[Federal Register Volume 73, Number 28 (Monday, February 11, 2008)]
[Proposed Rules]
[Pages 7692-7693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2454]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 133

[Docket No. FDA-2008-P-0086] (formerly Docket No. 2000P-0586)


Cheeses and Related Cheese Products; Proposal to Permit the Use 
of Ultrafiltered Milk; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period until April 11, 2008, for a proposed rule that was 
published in the Federal Register of October 19, 2005 (70 FR 60751). 
FDA issued a Federal Register notice to reopen the comment period on 
this proposal on December 11, 2007 (72 FR 70251), to seek further 
comment on only two specific issues raised by the comments concerning 
the proposed ingredient declaration. The agency is extending this 
comment period in response to a request to give interested parties 
additional time to provide the information requested by FDA in that 
notice.

DATES: Submit written or electronic comments by April 11, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
P-0086, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), 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.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 19, 2005 (70 FR 60751), FDA 
proposed to amend the definitions of ``milk'' and ``nonfat'' milk in 
Sec.  133.3 (21 CFR 133.3) for cheeses and related cheese products to: 
(1) Provide for ultrafiltration of milk and nonfat milk; (2) define UF 
milk and UF nonfat milk 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; and (3) require that such treated milk 
be declared in the ingredient statement of the finished food as 
``ultrafiltered milk'' and ``ultrafiltered nonfat milk,'' respectively.
    The agency received about 24 responses, each containing one or more 
comments to the 2005 proposal. Most comments supported the proposed use 
of fluid UF milk in standardized cheeses and related cheese products 
and several comments encouraged the agency to adopt the definition of 
fluid UF milk as proposed. However, although they did not disagree that 
fluid UF milk is significantly different from ``milk,'' several 
comments opposed the proposed provision to require fluid UF milk or 
fluid UF nonfat milk to be declared as ``ultrafiltered milk'' or 
``ultrafiltered nonfat milk,'' respectively. They cited several reasons 
for their opposition.
    FDA reopened the comment period on the proposed rule on December 
11, 2007

[[Page 7693]]

(72 FR 70251) to seek public comment only with respect to two issues 
raised in the comments that opposed the proposed provision to require 
fluid UF milk or fluid UF nonfat milk to be declared as ``ultrafiltered 
milk'' or ``ultrafiltered nonfat milk,'' respectively: (1) That, due to 
economic and logistical burdens, it would be impracticable for cheese 
manufacturers to comply with the labeling requirement; and (2) that the 
proposed provision to declare fluid UF milk as ``ultrafiltered milk'' 
would be misleading to consumers in that consumers incorrectly believe 
that cheeses that declare ``ultrafiltered milk'' as an ingredient are 
different from those cheeses that declare ``milk'' as an ingredient or 
``milk and ultrafiltered milk'' as ingredients.
    The agency has received a request for an additional 60 days to 
respond to the questions FDA asked in its December 11, 2007, document. 
The request expressed concern that the reopening of the comment period 
did not allow adequate time to provide the data and information that 
FDA requested.
    FDA has considered the request and is extending the request for an 
additional 60 days until April 11, 2008. The agency believes that this 
additional time will provide interested parties sufficient time to 
respond to the questions raised in the December 11, 2007, docment.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: February 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2454 Filed 2-8-08; 8:45 am]
BILLING CODE 4160-01-S