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.Full text
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.Full text
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.Full text
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.”Full text
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.
“Es ridículo,” was the reaction of a poultry plant worker when he heard of the USDA’s proposal to “modernize” poultry slaughter. The agency’s January 2012 proposal () would allow companies to increase assembly line speeds from about 90 to 175 birds per minute, and remove most USDA inspectors from the poultry processing line.
The Obama Administration should have heard the loud and clear opposition from civil rights, food safety, public health and the workers’ safety communities to the USDA’s proposal. When the public comment period closed in May 2012, the Southern Poverty Law Center (SPLC), Nebraska Appleseed, the American Public Health Association and other groups were on record urging the Administration to withdraw the proposed rule. The , the largest Hispanic civil rights organization in the U.S., put it bluntly:
“this proposed rule runs counter to what we would expect from an administration with a public commitment to protecting vulnerable workers.”
Although calls to withdraw the proposal have fallen on the Obama Administration’s deaf ears, poultry workers and their advocates have not given up. As last month, their appeal now extends beyond just demands to withdraw the proposed rule.
Fifteen organizations, including the Coalition of Poultry Workers, Farmworker Advocacy Network, Coalition of Black Trade Unionists, and the National Council for Occupational Safety and Health, filed a petition with the USDA and the U.S. Department of Labor’s OSHA to issue mandatory standards on line speeds in order to protect poultry and meatpacking workers from disabling musculoskeletal injuries. The well-researched, concludes:
This petition has demonstrated that there is a compelling need for a standard that properly regulates the dangerously high work speeds in meatpacking and poultry plants. The close relationship among the relentless speed of work, repetitive motions, and the prevalence of crippling and debilitating injuries establishes that OSHA and USDA have an obligation to regulate work speeds in these industries.
SPLC and the other petitioners have not yet received a response to their petition from OSHA. I’ll chalk up their delay to the government shutdown. (Ninety percent of OSHA’s staff is laid off, including everyone in the office responsible for developing new regulations.)
USDA, however, sent a a few weeks ago. The letter uses the mushy term “consider” to describe how it might address the evidence provided by commenters on the increased risk of musculoskeletal injuries with intensified line speeds. USDA Secretary Vilsack that worker safety matters are the responsibility of the Labor Department and CDC’s National Institute for Occupational Safety and Health (NIOSH). His agency makes no promise to accept OSHA’s and NIOSH’s recommendations for the rule on ways to minimize the risk of injury to poultry plant workers.Full text
OSHA’s proposed new silica standards promise to improve the health and safety of more than two million workers across the U.S. By reducing exposures to respirable silica dust, the standards are expected to save 700 workers’ lives and prevent 1,600 new cases of silicosis every year. Of course, these impressive benefits come at a cost to employers and those costs will be a major talking point for the business community as OSHA’s proposal moves through the rulemaking process. One argument that we’re sure to hear from the Chamber of Commerce and its allies is that the costs of complying with the new standards will fall disproportionately on small businesses. The plight of small business owners somehow always seems to pull at the heartstrings of the big businesses owners when federal agencies propose new public health and environmental protections – in stark contrast to the rest of the time the big business owners spend trying to knock their competitors out. OSHA’s proposed silica standards include some surprising numbers regarding the costs of compliance.
As indicated by the 20th anniversary of Executive Order 12866, which guides the workings of the Office of Information and Regulatory Affairs (OIRA) at OMB, OIRA has become a fixture of the regulatory landscape. OIRA review of proposed rules is problematic, as other blogs in this series have indicated. In the Obama administration, however, this is an additional problem. Other offices in the White House, besides OIRA, are more deeply involved in making regulatory decisions than in any other previous administration. This deeper involvement has made it more likely that regulatory decisions will reflect political considerations rather than policy considerations. When this happens, OIRA’s regulatory review under E.O. 12866 can become a fig leaf covering up for the political decisions that are being made.
There is an old saying that in government “where you stand depends on where you sit.” That is, your view of the world is formed by the institutional arrangements in which you work. White House officials are sensitive to public policy arguments based on expertise, but they also more concerned than their agency counterparts with the political ramifications of such decisions. The White House may seek to control a regulatory outcome to obtain good public policy, but it may also seek to do so to curry favor with political donors or to forestall potential political attacks on the President. Since agency administrators are not running for office, they and their staffs do not share these political concerns (except indirectly in response to pressure from the White House or Congress.)
The origins of Executive Order 12866 go all the way back to the Nixon and Ford Administrations.
Soon after the enactment of the Occupational Safety and Health Act and the Clean Air and Water Acts, affected industries began to complain bitterly about the burdens the new wave of public interest statutes imposed on them.
The business community was also chaffing under the National Environmental Policy Act’s requirement that federal agencies prepare environmental impact statements (EISs) for major federal actions that significantly affect the quality of the human environment. Although the EIS requirement only applied to federal agencies, it was applicable when a company needed a permit to build a nuclear power plant, drill on federal lands, and many other business related activities.
The business community observed the potential for EIS requirements to bog down agencies in a great deal of paperwork prior to taking action and decided that what was sauce for the goose was sauce for the gander. They posited: why not make regulatory agencies prepare lengthy statements detailing the effects of major regulatory actions not only on the environment, but on the regulated industries themselves?
Responding to calls for economic impact statements, the business-friendly Office of Management and Budget (OMB) persuaded President Nixon to require the newly created Environmental Protection Agency and Occupational Safety and Health Administration to send their proposed regulations through an interagency "Qualify of Life" review. The agencies were required to prepare a summary of the costs of each proposed regulation and its alternatives to accompany it through the review process.
Executive Order 12866 may be twenty years old, but formal, centralized review of agency rulemaking by the Office of Information and Regulatory Affairs (OIRA) is more than thirty years old, having been instituted by President Ronald Reagan in Executive Order 12291 in 1981. Since then, this centralized review has been carried out without significant change over five presidential administrations and has had bi-partisan support in both the House and Senate. Progressives have been less enamored with this review, seeing in it a deliberate bias against regulation by reason of its additional roadblocks to and delays in adopting regulations. This bias was clearly intentional in the origin of the centralized review by President Reagan, who famously said, “government is not the solution to our problem; government is the problem.” However, even when Democrats became President the bias remained. President Clinton’s E.O. 12866 begins with a statement of regulatory philosophy that agencies should adopt “only such regulations as are required by law . . . or are made necessary by compelling public need,” not regulations that simply further the public interest or increase the net welfare to society. President Obama not only retained E.O. 12866 but also, in his E.O. 13563 explicitly reaffirmed its principles.
Of course, there is nothing inherent in the concept of centralized oversight of agency regulation that requires a bias against regulation. After all, OIRA Administrator John Graham in the George W. Bush administration instituted “prompt letters,” which proactively requested agencies to take certain actions, including adopting new or strengthening older regulations. However, Although the “prompt letters” initiated by OIRA administrator John Graham in the George W. Bush administration demonstrate the ability of centralized review to spur regulation and to push for further regulation, the fact that there were only seven such letters in eight years probably reflects the exception that proves the rule.