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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

A Friday and Saturday night read – H.R. 2749 – Food Safety Enhancement Act 2009 – So, what’s really in it?

It is clear that most of the people chattering across the Internet on either side have never read the bill (arguably, many who voted on did not either). Below is a summary as I read the bill. In order to effectively read it, you have the Food, Drug and Cosmetic Act, Chapter IV open to track the amendments and changes – especially the definitions. So, here we go – H.R. 2749 – Food Safety Enhancement Act 2009:

State Law not preempted.

USDA Regulated Food products exempt from the requirements of the Act if the facility is regulated exclusively by the USDA. This includes Farms that are regulated by the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.  Read the following carefully, it should help explain that farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer are exempt.  (1) DEFINITION OF FACILITY.—Paragraph (1) of section 415(b) (21 U.S.C. 350d(b)) is amended to read as follows:  

(1)(A) The term ‘facility’ means any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.

“(B) Such term does not include farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any successor regulations).

“(C)(i) The term ‘retail food establishment’ means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).

“(ii) Such term includes—

“(I) grocery stores;

“(II) convenience stores;

“(III) vending machine locations; and

“(IV) stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals.

“(iii) A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.

“(D)(i) The term ‘farm’ means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.

“(ii) Such term includes—

“(I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;

“(II) such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;

“(III) such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;

“(IV) such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; and

“(V) a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.

“(iii) Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.

“(iv) The term ‘harvesting’ includes washing, trimming of outer leaves of, and cooling produce.

“(E) The term ‘consumer’ does not include a business.”

Alcohol-Related Facilities exempted.

Require yearly registration for domestic facilities and foreign facilities that export to the United States. Much more detailed requirements to explain the type of facility, what is produced and contact information. Registration can be canceled or suspended for violations of the Act.

Fees Relating to Food – Beginning 2010 an annual fee will be collected of $500 from each registered facility, not to exceed $175,000 for multiple facilities. Fee is to offset inspection costs and food safety activities. The fee provision even has a “sunset provision.”

Hazard Analysis, Risk-Based Preventive Controls, Food Safety Plan, Finished Product Test Results From Category 1 Facilities. This includes the facility conducting a hazard analysis, identifying and validating preventive controls and keeping records of such efforts. The HHS Secretary may establish by regulation or guidance preventive controls for specific product types to prevent intentional and unintentional contamination throughout the supply chain. HHS Secretary will review international standards.

HHS Secretary may exempt from compliance facilities that are solely engaged in a) the production of food for animals other than man or the storage of packages foods that are not exposed to the environment, b) the storage of raw agricultural commodities for further processing.

HHS Secretary shall consider the impact on small business in making rules and regulations.

HHS Secretary may take into account the differences between food intended for human or animal consumption.

Finished Product Test Results from Category 1 Facilities will be required to be submitted to HHS Secretary.

HHS Secretary will review and review and evaluate epidemiological on significant food-borne contaminants.

HHS Secretary shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting, and holding raw agricultural commodities, and shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection efforts and organic production methods.

Inspection of domestic and foreign manufacturers will be pursuant to a risk-based schedule. Category 1 – high – risk facilities – inspected once every 6-12 months. Category 2 – low – risk facilities – inspected once every 18 months to 3 years. Inspections can occur more frequently depending on the type of food and facility compliance.

Each person who produces, manufactures, processes packs, transports, distributes, receives, or holds an article of food in the US or for import to the US shall produce records (paper or electronically) bearing on whether the food may be adulterated. Records must be kept for 6 months to 3 years.

HHS Secretary shall by regulation establish a tracing system for food that is located in the US and for imports to the US. Direct sales by farms to consumer, restaurant or grocery store are exempted.

HHS Secretary can assess fees for violations and costs of additional inspection during recalls.

Imported food must be certified as complying with the Act.

Auditors and Laboratories must all be certified and audited. Test results of food items and environmental testing must be reported.

A facility shall recall an article of food, or ingredient, that presents a reasonable probability that it is a threat to human health. HHS Secretary may request a recall if the secretary has reason to believe the food is adulterated or misbranded. HHS Secretary my order a facility to cease distribution of a food product. HHS Secretary may order a recall.

Additional requirements on infant formula manufacturers to keep records and for additional clinical studies that the formula supports normal physical growth in infants. HHS Secretary must also report to Congress on Bisphenol A in food and beverage containers.  Also, a lead warning on ceramics was added.

The CDC shall enhance food-borne illness surveillance by coordinating Federal, State and Local food-borne systems.

HHS Secretary shall design and implement a national public education program on food safety.

HHS Secretary shall conduct food safety research.

HHS Secretary may seize food likely to have serious adverse health consequences and quarantine any geographic are of the US where the food originated after notification.

Criminal penalties increased to 10 years the penalties for selling misbranded or adulterated food.

Civil penalties now range from $20,000 to $7,500,000 for violating or knowingly selling misbranded or adulterated food.

Country of origin and disclosure of ingredients required.

A facility, including a farm, is prohibited against delaying, limiting or refusing inspections. HHS subpoena authority clarified.

Creation of a dedicated foreign inspectorate.

Whistleblower Protections – protections to employees who refuse to violate the Act or who disclose violations.

My suggestions as this moves to the Senate, Conference Committee and the President’s Desk:

1.  Raise more money – have a sliding scale based upon risk of contamination and size of operation.  Frankly, I would require registration of all who produce and sell food, but charge little, if anything, to farms that sell directly to consumers.  Raise enough money to actually fund all of this.

2.  Clearly excluded are all direct sales between farmer and customer (including direct sales to consumer, restaurant and farmer’s markets) from the necessity of most, if not all, the provisions of this legislation.  However, I would recommend and give resources so that State and Local Health and Agriculture authorities can work with farmers to produce safe food.

3.  Bottom line, regardless of size, if food is produced and put into the larger stream of commerce, the producer, small or large, must play by the same food safety rules.

4.  Perhaps not in this bill or the Senate version at this time, but we need to start dealing with creating a sustainable and regionalized agriculture.  We need to balance safety with environmental policy – both energy/global warming and protection of biodiversity.  We need a food policy that helps create healthy humans.

  • Helena

    Everyone who has been chattering should read this. I have been SO frustrated by the unbelievable amount of misinformation out there!

  • Ann Q

    Why are facilities manufacturing pet food excluded
    or exempted here? Has everyone forgotten all the
    Salmonella pet food recalls and how pet food can bring bacteria into homes? Has everyone forgotten the pet food recalls of 2007 except those of us who were victimized? In fact, animal feed and pet food should be included in this bill.

  • Sam

    So its sounding like pet food/animal feed is once again not included in any food safety requirements? People need to read Marion Nestle’s book, Pet Food Politics. Our animals are the canaries in the coal mine and you cant have safe human food if pet food/animal feed isnt also included, it wont work. Still hoping that the Senate version of this bill gets improved but have to admit at being skeptical. My guess is it will only get worse instead of better after the next round of changes.

  • Ray

    Nice analysis, many thanks! Having been with FDA and then Industry I can only hope that the Senate polishes some things that will be a diaster w/o adding anything to the Public Health. Stay well.

  • Thanks Bill for a thorough analysis. Also for the reminder that we are no where near done yet…this bill has a way to go before it reaches the Presidents desk.

  • @KyFarmersMatter

    Am going to have to agree with you here.
    The problem with this bill from the beginning was the “political” process. The bill should have never come out of committee looking as it did, which is what set the small producers/processors/farms etc… off in the first place. Unfortunately, now there are several different versions of this bill. Now the task of getting everyone who was against the original “versions” to understand and read the passed version. Oh the challenge!

  • Thanks, Bill, for the analysis. It’s of great help as I respond to questions about what’s in the bill. Also, I couldn’t agree more with your concluding statement: “but we need to start dealing with creating a sustainable and regionalized agriculture. We need to balance safety with environmental policy – both energy/global warming and protection of biodiversity. We need a food policy that helps create healthy humans.”

  • Brian Brandser

    “Bottom line, regardless of size, if food is produced and put into the larger stream of commerce, the producer, small or large, must play by the same food safety rules.”
    Great point. I agree-playing by the same food safety rules is key.

  • Too bad we have to have a specialty lawyer spend a nice summer weekend reviewing a piece of legislation to help us understand it…and even then there are important questions, to wit:
    1. Can HHS secretary require irradiation of meat and veggies or pasteurization of all milk based on this: “HHS Secretary shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting, and holding raw agricultural commodities, and shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms…”
    2. Is the FDA’s power to quarantine large areas of the country to counter foodborne illness at all subject to court oversight?
    3. Is a farm that has an intermediary sell its products at a farmers market considered to be selling direct? Does a farm that sells, say, 10% of its product to intermediaries and 90% direct, become completely subject to all the rules of HR 2749?
    4. How extensively can FDA search a food producer as part of reviewing its records without court-ordered search warrant?
    The fact that such basic rights are put in play by this legislation, and that the language is so vague as to be incomprehensible, is reason enough to reject it out of hand. Our rights are too precious to be left to the vagaries of technocrats at FDA.

  • David – thanks for the concerns about how I am spending my summer evenings. I’ll try and respond to your four points. One point of clarification, HHS Secretary can do nothing with meat or anything that is under USDA jurisdiction. Your point 1, HHS already does allow someone to irradiate certain veggies, but would have to go though rule making (with public input) and constitutional questions to require irradiation. On pasteurization of milk, it already requires it when it crosses state lines. Again, if it would make it required, it would have to go through rule making and constitutional challenges. Your point 2, within the legislation is an administrative remedy which would then trigger the right to go to Court. Your point 3, a farmer sells to a broker who sells to a farmers market? Interesting question. I think what the law is trying to get at is the small producer (like the organic farm in the 2006 spinach case) selling to a broker who then sells to a mass manufacturer. Frankly, I think it should be simple. If you sell a product that goes into a larger stream of commerce, other than direct sales to customers, restaurants, farmers markets – ie, direct sales, more oversight is needed. Your point 4, is the attempt to avoid the problems that happened is several large outbreaks where companies refused FDA requests for documents – including bacterial test results.

  • Mary

    Thanks for reviewing this legislation. Must not have been a fun way to spend the weekend.

  • Thanks for the quick response. Helps clarify. You definitely have more faith than I do in “administrative remedies”, “rule making” and that FDA won’t try to implement intrastate pasteurization requirement. I hate to hand over fundamental rights and trust in administrative and judicial remedies to set things right. Tends to be too late by then.

  • David – I do have faith in the rule of law and democracy. I am missing what fundamental right this legislation takes away from you?

  • Thanks for the quick response. Helps clarify. You definitely have more faith than I do in “administrative remedies”, “rule making” and that FDA won’t try to implement intrastate pasteurization requirement. I hate to hand over fundamental rights and trust in administrative and judicial remedies to set things right. Tends to be too late by then.

  • 1. Right to demand a search warrant before inspection of business records undertaken by FDA;
    2. Right to access the foods of our choice, should FDA implement pasteurization requirement on intrastate distribution of milk. (Language of legislation is clear, and you quote it, that HHS secretary “shall establish scientific based regulations…” No mention of public hearing, administrative review, etc.)
    3. Right to sell my food in a free market, should FDA implement a quarantine.
    Per your explanation, I’d have to seek administrative/judicial remedies AFTER the fact, when the horses are out of the barn–not easy for even skilled lawyer like yourself. Net net, food producers are LOSING key rights. I know it sounds overly dramatic to many here, but American soldiers are dying every day to protect these and other fundamental rights.

  • Bob Sanderson

    Thanks for the summary-
    Every 3rd party audit has its own slant, and unfortunately they can sometimes put more weight on less important things and overlook crucial things. I wonder if the FDA inspection criteria will be made up in an office in Washington? Would it make sense for different industries to communicate what they feel to be their critical inspection areas?

  • Marymary

    Um, a search warrant? Mr. Gumpert, you seem to be a well-meaning person, but why on earth would the FDA or any other pertinent regulatory agency need a search warrant to access business records?
    While your main concern appears to be access to raw milk, there is much more to the food industry than that. Unfortunately, I think your concerns about being able to access raw milk are coloring your perspective on the issue of FDA regulations and food safety in general. I used to do retail food establishment inspections. Sometimes those inspections required me to have access to business records, such as when trying to determine the source of an ingredient, meat, eggs, etc. Under your guidelines, I would have had to obtain a search warrant. Why should we insert criminal legal procedures into routine regulatory work?
    My job was to try to protect the public health, not to put people out of business. Frankly, many people should not have been in business due to their cavalier attitudes about food safety and the risks to their customers. Nevertheless, my agency (and our state dept. of health) bent over backwards to accommodate food businesses, sometimes, in my opinion, to the detriment of public health.
    Operating a retail food establishment, a wholesale food establishment, a food manufacturing and/or distribution center means that the premises are going to be subject to inspection, whether by local, state, or federal agencies. That’s just part of doing business in areas–such as food production–where there is a public health concern. The business records of a food producer, are vital in order to track supplies, suppliers, the finished product, etc. Those records are important to read during both routine inspections and investigations. As things stand now, apparently businesses such as Nestle are allowed to withhold HAACP plans and other records from the FDA. If the FDA had been allowed access to Nestle’s HAACP plan, perhaps they could have caught bad practices that Nestle would have been forced to correct. Perhaps the FDA could have prevented the recent cookie dough foodborne illness outbreak.
    Finally, there is no fundamental right to be able to operate a business in whatever manner you wish. None of our constitutional rights are absolute, none of them, not even the right to free speech.

  • Marymary

    Mr. Sanderson:
    From my experience, the food industry already has a lot of input into FDA regulations and policies. Some would say that they industry has too much input.
    I agree that third-party audits could be troublesome, but it depends on who is doing the audit and for what purpose. If someone like Mr. Costa is did handwashing and employee health “audits” at food manufacturers and distributors, I would be thrilled. He knows his stuff and is highly respected. If a third party reviewed HAACP plans for gaps and shortcuts, that could be good. FDA and/or USDA would still need to have access to the plans and to have the final say, however.

  • pete

    You have faith in the rule of law and democracy? Have you been paying attention lately? The rule of law went out the window long ago, money makes the rules now.

  • pete

    “we need to start dealing with creating a sustainable and regionalized agriculture”
    This will never happen while farms are subject to centralized federal and state regulation. It was regulation that killed our rationalized food system to begin with. You may not believe that, but I’ve talked to enough dairy farmers who got out because of the capricious grade ‘A’ rules. Same story for butchers.
    A farm will never be sustainable when its very existence is subject to the whims of a bureaucrat who often has your competitors interests more at heart than your own. This is the very nature of regulation and will always be a problem so long as we hold to the insane idea that other people can regulate our right to grow or access food.

  • Rick VanVranken

    Thanks for the analysis, though it’s a wonder anyone can ever figure out intent of legislation when it’s so full of DC-speak. Case in point —
    “I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;”
    –what farm consumes all of it’s own production?
    Second question–any clues in there as to what is an- “other retail food establishments”? Do retail grocers fit here? That would be ironic if they are exempt and will cause an uproar among their farmer suppliers as they are among the biggest pushers of this legislation.
    Lastly, I’m always amazed that we live in a country so blessed with an abundance and tremendous diversity of food that very few of us worry about where the next meal will come from, we take for granted that it’s safe to eat while we are living, longer healthier lives than anytime in history, yet “We need a [government] food policy that helps create healthy humans.”?
    Healthy Americans should be thanking the inexpensive food policy we do have coupled with modern production research and technologies for their quality of life. Additional burdensome and onerous regulations that do little to increase the actual safety of our food supply at a tremendous cost for compliance will threaten, not enhance, the viability and sustainability of our farms.
    Yes there are areas where prevention of potential food contamination can be improved, from the farm throughout the supply chain, but the bigger threats to healthy humans are lifestyle choices (you can lead a horse to water, but you can’t make it drink!) and distribution issues (urban food deserts for a variety of reasons).

  • Harry Hamil

    Your introductory statement (“In order to effectively read it, you have the Food, Drug and Cosmetic Act, Chapter IV open to track the amendments and changes √¢‚Ǩ‚Äú especially the definitions.) clearly shows the need for this bill’s revisions to be overlaid–with the usual strikethrough and italics techniques–onto the existing statute(s) and then published on the web. As you wrote, trying to understand what it says requires a lot of work. And as a small grower, distributor and retailer of food grown for local production, I am in the middle of harvest. Stopping long enough to read your review and write this comment means I won’t do some thing(s) that needs to be done TODAY. I need someone to do this overlay and publish it on the web so that I, and all the others like me who may be seriously negatively impact by it, can more easily understand what the legislation actually means and decide what actions are warranted. Whoever does so will be doing all of us a big favor and I would happily chip in $20 to reimburse him/her for the effort.
    Of course, this should be provided by the House and Senate with all their bills but that they are not currently doing so.
    For those who want to review specific parts of the legislation, the above reference to the statute being changed is slightly off. It is SUBCHAPTER 4 (Food) of Chapter 9 (Food, Drug and Cosmetics Act) of Title 21 (Food and Drugs) of the US Code. This can be accessed on the Cornell Legal Library’s website at http://www.law.cornell.edu/uscode/html/uscode21/usc_sup_01_21_10_9_20_IV.html.
    The bill passed by the House (HR 2749) can be found at http://www.govtrack.us/congress/billtext.xpd?bill=h111-2749.