Regulatory Comments and PetitionsApril 26, 1999
FSIS Docket Clerk
U.S. Department of Agriculture
Food Safety and Inspection Service
Room 102, Cotton Annex
300 12th Street, SW
Washington, DC 20250-3700
|Re:||Irradiation of Meat and Meat Products; Proposed Rule|
Docket No. 97P-076P
64 Fed.Reg. 9089 (February 24, 1999)
The Center for Science in the Public Interest (CSPI) appreciates this opportunity to provide comments on the Food Safety and Inspection Service’s (FSIS) proposed rule concerning the labeling of irradiated meat and meat products and the processing requirements for the irradiation of such products. CSPI is a nonprofit consumer group with over one million members that focuses primarily on nutrition and food-safety issues.
When irradiation is used, consumers want irradiated foods to be clearly and conspicuously labeled to indicate that fact. That strong preference, as well as other consumer preferences about how irradiated products should be labeled, was recently reflected in a nationally representative poll of over 1,000 adults commissioned by CSPI and AARP.(1) The poll, which was conducted on April 16-18, 1999, examined consumer attitudes toward irradiation labeling and found:
- Overwhelming support for labeling of irradiated foods to indicate that they have been irradiated (88.6 percent in favor);(2)
- Strong support for placement of the irradiation label on the front of the food package (59.1 percent in favor), as opposed to the back of the package (9.8 percent in favor);(3)
- Strong support for use of the labeling term "Treated by Irradiation" (57.8 percent in favor) instead of the alternative terms "Electronically Pasteurized" (15.3 percent in favor) or "Cold Pasteurized" (9.2 percent in favor).(4)
Those poll findings serve as benchmarks against which CSPI will judge the irradiation labeling provisions of FSIS’s proposed rule. In addition, CSPI’s comments will address whether the proposed rule requires an irradiation label that is sufficiently large and conspicuous to be easily read by consumers, including older Americans and others with impaired vision. As explained more fully below, while FSIS’s proposed rule satisfies most of the consumer expectations about irradiation labeling, it fails to require that the radiation disclosure statement use a type size large enough to ensure that it will be legible for all consumers.
In addition to requiring clear labeling, irradiation regulations should include provisions that prevent industry from misguidedly relying upon irradiation as a "silver bullet" treatment, at the expense of other effective pathogen-control measures and adequate sanitation procedures. As explained below, CSPI urges FSIS to revise its proposed rule to require that plants regularly conduct microbial testing immediately prior to the irradiation step. That requirement would ensure that sanitation and other pathogen-reduction measures are functioning effectively and that pathogen loads do not exceed the quantities for which the irradiation process has been demonstrated effective.
I. LABELING OF IRRADIATED FOOD PRODUCTS
A. FSIS Should Require Products Treated by Irradiation to Bear a Conspicuous, Easy-To-Read Statement Disclosing That Fact
CSPI applauds FSIS’s decision to require that the package labels of irradiated meat and poultry products bear the international radura symbol and a statement indicating that the product was treated by irradiation. Providing consumers with such basic information concerning how food products have been produced enables them to make informed purchasing decisions. Informed consumer choice is essential in a free-market economy, for producers cannot learn about the types of products consumers truly desire if consumers have inadequate information about products in the marketplace and cannot "vote with their pocketbooks" for the products of their choice.(5)
Disclosing whether a food product has been irradiated also satisfies another generally accepted principle, termed the consumer’s "right to know." That right was recognized by the General Assembly of the United Nations in its Guidelines for Consumer Protection, which are intended to provide "[a]ccess of consumers to adequate information to enable them to make informed choices according to individual wishes and needs."(6) The U.N. guidelines were inspired by President John F. Kennedy’s pronouncement, in his landmark message to Congress in March 1962, that consumers have a right "to be given the facts [they] need to make an informed choice," as well as a right "to be protected against fraudulent, deceitful, or grossly misleading information, advertising, labeling, and other practices."(7)
As already discussed, consumers themselves demand to know whether foods have been irradiated. In addition to the recent national opinion poll commissioned by CSPI and AARP, in which 88.6 percent of those surveyed said that irradiated foods should be labeled as such, a previous poll, commissioned in 1996 by CSPI, found that 92.4 percent of respondents favored the labeling of irradiated foods.(8) That overwhelming support for irradiation labeling is consistent with the findings of surveys that have been conducted throughout the world.(9)
Clear irradiation labeling serves the needs of at least two important groups of consumers. It imparts valuable information to those who would seek out irradiated products because they purchase foods for people at increased risk of developing foodborne illnesses (e.g., children or nursing-home residents) or because they generally desire for themselves or their families the lower-pathogen foods that irradiation may provide. At the same time, clear labeling reaches those who wish to avoid irradiated products, because they prefer fresh, natural, or minimally-processed foods or because they are concerned about environmental and worker-safety problems potentially caused by irradiation or find irradiated foods unappealing for any other reason.(10)
To effectively convey the message that a food product has been treated by irradiation, the radiation disclosure statement must be sufficiently clear, prominent, and conspicuous to ensure that it may be seen, read, and understood by consumers at the time of purchase. That means that the statement should be:
- accompanied by the radura symbol and located on the principal display panel of the food package near the product name, and not in any less prominent location;(11)
- positioned in such a way as not to be lost among the other text on the display panel; and
- printed using large type that can be read easily by elderly consumers and others who may have impaired vision.
The labeling provisions in FSIS’s proposed rule, as currently drafted, satisfy only the first two of those three basic requirements. With respect to the statement’s location, the proposed rule requires, as it should, that the radiation disclosure statement and the radura symbol appear on the principal display panel of the irradiated product’s packaging. While the proposed rule does not itself expressly state that the statement must be located on the principal display panel, CSPI understands such placement to be required for two reasons: (1) the statement would be subject to the provisions of 9 C.F.R. § 317.2(b), which mandate that all statements required under Part 317 of FSIS’s labeling regulations be placed on the principal display panel;(12) and (2) under the proposed rule the statement must "appear as a qualifier contiguous to the product name," which itself must appear on the principal display panel under existing labeling regulations.(13) To improve the clarity of its proposed rule, FSIS should revise it to state explicitly that the radiation disclosure statement must appear on the principal display panel.
As to the second basic requirement described above, that the statement and symbol not be lost among other text on the food label, FSIS’s general labeling regulations mandate that all statements required under Part 317 of the regulations "be prominently placed [on the label] with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use."(14) Thus, the radiation disclosure statement cannot be obscured by placing it in a position in which it would be rendered difficult to read by the presence of other items on the package label.(15)
Unfortunately, the foregoing provision addresses only the needs of the "ordinary consumer" and does not mandate that the radiation disclosure statement appear in sufficiently large and clear lettering to enable all targeted high-risk consumers to read it easily. Nor do the new labeling provisions included in the proposed rule fill that gap by establishing a minimum type size for the statement. Thus, under the proposed rule, the statement may be printed in type as small as that used for the ingredients list found elsewhere on the package. As a result, although the statement would be located in the principal display panel near the product name, it could appear in text that is too small to attract the notice of many consumers, especially in the likely event that a substantially larger type size is used for the product name or for other sales information on the front panel. FSIS’s decision therefore would significantly increase the likelihood that consumers would purchase a product without knowing that it had been irradiated.
Most importantly, by failing to require that the radiation disclosure statement be printed in large and legible letters, FSIS has ignored the needs of a large and growing segment of the population -- older Americans.(16) That group, which is particularly susceptible to foodborne illnesses,(17) suffers disproportionately from impaired vision and would benefit greatly from a disclosure statement that is written in large, easy-to-read type.(18)
To win consumer acceptance of the irradiation rule, especially among older consumers, FSIS should revise the proposed labeling provisions to mandate a larger type size for the radiation disclosure statement. Specifically, FSIS should rewrite the rule to make it consistent with the existing labeling rules for irradiated poultry products, which require that the letters used for the radiation disclosure statement be no less than one-third the size of the largest letter in the product name.(19) The rule should also require a specific minimum type size for the statement.(20) Such a requirement would ensure that the statement is large enough to be legible to most consumers and would reduce the likelihood that the statement would be obscured by other label elements or rendered largely inconspicuous because of its small size relative to the nearby product name.
According to an FSIS official, the agency decided not to require a minimum type size for the radiation disclosure statement to be consistent with the irradiation labeling regulations that FDA has promulgated in response to the Food and Drug Agency Modernization Act of 1997 (FDAMA).(21) Under section 306 of FDAMA, FDA may not require that radiation disclosure statements be more prominent than a product’s declaration of ingredients.(22)
While consistency in labeling regulations between FDA and FSIS generally may be appropriate, it is not so here. In amending the FFDCA to prohibit the use of a type size for the disclosure statement that exceeds the small print used for the ingredient list, Congress apparently was unconcerned about the special needs of older Americans and others who would benefit from a large, easy-to-read label indicating that a food has been irradiated. Consequently, FSIS should not follow the approach mandated by FDAMA.
Indeed, FSIS, unlike FDA, is not constrained by FDAMA’s irradiation labeling provisions, because FSIS’s irradiation regulations are promulgated under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), and not under the FFDCA. FSIS is, therefore, free to promulgate irradiation-labeling regulations that require a minimum type size larger than that used in the ingredients list. CSPI urges FSIS to adopt regulations that make it easy for consumers to identify irradiated products by requiring the type size of the disclosure statement to be no smaller than one-third the size of the largest letter in the product name, and, at a minimum, no smaller than 12 point.
B. FSIS Should Require That the Terms "Radiation" or "Irradiation" Be Used In the Radiation Disclosure Statement
FSIS should reject recommendations that any euphemistic alternatives to the terms "radiation" or "irradiation" be permitted in the required radiation disclosure statement. Suggested terms, including "electronic pasteurization" or "cold pasteurization," are no substitute for "irradiation" or "radiation." The suggested terms are devoid of meaning at best, and misleading at worst.
Moreover, there is a demonstrated lack of consumer acceptance for the alternative terms, as shown by the findings of the recent national opinion poll commissioned by CSPI and AARP. As previously stated, respondents in that poll expressed a strong preference for the labeling term "Treated by Irradiation" over the alternatives "Electronically Pasteurized" or "Cold Pasteurized."(23) Respondents favored "Treated by Irradiation" by almost a four to one ratio over "Electronically Pasteurized," and the gap widens to more than six to one when the number of consumers favoring "Treated by Irradiation" is compared to those who prefer "Cold Pasteurized."
To serve as an effective means of disclosure, the radiation statement must inform consumers of the actual, accepted name of the process, so that they can obtain further information about it from whatever sources they choose to consult (e.g., from the government, the company, the Internet, health-care providers, etc.). Only "irradiation" or "radiation" will lead consumers to the pertinent information; other terms may very well lead them astray.
C. Packages of Multiple-Ingredient Food Products Containing Irradiated Ingredients Should Disclose That Fact
CSPI applauds FSIS’s decision to require that all irradiated ingredients in multiple-ingredient products be listed in the products’ ingredient statement in conjunction with the words "irradiated" or "treated by irradiation." Such disclosure assures consumers that the industry does not conceal the presence of an irradiated ingredient in a multiple-ingredient product. However, CSPI is concerned that in certain products, such as those that contain only two or three ingredients and those in which the irradiated ingredient is the major component of the product, relegating the irradiation disclosure to the ingredients list would do a disservice to consumers. Where the irradiated ingredient is the major component of a product, consumers would rightly expect the front panel of the product to clearly indicate that the major constituent of the product has been subjected to irradiation.
CSPI urges FSIS to revise its proposed labeling provision pertaining to multiple-ingredient products to satisfy that consumer expectation. For instance, FSIS should consider requiring that any multiple-ingredient product bear the prescribed radiation disclosure statement if an irradiated ingredient constitutes more than 50 percent of the overall product by weight.(24)
D. Labels Stating that Irradiated Products Have Been Treated to Reduce Pathogens Should Be Rejected Unless Stringent Standards Are Satisfied
In the preamble to its proposed rule, FSIS requests comments on whether companies should be permitted to use "incentive labeling" to inform consumers that a meat food product has been irradiated to reduce pathogens generally. As FSIS points out, qualifiers such as "Treated by irradiation to reduce Salmonella and other pathogens" are already permitted under the irradiation labeling provisions for poultry products, provided such labels are not false or misleading.
CSPI agrees that statements such as those already permitted for poultry products are appropriate, but only if certain stringent requirements are met. Specifically, FSIS should define a minimum amount of pathogen reduction that must be achieved to allow companies to use a pathogen-reduction label. For instance, the agency should consider whether a statement that a meat product has been irradiated to reduce Salmonella must be supported by data showing that the irradiation treatment results in at least a 5-log reduction of the pathogen. Requiring a high degree of pathogen reduction is crucial, because the proposed incentive labeling could encourage consumers to reduce their vigilance in adhering to proper safe-handling techniques, with potentially disastrous consequences if the meat were to contain pathogens despite having undergone irradiation.(25) Such considerations also suggest that FSIS should require evidence that the irradiation treatment results in a significant reduction of foodborne-illness-causing pathogens other than those specifically named in the irradiation disclosure statement.
In addition, FSIS should require a company seeking approval for a label that indicates a product was treated by irradiation to reduce pathogens to demonstrate on a regular basis that use of irradiation in its specific production process reliably results in the requisite reduction of the specified pathogen. To satisfy that requirement, FSIS should require that the company provide the agency with processing documentation showing that the company’s Hazard Analysis Critical Control Point (HACCP) plan has been validated as achieving the requisite degree of pathogen reduction from irradiation treatment. In addition, the company should conduct, on a routine basis, microbial testing of the product immediately prior to the irradiation step, to show that all appropriate sanitation measures are being adhered to and that pathogen loads are not exceeding the level for which the company’s irradiation process can achieve the requisite level of pathogen reduction. Finally, FSIS should also require that the company routinely verify through microbial testing that the irradiation process is continuing to eliminate or reduce the levels of the pathogens in question, to the degree required.
Implementation and strict enforcement of the foregoing measures are crucial to consumer acceptance of the proposed incentive-labeling scheme. A label indicating that a product has been irradiated to reduce foodborne-illness-causing pathogens would mislead consumers if the irradiation process to which the food was subjected does not reliably achieve the necessary degree of pathogen reduction, because of equipment problems, mishandling, excessive pathogen loads on irradiated product, or any other problem. Worse yet, if an outbreak of foodborne illness were linked to products labeled as having been irradiated to reduce pathogens, consumer confidence in irradiation generally would be substantially undermined, if not destroyed. To earn the right to label their products as having been irradiated to reduce pathogen levels, companies should be required to demonstrate, to FSIS’s satisfaction, that they have met the minimum standards described above.
E. FSIS Should Not Permit Irradiated Products to Bear Labels Indicating that They Are Free of Pathogens
CSPI opposes the proposed incentive labeling that would allow companies to label their products as being completely free of a particular pathogen or pathogens. Such labels would pose the following problems:
- they potentially could mislead consumers and offer them a false sense of security if the irradiation process were unable consistently to achieve nondetectable levels of the cited pathogen;
- they potentially could mislead consumers if post-irradiation re-contamination were to occur, either before or after the product reaches consumers;
- they could reduce the level of care consumers use in handling and cooking meat and poultry products that have been irradiated, increasing the potential for cross-contamination -- in fact, a label indicating that a product is pathogen-free potentially could contradict the safe-handling instructions required under FSIS regulations and confuse consumers; and
- they could encourage careless handling of non-irradiated food products.
II. PROCESSING REQUIREMENTS FOR IRRADIATED MEAT AND POULTRY PRODUCTS
A. FSIS Should Require That Plants Using Irradiation Conduct Microbial Testing Immediately Prior to the Irradiation Step
CSPI is concerned that once the proposed rule goes into effect the meat and poultry industry will place too much reliance upon irradiation as a "silver bullet" treatment for the reduction of pathogens, leading to neglect of effective sanitation measures and other interventions that control pathogens and eliminate filth. As CSPI and other consumer advocates have long maintained, filthy meat and poultry products are unacceptable to consumers even if all pathogens have been killed by irradiation.
To assure consumers that meat and poultry plants will employ adequate sanitation and pathogen-control measures in addition to irradiation treatment, FSIS should revise the proposed rule to include a requirement that plants conduct routine microbial testing of products immediately prior to the irradiation step. Such a requirement would serve at least two important functions: (1) it would ensure that the industry does not rely solely upon irradiation to control microbial contamination; and (2) it would ensure that pathogen loads and filth levels on products destined for irradiation do not exceed the levels for which the irradiation process has been demonstrated to work.(26) FSIS should examine plants’ HACCP plans to verify that the proposed pre-irradiation microbial testing scheme is integrated into the plans.
CSPI also urges FSIS to remind plants intending to incorporate irradiation into their processes that the existing zero-tolerance standard for visible fecal matter in the agency’s regulations under both the FMIA and the PPIA will be unaffected by the decision to subject the products to irradiation. FSIS’s carcass-by-carcass inspection for compliance with the zero-tolerance standard will afford consumers an important measure of confidence that plants do not use irradiation to treat meat that is contaminated with filth due to lax sanitation measures.
In addition, FSIS should ensure that the HACCP plans of plants that irradiate their products include effective means to prevent re-contamination of irradiated products. The adverse consequences of re-contamination after irradiation are potentially devastating, because the process also eliminates non-pathogenic bacteria that can crowd out pathogenic bacteria.
B. FSIS Should Conduct Salmonella Sampling in Plants Not Yet Under HACCP That Choose to Employ Irradiation
FSIS proposes that very small meat and poultry plants that have not yet implemented HACCP plans should be allowed to irradiate their products if the plants develop and obtain approval for a special plan demonstrating how irradiation would be used safely and effectively. CSPI opposes that proposal because a critical component of the meat and poultry HACCP program is not in effect in those plants, namely FSIS sampling for compliance with Salmonella performance standards. In essence, under FSIS’s proposal the very small plants that have not yet implemented HACCP would be permitted to experiment simultaneously with both the HACCP program and irradiation technology, without the crucial check provided by FSIS regulatory sampling for Salmonella.
To assure consumers that use of irradiation by very small plants does not lead to a public-health problem, FSIS should conduct sampling of the plants’ product for Salmonella using the standards and procedures specified in the meat and poultry HACCP program. In addition, FSIS should mandate that the plants conduct routine microbial sampling to verify the efficacy of their pathogen-reduction systems.
Staff Attorney, Food Safety Program*
*Lucy Alderton, CSPI Project Coordinator, provided significant assistance in the preparation of these comments.
1. Bruskin/Goldring Research, Irradiation Telephone Survey for the Center for Science in the Public Interest and AARP, (April 16-18, 1999) [hereinafter cited as 1999 Irradiation Opinion Poll].
2. An additional 4.1 percent of respondents either did not respond or stated that they did not know whether foods should be labeled to indicate whether they have been irradiated. Ibid., Table 1.
3. An additional 30.3 percent of respondents stated that it does not matter whether the irradiation label is placed on the front or on the back of the food package, and 0.8 percent of respondents did not respond to the question or stated that they did not know. Ibid., Table 2.
4. An additional 17.7 percent of respondents either did not respond to the question or stated that they did not know which labeling term should be used. Ibid., Table 3.
5. Julie A. Caswell, "Uses of Food Labeling Regulations," Organization for Economic Cooperation and Development (OECD) Working Papers, Volume V (1997) No. 100. For a more general discussion of this and other principles supporting labeling of products to disclose the method of production, see Center for Science in the Public Interest, Food Labeling for the 21st Century: A Global Agenda for Action (Washington, DC: Center for Science in the Public Interest, May 1998), pp. 60-69.
6. United Nations, "Resolution Adopted by the General Assembly, Annex Guidelines for Consumer Protection," Apr. 16, 1985, at II.(c), reprinted in, Consumer Law in the Global Economy National and International Dimensions (Iain Ramsay, ed., Dartmouth Pub. Co., Ltd. 1997), p. 372.
7. President John F. Kennedy, Message Relating to Consumers’ Protection and Interest Program (March 15, 1962), p. 2.
8. Bruskin/Goldring Research, Food Labeling Telephone Survey for the Center for Science in the Public Interest (June 7-9, 1996) (on file with CSPI).
9. Tony Webb, Tim Lang, and Kathleen Tucker, Food Irradiation: Who Wants It?, (Thorson Publishers, Inc. 1987), p. 53 (citing Titlebaum, Dubin, and Doyle, "Will Consumers Accept Irradiated Foods," Journal of Food Safety, Vol. 5 (1983), pp. 219-228; Bruhn, Shultz, and Sommer, "Attitude Change Toward Food Irradiation Among Conventional and Alternative Consumers," Food Technology, Vol. 40 (1986), p. 86; Marplan Ltd., Food Irradiation, Omnibus Research conducted for the London Food Commission, London (January 1987) (British national opinion poll in which 95 percent of respondents thought all foods, including those containing irradiated ingredients, should be labeled).
10. Consumer surveys have shown that a significant percentage of consumers would choose not to purchase irradiated products. For instance, in one published survey, 19 percent of consumers said that they would not buy irradiated foods, and 36 percent were undecided. A.V.A. Resurreccion, et al., "Consumer Attitudes Toward Irradiated Food: Results of a New Study," Journal of Food Protection, Vol. 58, No. 2 (1995), pp. 193-96. Those consumers should be permitted to exercise their right to choose non-irradiated products, which is only possible when irradiated foods are clearly labeled as such.
11. As already mentioned, the national opinion poll commissioned by CSPI and AARP in April 1999 found strong support for placement of the radiation disclosure statement on the front of the food package. 1999 Irradiation Opinion Poll, Table 2. Specifically, 59.1 percent of respondents said that if a label is required it should be on the front of the package. Only 9.8 percent said that the label should be located on the back of the food package, and 30.3 percent stated that it doesn’t matter where the label is located. Ibid.
12. Under the proposed rule, the radiation disclosure statement would be a required statement under part 317 of FSIS’s labeling regulations. United States Department of Agriculture, Food Safety and Inspection Service, "Irradiation of Meat and Meat Products; Proposed Rules," Federal Register, Vol. 64, No. 36 (1999), p. 9102 (to be codified at 9 C.F.R. § 317.14(a)).
13. Ibid. An FSIS official confirmed that the proposed rule requires placement of the radiation disclosure statement on the principal display panel of the irradiated food product. Telephone conversation with Matthew Michael, United States Department of Agriculture, Food Safety and Inspection Service, Washington, DC, March 2, 1999.
14. 9 C.F.R. § 317.2(b).
15. CSPI urges FSIS to require, where necessary because the principal display panel of a food product is crowded with information, that the irradiation disclosure statement be separated from other text by a minimum distance (for instance, one-quarter or one-half inch), or that it be enclosed in a graphic box.
16. From 1965 to 1995, the number of Americans aged 65 years or older grew by 82 percent. It is expected that, within the next three decades, one-fifth of the U.S. population will be over the age of 65. Institute of Medicine, National Research Council, Ensuring Safe Food: From Production to Consumption, (Washington, DC: National Academy Press, 1998), p. 56.
18. Over 60 percent of those considered visually impaired are older persons. By age 65, virtually every person will suffer some loss of ability to focus, to resolve images, to discern colors, and to adapt to light. AARP, Truth in Aging: Guidelines for Accurate Communication, (Washington, DC, 1986), p. 25.
19. 9 C.F.R. § 381.135(a).
20. CSPI agrees with AARP that the minimum type size should be 12 point, based upon the recommendations of experts who have conducted readability research on older persons. AARP, Comments in re: U.S. Department of Agriculture, Food Safety and Inspection Service, Irradiation of Meat and Meat Products; Proposed Rule, Docket No. 97P-076P, April 26, 1999, p. 4.
21. Telephone conversation with Matthew Michael, United States Department of Agriculture, Food Safety and Inspection Service, Washington, DC, March 2, 1999.
22. 21 U.S.C. § 343-3.
23. Specifically, 57.8 percent of respondents said that the term "Treated by Irradiation" should be used if a label were required for irradiated foods, while 15.3 percent preferred the term "Electronically Pasteurized" and 9.2 percent preferred "Cold Pasteurized. In addition, 17 percent of respondents did not respond or said that they did not know which of the three terms should be used. 1999 Irradiation Opinion Poll, Table 3.
24. For instance, under CSPI’s proposal a chicken burrito containing irradiated chicken in an amount greater than 50 percent of its net weight would have to bear a radiation disclosure statement on its principal display panel. In that case, the product’s principal display panel might state, next to the product name: "Chicken treated by irradiation."
25. A stringent pathogen-reduction requirement is necessary because any amount of pathogenic contamination that is not eliminated during the irradiation process potentially could grow back to harmful levels by the time the irradiated food reaches the consumer.
26. Of course, CSPI is not urging that the pre-irradiation microbial testing establish that the food is pathogen free, but only that the pathogen loads will not overwhelm the irradiation treatment process.