Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 71107 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1030] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food Allergen 

Labeling and Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

31, 2014. 

ADDRESSES: 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: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Food Allergen Labeling and 

Reporting’’. Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Food and Drug Administration, 8455 

Colesville Road, COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Food Allergen Labeling and 

Reporting—(OMB Control Number 

0910–NEW) 

I. Background 

The Food Allergen Labeling and 

Consumer Protection Act of 2004 

(FALCPA) (Title II, Pub. L. 108–282) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by 

defining the term ‘‘major food allergen’’ 

and stating that foods regulated under 

the FD&C Act are misbranded unless 

they declare the presence of each major 

food allergen on the product label using 

the name of the food source from which 

the major food allergen is derived. 

Section 403(w)(1) of the FD&C Act (21 

U.S.C. 343(w)(1)) sets forth the 

requirements for declaring the presence 

of each major food allergen on the 

product label. Section 201(qq) of the 

FD&C Act (21 U.S.C. 321(qq)) defines a 

major food allergen as ‘‘[m]ilk, egg, fish 

(e.g., bass, flounder, or cod), Crustacean 

shellfish (e.g., crab, lobster, or shrimp), 

tree nuts (e.g., almonds, pecans, or 

walnuts), wheat, peanuts, and 

soybeans’’ and also as a food ingredient 

that contains protein derived from such 

foods. The definition excludes any 

highly refined oil derived from a major 

food allergen and any ingredient 

derived from such highly refined oil. 

In some cases, the production of an 

ingredient derived from a major food 

allergen may alter or eliminate the 

allergenic proteins in that derived 

ingredient to such an extent that it does 

not contain allergenic protein. In 

addition, a major food allergen may be 

used as an ingredient or as a component 

of an ingredient such that the level of 

allergenic protein in finished food 

products does not cause an allergic 

response that poses a risk to human 

health. Therefore, FALCPA provides 

two mechanisms through which such 

ingredients may become exempt from 

the labeling requirement of section 

403(w)(1) of the FD&C Act. An 

ingredient may obtain an exemption 

through submission and approval of a 

petition containing scientific evidence 

that demonstrates that the ingredient 

‘‘does not cause an allergic response 

that poses a risk to human health’’ 

(section 403(w)(6) of the FD&C Act (21 

U.S.C. 343(w)(6)). Alternately, an 

ingredient may become exempt through 

submission of a notification containing 

scientific evidence showing that the 

ingredient ‘‘does not contain allergenic 

protein’’ or that there has been a 

previous determination through a 

premarket approval process under 

section 409 of the FD&C Act (21 U.S.C. 

348) that the ingredient ‘‘does not cause 

an allergic response that poses a risk to 

human health’’ (section 403(w)(7) of the 

FD&C Act (21 U.S.C. 343(w)(7)). 

In the Federal Register of May 8, 2014 

(79 FR 26435), we published a notice of 

availability for the draft guidance 

document entitled, ‘‘Draft Guidance for 

Industry: Food Allergen Labeling 

Exemption Petitions and Notifications.’’ 

This draft guidance is intended to help 

industry prepare petitions and 

notifications seeking exemptions from 

the labeling requirements for 

ingredients derived from major food 

allergens. Persons with access to the 

Internet may obtain the guidance at 

http://www.fda.gov/FoodGuidances. 

II. Analysis of the Proposed 

Information Collection 

The proposed information collection 

seeks OMB approval of the third party 

disclosure requirements of food allergen 

labeling under section 403(w)(1) of the 

FD&C Act, as well as OMB approval of 

the reporting associated with the 

submission of petitions and 

notifications seeking exemptions from 

the labeling requirements for 

ingredients derived from major food 

allergens under section 403(w)(6) and 

(7) of the FD&C Act. 

A. Third Party Disclosure 

The labeling requirements of section 

403(w)(1) of the FD&C Act apply to all 

packaged foods sold in the United States 

that are regulated under the FD&C Act, 

including both domestically 

manufactured and imported foods. As 

noted, section 403(w)(1) of the FD&C 

Act requires that the label of a food 

product declare the presence of each 

major food allergen. We estimate the 

information collection burden of the 

third party disclosure associated with 

food allergen labeling under section 

403(w)(1) of the FD&C Act as the time 

needed for a manufacturer to review the 

labels of new or reformulated products 

for compliance with the requirements of 

section 403(w)(1) of the FD&C Act and 

the time needed to make any needed 

modifications to the labels of those 

products. 

The primary user of the allergen 

information disclosed on the label or 

labeling of food products is the 

consumer that purchases the food 

product. Consumers will use the 

information to help them make choices 

concerning their purchase of a food 

product, including choices related to 

substances that the consumer wishes to 

avoid due to their potential to cause 

adverse reactions. Additionally, we 

intend to use the information to 

determine whether a manufacturer or 

other supplier of food products is 

meeting its statutory obligations. Failure 

of a manufacturer or other supplier of 

food products to label its products in 

compliance with section 403(w)(1) of 

the FD&C Act may result in a product 

being misbranded under the FD&C Act 

and the manufacturer or packer and the 

product subject to regulatory action. 

Description of respondents: The 

respondents to this collection of 

information are manufacturers and 

packers of packaged foods sold in the 

United States. 

In the Federal Register of August 12, 

2014 (79 FR 47145), we published a 60- 

day notice requesting public comment 

on the proposed collection of 


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71108 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 

information. Although one comment 

was received, it did not respond to any 

of the four collection of information 

topics solicited and therefore is not 

discussed in this document. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1

FD&C Act Section Number of 

respondents 

Number of disclosures per 

respondent 

Total annual 

disclosures 

Avg. burden 

per disclosure Total hours Total capital 

costs 

403(w)(1); review labels for compliance with food allergen labeling requirements .................................... 77,500 1 77,500 1 77,500 0 

403(w)(1); redesign labels to comply with food allergen labeling requirements ........................................ 3,875 1 3,875 16 62,000 $7,071,875 

Total ...................................................................... .................... ........................ .................... .................... 139,500 $7,071,875 

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

We used our labeling cost model (Ref. 

1) to estimate the number of new or 

reformulated products sold in the 

United States, annually, that are affected 

by the requirements of section 403(w)(1) 

of the FD&C Act. We estimate that there 

are approximately 690,000 Universal 

Product Codes (UPCs) of FDA-regulated 

foods and approximately 85,000 UPCs 

of FDA-regulated dietary supplements 

for a total of 775,000 UPCs (Ref. 1). 

Using our labeling cost model, we 

estimate the entry rate of new UPCs to 

be approximately 8 percent per year. 

Based on the approximate entry rate of 

new UPCs, we estimate the rate of new 

or reformulated UPCs to be 

approximately 10 percent per year, or 

77,500 products (775,000 × 10 percent). 

Thus, we estimate that, annually, 77,500 

new or reformulated products are sold 

in the United States. Assuming an 

association of one respondent to each of 

the 77,500 new or reformulated 

products, we estimate that 77,500 

respondents will each review the label 

of one of the 77,500 new or 

reformulated products, as reported in 

table 1, row 1. We have no data on how 

many label reviews would identify the 

need to redesign the label. Therefore, we 

further estimate, for the purposes of this 

analysis, that 5 percent of the reviewed 

labels of new or reformulated products, 

or 3,875 labels (77,500 × 5 percent) 

would need to be redesigned to comply 

with the requirements of section 

403(w)(1) of the FD&C Act. Assuming an 

association of one respondent to each of 

the 3,875 labels, we estimate that 3,875 

respondents will each redesign one 

label, as reported in table 1, row 2. 

Our estimate of the average burdens 

per disclosure reported in table 1 is 

based on our experience with food 

labeling and our labeling cost model. 

We estimate the average burden for the 

review of labels for compliance with the 

food allergen labeling requirements 

under section 403(w)(1) of the FD&C Act 

to be 1 hour. Consequently, the burden 

of reviewing the labels of new or 

reformulated products is 77,500 hours, 

as reported in table 1. Using our labeling 

cost model, we estimate that it takes an 

average of 16 hours to complete the 

administration and internal design work 

for the redesign of a label to comply 

with the food allergen labeling 

requirements under section 403(w)(1) of 

the FD&C Act. Consequently, the burden 

of redesigning the 3,875 labels of new or 

reformulated products is 62,000 hours, 

as reported in table 1. 

Using our labeling cost model, we 

estimate the capital cost to be $1,825 per 

label for external design services for the 

redesign of a label. Consequently for 

3,875 labels, the total capital costs are 

$7,071,875 (3,875 labels × $1,825 per 

label), as reported in table 1. 

B. Reporting 

Under sections 403(w)(6) and (7) of 

the FD&C Act, interested parties may 

request from us a determination that an 

ingredient is exempt from the labeling 

requirement of section 403(w)(1) of the 

FD&C Act. An ingredient may obtain an 

exemption through submission and 

approval of a petition containing 

scientific evidence that demonstrates 

that the ingredient ‘‘does not cause an 

allergic response that poses a risk to 

human health’’ (section 403(w)(6) of the 

FD&C Act). This section also states that 

‘‘the burden shall be on the petitioner to 

provide scientific evidence (including 

the analytical method used to produce 

the evidence) that demonstrates that 

such food ingredient, as derived by the 

method specified in the petition, does 

not cause an allergic response that poses 

a risk to human health.’’ Alternately, an 

ingredient may become exempt through 

submission of a notification containing 

scientific evidence showing that the 

ingredient ‘‘does not contain allergenic 

protein’’ or that there has been a 

previous determination through a 

premarket approval process under 

section 409 of the FD&C Act that the 

ingredient ‘‘does not cause an allergic 

response that poses a risk to human 

health’’ (section 403(w)(7) of the FD&C 

Act). 

Our draft guidance document entitled, 

‘‘Draft Guidance for Industry: Food 

Allergen Labeling Exemption Petitions 

and Notifications,’’ sets forth our 

recommendations with regard to the 

information that an interested party 

should submit in such a petition or 

notification. The draft guidance states 

that to evaluate these petitions and 

notifications, we will consider scientific 

evidence that describes: 

1. The identity or composition of the 

ingredient; 

2. The methods used to produce the 

ingredient; 

3. The methods used to characterize 

the ingredient; 

4. The intended use of the ingredient 

in food; and either 

5. a. For a petition, data and 

information, including the expected 

level of consumer exposure to the 

ingredient, that demonstrate that the 

ingredient when manufactured and used 

as described does not cause an allergic 

response that poses a risk to human 

health; or 

5. b. For a notification, data and 

information that demonstrate that the 

ingredient when manufactured as 

described does not contain allergenic 

protein, or documentation of a previous 

determination under a process under 

section 409 of the FD&C Act that the 

ingredient does not cause an allergic 

response that poses a risk to human 

health. 

We will use the information 

submitted in the petition or notification 

to determine whether the ingredient 

satisfies the criteria of sections 

403(w)(6) and (7) of the FD&C Act for 

granting the exemption. 

Description of respondents: The 

respondents to this collection of 

information are manufacturers and 

packers of packaged foods sold in the 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 71109 

United States that seek an exemption 

from the labeling requirement of section 

403(w)(1) of the FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FD&C Act Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

403(w)(6); petition for exemption ......................................... 5 1 5 100 500 

403(w)(7); notification .......................................................... 5 1 5 68 340 

Total .............................................................................. ........................ ........................ ........................ ........................ 840 

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

Based on the number of petitions and 

notifications received in recent years, 

we estimate that we will receive an 

average of five petitions and five 

notifications annually, over the next 3 

years. Assuming an association of one 

respondent to each petition or 

notification, we estimate that five 

respondents will each submit one 

petition, and five respondents will each 

submit one notification, as reported in 

table 2, rows 1 and 2. 

We base our estimate of the average 

burdens per response reported in table 

2 on our experience with other petition 

processes. We estimate that a petition 

would take, on average, 100 hours to 

develop and submit (Ref. 2). Therefore, 

we estimate that the burden associated 

with petitions will be 500 hours 

annually (5 petitions × 100 hours per 

petition). 

The burden of a notification involves 

collecting documentation that a food 

ingredient does not pose an allergen 

risk. Either we can make a 

determination that the ingredient does 

not cause an allergic response that poses 

a risk to human health under a 

premarket approval or notification 

program under section 409 of the FD&C 

Act, or the respondent would submit 

scientific evidence demonstrating that 

the ingredient, when manufactured as 

described, does not contain allergenic 

protein. We estimate that it would take 

a respondent 20 hours to prepare and 

submit a notification based on our 

determination under a process under 

section 409 of the FD&C Act that the 

ingredient does not cause an allergic 

response. We estimate that it would take 

a respondent approximately 100 hours 

to prepare a notification submitting 

scientific evidence (including the 

analytical method used) that 

demonstrates that the food ingredient 

(as derived by the method specified in 

the notification, where applicable) does 

not contain allergenic protein. We have 

no data on how many notifications 

would be based on our determination 

that the ingredient does not cause an 

allergic response or based on scientific 

evidence that demonstrates that the food 

ingredient does not contain allergenic 

protein. Therefore, we estimate that 

three of the five notifications would be 

based on scientific evidence, and two of 

the five notifications would be based on 

our determination. The average time per 

notification is then estimated to be 68 

hours (2 × 20 hours +3 × 100 hours)/5). 

Therefore, we estimate that the burden 

associated with notifications will be 340 

hours annually (5 notifications × 68 

hours per notification), as reported in 

table 2. 

III. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

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

through Friday. 

1. RTI International. ‘‘Model to Estimate 

Costs of Using Labeling as a Risk 

Reduction Strategy for Consumer 

Products Regulated by the Food and 

Drug Administration, Final Report.’’ 

Prepared for Andrew Stivers, FDA/

CFSAN. Prepared by Muth, M., M. Ball, 

M. Coglaiti, and S. Karns. RTI Project 

Number 0211460.005. March, 2011. 

2. Gendel, Steven M. ‘‘Food Allergen 

Petitions and Notifications,’’ 

Memorandum to File. August 8, 2011. 

Dated: November 24, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28185 Filed 11–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0639] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Notification of the 

Intent To Use an Accredited Person 

Under the Accredited Persons 

Inspection Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

31, 2014. 

ADDRESSES: 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: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0569. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES