by Marion Nestle
Aug 22 2010

Effects of S. 510 on small farms: Senate staff analysis

Thanks to reader Michael Bulger for forwarding the Senate staff analysis of the impact of S. 510 on small farms.   Here’s what it says (slightly edited):

No Change in Agency for Regulated Foods: Only foods already regulated by the Food and Drug Administration (FDA) will be subject to S. 510. Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.

No Change in Definition of Facility: Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510. If an entity does not need to register now, it will not need to register under S. 510.

Flexibility for Small Businesses: Small businesses are given regulatory flexibility throughout S. 510. For example, small processors are given additional time to comply with new food safety practices and guidelines created by the bill and the Secretary may modify or exempt small processors from new hazard analysis and preventive control requirements based on size and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides to assist firms with the implementation of new practices.

Scale Appropriate Produce Safety Standards: In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruits and vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing, production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food which pose little or no serious risk to human health. Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies. Exemptions are also available for low risk commodities. FDA must minimize the burden of paperwork and, as appropriate, the number of separate standards for separate foods.

Increased Training Opportunities: The bill requires FDA to coordinate with the extension activities of the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and small processors about any new practices required by S. 510. Necessary funds are authorized to conduct these extension activities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act. Competitive grants are made available, for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

Risk-Based Traceability: The ability to trace back potentially unsafe food in the event of a food-borne illness outbreak is important. For the purpose of traceability, farms and small businesses that are not food facilities are not expected to create new records. During an active investigation of a foodborne illness outbreak, in consultation with state and local officials, the Secretary may ask a farm to identify potential immediate recipients of food if it is necessary to protect public health or mitigate a foodborne illness outbreak. Limitations are also included for restaurants, commingled agricultural commodities, direct to consumer sales, fishing vessels and products carrying an identity preserved label.

Regulatory Flexibility for Organic Foods: Throughout the bill, consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.

Protections for Farmers Markets, Cottage Industries and Direct Farm-to-Market Sales: Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new recordkeeping requirements under S. 510. This includes food sold through farmers’ markets, bake sales, public events and organizational fundraisers.

I hope this helps to calm things down a bit.  This bill needs all the support it can get.  It’s not perfect but it is a reasonable first step, and badly needed.

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  • http://www.healthyfoodcoalition.org Harry Hamil

    Please note, that “The Hill” which was the first to publish this analysis that was widely distributed on Capitol Hill on the day the Managers’ Package was distributed did not know who was circulating it.

    It is exactly this lack of transparency that causes people like me in the local, healthy food movement to take a wait and analyze ourselves approach to this.

    For a quite different QUICK analysis, go to http://farmandranchfreedom.org/sites/farmandranchfreedom.org/files/S510%20memo%20FARFA.pdf.

    Because of the limited resources of the local, healthy food movement and the significant number of changes (the page total went from 148 – 225); we may not have a complete analysis done by the time Congress reconvenes.

  • http://smartculturekitchen.blogspot.com Michael Bulger

    Henry, you speak of the “local, healthy food movement” as if it is a cohesive unit with FARFA at the center. Local, healthy farmers and producers are welcoming S. 510 and the transparency that it requires. Safe producers know that more inspections won’t hurt their businesses because they already employ safe practices.

    FARFA might need some more time to do an analysis, but let me help by pointing out the inaccuracies they have already published.

    In regards to FARFA’s take on HACCP:

    1. FARFA states that every facility will have to develop a HACCP-type plan. This is plainly false. The Secretary is given the authority to grant flexibility/exemption to facilities based on “income, harvestable acres, the number of employees, and the volume of the food manufactured, processed, packed, or held by a facility”. It will also be based on risk factor with low risk operations being granted flexibility/exemption.

    FARFA is either mistaken or misleading.

    2. See 1.

    3. FARFA says that flexibility is unenforceable. However, S. 510 clearly gives the Secretary authority to administer flexibility.

    On Inspections:

    2. FARFA seems to use the logistical and budgetary challenges involved in inspecting hundreds of thousands of foreign facilities as a sign that domestic producers are over-inspected. Here I am not sure what the problem is, but FARFA appears to compare apples and oranges.

    On Fees:

    FARFA points out that facilities will be liable for inspection costs. Yeah, we know. What FARFA does not include in its summary is this:
    “the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses.”

    On Produce:

    3. FARFA actually gets most of their produce facts straight. Here, direct-marketers are indeed included. They are included In that direct-markters are to be considered for flexible regulations.

    FARFA’s produce section amounts to the same old song and dance about the FDA coming to shut down good and wholesome foods. If the FDA misinterprets this bill and does not provide flexibility and exemptions for small businesses, it will find itself in a lot of hot water.

    In FARFA’s miscellaneous section:

    B. FARFA seems worried that small businesses will have to hire a consultant to “understand and comply” with food safety requirements. As far as understanding the new system, FARFA seems to have forgotten the Small Business Compliance Guide that the FDA will be required to publish. Presumably, on the issue of compliance, FARFA is concerned HACCP will break they business’ bank. The fact is, HACCP certification can be done online for under $50. If the business is unsafe and has not been exempted because of size and risk, then maybe they will need to spend more to upgrade. Would FARFA rather they continue to produce unsafe food?

    In general, Judith picks and chooses certain parts of S. 510 and highlights them in her summary. Her work is by no means a comprehensive overview of S. 510. Her statements are often misleading, are unbalanced, and at points are just untrue.

    In the end, Judith McGreary relies on mistrust of regulation as her crux. Unfortunately for true proponents of healthy, local foods (such as myself), Judith’s fears veil her eyes to the facts of the Food Safety Modernization Act.

    Sure, we can all wait around and waste more of Congress’ time. We can bide our time, waiting for Judith to finish her “analysis” and finally understand the bill. Meanwhile, more and more people will fall ill as a result of unsafe food. Or we can pass S. 510 and move on to the public comment period where we help the FDA do its job adjusting regulations and exempting small businesses and direct-marketers.

    I think its high time that Judith and her organization acknowledge the fact that they have not been elected representatives for healthy, local foods. Thankfully, I might add, since she fails to see the breaks being offered to us and the courtesy with which S. 510 treats small, local, healthy food.

  • http://www.FarmAndRanchFreedom.org Judith McGeary

    The discussion starts with a faulty premise, namely that small farms have somehow “gained” in S.510. The real issue is why were small direct-marketing farms and small-scale food producers ever included in the bill to begin with?

    There’s a fundamental issue of limited resources. The money that FDA will use to regulate small local food producers – our tax dollars – is money that could be used to inspect more Big Agribusiness and imported foods, which have been the source of the major foodborne illness outbreaks and food contamination problems. Yes, the logistics are different when one deals with overseas facilities, but it still comes down to how the government decides to use limited resources.

    None of the proponents of S.510 have provided data to support the contention that local, small-scale food producers should be regulated by FDA. These food producers are already regulated by both state and local health authorities, and none of the major foodborne illnesses have come from local, small-scale food producers.

    The analysis that we posted on the FARFA website focused on just some key points. I certainly never intended a 4-page list of bullet points to be taken as a comprehensive analysis of a 225-page bill, anymore than the one-page summary that Dr. Nestle posted is a comprehensive analysis either.

    Michael, you seem to have misunderstood the basic concern with the enforceability of the small-farm provisions in S. 510 — I’ll go back and see if I can claify it in the analysis. Certainly, if FDA adopts exemptions under the discretionary authority granted to it, then those exemptions will be enforceable. My comments about “unenforceable” referred whether or not the bill’s language creates any enforceable limitations on FDA’s authority. Many of the comments on the Managers Amendment have made it sound as if the grant of authority to FDA to provide exemptions means that there WILL be exemptions. Indeed, in your comment about whether all facilities will be required to do a HACCP (point 1), you make that assumption.

    But there is absolutely no guarantee than any exemptions will be granted. The bill starts with the requirement that all facilities do HACCP. FDA then has the discretion to choose to exempt facilities, if it wants to, using the listed criteria. FDA is absolutely free to decide to not provide any exemption, or to write the exemption so narrowly that the vast majority of small, local food producers still have to do a HACCP.

    Even where the bill doesn’t explicitly leave an issue to FDA’s discretion, such as in the directions to provide “flexibility” or make regulations “practicable” or provide “consideration,” the actual real-world effect is to leave the issue to FDA’s discretion. These are undefined terms and, under the long-standing court doctrine of deference to agency rulemaking, it would be all but impossible to overturn whatever regulations FDA decides to adopt. That conclusion is based on my experience as an administrative lawyer, dealing with cases on agency authority and rulemaking. For those who wish to learn more about the issue of deference in agency rulemaking cases, the seminal cases is Chevron v NRDC: http://www.law.cornell.edu/supct/html/historics/USSC_CR_0467_0837_ZO.html

    The alternative to the current version of S.510 is not simply to do nothing. Rather, Congress should adopt clear, unambiguous provisions that focus on solving the real problems (i.e. the industrialized food supply) without creating new burdens on small food producers who are providing consumers with the option to buy local, healthy foods. Focus federal regulation on food that affects people in large areas, while state and local authorities continue to regulate local food producers.

    As for whether farmers and small businesses will need, in practical terms, to hire outside consultants, I just spoke with an Extension agent whose division specializes in training farmers under the good agricultural practices (GAP) program, which is currently voluntary. The Extension agent said (without any prompting from me) that several of the farmers who have gone through the training have decided not to get certified because of the paperwork burdens and that some of them would probably need to hire an employee or independent contractor to handle the paperwork for them. The reality is that, with or without a small business compliance guide, many farmers do not have the time or expertise to handle the sort of paperwork required for these programs.

    Again, the first question is why were local, small-scale producers included in this bill? Certainly, there are significant problems with the industrialized food supply, with its commingling of raw ingredients, long supply chains, centralized processing, and widespread semi-anonymous distribution. Reform is clearly needed, and Congress should direct FDA – in clear, unambiguous, and enforceable terms – to make the changes needed to address food safety in the industrialized food supply. The problems in the industrialized food supply do not justify a new level of regulation on local, small businesses. And, moreover, the new regulation on these small businesses will waste taxpayer dollars that could be spent on inspections and enforcements of the big guys.

    People can disagree about the impacts of the bill or the appropriate solutions without attacking each other personally. I am a sustainable farmer and volunteer activist. I don’t get paid for my work for FARFA — I do it because I am part of the local food movement and believe strongly that it is the future for our health, our environment, and our local communities. I’ve already stated, both on this blog and your own, that I welcome people to check out who I am and what I work on. I’ll go one better now – come visit my farm. My husband and I work long hours, but we always welcome people who truly want to learn about how to raise food that is both safe and healthy.

  • http://smartculturekitchen.blogspot.com Michael Bulger

    That’s all good and fine, Judith. As to your questioning why small producers should even be considered for HACCP training, unfortunately food outbreaks come from small producers, too.

    You’ve seen these:
    A farmers market in Iowa: http://www.idph.state.ia.us/IdphNews/Reader.aspx?id=DD3ABF3B-F50E-4EB3-9D74-D88A15B66035

    Direct-marketed, small-scale, state-regulated raw goat milk sickens 24. E. Coli O157:H7 and Campylobacter: http://www.dailycamera.com/boulder-county-news/ci_15469283

    A toddler is hospitalized in Minnesota. Direct-marketing: http://www.startribune.com/lifestyle/health/94980484.html

    Yes, HACCP training.

    Section 405 of S. 510 sets up a competitive grant program to focus on the education and training of small-scale producers to improve food safety. This is to be done with consideration to a “variety of agricultural production systems, encompassing conventional, sustainable, organic, and conservation and environmental practices”.

    Priority will be given to “projects that target small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers.”

    Sounds like a great plan to me. I know you are going to reason that they should all just be exempt. I’m all for exemptions for low-risk facilities that service a reasonable number of consumers. The blanket, one-income-serves-all exemption that is the Tester amendment creates an enormous loophole for high-risk, high-impact entities. In this case, flexibility and discretion is prudent.

    The extent to which you are grasping at negative, nightmarish outcomes that involve the misinterpretation of this law astounds me. I feel like I am the one who continues to come to the defense of small and healthy producers and their customers.

  • Anthro

    Thank you Mr. Bulger for your calm and reasoned remarks. I am satisfied that small producers are being protected (maybe too much) in the pending legislation and very much appreciate your and Marion Nestle’s effort to keep us all factually informed.

    I certainly am an advocate of fresh, healthy, mostly local, food, but neither do I want to get sick if I can avoid it. I am even careful with the food I grow in my backyard as I know that all sorts of critters, visible and invisible get all over it. There is no substitute for good rules based on good science being enacted into law and enforced to some extent at every level. I don’t want some local farmer having no accountability to anyone and then selling me something that is dangerous for me to consume! Unless there was obvious filth or something like that, how would I know just by visiting the farm that the farmer was using best practices?

  • http://www.healthyfoodcoalition.org Harry Hamil

    The failure of Michael Bulger to even get my name right (It’s “Harry,” not “Henry”) demonstrates clearly his failure to the get the details straight. If he can’t get something that simple right, why should anyone trust that his other details are correct?

    Michael Bulger’s twisting of my statement about the resources of the local, healthy food movement that doesn’t mention FARFA into my “speaking of it” as “a cohesive unit with FARFA at the center” is hogwash and a blatant attempt to rewrite my plain meaning.

    After falsely asserting that I am claiming that the local, healthy food movement is centered around FARFA, Michael Bulger’s states as a fact, “Local, healthy farmers and producers are welcoming S. 510 and the transparency that it requires.” That’s beyond the pale! I have never seen nor heard a single small farmer or producer do that, nor is a single group of farmers supporting S 510. In fact, within the 157 organizations that have signed a letter supporting Tester-Hagan, there are numerous organizations of farmers calling to change it.

    Michael Bulger’s last statement, “Safe producers know that more inspections won’t hurt their businesses because they already employ safe practices,” is, once again, crafted to mislead. It is based upon the erroneous premise that all inspections are accurate. And, all too often in every area of American life where inspections occur, there are incompetent, lazy, venal and/or corrupt inspectors. Even worse there are frequently rules that clearly put certain entities at a disadvantage.

    This is best shown by another bill sponsored by Sen. Jon Tester, the author of the Tester-Hagan amendments. His “Meat Safety & Accountability Act” is designed to force the Food Safety Inspections Service (the USDA’s meat inspection service) to traceback contamination problems at downstream meat processors that originated from USDA approved meat from upstream slaughterhouses. This bill is necessary because the current rules cite the downstream processor for contamination introduced by USDA approved meat from another plant. For 8 years, John Munsell has fought to reverse the current system which endangers the public health and has forced innocent downstream processors to sell out.

    As for the rest of what Michael Bulger wrote, Judith McGeary clearly demonstrated the errors in what he wrote. In fact, the errors are so egregiously it raises the question of whether or not it is disinformation rather than misinformation.

    Finally, as has been well shown before, it is impossible to have a reasoned discussion with Michael Bulger; so I don’t intend to waste any more time on him in this blog.

  • http://www.healthyfoodcoalition.org Harry Hamil

    Anthro, I agree completely with your statement, “I don’t want some local farmer having no accountability to anyone and then selling me something that is dangerous for me to consume!” Fortunately, that is not the case. Depending on what a local farmer grows and how s/he brings it to market, there are many existing rules & regulations requiring his/her compliance and that can be used to hold her/him accountable.

    But the greatest accountability in a local farmer selling to the public or restaurant or local grocery store (like mine) is the short, transparent supply chain. If the farmer screws up, the error is quickly known and any needed action can be taken very quickly. And, if a food-borne illness occurs, the farmer is probably put out of business.

    Unfortunately, the same is not true for regulators. They are seldom, if ever, held accountable.

    The 2008 Salmonella saintpaul outbreak that was first attributed to tomatoes and then to peppers shows this clearly. The early epidemiological work was VERY poorly done. They were certain what the answer would be before they started it thereby biasing their work. It was questioned almost immediately by Jim Prevor and others. No one listened. During this, the FDA issued the astonishingly poorly worded alerts that cast doubt on millions of tomatoes and thousands of farms that could never have been involved in the outbreak. When this was pointed out by me and others, the FDA not only did NOT correct its errors, it compounded them.

    As a result, the fresh tomato market was destroyed for the entire season and scores of millions of dollars were lost by people whose tomatoes could not possibly have been involved.

    What was the FDA’s external response? It implemented extremely successful damage control that shifted the blame to lack of traceability when traceability was never an issue.

    Did the FDA ever a correction issued? No.

    Did the FDA ever make an apology? No.

    Did the FDA attempt to make whole those whom it had injured? No.

    Was ANYONE ever held responsible at the FDA? Not that has ever been made public.

    Anthro, the biggest reason for food safety problems in this country is the poor performance of the key federal regulators, the FDA and the FSIS. That is the accountability that you need to be most concerned about.

  • http://smartculturekitchen.blogspot.com Michael Bulger

    Thank you, George. I used Henry as it is an accepted nickname for George.

    Mr. George H. (Harry) Hamil is an ex-insurance salesman from North Carolina. People rave about his wife’s biscotti.

    Harry, I’ve got the details straight. I used Henry in response to you putting my name in quotations. My name really is Michael Bulger, but you can call me Mike if it pleases.

    As far as which small farms have come out in support? Try Joel Salatin’s Polyface Farms.

    I’ve countered every fear of yours and Judith’s with factual language from the bill. Considering the text and the spirit of S. 510, any inspector who persecutes or unduly burdens a small businesses will be violating the law. Don’t sacrifice the public’s health in favor of a fear of abuse of power.

    If a farmer feels that they have been abused in anyway, they should contact the FDA’s Office of Ombudsman: http://www.fda.gov/AboutFDA/ContactFDA/ResolveaDispute/default.htm

    “One of our fundamental duties is to be scrupulously fair, even-handed and objective. We can accept no less.” – FDA

  • http://smartculturekitchen.blogspot.com Michael Bulger

    Maybe you should file a lawsuit regarding the tomatoes instead of obstructing legislation designed to improve the system about which you complain.

    S. 510 calls for the establishment of 5 Integrated Centers of Excellence. These will be partnerships of federal, state, and local authorities advised by public, private, and academic entities. The goal is to improve investigation procedures and public notification standards. This should work towards eliminating some of the confusion that you speak of..

    Here I am.. quoting the actual bill instead of speculating wildly. Again.

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  • http://www.healthyfoodcoalition.org Harry Hamil

    @Michael Bulger. As you decided to call me out personally, I will make another response.

    I’m glad to hear that your name really is Michael Bulger. Now tell us which “Michael Bulger” as there are quite a few “Michael Bulger’s.” What in your documentable background makes you the authority you hold yourself out to be?

    In contrast, there appear to only be 3 actual “Harry Hamils” in the world. You’ll be hard pressed to find anything on the one in Northern Ireland and the one in CO is very quiet. Therefore, as I regularly point out, because I live a very public life and have been involved in lots of things for a very long time, I have a very long, accessible public record.

    You mention that I’m a former insurance salesman (as a local independent agent and as a regional managing general agent) though it has been several years since I did that. During my 35 years working in the insurance & securities industries, I turned in quite a few bad players and was the reason that the State of NC collected over $125,000 in unpaid taxes. It is also where I learned long ago that regulators frequently don’t do their jobs even when their duty is clearly pointed out to them. I, also, learned that NGOs (including Consumers Union) sometimes tell those depending upon their counsel the opposite of what is needed and, as in the case of Consumers Union, refuse to correct their errors.

    You failed to mention that my wife, Elaine, and I founded the Black Mountain Tailgate Market (and were volunteer coordinators of it and its predecessor for 14 years) or that we also initiated the idea of and helped found the Mountain Tailgate Market Assn.

    I have 2 final comments.

    First, you didn’t address our “fears,” Michael, because they are not “fears.” They are the way things are and can play out in the future. As for the likelihood of abuse of power, all one need do is look at “Shielding the Giant: USDA’s ‘Don’t Look, Don’t Know’ Policy for Beef Inspection” (http://www.whistleblower.org/storage/documents/Shielding_the_Giant_Final_PDF.pdf). It is the 23 page Government Accountability Project (GAP) investigative report published in July 2003 that documents the FSIS’s abuse of its food safety powers against my friend, John Munsell, because he wanted to trace the problem back to its source. Considering FDA Commissioner Hamburg recent cries about the FDA’s traceback problems, this is particularly ironic.

    Second, “file a lawsuit regarding the tomatoes?” LOL. That is exactly what the Government Accountability Project and John Munsell did. The lawsuit was dismissed because John had not exhausted every administrative remedy though the court admitted that the system was constructed so that it is impossible for John to exhaust all of his administrative remedies. Plus, as anyone who has tried to “hold government’s feet to the fire” well knows, it takes an astonishing amount of money to sue in that way. Not only do I know this firsthand but also my wife, Elaine, was a high end legal secretary for 17 years.

    As always, I will happily defend all I’ve written to those who are truly interested in learning the truth about the clear impact of S 510. Please write me at healthyfoodcoalition@gmail.com.

    Unfortunately, Michael, it is obvious that you have neither the ears to hear, the eyes to see nor the heart to understand the truth about the impact of S 510.

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