[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Proposed Rules]               
[Page 70251-70255]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-14]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 133

[Docket No. 2000P-0586 (Formerly Docket No. 00P-0586)]

 
Cheeses and Related Cheese Products; Proposal to Permit the Use 
of Ultrafiltered Milk; Reopening of 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) is reopening until 
February 11, 2008, the comment period for the proposed rule published 
in the Federal Register of October 19, 2005 (70 FR 60751), (herein 
after referred to as the 2005 proposed rule). In that document, FDA 
proposed to amend its regulations to provide for the use of fluid 
ultrafiltered (UF) milk in the manufacture of standardized cheeses and 
related cheese products. FDA received a number of comments that were 
opposed to the proposed requirement to declare fluid UF milk, when 
used, as ``ultrafiltered milk'' or ``ultrafiltered nonfat milk,'' as 
appropriate, in the ingredient statement of the finished cheese. FDA is 
reopening the comment period on the 2005 proposed rule to seek further 
comment only on two specific issues raised by the comments concerning 
the proposed ingredient declaration.

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

ADDRESSES: You may submit comments, identified by Docket No. 2000P-
0586, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     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 or the agency Web site, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

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. The 2005 Proposed Rule

    In the 2005 proposed rule, 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.
    FDA proposed these amendments principally in response to two 
citizen petitions, one submitted by the American Dairy Products 
Institute (Docket No. 1999P-5198 (formerly

[[Page 70252]]

Docket No. 99P-5198)) and another submitted jointly by the National 
Cheese Institute, the Grocery Manufacturers of America, Inc., and the 
National Food Processors Association (the NCI petition; Docket No. 
2000P-0586 (formerly Docket No. 00P-0586)). In the 2005 proposed rule, 
FDA explained the scientific and legal basis for its tentative 
conclusion to permit the use of fluid UF milk as an ingredient and 
provided a tentative definition of fluid UF milk. In addition, FDA 
tentatively concluded that fluid UF milk, as defined, is significantly 
different in its composition from the starting material ``milk'' and, 
therefore, proposed that fluid UF milk must be declared as 
``ultrafiltered milk'' in the ingredient statement of the finished 
cheese. FDA requested comments on the 2005 proposed rule by January 17, 
2006.

II. Comments to the 2005 Proposed Rule

    The agency received about 24 responses (letters and e-mails), each 
containing 1 or more comments, in response to the 2005 proposed rule. A 
majority of the comments were from industry, including cheese 
manufacturers and milk producers and processors, while other comments 
were from farmers or groups representing farmers, individual consumers, 
foreign governments, a research institution, and a member of Congress. 
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 is 
seeking public comment only with respect to two of their reasons that: 
(1) Due to economic and logistical burdens, it would be impracticable 
for cheese manufacturers to comply with the labeling requirement; and 
(2) 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. In 
section III of this document, the agency discusses the primary 
arguments that the comments presented with respect to each of these 
reasons.
    Comments also opposed other tentative conclusions that the agency 
stated in the 2005 proposed rule. The agency has considered those 
comments and intends to respond to all issues raised by the comments in 
any subsequent final rule. However, at this time, the agency is not 
seeking further comment on any topic other than the two related to the 
labeling provision, as described in section III of this document.

III. Request for Comments

    By way of background, section 403(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 343), which governs the labeling of 
ingredients in foods, requires, with few exceptions, the declaration of 
all ingredients by their individual common or usual names. Section 
403(i) of the act also provides that to the extent that compliance with 
this requirement ``is impracticable, or results in deception or unfair 
competition,'' FDA shall establish regulations for exemptions from this 
requirement.
    As noted in section II of this document, FDA received comments from 
industry opposing the proposed requirement to declare fluid UF milk as 
``ultrafiltered milk'' or ``ultrafiltered nonfat milk'' in the 
ingredient statement of the finished cheese in which these ingredients 
are used. FDA is seeking comments with respect to two of the reasons 
that these comments cited in support of their opposition to the 
proposed labeling provision, i.e., that it would be impracticable for 
industry to comply with the proposed labeling requirement and that 
declaring fluid UF milk as ``ultrafiltered milk'' would be misleading 
to consumers.
    Comments previously submitted to the Division of Dockets Management 
do not need to be and should not be resubmitted. All comments 
previously submitted to the docket number found in brackets in the 
heading of this document, and comments submitted in response to this 
limited reopening of the comment period, will be considered in any 
final rule to the 2005 proposed rule.

A. Impracticability

    Some comments stated that the proposed labeling requirement would 
be impracticable for the cheese industry to implement in a cost-
effective way. They stated that the cost of complying with the proposed 
labeling requirement would outweigh any economic benefits provided by 
the use of fluid UF milk in cheesemaking. They further maintained that 
cheese manufacturers have long used UF milk in cheddar and mozzarella 
cheeses without declaring it as ``ultrafiltered milk.'' Another comment 
emphasized that ``outsourced UF milk'' (a term the comments used to 
refer to milk that is ultrafiltered at a facility other than the plant 
where the cheese is produced) is widely used in today's marketplace and 
labeling changes at this time would reduce or eliminate the currently 
realized economic benefits of using UF milk. The comments contained 
several arguments in support of their claim of impracticability.
    (Comment 1) Some comments stated that cheese manufacturers do not 
use ``outsourced UF milk'' on a consistent basis and that they use milk 
and ``outsourced UF milk'' interchangeably as needed and economically 
practical and, therefore, it would be economically and logistically 
burdensome to monitor the use of UF milk.
    (Response) The agency questions the basis for this argument. The 
2005 proposed rule provides for optional (not mandatory) use of fluid 
UF milk and, therefore, manufacturers have the option to use fluid UF 
milk as an ingredient only if it is economically practical. Cost 
considerations would factor into a firm's decision to use fluid UF 
milk, as with any other ingredient. Furthermore, it is FDA's 
understanding that fluid UF milk is likely to be used simultaneously, 
not interchangeably, with milk. As FDA explained in the 2005 proposed 
rule (70 FR 60751 at 60759), most cheeses are amenable to the use of 
fluid UF milk, not in lieu of milk, but as a supplement to milk to 
produce a protein-standardized milk and thus increase cheese yield. In 
addition, the petitioners acknowledged that fluid UF milk is 
economically beneficial to cheese manufacturers because it increases 
cheese yield, decreases production time, and decreases costs associated 
with shipping of raw materials and disposal of whey (a byproduct of 
cheesemaking) (pp. 8-9, the NCI petition).
    (Comment 2) According to a trade association, cheese manufacturers 
do not have information technology systems in place to track and 
measure the presence of ``outsourced UF milk'' and tracking 
``outsourced UF milk'' becomes even more unmanageable as the cheese is 
further processed into other products, such as shredded cheese blends. 
Further, the comment indicated that suppliers often do not provide 
information on whether the cheese product is made from UF milk and to 
do so would mean more logistical difficulties and added costs. The 
comment also argued that a cheese processor has no way to test a 
product from a supplier to determine if UF milk

[[Page 70253]]

was used and thus ensure that the correct label was affixed to the 
finished food.
    (Response) It is the agency's understanding that most cheesemaking 
production lines are fully automated and allow manufacturers to track 
raw materials from receiving docks through to finished products. 
Published literature, including articles in trade journals, indicate 
that computer-integrated manufacturing systems are used to control 
ingredient feeders and maintain detailed records of the combination of 
ingredients used and results of laboratory analyses of ingredients and 
product formulations (Refs. 1 and 2). Another publication indicated 
that automation in the dairy industry enables manufacturers to track 
every batch of cheese that is produced, including the combination of 
ingredients that are fed into each batch (Ref. 3). Moreover, food 
manufacturers would have to monitor the ingredients that are used to 
manufacture the food they market in order to comply with the ingredient 
declaration provisions of Sec.  101.4 (21 CFR 101.4). Therefore, it is 
unclear to the agency why a cheese supplier would not provide 
information about the ingredients (including fluid UF milk, when used) 
that are used to produce the cheese. With respect to the cost argument, 
the 2005 proposed rule provides for optional (not mandatory) use of 
fluid UF milk and, therefore, manufacturers have the option to weigh 
any associated costs against benefits to determine whether it would be 
economically beneficial to use fluid UF milk in cheese.
    (Comment 3) The trade association also estimated that, in order to 
comply with the labeling requirement, cheese manufacturers will, at a 
minimum, need to triple their label inventory. According to this 
comment, associated costs that will also increase include:
     Producing more labels (estimated at $985,000 to $2.7 
million);
     Carrying additional packaging inventory, risk of obsolete 
packaging, and additional storage space (estimated at doubling or 
tripling of current costs);
     Increasing raw material inventory (estimated at $470,000 
to $5.8 million);
     Additional personnel (estimated at $240,000 to $900,000); 
and
     Administrative and logistical problems (estimates of $5.4 
million and $72 million).
    (Comment 4) Another comment stated that the proposed labeling 
requirement would result in costs to modify tracking systems, update 
specifications, and update quality control programs as well as costs 
associated with increased inventory of raw materials, packaging, and 
finished goods. This comment estimated the cost of complying with the 
labeling requirement to be about $23 million.
    (Response) The comments did not provide a detailed or itemized 
breakdown of the estimation of these costs sufficient to enable the 
agency to conduct any meaningful analysis of these figures. FDA 
requests that interested persons submitting comments on this issue 
provide such data. It is FDA's current understanding that cheese 
manufacturing facilities are already equipped with systems that can 
handle multiple ingredients and combinations of ingredients in the 
manufacture of a cheese product and, therefore, can easily adapt to the 
introduction of a single, new ingredient. Indeed, manufacturers 
routinely adjust existing product formulations or introduce new ones 
based on supply and availability of ingredients and market demand. 
Thus, FDA questions the additional cost described in the comments 
associated with the labeling of this new ingredient given the extensive 
monitoring systems already in place.
    (Comment 5) The trade association also asserted that under the 
proposed labeling requirement, operational efficiencies would decline, 
cheese plants would lose up to an hour a day changing packaging, and 
additional time would be spent auditing labels to ensure proper 
labeling.
    (Response) It seems possible to FDA that declines in operational 
efficiencies can be avoided by proper planning of the production run. 
Further, any decrease in efficiency due to the labeling requirement is 
likely to be offset by increased yield, increased through-put 
(decreased time between coagulation and cutting phases), and increased 
overall production efficiency. Moreover, the provision for fluid UF 
milk, as stated in the 2005 proposed rule, is optional and, if 
finalized as proposed, would not limit manufacturers' ability to weigh 
different cost considerations to determine whether it would be 
economical to use fluid UF milk in their cheese production.
    FDA is interested in factual information or data that would enable 
the agency to fully evaluate claims in these comments that it would be 
impracticable for the cheese industry to comply with the proposed 
labeling requirement. In particular, FDA seeks information on the 
following questions:
    1. What systems do cheese plants use to monitor ingredients 
received and ingredients used in different cheeses and related cheese 
products?
    2. How extensively are cheese plants automated with respect to 
tracking the use of different ingredients?
    3. What types of costs are associated with introducing a new 
ingredient into cheesemaking?
    4. How are costs associated with the use of fluid UF milk different 
from those associated with the use of any other new ingredient or other 
reformulation of a cheese product?
    5. Are the costs associated with the labeling of UF milk that are 
estimated by the two comments noted previously reasonable? Explain.
    6. What mechanisms do manufacturers of cheese-based products (for 
example, cheese spreads, processed cheeses, shredded cheese blends) 
currently employ to ensure that the ingredients used in their products, 
including the sub-ingredients of the cheeses used in their products, 
are accurately declared? Why are these same mechanisms inadequate to 
accurately identify fluid UF milk when it is a sub-ingredient of a 
cheese ingredient?

B. Misleading Ingredient Declaration

    Comments that opposed the proposed labeling requirement stated that 
this requirement would lead to consumer confusion and deception. They 
stated that consumers would be misled by special ingredient labeling of 
UF milk, given that the finished cheeses made with or without UF milk 
are indistinguishable and that there are no differing consequences of 
use or allergen-related concerns between the two cheeses. One comment 
also stated that the use of UF milk is not material information because 
cheeses made with or without UF milk are the same. In addition, 
comments from Kraft and those submitted jointly by the International 
Dairy Foods Association (IDFA) and the National Milk Producers 
Federation (NMPF) included consumer research, which they claim 
indicates that consumers, when shown cheese labels that declare either 
``milk,'' ``ultrafiltered milk,'' or ``milk and ultrafiltered milk'' in 
the ingredient statement, believe that the cheeses are different with 
respect to taste, healthfulness, and quality. Based on these results, 
these two comments stated that it would be misleading to consumers to 
declare UF milk as ``ultrafiltered milk'' because it would lead them to 
believe that the cheeses are ``different'' when, in fact, cheeses made 
with or without UF milk are ``identical.'' These comments urged the 
agency to remove the proposed labeling requirement from any final rule 
on this issue such that ultrafiltered milk and

[[Page 70254]]

ultrafiltered nonfat milk, when used as ingredients in standardized 
cheeses and related cheese products, would be declared as simply 
``milk'' and ``nonfat milk,'' respectively, in the ingredient statement 
of the finished food.
    With respect to the consumer research information that Kraft and 
IDFA/NMPF submitted, the agency reviewed these submissions and notes 
several limitations in the design of the surveys and interpretation of 
the results from these surveys (Refs. 4 and 5). In the case of the 
IDFA-commissioned consumer research (IDFA study; n=672), as an Internet 
study, the survey sample cannot be considered representative of the 
population as a whole. The study is essentially a survey with a key 
measure being forced comparisons between two product labels. However, a 
substantial limitation of the study is that the forced comparison 
questions (in which respondents are directed to examine specific label 
information) are not reliable indicators of what consumers are likely 
to do in realistic product selection situations (in which consumers may 
or may not review or consider such information in making their 
choices). A more useful and appropriate research method would be an 
experimental study, which looks to establish cause-effect relationships 
between changes in label information and consumers' judgments and 
inferences. The results of the IDFA study suggest that some study 
participants whose attention is directed to the ``ultrafiltered milk'' 
in a product's ingredient list may infer that the product may be 
different somehow from a product that does not have that specific 
ingredient listed. However, this conclusion is likely to be more a 
product of the logical deduction that something that is labeled 
differently must be different than it is to any understanding of what 
``ultrafiltered milk'' is or how this ingredient may affect the 
product. The IDFA study demonstrates that when study participants 
notice or are directed to notice a single ingredient difference between 
two otherwise similar product labels, some will believe the products 
differ in some way. Of the attributes tested, healthfulness of the 
product was believed to differ by the largest minority (45 percent). 
For taste and quality fewer expected a difference (38 percent and 35 
percent respectively).
    The Kraft consumer research is nearly identical to the IDFA study. 
It is an Internet panel study, with a smaller sample size (n=301), 
conducted among individuals who reported that they were cheese product 
consumers. Like the IDFA study, the Kraft study sample cannot be 
considered representative of the population as a whole or of all 
consumers of cheese products. As did the IDFA study, the Kraft study 
focuses narrowly on the question of whether disclosing ``milk'' or 
``ultrafiltered milk'' in the ingredient list of a cheese product 
affects study participants' perceptions of the product, and the Kraft 
study suffers from the same shortcomings as does the IDFA study. 
Kraft's study demonstrates that when study participants noticed or were 
directed to notice the ingredient difference between two otherwise 
identical product labels, some inferred that the products differ in 
some way. Of the attributes tested, healthfulness of the product was 
believed to differ by nearly half (48 percent) of the respondents. For 
taste and quality fewer respondents expected a difference (32 percent 
and 42 percent respectively).
    Because of the limitations in the design of these studies as noted 
previously, FDA tentatively concludes that the findings from both the 
IDFA study and the Kraft study fail to provide sufficient support for 
their assertion that labeling fluid UF milk on cheese products as 
``ultrafiltered milk'' would be deceptive to consumers.
    With respect to the recommendation of some comments that fluid UF 
milk and fluid UF nonfat milk should be permitted to be declared by the 
collective terms ``milk'' and ``nonfat milk,'' respectively, the agency 
seeks comment on the need for and appropriateness of such declaration. 
The existing provisions for the use of the collective terms ``milk'' 
and ``nonfat milk'' in Sec.  101.4(b) are relatively narrow and limited 
to those forms of milk and nonfat milk from which only water is removed 
to varying degrees. For example, concentrated milk, reconstituted milk, 
and dry whole milk are all permitted as basic ingredients in 
standardized cheeses and Sec.  101.4(b)(4) permits these ingredients to 
be declared as ``milk.'' However, the agency is being asked to consider 
extending this collective declaration provision to fluid UF milk. The 
petitioners and a number of comments in response to the petitions and 
to the 2005 proposed rule have noted that several substances present in 
milk (such as lactose, minerals, and water-soluble vitamins) are lost 
during the ultrafiltration process. The agency also explained the 
process of ultrafiltration and its effect on milk composition based on 
its own review of the scientific literature in the 2005 proposed rule 
(70 FR 60751 at 60752). Unlike concentrated milk, reconstituted milk, 
and dry whole milk, all of which differ from milk only with respect to 
their moisture content (and which are permitted under Sec.  101.4 to be 
declared by the generic term ``milk''), fluid UF milk, as defined in 
the 2005 proposed rule, has a composition that is significantly 
different from that of milk.
    Another factor that should be considered is that fluid UF milk is 
not the standardized food ``milk'' as defined 21 CFR 131.110. Given 
that there is currently no provision in Sec.  101.4 for fluid UF milk 
to be declared as ``milk'' in the ingredient statement of a finished 
food, and that fluid UF milk does not comply with the standard of 
identity for ``milk,'' current regulations do not permit fluid UF milk 
to be declared as ``milk.'' In such instances, consistent with 21 CFR 
101.3, the agency generally applies the principles of common or usual 
name regulations in 21 CFR 102.5 to determine an appropriate name that 
accurately identifies or describes the basic identity of the food. 
Consequently, in the 2005 proposed rule, the agency proposed 
``ultrafiltered milk'' as the appropriate declaration of this 
ingredient. In addition, in response to the petitions, the agency 
previously received comments from consumers who requested that, if 
ultrafiltered milk is permitted as an ingredient, cheeses made with 
this ingredient should be clearly labeled to distinguish them from 
cheeses made with only milk. The agency seeks public comment on the 
need for, and appropriateness of, declaring fluid UF milk (or fluid UF 
nonfat milk) as simply ``milk'' (or ``nonfat milk'') when used as an 
ingredient in standardized cheeses and related cheese products.
    Under certain conditions, FDA has previously permitted the use of 
``or,'' ``and/or,'' or ``contains one or more of the following:'' in 
the declaration of ingredients to accommodate relevant concerns related 
to ingredient supply and availability. For example, Sec.  101.4(b)(23) 
provides that when manufacturers are unable to adhere to a constant 
pattern of fish species ingredient(s) in the manufacture of processed 
seafood products containing fish protein, due to seasonal or other 
limitations of species availability, the common or usual name of each 
individual fish species need not be declared in descending order of 
predominance, and fish species not present in the fish protein product 
may be listed if they are sometimes used in the product. This provision 
permits the declaration of such ingredients using the terms ``or,'' 
``and/or,'' or ``contains one or more of the following:'' to indicate 
to consumers that all of the listed ingredients may not be present or 
that they may not be present in the listed descending order of

[[Page 70255]]

predominance. For example, the provision allows for the declaration 
``fish protein (contains one or more of the following: Pollock, cod, 
and/or pacific whiting).'' Given the concerns that industry has 
expressed with respect to impracticability of the agency's proposed 
labeling requirement (see section III.A of this document), we seek 
comment on the need for and appropriateness of a similar provision for 
the labeling of fluid UF milk that is used interchangeably with milk, 
as needed and when economically and logistically practical, in the 
manufacture of standardized cheeses and related cheese products.
    The agency seeks public comment on whether the labeling requirement 
that the agency proposed would be misleading or deceptive to consumers. 
Specifically, the agency seeks comment on the following questions:
    1. Considering that the products of ultrafiltration, as defined in 
proposed Sec.  133.3(f) and (g) in the 2005 proposed rule, are 
significantly different in composition from milk and nonfat milk, is it 
or is it not appropriate to require that they must be identified by a 
common or usual name other than ``milk'' and ``nonfat milk,'' 
respectively?
    2. If it is appropriate to permit fluid UF milk and fluid UF nonfat 
milk to be declared by the collective terms ``milk'' and ``nonfat 
milk,'' respectively, when used in standardized cheeses and related 
cheese products, what is the scientific and legal justification?
    3. Is there a need to consider the declaration of fluid UF milk and 
fluid UF nonfat milk by a term(s) other than their specific, individual 
common, or usual names when they are used as ingredients in 
standardized cheeses and related cheese products? Should this 
consideration be extended to fluid UF milk and fluid UF nonfat milk 
when they are used as ingredients in other foods? If they are required 
to be declared by different terms when used in standardized cheeses as 
compared to other foods, what would be the scientific and legal basis 
for the different labeling requirements?
    4. Is there a need for the agency to consider providing for ``and/
or'' labeling (similar to such provisions in Sec.  101.4(b)) when fluid 
UF milk or fluid UF nonfat milk are used as ingredients in standardized 
cheeses and related cheese products? What is the scientific and legal 
justification for such a provision?

IV. 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 in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)
    1. Johnson, M.E. and J.A. Lucey, ``Major Technological Advances 
and Trends in Cheese,'' Journal of Dairy Science, 89:1174-1178, 
2006.
    2. Dudlicek, J., ``Cutting Edge: Innovative Processes Keep Dairy 
Manufacturing Moving,'' in the February 2006 ed. of Dairy Field 
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dairyfield.com/content.php?s=DF/2006/02&p=10), accessed 

July 2, 2007.
    3. Tamime, A.Y. and B.A. Law (Eds.), Mechanisation and 
Automation in Dairy Technology, pp. 1-29 and 204-295, Sheffield 
Academic Press Ltd., Sheffield, England, 2001.
    4. Derby, B.M., Memorandum to Nalubola, R., Consumer Research on 
Ultrafiltered Milk Labeling, February 10, 2006.
    5. Derby, B.M., Memorandum to Nalubola, R., Kraft Consumer 
Research on Ultrafiltered Milk Labeling, August 16, 2006.

    Dated: December 3, 2007.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E7-23981 Filed 12-10-07; 8:45 am]

BILLING CODE 4160-01-S