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January 19, 1999

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852

                        Re: Proposed Rule on HACCP Procedures for the Safe and Sanitary                           Processing and Importing of Juice; Docket No. 97N-0511

Dear Sir or Madam:

    The Food Marketing Institute (FMI) is pleased to submit the following comments on the Food and Drug Administration's (FDA's) proposed rule for the institution of a Hazard Analysis Critical Control Point (HACCP) program for the safe and sanitary processing and importation of juice products.

    FMI is a nonprofit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $220 billion, which accounts for more than half of all grocery store sales in the United States. FMI's retail membership is composed of large multi-store chains, small regional firms and independent supermarkets. Our international membership includes 200 members from 60 countries.

    As explained more fully below, FMI and its members support the development of procedures to increase the existing high standard of food safety in the United States. We also recognize the value of applying HACCP-based procedures to the production of juice products that, if improperly processed, might pose a risk to consumer health and safety. FMI strongly supports the Agency's proposal to permit food retailers to adopt HACCP-based principles on a voluntary basis, and the concomitant exemption for retailers from the imposition of mandatory HACCP programs. It is the retailers' strong commitment to food safety and the considered application of a variety of food safety tools that will ensure the safest food products.

    Traditionally, food retailers have been regulated at the State and local level, and have strong total food quality and safety programs in place to ensure the safety of juice and other food products that they offer to consumers. As the safety of juice may best be achieved through a cumulative process involving the multiple steps on the farm-to-table continuum, the position of retailers at the end of this process renders them ill-suited for the adoption of a mandatory HACCP program that incorporates the 5-log pathogenic reduction performance standard described in the proposal. Accordingly, in response to FDA's request for comments on the intersection of the juice HACCP proposal and the companion regulation on juice labeling, we submit that the latter effectively coerces retailers into adopting a HACCP program - despite the explicit retail exemption from mandatory HACCP programs under the juice HACCP proposal - and, therefore, should be amended to provide for a retail exemption as well. Finally, as retailers may wish to adopt a juice HACCP program on a voluntary basis, we have provided comments on some of the salient parameters of the proposed juice safety program, including the 5-log reduction standard.

A. The Juice HACCP Retail Exemption

    Under draft Section 120.3(h)(2) of Title 21 of the Code of Federal Regulations (C.F.R.), FDA proposes to exclude "the operation of a retail establishment" from the regulatory definition of "processing," and, thereby, from the mandatory HACCP provisions of 21 C.F.R., Part 120 as they relate to the production of juice.¹ 63 Fed. Reg. 20449, 20482 (April 24, 1998). As a basis for the retail exemption from the juice HACCP program, FDA states that the Agency has traditionally refrained from regulating retail establishments directly and notes the training and other forms of technical assistance to State and local governments that inspect retail food establishments that the Agency routinely provides. Id. at 20464. In addition, FDA cites the comprehensive model codes developed by the Agency that have now been consolidated into a single, updated food code for the retail sector. Id. Accordingly, FDA concludes that "[a]ppropriate controls are included in the food code that can be applied to address juice hazards at retail." Id.

    FDA's rationale in the juice HACCP context is supported by the Agency's decision to provide an explicit retail exemption from the mandatory seafood HACCP program adopted in 1995. 60 Fed. Reg. 65096 (December 18, 1995). In that case, FDA again cited the significant regulation of the retail food sector by State and local governments along with the support provided by FDA through training, technical assistance, and the development of model codes, including the Food Code. 60 Fed. Reg. at 65112-13. Despite several comments favoring the inclusion of retailers in the mandatory seafood HACCP program, FDA recognized that, "although proper controls at the retail level are imperative to ensuring a safe product," FDA "should not mandate HACCP systems" for the seafood component of retail establishments and retained the retail exemption. 60 Fed. Reg. at 65114.

    In addition, commensurate with the importance cited above of "proper controls at the retail level to ensure safe food products," we note that retailers currently employ comprehensive total food safety management programs that are based on the complementary principles inherent in Good Retail Practices (GRP's) and Standard Operating Procedures (SOP's). Although FDA states in several places in the preamble to the proposed regulation that GMP's and SOP's are inadequate to assure juice safety in the manufacturing context, see, e.g., 63 Fed. Reg. at 20454, 20456, programs of this type are the appropriate tools to ensure safe production of juice at retail because of the substantial differences between the traditional juice "processor" and the retailer, e.g., quick turnover of juice products and the minimal transportation time involved at retail. As there may not be a critical control point in a retail juice HACCP program, we believe that a total food safety approach is a more effective means to ensure the safety of juice at the retail level. Maintaining optimal sanitation, using incoming and operational SOP's, and assuring that consistent GRP's for juice processing are in effect will substantially reduce any risks associated with juice products at retail.

    Moreover, retail juice preparation is itself ill-suited to a mandatory HACCP program that is based on a 5-log pathogen reduction performance standard because HACCP does not lend itself well to a program that has multiple "owners." That is, the best method for achieving the 5-log reduction that the Agency has proposed is through the aggregation of pathogenic reductions that occur at each stage of the farm-to-table continuum. Indeed, FDA states that "farming, harvesting, and processing practices may be considered in achieving the 5-log reduction, so long as the processor has control over these activities and the control measures are effective." 63 Fed. Reg. 37030, 37041 (July 8, 1998) (emphasis added).² Since most retailers do not and cannot exercise sufficient control over the "farming, harvesting, and processor activities" that are an integral part of producing safe juice products, retailers are not in a position to adopt a meaningful HACCP program as defined by the performance standard FDA seems determined to use. Thus, because of the well-recognized need for full commitment and ownership of the HACCP process, mandatory juice HACCP is not appropriate for retailers.

    Finally, the imposition of mandatory HACCP in the retail context would require extensive training of State and local inspectors, who are currently well-trained in the oversight programs conducted by their jurisdictions. Imposing the additional layer of mandatory HACCP on the comprehensive system currently in place would require substantial additional resources with no commensurate gain in food safety. Retailers and regulators can best assure food safety using the tools already available, such as the Food Code, SOP's, and GRP's.

    In summary, we agree with FDA that retailers should be exempt from mandatory HACCP and allowed to use the food safety tools already available.

        B.     The "Hobson's Choice" Presented by the Juice Labeling Regulation, Despite                    the Retail Exemption from Juice HACCP

    FDA requested comments on the relationship between the retail exemption from the HACCP proposal and the warning statement required under the juice labeling rule. 63 Fed. Reg. at 20465. As explained more fully below, despite the strong rationale cited above for the retail exemption FDA proposed in the draft juice HACCP regulation, the final juice labeling regulation together with the performance standards set forth in the juice HACCP proposal effectively negate the retail exemption and present retailers who wish to offer their customers particular juices, such as unpasteurized orange juice, with a "Hobson's choice" - an apparently free choice that offers no actual alternatives. See Webster's II, New College Dictionary at 526 (1995). That is, the juice labeling rule will effectively coerce retailers into adopting the juice HACCP program described in the proposal even though FDA recognizes that a mandatory HACCP program is not appropriate for the retail sector.

    Specifically, the juice labeling regulation apparently requires all juice products that are not the subject of a juice HACCP program as described in the regulation to bear a specific warning statement. 21 C.F.R. Section 101.17(g). However, our members report that consumers do not understand and, consequently, are confused and alarmed by the warning label. Many will not purchase the product because of the warning label, thereby reducing consumption of a healthy and safe product. Although labeling may be appropriate for unpasteurized juices for which no other steps are taken to reduce potential risks, a warning label is misleading in situations in which incoming SOP's, GRP's, and proven sanitation techniques are in place. Additionally, efforts by FDA and industry have proven effective in ensuring that products from which juice is produced are treated to reduce pathogenic risks.³

    As a theoretical alternative to the juice labeling requirement, the juice HACCP proposal would permit retailers to institute a HACCP program with a performance standard of a 5-log reduction in pathogenic organisms. However, as set forth above, a meaningful HACCP program that will reach the 5-log reduction standard proposed by the Agency for citrus juices is most effectively attained by a multi-step procedure that will involve steps that take place along several stages of the farm-to-table continuum that significantly precede the retail stage and, thus, are beyond the control of the retailer.

    The informative public meetings held by FDA demonstrated that fruit producers have achieved significant reductions in bacteria on the surface of fruit. Certain procedures, such as particular waxing and washing steps and the use of specific types of equipment, have already been implemented to produce a safer product. Accordingly, if properly prepared fruit is used at a retail facility, which is inspected by State and local authorities, under a comprehensive system of SOP's and GRP's, we submit that the resulting juice product may be safely provided to the consumer without the use of a warning label, even in the absence of a formal HACCP program.

    C.     Comments on Juice Safety Program

    As juice retailers may choose (or be forced) to adopt HACCP programs, we believe a few comments on the substantive aspects of the HACCP proposal are in order. First, we note FMI's opposition to mandatory HACCP programs; we believe that mandating HACCP is akin to the "command-and-control" system of regulation that FDA theoretically repudiates. See, e.g., 63 Fed. Reg. at 20477. We recommend allowing all stages of the farm-to-table continuum to adopt those procedures that will best further the cause of food safety. As a 1997 FDA study found that contamination of juice products most likely occurs during the growing and harvesting of the raw product, the Agency should concentrate on developing tools to ensure that contamination is minimized at this vital point in the continuum.⁴ Ensuring a safe starting product will help to ensure that consumers receive safe juice, regardless of whether the juice is made by a processor, a retailer, a restaurant, or the consumer, per se.

    Second, we agree with the Agency's proposal not to mandate pasteurization. As the Agency notes, although pasteurization is an effective and proven technology, there may be other methods that are equally effective. 63 Fed. Reg. at 20454. Indeed, several such methods were discussed at the instructive meetings FDA held in November, 1998. Accordingly, consumers should be provided with the broadest array of choices, including freshly squeezed juice, without being "warned" away by labels that do not recognize and acknowledge the risk reduction and pathogen control steps being implemented by retailers for juice production.

    Third, we object to FDA's intention to adopt an across-the-board requirement for a 5-log pathogen reduction standard for all fruits for several reasons. Specifically, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) recommended the adoption of a 5-log pathogen reduction standard without determining the degree of pathogenic contamination that was involved in causing the illnesses. No basis is provided for suggesting that all types of juice products require pathogen reduction of this magnitude. Moreover, the formula used by the NACMCF does not consider the varying dietary exposures to different types of juices that will occur, (e.g., the dietary exposure to carrot juice is likely to be far lower than the overall dietary exposure to apple juice), or the differences in produce handling and processing that are likely to ensure that the maximum level of pathogenic contamination may be much lower for some fruits, e.g., oranges, than others, e.g., apples. Until sufficient evidence is developed to support specific performance standards for different juice products, the Agency should not impose a single standard on all products.

* * *

    We appreciate your consideration of our comments and we look forward to working with you to ensure the continued safety and wholesomeness of our food supply.

Sincerely,

Tim Hammonds

President and Chief Executive Officer

¹ In this regard, we would appreciate the Agency's confirmation of one minor point concerning central kitchens or commissaries. As FDA explicitly stated in the preamble to the seafood HACCP rule, we trust that the Agency will "continue to classify central kitchens that distribute product to retail outlets that are owned by the same firm as a retail operation" so that central kitchens or commissaries that prepare juice are, thereby, exempt from the mandatory HACCP requirements under this rule, as well. See 60 Fed. Reg. 65096, 65114 (December 15, 1998).

²Although these remarks were made in the "juice labeling proposal," rather than the "juice HACCP proposal" under consideration here, the HACCP and labeling proposals are "directly linked" as the two regulations will "function together as a comprehensive program." 63 Fed. Reg. at 37039. Accordingly, the fact that this description appears in the discussion of the pathogen reduction performance standard that was included in the juice labeling proposal should not render it any less relevant to the juice HACCP program.

³Our remarks in this regard are explained further in comments submitted to FDA Docket No. 97N-0524 on May 22, 1998.

⁴ Lewis, "Critical Controls for Juice Safety," FDA Consumer (September-October 1998), citing unnamed 1997 FDA study.