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April 1, 2011

Monthly Update for April 2011

Bergeson & Campbell, P.C.


The following item is of major importance to many of our clients and friends. We will issue a more detailed analysis of the legislation early next week.

Lautenberg Introduces Safe Chemicals Act Of 2011: On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011, which is intended to modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. Lautenberg previously introduced TSCA reform legislation in the 111th Congress, the Safe Chemicals Act of 2010. In response to feedback from chemical industry leaders, public officials, scientists, doctors, academics, and non-profit organizations, Lautenberg states that he has made several changes to improve the bill. For example, according to Lautenberg, the updated bill establishes risk-based prioritization categories so that EPA can focus its resources on the highest-risk chemicals. It also requires chemical companies to submit initially basic hazard and exposure data to determine quickly the risk and assess the need for further testing or restrictions. The summary of the bill, which is available online, states that it would:

  • Ensure EPA has information on the health risks of all chemicals. The bill requires chemical companies to develop and submit a minimum data set for each chemical they produce. EPA would have full authority to require any data beyond the minimum data set needed to determine safety of a chemical.
  • Require EPA to prioritize chemicals based on risk. The Administrator must conduct an initial evaluation of the safety of all chemicals and place those that meet certain criteria into one of three classes: immediate risk management, safety standard determination, and no immediate action. Not all chemicals will meet the criteria to be placed in a class.
  • Expedite action to reduce risk from chemicals of highest concern. Persistent, bioaccumulative, and toxic chemicals for which there is the potential for widespread exposure will be placed into the category of chemicals requiring immediate risk management. EPA must then impose conditions that will immediately reduce exposure.
  • Further evaluate chemicals that could pose unacceptable risk. Chemicals that present uncertainty about their ability to meet the safety standard will be placed into the category of chemicals requiring a safety standard determination. EPA would then require additional testing and risk assessment. If the chemical cannot meet the safety standard, it cannot remain on the market. The Administrator, or industry on its own accord, may impose conditions on uses of a chemical that will reduce risk and allow the chemical to meet the safety standard.
  • Provide broad public, market, and worker access to reliable chemical information. EPA must establish a public database that will house both chemical information submitted to EPA and decisions made by EPA about chemicals. The bill narrows the conditions under which data submitted by industry can be claimed to be confidential business information (CBI). It provides access to CBI by workers and local and state governments so long as they protect the information’s confidentiality. EPA must impose requirements to ensure that information developed and submitted, and advice received from advisory committees convened by EPA, is reliable.
  • Promote innovation, green chemistry, and safer alternatives to chemicals of concern. The bill requires EPA to establish a program to develop market and other incentives for safer alternatives, and a research grant program targeted at priority hazardous chemicals for which alternatives do not presently exist. A network of research centers would be established to conduct green chemistry research and alternatives analyses, and to provide training, educational materials, and technical assistance to educational institutions, small businesses, government, and non-governmental organizations. The bill also allows some new chemicals onto the market using an expedited process for reviewing safety.

Lautenberg also posted a video on his Facebook and Twitter pages to promote his bill. The video is available online.

EPA Warns Online Shoppers About Illegal Pesticide Sales: On March 21, 2011, EPA announced that it has warned more than 2,800 customers across the United States about potential risks associated with a banned pesticide in an ant-control product they purchased online through The product, Fast Ant Bait, contained mirex, a pesticide that was banned in the United States in 1978 because it can cause liver, skin, reproductive, and nerve damage. EPA became aware of the product after the Washington State Department of Health reported that a woman became ill after using it in her home. In response, EPA identified and warned three online companies — Inc., CCNow, Inc., and eBay Inc. — to cease processing orders for the product that was produced and mailed from China. The three companies cooperated, immediately ceased processing orders, and consumers can no longer purchase products from, the original site that offered the product for sale. The companies also worked with EPA to provide sales information, which allowed EPA to contact customers directly about the dangers posed by the pesticide and proper disposal methods. The letter EPA sent to customers who bought the product provides detailed directions on how to clean up safely and dispose of the illegal product and what to do if they believe they were exposed or harmed. For more information on mirex or other pesticides, consumers can call the Agency for Toxic Substances and Disease Registry (ATSDR) Information Center at 1-888-422-8737 or the National Pesticide Information Center (NPIC) at 1-800-858-7378. A copy of the letter is available online. Information on using pesticides safely is available online.

Declassification Of CBI Chemicals: On March 24, 2011, EPA’s Office of Pollution Prevention and Toxics (OPPT) posted on its website an initial set of CBI declassifications by making public the identities of chemicals contained in 42 health and safety studies that were previously claimed as confidential by the submitters, submitted to EPA under TSCA Sections 8(e) or 8(d). In 2010, EPA challenged industry to declassify unwarranted CBI claims and issued new guidance on EPA’s review and declassification process for confidentiality claims for the identity of a chemical in health and safety studies. The posted declassifications of confidentiality claims are the result of both EPA’s and industry’s review of CBI claims. OPPT anticipates posting CBI declassifications on a regular basis. This action is part of EPA’s ongoing effort to increase the public’s access to chemical information and to increase transparency related to TSCA. For additional information, please visit online.

Representative Waxman Sends Letter To CEOs: On April 1, 2011, Representative Henry A. Waxman (D-CA) sent letters to Chief Executive Officers (CEO) of 15 chemical manufacturers asking each to provide certain information about persistent, bioaccumulative, and toxic (PBT) chemicals they may make. Waxman, ranking minority member of the House Energy and Commerce Committee, requested that the CEOs of the companies provide by April 22, 2011, answers to questions such as whether they make PBT chemicals, and, if so, the volume made and sold in each year between 2005 and 2010. Links to Representative Waxman’s letters to the 15 chemical manufacturers are available online; click on “Recent News.”

EPA Phases Out Paper As An Option Regarding New Chemical Notifications: Effective April 6, 2011, EPA has ceased accepting paper submissions of premanufacture notices (PMN) or significant new use notifications (SNUN). A final rule published by EPA in 2010 gives chemical manufacturers and importers two years to switch from paper submissions to electronic reporting for SNUNs. Details of EPA’s filing procedures, links to the final regulation, and links to the Central Data Exchange (CDX) that is to be used for electronic notifications are available online.

EPA Announces Peer Review Workshop On IRIS: On April 12, 2011, EPA announced that Eastern Research Group, Inc., 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 human health assessment titled, “Toxicological Review of Hexavalent Chromium: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-10/004C). 76 Fed. Reg. 20349. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD). EPA is releasing the draft assessment for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. The peer review panel workshop on the draft assessment for hexavalent chromium will be held on May 12, 2011, beginning at 8:30 a.m. and ending at 5:00 p.m. Eastern Time.

EPA Seeks Comment On Petition To Suspend/Cancel Registrations For Soil Fumigant Iodomethane (Methyl Iodide): On March 25, 2011, EPA requested comment on a March 31, 2010, petition from Earthjustice requesting that all uses of iodomethane (methyl iodide) be suspended and cancelled. 76 Fed. Reg. 16770. Following the public comment period, EPA will evaluate the petitioner’s request, consistent with the statutory standards set forth in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Comments must be received on or before April 25, 2011.

EPA Seeks Public Comment On Petition For Bilingual Pesticide Labels: On March 30, 2011, EPA requested comment on a petition from the Migrant Clinicians Network, Farmworker Justice, and other farm worker interest groups asking EPA to require that manufacturers make their pesticide product labels available in both English and Spanish. 76 Fed. Reg. 17607. EPA is requesting comment from all interested groups and members of the public before responding to the petition. The petition focuses on requiring bilingual labeling for agricultural pesticides to increase protection for Spanish- speaking pesticide applicators and farm workers. EPA requests comment on whether to require bilingual labeling in English and Spanish for all types of pesticide products. At present, EPA allows pesticide manufacturers to add labeling in other languages, in addition to providing pesticide product labels in English. For agricultural products subject to the Worker Protection Standard, EPA requires that certain parts of the pesticide label include words or phrases in Spanish. In response to the petition, EPA is considering whether to require bilingual labeling in English and Spanish for all pesticides or for only certain types of pesticides, certain pesticide use sites, certain pesticide active ingredients, pesticides in certain toxicity categories, or certain parts of pesticide labels. Comments are due by June 28, 2011. EPA’s fact sheet on the petition is available online.

New EPA Web Page Explains Regulation Of Skin Repellent Patch Products: On March 25, 2011, EPA announced it is launching a new web page geared to producers of insect repellent skin patch products to help them determine whether their products are regulated as a pesticide or exempt from registration under FIFRA. Certain skin patch products that claim to repel insects are required to be registered under FIFRA, while others — those that contain only ingredients deemed to pose minimal risk — may be exempt from registration. This new web page describes how to distinguish between the two categories under existing law and policy. For more information, visit “Determining Whether Insect Repellent Skin Patch Products Must Be Registered Under FIFRA” online.

EPA Proposes Rule To Clarify Labeling Of Pesticides For Export: On April 6, 2011, EPA proposed to revise the regulations on the labeling of pesticides and devices intended for export. 76 Fed. Reg. 18995. FIFRA Section 17(a)(1) requires that unregistered pesticides and devices intended for export be subject to several provisions that include labeling, production reports, inspection of establishments, reporting, and recordkeeping. These provisions are set forth in 40 C.F.R. Sections 168.65 and 168.85. FIFRA Section 17(a) further requires that exporters obtain a purchaser acknowledgement statement (PAS) before exporting an unregistered pesticide (but not a device). On February 18, 1993, EPA issued regulations interpreting the FIFRA requirements about the export of unregistered pesticides and devices as Subpart D of 40 C.F.R. Part 168. Subpart D implements FIFRA Sections 17(a) and 17(b). The current regulations in Subpart D have not been amended since 1993. According to EPA, an internal review determined that the 1993 regulations are not as clear as EPA intended and that the resulting ambiguity might have led to uncertainty in compliance. To clarify the regulations in order to aid compliance, EPA decided to propose adding a more specific labeling requirement. In addition, EPA is restructuring the regulations to increase ease of use. Clarification and restructuring of the current regulations are administrative actions with no significant policy issues. This proposed rule will supplement the requirements of 40 C.F.R. Section 168.65 Pesticide export label and labeling requirements. Specifically, EPA is proposing to clarify, restructure, and add specificity to labeling regulations for the export of unregistered pesticide products and devices according to Executive Order 12988 to eliminate ambiguity and simplify EPA regulations. According to EPA, this action is discretionary and is not subject to a statutory, judicial, or administrative deadline. EPA also proposed to include a specific indication that these requirements also pertain to unregistered export pesticide products and devices shipped between registered establishments operated by the same producer pursuant to 40 C.F. R. Section 152.30(a). Section 152.30(a) states that an unregistered pesticide product transferred between registered establishments operated by the same producer must be labeled according to 40 C.F.R. Part 156. There are additional label requirements at Section 168.65, however, that also apply to a subset of the products covered by Section 152.30(a), specifically, unregistered export pesticide products. For example, Part 156 does not require that the label indicate that the pesticide product or device is not registered for use in the U.S., while Section 168.65 requires the statement “Not Registered for Use in the United States” to appear on the label of any unregistered export pesticide product or device. This statement may be further amplified by adding the reason for the unregistered status. For example: (1) Not Registered for Use in the U.S. because the product is exempt from registration; (2) Not Registered for Use in the U.S. because pesticide devices are not required to be registered; and (3) Not Registered for Use in the U.S because [insert crop name] is not grown in the U.S. Comments are due on or before June 6, 2011.

EPA Launches Initiative To Evaluate Substitutes For Flame Retardant: On April 5, 2011, EPA launched an initiative to evaluate chemicals that might substitute for a flame retardant facing restrictions in Europe and potential restrictions in the U.S. and abroad. Hexabromocyclododecane, also known as HBCD or HBCDD, is one of the first six chemicals that by 2015 must have any uses authorized under the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The goal of the initiative is to identify viable alternatives for HBCD, evaluate their human health and environmental profiles, and inform decision-making as organizations choose safer alternatives to HBCD. The project will be conducted according to the Design for the Environment (DfE) Alternatives Assessment method (online). Health and environmental profiles for each chemical will be based on a public literature review, structure-activity relationship modeling, and, in some cases, proprietary information shared by stakeholders. Information from the partnership will be made available to decision-makers and the public in a manner that protects proprietary information. The participation of stakeholder groups will ensure that a full range of views are considered from the start of the project, and that they are appropriately incorporated into project objectives, method, data review, and implementation. Members of the partnership will contribute to a more complete understanding of the alternatives, including their hazards, functionality, the constraints imposed by existing flame retardant technology and opportunities for innovation in fire safety. EPA encourages the participation of individuals from a range of disciplines and interests to contribute to this partnership. Those developing new technologies in the area of flame retardants and fire safety are critical members of the group. Information on the HBCD partnership will be posted online.

Representatives Urge OMB To Withdraw Proposed IUR Amendments: On April 4, 2011, Representatives Fred Upton (R-MI) and John Shimkus (R-IL), Chairs of the Committee on Energy and Commerce (Committee) and the Committee’s Subcommittee on Environment and the Economy, respectively, sent a letter to Jacob Law, the Director of the Office of Management and Budget (OMB) urging the Administration to withdraw its rule proposing changes to the TSCA Inventory Update Reporting (IUR).

An IUR rule requires manufacturers and importers, but not processors, of certain chemical substances listed on the TSCA Inventory to report, usually every four years, data on production volume, plant site, and site-limited status of those chemical substances. EPA significantly amended the IUR rule in 2003 when it issued the Inventory Update Rule Amendments (IURA). 68 Fed. Reg. 848 (Jan. 7, 2003). On August 13, 2010, EPA proposed its much anticipated IUR Modifications Rule. 75 Fed. Reg. 49655. On January 20, 2011, EPA sent the draft IUR final rule to OMB for its review.

In the April 4, 2011, letter, Representatives Upton and Shimkus stated that the rule fails to meet the requirements of the Paperwork Reduction Act (PRA) and Executive Order 13563. PRA established the Office of Information and Regulatory Affairs within OMB and requires, in part, that all federal agencies obtain from OMB a “Control Number” before requiring any form that will impose the collection of information. Executive Order 13563 was issued by President Obama on January 18, 2011, and provides that each agency must: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; (2) tailor regulations to impose the least burden on society; (3) select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) specify performance objectives; and (5) identify and assess available alternatives to direct regulation.

Specifically, the April 4, 2011, letter provides examples of “unwarranted and burdensome modifications to the existing program, without identifying associated benefits” that are “contrary to the requirements of” PRA and Executive Order 13563. These include:

  • Data Collection Standard: By replacing the “not readily obtainable” standard with the more stringent “known to or reasonably ascertainable by” standard, Upton and Shimkus argue that the IUR is expanded “from a reporting program to a costly data- gathering exercise.” They also argue that this requirement may trigger the submission of poor quality data or information and will have significant adverse economic consequences.
  • Processing and Use-Related Information: EPA’s proposal to eliminate the two-tiered reporting scheme by lowering the 300,000 pound threshold for processing and use information to 25,000 pounds, thereby requiring all reporters of non-excluded substances to report information in all parts of the IUR Form U, will “double the reporting burden imposed on sites that manufacture or import chemicals in volumes below the 300,000 threshold.”
  • Byproduct Exemption: Upton and Shimkus state that EPA’s proposed “narrow interpretation” of the exemption for byproducts sent for extraction “would nullify that exemption and unnecessarily burden those who send byproducts for recycling with extensive IUR reporting.” They note that during a February 14, 2011, hearing on EPA’s interpretation, one witness stated that the burdens would be so great that many would stop recycling and instead send the materials to landfills.
  • IUR Reporting Periods: The proposal to return the IUR reporting period to a four year cycle from the current five year cycle was questioned as to the “utility to government for the private section to endure this burden sooner and more frequently.”
  • Multi-Year Reporting: Upton and Shimkus stated that the proposed rule would require submitters to report information for each year since the past report, instead of the current requirement that information only be reported for the prior year, which would “dramatically increas[e] the reporting burden without demonstrating how these data will be useful to the EPA.”
  • Determining Reporting Requirements: Upton and Shimkus argue that EPA’s proposal to retroactively require reporting if thresholds were exceeded in any calendar year since the last principal reporting year will require companies to conduct burdensome data collection and analysis even though EPA has not shown a “specific need for the additional information.”
  • CDX Reporting System: The proposed mandatory requirement to use EPA’s web-based CDX reporting system was questioned as to whether EPA has rigorously field tested the system.

The April 4, 2011, letter is available online.

EPA Announces Chemical Action Plans For MDI, TDI, And Related Diisocyanate Compounds: EPA released on April 13, 2011, chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), and related compounds. According to EPA, Americans may be exposed to these chemicals when they are used in certain applications, such as spray foam insulation, sealing concrete, or finishing floors. EPA states that diisocyanates are used to make polyurethane polymers. Most polyurethane products, such as foam mattresses or bowling balls, are fully reacted or “cured,” and are not of concern. EPA notes that some products, however, such as adhesives, coatings, and spray foam, continue to react while in use, and may contain “uncured” diisocyanates to which people may be exposed. EPA states that there has been an increase in the consumer availability of or incidental bystander exposure to polyurethane products containing uncured diisocyanates. The chemical action plan for MDI and related compounds is available online, and the chemical action plan for TDI and related compounds is available online. More detailed information is available online.

EPA Seeks Comment On Pilot Fragrance Notification Program: On April 15, 2011, EPA’s Office of Pesticide Programs (OPP) published for comment a proposed Pilot Fragrance Notification Program (PFNP) for registrants seeking to add new or modify existing fragrances in new or currently registered pesticide products. 76 Fed. Reg. 21347. EPA intends to implement the proposed PFNP for two years as a process improvement effort to streamline the current 90-day process used to amend registrations to a 30-day notification process when fragrance ingredients are added, removed, or modified. EPA’s notice follows up to the 2007 Fragrance Notification Pilot Program and it is similar in conduct. The proposed PFNP incorporates the ability to self certify and rely on the Fragrance Ingredient List (FIL). The FIL is comprised of more than 1,500 fragrance component ingredients contained in pesticide products previously reviewed and registered by EPA and have undergone an evaluation to determine their suitability for safe use as components of fragrances used in non-food use pesticide product formulations. Only fragrances in which all of the components in the fragrance are on the FIL are eligible to participate in the proposed PFNP. The objectives of the current pilot are to improve public transparency, reduce the amount of paperwork required of registrants, and decrease tracking. The number of fragrance documents needing to be tracked would be decreased because they would be submitted twice a year versus with every application. These efficiencies will allow resources to be focused on other regulatory work without compromise to public health or the environment. This is a voluntary program where interested entities have an opportunity to participate. EPA is publishing this for comment by registrants as part of process improvement. Comments on the proposed process are due May 16, 2011.

EPA Proposes New Regulation Language To Distinguish “Isolates” And “Strains”: On April 15, 2011, EPA proposed a rule to address regulatory ambiguity in the definitions of “isolates” and “strains.” 76 Fed. Reg. 21294. EPA states its regulations distinguish “isolates” and “strains” in a confusing and non-obvious manner. This has resulted in significant uncertainty within the regulated industry. This proposed rule seeks to address this problem by proposing new regulatory language that clarifies the requirements applicable to new strains that are considered to be new active ingredients under FIFRA. In conjunction with the proposed change detailed for 40 C.F.R. Section 158.2100(c)(2), EPA is also developing a draft microbial pesticide test guideline (OCSPP Guideline 885.1250) to explain the deposition of a sample in a nationally recognized culture collection data requirement, which is currently found in the tables in 40 C.F.R. Section 158.2120(c) and 40 C.F.R. Section 158.2171(c). Presently, there is no test guideline referenced in the tables for this requirement. Instead, information on this data requirement is briefly mentioned at the end of the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200): “A sample of registered [Microbial Pest Control Agents] MPCAs is to be maintained on deposit in a nationally recognized culture collection.” In 1996, this particular statement was transferred from the 1989 revision of Subdivision M of the Pesticide Assessment Guidelines (specifically 151A-11) to the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200). The term “maintained” was used because some culture collections will discard deposits after a certain time if they do not get subsequent requests to purchase samples from that deposit. In creating a distinct test guideline for the microbial deposition data requirement, EPA will provide a more easily found reference that can be added to the data requirement table. Other clarifying amendments are proposed in the rule. Comments are due July 14, 2011.

EPA Proposes Threshold Planning Quantities For Extremely Hazardous Substance: On April 15, 2011, EPA proposed to revise the manner by which the regulated community would apply the threshold planning quantities (TPQ) for those extremely hazardous substances (EHS) that are non-reactive solid chemicals in solution form. 76 Fed. Reg. 21299. Specifically, facilities with a solid EHS in solution would be subject to the Emergency Planning requirements if the amount of the solid chemical on-site, when multiplied by 0.2, equaled or exceeded the lower published TPQ, based on data that show less potential for the solid chemical in solution to remain airborne in the event of an accidental release. Previously, EPA assumed that 100% of the chemical could become airborne in the event of an accidental release. The proposed rule is intended to revise the manner by which the regulated community would apply the TPQ for EHS chemicals that are handled as solids in solution. There are 157 EHS chemicals that are non-reactive solids at ambient temperature, which could potentially be affected by this change, if they are handled by facilities in a solution form. The affected chemicals are identified in Appendix C in the “Technical Support Document for Revised TPQ Method for Solids in Solution.” These 157 chemicals appear with two TPQs, (the higher TPQ is 10,000 pounds) in Appendix A and B of 40 C.F.R. Part 355. The change will not apply to the 12 solid EHS chemicals that are reactive solids (noted by footnote “a” in Appendix A and B of 40 C.F.R. Part 355). Reactive solids are highly reactive with air or water or are explosive. Because of this, they are more likely, according to EPA, than other solids to be dispersed into the air due to the energy or heat created when they react. Comments are due June 14, 2011.


Green Ribbon Science Panel Subcommittees To Discuss Safer Consumer Product Alternatives Regulations: Three Subcommittees of the Green Ribbon Science Panel have scheduled several teleconferences between April 4 and April 19, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations. These teleconferences are open to the public and comments may be provided. The discussions held by the Subcommittees during these teleconferences are intended to help inform the discussions by the full Panel when it meets on May 5-6, 2011, in Sacramento. Agenda, meeting notices, other meeting materials, and how to access the various teleconferences are available online. A more detailed memorandum is available online.


NRC Includes Nanomaterials In Guidelines For Working With Hazardous Chemicals: On March 25, 2011, the National Research Council (NRC) announced the availability of a report entitled Prudent Practices in the Laboratory, which updates NRC’s guidelines on the safe use of hazardous chemicals. NRC last updated the guidelines in 1995, and the new edition includes new topics, including the handling of nanomaterials. The update sets out general guidelines for the management of nanomaterials. NRC developed the guidelines “from accepted chemical hygiene protocols for handling compounds of unknown toxicity.” The guidelines cover topics such as planning and assessing the hazards of nanomaterial work, information on grading the risk of working with different types of nanomaterial, and suggestions on ways to make sure the working environment is designed to protect laboratory personnel from exposure to nanoparticles.

European Parliament And EU Council Fail To Reach Agreement On Novel Foods Regulation: The European Parliament (EP) and EU Council failed to reach agreement on an update to the novel foods regulation, which would have updated the 1997 regulation to address several issues, including nanoscale ingredients in food. According to a March 29, 2011, press release, the EP and Council disagreed on labeling food from cloned animals and their descendents, as well as nanotechnology. The draft legislation passed by the EP in July 2010 would have banned nanoscale ingredients from food until the risks posed are better understood, and would have required that any nanoscale ingredients eventually authorized be clearly labeled as such. The EP issued a March 29, 2011, statement, which notes that the failure to reach an agreement on the legislation means “[t]here will continue to be no special measures regarding nanomaterials in food, for example.”

EPA Launches Public Process To Evaluate Testing Proposal From Carbon Consortium: EPA announced on April 11, 2011, plans to launch a public process to evaluate a testing proposal for carbon nanoscale materials offered by the NanoSafety Consortium for Carbon. The proposal involves the conduct of 90-day inhalation tests submitted by the Consortium to EPA on April 6, 2011. In its proposal, the Consortium offered to follow EPA’s standard procedures for enforceable testing consent agreements. Through the enforceable consent agreement, EPA invites interested parties to discuss proposed tests and make recommendations for what the companies would be required to do. In the proposal, ten companies that make carbon nanotubes and graphene nanoplatelets asked EPA to allow members to test a representative sample of the new chemicals they would like to make rather than requiring each manufacturer to be subject to a 90-day inhalation test with laboratory rats. The companies proposing to conduct the tests are: Angstron Materials LLC in Dayton, Ohio; Applied Sciences Inc. in Centerville, Ohio; Cheap Tubes Inc. in Brattleboro, Vermont; Continental Carbon Nanotechnologies Inc. in Houston; Nano-C Inc. in Westwood, Massachusetts; NanoLab in Waltham, Massachusetts; Nanoshel LLC in Wilmington, Delaware; Pyrograf Products in Cedarville, Ohio; SouthWest NanoTechnologies Inc. in Norman, Oklahoma; and XG Sciences Inc. in East Lansing, Michigan The types of engineered carbon nanomaterials that the Consortium is proposing to test include: multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene nanoplatelets. The Consortium is suggesting that two or three materials be tested within each of these four categories, but EPA would make that final decision after consulting with interested parties. The proposal is expected to be announced in a forthcoming Federal Register notice. The NanoSafety Consortium for Carbon’s testing proposal is available online.

House Subcommittee Holds Hearing On NNI Oversight: On April 14, 2011, the House Science, Space, and Technology Subcommittee on Research and Science Education held a hearing entitled “Nanotechnology: Oversight of the National Nanotechnology Initiative and Priorities for the Future.” According to the hearing charter, the purpose of the hearing was to examine the National Nanotechnology Initiative (NNI) and address the Nation’s research and development priorities for the future. More information is available online.

Witnesses included:

  • Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO);
  • Dr. Jeffrey Welser, Director, Nanoelectronics Research Initiative, Semiconductor Research Corporation;
  • Dr. Seth Rudnick, Chairman of the Board, Liquidia Technologies;
  • Dr. James Tour, Richard E. Smalley Institute for Nanoscale Science and Technology, Rice University; and
  • Mr. William Moffitt, President and CEO, Nanosphere, Inc.

The witnesses emphasized the need for Congress to reauthorize the NNI to ensure that the U.S. remains the global leader in nanotechnology. The 21st Century National Nanotechnology Research and Development Act (P.L. 108-153), which was signed by then President Bush in December 2003, established a statutory framework for the NNI and authorized appropriations for nanotechnology research and development (R&D) activities through fiscal year (FY) 2008. Since then, the House has passed bills in the 110th (H.R. 5940) and 111th (H.R. 554 and H.R. 5116) Congresses to amend and reauthorize the NNI, but the Senate did not act in either Congress. Since FY 2008, the NNI has received funding through annual appropriations bills, and President Obama’s FY 2012 budget request proposes $2.1 billion for the NNI, which is $200 million more than the FY 2010 enacted levels.

The President’s FY 2012 budget request for the NNI would fund three signature initiatives: Nanoelectronics for 2020 and Beyond; Sustainable Manufacturing: Creating the Industries of the Future; and Nanotechnology for Solar Energy Collection and Conversion. The budget request states the NNI’s continued support for the federal role in basic research, infrastructure development, and technology transfer, while renewing an emphasis on accelerating the transition from basic R&D into innovations that support sustainable energy technologies, healthcare, and environmental protection. Witnesses stressed the need for federal funding for basic research, which is too expensive for industry to fund on its own. Witnesses also testified that other countries, such as the EU, Japan, China, and South Korea, have increased their investment in nanotechnology, and are offering incentives to U.S. companies to open laboratories outside the U.S. According to witnesses, the public investment in nanotechnology will ensure that the U.S. remains at the technological forefront while also growing the U.S. economy through job creation and improved productivity and efficiency.

Representative Mo Brooks (R-AL), Chair of the Subcommittee, thanked Dr. Teague for his service as Director of the NNCO. Dr. Teague’s last day will be April 15, 2011.


EPA Establishes Clean Air Act Standards For Boilers And Incinerators: On March 21, 2011, EPA promulgated final Clean Air Act (CAA) standards for boilers and certain incinerators. 76 Fed. Reg. 15554, 76 Fed. Reg. 15608, and 76 Fed. Reg. 15704. In response to a September 2009 court order, EPA issued the proposed rules in April 2010. Based on public input received following the April 2010 proposal, EPA claims to have made extensive revisions, and in December 2010 requested additional time for review to ensure the public’s input was fully addressed. Because the final standards significantly differ from the proposals, EPA believes further public review is required. On March 21, 2011, EPA also announced the initiation of the reconsideration process. 76 Fed. Reg. 15266. EPA’s reconsideration will cover the emissions standards for large and small boilers and for solid waste incinerators. The final standards require many types of boilers to follow practical, cost-effective work practice standards to reduce emissions. EPA is also working with the Departments of Energy and Agriculture to provide the diverse set of facilities impacted by the standards with technical assistance that will help boilers burn cleaner and more efficiently. In separate but related actions, EPA issued final emission standards for sewage sludge incinerators. 76 Fed. Reg. 15372. All the final rules are effective May 20, 2011. More information is available online.

EPA Issues Extension To Greenhouse Gas Reporting Deadline: On March 18, 2011, EPA issued a final rule that extends the deadline for reporting 2010 data under the Greenhouse Gas (GHG) Reporting Program to September 30, 2011. 76 Fed. Reg. 14812. The original deadline was March 31, 2011. EPA previously announced its intent to extend the deadline on March 1, 2011. Under the GHG Reporting Program, entities required to submit data must register with the electronic GHG reporting tool (e-GGRT) no later than 60 days before the reporting deadline. With this reporting deadline extension, the new deadline for registering with e-GGRT is August 1, 2011. Following conversations with industry and others, EPA extended this year’s reporting deadline to September 30, 2011. This extension will allow EPA to test the system that facilities will use to submit data and give industry the opportunity to test the tool, provide feedback, and have sufficient time to become familiar with the tool prior to reporting. More information on this action is available online. More information on the GHG Reporting Program is available online.

EPA Updates Web Tool Providing Clean Water Violation Trends And State Enforcement Response: On March 24, 2011, EPA released updated data and a mapping tool designed to assist the public compare water quality trends over the last two years. The web-based, interactive map includes “state dashboards” that provide detailed information for each state, including information on facilities that are violating the Clean Water Act (CWA) and the actions states are taking to enforce the law and protect people’s health. The state dashboards incorporate data for both large and small sources of water pollution, along with the latest information from EPA’s 2009 Annual Noncompliance Report. The public can examine and compare information on the inspections conducted by both EPA and the state in their region, violations, and enforcement actions in their communities over the past two years and the penalties levied in response to violations. EPA’s Enforcement and Compliance Online (ECHO) database provides fast, integrated searches of EPA and state data for more than 800,000 regulated facilities, including information on inspections, violations, and enforcement actions. More information on interactive state dashboards for CWA violations is available online. More information on the 2009 Annual Noncompliance report is available online.

EPA Issues Final Rule Approving New Substitute In Motor Vehicle Air Conditioning Sector Under SNAP Program: On March 29, 2011, EPA announced that its Significant New Alternatives Policy (SNAP) program has expanded the list of acceptable substitutes for use in the motor vehicle air conditioning end-use as a replacement for ozone-depleting substances. 76 Fed. Reg. 17488. The CAA requires EPA to review alternatives for ozone- depleting substances and to disapprove substitutes that it concludes present risks to human health and the environment more significant than those presented by other alternatives that are available or potentially available. The substitute addressed in this final rule is for use in new passenger cars and light-duty trucks in the motor vehicle air conditioning end-use within the refrigeration and air conditioning sector. EPA determined that hydrofluoroolefin (HFO)-1234yf is acceptable, subject to use conditions, as a substitute for chlorofluorocarbon (CFC)-12 in motor vehicle air conditioning for new passenger cars and light- duty trucks. The substitute is a non-ozone-depleting gas and consequently does not contribute to stratospheric ozone depletion. The final rule is effective on May 31, 2011.


EPA Seeks Guidance For Evaluating Vapor Intrusion: On March 17, 2011, EPA requested public comment on the development of a final guidance entitled Evaluating Vapor Intrusion to Indoor Air Pathway from Contaminated Groundwater and Soil (Subsurface Vapor Intrusion Guidance). 76 Fed. Reg. 14660. A draft of the Subsurface Vapor Intrusion Guidance was released for public comment in November 2002. EPA is planning to issue the final guidance by November 30, 2012, and seeks public comment for consideration during the development of this document. EPA also intends to make another draft of the guidance available for public comment in the spring of 2012. According to the notice, comments received by May 14, 2011, will be considered in the development of the final Subsurface Vapor Intrusion Guidance.

EPA Issues Final Rule Identifying Non-Hazardous Secondary Materials That Are Solid Waste: On March 21, 2011, EPA published a final rule that identifies which non-hazardous secondary materials, when used as fuels or ingredients in combustion units, are “solid wastes” under the Resource Conservation and Recovery Act (RCRA). 76 Fed. Reg. 15456. This solid waste definition under RCRA will determine whether a combustion unit is required to meet the emissions standards for solid waste incineration units issued under CAA Section 129 or the emissions standards for commercial, industrial, and institutional boilers issued under CAA Section 112. EPA also issued in final a definition of traditional fuels. This rule is effective on May 20, 2011.

EPA Proposes Cooling Water Intake Rule: On March 28, 2011, EPA released a pre-publication of a proposed rule relating to cooling water intakes at power plants and other large industrial facilities. The proposal addresses impingement (trapping of fish against intake screens) and entrainment (drawing of fish into the cooling water system). The rule is being issued under CWA Section 316(b). Impingement-prevention controls would be required for existing facilities that withdraw at least 25 percent of their water for cooling and have a design intake flow of two million gallons or more per day. Entrainment controls would be based on site-specific determinations, which would include studies and public input. New units at existing facilities would be required to use closed-cycle cooling towers, which are already required for new facilities, EPA stated. The proposal was issued under a settlement agreement with Riverkeeper and other organizations requiring EPA to issue a proposal by March 14, 2011 (on March 11, 2011, the parties agreed to an amendment to the settlement agreement to extend the date for the proposed rule to March 28, 2011), and a final rule by July 27, 2012. The U.S. Court of Appeals for the Fifth Circuit in July 2010 granted a request by EPA to take back the part of its cooling water rule relating to existing facilities. ConocoPhillips v. EPA, 5th Cir., No. 06-60662 (July 23, 2010). Comments must be received 90 days after publication in the Federal Register. More information is available online.

EPA Updates SPCC Regulation To Exclude Milk And Milk Products: On April 12, 2011, EPA exempted milk and milk product containers from the Oil Spill Prevention, Control and Countermeasure (SPCC) rule. Based on input from the milk industry, EPA previously delayed SPCC compliance requirements for milk and milk product containers until the mandated regulatory process could be completed. In January 2009, EPA proposed a rule to exempt milk containers from the SPCC rule. The SPCC regulations, in place since the 1970s, require facilities storing more than 1,320 gallons of oil to create and implement plans to prepare, prevent, and respond to oil spills. Milk production is already subject to certain construction and sanitary standards and requirements that help prevent spills. The final exemption applies to milk, milk product containers, and milk production equipment. In addition, because some of these facilities may still have oil storage subject to the spill prevention regulations, EPA is also amending the rule to exclude milk storage capacity from a facility’s total oil storage capacity calculation. EPA is also removing the compliance date requirements for the exempted containers. The exemption does not apply to fuel oil and other applicable oils stored on farms; farms that store the regulatory threshold of fuel oil and other applicable oils are covered under the SPCC. The rule is intended to prevent damage to the inland waters and shorelines of the United States. More information on the milk and milk product containers exemption is available online.


European Chemicals Agency Publishes Labeling Guidance: On April 8, 2011, the European Chemicals Agency (ECHA) published guidance for chemical manufacturers and importers regarding packaging standards and the correct use of hazard labels for substances and mixtures in the EU. The guidance covers issues such as the minimum information requirements for chemical labels, use of hazard and precautionary statements, as well as use of supplemental labeling information. It describes the labeling standards that must be used in the EU to be in compliance with the 2008 CLP Regulation (classification, labeling, and packaging — Regulation (EC) No 1272/2008), which implemented the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) into EU law. The labeling guidance was more detailed than the sections on labeling that had previously been included in the broader guidance document, ECHA said. Full text of the guidance document on labeling and packaging under the CLP Regulation is available online. The guidance document on the application of the CLP Regulation is available online.

ECHA Updates REACH-IT To Allow Submission Of Notifications For Substances In Articles: ECHA announced on April 13, 2011, that it has updated REACH-IT to allow the submission of notifications for substances in articles. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are met:

  • The SVHC is present in those articles at a volume of >1 metric ton per manufacturer/importer per year; and
  • The SVHC is present in those articles above a concentration of 0.1 percent weight by weight (w/w).

ECHA states that, to explain the actual submission process, it developed a new data submission manual for substances in articles. To facilitate the submission of the information required to complete a notification, ECHA is making available pre-filled substance datasets in IUCLID 5.3 format for all substances on the Candidate List. According to ECHA, these datasets contain information on substance identification, classification, and labeling and they can be downloaded from the Candidate List webpage. More information is available online. See related memoranda online and online.


In the past several weeks, activity on Capitol Hill has focused on efforts to reach agreement on the text of a continuing resolution to fund the Federal Government for the remaining six months of 2011, put in place a budget for such funding for 2012, and enact a measure increasing the debt ceiling limit before the present limit is reached sometime in mid-May. In the midst of these activities, the ongoing debate regarding the jurisdiction of EPA over GHG emissions engendered activity in both the House and the Senate.

The 2011 Continuing Budget Resolution: Last week, Congressional leadership and the White House reached tentative agreement on cuts to be made to the budget requests for 2011 made by the Obama Administration earlier in the year. This agreement was needed to prevent shutting down the government on April 15. Among the $38 billion in cuts agreed to, there was a cut of $1.6 billion for EPA. That represents a 16% decrease from 2010 funding levels. Funding for the Department of Health and Human Services was proposed to be cut substantially, but those cuts do not appear to include big reductions for the Food and Drug Administration (FDA). The Continuing Resolution for 2011 is expected to pass and be signed by President Obama on or before the Friday, April 15, 2011, deadline.

The 2012 Republican Budget Blueprint: On Friday, April 15, 2011, the House is expected to vote on the “blueprint,” as prepared by Representative Paul Ryan (R-WI) and the House Budget Committee as the first step in the 2012 budget process. The Ryan budget would propose to reduce the present deficit by $4.4 trillion over ten years by repealing the Democrat’s health care bill passed and enacted last year, reforming entitlements like Medicare and Medicaid and making cuts to defense and imposing spending caps on domestic spending. The House Budget Committee will begin amending the plan shortly. After the budget passes, it will be up to the regular Committees to handle the process of allowing Representative Ryan to reach his targets. Among the cuts first to come up undoubtedly will be cuts relating to health care. The Republicans have pledged to repeal President Obama’s Affordable Care Act. A significant amount of the money the Republicans say they are saving by budget reductions comes from overturning this provision. They save $725 billion by repealing the subsidies that customers would have received to help buy health insurance. Another area where the Ryan plan would drastically affect how business is done would be with respect to Medicare. Instead of the government reimbursing doctors and hospitals for certain medical services, seniors would purchase a private health care plan among numerous options on an exchange. The government would then pay the private insurer in the form of a subsidy up to a specified amount. Changes to Medicare in the plan would not affect those currently age 55 and over.

EPA And GHG Emissions: Ongoing debate regarding the abolition of EPA’s jurisdiction over the regulation of GHG emissions continues to find its way into the budget process, with the objective of proponents being the denial of funding for such activity. On April 7, 2011, the House voted 255-172 to eliminate EPA’s jurisdiction. That vote was negated by the rejection in the Senate of four different proposals to small business legislation. The EPA jurisdiction issue is expected to surface in a variety of circumstances in coming months.

EPA Budget Request Anticipates Restructuring Of EDSP: According to the FY 2012 budget, EPA would begin restructuring its Endocrine Disruptor Screening Program (EDSP) to reduce the use of animal-based testing. The restructuring would occur during a multi-year period as part of a new Chemical Safety and Sustainability Program, which introduces several EPA research areas under a new approach to screening chemicals for potential human health effects. EPA plans to use both computational toxicology methods and high throughput screens as part of its new approach. In a two-page segment of its 2012 budget request, EPA stated that the new approach to chemical screening will allow EPA “to more quickly and cost-effectively assess potential chemical toxicity.” The restructuring is expected to reduce the costs of screening chemicals to determine their potential impact on the endocrine system. It costs $6 million and takes two years to test 300 chemicals using computational toxicology tools, EPA stated in its budget document, as compared to $2 billion and 30 years using traditional animal-based testing. EPA has issued test orders for 201 chemicals so far under the EDSP.

Senate Committee Holds Oversight Hearing On Disease Clusters And Environmental Health: On March 29, 2011, the U.S. Senate Committee on Environment and Public Works held a hearing entitled “Oversight Hearing on Disease Clusters and Environmental Health.” Committee Chair Barbara Boxer (D-CA) and Senator Mike Crapo (R-ID), Ranking Member of the Superfund, Toxics, and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor’s Law, on January 25, 2011. The bill would require EPA to:

  1. Develop, publish, and update guidelines on an approach to investigate suspected or potential disease clusters, environmental pollutants, or toxic substances associated with such clusters, or potential causes of such clusters;
  2. Establish and operate Regional Disease Cluster Information and Response Centers and Regional Disease Cluster Information and Response Teams;
  3. Ensure that the Office of Children’s Health Protection has a prominent role in developing and updating such guidelines and in establishing and operating such Centers and Teams;
  4. Establish Community Disease Cluster Advisory Committees to provide oversight, guidance, and advice relating to such investigations;
  5. Provide support to individuals on such Teams and Committees through grants and cooperative agreements with institutions of higher education;
  6. Compile and update a publicly available, online database that provides information relating to disease clusters; and
  7. Use available authorities and programs to compile, research, and analyze information generated by actions authorized under the Act.

Under the bill, any person could petition EPA, ATSDR, and the National Institute of Environmental Health Sciences (NIEHS) to request that a Response Team conduct an investigation or take action to address the potential causes of disease clusters. EPA would be authorized to make grants to any group of individuals that may be affected by such clusters. A more detailed memorandum is available online.


Jim Willis, EPA, To Join United Nations Environment Programme: Effective April 18, 2011, Jim Willis, Director of EPA’s OPPT Chemical Control Division (CCD), will join the United Nations Environment Programme (UNEP) as the Executive Secretary of the Basel, Stockholm, and Rotterdam Conventions. Willis has been with EPA for more than 20 years in various staff through senior management positions. He also worked with UNEP for a number of years before returning to EPA in 2004. During his time at UNEP, he was responsible for organizing and holding the negotiations which led to the Stockholm and Rotterdam Conventions. In 2010, the UNEP announced a global campaign intended to strengthen synergies in chemicals and waste management, which included bringing together the Conferences of the Parties to the Basel, Stockholm, and Rotterdam Conventions at a joint meeting held in Bali, Indonesia, on February 22-24, 2010. During the meeting, the parties agreed to the idea of a joint head of the three Conventions’ Secretariats, which presented an “irresistible challenge” to Willis.

For those of us who have worked with Jim for years, his leadership and vision will be greatly missed. Dr. Maria Doa will serve as Acting Director of CCD.

China To Implement Globally Harmonized System Of Classification And Labeling Of Chemicals: On March 12, 2011, China’s State Administration of Work Safety (SAWS) issued Decree 591, “Regulation on the Safe Management of Dangerous Chemicals,” which concerns the safe use of chemicals. The regulation is very wide ranging in scope and “sets the tone” for future chemicals legislation.

As one of the more immediate impacts, State Decree 591 uses the National Standards GB 13690-2009 on the general rules for the classification and hazard communication of chemicals, and GB 12528-2009 on precautionary labeling. The National Standards are effectively technical manuals that assist in the practical compliance with Decree 591.

Currently, the critical deadline is December 1, 2011, which is the implementation date of the Decree. The implementation date of the National Standards, May 1, 2011, is not of significant impact as the Decree date is the date recognized by the implementation authority. China has previously issued supplementary guidance, after promulgating final regulations, that contain transitional periods, and it is possible that the December 1, 2011, deadline will change.