Document ID: FDA-2008-P-0086-0036
Agency: fda
Document Type: Proposed Rule
Title: Cheeses and Related Cheese Products; Proposal To Permit the Use
of Ultrafiltered Milk; Reopening the Comment Period
Posted Date: 2020-04-15T04:00Z

[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Proposed Rules]
[Pages 20891-20893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07749]

=======================================================================
-----------------------------------------------------------------------

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.

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

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. FDA is reopening the comment period to update 
comments and to receive any new information.

DATES: FDA is reopening the comment period on the proposed rule 
published on October 19, 2005 (70 FR 60751), for

[[Page 20892]]

which we had reopened the comment period as recently as December 30, 
2019 (84 FR 71834). The reopened comment period ended on March 30, 
2020. Through this document, we are reopening the comment period again. 
Submit either electronic or written comments by August 13, 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 August 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 13, 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 
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.govinfo.gov/content/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: Jessie Zhao, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 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

[[Page 20893]]

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.
    In the Federal Register of December 30, 2019, we announced another 
reopening of the comment period to receive 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. The reopened comment period ended 
on March 30, 2020.
    Following publication of the December 30, 2019, document reopening 
the comment period for the proposed rule, we received requests to allow 
interested persons additional time to comment. In conjunction with the 
requests, we are providing an additional 120 days for persons to 
respond fully to FDA's specific requests for comments and to allow 
potential respondents to thoroughly evaluate and address pertinent 
issues. Therefore, we are reopening the comment period until August 13, 
2020.

    Dated: April 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07749 Filed 4-14-20; 8:45 am]
 BILLING CODE 4164-01-P