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Regulatory Leapfrog is Underway

USDA’s Food Safety and Inspection Service (FSIS) has announced a series of prevention-based food safety policy measures, including a final rule designed to make FSIS aware of adulterated or misbranded food in the supply chain that is similar to FDA’s Reportable Food Registry; a proposed rule for earlier, more expansive traceback for E. coli; and a draft guidance on validating HACCP systems.

FSIS published an advance copy of the Final Rule entitled “Requirements for Official Establishments to Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall Procedures, and Document Certain Hazard Analysis and Critical Control Points System Plan Reassessments.” The rule implements three provisions included in the 2008 Farm Bill and requires establishments to:

- notify FSIS within 24 hours that a meat or poultry product that could be subject to Class I, II or III recall has been shipped into commerce.

- prepare and maintain written recall procedures.

- document each reassessment of their HACCP plan.

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The notification requirements show some similarity to FDA’s Reportable Food Registry (RFR), however they clearly go much further in terms of what needs to be reported to FSIS. Also FSIS chose to implement a completely different system with facilities directed to notify, that is – make a phone call to – the appropriate District Office within 24 hours of “learning or determining that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has happened.”  As with many rules the precise interpretation of “reason to believe” is significant.  Would this mean that a presumptive positive is a reason to believe?

In contrast, the RFR (discussed in a previous newsletter) requires FDA-regulated food facilities to report when there is “reasonable probability” that an article of food will cause serious adverse health consequences – a Class I situation. Additionally, the report is to be submitted through the electronic RFR portal as soon as practicable, but in no case later than 24 hours after determining that an article of food is a reportable food.

Although FSIS received comment suggestions to follow the standard established by RFR, or to incorporate a de minimis standard (that is, the determining of a risk level that is too small to be concerned with). FSIS chose to maintain its standard of reporting of any adulteration or misbranding stating, “If the Agency adopted the RFR standard or a similar de minimis standard, establishments may not be required to notify FSIS about product that could trigger a Class II or Class III recall.” While this is certainly true it is most assuredly “leaping” over the current FDA RFR requirements in terms of regulatory stringency.

As such, the rule assesses the public health concern or hazard presented by a product then classifies the concern as:

Class I – a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death;

Class II – a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product; or

Class III – a situation where the use of the product will not cause adverse health consequences.

A further point to note is that the recall class definitions between FSIS and FDA are different, and this new rule will require the reporting of situations in which “the use of the product will not cause adverse health consequences.”

Additionally, FSIS noted that because the notification requirement is a preventive measure that will allow FSIS to determine more quickly whether a recall action is necessary (including detention and seizure of product by FSIS), the rule requires establishments to report all product that is believed to be adulterated or misbranded.

While the rule is similar to the RFR in that establishments are to report within 24 hours, USDA’s original proposed rule (published March 2010) gave establishments 48 hours to report, however after receiving comments that that may be too long, the Agency concluded “because notification can be made with a phone call, 24 hours is an appropriate time in which to expect official establishments that have shipped or received, or have reason to believe that they have shipped or received, adulterated or misbranded product, to notify the appropriate District Office of that situation.”

Additional provisions of the rule are that:

USDA establishments must provide all available information about the “destination” of adulterated or misbranded product. This rule does not create a duty to seek out new information; however, if establishments have additional information about the destination of adulterated or misbranded product beyond their direct consignees, they must provide it to the Agency.

Establishments are not required to submit their recall procedures to FSIS. They must, however, make the written recall procedures available for copying.

Existing large establishments will have six months from the date of publication of this final rule to implement it and prepare recall plans. Small and very small establishments will have one year.

The Agency is amending 9 CFR part 304.3 and 9 CFR part 381.22 to require that before being granted federal inspection, an establishment must have developed written recall procedures as required by part 418 of Title 9, Chapter III chapter.

Agreeing with comments that the documenting of HACCP reassessments is beneficial, FSIS is requiring that establishments document each reassessment of the HACCP plan and the reasons for any changes or for not changing. For annual reassessments, however, if no changes are deemed necessary, documentation is not needed.

While both USDA and FDA are focusing efforts and regulations on prevention, more coordination between the two could make life easier for those who must report to both. The addition of FSIS’ new notification requirement, which has no alignment with FDA’s RFR has, once again, created duplication of obligation for those who process or manufacturer products that include both FDA- and USDA-regulated ingredients. And with different reporting standards between the two, it seems to be moving the industry backward in documentation rather than forward.

E. coli and HACCP

The other two areas in which USDA also issued new policy are:

Earlier, more expansive traceback. FSIS is proposing a new procedure to be implemented when federal or state sampling finds raw beef presumptive positive for Escherichia coli (E. coli) O157:H7. The proposed procedure means that FSIS will no longer wait for a confirmed positive; rather when presumptivepositive test results in its routine sampling indicate E. coli O157:H7 contamination, it will move quickly to identify the supplier of the product and any processors who received contaminated product from the supplier, once confirmation is re
ceived. It is expected that this change will reduce response time by 24 to 48 hours.As a commentary on this policy, it is interesting given the June start date for testing of six other serotypes of Shiga Toxin Producing E. coli  (STEC) this policy change only appears to impact O157:H7 which appears to be a bit of a disconnect between FSIS policies.

Draft Guidance for HACCP Validation: The guidance defines the steps that are necessary to validate one’s HACCP systems, that is, to establish that the HACCP systems will work as designed to control the food safety hazards that they confront.  The draft guidance document is available for comment.Historically, FSIS moved ahead of FDA in terms of preventive control requirements in the mid 90′s with the meat and poultry HACCP requirements.  The signing of FSMA in 2011 moved FDA back out in front in terms of preventive control requirements, but we are now seeing FSIS snatch back the lead in certain key areas, namely what food companies are required to report in terms of adulterated or misbranded product, as well as early reaction to presumptive-positive testing results. While the food industry clearly understand the need to prevent problems, not just react to them, it would make life a whole lot less confusing if FDA and FSIS were consistent in their approaches – even allowing for statutory differences.

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David Acheson, former Assistant Commissioner for Food Protection in the FDA, is a partner at Leavitt Partners. This article was first published May 11, 2012 on the Leavitt Partners Food Safety blog

 

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