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Conflict Disclosures for Regulatory Science: Slow but Steady Progress at Last

Basic disclosures of conflicts of interest have been required by the top science journals for decades. Yet most regulatory agencies – despite strong urging from a variety of bipartisan sources – have failed to require these disclosures for private research submitted to inform regulatory decisions.  This omission is particularly alarming since, unlike journals, agencies used this research to determine the appropriate standards for protection of public health and welfare.  If anything, one would expect the agencies to apply higher scientific standards and insist on greater transparency for privately submitted research as compared to journal editors.

The failure of agencies to meet these bare minimum standards of science has not gone unnoticed.  Recently, the Administrative Conference of the U.S. recommended that agencies should, where possible, require these basic disclosures of conflicts, including “whether the experimenter or author had the legal right without approval of the sponsor of the research to: design the research; collect the data; interpret the data; and author, publish or otherwise disseminate the resulting report or full dataset.”   See Recommendation #11.  Both the Bipartisan Policy Center (p.42) and the Keystone Center (p.20,24) preceded the ACUS recommendation with similar calls for basic conflict disclosures for private research that informs regulation. An editor of Nature recently called for such disclosures, noting:  

It was the 1976 film All the President’s Men, about the uncovering of the Watergate political scandal by two Washington Post reporters, that popularized the phrase: “Follow the money.” He who pays the piper calls the tune. Science combats the undue influence of commercial interests — or at least tries to — by using a different guideline, illustrated by a popular catchphrase from another film: “Show me the money.” Give us transparency.

Even members of Congress recognize the need for basic conflict disclosures in environmental in reform legislation (see § 4(b)) that is otherwise considered by environmentalists to be far too lax.  

At last, one federal agency has begun to show leadership on this issue.  Last November, in a proposed rule that would set standards for silica exposure, OSHA requested that commenters voluntarily disclose funding sources in the course of submitting their comments.  While this is simply a voluntary request by OSHA (and compliance with this request may prove disappointing), it is still a step in the right direction.  Hopefully other agencies and Congress will follow suit and make the disclosure requirements mandatory for new research submissions that inform public and environmental regulation, holding this regulatory science to at least the minimum standards of the scientific community. 

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CPR Member Scholars file Comments on OSHA’s Silica Proposal

At long last, the comment period on OSHA’s silica proposal has closed and the next phase in this rule’s protracted timeline will commence.  In the four months since OSHA released the proposal, the agency has received hundreds of comments.  They run the gamut, from the expected support of unions and other advocates for working people, to the fear-mongering hyperbole of the major trade associations.  CPR Member Scholars Sid Shapiro and Martha McCluskey joined us in submitting our own comments to the record.  You can read them here.

Silica dust is a pervasive occupational hazard.  The vast majority of exposed workers toil in the construction industry, where clouds of dust surrounding jackhammers, masonry and concrete saws, and brick and mortar work are an all too common sight.  OSHA seeks to eliminate those dangerous conditions by encouraging employers to provide modern tools that have better dust collectors, shrouds, and water feeds to suppress the dust.  The proposal also addresses the myriad other industries where silica exposure leads to debilitating cases of lung cancer, silicosis, and silica-related kidney disease.  Dental laboratories, ship repair companies, and ceramic refractories will also be subject to the rule’s new requirements.

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Two House Hearings, One Bad Theme

Today, separate House committees will hold hearings that address two federal agencies’ efforts to regulate toxic chemicals.  The House Energy and Commerce Committee’s Subcommittee on Environment and the Economy will hold its fifth hearing on issues arising out of ongoing efforts to reform the Toxic Substances Control Act (TSCA).  Simultaneously, the House Education and Workforce Committee’s Subcommittee on Workforce Protections will hold a hearing addressing, among other things, OSHA’s recent attempts to spur better protections for workers who face chemical hazards.  The two hearings have been framed differently and will feature different witnesses, but they share a common thread: each committee’s Republican majority is championing a worldview in which federal agencies should be restricted from engaging in the most basic form of protective action – gathering and sharing information about toxic chemicals’ risks.

The Energy and Commerce hearing, which has a rather conspicuous absence of EPA officials on the witness list, will focus on the provisions of TSCA that relate to chemical testing.  It is commonly accepted that EPA – and especially, the public – lack sufficient knowledge about the hazards presented by toxic chemicals in our environment.  TSCA does not set out minimum requirements for testing that companies must undertake before putting a chemical in the stream of commerce, so we are left to deduce potential toxicity from whatever information companies voluntarily disclose to EPA in their “pre-manufacture notifications” and EPA’s own analysis of potential toxicity using models that compare chemicals of similar structure and composition.  To make matters worse, some 60,000 chemicals were already on the market when Congress wrote TSCA in 1976 and their uses were grandfathered in, meaning that companies were not required to submit any testing information to EPA.  Expect witnesses at the hearing to agree that more information would improve the balance between protecting the environment and protecting chemical companies’ bottom lines.  But don’t expect them to agree on how to get more information.  As we wrote in a July 2013 Issue Alert, the best solution involves multiple pieces:  minimum data sets for all new and existing chemicals, prioritized review of those data sets, and information sharing between EPA and the European Chemicals Agency, which is pulling in large amounts of new information through its revolutionary REACH legislation.

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Dangerous dust and deadly delay: OSHA's proposed silica rule

 It’s not easy to stare into the eyes of a dying man. But that is what David Michaels, the head of the Occupational Safety and Health Administration (OSHA), wants you to do.

A video called, “Deadly Dust,” featured on OSHA’s website, introduces Bill Ellis, a retired painter and sandblaster. After years of exposure to fine particles of blasted rock, he developed a respiratory disease called silicosis and died, leaving behind his wife, children, and grandchildren. Ellis’s final months were painful. For a silicosis patient, just drawing breath is an ordeal—like sucking air through a straw.

Thousands of laborers are exposed to the tiny stone particles, called silica, that killed Ellis. Any time workers blast sandstone, saw concrete, or cut brick, that dust is in the air. Because of the broad danger and the availability of relatively inexpensive protective gear, OSHA has released proposed rules updating worker safety standards for silica.  The current rules have not been revised in over forty years.

The proposal would lower the permissible exposure limit (PEL) of silica dust from 100-250 micrograms per cubic meter of air to 50 micrograms. The rule could save nearly 700 lives and prevent 1,600 new cases of silicosis each year. After including costs of implementation, average net benefits are estimated at $1.8 to $7.5 billion per year.

The potential benefits of the rule are truly remarkable. The result seems like a dream situation, where a government agency can protect people and save money. Isn’t that what regulatory agencies are supposed to do?

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What’s for Thanksgiving? Hopefully not more crippling pain for poultry workers! Learn more at upcoming webinar

When we all sit down for Thanksgiving dinner next week, we hope that the food we are feeding our families is wholesome and that the workers who produce it are safe.  Thanks to the U.S. Department of Agriculture (USDA), ever the mindless booster of corporate profits, that turkey at the center of the table already disappoints both expectations, and if USDA has its way, matters are about to get much worse.  Hiding behind disingenuous promises to “modernize” the food safety system, USDA has decided to pull federal food inspectors off the line at poultry processing plants across the nation.  No new preventative measures to ensure that poultry is free of salmonella would happen.  And already crowded, bloody, stinking lines would speed up dramatically—to as many as 175 birds per minute, or three birds/second. Workers who suffer grave ergonomic injuries from the repetitive motions of hanging, cutting, and packing the birds would endure conditions that are two or three times worse than the status quo.   

The consequences of USDA’s de-regulatory scheme are well documented. Back in 2001, the Government Accountability Office (GAO) found significant food safety concerns in pilot plants authorized to test the new system and just this past summer slammed the USDA’s data in justifying the program. The Agency is using data cherry-picked from two-year snapshots over a 15-year period of the piloted system to justify the program and relying on old and inaccurate economic analysis.  

 

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Deeply flawed economic analysis exaggerates the cost of FDA’s produce rule

 One of the healthiest things a person can do is to eat lots of fruits and vegetables. Unless they’re contaminated with dangerous pathogens, that is. Contaminated produce has been responsible for an alarming number of deaths and illnesses in recent years, from Listeria-tainted cantaloupes that killed up to 43 people in 2011 to a Cyclospora outbreak linked to salad mix and cilantro that sickened 631 people in 25 states this past summer. 

For this reason, the Food Safety Modernization Act (FSMA) directed the Food and Drug Administration (FDA) to set standards to ensure the safety of the fruits and vegetables in our food supply.   The FDA’s proposed rule on produce safety would address some of the most likely sources of contamination on farms, including tools and equipment, water used in agricultural activities, and worker health and hygiene. At the Center for Progressive Reform we submitted comments to the FDA, urging the agency to issue the final produce rule as soon as possible, in its strongest, most protective form.

We focused most of our attention on the economic analysis that accompanied the FDA’s proposal. The FDA found that the rule is easily justified on economic grounds, estimating annual benefits of $1.04 billion—representing 1.75 million avoided illnesses in the United States—and annual domestic costs of $460 million.

But once we looked behind these numbers, it became clear that the rule’s benefits will be even more significant, and its costs considerably smaller, than the FDA suggests. The agency’s estimates are built on flawed assumptions, and those flaws were greatly exacerbated by the White House Office of Information and Regulatory Affairs (OIRA) during the 13 months that it spent marking up the proposal and delaying its release. By misrepresenting the rule’s impacts, these distortions help to fuel needless negativity towards the rule, from members of Congress, produce-industry associations, and farmers themselves. 

Below are some examples of how the analysis overestimates the rule’s costs. 

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CPR's Tom McGarity to testify at Senate Hearing on regulatory ossification

Today, Center for Progressive Reform board member and University of Texas School of Law professor Thomas O. McGarity will testify at aHearing hosted by the Senate Judiciary Committee entitled, "Justice Delayed II: the Impact of Nonrule RuleMakiing in Auto Safey and Mental Health."

McGarity's testimony can be read in full here.

According to the testimony, some possible solutions to the problems created by nonrule rulemaking include:

Agencies that are conscientiously committed to carrying out their statutory missions will continue to employ informal rulemaking with all of its burdensome accoutrements if they have no other alternative.  For example, EPA’s statutes typically require it to use informal rulemaking to fill in the necessary implementation details, and they often specify precise deadlines for EPA action.  Its heavy rulemaking output during the past few years is a testament to the ability of a very determined agency to employ even a broken system to achieve important statutory goals.  But those efforts consumed scarce resources that are unlikely to be available in such quantities in the future.  The agency has on many occasions made policy through less formal devices like guidance documents that are not subject to many of the requirements that afflict informal rulemaking.  And it will no doubt continue to do so as the resources available to the agency dwindle.

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The human cost of regulatory ossification

Tomorrow, a subcommittee of the Senate Judiciary Committee chaired by Senator Richard Blumenthal (D. Connecticut) hosts a Hearing on the consequences of excessive regulatory “ossification” entitled, “Justice Delayed II: The Impact of Nonrule Rulemaking on Auto Safety and Mental Health.”  I will be testifying at that hearing on the effects of agencies’ moving to more informal rule-making procedures as a way to avoid the burdensome analytical and internal review requirements that currently make it so difficult for them to promulgate rules.

During the 1980s and 1990s, the rulemaking process became increasingly rigid and cumbersome as presidents, courts and Congress added an assortment of analytical requirements to the simple rulemaking model and as evolving judicial doctrines obliged agencies to take great pains to ensure that the technical bases for rules were capable of withstanding judicial scrutiny under what is now called the “hard look” doctrine of judicial review.  More than twenty years ago, Professor E. Donald Elliott, himself a former General Counsel of the Environmental Protection Agency, referred to this phenomenon as the "ossification" of the rulemaking process, and I wrote an article based on my study for the Carnegie Commission describing the ossification phenomenon, identifying some of its causes, and suggesting some ways to “de-ossify” the rulemaking process. 

My 2012 article on “blood sport” rulemaking highlights many of the tactics that stakeholders now use for slowing down or influencing the outcome of high-stakes rulemaking proceedings, many of which are employed outside the APA’s notice-and-comment process. Under the pressure of constant opposition from the regulated industries and with only sporadic countervailing pressure from beneficiaries of the regulated programs, statutory deadlines are missed, ambitious policy goals remain unachieved, and the protections envisioned by the authors of the statute gradually erode away.   

Along with many other scholars, I am convinced that the current rulemaking process is not merely ossified -- it is broken. 

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OSHA’s new tools for addressing chemical hazards could bolster enforcement

Today OSHA announced two new web-based resources designed to help employers eliminate chemical hazards in the workplace.  Both the toolkit for identifying less-hazardous substitutes and the annotated exposure limits table are useful informational resources designed to promote voluntary action by conscientious employers and informed demands by workers and their advocates.  But OSHA has to deal with both the “high road” and the “low road” employers, so using these new tools in enforcement proceedings is a necessary adjunct to voluntary employer efforts.  With some enterprising work by enforcement officials and strong support from the Solicitor of Labor the tools could be the basis for a new wave of enforcement under the OSH Act’s General Duty Clause.

As OSHA freely admits, the Permissible Exposure Limits (PELs) found in current regulations are out-of-date and inadequately protective.  Employers may expose workers to chemicals up to those limits without incurring fines for violating the standard, even though the exposures are patently dangerous.  Most were adopted in the early 1970s and were based on scientific research from the 1940s through 1960s.  In the late 1980s, the agency undertook an effort to set new exposure limits for hundreds of chemicals in one fell swoop, only to be thwarted by a court that wanted more detailed analyses of each individual chemical exposure limit.  Since then, OSHA has initiated and finalized just one new PEL – as part of a comprehensive standard for hexavalent chromium exposure – but only after Public Citizen and the Oil, Chemical and Atomic Workers Union petitioned the agency to do so and fought a protracted legal battle to get the rulemaking started and completed.  In the meantime, non-governmental organizations have continued to update their own occupational exposure limits (OELs) for chemicals found in the workplace, which many employers implement voluntarily because they know that OSHA’s standards don’t do enough to protect workers.

The broad recognition that workers face significant hazards even when chemical exposures are below OSHA’s PELs presents an interesting question about employers’ duty to protect their workers.  Fortunately, Congress foresaw the potential for such a problem and included in the OSH Act a provision known as the General Duty Clause (GDC).  Under the GDC, “Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”  

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SBA’s Office of Advocacy wants even more time to review OSHA’s silica proposal

SBA’s Office of Advocacy has added its voice to the chorus of business interests who want OSHA to delay publication of a new rule that would protect workers from the deadly effects of silica exposure. In a letter to OSHA chief David Michaels, the top lawyers from the Office of Advocacy claim that it will be “nearly impossible” for small business representatives to review OSHA’s proposal and prepare the comments and testimony due in early December.

To be sure, the rulemaking docket is voluminous and the issues are complex. But the bottom line is that each day of delay in publishing the new rule means another day when millions of workers will be exposed to elevated levels of a deadly dust. By OSHA’s estimates, hundreds of workers die each year from silica exposures that are perfectly legal under current standards; thousands of other workers suffer from non-fatal diseases. One of those suffering workers is Alan White; a foundry employee from upstate New York who shared his powerful story with the press on the day OSHA announced it would publish the new proposal. The sooner OSHA finalizes this proposal, the sooner employers will institute controls to protect Mr. White’s co-workers and millions of others who face unnecessary risks of silicosis, lung cancer, emphysema, chronic bronchitis, chronic renal disease, and a host of other maladies. For businesses, delaying the new rules might mean a few more days of avoided compliance costs, but those costs are small compared to the costs that workers pay as a result of the current, inadequate, protections.

The request for delay is especially rich coming from SBA’s Office of Advocacy. SBA and the small business community it purports to represent have already been granted a privileged spot in the rulemaking process. Before representatives of workers or other stakeholders get a chance to see an OSHA proposal, a draft document is run through the gauntlet otherwise known as “SBREFA review” (SBREFA is the Small Business Regulatory Enforcement Fairness Act). During that review, officials from SBA’s Office of Advocacy, the White House, OSHA, and the Solicitor of Labor’s Office work with a panel of “small entity representatives” to get the small business owners’ reactions to the proposal. Their reactions are memorialized in a report, and OSHA must include in its final rule a formal, written response to the concerns raised during SBREFA review. OSHA’s silica proposal and background documents include a draft response to the SBREFA review that clearly indicate SBA and the small business community know enough about the critical issues for this rulemaking to respond within the current comment period.

OSHA must resist the pressure to delay this rulemaking any longer. An early draft went through the SBREFA process a decade ago, it was adjusted to meet small business representatives’ critiques and updated with new scientific and economic research, and in 2011 it went to the White House, where it languished for two and half years. Now the rule is at a critical juncture: the public comment period and rulemaking hearing will give OSHA a chance to fine-tune the proposal based on input from a broad range of experts, but that process will take time. As we noted when OSHA announced the silica proposal, the process of getting from a proposed to a final rule has taken the agency three years, on average, in recent rulemakings. If this administration wants an OSHA health standard to its credit, it cannot afford to delay this rule any longer at the behest of the regulated industries.


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