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EPA Announces Proposed New Chemical Testing Rule and Holds Public Meeting on Voluntary Chemical Evaluation

Beveridge & Diamond, P.C., August 20, 2008

At the end of July 2008, EPA advanced two chemical evaluation programs of interest to chemical manufacturers, importers and processors when the Agency proposed a new test rule for high production volume chemicals under the Toxic Substances Control Act (“TSCA”) and held a public meeting to discuss proposed modifications to the Voluntary Children’s Chemical Evaluation Program (“VCCEP”).

TSCA Test Rule

On July 24, 2008, EPA proposed a TSCA test rule requiring that manufacturers, importers, and processors of 19 high production volume (“HPV”) chemical substances conduct specific testing to obtain screening level data for health, environmental effects, and chemical fate.  HPV chemical substances are chemical substances manufactured or imported in amounts equal to or greater than one million pounds per year.  EPA is proposing the testing of these chemical substances based on its preliminary findings that over one million pounds of each of these chemical substances is produced and/or imported into the U.S. each year, there is or may be substantial human exposure to these chemical substances, and there is insufficient data to quantify the potential health and environmental effects from these chemical substances.

Chemical manufacturers, importers and processors of the 19 HPV chemical substances will be required to conduct screening level tests for:  environmental fate, ecotoxicity, acute toxicity, genetic toxicity, repeat dose toxicity, and developmental and reproductive toxicity.  The tests are part of the Screening Information Data Set, a battery of tests agreed upon by the international community through OECD.  The proposed rule would not initially apply to processors or manufacturers than manufacture less than 1,100 pounds of the 19 HPV chemical substances per year, small quantities of the 19 HPV chemical substances for research and development, or one of the 19 HPV chemical substances as a byproduct or impurity, among other initial exemptions.

Data collected under the proposed rule will allow the Agency to evaluate health and environmental risks posed by these chemical substances and potentially take a wide variety of regulatory action.  In the past, EPA has used data from test rules to support the development of water quality criteria, Toxic Release Inventory (“TRI”) listings, chemical advisories, and reduction of workplace exposures.  In addition, exporters of the HPV chemical substances included in the final rule will be subject to TSCA section 12(b)(1) export notification requirements.  The Agency plans on proposing testing for additional HPV chemical substances at a later date.  Comments on the proposed rule must be received by October 22, 2008.  The Federal Register Notice announcing EPA’s proposed test rule is available at http://www.epa.gov/EPA-TOX/2006/March/Day-16/t2483.htm.

VCCEP

On July 22, 2008, EPA held a meeting to discuss its proposed modifications to the VCCEP.  The VCCEP is part of the 1998 Chemical Right to Know Initiative and is designed to address risks to children.  Through the VCCEP, EPA has asked companies that manufactured or imported one or more of 23 chemicals to which children have a high likelihood of exposure to volunteer to provide information on health effects, exposure, risk, and data needs. Thirty-five companies and 10 consortia volunteered to sponsor 20 of the 23 chemicals.  The VCCEP was first implemented as a pilot program to help determine the final VCCEP process.  EPA is now evaluating the program and considering options to modify it. 

EPA has proposed modifications in the following areas: (1) the chemical selection process; (2) the timing of data submission and review; (3) data needs determinations; and (4) cost control.  Regarding chemical selection, EPA proposes to select future VCCEP chemicals from chemicals that are identified through the Chemical Assessment and Management Program (CHaMP) as “being of special concern and as presenting hazard/exposure data needs that are relevant to characterizing risks to children.”  To address timeliness issues, EPA proposes to establish clear due dates as part of Sponsor commitment letters, combine Tier 2 (subchronic toxicity, prenatal developmental toxicity, reproductive and fertility effects, immunotoxicity, in vivo chromosomal aberrations or in vivo micronucleus tests, and metabolism and pharmacokinetics) and Tier 3 (neurotoxicity screening battery, carcinogenicity, and developmental neurotoxicity) review when reasonable, and provide 90 days for Sponsors to amend assessments before EPA issues its Data Needs Decision (and EPA will have 90 days to issue a decision).  Regarding data needs determinations, EPA proposes to continue to distinguish between “data gaps” and “data needs.”  With respect to cost control, EPA proposes to require Sponsors to contract with independent third parties to manage the peer consultation process and to bear the costs.  The Federal Register Notice announcing EPA’s proposed modifications are available at http://www.epa.gov/fedrgstr/EPA-TOX/2008/June/Day-27/t14528.htm.

For more information, please contact Cindi Lewis at clewis@bdlaw.com, Ami Grace-Tardy, agrace@bdlaw.com, or Bethany French, bfrench@bdlaw.com.