Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Agriculture

###### Food Safety and Inspection Service 

          - [Docket No. 00-014N] 

# AGENCY:

Food Safety and Inspection Service, USDA. 

# ACTION:

Notice; opportunity to comment. 

# SUMMARY:

                        The Food Safety and Inspection Service (FSIS) is requesting comment on a petition that asks FSIS to amend sections of the Hazard Analysis and Critical Control Point (HACCP) regulations “to increase the effectiveness” of the HACCP system and to make the regulations more consistent with the HACCP principles published in 1997 by the National Advisory Committee on Microbiological Criteria for Food (NACMCF). The petition is set out in this                         **Federal Register**                         notice. The petition was submitted by a group of trade associations. It contains no data or examples to support the requests it makes. In addition to comments from the public, FSIS will solicit comment from the members of the National Advisory Committee on Meat and Poultry Inspection (NACMPI) at its May 16-17, 2000, meeting.                     

# DATES:

Comments are due July 14, 2000. 

# ADDRESSES:

Send comments in triplicate to USDA, FSIS Docket Room, Docket No. 00-014N, Room 102 Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700. 

# FOR FURTHER INFORMATION CONTACT:

Philip Derfler, Deputy Administrator, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture (202) 720-2709. 

# SUPPLEMENTARY INFORMATION:

## Background 

                    On July 25, 1996, FSIS published a final rule in the                     **Federal Register**                    , entitled “Pathogen Reduction; Hazard Analysis and Critical Control Point Systems” (61 FR 38806), requiring that federally inspected meat and poultry establishments implement HACCP systems to address hazards that are reasonably likely to occur in their operations. This rule requires that all federally inspected meat and poultry plants develop and implement written sanitation standard operating procedures (sanitation SOPs); mandates that meat and poultry slaughter plants conduct microbial testing for generic                     *E. coli*                     to verify the adequacy of their process controls; requires that all meat and poultry plants develop and implement a system of preventive controls known as HACCP to improve the safety of their products; and sets pathogen reduction performance standards for                     *Salmonella*                     that slaughter plants and plants producing raw ground products must meet.                 

When FSIS issued this final rule, it was aware that the rule would bring about major changes in the way plants operate and in how FSIS conducts its inspections. To account for this impact, the implementation of the rule was phased in over a three-year period that concluded January 25, 2000. Also, to assist the industry in preparing for the implementation of HACCP, FSIS provided extensive technical assistance and guidance and held numerous public meetings to receive input from all stakeholders. 

### Petition 

FSIS received a petition dated December 30, 1999, signed by the following organizations: The American Meat Institute, American Association of Meat Processors, National Chicken Council, National Food Processors Association, National Meat Association, National Turkey Federation, and the North American Meat Processors. The petition requests that FSIS amend sections of the HACCP regulations in order, according to the petition, to increase the effectiveness of the HACCP system and to make the regulations more consistent with the HACCP principles published in 1997, by the National Advisory Committee on Microbiological Criteria for Food (NACMCF). 

The petitioners contend that FSIS has too narrowly interpreted its rulemaking and ignores the “* * * commonsense approach needed to make HACCP successful.” In particular, they point out that there are other components of a HACCP system that the Agency should recognize, such as good manufacturing practice (GMP) programs (referred to as prerequisite programs), and that FSIS does not permit prerequisite programs to address food safety concerns. In 61 FR 38805, FSIS stated that it expected the HACCP plan to be a stand-alone document addressing food safety. 

The petitioners also suggest that FSIS change some of the definitions contained in the HACCP regulations. Specifically, they suggest the following definition changes: 

1. Delete the term and definition for “food safety hazard” and replace it with the term “hazard.” A “hazard” would be defined as “a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” 

2. Change the definition of “hazard analysis” to “the process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.” 

3. Define “severity” as “the seriousness of the effect(s) of a hazard.” 

4. Define “shipped” as “a product has been shipped if it has been sold to a third party and is not under the direct or effective control of the inspected establishment. Products have not been shipped in circumstances such as when the product is still owned by the inspected establishment, whether stored at the inspected establishment or at another storage location, as well as when the product is moving from one facility to another that is owned by the same person or company.” The petitioners also suggest that throughout the regulations the word “shipped” should replace the phrase “enters commerce.” 

5. Lastly, the petitioners request that FSIS amend 9 CFR 417.6(e) to provide that a HACCP system may be found to be inadequate only when adulterated product has been shipped. Currently, the regulations state that the system may be found inadequate when adulterated product is produced or shipped. 

                    As part of the Agency's continued efforts to involve all stakeholders in                           ( print page 30953)                        issues related to the HACCP regulation and its implementation, FSIS is publishing the petition in this                     **Federal Register**                     notice. FSIS is also publishing this petition as part of its on-going efforts to keep stakeholders updated and informed about the Agency's activities. The Agency is working on a separate rulemaking related to the petition process, to more clearly define the requirements to be contained in a petition for changing the FSIS regulations.                 

### Questions 

FSIS is seeking public comment on the following questions about the petition: 

1. The industry petition relies mainly on the NACMCF document and does not provide any data or examples to support its request. Is there any information that would support taking any of the actions requested in the petition? 

2. Would amending 9 CFR 417.2(a) in the manner suggested in the petition result in regulations that provide the level of public health protection required by the Federal Meat Inspection Act and the Poultry Products Inspection Act? 

3. Should FSIS consider regulatory modifications that would acknowledge the prerequisite programs concept of NACMCF? 

4. Do FDA regulations, such as the GMP regulations, offer an approach that FSIS should consider? How would such an approach fit within the HACCP concept? How would FSIS implement such an approach? 

5. What will be the effects of making FSIS and FDA HACCP regulatory requirements dissimilar? 

6. Should the changes suggested in the industry petition be considered in light of the views expressed on HACCP by Codex and by other countries? 

### The Text of the Petition 

#### Petition for Rulemaking Amendments to Pathogen Reduction; Hazard Analysis Critical Control Point (HACCP); Final Rule

The member companies of the trade associations (the associations) identified below support the adoption of Hazard Analysis Critical Control Point (HACCP) as the best system available for enhancing the safety of meat and poultry products. Through this petition, the associations seek amendments that will contribute to the evolution and effectiveness of HACCP. Although some adjustments can be made to the inspection system administratively, certain amendments to the Pathogen Reduction; Hazard Analysis Critical Control Point Systems final rule (the Rule) published by the Food Safety and Inspection Service (FSIS or the agency) on July 25, 1996 (61 FR 38806) will be required to accomplish these objectives. 

                    Although HACCP implementation to date has been largely successful, disputes over “technical” non-conformances with certain elements of the Rule have arisen that have adversely affected the overall success of HACCP, without contributing to protection of consumers.[1]                                          In that regard, amending the rule would reduce the occurrence of these unproductive instances and help focus future activities of the industry and the agency on issues that are vital to consumer protection.                 

#### Background 

                    HACCP is a preventive system of hazard control, the inherent value of which is widely acknowledged. In that regard, the HACCP system has provided a framework for establishing more effective food safety measures. Nearly 15 years ago, the National Academy of Sciences (NAS) recognized the importance of incorporating HACCP into the meat and poultry inspection system and encouraged FSIS to move quickly to apply the HACCP system. [2] 

The seven principles of HACCP, as revised by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) in 1997, provide the basis for contemporary interpretations of the HACCP system. Those principles are: 

1. Conduct a hazard analysis. 

2. Determine the critical control points. 

3. Establish critical limits. 

4. Establish monitoring procedures. 

5. Establish corrective actions. 

6. Establish verification procedures. 

                    7. Establish recordkeeping and documentation procedures. [3] 

Through the application of these principles, simple production processes can be accommodated. Similarly, highly sophisticated procedures, even those that may pose some degree of risk can also be accommodated, assuming that the appropriate critical control points are identified and measurement criteria are established. 

These principles purportedly provide the basis for the agency's Rule. The  Rule as written, however, deviates from the intended application of these principles in several important ways. It is because the Rule as implemented by the agency does not adhere in its entirety to the principles of HACCP that this petition is submitted. 

The Rule and industry's adoption of HACCP have fundamentally changed many aspects of food safety practices and inspection. HACCP requires acceptance by industry that it is responsible for ensuring the safety of products it produces. That concept, and the challenges it presents, has been accepted by industry. 

The Rule also has required adjustments within the agency's inspection program. Companies' HACCP control activities occur in establishments under some form of continuous inspection and a wide range of enforcement sanctions remains available to FSIS. Indeed, the Rule has, in effect, expanded that capability through provisions permitting withholding actions in the event an establishment's HACCP plan is deemed to be inadequate. Under HACCP, however, inspection emphasis was to have shifted away from the application of subjective criteria and toward monitoring of specific, quantitative benchmarks. 

HACCP should result in a food inspection system with a much higher level of private and public cooperation. Ideally, under HACCP government and industry would find themselves working together to monitory food safety compliance, with the goal of providing the safest possible meat and poultry supply. 

#### Discussion

### The Rule Is Written and Interpreted Too Narrowly 

                    An important component of HACCP is the requirement that a written HACCP plan be developed for all products in accordance with HACCP principles. That plan should identify the hazards associated with the product, identify the critical control points in the process, establish quantitative monitoring procedures to assure compliance and corrective actions, and provide effective documentation of compliance. A HACCP plan is, however, only one part of a plant's overall food safety system. Other integral components of that system include Sanitation Standard                           ( print page 30954)                        Operating Procedures (SSOPs), and various good manufacturing practices and other prerequisite programs (hereinafter collectively prerequisite programs) that are needed to form the foundation for the HACCP system.[4] 

Unfortunately, the agency has elected only to recognize the sanitation part of these other components of establishments' food safety systems. For example, a beef plant typically controls temperature according to prerequisite programs to preserve product quality. Although this is a necessary program for meeting quality criteria, FSIS has apparently taken the posisiton that establishments must also incorporate product temperature controls into their HACCP plans. This position has resulted essentially in government mandated critical control points (CCPS)—contrary to the agencys often repeated statement that companies develop and operate their own HACCP plans and are responsible for the same. The role of prerequisite programs is a central question that needs to be addressed through a dialogue with the agency to determine the appropriate role for prerequisite programs as a component of a plant's operating system. 

This mandate arises out of the agency's refusal to acknowledge prerequisite programs and other important food safety systems as very important, integral components of an establishment's food safety system. The agency specifically points to the “in the absence of those controls” language it incorporated into section 417.2(a)(1) of the Rule. The agency's interpretation of the Rule's language is unduly narrow and ignores the commonsense approach needed to make HACCP successful. 

Notwithstanding the problems encountered to date, the Rule can be amended to enable the agency to consider the other important aspects of an establishment's food safety system, such as prerequisite programs. Rather than continue to implement a regulation that the agency interprets as forcing FSIS to ignore certain elements of a plant's program, the Rule should be amended to permit the agency to consider those other components when determining whether an establishment's HACCP plan is adequate. As discussed below, prerequisite programs will influence the likelihood that a food safety hazard will occur and, therefore, should be acknowledged by the Agency. 

Such an amendment will benefit the agency, the regulated industry, and most significantly will enhance food safety. In that regard, the agency will be better able to determine whether a company's HACCP plan is adequate, enabling the agency to apply its limited resources to situations in which the integrity of the food inspection system may be compromised. Similarly, regulated companies will be better able to direct their resources to address circumstances that involve legitimate food safety issues, rather than including additional and often unnecessary provisions in their HACCP plans in order to accommodate the current interpretation of HACCP contained in the rule. Making the system operate more efficiently benefits all interested parties, including consumers who benefit from lower prices and also benefit from the fact that a less complicated, less duplicative system contributes to a more effective system from a food safety standpoint. 

### The Definition and Interpretation of a Food Safety Hazard Should Be Amended 

                    The Rule's definition of “food safety hazard” is inconsistent with the definition of hazard provided by the NACMCF. Currently, the Rule defines a “food safety hazard” as any “biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” [5]                                          The NACMCF, however, developed a tighter, more appropriate defintion of “hazard” in its 1997 report.[6]                                          Specifically, NACMCF defines a “hazard” as a “biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” [7]                                          This definition will facilitate development of HACCP plans that focus on food safety, while encouraging firms to utilize prerequisite programs.                 

                    The Guidelines include a thorough discussion of that definition and, in that regard, provide that the purpose of a hazard analysis “is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled.” [8]                                          The Guidelines provide that each identified potential hazard should be evaluated, giving consideration to its severity and likely occurrence. That consideration should also include the food, its method of preparation, transportation, storage, and the persons likely to consume the product.[9]                                          Also included in these considerations would be the influence of prerequisite programs on the likely occurrence of the hazard under consideration. In short, the Guidelines make clear that significance, based on a variety of factors, is an integral part of determining whether a potential hazard is, in fact, a hazard that should be addressed in a HACCP plan.[10] 

The Rule, however, is not written, nor interpreted, in a manner consistent with the NACMCF Guidelines. The Rule provides a much broader definition of “hazard” because it identifies as a “hazard” those properties that may cause a food to be unsafe, regardless of whether the hazard is “significant” in terms of actually presenting a risk to human health. This interpretation has led to confusion regarding what should be covered in HACCP plans and how to make this determination. This problem could be addressed by changing the Rule's definition of “hazard.” The NACMCF definition and interpretation of a “hazard,” is more precise and consistent with the principles of HACCP because it provides useful guidance for identifying those properties that, when all factors are considered, present a significant risk of illness or injury. 

                    Prior to the implementation date for HACCP in the very large plants, the agency published the first of several notices that, in effect, dictate the adoption or establishment of hazards, without engaging in the necessary hazard analysis with respect to the significance and severity of those hazards. For example, in November 1997 FSIS published a notice telling establishments that zero tolerance for visible fecal material was a food safety standard and that FSIS would be determining compliance before the application of interventions. FSIS stated in the notice that visible fecal was a vehicle for microbial contamination. However, an establishment employing microbial interventions would typically set the critical control point at the intervention, not prior to it. In a situation such as this the visible contamination would need to be minimized but would not be the most critical point in the system. This notice, in effect, dictated the presence of CCPs in the production process, as well as its positioning.                           ( print page 30955)    

Immediately following large plant implementation the agency published a notice that effectively abandoned the concepts underlying HACCP in favor of a command and control regulatory system. Ultimately, the agency issued letters to numerous federally inspected facilities effectively dictating CCPs when a hazard analysis conducted by those plants, consistent with the NACMCF model for conducting such an analysis, indicated that the hazard was not of sufficient significance and severity to warrant its control through the HACCP plan. Finally, more recently, the agency has again insisted on dictating the presence and positioning of CCPs in plants that manufacture raw ground and not ground products. 

Implementing the change recommended by this petition would address this problem and would benefit the agency, consumers, and the regulated industry. As previously discussed, such a change would enable the agency to focus its resources in a more efficient and effective manner and would enhance food safety by doing so. Accordingly, the Rule should be amended to adopt the definition of “hazard” as set forth by the NACMCF and abide by the NACMCF's intent with regard to conducting a hazard analysis. 

### The Rule Does Not Adequately Address When a Product Is Within an Establishment's Control 

The Rule does not provide adequate guidance as to when a product has left the producing facility's control. The agency's interpretation of the Rule fails to acknowledge that products can be within an establishment's control even when the product is outside the physical boundaries of an establishment. For example, product on a company-owned or contracted truck is still under that company's control, as is product still owned by the establishment but held in a cold storage warehouse away from the production facility. FSIS has, on several occasions, contended that product was no longer within the establishment's control once it left the production facility's loading dock. Indeed, the agency has taken that position even when the product was stored on tractor-trailers still on the physical plant compound. 

The Rule should be amended to define, for purposes of compliance with the HACCP regulations, when a product is shipped. In that regard, product should be deemed to have been shipped for purposes of HACCP compliance when it has been sold to another entity and is no longer in the direct or effective control of the producing establishment. For example, when product owned by the establishment is stored at a cold storage warehouse and is still subject to movement at the direction of the establishment it should be deemed to be in the establishment's control. 

### The Provision Regarding Inadequate Plans Should Be Amended 

The Rule provides that a plant's HACCP plan may be deemed to be inadequate when “adulterated product is produced or shipped.” That provision however, is too draconian and should be amended to delete the reference to “produced.” 

The checks built into a HACCP plan are intended to identify not only when the production process is working as intended, but also to alert an establishment when the process has not met the critical limits relevant to the identified CCPs. A HACCP plan operating, as intended, will alert a company when a critical limit has not been met for one of many reasons that can, over the course of time, be expected to occur. In some cases, that will result in the production of “adulterated” product as that term is defined in the Federal Meat Inspection Act and the Poultry Products Inspection Act. What is relevant for purposes of compliance with the Rule is whether administration of the HACCP plan resulted in the company being able to detect the problem, as well as enabling the company to take corrective action. 

A plant's operation should not be in jeopardy when it identifies a problem, as its plan is designed to do—even though adulterated product has been produced. The Rule, however, puts the agency in the position of taking action and deciding that an establishment's HACCP plan is inadequate when adulterated product is produced, even if the company caught the problem before any product left the plant's control. If the system is working a company should not be penalized. At a minimum, no plan should be deemed to be inadequate for deviations detected by the company in pre-shipment review. Numerous examples of such technical non-conformances can be cited and such instances have encumbered the agency and industry in resource intensive discussions that do not enhance public health protection. By modifying the Rule the squandering of valuable inspection resources can be avoided. 

#### Specific Action Requested 

The undersigned organizations request that the FSIS HACCP regulations be amended as set forth below. 

Amend section 417.2(a)(1) to read as follows: “Every official establishment shall conduct, or have conducted for it, a hazard analysis to develop a list of hazards that are of such severity and significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to cause injury or illness do not require further consideration within a HACCP plan. The hazard analysis shall consider the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer.” 

Amend section 417.1 to include several necessary definitions to ensure consistency with the recommendations of the NACMCF. In that regard the following amendments should be promulgated. 
    - Delete the term food safety hazard and provide the following definition of hazard: “A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.”
    - Provide the following definition of hazard analysis: “The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.”
    - Provide the following definition of severity: “The seriousness of the effect(s) of a hazard.”
    - Provide the following definition of shipped: “A product has been shipped if it has been sold to a third party and is not under the direct or effective control of the inspected establishment. Products have not been shipped in circumstances such as when the product is still owned by the inspected establishment, whether stored at the inspected establishment or at another storage location, as well as when the product is moving from one facility to another that is owned by the same person or company.”

Amend section 417.3 to provide when product produced pursuant to a HACCP plan has been shipped for purposes of compliance with the rule. Specifically, section 417.3(b)(3) should be amended by striking the words “enters commerce” and inserting in lieu thereof “is shipped.” 

                    Amend section 417.6(e) to provide that a HACCP system may be found to be inadequate when adulterated product has been shipped. Specifically, section 417.6(e) should be amended by striking “produced or.”                           ( print page 30956)    

#### Conclusion 

Amendments to the Rule as suggested by this Petition will advance the interests of government, industry, and the consuming public. The Food Safety and Inspection Service should proceed without further delay toward adoption of these amendments. With regard specifically to prerequisite programs, the undersigned organizations intend to engage the agency in discussions to develop the appropriate consideration of these programs within a comprehensive system for managing food safety, quality, and wholesomeness. 

#### Certification 

The undersigned certifies that, to the best of his knowledge and belief, the Petition includes all information and views on which the Petition relies, and that it includes representative data and information known to the Petitioners that are unfavorable to the Petitioners. 

   Respectfully submitted,

American Meat Institute 

American Association of Meat Processors 

National Chicken Council 

National Food Processors Association 

National Meat Association 

National Turkey Federation 

North American Meat Processors

### Additional Public Notification 

                    Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and provide copies of this                     **Federal Register**                     publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations,                     **Federal Register**                     notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.                 

Done at Washington, DC, on: May 8, 2000.

Thomas J. Billy, 

Administrator. 

# Footnotes

1.                             Although HACCP   implementation will not be completed throughout the meat and poultry industry until next January, nearly 80 percent of meat and poultry production already occurs under HACCP systems. This experience suggests strongly, that the time is now to discuss ways to improve an HACCP-based inspection system.                    
        Back to Citation      

2.                                                     *Meat and Poultry Inspection—The Scientific Basis of the Nation's Program,*                         National Academy Press, 1985 (pp. 134-135).                    
        Back to Citation      

3.                             The NACMCF streamlined the principles in a report adopted August 14, 1997. That report reversed principles six and seven from the original order established by NACMCF to the order presented above. See Hazard Analysis and Critical Control Point Principles and Application Guidelines (hereinafter the Guidelines), J. of Food Protection, Vol. 61, No. 6, at 762-775, 1998.                    
        Back to Citation      

4.                             Prerequisite programs have been identified as the foundation upon which a HACCP plan is built. See “The Role of Prerequisite Programs in Managing a HACCP System,”                         *Dairy, Food and Environmental Sanitation,*                         Vol. 18, No. 7 at 418-423, July 1998.                    
        Back to Citation      

5.                             9 CFR sec. 417.1.                    
        Back to Citation      

6.                             FSIS cross-references hazard and food safety hazard in the Rule. See 9 CFR sec. 417.1.                    
        Back to Citation      

7.                             See Hazard Analysis and Critical Control Point Principles and Application Guidelines, National Advisory Committee on Microbiological Criteria for Foods, at 6 (August 14, 1997).                    
        Back to Citation      

8.                                                     *Id.*                         at 12-13.                    
        Back to Citation      

9.                                                     *Id.*                         at 12.                    
        Back to Citation      

10.                             Indeed, the Guidelines provide that hazards identified in one facility may not be significant in another plant for the same or similar product.                         *Id.*                         at 14.                    
        Back to Citation      

[FR Doc. 00-12156 Filed 5-12-00; 8:45 am] 

BILLING CODE 3410-DM-P