Header graphic for print

Food Safety News

Breaking news for everyone's consumption

Publisher’s Platform: S. 510 in a Nutshell

  

The Senate needs to pass the Linda Rivera Act.

 Linda Rivera (Senator Harry Reid’s Nevada constituent) ate premade cookie dough that was contaminated with E. coli O157:H7.  She has suffered liver and kidney failure, a stroke and the removal of her large intestine.  She has been hospitalized since May 2009 and has incurred over $4.5 million in medical expenses.  S. 510 should be renamed for her.

S. 510, the Food Safety Modernization Act, has been deemed dead more than once.  I do not have a crystal ball to know if it will ever surface again, or why it even died in the first place, but here is a bit of what we are giving up by not passing it.  I have read S. 510 more than a few times, but Senate staffers did a great job of summarizing it and I have used that, in part, as an outline.

Only foods already regulated by the Food and Drug Administration (FDA) will be subject to S. 510.  Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.  The beef industry has nothing to worry about here.

Under the Bioterrorism Act of 2002, certain food businesses were considered “facilities” and had to register with FDA.  Farms and restaurants were exempted. This definition is not changed in S. 510.  If an entity does not need to register now, it will not need to register under S. 510.  You are not required to register your backyard garden.

Small entities that produce food for their own consumption or market the majority of their food directly to consumers or restaurants are not subject to registration or new record-keeping requirements under S. 510.  This includes food sold through farmers’ markets; bake sales, public events, and organizational fundraisers.  Throughout the bill, consideration is given to the unique agricultural practices and requirements of organic foods under the Organic Foods Production Act of 1990.  If you sell your products locally and not into the broader stream of commerce, this act simply does not apply to you.

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

In coordination with the Secretary of Agriculture, FDA develops science-based standards for the safe production and harvesting of fruits and vegetables.  Priority is given to specific fruits and vegetables that have the highest risk of foodborne illness outbreaks.

Flexibility is given for different growing, production, and harvesting techniques.  FDA has the discretion to limit produce safety standards for small and very small entities that produce or harvest food, which pose little or no serious risk to human health.  Consideration is also given to conservation and environmental standards already established by federal natural resource and wildlife agencies. Exemptions are also available for low-risk commodities.  FDA must minimize the burden of paperwork and, as appropriate, the number of separate standards for separates foods.

The bill requires FDA to coordinate with the extension activities of the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and small processors about any new practices required by S. 510.  Necessary funds are authorized to conduct these extension activities. 

The bill also provides for the training and education of state, local, and tribal authorities to facilitate the implementation of new standards under the FDA Food Safety Modernization Act.  Competitive grants are made available, for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

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

A section of the bill that has not had much notice calls for increased surveillance by local, state and federal heath authorities to track foodborne illnesses.  The Department of Health and Human Services is to establish a pilot project to improve tracking methods and enhance surveillance systems, which can help regulators catch outbreaks much earlier.

Perhaps the bill is not perfect–nothing humans do is– but passing it is better than doing nothing at all.  Do it for Linda.

© Food Safety News
  • dangermaus

    I think you’re looking at food exclusively through the lense of foodborne illness – not as a matter of quality of life and nutrition, which is far more important. The lens that says corn syrup is better for you than home-fermented pickles, or salt-cured proscuitto because it doesn’t have ANY germs in it at ALL. If you want to hold the big agribusiness companies accountable for their actions, have your friends in congress start over with a bill that does only that. I trust the small farmers associations that say that this bill would hurt them very badly, not someone in your position, that makes money off food-borne illness cases.
    If this “flexibility” you’re referring to for small producers actually meant that small producers were actually effective for protecting them, I don’t see why you’d oppose the Tester Amendment (if you need a tweak to it, I’m sure Hagan and Tester would be reasonable – how about a labeling system that says whether or not the ingredients were subject to FSMA regulation?).
    The high-level, vague way you talk about the FDA using “science-based” methods for coming up with regulations sounds great, but you must know that one can find a PhD that will say just about anything you want (like when a university that get grant money from a candy company does a study that finds Chocolate is good for you!). At the end of the day, it’s going to come down to politicians writing these rules, big agribusiness outfits (with their overwhelming lobbying power) that are going to keep trying to make their way the ONLY way to produce food (such as how, in the origial version of the bill, pastured poultry is “dirty” because the animals are exposed to wild birds). If you want to protect small farmers from that kind of eventual doom, keep them entirely exempt from federal regulation.
    One of the primary tactics used for pushing this bill is citing individual tragedies like this one, and quoting numbers of food-borne illnesses in a given year. The problem with that kind of fear-mongering is that one never hears mention that one has no way of knowing how this bill will affect those statistics – especially if one were to compare the possible outcome of FSMA versus other, more specific, directed efforts – like, for example requiring that all soda cans have foil covers put over them, or that we require minimum square footage for egg-laying hens, or that we not feed cattle in a way that makes it necessary to prophylactically feed them antibiotics.
    Food-borne illness always has been with us, and it always will be. Because of that, one should always treat the food that one eats as if it is contaminated and should wash and/or cook it before eating it. This bill just helps make sure that we start will lower-quality ingredients that have been shipped hundreds of miles across the country, because that’s the only way it’ll be possible to produce food.
    Laws meant to keep us “safe” are stifling our economy and destroying out culture. Stop supporting those kinds of laws, support tort reform, and take care of yourself.

  • Once again, I challenge supporters of S 510 to explain how S 510 would have made any difference had it been in force at the time the cookie dough was made that sickened Linda Rivera.
    Did Nestlé not have a written food safety plan in force? I would be astonished if it didn’t but I might be wrong. If Nestlé didn’t have a written food safety plan, document that fact and then show how a written food safety plan would have made a material difference in this case.
    What other provision in S 510 would have actually made a material difference? If so, please describe how.
    If noting in S 510 would have made a difference, why are we naming it after her and passing it because of what happened to her?
    This is advocacy masquerading as a full analysis of S 510 and then wrapped in sentimentality.
    The fact that accidental sickening of Ms. Rivera had tragic, far reaching, long lasting, horribly expensive consequences doesn’t mean S 510 would have helped. It doesn’t mean that S 510 should be passed.
    Did the fact that the FDA’s Shell Egg Rule was in force when over 200,000,000 of the eggs recalled were produced make a difference?
    I see 3 appropriate responses to what happened to Ms. Rivera.
    First, and foremost, we need to hold the FDA, FSIS and the other agencies that have anything to do with food safety accountable. When a regulator or the regulatory processes screws up, we need to carefully investigate what happened and make amends by taking only appropriate action(s). Only by doing so will those of us who actually grow, pack, store, distribute and process food will be able to be held accountable. Tort law only holds individual companies accountable and, then, only some of the time. Scofflaws, like Jack DeCoster, can only be stop by well designed, fully enforced regulation.
    Second, we need to fully fund food regulation and not, as S 510 does, create large, unfunded mandates (e.g., the states would be required to inspect ALL 1,500,000+ farms in the US). As I understand it, the Congress has been substantially increasing funding for the last couple of years. They need to keep it up. Rome wasn’t built in a day and chronically underfunded food regulation will need years to build itself into what we need.
    Third, while we are waiting for food regulation to be up to the task of fully utilizing the authority it already has, we need to hold a full, open, transparent, national discussion of the issues impacting the healthfulness of our food. Healthy food need to be the goal, not just food that has been declared “safe” by some part of our government. Healthy food is always safe but safe food is NOT always healthy.
    Of course, none of this will occur as long as we allow fearmongered, false emergencies to force a debate and then jump to premature conclusions.
    Once again, I will happily defend all I have written. E-mail me at healthyfoodcoalition@gmail.com.
    And, I will happily debate anyone, including Bill Marler, on the first 8 sections of the S 510.

  • dangermaus

    I think you’re looking at food exclusively through the lense of foodborne illness – not as a matter of quality of life and nutrition, which is far more important. The lens that says corn syrup is better for you than home-fermented pickles, or salt-cured proscuitto because it doesn’t have ANY germs in it at ALL. If you want to hold the big agribusiness companies accountable for their actions, have your friends in congress start over with a bill that does only that. I trust the small farmers associations that say that this bill would hurt them very badly, not someone in your position, that makes money off food-borne illness cases.

  • dangermaus

    The high-level, vague way you talk about the FDA using “science-based” methods for coming up with regulations sounds great, but you must know that one can find a PhD that will say just about anything you want (like when a university that get grant money from a candy company does a study that finds Chocolate is good for you!). At the end of the day, it’s going to come down to politicians writing these rules, big agribusiness outfits (with their overwhelming lobbying power) that are going to keep trying to make their way the ONLY way to produce food (such as how, in the origial version of the bill, pastured poultry is “dirty” because the animals are exposed to wild birds). If you want to protect small farmers from that kind of eventual doom, keep them entirely exempt from federal regulation.
    One of the primary tactics used for pushing this bill is citing individual tragedies like this one, and quoting numbers of food-borne illnesses in a given year. The problem with that kind of fear-mongering is that one never hears mention that one has no way of knowing how this bill will affect those statistics – especially if one were to compare the possible outcome of FSMA versus other, more specific, directed efforts – like, for example requiring that all soda cans have foil covers put over them, or that we require minimum square footage for egg-laying hens, or that we not feed cattle in a way that makes it necessary to prophylactically feed them antibiotics.

  • Once again, I challenge supporters of S 510 to explain how S 510 would have made any difference had it been in force at the time the cookie dough was made that sickened Linda Rivera.
    Did Nestlé not have a written food safety plan in force? I would be astonished if it didn’t but I might be wrong. If Nestlé didn’t have a written food safety plan, document that fact and then show how a written food safety plan would have made a material difference in this case.
    What other provision in S 510 would have actually made a material difference? If so, please describe how.
    If noting in S 510 would have made a difference, why are we naming it after her and passing it because of what happened to her?
    This is advocacy masquerading as a full analysis of S 510 and then wrapped in sentimentality.
    The fact that accidental sickening of Ms. Rivera had tragic, far reaching, long lasting, horribly expensive consequences doesn’t mean S 510 would have helped. It doesn’t mean that S 510 should be passed.
    Did the fact that the FDA’s Shell Egg Rule was in force when over 200,000,000 of the eggs recalled were produced make a difference?
    I see 3 appropriate responses to what happened to Ms. Rivera.
    First, and foremost, we need to hold the FDA, FSIS and the other agencies that have anything to do with food safety accountable. When a regulator or the regulatory processes screws up, we need to carefully investigate what happened and make amends by taking only appropriate action(s). Only by doing so will those of us who actually grow, pack, store, distribute and process food will be able to be held accountable. Tort law only holds individual companies accountable and, then, only some of the time. Scofflaws, like Jack DeCoster, can only be stop by well designed, fully enforced regulation.
    Second, we need to fully fund food regulation and not, as S 510 does, create large, unfunded mandates (e.g., the states would be required to inspect ALL 1,500,000+ farms in the US). As I understand it, the Congress has been substantially increasing funding for the last couple of years. They need to keep it up. Rome wasn’t built in a day and chronically underfunded food regulation will need years to build itself into what we need.
    Third, while we are waiting for food regulation to be up to the task of fully utilizing the authority it already has, we need to hold a full, open, transparent, national discussion of the issues impacting the healthfulness of our food. Healthy food need to be the goal, not just food that has been declared “safe” by some part of our government. Healthy food is always safe but safe food is NOT always healthy.
    Of course, none of this will occur as long as we allow fearmongered, false emergencies to force a debate and then jump to premature conclusions.
    Once again, I will happily defend all I have written. E-mail me at healthyfoodcoalition@gmail.com.
    And, I will happily debate anyone, including Bill Marler, on the first 8 sections of the S 510.

  • emily

    Dangermaus:
    ‘but you must know that one can find a PhD that will say just about anything you want (like when a university that get grant money from a candy company does a study that finds Chocolate is good for you!)’
    I find it extremely offensive that you would suggest Scientists will do as we are told just for the money. Most of us have a very strong moral compass and it may surprise you that many Food Scientists have a passion and loyalty to local and organic food, to public health and to the truth. We do not gorge ourselves on high fructose corn syrup and hormone laden milk as we plot to take down the little guy!

  • dangermaus

    Emily, you’re misunderstanding me, and I should have been clearer. What I’m mostly talking about is the tendency for politicians and lobbyists to take scientific findings out of context to use them for their own purposes, and about the dangers of group-think that is always a danger in any field of study.
    If one is primarily interested in money, it’s really unlikely one would go into a career as a researcher.

  • dangermaus

    That didn’t sound right either – it sounded like a dig on the financial considerations of being a researcher, which wasn’t my intent – sorry… I have great deal of respect for people that devote their lives to science. Subjects of study that can be isolated from their environments and looked at experimentally, and verified independently – which is what I think is the heart of what science is – is really all we have against our internal (often unintentional and unknown) prejudices about the world, and you are the folks actually doing that messy, difficult, thankless work.
    What I’m talking about is the fact that if you ask a room full of people studying bad bugs found in food, and ask them about how to set food policy, you’re likely to get a very different set of answers than if you were to ask a group of Nutritionist, environmentalist, entrepreneur, Sociologist, or farmer. A clever person can cherry-pick from the wide range of information you’d get from all those groups, and come up with what looks like scientific support for what they wanted to do all along, anyway.

  • Paul

    First, and foremost, we need to hold the FDA, FSIS and the other agencies that have anything to do with food safety accountable. When a regulator or the regulatory processes screws up, we need to carefully investigate what happened and make amends by taking only appropriate action(s).
    ~
    This part I did not agree with it is worded to sound like noone is holding Food Safety Inspectors accountable and that is simply not true. Moreover, food processors have an opportunity to be in plant at all times and should take most of the responsibility if mistakes are made because inspection personnel are stretched very thin and can only do one thing at a time because we are always one person amoung a multitude of industry personnel. Exception, inspectors in cases of neglect and it’s proven that they were not doing their jobs or abuse of authority should be definitely held accountable.