- Information Date:04/10/1974
- Agreement Agency:Food and Drug Administration (FDA)
Memorandum of Understanding
The Food and Drug Administration
Department of Health, Education and Welfare
The Occupational Safety and Health Administration
Department of Labor
The Occupational Safety and Health Administration of the Department of Labor (herein referred to as OSHA) and the Food and Drug Administration of the Department of Health, Education, and Welfare (herein referred to as FDA) do hereby jointly agree to the following terms and conditions as stated herein.
To identify the authorities and roles for cooperative efforts between the two agencies, subject to this memorandum, in establishing uniform Federal standards relative to electronic product radiation and in determining compliance with these standards. Each agency in implementing its Congressionally delegated authority will thereby assure the maximum use of resources by the elimination of duplicate efforts and regulations.
Statutes and Regulations
The FDA is charged with the administration and enforcement of the Radiation Control for Health and Safety Act of 1968 (P.L. 90-602). The FDA evaluates reports of manufacturers' testing and quality control programs, inspects facilities, and samples and tests both imported and U.S. produced electronic products for the purpose of determining how the manufacturers' procedures assure that imported and U.S. produced electronic products will be in compliance with the standards prescribed under Section 358 of the Public Health Service Act, as amended (42 USC 263f). That Act provides that manufacturers of electronic products must certify that these products comply with applicable performance standards. The Act also requires that State standards on products for which there is a Federal standard established by FDA must be identical in the same aspect of performance as the Federal standard.
OSHA, established by the Occupational Safety and Health Act of 1970 (P.L. 91-596), hereafter referred to as the Act, authorizes the Secretary of Labor to develop and promulgate occupational safety and health standards, to develop and issue regulations, to conduct investigations and inspections, to determine the status of compliance with safety and health standards and regulations, and to issue citations for noncompliance with safety and health standards and regulations. The Act also requires that States with an approved State plan under Section 18 of the Act provide for the development and enforcement of safety and health standards relating to one or more safety or health issues, which standards (and the enforcement of which standards) are or will be at least as effective in providing safe and healthful employment and places of employment as the standards promulgated under Section 6 of the Act.
Items of Agreement
FDA agrees that:
Prior to the issuance of standards by FDA under the Radiation Control for Health and Safety Act to control the emissions of radiation from electronic products, representatives of FDA will consult representatives of OSHA, during the development stage of the standards, for advice to further assure that the FDA standards will be compatible with OSHA standards relating to radiation or other occupational safety and health hazards.
If FDA in its routine compliance program involving an environment has reason to believe that occupational factors are present which may raise questions under the Act, FDA will advise OSHA of its findings.
OSHA agrees that:
Prior to the issuance of standards developed under the Act relative to radiation from electronic products, representatives of OSHA will consult with FDA during the developmental stage to assure that the radiation safety and health regulations established by OSHA are compatible with the Federal performance standard for electronic product radiation emissions established by FDA.
If OSHA in its routine compliance program involving an occupational environment has reason to believe that there are factors present which may indicate a possible violation of FDA standards, OSHA will advise FDA of its findings.
Both OSHA and FDA agree to the following:
In States with an approved State plan under Section 18 of the Act, OSHA will encourage State safety and health officials to cooperate with State radiological health officials in the enforcement and the standard setting efforts relating to performance standards for electronic product radiation.
Exchange procedures and techniques used in determining compliance with the appropriate regulations promulgated by each agency.
Cooperate in the enforcement efforts and thereby avoid duplication of efforts for the purpose of assuring the full safety and health protection of both the employers and the public.
Meet on a quarterly basis, or more often as required, to implement and carry out this memorandum.
Name and Address of Participating Agencies
Occupational Safety and Health Administration Department of Labor 1726 M Street, N. W. Washington, D.C. 20210
Food and Drug Administration Department of Health, Education and Welfare 5600 Fishers Lane Rockville, Maryland 20852
Karen L. Mann Chief, Division of Interagency Coordination Office of Planning, Evaluation and Research Occupational Safety and Health Administration Department of Labor
Robert Britain Director, Division of Compliance Bureau of Radiological Health Food and Drug Administration
Period of Agreement
This Memorandum of Understanding shall continue in effect unless modified by mutual consent of both parties or terminated by either party upon thirty (30) days advance written notice to the other.
This Memorandum of Understanding does not modify existing agreements nor does it preclude entering into separate agreements setting forth procedures for special programs which can be handled more efficiently and expeditiously by special agreement.
Nothing in this agreement is intended to diminish or otherwise affect the authority of either agency to carry out its respective statutory functions.
This Memorandum of Understanding will become effective on the date of the last signature
JOHN H. STENDER
ASSISTANT SECRETARY OF LABOR
OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION U.S. DEPARTMENT OF LABOR
SAM D. FINE
ASSOCIATE COMMISSIONER FOR COMPLIANCE
FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH, EDUCATION AND WELFARE