Milk and Cream; Petition for an Administrative Stay of Action: Definitions and Standards of Identity for Yogurt, Lowfat Yogurt, and Nonfat Yogurt, 16394-16395 [2022-05804]
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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–8220.
SUPPLEMENTARY INFORMATION: FDA is
announcing that the name of the Bone,
Reproductive and Urologic Drugs
Advisory Committee, which was
established on March 23, 1978, has been
changed. The Agency decided that the
name ‘‘Obstetrics, Reproductive and
Urologic Drugs Advisory Committee’’
more accurately describes the subject
areas for which the committee is
responsible. The committee reviews and
evaluates data on the safety and
effectiveness of marketed and
investigational human drug products for
use in the practice of obstetrics,
gynecology, urology and related
specialties, and makes appropriate
recommendations to the Commissioner
of Food and Drugs. The mandate of the
committee no longer includes
osteoporosis and metabolic bone
disease. As osteoporosis and metabolic
bone diseases are topics related to
endocrinology and metabolic disease,
these will be discussed by the
Endocrinologic and Metabolic Drugs
Advisory Committee.
The Obstetrics, Reproductive and
Urologic Drugs Advisory Committee
name was changed, and its functions
changed in the charter renewal dated
March 23, 2022. In this final rule, FDA
is revising 21 CFR 14.100(c)(9) to reflect
these changes.
Publication of this final rule
constitutes a final action on this change
under the Administrative Procedure
Act. Under 5 U.S.C. 553(b)(B) and (d)(3)
and 21 CFR 10.40(d) and (e)(1), the
Agency finds good cause to dispense
with notice and public procedure and to
proceed to an immediately effective
regulation. Such notice and procedures
are unnecessary and are not in the
public interest because the final rule is
merely codifying the new name and the
function of the advisory committee to
reflect the current committee charter.
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
ACTION:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
1. The authority citation for part 14
continues to read as follows:
■
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
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2. Section 14.100 is amended by
revising paragraph (c)(8) heading and
paragraph (c)(8)(ii) to read as follows:
■
§ 14.100 List of standing advisory
committees.
*
*
*
*
*
(c) * * *
(8) Obstetrics, Reproductive and
Urologic Drugs Advisory Committee.
*
*
*
*
*
(ii) Function: The committee reviews
and evaluates data on the safety and
effectiveness of marketed and
investigational human drug products for
use in the practice of obstetrics,
gynecology, urology and related
specialties, and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
*
*
*
*
*
Dated: March 16, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–05965 Filed 3–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 130 and 131
[Docket No. FDA–2000–P–0126 (formerly
Docket No. 2000P–0658)]
RIN 0910–AI40
Milk and Cream; Petition for an
Administrative Stay of Action:
Definitions and Standards of Identity
for Yogurt, Lowfat Yogurt, and Nonfat
Yogurt
AGENCY:
Food and Drug Administration,
HHS.
Final rule; notification of
administrative stay.
The Food and Drug
Administration (FDA or we) is
providing notice of a stay of the
effectiveness of certain provisions of a
final rule published in the Federal
Register of June 11, 2021. The final rule
amended the definition and standard of
identity for yogurt and revoked the
definitions and standards of identity for
lowfat yogurt and nonfat yogurt. FDA is
publishing this notification in response
to objections timely filed in accordance
with regulatory requirements.
DATES: FDA is administratively staying
certain provisions in the final rule
SUMMARY:
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
published on June 11, 2021 (86 FR
31117). FDA will publish a document in
the Federal Register lifting the stay or
taking further action as needed.
ADDRESSES: For access to the docket, go
to https://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
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Joan
Rothenberg, Center for Food Safety and
Applied Nutrition, Office of Regulations
and Policy, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2021 (86 FR 31117), FDA issued a final
rule (the 2021 final rule) amending the
definition and standard of identity for
yogurt ((§ 131.200) (21 CFR 131.200))
and revoking the definitions and
standards of identity for lowfat yogurt
(21 CFR 131.203) and nonfat yogurt (21
CFR 131.206). The 2021 final rule’s
effective date was July 12, 2021.
Pursuant to section 701(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 371(e)), the 2021 final
rule notified persons who would be
adversely affected by the 2021 final rule
that they could file objections,
specifying with particularity the
provisions of the 2021 final rule deemed
objectionable, stating the grounds
therefor, and requesting a public hearing
upon such objections.
The International Dairy Foods
Association (IDFA) and Chobani timely
filed objections and requests for a
hearing with respect to several
provisions in the 2021 final rule (see
Objections and Request for Hearings
submitted by Michael Dykes, DVM,
President and Chief Executive Officer,
International Dairy Foods Association,
dated July 12, 2021, to the Dockets
Management Staff, Food and Drug
Administration (Comment ID FDA–
2000–P–0126–0109) and Objection and
Requests for Hearing submitted by
Matthew Graziose, Ph.D., Director,
Regulatory Affairs & Compliance,
Chobani, dated July 12, 2021, to the
Dockets Management Staff, Food and
Drug Administration (Comment ID
FDA–2000–P–0126–0108)). Section
701(e)(2) of the FD&C Act provides that,
until final action is taken by the
Secretary, the filing of objections
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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1
operates to stay the effectiveness of
those provisions to which the objections
are made. We established the definition
and standard of identity for yogurt in
1981 (1981 final rule) (46 FR 9924 at
9939, January 30, 1981). The 2021 final
rule amended some provisions in the
definition and standard of identity and
maintained others. Staying the
effectiveness of these provisions results
in the corresponding requirements in
the 1981 final rule remaining in effect.
This notice provides clarification on
which provisions of the 2021 final rule
have been stayed and which
requirements of the 1981 final rule are
in effect pending final action under
section 701(e) of the FD&C Act.
II. Objections and Requests for Hearing
IDFA’s objections were directed at
several provisions in § 131.200(a) of the
2021 final rule. IDFA objected to the
requirement in § 131.200(a) that yogurt,
before the addition of bulky flavoring
ingredients, has either a titratable
acidity of not less than 0.7 percent,
expressed as lactic acid, or a pH of 4.6
or lower. This provision of the 2021
final rule is stayed. FDA notes that the
definition and standard of identity
established in 1981 included a
minimum titratable acidity requirement
of 0.9 percent, but that provision was
stayed by the filing of objections in 1981
(47 FR 41519 at 41523, September 21,
1982). Consequently, no minimum
titratable acidity requirement or
maximum pH requirement is in effect.
IDFA also objected to the provision
that yogurt, before the addition of bulky
flavoring ingredients, contains not less
than 3.25 percent milkfat and the
provision requiring pasteurized cream,
if used as a basic dairy ingredient under
§ 131.200(b) or an optional dairy
ingredient under § 131.200(c), to be
added before culturing. These
provisions of the 2021 final rule are
stayed. However, a minimum milkfat of
3.25 percent before the addition of
bulky flavors and the requirement that
cream be included in the culturing
process remain in effect under the
definition and standard of identity
established in the 1981 final rule.
Chobani objected to the exclusion of
ultrafiltered milk from the basic dairy
ingredients in § 131.200(b). This
provision is stayed insofar as it
prohibits the use of ultrafiltered milk.
However, the provision in the 1981 final
rule remains in effect with respect to the
use of ultrafiltered milk. This means
that ultrafiltered milk may not be used
as a basic dairy ingredient in the
manufacture of yogurt. Because we
received no objections to the use of
ultrafiltered milk as an optional dairy
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ingredient under § 131.200(c) of the
2021 final rule, ultrafiltered milk may
be used to increase the milk solids, not
fat content, of the food above 8.25
percent, provided that the ratio of
protein to total nonfat solids of the food
and the protein efficiency ratio of all
protein present is not decreased as a
result.
IDFA also objected to provisions in
§ 131.200(d) for other optional
ingredients. These provisions included
§ 131.200(d)(2), which limits the use of
sweeteners to nutritive carbohydrate
sweeteners, and § 131.200(d)(8)(ii),
which requires a minimum vitamin D
content of 25 percent Daily Value (DV)
per reference amount customarily
consumed (RACC) if vitamin D is added.
Both provisions in the 2021 final rule
are stayed. Optional vitamin D addition
has been permitted since 1982 at a level
of 400 international units per quart (see
47 FR 41519 at 41520 and 41524); this
limitation on vitamin D addition
remains in effect. The prohibition on the
use of sweeteners other than nutritive
carbohydrate sweeteners remains in
effect under the 1981 final rule’s
definition and standard of identity.
Because we received no objections to
permitting the use of all safe and
suitable nutritive carbohydrate
sweeteners, nutritive carbohydrate
sweeteners are no longer limited to
those listed under § 131.200(c)(2) in the
1981 final rule.
This notification does not constitute a
determination that a hearing is justified
on any objections or requests for hearing
that have been filed (21 CFR 12.23).
Until FDA makes such a determination
and issues a notice under 21 CFR 12.28,
12.26, or 12.35, we intend to exercise
enforcement discretion with respect to
the following:
• Addition of vitamin D to yogurt
under § 131.200 and lower fat yogurt
products under § 130.10 (21 CFR
130.10) such that the food contains at
least 10 percent DV per RACC, within
limits of current good manufacturing
practices.
• Use of nonnutritive sweeteners in
yogurt under § 131.200 and lower fat
yogurt products under § 130.10 that are
not labeled with a statement of identity
that includes an expressed nutrient
content claim consistent with the use of
nonnutritive sweeteners.
• Use of bulky flavor ingredients in
lower fat yogurt products under § 130.10
that increase the total fat content above
the level specified in § 101.62(b) (21
CFR 101.62(b)) for the expressed
nutrient content claim in the statement
of identity, provided that the level of
milkfat in the product is consistent with
the level specified in § 101.62(b) and the
PO 00000
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Fmt 4700
Sfmt 9990
16395
statement of identity also includes a
descriptor of the bulky flavor ingredient
(e.g., ‘‘lowfat yogurt with coconut’’).
Under this enforcement discretion, we
do not intend to take action with respect
to yogurt and lower fat yogurt products
that meet these criteria provided that
the products otherwise conform to the
definition and standard of identity
under § 131.200 or § 130.10.
III. Provisions Stayed
Pursuant to section 701(e) of the
FD&C Act, we hereby announce that the
following provisions of the 2021 final
rule are stayed by the objections filed:
1. The requirement in § 131.200(a)
that yogurt, before the addition of bulky
flavoring ingredients, has either a
titratable acidity of not less than 0.7
percent, expressed as lactic acid, or a
pH of 4.6 or lower.
2. The requirement in § 131.200(a)
that yogurt, before the addition of bulky
flavoring ingredients, contains not less
than 3.25 percent milkfat.
3. The prohibition in § 131.200(a), (b),
and (c) on adding pasteurized cream
after culturing.
4. The exclusion of ultrafiltered milk
from the basic dairy ingredients in
§ 131.200(b).
5. The limitation on the use of
sweeteners in § 131.200(d)(2) to
nutritive carbohydrate sweeteners.
6. The requirement in
§ 131.200(d)(8)(ii) that vitamin D, if
added, must be present in such quantity
that the food contains not less than 25
percent DV per RACC, within limits of
current good manufacturing practices.
IV. Effective/Compliance Dates
This document hereby confirms the
effective date of the 2021 final rule as
July 12, 2021, and the compliance date
as January 1, 2024, except with respect
to the provisions in § 131.200(a), (b), (c),
(d)(2), and (d)(8)(ii) stated above, which
are stayed.
Dated: March 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05804 Filed 3–22–22; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16394-16395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 130 and 131
[Docket No. FDA-2000-P-0126 (formerly Docket No. 2000P-0658)]
RIN 0910-AI40
Milk and Cream; Petition for an Administrative Stay of Action:
Definitions and Standards of Identity for Yogurt, Lowfat Yogurt, and
Nonfat Yogurt
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; notification of administrative stay.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is providing
notice of a stay of the effectiveness of certain provisions of a final
rule published in the Federal Register of June 11, 2021. The final rule
amended the definition and standard of identity for yogurt and revoked
the definitions and standards of identity for lowfat yogurt and nonfat
yogurt. FDA is publishing this notification in response to objections
timely filed in accordance with regulatory requirements.
DATES: FDA is administratively staying certain provisions in the final
rule published on June 11, 2021 (86 FR 31117). FDA will publish a
document in the Federal Register lifting the stay or taking further
action as needed.
ADDRESSES: For access to the docket, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Joan Rothenberg, Center for Food
Safety and Applied Nutrition, Office of Regulations and Policy, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2021 (86 FR 31117), FDA issued
a final rule (the 2021 final rule) amending the definition and standard
of identity for yogurt ((Sec. 131.200) (21 CFR 131.200)) and revoking
the definitions and standards of identity for lowfat yogurt (21 CFR
131.203) and nonfat yogurt (21 CFR 131.206). The 2021 final rule's
effective date was July 12, 2021. Pursuant to section 701(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)), the
2021 final rule notified persons who would be adversely affected by the
2021 final rule that they could file objections, specifying with
particularity the provisions of the 2021 final rule deemed
objectionable, stating the grounds therefor, and requesting a public
hearing upon such objections.
The International Dairy Foods Association (IDFA) and Chobani timely
filed objections and requests for a hearing with respect to several
provisions in the 2021 final rule (see Objections and Request for
Hearings submitted by Michael Dykes, DVM, President and Chief Executive
Officer, International Dairy Foods Association, dated July 12, 2021, to
the Dockets Management Staff, Food and Drug Administration (Comment ID
FDA-2000-P-0126-0109) and Objection and Requests for Hearing submitted
by Matthew Graziose, Ph.D., Director, Regulatory Affairs & Compliance,
Chobani, dated July 12, 2021, to the Dockets Management Staff, Food and
Drug Administration (Comment ID FDA-2000-P-0126-0108)). Section
701(e)(2) of the FD&C Act provides that, until final action is taken by
the Secretary, the filing of objections
[[Page 16395]]
operates to stay the effectiveness of those provisions to which the
objections are made. We established the definition and standard of
identity for yogurt in 1981 (1981 final rule) (46 FR 9924 at 9939,
January 30, 1981). The 2021 final rule amended some provisions in the
definition and standard of identity and maintained others. Staying the
effectiveness of these provisions results in the corresponding
requirements in the 1981 final rule remaining in effect. This notice
provides clarification on which provisions of the 2021 final rule have
been stayed and which requirements of the 1981 final rule are in effect
pending final action under section 701(e) of the FD&C Act.
II. Objections and Requests for Hearing
IDFA's objections were directed at several provisions in Sec.
131.200(a) of the 2021 final rule. IDFA objected to the requirement in
Sec. 131.200(a) that yogurt, before the addition of bulky flavoring
ingredients, has either a titratable acidity of not less than 0.7
percent, expressed as lactic acid, or a pH of 4.6 or lower. This
provision of the 2021 final rule is stayed. FDA notes that the
definition and standard of identity established in 1981 included a
minimum titratable acidity requirement of 0.9 percent, but that
provision was stayed by the filing of objections in 1981 (47 FR 41519
at 41523, September 21, 1982). Consequently, no minimum titratable
acidity requirement or maximum pH requirement is in effect.
IDFA also objected to the provision that yogurt, before the
addition of bulky flavoring ingredients, contains not less than 3.25
percent milkfat and the provision requiring pasteurized cream, if used
as a basic dairy ingredient under Sec. 131.200(b) or an optional dairy
ingredient under Sec. 131.200(c), to be added before culturing. These
provisions of the 2021 final rule are stayed. However, a minimum
milkfat of 3.25 percent before the addition of bulky flavors and the
requirement that cream be included in the culturing process remain in
effect under the definition and standard of identity established in the
1981 final rule.
Chobani objected to the exclusion of ultrafiltered milk from the
basic dairy ingredients in Sec. 131.200(b). This provision is stayed
insofar as it prohibits the use of ultrafiltered milk. However, the
provision in the 1981 final rule remains in effect with respect to the
use of ultrafiltered milk. This means that ultrafiltered milk may not
be used as a basic dairy ingredient in the manufacture of yogurt.
Because we received no objections to the use of ultrafiltered milk as
an optional dairy ingredient under Sec. 131.200(c) of the 2021 final
rule, ultrafiltered milk may be used to increase the milk solids, not
fat content, of the food above 8.25 percent, provided that the ratio of
protein to total nonfat solids of the food and the protein efficiency
ratio of all protein present is not decreased as a result.
IDFA also objected to provisions in Sec. 131.200(d) for other
optional ingredients. These provisions included Sec. 131.200(d)(2),
which limits the use of sweeteners to nutritive carbohydrate
sweeteners, and Sec. 131.200(d)(8)(ii), which requires a minimum
vitamin D content of 25 percent Daily Value (DV) per reference amount
customarily consumed (RACC) if vitamin D is added. Both provisions in
the 2021 final rule are stayed. Optional vitamin D addition has been
permitted since 1982 at a level of 400 international units per quart
(see 47 FR 41519 at 41520 and 41524); this limitation on vitamin D
addition remains in effect. The prohibition on the use of sweeteners
other than nutritive carbohydrate sweeteners remains in effect under
the 1981 final rule's definition and standard of identity. Because we
received no objections to permitting the use of all safe and suitable
nutritive carbohydrate sweeteners, nutritive carbohydrate sweeteners
are no longer limited to those listed under Sec. 131.200(c)(2) in the
1981 final rule.
This notification does not constitute a determination that a
hearing is justified on any objections or requests for hearing that
have been filed (21 CFR 12.23). Until FDA makes such a determination
and issues a notice under 21 CFR 12.28, 12.26, or 12.35, we intend to
exercise enforcement discretion with respect to the following:
Addition of vitamin D to yogurt under Sec. 131.200 and
lower fat yogurt products under Sec. 130.10 (21 CFR 130.10) such that
the food contains at least 10 percent DV per RACC, within limits of
current good manufacturing practices.
Use of nonnutritive sweeteners in yogurt under Sec.
131.200 and lower fat yogurt products under Sec. 130.10 that are not
labeled with a statement of identity that includes an expressed
nutrient content claim consistent with the use of nonnutritive
sweeteners.
Use of bulky flavor ingredients in lower fat yogurt
products under Sec. 130.10 that increase the total fat content above
the level specified in Sec. 101.62(b) (21 CFR 101.62(b)) for the
expressed nutrient content claim in the statement of identity, provided
that the level of milkfat in the product is consistent with the level
specified in Sec. 101.62(b) and the statement of identity also
includes a descriptor of the bulky flavor ingredient (e.g., ``lowfat
yogurt with coconut'').
Under this enforcement discretion, we do not intend to take action
with respect to yogurt and lower fat yogurt products that meet these
criteria provided that the products otherwise conform to the definition
and standard of identity under Sec. 131.200 or Sec. 130.10.
III. Provisions Stayed
Pursuant to section 701(e) of the FD&C Act, we hereby announce that
the following provisions of the 2021 final rule are stayed by the
objections filed:
1. The requirement in Sec. 131.200(a) that yogurt, before the
addition of bulky flavoring ingredients, has either a titratable
acidity of not less than 0.7 percent, expressed as lactic acid, or a pH
of 4.6 or lower.
2. The requirement in Sec. 131.200(a) that yogurt, before the
addition of bulky flavoring ingredients, contains not less than 3.25
percent milkfat.
3. The prohibition in Sec. 131.200(a), (b), and (c) on adding
pasteurized cream after culturing.
4. The exclusion of ultrafiltered milk from the basic dairy
ingredients in Sec. 131.200(b).
5. The limitation on the use of sweeteners in Sec. 131.200(d)(2)
to nutritive carbohydrate sweeteners.
6. The requirement in Sec. 131.200(d)(8)(ii) that vitamin D, if
added, must be present in such quantity that the food contains not less
than 25 percent DV per RACC, within limits of current good
manufacturing practices.
IV. Effective/Compliance Dates
This document hereby confirms the effective date of the 2021 final
rule as July 12, 2021, and the compliance date as January 1, 2024,
except with respect to the provisions in Sec. 131.200(a), (b), (c),
(d)(2), and (d)(8)(ii) stated above, which are stayed.
Dated: March 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05804 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P
