The FDA’s proposed rule on “preventive controls for human food” would require manufacturers, processors, and warehouses to design a written food safety plan tailored to each facility’s products and operations. (The rule would also apply to mixed-type facilities that conduct processing activities on a farm.) In general, facilities would have to identify the potential hazards in their processes and then implement controls to minimize or prevent them. This system—Hazard Analysis and Risk-Based Preventive Controls, or HARPC—is intended to address microbiological, chemical, physical, and radiological hazards in food processing, as well as undeclared allergens.
CPR Member Scholars Rena Steinzor, Lisa Heinzerling, Sidney Shapiro, Policy Analyst Michael Patoka and I submitted comments to the FDA, urging the agency to issue the final rule as soon as possible and to select the options that are most protective of public health.
FDA Must Restore the Essential Provisions Eliminated by OIRA
During the 13 months the rule spent under review at the White House, the Office of Information and Regulatory Affairs (OIRA) eliminated a number of crucial provisions that the FDA had originally proposed, including requirements for:
(1) Certain sanitation practices;
(2) Food-safety training for employees;
(3) Review of consumer complaints;
(4) Environmental monitoring for pathogens (testing of locations throughout the facility);
(5) Finished product testing;
(6) Supplier approval and verification programs; and
(7) Review of the records associated with these activities.
In the gutted version that emerged from OIRA’s review, the FDA clarified that it is not proposing any of these measures at this time but is instead just requesting comment on them. Meanwhile, all the information prepared by the agency to explain and justify these requirements was relegated to an appendix at the back of the preamble.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
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.
After more than two years of White House review, OSHA has finally published its proposed new standards for silica exposure. Secretary of Labor Tom Perez, Assistant Secretary David Michaels, and many other people both inside and outside the agency deserve congratulations for finally shaking the proposal loose from the clutches of the president’s regulatory review team in OMB’s Office of Information and Regulatory Affairs. The publication of the proposal is an important step towards protecting millions of Americans who are exposed to the deadly dust in their workplaces.
But this is no time for the agency to rest on its laurels. As GAO noted in a recent report, OSHA proposals published in the 2000s took an average of three years to reach the “final rule” stage. If it takes that long to publish the final silica rule, it will be in jeopardy of falling prey to election-year politics. The Obama administration’s regulatory agencies published fewer final rules in 2012 than the agencies published in any of the prior 15 years. (Thanks to Curtis Copeland for this analysis.) It is incumbent upon Secretary Perez, Assistant Secretary Michaels, and their entire team to keep this rule moving along expeditiously. That means no extensions of the comment periods, efficient management of the rulemaking hearings, and a hardline stance against the White House’s regulatory review team, which has a history of holding up this rule.
Today marks an important step forward for workers, but the finish line is a long way off.Full text
Yesterday President Obama signed an executive order, entitled “Improving Chemical Facility Safety and Security,” that is designed to get state, federal and local chemical safety agencies and first responders to improve coordination, information gathering, and regulation with respect to the risks posed by the many highly reactive chemical compounds that are stored and used throughout the United States.
Coordination and Data Sharing.
The Executive Order also addresses the easier question of coordination and data sharing among agencies with responsibility for protecting the public from chemical explosions.
Among other things the working group is supposed to:
• Identify ways to improve coordination among the Federal Government, first responders, and State, local, and tribal entities
• Identify ways to ensure that the various state, local and federal entities with responsibilities for regulating reactive chemicals and reacting to explosions, either accidental or intentional (for example, acts of terrorism) of reactive chemicals “have ready access to key information in a useable format”
• Identify areas where joint collaborative programs can be developed or enhanced
• Identify opportunities and mechanisms to improve response procedures and to enhance information sharing and collaborative planning between chemical facility owners and operators and the relevant governmental agencies; and
• Examine opportunities to improve public access to information about chemical facility risks consistent with national security needs and appropriate protection of confidential business informationFull text
This morning, CPR Member Scholar Tom McGarity testifies at the Senate Committee on Environment & Public Works on "Strengthening Public Health Protections by Addressing Toxic Chemical Threats." His testimony can be found in full here. McGarity contributed the following blog post in advance of the hearing.
The Chemical Safety Improvement Act: The Wrong Way to Fix a Broken Federal Statute
We live in an era in which human health and the environment are threatened by toxic chemicals that have not been adequately tested and that are subject to a federal regulatory regime that is badly broken.
The fact that we do not often read about disease outbreaks caused by toxic chemicals in the newspapers probably stems from the fact that we know so very little about the risks posed by the thousands of synthetic chemicals that we encounter on a daily basis.
We are only beginning to learn of the adverse health effects of endocrine disrupting chemicals and various flame-retardants. The impacts of many ubiquitous chemicals on ecosystems are largely unknown. We know, for example, that the Potomac River contains high levels of endocrine disrupting chemicals and that there is an unusually high incidence of “intersex” (male fish exhibiting female characteristics) in smallmouth bass in the river. At the same time, people continue to be e exposed to some chemicals, like the carcinogen formaldehyde, that have well-known adverse effects on human health.
There is a federal law in place that is supposed to require manufacturers of chemical substances to conduct adequate toxicity testing and to empower the Environmental Protection Agency (EPA) to ban, phase-out, label, or otherwise regulate chemicals that pose unacceptable risks to human health or the environment. That statute is the Toxic Substances Control Act of 1976 (TSCA).
But that statute is severely broken. Congress is considering a bill, referred to as the Chemical Safety Improvement Act, that purports to fix TSCA’s problems. Unfortunately, that bill is not likely to be as effective as its supporters think, and it contains two provisions that will make matters affirmatively worse.
Lost among the high-profile opinions that the Supreme Court issued during the past two weeks was a case that attracted little media attention, but is of great importance to the millions of Americans who take generic drugs.
Karen Bartlett, a secretary for an insurance company filed the lawsuit against generic drug manufacturer Mutual Pharmaceutical Company. When Karen visited her doctor complaining of shoulder pain, he prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions. When Ms. Bartlett’s pharmacist filled the prescription, however, he gave her the generic version of the drug sulindac, rather than the brand-name drug.
Soon after taking the drug, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns on over 60-65 percent of her body. For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma. During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind. Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.
In a clear concession that it had made a grave mistake, FDA several months later required manufacturers of all NSAID drugs to include an additional warning on their labels concerning the risk of adverse dermatological effects, including SJS/TEN. But that was too late for Ms. Bartlett.
As I related in a previous blog, Ms. Bartlett’s attorneys made a powerful case for the proposition that the risks posed by sulindac far outweighed its very modest painkilling benefits and that numerous less dangerous alternatives were available for patients, like Ms. Bartlett, who suffered from shoulder pain.
Mutual Pharmaceutical did not put on a single witness to defend its product. Instead, it argued that Ms. Bartlett’s claim was impliedly preempted by the Federal Food, Drug and Cosmetics Act (FDCA) as amended by the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch/Waxman Act”). The former statute requires drug manufacturers to obtain FDA approval of their products by demonstrating that they are safe and effective. The latter requires the FDA to approve generic versions of approved drugs upon a showing that the active ingredient in its drug is chemically and biologically equivalent to the active ingredient in the previously approved brand-name drug and that the label is identical to the brand-name label.Full text
Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions. The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug.
The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain. Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions. When Ms. Bartlett’s pharmacist filled the prescription, however, it gave her the generic version of the drug sulindac, rather than the brand-name drug. Under federal law, the generic version of sulindac had to be chemically and biologically equivalent to the brand-name version that had been approved by the FDA.
Not long thereafter, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns over 60-65 percent of her body. For the next year, her life was, in the words of her surgeon, a “hell on earth” as she spent 100 days in five hospitals and several months in a medically induced coma. During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind. Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.Full text
[[Ed. Note: This post is a reprint, with minor updates, of McGarity’s post one year ago on the first anniversary of the proposed silica rule arriving at OMB. Little has happened on the issue in the past year – except more people have been sickened or killed by silica exposure.]]
Today marks the second anniversary of an event that received little media attention, but marked a major milestone in the progression of a regulation that is of great importance to thousands of Americans whose jobs bring them into contact with dust particles containing the common mineral silica. Exactly two years ago today the Occupational Safety and Health Administration (OSHA) completed a proposed rule requiring employers in the mining, manufacturing and construction industries to protect their employees from silica dust particles as they engage in such activities as sandblasting, cutting rocks and concrete, and jackhammering.
Silica dust is no newcomer to the growing list of workplace hazards. Public health professionals have known for more than one hundred years that exposure to airborne silica dust can cause a debilitating disease caused silicosis.
In 1929, as the nation entered the Great Depression, hundreds of workers made their way to Gauley Bridge, West Virginia to work on the Hawk’s Nest diversion project, a massive digging operation that created a three-mile long tunnel through Gauley Mountain to divert the flow of the New River for a Union Carbide power generation facility. Before the project was completed, more than one hundred workers had died of silicosis, and many more faced the prospect of slow and painful deaths as a result of their exposure to silica dust.
The Hawk’s Nest tragedy inspired public health officials to establish limitations on workplace exposures to silica dust, but they did not prevent workers from contracting the dreaded disease. Scientists estimate that thousands of workers still contract silicosis, resulting in hundreds of deaths, every year. And silica dust exposure has been linked to other diseases, like cancer, as well.Full text
When I teach my environmental law and food safety law students how to go about ascertaining the meaning of implementing regulations, I tell them to start with the sections of the regulations devoted to definitions and exemptions. Quite frequently the most hard-fought controversies during the rulemaking process through which the agency promulgated the regulations were over the definitions and exemptions.
That certainly seems to be true in the case of the long-awaited Food and Drug Administration’s (FDA) proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” which the Obama Administration, with much fanfare, issued on January 4. According to FDA’s analysis of the economic impact of the proposal, almost 80 percent of the country’s produce growers will not have to meet the standards because they are not covered in the definitions or are otherwise exempt.
The proposed rule, which was required by the landmark Food Safety Modernization Act of 2010, would for the first time establish legally enforceable standards for produce farmers. The standards set out requirements for sanitizing tools and equipment, for ensuring that agricultural water is safe and sanitary, for using animal-based fertilizers (e.g., compost) on food crops, for reducing contamination from domesticated and wild animals, and for training field workers and ensuring that they employ sound hygiene practices.Full text