81 FR 90267 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 240 (December 14, 2016)

Page Range		90267-90270
FR Document		2016-29968

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Fruit Juice and Vegetable Juice as Color Additives in Food.'' The draft guidance, when finalized, will help manufacturers determine whether a color additive derived from a plant material meets the specifications under certain FDA color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

Federal Register, Volume 81 Issue 240 (Wednesday, December 14, 2016)

[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Proposed Rules]
[Pages 90267-90270]
From the Federal Register Online [www.thefederalregister.org]
[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Fruit Juice and Vegetable Juice as Color Additives in Food; Draft
Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Fruit Juice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 The draft guidance,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10.115(g)(5)), to ensure that we consider your comment on the draft
guidance before we begin work on the final version of the guidance,
submit either electronic or written comments on the draft guidance by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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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.....
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 125
----------------------------------------------------------------------------------------------------------------
\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

[[Page 90270]]

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

90270 Federal Register / Vol. 81, No. 240 / Wednesday, December 14, 2016 / Proposed Rules

of information unless it displays a Instructions: All submissions received www.dtic.mil/whs/directives/corres/pdf/
currently valid OMB control number. must include the agency name and 540502p.pdf) is where DoD’s internal
docket number or Regulatory guidance that corresponds to 32 CFR
III. Electronic Access
Information Number (RIN) for this part 97 is located. The proposed
Persons with access to the Internet Federal Register document. The general revision also removes a large portion of
may obtain the draft guidance at either policy for comments and other the currently codified part that does not
http://www.fda.gov/FoodGuidances or submissions from members of the public apply to the public, such as items that
http://www.regulations.gov. Use the is to make these submissions available solely deal with internal Army
FDA Web site listed in the previous for public viewing on the Internet at procedures and actions, e.g., annual
sentence to find the most current http://www.regulations.gov as they are reporting requirements to Headquarters,
version of the draft guidance. received without change, including any Department of the Army.
Dated: December 8, 2016. personal identifiers or contact
Authority for This Action
Leslie Kux, information.
Authorities for this rulemaking
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
include the following:
[FR Doc. 2016–29968 Filed 12–13–16; 8:45 am] Major Thomas S. Hong, (703) 693–1093; • The Freedom of Information Act at
BILLING CODE 4164–01–P thomas.s.hong.mil@mail.mil. 5 U.S.C. 552 which provides the public
SUPPLEMENTARY INFORMATION: with a right to request access to federal
Executive Summary agency records or information, except to
DEPARTMENT OF DEFENSE the extent the records are protected from
The rule discusses departmental disclosure by any of nine exemptions or
Department of the Army responsibilities, procedures for service by one of three special law enforcement
of process, procedures for government record exclusions.
32 CFR Part 516 officials sued in their official capacities, • The Privacy Act of 1974 at 5 U.S.C.
and procedures for requests for release 552a, which establishes a code of fair
[Docket No. USA–2015–0016]
of official information, to include information practices that governs the
RIN 0702–AA69 witness testimony. The rule also collection, maintenance, use, and
discusses the release of official dissemination of information about
Release of Official Information and information and the appearance of individuals that is maintained in
Appearance of Witnesses in Litigation present and former Army personnel as systems of records by federal agencies.
AGENCY: Department of the Army, DoD. witnesses in response to requests for • Confidentiality of records at 42
interviews, notices of depositions, U.S.C. 290 which requires certain
ACTION: Proposed rule.
subpoenas, and other requests or orders medical records shall be confidential
SUMMARY: The Department of the Army related to judicial or quasi-judicial and disclosed only for authorized
proposes to amend its regulation proceedings. purposes.
concerning policies and procedures for For the purposes of this rule, Army • Executive Order No. 12988, Civil
release of official information and personnel include the following: Justice Reform (add a link to the E.O.)
testimony of Army witnesses in federal • Present, former and retired Army which establishes several requirements
and state courts where the Army or military personnel, including the U.S. on Federal agencies involved in
Department of Defense (DoD) has an Army Reserve, regardless of current litigation or contemplating filing an
interest in the matter. This regulation status. action on behalf of the United States.
was last published in the Federal • Present, former and retired civilian
employees of the U.S. Army, regardless Costs and Benefits
Register on July 29, 1994 (59 FR 38236).
At that time, a complete Army of current status. The proposed revisions benefit the
Regulation was codified. This revision • Soldiers of the Army National Department of the Army agencies, Army
removes a large portion of the currently Guard of the United States (Title 10, support to the Department of Justice,
codified part that does not apply to the U.S.C.) and, when specified by statute and interaction with state courts in
public, and is now included in DoD or where a Federal interest is involved, affirmative and defensive litigation
internal guidance. Army Regulation 27– Soldiers in the Army National Guard information. With the updates to the
40, Litigation, dated 19 September 1994, (Title 32, U.S.C.). CFR for statutory and other changes
is the corresponding document where • Technicians under 32 U.S.C. 709. since the document was published in
the internal guidance is located. • USMA cadets. 1994, Army’s support of federal
• Nonappropriated fund employees. litigation and response to requests to
DATES: Consideration will be given to all
• Foreign nationals who perform support state and private litigation will
comments received by: February 13,
services for the Army overseas. be improved.
2017.
• Other individuals hired by or for Although no formal study or
ADDRESSES: You may submit comments, the Army, including individuals hired collection of data are available, a review
identified by 32 CFR part 516, Docket through contractual agreements by or on of the closed Touhy requests for FY
No. USA–2015–0016 and or RIN 0702– behalf of the Army. 2016 shows that hundreds of hours were
AA69, by any of the following methods: expended by Army personnel
• Federal eRulemaking Portal: http:// Background
responding to these requests. Similar to
sradovich on DSK3GMQ082PROD with PROPOSALS

www.regulations.gov. Follow the This regulation was most recently costs in Freedom of Information Act
instructions for submitting comments. published in the Federal Register on processing, there are substantial costs
• Mail: Department of Defense, July 29, 1994 (59 FR 38236). It for searching, reviewing, and producing
Deputy Chief Management Officer, implements 32 CFR part 97. Department Army records and personnel for
Directorate for Oversight and of Defense Directive 5405.2, ‘‘Release of depositions and trial.
Compliance, 4800 Mark Center Drive, Official Information in Litigation and This rule will be included in DoD’s
ATTN: Box 24, Alexandria, VA 22350– Testimony by DoD Personnel as retrospective plan, completed in August
1700. Witnesses’’ (available at http:// 2011, and will be reported in future

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Document Created: 2016-12-14 00:48:52
Document Modified: 2016-12-14 00:48:52

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of availability.
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.
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.
FR Citation		81 FR 90267

81 FR 90267 - Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 240 (December 14, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration