August 29, 2000
FSIS Docket Clerk
Room 102, Cotton Annex
300 12th Street, SW
Washington, DC 20250-3700
Re: [Docket No. 97-036A] Other Consumer Protection(OCP) Activities; 65FederalRegister 14486; March 17, 2000
Dear Ms. Moore:
The undersigned trade associations respectfully submit these comments in response to the Food Safety and Inspection Service (FSIS) Advance Notice of Proposed Rulemaking (Notice) on Other Consumer Protection (OCP) activities. 65 Fed. Reg. 14486. We have appreciated the opportunity to work with FSIS over the past five years on modernizing the agency's food safety regulations and we remain committed to the production of safe, wholesome products.
We commend FSIS for undertaking this rulemaking to address the remaining regulatory issues. The advent of HACCP and related programs has moved food safety inspection into the 21st century. So too should the agency's OCP activities be modernized by moving away from the traditional "command and control" style of regulation. Establishments have the clear responsibility for compliance and implementing programs without prior approval. The appropriate role for FSIS is to promulgate performance-based requirements and verify compliance.
Industry has carefully reviewed the Notice and believes the best way to modernize OCP activities is to adopt a systems approach, handling all OCP activities in a manner similar to the approach for food safety activities. The benefits are: (1) it is an approach with which both the agency and industry are familiar; (2) it is an approach that has the capability of working well in the food safety context; (3) it would make the manner of regulation the same for all inspection activities; and (4) it would best allocate resources where they are needed.
Although we are recommending the same performance-based approach for general regulation, we strongly believe enforcement should be handled differently. Enforcement policies and sanctions must take into account the relative differences in severity between food safety issues and OCP issues.
These comments will summarize our recommended approach to OCP activities, both for general OCP activities and for labeling issues. They will provide specific comments on each of the seven categories of OCP activities identified by FSIS and will conclude with our responses to the agency's specific questions posed in the Notice.
Performance-Based Inspection for OCP Activities
We recommend the agency adopt a true performance-based inspection system for OCP. Under such a system:
- FSIS adopts OCP performance standards that establishments must meet;
- The establishment develops its own approach to best comply with the requirements; and
- The agency, through the in-plant inspector, verifies compliance with resources dedicated on the basis of an establishment's performance.
1. Adoption of OCP Performance Standards
The first step would be for FSIS to adopt performance standards for OCP requirements. In one regard, this has already been accomplished through the variety of existing regulations governing misbranding and economic adulteration. Nevertheless, those requirements can be streamlined in much the same manner as the agency's recently streamlined sanitation regulations. However, we must caution that merely streamlining the regulations is only part of effective performance-based requirements. In any such shift from "command and control," an inspection force properly trained so as to understand and verify compliance with such standards is essential to success.
We must note that labeling requirements do not fit so neatly within a performance standard, given the necessity for specification to achieve uniformity among inspected products and between inspected and non-inspected products. In this regard, we recommend FSIS be more selective in allocating resources. Our comments on labeling enforcement are set forth at page 4 below.
2. Establishments Develop Approach to Meet the Requirements
The second step would be to permit establishments to develop their own approach to meet the performance standards. Establishments must be given the ability to approach compliance in any way they desire and any FSIS requirements should be sufficiently flexible. We must emphasize that there should not be any requirement that the establishment have any specific written program, nor should FSIS adopt any mandatory program. Obviously, most, if not all of the establishments will have a written program. Once the agency requires a written program -- or worse, issues a guidance document -- questions as to the adequacy of a program that does not comport with the agency's guidance materials are immediately raised. We respectfully submit that for the OCP requirements "the proof is in the pudding;" if an establishment meets the performance standard, how it does that should be up to the establishment. We understand that without a substantive program in place, an establishment will have little recourse when failing to meet a standard.
3. Agency Verification
The third step would be for the agency to verify compliance.
As an initial matter, such verification must be performance-based – with the frequency of verification based on the industry's and the establishment's history of compliance.
With regard to general industry compliance, if broad nationwide surveys show few problems with a particular OCP, consistent agency attention to that OCP would be misplaced. Conversely, any national results which show an unacceptable level of problems should result in increased verification of the OCP.
Likewise, if an establishment has a strong compliance record, OCP compliance verification should be less frequent than at an establishment with a less than sterling record. By so prioritizing, FSIS will be able to allocate its resources better.
Verifying compliance could be done by observation, such as comparing ingredients to the label; by taking measurements, such as net weight compliance; or by laboratory analysis, such as with economic adulteration with water. However, verification should only be of finished product; i.e., immediately after the last point in the process where the establishment can correct a deficiency and before the product is shipped for sale to consumers. In effect, the system should be allowed to work.
When noncompliance occurs, FSIS should not treat the incident the same as a food safety noncompliance. In this regard, the agency should create a documentation device that will be distinct from the noncompliance record (NR). We suggest an "other consumer protection deficiency" report or "OCPD," so that NRs could be strictly limited to food safety concerns with the OCPD applicable to OCP standards. This would also enable better agency tracking of compliance.
If an establishment fails to comply with a particular requirement, the inspector would issue an OCPD. The establishment would then be required to restore its process control and take whatever steps are necessary to prevent recurrence. We anticipate, under a true performance-based system, that the inspection verification would be rescheduled until such time as the agency has confidence the establishment is, indeed, under control. Likewise, under a true performance-based system, an establishment would not routinely be subject to the same task.
We oppose any suspension action for failure to comply with an OCP standard. Indeed, it has been our experience that FSIS has not suspended any establishment for OCP issues -- rather, the matter is handled as a compliance investigation to determine if there was any intent to violate the law and/or defraud purchasers. Meanwhile, the establishment has been permitted to operate, albeit with enhanced regulatory oversight. We know of no reason to change this practice. Moreover, we respectfully submit that OCP activities should not be enforced in the same manner as food safety issues, given the different impact on consumers.
Finally, implicit in any performance-based system is the concept that if an establishment meets its responsibility for compliance, there will be less agency verification of the establishment's activities. On the other hand, if the establishment does not "own-up" to its responsibilities, it can, and should, expect additional agency scrutiny.
In the Technical Paper developed in connection with the Notice, FSIS repeatedly provides illustrations of how many OCP activities were conducted and the noncompliance rate. For example, with regard to ground beef fat levels, only 8 noncompliances were found out of 1,546 samples. Yet, the current PBIS task scheduling still monitors the industry at a fixed level. It is illogical to conduct so many tasks when the vast majority of the industry is in compliance. FSIS should direct its attention to those OCPs identified as being an industry problem and beyond that to those establishments where there is a concern. Moreover, the vast majority of the resources dedicated to the 1,546 samples should be redirected to food safety issues, with a fraction of those resources allocated for random sampling of industry.
Simply put, a sound, performance-based inspection system for OCP activities needs to be able to reduce sampling when there is general industry compliance, not merely increase sampling when noncompliance is detected. Such a change will significantly reduce the agency's expenditure of resources for OCP activities, thereby freeing needed resources for food safety activities, which must always remain the number one priority for both FSIS and the industry.
FSIS has identified seven OCP activities and each of these activities should be handled under the above-discussed proposed performance-based inspection system.
1. Food Standards/Food Labeling
On food standards, we understand that FSIS is working closely with the Food and Drug Administration to establish guidelines on how to address standards of identity -- both those established by regulation and those informally adopted in the Labeling Policy Book. Given this activity and the complexity of the issue, we reserve comment at this time on food product standards.
With regard to labeling generally, the performance standard approach must be modified given the greater specificity needed for labeling requirements. Consequently, FSIS should achieve greater efficiency through directing verification activities. We submit that FSIS should start tasking for those labeling issues where the agency's records show labeling problems that have arisen either through FSIS label reviewer corrections or appeals of reviewer decisions. In addition, the complexity of labeling issues may make it difficult in many situations for the in-plant inspector to make a determination as to compliance; specific expertise is necessary. In this regard, we respectfully submit that FSIS maintain a staff, possibly at the Technical Service Center, to review labels sent in by in-plant inspectors to determine compliance and to answer questions from industry about interpretation of the performance standards.
2. Food Labeling -- Net Weight
The current net weight requirements are a good example of a modern OCP performance measure. They were adopted several years ago with full input from industry and technical experts. However, FSIS should change its task verification activities. According to the Technical Paper, approximately 300,000 tasks are scheduled each year with a failure rate of around one out of 150 (2,000 failures per year). Unfortunately, because compliance is measured industry-wide, we could not ascertain whether the noncompliances were uniformly distributed among all establishments, or, as we suspect, certain establishments accounted for the bulk of the failures. Once again, a true performance-based system, where frequency is increased or decreased according to performance, will inevitably reduce the number of net weight tasks, freeing resources for food safety.
3. Species Identification
There is some concern as to whether the undeclared presence of certain species may present a food safety issue. Although the science is not definitive, FSIS allocates resources from its microbiological testing program (at the expense of other micro-testing for food safety), rather than food chemistry, which performs economic analyses, such as testing for added water or fat. We respectfully submit that if FSIS implements the changes to its PBIS system discussed herein, it will have reduced demands on its food chemistry activities. Accordingly, the species verification program should be transferred to the food chemistry activities. In addition, such testing should be limited to those situations where in-plant inspectors have concerns as to the improper substitution of species.
4. Food Labeling -- Nutrition Labeling
Under current regulations, establishments must have documentation to support nutritional information and claims. In 1996, FSIS sampled 300 products and found an overall compliance rate of 92 percent. Some nutrients, such as calories, had higher compliance (97 percent), whereas others, such as vitamin A, had lower (73 percent). FSIS should continue with its industry-wide surveying on a periodic basis. So long as industry is in substantial compliance, nutrition labeling issues would not be tasked, absent some basis to suspect a product's nutritional labeling is not in compliance. In such a case, a sample would be drawn and if out of compliance, the establishment would have the option of supporting its label or changing the label. If the industry-wide survey shows significant noncompliance with a nutrient of public health concern, FSIS could task verification across the industry to confirm compliance.
5. Economic Adulteration
In its technical paper, FSIS limits the discussion to moisture absorption during slaughter activities. Obviously, economic adulteration can include other deviations, such as excess fat, substitution of non-meat ingredients, and failure to comply with compositional requirements, e.g., PFF.
With regard to moisture absorption, we agree with the comment in the Technical Paper that FSIS verification activities (which account for an estimated 25 to 50 staff years) are more akin to a government-run QC program. Establishments should ensure there is no unacceptable moisture absorption and FSIS should limit its activities to limited random, in-plant verification checks. Consistent with a true performance-based system, only if there are repeated instances of non-compliance should there be heightened agency verification.
With regard to the other forms of economic adulteration, as noted above, the agency should allocate resources where there has been demonstrated noncompliance and a reduction of resources at those facilities with a good track record. A uniform frequency of verification tasking across the industry would constitute an inefficient utilization of limited resources.
6. Raw Product Quality After Slaughter
As an initial matter, most of the deficiencies addressed by raw product quality standards are aesthetic in nature. Deficiencies posing food safety concerns are already addressed by establishments under a prerequisite or HACCP program. Accordingly, our comments apply only to the aesthetic concerns addressed by OCP activities.
In essence, we respectfully submit that the marketplace will ensure products are wholesome and no OCP performance standard would be required. By and large, the majority of products subjected to quality inspections are intended for use in further processed products at inspected establishments. Thus, the customer in most cases is another FSIS inspected establishment and thus is both knowledgeable and has a vested interest in ensuring he or she receives the quality paid for. This assertion is true regardless of whether the purchaser simply further processes the product for retail sale or uses the product in a further processed product, such as sausages.
Even if the product is distributed directly to household consumers, they can readily observe any of the quality defects covered by this OCP activity. If they find the quality unacceptable, they will cease purchasing the product. Moreover, any consumer dissatisfaction will be conveyed to the retailer who will not react favorably to complaints.
Finally, it should be noted that such inspections are conducted on previously inspected and passed products. Thus, it is not that the product will never be inspected; rather re-inspection for such defects is not necessary in light of the subsequent user's inspection. Hence, in every case, the previously inspected product can be (and will be) inspected by the purchaser for quality. Aesthetic defects are not acceptable in today's market and any facility selling such products will soon find itself out of business. Indeed, of all the FSIS OCP activities, this most clearly can be justified only as a government funded quality control function. As such, all agency resources should be redirected to activities, primarily food safety, where the benefit accrues to the party paying for the service -- the public.
7. Carcass Sorting
We agree with the agency’s statement that the use of inspection program personnel at fixed stations on slaughter lines is not the most efficient and effective use of FSIS resources. The agency has stated that this Notice will not focus on OCP activities on the slaughter line because these activities are being addressed as part of the agency’s initiative to examine new inspection models.
Currently, regulations provide for a different focus in slaughter and processing. A differentiation, based on antiquated regulations, would be unnecessary if policies were kept abreast of marketing trends and new technologies. For example, the current poultry regulations were written based on industry practices of the 1950’s. Fifty years ago, the majority of finished product being ice packed was ready-to-eat whole birds. Currently, the majority of the poultry products being marketed are not whole birds, but further processed parts and cooked product.
Examining whole carcasses, particularly in the case of poultry, as part of a finished product standard does not allow a facility to complete the production process, nor is it the most effective use of FSIS inspection personnel. In many cases, facilities can more effectively correct OCP defects further along the processing line in the boning and cut-up areas, closer to the final package product stage.
Furthermore, as mentioned in section 6 above, OCP performance is consistently being determined by the purchasers of the end product, who have their own purchase specifications as to what is acceptable. FSIS should focus on product safety, not appearance, while allowing the marketplace to address quality specifications.
Response to Specific Questions
1. What level of resources should FSIS allocate to OCP program activities? What criteria should FSIS consider in allocating its resources between food safety and OCP issues?
A substantial majority of FSIS’ resources should be allocated to food safety. The level of resources directed to other consumer protection activities should be limited to that amount necessary to ensure overall compliance with OCP.
Current resource allocations to OCP are unnecessarily large. A review of the agency’s Other Consumer Protections Technical Paper reveals that the agency devotes a large amount of time to certain OCP issues. To be sure, FSIS has a role to play, but we are unaware of any reason why equivalent verification cannot be achieved with a lesser dedication of resources.
If establishments are complying with a particular OCP performance standard, it is illogical to dedicate appreciable resources to reaffirm this fact. If there are problem establishments, resources should be applied there, not as part of a general industry program.
Beyond implementation of a true performance-based inspection system for OCP activities, FSIS should explore other avenues to minimize expenditures in this area. For example, FSIS should initiate discussions with FDA and the states to correlate the management of non-food safety issues. It should be possible to provide an effective and efficient level of oversight with minimal overlap by coordinating the existing activities of the various federal and state regulatory authorities. FDA’s history of dealing with identical issues without a continuous inspection presence in establishments should be carefully considered by FSIS as it evaluates its options.
Likewise, the agency should consider actions already being taken by the states on these same issues. With assurance of consistent enforcement, these state activities could significantly minimize the level of effort needed by FSIS. However, it is important to keep in mind that on issues such as net weight compliance, not all states have the same policies as FSIS, even with respect to the parts of Handbook 133 governing net weight. If necessary to assure consistency of enforcement, FSIS preemption in this area may need to be exercised. Memoranda of Understanding with the states may offer mechanisms for taking advantage of activities the states already perform, while ensuring the uniformity of enforcement that is essential for industry.
2. What role, if any, should the agency have in examining raw product for quality defects?
Although we do not advocate the sale of foods of poor quality, we are hesitant to ascribe market issues to government control. Thus, it is our opinion that FSIS should have no role in quality matters, unless the issue becomes one of unwholesomeness or economic adulteration. The marketplace is the best and most appropriate determinant of consumer acceptance.
3. What priorities should FSIS give to misbranding concerns? For example, should the presence of excess sodium take priority over a misleading picture on a label?
As noted above, we believe the agency should focus the majority of its attention on matters that have a direct impact on public health. Some labeling issues could have public health consequences, such as the failure to label an allergen; most labeling issues have none.
In regard to the limited level of resources the agency should devote to OCP activities, the degree of misrepresentation and, to the extent discernible, any intent to deceive, should dictate the level of agency response. Gross misrepresentations or consistently excessive sodium levels that represent a sizable portion of a Daily Reference Value warrant agency attention. However, matters of puffery or subtle appearance issues (e.g., color, contrast, shading, etc.) are examples of minor issues that do not justify expenditure of substantial or any agency resources. Greater attention is appropriate for issues involving label claims than for those for which no claims are involved. Practices that result in unfair competitive advantage for one firm warrant the attention of the agency. Nevertheless, many of these matters require minimal agency resources due to self-policing within the industry. To the extent that members of the food industry are not hesitant to report to the agency actions by a competitor that result in an unfair economic advantage, the need for active agency vigilance to detect problems is reduced.
4. Should FSIS continue testing products to determine compliance with requirements related to fat content or water retention, or whether the product is fresh or frozen? If so, how should FSIS prioritize the sampling of products?
Fat content, and possibly water retention as well, are nutrition labeling compliance issues for processed foods, and may be for raw meat and poultry in the future. Special attention to these matters is not warranted.
This question relates to the earlier question regarding misbranding. As noted above, marketplace dynamics will identify products of inferior quality, while issues of purposeful deception and fraud are clearly appropriate for agency attention and effort. In this regard, however, a greater proportion of resources should be directed toward targeted rather than random testing. An increased level of testing is warranted for a firm’s products when past history or other relevant circumstances suggest a need for enhanced scrutiny.
FDA oversight of the vast majority of the food products in the marketplace offers a good model for FSIS to utilize with respect to meat and poultry products. Without devoting an excessive level of resources to marketplace monitoring, FDA takes action as necessary to stop inappropriate activities. Although there are distinctions between the two agencies, the presence of the USDA inspection legend on meat and poultry products should not preclude FSIS from taking a more efficient and resource conservative approach to fulfilling its mandate.
5. Should FSIS consider which OCP issues concern consumers? If so, how could FSIS determine this? For example, are there existing data FSIS can use or should FSIS conduct its own consumer surveys? To what extent should FSIS use information about consumers' concerns to prioritize the verification of the industry compliance with the OCP requirements?
The agency should compile and analyze data it already has in its records to help evaluate which OCP issues are problematic and should consult with FDA on research previously performed on consumer expectations regarding food standards. In this regard, we wish to draw to your attention the recently announced FDA Food Safety Consumer Survey. A similar survey was conducted in 1998. In this survey FDA hopes to obtain detailed information about a variety of food safety and labeling matters. See, e.g. 65 Fed. Reg. 50541 (August 18, 2000).
In addition, the staff of the FSIS Technical Service Center may have the background necessary to suggest prioritizing OCP issues. We also understand the FSIS Hotline 1999 annual report is available.
We recommend that the agency also seek guidance from the Federal Trade Commission standard in this area: particularly whether an issue is "material" to a purchase decision.
Finally, attached are surveys addressing consumer priorities
The first attachment is Trends in the United States: Consumer Attitudes & the Supermarket 1999, by Food Marketing Institute. This study, conducted annually, covers consumer attitudes on such issues as shopping, nutrition, and food safety. Of special interest is Table 48 which shows, for example, the percent of people who have changed purchasing habits because of label information.
The second attachment is Shopping for Health 1997, also by FMI. This study is not conducted annually but includes useful information on the proportion of shoppers who check nutrition/ingredient labeling the first time they purchase a product; what information on the nutritional facts panel is used, and what label information caused consumers to start or stop purchasing a specific food.
The last survey, not attached, is a joint Research Triangle Institute -- FSIS study on the significance of product name qualifiers conducted in 1988.
6. How should FSIS weigh the severity of noncompliance that leads to public health concerns versus noncompliances related to OCP concerns? What sanctions or penalties are appropriate for economic adulteration? How should FSIS deal with establishments that demonstrate no deliberate intent to cheat the public but experience intermittent problems of noncompliance that result in misbranding or economic adulteration?
Regarding OCP issues, intermittent noncompliance with no intent to cheat will be the most common scenario. The realities of commercial production are that periodically there will be minor deviations from prescribed parameters. However, there should be an expectation that noncompliances will be of a minor nature and of infrequent occurrence. The consequence of random noncompliance should be an expectation that firms will make a greater effort to control the particular attribute and, as appropriate, an increased level of FSIS testing. When firms have data that document control of an OCP element, this information should be considered in evaluating the significance of a random noncompliance for that element.
7. What enforcement strategy is appropriate for addressing noncompliance with OCP requirements? What portion of the Agency's enforcement resources should be allocated to OCP concerns? What levels of noncompliance with OCP requirements warrant the use of severe sanctions, such as withholding the marks of inspection?
When products of individual firms are called into question, the agency should bring the problem to the attention of the firm and then give the firm an appropriate period of time to develop and implement a remedy to the problem. It would then be the role of the agency to verify that the establishment's planned actions have been implemented and are effective. As discussed above, FSIS traditionally has not suspended inspection based on other consumer protection noncompliances and there is no reason to change this policy.
8. The Agency believes that inspected establishments need to have systems, i.e., quality control systems, managerial systems, or administrative systems, that ensure compliance with OCP requirements. Should FSIS consider promulgating a general process control regulation, or are there alternatives to such a regulation that would still enable the Agency to effectively and efficiently verify that an establishment's control systems for OCP requirements are satisfactory?
The agency should not mandate general process control regulations. As noted earlier, many in industry already utilize various forms of controls to assure compliance with their own quality standards. When issues arise with individual samples, firms that can demonstrate control of the issue over time should be credited for their efforts. Because the agency’s role is oversight and verification it is not necessary and would be a reversal of the agency’s current path for it to issue new command and control regulations or to attempt to micro manage the manner in which firms design and operate their quality control systems.
We appreciate the opportunity to express our views on this major undertaking. The implementation of a true performance-based inspection system for OCP will improve compliance and free resources for food safety activities. We look forward to working with the agency in completing the inspection modernization.
American Association of Meat Processors American Meat Institute
Food Marketing Institute National Chicken Council
National Meat Association National Pork Producers Council
National Turkey Federation Southeastern Meat Association
Southwest Meat Association