[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

[[Page 71836]]

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