March 27, 2006

[Name and address withheld]

Dear [Name withheld]:

Thank you for your letters to Ms. Marthe Kent, Regional Administrator of the Occupational Safety and Health Administration's (OSHA's) Boston Regional Office. Your letter was forwarded to the Directorate of Enforcement Programs (DEP) for a response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenario not delineated within your original correspondence.

In your letter to the Regional Office, you expressed your dissatisfaction with an OSHA investigation as well as with an OSHA letter of interpretation written to you regarding the relevance of OSHA's 29 CFR 1910.1020 to genetic coding information. You have attempted on your own and through a complaint to OSHA to obtain genetic coding for genetically engineered lentivirus (HIV) strains used to infect mouse embryonic stem cells that you believe were handled on an open laboratory bench near your office. You presume that the genetic coding (nucleotide sequence) of the lentivirus is an employee exposure record which is releasable under 29 CFR 1910.1020, however, your former employer asserts that the genetic coding of the lentivirus is a company trade secret and initially denied you access to that information on those grounds. The Boston Regional Administrator has requested an official interpretation on your behalf.

The term "trade secret" is defined by 29 CFR 1910.1020(c)(14) as "any confidential formula, pattern, process, device, or information or compilation of information that is used in an employer's business and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it."

In general, the regulation requires disclosure of specific chemical identifiers, but permits the employer to withhold this information from disclosable records if certain conditions can be met: (1) the employer can support the claim that it is a trade secret; (2) all other information concerning the toxic substance is disclosed as required; (3) the employer indicates that the specific chemical identity is being withheld as a trade secret; and (4) the chemical name is made available to health professionals, employees and designated representatives under certain specified circumstances. See Section 1910.1020(f)(2).

In non-emergency situations, employers are required to disclose the withheld specific chemical identity to employees, designated representatives and health care professionals providing medical or other occupational health services to exposed employees if certain conditions are met. A request for trade secret information must be in writing, and must describe with reasonable detail the medical or occupational health need for the information. To be considered a medical or occupational health need for purposes of the regulation, the health professional must be planning to use the information for one or more of the specified activities listed in Section 1910.1020(f)(4)(ii), including performing medical treatment to exposed employees. Your request for the company's "trade secret" information was submitted in writing as required by the regulation.

In your letter to your employer dated December 12, 2005, you made requests for the following information:

1. The genetic map of the vector outlining the 5' and 3' LTR, expression cassettes and antibiotic selection.
2. The complete nucleotide sequence of the vector (formatted as a Word document provided on CD).
3. DNA sample of the plasmid vector (glycerol stock or plasmid) and appropriate information for growth and maintenance.

We understand that your employer has offered you a hard copy of the nucleotide sequence information you sought, and your employer has offered to do so providing that you agree to execute a confidentiality agreement to protect the company's trade secret information. Section 1910.1020(f)(4)(iv)) does allow an employer and requester to enter into a written confidentiality agreement to limit disclosure of trade secret information to only information used for health needs. The confidentiality agreement stating that information will only be used for health needs, and not released under any other circumstances other than to OSHA, must also be signed by the parties.

The responses to the concerns raised in your December 12, 2005 letter are below:

a. Request for the genetic map of the vector outlining the 5' and 3' LTR, expression cassettes and antibiotic selection:

OSHA's regulation at 29 CFR 1910.1020, Access to employee exposure and medical records, provides for employee, designated representative and OSHA access to employer-maintained exposure and medical records. The regulation applies to all exposure and medical records falling within the definitions in 29 CFR 1910.1020(c)(5) and (c)(6), whether or not such records are mandated by an OSHA standard or regulation. The regulation is, however, limited to records of employee exposure to toxic substances or harmful physical agents in the workplace.

Section 1910.1020(c)(5) provides that "employee exposure record" means a record containing information concerning environmental monitoring or measuring, biological monitoring results, and material safety data sheets (MSDS) indicating that the material may pose a hazard to human health. In the absence of the above, subparagraph (c)(5)(iv) provides that an employee exposure record may include "a chemical inventory or any other record which reveals where and when used and the identity (e.g., chemical , common, or trade name) of a toxic substance or harmful physical agent."

We note that the definition of "toxic substance or harmful physical agent" in Section 1910.1020(c)(13) states, in pertinent part, "chemical substance, biological agent (bacteria, virus, fungus, etc.) . . . and has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer . . ." [emphasis added]. As a result, we conclude that records related to the virus in this matter fall under the scope of 29 CFR 1910.1020.

On May 21, 1980, OSHA issued its final rule addressing access to employee exposure and medical records [45 FR 35212]. The regulation was later revised by OSHA on September 29, 1988 [53 FR 38140]. During the development of 29 CFR 1910.1020, one of the subjects addressed by the rulemaking was the issue of trade secrets. OSHA received many comments on the issue, and the preamble to the final rule from 1988 includes background information on these discussions [53 FR 38157].

At the time 29 CFR 1910.1020 was developed, and later revised, much of the focus with regard to trade secret information was related to the disclosure of names and/or contents of chemical products. Although the majority of the comments contained in the 1988 preamble addressed a company's regard for chemical identification as trade secret, many of the principles that correspond to a complex chemical mixture can also extend to the unique circumstances at issue in this case. We liken your request for access to the DNA "sequence" and genetic map of a biological agent to that of a person requesting the percentage mixture information or the chemical "formula" of a chemical compound. The theory that the sequencing of a virus is the true identity of the virus is very much like stating that the chemical "formula" is what truly identifies a specific chemical. While the name and functionality of a chemical or harmful agent is releasable, the regulation does not require that an employer release the actual formula of a harmful agent [53 FR 38158]. As such, we are not able to compel your former employer to release to you the DNA sequence and genetic map of the viral inserts.

Nonetheless, according to the information presented in the correspondences from your former employer, it appears that the employer has expressed a willingness not only to disclose the DNA sequence directly to the physician or healthcare professional currently providing care to you, but that the employer has offered a photocopy (hard copy) of the DNA sequencing information to you under the terms of a confidentiality agreement. This willingness by your former employer is consistent with the provisions set forth in Section 1910.1020(f)(4). OSHA cannot further compel your former employer to provide the genetic map you seek.

b. Request for the complete nucleotide sequence of the vector (formatted as a Word document provided on CD):

With regard to the actual format in which information is provided, OSHA's regulation at 29 CFR 1910.1020, does not mandate that information be made available to the employee in any specific format. An employer is free to choose the format in which employee exposure records are maintained (e.g., paper document, microfiche, microfilm, automated data processing, etc.). The regulation does not obligate an employer to offer records in any specific format except that if photocopies are made, the employer must provide these at no cost to the employee and in the case of an original X-ray, the employer must either make arrangements for temporary loan or provide access for an on-site examination [29CFR 1910.1020(e)(1)(iii)and (iv)].

c. Request for DNA sample of the plasmid vector (glycerol stock or plasmid) and appropriate information for growth and maintenance:

With regard to your request for an actual DNA sample of the plasmid vector and appropriate information for growth and maintenance, 29 CFR 1910.1020 does not obligate employers to provide actual samples of toxic substances or harmful agents. As noted above, the regulation addresses access to employee exposure and medical records. We understand your concern; however, this request also goes beyond the scope of the regulation and beyond what OSHA may require any employer to provide.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at 202-693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Enforcement Programs