46302 Federal Register / Vol. 73, No. 154 / Friday, August 8, 2008 / Notices 

We also require three new collections 

which are the primary focus of this 

supporting statement. First, we have 

added new § 489.20(u)(2) to require a 

hospital to require all physicians who 

are members of the hospital’s medical 

staff to agree, as a condition of 

continued medical staff membership or 

admitting privileges, to disclose in 

writing to all patients they refer to the 

hospital any ownership or investment 

interest in the hospital held by 

themselves or by an immediate family 

member. The burden associated with 

this requirement is two-fold and 

pertains to both hospitals and 

physicians. First, hospitals are required 

to update by-laws and policies and 

procedures to reflect that as a condition 

of medical staff membership or 

admitting privileges, physicians must 

agree to disclose ownership or 

investment interests to patient. In 

addition, physicians are required to 

develop disclosure notices, distribute 

them to patients and maintain these 

disclosures in the patients’ medical 

records. 

Finally, we are including new 

language under § 489.20(v) to provide 

for an exception to the disclosure 

requirements for a physician-owned 

hospital that does not have at least one 

referring physician who has an 

ownership or investment interest in the 

hospital (or who has an immediate 

family member with an ownership or 

investment interest in the hospital), 

provided that the hospital attests, in 

writing, to that effect and maintains 

such attestation in its files. The burden 

associated with this requirement is 

limited to those physician-owned 

hospitals that do not have physician 

owners who refer patients to the 

hospital. 

The intent of the disclosures is to 

increase the transparency of the 

hospital’s ownership and operations to 

patients as they make decisions about 

receiving care at the hospital. 

Frequency: Reporting—Occasionally; 

Affected Public: Business or other forprofit; Number of Respondents: 2,697; 

Total Annual Responses: 49,735,828; 

Total Annual Hours: 840,318. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786–

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on September 8, 2008. 

OMB Human Resources and Housing 

Branch, Attention: OMB Desk Officer, 

New Executive Office Building, Room 

10235, Washington, DC 20503, Fax 

Number: (202) 395–6974. 

Dated: July 31, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–18361 Filed 8–7–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0429] 

Food Labeling; Current Trends in the 

Use of Allergen Advisory Labeling: Its 

Use, Effectiveness, and Consumer 

Perception; Public Hearing; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing on the use of advisory 

labeling of allergens in foods. FDA is 

developing a long-term strategy to assist 

manufacturers in using allergen 

advisory labeling that is truthful and not 

misleading, conveys a clear and uniform 

message, and adequately informs foodallergic consumers and their caregivers. 

To that end, FDA is soliciting comments 

and information to assist the agency in 

determining how manufacturers 

currently use advisory labeling, how 

consumers interpret different advisory 

labeling statements, and what wording 

is likely to be most effective in 

communicating to consumers the 

likelihood that an allergen may be 

present in a food. The agency is also 

interested in receiving comments about 

whether consumers find advisory 

labeling helpful for making food 

purchasing decisions. This public 

hearing is the first step in closing 

existing knowledge gaps in developing 

our long-term strategy. 

DATES: The public hearing will be held 

on September 16, 2008, from 9 a.m. to 

4:30 p.m. The closing date for 

registration is September 8, 2008. See 

section V of this document for other 

dates associated with participation in 

the hearing. Submit written or 

electronic comments (i.e., submissions 

other than notices of participation and 

written material associated with an oral 

presentation) by January 14, 2009. The 

administrative record of the hearing will 

remain open until January 14, 2009. 

ADDRESSES: Public hearing. The public 

hearing will be held at the Harvey W. 

Wiley Federal Building, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, (Metro stop: College Park on the 

Green Line). 

Registration. Submit electronic 

notices of participation for the hearing 

to http://www.cfsan.fda.gov/ 

register.html. We encourage you to use 

this method of registration, if possible. 

Submit written notices of participation 

by mail, fax, or e-mail to Isabelle Howes, 

U.S. Department of Agriculture 

Graduate School, 600 Maryland Ave., 

SW., suite 330, Washington, DC 20024–

2520, FAX: 202–479–6801, or e-mail: 

Isabelle_Howes@grad.usda.gov. You 

may also submit oral notices of 

participation by phone to Isabelle 

Howes, U.S. Department of Agriculture 

Graduate School (see FOR FURTHER

INFORMATION CONTACT). 

Written material associated with an 

oral presentation. Submit written 

material associated with an oral 

presentation by mail, fax, or e-mail to 

Isabelle Howes. 

Comments. Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. For additional 

information on submitting comments, 

see section VI in this document. 

FOR FURTHER INFORMATION CONTACT: 

For questions about registration or 

written material associated with an 

oral presentation, or to register 

orally: Isabelle Howes, 202–314–

4713. 

For all other questions about the 

hearing or if you need parking or 

special accommodations due to a 

disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Food allergies affect approximately 

two percent of adults and about five 


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1The purpose of advisory labeling is generally to 

alert food-allergic consumers to the possibility of 

allergen cross-contact. Although these labels vary 

by content, common formulations include ‘‘This 

product was processed on machinery used to 

process (allergen)’’ and ‘‘May contain (allergen).’’

While this document uses, where appropriate, the 

term ‘‘advisory labeling,’’ FDA considers the term 

‘‘advisory labeling’’ to be synonymous with 

‘‘precautionary labeling,’’ a term sometimes used to 

describe these circumstances. 

2Cross-contact occurs when a residue or other 

trace amount of a food allergen is present on a food 

contact surface or production machinery, or is airborne, and unintentionally becomes incorporated 

into a product not intended to contain the allergen. 

Cross-contact may also result from customary 

methods of growing and harvesting crops, as well 

as from the use of shared storage, transportation, or 

production equipment. FDA considers the term 

‘‘cross-contact’’ to be synonymous with ‘‘crosscontamination,’’ a term sometimes used to describe 

these circumstances. 

3As a verb, ‘‘rework’’ refers to the practice of 

reintroducing food product material that has been 

through some or all of the manufacturing process 

into an earlier stage of the production process of a 

subsequently produced food product. As a noun or 

adjective, ‘‘rework’’ refers to the food product 

material that is reintroduced into the production 

process. 

percent of infants and young children in 

the United States. Currently, there is no 

cure for food allergies. The only 

successful method to manage food 

allergies is avoidance of foods 

containing allergens. Consumers can 

attempt to avoid food substances to 

which they are allergic by reading 

ingredient labels to see whether a food 

product contains an allergenic 

ingredient. However, allergenic 

substances may be inadvertently 

incorporated into food products that are 

not formulated to contain these 

substances; consequently, their presence 

is not required to be declared on food 

labels. FDA is concerned with food 

allergens, including food allergens 

inadvertently incorporated into 

manufactured foods, due to the number 

of reports concerning consumers who 

have experienced adverse reactions 

following exposure to an allergenic 

substance in a food. This concern has 

prompted several agency actions 

targeting food manufacturers, including: 

(1) Issuing a notice to manufacturers 

entitled ‘‘Label Declaration of Allergenic 

Substances in Foods’’ in 1996 (Ref. 1); 

(2) forming an FDA/state partnership in 

1998 to increase industry’s 

understanding of food allergens and to 

identify effective manufacturing 

controls; and (3) issuing a food allergen 

guidance document in 2001 (Ref. 2). 

Information on these initiatives is 

available at the FDA Web site on 

allergens at http://www.cfsan.fda.gov/ 

~dms/wh-alrgy.html. 

FDA stated in the 1996 notice to 

manufacturers that it is aware that some 

manufacturers are voluntarily labeling 

their products with statements such as 

‘‘may contain (allergen).’’ FDA advised 

that, because adhering to current good 

manufacturing practices (CGMPs) is 

essential for effective reduction of 

adverse allergic reactions, advisory 

labeling1 should not be used in lieu of 

adherence to CGMPs. The agency urged 

food manufacturers to take all steps 

necessary to eliminate cross-contact2

and to ensure the absence of allergens 

in their finished food products. In 

addition, FDA encouraged 

manufacturers to declare voluntarily 

any allergenic ingredient of a flavor, 

spice, or color by identifying the 

allergenic ingredient in the ingredient 

list. 

A. Food Allergen Labeling and 

Consumer Protection Act of 2004 

On August 2, 2004, the United States 

Congress enacted the Food Allergen 

Labeling and Consumer Protection Act 

of 2004 (FALCPA) (Title II of Public 

Law No. 108–282). FALCPA amended 

the Federal Food, Drug, and Cosmetic 

Act (the act) by imposing new labeling 

requirements on packaged foods that 

contain ‘‘major food allergens.’’ Section 

201(qq) of the act (21 U.S.C. 321(qq)) 

defines ‘‘major food allergen’’ as milk, 

eggs, fish, Crustacean shellfish, tree 

nuts, wheat, peanuts, and soybeans or 

any other ingredient that contains 

protein derived from one of these foods 

or food groups. FALCPA requires that 

the labels of foods that contain an 

ingredient that is a major food allergen 

declare this ingredient in one of two 

ways: (1) By including the name of the 

food source from which the allergen is 

derived in parentheses following the 

common or usual name of the major 

food allergen in the list of ingredients in 

instances when the name of the food 

source of the major food allergen does 

not appear elsewhere in the ingredient 

statement or is not used in the common 

or usual name of the ingredient, or (2) 

by placing the word ‘‘Contains’’

followed by the name of the food source 

from which the major food allergen is 

derived immediately after or adjacent to 

the list of ingredients. 

These allergen labeling requirements 

assist consumers in avoiding substances 

to which they are allergic. However, as 

previously discussed in this section, 

allergenic substances may be 

inadvertently incorporated into food 

products that are not formulated to 

contain them. FALCPA does not require 

the use of advisory labeling, including 

statements describing the potential 

presence of unintentional ingredients in 

food products resulting from the food 

manufacturing process. 

B. Information Available to FDA 

Regarding Advisory Labeling 

FDA has gathered information on 

advisory labeling by conducting its own 

consumer research and reviewing other 

published consumer research. 

Additionally, the agency investigated 

cross-contact that occurs during 

manufacturing and examined 

manufacturers’ use of advisory labeling 

to alert consumers to the possibility that 

a food may contain allergens. The 

information FDA has collected provides 

insight into the types of advisory 

statements currently used by 

manufacturers and the reasons 

manufacturers use advisory labeling. 

Furthermore, the consumer research 

provides an understanding as to how 

consumers perceive particular advisory 

statements and what wording 

consumers prefer and find credible. 

FDA’s findings are summarized as 

follows: 

1. Cross-Contact and Use of Advisory 

Labeling 

FDA has found that unintentional 

cross-contact of foods with major food 

allergens may occur at almost any step 

of the manufacturing process and for 

various reasons (Ref. 3). Cross-contact 

can occur due to allergens in raw 

ingredients or in processing aids, 

allergens in reworked product,3 and 

allergen carry-over from the use of 

shared equipment. Such potential 

sources of unintentional allergen crosscontact exist regardless of the 

manufacturer’s size or food product. 

Many food manufacturers have allergencontrol measures in place, such as the 

use of dedicated facilities or dedicated 

production lines, to prevent the crosscontact of major food allergens with 

their products. Manufacturers also use a 

variety of advisory statements on 

package labels, such as, ‘‘May contain 

(allergen),’’ ‘‘Produced in a plant that 

processes (allergen),’’ ‘‘Produced on 

shared equipment that processes 

(allergen),’’ and ‘‘Processed on 

equipment that also processes 

(allergen).’’ These manufacturers use 

advisory labeling for a variety of 

reasons, such as to advise consumers of 

the potential presence of an allergen, to 

avoid the need to develop and use 

multiple labels, or to reduce legal 

liabilities. 

2. Consumer Studies 

FDA surveyed food-allergic adults or 

their caregivers and non-food-allergic 

adults to learn which of the following 

food-allergen advisory statements they 

preferred (Ref. 4): 


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4 It is important to keep in mind that these two 

consumer research studies focused on the presence 

of peanuts. Peanut allergy can produce severe 

allergic responses, and even those not affected by 

peanut allergy appear to be aware that peanut 

allergy is serious for those with the allergy. The 

research results may have been different had a food 

allergen other than peanut been the subject of the 

advisory statements. 

(1) ‘‘Allergy Information: May contain 

peanuts.’’

(2) ‘‘May Contain Peanuts.’’

(3) ‘‘Manufactured on the same 

equipment as foods that contain 

peanut.’’

(4) ‘‘Produced in a facility with an 

allergy control plan. The possibility of 

contact with allergenic ingredients has 

been minimized. May still contain trace 

amount of peanut.’’

Survey participants preferred the 

statement ‘‘Allergy Information: May 

contain peanuts’’ over the other three 

statements. This finding is similar to 

other research that shows that people 

prefer warning information that is 

preceded by signal words, such as 

‘‘Allergy Information,’’ possibly because 

signal words help to quickly draw 

people’s attention to important 

information (Ref. 5). 

FDA also conducted an experiment 

that compared the four statements listed 

previously relative to buying, eating, or 

serving a food item (Ref. 4). The 

experiment yielded two important 

findings. The first important finding 

was that participants thought the risk of 

the food containing allergens was 

greater when any of the four advisory 

statements was on the food label than 

when there was no allergen advisory 

statement. The second important 

finding was that participants answered 

the questions about buying, eating, or 

serving the product differently 

depending on which advisory statement 

they were responding to. The 

experimental results showed that 

participants who looked at food 

packages bearing the advisory 

statements ‘‘Allergy information: May 

contain peanuts’’ or ‘‘May contain 

peanuts’’ believed these foods were 

more likely to contain peanuts. In 

contrast, participants looking at food 

packages with the other two statements 

believed those foods were less likely to 

contain peanuts.4

FDA also reviewed research 

conducted by the Food Allergy & 

Anaphylaxis Network (FAAN). FAAN’s 

consumer surveys explored how 

consumers with food allergies 

responded to advisory labeling by either 

heeding it or ignoring it (Ref. 6). 

According to FAAN’s consumer 

surveys, consumers with food allergies 

are increasingly ignoring advisory 

labeling. Additional FAAN research 

examined retail packaged foods bearing 

various advisory labeling statements for 

peanuts and then analyzed the products 

to determine the prevalence of peanut 

residue. FAAN’s analysis found 

detectable peanut residues in some of 

the products with allergy advisory 

statements. This finding is important 

because it indicates that allergic 

consumers who ignore advisory labeling 

statements are risking their health by 

consuming foods that have advisory 

labeling because some of these foods 

contain allergens. 

C. Other Initiatives on Food Allergen 

Advisory Labeling 

The use of advisory labeling has 

steadily increased in the United States. 

As mentioned in section I.B.1. of this 

document, different food companies use 

different advisory statements and have 

different reasons for using advisory 

labeling. FDA is aware that voluntary 

criteria for determining when to use 

advisory labeling exist in the United 

States. In 2001, in response to food 

allergy concerns, the Food Allergy 

Issues Alliance (Ref. 7), a private group 

of representatives from industry, a trade 

group, a consumer group, and academia 

recommended using the following 

criteria to evaluate a food to determine 

whether advisory labeling is 

appropriate: 

• Whether the presence of a major 

food allergen is documented through 

visual examination or analytical testing 

of the processing line, equipment, 

ingredient or product, or other means; 

• Whether the risk of presence of a 

major food allergen is unavoidable even 

when current good manufacturing 

practices are followed; 

• Whether a major food allergen is 

present in some, but not all, of the 

product; and 

• Whether the presence of a major 

food allergen is potentially hazardous. 

FDA is aware that other countries 

have developed or are currently 

developing criteria to ensure uniformity 

in the use of advisory labeling to warn 

consumers that a food may 

inadvertently contain an allergen. The 

Canadian government is currently 

reviewing precautionary statements for 

food allergens and making 

recommendations regarding their use on 

the labels of packaged foods. For 

example, Canada is updating its policy 

to restrict the options for different 

precautionary statements. The proposed 

options for precautionary statements in 

Canada are: (1) ‘‘may contain (allergen)’’

or (2) ‘‘not suitable for consumption by 

persons with an allergy to (allergen)’’

(Ref. 8). Further, where incoming 

ingredients have been labeled with a 

precautionary statement, manufacturers 

are advised to use the same statement 

on the finished product label unless the 

allergen in the finished product is not 

likely to represent a health risk. 

Similar initiatives are evolving in 

Australia and New Zealand. An 

industry forum has developed the 

Voluntary Incidental Trace Allergen 

Labeling (VITAL) procedure to provide 

a risk-based approach for food 

manufacturers to use in assessing the 

impact of allergen cross-contact and to 

provide appropriate allergen advisory 

labeling (Ref. 9). The VITAL Allergen 

Action Level Grid (‘‘Vital Grid’’) 

determines whether allergens present in 

a food due to incidental cross-contact 

should be labeled and, if so, whether 

this labeling should state whether an 

allergen may be present or whether an 

allergen is actually present (i.e., 

identified as an ingredient). VITAL uses 

a three-level grid to determine if the 

presence of residual protein from 

allergenic substances through 

unavoidable cross-contact warrants 

advisory labeling. The VITAL Action 

Levels are: (1) Action Level 1—Green 

Zone—advisory labeling is not required 

for the allergen under evaluation; (2) 

Action Level 2—Yellow Zone—advisory 

labeling stating that the allergen under 

evaluation may be present is advised; 

and (3) Action Level 3—Red Zone—

significant levels of the allergen are 

likely to be present in the food; 

therefore, listing the allergen in the 

ingredient list is advised. 

D. Need for Long-Term United States 

Strategy to Manage Allergen Advisory 

Labeling 

As previously discussed in this 

document, FDA has reviewed available 

information and data and found that the 

use of advisory label statements is not 

uniform. In addition, research indicated 

a range of consumer understanding and 

behavior with regard to advisory 

labeling. Research also indicated that 

some food products that contain 

advisory labeling have been shown to 

contain detectable residues of food 

allergens (Ref. 6). Allergic consumers 

who ignore advisory label statements 

assume the risk of potential adverse 

reactions by consuming these food 

products. If manufacturers choose to use 

advisory labeling to inform consumers 

of the potential presence of food 

allergens in the finished products, such 

labeling must be truthful and not 

misleading and should provide clear, 

uniform, and accurate information to 

food-allergic consumers about the 

potential presence of food allergens. As 

currently used in the marketplace, 


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advisory labeling may not be protecting 

the health of allergic consumers; 

therefore, FDA believes that it is in the 

best interest of the public health, 

especially for food-allergic consumers, 

that FDA develop a long-term strategy to 

address allergen advisory labeling. 

II. Purpose and Scope of the Hearings 

FDA is developing a long-term 

strategy to assist manufacturers in using 

allergen advisory labeling that is 

truthful and not misleading, conveys a 

clear and uniform message, and 

adequately informs allergic consumers 

and their caregivers. To that end, FDA 

is soliciting comments and information 

to assist the agency in determining how 

manufacturers currently use advisory 

labeling, how consumers interpret 

different advisory labeling statements, 

and what wording is most effective in 

communicating to consumers the 

likelihood that an allergen may be 

present in a food. The agency is also 

interested in learning whether 

consumers find advisory labeling 

helpful for making food purchasing 

decisions. 

The scope of this hearing is 

determined by this document. FDA 

invites general comments on the issues 

and questions listed in section III of this 

document. 

III. Issues and Questions for Discussion 

The following issues and questions 

will be discussed at the public hearing: 

Issue 1: FDA is developing a longterm strategy to assist manufacturers in 

ensuring that allergen advisory labeling 

is truthful and not misleading, conveys 

a clear and uniform message, and 

adequately informs allergic consumers 

and their caregivers. To help us better 

understand under what circumstances 

manufacturers use advisory labeling, we 

ask the following questions: 

Question 1. What manufacturing 

circumstances prompt manufacturers to 

place advisory statements on a food 

label? What manufacturing 

circumstances do not prompt 

manufacturers to include an advisory 

statement? Why? 

Question 2. If we decide to develop 

guidance for using advisory labeling, 

should we incorporate any of the 

guidelines from the Food Allergy Issues 

Alliance or the principles of the VITAL 

system? If so, why? 

Question 3. Are there circumstances 

under which there is no possibility of 

cross-contact with a food allergen? If so, 

what are they? 

Question 4. When manufacturers 

declare an allergenic ingredient in the 

ingredient list or in the ‘‘Contains’’

statement, do they also use an advisory 

statement indicating the presence of that 

ingredient? If so, why? What do allergic 

consumers think of such labeling? Do 

consumers consume the food product if 

they are allergic to the allergen referred 

to in the advisory statement? Is the 

presence of both an advisory statement 

and a ‘‘Contains’’ statement that include 

the same allergen on the same food label 

confusing? Why or why not? 

Question 5. What criteria and 

considerations does a small firm rely on 

when determining whether to use 

advisory labeling? Are these the same 

criteria and considerations that a large 

firm relies on? How frequently does a 

small firm use advisory labeling 

compared to a large firm? If we decide 

to develop guidance for using advisory 

labeling, what options should we 

investigate to consider the 

circumstances of small firms? 

Question 6. How do manufacturers 

decide whether to label their finished 

products with advisory labeling when 

their incoming ingredients are labeled 

with advisory statements? 

Issue 2: FDA is also assessing whether 

advisory labeling is useful to consumers 

and how consumers interpret advisory 

labeling statements. Currently, industry 

uses many different advisory 

statements, such as ‘‘May contain 

(allergen),’’ ‘‘(allergen) traces,’’

‘‘Produced on shared equipment that 

processes (allergen),’’ and ‘‘Produced in 

a plant that processes (allergen).’’ We 

are concerned that allergic consumers 

may be risking their health by ignoring 

labeling designed to inform them of the 

potential presence of allergens in foods. 

To help us better understand what type 

of advisory labeling is most effective in 

helping consumers avoid adverse 

allergic reactions, we ask the following 

questions: 

Question 7. Consumer research 

suggests that different advisory 

statements convey different degrees of 

potential for the inadvertent presence of 

an allergen in a food. What message do 

manufacturers want to convey by an 

advisory statement generally? 

Question 8. What specific advisory 

statements adequately inform 

consumers of the potential risk of crosscontact with allergenic materials? What 

advisory statements most accurately 

communicate to consumers and their 

caregivers the potential risk of the 

presence of the allergen? Why? 

Question 9. If you are a food-allergic 

consumer or caregiver to such a 

consumer, do you ever ignore advisory 

statements? If so, which types of 

statements, and why? 

Question 10. In addition to the 

information and data mentioned in this 

document, what additional information 

or data are available that would assist us 

in understanding consumers’

perceptions of, use of, and need for 

specific advisory statements and 

advisory labeling in general? 

Issue 3: FDA is assessing how 

advisory statements should be worded 

to be the most effective in 

communicating the likelihood that an 

allergen may be present in a food. 

Consumer focus group research shows 

that the elements essential for an 

effective warning or safe handling 

statement are: a description of the 

hazard, handling instructions for 

avoiding the hazard, and an 

instructional statement that describes 

conditions under which the hazard 

occurs and what action to take if the 

hazard is not avoided (Ref. 10). This 

same research indicates that label 

messages are more credible when 

consumers know the reason for the 

message. The agency has previously 

used this consumer study information to 

craft the warning statements and safe 

handling statements found in 21 CFR 

101.17. To help us better understand 

how advisory statements should be 

worded to be the most effective in 

communicating the likelihood that an 

allergen may be present in a food, we 

ask the following questions: 

Question 11. What elements are 

needed in an advisory statement to 

adequately inform consumers of the 

potential for the inadvertent presence of 

an allergen and would communicate to 

allergic consumers a consistent and 

effective message regarding the risk of 

consuming the product? 

Question 12. How would the use of 

consistent and effective advisory 

labeling affect consumer understanding 

of the potential for an allergen to be 

present in a food? 

IV. Notice of Hearing Under 21 CFR 

Part 15 

Under authority delegated by the 

Commissioner of Food and Drugs (the 

Commissioner), the Associate 

Commissioner for Policy and Planning 

finds that it is in the public interest to 

permit persons to present information 

and views at a public hearing regarding 

the use of allergen advisory labeling and 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The presiding officer 

will be the Commissioner or his 

designee. The presiding officer will be 

accompanied by a panel of FDA 

employees with relevant expertise. 

Persons who wish to participate in the 

hearing (either by making a presentation 

or as a member of the audience) must 

file a notice of participation (see DATES, 

ADDRESSES, FOR FURTHER INFORMATION


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CONTACT, and section V of this 

document). Under authority delegated 

by the Commissioner, the Associate 

Commissioner for Policy and Planning 

has determined under § 15.20(c) that 

advance submissions of oral 

presentations are necessary for the panel 

to formulate useful questions to be 

posed at the hearing under § 15.30(e), 

and that the submission of a 

comprehensive outline or summary is 

an acceptable alternative to the 

submission of the full text of the oral 

presentation. For efficiency, we request 

that individuals and organizations with 

common interests consolidate their 

requests for oral presentation and 

request time for a joint presentation 

through a single representative. After 

reviewing the notices of participation 

and accompanying information, we will 

schedule each oral presentation and 

notify each participant of the time 

allotted to the presenter and the 

approximate time that the presentation 

is scheduled to begin. If time permits, 

we may allow interested persons who 

attend the hearing but did not submit a 

notice of participation in advance to 

make an oral presentation at the 

conclusion of the hearing. The hearing 

schedule will be available at the 

hearing. 

After the hearing, the schedule and a 

list of participants will be placed on file 

in the Division of Dockets Management 

(see ADDRESSES) under the docket 

number listed in brackets in the heading 

of this document. 

To ensure timely handling of any 

mailed notices of participation, written 

material associated with presentations, 

or comments, any outer envelope 

should be clearly marked with the 

docket number listed in brackets in the 

heading of this document along with the 

statement ‘‘Food Labeling; Current 

Trends in the Use of Allergen Advisory 

Labeling: Its Use, Effectiveness, and 

Consumer Perception; Public Hearing; 

Request for Comments.’’

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10, subpart C)). Under 

§ 10.205, representatives of the 

electronic media may be permitted, 

subject to the procedures and 

limitations in § 10.206, to videotape, 

film, or otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). For additional information 

about transcripts, see section VII in this 

document. 

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

appropriate contact person (see FOR

FURTHER INFORMATION CONTACT). 

To the extent that the conditions for 

the hearing, as described in this 

document, conflict with any provisions 

set out in part 15, this document acts as 

a waiver of these provisions as specified 

in §§ 10.19 and 15.30(h). In particular, 

§ 15.21(a) states that the notice of 

hearing will provide persons an 

opportunity to file a written notice of 

participation with the Division of 

Dockets Management within a specified 

period of time. If the public interest 

requires, e.g., if a hearing is to be 

conducted within a short period of time, 

the notice may name a specific FDA 

employee and telephone number to 

whom an oral notice of participation 

may be given. If the public interest 

requires, the notice may also provide for 

submitting notices of participation at 

the time of the hearing. In this 

document, the conditions for the 

hearing specify that notices of 

participation be submitted 

electronically to an agency Web site, to 

a contact person who will accept notices 

of participation by mail, telephone, fax, 

or e-mail, or in person on the day of the 

hearing (as time and space permits). In 

addition, the conditions for the hearing 

specify that written material associated 

with an oral presentation be provided to 

a contact person who will accept it by 

mail, fax, or e-mail rather than to the 

Division of Dockets Management. We 

are using these procedures to facilitate 

the exchange of information between 

participants and the agency. Under 

authority delegated by the 

Commissioner, the Associate 

Commissioner for Policy and Planning 

finds under § 10.19 that no participant 

will be prejudiced, the ends of justice 

will thereby be served, and the action is 

in accordance with law if notices of 

participation are submitted by any of 

the procedures listed in this document. 

V. How to Participate in the Hearing 

Registration by submission of a notice 

of participation is necessary to ensure 

participation and will be accepted on a 

first-come, first-served basis. The 

closing date for registration is 

September 8, 2008. The notice of 

participation may be submitted 

electronically, orally, or by fax, mail, or 

e-mail (see ADDRESSES and FOR FURTHER

INFORMATION CONTACT). We encourage 

you to submit your notice of 

participation electronically. A single 

copy of any notice of participation is 

sufficient. 

The notice of participation must 

include your name, title, business 

affiliation (if applicable), address, 

telephone number, fax number (if 

available), and e-mail address (if 

available). If you wish to request an 

opportunity to make an oral 

presentation during the open public 

comment period of the hearing, your 

notice of participation also must include 

the title of your presentation, the 

sponsor of the oral presentation (e.g., 

the organization paying travel expenses 

or fees), if any; and the approximate 

amount of time requested for the 

presentation. Presentations will be 

limited to the questions and subject 

matter identified in section III of this 

document, and, depending on the 

number of requests received, we may be 

obliged to limit the time allotted for 

each presentation (e.g., 5 minutes each). 

Under § 15.20(c), if you request an 

opportunity to make an oral 

presentation, you must submit your 

presentation (either as the full text of 

the presentation or as a comprehensive 

outline or summary). You may submit 

your presentation by e-mail, fax, or 

mail. A single copy of your presentation 

is sufficient. See ADDRESSES and FOR

FURTHER INFORMATION CONTACT for 

information on where to send your 

presentation. 

Persons who wish to request an 

opportunity to make an oral 

presentation must submit a notice of 

participation by August 26, 2008, and 

also must submit either the full text of 

the oral presentation or a 

comprehensive outline or summary of 

the oral presentation by September 8, 

2008. Individuals who request an 

opportunity to make an oral 

presentation will be notified of the 

scheduled time for their presentation 

prior to the hearing. All other persons 

wishing to attend the hearing must 

submit a notice of participation by 

September 8, 2008. Persons requiring 

special accommodations due to a 

disability must submit a notice of 

participation by September 8, 2008, and 

should inform the contact person of 

their request (see FOR FURTHER

INFORMATION CONTACT). Persons wishing 

to park onsite should inform the contact 

person of their request by September 10, 

2008. 

We will also accept notices of 

participation onsite on a first-come, 

first-served basis; however, space is 

limited and registration will be closed 

when the maximum seating capacity is 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 154 / Friday, August 8, 2008 / Notices 46307 

reached. Requests for an opportunity to 

make a presentation from individuals or 

organizations that did not make such a 

request in advance may be granted if 

time permits. 

Persons who submit a notice of 

participation in advance of the hearing 

should check in at the on-site 

registration desk between 8 a.m. and 9 

a.m. Persons who wish to submit a 

notice of participation on-site on the 

day of the hearing may do so at the 

registration desk between 8 a.m. and 9 

a.m. We encourage all participants to 

attend the entire hearing. Because the 

hearing will be held in a Federal 

building, hearing participants must 

present photo identification and plan 

adequate time to pass through the 

security system. 

We may post all submissions and 

received comments without change to 

http://www.regulations.gov, including 

any personal information provided. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments for consideration at or after 

the hearing in addition to, or in place of, 

a request for an opportunity to make an 

oral presentation (see section V of this 

document). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

VII. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm. It may be 

viewed at the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD-ROM after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

VIII. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES) 

and interested parties may see them 

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

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. Center for Food Safety and Applied 

Nutrition, U.S. Food and Drug 

Administration, ‘‘Notice to Manufacturers, 

Label Declaration of Allergenic Substances in 

Foods,’’ June 10, 1996. 

2. Food and Drug Administration, 2001, 

‘‘Statement of Policy for Labeling and 

Preventing Cross-contact of Common Food 

Allergens; Compliance Policy Guide’’

accessible at http://www.fda.gov/ora/ 

compliance_ref/cpg/cpgfod/cpg555–250.htm 

3. Center for Food Safety and Applied 

Nutrition, U.S. Food and Drug 

Administration, ‘‘Report to the Committee on 

Health, Education, Labor, and Pensions, 

United States Senate and the Committee on 

Energy and Commerce, United States House 

of Representatives,’’ July 2006, accessible at 

http://www.cfsan.fda.gov/~acrobat/ 

alrgrep.pdf 

4. Verrill, Linda and Conrad J. Choinie`re. 

(2009). ‘‘Are Food Allergen Advisory 

Statements Really Warnings?: Variation in 

Consumer Preferences and Consumption 

Decisions,’’ Journal of Food Products 

Marketing. 15(2) (accepted for publication). 

5. Wogalter, M.S., M.J. Kalsher, R. Rashid, 

(1999), ‘‘Effect of Signal Word and Source 

Attribution on Judgments of Warning 

Credibility and Compliance Likelihood,’’

International Journal of Industrial 

Ergonomics. 1999 24:185–192. 

6. Hefle, S.L., T.J. Furlong, L. Niemann, H. 

Lemon-Mule, S. Sicherer, S.L. Taylor, (2007), 

‘‘Consumer Attitudes and Risks Associated 

With Packaged Foods Having Advisory 

Labeling Regarding the Presence of Peanuts,’’

Journal of Allergy and Clinical Immunology, 

120(1):171–176. 

7. Food Allergy Issues Alliance, ‘‘Food 

Allergen Labeling Guidelines,’’ May 2001. 

8. Canadian Food Inspection Agency, 

‘‘Precautionary Labelling Regarding Food 

Allergens in Pre-packaged Foods’’ September 

25, 2007, accessible at http:// 

www.inspection.gc.ca/english/fssa/invenq/ 

inform/20070925e.shtml on March 26, 2008. 

9. Australian Food and Grocery Council 

Allergen Forum, ‘‘Food Industry Guide to 

Allergen Management and Labelling,’’ 2007 

revised edition, accessible at http:// 

www.allergenbureau.net/downloads/allergenguide/Allergen_Guide_2007.pdf on March 26, 

2008. 

10. Levy, A.S., ‘‘Review of Research 

Communicating Warning Information,’’

Consumer Studies Branch, Office of 

Scientific Analysis and Support, Center for 

Food Safety and Applied Nutrition, Food and 

Drug Administration, June 1997. 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18280 Filed 8–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Initial Review Group, 

Subcommittee I—Career Development. 

Date: September 30–October 1, 2008. 

Time: 8 a.m. to 5 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza National Airport, 

1480 Crystal Drive, Arlington, VA 

22202. 

Contact Person: Sonya Roberson, PhD, 

Scientific Review Officer, Resources 

And Training Review Branch, Division 

of Extramural Activities, National 

Cancer Institute, 6116 Executive Blvd., 

Room 8109, Bethesda, MD 20892, 301–

594–1182, robersos@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Initial Review Group, 

Subcommittee H—Clinical Groups. 

Date: October 13–14, 2008. 

Time: 8 a.m. to 9 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott, 5151 Pooks 

Hill Road, Bethesda, MD 20814. 

Contact Person: Timothy C. Meeker, 

MD, PhD, Scientific Review Officer, 

Resources and Training Review Branch, 

Division of Extramural Activities, 

National Cancer Institute, 6116 

Executive Boulevard, Room 8103, 

Bethesda, MD 20892, (301) 594–1279, 

meekert@mail.nih.gov. 


pwalker on PROD1PC71 with NOTICES