The Honorable Dan Glickman
Office of the Secretary
U.S. Department of Agriculture
Fourteenth Street and Independence Avenue, S.W.
Washington, DC 20250
Dear Secretary Glickman:
The Office of Advocacy has been involved in the rule makings for Hazard Analysis Critical Control Points (HACCP) for both the seafood and meat/poultry industries. The Office of Advocacy recently reviewed the final HACCP rule for meat/poultry, and continues to have serious concerns about the rule's economic impact on small processors.
While this office is not in the business of keeping small businesses afloat in the face of all evil, we do take an interest when fair competition is threatened by a particular rule. In our efforts to preserve competition between large and small businesses, the Office of Advocacy would like to go on record again as opposing the mandatory microbial testing and sanitation SOP provisions in the rule.
I. SANITATION SOPs
Sanitation SOPs are redundant within a HACCP model. The concept behind HACCP is that the industry will adopt its own standards to identify potential critical points where hazards are likely to occur and then take preventative action to avoid the hazard (contamination). However, it appears by the inclusion of sanitation SOPs and certain other provisions of the rule described herein that FSIS has no confidence in the ability of the industry to formulate and maintain successful HACCP plans.
The concept of sanitation is inextricably linked to any successful HACCP plan.(1) The Office of Advocacy ponders how a plant could seek to produce a safe product under a HACCP model (not the current inspection system) with insanitary conditions. A plant without sanitation as a critical control point would most likely never pass verification or validation processes. "Prevention" is supposed to be the operative word--not "prescription."
Implementing a separate process before HACCP plans can be developed--not to mention the daily record keeping and paperwork requirements--is nothing short of an onerous burden.(2) Moreover, failure to comply with the stated requirements would mean shutting down affected facilities. The final rule states, "even such minor instances of non-compliance might result in a temporary interruption of production unless the inspector could quickly and easily verify by other means that the procedure had in fact been completed." What are the implications under such circumstances when FSIS has verified (or, designates as adequate) a HACCP plan, or a plant uses a HACCP model provided by FSIS?
Nevertheless, during a May 31, 1996, meeting between FSIS officials and the Office of Advocacy, the best reason provided by FSIS supporting the need for sanitation SOPs was that businesses would be able to "build experience" with record keeping and other mechanical aspects of the rule, and be better prepared to deal with implementing HACCP when the time came. It seems more logical that experience building should come from the demonstration projects, actual implementation of a HACCP plan and/or voluntary verification procedures--not superfluous, mandatory record keeping requirements.
RECOMMENDATION: The Office of Advocacy recommends that FSIS withdraw the separate requirements for sanitation SOPs. Any such requirements should be a part of, and implemented at the same time as HACCP plans.
II. MICRO TESTING
HACCP was developed partly because testing was infeasible and costly. In the proposed rule, FSIS recommended certain chilling and anti-microbial washing procedures in addition to the micro testing. When the small business community and other concerned commenters objected, the former provisions were removed from the final draft rule because they were overly prescriptive, redundant and costly. The micro testing requirements are no different. They are prescriptive in nature, and amount to command and control over what is seen by many as a perfectly self-sufficient model. It might be just as well to leave in the provisions from the proposed rule and the testing and sanitation requirements in the final rule, and leave out HACCP altogether.
More importantly, there is conflicting scientific evidence regarding the need for and benefits of micro testing. FSIS relies on a Philadelphia conference and report (by a consumer- dominated group) which supports the notion that E-coli testing is the best, most reliable method to detect fecal contamination and maintain process control. With no other basis for its conclusion, and no prior testing of HACCP, FSIS chooses to ignore the opposing views of other objective researchers who believe that E. coli testing is an inaccurate indicator of process control.
In the "Review of the Hazard Analysis and Critical Control Point/Pathogen Reduction Regulation," the Office of Risk Assessment and Cost-Benefit Analysis (ORACBA),(3) stated that FSIS should proceed without the testing component, and that there was, "insufficient scientific basis to rely on E. coli for process control verification to ensure Salmonella reduction on carcasses."(4) Because carcass sampling procedures include so many variables (the selection of a single anatomical site on the animal carcass, the location of the site, the method for collecting samples from the site, and the between plant differences in the sample collection), the panel concluded that finding E. coli in a sample is more the result of some `unlucky' sampling than it is an indicator of a poor HACCP plan."(5)
The report also raised concerns, consistent with Advocacy's position, about additional regulatory cost. According to the report,
"The E. coli testing portion of the regulation is not shown to be an effective component of a strategy aimed at reducing and controlling pathogenic microorganisms. It is an audit process with little or no ability to provide feedback or consequences that foster improvement. As a result, the rule could impose additional regulatory costs with little justification."
Finally, in the May 31 meeting referenced earlier, FSIS officials conceded that E-coli may not be an adequate indicator for certain emerging pathogens, and that it could not detect the existence of other non-pathogenic agents.
RECOMMENDATION: Abandon micro testing for E. coli as a mandatory process. Any such testing should be used as a verification/screening procedure only when a plant deems it necessary or useful.
III. REGULATORY FAIRNESS
Small businesses do not wish to be exempt from HACCP requirements--nor are they necessarily opposed to voluntary testing. However, the extraneous provisions discussed above are highly troublesome for the entire industry--and perhaps USDA. Under the Small Business Regulatory Enforcement Fairness Act of 1996 (the Act),(6) aggrieved small businesses may sue USDA based on the judicial review provisions contained in the Act which take effect on or about June 28, 1996. Hundreds, if not thousands, of aggrieved small businesses could sue USDA because of the scientifically unsound micro testing requirements and unnecessary sanitation SOPs (among other more minor things).
Will a court find this rule-making arbitrary and capricious under the Administrative Procedure Act? Will FSIS' final regulatory flexibility analysis hold up under judicial scrutiny? Will a court find that adequate justification exists for the alternatives selected under the Unfunded Mandates Act or Executive Order 12,866? If FSIS is not certain of the outcome in each of these situations based on the evidence presented, then it would be advisable for FSIS to pursue less onerous requirements until it can formulate a more scientific basis for its alternatives.
Finally, if judicial review is not a sufficient reason to reconsider the prescriptive mandates, then perhaps the added certainty of Congressional review is.
IV. CONCLUSION
The case made by the consumer advocates is certainly compelling, and economic concerns hardly outweigh the health of our population. However, no evidence is presented with respect to the insufficiency of HACCP as a stand-alone proposition. Mandatory micro testing and sanitation SOPs simply have no place in HACCP and threaten competition among businesses of differing sizes.
Therefore, the Office of Advocacy recommends strongly that FSIS proceed with publication of the final rule without the micro testing and sanitation SOP requirements. Instead, reconsideration should be given to those requirements if and when they are proven to be scientifically necessary--or at least until the demonstration projects prove their necessity.
Thank you for your consideration of this matter. Please do not hesitate to contact me if you have any questions regarding the aforementioned comments, 202-205-6533.
Sincerely,
Jere W. Glover
Cjief Counsel for Advocacy
Shawne Carter
Assistant Chief Counsel for Advocacy
END NOTES
1. Although the thirteen HACCP models being prepared for FSIS are not yet completed, the Office of Advocacy would be interested to note whether sanitation procedures are included in those plans.
2. The rule does allow for sanitation SOP steps to be dropped if that step is included within the HACCP plan. This is little consolation for small businesses who have already implemented record keeping procedures first to comply with sanitation SOP which come on line 60 days following publication of the final rule. If every single SOP requirement is not met by the HACCP plan, however, dual records must be maintained.
3. This office was created by legislation in 1995 under the umbrella of the U.S. Department of Agriculture. Although the HACCP regulation was proposed prior to the effective date of ORACBA, and there is no legal effect resulting from the opinions of the panel, the findings stated in the draft report have extremely important policy implications. Also, the draft report, dated March 19, 1996, was never submitted in final, but was received and commented on by FSIS.
4. Draft Report p. 5. Out of twenty positive Salmonella tests found in the baseline survey, there were seventeen negative E. coli tests.
5. Draft Report p. 9.
6. Pub. L. 104-121.
June 12, 1996
Ms. Sally Katzen, Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office Building
Washington, D.C. 20503
Dear Ms. Katzen:
For your review, I am enclosing a copy of the comments submitted to Secretary Glickman by the Office of Advocacy regarding our impressions of the draft final rule concerning Hazard Analysis Critical Control Points (HACCP) for meat and poultry. The final rule is being issued by the Food Safety and Inspection Service (FSIS) and was apparently submitted to you for expedited review. While the Office of Advocacy is sensitive to the pressure to publish a final HACCP rule, the rule in its present form still presents several serious problems for small meat and poultry processors.
As indicated in the attached letter to the Secretary, the mandatory and duplicative sanitation SOPs, as well as the mandatory E. coli micro testing requirements have not been demonstrated to be effective components of a food safety system that controls food pathogens. As such, the detrimental impact on small business competition would be tremendous.
Please review this information and contact me, or Ms. Shawne Carter of my staff, with any questions you may have, 202-205- 6533.
Sincerely,
Jere W. Glover
Chief Counsel for Advocacy