Gothic MysteryGothic mystery: Will S. 510 put small farmers out of business? Photo: Carol Von CanonWord has it that debate and voting of the Food Safety Modernization Act will begin this Wednesday in the Senate. If passed, S. 510 will greatly expand the FDA’s authority over both processed foods and fresh fruits and vegetables. Will it thus make all of us eaters less likely to get sick? Last week, our esteemed panelists agreed that it will, with some caveats. (For all installments in this Food Fight series, see box, upper right; full bios are here.)

But now we come to one of the most contentious questions surrounding the bill: At what cost? Meaning, are S. 510’s measures so onerous to small farmers and producers as to put them out of business … and thus limit the choices available to us eaters?

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Our experts are drawn from both sides of the electrified fence: consumer organizations and victim-advocacy groups that want to see the strongest safeguards enacted possible, and small, sustainable farming advocates who fear that a nascent local-food system will be crushed by Congress’s industrial-scale sausage-maker. (Plus one very scrappy Grist-reading grad student.)

As you will read in the following pages (yes, that’s plural; please note that there are three pages for this epic discussion), they disagree, sometimes violently, about whether S. 510 will do more harm than good. Sens. Jon Tester (D-Mont.) and Kay Hagan (D-N.C.) were concerned enough about the answer to propose the Tester-Hagan amendment to S. 510, which exempts certain small farms and food-processing businesses from the requirements. (PDFs available here and here from Tester’s office.) Problem solved, right? Well no. Some think that the Tester amendment dilutes the bill or would let risky farms slip through the safety nets.

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Most issues in food politics are complicated, and this one is no exception. There are no quick soundbites. But if you take the time to read along, you’ll be much better prepared to call your senator and urge him or her to pass or block S. 510 (go to www.Senate.gov for their contact information, or call the Capitol switchboard, 202-224-312). Because while it’s great to vote with your forks, sometimes you have to vote with your voices, in order to shape the policies that determine what even makes it onto your forks.

Lecture over. May the Food Fight commence!

Queston 3: Is S. 510 so burdensome on small farms as to harm them or even put them out of business? Does the Tester amendment mitigate this enough?

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Tom PhilpottTom Philpott, Grist senior food writer: For me, any food-safety legislation that is blind to differences in scale is atrocious. If I cram tends of thousands of hens together in cages to produce eggs, I am creating egg-cellent conditions for pathogens that endanger millions of people across the nation with a single week’s output. If I produce eggs with an outdoor flock to sell at a farmers market, I create dramatically less hazardous conditions, and risk endangering mere dozens of people.

The risks are different and thus the rules must be different. Large industrial operations that threaten public health as a matter of course must be regulated robustly, but not in a way that wipes out smaller players and consolidates the food industry still more.

Today, thousands of small farms and food purveyors are building out alternative food systems rooted in community development and ecological sustainability, not just profit. I can testify firsthand that they are economically fragile, as they (unlike the dominant food system) operate without government support or subsidy. Without the Tester amendment, S. 510 could end up only slightly reining in the ruinous practices of large players while clobbering these alternative food networks. That would be disastrous.

jeanJean Halloran, director of food policy initiatives at Consumer Union (publisher of Consumer Reports): We all agree that an industrial egg farm and a farm that sells eggs at a farmers market should not be regulated in the same way. In fact, FDA recognized that — the egg rule that just went into effect this summer only applies to egg farms with more than 3,000 chickens. FDA completely exempted all the very small producers, and some slightly bigger ones too.

S. 510 as written includes instructions to FDA to take size into account, but leaves it up to FDA to actually draw the line as to who it would regulate and who it would exempt, since “big” varies from one type of producer to another.

Many small farmers and processors have been extremely uncomfortable with giving FDA that leeway, and are supporting the Tester amendment to make absolutely sure that FDA does not go nuts and go after every small jam maker in the country. But if we’re going to go that route, then we better be sure that the Tester amendment draws the lines in the right place. It is consumer groups’ view that creating an exemption for food processors and farms that sell more than half their output within 400 miles or intrastate, provided total sales are less than $500,000, goes too far — it will tie FDA’s hands in terms of protecting consumers in certain cases where it might need to act: 400 miles in particular is a big radius. The key question here is how do you insure that FDA will do its job while providing sufficient guidance in the law to insure that FDA is spending its resources in the most effective manner?

David GumpertDavid E. Gumpert, health and food issues reporter: I’m sorry, but to worry that the Tester amendment, or whatever, will “tie the FDA’s hands” is laughable. The FDA already has tremendous power (for all its crybaby protests that it doesn’t have enough), and whether there is a Tester amendment or not, FDA will have a huge amount of new power if S. 510 passes.

It’s important to realize that small operations are consumed with survival. When the FDA, or its state representatives, move in on a small operation that isn’t necessarily creating problems, it is usually devastating for the small operation. We are seeing that right now in the FDA’s crackdown on raw milk cheesemakers. It has Morningland Dairy of Missouri and Estrella Family Creamery of Washington on the ropes. The Farm-to-Consumer Legal Defense Fund has taken up Morningla
nd’s cause, but if they weren’t around, Morningland wouldn’t have had a way of fighting back. While corporations have their own lawyers on staff, hiring your own team of lawyers to fight a protracted legal battle with the FDA is beyond what most small concerns can afford.

Remember, the two outfits I am referring to here haven’t made anyone ill.

Michael BulgurMichael Bulger, a master’s candidate in food studies at New York University: David, let’s be realistic. Both of those dairies tested positive for listeria monocytogenes (see here and here). If a large factory showed the same positive tests and put their customers at risk, there would be outrage if the FDA didn’t take action.

This is a discussion about S.510. I don’t think we should digress into arguing the specifics of pending legal cases. It might well sell books to paint a picture of the FDA being made up of a group of sinister incompetents lolly-gagging about with their tongues swinging asunder, recklessly smashing the hopes and dreams of the best our food system has to offer. It does not, however, contribute meaningfully to improving our food’s safety. The FDA employs highly educated scientists and qualified public health experts and should be utilized to protect our country.

The issue of the harsher relative economic costs of recalls for smaller businesses is important. If S. 510 becomes law, the FDA is commanded to submit to the U.S. Comptroller General a report on current and possible future compensation mechanisms for businesses. The USDA is to make a similar report, thereby getting the ball rolling from two different directions. Compensation has happened before and the government has paid out to farmers.

Every mandatory recall the FDA orders will result in a prompt hearing at which the business may state any misgivings they might have with the order. In the meantime, companies both large and small should not be allowed to flagrantly distribute contaminated products while the health departments scramble for weeks to force a recall. This happens too often and unnecessarily puts the lives of Americans in very real danger.

JudithJudith McGeary, founder and executive director of the Farm and Ranch Freedom Alliance: S. 510, as it is currently written, will almost certainly put many local farmers and food producers out of business. These small businesses do not have the resources to absorb the time and expense of extensive new federal regulations.

We have only to look at what happened when HACCP was required for slaughterhouses, and the resulting flood of small and medium-size slaughterhouses that went out of business, to predict the results of S. 510 as it stands now. That’s why 130 groups have signed a letter [PDF] in support of the Tester-Hagan amendment to protect small-scale direct marketing food producers. The letter, coordinated by the Farm and Ranch Freedom Alliance and the Western Organization of Resource Councils, is signed by groups such as the Center for Food Safety, Organic Consumers Association, The Cornucopia Institute, Farm Aid, state and local nonprofits, and dozens of local co-ops. It represents the concerns of both the local food producers and the consumers who rely on them for healthy, local food as an alternative to the industrial food system that has created so many problems.

The language that people such as Michael and Jean point to in the latest version of the bill, calling for FDA to consider exemptions, look at economic burdens, etc., certainly makes the bill sound better, but that language has only marginal use in truly restraining FDA’s discretion. I’ve worked on cases dealing with the scope of agency authority, and the courts give a great deal of deference to agencies’ decisions. The language in the bill essentially directs FDA to be nice to local food producers, but it does not provide any clear limits on the agency’s power.

Michael writes: “Compensation has happened before and the government has paid out to farmers.” If you’re referring to the recent settlements to farmers under Pigford and related discrimination cases, it has taken decades for the farmers to get compensation.

S. 510 empowers FDA to seize food because it “has a reason to believe” that the food is misbranded — something which would encompass technical violations that pose no human health threat at all. A small farm or food producer could be driven out of business in a matter of months.

Michael also writes that “The FDA employs highly educated scientists and qualified public health experts and should be utilized to protect our country.” Absolutely they should be. But is there any reason to think they will be under S. 510?

The Center for Food Safety just broke the news that the FDA knowingly withheld information about genetically engineered salmon. [See Grist coverage.] See the Atlantic for the flaws with the sorts of medical studies that the FDA routinely relies on in its decision making. The FDA’s track record, even under this administration, is one where the interests of large corporations repeatedly trump sound science.

The Tester-Hagan amendment is a significant improvement. It would protect small-scale, direct-marketing farmers and food processors from the imposition of two of the most burdensome provisions of the bill: the HACCP/HARCP requirements [formal risk assessment and contamination prevention plans] and the produce safety standards. It’s important to realize that the Tester-Hagan amendment isn’t truly an “exemption” — the producers who fall within it will remain subject to all existing federal food safety laws and state and local regulation. Perhaps even more importantly, as direct marketers, these producers have a relationship with their customers that creates greater accountability and transparency than any level of government regulation.

Philpott: I am not enough of a policy expert to weigh in substantially on this; I tend to defer to policy analysts who I know (a) have a truly critical perspective on Big Food; (b) acknowledge that most people in our society are fed by Big Food, and that those people deserve to be protected from its excesses; and (c) also have a commitment to the farmers and artisans (sorry, Bonnie) who are working so hard to build out alternatives to Big Food. I must admit that Food Fight panelists Patty and Ferd are among my gurus in this regard.

I want to add that the history of regulation has not always been kind to small players. When I was a kid in the ’70s, I remember a nation dotted with independent gas stations that doubled as mechanic shops. At a certain point, much-needed regulations came into effect regarding the way gas stations protected surrounding groundwater from petrochemical contamination. These regulations carried heavy costs — and as I understand it, drove thousands of small players out of business. Today, gas stations are controlled almost exclusively by the few remaining major oil companies.

If
much-needed reforms in food safety regulations are poised to do the same thing, then I say, To hell with them. So far, Jean has not convinced me that S. 510, stripped of the Tester amendment, won’t fall too hard on small farms, or that S. 510 with it added would significantly detract from public safety.

RussRussell Libby, executive director of the Maine Organic Farmers and Gardeners Association: Yes, S. 510 will hinder small farmers. The Tester amendment will make a big difference. So far, however, I still lean toward supporting S. 510, because I’m worried about the regulatory direction of FDA absent Congressional direction.

FDA is prepared to issue produce safety regulations next spring. If S. 510 is passed, and directs FDA to be sensitive to the needs of small farmers, organic farmers, wildlife, and more, that at least gives us grounds for argument in the regulatory process.

This is just one step in a continuing political debate about the role of the states versus the federal government, and, more to the point, about the importance of a decentralized food system versus one where only a few suppliers distribute to only a few buyers.

All centralized systems tend to support other centralized systems. That’s the reality of the scale at which Washington, and FDA, work. It’s up to all of us to develop clear, workable alternatives that we can use as our counterarguments. Farmers are not ignoring food safety — they are eating the same food they are selling their customers. We need to push to develop the decentralized systems that both work for farmers and provide the basic assurances that everyone wants.

Gumpert: To Michael’s argument that we shouldn’t “digress into arguing the specifics of pending legal cases,” I would suggest we can learn much about how an agency will behave in the future based on how it has behaved in the past. The FDA has stated at least twice over the past year that it is concerned about the 60-day aging rule on cheese (which has been in effect since 1949).

More to the point, one of the two cases Michael finds so irrelevant — the case of Morningland Dairy’s supposedly contaminated cheese — grows out of a multi-agency (armed) raid on a small private food club in Los Angeles … led by the FDA. [See my coverage for Grist.] There were no allegations of illness, or contamination. The FDA’s allies at the California Department of Food and Agriculture allegedly found listeria in cheese seized in that raid. I say allegedly because the paperwork in the list of seized items left behind for the food club (by FDA and CDFA) is very sloppy, and inconsistent.

This sort of thing doesn’t happen to large companies. FDA focuses its attention on small organizations that it knows can’t afford to stand up legally to its arsenal of weapons. Giving FDA more weapons isn’t the answer.

I would just add to Tom’s recollection of many independent gas stations a case more to the point: until the late 1990s, there were loads of small slaughterhouses. Then they had to come up with HACCP plans under USDA requirements. Many couldn’t, now there is a shortage of small slaughterhouses. Small farms are penalized because they have smaller orders, and often have to wait weeks or even months to get scheduled in the few slaughterhouses that remain.

Patty LoveraPatty Lovera, assistant director of Food & Water Watch: For normal human beings reading Grist who don’t speak in food safety jargon, HACCP is a food-safety philosophy called Hazard Analysis Critical Control Point. It brings an engineering mindset to food processing systems; first you assess the “where” it is likely that hazards could occur in our system, then you put procedures in place at these “critical control points” to try to make sure those hazards don’t occur. Then you verify that those procedures worked.

It sounds very official and straightforward, but as we all should know by now, there is no such thing as straightforward when it comes to food — the devil is always in the details. This was especially true for how USDA put this philosophy into practice in meat and poultry processing plants. At Food & Water Watch, we’re quite familiar with the sordid history of how USDA implemented HACCP in the meat and poultry sector. We actually wrote a report on this last year, and identified some ways that HACCP could be modified to make it work better for small plants (and we think for consumers).

I think there are lessons learned from the HACCP experience at USDA that should inform anything FDA does on food safety, with or without legislation. One is to focus on the hazard analysis part, which doesn’t have to mean what it did during USDA’s rollout of HACCP for slaughterhouses (small plants paying too much money to consultants to write food-safety plans for them.) It could mean using the pieces of 510 that provide for training and education to help small farms and processors get good information and take a fresh look at where they might have points in their system that could improve. That’s where the rulemaking process is going to be critical — making FDA create a system that acknowledges that food safety plans come in all shapes and sizes (and this goes for the produce-safety standards they say they are going to do next year, too.)

On the Tester amendment, we do think it makes the bill better. On the question of how the amendment would impact the safety of imported foods, we don’t have the same concern Jean does above. Imports are covered in their own sections of the bill, which we think could actually be stronger. The Tester amendment’s exemptions are tied to facilities and farms that meet several tests about the size of the operation and the way they market their products, as well as distance. So just applying the distance in the amendment across borders isn’t the only factor.

USDA inspects about 10 percent of imported meat at the border. The European Union gets to 20 percent for some imported foods. FDA averages about 1 percent inspection for the foods it regulates. So there is plenty to do to get FDA to be tougher on imported food.

We will continue to push for more inspection done by our government inspectors (not other countries’ or private companies’), and we don’t see the Tester amendment conflicting with that.

The other note about the Tester amendment is on the 400 miles. I have spent more time than I care to think about over the last year asking people how to define a small farm (including bothering some of the other panelists here multiple times). And there’s no good answer — it’s a big country, and a small farm in California is a massive farm in New England, and $200,000 worth of cabbage comes from a much different-sized operation than $200,000 of artisanal cheese.

So while I probably wouldn’t have picked 400 miles as the limit, I can see why it’s there — it exists in other laws. And the structure of how this amendment works is key: you have to meet multiple conditions (size, method of distribution, distance) to qualify, not just one.

Mark KastelMark Kastel, co-founder of The Cornucopia Institute and director its Organic Integrity Project: I’m sorry I don’t h
ave time for anything more comprehensive and appreciate the folks that are digging deep on this. And while I appreciate the passion of this discussion, there’s a bit of sniping going on that makes me personally feel uncomfortable.

Here’s a few off-the-cuff responses:

I can’t imagine, in the constrained budgetary environment were all going to be working in, that S. 510 will be adequately funded. That will make it more important to make sure that limited resources truly are targeted to achieve the best bang for the buck in terms of protecting the citizenry. We know where the greatest risks are both in terms of hazards and scale — indirect, through many middlemen and sundry brands, and national distribution. It makes no logical sense whatsoever to focus on owner-operated direct marketers.

Kathleen made the comment [in the thread to be posted next] that nothing had been decided about the Good Agricultural Practices. Setting up metrics and other definitions will truly be the devil’s details. And I’m not sure that this sausage-making operation will be pretty. In this new era of unrestrained corporate spending on federal elections, I can’t imagine that this is not going to get tougher for those in society, including family-scale farmers, who are not in a position to invest in Washington. Whatever happens next week in the lame duck session will only be round one.

Food does need to be safe no matter who produces it. Although the Tester amendment will not exempt smaller producers from acting responsibly, maybe a labeling requirement stating that they are exempt from certain regulatory oversight — by virtue of their scale and intimate relationship with customers — should be articulated on packaging or at farmers market stands. And consumers can make an informed decision. Many will use that as a “brand” illustrating authenticity and maybe even seek out those smaller direct marketers?

I don’t know who else on this list has gotten their hands dirty or cracked a sweat producing food but I can tell you, both from personal experience and by virtue of working for thousands of farmers, that the profit margins are so slim, and that producers are so time-pressured during the season, that adding any level of additional record keeping, testing, or regulatory hoops to jump through will make it difficult for many families who are struggling to continue. I can guarantee you these folks are not getting rich and their only desire, in most cases, is to make a fair wage.

In terms of the qualifications for regulatory exemption under Tester/Hagan, 400 miles might not be overly generous, in many Midwestern and western states, for regional marketers. These are folks who have worked hard building specialty businesses and need to compete with multimillion-dollar, multinational agribusinesses. In terms of $500,000, without further processing, we have a handful of members that do that kind of volume with their community supported agriculture programs. And you can’t get any more direct, in terms of marketing or potential trace-backs than that!

Remember that although Tester might provide more targeted regulatory oversight, it will not exempt any of these marketers from state regulation.

In terms of Judith’s skepticism concerning the potential behavior of what Michael calls “highly educated scientists and qualified public health experts,” the FDA certainly has many dedicated employees, but it also has an institutional bias. During my 30-year career, I’ve observed that regulators who oversee highways like to build highways. And the best highway is flat and fast. Likewise, professionals who oversee food safety would like to sterilize our food supply. Their motivation may be to keep us safe, but if they denature our food our health and well-being will suffer.

I used to like the institutional advertising that the Caterpillar Tractor Company did, years ago: “There Are No Easy Answers — Only Intelligent Alternatives.”

Given the food production infrastructure that exists in this country, there is no quick fix. We have chosen to support this legislation as long as it is amended to eliminate collateral damage to the farmers in this country who are undoubtedly the safest and producing nutritionally-superior food.

Bulger: First, a few quibbles. Judith, I question the importance of the Atlantic article. It never once mentions the FDA and instead focuses on a group of researchers who act as watchdogs for popular science publications. Scientists are not infallible, but that is hardly news. next, note the comments by the doctoral student in this recent Grist post regarding the GE salmon. She notes that the “withheld” information was not relevant to FDA’s decision-making for a number of reasons. Finally, no I was not referring to the Pigford cases. Those involved the USDA, not the FDA, and had to do with racial bias and not recalls.

This is all off-topic, though. Back to the question: Will S. 510 harm small farmers too much and will the Tester amendment save the day?

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.

FerdFerd 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?