Sunday, November 29, 2009

Where Is Justice For Peanut Outbreak Victims?

"Justice Delayed Is Justice Denied"

Like it or not – agree with the sentences or notChina took swift and decisive action against perpetrators of last year's milk adulteration scheme.

Unfortunately, the 700+ victims of Stewart Parnell's Salmonella-poisoned peanuts – and the family members of the 9 people who died as a result of their infections – will have to wait a lot longer before the US government lays charges against Parnell and the Peanut Corporation of America. If charges are ever laid at all!

Last January, Senator Patrick Leahy and Representative Rosa DeLauro asked the US Justice Department to launch a criminal investigation into the actions of Peanut Corporation of America (PCA) and its CEO, Stewart Parnell, saying,

"It is clear that the behavior of the Peanut Corporation Of America was egregious - harming hundreds of Americans and endangering many thousands more. We believe it is critical to determine whether the actions and omissions of this company rose to the level of criminal conduct. If crimes were committed, those responsible must be identified and held accountable."


The FBI acknowledged in February that it was assisting FDA in the PCA investigation. Since then, there has been only silence.


Anyone who is surprised at FDA and the Justice Department's slow response (a) to Parnell and PCA having sold and shipped peanuts that it knew to be Salmonella-contaminated; (b) to Parnell and PCA's practice of lab-shopping (changing labs when the results reported by the first lab were unfavorable); and (c) to Parnell's lack of cooperation with the Congressional investigation, hasn't been following FDA's enforcement performance in recent years. Just look at the way FDA handled repeated violations at Haifa Smoked Fish, Inc. A turtle is supersonic by comparison.


Haifa Smoked Fish, Inc. – An FDA Timeline Case Study
  • Feb 1999: Haifa Smoked Fish, Inc. is incorporated in New York State.
  • Jan 2001: FDA inspection uncovers significant flaws in Haifa's procedures, and gaps in the Company's HACCP plan .
  • June 2001: Follow-up inspection continues to find significant gaps in Haifa's HACCP plan
  • July 2001: FDA issues a Warning Letter to Haifa, detailing the Company's deviations from regulatory requirements and requesting a written response within three weeks.
  • June/July 2002: FDA inspection reveals flaws in Haifa's HACCP plan, temperature control and hygiene habits.
  • Jan 2003: HACCP plan still flawed.
  • June 2004: FDA inspection report details continuing flaws and inadequacies in Haifa's HACCP plan, its product temperature control, and its sanitation practices.
  • July 2004: FDA issues a second Warning Letter, which states "We may take regulatory action without further notice if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating." A response is demanded within 15 working days.
  • July 2005: One year after the Warning Letter was issued, FDA reinspects Haifa and finds that nothing has changed.
  • Sept/Oct 2005: FDA inspection report lists 14 pages of procedural flaws and processing and sanitation deviations, many of which were first reported in 2001.
  • June/July 2006: FDA re-inspection reveals continuing significant deviations.
  • July 2009: After being Missing In Action for three full years, FDA finally revisits Haifa and finds serious sanitation and pest control issues, including, live maggots on a table in the eviserating room, and fish lying on the processing room floor, as well as the usual lack of HACCP compliance.
  • July 10, 2009: Haifa Smoked Fish, Inc. issues voluntary recall of "... all Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009 ..." due to possible contamination with Listeria monocytogenes.
  • Nov 13, 2009: FDA seeks permanent injunction against Haifa Smoked Fish, Inc. and two of its top officers, in order to prevent Haifa from manufacturing, distributing and selling its products until the company corrects its unsanitary practices.

Michael Chappell (acting FDA Associate Commissioner for Regulatory Affairs) explained the agency's decision to take legal action against Haifa and its officers as follows:

"This company has consistently failed to make corrections to improve the insanitary conditions under which it processes smoked fish products, despite frequent warnings to do so. The FDA will not tolerate food companies that fail to provide adequate safeguards to protect the public.”

Really?

And will it take eight years before FDA and the Department of Justice decide whether or not to file charges against Stewart Parnell and the Peanut Corporation of America?

4 comments:

  1. I understand that the FDA requires some sort of registration for food manufacturers, but is there any type of pre-operational notice, review of HACCP plans, or inspection required? Why was Haifa allowed to open if there were gaps in its HACCP plan that obviously led to poor practices? Is there any requirement for food safety certification at the federal level? Mind you, I'm not convinced that HACCP plans and food safety certification do a whole lot of good if food manufacturers can ignore the HACCP plan and forget what they learned to obtain the certification. Still, I wonder how much could have been done before Haifa opened.

    Whatever did or didn't happened before Haifa opened, it doesn't excuse the FDA's foot-dragging once the violations were uncovered. From what I've seen, and admittedly it is a small part of the food safety "system" we have in place, there is attitude among food safety supervisors and administrators that inspectors must keep the industry happy and operating no matter how serious the violations. I've known some inspectors with that attitude also.

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  2. Dear Anonymous.

    Thanks for your thoughtful and detailed comment. There is no requirement, to the best of my knowledge, for food processors to obtain FDA approval of their facilities and processes before they begin operation. HACCP programs are mandatory for certain industry sectors, including fish and seafood. But the onus is on the company to comply "voluntarily", with FDA acting as a policing agency - much as the onus is on automobile drivers to comply with speed and seat belt laws.

    Unfortunately, FDA is far less prompt at taking real enforcement action against food processors that are out of compliance than the Highway Patrol is at flagging down speeders!

    Phyllis

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  3. Thanks for your response and for the review of Haifa's violations. I think it is interesting that pre-operational inspections and submission of facility plans are required for local retail food operations but not for operations that fall under FDA's authority. Local and state health departments aren't always great about enforcement, unfortunately.

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