO) that meet the regulatory thresholds of number of animals for various animal types. EPA’s goal is to take action to reduce animal waste pollution from livestock and poultry operations that impair our nation’s waters, threaten drinking water sources, and adversely impact vulnerable communities;
- Cutting Toxic Air Pollution That Affects Communities’ Health: EPA will target and reduce emissions of toxic air pollutants in three areas where it has determined there are high rates of noncompliance: (A) leak detection and repair; (B) reduction of the volume of waste gas to flares and improvements to flare combustion efficiency; and (C) excess emissions, including those associated with startup, shut down, and malfunction;
- Reducing Widespread Air Pollution from the Largest Sources, Especially the Coal-fired Utility, Cement, Glass, and Acid Sectors: EPA has made considerable progress in reducing excess pollution by bringing enforcement actions against coal-fired power plants, cement manufacturing facilities, sulfuric and nitric acid manufacturing facilities, and glass manufacturing facilities. Work remains to be done to bring these sectors into compliance with the CAA and protect communities burdened with harmful air pollution;
- Reducing Pollution from Mineral Processing Operations: EPA will continue its enforcement initiative to bring these facilities into compliance with the law and protect the environment and nearby communities; and
- Assuring Energy Extraction Sector Compliance with Environmental Laws: EPA will continue to use a wide range of authorities, including the CWA, the CAA, and the Safe Drinking Water Act, among others, to ensure that natural gas development proceeds in a manner protective of human health.
More information is available online.
EU Publishes Fees For Biocidal Product Authorizations: On June 18, 2013, the EC signed off on a regulation setting forth the fees that must be paid to the ECHA for the approval of active substances in rodenticides, disinfectants, and other products covered by the EU’s Biocidal Products Regulation (BPR). Regulation (EU) No. 564/2013 states that the standard fee for “the first product-type for which that active substance is approved” is €120,000 ($158,830). The standard fee for renewal of an active substance authorization is €15,000 ($19,850). Fees are reduced for new products containing substances that have already been approved, while for smaller companies a reduction of up to 60 percent against standard fees applies. Other fees relate to appeals of ECHA decisions, modifications to authorization application dossiers, and confidentiality requests. Regulation (EU) No. 564/2013 on fees payable to ECHA in connection with the BPR is available online.
ATSDR Issues Draft Toxicological Profiles: On June 28, 2013, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability of Set 25 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 25 substances. 78 Fed. Reg. 38982. The profile are:
|Dinitrotoluenes (DNT) (UPDATE)
Comments are due September 30, 2013.
WHO Launches New Chemical Risk Assessment Network: On July 1, 2013, the World Health Organization (WHO) announced the launch of a network of “leading risk assessment institutions” from around the world, to improve chemical risk assessment globally. The network will scale up action and facilitate sustainable interaction between institutions on chemical risk assessment. The network is a voluntary, collaborative initiative. The network objectives are: provide a forum for scientific and technical exchange; facilitate and contribute to capacity building; promote best practices and the harmonization of methodologies; assist in the identification of research needs and promote the application of new science in risk assessment practice; assist in the identification of emerging risks to human health from chemicals; share information about work programs to avoid duplication of effort; and upon request, assist WHO in the development of training and other materials in support of the above. More information is available online.
California OEHHA Lists Hydrogen Cyanide And Cyanide Salts Under Proposition 65: On July 5, 2013, the California Office of Environmental Health Hazard Assessment (OEHHA) added hydrogen cyanide (HCN) and cyanide salts (CN salts) to the list of chemicals known to the State to cause reproductive toxicity for purposes of Proposition 65. OEHHA’s responses to public comments received on the Notice of Intent to List are available online.
EPA Releases Regulatory Agenda: On July 3, 2013, EPA released its spring regulatory agenda, which reports on the likely timelines for several environmental rulemakings. The agenda is available online. Among other items, the agenda suggests that in September EPA intends to reissue a revised proposed rule to control emissions of greenhouse gases from new power plants. It also indicates that EPA will likely issue by December five significant SNURs under TSCA.
U.S. And China Unveil Joint Climate Initiatives: On July 10, 2013, the U.S. and China — the world’s top greenhouse gas emitters — unveiled a series of joint initiatives intended to combat climate change. The two countries pledged to deepen bilateral cooperation with efforts to curb carbon emissions from heavy-duty vehicles and advance carbon storage technology. They also called for expanded cooperation on energy efficiency, data collection on greenhouse gases, and the deployment of smart grid technologies for electricity. The five “action initiatives” do not create any binding requirements or emissions targets, but rather will broaden existing green energy and climate cooperation agreements between the two nations.
OEHHA Will Hold Public Workshop On Concept For Regulation Addressing Proposition 65 Warnings: On July 30, 2013, OEHHA will hold a public pre-regulatory workshop for the purpose of gathering input from interested parties on the content of a regulation that would address Proposition 65 warnings. The notice states that such a regulation, if formally proposed and adopted, would either supplement or replace existing OEHHA regulations governing Proposition 65 warnings and conform to any statutory changes if enacted. According to OEHHA, the regulation would offer a variety of options for businesses that are required to provide these warnings, and would provide businesses with greater certainty that their warnings comply with Proposition 65. At this time, OEHHA believes the regulation should include the following:
- A requirement that a warning inform an individual that he or she will be exposed to a listed chemical;
- The minimum information that must be included in all warnings, including the health effect for which the chemical(s) involved in the exposure was listed; information on how a person will be exposed; and, where applicable, simple information on how to avoid or reduce an exposure;
- Approved warning methods and content for use by product manufacturers and retailers regarding exposures to listed chemicals from consumer products, including products sold at retail establishments and products sold via the Internet;
- Approved warning methods and content for use by manufacturers and retailers regarding exposures to listed chemicals in foods, including foods sold at retail establishments and food products sold via the Internet;
- Approved warning methods and content for environmental exposures, including exposures an individual may experience when entering or spending time in an area where listed chemicals are present. OEHHA intends to provide specific warning language and methods for some common environmental scenarios, such as parking structures, food courts, hotels, apartments and other businesses, to provide greater clarity and certainty where appropriate;
- Requirements and approved methods for providing additional contextual information to persons concerning exposures to listed chemicals. This information would not have to be provided prior to the exposure, but instead would have to be available to the public on a website or other generally accessible location; and
- Reasonable transition times for businesses to come into compliance with this regulation and recognition of existing warnings that are included in court-approved settlements.
Written comments are due August 30, 2013. OEHHA notes that if it decides to propose formally a Proposition 65 warning regulation, it will provide additional opportunities for public input. The notice is available online.
This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.