FSIS Docket Clerk
Docket #97-036A
Food Safety and Inspection Service
U.S. Department of Agriculture
Room 102 Cotton Annex Building
300 12th Street, SW
Washington, DC 20250-3700

Re:     Other Consumer Protection Activities; Docket No. 97-036A

Dear FSIS Docket Clerk:

The Food Marketing Institute (FMI) is pleased to respond to the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service’s (FSIS’s) request for comments on the advance notice of proposed rulemaking concerning the Department’s “other consumer protection” (OCP) activities. 65 Fed. Reg. 14486 (March 17, 2000).   FSIS has specifically requested guidance on the “need and desirability” of revising its approach to verifying that meat and poultry products are not misbranded, economically adulterated, or otherwise unacceptable for reasons that do not necessarily raise food safety concerns. Id.

As discussed more fully below, the consumer is best protected if the Agency follows the most fundamental principal of prevention – that is, focusing detection resources as close as possible to the source of a problem. Accordingly, USDA should continue to focus its OCP activities in plants rather than in the distribution chain. Moreover, our data indicate that consumers are most concerned about food safety and pesticide residues. Therefore, we urge USDA not to shift valuable resources away from food safety toward OCP activities.

FMI is a non-profit 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 $300 billion, which accounts for more than half of all grocery 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.

A.     Economic Adulteration, Misbranding and the Current FSIS OCP Program

     The Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) (collectively, “the Acts”) broadly prohibit the adulteration of food. See 21 U.S.C. §§ 451, et seq.; 21 U.S.C. §§ 601, et seq. In addition to adulteration related to food safety, the Acts prohibit economic adulteration and misbranding. See 21 U.S.C. §§ 458, 610. Economic adulteration includes: concealing inferiority or damage; omitting a valuable constituent; substituting a substance; or adding a substance to increase the weight, to reduce the quality or strength, or to make the food appear of better quality that it otherwise would. Meat or poultry products are misbranded if their labeling is false or misleading in any particular, including, for example, if an ingredient that is declared on the package is omitted from the food or if the label fails to declare an ingredient that is present in the food.

     To ensure that meat and poultry products are not economically adulterated or misbranded, the Agency conducts a range of activities that are broadly described as “Other Consumer Protection” or OCP activities. For example, FSIS enforces food standards and food labeling requirements, such as the accuracy of net weight, species identification, and nutrition labeling statements. In addition, the Agency looks for evidence of economic adulteration through the reinspection and carcass sorting processes.

B.     FSIS Seeks Input on OCP Program

     The Agency is investigating ways in which to improve its OCP program, although USDA has not indicated that the current program is ineffective, that OCP problems are widespread, or that consumers are concerned that OCP issues are not being properly addressed. However, the Agency has requested comments on an advance notice of proposed rulemaking (ANPRM) that sets forth some of the issues FSIS is considering. 65 Fed. Reg. 14486 (March 17, 2000). In conjunction with the notice, the Agency made available a technical paper entitled, “Other Consumer Protection Technical Paper” (no author or date given) (hereinafter “Technical Paper”).

     FSIS states three reasons that the Agency should change its approach to OCP activities. First, USDA is concerned that industry is relying too heavily on government to perform functions more properly conducted by industry. Second, the Agency would like to increase the efficiency with which the resources allocated to OCP activities are used. Third, USDA would like to increase its accountability to the public. 65 Fed. Reg. at 14487.

     Although alluded to only in passing in the ANPRM, these references combined with the discussion during the Agency’s recent public meeting on the in-distribution pilot program indicate that one of the most significant changes to the program that USDA is considering is moving OCP compliance activities out of federally inspected establishments and into retail stores and other “in distribution” locations. As explained more fully below, none of the concerns expressed by the Agency would be addressed by shifting OCP inspection to retail. However, such a shift would substantially diminish the OCP program’s effectiveness in achieving its eponymous goal: consumer protection.

C.     Some of Agency’s Goals May Be Achieved by Shifting OCP Activities To Distribution Chain, But Consumer Protection Will Be Compromised

The first goal discussed in the ANPRM is reducing industry reliance on FSIS personnel to achieve OCP standards. 65 Fed. Reg. at 14487. Reducing industry reliance is a recurring theme in the Technical Paper, as well. Indeed, the Agency suggests that the “relatively high frequency” of some problems may indicate that some establishments are relying on FSIS to monitor accuracy. Technical Paper at 23.

FMI agrees that industry should be responsible for ensuring that all OCP standards are met by meat and poultry products before they are shipped from the plant. However, FSIS’s responsibility is to monitor plants for their compliance. Those companies with higher frequency of violations need more oversight from FSIS, not less. If FSIS fails to monitor these plants, consumer protection will be compromised. We see no reason why testing outside the plant would encourage plants to do a better job than testing inside the plant would. Testing in plant also allows the Agency to base its testing on the degree of risk rather than sampling at retail where all would be assessed of equal risk. Eliminating OCP programs from plants will impair the ability of the OCP program to protect consumers. Decreasing OCP monitoring at the location of corrective action will only mean less corrective action and, therefore, potentially more economically adulterated product sold to consumers.

The second goal discussed in the ANPRM is increasing the efficiency with which OCP resources are used. 65 Fed. Reg. at 14487. USDA explains that FSIS personnel generally perform OCP verification activities at the same frequency in all plants and that the Agency is considering whether to base the rate of verification checks on the compliance history of a particular establishment. Id. Similarly, the Technical Paper observes on several occasions that the Agency monitors the entire industry at a fixed level, suggesting that sampling should be targeted to establishments with a significant history of violations. See, e.g., Technical Paper at 17, 20-21.

     We agree that the Agency should target its resources based on compliance history, rather than choosing and abiding by a fixed, testing frequency. That is, FSIS should use “risk” as the basis to assure industry accepts responsibility to meet standards. If a company fails to meet standards at a high frequency, then FSIS should monitor more frequently and take corrective action on a scale that increasingly applies pressure to the company to ensure that they comply or stop operating if they cannot meet the standard. Broad testing programs at retail are less likely to be targeted and, therefore, are less likely to be an efficient use of resources than targeted in-plant testing.

     The third goal stated by the Agency is to improve accountability. 65 Fed. Reg. at 14887. FSIS is particularly interested in improving the way in which the Agency measures establishments’ compliance with OCP requirements. Accountability would also allow the Agency to have better information to make resource allocation decisions. id.

     This concern seems to be reflected in the Technical Paper’s remarks that the data FSIS has historically gathered through the OCP program are not structured in a way to generate summary statistics concerning compliance regulatory requirements. See, e.g., Technical Paper at 14. As a result, FSIS seems to be leaning toward a “market basket” approach of gathering data on a particular issue at retail, rather than in-plant. FSIS suggests that a market basket approach would allow the Agency to gather broadly applicable data to target enforcement actions. For example, in the nutrition labeling area, FSIS stated that such studies would allow the Agency to conduct follow-up testing on more products from establishments whose nutrition labels were out of compliance or initiate a targeted effort on vitamin A analyses if FSIS determines that it was a significant priority and concern. Technical Paper at 24-25.

     We agree that FSIS should be accountable for its use of resources and we encourage the agency to gather data useful for targeting their resources most effectively, however, we expect that the information USDA would hope to get from a market basket approach is already available to the Agency as a result of the vast numbers of inspections and samplings that FSIS personnel perform annually. (These numbers are documented throughout the Technical Paper.) The issue seems to be the format in which the data are housed. Therefore, rather than re-designing the OCP system, we believe it would be more efficient for the Agency to reconfigure its data systems so that they can generate the types of reports and information that the Agency desires. USDA can address each of the stated goals without restructuring the entire OCP program.

D.     Shifting OCP Activities To Distribution Chain Will Substantially Reduce Consumer Protection from Economic Adulteration and Misbranding

     The Agency’s Technical Paper explains in significant detail the various OCP activities in which FSIS is currently engaged. These include checking meat and poultry to ensure that they meet the limits for fat, added water, protein content, and any required ingredients for formulated products. For many of these issues, the only way to ensure that the consumer is protected from economic adulteration is to ensure that all of the relevant standards are met before the product leaves the plant.

In-plant observation and monitoring are critical in the prevention of many types of economic adulteration or misbranding. The Agency states, “Observing the formulation of a product during production can determine both whether there is compliance with a minimum meat requirement, and whether the list of ingredients is accurate.” Technical Paper at 3. The Agency states that some incidences of noncompliance are “documented only because inspection program personnel actually observed the violation occurring.” Technical Paper at 9 (emphasis added). Thus, some types of economic adulteration will not be detected downstream. The only way to prevent the activity and to protect consumers in that case is to observe the incident in the plant.

     One of the specific OCP functions discussed in the Technical Paper is verifying net weight. Toward this end, inspectors check the accuracy of an establishment’s scales and also perform net weight checks on product lots. Shifting an activity such as net weight verification to retail would undermine the purpose and effectiveness of the activity, since it is best conducted in conjunction with verifying the accuracy of the equipment.   Indeed, retailers are prohibited from changing a label that is applied to product under federal inspection, even if the change would correct an error.

E.     Consumers Will Have No Meaningful Remedy if OCP Activities Are Shifted to Distribution Chain

     The results of retail testing aimed at economic adulteration and misbranding will primarily be obtained only after consumers have purchased the products despite any economic or labeling defects. Accordingly, the harm will occur before it will be found or remedied if inspectors wait to look for it until after the food is presented for sale to consumers at the store. In some cases, costly investigative and traceback procedures would be required, which would not have been necessary if the problem had been ameliorated at the plant. Restitution to consumers for harm caused by economic adulteration or misbranding would then necessitate product recall or reimbursement procedures, both of which are extremely costly and labor-intensive actions that would profoundly diminish consumer confidence in the food supply and erode confidence in the efficacy of the regulatory bodies that are charged with its protection.

     FMI opposes any changes in the OCP program that would lead to these unnecessary and counterproductive actions. The Agency should ensure that meat and poultry comply with OCP standards before they are offered to sale to consumers.

F.     Consumers Are Concerned about Food Safety

     USDA also requested information on consumer priorities within the OCP realm; for example, whether consumers were more concerned about the accuracy of the net weight statement or the accuracy of nutrition labeling.

     The Food Marketing Institute has been documenting trends in consumer preferences for many years. Our surveys show a continued and strong public interest in ensuring that food products are safe and free of pesticide residues. We are not aware of any data indicating that consumers have a high degree of concern in the issues grouped under the OCP umbrella, which suggests that consumers are confident that the Agency’s current procedures provide effective protections for consumers in the areas of economic adulteration and misbranding. FMI is committed to continuing to monitor consumer interests and would be happy to report any relevant data to the agency.

Given the high degree of consumer confidence and the data cited in the technical report, which indicate general compliance with OCP standards, USDA should continue its current activities with minimal revisions and apply the resources that would be necessary to reformulate the OCP program to true food safety needs. The Agency should certainly conduct a comprehensive cost-benefit analysis before proceeding as the costs in reduced consumer protection seem to seriously outweigh any benefits USDA might be considering.
     

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We appreciate the opportunity to provide our comments on this issue. If we may be of assistance as you move forward, please do not hesitate to let us know.

Sincerely,

Tim Hammonds
President and CEO