Wednesday, May 23, 2012

OSHA: It’s Not As Easy Making Standards As You Might Think!

Many people have commented about how slow OSHA is to issue new standards or to update the old ones. As has been discussed on this blog before, most of the current OSHA PELs were adopted under the 1970 Occupational Safety and Health Act (OSH Act) from the 1968 ACGIH TLV values. With a few exceptions, the majority of the PELs today are unchanged since they were first adopted even though a considerable amount of chemical safety data has been collected since then and the ACGIH TLVs have been regularly updated.

• Recently the Government Accountability Office (GAO) issued a report “Workplace Safety and Health – Multiple Challenges Lengthen OSHA’s Standard Setting, April 2012” asking why. The GOA found that it took OSHA from 15 months to 19 years, average 7 years to pass a standard over the period from 1981 to 2010. OSHA as with other government agencies has a fairly long procedure to issue standards requiring giving notice and opportunity for interested parties to comment before issuing a standard as required under the Administrative Procedure Act. However the GAO found that there were several reason why OSHA took so much longer than other agencies.

• Courts generally defer to the expertise of government agencies and will only overturn a regulation if it is found to be ‘arbitrary and capricious,’ an easy standard to defend against anyone trying to get a regulation overturned. OSHA in contrast is held to a much more difficult standard, the “substantial evidence in the record considered as a whole.” OSHA has had several major standards overturned in the courts (Benzene standard US Supreme Court, 1980) and the PEL update (11th Cir. 1992) and has since been rather reluctant to issue any new PELs absent overwhelming support.

• OSHA is required by the US Supreme Court and Executive Order to understand how any new standard would operate in any workplace that it applies to. OSHA’s mandate of every workplace in the US is very broad; and so OSHA, or more often OSHA’s contractors typically spend a lot time assessing both technological and economic feasibility before issuing new standards.

• OSHA has not worked as closely with NIOSH, and other agencies as it could have done. NIOSH’s role is to perform occupational safety research and for a while OSHA was duplicating this effort.

• Unlike some other agencies such as the EPA and section 112 of the Clean Air Act, OSHA is not required to periodically update its standards; and so they languish steadily graying. The report also said that OSHA officials consider that it reflects poorly on the agency when OSHA issuing citations to employers that are following current industry consensus standards, but are being cited because the OSHA standard is obsolete.

OSHA also has the authority under the OSH Act (sec. 6) to issue emergency standards for 6 months, but has declined to do so since 1983 because of the evidence needed to meet the statutory requirements.

The GAO recommends that OSHA work more closely with other government agencies, especially NIOSH, and OSHA is working more closely with them than before. Another suggestion is the change the evidential standard that OSHA must reach to issue a standard, but there is a concomitant concern to lower quality regulation. This blog supports the idea of changing the evidential standard or using consensus standards such as ACGIH, but also requiring periodic review of the standards as assurance of regulation quality. Such a change would require modification of the OSH Act and thus Congressional action.

Thursday, May 17, 2012

Federal Governments Looks to ACGIH for Occupational Exposure Levels

There is a little known group called the Federal Advisory Council on Occupational Safety and Health (FACOSH) whose function is to advise the Secretary of Labor on matters relating to the occupational safety and health of federal employees. FACOSH's objective is to minimize the number and severity of workplace injuries and illnesses in the Federal Government.

One of the topics discussed at the May 3rd meeting was the use of occupational exposure limits (OELs) by the federal government other than the OSHA permissible exposure limits (PELs). In particular, several federal government agencies also use the NIOSH recommended exposure limits (RELs) and ACGIH Threshold Limit values (TLVs). The Executive Summary of the FACOSH report explains their position.

Executive Summary Because the Occupational Safety and Health Administration’s (OSHA’s) Permissible Exposure Limits (PELs) have remained unchanged since their adoption on May 29, 1971, and do not account for 40 years of advances in technology or the latest peer-reviewed published toxicological information, the Federal Advisory Council on Occupational Safety and Health (FACOSH) asked its Emerging Issues Subcommittee to analyze Federal agencies’ use of PELs. The Subcommittee examined how Federal Executive Branch agencies use occupational exposure limits (OELs) published by other agencies, professional organizations, and other foreign or domestic entities.
The Subcommittee considered all aspects of controlling a potential hazardous chemical in the workplace including risk assessment approaches and the hierarchy of controls. The Subcommittee concluded that FACOSH should recommend that Executive Branch departments and agencies use the most protective and feasible OELs in Federal workplaces, notwithstanding the existence of a PEL for a given substance of concern; require contractors, subcontractors, recipients, and subrecipients to use the most protective and feasible OEL while working on behalf of the Federal government; and designate a person deemed to be competent by virtue of training and experience to make recommendations regarding acceptable chemical exposure risks, appropriate OELs, and employee exposure controls.

The committee recognizes that the OSHA PELs are dated and that many of the exposure limits are well above the values consistent with current understanding of occupational safety. It also concluded that because of the evidential and procedural requirements OSHA must meet, it is unlikely that OSHA will issue many new PELs. Therefore several federal agencies already use the more restrictive of the ACGIH and the OSHA PEL.

• The Department of State uses the more restrictive of the OSHA PELs or the ACGIH TLV, and if neither exists, then it uses the NIOSH PEL.
• The Department of Energy uses the more restrictive of the OSHA PELs or the ACGIH TLV, together with OELs from several other sources.
• The Department of Defense (Army) uses the more restrictive of the OSHA PELs or the ACGIH TLV and the Navy, Airforce and Marine Corps use a combination of OSHA, ACHIH and other standards.

The committee is recommending that this policy be adopted across the federal government. The full report is titled “Recommendations for Consideration by the U.S. Secretary of Labor on the Adoption and Use of Occupational Exposure Limits by Federal Agencies Prepared by the Federal Advisory Council on Occupational Safety and Health (FACOSH)]”, available from

It is a sad reflection of the state of the current OSHA PELs that even the federal government needs to look elsewhere for modern standards. Almost everyone recognizes that the current procedure is so slow that OSHA is effectively unable to function in developing new and revised standards. OSHA plans to update the PELs, but the problem is that OSHA’s hands are tied by the procedures and evidential standards it must meet. This blog supports reform of the Occupational Safety and Health Act of 1970, sec 6 that sets the procedures that OSHA must follow to issued new or updated standards.

Organizations outside the federal government should also follow the recommendations of this committee and use the more restrictive standards of the OSHA PELs, ACGIH TLV and other recognized standards to promote workplace safety.

Tuesday, May 15, 2012

Safe Use of Chemicals for Sterilization in Healthcare

ChemDAQ’s Richard Warburton has an article in the latest issue of The Association for Advances in Medical Instrumentation’s (AAMI) peer reviewed journal Biomedical Instrumentation and Technology. The Spring 2012 edition focuses on sterilization; and the article is titled “Safe Use of Chemicals for Sterilization in Healthcare” The article reviews the various types of low temperature chemical sterilization used today. Sterilization is achieved by exposing the items to be sterilized to high concentrations of reactive chemicals and sterilant chemicals, therefore these chemicals are by their nature hazardous, otherwise they would not function well in this role. Sterilant chemicals fall into two broad chemical groups, the alkylating agents (ethylene oxide, aldehydes) and the oxidizing agents (hydrogen peroxide, peracetic acid, ozone). The article discusses the hazards associated with their use, the evolving occupational exposure limits associated with them (especially PAA) and offers advice to employers how to assess and mitigate the risk of using these chemicals and meet the requirements of the workplace safety laws. Article Citation: P. Richard Warburton (2012) Safe Use of Chemicals for Sterilization in Healthcare. Biomedical Instrumentation & Technology: Reprocessing, Vol. sp12, No. 1, pp. 37-43. The journal requires AAMI membership or payment to gain access.

Flammable Cabinets for Ethylene Oxide Must be Vented.

Many hospitals use ethylene oxide (EtO) for low temperature sterilization despite the faster cycle times of competing technologies using hydrogen peroxide or ozone because of its great efficacy, broad application (lumens, cellulose products can all be sterilized) and much less damage to certain medical devices than the oxidative sterilants. EtO sterilization used to be supplied in tanks, blended with non-flammable balance gases, but the modern trend is to use single use cartridges with about 100 to 170 g of 100% EtO in them. These single use cartridges greatly improve safety compared to the older tanks because if there is a leak the amount of EtO involved is much smaller and cylinders no longer have to be changed. As with all the sterilant gases, EtO poses health risks for anyone exposed to it. It has the same OSHA permissible exposure limit (PEL) and hydrogen peroxide, (1 ppm calculated as an 8 hr time weighted average (EtO 29 CFR 1910.1047, H2O2 29 CFR 1910.1000 Tbl Z-1 because of EtO’s toxicity and carcinogenicity. In addition, EtO is a flammable low boiling point liquid (BP = 12 oC) and so should be stored in an NFPA approved flammable cabinet (NFPA 30). Most hospitals that we visit do store their single use cartridges in flammable cabinets, but a surprising number do not vent the cabinets. These single use cartridges often seep small amounts of EtO. If the cartridges were in the open, the EtO seepage though not good would be dispersed into the air and with the high air turn over in most sterile processing departments, not pose a great threat. However, if the cartridges are in an unvented flammable cabinet, the EtO that seeps from the cartridges can accumulate within the cabinet to be released only when the door is opened. We have seen a surprisingly large number of unvented flammable cabinets being used to store EtO single use cartridges. Facilities are using flammable cabinets because of the flammability of EtO, but are ignoring the toxicity of EtO. Hospitals that use EtO are required to have a dedicated exhaust and so in most cases the cost of connecting the EtO flammable cabinet to the exhaust is minimal. If the EtO flammable cabinet in not vented then the cost in terms of employees health in the long term may be much larger. It is not just ChemDAQ that is raising this concern, 3M, one of the major suppliers of these single use cartridges also recommends the use of vented flammable cabinets. Most flammable cabinets have vents built into the side of them by the manufacturer, and so exhaust ducts can easily be connected to the flammable cabinets using standard plumbing fixtures. It is important that the cabinets be actively vented, i.e. the gas inside the cabinet is sucked out. Simply opening the vents on the side of the cabinet and relying on air diffusion does not suffice since air diffusion is relatively slow especially if there are flame arrestor grids in the vent holes. In summary, EtO cartridges should be stored in a flammable cabinet, but since EtO has such a low PEL, the cabinet should be actively vented to prevent exposure of workers using the EtO cartridges to EtO.