[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Proposed Rules]
[Pages 90267-90270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-D-4120]


Fruit Juice and Vegetable Juice as Color Additives in Food; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Fruit Juice 
and Vegetable Juice as Color Additives in Food.'' The draft guidance, 
when finalized, will help manufacturers determine whether a color 
additive derived from a plant material meets the specifications under 
certain FDA color additive regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
February 13, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

[[Page 90268]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-4120 for the draft guidance for industry entitled ``Fruit 
Juice and Vegetable Juice as Color Additives in Food.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on http://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov 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.
    Submit written requests for single copies of the draft guidance to 
the Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: With regard to the draft guidance: 
Laura A. Dye, Center for Food Safety and Applied Nutrition (HFS-265), 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 
240-402-1275. With regard to the proposed collection of information: 
Ila Mizrachi, Office of Operations, Food and Drug Administration, Three 
White Flint North (3WFN), 10A63, 11601 Landsdown St., North Bethesda, 
MD 20852.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Fruit Juice and Vegetable Juice as Color Additives in 
Food.'' We are issuing the draft guidance consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    When a food substance, including plant material, is deliberately 
used as a color, it is a color additive (see 21 CFR 70.3(f)). We have a 
statutory obligation to ensure that authorized (or listed) color 
additives are suitable and safe for their intended use. FDA has 
authorized the use of the color additive ``fruit juice,'' under Sec.  
73.250 (21 CFR 73.250), that is prepared either by expressing the juice 
from mature varieties of fresh, edible fruits, or by the water infusion 
of the dried fruit. Similarly, Sec.  73.260 establishes that the color 
additive ``vegetable juice'' is prepared either by expressing the juice 
from mature varieties of fresh, edible vegetables or by the water 
infusion of the dried vegetable. The underlying premise of Sec. Sec.  
73.250 and 73.260 is that the safety of fruit juice and vegetable juice 
as color additives for use in food is assured by the fact that the 
fruit or vegetable from which the color additive is derived has been 
safely consumed as food, such that there would not be safety concerns 
in using the juice or water soluble color components from the fruit or 
vegetable as a color additive. The fact that plant material can be 
eaten does not necessarily mean that juice from such plant material 
meets the specifications of these regulations. We also note that, in 
addition to the color additive regulations for fruit juice in Sec.  
73.250 and vegetable juice in Sec.  73.260, we have authorized color 
additives derived from plant materials in separate color additive 
regulations, including Sec.  73.169 (grape skin extract) and Sec.  
73.500 (saffron).
    The draft guidance, when finalized, is intended to help 
manufacturers determine whether a color additive derived from a plant 
material meets the specifications for fruit juice under Sec.  73.250 or 
vegetable juice under Sec.  73.260. The draft guidance, including our 
interpretation of the terms used in Sec. Sec.  73.250 and 73.260, is 
limited to these color additive regulations. The draft guidance does 
not address the use of fruit- or vegetable-derived color additives that 
are authorized under different color additive regulations or that are 
the subject of a color additive petition.
    Since we issued the color additive regulations for fruit juice and 
vegetable juice, we have received inquiries from industry regarding 
whether certain plant materials are covered by these color additive 
regulations. The draft guidance provides the criteria that should be 
used to determine if a plant material is a mature, fresh, edible fruit 
or a mature, fresh, edible vegetable under Sec. Sec.  73.250 and 
73.260. The draft guidance also encourages firms to consult us if they 
are unsure of the regulatory status of a substance that they propose to 
derive from plant materials for use as a color additive for food. 
Separately, we have posted on our Web site a summary table of the 
informal opinions that we have issued in response to the specific 
inquiries we have received regarding the applicability of Sec. Sec.  
73.250 and 73.260. The draft guidance document contains the Web site 
link to the summary table.

II. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of

[[Page 90269]]

Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 
CFR 71.1 have been approved under OMB control number 0910-0016.
    The draft guidance also refers to new collections of information 
found in FDA regulations. Under the PRA, Federal Agencies must obtain 
approval from OMB for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the information to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
new collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Title: Fruit Juice and Vegetable Juice as Color Additives in Food; 
Draft Guidance for Industry--OMB Control Number 0910--NEW

    The draft guidance, when finalized, will help manufacturers 
determine whether a color additive derived from a plant material meets 
the specifications for fruit juice under Sec.  73.250 or vegetable 
juice under Sec.  73.260. Information in the draft guidance regarding 
submission of a color additive petition has been previously approved by 
OMB in accordance with the PRA under OMB control number 0910-0016.
    The proposed new information collection provides manufacturers the 
opportunity to request a meeting with FDA if they are unsure whether a 
color additive that is derived from plant material and that is intended 
for use in food meets the identity for fruit juice or vegetable juice 
in Sec.  73.250 or Sec.  73.260. When manufacturers request a meeting, 
the draft guidance suggests that they provide the scientific name, 
common name(s), origin, cultivation state, and life-stage of the plant 
material from which they wish to derive the color additive, and which 
plant structure will be declared the mature, fresh, edible fruit or 
vegetable, as well as a complete description of the manufacturing 
process for the color additive. Manufacturers also may provide 
information to us to verify that the plant material can be consumed for 
its taste, aroma, or nutrient properties in its fresh state and to 
document the amount and frequency of consumption and the history of 
safe consumption. If we determine that a proposed color additive does 
not meet the specifications for fruit juice or vegetable juice under 
Sec.  73.250 or Sec.  73.260, the manufacturer may submit a color 
additive petition, the collection of information for which has been 
approved under OMB control number 0910-0016.
    Description of respondents: The respondents to this collection of 
information are manufacturers who are trying to determine whether a 
color additive derived from a plant material meets the specifications 
for fruit juice under Sec.  73.250 or vegetable juice under Sec.  
73.260.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Color manufacturer's request for               5               1               5               1               5
 meeting and identification of
 fruit juice or vegetable juice
 information....................
Manufacturer's collection of                   5               1               5              24             120
 data supporting the plant
 material as a consumable food,
 amount and frequency of
 consumption, and history of
 safe consumption by humans.....
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    Total.......................  ..............  ..............  ..............  ..............             125
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's estimate of the number of respondents and number of responses 
in table 1 is based on the average number of meetings that are expected 
to be requested annually by manufacturers over the next 3 years. Based 
on past experience, we expect the request for a meeting and the 
submission of fruit juice or vegetable juice information can be 
completed by a qualified plant taxonomist in less than 1 hour. We also 
expect that some manufacturers may want to provide research supporting 
the plant material as a consumable food, the amount and frequency of 
consumption, and the history of safe consumption of the mature fruit or 
vegetable by humans. We estimate that, in these cases, it would take a 
qualified toxicologist up to 3 days (24 working hours) to perform a 
thorough literature and plant database search. This estimate includes 
the time we expect it would take for a submitter to compile the 
information for submission to FDA.
    To be conservative, the total number of annual burden hours, 
therefore, would be 125 hours, which would include 5 hours to complete 
the initial request for a meeting and of the submission of associated 
information to FDA, and 120 hours to complete a literature and database 
search and to present this information for submission to FDA.
    Before the proposed information collection provisions contained in 
the draft guidance become effective, we will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection

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of information unless it displays a currently valid OMB control number.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the draft guidance.

    Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29968 Filed 12-13-16; 8:45 am]
BILLING CODE 4164-01-P