Keep Food Legal Foundation submitted comments yesterday to the FDA on two supplemental rules the agency has proposed to implement as part of the Food Safety Modernization Act (FSMA).
"Our criticism of the proposed rules goes to the heart of the matter," says Keep Food Legal Foundation executive director Baylen Linnekin. "These rules would erect new costs and regulatory barriers without making food or consumers safer."
The basis of our criticism? The FDA's own data on the likely benefits provided under the rules--which the agency intends to be the centerpiece of its efforts to reduce the 48 million cases of foodborne illness in America each year--are slight at best, as our comments describe:
Even if all of the benefits possible under the supplemental rules proposed in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 are realized, the maximum benefit of these FSMA rules would be a reduction of 5.3 percent of foodborne illnesses. Meanwhile, the agency also floats a break-even figure of reducing 228,000 cases of foodborne illness under the manufacturing rules. The benefits of such a reduction are incalculably small. And if that smaller figure were realized, then it would mean the two proposed supplemental rules, taken together, would reduce cases of foodborne illness by only up to 3.3 percent. Ergo, the new range for FSMA “success” is a paltry reduction in cases of foodborne illness of between 3.3 percent and 5.5 percent.
And that’s an optimistic view. The FDA offers no floor on its estimate that the revised produce rule will reduce up to 1.57 million cases of foodborne illness. If the revised produce rule prevents 1 million cases instead of 1.57 million, for example, then the lower end of the FDA’s predicted benefit falls to a 2.6 percent overall reduction. With this data in mind, it’s easy to see the disconnect between what Congress promised under FSMA and what the FDA rules are capable of delivering.
In promoting FSMA, the FDA referred to foodborne illness as “a significant public health burden that is largely preventable.” Foodborne illness may be largely avoidable—through things like improved education and increased hand-washing. But the proposed supplemental rules contained in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 demonstrate that FSMA has little to do with preventing foodborne illness, and much more to do simply with “modernizing” America’s food-safety regime. Taken together, the maximum benefits predicted by the FDA for the supplemental rules proposed in Dockets No. FDA-2011-N-0920 and FDA-2011-N-0921 are underwhelming. Their costs to producers, consumers, and taxpayers far outweigh their benefits.
Read our complete comments here. We also joined with other groups that support small farmers and ranchers by signing on to comments drafted by the Farm & Ranch Freedom Alliance. Read those comments here. And read more comments we've submitted on proposed food regulations impacting everything from food trucks to trans fats here.
Keep Food Legal submitted comments yesterday on behalf of members and supporters like you in two controversial FDA rulemakings that could reshape the food landscape for decades to come.
The proposed rules stem from passage in 2011 of the Food Safety Modernization Act ("FSMA"). The rules would increase the regulatory burden around produce safety and around what the agency refers to in sterile fashion as "preventive controls for human food."
In our comments to the agency, Keep Food Legal urged the FDA to reject the proposed rules for three reasons.
First, we argued that the proposed rules would hurt small farmers, other small food entrepreneurs, and their customers. Second, we argued the proposed rules, despite their great cost, are unlikely to make food any safer. Third, we argued the proposed rules violate the U.S. Constitution.
1) The FDA should reject the proposed rules because they would hurt small farmers and small food entrepreneurs
The two main concerns we've heard voiced by small farmers and their supporters over the past year with regard to these proposed FSMA rules are 1) that farmers would have to comply with rules that are completely inappropriate for their business(es) and 2) the cost of complying with the proposed rules would be prohibitive. Examples of these concerns abound. For example, the low ceiling for gross sales under the proposed rules—especially the inclusion of sales not subject to the FSMA—would ensnare many small farmers. Excessive composting rules would make compliance particularly difficult for small organic farmers (whether or not certified organic by the USDA). And water sanitation requirements would hurt still more farmers.
The FDA has heard these arguments against adoption of the proposed rules from hundreds of small farmers in listening sessions around the country over the past year. It is incumbent upon the agency not just to listen to these legitimate concerns. The FDA should reject these proposed rules outright because they would impose costly, discriminatory, burdensome, and inapt new requirements on small farmers.
2) The FDA should reject the proposed rules because they are expensive and unlikely to make food safer
As we note in our comments, the FDA says the specific purpose of the proposed FSMA rules is to “reduc[e] the public health burden of foodborne illness.” But according to the FDA's own data, these rules would likely only make a tiny dent in foodborne illness.
Based on Keep Food Legal's analysis, the proposed rules--if implemented with an entirely unprecedented degree of precision—-could under the FDA’s own best-case scenario reduce incidences of foodborne illness only by up to 5.7 percent. Using more realistic FDA estimates, that already meager percentage drops to somewhere between a likely reduction in foodborne illnesses of between 3.7% and 5.7%. All that for just a billion dollars per year!
3) The FDA should reject the proposed rules because they are unconstitutional
The U.S. Constitution’s Commerce Clause empowers Congress alone to regulate interstate and foreign commerce. The Tenth Amendment to the Constitution, part of the Bill of Rights, leaves to states and individuals alone decisions pertaining to purely intrastate commercial activities. Consequently, Keep Food Legal is as confident that the FDA has no authority to regulate purely intrastate commercial activity pertaining to food as we are that the FDA has plenary power to regulate interstate commerce. That means the FDA has absolutely no authority under the Constitution—and certainly under the Food Safety Modernization Act—to regulate farms and other food businesses that operate entirely within any one state. In addition to protecting individual rights and respecting the power of a state to regulate farms and other food businesses that operate solely within that state, this constitutional limit on the FDA’s authority has an important practical effect. After all, even if Congress and the FDA view the agency’s authority under the Constitution as more expansive than we do, individual farmers and entrepreneurs (primarily) and the local and state officials they elected (secondarily) know what is the best approach for maximizing both the safety and profitability of these farms and other food businesses.
For the foregoing reasons, Keep Food Legal urged the FDA, in comments we filed yesterday, not to adopt its proposed FSMA rules.
Read the complete comments we submitted here. And read Keep Food Legal executive director Baylen Linnekin's 2012 law review article on the history of America's flawed food safety regulations, The Food-Safety Fallacy: More Regulation Doesn't Necessarily Make Food Safer, here. Also be sure to check out other comments and testimony we've offered at the federal, state, and local level--on issues from food trucks to soda taxes to food marketing--here.
In addition to filing our own comments on the proposed FSMA rules, Keep Food Legal also signed on to comments by the Farm and Ranch Freedom Alliance--a fellow nonprofit advocacy group--that provide a more detailed critique of the FSMA's neutered provisions for exempting small farms.
Keep Food Legal executive director Baylen Linnekin has appeared recently in a variety of media outlets to share our stance on many of the more controversial food issues today.
For example, Linnekin appeared on BBC Radio (audio starts at about 28:30) this week to discuss the state of the U.S. food safety system in the face of an ongoing scandal involving the misbranding of meat--in this case horsemeat being sold as ground beef--across the European Union. And earlier this month, a column by Linnekin critical of the FDA's newly proposed food safety rules appeared at Food Safety News, a leading food safety website. The column's fact-based criticism of the FDA's costly but ineffective proposals so riled many regulatory cheerleaders that it led Food Safety News to print a response by the Center for Science in the Public Interest (CSPI)--a multi-million-dollar interest group that advocates for dramatic increases in food regulations at all levels of government.
Because new soda taxes and bans seemingly are proposed on a weekly basis, Linnekin also appeared on News/Talk 760 WJR (audio runs about 10-1/2 minutes) in Detroit to present our arguments against a petition to the FDA by CSPI urging the agency to place a hard cap on the amount of sweetener that can appear in beverages. He also appeared on WVMT NewsTalk 620 in Vermont to discuss Keep Food Legal's opposition to a potential soda tax in the state. (See more on that story--including our written testimony before the Vermont legislature--in the blog post at left.)
Other media appearances have focused on a variety of issues--including everything from the popular Dodge "God Made a Farmer" Super Bowl commercial (which Linnekin discussed in his weekly Reason column) and an appearance on New York University's WNYU radio to discuss the unintended consequences of farm subsidies.
Stay tuned--quite literally--for more from Keep Food Legal! And make sure to follow us on Twitter, where we always announce our scheduled media appearances before they happen.
Keep Food Legal executive director Baylen Linnekin's latest academic research, The Food-Safety Fallacy: More Regulation Doesn't Necessarily Make Food Safer, has just been published by the Northeastern University Law Journal. The article is based on a talk Linnekin gave as an invited speaker at the Journal's 2011 food-law conference.
In the article, Linnekin uses historical examples to rebut the common misconception that more and more regulation leads to safer and safer food. Instead, Linnekin argues that food-safety regulations have often made food (and, consequently, people) less safe.
Examples featured in the article include 1) France's 18th Century potato ban, which Thomas Jefferson witnessed firsthand and condemned in strong terms; 2) the USDA's nine-decade "poke and sniff" inspection scheme, inwhich USDA inspectors likely transmitted filth from diseased meat to fresh meat on a daily basis; and 3) the summer 2010 recall of hundreds of millions of eggs due to negligent USDA oversight at the laying facility--even as the agency's egg graders provided the public with the false veneer of food safety.
The article first defines and describes key differences between “old” and “new” conceptions of public health (relying on the writings of Prof. Richard Epstein), and the evolving relationship of these terms to food safety. It then provides several examples of food-safety regulations that made consumers less safe, rather than safer. Finally, the article urges a return to “old” public health as a meaningful alternative to increased federal spending and authority in the area of “new” public health.
Congress should require federal agencies to return to regulating on behalf of the old public health. The government should stop trying to eliminate all risk from the adult diet, and let people knowingly make decisions about their own health vis-à-vis food (as with unpasteurized dairy products or Four Loko).
A return to old public health would help agencies that claim to be hampered by limited budgets to fulfill more effectively their missions. Efforts by the FDA to prevent mad cow disease by banning the feeding of offal to animals, for example, demonstrate a proper “old” public-health focus that government regulators should pursue.
In addition to Pres. Jefferson and Prof. Epstein, Linnekin's research cites early-20th Century advocates like Upton Sinclair and Harvey Wiley (the father--and later harsh critic--of the FDA) and contemporary writers like Mark Bittman, Marion Nestle, Michael Pollan, Eric Schlosser, Greg Conko, and others.
By Baylen J. Linnekin
Last year President Barack Obama signed into law a sweeping update of the nation’s food-safety system. Many commentators have called the new legislation the most important update of Food & Drug Administration (FDA) authority in nearly seventy-five years.
Just what does the new $1.4-billion law provide taxpayers? The general consensus among supporters of the Food Safety Modernization Act (FSMA) is that it will both give the FDA more power to crack down on food-safety scofflaws and decrease the incidence of foodborne illness across the country.
The Act will almost certainly accomplish the former by providing the agency with not just tens of millions of additional dollars to spend each year, but also new ways to spend the money, including the ability to hire thousands of new inspectors with new powers. But was FDA power and authority really an issue?
Prominent food-safety advocates from Marion Nestle to Michael Pollan over the years have painted the FDA as a neutered agency powerless to stop the excesses of large food producers. Similarly, a joint Institute of Medicine/National Research Council food-safety report issued in 2010 concluded that the FDA needed more power, a claim the agency immediately embraced. Others, though, chafe at this characterization. One critic claims the FSMA will “waste billions of taxpayer dollars without making our food supply any safer.”
Who will see their competing vision proven correct—critics or supporters of the new law? While only the future will tell, we can and should look to the past to predict whether costly government efforts to make our food safer will succeed. In hindsight, the FDA’s own record—and those of other federal agencies—shows that food-safety regulations often rest on factually erroneous premises and, consequently, can sometimes be so counterproductive that they may tend to actually make consumers less safe. Examples of this phenomenon exist throughout history, and these examples will serve as the focus of this article.
Section II of this article describes key differences between “old” and “new” conceptions of public health, and the evolving relationship of these terms to food safety. Section III gives several examples of food-safety regulations that made consumers less safe, rather than safer. Finally, Section IV suggests a return to “old” public health as a meaningful alternative to increased federal spending and authority in the area of “new” public health.
Read Linnekin's complete article (including footnote citations) in the forthcoming symposium edition of the Northeastern University Law Journal.
Keep Food Legal executive director Baylen Linnekin will present his research in the area of food safety on Friday, Jan. 21 as part of the Northeastern University Law Journal symposium, “From Seed to Stomach: Food and Agricultural Law.” Linnekin will sit on a food-safety panel and present his draft article, The Food-Safety Fallacy: Why More Regulations Don’t Make for Safer Food. Click here to learn more about the symposium.