Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Proposed Rules 16291 

airplanes, certificated in any category; serial 

numbers 4001 and 4003 and subsequent. 

Unsafe Condition 

(d) This AD results from reports of fluid 

loss in the No. 2 hydraulic system, causing 

the power transfer unit to overspeed, 

increasing the fluid flow within the No. 1 

hydraulic system. We are issuing this AD to 

prevent possible loss of both the No. 1 and 

No. 2 hydraulic systems, resulting in the 

potential loss of several functions essential 

for safe flight and landing of the airplane. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Airplane Flight Manual (AFM) Revision 

(f) Within 14 days after the effective date 

of this AD, revise the Limitations section of 

the applicable AFM to include the 

information in the applicable Bombardier 

temporary amendment specified in Table 1 of 

this AD, as specified in the temporary 

amendment. These temporary amendments 

introduce procedures for pulling the ‘‘HYD 

PWR XFER’’ circuit breaker in the event of 

the loss of all hydraulic fluid in the No. 1 or 

No. 2 hydraulic system. Operate the airplane 

according to the limitations and procedures 

in the applicable temporary amendment. 

TABLE 1.—AFM TEMPORARY AMENDMENTS

For Model—

Use Bombardier Temporary Amendment—

Issue— Dated—

To Bombardier 

Dash 8 Q400 Airplane Flight Manual—

–400 airplanes ............................................. 13 1 July 14, 2005 .............................................. PSM 1–84–1A. 

–401 airplanes ............................................. 13 1 July 14, 2005 .............................................. PSM 1–84–1A. 

–402 airplanes ............................................. 13 1 July 14, 2005 .............................................. PSM 1–84–1A. 

Note 1: This may be done by inserting a 

copy of the applicable temporary amendment 

into the applicable AFM. When the 

applicable temporary amendment has been 

included in general revisions of the AFM, the 

general revisions may be inserted into the 

AFM, provided the relevant information in 

the general revisions is identical to that in 

the temporary amendment. 

Alternative Methods of Compliance 

(AMOCs) 

(g)(1) The Manager, New York Aircraft 

Certification Office, FAA, has the authority to 

approve AMOCs for this AD, if requested in 

accordance with the procedures found in 14 

CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Related Information 

(h) Canadian airworthiness directive CF–

2006–08, dated April 26, 2006, also addresses 

the subject of this AD. 

Issued in Renton, Washington, on March 

26, 2007. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–6267 Filed 4–3–07; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

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 email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 


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16292 Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Proposed Rules 

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 http:// 

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 http:// 

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 xradiation,’’ ‘‘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 


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1Food refers to conventional foods as well as 

dietary supplements. 

2Currently, we are not aware of any changes to 

the nutritional properties of any food FDA has 

approved for irradiation. 

3The 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. 

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 foods1, 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. 

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 nutritional2, 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. 

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 


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4Now the Government Accountability Office. 

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 § 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 Office4 (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: 

http://a257.g.akamaitech.net/7/257/ 

2422/10apr20061500/ 

edocket.access.gpo.gov/cfr_2006/aprqtr/ 

21cfr179.26.htm. 

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 premarket 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 § 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. 


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Therefore, FDA is proposing to amend 

§ 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 § 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 (§ 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 

§ 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 § 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 § 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 http://www.fsis.usda.gov/ 

OPPDE/rdad/FRPubs/88-026F.pdf; for 

the MOU, see http://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 http:// 

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’’). 


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5Now 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). 

• 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 (§ 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 

Office5 (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 Act6, 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. 

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 (§ 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 


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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

Food Category Compliance 

Period 

Percentage of 

Firms Affected by 

Rule 

Cost Estimates 

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 


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TABLE 1.—COST ESTIMATES: IRRADIATION RELABELING, PRINCIPAL DISPLAY PANEL—Continued 

Food Category Compliance 

Period 

Percentage of 

Firms Affected by 

Rule 

Cost Estimates 

Low Medium High 

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

Food Category Compliance 

Period 

Percentage of 

Firms Affected by 

Rule 

Cost Estimates 

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 $656,970 

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 3A.—COST ESTIMATES: 

STICKER ADMINISTRATIVE COSTS

Number 

of Firms 

Administrative 

Costs 

Printing 

Costs 

Total 

Administrative 

Costs 

1%, or 57 $100 $250 $19,950 

5%, or 

283 

$100 $250 $99,050 

TABLE 3B.—COST ESTIMATES: 

STICKER LABOR COSTS

Pounds 

Per Hour 

Hourly 

Wage 

Hours 

Needed 

Total 

Labor 

Cost 

240 $10.75 6,250 $67,188 

360 $10.75 4,167 $44,792 

480 $10.75 3,125 $33,594 

Option 4: Maintain the current 

labeling requirement, but propose to 

also allow alternate terms to 

‘‘Irradiation’’ (e.g., ‘‘Pasteurized’’) 

The current regulation (§ 179.26(c)) 

states that irradiated food must bear the 

radura logo and the phrase ‘‘Treated 

with radiation’’ or ‘‘Treated by 

irradiation.’’ Currently, no alternate 

terms to irradiation are allowed. This 

option would maintain the requirement 

that irradiated food must be labeled but 

allow the label to contain terms other 

than ‘‘irradiated,’’ such as 

‘‘pasteurized.’’ But the term 

‘‘pasteurized’’ may be used only if the 

process meets the definition as provided 

in section 403(h)(3) of the act. 

Costs: This option generates costs 

because some firms would opt to relabel 

their products, but it is uncertain how 

many firms would do this because this 

option would be voluntary. However, 

firms would only relabel if they thought 

doing so would increase profits. Tables 

1 and 2 contain cost estimates for the 

main food categories that may be 

affected by this option. It is probable 

that firms would select a 24 to 36 month 

compliance period to keep costs down 

by coordinating the relabeling with 

regular labeling changes. 

In the short run, there may be 

increased consumption of irradiated 

food if those consumers who do not 

want irradiated food do not equate the 

alternative term with irradiation. Also, 

confusion could result from the use of 

alternative terms with uncertain 

meanings, causing some consumers to 

increase search costs. Research indicates 

that many consumers regard substitute 

terms for irradiation to be misleading 

(Refs. 2 and 5). In the long run (defined 

here as a time period long enough for 

consumers to adjust to and understand 

the meaning of the alternate terms), 

consumers’ distaste for the term 

‘‘irradiation’’ would extend to alternate 

terms used in labeling, especially if 

there is no additional statement of 

purpose. Once consumers understand 

that the alternate terms all mean 

‘‘irradiation,’’ the result would likely be 


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a return to the baseline number of 

irradiated products and labels. 

Benefits: It is possible that, in the 

short run, consumers will not 

understand that the alternate terms 

mean the same as ‘‘irradiation.’’

However, to the extent that the 

substitution of terms induces consumers 

to buy relabeled food that they may 

have previously avoided and to the 

extent that these products benefit them 

in terms of safety or longer shelf life, 

then consumers will benefit from the 

substitution of terms. In the short run, 

the quantity of irradiated food supplied 

may increase in response to increased 

demand. As previously mentioned, the 

long run outcome may be the same as 

the baseline because, over time, 

consumers will come to understand that 

any alternate terms have the same 

meaning as ‘‘irradiation.’’ Once 

consumers understand that the alternate 

terms have the same meaning as 

‘‘irradiation’’ they may want to 

discontinue consumption of the food, 

resulting in the number of irradiated 

foods returning to the same number as 

before the change in terms. This is a 

result of producers responding to the 

change in demand by reducing the 

quantity of irradiated food supplied. 

Option 5: The Proposed Regulation 

Only those foods treated with 

irradiation, and in which the irradiation 

caused a material change in the food 

such that it would change the 

characteristics of the food in a way that 

is not readily apparent to the consumer 

at the point of purchase must bear: (1) 

The radura logo and (2) the term 

‘‘irradiated’’ or a derivative thereof, 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’’). If a firm chooses to 

use an alternate term to ‘‘irradiation’’

other than ‘‘pasteurized,’’ it must submit 

a petition to the Secretary (FDA). If a 

firm wishes to use the term 

‘‘pasteurized,’’ it must submit a 

notification including effectiveness data 

regarding the process or treatment to the 

Secretary (FDA). 

This option deviates from the current 

regulation (§ 179.26(c)) in two major 

ways. First, this option would require 

irradiation labeling only for food items 

treated with irradiation if irradiation 

causes a material change in the food or 

consequences that may result from use 

of the food. Secondly, this option 

requires explicit language describing the 

material change and allows use of 

alternate terms for irradiation, as long as 

a petition is approved by the agency or, 

in the case where ‘‘pasteurized’’ is used, 

a notification is sent to FDA to which 

the agency does not object. This option 

allows for more labeling flexibility and 

it is possible that the radura logo and 

label statements on some irradiated 

food, as long as the irradiation caused 

no material change, could be removed. 

The number of products that could be 

marketed without irradiation labeling is 

uncertain because labeling requirements 

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, 

i.e., time and dosage, because the effect 

of irradiation on the properties of 

concern depends on the particular food. 

It is more likely that this option would 

simply allow firms more flexibility in 

how they label irradiated food. 

Costs: This proposed rule generates 

costs because it requires firms to relabel 

some irradiated products. As with other 

options, Tables 1 and 2 contain cost 

estimates for relabeling in selected food 

categories. Note that cost estimates take 

into account all relabeling costs, 

including the costs of removing 

irradiation label statements. The 

requirement of a material change could 

reduce the number of products that 

would need to be labeled, so some firms 

would be able to remove current 

irradiation labeling. This rule would 

generate additional costs because, in 

order for a firm to be able to use an 

alternative to the term ‘‘irradiation,’’ a 

firm would have to submit a petition to 

the agency (as addressed in proposed 

§ 179.26(c)(2)(i)). If it is the case that the 

desired alternate term is ‘‘pasteurized,’’

then, instead of submitting a petition, a 

firm must notify the agency and also 

submit effectiveness data on the method 

used in its process (as addressed in 

proposed § 179.26(c)(2)(ii)). Firms are 

not required to use an alternate term. It 

is assumed that a firm would choose to 

use an alternate term only if doing so 

would increase profits. 

Based on previous estimates of the 

cost to prepare a petition or notification, 

FDA is assuming the average cost to 

prepare a petition or notification is $84 

per hour (Ref. 13). The agency estimates 

the total cost of a petition or notification 

as the time needed to prepare the 

notification or petition multiplied by 

$84, the approximate cost associated 

with the person for preparing the 

notification or petition. In the case 

where a firm wants to use the term 

‘‘pasteurized,’’ the agency does not 

assume this rule generates any 

additional cost of gathering 

effectiveness data; that is, presumably 

the firm will already have data on the 

effectiveness of its method, or it would 

not undertake the cost of irradiation. As 

mentioned earlier, it is not known how 

many firms that currently irradiate or 

will irradiate in the future will be 

required to label a product as irradiated, 

and will desire to use an alternative to 

the term ‘‘irradiation.’’ Therefore, the 

cost estimates are based on an estimate 

of the number of firms manufacturing 

foods that are currently approved for 

irradiation choosing to submit a 

notification or petition. 

Table 4 of this document contains the 

initial cost estimates of preparing a 

notification or petition. The number of 

firms is based on the 2002 Census of 

Manufacturers (Refs. 6, 7, and 8). 

According to the Census of 

Manufacturers, there are 275 companies 

that manufacture spices and extracts, 

311 companies that process poultry and 

shell eggs (the Census of Manufacturers 

groups poultry and shell egg processing 

together), and 5,836 firms that process 

fresh fruits and vegetables, for a total of 

6,422 firms. It is possible that 1 percent 

of, or 64 firms in the industry will want 

to use an alternate term and it is 

possible that 5 percent of, or 321 firms 

in the industry will want to use an 

alternate term. The average of this range 

is 193 firms. 

Table 5 of this document presents cost 

estimates of the annual reporting burden 

for additional product notifications or 

petitions after the initial compliance 

period due to, for example, new firms 

entering into the industry. It is assumed 

that one petition to use an alternate term 

other than ‘‘pasteurized’’ will be 

submitted per year. The time estimates 

for both tables 4 and 5 are taken from 

section IV of this document. We 

estimate that the annual notifications 

would be about 10 percent of the initial 

number, that is, 10 percent of 193 (the 

estimate in table 4), or 19 firms. 

TABLE 4.—ESTIMATE OF TOTAL COST OF SUBMITTING NOTIFICATION OR PETITION

21 CFR Section No. of Respondents Total Hours Cost Per Hour Total Cost 

179.26(c)(2)(i) 1 150 $84 $12,600 


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TABLE 4.—ESTIMATE OF TOTAL COST OF SUBMITTING NOTIFICATION OR PETITION—Continued 

21 CFR Section No. of Respondents Total Hours Cost Per Hour Total Cost 

179.26(c)(2)(ii) 193 28,950 $84 $2,431,800 

Total $2,444,400 

TABLE 5.—ESTIMATED ANNUAL COST OF SUBMITTING NOTIFICATION OR PETITION

21 CFR Section No. of Respondents Total Hours Cost Per Hour Total Cost 

179.26(c)(2)(i) 1 150 $84 $12,600 

179.26(c)(2)(ii) 19 2,850 $84 $239,400 

Total $252,000 

If irradiation causes no material 

change in the food, irradiation labeling 

would be removed under this option. 

Removing irradiation labeling could 

cause increases in search costs for 

consumers who desire to avoid 

purchasing irradiated goods and must 

find alternative sources to maintain 

knowledge of producers that irradiate 

their products. 

Some producers may alter their 

products’ labels to use a term other than 

irradiated (e.g. ‘‘pasteurized’’). However, 

it is uncertain how many producers 

would use alternate terms. Again, the 

use of alternative labels would generate 

potential costs because some consumers 

may wish to avoid irradiated products. 

As mentioned before, research indicates 

many consumers regard substitute terms 

for irradiation to be misleading (Refs. 2 

and 5). These individuals would have to 

increase their search efforts in order to 

continue to be informed about approved 

alternate terms to irradiation. We 

request comment on the potential for 

this proposed rule if finalized to 

increase search costs, particularly for 

consumers and retailers who desire nonirradiated foods. 

Benefits: This proposed rule generates 

benefits because it could allow 

consumers to make more informed 

decisions about the food they purchase. 

If the addition of a statement of purpose 

causes people to buy relabeled 

irradiated products that they may have 

previously avoided and if these 

products have, for example, longer shelf 

life or lower risk of illness, then 

consumers will benefit. If, as a result of 

this proposed rule, consumers look 

more favorably on irradiated foods, the 

supply of such foods may increase. If 

retailers are more willing to carry 

relabeled irradiated products, then 

consumers benefit from the added 

opportunity to buy these products. 

As mentioned in the costs section of 

this option, if irradiation causes no 

material change, it is possible that some 

products would no longer have to bear 

the irradiation label statement or the 

radura logo, but it is uncertain how 

many products would fall into this 

category. For producers who voluntarily 

choose the no-label option, private 

benefits exceed private costs, since they 

no longer are required to continue with 

the existing labeling. That is, a firm 

would choose the no-label option if it 

believes doing so will increase profits. 

Reiterating the idea that the supply of 

irradiated food may increase as a result 

of this rule, it is possible that some 

manufacturers not currently using 

irradiation as a safety tool (because of 

the current labeling requirement) may 

opt to start using irradiation in order to 

enhance the safety of their products, if 

there is no material change in the 

product. Again, firms will only start 

using irradiation if they believe doing so 

will increase profits. As already pointed 

out, however, there are potential search 

costs for some customers. 

This analysis also applies to those 

firms who choose alternate terms for 

irradiation. Private benefits will exceed 

private costs for firms that voluntarily 

choose alternate terms for irradiation, 

because they will no longer be required 

to continue using existing labeling. 

These firms will only choose alternate 

terms to irradiation if they believe doing 

so will increase profits. Again, this use 

of alternate terms can result in the 

previously mentioned increase in search 

costs for consumers who desire to avoid 

irradiated goods. 

If the removal of explicit language 

indicating that a food has been 

irradiated causes people to buy 

irradiated products that they previously 

avoided, and if these products have 

lower prices or higher quality, then 

some consumers will benefit from the 

removal of information. Also, if retailers 

are more willing to carry unlabeled 

irradiated products at lower prices, then 

all consumers benefit from the lower 

prices. But it is uncertain that unlabeled 

irradiated products will be offered for 

lower prices than products that are not 

irradiated, because the irradiation 

process itself is not costless. If 

irradiation increases product quality but 

also increases the cost of production, 

then prices of irradiated products could 

be higher than the same non-irradiated 

products, with or without labels. 

C. Summary of Options 

Table 5A of this document 

summarizes the costs and benefits of 

each option analyzed. Costs are given 

based on the assumption that 1 percent 

of firms irradiate and relabel (at the 

medium cost level) using a 2-year 

compliance period if the option requires 

relabeling and a 3-year compliance 

period if relabeling is permitted 

voluntarily. For Option 5, it also 

assumes that 1 percent of firms prepare 

a notification to use the term 

‘‘pasteurized’’ in the first year and 1 

firm petitions to use another alternative 

term in the first year. The range of costs 

represents our uncertainty about the 

need for changes to the principal 

display panel or the information panel 

and the number of pounds of fresh fruits 

and vegetables that can be stickered per 

hour. For Option 5, the quantified costs 

are likely to be less than listed because 

some firms would be able to remove the 

irradiation labeling when it results in no 

material change when it is least costly 

for them to do so and will not need to 

submit notifications or petitions. 


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TABLE 5A.—SUMMARY OF COSTS AND BENEFITS OF OPTIONS

Quantified Costs Unquantified Costs Unquantified Benefits 

Option 1 (baseline) 0 0 0 

Option 2 0 Greatest increase in search costs Most additional labeling flexibility, potentially 

longer shelf-life 

Option 3 $341,000 - $681,000 0 Most additional information for consumers 

Option 4 $133,000 - $252,000 Increased search costs Additional labeling flexibility 

Option 5 (the proposed 

rule) 

Less than $2,785,400 - 

$3,125,400 

Lowest non-zero increase in 

search costs 

Additional information for consumers, Least nonzero additional labeling flexibility 

We request comments on the 

estimates for these options and 

specifically on the following three 

issues: 

1. The number of firms or products 

that would be affected by a new 

irradiation rule. 

2. The number of firms that would 

begin irradiating products as a result of 

the various options described here. 

3. Whether some industry sectors 

should be given more time to comply 

than others to reduce the economic 

impact on them. 

D. Small Entity Analysis 

FDA has examined the economic 

implications of this proposed rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). If a rule has a 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would lessen the economic effect of 

the rule on small entities. It is not 

known how many small firms currently 

irradiate food or will want to irradiate 

food. If small firms are using this 

technology, this proposed rule may have 

a significant economic impact on a 

substantial number of small entities. 

The agency requests comments on how 

this proposed rule will impact small 

firms. 

Under contract, Eastern Research 

Group developed a model framework for 

estimating regulatory impacts on small 

businesses. The model is designed to 

accommodate a variety of potential 

regulatory activities, ranging from 

Hazard Analysis Critical Control Point 

(HACCP) to product labeling. 

Using the 2002 Economic Census and 

other data, the model estimates the cash 

flows of representative establishments 

of varying class sizes of food 

manufacturers. Based on post-regulation 

cash flow and distribution of income for 

each model facility, the model generates 

the percentage of facilities in each 

model class that are vulnerable to 

closure. The model allows the agency to 

(1) Predict the probability and frequency 

of small business failure as a result of 

FDA regulations and (2) estimate the 

effects of various forms of regulatory 

relief on the survival of small businesses 

on a per-establishment basis. 

Cost estimates produced by the FDA 

Labeling Cost Model were used to help 

generate estimates of the average 

relabeling cost for firms in two of the 

four food categories examined here: 

spices/seasonings and dried vegetables. 

The middle estimated costs in each food 

category were divided by the estimated 

affected stockkeeping units (SKUs) in 

each food category to arrive at average 

cost per SKU. Affected SKUs per 

category are then divided by total 

number of firms in each category to 

arrive at average number of affected 

SKUs per firm. The number of firms in 

each food category comes from the 

Ready-to-Eat Food Manufacturing 

Industry category in FDA’s Small 

Business Impact Model (Ref. 9). We use 

these estimates to calculate cost per firm 

using the following formula: 

Cost/Firm = (Average SKUs per firm) 

x (Average Middle Relabeling Cost/ 

SKU) 

This formula allows us to estimate the 

approximate average relabeling costs for 

firms in each food category. Keep in 

mind these are merely estimates and 

cost structures are treated identically 

across firms. That is, we assume that 

costs for small firms are similar to costs 

for large firms. The average relabeling 

costs for compliance periods of 12, 24, 

and 36 months were then entered into 

the Small Business Impact Model to 

estimate the number of firms at risk for 

negative cash flow, assuming all firms 

in each category must relabel. The 

results of these estimates are presented 

in tables 6 and 6A of this document. 

The table is divided into two sections, 

one for estimates if the information 

panel is affected and another for the 

principal display panel. 

TABLE 6.—ESTIMATES OF FIRMS AFFECTED BY THE IRRADIATION RULE—CHANGES IN INFORMATION PANEL

Food 

Category 

Compliance 

Period 

Firms with less than 20 Employees Firms With 20 to 499 Employees Firms With 500+ Employees 

Affected Firms At-Risk Firms1 Affected Firms At-Risk Firms1 Affected Firms At-Risk Firms1

Spices/ 

Seasonings 12 months 139 18 133 0 2 0 

24 months 139 7 133 0 2 0 

36 months 139 1 133 0 2 0 

Dried Vegetables 12 months 23 8 25 0 1 0 

24 months 23 3 25 0 1 0 

36 months 23 2 25 0 1 0 

1 Note: An ‘‘at-risk’’ firm is one that could potentially suffer from negative cash flow as a result of this proposed rule. 


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TABLE 6A.—ESTIMATES OF FIRMS AFFECTED BY THE IRRADIATION RULE—CHANGES IN PRINCIPAL DISPLAY PANEL

Food 

Category 

Compliance 

Period 

Firms with less than 20 Employees Firms With 20 to 499 Employees Firms With 500+ Employees 

Affected Firms At-Risk Firms1 Affected Firms At-Risk Firms1 Affected Firms At-Risk Firms1

Spices/ 

Seasonings 12 months 139 39 133 1 2 0 

24 months 139 11 133 0 2 0 

36 months 139 2 133 0 2 0 

Dried Vegetables 12 months 23 8 25 0 1 0 

24 months 23 8 25 0 1 0 

36 months 23 3 25 0 1 0 

1 Note: An ‘‘at-risk’’ firm is one that could potentially suffer from negative cash flow as a result of this proposed rule. 

The numbers of at-risk firms in the 

table are estimates generated by the 

model. These estimates are not based on 

specific data about the number of small 

firms affected, because there are no data 

available; however, they illustrate the 

idea that small firms, especially firms 

with fewer than 20 employees, could 

potentially be adversely affected by this 

proposed rule. For example, in the dried 

vegetable category, for a compliance 

period of 12 months, if as the model 

estimates, 23 firms would be affected, 

approximately 8 of these firms (or 

around 35 percent) would be at risk for 

negative cash flow as a result of this 

rule. However, for firms with less than 

20 employees, the number of at risk 

firms decreases as the length of the 

compliance period increases. As 

illustrated in tables 1 and 2, when 

compliance periods increase, costs 

decrease because firms can coordinate 

new changes in food labels with 

already-scheduled changes in labels. By 

contrast, the model generates no at-risk 

firms among firms with 500+ 

employees, regardless of the compliance 

period. This result is important because 

the industry is characterized by a large 

number of small entities. The most 

effective regulatory relief for small firms 

would be extended compliance periods. 

As shown in tables 6 and 6A, as the 

compliance period increases from 12 to 

36 months, the number of small firms 

at-risk virtually disappears. 

Firms producing shell eggs are not 

included in the Ready-to-Eat 

Application of the Small Business 

Impact Model because eggs are not 

considered ready to eat. Therefore, it is 

not possible to estimate the number of 

at-risk firms. Nonetheless, small firms 

producing shell eggs must still be 

addressed in this analysis. According to 

the 2002 Census of Manufacturers (Ref. 

6), there are 311 companies that process 

poultry and shell eggs. Of this number, 

about 25 percent, or 79 firms have 20 

employees or less. Again, it is not 

known how many processors irradiate 

or will want to irradiate as a result of 

this rule. Therefore, we will assume this 

rule could affect 1 percent, or 

approximately 1 firm. 

Firms processing fresh fruits and 

vegetables are also not included in the 

Small Business Impact Model. Again, it 

is not possible to estimate the number 

of at-risk firms. According to the 2002 

Census of Manufacturers, there are 

5,836 firms that process fresh fruit and 

vegetables. Because firm size for firms 

that process fresh fruits and vegetables 

is not yet available for the 2002 Census 

of Manufacturers, we use data from the 

1997 Census of Manufacturers that 93 

percent of these firms are single unit 

firms. Therefore, we estimate that there 

are 5,427 single unit firms that process 

fresh fruit and vegetables. As with the 

other food categories, it is not known 

how many of these firms irradiate or 

will want to irradiate as a result of this 

rule. Therefore, we will assume this rule 

could affect 1 percent, or approximately 

54 firms. The agency requests comments 

on the number of small shell egg 

producers and fresh fruit and vegetable 

producers that could be affected by this 

rule. 

The effects on small businesses 

depend also on whether the labeling 

change is required or voluntary. If, for 

example, the labeling change is to allow 

an alternate term, or to remove the 

current label, the small business would 

do so only if it did not impose a burden. 

For required labeling changes, however, 

the labeling costs could indeed put 

additional firms at risk of going out of 

business. The length of the compliance 

period for labeling requirements is the 

most important variable affecting the 

burden. The other important factor is 

how much of the label needs 

redesigning. If the labeling change is 

similar to a change in the information 

panel, and if small businesses are given 

at least 36 months to comply, few will 

be at risk. 

The agency requests comments on the 

likely effect on small firms as a result of 

this proposed rule, and on the effects of 

longer compliance periods for these 

firms. 

E. Unfunded Mandates Reform Act of 

1995 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4) requires that agencies 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes any Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $122 million, 

using the most current (2005) Implicit 

Price Deflator for the Gross Domestic 

Product. FDA does not expect this 

proposed rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

Paperwork Reduction Act of 1995 (the 

PRA) (44 U.S.C. 3501–3520). A 

description of these provisions is given 

below with an estimate of the reporting 

burden. Included in the estimate is the 

time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the 

information and data needed and 

completing and reviewing each 

collection of information. 

Title: Notice Concerning the 

Submission of Information to Use an 

Alternative to ‘‘Irradiation’’

Description: In this proposed rule, 

FDA is proposing to require the 

submission to the agency of data and 

information regarding the use of 

alternate terms to the word ‘‘irradiated’’

in foods that have been treated by 

irradiation using radioactive isotope, 


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electronic beam, or x-ray. FDA is 

proposing that an alternate term may be 

used in lieu of ‘‘irradiated’’ if its use is 

approved in response to a petition that 

has been submitted to FDA. If the 

desired alternate term is ‘‘pasteurized,’’

a notification must be sent to the 

Secretary (FDA) that includes 

effectiveness data to show that the 

process or treatment meets the 

requirements of section 403(h)(3) of the 

act. 

Description of Respondents: 

Manufacturers that irradiate food and 

desire to use an alternate term to 

‘‘irradiation.’’

FDA estimates the burden of this 

collection of information as follows: 

TABLE 7.—ESTIMATED ONE-TIME REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Frequency 

of Response Total Responses 

Hours Per 

Response Total Hours 

179.26(c)(2)(i) 1 1 1 150 150 

179.26(c)(2)(ii) 193 1 193 150 28,950 

Total 29,100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 8.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Frequency 

of Response Total Responses Hours Per Response Total Hours 

179.26(c)(2)(i) 1 1 1 150 150 

179.26(c)(2)(ii) 19 1 19 150 2,850 

Total 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Tables 7 and 8 of this document 

describe the reporting burden as a result 

of the provisions set forth in this 

proposed rule. Table 7 shows the 

estimated one time reporting burden 

after the regulation initially goes into 

effect. Table 8 shows the estimated 

annual reporting burden, perhaps due to 

firms entering into the industry and/or 

currently existing firms deciding to 

irradiate at a later date. The agency does 

not know how many firms will submit 

a notification or a petition to the agency 

to use an alternate to the term 

‘‘irradiation.’’ It is also not known how 

many firms currently irradiate food they 

manufacture, although it is known that 

the amount of food irradiated each year 

is very small and there is only one 

facility that can irradiate food. However, 

it is assumed that most firms wishing to 

use an alternate term will choose to use 

‘‘pasteurized’’ and submit a notification 

to FDA along with effectiveness data. It 

is also assumed that one firm per year 

will submit a petition to use an alternate 

term other than ‘‘pasteurized’’ as shown 

in the row corresponding to proposed 

§ 179.26(c)(2)(i) in table 7. Proposed 

§ 179.26(c)(2)(ii) addresses notifications. 

The number of firms is based on the 

2002 Census of Manufacturers (Refs. 6, 

7, and 8). According to the Census of 

Manufacturers, there are 275 companies 

that manufacture spices and extracts, 

311 companies that process poultry and 

shell eggs (the Census of Manufacturers 

groups poultry and shell egg processing 

together), and 5,836 firms that process 

fresh fruits and vegetables, for a total of 

6,422 firms. Table 7 shows the number 

of respondents presented as an average, 

based on percentages of total firms that 

process shell eggs, spices, and fruits and 

vegetables, the three categories of FDAregulated foods that are currently 

approved for irradiation. It is possible 

that 1 percent of, or 64 firms in the 

industry will want to use an alternate 

term and it is possible that 5 percent of, 

or 321 firms in the industry will want 

to use an alternate term. The average of 

this range is 193 firms. Submission of 

the notification is voluntary because the 

proposed rule does not require all firms 

to submit notifications, only those firms 

that will be required to label a product 

as ‘‘irradiated’’ and desire use of an 

alternative to the term ‘‘irradiation’’. 

Therefore, it is assumed that there will 

be no annual reporting burden for this 

rule for products that have already 

submitted notifications. 

Based on previous estimations of 

preparing notifications and preparing 

petitions, FDA is estimating that the 

time needed to prepare a notification is 

150 hours. The agency already has a 

process for submitting citizen petitions, 

the burden of which is reported and 

approved under § 10.30. However, given 

some of the controversy surrounding 

irradiation and the use of alternative 

terms to irradiation, we expect more 

documentation and more hours spent on 

these petitions associated with 

irradiation labeling. Therefore, the 

agency is assuming submitting a 

petition will take a total of 190 hours. 

It is estimated that 40 of these hours are 

specific to the citizen petition process 

reported under § 10.30, with an 

additional 150 hours specific to the 

issues associated with irradiation 

labeling. It is this additional burden that 

is reported in table 7. 

The annual burden following the 

initial round of submissions would 

consist of submissions for additional 

products, perhaps as a result of market 

entry. This burden is shown in table 8. 

Again, we also assume that, each year, 

one firm will petition the agency to use 

an alternate term other than 

‘‘pasteurized,’’ in response to proposed 

§ 179.26(c)(2)(i). We do not know how 

many additional firms will submit 

notifications in response to proposed 

§ 179.26(c)(2)(ii) each year, so table 8 

assumes the number of additional firms 

will be 10 percent of the firms reported 

in table 7. We also assume that there 

will not be an additional recordkeeping 

burden associated with this rule, as it is 

assumed that firms already have the 

effectiveness data required by the 

agency for inclusion in the notification. 

In compliance with the PRA (44 

U.S.C. 3507(d)), the agency has 

submitted the information collection 

provisions of this proposed rule to OMB 

for review. Interested persons are 

requested to submit comments regarding 


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Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Proposed Rules 16305 

information collection to OMB (see 

ADDRESSES). 

V. Analysis of Environmental Impact 

The agency has determined under 21 

CFR 25.30(k) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environment assessment nor 

an environmental impact statement is 

required. 

VI. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency tentatively concludes that the 

proposed rule does not contain policies 

that have federalism implications as 

defined in the order and, consequently, 

a federalism summary impact statement 

is not required. 

VII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site address, but we are not 

responsible for subsequent changes to 

the Web site after this document is 

published in the Federal Register.) 

1. Conference Report on S. 830, Food and 

Drug Administration Modernization Act of 

1997, 143 Cong. Rec. H10452, 10477, 

(November 9, 1997). 

1a. Prakash, Anuradha and Denise Foley, 

‘‘Improving Safety and Extending Shelf Life 

of Fresh-Cut Fruits and Vegetables Using 

Irradiation in Irradiation of Food and 

Packaging; Recent Developments,’’ ACS 

Symposium Series 875, V. Komolprasert and 

K. Morehouse editors, American Chemical 

Society, Washington, DC 2004. 

1b. Kader, Adel A., ‘‘Potential Applications 

of Ionizing Radiation in Postharvest Handling 

of Fresh Fruits and Vegetables,’’ Food 

Technology, 117–121, June 1986. 

2. ORC Macro, ‘‘Consumers’ Understanding 

of Food Irradiation Labeling,’’ Focus Group 

Report, December 2001. 

3. Schutz, Howard G., Christine M. Bruhn 

and Katherine V. Diaz-Knauf, ‘‘Consumer 

Attitude Toward Irradiated Foods: Effects of 

Labeling and Benefits Information,’’ Food 

Technology 43, (October 1989): 80–86. 

4. Fox, John A., Dermot J. Hayes, Jason F. 

Shogren, ‘‘Consumer Preferences for Food 

Irradiation: How Favorable and Unfavorable 

Descriptions Affect Preferences for Irradiated 

Pork in Experimental Auctions,’’ The Journal 

of Risk and Uncertainty, 24:1 (2002): 75–95. 

5. Cates, Sheryl C., et al., ‘‘Consumer 

Research on Food Safety Labeling Features 

for the Development of Responsive Labeling 

Policy,’’ RTI, March 22, 2002. 

6. ‘‘United States Census Bureau, Poultry 

Processing: 2002 Economic Census 

Manufacturing Industry Series,’’ available 

from http://www.census.gov/prod/ec02/ 

ec0231i311615.pdf (accessed October 20, 

2006). 

7. ‘‘United States Census Bureau, Spice 

and Extract Manufacturing: 2002 Economic 

Census Manufacturing Industry Series,’’

available from http://www.census.gov/prod/ 

ec02/ec0231i311942t.pdf (accessed October 

20, 2006). 

8. ‘‘United States Census Bureau, 

Comparative Statistics: 2002 Economic 

Census Manufacturing Industry Series,’’ p. 9, 

available from http://0- 

www.census.gov.mill1.sjlibrary.org/prod/ 

ec02/ec0200ccomp.pdf (accessed October 20, 

2006). 

8a. Private Industry by State and 6-Digit 

NAICS Industry: Establishments, 

Employment, and Wages, 2004 Annual 

Averages, http://www.bls.gov/cew/ 

ew04sector11.pdf, December 30, 2005. 

9. Eastern Research Group, Inc., ‘‘Model for 

Estimating the Impacts of Regulatory Costs 

on The Survival of Small Businesses and its 

Application to Four FDA-Regulated 

Industries,’’ Contract No. 223–01–2461, June 

7, 2002. 

10. General Accounting Office, ‘‘Food 

Irradiation: Available Research Indicates 

That Benefits Outweigh Risks,’’ GAO/RCED–

00–217, August, 2000. 

11. RTI International, ‘‘FDA Labeling Cost 

Model,’’ RTI Project Number 06673.010, 

January 2003. 

12. Office of Management and Budget, 

‘‘GDP and Deflators Used in the U.S.,’’

Budget of the United States Government 

Fiscal Year 2004, Historical Table 10.1, 2003. 

13. U.S. Food and Drug Administration, 

Substances Generally Recognized as Safe: 

Notification Procedure, OMB No. 0910–0342, 

Supporting Statement available from http:// 

www.fda.gov/OHRMS/DOCKETS/98fr/05n0457-ss00001.pdf. 

List of Subjects in 21 CFR Part 179 

Food additives, Food labeling, Food 

packaging, Radiation protection, 

Reporting and recordkeeping 

requirements, Signs and symbols. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 179 be amended as follows: 

PART 179—IRRADIATION IN THE 

PRODUCTION, PROCESSING AND 

HANDLING OF FOOD 

1. The authority citation for 21 CFR 

part 179 continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 343, 348, 

373, 374. 

2. Section 179.26 is amended by 

revising paragraph (c)(1); by 

redesignating paragraphs (c)(2) and 

(c)(3) as paragraphs (c)(3) and (c)(4), 

respectively; by revising newly 

redesignated paragraph (c)(3); and by 

adding new paragraph (c)(2) to read as 

follows: 

§ 179.26 Ionizing radiation for the 

treatment of food. 

* * * * * 

(c) Labeling. (1) The label and labeling 

of a retail package of a food irradiated 

in conformance with paragraph (b) of 

this section that has, as a result of the 

irradiation, undergone a material change 

in the characteristics of the food or in 

its consequences of use shall bear the 

following logo along with 

the statement ‘‘irradiated,’’ or any 

derivatives of the term ‘‘irradiated’’ (e.g., 

‘‘irradiation,’’ ‘‘irradiate,’’ ‘‘radiation,’’

etc.) or an alternate term as provided in 

paragraph (c)(2) of this section, in 

conjunction with language describing 

the material change in the 

characteristics of the food or its use. The 

logo shall be placed prominently and 

conspicuously in conjunction with the 

required statement. The radiation 

disclosure statement is not required to 

be more prominent than the declaration 

of ingredients required under § 101.4 of 

this chapter. As used in this provision, 

the term ‘‘radiation disclosure 

statement’’ means a written statement 

that discloses that a food has been 

intentionally subjected to irradiation 

and identifies the material change in the 

characteristics of the food or the 

consequences that may result from its 

use as a result of the irradiation. 

(2) An alternate 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 in lieu of ‘‘irradiated,’’ or any 

of its derivatives, if its use is approved 

in response to a petition that has been 

submitted to FDA using the procedures 

under § 10.30 of this chapter for 

approval of the alternate term, or, if use 

of the term ‘‘pasteurized’’ is permissible 


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16306 Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Proposed Rules 

under the requirements in paragraph 

(c)(2)(ii) of this section. The petition 

should include all relevant information 

and views on which the petitioner 

relies, including any data, e.g., 

qualitative or quantitative consumer 

research, that show consumer 

understanding of the purpose and intent 

of the alternative labeling. 

(ii) The term ‘‘pasteurized’’ may be 

used in lieu of ‘‘irradiated’’ or any of its 

derivatives if the irradiation process is: 

(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; 

(C) Effective for a period that is least 

as long as the shelf life of the food when 

stored under normal and moderate 

abuse conditions; and 

(D) The subject of a notification to the 

Secretary of Health and Human Services 

(the Secretary) that includes 

effectiveness data regarding the process 

or treatment and the Secretary has not 

made a determination in 120 days after 

the receipt of the notification that the 

process or treatment involved has not 

been shown to meet the requirements 

provided in paragraph (c)(2)(ii)(A), (B), 

and (C) of this section. 

(3) For an irradiated food not in 

packaged form that has, as a result of the 

irradiation, undergone a material change 

in its characteristics or conditions of 

use, the required logo and the following 

disclosure statements, ‘‘irradiated,’’ or 

any of its derivatives, or an alternate 

term as provided in paragraph (c)(2) of 

this section in conjunction with 

language describing the material change 

in the characteristics of the food or 

conditions of use as a result of the 

irradiation, shall be displayed to the 

purchaser with either of the following: 

(i) The labeling of the bulk container 

plainly in view or 

(ii) A counter sign, card, or other 

appropriate device bearing the 

information that the product has been 

treated with radiation. As an alternative, 

each item of food may be individually 

labeled. In either case, the information 

must be prominently and conspicuously 

displayed to purchasers. The labeling 

requirement applies only to a food that 

has been irradiated, not to a food that 

merely contains an irradiated ingredient 

but that has not itself been irradiated. 

* * * * * 

Dated: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1636 Filed 4–3–07; 8:45 am] 

BILLING CODE 4160–01–S 

LIBRARY OF CONGRESS 

Copyright Office 

37 CFR Part 202 

[Docket No. RM 2007–3] 

Registration of Claims to Copyright—

Renewals 

AGENCY: Copyright Office, Library of 

Congress. 

ACTION: Notice of Proposed Rulemaking. 

SUMMARY: The Copyright Office is 

proposing to amend its regulations 

governing applications for registration 

of claims to the renewal term of 

copyright. This notice seeks public 

comment on the proposed amended 

regulations, which will take into 

account the fact that, since January 1, 

2006, all applications for renewal have 

necessarily related to works which are 

subject to automatic renewal and, thus, 

are already in their renewal terms, 

making impossible any 28th– year 

registration of claims to the renewal 

term. 

DATES: Comments are due May 4, 2007. 

ADDRESSES: If hand delivered by a 

private party, an original and five copies 

of a comment or reply comment should 

be brought to Library of Congress, U.S. 

Copyright Office, 2221 S. Clark Street, 

11th Floor, Arlington, VA. 22202, 

between 8:30 a.m. and 5 p.m. The 

envelope should be addressed as 

follows: Office of the General Counsel, 

U.S. Copyright Office. If delivered by a 

commercial courier, an original and five 

copies of a comment or reply comment 

must be delivered to the Congressional 

Courier Acceptance Site (‘‘CCAS’’) 

located at 2nd and D Streets, NE, 

Washington, DC between 8:30 a.m. and 

4 p.m. The envelope should be 

addressed as follows: Office of the 

General Counsel, U.S. Copyright Office, 

LM–401, James Madison Building, 101 

Independence Avenue, SE, Washington, 

DC. Please note that CCAS will not 

accept delivery by means of overnight 

delivery services such as Federal 

Express, United Parcel Service or DHL. 

If sent by mail (including overnight 

delivery using U.S. Postal Service 

Express Mail), an original and five 

copies of a comment or reply comment 

should be addressed to U.S. Copyright 

Office, Copyright GC/I&R, P.O. Box 

70400, Southwest Station, Washington, 

DC 20024. 

FOR FURTHER INFORMATION CONTACT: 

Nanette Petruzzelli, Special Legal 

Advisor for Reengineering, P.O. Box 

70400, Washington, DC 20024–0400. 

Telephone: 202–707–8350. Telefax: 

202–707–8366. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The 1976 Copyright Act, 17 U.S.C. 

101, et. seq., carried over provisions for 

the continued protection of certain 

works first published or registered for 

copyright under the 1909 Copyright Act. 

Reenacting and preserving the 

provisions of section 24 of the 1909 law 

for all works which were then in their 

first term of copyright protection, 

Section 304(a) of Title 17 as originally 

enacted in 1976 provided that renewal 

registration had to be made during the 

28th year of the original term of 

copyright in order to secure the 

additional (then 47) years of renewal–

term protection. 17 U.S.C. 304(a) (1976). 

In 1992, Congress enacted a revision 

of section 304(a) of Title 17 which made 

renewal copyright automatic for works 

first published or registered from 

January 1, 1964, through December 31, 

1977. This amendment allowed the 

renewal right to vest without 

registration of: [a] the claim to copyright 

during the original, 28–year term; or, [b] 

the claim to renewal copyright during 

the year immediately prior to the 

beginning of the renewal term (i.e., 

during the 28th year); or, [c] the claim 

to renewal copyright during the renewal 

term. Pub. L. No. 102–307, 106 Stat. 

264, enacted June 26, 1992. In order to 

encourage renewal registration and 

provide a public record of renewal 

rights, however, Congress also amended 

section 304(a) to provide certain 

benefits to a party who undertook the 

renewal registration within the 28th 

year of the original term of copyright. 

These benefits for works with timely 

renewal registrations include: 

1. A certificate of registration 

constitutes prima facie evidence as to 

the validity of the copyright during its 

renewal term and of the facts stated in 

the certificate. 17 U.S.C. 304(a)(4)(B). 

2. A derivative work prepared under 

the authority of a grant of a transfer or 

license of copyright in a work made 

before the expiration of the original term 

of copyright may not continue to be 

used under the terms of the grant during 

the renewal term without the authority 

of the owner of the renewal copyright. 

17 U.S.C. 304(a)(4)(A). 

3. A renewal copyright vests upon the 

beginning of the renewal term in the 


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