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
Last Friday, the FDA posted the revisions the White House Office of Information and Regulatory Affairs (OIRA) made to two food safety rules drafted by the agency two years ago. The proposed rules were issued under the Food Safety and Modernization Act, which Congress passed in the wake of widespread food safety disasters.
As we’ve mentioned in this space before, OIRA is the regulatory review body within the White House that frequently holds onto agency rules for longer than the 120-day limit set by Executive Order 12866, often mangling and weakening the protections developed by agencies at the behest of regulated industries. For one of these rules, on the Foreign Supplier Verification Program (FSVP), OIRA didn’t loosen its grip for a year and eight months, giving it plenty of time to tinker around with the FDA’s proposal behind closed doors.
According to a memo accompanying each of the recent releases, the FDA was prepared to post the “redlined” documents showing OIRA’s revisions on August 15 of this year, and that is also the date the documents were supposedly “received” in the electronic rulemaking docket. So, why did they come out only last week? We may never know the answer, but we can finally see how the White House chopped and diced through the FSVP rule in ways that make it less protective of consumers and more appealing to food corporations.
The Importance of the FSVP Rule
This rule is intended to strengthen oversight of imported foods, which for the most part fall right through the cracks in our food safety system and land directly on our plates. Over 15 percent of the food we eat is imported, including over 50 percent of our fresh fruit, 20 percent of our fresh vegetables, and 61 percent of our honey. In 2011, 10.5 million unique food products were brought into the country, but the resource-strapped FDA was able to inspect just 2 percent of all imports and only 0.4 percent of foreign food facilities.
Much of this food is produced in developing countries with inadequate regulatory systems, where unsanitary practices are common. This year alone, we’ve seen a 162-person outbreak of Hepatitis A caused by pomegranate seeds from Turkey, an 84-person Salmonella outbreak caused by cucumbers from Mexico, and a 643-person Cyclospora outbreak linked to imported salad mix in two states and to imported cilantro in another.
The FSVP rule would make importers responsible for verifying that their foreign suppliers are providing the same level of public health protection that is required of domestic food producers. Importers must perform certain verification activities to ensure hazards are being adequately controlled. Beyond that, they must investigate and take corrective actions when problems arise. Companies that import foods without an adequate FSVP would face penalties.
Below is a summary of OIRA’s changes to the rule, compared to the FDA’s original draft.Full text
In January of this year, the Food & Drug Administration proposed a rule on produce safety, as required by the 2011 Food Safety Modernization Act (FSMA). The rule would establish comprehensive standards designed to prevent foodborne illnesses linked to fruits, vegetables, and nuts—like the ongoing Cyclospora outbreak that has sickened 630 people so far, or the 159 cases of Hepatitis A caused by imported pomegranate seeds.
Sofie Miller and Cassidy West, two analysts from the George Washington University Regulatory Studies Center (RSC) recently filed acomment on the FDA’s proposal, recommending a number of changes that would leave gaping holes in the rule’s protections. (A little background: the RSC was founded in 2009 with an initial grant from the right-leaning, anti-regulation Searle Freedom Trust, although that fact is no longer disclosed on their website, nor do the commenters explain which—if any—stakeholders they represent.)
Probably because their analysis is not grounded in the real-world concerns of anyone actually affected by the rule, the RSC analysts tinker with its design as if they were bookkeepers balancing a ledger, rather than stopping to consider what those numbers really mean for public health. Applying rigid cost-benefit analysis, they seem to look for ways to minimize how much the rule would improve public health, making it easier to argue that its costs are excessive.Full text
Three years after the EPA proposed a rule to protect communities from coal ash—a byproduct of coal-power generation that’s filled with toxic chemicals like arsenic, lead, and mercury—a final rule is still nowhere in sight. Meanwhile, power plants are dumping an additional 94 million tons of it every year into wet-ash ponds and dry landfills that are already filled to capacity.
Seemingly untouched by this sense of looming disaster, the Obama Administration continues to dawdle in the face of resistance from the coal industry and perennial attempts from House Republicans to deprive the EPA of its authority over the issue. As the EPA fiddles with new power-plant data and reassesses the rule ad nauseam, the next coal ash catastrophe is waiting to happen. As we examine the wreckage, we’ll have to remember how this rule gathered dust on the Administration’s desk.
A Brief History of a Not-So-Brief Rulemaking
Although the EPA has debated whether to regulate coal ash for decades, the issue took on a new urgency after 1.1 billion gallons of ash slurry spilled from a ruptured dam in Kingston, Tennessee in 2008, doing irreversible damage to the surrounding community (but miraculously killing no one). The spill refocused attention not only on unstable ash ponds, but also on the leaching of chemicals into groundwater from unlined or improperly lined waste sites, and the spewing of dry ash into the air. Exposure to the toxic ash can cause cancer, birth defects, and a host of neurological and respiratory disorders, as nearby communities are painfully aware. (See here for a brand-new series of excellent films on coal ash).
After Kingston, the EPA promptly drafted a proposal that would regulate coal ash as hazardous waste, setting enforceable, nationwide standards for management and disposal. But before being released, the proposal had to pass through the deregulatory gauntlet of the White House Office of Information and Regulatory Affairs’ (OIRA) review process, which went four months beyond its deadline. During that time, industry groups met with OIRA a staggering 33 times, a record even for the heavily lobbied OIRA. They claimed that hazardous-waste regulation would impose a costly “stigma” on the use of recycled ash (in construction and landscaping materials), which would dwarf any benefits to public health and safety.
By the time the White House was through with the proposal in June 2010, it had become bloated with weak options that would regulate coal ash as “non-hazardous solid waste,” leaving in place a dysfunctional patchwork of state regulations with no federal oversight. The proposal was accompanied by a severely flawed cost-benefit analysis designed to make the weak options look attractive by embracing the industry’s unfounded stigma argument.
The coal-utility and ash-recycling industries launched a massive lobbying campaign in Congress and in public to further block the rule. The EPA was flooded with 425,000 comments, and the enormous task of sifting through them became part-reason, part-excuse for delaying the final rule—first beyond 2011, then to the end of 2012 or the beginning of 2013, and finally into 2014.
About 15 percent of all foods we consume are imported. Looking at some particular categories, the numbers are far more striking: imports make up 91 percent of our seafood, 60 percent of our fruits and vegetables, and 61 percent of our honey. Most of these imports come from developing countries that lack any effective health and safety regulation—like China, which has had a seemingly endless run of food safety scandals and yet supplies 50 percent of our apple juice, 80 percent of our tilapia, and 31 percent of our garlic.
Unsanitary practices in these countries are well-documented: Vietnamese farmers are known to send shrimp to America in tubs of ice made from bacteria-infested water; and Mexican laborers are often given filthy bathrooms and no place to wash their hands before gathering onions and grape tomatoes for export. Despite the obvious risks of adulteration and contamination, the resource-strapped Food and Drug Administration (FDA) inspected only 2 percent of food imports and just 0.4 percent of foreign food facilities in 2011. Import-related outbreaks—like the 81 people sickened by Mexican cucumbers just a couple months ago—have become even more frequent in recent years.
The foodborne pathogens that make it to our tables often prove deadly for children, the elderly, and those with compromised immune systems. In 2008, after undergoing chemotherapy and radiation, 67-year-old Raul Rivera was told by his oncologist that he would likely survive non-Hodgkin’s lymphoma. He celebrated by taking his family out for dinner, where they ate pico de gallo. It was later discovered that the jalapeños in the salsa were imported from a Mexican farm that had used Salmonella-tainted water for irrigation. Rivera died two weeks later, not of cancer but of salmonellosis.
In January 2011, President Obama signed the Food Safety Modernization Act (FSMA), a set of sweeping reforms that would be fleshed out in rules issued by the FDA. Two and a half years later, only two proposed rules have been released—one on produce safety standards, and the other on preventive controls for human food. The FDA has drafted three other proposed rules that could significantly improve the safety of imports, but they are currently languishing at the Office of Information and Regulatory Affairs (OIRA), an office inside the White House that is notorious for blocking, weakening, and delaying the rules that it reviews.
These three rules, described below, are already many months beyond their statutory deadlines, and OIRA has held them well past the 90-day limit established by Executive Order 12866. Whenever these rules finally emerge, we should be alert to the ways that OIRA may have undermined their effectiveness, just as it substantially weakened the FDA’s preventive-controls rule before it was released in February.
The Department of Agriculture’s (USDA) proposal to “modernize” the poultry inspection system by replacing government inspectors with company employees, and speeding up the processing line to a staggering 175 birds per minute, has been exposed on numerous occasions as a disaster-waiting-to-happen for food and worker safety. In its zeal to save money for poultry corporations, the White House’s Office of Information and Regulatory Affairs (OIRA) failed to conduct its much-vaunted “interagency review” before giving the proposed rule its stamp of approval—it even neglected to invite the Occupational Safety and Health Administration (OSHA) to weigh in on the obvious dangers posed to workers.
As if more evidence were needed that the poultry rule is a horrible idea, it turns out that the rule also poses a number of serious threats to the environment that went unaddressed in the USDA’s analysis, as CPR President Rena Steinzor and I explain in a letter sent today to OIRA Deputy Administrator Dominic Mancini.
As proposed, the rule threatens to significantly increase water pollution in at least two distinct ways. First, it would lead to an increase in the use of poultry-sanitizing chemicals, which then have to be discharged into nearby water bodies where they will have toxic effects on aquatic life and threaten ecosystems. Poultry plants are expected to increase their reliance on something called “online reprocessing” (OLR), where all carcasses, visually contaminated or not, pass through automatic sprayers on the line that drench them with large amounts of antimicrobial chemicals like chlorine and trisodium phosphate (imagine a car wash … but for chickens). In the more traditional method, only those carcasses that are visually identified as contaminated are taken off the line for reprocessing, undergoing procedures that use smaller amounts of chemicals.Full text
In late 2011, a little known but surprisingly influential independent federal agency called the Administrative Conference of the United States (ACUS) conducted a research project on “International Regulatory Cooperation” (IRC), culminating in a set of recommendations to U.S. agencies. In a letter sent yesterday (March 21), CPR Member Scholars Rena Steinzor and Thomas McGarity, and I urge ACUS Chairman Paul Verkuil to look back over the project’s many flaws, which reflect—in both process and substance—ACUS’s pervasive bias toward the views of regulated industries.
What exactly is meant by “international regulatory cooperation”? As we write:
The principal objective of IRC is to “harmonize” U.S. regulatory standards with those of other countries or international standard-setting organizations. …. There is always a danger that such harmonization efforts will become a deregulatory “race to the bottom” in which nations, at the urging of business groups, converge on the least protective standard in the interest of maximizing international trade.
A number of current proposals (described in an attachment to the letter) illustrate how “harmonization” efforts can significantly reduce health, safety, or environmental protections. For example, the Food and Drug Administration (FDA) has proposed establishing “import tolerances” for residues of unapproved animal drugs in foods shipped to the United States. Instead of its normally rigorous drug approval process, the FDA would essentially rely on a foreign government’s approval of the drug in question, conducting a much less comprehensive review before signing off on the wholesale importation of foods containing that residue. The FDA would in many cases borrow the “maximum residue limits” established by the Codex Alimentarius, an international standard-setting body heavily influenced by industry groups. Since much of the food we eat in the United States is imported (15 percent of all our food, 91 percent of our seafood, 61 percent of our honey, and 8 percent of our red meat), the presence of unapproved drug residues could expose Americans to much higher risks of allergic reactions, cancer, and other serious health problems.Full text
A report released yesterday by the Southern Poverty Law Center (SPLC) and the Alabama Appleseed Center for Law and Justice offers a devastating glimpse into the world of Alabama poultry workers. Forced to hang, fold, gut, or slice more than 100 carcasses each minute, these workers suffer injuries at astounding rates: of the 302 workers interviewed, almost three-quarters have experienced a significant work-related injury or illness, from deep cuts and debilitating hand pain to chemical burns and respiratory problems. More than anything, these injuries are a result of the punishing line speeds that workers have to keep up with—lines that never slow or stop when a worker is in pain, but only when a piece of chicken becomes lodged in the machinery.
Unsafe at These Speeds: Alabama’s Poultry Industry and Its Disposable Workers is a sobering report, especially since it comes at a time when the Department of Agriculture (USDA) is preparing to finalize a proposed rule that would allow poultry plants to raise line speeds to a staggering 175 birds per minute (up from current limits of 70-140 birds per minute) and would leave only one federal inspector on each line. In other words, workers would have only one-third of a second to spend on each carcass, and the inspection duties previously handled by USDA inspectors would be turned over to company employees. As disturbing as that looks on paper, the real-world implications are even worse in light of the working conditions described in this report.
The new report describes how the relentless pace of the processing line creates a frenzied work environment that affects every aspect of the job. Not only do workers face greater injuries from performing their tasks, they are also denied necessary breaks as supervisors insist that they stay on the speeding line. Some literally run to the bathroom on slippery blood-streaked floors, racing back to the line to avoid getting in trouble. Because workers are not given the time to sharpen their knives, they are made to use dull knives, which require them to strain their muscles even harder to cut through meat and bone.Full text
CPR President Rena Steinzor and Member Scholar Thomas McGarity sent a letter this morning to Paul Verkuil, Chairman of the Administrative Conference of the United States (ACUS), taking the independent federal agency to task for its increasingly apparent bias toward the views of industry groups and its troubling alliance with current and former officials at the White House Office of Information and Regulatory Affairs (OIRA). By repeatedly partnering with groups engaged in destructive battles with the agencies that write protective regulations, ACUS deviates from its stated mission of “providing nonpartisan expert advice and recommendations for improvement of federal agency procedures,” argue Steinzor and McGarity.
After losing its funding in 1995, ACUS was officially revived in 2010 at the urging of a broad spectrum of experts and organizations, including public interest groups, some of which are represented among ACUS’ membership. As Steinzor and McGarity write:
[One] reason advanced for ACUS’ reemergence was the inability of existing institutions, such as OIRA itself, to be reliably neutral and independent in studying ways to improve the administrative process. If ACUS comes to be seen as merely another vehicle for OIRA loyalists and their industry allies to press their agendas and drown out opposing voices, then ACUS will lose part of its distinctive raison d'être.
In that event, they suggest, many of ACUS’ original supporters may be forced to reassess its value and even withdraw from the organization.Full text