The Senate has just voted for cloture for the Food Safety Modernization Act. For those who need a civics refresher — and Grist’s food editor did — that means up to 30 hours’ worth of debate can now commence, which will begin later today. Fifty votes are needed on the motion to proceed, and then there will be votes on the amendments (including Tester-Hagan, which our Hill insiders say is still very much in play and may yet get into the manager’s amendment).

Meanwhile, here is our final installment in our Food Fight over the bill. Our participants have debated — passionately, articulately, and at great length — whether there is in fact a food-safety crisis, whether S. 510’s provisions will improve food-safety for most Americans, whether S. 510’s provisions will harm small farms or producers, and whether the Tester-Hagan amendment designed to mitigate that harm puts more consumers at risk.

We’ll have a recap of the major points made in this epic series once the bill passes (or fails). Now, the final question:

Does the bill give the FDA too much power — or not enough? Or is it just right?

David GumpertDavid E. Gumpert, health and food issues reporter: If S. 510 were just about food safety — encouraging education of producers and helping FDA to more easily go after scofflaws — I might be for it. But S. 510 is about much more than that. It gives the FDA vast new powers to inspect any company’s records at will (with no cause having to be shown), to require all producers to have HACCP plans (with FDA having arbitrary power to approve or disapprove), and to implement Good Agricultural Practices (once FDA decides what these are).

Unfortunately, as I’ve said in previous discussions, FDA has shown itself repeatedly to treat “food safety” as a political matter rather than a safety matter. My big concern is this: Who will oversee the FDA’s implementation of the vast new powers this legislation will give the agency? Presumably this is Congress’ responsibility, but when you come down to it, no one truly oversees the agency now, and calls it to task when it comes down on small food producers. So how can we expect any different situation once FDA gets vast new powers?

I think you all are being naive in thinking the FDA will somehow change its stripes and be a fair enforcer of new regulations. A tiger doesn’t change its stripes. Arrogant bureaucrats just become more arrogant if you reward their hostile behavior with additional power.

JudithJudith McGeary, founder and executive director of the Farm and Ranch Freedom Alliance: I agree with David about the agency’s motivations and the lack of oversight of its decisions. And I think there’s another layer to the problem, namely that even those people who may be well-intentioned clearly do not understand the realities of local, sustainable food production. Giving people power to regulate what they don’t understand is a recipe for disaster.

Invariably, whenever we talk about the safety of local, sustainable food production, the FDA or an advocate of S. 510 will bring up the spinach contamination in California, noting that it was from a “small” (three-acre) farm that was transitioning to organic. As others pointed out in earlier threads, the example is flawed from the beginning, as we don’t really know where the contamination came from.

But even leaving that aside, the idea that the spinach farm at issue is an example of local, sustainable agriculture is simply wrong. It was growing a monocrop, harvesting it by machine, and shipping it to a centralized processing facility where it was mixed with spinach from many other farms, bagged, and then shipped all over the country. The isolated elements of size and government certification do not make this equivalent to local sustainable farms.

Compare it to the farm where I buy my spinach: a 10-acre farm that grows over 100 different crops each year, harvested by hand, and sold directly to customers usually within a day or two of harvesting. The farmers eat their own produce every single day, along with their workers and families. Hundreds of families have bought leafy greens from this farm for the last 18 years, and none of them have ever reported any illnesses resulting — even though, like me, many eat the baby spinach raw while driving home because it’s just too good to wait for.

As has been said in previous threads, the safety and quality of food is the result of the entire system that it is grown in. Even the well-intentioned people within FDA simply do not understand this paradigm. FDA is staffed by people who come from within the industrial food system, many of whom are looking to get jobs in that food system when they leave the agency. Expanding their authority over the local sustainable food system gives them too much power.

Michael BulgurMichael Bulger, a master’s candidate in food studies at New York University: The farm Judith describes as her source for spinach does not sound like a food facility required to register with the FDA.

The FDA’s compliance guide has an exemption that reads: “Farms, which are establishments devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting.” Packing food from ones own farm is also exempt.

This might be a good point to let the readers in on the fact that S. 510 applies to around 150,000 domestic facilities (the rest are overseas). There are over two million farms in the United States; and not all the facilities covered by S.510 exist on farms.

Next, the idea that FDA regulates small producers and ignores the larger companies just doesn’t hold up to the facts. The majority of food recalled in the United States is not from small businesses. Just recently the FDA recalled cilantro products in California and Cal-Maine eggs because of positive tests for pathogens.

If we listened only to David, we’d think that [raw-dairy crackdowns] were the only type of work FDA was doing. That’s just clearly not the case.

Raw dairy is consumed by a very, very small percentage of Americans, yet it manages to account for over 70 percent of the dairy-related illnesses. We expect the FDA to take action when a large company tests positive for a pathogen. Why would we want them to ignore dangerous bacteria from a small business?

Regarding oversight of the FDA, the implementation of S. 510 would fall on the Secre
tary of the Department of Health and Human Services and the commissioner of the FDA. The FDA would be under the oversight of Congress to a significant extent, as they are required in the bill to make annual and biennial reports to Congress regarding many of FDA’s activities. Reading through the bill, required reporting to Congress appears, on average, every 15 pages. The clear intent of the bill would also be a matter that would be upheld by law, should a justified case be brought to court.

So, we see it is neither a matter of a one-sided regulatory agency exclusively harassing small businesses, nor is it a case of the FDA being granted excessive powers with no oversight.

McGeary: That’s not really relevant to the point I was making, namely that neither the FDA nor the proponents of S. 510 understand the complexities of small-scale, sustainable food production. The farm I referred to will be directly impacted by Section 105 of the bill, which gives FDA authority to set standards for how fruits and vegetables are grown and harvested.

But Michael’s comment shows yet again how proponents of S. 510 don’t appear to understand the full impact of the bill they are promoting. The farm I was discussing actually is a “facility” under FDA’s regulations because of their famous sun-dried tomatoes, made from heirloom varieties picked by hand and carefully processed. Under the FDA”s definitions and S. 510, a farm that processes any of its foods is a facility if they sell any of that food.

FDA has seriously underestimated the number of “facilities” in this country. Thousands of farmers do some level of “processing” of their foods, from drying fruits to mixing salad greens to making jams. Without the Tester-Hagan amendment, all of those farmers would be required to write HACCP/HARCP plans and be inspected by the FDA.

And then you have to account for all the other small-scale processors — people who buy produce from local farmers to turn into canned or baked goods, cheeses, etc. At best, millions of taxpayer dollars will be wasted on federal regulations and inspection of these facilities that have not been the source of widespread outbreaks. At worst, FDA will selectively use its resources to focus on these facilities and continue to give the large industrial facilities a pass. The bill’s directive to FDA to inspect facilities every X years means little if there simply are not enough resources to do so.

Mark KastelMark Kastel, co-founder of The Cornucopia Institute and director its Organic Integrity Project: I am very impressed with the thoughtful answers, from many different perspectives.

Some thoughts: Something needs to happen here. In pursuit of profit, some corporations are poisoning the citizenry. It’s a scary thing when you feel you’re playing Russian roulette with your family’s health when you go grocery shopping. Yes, this has to do with scale and fundamentals but it also has to do with the bottom line.

We have a “cheap food policy” in this country. We spend less for food than any other country in the world. And the byproduct is an obese and unhealthy populace … with the highest health care costs in the world and certainly not the best outcomes.

So, something needs to happen. The most tangible contribution many of us can make is to continue to make sure that the “good food movement” continues to be a viable alternative in terms of quality for people seeking out superior nutrition and safety. And we need to fight like hell to make sure that these farmers are not economically injured and competitively disadvantaged in the marketplace, as we discussed in the last thread.

If S. 510 passes, we’re going to have to work very judiciously, during the rulemaking process, to make sure that the benefits are not sold out and that this doesn’t end up being “payback time” for giant companies that would like to crush the fastest-growing elements in food marketing.

Normally, yes, we would look to Congress for oversight over the FDA. But we are in uncharted waters, since the Citizens United decision in the Supreme Court. We’ve always been challenged to have a balance of power, but the future could skew that power dynamic and turn Congressional oversight into a façade of sorts.

Kathleen ChrismerKathleen Chrismer, food-safety victims’ advocate: The general authority granted to the FDA under S. 510 is appropriate. I agree with the comments made by many contributors in the first thread that the FDA is horribly under-staffed and does not perform inspections as often as it should. However, some of Mr. Gumpert’s assertions about S. 510 are incorrect and misleading, and demonstrate the types of comments that cause people to fear something that is designed to prevent illness and death.

  1. “It gives the FDA vast new powers to inspect any company’s records at will (with no cause having to be shown)”

    Fact: Sec. 101(a) provides that if the Secretary of Health & Human Services reasonably believes a food item is a risk to public health, the FDA can, with “written notice … at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records” regarding that food item.

  1. “require all producers have HACCP plans (with FDA having arbitrary power to approve or disapprove)”

    Fact: Sec. 103, titled “Hazard Analysis and Risk-Based Preventive Controls”, requires an owner or operator of a facility* to (i) identify where contamination may occur in the food production process; (ii) take the steps necessary to prevent the contamination; (iii) monitor whether the preventative steps are effective and make corrections as necessary; and (iv) put this information in writing. There is no mention of approval or disapproval by FDA, only a requirement that the written plan be made available upon request. Additionally, “HACCP” applies only to seafood, juice, and low acid canning facilities that are subject to separate FDA HACCP standards specifically for those industries, not all producers.

    *Facility is defined as “any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer”. Sec. 415. [21 USC §350d]

    **Note – this does not include your home garden and will not make it a crime to share your home grown veggies with your neighbor.

  1. ” … implement Good Agricultural Practices (once FDA decides what these are).”

    Fact: Sec. 105, titled “Standards for Produce Safety”, essentially lays out the requirements for FDA to establish science-based minimum standards for safe agricultural production of fresh fruits and vegetables. As with any new legislation, there will be a rule making period, during which I would hope that farmers, producers, and industry (yes, including the small ones) would offer constructive comments based on their experiences. S. 510 directs FDA to complement its produce regulations with updated good agricultural practices (GAPs) and guidance for the safe production and harvesting of specific types of fresh produce under this section. These GAPs and guidance documents will also be subject to public comment. Mr. Gumpert’s cynical commentary is an injustice to the farmers and producers who have joined together to at least attempt to correct past
    mistakes and oversights. As the parent whose child nearly lost her life due to oversights in agricultural production, I have as much right as anyone to be cynical and bitter about this issue. However, we need to acknowledge that some farmers and producers are willing to do the right thing and S.510 is a vehicle to get the ones with less than safe practices into line.

I know that an area of concern for small producers is the food safety requirements of the legislation, but this concern is unfounded. S. 510 contains numerous provisions that require FDA to take into consideration the impact on small businesses.

For example, FDA is required to factor in the impact on small entities when it determines which traceability methods to adopt. S. 510 also directs the agency to provide small growers and processors with tailored regulatory requirements; requires FDA to publish several user-friendly, small-entity compliance guides to assist firms with the implementation of new requirements; and authorizes grants to enhance education, training and technical assistance related to compliance with the new law.

The goal in all of these provisions is to strike the right balance between protecting public health and ensuring that small growers and processors are not unduly burdened.

Whether it comes from a small producer or large manufacturer, food must be safe and consumers have a right to demand it, without compromise.

RussRussell Libby, executive director of the Maine Organic Farmers and Gardeners Association: FDA already has extensive power to regulate almost any place where food is handled, stored, sold, etc. They don’t have the resources to do it well, or effectively.

The largest businesses have already implemented most of the systems FDA would like to see: HACCP plans, extensive recordkeeping, traceability, employee training. S. 510 would add recall authority, something that so far has remained with the companies. Although most companies already do voluntary recalls, the ability to require involuntary recalls is a strong tool. It might be particularly important for imported foods, which are one of the focus areas of the bill.

On the other hand, FDA and its field offices seem to have a hard time drawing a clear line between a farm and a “facility” — i.e., processor. Most farms that direct-market perform some “processing” activities. They have been exempt from facility registration because the majority of sales are direct to individual consumer — and because they’ve been invisible to FDA to date. That is likely to change as the number of regulated products increases from sprouts and juice to include a full range of produce items.

I think ultimately FDA will have too much authority, and not enough power. Their authority is, and will be, broad-reaching. But FDA’s power depends on funding, which is unlikely to be forthcoming in any major way. Their power also depends on their ability to sort out the real food safety issues, and create solutions. That will only happen if they are working with the people who are producing food, and not perceived as a threat.

Ultimately, the public will have to make real decisions about what kind of food system we want. Who’s your farmer? If you know, this whole conversation seems somewhat irrelevant, and even potentially damaging. If you don’t know who produced your food, then there are a lot of reasons why you might want a strong FDA to act as an intermediary.

That, it seems to me, is what underlies the entire conversation about food safety that is embodied in S. 510. It won’t be resolved anytime soon.

Bulger: Section 105 states that produce standards must “provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities.” It goes on to state its effects in terms of facilities.

It would take a gross misinterpretation of Congressional intent for the regulations to extend to the lowest levels of commerce and an even more significant misinterpretation for them to be unfit for the levels of business to which they do extend.

S. 510 orders FDA to publish a small entity compliance guide that is intended to clear up the confusion about what they consider a facility. That should make it clear if their estimates for the number of facilities they require to register were more accurate than you suspect. Somehow, I think the FDA has a better grasp on what they meant than the casual observer.

For those members of the panel who are so convinced the FDA inspectors are out to get small farmers, it might cheer you to know that S. 510 calls for a field staff of at least 5,000 FDA employees by 2014. Adding new blood should dilute those mean old government employees you fear.

FerdFerd Hoefner, policy director for the National Sustainable Agriculture Coalition: I can only give this thread a very quick scan, but the repeat of this 150,000 domestic facilities number jumped out at me.

For the record, FDA’s new official position on how many farms are facilities is “we have no idea” as per their written response to the question submitted by Sen. Jeff Bingaman (D-N.M.). Moreover, USDA economists at the Economic Research Service say that they do not know either, though their best professional judgment guess, looking at available NASS and ERS data sources, is that it is very likely in the hundreds of thousands. Hence, the 150,000 number is simply not an accurate reflection of reality. In fact, as long as the official FDA message is “we have no idea” about farm facilities, there is therefore no official number of domestic facilities in total.

Gumpert: I find it staggering that the FDA has no idea how many food facilities it might be policing. The agency has supposedly been watching this arena for many years; at the least, it’s had more than a year since this legislation was proposed.

Actually, if you examine the testimony FDA officials gave to the House committee, you’ll see it is very sparse in terms of justifying the new legislation — the same old stats on “76 million food-borne illnesses, yada, yada, yada.” I guess the FDA figured passage was a slam dunk, so no need to do any homework.

Michael, you question the suggestion that FDA might be staffed by “evil people.” Not quite. Evil leadership, yes. It’s the leadership that determines how the troops think and behave. Enlightened leadership could turn things around there pretty quickly — make food safety a cooperative matter between regulators and industry, and above all, bring it back from the political realm.

Libby: The language you refer to is here because there hasn’t been any clear Congressional intent, and we’ve worked hard to get that direction included in the Senate bill. It’s part of why I’m supporting S. 510, hopefully with Tester/Hagan included.

No one wants to “get” small farmers in this conversation, on either side. But the impact of the original S. 510, before the manager’s amendment, and HR 2749, is that a lot of small farmers will be surprised to learn that they are regulated facilities, and that there are many more hoops to jump through than simply regulation.

McGeary: I agree with Russell’s conclusion about the difference between people who know their farmer and people who do not, and the role that
plays in their views of FDA and the bill.

In my opinion, when it comes to local, sustainable food producers, S. 510 gives FDA too much power. As we’ve discussed in previous threads, these producers use a systems approach that achieves greater safety and quality than any industrial producer using HACCP or GAPs, and are held accountable by the direct-to-consumer relationship, which creates greater transparency than any government regulation.

Section 103 of the bill, the “Hazard Analysis and Risk-Based Preventive Controls,” is effectively a recitation of HACCP requirements. The Senate simply changed one word in the title, causing the acronym to be HARCP instead. It takes the bill five pages just to list what must be included in the HARCP plan, and clearly states that the owner of a facility “shall” create and implement this plan. In addition, FDA has the authority inspect the facility and its paperwork.

Do the proponents of S. 510 truly interpret this language to mean that the facility owner could write whatever document he wants and FDA would be powerless to disapprove it?

On the produce safety standards under Section 105, I think it is accurate to say that FDA will get to decide what these are. In administrative law, an agency is not required to change its regulations to adopt any portion of the public’s comments. As just one example, FDA has repeatedly approved genetically modified foods without labeling despite significant public opposition.

It is important and useful to be involved in the regulatory process, but relying on it to ensure a positive outcome ignores both the law and the experience of the sustainable agriculture community.

As an attorney trained in administrative law, I have been involved in several cases addressing the scope of an agency’s authority. Language directing FDA to provide “flexibility” and to write regulations “appropriate” for different scaled operations will provide little, if any, enforceable limitations on the agency’s discretion in the final equation. It may well be a misinterpretation of Congressional intent for the agency to develop regulations that drive small farms and local processors out of business. But that misinterpretation would almost certainly be upheld in court as long as the FDA provided a written response to the comments.

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.

Ultimately, the power will lie in FDA’s hands, a precarious situation for the local foods movement.

Patty LoveraPatty Lovera, assistant director of Food & Water Watch: I think Russell raises a good point about your view of the bill depending on which food system you’re in. At Food & Water Watch, we see both sides — we don’t want to make life harder for small operations that have plenty of other things to deal with, but we’ve been trying for way too long to get FDA’s food safety program to be about more than responding to the latest illness outbreak.

But at the risk of sounding like a broken record, I have to point out that the status quo is not working all that well. The liability risk is a huge piece of the puzzle on food safety and many food processors, institutional buyers, and grocery stores have responded by imposing specific food safety requirements and audits on their suppliers. Which means that a lot of our food is subject to some set of standards — but those standards vary from brand to brand, are often too burdensome for small operations to comply with (so they don’t get to sell into these channels), and are often not even disclosed because they are proprietary.

Many producers are being regulated — just not by the government, and not in a way that the public has any chance to influence. That liability issue (and the improved detection technology that links illnesses to specific foods) isn’t going away. Which means the pressure to meet some kind of food safety requirements won’t go away, even if there is no food safety legislation passed.

So that’s not an excuse to unleash a government agency with unlimited new power and no guidance on how it should operate. But it is a reason to try to find some way to make FDA better at its job — by having recall authority, by having a mandate to inspect processing facilities often enough (which we think would be more often than once every five years), and being able to inspect the facility’s paperwork before there’s a problem (rather than finding out that they haven’t been keeping records when there’s a problem.)

Directives like the Tester amendment (and the Brown and Bennett amendments and other provisions focused on flexibility for small operations) help point FDA in the right direction, focusing the agency on facilities that are producing more food that puts more people at risk.