FDA's preventive controls rule: hollowed out by OIRA, and less costly than the agency suggests
From frozen meals and spices to nutbutters and cheeses, processed foods have been responsible for an alarming number of outbreaks in recent years.
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 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 …
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 …
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 …
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 …
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.
Inspired by the tragic explosion of a fertilizer plant in West, Texas on April 17 of this year, the Executive Order establishes a federal working group chaired by Secretaries of Labor and Homeland Security and the Administrator of the Environmental Protection Agency (EPA) and orders the working group to develop a plan to “support and further enable efforts by State regulators, State, local, and tribal emergency responders, chemical facility owners and operators, and local and tribal communities to work together to improve chemical facility safety and security.”
Coordination and …
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 …
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 …
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 …
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 …
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 …
