Memorandums of Understanding - Table of Contents|
| Information Date:||01/19/1981|
| Agreement Agency:||The Office of Pesticides and Toxic Substances and U.S. Environmental Protection Agency|
- GENERAL COOPERATION
- SHARING OF CONFIDENTIAL BUSINESS INFORMATION
- OSHA-EPA COOPERATION IN THE TSCA PREMANUFACTURE NOTIFICATION PROGRAM
- TRANSFER OF EPA INFORMATION ON SUBSTANTIAL RISK NOTICES
I. GENERAL WORKING AGREEMENT
This Memorandum of Understanding establishes a general working relationship between the Occupational Safety and Health Administration, U.S. Department of Labor, and the Office of Pesticides and Toxic Substances, U.S. Environmental Protection Agency, regarding matters having or potentially having an effect on the activities and responsibilities of the two agencies.
To achieve the coordination desired by both EPA AND OSHA, each agency hereby designates a coordinating office. The coordinating office for the Office of Pesticides and Toxic Substances (OPTS) will be the Office of Toxics Integration (OTI); for the Occupational Safety and Health Administration (OSHA), the Division of Interagency Programs. These offices shall serve as the initial communication link between the two agencies. Future specific agreements will be made by the program offices of OSHA and EPA's Office of Toxic Substances. Parts A, B and C below are directed at specific areas of coordination for sharing of confidential business information, OSHA's cooperation in the OPTS premanufacture notification program, and referral to OSHA of TSCA section 8(e) notices.
In carrying out their respective responsibilities, OPTS and OSHA will, to the extent practicable, consult and exchange information with each other through the coordinating offices. Specifically they will:
(1) Coordinate programs, including the development of standards, to avoid duplication of effort, to assist in setting priorities, and share information and research;
(2) When appropriate, consider the development of joint regulatory efforts. If no joint efforts are possible, both agencies will coordinate the development of any regulations concerning occupational exposure to new chemicals, to the extent feasible;
(3) Exchange information and report on general enforcement matters and on particular situations of common concern to each agency;
(4) Make every effort to achieve uniformity of approach in long-range planning;
(5) Obtain legal and policy positions on statutory authority regarding the extent to which the other agency can remedy a particular condition or matter that may be within the regulatory purview of the agencies;
(6) Use communication systems available to both agencies for educational services to the public about safety and health topics.
A. Confidential Business Information Exchange
This section allows OSHA to have access to confidential business information (CBI) submitted to EPA under the Toxic Substances Control Act (TSCA). OSHA will use this information to assist in fulfilling its duty to protect worker health under the Occupational Safety and Health Act of 1970.
OSHA is permitted access to all confidential business information submitted to EPA under TSCA. When OSHA requests transfer of specific CBI, a justification of the need for access will be submitted through the OSHA Document Control Office (DCO) to any DCO in OPTS. OSHA will treat all such information in accordance with the Memorandum of Understanding. When OPTS initiates the transfer of CBI, a justification of OSHA's need for access should be prepared by the appropriate EPA program official and submitted to an OPTS DCO prior to the transfer of any documents containing confidential business information. The appropriate OPTS DCO must approve the justification prior to transfer of CBI.
(1) OSHA will protect information received from EPA under this agreement by following the procedures set forth in its "OSHA TSCA Confidential Business Information Security Manual." The procedures have been approved by EPA's Inspector General's Office, and they meet or exceed the requirements of EPA's own "TSCA Confidential Business Information Security Manual."
(2) OSHA agrees that it will not release or transfer TSCA confidential business information outside of OSHA without the prior approval of EPA.
(3) OSHA will normally return confidential documents to EPA within one year, but with approval by the OPTS Document Control Officer, will be granted extensions. In addition, with approval of the OPTS Document Control Officer, OSHA may destroy the documents according to the requirements of the EPA TSCA Security Manual instead of returning them to EPA.
(4) OSHA personnel will be made aware of the possible criminal liabilities that may result from unauthorized release of CBI and will sign the TSCA-Federal non-EPA employee confidentiality agreement (Appendix 14).
(5) The Information Control Branch of the Management Support Division of OPTS (EPA) will provide initial CBI training to appropriate OSHA staff.
(6) A physical inspection of OSHA's security facilities will be made by EPA. No exchange of TSCA CBI will be made until such facilities are found to be satisfactory. There will be future periodic inspections of OSHA's security program by EPA.
(7) Following inspection and approval of OSHA's security facilities, a Federal Register notice will be published announcing this agreement and will provide the required ten days of notice, covering all future sharing of data under this section, pursuant to section 2.209 of EPA's regulations on confidentiality of business information, 40 CFR Part 2, Subpart B.
B. Premanufacture Notification (PMN) Data Exchange Procedure
This section deals with the exchange of PMN data between OSHA and OPTS. PMNs can provide information about possible worker exposure to new chemicals before they are produced on a large scale, enabling both OSHA and OPTS to discuss any possible hazards to exposed worker populations and, if necessary, coordinate action on these chemicals.
OSHA and OPTS will work to assure that complete and timely notification is made concerning PMNs which may involve or affect occupational exposures to chemical hazards, and also to assure necessary coordination between OPTS and OSHA, including joint review of selected PMNs. This will permit OPTS to have the benefit of OSHA expertise in assessing occupational exposure risks, and will alert OSHA to possible chemical threats to worker health.
To assure the above conditions are met, the following procedures are established:
(1) Contacts with OSHA concerning PMNs will be initiated by the Notice Manager for a particular PMN or by OTI through the designated individual in the OSHA Division of Interagency Programs. This individual will receive all data and information from EPA and be responsible for the response from OSHA. This individual shall coordinate the OSHA response or refer the EPA Notice Manager to the appropriate OSHA staff.
(2a) In order to assure that OSHA is informed of the status of EPA actions on PMNs, EPA's Chemical Control Division (CCD) will forward to the OSHA representative, as available, a copy of EPA's weekly PMN report. OSHA will use the report to identify PMNs of potential concern about which OSHA has not been contacted by OTI or the Notice Manager.
(2b) If the occupational exposure to a chemical is a concern during initial review, the Notice Manager or OTI will notify OSHA. EPA may request OSHA data concerning the chemical or its analogue or may refer the PMN to OSHA for information or consideration if no TSCA action is to be taken.
(2c) If a PMN for which there is concern regarding potential occupational exposure, goes into a more detailed review, the Notice Manager or OTI will notify OSHA. During the detailed review, Chemical Control Division may request technical assistance from OSHA to aid in EPA's assessment of the PMN and invite OSHA to participate in the work group.
(3) During the development of any regulatory action on a PMN for which occupational exposure is of concern, CCD will consult with OSHA. OSHA may be asked to participate in the detailed review work group for the PNM to assist in development of regulatory options. At that time, OPTS will provide OSHA with copies of documents generated by the OPTS initial review which describe the problem. As a member of this group the OSHA staff may be involved in reviewing draft regulatory actions and will be provided with a copy of the package which enters the EPA official rulemaking and clearance process.
(4) EPA will notify OSHA representatives of the final action taken by EPA on any PMN where occupational exposure is a concern.
C. Notices of Substantial Risk
This section provides a mechanism for EPA to provide OSHA with information submitted by industry under section 8(e) of TSCA, Notices of Substantial Risk.
Section 8(e) of TSCA requires that any person who manufactures, processes, or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that the substance of mixture presents a substantial risk of injury to health or the environment shall immediately inform EPA.
For each 8(e) notice received, the OPTS Chemical Hazard Information Branch (CHIB) prepares a status report. CHIB will, by this agreement, refer to OSHA any 8(e) notices in connection with which CHIB identifies an occupational exposure of concern. OTI will coordinate any necessary follow-up work with OSHA, such as plans for further evaluation or discussion of regulatory action.
The Office of Pesticides and Toxic Substances enters into this agreement under the authority of Sections 9 and 14 of the Toxic Substances Control Act (15 USC 2601, et seq.). Section 9 of TSCA requires certain coordination of actions taken under TSCA with actions taken under other Federal laws. Section 14 of TSCA provides that confidential business information may be disclosed to any officer or employee of the United States in connection with the official duties of such officer or employee under any law for the protection of health or the environment.
The Occupational Safety and Health Administration enters into this agreement under authority of the Occupational Safety and Health Act of 1970 (29 USC 651, et seq.), Section 7(c)(1). That section allows the Secretary of Labor to "use, with the consent of any Federal agency, the services, facilities, and personnel of such agency, with or without reimbursement...."
IV. PERIOD OF AGREEMENT
This Memorandum of Understanding shall continue in effect unless modified by mutual assent of the parties or terminated by either party upon a 30-day advance written notice to the other party.
This Memorandum does not preclude the parties from entering into separate agreements setting forth procedures for special programs which can be handled more efficiently and expeditiously by such 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 will become effective on the date of the last signature.
Marilyn C. Bracken
Associate Assistant Administrator
for Toxics Integration
Warren R. Muir
Deputy Assistant Administrator
for Toxics Substances
Steven D. Jellinek
Assistant Administrator for
Pesticides and Toxic Substances
Environmental Protection Agency
Assistant Secretary of Labor
Occupational Safety and Health Administration
|Memorandums of Understanding - Table of Contents|