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Sept. 14, 2015 by Thomas McGarity

FDA's New Regulations for Food Processors: The Devil is in the Implementation

At long last, the Food and Drug Administration has promulgated two critical regulations implementing the Food Safety Modernization Act of 2011 (FSMA).  The regulations flesh out the statute’s requirements for facilities that process human food and animal feed.  Of the regulations that FDA has proposed in order to implement the FSMA, these are perhaps the least controversial.  Indeed, they have won praise from everyone from the Grocery Manufacturers Association to the food safety director of the Pew Charitable Trusts.  This blog post focuses exclusively on the regulations governing human food. 

The regulations require all processors of human food to prepare and maintain plans for ensuring that their products are not contaminated with pathogens.  A processing facility must conduct a hazard analysis and institute preventive controls to mitigate the hazards identified in the analysis.  The company must monitor those controls, conduct verification activities to ensure that the controls are effective, take appropriate corrective action when the controls fail to ensure against future failure, and maintain records documenting those activities. 

These requirements are consistent with, although not identical to, the hazard analysis at critical control points (HACCP) programs that were initially developed by the Pillsbury Corporation for ensuring the safety of …

Aug. 26, 2015 by Thomas McGarity
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In Albert O. Hirschman’s brilliant analysis of conservative responses to progressive social programs entitled The Rhetoric of Reaction, he identifies and critiques three reactionary narratives that conservatives use to critique governmental programs -- the futility thesis; the jeopardy thesis; and the perversity thesis.

The futility thesis posits that governmental attempts to cure social ills or to correct alleged market imperfections are doomed to fail because the government cannot possibly identify the problem with sufficient clarity, predict the future with sufficient accuracy, and devote resources sufficient to “make a dent” in the problem.

The jeopardy thesis argues that “the cost of the proposed change or reform is too high as it endangers some previous, precious accomplishment.” The jeopardy thesis thus subjects governmental interventions to a cost-benefit analysis and finds them wanting because the gains to the beneficiaries never exceed the costs to society of putting existing social arrangements …

June 30, 2015 by Thomas McGarity
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Yesterday, the Supreme Court in Michigan v. EPA threw out EPA’s regulations protecting the American public from mercury and other hazardous emissions of power plants.

In another instance of judicial activism by the Roberts court, the majority refused to defer to EPA’s decision to ignore costs in deciding whether to regulate power plant emissions.

The decision turned on the meaning of the word “appropriate” in a section of the Clean Air Act that addressed hazardous air pollutant (HAP) emissions from fossil fuel-fired power plants. Before EPA subjected HAPs emissions from power plants to stringent technology-based regulations, it had to decide whether regulating those emissions was “appropriate and necessary,” given the other controls that the statute imposed on power plants to reduce acid rain.

If EPA made the “appropriate and necessary” finding, the statute required EPA to subdivide power plants into various categories and promulgate emissions …

June 29, 2015 by Thomas McGarity
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In a sweeping display of judicial activism the Supreme Court has made it much harder for the EPA to protect Americans from the dangers of exposure to mercury emissions.

The Supreme Court today tossed out EPA’s regulations protecting the American public from mercury and other hazardous emissions of power plants. 

Justice Scalia refused to defer to EPA’s decision to ignore costs in deciding whether to regulate power plant emissions.

Unfortunately, this means that EPA will have to go back to the drawing board and make a fresh determination whether it is appropriate to regulate mercury emissions from power plants after considering the costs of the regulations.

Fortunately, EPA has already determined that the benefits of the regulations far outweigh the costs.  The agency just needs to formalize that determination after allowing public comment on it.

The Supreme Court’s decision will not have much …

June 15, 2015 by Thomas McGarity
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In the shadow of the upcoming Supreme Court decisions on Obamacare and same-sex marriage is an important environmental case that has important implications for the health of women of childbearing age in America.  The Court will decide whether to uphold the Environmental Protection Agency’s stringent limitations for emissions of the toxic metal mercury from the nation’s coal- and oil-fired power plants. And as with the Obamacare case, the case turns on a matter of language: the single word, “appropriate.” 

If the Court adheres to a long line of its own precedents on how courts are to interpret statutes that delegate decisionmaking power to regulatory agencies, the case should be an easy win for EPA.  If, however, some of the Justices cannot resist the temptation to impose their own policy preferences on EPA, the upcoming decision could be a very bad one for environmental regulation and …

May 26, 2015 by Thomas McGarity
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Cross-posted with ACSBlog.

The Wall Street Journal recently devoted nearly two pages of its Saturday Review section to an editorial by Charles Murray of the American Enterprise Institute urging American corporations to violate laws that they deem to be “pointless, stupid or tyrannical” as acts of civil disobedience.  The article, which is a capsule summary of his recently published book titled By the People: Rebuilding Liberty Without Permission,” betrays a profound misunderstanding of the concept of civil disobedience and a deplorable contempt for the laws that Congress and state legislatures have enacted to protect their citizens from corporate malfeasance.

This is, of course, the same Charles Murray who has made millions of dollars writing poorly documented books like The Bell Curve and Losing Ground, which were designed to allow conservative politicians to feel good about reducing welfare for the poor, limiting immigration from Latin America, and eliminating …

April 17, 2015 by Thomas McGarity
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Growing up in Port Neches, Texas, long before anyone ever heard of Earth Day, it was not hard to be an environmentalist. 

When my father announced that the family would be moving to Port Neches, he tried to soften the blow to his 13-year-old son by stressing the fact that we would be living across the street from the city park and that the Neches River ran along one end of the park.  For the remainder of the summer, I could go fishing any time I wanted.

The day we arrived at our new home, I walked the two blocks to the river to scout out future fishing holes.  It was much wider than I had imagined, but what really shocked me was the huge ocean-going oil tanker that was slowly making its way upstream to the refineries and the turning basin in the Beaumont area.  In …

Feb. 12, 2014 by Thomas McGarity
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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 …

Nov. 14, 2013 by Thomas McGarity
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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 …

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 …

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