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General Comments

This page offers several introductory comments about the proposed FDA regulations for implementing the Hazard Analysis and Preventive Controls as mandated by Congress in the FSMA.

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Observations or Comments

Observations about the Proposed Rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls:

Hazard analysis and critical control points (HACCP) has its foundation in the 1960s and has evolved since its inception.  An initial focus of HACCP was upon biological problems that could render the food unfit for consumption.  Accordingly, early HACCP plans focused controlling the points in food processing that were likely sources of biological concerns.  During the past five decades, the food industry has grown to recognize that HACCP principles also can be applied to other hazards; that is, HACCP principles can be applied to reduce all risks.  Congress confirmed this observation when it enacted a broad definition for risk management as part of the FSMA.  Accordingly, the latest version of HACCP emphasizes "reducing risk," rather than focusing on "critical control points."  Even though the FSMA does not use the HACCP term, the concept is alive and well.  It has been expanded and refined with nearly 50 years of experience.  FSMA defines the next generation of HACCP.

The FSMA also clarifies that hazard analysis and risk reduction includes good manufacturing practices, recall plan, employee training and other concepts that advance the goal of "reducing the risk of hazards reasonably likely to occur."

The FSMA clarifies the relationship or association between Hazard Analysis and Critical Control Points (HACCP) and Good Manufacturing Practices (GMP).  GMP were conceptualized prior to the development of HACCP (1970s versus 1990s).  Initially, HACCP was defined extremely narrow.  With experience, HACCP was defined more broadly and the distinction between between the two concepts (HACCP and GMP) became less clear.  FSMA makes it explicit that GMP and HACCP are complementary concepts.  See 21 USC 350g(o)(3)(F).

The Hazard Analysis of FSMA differs from previous HACCP for seafood, juice, meat and poultry, but the primary difference is that Hazard Analysis for FSMA recognizes the benefits of applying the concept of Hazard Analysis more broadly.  Accordingly, Hazard Analysis for FSMA can be described as encompassing all components of past HACCP plus more.  FSMA Hazard Analysis is the next generation of HACCP

Anticipate that past HACCP standards (seafood, juice, meat and poultry) will be raised to the FSMA Hazard Analysis standards sometime in the future.  In fact, some business that are subject to past HACCP may decide to voluntarily migrate to the standards of FSMA Hazard Analysis.  Also anticipate that these new Hazard Analysis standards will come from  industry, as much as they will arise from government.  Restated, an increasing portion of food buyers will require their suppliers of processed food to meet the FSMA Hazard Analysis as part of their contractual standards.  Past HACCP food businesses might as well get ahead of the oncoming tide.

It is not clear yet whether FSMA Hazard Analysis will be called HACCP, or whether FSMA Hazard Analysis will be given a different name to distinguish it from the previous generation of HACCP.  It is probably helpful to use terminology to distinguish between the generations of HACCP; but overtime, a single term MAY be acceptable once the standards for the different "generations" of HACCP/Hazard Analysis merge into a more common standard.

Note:  hazard analysis is based on reducing the risk of unsafe food.  This law (society through government) does not expect industry to guarantee that all food is safe (known or reasonably foreseeable hazards, further refined to reasonably likely to occur).  However, do not be surprised if society/consumers through industry will demand even lower risks than government will mandate.  This demand from consumers is likely appear in the food market (such as "document your production and processing practices before I buy your product") as well as product/absolute liability (i.e., tort law) in civil lawsuits brought by injured consumers against food businesses.

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Must every risk or uncertainty be addressed within the Hazard Analysis?  The initial answer to this question is "no".  The law recognizes that food is NOT going to be absolutely safe.  Instead, the settled goal is to reduce the risk of unsafe food.  Several statutes/regulations illustrate this point.

  • 21 USC 350g -- known or reasonably foreseeable hazards ... will be significantly minimized or prevented
    • proposed 21 CFR 117.130(c) -- determine whether the hazards are reasonably likely to occur
  • 21 USC 350f --  The term “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.
  • 21 USC 350h -- establish science-based minimum standards for the safe production and harvesting of ... fruits and vegetables ... that are raw agricultural commodities for which ... such standards minimize the risk of serious adverse health consequences or death.
  • 21 CFR 117.110  (proposed) Defect action levels. Natural or unavoidable defects in food for human use that present no health hazard:  (a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. FDA establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.

Arguably, none of these laws are imposing a standard of perfection; these laws are addressing the most serious concerns and attempting to minimize risk.  Other commentators, however, would argue that these and similar laws do not leave room for flexibility within the food industry, that these statements are not meant to convey any flexibility.  Only time will tell which interpretation will be adopted.  If there will be reluctance to grant some leeway within these expectations, (as suggested previously) the least leeway will likely be shown by consumers initiating personal injury (tort) actions against members of the food industry.

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Regulatory standards do not necessarily define standards of conduct for a tort action.

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Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

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