Irradiation in the Production, Processing and Handling of Food, 16291-16306 [07-1636]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Proposed Rules]
[Pages 16291-16306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 2005N-0272]
RIN 0910-ZA29


Irradiation in the Production, Processing and Handling of Food

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is proposing to revise 
its labeling regulations applicable to foods (including dietary 
supplements) for which irradiation has been approved by FDA. FDA is 
proposing that only those irradiated foods in which the irradiation 
causes a material change in the food, or a material change in the 
consequences that may result from the use of the food, bear the radura 
logo and the term ``irradiated,'' or a derivative thereof, in 
conjunction with explicit language describing the change in the food or 
its conditions of use. For purposes of this rulemaking, we are using 
the term ``material change'' to refer to a change in the organoleptic, 
nutritional, or functional properties of a food, caused by irradiation, 
that the consumer could not identify at the point of purchase in the 
absence of appropriate labeling. FDA is also proposing to allow a firm 
to petition FDA for use of an alternate term to ``irradiation'' (other 
than ``pasteurized''). In addition, FDA is proposing to permit a firm 
to use the term ``pasteurized'' in lieu of ``irradiated,'' provided it 
notifies the agency that the irradiation process being used meets the 
criteria specified for use of the term ``pasteurized'' in the Federal 
Food, Drug, and Cosmetic Act (the act) and the agency does not object 
to the notification. This proposed action is in response to the Farm 
Security and Rural Investment Act of 2002 (FSRIA) and, if finalized, 
will provide consumers with more useful information than the current 
regulation.

DATES:  Submit written or electronic comments on the proposed rule by 
July 3, 2007. Submit comments regarding information collection by May 
4, 2007 to OMB (see ADDRESSES).

ADDRESSES: You may submit comments, identified by Docket No. 2005N-0272 
by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the

[[Page 16292]]

Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No. 2005N-0272 or Regulatory Information Number (RIN) for 
this rulemaking. All comments received will be posted without change to 
https://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For detailed instructions on submitting comments 
and additional information on the rulemaking process, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB).To ensure 
that comments on the information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

A. Current Labeling Requirements for Irradiated Foods

    In the Federal Register of February 14, 1984 (49 FR 5714), FDA 
published a proposed rule (the 1984 proposal) to approve the use of 
ionizing radiation on several foods. The 1984 proposal did not include 
a requirement for labeling disclosing the use of ionizing radiation. 
FDA received over 5,000 comments on this proposal, including numerous 
comments on the issue of labeling irradiated foods. Based on the 
comments and information received in response to the 1984 proposal and 
on further analysis, FDA published a final rule in the Federal Register 
on April 18, 1986 (51 FR 13376) (the 1986 final rule). The 1986 final 
rule required that the label and labeling of retail packages and 
displays of irradiated food bear both the radura logo and a radiation 
disclosure statement (``Treated with radiation'' or ``Treated by 
irradiation''). FDA concluded that labeling indicating treatment of 
food with radiation was necessary to prevent misbranding of irradiated 
foods because irradiation may not visually change the food and in the 
absence of a label statement, the implied representation to consumers 
is that the food has not been processed. We stated in the preamble to 
the 1986 final rule that, in addition to the mandatory language, the 
manufacturer may also state on the wholesale or retail label the 
purpose of the treatment process or further describe the kind of 
treatment used (51 FR 13376 at 13387). That is, the manufacturer may 
include in the labeling any phrase such as ``treated with radiation to 
control spoilage,'' ``treated with radiation to extend shelf life,'' or 
``treated with radiation to inhibit maturation,'' as long as the phrase 
truthfully describes the primary purpose of the treatment. Similarly, 
the manufacturer may choose to state more specifically the type of 
radiation used in the treatment, i.e., ``treated with x-radiation,'' 
``treated with ionizing radiation,'' or ``treated with gamma 
radiation,'' if more specific description is applicable.

B. The 1999 Advanced Notice of Proposed Rulemaking (ANPRM) on the 
Labeling of Irradiated Foods

    On November 21, 1997, the Food and Drug Administration 
Modernization Act (FDAMA) (Public Law 105-115) was enacted. Section 306 
of FDAMA amended the act by adding section 403C (21 U.S.C. 343-3). 
Section 403C of the act addressed the disclosure of irradiation on the 
labeling of foods as follows:
    ``(a) No provision of section 201(n), 403(a), or 409 shall be 
construed to require on the label or labeling of a food a separate 
radiation disclosure statement that is more prominent than the 
declaration of ingredients required by section 403(i)(2).
    (b) In this section, the term ``radiation disclosure statement'' 
means a written statement that discloses that a food has been 
intentionally subject to radiation.''
    Although section 403C of the act addressed only the prominence of 
the radiation disclosure statements, the language in the FDAMA Joint 
Statement (H. Rep. 105-399, 105th Cong., 1st sess., at 98-99) stated 
that FDA should seek public comment on whether additional changes 
should be made to current regulations relating to the labeling of foods 
treated with ionizing radiation. Specifically, the Joint Statement 
stated that ``the public comment process should be utilized by the 
Secretary to provide an opportunity to comment on whether the 
regulations should be amended to revise the prescribed nomenclature for 
the labeling of irradiated foods and on whether such labeling 
requirements should expire at a specified date in the future.'' The 
FDAMA Joint Statement also indicated that ``The conferees intend for 
any required irradiation disclosure to be of a type and character such 
that it would not be perceived to be a warning or give rise to 
inappropriate anxiety'' (Ref. 1).
    In response to the conferees' report, FDA published an ANPRM in the 
Federal Register of February 17, 1999 (64 FR 7834) seeking public 
comment on the meaning of the current irradiation labeling statement 
and soliciting suggestions for possible revisions. The 1999 ANPRM 
described the intent of the conference report, cited several documents 
related to irradiation labeling, and asked for comment on how the 
current label is perceived by consumers. The 1999 ANPRM also described 
whether other labeling would more accurately convey that the food was 
irradiated without implying a warning or causing inappropriate consumer 
anxiety.
     FDA received over 5,550 comments in response to the 1999 ANPRM on 
the meaning of the current irradiation labeling statement and 
suggestions for possible revisions. The majority of comments urged FDA 
to retain the current labeling for irradiated foods. Some comments 
suggested alternate wording, such as ``cold pasteurization,'' or 
``electronic pasteurization,'' while other comments contended that 
these terms serve only to obscure information and confuse consumers. A 
few comments stated that additional labeling, such as ``irradiated to 
kill harmful bacteria,'' was helpful.

C. Consumer Research

    To better assist FDA in formulating specific revisions that would 
accomplish the objectives outlined in the FDAMA Joint Statement and 
also satisfy the requirements of the act, the agency, in addition to 
publishing the ANPRM, conducted focus group research in Maryland, 
Minnesota, and California, during June and July 2001. The primary focus 
of the research was to ascertain from focus group participants how they 
viewed the current irradiation disclosure statement. We were 
particularly interested in whether the focus group participants 
perceived the current irradiation disclosure statement as a warning. 
The

[[Page 16293]]

focus group data indicated that the majority of participants were 
uncertain about the safety, effectiveness, and appropriateness of 
irradiated food products and greatly desired more information. Most of 
the participants viewed alternate terms, such as ``cold 
pasteurization'' and ``electronic pasteurization,'' as misleading, 
because such terms appeared to conceal rather than to disclose 
information. Participants did not see the current disclosure labeling 
as a warning, per se, because knowledgeable participants considered 
irradiation to be a positive safety attribute. Less knowledgeable 
participants, such as those who associated irradiation with things such 
as x-ray or radiation, wanted more information about the 
appropriateness of food irradiation. All participants agreed that 
irradiated foods should be labeled ``honestly.''

D. Farm Security and Rural Investment Act of 2002 (FSRIA) (Public Law 
107-171)

    On May 13, 2002, the President signed into law the FSRIA. The law 
included two provisions that relate to irradiation labeling. One of 
these provisions, section 10808, as discussed in the following 
paragraph, includes new criteria for use of the term ``pasteurization'' 
in labeling. The other provision, section 10809, directed FDA to 
publish for public comment proposed changes to the current regulations 
relating to the labeling of foods that have been treated by irradiation 
using radioactive isotope, electronic beam, or x-ray to reduce pest 
infestation or pathogens. The provision further stated that ``[p]ending 
promulgation of the final rule * * * any person may petition the 
Secretary [FDA] for approval of labeling, which is not false or 
misleading in any material respect, of a food which has been treated by 
irradiation using radioactive isotope, electronic beam, or x-ray.'' 
Section 10809 also requires that, pending issuance of the final rule, 
``* * * [t]he Secretary [FDA] shall approve or deny such a petition 
within 180 days of receipt of the petition, or the petition shall be 
deemed denied, except to the extent additional agency review is 
mutually agreed upon by the Secretary [FDA] and the petitioner.''
    Section 10808 of the FSRIA, which includes new criteria for use of 
the term ``pasteurized'' in labeling, revised section 403(h) of the act 
to provide that a food may purport to be or be represented as 
pasteurized if the food has been subjected to a safe process or 
treatment that is prescribed as pasteurization for such food in a 
regulation issued under the act or the food has been subjected to a 
safe process or treatment that meet certain criteria. The criteria 
prescribed in section 10808 of the FSRIA are that the food has been 
subjected to a safe process that: (1) Is reasonably certain to achieve 
destruction or elimination in the food of the most resistant micro-
organisms of public health significance that are likely to occur in the 
food, (2) is at least as protective of the public health as a process 
or treatment prescribed by regulation as pasteurization, (3) is 
effective for a period that is at least as long as the shelf life of 
the food when stored under normal and moderate abuse conditions, and 
(4) is the subject of a notification to the Secretary (FDA) that 
includes effectiveness data regarding the process or treatment and at 
least 120 days have passed after receipt of such notification without 
the Secretary making a determination that the process or treatment 
involved has not been shown to meet the requirements.
    As part of FDA's implementation of section 10809 of the FSRIA, FDA 
issued a guidance document entitled ``Guidance; Implementation of 
Section 10809 of the Farm Security and Rural Investment Act of 2002, 
Public Law No. 107-171, section 10809 (2002) Regarding the Petition 
Process to Request Approval of Labeling for Foods That Have Been 
Treated by Irradiation'' (the 2002 Guidance). The 2002 Guidance was 
issued in accordance with FDA's Good Guidance Practices regulation in 
21 CFR 10.115. The 2002 Guidance also advised how interested parties 
may petition the agency for the approval of labeling that may be used 
on irradiated food as an alternative to the currently required 
irradiation disclosure statement. FDA noted that this was an interim 
process and that it could be used until FDA published any final 
regulation on this issue. FDA published a notice in the Federal 
Register announcing the availability of the 2002 Guidance document on 
October 7, 2002 (67 FR 62487). To date, FDA has not received any 
petitions requesting the use of alternative labeling for irradiated 
foods.

II. The Proposal

A. Legal Authority/Statutory Directive

    FDA's authority to require labeling of all foods\1\, including 
irradiated foods, derives from sections 201(n) and 403(a)(1) of the act 
(21 U.S.C. 321(n) and 343(a)(1)). In addition, section 701(a) of the 
act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the 
efficient enforcement of the act. Under section 403(a)(1) of the act, a 
food is misbranded if ``its labeling is false or misleading in any 
particular.'' Section 201(n) of the act mandates that, in determining 
whether labeling is misleading, FDA take into account, among other 
things, whether the labeling fails to reveal facts that are material in 
the light of representations made or suggested or with respect to 
consequences that may result from the use of the product to which the 
labeling relates under the conditions of use prescribed in the labeling 
or under such conditions of use as are customary or usual.
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    \1\ Food refers to conventional foods as well as dietary 
supplements.
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    Historically, the agency has generally interpreted the scope of the 
materiality concept to mean information about the characteristics of 
the food. FDA has required special labeling on the basis of it being 
``material'' information in cases where the absence of such information 
leads the consumer to assume that a food, because of its similarity to 
another food, has nutritional\2\, organoleptic (e.g., taste, smell, or 
texture), or functional (e.g., storage)\3\ properties of the food it 
resembles when in fact it does not. For example, the labeling of 
margarine that has been processed in a way that results in it no longer 
being suitable for frying must disclose this difference from regular 
margarine.
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    \2\ Currently, we are not aware of any changes to the 
nutritional properties of any food FDA has approved for irradiation.
    \3\ The statutory phrase ``the consequences that may result from 
the use of the food'' (section 201(n) of the act) generally can also 
be described as changes in a food's functional properties. For 
brevity and clarity, we use the latter terminology in this document.
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    Irradiation has various effects on foods that may cause changes in 
the characteristics of the food. Such changes may occur in the food's 
organoleptic, nutritional, or functional properties that would not be 
noticeable at the point of purchase but could be apparent when consumed 
or cooked. If these changes are not within the range of characteristics 
ordinarily found in such foods, they would be considered ``material'' 
under this proposal. In the absence of appropriate labeling disclosing 
these changes in the characteristics of the food, consumers would not 
have all of the necessary information needed to make a purchase 
decision or properly use the food. Thus, in the absence of information 
about these changes in the characteristics of the food, the labeling 
would be misleading under 201(n) of the act and the food would be 
misbranded. These

[[Page 16294]]

changes are typically process specific and will vary with the food and 
the irradiation conditions. In addition, these changes and the degree 
of the changes may be measurable and of consequence to consumers. Thus, 
a blanket statement on when labeling would be required due to 
irradiation causing material changes cannot be made in advance for all 
products. Rather, the need for labeling must be determined on a case-
by-case basis by appropriate testing of the food irradiated under 
specific conditions, e.g., time and dosage, because the effect of 
irradiation on the properties of concern depends on the particular 
food.
    Under the proposal, the fact that a food has been irradiated would 
not by itself require disclosure on the label. FDA is proposing to 
require that only those irradiated foods in which irradiation causes a 
material change in a food's characteristics (e.g., organoleptic, 
nutritional, or functional properties) under the conditions of use 
prescribed in the label and labeling or under customary or usual 
conditions of use bear the radura logo. Those irradiated foods must 
also bear the term ``irradiated'' or any derivative thereof (e.g., 
``irradiate,'' ``irradiation,'' ``radiation,'' etc.) in conjunction 
with language describing the material change. Additionally, FDA will 
not object to the use of additional terms to indicate that a food has 
been subjected to the process of irradiation, e.g., ``treated with 
radiation,'' ``treated by irradiation,'' or ``processed with 
radiation.'' However, in the absence of a material change, under the 
proposal, the fact that the food has been irradiated is not considered 
a material fact and, therefore, no logo or label statement would be 
needed. For such foods, FDA would not object to manufacturers 
voluntarily labeling their products to indicate that the food is 
irradiated. FDA is also proposing to allow the use of alternate terms 
to ``irradiated'' or any of its derivatives if use of the term has been 
approved by FDA in response to a citizen petition submitted in 
accordance with Sec.  10.30 (21 CFR 10.30).
    As discussed in more detail in section I of this document, the 
FSRIA amended section 403(h) of the act to include new criteria for the 
use of the term ``pasteurized'' in labeling. This section gives FDA 
authority to determine for labeling purposes whether alternate 
processes, e.g., irradiation, are equivalent to pasteurization in 
destroying pathogens. Therefore, FDA is also proposing to require that 
anyone seeking to label a food as ``pasteurized'' under this provision 
in lieu of referring to irradiation must notify FDA and provide 
supportive data. Provided the agency has not objected to the 
notification within 120 days after receipt of the notification, the 
notifier would be able to label a food as ``pasteurized'' in lieu of 
``irradiated.''
    Under section 409 of the act, no food may be irradiated without 
approval by FDA. Currently, FDA has approved irradiation for a number 
of foods, including spices, shell eggs and fruits and vegetables, 
although only a small fraction of these foods are actually irradiated. 
According to a report by the U.S. General Accounting Office\4\ (2000), 
only 0.005 percent of fruits and vegetables consumed in the United 
States (about 1.5 million pounds), and 9.5 percent of all spices 
consumed in the United States (about 95 million pounds of spices and 
dry or dehydrated aromatic vegetable substances) are irradiated 
annually. See the following Web site for a listing of all foods that 
have been approved for irradiation: https://a257.g.akamaitech.net/7/257/
2422/10apr20061500/edocket.access.gpo.gov/cfr_2006/aprqtr/
21cfr179.26.htm.
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    \4\ Now the Government Accountability Office.
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B. Proposed Amendment

    As previously discussed in section II.A of this document, 
irradiation has various effects on foods that may change a food's 
characteristics. For example, as with other forms of processing, the 
effects of irradiation that kill or weaken insects and microorganisms 
may also cause some changes in the food itself. Many of these changes 
are of little significance, as the composition of the food will remain 
within normal variations of unirradiated foods. However, other changes 
to organoleptic, nutritional, and functional properties may occur. 
Changes to shelf life are likely to be among the most common of these 
changes. Bananas and spices are illustrative of irradiated foods that 
may have an extended shelf life and are discussed in the following 
paragraph.
    Bananas may be irradiated to delay ripening and extend shelf life. 
This is an example of a material change. Consumers have a general idea 
of the shelf life and ripening time of unirradiated bananas based upon 
their appearance and make purchase decisions based at least in part on 
the bananas' appearance (i.e., ripeness) and intended use. If 
irradiated bananas were not labeled to indicate the material change, 
e.g., delayed ripening, consumers would purchase the bananas expecting 
the faster ripening schedule of unirradiated bananas. A consumer who 
wanted to make a food that required very ripe bananas (e.g., banana 
bread) would not know, without labeling, that the irradiated bananas 
would not be ripe enough to make the banana bread when he wanted to do 
so. Thus, if the irradiated bananas are not labeled, the consumer might 
purchase the bananas and then discover later that they are unsuitable 
for the consumer's planned use.
    In contrast, there are instances where treatment with irradiation 
may extend a food's shelf life without changing any of its functional 
characteristics in a way that may require using the food differently 
than its unirradiated counterpart. For example, while spices that are 
irradiated to control microbial growth will likely have their shelf 
life extended, FDA tentatively believes that the extension in shelf 
life in this case does not have the potential to be detrimental to the 
consumer (e.g., to prevent the consumer's planned use of the food) 
because the irradiated spice can be used identically to an unirradiated 
spice. That is, in addition to possibly benefiting from the extended 
shelf life, a consumer buying the irradiated spice can use the 
irradiated spice the same as he would the unirradiated spice. Unlike 
the consumer of irradiated bananas described above, the spice consumer 
does not need additional information to prevent the potential for a 
detrimental consequence from using the irradiated food the same as its 
unirradiated counterpart. Thus, FDA tentatively believes that the 
extension of a spice's shelf life due to irradiation would not be 
material information that consumers need to know; therefore the 
producer would not be required to declare this information on the spice 
label. We request comment on the utility, for purposes of labeling, of 
distinguishing between those changes to a food's functional properties 
from irradiation that may make a food unsuitable for a particular use 
(e.g., delayed ripening) and those changes that still allow for the 
food to be used identically to one that is not irradiated (e.g., 
extension of shelf life alone).
    One of the goals of food science research on irradiation is to 
determine irradiation conditions that would minimize those unexpected 
effects that would be material to consumers. In a review article on the 
effects of irradiation on fresh-cut fruits and vegetables, Prakash and 
Foley (Ref. 1a) cite research illustrating how effects can vary 
depending on the food, irradiation conditions, and mitigating steps 
that can be taken. They report that in some cases low doses can cause 
significant loss in firmness; however, in other fruits and vegetables 
no such loss is observed, even at a higher dose. For example,

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firmness of diced Roma tomatoes irradiated at 0.5 kilogray (kGy) 
decreased by 30 percent and firmness of cut romaine lettuce irradiated 
at 0.35 kGy decreased by 10 percent. However, no change in firmness was 
observed in shredded carrots or fresh-cut iceberg lettuce following 
irradiation at 1 and 2 kGy, or in celery irradiated at 1 kGy. In diced 
bell peppers, irradiation at 3.7 kGy reduced bell peppers' flavor and 
produced some off-flavors, while no effect on flavor or aroma was 
perceived in a control group of bell peppers that were not irradiated 
and in peppers irradiated at 1.32 kGy. Additionally, after storage for 
9 days, off aroma was significantly higher in the control sample of 
bell peppers than in the two groups of irradiated peppers, coinciding 
with a slimy appearance attributed to microbial spoilage. Prakash and 
Foley also report that combining irradiation with other technologies, 
such as calcium treatment, warm water dips, and modified atmosphere 
packaging further mitigated measurable adverse effects on quality. 
Similarly, Kader (Ref. 1b) reported that fruits and vegetables such as 
papaya, strawberry, tomatoes, and dates have a high tolerance to 
irradiation at doses (below 1 kGy) used for insect control, while 
cucumber, green bean, grape, and lemon have a low tolerance at this 
same kilogray. Thus, whether effects occur that would change the food 
in a significant way will depend on the particular food that is 
irradiated and the dosage of irradiation used. In its decision 
approving the use of radiation on shell eggs, FDA cited to data in the 
petition showing an increased color loss in the irradiated egg yolk and 
a change in the egg's viscosity as the radiation dose was increased (65 
FR 45280 at 45281; July 21, 2000). Such a change in the viscosity or 
other characteristics of the egg would affect its functionality, e.g., 
its cooking or binding properties. This change could be significant 
enough that consumers should be informed of the irradiation and its 
effect on the food.
    In sum, irradiation of food can cause effects in food that are 
material in light of representations made or on consequences of use. 
However, whether such effects are sufficient to meet the standard of 
section 201(n) of the act will vary based on several factors and cannot 
be determined without considering the particular food and irradiation 
processing applied. If the change in the irradiated food is within the 
range of characteristics ordinarily found in such foods, then the fact 
that the food is irradiated and the resulting change would not be 
material information and would not be required to be declared on the 
label.
    The use of irradiation is strictly voluntary and generally approved 
up to a maximum dose. We believe that manufacturers may adjust the 
dosage to get the most effective dose, while minimizing unexpected 
effects in the irradiated food. These food manufacturers or producers 
may choose to irradiate their food only if the irradiation does not 
alter in a significant way characteristics of the food that are 
material to the consumer. Thus, it is possible that many uses of 
irradiation will not result in a material change within the framework 
set out in this rule. FDA is interested in receiving information about 
the types of pre-market investigations, e.g., taste test panels or 
functional studies, done by food manufacturers to evaluate whether to 
irradiate and at what dose to irradiate in such a way that a material 
change does not result.
    Food is most commonly irradiated to control food-borne pathogens. 
FDA is not aware of data indicating that control of food-borne 
pathogens as a result of food irradiation would, by itself, result in a 
change in the food's characteristics that would not be apparent at the 
point of purchase of the food and, thus, would have to be disclosed in 
the labeling of the food to prevent the labeling from being misleading. 
Consumers expect food to be safe and of a certain quality, and 
therefore, FDA tentatively concludes that control of food-borne 
pathogens alone is not an unexpected change in the food. Thus, in 
instances where a food has been irradiated to enhance or maintain the 
safety of a food by controlling food-borne pathogens that may be 
present, and no other changes to the food have resulted, FDA 
tentatively concludes that information that the food has been 
irradiated is not necessary to prevent the labeling from being 
misleading. FDA is interested in receiving any information on whether 
the control of food-borne pathogens changes the characteristics of the 
food in an unexpected way, i.e., outside of the normal variation of the 
food, and would therefore require additional labeling to inform the 
consumer of such change. FDA also solicits comments on any specific 
changes that might be caused by irradiation that might constitute non-
material changes.
    On the other hand, there may be situations in which irradiation to 
control food-borne pathogens has had other effects on foods, such as 
changes to organoleptic, nutritional, or functional properties which 
would not be readily apparent to the consumer. In such situations, 
information that there are changes in the characteristics of the food 
as a consequence of irradiation is the material information that is 
required in labeling in keeping with the act, to prevent the labeling 
from being misleading. Further, with regard specifically to shelf life, 
FDA recognizes that irradiation to control the growth of food-borne 
pathogens may have the unintended effect of extending shelf life. We 
specifically request comment on the effect of irradiation on shelf life 
and the extent of any relationship between control of food-borne 
pathogens and extension of shelf life.
    In the past, FDA policies on irradiation labeling have focused on 
the fact that the food has been processed. In the preamble to the 1986 
final rule, we stated that ``* * * irradiation may not change the food 
visually so that in the absence of a statement that a food has been 
irradiated, the implied representation to consumers is that the food 
has not been processed'' (51 FR 13376 at 13388). FDA concluded that, to 
prevent deception, the fact that the irradiated food is processed is 
material information that is required to be disclosed on the label. 
Thus, FDA required in Sec.  179.26(c) (21 CFR 179.26(c)) that, in 
addition to the radura logo, the label and labeling of irradiated foods 
bear the statement ``Treated with radiation'' or ``Treated by 
irradiation.''
    In recent years, FDA policies on the labeling of foods have focused 
on the results of the processing of the food rather than the processing 
itself. As discussed earlier, although foods that have been irradiated 
have been processed, the irradiation does not always result in a 
material change in the food or in the consequences of use. Further, FDA 
consumer research indicates that information provided to consumers on 
the labels of foods is more meaningful if it describes the purpose of 
the irradiation (Ref. 2). FDA recognizes that labeling to inform the 
consumer that the product has been irradiated does not, in itself, 
inform the consumer if or how the product is materially changed. Thus, 
FDA tentatively believes that when the irradiation causes a material 
change in the characteristics of the food, the consumer needs to know 
about this change, and not just the fact that the food has been 
irradiated. FDA believes that this information should be provided in a 
disclosure statement on the label of the irradiated food. The 
disclosure statement would describe the material change in the 
properties of the food and give consumers additional information that 
would enable them to make better informed decisions about whether to 
purchase an irradiated food.

[[Page 16296]]

    Therefore, FDA is proposing to amend Sec.  179.26(c)(1) and (c)(2) 
to require that only those foods that have been treated with radiation, 
and in which the irradiation caused a material change in the 
characteristics of the food must bear the radura logo and the term 
``irradiated,'' or other derivatives as discussed previously in section 
II.A in conjunction with explicit language describing the change in the 
food or its conditions of use (e.g., ``irradiated to inhibit 
sprouting''). In addition, as noted in the 1986 final rule (51 FR 13376 
at 13391), FDA believes that the logo is still a necessary part of the 
label statement because it derives from the symbol that has been used 
internationally to convey the fact that the food has been irradiated. 
FDA tentatively concludes that this approach is appropriate because it 
would require that consumers be provided with more precise information 
about the material change in the characteristics of the food than what 
is currently required. As noted previously, such material changes may 
affect how products are stored and subsequently used by consumers, as 
well as whether or not the products are purchased in the first place. 
However, FDA requests comments on whether the term that describes the 
process, e.g., ``irradiated'' or an alternate term such as 
``pasteurized,'' is a necessary part of the label statement to ensure 
that consumers completely understand the statement.
    As previously discussed in section I.D of this document, section 
10809 of the FSRIA provides that anyone requesting approval of 
alternative labeling for a food that has been treated by irradiation, 
may petition FDA. As discussed in the 2002 Guidance, FDA believes that 
it is appropriate to use the citizen petition process provided in Sec.  
10.30. This regulation requires the petitioner to submit to the agency 
all relevant information regarding the petition. This relevant 
information includes both the information and views upon which the 
petitioner relies and the information known to the petitioner that is 
unfavorable to the petitioner's position. Thus for these purposes, 
relevant information would include any data known or relied upon by the 
petitioner (e.g., qualitative or quantitative consumer research), that 
show consumer understanding of the purpose and intent of the proposed 
alternative labeling. FDA believes that such information might include, 
but is not limited to, the following information: (1) Data on 
consumers' prior assumptions about, and perceptions of, the product 
characteristics in light of the proposed labeling statements and (2) 
data on consumer acceptance and comprehension of the proposed labeling 
statements in comparison to consumer acceptance and comprehension of 
the irradiation statement required by the current regulation (Sec.  
179.26(c)(1)). Also, as noted in section I.D of this document, section 
10808 of the FSRIA revised section 403(h) of the act to permit the use 
of the term ``pasteurized'' on labels of foods that have been subjected 
to a safe process as long as the process meets certain criteria.
    Therefore, we are proposing in Sec.  179.26(c)(1) to permit the use 
of alternate terms to ``irradiated'' or any of its derivatives, on the 
labels and labeling of irradiated foods. We are proposing in Sec.  
179.26(c)(2) that the alternate term may be used on the labels and 
labeling of foods that have been treated by irradiation, that is, if 
use of the term has been approved by FDA in response to a citizen 
petition submitted in accordance with Sec.  10.30. In the case that the 
alternative term is ``pasteurized,'' the irradiation process must meet 
the criteria of section 403(h)(3) of the act. Anyone seeking to label a 
food as ``pasteurized'' under this provision must notify FDA and 
provide effectiveness data regarding the process or treatment used. The 
agency intends to issue guidance to interested parties who wish to 
notify the agency to use the term ``pasteurized'' in accordance with 
section 403(h)(3) of the act.
    FDA and the Food Safety and Inspection Service (FSIS), U.S. 
Department of Agriculture, entered into a memorandum of understanding 
(MOU) establishing procedures to jointly respond to petitions to use 
food ingredients and sources of irradiation in the production of meat 
and poultry products (see 64 FR 72168, December 23, 1999, at https://
www.fsis.usda.gov/OPPDE/rdad/FRPubs/88-026F.pdf; for the MOU, see 
https://www.fsis.usda.gov/Regulations_&_Policies/Labeling_FDA_MOU/
index.asp). FSIS has separately issued regulations at 9 CFR 424.22(c) 
regarding the irradiation of meat and poultry products (see 64 FR 
72150, December 23, 1999, at https://www.fsis.usda.gov/OPPDE/rdad/
FRPubs/97-076F.pdf).

III. Analysis of Economic Impacts

A. Introduction

    FDA has examined the economic implications of this proposed rule as 
required by Executive Order 12866, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4). Executive Order 12866 directs agencies to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
Executive Order 12866 classifies a rule as significant if it meets any 
one of a number of specified conditions, including: having an annual 
effect on the economy of $100 million or more or adversely affecting in 
a material way a sector of the economy, competition, jobs, the 
environment, public health, or safety, or State, local, or tribal 
governments or communities. A regulation also is considered a 
significant regulatory action if it raises novel legal or policy 
issues. We have determined that this rule is a significant regulatory 
action as defined by Executive Order 12866 because it raises novel 
policy issues.

B. Preliminary Regulatory Impact Analysis

1. The Need for the Proposed Irradiation Labeling Rule
    Executive Order 12866 states, ``Federal agencies should promulgate 
only such regulations as are required by law, are necessary to 
interpret the law, or are made necessary by compelling need, such as 
failures of private markets to protect or improve the health and safety 
of the public, the environment, or the well being of the American 
people.''
    As previously discussed in section I.D of this document, on May 13, 
2002, the President signed into law the FSRIA, which contains a 
provision relating to irradiation labeling. Section 10809 directs FDA 
to publish a proposed rule and, with due consideration to public 
comment, a final rule to revise the current regulation governing the 
labeling of foods that have been treated by irradiation. This rule is 
proposed not to address any market failure, but to respond to section 
10809 of FSRIA and because we tentatively believe that it may no longer 
be necessary to require that all irradiated food be labeled as such.
2. Regulatory Options
    We analyzed five options for the proposed irradiation regulation:
     No new regulatory action (current state of the world, 
baseline).
     Remove labeling requirements for irradiated foods.
     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'').

[[Page 16297]]

     Maintain the current labeling requirement, but also allow 
alternate terms to irradiation (e.g., ``pasteurized'').
     The proposed regulation--Only those foods treated with 
irradiation and for which the irradiation caused a material change in 
the food must bear the radura logo and the term ``irradiated'' or an 
alternate term such as ``pasteurized'' in conjunction with explicit 
language describing the change in the food or its conditions of use 
(e.g., ``irradiated to inhibit sprouting''). A food undergoes a 
material change if irradiation changes the properties of the food in a 
way that is not readily apparent to the consumer at the point of 
purchase. Therefore, in the absence of a material change, the fact that 
the food was irradiated is not considered a material fact and, 
therefore, no radura logo or label statement would be needed.
    Option 1: No New Regulatory Action (baseline).
    Taking no new regulatory action on irradiation labeling is option 1 
in our analysis. The FSRIA requires FDA to publish a proposed rule and, 
with due consideration to public comment, a final rule to revise the 
current irradiation labeling regulation. So this is not a viable 
option. We include it here because the Office of Management and Budget 
(OMB) cost-benefit analysis guidelines recommend discussing statutory 
requirements that affect the selection of regulatory approaches. These 
guidelines also recommend analyzing the opportunity cost of legal 
constraints that prevent the selection of the regulatory action that 
best satisfies the philosophy and principles of Executive Order 12866. 
This option will serve as the baseline against which other options will 
be measured for assessing costs and benefits, and we assume the 
baseline has zero costs and benefits.
    The current regulation (Sec.  179.26) states that irradiated food 
must bear the radura logo and the phrase ``Treated with radiation'' or 
``Treated by irradiation'' and does not explicitly address the 
inclusion of additional information that directs attention to shelf 
life or food safety. Currently, FDA has approved iradiation for a 
number of foods including spices, shell eggs, and fruits and 
vegetables; however, only limited amounts of irradiated foods are sold 
in the United States. According to a report by the General Accounting 
Office\5\ (2000), it is estimated that 97 million pounds of food 
products are irradiated annually (including ``meat food products'' 
under the Federal Meat Inspection Act and ``poultry'' under the Poultry 
Products Inspection Act\6\, which are regulated by the United States 
Department of Agriculture), which is only a small fraction of the total 
amount of food consumed. For example, about 1.5 million pounds of 
fruits and vegetables are irradiated annually. This represents only 
0.005 percent of the total amount of fruits and vegetables consumed. 
About 95 million pounds of spices and dry or dehydrated aromatic 
vegetable substances are irradiated annually, which represents 9.5 
percent of all spices consumed. Because spices, shell eggs, fruits and 
vegetables account for virtually all the food irradiation done in the 
United States, we use only data about those foods in our economic 
analysis.
---------------------------------------------------------------------------

    \5\ Now the Government Accountability Office.
    \6\ It is our understanding that as of 2000 only a very small 
proportion of poultry (0.002 percent of annual consumption) and no 
meats were irradiated and available commercially (Ref. 10).
---------------------------------------------------------------------------

    Option 2: Propose to remove labeling requirements for irradiated 
foods
    This option also may not be viable because it could violate section 
403(a) of the act, which provides that the labeling of all foods, 
including irradiated foods, must be truthful and not misleading. In 
addition, section 201(n) of the act mandates that, in determining 
whether particular labeling is misleading, FDA consider whether the 
labeling fails to reveal material facts in light of representations 
made, or with respect to, the consequences that may result from the use 
of the product. Having no labeling requirements might violate these 
provisions. If this option were chosen, costs and benefits would be 
generated if many firms ceased labeling their irradiated products.
    Costs: Since this option would not require labeling, search costs 
would increase for purchasers who do not want irradiated food. There 
will be an increase in search costs because these consumers would need 
to increase efforts to find information about irradiated foods other 
than on the labels or in the labeling, or obtain knowledge of producers 
who irradiate their food products. If firms decide to drop labeling, 
they would incur relabeling and label inventory costs but they would 
choose the least costly labeling option.
    Benefits: This option could be beneficial to those firms currently 
labeling irradiated food by allowing them to reclaim label space on the 
label for private purposes, such as marketing messages or label art. 
Without a labeling requirement, it is possible that irradiation would 
become more attractive to firms because of this benefit. Any increases 
in the numbers of irradiated foods could, in turn, result in increased 
food safety or shelf life.
    Option 3: Maintain the current labeling requirement (i.e., require 
that all irradiated food be labeled ``Treated with radiation'' or 
``Treated by irradiation,'' along with the radura logo), but propose to 
also require statements of purpose (e.g., ``Treated with irradiation to 
inhibit sprouting,'' etc.).
    The current regulation (Sec.  179.26(c)) states that irradiated 
food must bear the radura logo and the phrase ``Treated with 
radiation'' or ``Treated by irradiation.'' The current regulation does 
not explicitly address the inclusion of additional information that 
directs attention to, for example, shelf life or food safety. This 
option would amend the current regulation to include explicit 
requirements on inclusion of additional information on irradiation 
benefits. While it is possible that some firms that irradiate food 
currently include statements of purpose, this option would formally 
require this inclusion.
    Costs: This option would generate costs because firms would be 
required to relabel their products in order to include statements of 
purpose. Tables 1 and 2 of this document outline estimated labeling 
costs for sectors of the food industry that may require relabeling. The 
food categories included in the table are currently approved for 
irradiation by FDA.
    Table 1 outlines low, medium, and high cost estimates based on a 
change in the principal display panel. Table 2 outlines low, medium, 
and high cost estimates based on a change in the information panel or 
assuming that the irradiation statement is similar in cost to a 
nutrient content claim or health claim. It is not certain which table 
most likely represents costs to firms because it is not certain what 
conditions would make the costs in table 1 more likely or what 
conditions would make table 2 more likely. Both tables show estimated 
costs under compliance periods of 12, 24, and 36 months. In both tables 
1 and 2, compliance costs decrease as the length of compliance period 
increases for all product categories because firms can coordinate new 
changes in labels with already-scheduled changes in labels. In 
addition, the compliance period affects whether or not firms would 
incur additional labor costs, such as overtime, and the volume of 
labeling inventory that would have to be discarded as a result of a new 
rule.
    Cost estimates are shown in two proportions for each compliance 
period: If 1 percent of the industry irradiates

[[Page 16298]]

and if 5 percent of the industry irradiates. As can be seen in the 
tables, industry costs decrease as the number of firms irradiating food 
decreases. Data on the actual number of firms that irradiate food or 
will want to irradiate food in the future are not currently available. 
The agency requests comments on the number of firms or products that 
would be affected by a new irradiation labeling rule.
    The cost model used in this analysis does not include costs for 
labeling fresh produce without packaging because fresh fruits and 
vegetables do not have Universal Product Codes that can be scanned. 
Nonetheless, it is still necessary to estimate costs associated with 
labeling fresh fruits and vegetables that have been irradiated.
    One way of labeling fresh fruits and vegetables is by placing 
stickers on the produce. While it is not known how many fruit and 
vegetable manufacturers irradiate or will want to irradiate as a result 
of this rule, according to the 2002 Census of Manufacturers (Ref. 8), 
there are 5,836 firms that process fresh fruits and vegetables. As with 
costs estimates for the other food categories, it is assumed that 1 
percent of these firms, or 58, may want to irradiate, or 5 percent of 
these firms, or 292, may want to irradiate. Our 1 percent and 5 percent 
assumptions are based on the generally observed very low rate of 
adoption of irradiation technology in food processing to date. We do 
not have specific data to estimate the number of firms that will 
irradiate if this rule is finalized, and we request comment on this 
assumption.
    For firms, there are administrative costs involving the 
establishment of what the sticker will look like, as well as the costs 
of finding the printer to produce these stickers. Based on previous 
estimates of similar costs in the final rule on the Labeling of Juice 
Products (63 FR 24254; May 1, 1998), the agency estimates these 
administrative costs to be $100 per firm. In addition, printers levy 
one time charges for set-up in addition to the basic per unit cost of 
labels. The agency estimates these costs to be $250 per firm. Table 3A 
summarizes administrative costs associated with using stickers if 1 
percent of the industry irradiates and if 5 percent of the industry 
irradiates.
    In addition to administrative costs, there are labor costs 
associated with affixing stickers to the fruits and vegetables. The 
agency estimates the labor cost of applying the labels by multiplying 
the average agricultural hourly wage ($10.75) (Ref. 8a) by the 
approximate number of hours needed to label the irradiated fruits and 
vegetables. Assuming it takes one worker 1 hour to label 240 pounds of 
fruits or vegetables (4 pounds per minute multiplied by 60 minutes) it 
would take approximately 6,250 hours to label 1.5 million pounds of 
fruits and vegetables, the approximate amount of fruits and vegetables 
irradiated annually in this country. The total labor costs associated 
with labels would then be $67,188. Table 3B summarizes total labor 
costs if one worker can label 240 pounds per hour, 360 pounds per hour 
or 480 pounds per hour. The agency requests comments on costs 
associated with labeling fresh fruits and vegetables that have been 
irradiated.
    Benefits: A statement regarding the purpose of irradiation would 
serve to provide more information to consumers than what is currently 
on the label. To the extent that the addition of the statement of 
purpose causes people to purchase irradiated products they may have 
previously avoided, and to the extent that these products have longer 
shelf life or lower risk of illness, then consumers will benefit. 
Consumers may look more favorably on irradiated food once they 
understand the purpose, which in turn, could result in more irradiated 
food in the market due to the increase in demand. Information may also 
be a benefit in itself even if purchases do not increase. Research 
indicates that providing a statement of purpose results in a more 
positive attitude by consumers toward the purchase of irradiated food 
(Ref. 3). Furthermore, research indicates that providing information 
about the benefits of irradiation may increase willingness of consumers 
to pay for irradiated food (Ref. 4).

                                        Table 1.--Cost Estimates: Irradiation Relabeling, Principal Display Panel
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Percentage of                                  Cost Estimates
             Food Category                   Compliance     Firms Affected by --------------------------------------------------------------------------
                                               Period              Rule                  Low                     Medium                    High
--------------------------------------------------------------------------------------------------------------------------------------------------------
Spices/Seasonings                                12 months                 1%                 $406,553                 $581,000                 $966,000
                                         .................                 5%               $2,032,033               $2,905,689               $4,831,841
                                                 24 months                 1%                 $195,967                 $279,944                 $468,000
                                         .................                 5%                 $981,269               $1,400,095               $2,335,798
                                                 36 months                 1%                  $27,799                  $39,650                  $66,269
                                         .................                 5%                 $138,995                 $198,248                 $331,343
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shell Eggs                                       12 months                 1%                 $236,341                 $314,692                 $568,084
                                         .................                 5%               $1,181,032               $1,570,997               $2,844,160
                                                 24 months                 1%                 $144,063                 $191,041                 $345,471
                                         .................                 5%                 $718,210                 $955,915               $1,728,457
                                                 36 months                 1%                  $61,852                  $82,324                 $149,000
                                         .................                 5%                 $309,262                 $411,618                 $744,275
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dried Vegetables                                 12 months                 1%                 $164,604                 $218,663                 $394,000
                                         .................                 5%                 $822,781               $1,094,153               $1,969,567
                                                 24 months                 1%                  $92,292                 $122,838                 $222,307
                                         .................                 5%                 $461,461                 $614,191               $1,110,562
                                                 36 months                 1%                  $32,092                  $42,713                  $77,233
                                         .................                 5%                 $160,459                 $213,566                 $386,163
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals                                           12 months                 1%                 $807,498               $1,114,355               $1,928,084
                                         .................                 5%               $4,035,846               $5,570,839               $9,645,568
                                                 24 months                 1%                 $432,322                 $593,823               $1,035,778
                                         .................                 5%               $2,160,940               $2,970,201               $5,174,817
                                                 36 months                 1%                 $121,743                 $164,687                 $292,502

[[Page 16299]]

 
                                         .................                 5%                 $608,716                 $823,432               $1,461,781
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Cost estimates include administrative, graphic design, prepress, engraving, analytical testing, market testing, and discarded inventory.
Source: RTI International, ``FDA Labeling Cost Model'' RTI Project 06673.010, March 2003.


                                           Table 2.--Cost Estimates: Irradiation Relabeling, Information Panel
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Percentage of                                  Cost Estimates
             Food Category                   Compliance     Firms Affected by --------------------------------------------------------------------------
                                               Period              Rule                  Low                     Medium                    High
--------------------------------------------------------------------------------------------------------------------------------------------------------
Spices/Seasonings                                12 months                 1%                 $192,245                 $285,335                 $447,000
                                         .................                 5%                 $959,479               $1,426,545               $2,233,436
                                                 24 months                 1%                  $91,101                 $134,964                 $213,209
                                         .................                 5%                 $455,504                 $674,821               $1,065,921
                                                 36 months                 1%                  $12,860                  $19,042                  $30,121
                                         .................                 5%                  $64,298                  $95,208                 $150,605
--------------------------------------------------------------------------------------------------------------------------------------------------------
Shell Eggs                                       12 months                 1%                 $107,773                 $151,940                 $254,488
                                         .................                 5%                 $538,863                 $759,434               $1,273,169
                                                 24 months                 1%                  $65,539                  $92,365                 $154,472
                                         .................                 5%                 $327,694                 $461,827                 $774,240
                                                 36 months                 1%                  $28,221                  $39,773                  $66,678
                                         .................                 5%                 $141,105                 $198,863                 $333,388
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dried Vegetables                                 12 months                 1%                  $76,347                 $107,227                 $178,332
                                         .................                 5%                 $381,735                 $536,134                 $891,881
                                                 24 months                 1%                  $42,110                  $59,346                  $99,492
                                         .................                 5%                 $210,549                 $296,732                 $497,462
                                                 36 months                 1%                  $14,642                  $20,636                  $34,595
                                         .................                 5%                  $73,212                 $103,179                 $172,977
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals                                           12 months                 1%                 $376,365                 $544,502                 $879,820
                                         .................                 5%               $1,880,077               $2,722,113               $4,398,486
                                                 24 months                 1%                 $198,750                 $286,675                 $467,173
                                         .................                 5%                 $993,747               $1,433,380               $2,337,623
                                                 36 months                 1%                  $55,723                  $79,451                 $131,394
                                         .................                 5%                 $278,615                 $397,250