Reproductive and Developmental Toxicants:

Regulatory Actions Provide Uncertain Protection

PEMD-92-3: Published: Oct 2, 1991. Publicly Released: Oct 30, 1991.

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Pursuant to a congressional request, GAO reviewed the sufficiency of federal regulation on environmental chemicals known to cause adverse reproductive and developmental outcomes.

GAO found: (1) no federal agency has listed chemicals known or suspected to be human toxicants; (2) two-thirds of the major regulatory decisions for the 30 chemicals reviewed were based on cancer and acute toxicity; (3) agencies reported taking 138 regulatory actions on the 30 toxicants reviewed, including 20 cases of banning or cancelling selected uses, 97 cases of getting numerical standards or restrictions, and 21 cases of guidance or guidelines; (4) all but one of the 30 chemicals were covered by 1 or more major regulatory actions, two-thirds were covered by at least 4 actions and 7 were covered by 7 or more actions; and (5) in roughly half of the cases, agency officials judged their own standards and guidelines to be of uncertain protection against reproductive and developmental disease.

Matters for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: Congressional staff indicated that they preferred individual agency attention.

    Matter: Congress may wish to consider designating an office with the responsibility for preparing a periodic report on reproductive and development hazards. This report would list, much as is done for carcinogens, the substances reasonably thought to be reproductive and developmental hazards to which a significant number of people in the United States are exposed.

  2. Status: Closed - Not Implemented

    Comments: Congressional staff indicated that the issue will be considered at the time of individual bill reauthorization.

    Matter: In light of the GAO finding that reproductive and developmental toxicity information is not being used in regulatory decisionmaking for even the 30 chemicals of high concern, Congress should consider amending those laws that do not currently specify the protection of the broad range of reproductive and developmental health issues and use of reproductive and developmental data. Congress could specify that all environmentally caused developmental, female reproductive, and male reproductive disease is part of the public health protection responsibility under the 12 laws.

  3. Status: Closed - Not Implemented

    Comments: The conclusion is that current authority is adequate. Other actions will not be addressed.

    Matter: Congress should consider making authority for alcohol and tobacco regulation explicit for the appropriate offices. In addition, Congress could either encourage EPA to exercise its childproof packaging authority or include household pesticides in CPSC authority for childproof packaging.

  4. Status: Closed - Not Implemented

    Comments: The issue will be addressed in individual bill reauthorizations.

    Matter: Congress should consider how to increase the availability of those data. This could include revising the laws to allow agencies to demand reproductive and developmental toxicity testing at the expense of the entities manufacturing, importing, selling, emitting, or discarding products containing chemicals.

  5. Status: Closed - Not Implemented

    Comments: The issue will be addressed in individual bill reauthorizations.

    Matter: In light of a GAO finding that one-quarter of the major regulatory decisions on the reproductive and developmental chemicals of high concern antedate 1980 and that a dozen standards adopted from nonfederal authorities are still the effective regulation or standard, Congress should establish a periodic review of regulations using recent information on reproductive and developmental toxicity. Specifically, Congress should consider limiting the length of time regulations adopted from outside authorities can be maintained in lieu of federal decisions.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: Agencies have determined tht protection is sufficient. No further action is required.

    Recommendation: The Commissioners of the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), the Administrator of the Environmental Protection Agency (EPA), and the Assistant Secretary of the Occupational Safety and Health Administration (OSHA) should review the existing regulations on the 30 chemicals to ensure that they provide sufficient protection against reproductive and developmental diseases and revise them if necessary.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Not Implemented

    Comments: Agencies have determined that protection is sufficient. No further action is required.

    Recommendation: The Commissioners of the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), the Administrator of the Environmental Protection Agency (EPA), and the Assistant Secretary of the Occupational Safety and Health Administration (OSHA) should review the existing regulations on the 30 chemicals to ensure that they provide sufficient protection against reproductive and developmental diseases and revise them if necessary.

    Agency Affected: Department of Labor: Occupational Safety and Health Administration

  3. Status: Closed - Not Implemented

    Comments: Agencies have concluded that protection is sufficient. No further action is required.

    Recommendation: The Commissioners of the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), the Administrator of the Environmental Protection Agency (EPA), and the Assistant Secretary of the Occupational Safety and Health Administration (OSHA) should review the existing regulations on the 30 chemicals to ensure that they provide sufficient protection against reproductive and developmental diseases and revise them if necessary.

    Agency Affected: Consumer Product Safety Commission

  4. Status: Closed - Not Implemented

    Comments: Agencies have concluded that protection is sufficient. No further action is required.

    Recommendation: The Commissioners of the Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA), the Administrator of the Environmental Protection Agency (EPA), and the Assistant Secretary of the Occupational Safety and Health Administration (OSHA) should review the existing regulations on the 30 chemicals to ensure that they provide sufficient protection against reproductive and developmental diseases and revise them if necessary.

    Agency Affected: Environmental Protection Agency

  5. Status: Closed - Not Implemented

    Comments: Agency indicates outcomes considered in current program. No further action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should perform separate analysis for reproductive and developmental outcomes in risk assessments for those 30 chemicals and for future regulatory decisionmaking.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  6. Status: Closed - Not Implemented

    Comments: Agency indicates outcomes considered in current program. No further action required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should perform separate analysis for reproductive and developmental outcomes in risk assessments for those 30 chemicals and for future regulatory decisionmaking.

    Agency Affected: Department of Labor: Occupational Safety and Health Administration

  7. Status: Closed - Not Implemented

    Comments: Agency indicates reproductive/developmental risks considered. No further action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should perform separate analysis for reproductive and developmental outcomes in risk assessments for those 30 chemicals and for future regulatory decisionmaking.

    Agency Affected: Consumer Product Safety Commission

  8. Status: Closed - Not Implemented

    Comments: Agency indicates outcomes considered. No additional action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should perform separate analysis for reproductive and developmental outcomes in risk assessments for those 30 chemicals and for future regulatory decisionmaking.

    Agency Affected: Environmental Protection Agency

  9. Status: Closed - Not Implemented

    Comments: Agency indicates it acquires data without demand authority. No authority is needed.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should ensure the ready availability of reproductive and developmental data to by asking Congress for the power to demand reproductive and developmental toxicity test data from entities manufacturing, importing, selling, emitting, or discarding reproductive and developmental hazards, and by organizing office databases so that reproductive and developmental data are available.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  10. Status: Closed - Not Implemented

    Comments: Agency indicates it acquires data without demand authority. No authority is needed.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should ensure the ready availability of reproductive and developmental data to by asking Congress for the power to demand reproductive and developmental toxicity test data from entities manufacturing, importing, selling, emitting, or discarding reproductive and developmental hazards, and by organizing office databases so that reproductive and developmental data are available.

    Agency Affected: Department of Labor: Occupational Safety and Health Administration

  11. Status: Closed - Not Implemented

    Comments: Agency indicates it acquires data without demand authority. No additional authority is needed.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should ensure the ready availability of reproductive and developmental data to by asking Congress for the power to demand reproductive and developmental toxicity test data from entities manufacturing, importing, selling, emitting, or discarding reproductive and developmental hazards, and by organizing office databases so that reproductive and developmental data are available.

    Agency Affected: Consumer Product Safety Commission

  12. Status: Closed - Not Implemented

    Comments: Agency indicates it acquires data without demand authority. No additional authority is needed.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should ensure the ready availability of reproductive and developmental data to by asking Congress for the power to demand reproductive and developmental toxicity test data from entities manufacturing, importing, selling, emitting, or discarding reproductive and developmental hazards, and by organizing office databases so that reproductive and developmental data are available.

    Agency Affected: Environmental Protection Agency

  13. Status: Closed - Not Implemented

    Comments: FDA indicates it has such information. No additional action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should develop information on the occurrence of each chemical in the media, products, or situations within their area of responsibility.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  14. Status: Closed - Not Implemented

    Comments: Agency indicates it has such information. No additional action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should develop information on the occurrence of each chemical in the media, products, or situations within their area of responsibility.

    Agency Affected: Department of Labor: Occupational Safety and Health Administration

  15. Status: Closed - Not Implemented

    Comments: Agency indicates that it has information. No additional action is required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should develop information on the occurrence of each chemical in the media, products, or situations within their area of responsibility.

    Agency Affected: Consumer Product Safety Commission

  16. Status: Closed - Not Implemented

    Comments: Agency indicates it develops such information as it considers regulatory action. No additional action required.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should develop information on the occurrence of each chemical in the media, products, or situations within their area of responsibility.

    Agency Affected: Environmental Protection Agency

  17. Status: Closed - Not Implemented

    Comments: Agency concluded that its review was complete.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should conduct a search for and examination of the reproductive and developmental toxicity data for the unregulated chemicals, proceeding to a thorough hazard assessment.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  18. Status: Closed - Not Implemented

    Comments: Agency indicated that it was sure unregulated chemicals were not within its jurisdiction or present problems.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should conduct a search for and examination of the reproductive and developmental toxicity data for the unregulated chemicals, proceeding to a thorough hazard assessment.

    Agency Affected: Department of Labor: Occupational Safety and Health Administration

  19. Status: Closed - Not Implemented

    Comments: No additional action is planned.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should conduct a search for and examination of the reproductive and developmental toxicity data for the unregulated chemicals, proceeding to a thorough hazard assessment.

    Agency Affected: Consumer Product Safety Commission

  20. Status: Closed - Not Implemented

    Comments: Agency indicated that it had such information for unregulated chemicals.

    Recommendation: The Commissioners of CPSC and FDA, the Administrator, EPA, and the Assistant Secretary, OSHA, should conduct a search for and examination of the reproductive and developmental toxicity data for the unregulated chemicals, proceeding to a thorough hazard assessment.

    Agency Affected: Environmental Protection Agency

 

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