As recently as Monday, the Food Safety Modernization Act (S. 510) seemed set to sail through the House and to the president’s desk for rubber-stamping. But now it’s stalled in the Senate yet again, due to a technical error that could well sink the legislation — and with it any prospects for food-safety reform for a generation. While advocates fight for the bill’s life amid the chaos of the lame-duck Senate, renewed opposition to S. 510 is popping up in some surprising corners.
Many family-scale farm supporters had been overjoyed at the inclusion of the Tester-Hagan amendment into the Manager’s amendment package. Tester-Hagan is designed to protect small farms and processors from onerous regulations more appropriate to mega-scale food manufacturers and processors.
Yet euphoria around the Tester-ized bill is hardly unanimous. Some advocates are still sending emails, Tweets, and Facebook posts insisting that the Senate did Monsanto’s bidding by crafting S. 510. (We’re among the company’s biggest critics, but even we can’t see the connection on this one.) According to this surprisingly persistent line of reasoning, S. 510 would criminalize backyard food growing and end the practice of seed saving, thus giving Monsanto a complete monopoly over the seed market. In fact, S. 510 deals with neither gardening nor seed-saving. And to enforce this new draconian order, 4,000 armed thugs from the FDA will soon be kicking down the doors of small farms everywhere.
While such fears are clearly anti-government, Tea Party-fueled fantasia, Grist contributor David Gumpert has been making a calm, rational case that S. 510 poses a serious threat to small-scale farming, most recently in Food Fight series. Spurred by criticism of the Tester amendment from the independent news blog Activist Post, Gumpert took a closer look at the language of the revised bill, and didn’t like what he saw. As many of you out there on the Interwebs share his concerns, we called our battle-weary Food Fight participants back to duty to really drill down into the nitty-gritty details of the protections. As Judith McGeary of FARFA said, it’s “very ugly sausage making” — but the bill did not sacrifice our nascent local-food system to the grinder as some are saying. If you’re in a hurry, jump straight to McGeary’s magisterial, point-by-point defense of Tester’s protections that closes this piece.
We won’t pretend that this stuff is easy reading: it’s not. But if you — or someone you love to support — has a small farm or food business, this exchange should answer most of your questions. And if it doesn’t, post them in the comments, and we’ll see what we can do.
David E. Gumpert, health and food issues reporter: Shame on me (and nearly everyone else reporting on this) for not having read the Tester amendment in its entirety before the voting began, and instead relying on the mass-media accounts stating simply that it exempted small food producers — those selling within a radius of 275 miles and having less than $500,000 annual revenues. And congrats to Eric Blair, of Activist Post for combing through the actual text, and reporting on major concerns. A little late, perhaps, but better late than never.
As Blair sees it, the big problem with the amendment is that it doesn’t exempt small producers as easily, or completely, as suggested in the media reports. A small producer would need to be prepared to prove to the FDA that it qualifies, and to qualify, must show it has “identified potential hazards associated with the food being produced” and is “implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective.” These are similar to what larger food producers must do.
Now, I’d go further and say that the Tester-Hagan Amendment looks to me to be a wolf in sheep’s clothes on the long-standing and thorny issue of farm registration. Here’s why: For years, the USDA sought to implement a program that would force farmers to register their farms (or “premises”) and each and every animal — known as the National Animal Identification System (NAIS). It finally pulled back last year, in the face of growing farmer outrage that the hidden agenda of NAIS was to remove any vestiges of privacy enjoyed by farmers, and allow the feds ever-expanding control over their animals, and their land.
Well, Tester-Hagan may wind up accomplishing something similar to the NAIS goals. I had assumed that to qualify for the Tester-Hagan protections, a small food producer would simply stay away from FDA offices, or tell an inspector the facility didn’t qualify. Presumably, if the FDA felt differently from information it might have, it could audit a small producer to make sure it qualified. Absolutely not so.
Under Tester-Hagan, small producers need to take the initiative and make the case to the FDA that they qualify by producing “documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a state department of agriculture), or other evidence of oversight)…”
That’s not all. They will be required to show additional as yet unspecified “documentation” specified in a “guidance document” to be produced by the FDA within a year of passage of S. 510.
You don’t have to have a very fertile imagination to conjure up what might be in that “guidance document.” How many cows, chickens, pigs, and goats do you have? How is your land being apportioned to different crops, by exact acreage or square footage?
Still skeptical about where I’m going? Then consider this additional requirement under the Tester-Hagan Amendment: That within 18 months of enactment of the new law, the FDA and USDA shall conduct a study of the food processing sector regulated by the Secretary to determine: (i) the distribution of food production by type and size of operation, including monetary value of food sold; (ii) the proportion of food produced by each type and size of operation; (iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; (iv) the incidence of food-borne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; and (v) the effect on food-borne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.
As I read this, the FDA and USDA will need to send out an army of inspectors to each farm and food production facility in the country and conduct a detailed analysis of the business of each. Not to mention a detailed assessment of the “incidence of food-borne illness” and “the effect of food-borne illness” — whatever that means.
And this is all on top of the requirement that all farms, including those that might be exempted under Tester-Hagan, need to conform with “Good Agricultural Practices”. This is the program originated by the United Nations that involves the government in farm operations.
And what if the small producers simply ignore the whole thing, and don’t produce all the documentation needed to register and conform with the “guidance document” and participate in the study and be part of the GAP program? Presumably they’d be subject to the very strict penalties articulated in S. 510, which is up to 10 years’ imprisonment.
I hate to be a cynic, because I like to think that supporters of this amendment have had the best interests of smaller food producers in mind in pushing for an exemption. But when you review the fine print, you can’t help but conclude that Tester-Hagan represents an unprecedented intrusion by government into the lives of small farms and food producers.
I hope the U.S. House has the guts to stand by its inclination to not vote on S. 510 — ostensibly because it’s a revenue-producing legislation, which is supposed to originate in the House. Whatever reasons the House might come up with, S. 510 should not stand.
Michael Bulger, master’s candidate in food studies at New York University: Currently, private residences and farms devoted to crop and/or livestock harvest are exempt from the Bioterrorism Act from registering as facilities. The Tester amendment does nothing to change the definition of facility, except that it specifies farmers markets and CSAs are also exempt.
I don’t think we should expect the FDA to visit every single one of the over 2 million farms and the approximately 160,000 food facilities in order to conduct the study prescribed by the Tester amendment. For one thing, it’s not feasible. For another, the amendment calls for a study of the food processing sector, not the entire food system. In reality, it will most likely manifest itself in the FDA conducting observations at registered facilities that make up a representative sample of the food processing sector.
If a food facility did not register, you worry that they might be subject to 10 years’ imprisonment. You also say this is “articulated” in the bill. Can you quote the section where this appears, or like the Tester amendment, are you relying upon secondary sources?
Finally, the authority to collect fees as stipulated by S. 510 is dependent upon its implementation being revenue-neutral. It does not generate any additional revenue for the FDA, but merely seeks to pay for its own costs.
Margie McDonald, regional organizer with the Western Organization of Resource Council (filling in for McGeary, who was tied up until late in the discussion): David Gumpert’s analysis and critique of the Tester amendment rests on a faulty premise that’s critical to understanding the sweep of S. 510. Gumpert is assuming that the Tester amendment somehow brings into FDA’s purview a bunch of small facilities that are not already required to register with the FDA. That premise is in error and that mistake dramatically undermines the rest of his arguments against the amendment.
The amendment has two distinct pieces: the exemption for qualifying facilities and the exemption for qualifying farms. Starting with the issues related to facilities, it is important to make clear that the Tester amendment does not change current law, the Bioterrorism Act of 2002, which already requires small facilities to register with the FDA. Without the Tester amendment, every facility that is required to register with the FDA under the Bioterrorism Act, which includes tens of thousands of small local food businesses that are already being inspected and certified under local health departments, and farms that add value and sell their produce off-site, would be subject to an arduous and extensive laundry new laundry list of hoops and steps detailed in Sec. 103 of S. 510, that might be appropriate for large industrial processors but are going to swamp small local food business with costly and ongoing burdens.
The following paragraph summarizes Sec. 103 requirements of all facilities as the bill was written.
Identify and evaluate known or reasonably foreseeable hazards; develop a written analysis of the hazards; identify and implement preventive controls; monitor the effectiveness of the preventive controls; establish procedures that a facility will implement if the preventive controls are found to be ineffective; verify that the preventive controls are adequate and the owner operator is conducting monitoring and is making appropriate corrective actions and that the preventive controls implemented are effectively and significantly minimizing or preventing the occurrence of identified hazards including the use of environmental and product testing and that there is documented, periodic reanalysis of the plan to ensure that it is still relevant; maintain for not less than 2 years records documenting the monitoring of the preventive controls, instances of nonconformance, testing results and other verification and corrective actions; prepare a written plan that documents and describes the procedures used by the facility to comply with the measurements of this section; and conduct a reanalysis whenever a significant change is made in the activities conducted at a facility or every 3 years whichever is earlier.
Tester’s amendment takes a group of facilities already subject to FDA oversight and registration under current law (even without passage of S. 510 or H.R. 2749) and gives them three pathways to avoid the above list of expensive regulatory steps.
1) First, there is a threshold identifying which facilities are not subject to the above lengthy and detailed requirements, which is what is referred to in the Tester amendment as “qualifying facilities.” There are several screens to define a qualifying facility:
- the FDA is instructed to study and define a new category of very small business that is not required to comply with the above section
- OR the business does less than $500,000 in sales and sells more than half of its products directly to qualified end users, which includes not only consumers, but restaurants, groceries, or institutional buyers such as schools
- and it sells within a geographic foodshed range defined as either in-state or within 275 miles.
2) There are two avenues for a “qualifying facility” to avoid extensive hazard analysis and control requirements detailed in S. 510. The simplest and easiest path is by documenting that the facility is already being inspected at the local or state level, and the vast majority of these facilities already are inspected by local public health agencies. Alternatively, if a facility cannot demonstrate it is subject to state or local public health oversight, it can submit a much simpler, shorter statement addressing potential hazards and prevention steps.
3) With respect to farms, the exemption is simpler. Under the Tester-Hagan amendment, a qualifying farm — one that grosses under $500,000 and sells more than half its products directly to qualified end users — is exempt. Period. There is no need to provide special documentation or go through any process, beyond putting a label or displaying a sign with the farm’s name and address.
Without the Tester-Hagan amendment, under S. 510, these farms would be subject to the produce safety stan
dards or, as Gumpert discusses, what is often termed “good agricultural practices” or GAPs. With Tester-Hagan, these small, direct-marketing farms do NOT have to comply with GAPs.
Jean Halloran, director of food policy initiatives at Consumers Union, publisher of Consumer Reports: Margie has it right. Small facilities, for better or worse, are already required to register with FDA under the Bioterrorism Act of 2002.
Margie also says correctly that there are two avenues for a small (under $500,000 in sales), local (selling within state or 275 miles) facility to avoid extensive HACCP requirements: show FDA it complies with relevant state law, or develop a simple food safety plan.
Consumer groups are actually concerned that the second alternative may never come into play, because there will always be some state, county, or local law that a food production facility will be governed by, even if that law only specifies that the cooking utensils need to be washed in hot water at the end of the day. We are concerned that small producers need only show they are in compliance with local law. There is no requirement that the local law be strong. Thus this seems like a pretty modest requirement.
As to whether legions of FDA inspectors will be swarming over the country checking on small farms and facilities, I wish Congress would consider giving FDA the huge budget increase that would require. However, such a budget increase seems unlikely to me. Remember, FDA currently visits food producers on average once every 10 years. S. 510 goes the radical step of raising that to once every five years, for high-risk facilities.
There is no minimum inspection frequency for farms, and FDA seldom visits any. We’ll be extremely lucky if FDA actually visits the Peanut Corporation of Americas of this country more than once every five years. I don’t think the average small farm or producer will see much of FDA unless they, or their crop or product, are involved in an outbreak.
Russell Libby, executive director of the Maine Organic Farmers and Gardeners Association: Jean’s opening sentence is accurate, and points to an essential issue. The Food Bioterrorism Act of 2002 swept all “facilities” into a registration program. Simple enough. But Congress, in the original legislation, said that farms are exempt. Great — except that “farms” were defined narrowly in the subsequent rules, and “facilities” were defined broadly.
I’ve been arguing for almost two years now that the facility definition, in those rules, is the heart of the problem. The Tester-Hagan amendment, now included in the original bill, at least begins to put some small bounds around those definitions.
However, I fundamentally disagree with David Gumpert when he says that it appears the intention of the Tester-Hagan amendment was to send FDA to the farms, and that farms have to prove they are exempt to be exempt. Sen. Tester, with Sen. Hagan, has worked from the beginning to narrow the number of farms subject to direct FDA oversight. It’s wrong to say otherwise.
Similarly, most farmers I know will continue to operate as usual until someone questions their “exempt” status, at which point they’ll be able to show a number of state licenses that will support their position.
Nothing in S. 510 changes the underlying reality that FDA has broad authority, already, to visit any farm or facility where they suspect any kind of food safety issue.
The ongoing debates about raw milk, raw-milk cheeses, and how FDA treats bacteria more strictly than they do chemical residues and genetically-engineered foods are not going away, whether this bill ultimately passes or not. But those issues are not at the heart of the bill, nor are they the reason the Tester amendment was proposed and supported by many sustainable agriculture groups.
Gumpert: I appreciate the input and discussion. I stand corrected about the information small enterprises must show. I said they had to provide data on two categories, but in reality they can use either of two ways to document their exemption — showing a hazard control plan or various local permits, inspections, and other regulatory documents — but are not required to do both.
I would say that there is a fundamental difference between the requirements under S. 510 and the Bioterrorism Act of 2002. Under Tester-Kagan, enterprises are actively seeking the FDA’s permission for the exemption. Registration under the Bioterrorism Act is passive in that you fill out an information form. Everyone can say the permission process under Tester-Kagan is routine and pro forma, but that’s not what the legislation says.
I am definitely getting bleary-eyed from reading and re-reading the legislation, but I can’t find anything that says approved small enterprises are exempt from the Good Agricultural Practices provision, as Margie says.
Several people say not to worry about the survey/study that the FDA is supposed to do of smaller enterprises, that the FDA doesn’t have enough funds to send the army of investigators that I envision. It may be that FDA won’t have the funds initially. But the fact that the requirement is on the books means the FDA will seek funds and, equally significant, has the legal requirement to carry it out.
No offense, but the reassurances people are offering now count for nothing. Everyone affected by this legislation has to assume the provision is there for a reason, and will be carried out.
Nor has anyone said anything about what the “guidance document” that FDA must produce within a year might contain. I presume that’s because no one knows, and didn’t choose to let their imaginations go a little like I did.
As Russell indicates, there is a fair amount of confusion about when a farm becomes a facility and falls under S. 510. According to the legislation, when a farm “packages” food, it becomes subject to the requirements, and lots of farms package food.
He also states, “… most farmers I know will continue to operate as usual until someone questions their ‘exempt’ status, at which point they’ll be able to show a number of state licenses that will support their position.” That’s what I was assuming would happen from the beginning, but once again, that isn’t what Tester-Hagan necessarily allows. Many farmers will essentially be on the defensive, potentially vulnerable if the FDA decides for some reason to do a sweep (as it did earlier this year on more than 100 cheesemakers).
Bottom line, the FDA controls the exemption process, and is under mandate to collect vast amounts of new data about smaller enterprises, many of which will likely be farms. We can hope the agency is benevolent, but that is not its history.
Bonnie Azab Powell, Grist food editor and Food Fight moderator: David, it seems to me that the difference here is one of interpretation of vague language, which is influenced by whether one believes the FDA will use its new powers to address the source of most food-borne illness or to harass weaker targets. To me, there’s an analogy in the drug wars: Law enforcement should be targeting meth distribution networks, not backyard pot growers. I definitely see your point that the FDA’s rec
ent actions toward raw-milk and cheesemaking farms does not provide much reassurance that it will adopt a laissez-faire attitude toward similar operations going forward.
However, call me naively optimistic, but I think that the growing visibility of the real-food, know-your-farmer movement, and the public’s outrage over these massive recalls and foodborne illness outbreaks, will go a long way toward ensuring that the FDA’s focus stays where it belongs: on high-risk industrial plants. The Tester amendment’s language isn’t perfect, but its incorporation does at least send the message that the government’s food-safety measures should be scale-appropriate and risk-based. I don’t think it’s going to get any better than that. Mainly, even though I too am skeptical, I’d rather be on the side of small-farm advocates such as Ferd, Russell, and Judith, who feel the Tester amendment provides enough protections, than get lumped in with FDA-haters such as Glenn Beck.
Patty Lovera, assistant director of Food & Water Watch: I agree with what Margie, Russell, and Jean have already pointed out about the structure of the Tester amendment and the underlying issue of the Bioterrorism Act’s definition of facilities. Just a couple other points to add:
- The Leahy amendment on criminal penalties did not make it into the final version of the bill.
- On the study of food safety and operation size, we are very interested in the results and are happy this piece was in the amendment. The debate over the last two years on this legislation, the proposal for a national Leafy Greens Marketing Agreement, and lots of other food safety topics have been really limited by a lack of data about the sources of food-borne illness. Lots of us have very strong opinions about the role of large vs. small, but there’s not really a lot of actual data — a lot of discussions and debates are being conducted on the basis of anecdotal evidence, news reports, and not much else. FDA can gather the information that already exists in various branches of government about incidence rates, and when it’s known, attribution data for food-borne illness outbreaks. That will be useful information to have so we can all work to focus FDA’s efforts on the right parts of the food system.
- On the question about whether the amendment exempts farms from Good Agricultural Practices, I think Margie might have been referring to the Standard for Produce Safety section. The produce standards (which are not written yet) might be based on GAPs or other guidances the agency already has, but at this point GAPs are voluntary (although not so voluntary if your buyer requires them) programs, not regulation. And the proliferation of different versions of the GAPs, offered by different entities, is part of the mishmash of private standards that already exist that we find really frustrating.
Judith McGeary, founder and executive director of the Farm and Ranch Freedom Alliance: First, the simpler issue: GAPS, or good agricultural practices. You won’t find that term anywhere in S. 510, but the basic substance is in Section 105, which authorizes FDA to issue “produce safety standards” that tell farmers how to grow and raise crops. Page 51 of the bill includes the Tester-Hagan language and exempts farms that gross under $500,000 (adjusted for inflation) and that sell more than half their products directly to individual consumers, local restaurants, or local retail food establishments. There is no requirement for the farm to submit paperwork to the FDA or to register.
The more complex issue is the one with “facilities.” First, let’s sort through the existing law:
“Facilities” are any business that processes, manufactures, holds, or stores food. Under the 2002 Bioterrorism Act, all facilities must register with the FDA. Those regulations have been in force for several years, although enforcement has been very lax.
“Farms” are not “facilities.” BUT, if the farm processes or manufactures food, it becomes classified as a facility.
“Retail food establishments” are also not facilities. Retail food establishments are entities whose primary purpose is to sell to consumers, specifically those businesses that sell more than half of their products directly to individual consumers (not businesses, so the direct sales does not include sales to restaurants, etc). BUT there is also a catch on the retail food establishments issue, namely that the Bioterrorism law is based on each location registering. So, if a business processes food at one location and sell at another — such as someone who makes jams in their kitchen and then sells it at the local farmers market — the existing law is unclear as to whether or not they would be a retail food establishment. FDA has made conflicting statements over whether such operations would have to register under the EXISTING law.
Second, we look at the issues of S. 510 and the Tester-Hagan amendment. S. 510 would layer extensive HACCP-type requirements on every facility that has to register under the existing law. The Tester-Hagan amendment’s purpose was to try to mitigate that harm for small-scale producers. Politically, it was not going to be able to undo the existing Bioterrorism Act.
Even so, the Tester-Hagan amendment DOES fix one of the problems with the existing Bioterrorism Act requirements. The amendment directs FDA to clarify its definition of “retail food establishment” to include businesses that sell more than half their products directly to consumers at locations such as roadside stands and farmers markets, and through CSAs. (See pages 11-12 of the bill.)
So, under existing law, the farmer who makes a few jars of jam from his produce and sells them at a farmers market may have to register with the FDA under the Bioterrorism Act because he doesn’t qualify as either a “farm” or a “retail food establishment.” The same is true for the small-scale bread-maker or cheese-maker. And under S. 510, that farmer/bread-maker/cheese-maker would have to go through the full HACCP-type process. Under the Tester-Hagan amendment, that farmer/bread-maker/cheese-maker would now be exempt from both the registration requirement and the HACCP process as a “retail food establishment.”
Make no mistake — this was a hotly negotiated provision.
That didn’t end the issue, though, because the question is, what about food producers who sell their products directly to local restaurants, co-ops, and other local outlets that are very important to the growth of the local foods movement? The “retail food establishment” exemption, even as broadened by the Tester-Hagan amendment, requires a majority of sales to individual consumers, not businesses.
That’s where the Tester-Hagan amendment kicks in again. A business that is a “facility” (i.e. that doesn’t qualify for the exemptions for farms or retail food establishments) can avoid going through the HACCP-type process by showing that it qualifies, i.e. that it has gross sales under half a million and sells more than half directly to qualified end users (individual consumers, or local restaurants and local retailers). Yes, that will require some paperwork. I would have preferred that it didn’t, and that the onus rest with the agency, but this is what was politically achievable.
Final results under
the Tester-Hagan amendment:
- Farms that grow fruits and vegetables will NOT have to comply with the produce safety standards (often referred to as “GAPs”) if they gross under half a million (adjusted for inflation) and sell more than half their products directly to consumers, local restaurants, or local retailers. The farms are not required to register. They do have to either put label on or display a sign with the farm name and address. And if FDA directly links the farm to an outbreak, the exemption can be withdrawn for that farm; the onus to prove the basis for the withdrawal is on the agency, not the farm. See pages 51-53 of the bill.
- Businesses that process foods and sell more than half their products directly to individual consumers (not businesses) will not have to register with FDA nor comply with the HACCP-requirements. See pages 11-12 of the bill.
- Businesses that process foods and sell LESS than half their products directly to individual consumers may have another option if they qualify (i.e. gross under half a million and sell more than half their products to individual consumers, local restaurants, and local retailers combined). They can produce paperwork showing (1) that they qualify and (2) that they comply with any applicable local and state laws. If so, they still have to register because of the existing requirements under the Bioterrorism Act, but they do not have to go through the extensive HACCP-type requirements that will be added on under S. 510. Again, there is withdrawal provision that places the onus on the agency. See pages 19-24 of the bill.
As for the study (pages 24-26 of the bill), the bill directs FDA to conduct a study that would, for the first time, look at the issues of scale and type of processes in relation to food-borne illness. It does not mandate that any individual person hand over the information to the government. Also, FDA is directed to provide a report to Congress within 18 months. Regardless of the agency’s motivations, it would be logistically impossible for it to send agents to every small farm and food processor in the country in that time period. The most feasible course of action is for the agency to use existing data on food distribution (from the census) and outbreaks (from CDC and state health departments), and do follow-up investigations on the source of the outbreaks. And, as is always the case for local foods producers, we need to stay informed and be ready to respond if the agency does try to overstep.
And there’s a positive reason behind this study. In arguing that local foods and small farms are safer and should not be regulated by FDA, we don’t have a lot of hard data to back us up. The directive to do a study is the first attempt to make a get data to show that smaller-scale producers who don’t commingle their products and who do less processing and transportation produce safer food.
None of this is a perfect solution — S. 510 and the Tester-Hagan amendment involved very ugly sausage making. The Tester-Hagan amendment ultimately fixes some of the existing problems caused by the 2002 Bioterrorism Law and a very significant part of the problems that would be caused if S. 510 passes.
But it is, at its heart, damage control. That isn’t the fault of Sens. Tester or Hagan or any of the people who advocated for this amendment. It’s due to agribusiness’s capture of FDA and much of Congress — a problem that has developed over decades and that we will need to spend the next decade fighting.
Gumpert: I appreciate the optimism most have here about the FDA’s good intentions. That has not been its hallmark for small food enterprises, but I suppose there’s a first time for everything.
Also, I definitely would use Judith McGeary for my lawyer if I was a food producer. Unfortunately, I think lots of them will need her. In that vein, if I was advising entrepreneurs about whether to start a business in the food production arena (and I’ve advised a fair number over the years), I would tell them to avoid this entire morass … unless they are prepared to go entirely private, and never register for a single permit.