• Energy and Commerce Subcommittee Hearing on "Prioritizing Chemicals for Safety Determination"
  • November 24, 2009 | Author: Thomas C. Berger
  • Law Firm: Keller and Heckman LLP - Washington Office
  • On November 17, 2009, the House Energy and Commerce Committee's Subcommittee on Commerce, Trade and Consumer Protection held a hearing entitled "Prioritizing Chemicals for Safety Determination." The purpose of the hearing was to examine the options for prioritizing chemicals for safety determinations in the event that the Committee amends the Toxic Substances Control Act (TSCA). Rep. Rush presided over the hearing, and his opening statement is available here. Although Rep. Waxman did not attend the hearing, his opening statement is available here. (This opening statement references The Safer Chemicals, Healthy Families coalition, which conducted the recent poll on TSCA modernization.)

    The following witnesses provided testimony at the hearing:

    • Mr. Steve Owens, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Environmental Protection Agency
      Testimony of Steve Owens
    • Mr. Eric Sampson, Director, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention
      Testimony of Eric Sampson
    • Mr. Daryl Ditz, Senior Policy Advisor, Center for International Environmental Law
      Testimony of Daryl Ditz
    • Mr. William J. Greggs, Consultant, Consumer Specialty Products Association, the Grocery Manufacturers Association, and the Soap and Detergent Association
      Testimony of William J. Greggs
    • Ms. Beth Bosley, Consultant, Society of Chemical Manufacturers and Affiliates
      Testimony of Beth Bosley

    Opening Statements

    Congress Takes Aim at TSCA with Mixed Reactions

    Representatives attending the hearing delivered opening statements that touched on several themes. Many discussed the Environmental Protection Agency's (EPA) inability to meet the "unreasonable risk" standard under Section 6 of TSCA, and suggested that TSCA reform bolster EPA's authority to ban or restrict chemicals. Several Representatives mentioned the importance of protecting sensitive populations and supported efforts to prioritize chemicals and update the TSCA Inventory. Rep. DeGette warned that prioritization should not be used as an excuse to delay action on chemicals. Rep. Schakowsky highlighted the fact that, when the TSCA Inventory was established, chemicals in commerce at the time were grandfathered in as "existing chemicals" that were never tested. Several representatives expressed dismay that many chemicals currently in commerce would not undergo assessment under the current TSCA regime. Rep. Schakowsky also mentioned that the committee had met with EPA Administrator Jackson over breakfast to discuss TSCA reform. Rep. Murphy suggested using existing data and models from the European Union and Canada to evaluate chemicals in the U.S.

    Several Representatives warned against making changes to TSCA that would drive companies and jobs overseas, particularly in this economically difficult time. Rep. Radanovich was especially vocal on this issue. He reminded attendees that many other statutes regulate chemical products, and that Section 6 of TSCA was meant to be a gap-filler. He also warned of creating overly expansive lists of problem chemicals that could scare the public. Rep. Dingell also mentioned the financial burdens on industry and noted that funding is a problem for EPA as well.

    EPA Moves Forward with Prioritization

    Steve Owens, Assistant Administrator in EPA's Office of Prevention, Pesticides, and Toxic Substances, opened by stating that TSCA is the only major environmental statute that has not been reauthorized. He emphasized that EPA does not have sufficient authority to reevaluate those existing chemicals that were grandfathered into the Inventory at the time of its creation.

    Mr. Owens noted that, while Congress deliberates legislative TSCA reform, EPA has already begin regulatory prioritization. He explained that EPA will prioritize chemicals based on their presence in human blood, whether they are PBTs, their toxicity, and their volume of production. Mr. Owens also mentioned that EPA will begin issuing "action plans" for a set of chemicals every four months, starting in December. On its website, EPA has identified the following chemicals as among the first chemicals for which the agency will develop action plans:

    • Benzidine dyes and pigments
    • Bisphenol A (BPA)
    • Penta, octa, and decabromodiphenyl ethers (PBDEs) in products
    • Perfluorinated chemicals
    • Phthalates
    • Short-chain chlorinated paraffins

    CDC Highlights Biomonitoring as Key Tool for Prioritization

    Eric Sampson, Director of the Division of Laboratory Sciences in the National Center for Environmental Health with the Centers for Disease Control and Prevention (CDC), emphasized the value of biomonitoring in prioritization efforts. He recommended using biomonitoring tools to take a snapshot of exposures in various populations and identify high exposures. He also recommended partnering with states, schools, and international organizations to examine exposures in vulnerable populations.

    Mr. Sampson mentioned several ongoing biomonitoring efforts, including the National Health and Nutrition Examination Survey conducted by the CDC's National Center for Health Statistics. The Survey involves a complete physical exam, a detailed questionnaire that collects more than 1,000 pieces of information, and the collection of blood and urine samples. Mr. Sampson also noted one study he hopes will be particularly useful: a study sponsored by the National Institutes of Health that is designed to follow 100,000 children from conception to age 21.

    NGO Calls for TSCA Overhaul to Regulate "Worst of the Worst"

    Daryl Ditz, a Senior Policy Advisor for the Center for International Environmental Law, proposed three ways to fix TSCA. First, he stated that EPA needs the authority to effectively regulate "the worst of the worst," such as formaldehyde, bisphenol A, asbestos, phthalates, PBTs, and chemicals subject to the Stockholm Convention on persistent organic pollutants. He stated that the "unreasonable risk" standard has incapacitated EPA from regulating the worst chemicals, and, if EPA has the necessary legal authority, the worst chemicals can be phased out quickly.

    Second, Mr. Ditz discussed the 2008 Kid Safe Chemicals Act. He explained that while the Act's requirement that EPA prioritize chemicals is a well-intentioned provision, it may be used to shortcut the process of assessing all chemicals by requiring evaluation of only a select few and excluding the majority from review. Finally, Mr. Ditz recommended that, like the legal frameworks for pesticides and pharmaceuticals, a revised TSCA should require that data be submitted for all chemicals. He also noted that EPA could make use of information submitted to satisfy the European regulation on Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH).

    Industry Representatives Offer Measured Support for Prioritization Efforts

    William J. Greggs, a consultant for the Consumer Specialty Products Association, the Grocery Manufacturers Association, and the Soap and Detergent Association, stated that prioritization of chemicals should be based on both hazard and exposure. Mr. Greggs believed that EPA should give priority to chemicals with both the highest hazards and the highest potential exposures.

    Beth Bosley, a consultant for the Society of Chemical Manufacturers and Affiliates, emphasized that TSCA should be amended in a way that does not eliminate jobs or useful chemicals. Ms. Bosley explained that implementing an approach in the U.S. modeled after REACH would devastate small and medium businesses. She also urged legislators and regulators to acknowledge the elements of TSCA that have been successful, such as the premanufacture notification (PMN) process. Ms. Bosley suggested that EPA use data generated under the High Production Volume (HPV) Challenge Program, and that the agency gather data on all effects, not merely adverse effects. Finally, Ms. Bosley cautioned against establishing requirements tied to the particular uses of chemicals.

    Questions and Answers

    Rep. Rush asked whether EPA's requests for voluntary submission of data been successful.

    Mr. Owens stated that EPA needs comprehensive data collection to make safety determinations, and that the voluntarily information collection programs have not been successful. He explained that the Chemical Assessment and Management Program (ChAMP) was only modestly beneficial, but too focused on categorizing chemicals based on incomplete information. Mr. Owens noted that TSCA has created disincentives for companies to conduct studies, because they are required by the statute to then submit those studies.

    Rep. Radanovich asked the witnesses about chemicals on the Inventory, and chemicals they would consider to be "the worst of the worst." He feared that the chemical industry would be driven out of the U.S. if no efforts are made to differentiate among the approximately 80,000 chemicals on the Inventory. He asked Mr. Owens whether EPA wanted the chemical production industry to leave the U.S. (answer: no), and whether EPA was aware that the unemployment rate is currently above 10% (answer: yes).

    Mr. Owens believed that most of the approximately 80,000 chemicals on the Inventory are in commerce today. However, Mr. Owens did support a reset of the Inventory to be undertaken after the TSCA reform effort has been completed.

    Mr. Ditz identified PBTs as among "the worst of the worst" chemicals, but noted that it is impossible to know which chemicals are the worst without sufficient data.

    Rep. Radanovich asked Mr. Owens about the success of ChAMP.

    Mr. Owens explained that data obtained under ChAMP is very spotty. He noted that it took much too long to cajole the data out of industry. Now EPA is focused on its "action plans" for priority chemicals and plans to release the first set of action plans in December.

    Rep. Schakowsky asked Mr. Owens about the "quick start" approach, which would involve prioritizing 50-100 chemicals immediately so that EPA could take action now.

    Mr. Owens believed that a "quick start" program would be a good starting point, but should be used as a floor, not a ceiling, for prioritization efforts. He explained once more EPA's "action plans" process, which is designed to glean information on the worst chemicals.

    Rep. Schakowsky asked whether minimum data requirements should be mandatory under TSCA.

    Mr. Greggs acknowledged that EPA needs sufficient data to make decisions regarding risk. He suggested that EPA first identify priority chemicals, and noted that the data to support a "quick start" prioritization exists and could be provided to the agency by industry. Ms. Bosley explained that industry is not sure what type of data EPA wants, but that industry will submit data as soon as it receives clear direction from the agency.

    Mr. Owens stated that EPA needs authorization to require submission of data--otherwise, requests for voluntary submission of information are ignored.

    Rep. Scalise asked Mr. Sampson whether the CDC still believes that the levels and concentrations of chemicals found in humans are more important for determining risk than the merely presence of such chemicals.

    Mr. Sampson agreed with the above statement.

    Rep. Scalise asked the witnesses about REACH.

    Mr. Greggs believed that legislators and regulators should look at the best parts of REACH and the Canadian chemical management program, determine which elements would be appropriate in the U.S., and implement those elements.

    Rep. Scalise asked whether EPA should have a list for chemicals of concern.

    Mr. Greggs stated that criteria for prioritization should be developed and given to EPA, and that the agency would apply those criteria to come up with an appropriate list.

    Rep. Sarbanes asked about the usefulness and integrity of data submitted voluntarily by industry to EPA.

    Mr. Ditz noted that while the voluntary reporting programs ask for data on hazards, EPA also needs information on exposure. Without exposure information, it will be impossible to make risk prioritizations. Mr. Ditz noted that REACH asks for information on how chemicals will be used, in addition to information on the chemicals' properties. He also mentioned that data collection under REACH will prove valuable for EPA because the REACH data will be made publicly available.

    Rep. Sarbanes asked whether looking for "the worst of the worst" will distract regulators from other important chemicals that should be regulated.

    Mr. Ditz noted that stakeholders should be able to quickly agree on "the worst of the worst" chemicals because many of these chemicals have already been essentially phased out and restricting their use will not eliminate any jobs. Mr. Ditz identified brominated flame retardants and chemicals subject to the Stockholm Convention as among the worst chemicals.

    Mr. Owens discussed the problems posed by protections under TSCA for confidential business information. He stated that many chemicals of the Inventory have confidential chemicals names, and through TSCA reform, much information about the Inventory chemicals should be made public.

    Rep. Castor asked if all the witnesses could agree that TSCA needs reform (all answered yes).

    Mr. Ditz believed that EPA has sufficient information to act now. He recommended that legislators fix the basic structure of TSCA and require information submitted under the Act to be made publicly available.

    Rep. Matheson asked whether EPA has access to the CDC's data.

    Mr. Sampson explained that EPA does have access to the CDC's data, and that CDC is expanding its present activities to improve its biomonitoring efforts.

    Rep. Markey asked whether there are chemicals that are known to be so dangerous that they should be phased out or subject to strict restrictions?

    Mr. Ditz identified brominated diphenyl ethers and fluorinated compounds as chemicals that should be phased out or subject to strict restrictions, as well as certain uses of asbestos. Mr. Greggs stated that there are chemicals known to be so dangerous as to warrant immediate phasing out or restriction, and believed that the "quick start" approach would be appropriate for such chemicals.

    Rep. Markey asked whether the Endocrine Disruptor Screening Program should be updated.

    Mr. Owens explained that the first test orders under the program were issued in October, and that EPA is currently considering expanding the program to non-pesticide chemicals.

    Rep. Markey questioned whether the PMN process is effective, as many chemicals notified under the process were accompanied by very little or insufficient health effects data.

    Ms. Bosley explained that EPA evaluates chemicals notified under the PMN process by comparing the structures of the notified chemicals to the structures of known chemicals. Mr. Owens again discussed the confidentiality provisions under TSCA, noting that they are problematic when it comes to prioritization of chemicals.