UPDATE (March 9, 2016): In honor of Micheal Taylor’s announcement yesterday that he was jumping ship retiring from his horrible job as top food safety man at the FDA, I spruced up this old post a bit (originally published in April 2012) – gave it a bit of a spit and polish, because anyone who held that post, even if they did once work for Monsanto, without cracking up, deserves some credit, even if it is in the form a spoof. This one’s for you, Mike.

Poor Michael R. Taylor.

Alternatively known as the Food and Drug Administration’s “Food Safety Czar” or the guy voted by Americans they would most like to see thrown out of a job, he’s got to have one of the most nerve-wracking jobs of all time. Can you imagine going to work every day knowing you are responsible for food safety in America?

I imagine poor Mike furiously gnawing his fingernails to a nub, plagued by fits of unexpected panic attacks, teetering dangerously close to a complete nervous breakdown were it not for a prescription for Xanax.

Maybe Mike agonizes over the daily pounding he gets in the press. Maybe his personal life is in shambles, his house littered with empty beer bottles, unopened mail, crumpled pizza boxes and newspapers with stories about him, mocking him. Maybe he regrets having been vice president for public policy at Monsanto.

Poor Mike probably just needs a back rub and some aromatherapy. Maybe we can imagine a more human Mike, someone who, just like the rest of us, is worn out by the pressures of work just wants a break from it all. Perhaps he dreams of swaying palm trees, soft sandy beaches and ice-cold Margaritas.  Maybe he just needs a little TLC.

It’s not hard imagine, when you hear him describe the enormous, almost insurmountable, job of implementing the FSMA, “…this is part of the empathy-inducing aspect of the law, because it is, in fact, a huge work load. But one that we readily embrace.”

“Empathy,” “embrace?” Wow, I feel like I’m back on the Commune.

With that thought in mind, a speech he gave at the pet food industry’s Petfood Forum recently struck me. While the tone was typical Mike, upbeat and positive, I couldn’t help imagining what he might really be thinking while reading his keynote speech at the 2012 Petfood Forum in held in Illinois last Wednesday.

Letting my mind wander, I translated what, I imagined, that poor man might really be feeling during his talk…

Role of the Food Safety Modernization Act in Ensuring the Safety of Pet Food

Remarks at the Pet Food Forum
Schaumburg, IL April 4, 2012

Michael R. Taylor
Deputy Commissioner for Foods
U.S. Food and Drug Administration

Welcome

Mike: “It’s a pleasure to be here today with pet food industry leaders from around the world. At the FDA, we recognize the important role your industry plays—not only regarding the health of companion animals but regarding the health of their owners.

The convergence of human and animal health is a topic you understand well, but many consumers still have a high learning curve.”

Translation: “Let’s face it, most consumers are nincompoops, easily misled, so it’s our job to gently steer them to our way of thinking before they get completely brainwashed by those Godforsaken food safety bloggers. Take that Bettina…Oh, never mind.”

“…For example, many people don’t realize that the basic principles of food safety apply to their pets’ food too.”

Translation: “Like I said, some people are just one sandwich short of a picnic.”

“…We advise consumers on foodsafety.gov—the Federal government’s web site for food safety—that they should wash their hands after handling pet food. Many don’t understand that if pet food is contaminated…”

Translation: “So it’s our job to warn consumers that a product they think we regulate, but actually don’t, may be contaminated with dangerous pathogen, but in a good way. Then should someone, God forbid, in their family become ill or die they will be forever burdened with the guilt that it might have been their fault because, after all, we told them to wash their hands.”

“…and is not handled properly, it can cause serious illness in people, especially children. The incredible growth in the pet food industry is good news to this audience. But with this growth comes a responsibility to ensure these products are as safe as they possibly can be for both pets and their owners.”

Translation: “The reality is, your responsibility ends with the compliance policies that allow you to have a free hand to put any old crap in pet food and we won’t do a thing about it – my lips may be moving, but that doesn’t mean you should listen to a single word I’m saying, because you and I both know it is complete and utter nonsense.”

“We must recognize that just as the pet food supply is global, food safety must be global as well. So it makes sense for all of us to make food for humans and pets as safe as it can possibly be.”

FSMA Principles

Mike:  “I believe that the Food Safety Modernization Act is taking us in the right direction. Congress has made prevention the foundational principle of the new law. FSMA shifts our food safety focus from reaction and response to prevention—from catching food safety problems after the fact to systematically building in prudent preventive measures across the food system.”

Translation: “And that would be awesome if the FSMA ever becomes a reality, which you and I both know ain’t ever gonna happen. Sorry, but Congress will never approve the budget necessary to make any of the meaningful aspects of it come to fruition. So just forget every word I say on the subject of the FSMA because, honey, that dog is dead so just quit beatin’ it already, huh?”

“…The law also codifies the principle that the primary responsibility for prevention rests with the food and feed industries. Within the preventive controls framework, FDA plays its role most effectively by setting science-based, prevention-oriented standards and working to ensure high rates of industry compliance with the new standards.”

Translation: “Bla bla bla ain’t gonna happen bla bla bla keep dreamin’ fool bla dee bla dee bla.”

“…Recognizing the globalization of the food supply, FSMA embraces the prevention principle for imported food and feed and calls for a fundamental shift in how FDA oversees the rapidly rising volume of imports.

And finally, the law calls for partnerships to make needed changes both domestically and internationally.”

Translation: “Sweetie, the law may be callin’, but I can tell you ain’t nobody listenin’, ’cause Congress ain’t gonna pay for diddly squat, hear?”

Key Foundational Proposed Rules

Mike: “Implementing the new law is a big job, so we have been prioritizing our work. We have completed a number of initial actions mandated by Congress.  For example, we have issued interim final rules on criteria for administrative detention and have used this authority several times.”

Translation: “Gotta tell you, the one bright spot is the awesome new administrative detention authority we have. I just get all goose-pimply just thinking about it! Brrr! FSMA gives us access to a company’s records and mandatory recall authority if a company refuses to voluntarily recall a product. And we don’t need proof, we just have to find “reasonable probability” the product is adulterated. Bitchin’.”

“…We have issued interim final rules on prior notice for imported food and an interim final rule and draft guidance on records maintenance and access.

But the first major milestone in implementing FSMA will be the issuance of four foundational proposed rules that are critical to fulfilling the FSMA vision of a modern, prevention-oriented food safety system. We hope to publish them soon. They are:

• Preventive controls for animal food
• Preventive controls for human food
• Produce safety
• Foreign supplier verification program”

Translation: “The operative word here being “hope” and “soon”. Which, in reality means:  Dude, don’t get your hopes up and don’t hold your breath waiting for the publications either, fool.”

“…The general principles for the rules are the same. They are science and risk-based, flexible to address the diversity of operations, and sensitive to small businesses.

The first two proposals require preventive controls for human food and animal food. Prevention is not new, but Congress has given FDA explicit authority to use the tool more broadly. Facilities will be required to establish modern preventive controls that are consistent with the internationally recognized principles of HACCP– or Hazard Analysis and Critical Control Points.”

Translation: “Which is all good, but…enforcing it…well…we’ll cross that bridge when we come to it. But let’s just say that if and when you do get busted for anything, you’d better have your HACCP plan in place or we’ll bust you on that too, hear?”

“…We are developing separate rules for human food and animal food to take into account some differences in how preventive controls would work in these facilities. The animal food rule will address issues specific to animal food and will not address issues that pertain only to human food.  For example, the animal food proposed rule does not require controls for allergens, since severe allergic reactions are not common in animals.”

Translation: “Let’s just skip over the nitty-gritty huh? I’ll just give you a lame example so I can keep this speech brief, ‘kay?”

“…And there are several areas addressed by the animal food rule that are not in the rule for human food. The proposed rule will require that pet food and animal feed are correctly labeled as to the species for which they are intended since nutritional requirements differ considerably among species.”

Translation: “Because, you know, that before this proposed rule, pet food and animal feed labeling was just all over the map, willy-nilly. Lord, it’s a miracle they didn’t all die of malnutrition! Fish food was labeled dog food and chicken feed was labeled cat food – it was Hell, I tell ya – a real mess!”

“…In addition, nutrient content will need to be controlled for optimal health, which of course is extremely important considering animals may eat the same food their entire lives.”

Translation: “Because you know – it was uncontrolled nutritional mayhem before this new-fangled rule. It’s a bloody miracle how they survived – the poor critters.”

“…The animal food rule also addresses hazards that could affect human health, and here is where the convergence of human and animal health comes into play. An example is aflatoxin, which would not generally be harmful for dairy animals but could end up as a carcinogenic residue in milk consumed by humans.”

Translation: Chronic ingestion of feed or food contaminated with Aflatoxin is not safe for any species, but since we place a greater importance on the health of humans, that’s the message I want you to hear.

“…Aflatoxin in the same way, Salmonella must be controlled in pet food not because it can harm cats and dogs but because it could affect humans through cross contamination if mishandled in the home.”

Translation: “Since the human-health agencies have been on us about this problem, we are just letting you know that you better keep a close eye on this Salmonella problem, because it only takes one sick kid to wipe one of you guys out. The first lawsuit will start a sh*t storm the likes of which your industry has never seen. Since we are making an effort to warn the public about this issue, it is just a matter of time before a customer puts 2+2 together and you guys will be feeling a world o’ hurt. Get it?”

“…The third rule addresses the safety of produce. Farms that grow fresh produce must take a preventive approach as well, but because of the nature of these operations, the preventive controls will be different from those in facilities that manufacture food and feed. The produce safety rule will set carefully targeted science- and risk-based standards for the safe production and harvesting of fruits and vegetables.”

Translation: “But, you all don’t need to worry about that anyway because with the compliance policies, they don’t give a hoot, more or less, what condition the fruits and veg are you put in pet food or animal feed – trust me.”

“…The fourth rule addresses import safety, and it is closely tied to the preventive controls and produce safety requirements. The proposed rule on Foreign Supplier Verification calls for a fundamental paradigm shift. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, importers must manage their supply chains to ensure the safety of imported foods. FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with U.S. standards, or under modern preventive controls that provide the same level of public health protection.  The FSVP rule will lay out how importers can meet this new requirement.”

Translation: “In other words, since we are busted and strapped for manpower, it’s about time you all took responsibility for checking your own damn ingredients anyway. And brother, if we catch you asleep on that job we will throw the book at you. Remember 2007? This time you guys won’t be able to blame the supplier – it’s up to you to make sure the cr*p you buy from China or where ever isn’t contaminated, because Dude, in this global economy and us only checkin’ on 1.5% of imports, you better believe there is some nasty sh*t getting through.”

“…Having preventive control requirements apply to both domestic and imported products is, of course, essential for food safety and for consumer confidence in today’s global marketplace. Together, these closely interconnected requirements –preventive controls for facilities and farms and importer verification that imported food meets U.S. standards – establish the central core of the regulatory framework envisioned by FSMA. The four proposed rules establishing this framework are in the final stages of review and should be published for public comment soon.”

Accredited Third Party Certification

Mike: “Following closely behind these four rules will be a proposed regulation on accredited third-party certification. The FSVP program that importers use to show they are managing their supply chains is a central element of the new import safety system envisioned by Congress, but it is not the only element. Rather, it is part of a larger tool kit for import safety that includes FDA conducting more foreign inspections and working closely with foreign governments to strengthen food safety oversight.

In addition, Congress has recognized the important role already being played in the international arena by private sector third-party audits. Congress and FDA recognize that some of these audits are rigorous and add significant food safety value—and that some do not. To build on the strengths of this private effort, Congress has given FDA a mandate to establish an Accredited Third-Party Certification Program.

Under this program, FDA will recognize accrediting bodies and set standards for accreditation of private third-party auditors that will help ensure the rigor, objectivity and transparency of privately conducted audits. Transparency means that the audit results will be available to FDA, which in turn means that we can rely on private audits as a legitimate part of the public system of assurances and accountability for food safety.

I want to emphasize, though, that in our vision of the future, we see third-party audits—even those conducted under FDA’s program—complementing but not replacing direct regulatory oversight. We are on a pathway to strengthened partnership and we want to reply on the efforts of others, but government oversight at ports of entry and elsewhere across the system will continue to be critical.”

Translation: “Hey! You guys still awake, damnit? Sheesh!”

Outreach

Mike:  “We know that building the new food safety system mandated by FSMA requires partnership with the many public and private parties who play critical roles in the system. Thus, stakeholder engagement is a key part of our implementation strategy. It is an important way to help determine reasonable, practical and effective ways to implement the provisions. What we’ve done differently under FSMA is to engage stakeholder even before the proposals are written, which is not common for regulatory agencies to do.”

Translation: “It’s a love-in, man. It’s a groovy new paradigm, Dude.”

“…Since FSMA enactment, we have held three public meetings, made more than 350 presentations to groups nationwide, including those representing the animal food industry. In fact, I met with the board of directors of the Pet Food Institute just a few months ago.  We have opened numerous dockets for early comments on what the proposed rules and guidance materials should cover. We toured farms and facilities, including a feed mill.”

Translation: “Hey, you and I both know we are in bed with industry, in fact, if you really must know we are in a deeply committed, monogamous relationship, so quit your sniggering! I see you in the back…”

“…Outreach with the international community has been a priority as well. This includes both our regulatory partners and industry stakeholders. Outreach with our international partners is important in implementing the various FSMA provisions, since they apply to imported products as well. It is also a way to avoid potential trade disputes. At each stage of the implementation process, we are making every effort to ensure that our proposed activities, policies and measures are consistent with the World Trade Organization.”

Translation: “‘Cause God knows, we don’t want to piss them off or we’re in a heap o’ trouble! My job is hard enough.”

“…I have led a number of delegations overseas to inform foreign governments and stakeholders about FSMA and in particular how the import provisions will affect foreign countries. For example, I have made several trips to China and have visited Mexico, Canada and the EU.”

Translation:  “Just between you and me, China was a sh*t hole, OMG, girlfriend! The corruption there…Oh, honey, you never! And you know, we can’t piss them off either, so I have to stick to the party line and tell you its all good when in fact it’s a Goddamn mess! But Mexico was cool and the Margaritas they serve…Oh, sorry. I wandered off there for a bit…”

Outreach and Technical Assistance Moving Forward

Mike:  “Outreach will continue as we move forward. Once the proposed rules are published, it will be important for us to explain them so we can get the best input possible before issuing final rules. We thus will hold additional public meetings, give presentations and have listening sessions during the comment period. We also will be providing technical assistance through three Alliances that have been established with partner organizations—the Produce Safety Alliance, the Preventive Controls, and the Sprouts Safety Alliance. They will provide education, training and technical assistance for industry and government food safety officials. The Preventive Controls Alliance will address both human and animal food, so your industry will have a place to go for technical assistance.”

Translation: “In other words, everything will move at the glacial speed with which I’m sure you can all appreciate considering all the hand-holding, ass-kissing, and the mangle of bureaucratic red tape we have to wade through. So, cut us some slack will ya? Sheesh! Trust me honey, you do NOT want my job.”

“…And we also will publish a number of guidance documents both with the final rules and later so that industry and FDA inspectors alike can have a common understanding of what’s expected.”

Translation: “Which as you know, will take forever and a day to complete, so get off my back, my job is hard enough without you all breathing down my neck!”

Infrastructure Improvements within FDA

Mike: “As we proceed with FSMA implementation, we also are focusing on infrastructure changes within FDA to operate more efficiently and effectively in the FSMA environment.

Under a recent FDA reorganization, the Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition now comprise the Foods and Veterinary Medicine program. This change was made to better integrate food and feed safety, nutrition, and other critical areas.

Within the Foods and Veterinary Medicine Program, just recently, Dr. Linda Tollefson joined our staff as Associate Commissioner. She will serve as a full deputy to me and work closely with senior management at CVM, CFSAN and Office of Regulatory Affairs on all of our issues. Dr. Tollefson is a commissioned officer in the U.S. Public Health Service, a veterinarian, and has a Masters of Public Health degree. She has more than 25 years of experience at FDA and has held positions in both CVM and CFSAN. So she knows the issues that your industry cares about.”

Translation: “And Linda will probably become a cynical, beleaguered neurotic with serious anxiety issues within a year, so cut her some slack too, poor thing. I know – ‘cause honey, let me tell you – I’ve been there, done that, bought the friggin’ t-shirt.”

Closing

Mike:  “In closing, we have a lot of work ahead of us and want to continue our partnership to make sure the rules we have in place, and the other changes implemented, are reasonable and practical for industry while improving the safety of all products we regulate.

The pet food industry has customers with high expectations. We all know that by the calls we get when something goes wrong. The melamine contamination of pet food in 2007 is a good example; we received more than 14,000 reports in the first four weeks after the contamination was discovered.”

Translation: “In fact, it was those hysterical pet parents that sent me straight over the edge. If it wasn’t for Xanax; I don’t know what I would have done! And I can honestly tell you I have not been the same since. I still, to this day, can’t look at a bag or a can of pet food without breaking into a cold sweat and having a full-blown panic attack. It was awful!!”

“…The changes we are making through FSMA will improve public health, animal health, and also improve consumer confidence in the global food and feed supply. These are benefits for all of us.

I encourage you to provide your input when our proposed rules publish—in fact, we will be depending heavily on your input to ensure we have the best regulations possible.

Thank you for this opportunity to be here today.”

Translation: “Hey! Anyone up for jelly shots? I’m paying!!!”

Source: Role of the Food Safety Modernization Act in Ensuring the Safety of Pet Food; Remarks at the Pet Food Forum, Schaumburg, IL, April 4, 2012