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.
June 1, 1992
ALL REGIONAL ADMINISTRATORS
PATRICIA K. CLARK, DIRECTOR
DIRECTORATE OF COMPLIANCE PROGRAMS
Clarification of Issues under the Bloodborne Pathogens Standard Settlement Agreements
The National Funeral Directors Association (NFDA) and the American Health Care Association (AHCA), which represents nursing homes, have requested clarification on certain issues under the bloodborne pathogens standard that concern their industries. The NFDA was concerned about: (1) whether human remains would be regarded as "regulated waste;" (2) the significance of including human remains in the definition of "source individual;" and (3) the extent to which funeral home employers would be required to ensure that their workers wear personal protective equipment. The AHCA asked for clarification on the considerations that enter into the exposure determinations the employer must make under paragraph (c)(2) and on whether the records retention requirement of paragraph (h) required the employer to physically maintain employee medical records at the worksite.
The attached letters from the Acting Assistant Secretary explain OSHA's position on the points raised by NFDA and AHCA and should be consulted for guidance in enforcing the standard with respect to the above issues.
April 29, 1992
Ms. Carol J. Hendrick
Government Relations Coordinator
National Funeral Directors Association
11121 West Oklahoma Avenue
Milwaukee, WI 53208
Re: Clarification of Application of Certain Provisions of OSHA Bloodborne Pathogens Standard to Funeral Homes
Dear Ms. Hendrick:
The Occupational Safety and Health Administration's (OSHA) bloodborne pathogens standard, issued on December 6, 1991, applies to all occupational exposure to blood or other potentially infectious materials. As the National Funeral Directors Association acknowledged during the rulemaking proceeding, funeral homes are among the workplaces known to have such exposure.
In a meeting with members of my staff on February 20, you explained that you support the standard but asked for guidance on the manner in which certain of its provisions would apply to funeral homes. Your concerns included whether a dead human body would be considered "regulated waste," as that term is used in the standard, and how the inclusion of human remains in the definition of "source individual" would affect funeral homes. You also expressed concern that OSHA would require funeral home employers to ensure the use of personal protective equipment in situations in which employees' exposure to blood or other potentially infectious materials is not reasonably anticipated.
First, employees handling a body must, as you recognize, be protected against contact with blood and other potentially infectious materials. However, the standard does not include a human body within the term "regulated waste," which is defined as:
[... liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.]
Since human remains are not regulated waste under the standard, the requirements governing the containment, disposal, and labeling of regulated waste found in 29 CFR 1910.1030(d)(4)(iii)(B) & (C) and 29 CFR 1910.1030(g)(1) do not apply to a human body or to containers used to store, transport, or ship a human body. Moreover, an intact human body, whether alive or dead, is not a "specimen" of blood or other potentially infectious materials to which the containerization and labeling requirements of 29 CFR 1910.1030(d)(2)(xiii) would apply. Although the standard does not require labeling of a container holding a human body as a biohazard, nothing in this letter should be read as detracting from the need to utilize a means of containment under certain circumstances, such as decay or trauma, to contain blood or other potentially infectious materials and prevent exposure.
Second, the standard defines "source individual" to include: [any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Examples include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of hospices and nursing homes; human remains; and individuals who donate or sell blood or blood components.]
By including human remains in this definition, OSHA intended that a specific exposure incident resulting from contact with blood or other potentially infectious materials from human remains would trigger the requirements of 29 CFR 1910.1030(f) regarding evaluation, treatment, and follow-up of an employee who suffers an exposure incident. OSHA considers the inherent risk of exposure from human remains to be similar to that from a living human being. As with living human beings, occupational exposure from human remains arises only from reasonably anticipated contact with blood or other potentially infectious materials. For the purpose of this standard, occupational exposure does not occur if contact with such material is not reasonably anticipated.
Third, with regard to the use of protective equipment, OSHA recognizes that the selection and type of personal protective equipment and the degree to which it must resist penetration are performance-based. The employer must evaluate the task and the type of exposure expected and, based on the determination, select the "appropriate" personal protective equipment in accordance with paragraph (d)(3)(i) of the standard. As OSHA stated in the preamble to the final standard (56 Fed. Reg. at 64125):
It is not the Agency's intent that employees be outfitted in all possible personal protective equipment or a "moon suit" for all tasks or procedures that they perform. The protective equipment utilized is simply to be chosen to protect against contact with blood or other potentially infectious materials based upon the type of exposure and quantity of these substances which can be reasonably anticipated to be encountered during performance of a task or procedure.
I appreciate your interest in working with OSHA to assure that employers in your industry understand their obligations under the standard. I hope this letter clarifies the specific points you have raised. Although OSHA does not now intend to develop training materials that are specific to funeral homes, should the Agency do so in the future it will afford your Association the opportunity to review such materials to assure that they accurately reflect industry practices.
Dorothy L. Strunk
Acting Assistant Secretary
April 29, 1992
Dr. Paul R. Willging
Executive Vice President
American Health Care Association
1201 L Street, N.W.
Washington, DC 20005
Dear Dr. Willging:
Thank you for your letter of March 24, which Mr. Adkins has forwarded to me, explaining the American Health Care Association's concerns over the application of the bloodborne pathogens standard to nursing homes. Your letter raises issues concerning the exposure determinations employers must make under paragraph (c)(2) of the standard and the records retention requirements of paragraph (h).
The exposure determinations required by paragraph (c)(2) are intended to identify employees who are occupationally exposed to bloodborne pathogens. "Occupational exposure" is defined as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties." The employer must fully comply with the standard with respect to all employees who perform tasks and procedures in which occupational exposure occurs. However, employees who do not perform such tasks and procedures are not considered occupationally exposed under the standard.
Paragraph (c)(2) requires each employer with employees exposed to bloodborne pathogens to make an exposure determination listing:
(A) job classifications in which all employees have occupational exposure;
(B) job classifications in which some, but not all, employees have occupational exposure; and
(C) the tasks and procedures, or groups of closely related tasks and procedures, in which occupational exposure occurs in the job classifications in which some, but not all, employees have occupational exposure.
These determinations must be made without taking into account the use of personal protective equipment.
For the job classifications in which some, but not all, employees have occupational exposure, each employer must designate that employees who perform the specific tasks and procedures that subject them to occupational exposure are within the scope of the standard. Employees within the same job category that the employer designates as "non-exposed," and therefore outside the scope of the standard, should be trained to identify the circumstances that can lead to exposure and to defer such tasks to employees designated to perform them. For example, an employee who handles linens soiled with feces, nasal secretions, sputum, sweat, tears, urine, vomitus, or saliva (other than saliva from dental procedures) that are not contaminated with visible blood would not be occupationally exposed during that task, for these substances are not "other potentially infectious materials" as defined in the standard unless they are contaminated with visible blood. See 56 Fed. Reg. at 64103 (adopting June 1988 CDC guidelines to determine the body fluids defined as "other potentially infectious materials"). But if that employee were to handle, for example, linens soiled with urine that did contain visible blood or for which the presence of blood would be reasonably anticipated because the particular patient has a medical condition that typically leads to blood in the urine, the employee would be occupationally exposed. The employee should therefore be instructed to defer all tasks involving visible blood contamination or reasonably anticipated blood contamination to employees designated to perform tasks involving exposure to blood or other potentially infectious materials.
Where an employer determines that some employees in a job classification have occupational exposure and others do not, the compliance officer will verify that employees who are designated as exposed are the only ones who perform tasks and procedures that will cause exposure. If the compliance officer does not find evidence demonstrating that employees designated as non- exposed are performing tasks and procedures that cause occupational exposure, the employer shall be deemed in compliance with respect to those employees.
With respect to the standard's recordkeeping provisions, you have asked for a reduction of the 30-year retention requirement and for clarification about whether it is permissible for the records to be kept at a location other than the worksite. OSHA believes that the 30-year retention period is necessary and not overly burdensome. With respect to the location of records, paragraph (h) requires employers to establish and maintain for each employee medical records that include hepatitis B vaccination status and evaluation and follow-up of exposure incidents. The records need not be kept at the place of employment but must be maintained in a manner that makes them accessible to OSHA. See 56 Fed. Reg. at 64169. Some employers may contract with the healthcare professional or professionals that perform the vaccination or post-exposure evaluation and follow-up to maintain the records. If the employer does not retain possession of the records, the employer must assure that the records are available to OSHA and make them accessible by identifying where the records are kept and how they may be accessed by OSHA. One way in which this can be accomplished is by maintaining a statement in each employee's record identifying the location where that employee's records are kept and how OSHA may access the records.
I hope that this letter adequately answers your concerns.