
[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)]
[Rules and Regulations]
[Pages 37815-37817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 133

[Docket No. FDA-2017-D-4713]


Ultrafiltered Milk in the Production of Standardized Cheeses and 
Related Cheese Products: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Ultrafiltered Milk 
in the Production of Standardized Cheeses and Related Cheese Products: 
Guidance for Industry.'' The guidance advises manufacturers who wish to 
use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF 
nonfat milk) in the production of standardized cheeses and related 
cheese products that, pending completion of a rulemaking regarding the 
use of UF milk in the production of these products, we intend 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. We also intend to exercise enforcement 
discretion regarding the declaration of ingredients in the labeling of 
standardized cheeses and related cheese products when fluid UF milk and 
fluid UF nonfat milk are used as ingredients.

DATES: The announcement of the guidance is published in the Federal 
Register on August 14, 2017. Submit either electronic or written 
comments on FDA guidance at any time.

ADDRESSES: You may submit comments as follows:

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-2017-D-4713 for ``Ultrafiltered Milk in the Production of 
Standardized Cheeses and Related Cheese Products: Guidance for 
Industry.'' Received comments 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.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

[[Page 37816]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Terri Wenger, Center for Food Safety 
and Applied Nutrition (HFS-800), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2373.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Ultrafiltered Milk in the Production of Standardized Cheeses 
and Related Cheese Products: Guidance for Industry.'' We are issuing 
this guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance represents the current thinking of FDA on 
this topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.
    Our regulations specify the standards of identity for cheeses and 
related cheese products in part 133 (21 CFR part 133). The general 
provisions within part 133, in part, define ``milk'' and ``nonfat 
milk'' that may be used in the manufacture of cheeses and related 
cheese products. The definitions for ``milk'' and ``nonfat milk'' in 
Sec.  133.3(a) and (b), respectively, list different forms of milk and 
nonfat milk, including concentrated, reconstituted, and dried forms, 
that may be used in the making of cheeses and related cheese products. 
However, fluid or dried filtered forms of milk obtained through 
mechanical filtration of milk or nonfat milk are not included within 
these definitions. Therefore, while current regulations permit the use 
of concentrated, reconstituted, and dried forms of milk and nonfat milk 
as basic dairy ingredients (i.e., the only difference in these 
ingredients is the amount of water), they do not provide for the use of 
fluid or dried filtered milk or fluid or dried filtered nonfat milk as 
basic dairy ingredients in standardized cheeses and related cheese 
products.
    Mechanical filtration technologies available for milk processing 
include ultrafiltration. For purposes of this guidance, we consider 
filtration to be a process whereby milk is passed over a series of 
semipermeable membranes with varying pore sizes. Ultrafiltration 
retains macromolecules and particles larger than about 0.001-0.02 
micrometers. In dairy processing, ultrafiltration is typically used to 
retain all protein components of milk, including casein and whey 
proteins, while some of the lactose, minerals, and water soluble 
vitamins present in milk are lost along with water.
    For purposes of the guidance, UF milk means raw or pasteurized milk 
that is passed over one or more semipermeable membranes to partially 
remove water, lactose, minerals, and water-soluble vitamins without 
altering the casein::whey protein ratio of the milk and resulting in a 
liquid product. UF nonfat milk is defined similarly, except that raw or 
pasteurized nonfat milk is used.
    In the Federal Register of October 19, 2005 (70 FR 60751), we 
issued a proposed rule that would amend our regulations to provide for 
the use of fluid UF milk in the manufacture of standardized cheeses and 
related cheese products. We tentatively concluded that the proposed 
rule, if finalized, would promote honesty and fair dealing in the 
interest of consumers and, to the extent practicable, achieve 
consistency with existing international standards of identity for 
cheeses and related cheese products.
    While we have not completed the rulemaking as of August 2017, we 
are aware of issues regarding UF milk in the United States. In brief, 
due to recent developments in the export market, the United States 
dairy industry is experiencing an oversupply of and pricing challenges 
with domestically produced UF milk (Refs. 1 and 2). Additionally, we 
have received requests to exercise enforcement discretion while the 
rulemaking is pending, in part to mitigate the impact on U.S. companies 
producing UF milk (Ref. 3).
    FDA believes that food standards should provide for flexibility in 
manufacturing procedures and ingredients, provided that the basic 
nature and essential characteristics of the food are preserved. Given 
the oversupply of UF milk and the pending rulemaking, through this 
guidance we are announcing 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 
under part 133, in addition to the other required dairy ingredients, 
provided that the physical, chemical, and organoleptic properties of 
the cheese or cheese product are not affected. FDA is also announcing 
its intent to exercise enforcement discretion with respect to the 
labeling of standardized cheeses and related cheese products, when, in 
addition to milk or nonfat milk, fluid UF milk or fluid UF nonfat milk 
is used as an ingredient, but is not declared in the ingredient 
statement, provided that milk or nonfat milk is declared in the 
ingredient statement. We are exercising 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 encourage industry to identify these ingredients as 
``ultrafiltered milk'' and ``ultrafiltered nonfat milk'' to the extent 
feasible and appropriate. We intend to exercise enforcement discretion 
until we have completed a rulemaking process amending our regulations 
with respect to the issues covered by this guidance, or announce in the 
Federal Register our determination not to proceed with such a 
rulemaking.
    We are issuing this guidance without prior public comment under 21 
CFR 10.115(g)(2) because we have determined that prior public 
participation is not feasible or appropriate, as this guidance 
implements a temporary enforcement policy to address an oversupply of 
UF pending the completion of rulemaking regarding the use of UF milk in 
the production of standardized cheeses and related cheese products. The 
oversupply of UF milk would be worsened if we deferred exercising of 
enforcement discretion regarding the matters in the guidance while 
providing an opportunity for prior public comment. (We also note that, 
as we stated in the preamble to the 2005 proposed rule, we tentatively 
conclude that fluid UF milk can be used in standardized cheeses while 
maintaining the essential characteristics of those cheeses specified in 
the individual standards of identity in part 133 (see 70 FR 60751 at 
60756 through 60757).) However, as with all Agency guidances, the 
public may comment on the guidance at any time. This guidance is not 
subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

[[Page 37817]]

III. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.
1. Letter from Senator Amy Klobuchar, Senator Al Franken, 
Representative Collin Peterson, and Representative Tim Walz, to 
President Donald J. Trump, accessed on the Web at https://www.klobuchar.senate.gov/public/index.cfm/2017/4/klobuchar-franken-peterson-walz-urge-administration-to-support-minnesota-dairy-farmers-through-strong-enforcement-of-our-trade-laws-with-canada.
2. Congressional Research Service, ``New Canadian Dairy Pricing 
Regime Proves Disruptive for U.S. Milk Producers,'' dated April 20, 
2017, accessed on the Web at https://www.everycrsreport.com/reports/IN10692.html.
3. Letter from Michael D. Dykes, D.V.M., President and CEO, 
International Dairy Foods Association, to Stephen Ostroff, M.D., 
Deputy Commissioner for Foods and Veterinary Medicine, Food and Drug 
Administration, dated June 22, 2017.

    Dated: August 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17118 Filed 8-11-17; 8:45 am]
BILLING CODE 4164-01-P


