When President Obama signed the Food Safety Modernization Act (FSMA) into law in January 2011, it was considered a long-fought, but significant and bipartisan, victory to update the U.S. Food and Drug Administration’s authority and oversight of the food supply. While much of the wrangling over the language of the law was made public through media coverage of Congressional hearings, the ensuing industry influence over implementation of the law has been subject to far less public scrutiny (with the exception of FDA’s unlawful delay of FSMA’s critical implementing regulations, over which Center for Food Safety has successfully sued). As a recent report from the Sunlight Foundation illuminates, industry lobbyists have been on FDA’s doorstep from the beginning, even more so since FSMA passed, influencing the agency’s implementation of the law. Not content to pay their way into the public forum of legislation, industry groups also devote significant time and resources to influencing rulemaking and post-food-crisis management. Sunlight explains that:

“Using FOIA, Sunlight obtained memoranda of meetings for the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) over a two-year period, yielded dozens of industry contacts with the regulators who oversee them. Industry group representatives were present at meetings four times as often as representatives of consumer interests.”

Winning the prize for the most frequent visitor to FDA over the two-year period was Miriam Guggenheim of the law firm Covington & Burling. Thanks to her efforts, members of the American Bakers Association (ABA) will likely be exempt from FSMA’s proposed regulations regarding warehouse temperatures, measures, FDA says, “prevent problems that can cause foodborne illness.” The exemption, the ABA press release notes, “was allowed under language in FSMA that was included at ABA’s recommendation.” Well done. Guggenheim also accompanied representatives from Mars candy when the company wanted faster approval processes for food additives and held telephone calls with FDA about “bottled water labeling,” among other client needs. But, despite Guggenheim being identified as a frequent visitor to FDA, according to Sunlight, she has not been registered as a lobbyist since 2010, before FSMA even passed. How so? Sunlight says it just shows the weakness of our lobbying disclosure rules and a lack of enforcement:

“Guggenheim’s work on behalf of food industry heavyweights shows how much of the influence game in Washington still remains in the shadows. Not everyone who pushes private agendas in Congress and at regulatory agencies registers to lobby. Those who are registered to lobby disclose minimal information about their activities.”

The only way Sunlight was able to obtain the information it did was because “agencies keep track of which special interests come calling and why.” However, “those records are rarely made available to the public without a Freedom of Information Act request.” The documents Sunlight obtained from FDA revealed a wide variety of lobbying by industry, in no way limited to the FSMA rulemaking process. Several issues reveal an interesting cause-and-effect pattern: Soon after an industry-tarnishing report appears in the media, meetings at FDA ensue. Take, for example, highly caffeinated energy drinks, which have caused a lot of controversy lately. On Nov. 14, 2012, The New York Times ran a story with the headline, “Caffeinated Drink Cited in Reports of 13 Deaths.” The next day, D.C. lawmakers, led by U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT), once again called on FDA to investigate the safety of energy drinks, following up on letters the senators sent in April and September of that year. “We urge the agency,” they wrote, “to assert its regulatory authority over caffeine levels in energy drinks marketed as beverages.” Just two weeks later, on Nov. 30, 2012, Guggenheim and three of her Covington colleagues, as well as Thomas P. Davis, the chief scientific officer for their client, Monster Energy Drink, sat down with 13 members of FDA. The description of the discussion in the official memorandum is vague, but proving the drinks were safe was clearly a top priority. Dr. Davis provided “studies relating to the safety of Monster energy drink ingredients” and “emphasized the safety of Monster’s products.” Almost a month-and-a-half later, on Jan. 11, 2013, the Times ran another story on the dangers of energy drinks, this one with the headline, “More Emergency Visits Linked to Energy Drinks.” Just four days later, on Jan. 15, FDA hosted another meeting with energy drink insiders, this time with Kraft Foods representatives, on the topic of their new energy beverage, MiO Liquid Water Enhancer (which was not specifically named in the Times article). Another hot topic in the news has been arsenic in rice. A Consumer Reports study published on Sept. 19, 2012, revealed that organic rice, baby cereal, and numerous other rice products contained arsenic, often “at worrisome levels.” Within a few weeks, on Nov. 8, 2012, members of the Organic Trade Association, rice producer Lundberg Family Farms, California Natural Products, USA Rice, and others met with representatives from FDA’s Center for Food Safety and Applied Nutrition. The subject, according to the memorandum, was “Arsenic in Rice.” That large corporate interests lobby our lawmakers to legislate (or not legislate) in their favor is nothing new. But the Sunlight report shines a light on a dark corner of the workings of the Big Food lobby that — in part thanks to the complicated FOIA process — we rarely get to see. A review of the agency’s records shows that, while FDA also takes meetings with consumer interest groups, the vast majority of the agency’s schedule is composed of meetings with large corporations such as Coca-Cola and Campbell Soup Company, along with major trade groups, including the National Chicken Council, the Grocery Manufacturers Association, and the American Spice Trade Association (turmeric and cardamom need lobbyists, too). According to Sunlight, consumer groups were present at only 18 percent of the meetings, while industry representatives were showing up 78 percent of the time. So how can those of us not adept at filing regular FOIA requests even know that these meetings with government officials in charge of food safety are happening? The report’s author, Nancy Watzman, told me that federal lobbying disclosure rules are “very porous, rely on the honor system, and give a very incomplete picture of what’s really going on.” Given these weaknesses, Sunlight’s government affairs consultant recommends several improvements, including a requirement that all lobbyists report the name of the official contacted by the lobbyist, a summary of issue discussed, specific actions requested, and the name of the client. This sort of transparency Sunlight says, would have an important impact on democracy:

“Had these principles been in place while the lobbying for an exemption to the food safety rules had been ongoing, it would not have taken the relentless digging of an intrepid reporter to uncover who was shaping the rules. More importantly, real time, public disclosure of industry’s efforts for special treatment is paramount for healthy debate.”

  • Mike_Mychajlonka_PhD

    Elsewhere in this same issue of Food Safety News we are informed that Dr. Elizabeth Hagen has become yet another Under Secretary for Food Safety at USDA to have taken a quick trip through Washington’s revolving door in the apparent eagerness to make use of her contacts while they are still fresh. In the sense of this article, it might be interesting to make a case study of her upcoming meetings with her former regulatory colleagues still employed by the government, regardless of agency.

  • Wednesday, December 4, 2013

    Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine
    Products; Final Rule Federal Register / Vol. 78 , No. 233 / Wednesday, December
    4, 2013

    wrote on, kind of like the mad cow feed ban of August 1997, nothing but ink on
    paper $$$

    full text ;


  • Oginikwe

    Right. Because we only care about the ones who die. The huge number of people, including the elderly and children, who get sick at varying levels of intensity don’t count. Nor does it count when someone dies of something else after being weakened from fighting a food borne illness. .

    • Rob Stuart, Ph.D.

      Does anyone know the anticipated cost to industry to implement this act? Most of the responders seem to think that the industry wants to make people sick. The last thing a company wants is for a consumer to get sick from consuming its food. Sure it upsets me when someone gets sick from consuming food that has been contaminated, because I am a part of that industry. But to hear what the NY congresswoman Slaughter said in her interview about how animals are treated by my industry is so dumb. For the industry to have to spend over $2 billion per year to implement this ACT is crazy. Over thirty thousand people die on our highways each year and what are we doing about that?



        NO COMPANY intentionally gets someone sick!!!!! NO ONE thinks there are companies out there dedicated to selling intentionally contaminated food!!!



        its always cheaper to do things right the first time.

        obviously the “industry” for one reason or another whether it be ignorance, accidents, lack of knowledge or what have you, did not do it right the first time…

        So now yes its expensive for the companies who havent been keeping up with the times and more effective ways to keep their product safe.

        GET OVER IT.

        There are companies out there who will not be affected by FSMA at all because they are ahead of the game. Those companies work hard and spent alot of money to get where they are at on their own initiative will now have a tremendous advantage compared to less responsible ones who throw a receptionist in as their FOOD SAFETY MANAGER and only do a test to get their certification and have something on file…..

        • Dr. Rob Stuart

          These responses show me how misinformed the readers are. Name me one food or feed company that will not be affected by FSMA. And furthermore, this is not a game. We are trying to feed a hungry world as economically as possible. Yes, I am part of the 99% and work and pay taxes and have been a member of the agricultural industry all my life.

          • MorganLvr

            “As economically as possible,” you say. Did you ever ASK people if they’d be willing to pay more for SAFE food that was prepared while being as humane to the animals involved as possible? No, because someone would under price you and you’d lose MONEY.

            If you people had been up front in the beginning and just said we can produce safe, healthful food and be humane to our animals, but it will have to cost more than that put out by those who cut corners on safety and humane treatment of animals, you’d have been amazed at how many would have chosen your products over the corner-cutters.

            But, it’s too late now. Factory farm companies have lied to us so much that we no longer believe a word you say. Especially when we learn that Big Meat has been doing heavy lobbying for bringing horse slaughter back to the US ever since it was shut down. Horses are NOT food animals in this country, and most of their veterinary medications and other widely used products as well are not safe for humans to consume – there are food safety LAWS banning these products from being used in any food animal ever. Why are you ignoring that simple fact?

            These regulations would affect factory farms almost exclusively, and personally, I’d rather pay more and see ALL factory farms shut down. For the sake of people AND animals.

  • Common Sense

    The U.S. population is 316,668,567 people. 1 person dies every 12 seconds, which correlates to 7,200 deaths per day, 2,628,000 deaths per year and you mean to tell me you don’t think at least 3,000 of those 2.68 million deaths are related to what those people ate??? 0.11% of deaths are food-born pathogen related and you dont think this is possible??

    I agree the FSMA is flawed and things need to be more logical/practical in alot of cases throughout the legislation, but you honestly think its a sham?? Do you like the taste of contaminated food? Do you have any kids? What would you do if your daughter or son or mother or dad got listeria and died from eating a piece of fruit? would you think its acceptable?

    would you say oh thats not too bad for the year, my mom and daughter were the only 2 who died because they ate a dirty piece of food since January 1 2013?

    • Dr. Rob Stuart

      How can you be so sure that a new law will make food safer. More costly, Yes. Safer, No. For Congress to use numbers from one study to write a law is very disappointing. No I don’t think it is possible for 0.11% of the deaths to be due to food-borne organisms introduced by the manufacturer. We can’t all afford free-ranging, naturally-grown, native genetics, organically fed, non-GMO, and what other adjectives you can think of to describe animals grown for slaughter. I saw that a woman in Virginia was selling “organic” turkeys for $160-200 each. That is amazing when a person could buy a fresh turkey at any supermarket for under $20. Only in America!!!

  • Dr. Rob Stuart

    You don’t give a rat’s butt about my industry and what it’s going to cost.
    So what price would you think would be equitable and what is your definition of safe? My best response to someone like you would be to only eat canned food. Do not prepare any raw products in your kitchen. That would make your food intake almost 100% safe and free of pathogens.

    • Oginikwe

      We started raising all of our own meat because of your industry and its poisonings. We eat very well and don’t worry about any of organisms your industry has spawned. The biggest surprise of all was the taste–it actually has some.

    • MorganLvr

      Now you’re insulting our intelligence again. But, thank you Dr. Stuart, for showing your true colors when it comes to food safety. Your sarcasm is lost on people as dumb as we are anyway, right?

  • Dr. Rob Stuart

    What part of the industry are you in? Being pro-active does not make one a part of the industry. A cheaper more effective plan to reduce food-borne illnesses is to not buy fresh produce and meats. Enjoy life by eating canned foods for the remainder of your natural life.

    • Michael Bulger

      This Dr. Stuart character is preposterous. Must be a joke.

    • MorganLvr

      We don’t have to be part of “your industry.” All we have to do is eat your crappy products which have become almost impossible to avoid. Actually, I would never be part of “your industry.” I’m the first generation of my family on both sides to grow up off the farm. I loved the family farms, but they are long gone now and we have YOU. What a tragedy.

  • Dr. Rob Stuart

    According to the 1938 FDandC Act, food is defined as follows:
    21 CFR Chapter 9 Subchapter ll. 321(f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

    Is the moral of your pool analogy “don’t pee in the water, and especially don’t drink it”. Do you have any idea what it takes to get a product, either food or drug approved in this country? PDUFA application fee for a new drug will be $2.1 million dollars. That is not the cost of clinical studies. You are your own protector. Don’t depend on our government to protect you. If you think something is bad, for heaven’s sake, don’t consume it. And I hope you don’t consume hormones taken in the form of birth control pills. Or does that only apply to meat?

    • MorganLvr

      One can make a personal decision about taking medications. But everyone has to eat and we don’t all have access to “local” producers. Make all the excuses you want, no one buys that anymore.

    • JC Mansfield

      There was no moral–it wasn’t an Aesop’s Fable. Its an analogy of our current existing circumstances. The only standard lacking in this equation is the definition of FOOD. The definition defined is limited to a corporate generalization that does not ascertain what substances are in fact conducive for human consumption and health, or even an accurate assessment of what health is. These points must be addressed as they largely lack any substantial determination of dietary criteria for the human body, and yet here we allow any and all substances to invade us. This is not an attack on your comment as much as it is further conversation. I am in agreement that the process is outlined to fail. Basically the criteria is too broad and the scope of product endorsement is financially impossible (accept to a select few with the means…) Chewing gum? articles used for components could be defined as ARSENIC which in fact is found in nearly everything we consume. Money is the bottom line in this picture painted nightmare and serves as a scape-goat for all political agendas and all corporate incentives. The 1938 FDandC Act? 1938 is hardly fair or relative representation of our current technologies or modifications to our viable “food” or resources. If there was a moral to my lousy fish tale, it would be “don’t chase the invisible bone tied to your tail, its not real and its probably laced with chemicals…”