by Marion Nestle
Aug 4 2010

We need S. 510 to pass, despite tea bagging

My policy is to ignore snippy comments on this site but I recently received one that raises an issue worth attention.  In response to my most recent post about the endless—and to my mind, appalling—delays in passing S. 510, a bill that will give the FDA authority to require safe food production, a critical reader, Harry Hamil, writes:

Dr. Nestle, your statement, “What’s holding up this bill? Nothing but politics of the worst kind,” is absolutely false and you know it.  As you well know, there is broad, deep and large opposition to the industrial-size-only approach to food safety that S 510/HR 2749 will make the law of the land….And, once again, I challenge you to a debate of the actual provisions of the bill. Your previous blogs demonstrate a remarkable ignorance of the actual provisions and little understanding of the real world consequences.

As readers of this blog know, I believe that all food, no exceptions, from large producers and small, should be produced safely, meaning that producers should follow food safety plans that involve preventive controls.  But this comment raises another issue: the unhelpful tone of this debate.

Bill Marler, the Seattle lawyer who represents the victims of food poisonings, gets such comments all the time.  In a post on FoodSafetyNews.com, he deals with the tone issue in response to rather nasty comment about his views of raw milk.  Marler says:

Actually, I get more than a few emails like this.  Most do a bit better at spelling and punctuation, but nearly all are from raw milk proponents, producers, or consumers (although there are a few from the anti-S. 510 cabal).  Some, but not all, have a level of passion that borders on violence.  Perhaps not directed at me, but generally in the “do not tread on me”–“tea party” shouting that we have been subjected to over the last year.

Frankly, I was perplexed at the “yell fest” that passed for discussion of whether we should expand health care to the 40 million of our fellow citizens without health insurance.  I am shocked at how we scream at each other via email or blog comments about raw milk or honest differences about how food safety legislation should be modeled.  It is like screaming at and belittling each other at the dinner table–albeit, a very large table.

What is with all this anger over food?  I mean, honestly, it seems like there are bigger fish to fry.  What about the wars?  Global warming?  Energy policy?

But, folks are angry about their view of food–especially the proponents of raw milk (affectionately, “raw milkies”) and the anti-S. 510 folks (affectionately, “organic tea baggers”).  Both groups view themselves as victims of big government and big business bent on reducing them to servitude or extinction.  They cannot see that perhaps, just perhaps, people who see the dangers of raw milk or the value of S. 510, might simply have an honest disagreement with those that see raw milk as the nectar of the gods or S. 510 as more than a method of lining the pockets of Monsanto.  But, hey, that is just me.

So, do the yelling, threats and belittling of the anti raw milk/pro S. 510 crowd actually work?  Are some convinced that those that yell the loudest have the best arguments?  Or, do some simply shy away from their positions after being the target of a nasty blog post or scathing email or comment?  I think some do.  I know I have been tempted to simply focus on other pressing issues surrounding food safety–there are many–and let folks guzzle raw milk to their heart’s content and let S. 510 die a lingering death.

But, that is not my style.  Even as a child when told to do A I usually did B.  When the raw milk party calls me a tool of big dairy or an ambulance chaser, I come back with reasoned pros and cons of raw milk consumption, videos of raw milk consumers sickened, and a website–Real Raw Milk Facts–dedicated to having a reasoned discussion about raw milk.  I am also beginning to work on a raw milk retail sampling project to test its safety.

As for S. 510, the nastier the emails from small producers who want little or no food safety regulation, the more money I donate to political campaigns, the more trips I take to DC, and the more often I fund victim visits to their favorite senator.

And, to do the above, I hardly raise my voice.  Well, once in awhile I do.

Me too.  Thanks Bill.
  • http://www.bullshitexpress.com David

    Lots of interesting input on this post. I’m curious to know “exactly” how this bill will put small producers out of business? Cheeses are the main users of raw milk products and that will not change. From what I have read (and it’s not everything) standardization is needed so that we know that buying product “A” in New York has the same level of safety as is I buy product “A” in New Mexico.

    We all remember the tomato scare recently where you couldn’t buy tomatoes for MONTHS. And how about Beef Products Inc who brags about turning beef waste into an ammonia laden soup to add to your hamburgers? I want to know EXACTLY what is in my burger.

    Being able to make informed decisions is what I think we all want. I don’t care if you drink raw milk, but if you get sick doing it, don’t blame something else to justify your belief system.

  • Harry Hamil

    @David, simply stated, S 510 “modernizes” the FDA for the large corporation dominated, global food system at the turn of the 21st century but does not adequately take into account the evolving local, regional food systems of the 21st century.

    As written, S 510 will require ALL growers, packers, processors and distributors–regardless how small–to implement expensive Hazard Analysis and Risk-based Preventive Control (HARPC) plans and/or FDA created standards for produce safety designed for and needed by the industrial food system not local, healthy food. Their cost in time and money will overwhelm most small food businesses and cause them to disappear as occurred when HACCP was implemented in the meat and poultry business.

    Small, grade B cheese only dairies will be one of the hardest hit groups. Pug’s Leap Farm of Sonoma, CA estimates its cost would be $50,000 annually so it is already in the process of closing.

    The tomato scare did NOT last for MONTHS. It only lasted a couple of weeks but destroyed the entire tomato market. The losses to growers, packers and distributors have been estimated at over $100 million despite no evidence that they were in involved. It was due ENTIRELY to the incompetence of the CDC and FDA and no one was ever held accountable but those of us in the business paid the price.

    If you want to make an informed decision about S 510, I suggest you read the “Older comments” linked above, particularly those beginning with Judith McGeary at 5:06 PM on August 7th and follow the links provided. Also, I will be happy to attempt to answer any question, if you write me at healthyfoodcoalition@gmail.com.

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

    David,

    The references to raw milk sprung from Bill Marler’s comments, but S. 510 is much broader than that. The bill gives FDA extensive powers to regulate all produce and processed foods. The bill does not address meat because that’s within USDA’s jurisdiction, not FDA.

    I remember the tomato scare very well — and the fact that people flocked to the farmers markets to buy tomatoes from the local farmers, because they knew those tomatoes weren’t part of the problem. The ability for people to make informed choices, and to continue to have access to both healthy and safe foods, is exactly what we are fighting for.

    For example, one of the provisions of the bill, “produce safety standards,” will involve FDA telling farmers how to grow and raise their crops, based on the “risk” of the crop. The first problem is that risk levels have a lot more to do with the type of food system than the crop itself. For example, spinach raised on a small farm, hand-cut , and sold within 24 hours in loose baskets is a very low risk food. But spinach raised on a farm that is cut by machine, sent to a centralized processing facility where it is mixed with thousands of pounds of spinach from dozens of other farms, bagged, and shipped all over the country where it sits on grocery store shelves incubating bacteria, carries a much higher risk. But FDA’s position has been to address the crop, rather than the problems with the centralized, industrial food system.

    The second problem with the produce safety standards is that the FDA, with its revolving door, approaches regulations based on the needs of the large, industrial farms. For example, FDA has already approved of an approach that writes different regulations for different crops. So there will most likely be a set of regulations for growing tomatoes, a different set for growing leafy greens, a different set for growing canteloupes, etc. This works fine for large farms growing hundreds of acres of monocultures. It’s not feasible for sustainable farms that may grow as many as 100 crops on 10 acres (yes, that is an actual example).

    Please listen to my testimony to FDA at http://www.youtube.com/watch?v=pmhn_NKgFs8

    We also have the videotaped testimony from several other small farmers at: http://www.youtube.com/user/FarmAndRanchFreedom

    There are also provisions in the bill to require anyone who does any food processing to comply with HACCP-type plans. This would include local breadmakers, cheesemakers, jam-makers, etc. Notably, this does not require businesses to actually produce safe food; rather, it’s a paperwork system that requires businesses to write a long, detailed plan discussing every step of their process. The government then inspects that paperwork. HACCP was required for meat processing in the 1990s, and it helped lead to the loss of many small slaughterhouses, without preventing the many contaminations that have occurred in the big meat processors since then.

    We have fact sheets about the bill posted at http://farmandranchfreedom.org/food_safety_bills_09

    We also have information about the Tester-Hagan amendments, which would exempt small-scale and direct-marketing producers from these provisions of the bill. These producers would remain subject to the regulations at the state and local level, such as those for commercial kitchens and retail food establishments.

    In essence, we’re asking that Congress direct FDA to regulate the centralized, industrial food system that has been the source of all the major foodborne illnesses, without imposing unnecessary and unsuitable federal regulations on small farmers and small businesses that have NOT caused major problems.

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

    @Harry: I visited you site. Interesting proposals. Any response to this would be welcome:

    (1) GENERAL RULE- The amendments made by this section shall take effect 18 months after the date of enactment of this Act.

    (2) EXCEPTIONS- Notwithstanding paragraph (1)–

    (A) the amendments made by this section shall apply to a small business (as defined by the Secretary for purposes of this section, not later than 90 days after the date of enactment of this Act) after the date that is 2 years after the date of enactment of this Act; and

    (B) the amendments made by this section shall apply to a very small business (as defined by the Secretary for purposes of this section, not later than 90 days after the date of enactment of this Act) after the date that is 3 years after the date of enactment of this Act.

    That is from the HACCP section. To me, it seems that the one-size-fits-all fear is scare-mongering in order to exempt big business. It doesn’t appear that small ranchers, farmer’s markets, CSAs, etc. are specified in this bill. It would be up to the Secretary of Agriculture to implement the bill at their level. The government typically considers small agriculture as $75k annually. By proposing exempting businesses under $500,000 from regulations, your organization is advocating exempting big business. Wouldn’t this do just what you are saying you fear, by making small businesses compete with those making above $75k?

    Very small businesses are typically under 20 employees. Are you seriously suggesting they compete with a $500,000 business that you propose to exempt?

    I’d be very interested to understand how you purport to represent small farms.

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

    Excuse me. “By proposing the EXEMPTION of businesses under $500,000″.

    My apologies for the grammar.

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

    @Judith&Henry: I am very sorry for my mistake. The correct figure for what the U.S. Small Business Administration considers to be a “small business” in agriculture is $750,000. Not $75,000. Please except my apologies. It was a break in faith.

    Nonetheless, what do you make of the allowance for the Secretary’s discretion.

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

    I hope everyone will acknowledge that I made an effort to be open-minded during this discussion. I have made some mistakes, one of which I will correct in just a moment. That being said, I have read the text of the bill and referenced the Food, Drug, and Cosmetic Act when appropriate. I hope that a few key points will put this thread to bed. I invite anyone who disagrees to continue the discussion in a civil manner on my blog and I will post an entry today to make this possible. Dr. Nestle has been very accommodating, and I’d like to thank her for her valuable patience.

    1. I referred to the authority in this bill as being bestowed upon the Sec. Of Ag. It would go to the Sec. of HHS. Sorry for the confusion.

    2. After reading the bill, one finds that it clearly exempts “farms and restaurants”. This is very clear.

    3. It provides numerous directions to the Secretary to make provisions that would consider small businesses. This includes the collection of fees, regulation of produce sold directly to the consumer, and traceback requirements.

    4. It maintains current guidelines on low-acid canning, seafood, and juice.

    5. It protects organics from undergoing any changes that compromise their current standards.

    I honestly hope this dispels any fears you might have had in regards to the Food Safety Modernization Act. I find the bill quite well-crafted and would support its passage.

  • Harry Hamil

    @Michael Bulger:

    What blog is that? I found a lot of “Michael Bulgers,”

    1. This fact is VERY important. Sec. 105 requires the “Secretary…to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.” HHS has almost no experience and expertise in the production of crops which become food. Why is it being granted such huge authority over all farms in the America?

    2. To which part of S 510 are you referring? Sec. 103 HARPC does not contain any form of “farms” or “restaurants.” Rather, they are brought in via the definition of “facility” from the 2002 Bioterrorism Act which clearly says “Such term does not include farms; restaurants; other retail food establishments;…” Yet, because of definitions promulgated by the FDA (21CFR1.227) were designed for agriculture in the global, industrial food system not local food systems, tens of thousands of small farms are also facilities.

    3. Absolutely true and even more are in the Bill Manager’s Mark. Unfortunately, in the real world this means very little. As well demonstrated by the Bush Administration’s oversight of the National Organic Program (NOP); the “Secretary” in charge of something can largely do what s/he wants to do as long s/he jumps through the hoops that give the appearance of taking things into account. All the “Secretary” has to do is say, “I disagree with this comment.”

    Ask the Cornucopia Institute how well the NOP has been enforced since its inception and how much effort the Cornucopia has expended to require its enforcement. Small agriculture doesn’t have the resources (time or money) to withstand federal rulemaking.

    4. Agreed, they are “deemed [in] compliance.” Of course, seafood and juice already have HACCP requirements that have caused the closing of quite a few small businesses. Furthermore, the current low-acid canning requirements can be changed to a similar HACCP requirement with simple rulemaking changes. Dairies, bakeries and many other processors will still have to generate HARPC plans.

    5. There is no such “protection” in the 12-18-09 version of S 510 approved by the Senate’s HELP Committee. It is reported to be in the Bill Manager’s Mark but the Bill Managers have not released the version of S 510 that they hope to bring to the floor. Furthermore, my comment on #3 applies here.

    I hope it is obvious from what I have written, Mr. Bulger, that you haven’t dispelled a single iota of my fear about the impact of S 510 (and HR 2749 is even worse) because my fear is based upon knowledge of the actual language of S 510, the current Code of Federal Regulations (CFR) and my knowledge and experience of local food systems.

    But this is only a portion of the problems of S 510. There are others that have gotten ZERO attention.

    For example, no one, except me, points out the impact of S 510’s requirement of HARPC plans of all businesses that “hold” (i.e., store) food even temporarily. The inclusion of “holding” food in the definition of facility is why so many of the facilities registered under the 2002 Bioterrorism Act are food distributors and storage facilities. By their very nature, they only “store” and “transport” food. They don’t do anything to it; therefore, they can’t implement preventive controls greater than the existing Good Handling Procedures (GHPs) and recently update FDA rules for transporters of food unless them become processors, too.

    HARPC plans are completely ineffective and inappropriate for these parts of the food system. I can’t find a single case of an outbreak that began at one of these facilities. Yet, they will have to spend lots of money to create plans that appear to be useful. As I am a small food distributor, I know this first hand. I will only be able to continue distributing food because of our store’s exemption from registration as a “facility” because it is a “retail food facility.” I won’t be able to spin it off or expand it very much.

    I find the S 510 astonishingly ineptly crafted. It demonstrates that either its authors have a very limited knowledge of how our food system actually works or a partially hidden agenda.

    As always, I will happily defend everything I have written, if you or anyone writes me at healthyfoodcoalition.org.

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

    Click on my name, Henry. There you will find my blog. In response to each of your points:

    1. The FDA does know food pathogens.

    2. It references the Food, Drug, and Cosmetics Act not the Bioterrorism Act. You seem to be looking at the wrong act. If you download the pdf file here: http://thomas.loc.gov/cgi-bin/query/z?c111:S.510: You can find the exemption on page 122, line 14. Additionally, throughout the bill it uses the term “facility” or variations thereof as per the definition found in Section 415 (21 U.S.C. 350d) of the Food, Drug, and Cosmetics Act. This definition clearly excludes farms and restaurants. See page 134, line 7 for its use in connection with HACCP.

    3. Using this as an excuse to allow big processors to go on as they are would amount to being paralyzed by fear. Demonizing the people who work for the FDA in the interest of public health and glorifying corporations that are contractually bound by profit is not productive.

    4. Have you ever operated a HACCP plan? For a small bakery, this would be simple. A written plan for refrigeration, trash disposal, rodent control, etc. and the documentation of failings would be sufficient. Here’s a sample: http://www.be-sy.org.uk/pdfs/PDF%20Science/Fletchers/2.5%20FletchersHACCPanalysis.pdf. It might look more complicated than it is to you, I’m sorry. You can see that the control measures are things like having a refrigerator that works and checking temperatures regularly. That’s just common sense.

    5. Page 142, line 18. Standards for for Produce Safety. Explicit protection extended to organic standards.

    You might find it ineptly crafted because you are referencing sections of the Bioterrorism Act of 2002. This bill is amending the Food, Drug, and Cosmetic Act, linked here: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm

    Does that explain?

  • Harry Hamil

    @Michael Bulger: I look forward to responding on your blog. As for this, I will respond in the same order as you.

    1. The fact that the FDA “know[s] food pathogens” is totally irrelevant to the point I made. One of the problems that those of us working to improve S 510 have is that S 510’s supporters seldom respond to the points we make. The FDA does NOT have the expertise to do what it is currently attempting to do and the time, energy and money it is already siphoning away from the local, healthy food movement is huge.

    2. As your link to Thomas doesn’t work, I went to the “as reported” version of S 510 on Thomas (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s510rs.txt.pdf) and found what you cited. The previous page says this exemption applies ONLY to “Records Inspection” of “Adulterated Foods” in Section 414(a) of the Federal Food, Drug & Cosmetic Act (FFDCA). It doesn’t apply to what we are discussing.

    Section 415 Registration of Food Facilities of the FFDCA (21 U.S.C. 350d in the US Code) was entirely created by the 2002 Bioterrorism Act. As I pointed out in my most recent previous comment, the U.S. Code clearly excludes farms, restaurants and other retail food establishments; however, the code does NOT define them. Rather, they were later defined by the FDA in the Code of Federal Regulations (21CFR1.227). The definition of farm in the CFR is very narrow and does NOT include many of the farms in the local, healthy food movement.

    3. I have NOT demonized anyone, Mr. Bulger. I have described the reality in which the local, healthy food movement (which includes those who began organic) is trying to produce healthy food for local markets. And how you stretch this to my “glorifying corporations” is beyond me. One of the main complaints of everyone in the local, healthy food movement is that S 510 lets the industrial ag off way too easily. S 510 does NOT address the primary sources of food-borne illness. You’ve got it backwards.

    4. No, I have never operated a HACCP plan. Have you? I do have a lot of experience in risk management which is the basis of HACCP and HARPC; so I understand their intentions, techniques and implications fairly well. Pascal Destandau of Pug’s Leap Farm has lots of experience with HACCP plans and he estimated that it would take 25-30 additional hours per week to administer the HARPC plan that HR 2749 would require for his goat cheese dairy in Sonoma County, CA. He estimated the financial cost as $50,000/year.

    Thanks for the bakery example. I had never seen it. You appear to have not noticed that this is only the part of the plan for baking one type of bread. It is NOT a full HACCP plan. EVERY other product/process must have a separate plan.

    In addition, this does not include the verification and validation required by S 510. The “monitoring procedure” column gives overall descriptions but not the details of the administration.

    Also, this does not show that those administering the plan have to have expensive training.

    This is far from simple and clearly more complicated than you recognized.

    5. Thanks for pointing this out. I had forgotten it is in the Chairman’s mark. Once again, it depends upon the administrators involved as to how it will actually work, particularly, as it gives the FDA the authority to overrule the NOP with the final phrase, “while providing for public health protection consistent with the requirements of this Act.”

    As I pointed out above, one of the things the 2002 Bioterrorism Act did was amend the FFDCA. However, what I declare as being “astonishingly ineptly crafted” is S 510. In part, that is because S 510 used a section of the FFDCA designed to combat intentional acts (including bioterrorism) to address problems which arise unintentionally.

    Finally, Mr. Bulger, I applaud your attempt to address my responses to your points. Very few supporters of S 510 do.

    Now will you please respond to what I have just provided and address the additional issue I raised in that comment of the inappropriate application of HARPC plans to businesses that only “hold” and/or “transport” food. Also, in the “Older Comments” there are additional points raised by others, particularly Judith McGeary, and me that you haven’t addressed. So, there are still lots of objections that you will have to overcome before I will support S 510.

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

    1. This bill is designed to promote safe food. Nobody is trying to squash production of squash. It comes down to whether or not you trust the FDA.

    2. So, you concede that the exemption exists. Additionally, your concerns about definitions seem to extend only to a fancied interpretation of the law. If it is your choice to imagine nightmare scenarios of the abolishment of farmer’s markets, so be it.

    3. Denying this bill would be “letting industrial ag” off easy. Do you propose to do nothing?

    4. Yes. I am trained in HACCP. If you have safe business practices already, you should be all set. Just write them out and keep track of them. If Mr. Destandau feels he is 25-30 hours and $50k behind on HACCP, I’d be concerned about the state of his operation. Besides, he’d still be able to comment publicly and urge the Sec. of HHS to consider the size of his business.

    As for the bakery example. Once again, this seems to be more complicated to you than it is to me. Different types of bread can be stored and processed using the same equipment. Maybe you’d need redundant paperwork (i.e., writing bake sourdough bread and bake rye bread on two pieces of paper once in a blue moon), but you wouldn’t need to buy another oven.

    Administering a plan is not complicated and it is not expensive to receive training. You can do it online for about $50 and it does not have to be renewed annually. Some certification programs offer discounts for groups.

    5. Once again, you seem worried about a broad misinterpretation of law. To the same extent you could attack any law on these grounds such as what defines a “person” or a “residence”.

    I hope you are satisfied. If you continue to have fears of government agents bypassing the IBP slaughterhouse and coming to take away your backyard chicken, I advise you to reassess whether or not you should be expending your energy reading law. I think the authors of this bill have shown quite clearly that they intend it to respect small, local, and organic farms. Having been certified in food safety and sanitation, I have experience with HACCP and find that it is not at all challenging for any business already producing safe food.

    As for Judith McGreary and her organization FARFA, I have just posted a blog entry about their attempts to sneak larger farms into exemptions from regulation. A real supporter of CSAs and farmer’s markets would not buy into their plan.

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

    Mr. Bulger, I have responded to both your flawed substantive arguments and your unfounded ad hominen attacks on your blog. I have spent the last several years working as a full-time volunteer to support the local foods movement, along with being a sustainable, small-scale farmer myself. Moreover, many of the groups who support the Tester Amendments have proven over many years to be supporters of local foods. People can see the list of groups at:
    http://farmandranchfreedom.org/sites/farmandranchfreedom.org/files/Amend-S510-June-7.pdf

    To respond to your substantive comments on this blog:

    1. I find the statement “it all comes down to whether or not you trust FDA” to be a strange basis for supporting a bill. Are you recommending that Congress pass a bill that completely overhauls our food system in this country based on the nebulous concept of trust? And who are you suggesting we trust? President Obama, as the leader of the executive branch? Secretary Hamburg? But who will be in their positions in 5 or 10 years? Do you want people to trust Michael Taylor, the current Deputy Commissioner of Foods, who has a long history of connections to Monsanto? Or are we supposed to determine whether we trust the thousands of individuals who work for FDA?

    If you mean we should “trust” the agency as a whole, let’s look at its history. This is the agency that has opposed labeling of genetically modified foods, so that consumers don’t have the ability to make informed choice. This is the agency that has repeatedly approved drugs and medical devices that were later shown to be dangerous and/or ineffective. This is the agency that, in the midst of complaining that its budget is too small to effectively inspect huge food processing plants, somehow finds the money to take enforcement actions against local co-ops. http://www.grist.org/article/food-five-tips-for-surviving-a-raid-on-your-farm-or-food-club/

    Yet, despite having solid grounds to not trust FDA, I don’t suggest that people oppose the bill on that basis. The bottom line is that administrations and personnel change over time. If the provisions of the bill can be abused, then they need to be changed before Congress passes it, so that we’re not dependent on the goodwill of agency personnel.

    2. Yes, there is an exemption for “farms” from the requirements for facilities. That does not mean that the concerns are based on “fancied interpretations”

    a) The exemption does NOT exempt farms from the bill’s provisions for FDA to adopt “produce safety standards,” which will govern how farmers can grow and harvest their crops

    b) If you look at the language of the exemption, it is extremely narrow. The FDA’s guidance document says a “farm” is not a “facility,” but only if the farm does not sell any processed goods. The definition of processing is extremely broad and covers almost everything other than fresh-cut produce. So a farmer that makes sun-dried tomatoes, jams from their own fruits, mixed frozen fruits, or any number of other value-added products would NOT be a “farm” under FDA’s definition and WOULD be subject to the bill’s HACCP-type requirements.

    3) You are setting up a false choice between supporting a flawed bill and doing nothing. Many of us are concerned that the bill does not address the real sources of the food safety problems:

    a) We cannot effectively address microbiological contamination of produce without addressing CAFO’s. There’s excellent science showing that e. coli 0157:H7 is rarely found in wildlife or grass-fed cattle, but is much more common in concentrated, grain-fed cattle. The continued avoidance of this issue creates a huge loophole.

    b) Substituting paperwork inspections for actual inspections does little to improve food safety, while providing political cover for large companies. Congress needs to focus resources on actual inspections, not HACCP.

    c) The GAO and others have identified that one of the core problems with food safety is the consolidation of our food supply, which allows contamination at one farm or in one plant to sicken thousands of people across the country. Yet the advocates of S.510 simply ignore the threat of increasing consolidation. Any food safety bill should include an analysis of how its requirements will affect small, local producers, and encourage decentralization. This is not just about fairness for the producers themselves – it’s a necessary piece of addressing food safety.

    4) Based on the website link, your HACCP example appears to have been from the UK, not the U.S. We’ve repeatedly asked for anyone who has an example of a simple HACCP for U.S. products – and no one seems to be able to produce one. You are also rather cavalier in brushing off the point that a HACCP like the one you linked to (or even more complex) would have to be done for each product. My local baker makes a dozen different breads. Some of them involve fermenting. Some involve fruits or nuts. Some involve unusual spices or seeds. The ingredients are sourced differently, the preparation varies, and the baking varies. All of these would have to be addressed separately. How many small businesses can afford to have an employee spend the time on all this paperwork? Or will they have to hire a specialist trained in HACCP, and at what cost? The very nature of HACCP favors big businesses that do large quantities of products, rather than small, artisan producers.

    5) The protection for organic standards only applies to certified organic operations. Many small sustainable farmers are not certified by USDA because of the expense and paperwork burdens. Moreover, the protection for certified organic producers only requires FDA to not “include any requirements that conflict with or duplicate the requirements of the national organic program.” But the FDA can still add additional, burdensome and unnecessary requirements even for certified organic producers. While the protections for certified organic producers are a positive step, they are a far cry from what is needed to ensure that small, sustainable farmers are not driven out of business.

    Prior to becoming an activist, I was a practicing attorney and a significant portion of my practice involved administrative (i.e. agency) law. Having analyzed the language of the bill, I am far from satisfied that it “respects small, local and organic farms.” To the contrary, it appears to be based on the myth that all food should be subject to FDA regulation in order to be safe, and it leaves FDA with extensive discretion over even the smallest of farms and food producers.

  • Harry Hamil

    Unfortunately, the disinformation that is being put out by Michael Bulger is in keeping with that put out by the majority of the supporters of S 510.

    He doesn’t have the “ears to hear nor the eyes to see” anything which contradicts his view.

    Do I trust the FDA’s handling of food? Of course not! It has an abysmal record. The FDA’s incompetence and failure to use its existing powers are key reasons for a number of our problems. Those of us who actually grow, pack, process, distribute and retail food have ZERO recourse and have lost hundreds of millions of dollars because of the FDA’s incompetence.

    And the FDA will remain incompetent as long as its senior administrators continue to be unaccountable.

    Finally, FARFA is a true grassroots national organization that has led the fight against NAIS and is one of the leaders in the fight for legislation that will actually improve the safety of food. As Judith McGeary wrote earlier and Michael Bulger ridicules on his own blog, the Tester-Hagan amendments are supported by over 155 national, regional and local organizations. I urge you to read the list of organizations that have signed the letter at http://farmandranchfreedom.org/sites/farmandranchfreedom.org/files/Amend-S510-June-7.pdf. I am a member of 2 of the signers and personally obtained 5 other signatures. Michael Bulger’s disparaging remarks about FARFA are false and despicable.

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

    Wonderful. I was wondering if you two had checked out. Before I begin point for point, let me draw everyone’s attention to what Judith failed to respond to from my blog. Her organization, FARFA, is hoping that the Tester-Hagan amendment will be included in the bill with an exemption for facilities who’s adjusted-gross income is below $500,000. That is income after deductions (which might include labor, fuel, etc. and be quite substantial). For a business to do enough sales to generate $500,000 AGI, they would not be what I consider small and local. To use her example from my blog, her “small” jam-maker with a $499,999 AGI would have to sell approx. 93,750 jars of jam at an high price of $8 a jar. Is it just me, or is that a lot of food?

    Is Judith honestly trying to say that a business that big is going to be crippled by a $500 registration fee? Or is she trying to sneak big business in with actual small farms?

    Now.

    1. Judith has seemed to validate my argument in her last paragraph. She feels that term-limits leave us susceptible to tyranny. It stems from either a lack of trust in government or a lack of confidence in the ability of the food industry to produce safe food. If she responds with another round of “she’s looking out for small producers”, I direct you to my preamble.

    It seems more desirable to Judith that there be no regulation of our food system. From my perspective, Judith trusts the industry to take care of itself without outside interference, but doesn’t trust the government to participate in food safety judiciously.

    2. The language of the bill is very clear that care is to be taken to not burden small producers. There will be an ensuing public comment period where the definition of “small” will be defined for the purposes of these amendments.

    Judith and FARFA would rather go ahead and ensure their big farms and packers are exempt with an amendment. They don’t want to wait for people outside of their industry to consider the size of their operations and set the thresholds for who is exempt at a lower level than FARFA wants.

    3. a) I am no fan of CAFOs and this bill would allow the FDA to do more about the microbial contamination than it is authorized to do now. Supporters of a safer food supply would welcome more inspections. The idea that the FDA is going to be rooting around in a lettuce patch and not focusing their resources on large producers is silly. This bill targets the problem areas of the food system and gives the FDA authorization to intervene when appropriate.

    As for grass-fed vs. CAFO meat, while I agree that CAFOs create conditions favorable to bacterial growth, grass-fed operations are not beyond contamination. The recent bison-meat recall is one example.

    b) Substituting paperwork for actual inspections wouldn’t improve food safety, you’re right. I was not suggesting that at all. However, having paperwork would assist in the response to outbreaks and allow inspectors to identify weak points in a system. Opening your eyes when driving isn’t a substitute for steering, but it sure does help. (Sorry, that was too easy).

    c) I’ve come to consider myself an advocate of this bill’s passage, a lively public comment period, and its common-sense implementation. I whole-heartedly support a reexamination of the current centralization of our food system. This bill should do nothing to further centralize our food supply, and indeed will not have that consequence. I find your point here erroneous.

    4. That the particular HACCP plan I linked to was from the UK is quite irrelevant. The point of that sample was to illustrate the type of paperwork and procedures that you seem to think would be a burden that could cripple our jam-maker. If they already produce safe food, it will be a simple matter of paperwork. If that seems cavalier to you, I am surprised. I personally find filling out “refrigerate” on a piece of paper very simple and it does not take long.

    As far as HACCP training, I’ve already pointed out that it can be done online for around $50. That doesn’t seem like a lot of time or money for our jam-maker.

    5. To certify organic, your “small” AGI $500,000 farm would have to pay about $2,500. That doesn’t seem like much, and would likely be easily made up in sales and higher market prices. In this section of your post, you once again diverge into the mindset of fear of oversight. Your imagined burdensome regulations are just catch-points that you have failed to illustrate. When you conjure them outside of the realm of non-specific rhetoric, I’d be happy to ponder them.

    Congratulations on your career in law, Judith. This bill does not grant you the power to set the level of AGI for what will be considered a small business for the purposes of this amendment to the Food, Drug, and Cosmetics Act. Your lack of satisfaction with that is apparent, I assure you.

  • Harry Hamil

    @ Michael Bulger: What claptrap!

    Your glossing over the full costs of specific regulations is only less dazzling than your conviction that you know everything important in these matters. You make lots of statements with few cites. And the cites you give (e.g., to the partial HACCP plan from the UK) don’t do support what you say. And when both of us individually point out that it is only ONE part of the full HARPC plan that will be required of bakers, you ignore us and change the subject.

    For those who truly want to understand how difficult the HARPC plans are, please see “HACCP for Salad Greens” (http://buylocalfood.org/page.php?id=285). The full feasibility study was done in late 2009 for Community Involved in Sustaining Agriculture (CISA) in western MA.

    You suggested, Mr. Bulger, that we move the discussion to your blog and then you blocked my posts on both of your blog entries.

    I guess that you have some power that we don’t have, namely, the ability to make amendments to legislation in the U.S. Senate. If Tester-Hagan is not included in the bill manager’s mark, then our choice is between that version, that version amended by the Tester-Hagan amendments or to oppose S 510 entirely. We don’t have the power to introduce amendments.

    If we are going to err on the size of businesses protected, then we will include some that are larger than might be needed because if we err too small, people will be put out of business and there won’t be a second chance to save them. Tester-Hagan will save what S 510 would destroy with its industrial-size-only approach to food safety.

    At the same time that the FDA is crying for new powers, in an existing federal case questioning it power in Georgia, the FDA filed a brief on 4-26-10 (see http://www.farmtoconsumer.org/litigation/ey100426–ds%20mtd%20memo%20in%20support.pdf) claiming to already have every one of those powers except mandatory recall. And we aren’t opposed to that. We simply want recourse for those hurt when the FDA screws up, as it regularly does.

    The FDA is claiming to have these powers under the Public Health Service Act (PHSA) including the ability to control ALL sales of food including intrastate ones. The Federal Food Drug and Cosmetic Act (FFDCA), on the other hand, clearly prohibits such action.

    As you seem to desire to have the final word, Mr. Bulger, have at it. This is my last post.

    How about you include a bio that can be corroborated on line as Ms. McGeary’s and mine can? We have each spent over a decade producing healthy food sold to local people. We have each donated thousands of hours working to expand the availability of local, healthy food locally, regionally and nationally. What have you done for our movement?

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

    Michael,

    Your accusation that I am trying to “sneak” in Big Ag is very strange, given that the text of the amendments I support are quoted, word-for-word, in the letter of support posted on our website. Everything I’ve done is out in the open, and I invite anyone to check out who I am and what I work on.

    I never raised the specter of tyranny. You had claimed that the issue was whether we “trusted FDA” or not. I used specific examples to show why “trust” is a nebulous concept in the context of agencies, and provided my view that the actual language of the law is the issue. I made a point that many people seem to ignore: laws stay in place beyond the current administration and people involved.

    You continue to promote the false claim that we either pass S. 510 and give FDA power to regulate all food producers, or the industry is left with no regulation. And you’ve pushed it one step further to portray me as an anti-government proponent of no regulation. Both are false. There are extensive state and local regulations already in place, and the amendments I support would not change the state and local regulations in any way. So, in your example of the person selling $500,000 worth of jam, that person would be subject to their state’s and municipality’s regulations for commercial kitchens and retail food establishments.

    The only issue is whether there needs to be an ADDITIONAL layer of regulation by the FDA on small-scale producers and direct-marketing farmers. Notably, none of the advocates of S. 510 have been able to show that the local and state regulations are insufficient to address small-scale food production. There’s been rhetoric about the differences among state regulations, but absolutely no data showing that any producer who would be exempt under the Tester Amendments has caused any significant foodborne illness outbreak. Instead, while pointing to the problems that have been caused by Big Agribusiness, the advocates of S. 510 repeatedly insist that all food producers need to be subject to FDA regulation.

    Compared with the scope of the industrial food supply, yes, I do consider $500,000 AGI a small business. The Small Business Administration categorizes anyone grossing under $750,000 in sales in agriculture as a small business. While AGI allows for some deductions, it still is closer to gross sales than net profits. In contrast, the big companies, such as Kraft, Smuckers, Ms. Bairds, ADM, Cargill, Tyson, etc. gross in the billions of dollars, with PROFITS in the hundreds of millions or even billions.

    I have spoken with multiple farmers and artisan food producers who gross between $250,000 and $500,000. These are labor-intensive businesses with high overhead. Most of them have profit margins of between 10% and 15%, often with both spouses working on the farm or business. So their income for both spouses combined is typically between $30,000 and $75,000.

    The issue is not simply a $500 registration fee (which is actually in the House version of the bill, not S. 510). The issue, as set out in comments above, is the entire HACCP process. You have chosen to look only at individual pieces, providing one example from the UK (which would not necessarily be approved by FDA) of a 4-page HACCP that covers just one product, and then dodge the issue of how many different versions of this 4-page chart would have to be developed by an artisan baker or cheesemaker. The real-world experience in the local foods community is that the implementation of HACCP requirements on small-scale slaughterhouses in the 1990s caused many to go out of business.

    In fact, you seem to reduce all the costs to food producers to mere filing or registration fees. For example, your comment about the cost of certifying organic ignores all of the requirements that go into certifying a farm. You can’t just pay a fee. You have to fill out extensive paperwork, document everything you buy or even try to buy (for example, if a farmer can’t find certified organic seeds, the Texas certification agency says that the farmer has to provide phone logs of calls with 4 companies showing who they talked to for each and every different crop they plant), deal with inspections, and many other things that take both time and labor. Any small business owner knows that time and labor are in short supply, and that additional paperwork requirements inevitably favor the large businesses who can afford to have employees devoted solely to tese tasks.

    You also appear uninterested in dealing with the real substance of the amendments since you ignored my explanation on your blog of how you have mischaracterized the amendments. As I explained at length on your blog, there are two different amendments: one that deals with “farms” and one that deals with “facilities.” The exemption for farms is for those that direct-market their fruits and vegetables to consumers and other end-users.

    The exact text of the proposed amendments is posted at http://farmandranchfreedom.org/sites/farmandranchfreedom.org/files/Amend-S510-June-7.pdf We also have several fact sheets posted explaining what each amendment does and does not do.

    1) The first proposed amendment is for FACILITIES (not farms) that have an adjusted gross income of under $500,000. This addresses small businesses that process foods, such as people who make bread, jams, and cheeses. These businesses have to buy the raw ingredients and comply with the regulations governing commercial kitchens and retail food establishments at the local and state level. These are precisely the types of small-scale processors who sell foods at farmers markets and through local co-ops.

    You repeatedly claim that we’re dealing with hypotheticals, Michael. Yet I can have spoken with several food producers who fit this exact profile. In contrast, none of the advocates for S. 510 have been able to point to a “Big Agribusiness” that has an AGI of $500,000.

    2) With respect to farms, the proposed amendment would exempt farmers who sell more than half of their products directly to consumers, restaurants, hotels, and institutions. These are the farms who provide fruits and vegetables to people through CSAs, farmers markets, local restaurants, and farm-to-school programs. Again, none of the advocates of S. 510 have provided any evidence at all that the direct-marketing farmers have been the source of any significant foodborne illness outbreaks.

    There’s room to discuss how to modify the amendments to ensure that we don’t create loopholes for Agribusiness. And I welcome that discussion with anyone who is serious about addressing the real-world concerns of small food processors and direct-marketing farmers. I can be contacted through FARFA at Judith@FarmAndRanchFreedom.org

    Michael, the final word is yours if you wish. I will stand on the comments I’ve made.

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

    You say there is no evidence that your versions of small-scale producers have been associated with any “significant” outbreaks. First of all, I’m not sure what you’d consider significant. Serious illnesses are significant in my mind, whether they sicken or kill ten people or a hundred people. Secondly, small-scale producers are indeed associated with foodborne illnesses. I will even provide some links:

    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

    Unregistered Canadian producers blamed for 500 Salmonella illnesses: http://www.vancouversun.com/health/Eggs+imported+from+blamed+rise+salmonella/3051842/story.html

    I could go on, but I think the point has been made. Local, direct-marketers and farmers markets are not beyond outbreaks. State and local regulations are an important part of the food safety system, but more resources and guidance is needed. The Institutes of Medicine recently reviewed the system and recommended Congress give the FDA the authority to take the lead on food safety. The report is here: http://iom.edu/Reports/2010/Enhancing-Food-Safety-The-Role-of-the-Food-and-Drug-Administration.aspx

    S. 510 will enable the FDA to fill in the regulatory gaps that exist within states and local communities.

    As for the Tester-Hagan amendment and you’re figures regarding AGI exemption, when you compare a smaller producer to an agricultural giant it detracts from the issue of units sold. The amendment would exempt food businesses that distribute to a large number of consumers. Hundreds of thousands of customers might not seem like a lot when you compare the number to millions, but it is nonetheless a significant number. I have already shown that the Tester-Hagan amendment would exempt businesses that have the potential for causing serious foodborne illness outbreaks.

    As you continue on in your last post, you claim I am dodging the issue of paperwork. Judith, you’re mistaken. I’m just having a hard time responding to your complaint that multiple pages of HACCP paperwork is somehow cripplingly burdensome. I find the notion laughable. It is hard to understand your unreasonable aversion to filling in charts.

    If a producer already has safe practices in place, the additional requirements should be easily met. To use the burden of organic certification as an example of government holding down small farmers is almost (almost, not as) ridiculous as your fear of charts. Organics are the fastest growing segment of the food industry. The federal government offers cost-share funding and certification fees are reduced for small farms. Similar provisions will be discussed during S. 510’s public comment period.

    Judith, your amendment would exempt businesses whose scale allows them to reach a large number of consumers. These businesses are not above causing outbreaks, indeed I have shown a sample of such incidences. To exempt them in the text of this bill would be irresponsible to the public. There exists in the text of the Food Safety Modernization Act language that explicitly instructs the Secretary of Health and Human Services to be responsive to the needs of small facilities. During the public comment period, meetings will be held at different locations around the U.S. and there will be ample opportunity to submit opinions.

    This bill should pass, and soon, without the addition of the Tester-Hagan amendment. The exemption therein is far too broad and not realistically tailored, nor refined enough, for the purposes of this bill. The protection of small businesses is important and that is why I think it should be done after the passage of this bill.

  • sharpinla

    How many taintings are from small farmers? Do you recall the last time a “mass recall” occurred and 500 pounds of beef was recalled?

    No? Gosh, why is that? Because it is the big agri/farmer/growers that have poor conditions, cutting corners to get profits-profits-profits, it’s about the profits, not the animals, the soil and the ultimate consumer of the product.

    Small farmers KNOW their customers, they are often family, for sure friends, people who CARE about their communities. They don’t ship tens of millions of pounds of product across the nation and globe, impacting millions of people with potential taint; in fact in their lifetime they could never produce the amounts being recalled today.

    People need to take probiotics now as a supplement because all the natural good bacteria (found in food milk products) has been homogenized and pasteurized out of our food. Gee, I wonder if that’s why so many have digestive problems. Yes, it is.

    Plus, was this nation not built on people getting their produce locally and eating it hours after harvest (versus days and weeks when you have to rely on a food source in another state that has to ship it to you), reaping the most nutritional benefit?

  • Rachel

    For somebody who bemoans being yelled at, he sure doesn’t seem to have a problem with snarky and passive aggressive come-backs. Clearly everyone needs to be concerned with food production safety but we must do our best to give small scale, whole foods producers the chance to get their healthy products to consumers!

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