Much has been made of the HACCP requirements and parallels have been drawn to the decline of small slaughterhouses after the implementation of USDA HACCP in the late 1990s. First, small slaughterhouses had been rapidly declining in numbers for half a century, the USDA says [PDF]. In 1972, small slaughterhouses accounted for 23 percent of the beef output in the US. In 1992, before HACCP rules were in place, that number had already declined to 5 percent. While the new requirements were cited by some business owners as a reason they closed shop, it’s hard to single them out as having caused the downfall of an already sad market sector.
As Patty demonstrated, lessons have been learned from the USDA’s experience and should be applied to FDA’s proposed regulations. What is absent from most discussions of S. 510 is the fact that, as written, the FDA would not have the authority to tell facilities what “specific technologies, practices, or critical controls” they have to use. [See S.510 Sec. 418(a)(m)(4)]. Nobody is going to gain the authority to sterilize your food when these rules go into effect.
We must also consider that the FDA is going to have to:
- “…provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm” [S.510 Sec. 418(a)(m)(3)(A)]
- pay “special attention to minimizing the burden” of paperwork on small businesses [S.510 Sec. 418(a)(m)(3)(B)]
- give small and very small facilities longer to comply [S.510 Sec. 418(i)(2)]
- exempt small, low-risk facilities [S.510 Sec. 418(c)(1)(D)(i)]
- publish a guide to help those small businesses that are not exempt to comply with the new requirements [S.510 Sec 418 (d)]
Similar stopgaps to FDA abuse exist in the produce section of S. 510 and elsewhere throughout the bill.
Personally, I think the Tester amendment is Congress doing FDA’s job. What will really happen? Most of the same operations will be exempt, but with the Tester amendment we’d add facilities that are high risk and really might be better off taking a moment to improve their businesses before someone gets sick.
My biggest concern is that when outbreaks occur we might see a backlash against the movement we’ve been working to build. The large players fought regulation for a long time and paid the price in consumer confidence and hospital bills. I hope our farmers markets don’t step in the same hole.
Overall, I think the bill adequately protects small farms. Even though I don’t see it as necessary, I would accept the Tester amendment if that’s what it took to get
this bill through and get the FDA moving on the big facilities. I appreciate the work of the small farm advocates on this panel and hope we can all work together to grow a healthier food system. Sustainable food isn’t sustainable if its causing illnesses and death.
I think that the majority of people, both consumers and producers, would like to see a win-win compromise. Most would agree that the real work will come after the bill has become law.
Ferd Hoefner, policy director for the National Sustainable Agriculture Coalition: I agree with Michael’s last comment. Most people do want to see a win-win compromise. The Tester-Hagan amendment is such a compromise, as are the many other small and mid-sized farm, organic, conservation, and other points of compromise already achieved and incorporated into the bill as passed in Committee and into the Manager’s amendment.
Unfortunately, many though not all national consumer groups and produce industry associations continue to spread disinformation about the amendment. This is bad in and of itself, but also, for those who want to see a bill passed in this waning session of Congress, whipping up a controversy based on gross distortions is not a very good strategy for getting a bill done.
A couple of quick points. First, I want to call readers attention to a short new farmer food-safety treatise that has been issued by the National Sustainable Agriculture Coalition. It includes 16 guiding principles for achieving sustainable, safe and healthy food systems. I highly recommend it.
Second, I very much appreciate all the points in Michael’s quick bulleted list of important bill provisions — and there are other very important similar provisions in addition to these. But here’s the point I want to emphasize due to its relevance to the Tester-Hagan debate: Each and every one has been fought for and achieved, via compromise, through the hard work of family farm, local food, and organic advocates. None were in the bill as introduced and only a few made it into the bill as marked up by Committee. Each was initially opposed by many national consumer organizations — some more than others — and a few were opposed initially by national produce industry associations.
The fact that we got to “yes” on all of that should have meant it would be relatively simple to get to “yes” on Tester-Hagan. Sadly that has not been the case, though kudos to Food & Water Watch for taking its positive stance on the amendment where others did not.
Some consumer and produce-industry organizations, in letters to the Senate in the past two weeks, have argued that Tester-Hagan would provide direct market farmers (or small processors) with a state regulatory option even where no state regulation exists. This is simply wrong as even a cursory reading of the amendment reveals.
The amendment provides two options for farms that are facilities (i.e., that due some degree of processing, however minimal). First, they can document compliance with applicable state regulations as determined by FDA. Second, if state regulations do not exist, or if the farmer or processor simply prefers to come under federal requirements, they can document compliance with food safety plans (hazard analysis, implementation, and evaluation) that are appropriate for smaller, direct-market entities, again, as determined by FDA.
Somehow, rather than being seen as a reasonable, common sense, money saving (on the part of FDA, i.e., the taxpayer, and the farmer) proposition, this has been blown up, rather hysterically, into a scary proposition. It is difficult not to conclude from this that shoehorning small producers into the industrial model (and thus likely ultimately out of business) is the aim of those raising the scare tactic.
Some on all sides of the Tester amendment, for and against, have exaggerated its scope. It applies to those farms and other small food facilities that the FDA determines are “very small facilities” as well as to farms and other small food facilities that direct market (to consumers, stores, or restaurants) more than 50 percent of their total product; who gross less than $500,000 a year; and whose direct markets are located within 400 miles. The scope of the first application will depend on how FDA defines very small facility. The scope of the second application, the legislated tri-fold test, is a narrow band of enterprises.
Much has been made about the 400-mile test. The genesis of that provision is the 2008 Farm Bill, which defines local food enterprises as those within 400 miles, farm to fork. That measure was championed by then Agriculture Committee chairman, now HELP Committee chairman Tom Harkin (D,-Iowa). It is being used by USDA in implementation of several marketing and rural development programs.
It makes all the sense in the world for USDA and FDA to use the same measure, rather than going the usual bureaucratic route and having the two agencies have different definitions. Moreover, while there are some direct marketers who must transport more than 400 miles (as will be true for any cutoff point), this measure incorporates most of the direct marketing happening in today’s marketplace. It is not uncommon for farmers markets to draw from as far as 250 and 350 miles, and farm-to-store and restaurant sales, especially in the less-populated West, often exceed 300 and even 400 miles. In fact, 400 miles in the Farm Bill was not surprisingly itself a compromise between Eastern and Western senators.
All that said, in a likelihood, the virulence of the campaign against 400 miles will likely result in the number being reduced, a greater number of direct-market farmers falling outside the definition, and two conflicting federal definitions for years to come. That’s too bad. But it may just be the pound of flesh, however unnecessary, needed to get an agreement.
Much has also been made about the difficulties of traceback for food coming under Tester-Hagan’s alternative food safety requirements. This is also a strange argument. Under the Manager’s amendment, food from farms that include packaging with the name and business address of the farm are exempt from additional and potentially far more costly traceback requirements. This language was championed by Senator Sherrod Brown of Ohio. The Tester-Hagan amendment includes very similar language, but applies as well to food at farmers markets or food sold farm-to-store or by restaurants, where the same name and business address requirements apply. These are commonsense provisions that allow the new alternative markets to continue to grow while requiring lower-cost, alternative traceback information be transmitted. The Sustainable Agriculture Coalition has posted a rebuttal to these and other false claims lodged against the amendment.
I will conclude by coming full circle to Michael’s endorsement of win-win compromise. In my view, that is what the Tester-Hagan amendment is. In combination with other provisions already included in the Manager’s amendment, including those championed by Senators Sanders, Stabenow, Bennet, Boxer, and Brown, the inclusion of Tester-Hagan would result in a bill that, while far from perfect, could get our endorsement as a reasonable compromise.
All that is needed in the coming few days is for the bill’s sponsors and the amendment’s sponsors to block out the noise of the disinformation campaign, come together around a few additional technical improvements to the language, pull the amendment into the Manager’s language, and get the bill passed as quickly as possible and over to the House while there are still so
me days left in the lame duck session for the House to consider the Senate bill.
Halloran: Ferd believes that the Tester-Hagan amendment does not offer an option to be state regulated, regardless of how weak state or even non-existent state law may be. I have to disagree. The draft amendment says as follows under (2) EXEMPTION — a qualified facility “shall submit [to HHS]…..documentation that…the facility has identified potential hazards…is implementing preventive controls…and is monitoring the preventive controls…OR….. documentation (which may include licenses, inspection reports, certificates, permits, credentials…or other evidence…) that the facility is in compliance with State, local, county or other applicable non-Federal food safety law.”
Nowhere does it say what the “applicable” law needs to be. To my reading, the amendment says that whatever food safety law there is in a state, county or locality-the “applicable” law– the exempt facility has to show compliance. But if those applicable laws are weak to non-existent, it doesn’t matter. There is nothing here that says they have to be as good as federal law. It says only that whatever the state and local law is, the facility must show compliance.
We know that some states have good food safety laws (regarding, say sanitation at a food processor) and some don’t have much at all. Only one state has any on-farm safety standards for growing produce (Florida, for tomatoes). The Peanut Corporation of America case provided graphic evidence of how ineffective state regulation of processors can be.
I therefore think it is very important to limit the scope of the Tester amendment to facilities that are genuinely local and genuine small, and if possible to ones that are actually located in the United States. With a 400-mile exemption, facilities in Mexico claiming to be doing under $500,000 a year in business (and who will check up on that?) and who have a certificate saying they are in compliance with applicable Mexican law (will this be hard to get?), could ship to the entire Los Angeles area.
At the same time, facilities from Maine to Ohio to North Carolina could ship and sell to New York City. USDA may believe that 400 miles is local, but no East Coast consumer I know would agree. A smaller mileage number could, however, actually allow the kind of personal relationship at a farmers market, grocery store or restaurant, that might be some insurance against getting food from a farm or processor who is willing to cut corners or might be careless.
McGeary: The Tester-Hagan amendment is the only thing under discussion that would provide an unambiguous, enforceable protection to prevent the FDA from imposing burdensome and counter-productive regulations on small-scale, direct marketing food producers under S. 510.
Let’s put the current language of the bill in a real-world context. Extended deadlines and guidance documents aimed at small producers are good steps, but their impact is limited if the actual burdens are too much, as Mark set out very well in his point about the long hours and low profit margins that most local food producers experience.
Providing “sufficient flexibility” and “minimizing burdens” sounds good, but as legal standards they are extremely weak. What will actually happen is that FDA will propose rules, everyone will submit comments, FDA will write a response in which it agrees or disagrees with the comments, and then FDA will adopt the regulations it deems appropriate. A court challenge to the regulations on the basis that they don’t provide sufficient flexibility or minimize the burdens is almost certain to fail under the legal standards for deference to the agency. In practical terms, these provisions give the local-foods movement the opening to present ideas and evidence to the agency, but absolutely no guarantee that the agency will address them in a reasonable fashion.
As for the so-called “exemption” already in the bill, Michael left out the key modifying language. The bill states that FDA “shall exempt certain facilities … or modify the requirements [for HARCP], as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.” [S.510 Sec. 418(c)(1)(D)(i)].
In other words, the bill allows FDA to exempt certain low-risk, on-farm processors. FDA is completely free to decide that no exemption or modification is “appropriate.” And the provision does nothing to protect farmers who grow produce from the growing and harvesting standards, nor those doing off-farm processing or processing foods that would be categorized as “high risk,” which is likely to include things such as salad mixes and cheeses.
The Tester-Hagan amendment represents Congress doing its job, not abdicating it. If you read the cases on the establishment of administrative agencies, one of the core issues is that the legislature is supposed to set the policy and clear limitations for the agency to function within. The Tester-Hagan amendment does that by setting the clear policy that local, direct-marketing producers are to be regulated by their state and local authorities.
While I agree with Jean that state and local laws vary, that simple fact doesn’t mean that federal regulation is needed. There is no evidence that producers who would fall within the Tester-Hagan amendment have been the source of significant food-borne illness outbreaks, regardless of the laws of their local jurisdiction. If we say that the federal government must regulate every single issue that has varied state and local laws, then we might as well abolish all state and local law in favor of federal law. This is particularly absurd in the context of food and agriculture — one of the main tenets of local foods is that we recognize that every area is different, based on its ecology and the community.
As Patty and Ferd noted, the 400-mile radius is not a standalone provision. It’s only one-prong of a multi-prong test that also requires that the producer gross under $500,000 and that he be selling directly to consumers or retail food establishments that sell directly to consumers. That combination of requirements creates a holistic approach to defining a concept that is extremely difficult to define. The amendment’s test may not be perfect, yet why should the amendment be held to the standard of perfection while the proponents of the bill argue for passing a very clearly imperfect bill?
I share Jean’s concern about imported foods. But what importer is selling directly to consumers or even to retailers who sell directly to consumers? As far as I know, all of the outbreaks traced to imported foods have involved long supply chains, where the imported food was sold through layers of distribution. They wouldn’t fall within the Tester-Hagan amendment.
The stakes in this discussion are high — once a small business is driven out, it’s hard to get it back. This is particularly true for farming, where if a small, sustainable farmer goes out of business, the land itself may be lost to development or placed into industrial ag production.
In the push to address the problems with the industrial food system, it’s critical that we not destroy the local food system that is producing food that is not only safe, but also healthy and environmentally friendly. There is a complete absence of evidence that any of the producers who would fall within the Tester-Hagan amendment have been the source of significant problems — the arguments against the amendment are all based on “what if” and “we don’t know” and “just leave it to the agency.”
Those of us who are local food producers work very long hours for very little money, and we do so bec
ause we believe deeply in the importance of raising good food. We provide significant social benefits: carbon sequestration, clean water, soil preservation, and support of local economies, to name just a few. People who support these values should be on the front line of supporting the Tester-Hagan amendment.
Tomorrow: Does S. 510 give the FDA enough power — or too much?