Date: Feb 02, 2001
On December 26, 2000, the U.S. Environmental Protection Agency (EPA) announced the Voluntary Children's Chemical Evaluation Program (VCCEP) that asks manufacturers, including importers of 23 chemicals to volunteer to sponsor data development and evaluation efforts in a pilot of the VCCEP. 65 Fed. Reg. 81700. The stated purpose of the VCCEP is to provide data that will enable the public to understand the potential health risks to children associated with certain chemical exposures.
Origins: EPA traces the origin of this program to the Chemical Right-to-Know Initiative (CRK Initiative) announced by Vice President Gore on Earth Day 1998. One goal of the CRK Initiative was to ensure that there are adequate publicly available data to assess the special impact industrial chemicals may have on children. Initially, EPA planned to issue a Toxic Substances Control Act (TSCA) Section 4 Test Rule that would have required testing of almost 100 chemicals to which children are believed to have a high likelihood of exposure. After a series of stakeholder meetings, the Agency decided to focus its initial efforts on implementing a pilot program to examine a select list of chemical which the Agency contends have been found to be present as contaminants in human tissues or fluids, food and water children may eat or drink, or air children may breathe.
While 50 chemicals were identified as candidates for inclusion in the VCCEP, EPA trimmed the list to 23 for this pilot program after further review. More information on the chemical selection process is available in an EPA document entitled, Methodology for Selecting Chemicals for the Voluntary Children's Chemical Evaluation Program Pilot.
Three-Tier Approach: The VCCEP adopts a three-tier approach to gathering test data on the identified chemicals.
Tier 1 requires data from the following tests: (1) acute oral toxicity or acute inhalation toxicity, (2) in vitro gene mutation: bacterial reverse mutation assay, (3) combined repeated dose toxicity with reproductive and developmental toxicity screens or repeated dose oral toxicity and reproductive toxicity (1-generation), and (4) in vitro chromosomal aberrations or in vivo chromosomal aberrations or in vivo mammalian erythrocyte micronucleus.
Tier 2 requires data from the following tests: (1) 90-day subchronic toxicity in rodents, (2) reproduction and fertility effects, (3) prenatal developmental toxicity (two species), and (4) in vivo mammalian bone marrow chromosomal aberrations or in vivo mammalian erythrocyte micronucleus (triggered off results from in vitro mammalian chromosomal aberration test if conducted in Tier 1). Tier 3 requires data from the following tests: (1) carcinogenicity or chronic toxicity/carcinogenicity, (2) neurotoxicity screening battery, and (3) developmental neurotoxicity. (There is some debate over the appropriate test protocols and data interpretation of the neurotoxicity screening battery and developmental neurotoxicity studies.)
Tier 2 requires data from the following tests: (1) 90-day subchronic toxicity in rodents, (2) reproduction and fertility effects, (3) prenatal developmental toxicity (two species), and (4) in vivo mammalian bone marrow chromosomal aberrations or in vivo mammalian erythrocyte micronucleus (triggered off results from in vitro mammalian chromosomal aberration test if conducted in Tier 1).
Tier 3 requires data from the following tests: (1) carcinogenicity or chronic toxicity/carcinogenicity, (2) neurotoxicity screening battery, and (3) developmental neurotoxicity. (There is some debate over the appropriate test protocols and data interpretation of the neurotoxicity screening battery and developmental neurotoxicity studies.)
A Tier 1 Hazard Assessment should include "robust summaries" of the studies used to generate the Tier 1 test data, as well as any available Tier 2 or Tier 3 hazard data. A robust summary must include an objective, discussion of methods, results, and conclusions. Exposure Assessments should contain information that answers the following questions: (1) who and how many people are exposed, (2) what are sources of exposure, (3) does the exposure occur through breathing air, drinking water, eating food, contact with skin, or any other route, (4) how intense is the exposure, and (5) what is the frequency and duration of exposure? A Tier 1 Exposure Assessment must contain screening level information on exposure from manufacturing, downstream processing and use activities, and specific information on children's exposures.
Risk Assessments must integrate the Hazard and Exposure Assessments and characterize the risks to children and, if relevant, prospective parents. A Data Needs Assessments involves the sponsor identifying the additional hazard and/or exposure data needed to adequately assess the chemical's risk to children and prospective parents. The Tier 1 sponsor must develop an assessment of the need for Tier 2 data and, in a similar manner, the Tier 2 sponsor must develop an assessment of the need for Tier 3 data. Tier 2 and 3 Assessments are advanced assessments that are designed to produce more accurate and complete evaluations.
Peer Consultation Process: A key aspect of the VCCEP is the Peer Consultation Process. The Peer Consultation Process is an, admittedly, non-consensus based process in which scientists and experts from various stakeholder groups will be given the opportunity to exchange views on the sponsor's Assessments and to provide these views to a third party contractor. For each tier, the sponsor of a particular chemical is responsible for preparing a Peer Consultation Document that basically consists of the four Assessments. EPA will make this document available to the public and a third party contractor who will distribute the document to the Peer Consultation Group. Although, it is not clear exactly how the Peer Consultation group will be chosen, all subsequent meetings and deliberation will be open to the public and interested parties will be given an opportunity to provide comments. An independent third party contractor will compile the results of the Peer Consultation Process into a report to EPA. The Agency will then announce which data are needed for the next tier. If EPA's recommendations differ significantly from those indicated by the third party report, then the Agency will provide a rationale and allow stakeholders 60 days to comment.
Sponsorships: Companies/consortia may choose to sponsor a particular chemical to meet the requirements of a single tier. For each tier, four types of assessments are required: a Hazard Assessment, an Exposure Assessment, a Risk Assessment, and a Data Needs Assessment (Tiers 1 and 2 only). The amount of information in each assessment will increase with each successive tier as additional data are gathered and used to build upon the results of the lower tier assessments.
To sponsor a chemical at Tier 1, companies or consortia must send a letter of commitment to EPA by June 25, 2001. Notably, by design many of the chemicals selected for the VCCEP are already sponsored under the HPV Challenge Program and the tests and guidelines required in Tier 1 of the VCCEP are the same as those for the HPV Challenge Program. With some exceptions, companies/consortia who agree to sponsor a chemical at Tier 1 must commit to beginning the development of hazard and exposure data within six months after the end of the sign up period, although sponsors are permitted to delay the start year for developing such data to be consistent with a commitment made to the HPV Challenge Program.
Although the VCCEP is supposedly designed to be flexible, EPA has specified the amount of time it deems sufficient for sponsors to complete the required tests. Depending on the particular test involved, sponsors have from 12 months (e.g., prenatal developmental toxicity) to 60 months (e.g., carcinogenicity) to complete the required testing and to prepare the final reports. An additional 4 months is available, upon request, to prepare the Exposure, Risk, and Data Needs Assessments. Upon completion of Tier 1 and following EPA's final decision regarding Tier 2 data needs, prospective sponsors would have four months to commit to Tier 2 of the pilot program, and, subsequently, four months to commit to Tier 3. EPA intends to utilize a "risk-based, scientifically sound process" to decide whether to gather additional information or to take reduction actions. Furthermore, depending on the findings for a particular chemical, EPA anticipates requiring additional risk communication or risk reduction activities.
The commitments EPA is seeking are not enforceable agreements or contracts, but an agreement to participate obviously creates practical and perception obligations. However, a sponsor may withdraw at any time, and EPA may choose to exercise its authority to require testing, if appropriate under Section 4 of TSCA. But, the Agency plans to consider whether a particular chemical is being sponsored under the VCCEP when determining whether to take additional action under Section 4 of TSCA.
Outlook: EPA plans to evaluate the success of the pilot program at 3 and 6 years after initiation of the Program. Depending on the success of the pilot, the Agency will consider whether to utilize this approach in lieu of more conventional regulatory approaches (e.g., TSCA Section 4 Test Rule) in other areas such as in following up on chemicals addressed in the HPV Challenge Program. The Agency is especially interested in evaluating how well the Peer Consultation Process works, as some critics fear that this process could become too time-consuming, burdensome, and politicized to yield fair and reasonable results.
Although EPA emphasizes that identification for the VCCEP does not mean the Agency has made or will make a determination that any uses of a particular chemical pose significant risks to children's health, some stakeholders fear that the mere inclusion of a chemical on a VCCEP listing will create an unwarranted stigma that will hamper the marketing and sale of safe, effective, and needed chemical products. Even if your company does not have a specific interest in any of the listed chemicals, because this is a pilot study that could lead to a more extensive program, this topic should be of general interest to a broad range of chemical and consumer product manufacturers. Finally, at this time this article was prepared, there is no indication of how the program might be changed under the new administration of President George W. Bush.
LIST OF PILOT CHEMICALSAcetonep-DichlorobenzeneDecaneBenzeneEthylene dibromideTetrachloroethyleneVinylidenechlorideEthylene dichloridem-DichlorobenzeneMethyl ethyl ketonem-XyleneUndecaneTrichloroethyleneTolueneDecabromodiphenylethera-PineneChlorobenzenePentabromodiphenyl ethero-Xylenen-DodecaneOctabromodiphenyl etherEthylbenzenep-Dioxane
LIST OF PILOT CHEMICALS
For further information, please contact Peter de la Cruz at (202) 434-4141 or via e-mail at email@example.com, or Trent Doyle at (202) 434-4161 or via e-mail at firstname.lastname@example.org.