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Food Safety Acts Compared: HR 2749 vs. S 510

Shortly before the summer recess, the House overwhelmingly passed HR 2749 – The Food Safety Enhancement Act.  The Senate may now either adopt the House version, or S 510 – The Food Safety Modernization Act.  Both Acts have similar goals; however, the real question is whether they will succeed achieving their goals, and by what means each bill will seek success.

capitol-building.jpgHR 2749

  • Exempts all food products regulated by USDA/FSIS
  • Exempts farms; private residences; restaurants; other retail establishments; and nonprofit food establishments
  • Requires yearly registration of a factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food
  • Assesses annual fees of $500 for each registered facility, not to exceed $175,000 for multiple-owned facilities
  • Requires Hazard Analysis, Risk-based Prevention Controls, a Food Safety Plan, and Finished Product Tests for Class I facilities (those where high risk products are manufactured) by FDA regulation
  • Allows FDA to exempt pet food , and requires FDA to consider the impact regulations will have on small businesses
  • States that FDA shall establish scientific-based regulations for growing, harvesting, processing, packing, sorting, transporting and holding raw agricultural commodities and shall take into consideration the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection practices and organic production methods
  • Requires that domestic and foreign manufactures be inspected on a risk-based schedule, with Category 1 – high-risk facilities – inspected once every 6-12 months and Category 2 – low risk facilities – inspected once every 18 months to 3 years
  • Requires facility record keeping and traceability
  • Requires auditors and laboratories to be certified and food test results and environmental sampling to be reported to FDA
  • States that CDC shall enhance foodborne illness surveillance by coordinating Federal, State and Local foodborne systems
  • Requires the FDA to conduct food safety research and a national public education program on food safety
  • Gives FDA the authority to seize and quarantine food likely to cause serious health consequences.  FDA with have recall procedures for food that is deemed to be dangerous, with the basis for this determination resting in whether the Secretary of Agriculture has “reason to believe” the food poses a health risk
  • Increases Criminal and Civil penalties
  • Requires country of origin labeling

S 510

  • Requires an inspection of manufacturing, processing, packing, distribution, receipt, holding, or food import records, with the exclusion of farm and restaurant records
  • Requires bi-annual facility registration with assurance that entry is allowed on the property.  Registration can be suspended if the FDA determines the food product is reasonably probable to cause adverse health consequences to humans or animals
  • Requires facilities to utilize Hazard Analysis and Risk-based prevention controls
  • Allows FDA to modify regulations of animal food facilities
  • Requires the review of foodborne health data every two years to determine the most significant contaminants
  • Requires the creation of standards for produce safety to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables
  • Requires FDA to promulgate rules for protection against intentional adulteration
  • Allows FDA to collect fees from domestic facilities and importers subject to re-inspection to cover re-inspection-related costs
  • Requires FDA to report to Congress within two years of the act on the need for other programs and practices to promote food safety.  This would include regulations, food testing, and potential sources of emerging threats, communication strategies, surveillance strategies and education strategies
  • Requires risk-based inspection of domestic, foreign facilities, and Ports of Entry – once every two years for high risk and once every four years for less risk
  • Requires laboratory accreditation
  • Requires traceback and recordkeeping after a pilot project on selected fruits and vegetables
  • Requires enhanced surveillance by CDC, State, and Local Health Departments
  • Allows for mandatory recall authority – if there is a reasonable probability to believe an article of food is adulterated, FDA will allow the facility to issue a recall.  If the facility does not recall the product, FDA can
  • Allocates $825,000,000 for food safety in 2010
  • Increases the number of field staff to 3,800 in 2010, 4,000 in 2011, 4,200 in 2012, 4,600 in 2013 and 5,000 in 2014

farmers-market.jpgThe bottom-line is that these bills are pretty similar. Here are my suggestions as things move to the Senate, Conference Committee, and the President’s desk:

Raise more money – have a sliding scale based upon risk of contamination and size of operation.  The $500 flat fee per facility up to a $175,000 for multiple facilities under same ownership is not exactly a progressive financing system.  Frankly, I would require registration of all who produce and sell food, but charge little, if anything, to farms that sell directly to consumers.  At the same time, I have no problem whatsoever taking a few million from some of the multi-billion dollar food conglomerates for regulatory services that greatly benefit them.  Raise enough money to actually fund all of this.

Give resources so that state and local health and agriculture authorities can work with farmers to produce safe food.  Clearly excluded in these bills are all direct sales between farmer and customer (including direct sales to consumers, restaurants, and farmer’s markets) from the necessity of most, if not all, the provisions of this legislation.  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.

Finally, perhaps these bills are not the appropriate place to begin, but we need to start dealing with creating a sustainable and regionalized agriculture.  We need to balance safety with environmental policy – both energy/climate change and protection of biodiversity.  We need a food policy that promotes healthy humans.

Farmers Market photo courtesy CDC/ Dr. Edwin P. Ewing, Jr.

© Food Safety News
  • anonymous

    a bit off topic…these bills don’t appear to have any provisions against misuse. unintended consequences. mr. moneybags, coveting his neighbours farm might be able to coerce multiple inspections, causing severe financial stress to mom and pop. just one broad example. this is one of my major concerns, that the level of expertise in Congress has fallen dramatically. almost everything coming out recently seems to riddled with holes that are exploited.
    good on you for this site, it will start to show on reddit, digg etc.

  • hhamil

    Bill, your statement that HR 2749 “exempts farms” gives the impression that ALL farms are exempted from the entire act. That is absolutely not true. Only farms, AS HR 2749 DEFINES THEM, are exempted from registration as a “facility.” AND any farm that does anything more to its produce than trim off outer leave and wash, cool and pack it must register as a facility.
    Mix varieties of greens together and a farm becomes a facility. Make value added products in completely licensed kitchens and a farm becomes a facility. Sell produce to the public directly totaling LESS than half of the farm’s total sales and a farm becomes a facility. Pack a neighboring farm’s produce for it and a farm becomes a facility.
    And what does becoming a “facility” mean? It means the farm must do all those other things you listed above AND do them INDIVIDUALLY for each product the farm produces.
    Just look at the FDA’s recent issuance of a separate “guidance” for each for the following: leafy greens, melons and tomatoes. That’s how these “food safety” programs are designed.
    Plus, Bill, Sections 103 & 104 of HR 2749 subject farms to “performance” and “safety” standards as your 7th bullet points out.
    As for the requirement to “take into consideration the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection practices and organic production methods,” the requirement is only “to take into consideration.” How can this possibly be done, when separate plans are required for each product? And, don’t forget, all that the FDA needs to do is go through the motions of getting input. Afterwords, it can do whatever it wants. How many times was that done to us during the Bush administration?
    And who is the Commissioner of the FDA, Dr. Hamburg, listening to?
    Surely Michael Taylor, her “Senior Advisor” appointed just over 2 months ago. Of course, Taylor IS the poster child for the revolving door regulation. He’s been with the FDA, USDA, industrial agriculture funded NGOs, Monsanto and law firms representing industrial agriculture and now back with the FDA.
    And just as surely, Dr. Hamburg will listen to United Fresh Produce–one of industrial agriculture’s largest trade groups. Dr. Hamburg gave the breakfast keynote address at its Washington Public Policy Conference(WPPC)last week. And, according to United Fresh’s website, “United Chairman Jim Lemke put our work in Washington over the past three days into perfect perspective, saying ‘United is being heard on the Hill… but public policy is not something that the industry can afford to leave in Washington until next year’s WPPC. It’s a year-round process, and as an industry, we must be diligent if we want to continue our progress.’”
    As for S 510, I haven’t gotten to it yet but I have no question that, as introduced, it will join HR 2749 in keeping the healthy food movement–local, sustainable and no spray/low spray or organic–from expanding beyond the niche in which it started.
    Bill, I am glad to see that your last paragraph got very close. Remove the “perhaps” and you will have it right. “Finally, these bills are not the appropriate place to begin…” is where we really are.
    The appropriate place to begin is to fully fund all of the inspection services–FDA & USDA–just as you suggested. As the GAO found last fall, the FDA is not using much of the authority it already has.
    The second step is to declare that “safe food” as it is now defined by the FDA and USDA is not enough. Our goal must be HEALTHY food.
    The third step toward HEALTHY food is to recognize that HACCP, per se, can never work in anything but heavily processed food. As Dr. William H. Sperber, one of the key developers of HACCP at Pillsbury titled a professional paper he published in 2005, “HACCP Does Not Work from Farm to Table.”
    And the fourth step is demand a truly “science-based” path to healthy food, not the quasi-science employed by the FSIS. This means emphasizing real food, fresh food raised locally, sustainably and using the best no spray/low spray regimens using only safe sprays.
    Thanks for taking the time to review both bills and consider what more is needed.

  • Harry Hamil

    Bill, your statement that HR 2749 “exempts farms” gives the impression that ALL farms are exempted from the entire act. That is absolutely not true. Only farms, AS HR 2749 DEFINES THEM, are exempted from registration as a “facility.” AND any farm that does anything more to its produce than trim off outer leave and wash, cool and pack it must register as a facility.
    Mix varieties of greens together and a farm becomes a facility. Make value added products in completely licensed kitchens and a farm becomes a facility. Sell produce to the public directly totaling LESS than half of the farm’s total sales and a farm becomes a facility. Pack a neighboring farm’s produce for it and a farm becomes a facility.
    And what does becoming a “facility” mean? It means the farm must do all those other things you listed above AND do them INDIVIDUALLY for each product the farm produces.
    Just look at the FDA’s recent issuance of a separate “guidance” for each for the following: leafy greens, melons and tomatoes. That’s how these “food safety” programs are designed.
    Plus, Bill, Sections 103 & 104 of HR 2749 subject farms to “performance” and “safety” standards as your 7th bullet points out.
    As for the requirement to “take into consideration the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection practices and organic production methods,” the requirement is only “to take into consideration.” How can this possibly be done, when separate plans are required for each product? And, don’t forget, all that the FDA needs to do is go through the motions of getting input. Afterwords, it can do whatever it wants. How many times was that done to us during the Bush administration?
    And who is the Commissioner of the FDA, Dr. Hamburg, listening to?
    Surely Michael Taylor, her “Senior Advisor” appointed just over 2 months ago. Of course, Taylor IS the poster child for the revolving door regulation. He’s been with the FDA, USDA, industrial agriculture funded NGOs, Monsanto and law firms representing industrial agriculture and now back with the FDA.
    And just as surely, Dr. Hamburg will listen to United Fresh Produce–one of industrial agriculture’s largest trade groups. Dr. Hamburg gave the breakfast keynote address at its Washington Public Policy Conference(WPPC)last week. And, according to United Fresh’s website, “United Chairman Jim Lemke put our work in Washington over the past three days into perfect perspective, saying ‘United is being heard on the Hill… but public policy is not something that the industry can afford to leave in Washington until next year’s WPPC. It’s a year-round process, and as an industry, we must be diligent if we want to continue our progress.’”
    As for S 510, I haven’t gotten to it yet but I have no question that, as introduced, it will join HR 2749 in keeping the healthy food movement–local, sustainable and no spray/low spray or organic–from expanding beyond the niche in which it started.
    Bill, I am glad to see that your last paragraph got very close. Remove the “perhaps” and you will have it right. “Finally, these bills are not the appropriate place to begin…” is where we really are.
    The appropriate place to begin is to fully fund all of the inspection services–FDA & USDA–just as you suggested. As the GAO found last fall, the FDA is not using much of the authority it already has.
    The second step is to declare that “safe food” as it is now defined by the FDA and USDA is not enough. Our goal must be HEALTHY food.
    The third step toward HEALTHY food is to recognize that HACCP, per se, can never work in anything but heavily processed food. As Dr. William H. Sperber, one of the key developers of HACCP at Pillsbury titled a professional paper he published in 2005, “HACCP Does Not Work from Farm to Table.”
    And the fourth step is demand a truly “science-based” path to healthy food, not the quasi-science employed by the FSIS. This means emphasizing real food, fresh food raised locally, sustainably and using the best no spray/low spray regimens using only safe sprays.
    Thanks for taking the time to review both bills and consider what more is needed.