Reproductive and Developmental Toxicants: Regulatory Actions Provide Uncertain Protection
PEMD-92-3
Published: Oct 02, 1991. Publicly Released: Oct 30, 1991.
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Highlights
Pursuant to a congressional request, GAO reviewed the sufficiency of federal regulation on environmental chemicals known to cause adverse reproductive and developmental outcomes.
Recommendations
Matter for Congressional Consideration
| Matter | Status | Comments |
|---|---|---|
| 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. | Congressional staff indicated that they preferred individual agency attention. | |
| 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. | Congressional staff indicated that the issue will be considered at the time of individual bill reauthorization. | |
| 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. | The conclusion is that current authority is adequate. Other actions will not be addressed. | |
| 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. | The issue will be addressed in individual bill reauthorizations. | |
| 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. | The issue will be addressed in individual bill reauthorizations. |
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Food and Drug Administration | 1. 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. |
Agencies have determined tht protection is sufficient. No further action is required.
|
| Occupational Safety and Health Administration | 2. 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. |
Agencies have determined that protection is sufficient. No further action is required.
|
| Consumer Product Safety Commission | 3. 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. |
Agencies have concluded that protection is sufficient. No further action is required.
|
| Environmental Protection Agency | 4. 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. |
Agencies have concluded that protection is sufficient. No further action is required.
|
| Food and Drug Administration | 5. 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 indicates outcomes considered in current program. No further action is required.
|
| Occupational Safety and Health Administration | 6. 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 indicates outcomes considered in current program. No further action required.
|
| Consumer Product Safety Commission | 7. 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 indicates reproductive/developmental risks considered. No further action is required.
|
| Environmental Protection Agency | 8. 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 indicates outcomes considered. No additional action is required.
|
| Food and Drug Administration | 9. 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 indicates it acquires data without demand authority. No authority is needed.
|
| Occupational Safety and Health Administration | 10. 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 indicates it acquires data without demand authority. No authority is needed.
|
| Consumer Product Safety Commission | 11. 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 indicates it acquires data without demand authority. No additional authority is needed.
|
| Environmental Protection Agency | 12. 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 indicates it acquires data without demand authority. No additional authority is needed.
|
| Food and Drug Administration | 13. 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. |
FDA indicates it has such information. No additional action is required.
|
| Occupational Safety and Health Administration | 14. 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 indicates it has such information. No additional action is required.
|
| Consumer Product Safety Commission | 15. 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 indicates that it has information. No additional action is required.
|
| Environmental Protection Agency | 16. 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 indicates it develops such information as it considers regulatory action. No additional action required.
|
| Food and Drug Administration | 17. 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 concluded that its review was complete.
|
| Occupational Safety and Health Administration | 18. 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 indicated that it was sure unregulated chemicals were not within its jurisdiction or present problems.
|
| Consumer Product Safety Commission | 19. 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. |
No additional action is planned.
|
| Environmental Protection Agency | 20. 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 indicated that it had such information for unregulated chemicals.
|
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