Michael Hansen, PhD.
July 3, 2007
Summary
Consumers Union(1) (CU) welcomes the opportunity to comment on FDA’s proposed revision to labeling requirements for irradiated foods. We strongly urge FDA not to weaken current requirements for labeling of irradiated foods. FDA should not limit labeling of irradiated foods to situations in which the irradiation caused a “material change” to the food. Consumers desire to know about whether the food they eat has been irradiated constitutes a “material fact” in FDA parlance. Indeed, consumer comments to FDA on previous irradiation labeling proposals, as well as numerous surveys and focus groups, carried out by FDA, the Food Safety Inspection Service (FSIS) and others have clearly shown that consumers want to be informed, via labeling, whether a food has been irradiated. Further, labeling a food as irradiated only if the irradiation causes a “material change” would clearly be misleading, as consumer surveys show overwhelming support for present required labeling irradiated foods.
In addition, limiting labeling of “irradiated” to “material changes” to a food introduces unneeded complexity and opportunities for errors and confusion, as well as potentially increased regulatory/enforcement costs. Who determines when a change is large enough to be considered material? How large a changes in a nutrient level does there need to be for it to be considered “material’? How much a change in odor, or texture does there have to be? How would the law be enforced? FDA regulators would be asked to spend precious time and resources determining on a case-by-case basis which changes in irradiated food would NOT be “material” and thus would be exempt from labeling.
FDA should maintain a clear policy and require all foods treated with irradiation to be labeled as such; otherwise consumers will be misled. In addition, FDA should not allow the term “pasteurized” to be used in lieu of “irradiated.” Lots of consumer research—by FDA, USDA and various consumer groups—have all clearly shown that people consider the terms associated with “pasteurization”—such as “cold pasteurized” or “electronic pasteurization”—to be misleading when applied to irradiated food.
Introduction—Consumers want labeling/labeling is a material fact
FDA is proposing a major revision to its policy regarding the labeling of foods (including dietary supplements) that have been irradiated. The original policy on labeling of irradiated foods, published in the Federal Register in 1986, required that the label on all irradiated foods contain the radura logo and a radiation disclosure statement (“Treated with radiation” or “Treated by irradiation”); an unlabeled irradiated food is considered to be misbranded because the label contains false or misleading information. FDA now proposes that labeling should only be required on those irradiated foods in which the irradiation has lead to a “material change”—defined as a “change in the organoleptic, nutritional or functional properties”—in the food that is not obvious to the consumer at the point of purchase. Thus, not all irradiated food would be required to be labeled.
This policy deviation appears to be based on a change in the way FDA interprets the word “material.” As FDA notes, their authority to require labeling of all foods derives, in part from section 201(n) and 403(a)(1) of the Federal Food Drug and Cosmetic Act. A label is considered “misleading” if it “fails to reveal facts that are material in light representations made. . .” FDA then states that “Historically, the agency has generally interpreted the scope of the materiality concept to mean information about the characteristics of the food” and goes on to discuss the ways in which irradiation “may cause changes in the characteristics of the food” (72 FR 64, pg. 16293).
We disagree strongly with the FDA’s new interpretation and believe it was correct in 1986 when it decided that all irradiated food should be required to be labeled. FDA is unjustifiably changing their view of the “materiality concept.” “Materiality” does not just refer to “information about the characteristics of a food;” it also refers to information that is of importance to consumers. In the past, FDA has determined that “material” information may include information that is of importance to consumers for whatever reason. In its final rule on food irradiation (April 18, 1986, 51 FR 13376 at 13380), FDA stated that the large number of respondents who asked for labeling of retail products was one factor indicative of the materiality of food irradiation: “Whether information is material under section 201(n) of the act depends not on the abstract worth of the information but on whether consumers view such information as important and whether the omission of label information may mislead a consumer. The large number of consumer comments requesting retail labeling attest to the significance placed on such labeling by consumers” (italics ours).
Material facts other than material changes have long bee required for other reasons that are important to consumers. Labeling the source of protein hydrolysates was required because of the concern of vegetarians and observant Jews and Muslims. As the FDA stated, “the food source of a protein hydrolysate is information of material importance for a person who desires to avoid certain foods for religious or cultural reasons” (56 FR 28592 [1991]). Thus, “information of material importance” to a consumer is not simply restricted to “information about the characteristics of a food.”
Since the 1986 final rule on labeling of irradiated food, comments to the agency as well as a number of studies have shown that consumers overwhelmingly want to know if the food they eat has been irradiated. When Congress passed the FDA Modernization Act (FDAMA) in 1997, the language of the FDAMA Joint Statement made it clear that Congress thought that FDA should seek public comment on whether changes should be made to current regulations relating to labeling of irradiated foods and that any language of the label would “not be perceived to be a warning or give rise to inappropriate anxiety.” Consequently, FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) on Labeling of irradiated foods in 1999. They received over 20,000 comments, of which some 16,000 were postcards. An analysis of the public comments by ICF Consulting, which the FDA had hired for this work, found that 78.7% of those who commented on labeling said that they wanted the current labeling requirements maintained; another 19.5% wanted the requirements strengthened to include foods with irradiated ingredients(2) . Thus, an overwhelming 98.2% said they wanted the current labeling requirements maintained or strengthened.
Another poll found a similar result. A nationally representative poll of over 1,000 adults, commissioned by Center for Science in the Public Interest (CSPI) and American Association of Retired Persons (AARP), and conducted in April, 1999 found that 88.6% supported labeling of irradiated foods to indicate that they have been irradiated(3) .
Finally, the FDA’s own focus group research on the issue of irradiation labeling, conducted during June and July 2001 in California, Maryland and Minnesota clearly showed that consumers overwhelmingly support the current irradiation labeling guidelines. As FDA noted in a report to Congress, “Everyone agreed that irradiated foods should be labeled honestly. They indicated that current required statement is a straightforward way for labeling irradiated foods(4)(emphasis added)
It is clear from the above research that consumers want irradiated foods to be labeled as such and support current FDA irradiation labeling requirements. To consumers, knowledge of whether a food has been irradiated is a “material fact”. Consequently, labeling a food as irradiated only if the irradiation causes a “material change” would clearly be misleading, as consumer surveys and focus groups show overwhelming support for present required labeling irradiated foods. We also urge FDA to reject their present narrow interpretation of the “materiality concept” and admit that “materiality” is not restricted to the characteristics of a food but can also include information that is of importance to consumers, such as whether a food has been irradiated or whether protein hydrolysates come from plants or animals or from pigs.
In addition, labeling only if irradiation causes “material changes” to a food introduces unneeded complexity and opportunities for errors and confusions, as well as potentially increased regulatory/enforcement costs. The doses of radiation needed to treat the various foods differs dramatically. Indeed, the dose of radiation can vary from batch to batch of food treated depending on variety of food and even size of package. Who determines when a change is large enough to be considered material? How large a change in a nutrient level does there need to be for it to be considered “material’? How much a change in odor, or texture does there have to be? How would the law be enforced? FDA regulators would be asked to spend precious time and resources determining on a case-by-case basis which changes in irradiated food would NOT be “material” and thus would be exempt from labeling. FDA should not undertake such work.
FDA should not allow the use of alternative terms such as “pasteurization” as they are misleading and may violate the law
CU strongly believes that the current FDA requirement that irradiated foods bear the radura symbol and a statement that the product was treated with irradiation should be maintained. The FDA should not permit the use of the alternative term “pasteurization” or its derivatives, eg. “cold pasteurization” or “electronic pasteurization,” as such terms would be misleading to consumers. In addition, we believe that the term “pasteurized” also fails to meet the criteria spelled out in section 10808 of the Farm Security and Rural Investment Act (FSRIA).
A great deal of consumer research—by FDA, USDA and various consumer groups—have all clearly shown that people consider the terms associated with “pasteurization”—such as “cold pasteurized” or “electronic pasteurization”—to be misleading when applied to irradiated food. Results from FDA’s own focus group research of food irradiation show that. As FDA noted in a report to Congress, “Most of the participants viewed alternative terms such as ‘cold pasteurization’ and ‘electronic pasteurization’ as misleading, because they appeared to conceal rather than disclose information about irradiated food products”(5).
Results from consumer focus groups conducted by the USDA’s Food Safety Inspection Service (FSIS) during March 2002 in Pennsylvania, North Carolina and Missouri, also found that consumers consider it misleading to label meat and poultry products as “pasteurized”: “Participants consider irradiation and pasteurization to be two different processes; hence, they consider it misleading to label irradiated meat and poultry products as ‘pasteurized.’(6)
The governments’ own consumer studies clearly show that labeling irradiated food as “pasteurized” would mislead consumers. Consequently, FDA should not allow this type of label as it would appear be illegal under the present FDA proposal. Among the proposed FDA language, Section 179.26(c)(2) (i) states: “An alternative term may be used in lieu of ‘irradiated,’ or any of its derivatives, if it meets the following provisions. (i) A term that is not false or misleading in any material respect may be used . . .” But both FDA and FSIS consumer focus groups have found “pasteurization” to be a misleading term.
Other parts of the proposed FDA language, Section 179.26(c)(2) (ii), would allow use of the word “pasteurized” in lieu of “irradiated” if it meets certain criteria. Research to date suggests that most irradiated foods are unlikely to reliably meet at least two of these criteria. The first two criteria under this section are: “(A) Reasonably certain to achieve destruction or elimination in the food of the most resistant microorganism of public health significance that is likely to occur in the food; (B) At least as protective of the public health as a process or treatment that is defined as pasteurization in this chapter.” As for criterion (A), we note that irradiation does not result in “destruction or elimination” of a “resistant microorganism.” Irradiation can reduce the number of microorganisms, but it does not always completely eliminate them. For example, CU testing of irradiated ground beef and poultry parts in 2003 found that while irradiated meat tended to have a lower incidence and prevalence of microorganisms, such as generic E. coli, Listeria and enterococci, our meat samples were not always free of such organisms. In contrast, pasteurization can virtually destroy or eliminate pathogens. At present, there are FDA regulations covering the pasteurization of milk(7) , juice(8) , eggs(9) , and seafood(10). In all the cases, FDA talks of achieving zero pathogen levels through pasteurization. In practice, what is meant by “zero pathogen level” or “destruction or elimination” of a “[heat] resistant] microorganism” is reducing the offending pathogenic microorganism by at least 5 orders or magnitude, e.g. a 100,000-fold reduction, also know as a 5-log reduction.
As for criterion (B), we note that at present, pasteurization results in at least a 100,000-fold reduction in pathogens. In fact, in response to FSRIA which in part called for the broadening of the definition of pasteurization, the US government established the National Advisory Committee on Microbiological Criteria for Food (NACMCF). The NACMCF came out with a report in 2004 that was ultimately published in 2006. That paper, “Requisite scientific parameters for establishing the equivalence of alternative methods of pasteurization,” covered the full range of foods that can be irradiated and the pathogen reductions to meet pasteurization standards for various foodstuffs were all at least 5 orders of magnitude (e.g. 100,000-fold), and some were much higher(11). For example FSIS regulations for processed liquid eggs require an 8.75-log reduction in Salmonella levels, while FDA criterion for pasteurization for intact eggs is 5-log reduction in Salmonella. For crabmeat, FDA pasteurization criterion is more than a 12-log reduction in type E C. botulinum (bacteria responsible for botulism); for seafood in general the criterion is 6-log reduction in non-proteolytic C. botulinum. We question whether irradiation can achieve the same levels of reduction in pathogens as pasteurization standards for many foods and not also result in off flavors, odors or declines in nutritional value, or other characteristics that would require labeling under FDA’s narrow interpretation of “materiality.”
FDA may consider use of statements of purpose (e.g. “irradiated to reduce pathogens,” “irradiated to inhibit sprouting” or “irradiated to prolong shelf-life”)
We believe that FDA may consider the use of statements of purpose, although we have specific concerns with statements of purpose about safety. Safety statements of the form “irradiated to reduce pathogens,” may lead to increased consumer laxity and a reduction in practicing food safety strategies at home. Although such labels/safety statement are permitted on chicken, we are not aware of any studies of consumer behavior to see if such labels decrease the probability that consumers practice adequate safety strategies when handling these foods in the home. We would consider allowing such safety statement of purpose for foods regulated by FDA if such consumer research is done and it shows that consumers do not become more lax in practicing food safety strategies at home.
After such research is done, FDA should also require that, in order to be able to use a safety statement of purpose label, a processor/food producer must:
Meet at least the pathogen reduction level for the specific foodstuff as laid out by NACMCF; this will be at least a 5 log reduction (e.g. 100,000-fold) of pathogen level.
Demonstrate that its plan is sufficient to achieve the reduction claimed,
Demonstrate that the plan has been validated
Conduct microbial testing on a routine basis prior to the irradiation step to show that the irradiation process is sufficient to reduce effectively the levels of pathogens present.
Conduct microbial sampling to verify that its process is effective in reducing pathogen levels.
As for other statements of purpose, e.g. “irradiated to extend shelf life” or “irradiated to prevent sprouting,” we feel these should be allowed as long as they are truthful and the processor/food producer has demonstrated that they can verify their claims. However, we are concerned that these other statements of purpose may be misinterpreted for as a safety claim. In particular, consumers may view the statement “irradiated to extend shelf life” as implying that such foods also have reduced pathogen levels and so may lead to increased consumer laxity and a reduction in practicing food safety strategies at home. This would be an incorrect assumption. Produce is more easily damaged (e.g. unacceptable changes quality and sensory appeal) by irradiation and so is treated at lower doses than meat. Indeed, irradiation of produce generally reduces bacterial loads by only 2 to 4 logs(12). While such doses may be enough to retard spoilage bacteria, those doses will not be enough to adequately control pathogenic bacteria, for which there should be at least a 5 log reduction before any safety statement of purpose can be made. Thus, for statements of purpose such as “irradiated to prolong shelf life” FDA should also require a clarifying statement that states that such language does not have any food safety implications.
In sum, of the 5 options that FDA laid out, we are most comfortable with a variation on Option 3. Option 3 is “Maintain the current labeling requirement (that is, all food that is irradiated must be labeled), but also require statements of purpose (e.g., Irradiated to extend shelf life”). We can agree with option 3 as long as FDA has stringent criteria, as we laid out above, before they allow the use of a statement of purpose referring to pathogen reduction.
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(1) Consumers Union, publisher of Consumer Reports, is an expert, independent nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, Consumers Union accepts no outside advertising, no free test samples, and has no agenda other than the interests of consumers. Consumers Union supports itself through the sale of our information products and services, individual contributions, and a few noncommercial grants. Some 4.5 million people subscribe to Consumer Reports, with another 2.5 million subscribing online.
(2) ICF Consulting. 2001. FDA’s Proposed Revisions to the Labeling Requirements for Irradiated Foods: Overview of Public Comments—Final Report. Farifax, VA. March, 2001.
(3) Comments of CSPI to FSIS, April 29, 1999. At: www.cspinet.org/foodsafety/irradiation_usda.html
(4) Congressional Report on Food Irradiation Labeling—House Report 107-116; HR 2330 and Conference Action P.L. 107-76, June 2002, pg. 3.
(5) Congressional Report on Food Irradiation Labeling—House Report 107-116; HR 2330 and Conference Action P.L. 107-76, June 2002, pg. 3.
(6) RTI International. 2002. Consumer Research on Food Safety Labeling Features for the Development of Responsive Labeling Policy. March 22, 2002.
(7) 21 CFR 131
(8) 21 CFR 146.10
(9) 21 CFR 160.115; 21 CFR 160.140; 21 CFR 160.180
(10) FDA. 2001. Fish and Fisheries Products Hazards and Control Guidance. Center for Food Safety and Applied Nutrition. 3rd edition.
(11) NACMCF. 2006. Requisite scientific parameters for establishing the equivalence of alternative methods of pasteurization. Journal of Food Protection, 69(5): 1190-1216.
(12) Nierma, BA. Irradiation of fresh and minimally processed fruits and vegetables. In Microbial Safety of Minimally Process Foods, eds (J.S. Novak, G.M. Sapers and V.K. Juneja. CRC Press, Inc. Chp. 13, pp. 279-299. ERRC Publication 7167, available at http://wyndmoor.arserrc.gov/PAge/2002/7167.pdf