[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Proposed Rules]
[Pages 71834-71836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28145]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 133
[Docket No. FDA-2008-P-0086]
Cheeses and Related Cheese Products; Proposal To Permit the Use
of Ultrafiltered Milk; Reopening the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the proposed rule published in the Federal Register
of October 19, 2005, entitled ``Cheeses and Related Cheese Products;
Proposal to Permit the Use of Ultrafiltered Milk.'' The proposed rule
would amend our regulations to provide for the use of fluid
ultrafiltered (UF) milk in the manufacture of standardized cheeses and
related cheese products. We are reopening the comment period to receive
new information and further comment on current industry practices
regarding the use of fluid UF milk and fluid UF nonfat milk in the
manufacture of standardized cheeses and related cheese products, and
the declaration of fluid UF milk and fluid UF nonfat milk when used as
ingredients in standardized cheeses and related cheese products.
DATES: FDA is reopening the comment period on the proposed rule
published on October 19, 2005 (70 FR 60751). Submit either electronic
or written comments by March 30, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 30, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2008-P-0086 for ``Cheeses and Related Cheese Products; Proposal to
Permit the Use of Ultrafiltered Milk.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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
[[Page 71835]]
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. 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:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, 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.
FOR FURTHER INFORMATION CONTACT: Daniel Reese, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 19, 2005, we proposed to amend
our regulations to provide for the use of fluid UF milk in the
manufacture of standardized cheeses and related cheese products.
Specifically, the proposed rule, if finalized, for standardized cheeses
and related cheese products, would (1) Amend the definitions of
``milk'' and ``nonfat milk'' in Sec. 133.3 (21 CFR 133.3) to provide
for ultrafiltration of milk and nonfat milk; and (2) define
ultrafiltered milk and ultrafiltered nonfat milk in Sec. 133.3 as raw
or pasteurized milk or nonfat milk that is passed over one or more
semipermeable membranes to partially remove water, lactose, minerals,
and water-soluble vitamins without altering the casein-to-whey protein
ratio of the milk or nonfat milk and resulting in a liquid product. FDA
also proposed that the name of such treated milk be ``ultrafiltered
milk'' or ``ultrafiltered nonfat milk,'' as appropriate. Consequently,
when this type of milk is used, it would be declared in the ingredient
statement of the finished food as ``ultrafiltered milk'' or
``ultrafiltered nonfat milk.''
This proposal was issued in response to citizen petitions from the
American Dairy Products Institute and the National Cheese Institute,
the Grocery Manufacturers of America, Inc., and the National Food
Processors Association. Interested persons were originally given until
January 17, 2006, to comment. We subsequently reopened the comment
period to seek further comment on two specific issues raised by the
comments concerning the proposed ingredient declaration (72 FR 70251,
December 11, 2007); the reopened comment period was scheduled to end on
February 11, 2008. In the Federal Register of February 11, 2008 (73 FR
7692), we extended the comment period until April 11, 2008.
In the Federal Register of August 14, 2017 (82 FR 37815), we
announced the availability of a guidance for industry entitled
``Ultrafiltered Milk in the Production of Standardized Cheeses and
Related Cheese Products.'' In the guidance, we notified manufacturers
who wish to use UF milk or UF nonfat milk in the production of
standardized cheeses and related cheese products of our intent to
exercise enforcement discretion regarding the use of fluid UF milk and
fluid UF nonfat milk in the production of standardized cheeses and
related cheese products, provided that the physical, chemical, and
organoleptic properties of the cheese or cheese product are not
affected. We also stated our intent to exercise enforcement discretion
with respect to the labeling of fluid UF milk and fluid UF nonfat milk
in recognition of the costs and logistics involved in label changes;
however, we encouraged industry to identify these ingredients as
``ultrafiltered milk'' and ``ultrafiltered nonfat milk'' to the extent
feasible and appropriate. We further explained that we intend to
exercise enforcement discretion until we have completed a rulemaking
process amending our regulations with respect to the issues covered by
the guidance or announced our determination not to proceed with such a
rulemaking.
II. Additional Issues for Consideration
To inform our decision on whether to proceed with the rulemaking
initiated in the October 19, 2005, proposal, we seek new information
and public comment on current industry practices regarding the use of
fluid UF milk and fluid UF nonfat milk in the manufacture of
standardized cheeses and related cheese products, and the declaration
of fluid UF milk and fluid UF nonfat milk in the labeling of these
products when used as ingredients. Of particular interest, we seek
comment on the following questions:
1. We would like to understand whether there is variable use of
fluid UF milk or fluid UF nonfat milk in the production of standardized
cheeses and related cheese products. For example, if a company uses
fluid UF milk in the production of a standardized cheese, does the
amount of fluid UF milk remain constant, or does the amount vary
depending on certain factors (such as the cost of fluid UF milk)?
Please explain whether the amount of fluid UF milk or fluid UF nonfat
milk varies for specific standardized cheeses and related cheese
products and the factors that influence the variability. To maintain
the essential characteristics of the standardized cheese or cheese
product, is the amount of fluid UF milk or fluid UF nonfat milk limited
to a range (i.e., a minimum and maximum amount)? Please identify the
specific standardized cheese or cheese product and provide any ranges
or amounts and explain your reasoning.
2. (a) We invite comment on why manufacturers may sometimes produce
their particular brands of standardized cheeses and related cheese
products with fluid UF milk or fluid UF nonfat milk and sometimes
without fluid UF milk or fluid UF nonfat milk. Please explain your
reasoning.
(b) Given that manufacturers may sometimes choose to produce these
products with or without fluid UF milk or fluid UF nonfat milk, we are
interested in how ingredient labeling of these standardized cheeses and
related cheese products could be addressed.
Our understanding is that fluid UF milk and fluid UF nonfat milk,
when used as ingredients in cheese, are always used in lesser amounts
by weight than milk and nonfat milk in order to avoid affecting the
physical, chemical, and organoleptic properties of the cheese. For
example, a manufacturer might use milk and fluid UF milk, but our
understanding is that the amount of fluid UF milk will be less than
that of milk. As such, milk would be the predominant ingredient and
declared first in the ingredient statement, per FDA's regulations that
require ingredients to be declared by their common or usual names in
descending order of predominance by weight (21 CFR 101.4(a)). Fluid UF
milk, if used, would be declared thereafter.
Based on our understanding, we are considering whether, when fluid
UF milk and fluid UF nonfat milk are sometimes used as ingredients, the
labeling of standardized cheeses and cheese products may alternatively
declare ``milk or milk and ultrafiltered
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milk'' or ``nonfat milk or nonfat milk and ultrafiltered nonfat milk''
in the ingredient statements. We invite comment on this consideration
and whether such declarations would indicate that fluid UF milk or
fluid UF nonfat milk may be an ingredient, but not as predominant as
milk or nonfat milk, and also enable manufacturers to avoid relabeling
costs if they use varying amounts of fluid UF milk or fluid UF nonfat
milk. Please discuss whether such declarations would be informative
(or, conversely, potentially misleading to consumers) and please
explain your reasoning.
3. We also are interested in issues related to the costs of
printing different product labels and the logistics involved in label
changes when fluid UF milk and fluid UF nonfat milk are sometimes used
as ingredients in the production of a manufacturer's standardized
cheese or cheese product. For example, what impacts, if any, would a
label statement of ``milk or milk and ultrafiltered milk'' or ``nonfat
milk or nonfat milk and ultrafiltered nonfat milk'' have on labeling
costs? How would these costs compare if fluid UF milk and fluid UF
nonfat milk are declared only when used in the standardized cheese or
cheese product? Please explain your reasoning.
4. Ultrafiltered milk is being used in a greater number of food
products than in the past. There are dairy products in the marketplace,
which appear to have gained consumer acceptance, where ``ultrafiltered
milk'' has appeared in the statement of identity or declared in the
ingredient statement on the product label. Are there any situations
where retailers or consumers would not purchase standardized cheeses or
cheese products labeled as containing ``ultrafiltered milk'' as an
ingredient? Please describe such situations and provide any recent
consumer data or market analyses you may have to explain your
reasoning.
Dated: December 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28145 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P