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FDA Hosts Meeting on FSMA and Preventive Controls

The U.S. Food and Drug Administration is continuing its outreach to stakeholders to bring them up to speed on the new FDA Food Safety Modernization Act signed into law in January. The agency announced it will hold an all-day public meeting next Wednesday, April 20, to focus on the new preventive controls measures.

Those interested in participating can do so in person or via webcast by registering here.  FDA recommends registering early because capacity is limited.

Here are the details:    

When: Wednesday, April 20, 2011 from 9:00 a.m. to 5:30 p.m. ET, with registration open at 7:30 a.m.
Where:  FDA White Oak Campus, The Great Room, Building 31, Room 1503, 10903 New Hampshire Avenue, Silver Spring MD 20993
Purpose:  To provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes. The public will have an opportunity to provide information and share views that will inform the development of guidance and regulations on preventive controls for food facilities that manufacture, process, pack or hold human food or animal food and feed (including pet food).
Who: FDA speakers include:

    * Michael Taylor, FDA, Deputy Commissioner for Foods
    * Murray Lumpkin, FDA, Deputy Commissioner for International Programs
    * Donald Kraemer, Chair, Implementation Team for Preventive Standards
    * Daniel McChesney, Chair, Implementation Team for Preventive Standards 

Breakout Sessions: Meeting participants will be able to attend three of five breakout sessions. Each small group breakout session will be 75 minutes.

    * Preventive Controls Guidance
    * On-Farm Manufacturing and Small Business
    * Product Testing and Environmental Monitoring; Training and Technical Assistance
    * Preventive Controls and the Relationship to cGMP 


Photo of FDA inspectors in Los Angeles, courtesy the U.S. Food and Drug Administration.

© Food Safety News
  • Doc Mudd

    “The public will have an opportunity to provide information and share views that will inform the development of guidance and regulations on preventive controls for food facilities that manufacture, process, pack or hold human food or animal food and feed (including pet food).”
    Oh, heck, that’s an easy one.
    Let’s just grant Tester-style exemptions to any facility that whines about the inconvenience of producing safe food. I mean, we’ve got the majority of producers exempt already, what’s a few more?

  • Michael Bulger

    Just a reminder: The Tester amendment exempts only those businesses selling over half of their less than $500k AGI to “qualified end-users” within a set geographical area.
    Direct sales account for a small percentage of industry sales, thus only a small percentage producers are exempt from any parts of the FSMA.

  • Doc Mudd

    Correction to the above misleading “reminder”: Tester exempts practically every entrepreneurial Tom, Dick and Shirley who produces and sells at CSAs, farmers markets, roadside stands, neighborhood diners, local bodegas etc. – it excuses from accountability any of these farmers and food producers grossing less than half a million dollars in annual sales (and that’s nearly all of them).
    By headcount, these many, many “small” capitalists who are Tester-exempt from FSMA (and free to ignore food safety protocols as they please) represent a majority of all producers.
    Lots and lots of independent small operations, each with the capacity and Tester-protected opportunity to contaminate/adulterate food products that could sicken you and your family.
    True – these many, many exempt businesses are hideously ineffective producers, so they account for a small percentage (by volume) of all product trading in the market.
    But the end result is a majority of unregulated, uninspected operators foisting food of dubious safety in dribs and drabs through many outlets onto your family’s dinner plate…regardless of how preventive control measures for FSMA might be negotiated and defined at this upcoming FDA meeting.

  • Michael Bulger

    I assure you that if you bothered to examine USDA data, a “headcount” of producers exempt under the Tester amendment would not even approach a majority of all producers.
    But, we must resign ourselves to the knowledge that facts are unimportant to “Mudd”.
    From the Census of Agriculture of 2007: “Nearly 83 percent of U.S. organic sales in 2008 were to wholesale markets, primarily processors, millers or packers (28.7 percent) and
    distributors, wholesalers, brokers or re-packers (26.6 percent).”
    That is 83% of Organics that does not qualify for exemption right off the bat. This number is for just the organic sector, which I think we all would agree would be expected to be doing a higher percentage of sales at farmers markets, CSAs, and other “qualified end-users”. (Additionally, the % of organic sales to wholesalers has been trending up as big box stores shelve more organic products.)
    Keep in mind that income and distance come into play (and the fact that they are still subject to state and local laws and inspections, as well as covered by federal regulations and inspections) and Mudd’s assertion that the majority of food producers are “unregulated, uninspected” Tester-exempt operators is so simply wrong.

  • Doc Mudd

    Heh, still counting volume of sales and stubbornly ignoring headcount of producers.
    But, of course, the individual producer/processor is the relevant unit of interest when contemplating incidence of product contamination. Each and every individual producer is capable of messing up. Some more capable than others, especially those blissfully Tester-exempt from bothersome FSMA food safety regulations.
    So, given human error and human nature, the more individual producers = the more opportunities for portions of my food and yours to be adulterated by someone’s ignorance, by their goofy superstitious beliefs or simply due to callous disregard for food safety.
    What, do you suppose are the chances someone who would deliberately misinform you might also risk your family’s safety?
    Organc pitchman Bulger: “I assure you that if you bothered to examine USDA data, a “headcount” of producers exempt under the Tester amendment would not even approach a majority of all producers.”
    Well now, consulting USDA data, number of farms broken out by gross income looks something like this:
    percent of farms grossing >$500,000 during 2007 = 5.3%
    percent of farms grossing $100,000 – $499,999 = 10.9%
    percent of farms grossing S50,000 – $99,999 = 5.7%
    percent of farms grossing $10,000 – $49,000 = 18.3%
    percent of farms grossing <$10,000 during 2007 = 59.8%
    Oh oh, pants afire Bulger! At 95% of the total, the Tester-exempt little guys (<$500,000) look like a majority to my eye.
    Someone’s earnest assurance wasn’t worth diddly squat, was it?
    Caveat emptor, baby, caveat emptor!

  • ICBM

    Ah your Royal Muddiness — reminds me of the maxim — “figures can’t lie but liars can figure” — the NUMBER of farms is one thing — but 95% + of our overall food supply is produced by the top 10% of industrialized farms. When an eColi outbreak in one field is commingled and distributed to poison, sicken and kill people all across the country — now THERE’S RISK!
    And if you bother to actually read the Food Safety Modernization Act you’ll see that NO farms are exempt — they’re just covered in different scale-appropriate ways…

  • Michael Bulger

    I see what you’re saying, but the 95% under the income threshold aren’t necessarily selling to qualified end-users. The majority of sales are still to wholesalers, which means the majority of food you are eating is not exempt.
    Any exempt facilities that this article pertains to would still be subject to inspection, mandatory recall, be required to submit documentation that they’ve identified potential hazards, comply with state and local laws, etc., etc.

  • Michael Bulger

    Just to clarify, I always thought the $500,000 threshold was too high. I think I was quite public about that..