Changing the U.S. food and agriculture system is a complex process. There are issues with local health department permitting, state regulations on raw milk and other healthy foods, federal meat regulations, federal subsidy programs that distort the market, even international trade agreements. The problem is compounded by different levels of government, with literally thousands of different players, taking dozens of different approaches to the issues. At times, we have a clear, high-profile focus, such as when we were fighting the National Animal Identification System or the Food Safety Modernization Act (FSMA). And then those immediate crises end, whether with losses, victories or something in between, and we’re left with the day-to-day reality of trying to make change: working on bills, engaging the regulatory agencies, staying alert for old threats coming back, and more.
FDA AND RAW CHEESE
For years, FDA has targeted raw milk cheese, claiming that it is a high-risk product. Through enforcement actions and harassment, the agency has forced several cheesemakers out of business and discouraged many from starting up. A year ago, the agency published notice that it planned to revisit the regulations governing aged raw milk cheese, potentially making it much harder to produce this nutrient-dense food. WAPF submitted detailed comments, based on scientific studies and an analysis of foodborne illness reports, showing that raw milk cheeses that have been aged for 60 days are actually a very low-risk product (see westonaprice.org/wp-content/uploads/WAPF-cheese-comments-with-appendix.pdf).
And now even FDA is being forced to admit—at least to some extent—that aged raw milk cheese really doesn’t pose a significant risk, based on its own data.
In response to a congressional directive in the Food Safety Modernization Act to take a preventive approach, the FDA developed plans to test large numbers of samples of different foods, to learn more about the prevalence of pathogens and to help the agency identify patterns that may help predict and prevent future contamination.
Raw milk cheese was one of the very first foods FDA set out to test. It tested just over sixteen hundred samples of both domestic and imported aged raw cheeses in 2014 and 2015.
The agency announced the results in late July of this year; the full report is available at fda.gov/downloads/Food/ComplianceEnforcement/Sampling/UCM512217.pdf.
The FDA found raw milk cheese aged sixty days to have less than a one percent contamination rate for salmonella, Listeria monocytogenes, E. coli O157:H7 and Shiga toxin-producing E. coli. Specifically, the FDA found only three samples with salmonella, ten samples with listeria (three from the same business), and one sample with pathogenic Shiga-toxin producing E. coli. That is fourteen samples out of sixteen hundred six, or a rate of 0.87 percent contamination with pathogens.
Even from the cheeses that had pathogens in the samples, there were no illnesses reported (FDA, FY 2014-2016 Microbiological Sampling Assignment, Summary Report: Raw Milk Cheese Aged 60 Days, pages 9-10 & 15 (July 21, 2016)).
The agency also tested for generic E. Coli, and found 5.4 percent of the samples had levels above the regulatory requirements. Generic E. coli rarely causes illness, but is often used as an “indicator” of unsanitary processing conditions.
Interestingly, out of the fourteen samples that were found to have pathogens, only one of them also had high levels of generic E. coli. FDA admitted that this data “provided no evidence of an association between generic E. coli and pathogenic bacteria.” The FDA further admitted, that “it is established in scientific literature that the presence of index or indicator organisms, such as E. coli, coliforms, fecal coliforms and enterobacteriaceae, generally does not correlate well with the presence of foodborne pathogens and is not useful for determining contamination of individual lots of food by pathogens” (Summary Report at page 13). Yet, neither the FDA nor the state health departments appear to be prepared to align their testing regimes with science. Interestingly, the FDA also released preliminary results from its testing on cucumbers and hot peppers at the same time. While that testing is incomplete, at the time of the report the agency had tested four hundred fifty-two samples of hot peppers and three hundred fifty-two samples of cucumbers. Of those, thirteen of the hot pepper samples and three cucumber samples tested positive for salmonella—a 1.9 percent contamination rate (fda.gov/Food/ComplianceEnforcement/Sampling/ucm473112. htm). The FDA stated that this testing is still underway and no conclusions could be drawn at this time, but these rates were more than double the rate of contamination in aged raw cheese.
FDA at least partly acknowledged the significance of the data: “The data collected by the FDA indicate that the prevalences of salmonella and pathogenic Shiga toxin-producing E. coli are relatively low and similar to the contamination rates in many other foods” (Summary Report at p. 19, emphasis added). The agency is not planning additional large-scale sampling of raw milk cheese, although it will continue its “Domestic and Imported Cheese Compliance Program for routine sampling of cheeses.” Raw milk cheese will also be sampled, as will other foods, based on two criteria:
• A firm has a previous history of unmitigated microbiological contamination in the environment and/or in finished product (such as illness complaints, recalled or seized product, previous inspectional history, or environmental pathogens without proper corrective actions by the facility), or
• For cause (as when inspectional observations warrant collections of samples for microbiological analyses).
Unfortunately, despite the fact that only ten samples were found to have listeria (a contamination rate of 0.6 percent), the FDA signaled that the debate on that front may not yet be over: “Taking into account the prevalence found and known pathogenicity, the FDA continues to be concerned about the presence of listeria in raw milk cheese, which is a ready-to-eat food, and we will take action as necessary.”
While there may be some continued fighting over the issue of listeria, the FDA’s report marks significant progress in the agency’s position on raw milk cheese. Without the work of WAPF and other raw cheese supporters, however, the agency most likely would have simply continued to act based on false fears and assumptions, rather than undertake this testing. While it may sometimes seem like we’re talking to a brick wall, continuing to push for public policy based on actual risks, rather than rhetoric, is important in the long run.
GMO LABELING: BIG LOSS, BUT THE LARGER FIGHT CONTINUES
Unfortunately, while we made progress on the raw cheese front, our movement took a large step backward on the GMO front this summer.
In July, President Obama signed into law a bill that will prevent states from requiring clear, easy-to-read GMO labels on food packages. Nicknamed the Deny Americans the Right to Know (DARK) Act, the bill was supported by Senators Pat Roberts (R-Kan.) and Debbie Stabenow (D-Mich.), Monsanto and its biotech allies, and the Grocery Manufacturer’s Association, a trade group for Big Food.
The original version of the bill, passed by the House last summer, was already bad; it preempted all state laws on GMO labeling in favor of a voluntary federal scheme, an approach that had failed to produce any GMO labels over the previous fourteen years.
The Senate version, which is what ultimately passed both chambers, is arguably even worse. Although the bill was touted as a “compromise,” it has no positive features. At the same time that it preempts state laws that require mandatory labels, it defines genetic engineering so narrowly that most GMOs on the market don’t qualify. For the small number of GMOs that are covered, the companies can choose whether to put the words “produced with genetically engineered ingredients” or simply a website, an eight-hundred number, or a QR code on the package; consumers would then have to scan the code or follow the link and hunt around the website to find out whether there are GMOs in that specific product. And, ultimately, there are no federal penalties, so companies can ignore even these pathetically inadequate requirements with impunity.
The DARK Act represents a betrayal of American farmers and consumers, undermining our right to know what’s in our food and states’ rights to regulate business activity within their borders.
Why did so many legislators vote for such a patently bad bill? The grassroots opposition to this terrible bill had halted it for over a year, since the House first considered it. Ultimately, one of the keys to its passage was the endorsement from the Organic Trade Association (OTA). While many good companies are OTA members, its leadership is dominated by large corporations who view organics as simply a profitable niche market. They appear to have been willing to sell out the movement in return for political support on organic marketing issues. When OTA endorsed the bill, the proponents were able to claim support from both conventional and organic industries—and the grassroots simply wasn’t able to counter that message effectively.
There is nothing positive to say about this situation. In addition to the setback for GMO labeling, it shows yet again how much power the Big Agribusiness and Big Food lobbies have in our system. It is also a sign of how the organics movement has been co-opted by big business.
But the fight is not over. What Congress has done, it can undo—or perhaps the courts will, since the Center for Food Safety has brought a lawsuit. And we will continue to fight for people to have a meaningful choice in their foods in other ways: educating people to look for non-GMO labels, protecting farmers against harassing lawsuits for patent infringements, and promoting non-GMO seeds and sustainable growing methods. We must keep building power, so that the voices of truly sustainable farmers and consumers who want to buy food from them will prevail.
FDA IMPROPERLY NARROWS THE TESTER-HAGAN AMENDMENT
And in more bad news, the FDA has taken it upon itself to narrow the scope of the Tester-Hagan amendment through rulemaking. The issue at hand is the definition of “retail food establishment.” The importance is that retail food establishments, along with farms, are not “facilities.” And while facilities have to comply with the new requirements for “preventive controls,” which will cost thousands of dollars each year in compliance expenses, retail food establishments do not have to comply.
To understand why the FDA’s definition of retail food establishment is flawed, one first has to look at the origin of these terms. In 2002, Congress created a requirement for food “facilities” to register. The Bioterrorism Act of 2002 exempted both “farms” and “retail food establishments” from the definition of “facilities,” but did not define the terms. In 2005, the FDA defined “retail food establishment” to include any establishment whose primary function was to sell directly to consumers, defined as selling more than half of the products directly to individual consumers.
However, since the Bioterrorism Act focused on registration of each location, it appeared that the sales had to occur at the same location as the food processing in order to qualify as a retail food establishment. In other words, under the FDA’s 2005 regulation, a business that made jams in a commercial kitchen and then sold them at a farmers market would most likely not be classified as a “retail food establishment” even if more than half (or all) of its sales were direct to individual consumers. Not many people paid attention to this issue because the requirement was rarely enforced and it involved only a one-time, free registration.
In 2010, as FSMA was being debated by Congress, this issue came up because the extensive new requirements for food safety plans and other measures were to be triggered by the classification as a “facility.” Thus, whether or not a business was a “retail food establishment” became a high-stakes question.
The Tester-Hagan amendment, as incorporated into the manager’s amendment of FSMA, addressed this issue. In it, Congress made it clear that they did not intend for direct-marketing businesses to be treated as facilities, directing the FDA to amend its definition of retail food establishment to “clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include the sale of such food directly to consumers by such establishment” at a roadside stand, at a farmers market, through a CSA, or “any other such direct sales platform as determined by the Secretary” (FSMA Section 102, amending 21 USC 350d).
This language addresses all direct-marketing food businesses. Yet, in both the proposed and final regulation, the FDA limited the definition of retail food establishments only to those operations that are located on farms.
As a result, under FDA’s definition for “retail food establishment,” a farmer who makes a value-added product on his or her farm and sells it directly to consumers at a farmers market is a “retail food establishment.” Because he or she is classified as a retail food establishment, the farmer is not subject to the very extensive and expensive requirements for a food safety plan, supplier verification, and more.
But an artisan producer who makes the same product and sells it directly to the same consumers at the same farmers market is not a retail food establishment because the business is not located on a farm. Thus, the artisan producer is subject to all these new expensive regulations even though he or she is doing the exact same thing as the direct-marketing farmer.
In addition to the lack of consistency with FSMA’s statutory language, this simply makes no sense from a public health perspective. When the FDA proposed this definition last year, WAPF joined with other organizations to point out both the legal and practical flaws, but the FDA chose to forge ahead with this flawed definition.
In practical terms, very small start-up businesses will still be exempt, thanks to another provision in the Tester-Hagan amendment that exempted businesses with less than one million dollars in gross sales. But given the very small profit margins for many food businesses, even those with over one million dollars in gross sales will find it difficult to comply with these regulations—and those selling primarily direct to consumers simply should not have to.
POSITIVE STEPS IN CONGRESS: THE TPP AND CHECKOFF REFORM
We’ll end with a couple of positive developments in Congress, although admittedly both are far from final.
The first is the filing of two bills to reform the “Checkoff” system, S.3200 and S. 3201. There are currently eighteen mandatory “Checkoff” programs. Under these programs, anytime a farmer sells a beef cow or a gallon of milk or any other covered commodity, the farmer is legally required to pay a fee to industry-run organizations. These funds are used to pay for things such as the “Got Milk?” and “Pork, the other white meat” advertising campaigns. These advertising campaigns benefit primarily the retailers and grocery stores, yet the farmers are stuck paying the bills. When it comes to raw milk, the industry adds insult to injury by promoting only pasteurized milk products and even running ads against raw milk—but they still require raw milk farmers to pay to support those ads.
In 2012, WAPF joined with many other groups in an effort to amend the Farm Bill to replace the mandatory checkoffs with voluntary programs. That attempt failed, with only twenty senators (and no Democrats) voting for the amendment. Since then, the issue has been largely dormant with the Checkoffs continuing unabated. Not only is the filing of these two bills a positive step, but also the fact that S.3200 has a democratic co-sponsor, Senator Booker of New Jersey. Given the timing, it is unlikely that either bill will move forward this year, but they lay the groundwork for a renewed effort next session.
More importantly, the Trans-Pacific Partnership (TPP) is showing signs of being on life support, despite President Obama’s continued campaign to have it ratified. In early August, the President filed formal notice that a bill to approve this massive trade agreement would be submitted; the Administration also announced plans for more than thirty high-profile events with cabinet members that same month to push members of Congress to support the TPP.
But just a few weeks later, The Hill, a Capitol-area publication, reported that Senate Majority Leader Mitch McConnell (R-Ky) said: “The current agreement, the Trans-Pacific [Partnership], which has some serious flaws, will not be acted upon this year.” Given that Senator McConnell was one of the driving forces behind the Fast Track approval last year—which severely limits debate on any trade agreement approvals and essentially “greased the wheels” for the TPP—this is a significant reversal.
No matter what any legislator says now, the lame duck session after the elections can be a treacherous time. And McConnell also said that the TPP could pass next year with some changes: “It will still be around. It can be massaged, changed, worked on during the next administration.” So it’s not over yet. But in order to make changes, the TPP would have to be re-negotiated with the other countries, many of whom face significant grassroots opposition to it within their own borders as well. Thanks to the outcry from thousands of people, including WAPF members, we have a realistic chance of stopping this damaging trade deal, and taking a step along the path of regaining control over the laws and regulations that govern our country.
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Fall 2016