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 million illnesses, which cost society about $2 billion—without estimating how effective the rule would be in reducing them (presumably because it is difficult to predict how each facility would design and implement its own unique food safety plan).
As we explain in our comments, the Food Safety Modernization Act (FSMA) does not call for the use of a “cost-benefit standard” that involves quantifying and monetizing all the potential benefits of the proposed rules (an inherently flawed task) and finding the optimal balance between costs and benefits. Instead, given the relevant statutory mandates, the FDA should base the rules’ standards on the best available methods for preventing food safety hazards, while ensuring that the overall costs remain reasonable.
Nevertheless, to the extent that the FDA continues to use these economic analyses, either as a decisionmaking tool or as a way of expressing the rules’ impacts, they should at least be made as comprehensive and accurate as possible.Full text
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
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
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 . They are, in the words of artist Mierle Laderman Ukeles, “.”
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 are concentrated in the Bronx, Queens, and Brooklyn. In 1996, the to address this injustice, and over the next decade these groups worked with hundreds of concerned citizens, ultimately culminating in the passage of the City’s . Although the plan laid the foundation for a more equitable distribution of these facilities, attempts to locate a waste transfer station in Manhattan have been met with litigation and outrage.Full text
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 Control Act (TSCA) over the years, they are generally not connected to EPA’s failure to make use of the best available science when promulgating regulations.
2. By contrast, there is broad consensus that the primary problem crippling EPA’s regulatory efforts under TSCA is the dearth of information about chemicals. The Senate Bill not only appears oblivious to the scarcity of toxicity and related information on most chemicals, but may aggravate the problem by preventing EPA from considering research that has the potential to inform EPA’s assessments in scientifically acceptable ways.
3. The various good science requirements and procedures are also loaded with ambiguities, creating numerous “attachment points” that present opportunities for a steady stream of legal challenges to EPA’s rules. If history is any guide, entities with the most at stake (e.g., manufacturers of the least effective and least safe chemicals) will use these attachment points to delay EPA’s implementation or force EPA into negotiations before, during, or after a rule is published. Senate Bill 1009 also lacks enforceable legislative deadlines to counteract this inevitable delay for most provisions. The Bill also makes fails to provide procedural protections that will prevent or at least illuminate these compromises that fall outside the formal processes and out of the public eye.
4. Protracted delays in implementation, with corresponding, potentially high costs to protection of the public health, seem inevitable from the cumulative problems with the good science provisions in S. 1009.
5. Chemical regulation will be effective only if it provides incentives for the manufacture of safer and more effective chemicals. The Senate Bill does not provide these incentives.
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
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 Mudlick Run, a nearby stream, by means of “man-made ditches” (opinion, p.5). Normally, a concentrated animal feeding operation (CAFO) like Ms. Alt’s must get a permit to discharge into surface waters. Congress added a provision to the CWA in 1987 excusing agricultural stormwater discharges from permitting requirements. EPA has construed this exemption as only covering areas in which manure was applied to land in accordance with specific guidelines. Judge Bailey’s decision—that the discharge from Ms. Alt’s farm fits under the CWA’s agricultural stormwater exemption—would greatly extend the scope of the exemption.
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, the average time for OIRA to complete reviews increased [from 51 days] to 79 days, and in the first half of 2013, the average review time was 140 days –nearly three times the average for the period from 1994 through 2011.”
The report went on to note that the number of rules languishing at OIRA for 6 months or a year or more has risen dramatically in the Obama administration. This is particularly disturbing, since Executive Order 12866, which governs OIRA review, sets a clear, mandatory 90 day deadline for review, with a one-time 30-day extension permitted in certain limited circumstances.
According to the report:
From 1994 through 2011, an average of fewer than 10 completed reviews per year (less than 2%) took more than six months; however, in the first half of 2013, 63 reviews (nearly 30%) took more than six months, and 27 (nearly 13%) took more than one year. Further, these statistics may understate the extent of the delays. According to senior employees in 11 departments and agencies (who were interviewed for this report anonymously and without indication of agency affiliation), OIRA has increasingly used “informal reviews” of rules prior to their formal submission [.]
At CPR, we’re glad to see ACUS focus on the important problem of OIRA delay, which we’ve commented on in the past. But many of us at CPR were disappointed to see that the report misses important causes of delay at OIRA and that many of the recommendations might continue or expand OIRA’s interference in agency rulemakings in ways that were never authorized by Executive Order 12866.
Yesterday, CPR President Rena Steinzor, Member Scholars Tom McGarity, Wendy Wagner, Sid Shapiro and Senior Analyst James Goodwin and I submitted comments highlighting some of the problems at OIRA that ACUS should seek to address in its report and subsequent list of recommendations.
This week, it was reported that Senate Democrats plan to force a vote to confirm one judicial nominee to the D.C. Circuit Court of Appeals if Republican Senators continue to block the nominee’s confirmation. Patricia Ann Millett, who has worked for Democratic and Republican administrations in the past, is the contested candidate. Although the circuit court has three vacancies, the Republicans oppose a vote because they say the D.C. Court of Appeals has too many judges. Senator Jefferson Sessions, for example, is quoted as saying about the court, "They have, by far, the lowest caseload per judge. They take the summers off." Other than this political rhetoric, there is nothing to back up this claim. The Republican’s true objection is that, after the President fills the vacancies, the court will have more judges that will have been appointed by presidents who were Democrats than Republicans. But this is our constitutional system. If a party wins the presidency, the President gets to fill judicial vacancies and the Senate concurs unless the person nominated is not competent.
From the time the President announced his nominations to the Court back in June, Republicans have kept up a steady stream of misinformation about the need to fill the court. First they claimed that filling the court vacancies would amount to “court-packing,” a term that refers to an effort during the Roosevelt administration to add more judges to the Supreme Court -- not to eliminate existing seats, as the Republicans would like to do here. In addition, they were more than happy to fill the seats vacated during the Bush Administration.
Now they claim that the D.C. Circuit does not need as many judges as it current has. Senator Grassley has crafted legislation to permanently eliminate seats on the circuit court to preclude the possibility that the President can fill the existing vacancies. In the past, however, Congress has determined how many judges are needed in each of the federal circuit courts based on recommendations of the non-partisan Federal Judicial Center, which studies caseloads and makes its recommendations based on available empirical evidence. This is why Chief Justice Roberts has asked Congress to fill the vacancies on the D.C. Circuit. As Chief Justice, he is the head of the Center and he is acting on its recommendations. In fact, the average caseload for the Court is up, from 119 cases in 2005 to 188 cases this year. The cases before the Court are also more complex than other circuits because it reviews cases involving complicated regulations adopted by agencies. It would be a shame if decisions about the number of judges in each circuit, one of the few remaining vestiges of non-partisanship left in Congress— were wiped out by Republican partisanship.
Why are the Republicans talking through their hats? The answer lies in the D.C. Circuit's unique jurisdiction over environmental, health, safety and other regulations, which gives it a particularly important role in the federal judiciary. For years, the circuit court has had more judges appointed by Republican presidents than presidents who were Democrats. Now that President Obama has won reelection, and can change the balance, the Republicans are no longer willing to fill the vacancies that they were only to happy to fill when it was a Republican president who was choosing the nominees.
The American people deserve better and are not falling for the Republicans’ hot air. Editorials from local papers across the country have come out in support of filling the Court’s remaining seats. Senator Grassley’s own local paper the Daily Iowan notes:
Unlike the attempted 1937court-packing power grab by Roosevelt, Obama is not seeking to create new seats on the Court of Appeals to tilt the court’s partisan balance in his favor. Obama seeks only to fill judicial vacancies in accordance with his Constitutional job description.... Grassley argues that the court’s relatively low caseload requires such a reduction in seats, but an April report from the nonpartisan Judicial Conference of the United States, a group led by Roberts, recommended keeping the number of judges on the D.C. court at 11. The actions and the rhetoric of Grassley and the rest of his Senate partisans smack ultimately of obstructionism.
The argument that we should move seats from this circuit to other circuits because the Court is "not busy enough" is laughable at best and deeply cynical at worst. The Republican Senators simply cannot accept that their party lost the election, and they are prepared to stall judicial nominations until they win again, no matter the cost to the country or the Constitution.Full text