July 6, 1990

Betty J. Dabney, Ph.D.
Managing Editor
TOMES Plus Information System
Micromedex, Inc.
600 Grant Street
Denver, Colorado 80203-3527

Dear Dr. Dabney:

Thank you for your letter of May 23, addressed to my attention, and also your letter of May 30, addressed to Ms. Melody Sands of my staff, requesting an interpretation on whether "an equivalent electronic information system" could be used in lieu of Material Safety Data Sheets (MSDSs) to satisfy the requirements of the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200. My office also is in receipt of copies of other letters you have sent to OSHA's Regional Offices. This letter serves as our consolidated response to all these similar requests.

First of all, let me clarify that while each of OSHA's Regional Administrators does have authority over the compliance activities in his or her region, each also ensures that OSHA's standards are uniformly enforced throughout the country. Further, OSHA's -National Office develops and disseminates to all OSHA regions inspection guidelines for OSHA enforcement personnel to utilize when checking for compliance with the HCS. A copy of the current OSHA Instruction, CPL 2-2.38B, "Inspection procedures for the Hazard Communication Standard," is enclosed for your reference. All inspections are conducted in accordance with the policies and procedures set forth in CPL 2-2.38B.

With regard to the specific questions raised in your letters regarding the MSDS requirements of the HCS, the standard requires that the MSDS itself, not just "MSDS information" be kept at the workplace. The Agency has interpreted the MSDS availability requirement to allow the use of computers or telefax or any other means, as long as a readable copy of the MSDS is available to the workers while they are in their work areas, during each workshift. The key to compliance with this provision is that employees have no barriers to access the information. This can be accomplished by the employer maintaining a hard copy of the MSDS itself on-site, or, again, by using a computer or telefax system capable of producing the same readable copy on-site. Under the HCS, MSDSs are the basis of the employer's hazard communication program. Employers must have at their workplace the MSDS for each hazardous chemical they use, and they may rely on the validity of the MSDS information received from the supplier. As you are aware, it is the responsibility of the chemical manufacturer or importer to evaluate and compile all the hazard information known about the chemicals he produces. It is also his responsibility to transmit and update that information on MSDSs sent to downstream users. Any party who changes a chemical's MSDS or label then becomes the responsible party for the change.

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The MSDS used in an employer's hazard communication program must be specific to each chemical used on-site, since each MSDS contains the specific chemical identity as used on and therefore cross-referenced to the required label on the chemical's container. Further, the HCS requires that each chemical manufacturer or importer list on the chemical's MSDS his name, address and telephone number or the same information for a "responsible party" who will provide additional information on the hazardous chemical and appropriate emergency procedures (see 1910.1200(g)(2)(xii)). MSDSs therefore provide specific telephone number or other emergency contact information for the chemical manufacturer, again, for the specific chemical that is being used on-site, as required at 1910.1200(g)(2)(xii) of the standard. For these reasons, the use-of "the same information covered by an MSDS" cannot be used "in lieu of an MSDS" as proposed in your letter.

You also raised a question regarding enforcement of the HCS with respect to "non-manufacturing exposure to drugs in hospitals." MSDS are required for all drugs defined under the Federal Food, Drug and Cosmetic Act except for drugs in solid, final form for direct administration to the patient (i.e., tablets, pills, capsules). The Supreme Court upheld this requirement in its decision dated February 21, 1990 (see Dole, Secretary of for, et. al. v. United Steel workers of America et. al. No. 88-1434). The requirement to have on-site MSDSs for pharmaceuticals workers may be exposed to therefore remains in effect and is fully enforceable. In its Notice of Proposed Rulemaking on the HCS (Federal Register, Vol. 53, No. 152, August 8, 1988), OSHA proposed for public comment the provision that package inserts or information from the Physician's Desk Reference (PDR) be considered a MSDS for purposes of compliance with the HCS in the non-manufacturing sector. This is only a proposed provision, however, awaiting final rulemaking by the Agency. At the present time, the package insert or PDR reference is not acceptable in lieu of the MSDS.

We hope this answers your questions regarding the MSDS requirements of OSHA's HCS. Please feel free to contact us again if we can be of further service.

Sincerely,

Patricia K. Clark Director
Designate Directorate of Compliance Programs

Enclosure

May 3, 1990

Dean Ikeda
Department of Labor-OSHA
111 3rd Ave. Suite 715
Seattle, WA 98101

Dear Mr. Ikeda,

We would like a clarification from the OSHA Regional Office as to whether or not equivalent information in some other form, such as a comprehensive computerized information system, would satisfy the information requirements of CFR 1910.1200, the OSHA Hazard Communication Standard, in lieu of Material Safety Data Sheets in your region. As I understand it, each Regional Office has the authority to determine how the OSHA standards are enforced in its region, and there is no required format for MSDS's under the Federal Standard.

We have received requests from several of our users for clarification of this point, especially with respect to enforcement of the Hazard Communication Standard for non-manufacturing exposure to drugs in hospitals. We are therefore contacting every OSHA Regional Office to get a ruling on this question. Enclosed for your information is a packet containing product literature on the various databases in the TOMES Plus Information System and document outlines for all the databases. I understand that it is OSHA's policy not to endorse specific products, and we are not asking for your endorsement. Rather, we would like your ruling on whether the same information covered by an MSDS could be used in lieu of an MSDS to satisfy the information requirement in your region. Your written reply would be greatly appreciated. Thank you very much for your consideration of this matter. Yours truly,

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Betty J. Dabney, Ph.D.
Managing Editor
TOMES Plus Information System

cc: Ms. Kitty Gallagher Micromedex Regional Sales Manager

May 3, 1990

Enforcement Officer/Hazard Communication
Department of Labor-OSHA Region IV
1375 Peachtree Street, N.E. Suite 587
Atlanta, GA 30367

Dear Sir,

We would like a clarification from the OSHA Regional Office as to whether or not equivalent information in some other form, such as a comprehensive computerized information system, would satisfy the information requirements of CFR 1910.1200, the OSHA Hazard Communication Standard, in lieu of Material Safety Data Sheets in your region. As I understand it, each Regional Office has the authority to determine how the OSHA standards are enforced in its region, and there is no required format for MSDS's under the Federal Standard.

We have received requests from several of our users for clarification of this point, especially with respect to enforcement of the Hazard Communication Standard for non-manufacturing exposure to drugs in hospitals. We are therefore contacting every OSHA Regional Office to get a ruling on this question. Enclosed for your information is a packet containing product literature on the various databases in the TOMES Plus Information System and document outlines for all the databases. I understand that it is OSHA's policy not to endorse specific products, and we are not asking for your endorsement. Rather, we would like your ruling on whether the same information covered by an MSDS could be used in lieu of an MSDS to satisfy the information requirement in your region. Your written reply would be greatly appreciated. Thank you very much for your consideration of this matter.

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Yours truly,

Betty J. Dabney, Ph.D.
Managing Editor
TOMES Plus Information System

May 15, 1990

Betty J. Dabney, Ph.D.
Managing Editor
TOMES plus Information System
Micromedix, Inc.
600 Grant Street
Denver, Colorado 80203-3527

Dear Dr. Dabney:

This is in reply to your request for clarification concerning whether maintaining information on a computerized system is acceptable in lieu of a material safety data sheet. Such a system would be acceptable provided that access to the information is not impeded by the use of a computerized information system, i.e. all employees have ready access to terminals and are familiar with access procedures. All other access provisions of the OSHA hazard communication standard as applied to MSDS access would also be necessary, such as terminals located in work areas which are accessible during all times that the employees are working.

Please contact this office if we can be of further assistance.

Sincerely,

LINDA R. ANKU
Regional Administrator

May 15, 1990

Betty J. Dabney, Ph.D
Managing Editor
Micromedex, Inc.
660 Grant Street
Denver, CO 80203-3527

Dear Ms. Dabney:

Thank you for your letter requesting a clarification on using a comprehensive computerized information system, in lieu of Material Safety Data Sheets. Your request has been forwarded to our National Office for response.

If you have any questions for them you may contact Patricia K. Clark, Director, Directorate of Compliance Programs. She ~may be reached at U.S. Department of Labor, Occupational Safety and Health Administration, Room N-3463, 200 Constitution Ave., N.W., Washington, D.C. 20210.

If you have any further questions for us, please contact Sven Rundman of my staff at (404)347-2281.

Sincerely,

CYNTHIA P. WOLFE
Assistant Regional Administrator
for Technical Support

May 23, 1990

Patricia K. Clark Director,
Directorate of Compliance Programs
U.S. Department of Labor
Occupational Safety and Health Administration
Room N-3463
200 Constitution Ave., N.W.
Washington, D.C. 20210

Dear Ms. Clark,

We would like a clarification from OSHA as to whether or not equivalent information in some other form, such as a comprehensive computerized information system, would satisfy the information requirements of CFR 1910.1200, the OSHA Hazard Communication Standard, in lieu of Material Safety Data Sheets.

We have received requests from several of our users for clarification of this point, especially with respect to enforcement of the Hazard Communication Standard for non-manufacturing exposure to drugs in hospitals.

Enclosed for your information is a packet containing product literature on the various databases in the TOMES Plus Information System and document outlines for all the databases. I understand that it is OSHA's policy not to endorse specific products, and we are not asking for your endorsement. Rather, we would like your ruling on whether' the same information covered by an MSDS could be used in lieu of an MSDS to satisfy the information requirement in individual regions.

We have already written the eight Regional Offices for clarification on this question. As I understand it, each Regional Office has the authority to determine how the OSHA standards are enforced in its region, and there is no required format for MSDS's under the Federal Standard. Enclosed are copies of the two replies we have received so far. The Atlanta office referred our request to you, and the Philadelphia office said that such a system would be acceptable so long as the information was accessible to employees in the workplace. Your written reply would be greatly appreciated. Thank you very much for your consideration of this matter. Yours truly, Betty J. Dabney, Ph.D. Managing Editor TOMES Plus Information System

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Attachments: OSHA Regional Letters

Enclosure: TOMES Plus Literature Packet

May 30, 1990

Ms. Melody Sands
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, N.W.
Washington, D.C. 20210

Dear Ms. Sands

Mr. Stan Rundman of the Atlanta office asked me to send you a copy of the original cover letter we sent to him for a ruling on whether or not an equivalent electronic information system could be used in lieu of Material Safety Data Sheets to satisfy the Hazard Communication Standard. Also enclosed is a copy of the reply from the Atlanta region referring this request to your office.

Last week we sent a duplicate letter and packet of information to Patricia Clark in the Washington office of OSHA. Hopefully you have all the information you need to give Us a ruling.

If you have any further needs or questions, please feel free to give me a call. Thank you for your Consideration of this matter

Yours truly,

Betty J. Dabney Ph.D.
Managing Editor,
TOMES Plus Information System

Attachments: Previous letters

May 31, 1990

MEMORANDUM FOR: PATRICIA CLARK, Director, Directorate of Compliance Programs
FROM: JAMES W. LAKE Regional Administrator Region X
SUBJECT: Hazard Communication Interpretation Request, Micromedex, Inc.

This is in response to your memorandum of May 21, 1990, wherein you requested that inquiries from Micromedex, Inc., be forwarded to your office for a reply. Attached is the letter we received from Micromedex, Inc. We have advised them that a response from the National Office is forthcoming.

Attachment