With anÂ announcement today in the Federal Register,Â Labor Secretary Solis’ OSHA is moving in a new direction to address occupational exposure to diacetyl.Â The butter-flavoring agent isÂ associated with respiratory harm, including bronchiolitis obliterans.Â Just six days ago, Ronald Kuiper, 69, a former American Pop Corn Co succumbed to theÂ disease.
OSHA announced it isÂ withdrawing the advanced notice of proposed rulemaking (ANPRM) issued on January 21, 2009, and planning to convene aÂ panel of small business representatives (SERs) asÂ required by SBREFA.* With this move, OSHA may beÂ one step closer to proposing a rule on diacetylÂ because theÂ SBREFA process requiresÂ OSHAÂ toÂ complete and then share its proposed regulatory text and economic analysis with the SERs.Â
I translate this to mean thatÂ OSHA staff are working right now to completeÂ these key documents.Â The OSHA notice does not offer a target date for convening the SBREFA panel, but based on the strong language contained in Secretary Solis’ news releaseÂ she expects prompt action.
“‘I am alarmed that workers exposed to food flavorings containing diacetyl may continue to be at risk of developing a potentially fatal lung disease.Â …These deaths are preventable, and it is imperative that the Labor Department move quickly to address exposure to food flavorings containing diacetyl…'”
The news release also notes:
“Secretary Solis’ interest in this issue began when she was a member of Congress and workers in her former California district developed the irreversible lung disease after being exposed to this workplace hazard.”
I noticed two other interesting items in OSHA’s Federal Register notice today.Â One isÂ positive, theÂ other is puzzling and possibly a step in the wrong direction.
First, the positive move.Â Â For the first time, OSHA indicates that its meetings with the SERs pursuant to SBREFA will be open to the public.Â This has not been the case on the nine previous occassions when OSHA has convened a SBREFA panel.Â Â In the past, OSHA did not announce theÂ date of the SBREFA conference call and/or meetingÂ and onlyÂ in rare instances were non-SBREFA participants allowed to listen in on the deliberations.Â Â Opening up the SBREFA panel discussions to the public is aÂ welcome change.Â
Moreover, IÂ hope that by making the SBREFA process open to public observation, we’ll beÂ able to assess whetherÂ thisÂ special adjunct process for small business representativesÂ really adds significant value to the OSHA rulemaking process.Â Do theÂ alleged benefits of the SBREFA process exceed the costs associated with it, in particularÂ the delay in worker protection caused by this extra step?Â Â
I’ve neverÂ been a fan ofÂ required OSHA SBREFA panels.Â ItÂ seems to me that after the Small Business Administration’s (SBA) 10 years of experience with OSHA through the SBREFA process, SBA staff is now adequately equipped to reach out to smallÂ employers and engage them in the regular notice and comment process—the same processÂ offered to allÂ interested parties.Â Â Â
I’m puzzled and concerned, however, by a second item in OSHA’s Federal Register notice today, and hope itÂ isn’t aÂ step in the wrong direction for OSHA’s already bogged-down rulemaking process.Â The notice states:
“OSHA also intends to conduct expert peer review of the preliminary risk and feasibility asessments…” [emphasis added by me]
I know the G.W. Bush’s OMB/OIRA was addicted to the notion of peer review, but I’d hope that the Obama Adminstration would be getting that compulsion out of its system.Â You may recall that the G.W. Bush OMB’s peer review mandate got off to a rocky start, was scaled back, but in December 2004, theyÂ issued finalÂ peer review guidelinesÂ (under claimed authority of the Information Quality Act (P.L. 106-554)).Â Â Prior to this bulletin, OSHA was not obliged to conduct peer review of scientific information; theÂ agency head had the discretion to decide whether external peer review was necessary.Â (On several occassions, the OSHA chief decided thatÂ an external expert peer review would enhance a health risk assessment and such a review was conducted.)Â
Once OMB’s final peer review guidelines were issued, however, they became the law of the land for OSHA, and most regualtory agencies.Â The guidelines apply to a wide range of “scientific information” including factual inputs, data, models, and analyses, which covers the the biomedical and public health data used in OSHA’s health risk assessment, but also the engineering and behavioral and social scienceÂ evidence used by OSHA in itsÂ analysis of technological and economic feasibility.Â Â
OSHA’s announcement that it intends to conduct anÂ expert peer review of its feasibility asessmentÂ would be a new formal step inÂ the Agency’s rulemaking process.Â Â Who decided thatÂ this new step is necessary?Â Â Â
Like my views on the OSHA SBREFA panel, I’m not convinced that a formal peerÂ review of everyÂ OSHA health risk assessment is good public policy.Â Â I’m even lessÂ persuaded thatÂ peer review is needed for OSHA’s feasibility analyses.Â Â In fact, I’d suggest that one of the most robust alternatives to traditionalÂ peer review isÂ the manner in which OSHAÂ already conducts its public hearing on a proposed rule.Â Â
For those who haven’t witnessed it, an OSHA public hearing isÂ day-after-day of complete give-and-take between agencyÂ scientists, economists and attorneys,Â agency-selected expert witnesses, and anyÂ individual who notified the Agency of his/her intention to participate.Â Â Speakers,Â including experts retained by interest parties, are encouraged toÂ delve deeply into the assumptions and uncertainties in the OSHA risk assessment (and any other document associated with the rulemaking) and bring the comments, questions and alternative analyses to the public hearing.Â Â Participants question OSHA staff, OSHA staff question witnesses,Â and speakers question other speakers.Â Â AnÂ administrative law judge oversees the process, allowing a civilizedÂ and open exchange of questions, answers and comments.Â Â
It is exactly because of this dynamic OSHA process that I question the necessity for a formal peer review of OSHA’s riskÂ assessment.Â Now, itsÂ feasibility assessment will be subject to expert peer review, too?Â Â One purpose of theÂ SBREFA panel is toÂ assess whether OSHA’sÂ regulatory actionÂ is feasible for small business.Â Â Doesn’t that process already serve as a peer review ofÂ OSHA’s feasibility analysis?Â Â
Are you puzzled, too?
SBREFAÂ requires OSHA to convene a special panel of small business representatives (i.e., an employer with 500 or fewer employees) in order toÂ review theÂ proposed regulatory text of anÂ OSHAÂ standard (or EPA standard) along with the agency’s preliminary economic analyses.Â Â In practice, theyÂ get this opportunity before any other member of the public and to suggest changes to the rule or to the preliminary economic analysis.Â The comments, recommendations and resulting changes to the pre-proposed rule are documented in aÂ so-called SBREFA report which becomes part of the rulemaking record.