EPA Agreement No. PW 16931704-01-1

MEMORANDUM OF UNDERSTANDING
BETWEEN THE
ENVIRONMENTAL PROTECTION AGENCY
AND THE
DEPARTMENT OF LABOR

1. PURPOSE

   The purpose of this agreement is to set forth the working relationship between the Environmental Protection Agency (EPA) and the Department of Labor (DOL), specifically the Occupational Safety and Health Administration (OSHA) with respect to the requirements of section 9(a) of the Toxic Substances Control Act (TSCA).

   This Memorandum of Understanding (MOU) establishes a process for notification and consultation to aid in EPA's preparation of section 9(a) reports which are submitted to OSHA. This MOU is intended to promote efficient administration of section 9(a) of the TSCA and is in conformance with the legal responsibilities of each agency.

2. BACKGROUND

   EPA and OSHA have different, though related, responsibilities and objectives in carrying out their respective statutory powers with regard to regulation of toxic substances. As described below, the Toxic Substances Control Act requires EPA to make a finding of unreasonable risk of injury to health or the environment in order to regulate a toxic substance, while the Occupational Safety and Health Act requires OSHA to demonstrate that there is a significant risk to employees from a toxic substance in the workplace in order to regulate that substance.

   Toxic Substances Control Act

   The Toxic Substances Control Act (15 U.S.C. 2601 through 2629) was enacted into law in 1976. The administrator of the Environmental Protection Agency is responsible for carrying out TSCA's requirements. Within EPA, the Assistant Administrator for Pesticides and Toxic Substances has been delegated authority to oversee TSCA's functions.

   The goal of TSCA is to identify and regulate unreasonable risks to health or the environment posed by chemicals imported, manufactured or processed in the United States. To achieve this goal, EPA is authorized, among other things, to promulgate rules requiring industry to test certain chemicals suspected of posing an unreasonable risk; require submission of production site, volume, and other data about chemicals imported or produced in the United States; review and assess potential risks posed by all new chemicals prior to their production; and issue orders and rules to ban or control the manufacture, processing or use of both new and existing chemicals that pose unreasonable risks.

   Through TSCA's broad information-gathering authority EPA has, among other things, compiled and kept current an inventory of all chemicals in commercial production subject to TSCA coverage; promulgated a model rule requiring automatic submission of health and safety studies pertaining to chemicals recommended for testing by the Interagency Testing Committee; and proposed a rule to update production volume and plant-site data for a critical portion of the 64,000 chemicals on the TSCA Inventory. Under the new chemical review program, EPA has reviewed more than 5,600 chemicals. Of these, four have been banned; 92 have been voluntarily withdrawn by the manufacturer; 277 have had production controls imposed or voluntarily accepted; and 92 are being or have been tested. Under TSCA's existing chemical program, EPA has promulgated 16 rules banning or controlling production or use of four chemicals.

   Congress generally requires that control regulations under TSCA be based upon findings that chemicals present or may present unreasonable risks. This requires that EPA take into account the effects of a chemical on health and the environment, the magnitude of exposure, the benefits of the chemical for various uses, availability of substitutes, and the reasonably ascertainable economic consequences of the regulation.

   Occupational Safety And Health Act (OSHA Act)

   The Occupational Safety and Health Act (29 U.S.C. 651 et seq.) was enacted in 1970. The Occupational Safety and Health Administration (OSHA), headed by an Assistant Secretary for Occupation Safety and Health, was established in the Department of Labor in 1971 to administer this law. The goal of the OSH Act is to assure so far as possible every working man and woman in the nation safety and healthful working conditions. To achieve its purpose, that Act provides broad authority for a variety of activities and programs designed to reduce the number of occupational safety and health hazards in places of employment. Among these is the authority to promulgate and enforce mandatory safety and health standards for private sector workplaces.

   OSHA standards contain requirements designed to protect employees against workplace hazards. In general, safety standards are intended to protect against traumatic injury. Health standards, for the most part, address potential overexposures to toxic substances and harmful physical agents and may protect against illnesses which do not manifest themselves until many years after initial exposure. OSHA has issued standards which set permissible exposure limits for more than 400 substances, and comprehensive health standards which regulate 22 substances. These comprehensive standards have varied requirements, including provisions for engineering controls, work practice controls, medical monitoring, and personal protective equipment. In instances in which OSHA has not promulgated specific standards, OSHA may enforce the general duty provisions of the OSH Act, which require each employer to furnish a place of employment free from recognized hazards that are causing or are likely to cause death or serious physical harm.

   The OSH Act (as interpreted by the U.S. Supreme Court in Industrial Union Department, AFL-CIO v. API) requires that before a health standard can be promulgated, OSHA must demonstrate the existence of a significant risk to employees and must further demonstrate that the standard in question will actually reduce that risk. The OSH Act (as interpreted by several Federal appellate courts, initially in IUD v. Hodgson) also requires OSHA to gather data to show that the regulation is economically and technologically feasible for the industry as whole.

   TSCA Section 9(a)

   Thus, EPA and OSHA have related responsibilities and objectives in exercising their respective statutory powers. The possibility that EPA's activities could overlap with other agencies' was recognized at the time TSCA was enacted and led to inclusion of section 9, "Relationship to Other Federal Laws," which among other specifications, provides that the EPA Administrator "shall consult and coordinate" with other agencies in administering TSCA (see section 9(d)). In addition, section 9(a) of TSCA states that:

   "If the Administrator has reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents or will present an unreasonable risk of injury to health or the environment and determines, in the Administrator's discretion, that such risk may be prevented or reduced to a sufficient extent by action taken under a Federal law not administered by the Administrator, the Administrator shall submit to the Agency which administers such law a report which describes such risk and includes in such description a specification of the activity or combination of activities which the Administrator has reason to believe so presents such risk." Such report shall also request such agency -

   (A)(i) to determine if the risk described in such report may be prevented or reduced to a sufficient extent by action taken under such law, and

   (ii) if the agency determines that such risk may be so prevented or reduced to issue an order declaring whether or not the activity or combination of activities specified in the description of such risk presents such risk; and

   (B) to respond to the Administrator with respect to the matters described in subparagraph (A).

   Any report of the Administrator shall include a detailed statement of the information on which it is based and shall be published in the Federal Register. The agency receiving a request under such a report shall make the requested determination, issue the requested order, and make the requested response within such time as the Administrator specifies in the request, but such time specified may not be less than 90 days from the date the request was made. The response of an agency shall be accompanied by a detailed statement of the findings and conclusions of the agency and shall be published in the Federal Register.

   (1) action under the law (or laws) administered by such agency to protect against such risk associated with such activity or combination of activities, the Administrator may not take any action under section 6 or 7 with respect to such risk.

   (2) If the Administrator makes a report under paragraph (a) with respect to a chemical substance or mixture and the agency to which such report was made either -

   (A) issues an order declaring that the activity or combination of activities specified in the description of the risk described in the report does not present the risk described in the report, or

   (B) initiates, within 90 days of the publication in the Federal Register of the response of the agency under paragraph

   (3) If the Administrator has initiated action under section 6 or 7 with respect to a risk associated with a chemical substance or mixture which was the subject of a report made to an agency under paragraph (1), such agency shall, before taking action under the law (or laws) administered by it to protect against such risk, consult with Administrator for the purpose of avoiding duplication of Federal action against such risk.

   It is desirable and in the public interest to set forth in this Memorandum of Understanding the working arrangements by which EPA and DOL agree to efficiently carry out their respective responsibilities under section 9(A) of TSCA.

3. SUBSTANCE OF AGREEMENT

   1. PRE-REPORT NOTIFICATION

      1. Twice each year, by April 30 and October 31, EPA will transmit to OSHA a written notice containing a list of chemical substances under consideration for section 9(a) reports. EPA will transmit the notice from the Assistant Administrator for Pesticides and Toxic Substances to the Assistant Secretary for Occupational Safety and Health.

      2. EPA will include in the notice the following information for each substance:

                 a.  Chemical name or identifier;
         
                 b.  An abstract describing the chemical;
         
                 c.  Anticipated quarter of submission;
         
                 d.  Name of a staff member designated to 
                     manage the detailed activities of developing the
                     potential section 9 report. In most cases, 
                     EPA will designate the Director of the 
                     Chemical Control Division, Office of Toxic 
                     Substances.
                 

      3. Within 30 days, the Assistant Secretary for Occupational Safety and Health will acknowledge, in writing, receipt of the list. Acknowledgment will include the name of the OSHA staff member designated to manage the OSHA response to the potential section 9(a) report. In most cases, OSHA will designate the Director of Health Standards Programs to manage the report.

      4. EPA and OSHA agree that the Pre-Report Notification is for administrative purposes only and does not represent a final determination by EPA and OSHA regarding the extent of occupational risks or the need for a section 9(a) report.

      5. EPA and OSHA further agree that, similarly, OSHA's acknowledgment of receipt of the notification is for administrative purposes only and does not represent a determination by OSHA or EPA that an OSHA standard is needed, that there are only occupational risks, or that the risks are significant under the OSH Act.

   2. PRE-REPORT CONSULTATIONS

      1. After EPA submits the Pre-Report Notice and OSHA acknowledges receipt, the EPA and OSHA staff members will begin Pre-Report consultations. They will meet on the first Wednesday of the month following OSHA's acknowledgment and use the Notice as the basis for further discussions.

      2. The discussions will cover but not be limited to information possessed by either agency concerning:

          
                           a.  Content of the reports including the 
                               specific activities which give rise to 
                               the risk;
                           b.  Extent of occupational exposure, extent 
                               of non-occupational exposure, significance 
                               of risks;
                           c.  Risk analyses;
                           d.  Data collected by EPA and OSHA, 
                               including information obtained through 
                               ANPR publications, contractor activities 
                               and TSCA section 8(a) reporting requirements.
                           e.  The most effective means of reducing the 
                               risk under the OSH Act, TSCA, other EPA 
                               statutes, any or none of these;
                           f.  Coordination of any concurrent FEDERAL 
                               REGISTER notices anticipated by OSHA;
                           g.  Anticipated report publication dates; 
                               anticipated OSHA response dates.
                     

      3. EPA and OSHA staff may jointly agree to hold additional meetings or to cancel unnecessary meetings. They may also jointly agree to exchange drafts or data pertinent to the possible report.

   3. SECTION 9(a) REPORTS

      1. After full consultation with OSHA, EPA when appropriate, will publish a section 9(a) report in the FEDERAL REGISTER including the response deadline.

      2. Prior to FEDERAL REGISTER publication, EPA will ensure that its risk analysis associated with the report has had adequate peer review including, where appropriate and feasible, review by the EPA Science Board.

      3. Prior to FEDERAL REGISTER publication, the Director of EPA's Chemical Control Division will notify OSHA's Director of Health Standards Programs, via telephone, within 48 hours of the EPA Administrator's signature of the Section 9(a) report. EPA will also identify the anticipated FEDERAL REGISTER publication date.

   4. POST-REPORT CONSULTATIONS

      1. After a Section 9(a) report is published in the FEDERAL REGISTER, appropriate EPA and OSHA staff will begin Post-Report consultations, on a monthly basis as before the Report, to discuss the OSHA response, using the section 9(a) report as the basis for their discussions.

      2. The discussion will cover but not be limited to information possessed by either agency concerning: a. The basis for EPA's determination of "unreasonable risk"; b. The basis for EPA's determination that the risk may be reduced to a sufficient extent by OSHA's authorities.

         1. Content of the response;

         2. Extent of the workplace exposure, extent of non-workplace exposure, feasibility considerations, significant workplace risk considerations, OSH Act control options, comparable TSCA controls, and other possible EPA actions and risk reduction requirements.

      3. The EPA and OSHA staff may jointly agree to hold additional meetings or to cancel unnecessary ones. They may also jointly agree to exchange drafts or data pertinent to the report.

      4. After full consultation with EPA, OSHA will publish in the FEDERAL REGISTER, as required, its response to EPA's section 9(a) report.

      5. Prior to FEDERAL REGISTER publication, OSHA's Director of Health Standards Programs will notify the Director of EPA's Chemical Control Division, via telephone, within 48 hours of the OSHA Assistant Secretary's signature of OSHA's response to the section 9(a) report. OSHA will also identify the anticipated FEDERAL REGISTER publication date.

   5. SPECIAL PROVISIONS

      1. Under exceptional circumstances, EPA may submit a section 9(a) report to OSHA that was not anticipated during the semi-annual notification process. Prior to publishing the report, the Assistant Administrator for Pesticides and Toxic Substances will provide written notification to the Assistant Secretary of OSHA as expeditiously as possible of EPA's intention to submit a report for an additional substance.

      2. After written notification, EPA and OSHA will comply with all specifications contained in Units III.A through G of this agreement.

   6. CONFIDENTIAL BUSINESS INFORMATION

      Both agencies will continue to comply with appropriate requirements for sharing Confidential Business Information.

   7. DELEGATION OF RESPONSIBILITY

      The responsibility for ensuring successful implementation of this MOU is delegated to EPA's Assistant administrator for Pesticides and Toxic Substances and the Assistant Secretary for the Occupational Safety and Health Administration.

4. OTHER AGREEMENTS

   Nothing in this MOU precludes the agencies from entering into additional, separate agreements with each other as they deem appropriate to achieve the purpose of the Toxic Substances Control Act or of the Occupational Safety and Health Act.

5. NAME AND ADDRESS OF AGENCIES

      1.  Environmental Protection Agency
           401 M Street, SW 
           Washington, D.C.  20460
   
       2.  Department of Labor 
           200 Constitution Ave., NW 
           Washington, D.C.  20210
     

6. PERIOD OF AGREEMENT

   This agreement will become effective upon acceptance by both parties as indicated below and will continue indefinitely. It may be modified by mutual consent or terminated by either party upon a 30-day advance written notice to the other party.

   APPROVED AND ACCEPTED FOR THE U.S. ENVIRONMENTAL PROTECTION AGENCY:
   DATED: January 22, 1986

   Lee M. Thomas,
   Administrator,
   U.S. Environmental Protection Agency

   APPROVED AND ACCEPTED FOR THE DEPARTMENT OF LABOR:
   DATED: 6 FEB. 1986

   William E. Brock
   Secretary,
   U.S. Department of Labor