OSHA issues latex allergy warning amid intense storm of accusations
Technical bulletin alerts field inspectors to risks for health care workers
The U.S. Occupational Safety and Health Administration (OSHA) has issued a controversial technical bulletin alerting compliance officers to latex hazards for health care workers despite a storm of protest from organizations and individuals accusing the agency of promoting fraudulent science and fueling hysteria.
OSHA officials insist the bulletin is only an advisory and not a new regulation. Medical officer Angela C. Presson, MD, MPH, says the bulletin was developed in response to "numerous questions" from compliance officers who inspect health care facilities, in an effort to provide background information.
Opposition to the proposed OSHA bulletin converged at a hastily called congressional subcommittee hearing recently. The Subcommittee on Oversight and Investigations of the House Education and the Work force Committee, chaired by Rep. Peter Hoekstra (R-MI), heard testimony from both critics and supporters of the document, which had not been released at that point.
Testifying before the subcommittee, Presson said the bulletin is "only advisory; it is not a new regulation or a standard, and its purpose is to assure that our field staff have accurate information on this issue."
The OSHA bulletin does not differ significantly in content from the latex hazard warning issued by the National Institute for Occupational Safety and Health (NIOSH) in 1997.1 (See Hospital Employee Health, September 1997, pp. 97-101.) That, too, met with active opposition during development, mainly from latex glove manufacturers. It also is similar in many respects to 1996 latex guidelines published by the Arlington Heights, IL-based American College of Allergy, Asthma, and Immuno logy.2 (See HEH, January 1997, pp. 5-7.)
Intended to educate and alert field inspectors to the potential for HCWs to have allergic reactions to natural rubber latex (NRL) in the workplace (see "Types of reactions" table, p. 63), the bulletin recommends reducing unnecessary exposure to NRL proteins.
To reduce worker exposure to NRL proteins, OSHA recommends hospitals follow general administrative procedures, including the following:
• in selecting latex gloves for worker use, designating NRL as a choice only in situations requiring protection from infectious agents;
• choosing NRL gloves with lower protein content, as well as powder-free gloves offering the additional benefit of reducing systemic allergic responses;
• providing alternative non-NRL gloves as choices for worker use (and as required by OSHA’s bloodborne pathogens standard) for workers allergic to NRL gloves.2
Attempt to circumvent rulemaking?
OSHA had developed and sent to stakeholders several versions of the bulletin during the past two years, each time revising it according to comments received. Nevertheless, some critics testifying before the congressional subcommittee charge that OSHA is attempting to disguise rulemaking in the form of an information bulletin.
F. Samuel Eberts III, associate general counsel for latex glove manufacturer Allegiance Health care Corp. in McGaw Park, IL, called upon the panel to address "OSHA’s circumvention of the federal notice and comment rulemaking procedures under the guise of issuing its proposed bulletin." Alle giance is a market leader in latex glove sales and also produces a smaller line of non-latex alternatives.
In lengthy testimony, Eberts also charges that the bulletin is riddled with "scientific deficiencies," including "unethical," "fraudulent," and "biased" data. He says no proof exists that exposure to airborne powder from latex gloves has sensitized HCWs (see related story, p. 65), and further maintains that NRL allergy is not occupationally linked.
Allegiance officials did not respond to repeated requests for an interview to explain their testimony.
Also speaking against the bulletin were former U.S. Surgeon General C. Everett Koop, MD, and Charles E. Reed, MD, retired head of the division of allergic diseases and internal medicine at Mayo Clinic in Rochester, MN. HEH has learned from several sources that both are paid consultants to Allegiance Healthcare Corp., although the company would not confirm this.
Both Koop and Reed claim that the OSHA document will unnecessarily frighten health care workers into abandoning universal precautions or even their careers.
Many HCW symptoms are actually due to "anxiety attacks" rather than latex allergy, Reed states.
"Because of the sensationalism that has developed around latex allergy, some . . . health professionals have become terrified of their workplace. Often they have been led to fear that exposure to rubber in any form may kill them. . . . They often conclude that their professional lives are over. . . . For these unfortunate people, the fear generated by the sensationalism is more disabling than the disease would ever be," Reed testified.
He says the OSHA bulletin’s wording is "alarming" and will exacerbate the problem.
Koop, testifying by videotape, said powdered latex gloves have come under attack in the past few years due to "hysteria" that is "reminiscent of the hysteria surrounding AIDS in the early years." HCWs have become "unduly frightened" about latex glove use, he states.
OSHA has "fueled this hysteria by interjecting itself into latex glove regulation," Koop charges. He predicts the bulletin will undermine universal precautions, with a "spin-off" of undermining latex condom use, as well.
The more education, the less hysteria’
Presson responds that the bulletin is intended to quell fears, not fuel them.
"We believe that the more education that is out there, the less hysteria there will be. Some hospitals have eliminated latex, believing that’s the length they have to go to in order to protect [HCWs] from developing latex allergy, but that’s not our belief at OSHA," Presson says. "I would think our position is helping counter any anti-latex sentiment that others may feel by explaining what the issues are and what components of latex are a problem for a minority of workers," Presson explains.
She says the agency does not intend to discourage all workers from using latex, but that hospital employees such as foodservice staff and others who don’t need protection from bloodborne pathogens are encouraged to use alternative types of glove material.
Other critics claim that OSHA is entering Food and Drug Administration (FDA) territory by issuing the bulletin.
Rep. Charlie Norwood (R-GA), DDS, vice chairman of the subcommittee, says he questions whether OSHA should be "stepping into this arena."
Recalling his career as a latex-glove-wearing dentist, Norwood testified that the bulletin "seemed to advocate a position in favor of alternatives to latex gloves — such as powder-free or reduced protein gloves," without specifying the definition of those gloves.
"It seems to me that two federal agencies [OSHA and FDA] regulating’ in this arena with one advocating a particular position in favor of certain types of medical gloves could create confusion," he says.
However, OSHA and FDA deny any conflict.
"We and the FDA both explained that very well at the hearing," Presson says. "OSHA has worked collaboratively with the FDA . . . to assure coordinated activities in addressing the health hazards associated with exposure to natural rubber latex."
So far, FDA regulatory activity related to latex has focused on promulgating a rule requiring labeling statements on medical devices and device packaging containing NRL.4 Labeling information allows sensitized people to avoid exposure and enables users to make informed choices about gloves and other products. (See HEH, December 1997, pp. 138-140.)
Noting that the FDA "routinely collaborates" with OSHA and other federal agencies to ensure coordinated actions, Elizabeth D. Jacobson, PhD, acting director of the FDA’s Center for Devices and Radiological Health, assured panel members that recommendations contained in the OSHA bulletin do not conflict with FDA regulations.
In fact, "FDA has been an active participant as the bulletin has been developed," Jacobson says.
Those testifying in favor of the bulletin included Robert G. Hamilton, PhD, associate professor of medicine at Johns Hopkins University School of Medicine in Baltimore and developer of the first reliable puncture skin test reagent for diagnosing latex allergy. The test is currently awaiting FDA approval.
After considerable study and investigation, Johns Hopkins Hospital decided to eliminate latex gloves last year, Hamilton told the subcommittee. (See HEH, May 1998, pp. 57-60.) The transition has been accomplished with minimal increased cost.
"The OSHA bulletin is an important and positive document," Hamilton says. "Emphasis in this document needs to remain on removal of the powdered latex glove from the work environment, as we believe that it is the single largest source of latex allergen exposure for health care workers and their patients."
The Washington, DC-based American Nurses Association (ANA) also supports OSHA’s action. Testifying before the subcommittee on behalf of the ANA and a coalition of HCW labor unions, Susan Q. Wilburn, RN, MPH, senior occupational health and safety specialist, said latex allergy is increasing among HCWs.
ANA research shows that up to 200,000 registered nurses are allergic to latex.
"Chronic exposure to latex in an allergic worker can lead to permanent pulmonary and cardiac diseases and premature death," she states.
Latex allergy is largely preventable, Wilburn says, mainly by switching to powder-free and non-latex gloves. Leading U.S. health care facilities, including the Mayo Clinic, Kaiser Permanente, the Brigham and Women’s Hospital in Boston, and Emory University Hospital in Atlanta have made the switch, she points out.
OSHA’s technical information bulletin is the "bare minimum needed to protect health care workers," Wilburn testified.
Congress takes no action
Since the hearing, Congress has taken no further action to delay release of the bulletin, which recently was sent to OSHA field offices and compliance officers. Yet, certain questions remain. Why did the subcommittee find a hearing necessary for an information bulletin, which is nonregulatory and contains much of the same information already contained in other recommendations? Also, what was the selection process that determined who would testify? (See related story, at right.)
Gary Visscher, general labor counsel for the House Committee on Education and the Work force, says hearings provide "a limited number of seats," which did not allow for more witnesses. Witnesses are suggested by the agencies involved, or they can volunteer to testify.
The congressional panel’s main concern in calling a hearing was whether the OSHA document was helpful or confusing. More importantly, Congress is worried that informal rulemaking is occurring, Visscher says.
"The concern was whether OSHA has reviewed all the evidence, as they would have to in the regulatory process. There is no assurance of that in an informal process," he states. "One concern that Congress has had is that OSHA, along with other agencies, is moving in the direction of making policy on an informal basis. This may be only a technical bulletin, but if it impacts or influences OSHA’s enforcement under the general duty clause, [it] should go through regulation. The question is whether this sort of informal process is acceptable."
(Editor’s note: The technical information bulletin is available on the Internet at members.tripod.com/latexallergylinks/LA-TIB.html, and will soon be available on OSHA’s Web site at www.osha.gov. Most of the congressional hearing testimony is available on the Web at www.house.gov/eeo/hearings/106th/oi/latex32599/wl32599.htm. Wilburn’s testimony is available at www.nursingworld.org/gova/federal/legis/testimon/1999/latx0325.htm.)
References
1. National Institute for Occupational Safety and Health. NIOSH Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. DHHS (NIOSH) Pub. No. 97-135. Washington, DC: NIOSH; 1997.
2. Sussman G, Gold M. Guidelines for the Management of Latex Allergies and Safe Latex Use in Health Care Facilities. Arlington Heights, IL: American College of Allergy, Asthma, and Immunology; 1996.
3. Occupational Safety and Health Administration. Technical Information Bulletin: Potential for Allergy to Natural Rubber Latex Gloves and Other Natural Rubber Products. Washington, DC: OSHA; April 12, 1999.
4. Department of Health and Human Services, Food and Drug Administration. Natural rubber-containing medical devices; user labeling. 62 Fed Reg 51,021 ( Sept. 30, 1997).
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