A Statement Concerning the Differences between Kevin’s Law and HACCP’s Final Rule

Written by Patricia Buck

September 2004

In 1998, the U.S. Department of Agriculture switched from its traditional sight, smell and probe meat and poultry inspection system to a process oriented, science-based system called Hazard Analysis at Critical Control Points (HACCP). Adopting this new inspection system became a priority with the emergence of deadly new pathogens that cause serious illnesses in humans. Only microbial testing detects these powerful bacteria, so HACCP’s Final Rule incorporated two microbial performance standards (9 CFR Part 304, et al; 7/25/96; Part II).

For the past five years, USDA has struggled with enforcing these performance standards. During that time, tens of thousands of people have had serious foodborne illnesses, but until the Final Rule is clarified, the USDA will not be able to enforce the microbial standards for meat and poultry. No agency can effectively work from a document that presents arguments that run counter to the fundamental principles of its plans, yet this is what has been happening. With thousands of Americans being harmed each year, it is now imperative that legislators address this difficulty. Congress needs to enact a law that will give USDA the authority to use microbial performance standards to validate and verify HACCP’s processes and goals. Without clarification, the Final Rule will continue to limp along allowing thousands of Americans to endure needless sickness, long-term injury or death.

The Meat and Poultry Pathogen Reduction and Enforcement Act, otherwise known as Kevin’s Law, is primarily a restatement of HACCP’s Final Rule, except Kevin's Law is written in a straightforward, clear fashion. The Final Rule is organized in a see-saw pattern which opens areas of doubt about what authority the USDA really has. For example, on page 38849, it very clearly states that if an establishment fails the Salmonella pathogen reduction performance standard three times, the FSIS, an arm of the USDA, will withdraw its services; but two pages later (38851), a commenter's remark suggests that the agency does not have the legal authority "to impose sanctions for failure to meet established standards." This type of contradictory positioning invites confusion, even though the overall tone of the Final Rule maintains that "HACCP must be coupled with appropriate performance criteria and standards against which the effectiveness of the controls developed by each establishment can be validated and verified" (38836).

Secondly, Kevin's Law clearly establishes pathogen reduction performance standards as regulatory tools. Throughout the Final Rule, "Salmonella performance standard" and "generic E. coli performance criteria standard" are terms used to identify standards for two distinct testing procedures. According to the Final Rule, the E.coli criteria standard is to be used as a guideline, while the Salmonella performance standard is supposed to be enforced. Furthermore, the Final Rule discusses at length the generic E.coli criteria standard with multiple references that these "standards" are only "indicators" or "guidelines" or "targets," and as such, they are "not regulatory" (38841) nor are the standards to be used "to judge whether specific lots of product are adulterated under the law" (38836). Due to these remarks about the generic E.coli criteria standard, the Final Rule sometimes provides opportunities for groups—particularly those opposed to an enforceable microbial performance standard on end products—to falsely claim that the USDA does not have authority to enforce the pathogen reduction Salmonella performance standard.

This creates an untenable problem. HACCP's Final Rule relies on microbial performance standards (38808, 38811, 38812, 38817, 38818, 38836, 38846, 38850, 38852, 38854, 38855—there are probably more citations, but these pages do contain statements that plainly and specifically refer to microbial performance standards as an essential component of the HACCP system.) Kevin's Law would remove any ambiguity and establish microbial performance standards as regulatory and enforceable tools. Without microbial, critical control point testing and end-product microbial performance standards, it seems unlikely that HACCP will achieve its goal of reducing pathogens on raw meat and poultry products.

A third (and perhaps most important) difference between Kevin's Law and the Final Rule is that the Final Rule has no procedure detailing how the FSIS will monitor performance standards to assure that the government is using the best standard for pathogen reduction. True, the Rule makes references to establishing a plan, but no specifics are given; on the other hand, Kevin's Law clearly provides an orderly system for revising and reviewing the pathogen reduction standards in a timely fashion.

In addition, Kevin’s Law reverses serious erosion of USDA's mandate and Congress’s intent to provide Americans with the safest possible meat and poultry products. Supreme Beef challenged the USDA about the Salmonella performance standard within one year of HACCP's introduction. Their eventual 2001 victory was followed by Nebraska Beef's 2003 settlement involving the USDA's authority to monitor sanitation plans using on-going, generic E.coli testing. Since the HACCP system embraces both Salmonella for its end-product pathogen reduction test and generic E.coli for its critical control points sanitation criterion tests, it seems apparent that some establishments really do not want any microbial testing as part of the inspection process.

In response to these developments, USDA claims that it needs more time and studies in order to implement HACCP. Others, in particular some consumer groups, legal experts and scientists, believe that USDA needs to stand up against industrial pressure and insist that establishments report their criterion testing results and meet HACCP's pathogen reduction standard or risk the withdrawal of FSIS inspection. In recent reports, the National Academies of Science Report (2003), the GAO Report (2002), and the Senate’s OIG Audit (2003) seem to agree with this assessment and contain recommendations that urge stronger legislation to clarify USDA’s authority.

At this point in time, Congress is the only governmental power capable of affirming the Secretary of Agriculture’s authority to use microbial testing as part of the HACCP system. The American people want safer meat and poultry products. In May 2003, members of Congress were presented with 6000 signatures from 36 states on the “Petition for Safer Meat,” asking for support of Kevin’s Law. This bill (S.1103 / H.R. 2203) now sits in the Senate and House Agriculture Committees, but it needs active consideration by the whole of Congress.

Thank you for your attention and for your support of this important piece of legislation.

Patricia K. Buck, grandmother of E.coli O157:H7 victim, Kevin Kowalcyk
40 Forest Glen Drive, Grove City, Pennsylvania 16127, 724-458-4603

Statement released December 7, 2003, for 3rd Annual Birthday Blood Drive, Mt. Horeb, WI
In honor of Kevin Michael Kowalcyk (12/10/98 - 8/11/01); Updated 9/14/04
Sources:

Congressional Research Services. Meat and Poultry Inspection Issues by Jean Rawson, Resources, Science, and Industry Division, August 2003.
Order Code IB10082

Committee on the Review of the Use of Scientific and Performance Standards for Safe Food, National Research Council. Scientific Criteria to Ensure Safe Food. National Academies of Science, 2003.

HACCP Final Rule: www.fsis.usda.gov/oa/fr/rule1.pdf, 1996.

U.S. Department of Agriculture. Office of Inspector General: Great Plains Region.
Food Safety and Inspection Service Oversight of Production Process and Recall at ConAgra Plant (Establishment 969). Report No. 24601-2-KC, September, 2003.

U.S. General Accounting Office. Report to the Committee on Agriculture, Nutrition
And Forestry, U.S. Senate. Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902 Meat and Poultry, August 2002.