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Protocol for TEACH Chemical Summaries

Last revised 9/21/05

I. General

To aid in reading and understanding, the Chemical Summaries are written and formatted in a consistent manner:

  1. Margins are identical.
  2. Footers are included on every page.
  3. Bullet placement is consistent.
  4. Each Chemical Summary has the layout described below.

II. Chemical Summary Heading

Under the words "TEACH Chemical Summary" in the heading of the first page, a standard paragraph will be included: This TEACH Chemical Summary is a compilation of information derived primarily from U.S. EPA and ATSDR resources, and the TEACH Database. The TEACH Database contains summaries of research studies pertaining to developmental exposure and/or health effects for each chemical or chemical group. TEACH does not perform any evaluation of the validity or quality of these research studies. Research studies that are specific for adults are not included in the TEACH Database, and typically are not described in the TEACH Chemical Summary.

III. Introduction

A brief overview of the issues pertaining to the chemical is provided, including:

  1. The chemical forms that may be encountered and where they are found.
  2. Major uses and volume of use in the U.S.
  3. Health effect concerns for exposed children, and target organs if known.
  4. How children and pregnant women are likely to be exposed.

IV. Exposure

1. This Section organizes and distills, in a concise format, information on the major sources and transport mechanisms by which a chemical would enter environmental media to serve as a potential source for human exposure. The general selection criteria are:

  1. A standard set of seven "Exposure Media" (indoor air, ambient air, groundwater, drinking water, soil, sediment, diet) will be listed for all chemicals that represent environmental media into which a chemical would be encountered, placed in order of potential for exposure with highest potential listed first.
  2. The major chemical sources (e.g., release sources, pollution sources) that are judged to cause direct contamination of the selected environmental medium will be identified and described in concise terminology in the basis column when relevant.
  3. The major transport mechanisms (e.g., migration, volatilization) that are judged to cause movement of the chemical from one environmental medium to another medium will be identified and described in concise terminology when relevant.
  4. Based on the available information about the chemical sources and transport mechanisms, professional judgments will be made on the relative importance of each selected environmental medium to serve as a potential pathway for exposure (these judgments will be noted as a "Relative Potential for Children's Exposure").

2. This Section will not cite specific references. Rather, information from EPA reports and databases, other government documents, and other published literature will be consulted to identify information included in this section.

3. Information will also be included based on professional experience of members of the TEACH Workgroup.

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V. Toxicity Summary

Identify toxic effect(s) associated with exposure to the agent, with supporting citations. Identify the developmental stage when exposure and testing occurred, if applicable, and include supporting citations. Include cancer effects and noncancer effects, and distinguish effects of chronic and acute exposures, if relevant. Briefly describe experimental animal and/or human study evidence of greater early lifestage susceptibility (if any) with supporting citations; if no such evidence is available, state that.

VI. Exposure and Toxicity Studies from the Teach Database

1. The Exposure and Toxicity Studies section will be divided into two parts: Human Exposure and Effects; and Experimental Animal Exposure and Effects.

2. Under each section, a brief description of studies listed in the TEACH Database will be given, organized by the type of study (see Item 5 below). Studies will be described, with no evaluation as to the merit or validity of the study performed. A brief description of results will be provided, though technical readers may wish to consult the original article for more details about the study.

3. The types of primary research studies included in this section fit certain criteria. Studies that described statistically significant results will be described; studies that describe non-significant trends will be included if relevant, and will be clearly identified as non-significant trends. Only studies that measured or estimated exposure to the specific chemical of interest will be included in this section of the Chemical Summary (e.g., studies of exposure to traffic exhaust will be included only if a TEACH chemical such as benzene is measured in that study).

4. Subheadings under human or animal studies may be included for particular chemicals to clarify organization of the information.

5. Information to be included in each section includes:

  1. Studies on exposure or scenarios that suggest that children or the unborn are at special risk due to chemical of interest, including and incorporating biomarker data that suggests children's exposure.
  2. Evidence that developing lifestages in children or experimental animals are sensitive to chemical of interest.
  3. Adverse health effects due to exposure to chemical of interest, including cancer effects following early life exposure to the chemical of interest.

6. Information will be included in each section in the following order:

  1. Exposure studies and scenarios, including biomarker studies, organized in order of the lifestage during which exposure occurred, from germ cells through adolescence.
  2. Health effect studies also in order of lifestage when exposure occurred, from germ cells through adolescence.
  3. Early life exposure which resulted in cancer endpoints are to be placed before noncancer endpoints.

7. Each entry will include a brief description of the study and outcomes of the study, followed by a reference number, with more emphasis on the general conclusion of the study, rather than details of results. In order to summarize critical issues for children's health, some level of overview or summary of related papers is to be included at the beginning of the paragraph.

8. Animal study summaries should include the route of exposure used in the study.

9. Cited references will be numbered according to progressive order of appearance in each Chemical Summary.

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VII. Considerations for Decision-Makers

1. Include information about any major (e.g. national, regional, state) exposure assessments that have been done for the chemical of interest that include children in the study population. If possible, include a summary of data available (e.g. range of personal sampling data).

2. Identify any existing reference values that specifically take into account developmental effects for the chemical of interest.

3. Answer the following questions in this section:

  1. Are there exposure data or scenarios that suggest that children or fetuses are at special risk?
  2. Is there a reason to believe that developing lifestages may be particularly sensitive to this agent?

4. Suggest special risk management strategies that should be considered in order to protect children from chemical of interest. Include suggestions for parents, caregivers, teachers, and the general public that can help them take action to avoid exposures of children to the chemical of interest (may have been intended in existing text, but addition here to clarify).

5. Highlight available U.S. government resources for risk assessors, including Toxicological Profiles, Toxicological Reviews, and health risk assessments.

6. List the ranking of the chemical of interest in the CERCLA Priority List of Chemicals when applicable.

VIII. Toxicity Reference Values

1. List carcinogenicity information using the "Carcinogenicity weight-of-evidence classification" and provide descriptor under proposed cancer guidelines (carcinogenic; likely; suggestive evidence; inadequate information; not likely) and basis, or prior letter classification under 1986 Guidelines (A-B-C-D-E) and basis. Include the WHO IARC classification as well.

2. Provide U.S. EPA (e.g. RfD; RfC; unit risk estimates; MCL; etc.) and ATSDR (e.g. MRL) reference values/guidelines, including their bases and Last Agency Consensus Dates.

IX. Regulatory Information

List information about regulatory values in this section. Such information can include, when available: REDs, HAP listing, any banned uses of the chemical of interest, FQPA listings, CERCLA rankings, and reportable quantities under EPCRA. Citations supporting information should be included.

X. Background on Chemical

The most recent numbers available on production, sales, TRI total reported releases or disposals, and environmental fate will be included.

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