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FDA Food Safety Modernization Act: Out of the Box

Editor’s note:  This is the first in a series of articles from CSPI Food Safety Director Caroline Smith DeWaal on the implementation of the FDA Food Safety Modernization Act.  In the first installment, DeWaal explains which provisions of the historic law will be the first to benefit consumers.

With the signing of the historic FDA Food Safety Modernization Act, President Obama and Congress have adopted the first comprehensive overhaul of the food safety program at the Food and Drug Administration.  This overhaul will replace the reactive legal structure under which FDA responded to problems–adulterated or misbranded foods already on the market–with a preventive mandate.  The new structure gives FDA much greater oversight over the food industry, including requiring facilities to register every two years, to develop new food safety plans, and to provide the agency with test results.  The bill also gives greater incentives for the industry and importers to implement strong food safety programs, so that one bad actor is less likely to have an adverse impact on an entire segment of the industry, which is what happened to spinach growers a few years ago. 

The new program will take several years to roll out; even longer to become fully effective.  In a series of articles, CSPI will give FDA-watchers a timeline for implementation of the new law, with emphasis on speed and priorities, highlighting things with the greatest consumer and industry impacts. 

In this first installment, we will focus on several little known provisions that complement the mandatory recall provision. This has been widely touted as one of the biggest victories for consumers, though it may see little use if the food industry is careful and compliant with FDA’s requests for voluntary recalls.   

Mandatory recall is one of the few provisions of the Modernization Act that goes into effect immediately. The provision will likely reduce the length of time that FDA spends in negotiating voluntary recalls with the companies involved.  And delays in recalls can have serious consequences.  Consumers are often the last to know when there is a problem with the food supply, and too often they are not alerted until the food is already being sold, which means that it could already be on their shelves or in their family’s dinner. 

Second, the legislation requires FDA to develop by this coming April a consumer-friendly website to help identify food that is subject to a recall.  That website should provide searchable, product-specific information for consumers, as well as information about the status of the recall (ongoing, completed, etc).  The current FDA recall search engine is cumbersome and not useful to consumers looking for brand names or other key terms. 

Third, in a two-step process, the legislation requires grocery stores to provide notices about recalls to customers when they are shopping.  FDA will first identify for grocery stores “conspicuous locations” for posting such notices, and in 18 months, food companies will be required to give grocery stores notices to post.  Currently consumers receive little or no in-store messaging, which leaves many standing in the grocery store wondering about a current recall and whether something they purchased last week was involved.  The Secretary’s list of conspicuous locations for notice will include targeted recall information at the point of purchase, and may extend to other types of notification, such as via text, phone or email of a recall.   

While the overall goal of the FDA Food Safety Modernization Act is to prevent food from becoming contaminated in the first place, these provisions will provide some immediate consumer benefits before the other components come on-line. 

Next installment —  New teeth in the law:  Registration, suspension and records access 

© Food Safety News
  • Doc Mudd

    “…so that one bad actor is less likely to have an adverse impact on an entire segment of the industry, which is what happened to spinach growers a few years ago.”
    Hmmmm, will a ‘bad actor’ like Mission Organics (a small 50 acre farm, responsible for the 2006 spinach outbreak, arguably <$500,000) now be exempt under FSMA? Would its feces-laden greens still find their way into the larger commercial pipeline, or would they merely poison folks within 275 miles of Salinas? How will that work, exactly?
    “…the legislation requires grocery stores to provide notices about recalls to customers when they are shopping.”
    Seems logical that product from small, exempt producers should be conspicuously labeled to notify shoppers. You know, something like “this food product not reviewed for safety by USDA”, just a gentle reminder that ‘caveat emptor’ is the operative rule of engagement for this friendly local vendor.

  • Michael Bulger

    Mission Organics would not be exempt due to the fact that they were not selling to “qualified end-users.”
    They would have to do the majority of their sales direct to consumers, restaurants, or grocers, in order to be exempt. These sales would have to be within 275 miles.

  • Doc Mudd

    Thanks Michael.
    Sorting through producer statements and granting Tester exemptions will be a complicated job for someone at USDA. Wonder if, in practice, exemption decisions will occur before or after a producers next incidence of food contamination?

  • food dork

    Michael Bulger is exactly right — to be exempt farms cannot be selling a majority of their food to third party distributors.

  • http://www.healthyfoodcoalition.org hhamil

    Thank you, Michael Bulger, for pointing out one of the obvious problems in “Doc Mudd’s” reasoning.
    Unfortunately, that blatant error obscures additional problems with his dissembling misinterpretation of the Tester-Hagan amendment’s threshold.
    First, as I recall, Mission Organics’ product was co-mingled with product from other farms. Therefore, it cross contaminated lots of product and extended its impact. That hazard (using the language of Sec. 103 HARPC of FSMA) is materially reduced under Tester-Hagan and, therefore, part of its rationale.
    Second, at the time of the purchase, the end user had no way of knowing who grew the spinach. That too runs contrary to Tester-Hagan.
    Third, most commercially grown spinach matures in about 2 months. I would be astonished if a 50 acres spinach operation in year-round growing season of the central valley of CA didn’t generate more than $500,000 gross sales even at the producer level in industrial ag.
    Fourth, as shown in my third point, Tester-Hagan’s gross sales are at the higher retail and distributed wholesale level pricing of the food system. As a result, the actual volume of product is much smaller.
    Fifth and by far the most important, Mission Organics was state of the art in industrial agriculture AND so was its processor. As a result, had the FDA Food Safety Modernization Act been fully in force back in 2006, it would NOT have made any difference. This outbreak still would have taken place.
    And that was been the carefully obscured secret of the supporters of the FSMA through out the legislative process. The FSMA would not have changed what occurred in any of their oft cited outbreaks nor will it materially reduce the number of outbreaks nor their severity.

  • http://www.healthyfoodcoalition.org hhamil

    The FSMA had been signed barely a day when Caroline Smith DeWaal and the CSPI began their cover up of how small the actual impact of the FSMA will be on the number and severity of outbreaks of foodborne illness.
    During their push for the legislation, Ms. DeWaal and CSPI stressed again and again the importance of the lack of mandatory recall.
    When Sen. Coburn mistakenly said no company had ever failed to voluntarily recall its product, all the supporters could allege were 6 cases.
    Now, Ms. DeWaal admits mandatory recall “may see little use IF [my emphasis] the food industry is careful and compliant with FDA’s requests for voluntary recalls.” As Ms. DeWaal and CSPI well know—but refused to acknowledge during the debate—essentially all food processors already are “careful and compliant with FDA’s requests for voluntary recalls.” One of the worst scofflaws—Wright County Egg—had its voluntary recall out less than 24 hours after getting the info needed from the FDA.
    Furthermore, a quick review of recent recalls show that a substantial number were instigated by the company involved due to its own internal procedures. The FDA was involved only after the decision to recall had been made.
    Ms. DeWaal further asserts, “The provision [mandatory recall] will likely reduce the length of time that FDA spends in negotiating voluntary recalls with the companies involved.”
    What hogwash!
    I urge every FSN reader to read Sec 206 Mandatory Recall Authority (see http://www.healthyfoodcoalition.org/page/421742160). As mandatory recall is government compelling a business to take an action it doesn’t want to take, mandatory recall will always be an involved process. That’s one of the most basic protections of the rule of law. Of course, that is one of the reasons it has been voluntary—voluntary is much faster.
    Furthermore, Ms. DeWaal and CSPI’s push for mandatory recall has obscured the fact that the FDA has ALWAYS been able to force a recall. All the FDA had to do was get the appropriate federal district court judge to agree a recall was needed. In other words, mandatory recall will have to go through a similar procedure. The difference is that instead of a district court judge making the decision, it will have to be the Secretary of HHS! The new subsection 423(h) of the Federal Food, Drug and Cosmetic Act (FFDCA) clearly states, “No Delegation – The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.”
    I would be astonished if it doesn’t take longer to work a hearing into the schedule of the Secretary of HHS than it would the appropriate federal district court judge.

  • Michael Bulger

    Harry, FSMA provides a myriad of ways in which this outbreak could have been prevented or lessened.
    As I pointed out, and you reaffirmed, Mission Organics would not be exempt from the full spectrum of the law as written. Let’s put aside your enduring pessimism and imagine the way things could have worked out better for those involved in the outbreak.
    First, produce standards written under the direction of FSMA could have challenged Mission Organics to grow and harvest their spinach under conditions that prevented the initial contamination. The standards are as yet unpublished, but you must allow that Mission Organics might have been doing something wrong that could have been corrected by good practice.
    Second, the processing facility that co-mingled Mission Organics’ spinach with other greens would have been required by FSMA to have a HARPC plan. This could have identified ways to prevent contamination and might possibly have included periodic microbiological testing of the products and/or facility.
    Third, the FDA and/or State and local inspectors would be required to visit the facility more regularly under FSMA. Their own testing, if carried out, might have revealed the E. Coli O157:H7. If the packaging facility was doing testing, the inspectors and FDA would have access to the test results whenever they requested.
    Fourth, had the contaminated product made it to consumers and caused illnesses, FSMA would enable FDA and CDC to better spot the outbreak. FSMA strengthens and expands the network of laboratories that monitor for outbreaks. An uptick in illnesses should be more readily detected.
    Fifth, upon detecting an outbreak, the FDA would have more resources to identify the source of the illnesses.
    Sixth, tracking the source of the outbreak would be quicker and easier under FSMA. Enhanced record-keeping and access to records would allow the FDA to notify distributers and the facility responsible for packaging, as well as Mission Organics, of their potentially deadly product. Production could be halted, Mission Organics spinach could be quarantined, and products could be recalled from stores.
    Seventh, consumers could be notified through FSMA’s prescribed internet resource. This could occur earlier due to FSMA’s effects on the previous steps.
    What I have detailed is the process in which FSMA could have prevented the outbreak in the first place or very likely lessened the number of people who became ill as a result of eating Mission Organics spinach.
    You’ve been working for a long time on issues involving FSMA, Harry. You continue to miss the point. Personally, I think you’ve invested yourself so heavily in opposing the bill that you are unable to get your mind around the very simple principles of FSMA. In the end, it has enormous potential to seriously improve the state of food safety in the United States. Thankfully, both Houses of Congress and the President have made it law.

  • http://www.marlerblog.com bill marler

    Caroline, as you know I have been a long supporter of this legislation, but I have a couple of comments. You say:
    “The bill also gives greater incentives for the industry and importers to implement strong food safety programs, so that one bad actor is less likely to have an adverse impact on an entire segment of the industry, which is what happened to spinach growers a few years ago.”
    Although I agree that the bill “gives greater incentives for the industry and importers to implement strong food safety programs,” I am not sure there really was a “bad actor” in the spinach case. Although there was never an E. coli positive sample in the organic spinach field that was the likely source of the contaminated spinach (field had by then been turned under), there were E. coli positive samples in range/grass fed beef poop in a neighboring field that matched the outbreak strain and there were indications of wild pig intrusion in the spinach field (there were E. coli positives in wild pigs as well). If there was a “bad actor” it was the entire mass-produced, bagged, leafy green industry for failing to heed multiple prior FDA warnings and the over 20 prior outbreaks and recalls.
    There is one other thing that I though I would mention and that is recall authority. I am not a fan of mandatory recall authority – I never felt that it was necessary. In my experience, there is little delay in getting companies to recall likely tainted product. I am hopeful that the provision in the bill requiring more coordination between CDC and local and state health departments, will make recalls more accurate, so when a recall is done (ordered or voluntary) the right product or specific manufacturer is implicated. Public health and industry does not need another Tomato – ooops, its Peppers moment, nor does it need to implicate all spinach when it actually was Dole Baby Spinach manufactured by Natural Selections Foods and harvested my Mission Organics in one field on August 15, 2006.

  • http://www.healthyfoodcoalition.org hhamil

    Michael, I suggest that you read Bill Marler’s comment, as Marler Clark litigated the matter.
    Once again, your comments show an utter disregard for what I have written and the facts of the case being discussed. You do that despite the fact that this outbreak has been written about extensively by the FDA, California investigators and USA Today. Even one of the FDA’s self serving accounts (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094555.htm) shows how disconnected your comments are from what actually took place.
    Like Caroline Smith DeWaal, you write about coulda, shoulda, mighta, woulda with 20/20 hindsight instead of staying with the actual facts of the outbreak and the FSMA.
    The point is, Michael, what actually occurred runs contrary to what you want to believe to be true. In fact, Mission Organics and Natural Selections were doing state of the art industrial ag and the FSMA wouldn’t have made any difference.
    I’m invested in making healthy food available at a fair price to more Americans. People like you and laws like the FSMA get in the way of that so I’ll oppose all of you for as long as it takes.
    Just as I have repeatedly challenged your mentor, Marion Nestle, and, as I recall you, I’ll happily discuss this in public with you and whomever you bring along any where, any time in the state of NC. My only restriction is that the maximum panel be 6 people–you + 2 you’ve invited and me + 2 I’ve invited.

  • dangermaus

    Harry, I’d try to drive down to NC from Chi-town to see that! I’ve wanted to visit Polyface Farm, anyway!

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

    Thank you, Michael Bulger, for pointing out one of the obvious problems in “Doc Mudd’s” reasoning.
    Unfortunately, that blatant error obscures additional problems with his dissembling misinterpretation of the Tester-Hagan amendment’s threshold.
    First, as I recall, Mission Organics’ product was co-mingled with product from other farms. Therefore, it cross contaminated lots of product and extended its impact. That hazard (using the language of Sec. 103 HARPC of FSMA) is materially reduced under Tester-Hagan and, therefore, part of its rationale.
    Second, at the time of the purchase, the end user had no way of knowing who grew the spinach. That too runs contrary to Tester-Hagan.
    Third, most commercially grown spinach matures in about 2 months. I would be astonished if a 50 acres spinach operation in year-round growing season of the central valley of CA didn’t generate more than $500,000 gross sales even at the producer level in industrial ag.
    Fourth, as shown in my third point, Tester-Hagan’s gross sales are at the higher retail and distributed wholesale level pricing of the food system. As a result, the actual volume of product is much smaller.
    Fifth and by far the most important, Mission Organics was state of the art in industrial agriculture AND so was its processor. As a result, had the FDA Food Safety Modernization Act been fully in force back in 2006, it would NOT have made any difference. This outbreak still would have taken place.
    And that was been the carefully obscured secret of the supporters of the FSMA through out the legislative process. The FSMA would not have changed what occurred in any of their oft cited outbreaks nor will it materially reduce the number of outbreaks nor their severity.

  • Doc Mudd

    Wear your hip boots dangermaus. Maybe bring a snorkel.

  • Michael Bulger

    Harry, my points stand. I was responding to your assertion that, “…had the FDA Food Safety Modernization Act been fully in force back in 2006, it would NOT have made any difference.”
    I demonstrated that it might very well have made a significant difference.
    As for your proposal, it is certainly an entertaining thought. I’d be curious as to who you’d invite to be on the panel. Might you enlighten me?
    My only restriction would be that you pay my way. Otherwise, I can assure you that if I venture to the fine state of North Carolina in the near future, I will not invest my time in engaging your quixotic fantasies. I apologize, but I don’t take you that seriously. The arguments you put forth are far to permeable at their base.
    I really don’t mean to offend. If you can manifest an actual event, I’d happily reconsider. Until then, let me remind myself of your recent words here on FSN:
    “Harry Hamil
    12/31/2010
    9:29AM
    For those who have read my comments since the inception of Food Safety News, I want you to know that I am returning to be a full-time grower, distributor and retailer of the local, healthy food. I expect that I will seldom have time to make comments on this venue.”

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

    The FSMA had been signed barely a day when Caroline Smith DeWaal and the CSPI began their cover up of how small the actual impact of the FSMA will be on the number and severity of outbreaks of foodborne illness.
    During their push for the legislation, Ms. DeWaal and CSPI stressed again and again the importance of the lack of mandatory recall.
    When Sen. Coburn mistakenly said no company had ever failed to voluntarily recall its product, all the supporters could allege were 6 cases.
    Now, Ms. DeWaal admits mandatory recall “may see little use IF [my emphasis] the food industry is careful and compliant with FDA’s requests for voluntary recalls.” As Ms. DeWaal and CSPI well know—but refused to acknowledge during the debate—essentially all food processors already are “careful and compliant with FDA’s requests for voluntary recalls.” One of the worst scofflaws—Wright County Egg—had its voluntary recall out less than 24 hours after getting the info needed from the FDA.
    Furthermore, a quick review of recent recalls show that a substantial number were instigated by the company involved due to its own internal procedures. The FDA was involved only after the decision to recall had been made.
    Ms. DeWaal further asserts, “The provision [mandatory recall] will likely reduce the length of time that FDA spends in negotiating voluntary recalls with the companies involved.”
    What hogwash!
    I urge every FSN reader to read Sec 206 Mandatory Recall Authority (see http://www.healthyfoodcoalition.org/page/421742160). As mandatory recall is government compelling a business to take an action it doesn’t want to take, mandatory recall will always be an involved process. That’s one of the most basic protections of the rule of law. Of course, that is one of the reasons it has been voluntary—voluntary is much faster.
    Furthermore, Ms. DeWaal and CSPI’s push for mandatory recall has obscured the fact that the FDA has ALWAYS been able to force a recall. All the FDA had to do was get the appropriate federal district court judge to agree a recall was needed. In other words, mandatory recall will have to go through a similar procedure. The difference is that instead of a district court judge making the decision, it will have to be the Secretary of HHS! The new subsection 423(h) of the Federal Food, Drug and Cosmetic Act (FFDCA) clearly states, “No Delegation – The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.”
    I would be astonished if it doesn’t take longer to work a hearing into the schedule of the Secretary of HHS than it would the appropriate federal district court judge.

  • http://www.healthyfoodcoalition.org hhamil

    Michael, it is so sad to me that an obviously bright person like yourself uses debating techniques to avoid addressing the serious issues.
    You did NOT in any way demonstrate that the FSMA “might very well have made a significant difference.” The involved investigation of the California regulators and Marler Clark and other litigators couldn’t even come up with clear evidence as to the vehicle for the contamination.
    What do you think “state of the art” means, Michael?
    Sec. 105 Standards for Produce Safety calls for the FDA “to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables.” That’s MINIMUM STANDARDS, Michael. Minimum standards don’t exceed state of the art.
    Furthermore, the HACCP-styled food safety plans are a dependent entirely upon a “hazard analysis” to “identify and evaluate known or reasonably foreseeable hazards.” Natural Solutions did exactly that and something new turned up. So the new techniques were designed to address the new issue.
    Finally, as shown in the FDA article I cited and Bill Marler’s comment, the traceback went extremely well. It is hard to be more definitive than the knowing the actual harvest of a specific field.
    And my comment on 12/31/10 remains true. A key difference between us is my commitment to honesty and truth. You wrote something accurate and I complimented it. But you can’t leave it alone and divert attention from what else I wrote.
    One of the foci of my comments in 2011 will be to point out the more flagrant dissembling by Caroline Smith DeWaal.
    You may have the last word.

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

    Michael, I suggest that you read Bill Marler’s comment, as Marler Clark litigated the matter.
    Once again, your comments show an utter disregard for what I have written and the facts of the case being discussed. You do that despite the fact that this outbreak has been written about extensively by the FDA, California investigators and USA Today. Even one of the FDA’s self serving accounts (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm094555.htm) shows how disconnected your comments are from what actually took place.
    Like Caroline Smith DeWaal, you write about coulda, shoulda, mighta, woulda with 20/20 hindsight instead of staying with the actual facts of the outbreak and the FSMA.
    The point is, Michael, what actually occurred runs contrary to what you want to believe to be true. In fact, Mission Organics and Natural Selections were doing state of the art industrial ag and the FSMA wouldn’t have made any difference.
    I’m invested in making healthy food available at a fair price to more Americans. People like you and laws like the FSMA get in the way of that so I’ll oppose all of you for as long as it takes.
    Just as I have repeatedly challenged your mentor, Marion Nestle, and, as I recall you, I’ll happily discuss this in public with you and whomever you bring along any where, any time in the state of NC. My only restriction is that the maximum panel be 6 people–you + 2 you’ve invited and me + 2 I’ve invited.

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

    Michael, it is so sad to me that an obviously bright person like yourself uses debating techniques to avoid addressing the serious issues.
    You did NOT in any way demonstrate that the FSMA “might very well have made a significant difference.” The involved investigation of the California regulators and Marler Clark and other litigators couldn’t even come up with clear evidence as to the vehicle for the contamination.
    What do you think “state of the art” means, Michael?
    Sec. 105 Standards for Produce Safety calls for the FDA “to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables.” That’s MINIMUM STANDARDS, Michael. Minimum standards don’t exceed state of the art.
    Furthermore, the HACCP-styled food safety plans are a dependent entirely upon a “hazard analysis” to “identify and evaluate known or reasonably foreseeable hazards.” Natural Solutions did exactly that and something new turned up. So the new techniques were designed to address the new issue.
    Finally, as shown in the FDA article I cited and Bill Marler’s comment, the traceback went extremely well. It is hard to be more definitive than the knowing the actual harvest of a specific field.
    And my comment on 12/31/10 remains true. A key difference between us is my commitment to honesty and truth. You wrote something accurate and I complimented it. But you can’t leave it alone and divert attention from what else I wrote.
    One of the foci of my comments in 2011 will be to point out the more flagrant dissembling by Caroline Smith DeWaal.
    You may have the last word.