FSIS Docket Clerk
Room 3806
South Agriculture Building
Food Safety and Inspection Service
US Department of Agriculture
14th St. & Independence Ave.
Washington, DC 20250
Re: DOCKET #95-049A; Transportation and Storage Requirements for Potentially Hazardous Foods.
Dear Docket Clerk:
On November 22, 1996, the Food Safety and Inspection Service of the U.S. Department of Agriculture (FSIS and USDDA, respectively) in conjunction with the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPR) concerning certain food safety "improvements" for the transportation and storage of poultry, meat, eggs, egg products, fish, seafood and dairy products. 61 Fed. Reg. 59,372.1 The instant rule is intended to address specifically the problem of "potentially hazardous foods" that are capable of supporting the rapid multiplication of microorganisms that cause foodborne illness by mandating certain temperatures during transportation and storage.
The Office of the Chief Counsel for Advocacy of the U.S. Small Business Administration was created in 1976 by Pub. L. No. 94-305 (codified as amended at 15 U.S.C. Sections 634a-g, 637) to represent the views and interests of small businesses in federal policy making activities. The Chief Counsel participates in rulemakings when he deems it necessary to ensure proper representation of small business interests. In addition to these responsibilities, the Chief Counsel monitors agency compliance with the Regulatory Flexibility Act (RFA) and works with federal agencies to ensure that their rulemaking procedures analyze the impact that regulatory proposals will have on small businesses.
The Office of Advocacy commends FSIS and FDA for seeking input from the regulated community at an early stage via an ANPR. Based on input received thus far from the debates over HACCP time and temperature requirements, and on the public hearings for the instant rulemaking, it is apparent that there can be no standard or single temperature at which a product can be deemed safe. Moreover, adequate safeguards apparently already exist to insure food safety after processing. Although the Office of Advocacy has publicly stated its support for farm-to-table initiatives in the past, we cannot support command and control requirements on post-processing industries because such requirements would be violative of the HACCP regulatory strategy and the Regulatory Flexibility Act.
I. One Size Does Not Fit All:
Regulatory Flexibility Act Requirements The vast majority of firms that may be affected by the instant rule are small. As correctly noted in the ANPR, a small entity in the motor freight transportation and warehousing category is one whose annual receipts are $18.5 million or less. A small entity in the category that includes air freight or railroad transportation is one with 1,500 or fewer employees. A small entity in the categories of water transportation or food processing is one that employs 500 or fewer people.2 There are no precise standard industrial classifications that correspond to the aforementioned transportation industries. The classifications do not break down transportation with regard to the various commodities being transported. To arrive at some acceptable impact assessment of the rule as to these industry sectors, FDA and FSIS will need to develop this information via outreach to the affected industry trade associations and through information gathered during the ANPR process. There are numbers available through the Department of the Census for the processing industries.3 The Office of Advocacy is willing to assist the agencies in obtaining this data.
In any event, there is prima facie evidence that there will be a significant economic impact on a substantial number of small entities based on existing data which shows that the vast majority of affected entities are small and on testimony garnered during the November meetings held at USDA. This information is important because the agencies are required by the Regulatory Flexibility Act (RFA) to perform an initial regulatory flexibility analysis (IRFA) in the proposed rule to determine the impact on small entities and consider the alternatives which will allow them to accomplish their regulatory objectives, but impose the least burden on small entities. The RFA, and the recent amendments to the RFA by the Small Business Regulatory Flexibility Act of 1996, require that agencies to fit regulatory requirements to the scale of the entity being regulated. The agencies must be mindful of the fact that fixed costs associated with a regulation cannot be absorbed as easily by small entities as they can by large entities. The agencies are proposing six alternatives to implement the instant regulation. The Office of Advocacy has reviewed each alternative with an eye toward compliance with the RFA.
II. FSIS/FDA Alternatives
1. Temperature Performance Standards
The ANPR suggests two possible temperature performance standards--41(F and 45(F-for potentially hazardous foods like, eggs, milk, meat, poultry and seafood.4 The basis for the former option is that the 1995 Food Code recommends this temperature for cooling and holding. The basis for the latter option is that the European Union requires that particular temperature for the transportation of raw meat products. The performance standard option is problematic for a number of reasons. It would not be appropriate for the agencies to designate a single temperature at which it can conclusively be determined that food is or is not safe for consumption. Similarly, failure to maintain a certain temperature at all times is not an appropriate measure of food safety with respect to potential enforcement action (e.g., confiscation of the "unsafe" or adulterated product). If, during a routine inspection, a food product reaches 42(F, should it then be confiscated? Should the producer, shipper or warehouser be fined? Are there suddenly unsafe levels of food pathogens present? Artificial temperature standards will not necessarily contribute to food safety. This is not to say that temperature does not matter. Rather, it is but one element contributing to food safety. For instance, temperature abuse means little outside the context of time abuse. Moreover, the agencies have not provided sufficient evidence that non-uniform temperatures cannot result in wholesome food. Expert testimony during the November 1996 hearings revealed that most transportation temperature problems occur when refrigeration fails completely, and not when the temperature fluctuates. Other testimony revealed that seafood has natural toxins not occurring in meat. Therefore, it is hard to lump them in the same refrigeration category. In the case of eggs, studies have shown that 1 in 10,000 subjected to mild temperature abuse is contaminated with SE organisms. Even at room temperature, it takes three weeks for the membrane to break down sufficiently for organisms to enter the yoke. A "sell by" date, which is already widely used, would likely be sufficient.5 A final question not to be overlooked is who is to blame when the standard set by the agencies has been met, but foodborne illness still occurs? The agencies? The combination of enforcement uncertainties, if not impossibilities, and the lack of science-based theory supporting a single temperature, make this an undesirable alternative. It neither accomplishes the agencies' stated objectives nor is it the best available alternative with respect to small business burden.
2. Shipper Recordkeeping
The Office of Advocacy does not object to the shipper recordkeeping alternative with regard to carriers of both food and non-food products. Carriers of both types of products should be allowed to demonstrate through records that their vehicles have been cleaned adequately or that the products have not been co-mingled. Consideration should be given to exempting carriers of food-only products from such a requirement.
3. Mandatory HACCP-type Systems
The Office of Advocacy supports the position of the American Meat Institute (AMI) with regard to this issue. AMI recommends that shippers and storage facilities have the equivalent of Sanitation Standard Operating Procedures, which are distinct from a HACCP plan. Not only would such a proposition be less costly, it would achieve the goals of the agencies. If a HACCP-type plan were implemented, what parties would be responsible for drafting a HACCP plan and how would the plan be enforced? Would a carrier with a fleet of 5 trucks and drivers have to train each of its drivers how to implement a HACCP plan? Does the carrier of multiple products have to have multiple HACCP plans? What happens when a plan is found to be inadequate? Does the product go back to the plant for re-processing? Will the product be confiscated by inspectors? What are the critical control points-the time it takes to load a product onto a truck?--the temperature of the truck before or after loading?--the temperature of the product before or after loading?--the temperature in the middle of the truck or along the perimeter? Who ultimately bears the cost for product that never makes it to market because of a carrier plan that has been found to be inadequate? The questions are too numerous to make this a viable alternative.
4. Voluntary Guidelines
There are several existing guidelines currently in use in various segments of the food industry-"Guideline for the Transportation of Food" by the Association of Food And Drug Officials, "Frozen Food Handling and Merchandising" by the Frozen Food Round Table, "Protecting Perishable Foods During Transport by Truck" by the USDA Agricultural Marketing Service, etc. These organizations could work together to provide industry-specific guidelines to serve as a model for the safe transport and storage of food products. Moreover, the model Food Code contains provisions that already address food holding temperatures and other standards. As indicated in the ANPR, most state and local food statutes, regulations, and ordinances are based on some edition of FDA's model food code and address food safety issues once products leave the processing plant.6 Perhaps an updating of the Food Code would suffice to address the issue of safe storage and transportation. 5-6. Other Alternatives
inally, the agencies suggest implementing either a combination of approaches or taking no action at all. The Office of Advocacy would support a combination of any of the proposals recommended herein. The no action alternative probably is not a valid alternative given the possibility that time and temperature abuse could occur during storage and transportation-even with the agencies' current authority to detain or seize adulterated and misbranded food products in interstate commerce. The agencies simply do not have the resources to exercise the full extent of their authority-another reason why a complicated federal plan would be unworkable. A combination of Sanitation SOPs with some paperwork requirement and voluntary guidelines seem to be reasonable options at this point.
III. Conclusion
The Office of Advocacy is pleased to have participated in this early stage of the rulemaking. We urge your favorable consideration of the recommendations contained herein, and hope to work with you in the further development of this rule. Please do not hesitate to contact either of us if we may assist you during this rulemaking, 202-205-6532.
Sincerely, Jere W. Glover
Shawne Carter McGibbon
Chief Counsel for Advocacy
Assistant Chief Counsel for Advocacy
ENDNOTES
1 Provisions similar to the ones contained in the instant rulemaking were explored previously in the proposed rule concerning implementation of Hazard Analysis and Critical Control Points (HACCP) for meat and poultry. See 60 Fed. Reg. 6,774 (February 3, 1995). The provisions were dropped from the final HACCP rule in order to be explored more fully at a later date. At that time, FSIS also announced its intention to develop a rulemaking covering the adoption of standards for cooling of raw products outside of the plant--during transportation and storage. See 61 Fed. Reg. 38,806 (July 25, 1996). FSIS abandoned its effort to include the standards in the HACCP proposal because they determined that it would be "inconsistent with the HACCP concept that establishment management is responsible for designing a system of controls appropriate for each establishment." 61 Fed. Reg. at 38,812. FSIS also determined that "the specific time-and-temperature combinations proposed by FSIS were too restrictive." Id. at 38,812. FSIS proposed a requirement that meat carcasses be cooled to a temperature of 50( F or below within a specified time period and raw meat products be cooled to 40( F or below prior to shipping. It is interesting to note that FSIS cited $45.5 million in savings by eliminating the in-plant time/temperature requirements from the final HACCP rule. Id. at 38,859.
2 This data is derived from the small business size standard regulations published by the U.S. Small Business Administration, 13 CFR Part 121.
3 The data is derived from the U.S. Enterprise and Employment Microdatabase (USEEM), and is prepared by the U.S. Department of the Census with partial funding from the Office of Advocacy. The information is available on the Internet, http://archive.sba.gov/ADVO/stats/intro.html. See Major Group 20 (Food and Kindred Products) for the number of meat, poultry, and milk processing plants (industry groups 2011, 2015 and 2026, respectively). See also Major Group 9 (Fishing, Hunting and Trapping) for the number of Finfish and Shellfish operations (industry groups 0912 and 0913, respectively). See also Major Group 2 (Agricultural Production-Livestock and Animal Specialties) for the number of chicken egg producers (industry group 0252).
4 It is not clear from the ANPR whether the temperature recommendations are for ambient or food surface temperature.
5 Existing Federal legislation on the egg temperature issue may moot this particular argument.
6 61 Fed. Reg. at 59,374.