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Nov. 14, 2013 by Thomas McGarity

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 …

Nov. 14, 2013 by Michael Patoka
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CPR Member Scholars Rena Steinzor Lisa Heinzerling, Tom McGarity, Sidney Shapiro, and I submitted comments to the FDA on two food safety rules—one on raw produce, and one on preventive controls for human food (which applies to food manufacturers and processors).

In separate blogs posted today, we address issues of regulatory design and how the costs of both these rules would be significantly smaller than suggested in the FDA’s economic analyses. Here, we explain why these rules offer much greater benefits than those presented in the agency’s analyses. (The analyses for both rules essentially rely on the same benefits methodology.) 

The FDA estimates that the produce rule would prevent about 1.75 million foodborne illnesses, representing an annual benefit to society of $1.04 billion. For the preventive controls rule, the FDA calculates the annual burden of illnesses attributed to processed foods—nearly one …

Nov. 13, 2013 by Erin Kesler
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Today, Center for Progressive Reform Member Scholar and law professor at the University of Texas School of Law, Wendy Wagner will testify at a House Subcommittee on Energy and the Environment Hearing entitled, "S. 1009, Chemical Safety Improvement Act."

Wagner's testimony can be read in full here.

According to her testimony:

My testimony will focus on the various good science provisions in S.1009 and how they are likely to impact EPA’s use of science.  I will make the following points in my remarks: 

1.  The Senate bill contains dozens of unprecedented requirements that limit the scientific evidence EPA can consider when developing regulations and how this evidence can be used.  Yet despite the detailed level of scientific prescription in the Bill, it is not clear what problem the Bill is trying to fix.  While there have been many failures associated with the Toxic Substances …

Nov. 13, 2013 by Rebecca Bratspies
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We have a problem in New York City: We generate more than 30,000 tons of waste each day. Roughly one third of that waste is household trash, and the daunting task of collecting garbage from New York City’s three million households falls to 7,000 workers from the NYC Department of Sanitation.  They are, in the words of artist Mierle Laderman Ukeles, “keeping New York City alive.” 

All of NYC’s waste is shipped out of state for disposal. But first, the city must consolidate the garbage at one of 58 waste transfer stations. In addition to the overpowering odors the trash itself produces, these stations generate a constant stream of truck traffic, air pollution, noise pollution, and safety issues. So, of course, no one wants to live near them.

Thus, it may come as no surprise that most of NYC’s waste transfer stations …

Nov. 7, 2013 by Erin Kesler
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Today, Center for Progressive Reform board member and University of Texas School of Law professor Thomas O. McGarity will testify at a Hearing 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 …

Nov. 6, 2013 by Thomas McGarity
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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 …

Nov. 5, 2013 by Anne Havemann
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Lois Alt is a 61-year-old grandmother who sued EPA in federal court arguing that her large chicken farming operation is exempt from Clean Water Act (CWA) permitting requirements. On October 23, the judge ruled in her favor in an alarming decision that could mean thousands of other large industrial farming operations do not need permits. 

The case began when EPA found Ms. Alt in violation of the CWA for discharging without a permit. EPA ordered her to apply for one and informed her that, under the law, she could be subject to civil or criminal penalties. The agency later withdrew the notice, essentially mooting the case. Nevertheless, Judge Bailey felt compelled to rule on the merits.

The facts are not disputed. Ventilation fans blow litter and manure out of Ms. Alt’s eight chicken houses. Rainwater washes this pollution from the yard surrounding the chicken houses into …

Nov. 5, 2013 by Amy Sinden
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Since the Reagan Administration, federal agencies have been required by Executive Order to send their major rules to the White House’s Office of Information and Regulatory Affairs (OIRA) for review before releasing them to the public. OIRA review consists of, among other things, ensuring that agencies subject their rules to cost-benefit analysis to make sure the dollar value of their costs to industry exceeds the dollar value of the benefits they confer on the public.

It was no surprise under the Reagan administration – or more recently under the George W. Bush administration – that OIRA review served largely to delay and weaken rules. But you might be surprised to hear that the Obama administration’s record on OIRA delays has been significantly worse than the George W. Bush administration’s. A new report prepared by the Administrative Conference of the United States (ACUS) found that “in 2012 …

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