[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Rules and Regulations]
[Pages 79251-79253]
[FR Doc No: 2022-28035]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2021-N-0851]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Human Leukocyte Antigen Typing Companion
Diagnostic Test

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying the human leukocyte antigen typing companion diagnostic
test into class II (special controls). The special controls that apply
to the device type are identified in this order and will be part of the
codified language for the human leukocyte antigen typing companion
diagnostic test's classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective December 27, 2022. The classification
was applicable on November 28, 2022.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 72, Rm. 7301, Silver Spring, MD, 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the human leukocyte antigen typing
companion diagnostic test as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On July 1, 2022, One Lambda, Inc., submitted a request for De Novo
classification of the SeCORE CDx HLA Sequencing System. FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on November 28, 2022, FDA issued an order to the
requester classifying the device into class II. In this final order,
FDA is codifying the classification of the device by adding 21 CFR
866.5960.\1\ We have named the generic type of device human leukocyte
antigen typing companion diagnostic test, and it is identified as a
prescription genotyping or phenotyping in vitro diagnostic product
intended for use as an aid in identifying patients who have specific
human leukocyte antigen (HLA) allele(s) or express specific HLA
antigen(s) and may benefit from treatment with a corresponding
therapeutic product or are likely to be at increased risk for serious
adverse

reactions as a result of treatment with a corresponding therapeutic
product.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Human Leukocyte Antigen Typing Companion Diagnostic Test Risks
                         and Mitigation Measures
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            Identified risks                   Mitigation measures
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Inaccurate test results (false positive  Labeling, design verification
 or false negative results) can result    and validation, clinical
 in adverse health consequences.          validity data, bridging study.
Failure of software to correctly         Software verification and
 interpret test results can result in     validation.
 adverse health consequences.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in 21 CFR part 860, subpart D, regarding De Novo
classification have been approved under OMB control number 0910-0844;
the collections of information in 21 CFR part 814, subparts A through
E, regarding premarket approval, have been approved under OMB control
number 0910-0231; the collections of information in part 807, subpart
E, regarding premarket notification submissions, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820, regarding quality system regulation, have been
approved under OMB control number 0910-0073; and the collections of
information in 21 CFR part 809, regarding labeling, have been approved
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.5960 to subpart F to read as follows:

Sec.  866.5960  Human leukocyte antigen typing companion diagnostic
test.

    (a) Identification. A human leukocyte antigen (HLA) typing
companion diagnostic (CDx) test is a prescription genotyping or
phenotyping in vitro diagnostic product intended for use as an aid in
identifying patients who have specific HLA allele(s) or express
specific HLA antigen(s) and may benefit from treatment with a
corresponding therapeutic product or are likely to be at increased risk
for serious adverse reactions as a result of treatment with a
corresponding therapeutic product.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The intended use of the device must specify the target HLA
allele(s) or antigen(s), the patient population(s), and the
corresponding therapeutic product(s).
    (2) Design verification and validation must include:
    (i) Detailed documentation of an analytical accuracy study that
uses well-characterized samples including clinical samples from
intended use population(s) focusing on the target allele(s) needed for
patient selection;
    (ii) Detailed documentation of precision studies (repeatability,
reproducibility) that evaluate possible sources of variation that may
affect test results;
    (iii) Detailed documentation of a study determining range of input
sample concentrations that meet performance specifications;
    (iv) Detailed description of the ambiguity resolution method, if
applicable;
    (v) For a sequencing-based assay, documentation of coverage and
predefined coverage threshold of target genomic regions, pertinent
variant types, and sequence contexts;
    (vi) For multiplex assays, documentation of a risk assessment and
design specifications that are in place to prevent incorrect reactivity
assignment;
    (vii) Description of a plan on how to ensure the performance of the
device does not change when new HLA alleles are identified, and/or when
reactivity assignments are changed; and
    (viii) Detailed description of device software including standalone
software, or software and bioinformatics analysis pipeline, if
applicable, incorporated in the instruments, and documentation of
software including the level of concern and associated risks, software
requirement specifications, software design specifications (e.g.,
algorithms, alarms and device limitations), hazard analysis,
traceability matrix, verification and validation testing, unresolved
anomalies, hardware requirements, and effective cybersecurity
management.
    (3) Clinical validity data (which may include summary reports from
clinical trials, comparison studies using clinical samples, or through
an alternative approach determined to be appropriate by FDA),
demonstrating the following, as applicable:
    (i) Which patients identified by the HLA CDx test are most likely
to benefit from the corresponding therapeutic product; and
    (ii) Which patients identified by the HLA CDx test are likely to be
at increased risk for serious adverse reactions as a result of
treatment with the corresponding therapeutic product.
    (4) If the HLA test used in the clinical trials is different from
the HLA CDx test

in the premarket notification submission, the submission must include
results of a bridging study, or an alternative approach determined to
be appropriate by FDA.

    Dated: December 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28035 Filed 12-23-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Rules and Regulations]
[Pages 23876-23879]
[FR Doc No: 2011-10321]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-HQ-OAR-2010-0293; FRL-9300-2]
RIN-2060-AQ56

Clarifications to Indian Tribes' Clean Air Act Regulatory
Requirements; Direct Final Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is taking direct final action to amend certain Clean
Air Act regulations pertaining to Indian tribes. This action changes
the title of the regulations titled, ``Tribal Clean Air Act Authority''
to the more accurate ``Indian Country: Air Quality Planning and
Management.'' The action also reorganizes existing sections for better
placement within the regulations.

DATES: The direct final rule is effective on July 28, 2011 without
further notice, unless EPA receives relevant adverse comments by May
31, 2011. If EPA receives relevant adverse comments, we will publish a
timely withdrawal in the Federal Register informing the public that the
amendments in this rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0293, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Indian Country: Air Quality Planning and Management
Docket, Environmental Protection Agency, Mailcode: 6102T, 1200
Pennsylvania Ave., NW., Washington, DC 20460. Please include a total of
two copies.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC 20460.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0293. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be confidential business information (CBI) or other

information whose disclosure is restricted by statute. Do not submit
information you consider to be CBI or otherwise protected through
http://www.regulations.gov or e-mail. The http://www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through http://www.regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the
Indian Country: Air Quality Planning and Management Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Darrel Harmon, Office of Air and
Radiation (OAR/IO 6101A), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-7416, facsimile number<PHONE_NUMBER>; electronic mail (e-mail)
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information presented in this preamble
is organized as follows:

I. Why is EPA using a direct final rule?
II. What is the purpose of this action?
III. Why is this action needed?
IV. Where can I get a copy of this document?
V. What should I consider as I prepare my comments for EPA?
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. Why is EPA using a direct final rule?

    The EPA is publishing this direct final rule without a prior
proposed rule because we view this as a non-controversial action and
anticipate no adverse comments. This action does not make changes to
any requirements; the action simply renames the existing 40 CFR Part 49
to more accurately reflect its purpose and relocates existing sections
for better organization within the part. Any parties interested in
commenting must do so at this time. Because this is an amendment of
regulatory language through rulemaking, a redline version of the
regulatory language has been created and has been placed in the docket.
(http://www.regulations.gov, see docket number EPA-HQ-OAR-2010-0293) to
aid the public's ability to comment. For further information about
commenting on the rule, see the ADDRESSES section of this document. If
EPA receives adverse comments, we will publish a timely withdrawal in
the Federal Register informing the public the amendments in this direct
final rule will not take effect. We will address any comments received
in a subsequent final rule based on the proposed rule.

II. What is the purpose of this action?

    The purpose of this action is to (1) retitle 40 CFR Part 49
``Tribal Clean Air Act Authority'' to the more accurate ``Indian
Country: Air Quality Planning and Management,'' and (2) relocate three
existing sections from Subpart A, which is intended to include only
general tribal authority-related provisions, to Subpart L, which
includes provisions specific to implementation plans for tribes located
in EPA Region IX. The three sections that will be moved from 40 CFR
part 49 subpart A to Subpart L are Sec.  49.22 Federal Implementation
Plan for Tri-cities Landfill, Salt River Pima-Maricopa Indian Community
(will become Sec.  49.5511), Sec.  49.23 Federal Implementation Plan
Provisions for Four Corners Power Plant, Navajo Nation (will become
Sec.  49.5512), and Sec.  49.24 Federal Implementation Plan Provisions
for Navajo Generating Station, Navajo Nation (will become Sec.
49.5513). Sections 49.22, 49.23, and 49.24 will be reserved in the
event new general tribal authority-related provisions are promulgated
in the future.

III. Why is this action needed?

    This rule is needed to provide regulatory clarity to Indian tribes.
The change in the title of the part from ``Tribal Clean Air Act
Authority'' to the more accurate ``Indian Country: Air Quality Planning
and Management'' is needed because the current title suggests the part
only includes requirements applicable to the granting of authority to
tribes under the Clean Air Act. While the title was appropriate when
Part 49 was originally promulgated, since then other regulations not
relating to tribal authority have been added to the part such that the
title is no longer broad enough to encompass the entire scope of these
regulations. ``Indian Country: Air Quality Planning and Management'' is
a broader, more accurate title which identifies the Part 49 regulations
as relating more generally to the planning and management of air
quality in Indian country. It has been long recognized by EPA
Headquarters (HQ) and Regions the title did not fully illustrate the
context of the rule and could be misread. For this reason, EPA HQ and
Regions have an interest in changing the title to reduce any confusion.
This change will also enable tribes to more easily recognize the Clean
Air Act regulation that affects them.
    The rule also moves sections 49.22, 49.23 and 49.24 out of Subpart
A, which is intended to include provisions relating generally to tribal
authority regardless of the EPA Region in which a tribe is located, to
Subpart L, Implementation Plans for Tribes in Region IX, such that all
implementation plan provisions that apply specifically to Region IX
tribes are located together.

IV. Where can I get a copy of this document?

    In addition to being available in the docket, an electronic copy of
this final

action will also be available on the Worldwide Web (WWW) through the
Technology Transfer Network (TTN). Following signature, a copy of this
final action will be posted on the TTN's policy and guidance page for
newly proposed or promulgated rules at the following address: http://www.epa.gov/ttn/oarpg/. The TTN provides information and technology
exchange in various areas of air pollution control.

V. What should I consider as I prepare my comments for EPA?

    Do not submit information containing CBI to EPA through http://www.regulations.gov or e-mail. Send or deliver information identified
as CBI only to the following address: Roberto Morales, OAQPS Document
Control Officer (C404-02), Office of Air Quality Planning and
Standards, Environmental Protection Agency, Research Triangle Park,
North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2010-0293.
Clearly mark the part or all of the information you claim to be CBI.
For CBI information in a disk or CD ROM that you mail to EPA, mark the
outside of the disk or CD ROM as CBI and then identify electronically
within the disk or CD ROM the specific information that is claimed as
CBI. In addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR Part 2.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is, therefore, not subject to review under the Executive Orders 12866
and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
These amendments do not result in changes to the information collection
requirements of the existing regulations and will have no impact on the
information collection estimate of projected cost and hour burden made
and approved by the Office of Management and Budget (OMB) during the
development of the existing regulations. However, the Office of
Management and Budget (OMB) has previously approved the information
collection requirements contained in the existing regulations (40 CFR
Part 49) under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB control numbers (2060-0306 and 2060-
0558). The OMB control numbers for EPA's regulations in 40 CFR are
listed in 40 CFR Part 9. Therefore, the information collection requests
have not been amended.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the Agency certifies the rule
would not have a significant economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For the purposes of assessing the impacts of this rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's regulations at 13 CFR 121.201;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district, or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify this action will not have a significant economic
impact on a substantial number of small entities. This rule will not
impact small entities due to the fact these amendments simply rename
the title and reorganize existing sections for better placement within
the regulation. There are no substantive changes to the regulation.
Small entities will not incur any adverse impacts as a result of this
rule because this action does not create any new requirements or
burdens. No costs are associated with these amendments.

D. Unfunded Mandates Reform Act

    This rule does not contain a Federal mandate that may result in
expenditures of $100 million or more for state, local, and tribal
governments, in the aggregate, or to the private sector in any one
year. This direct final rule is not expected to impact state, local, or
tribal governments. Thus, this rule is not subject to the requirements
of sections 202 and 205 of the Unfunded Mandates Reform Act (UMRA).
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. These amendments
simply rename the title and move subparts to fit more appropriately in
later subparts. There are no substantive changes to the regulation.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This direct final rule does not
impose any requirements on state and local governments. Thus, Executive
Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 6, 2000). These amendments
do not impose requirements on tribal governments. This direct final
action will not have tribal implications and we received no adverse
comments when the proposed changes were presented to the National
Tribal Air Association (NTAA) in March 2010. Tribes at the meeting
supported these proposed changes; thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 (62 FR 19885, April 23,
1997) as applying to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not have
a substantive impact on existing regulations, and does not create any
new requirements.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22,

2001) because it is not a significant regulatory action under Executive
Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA), Public Law 104-113 (15 U.S.C. 272 note) directs EPA to use
voluntary consensus standards in its regulatory activities, unless to
do so would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., materials specifications, test methods, sampling procedures, and
business practices) that are developed or adopted by voluntary
consensus standards bodies. NTTAA directs EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards. This action does not
involve technical standards. Therefore, EPA did not consider the use of
any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    The EPA has determined this direct final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. These amendments simply rename the title and move subparts
to fit more appropriately in later subparts. There are no substantive
changes to the regulation.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of Congress and to the Comptroller General
of the United States. The EPA will submit a report containing these
amendments and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the amendments in the Federal Register.
A major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2). This direct final rule will be effective on July 28,
2011.

List of Subjects in 40 CFR Part 49

    Environmental protection, Air pollution, Indians--lands, Indians--
tribal government.

    Dated: April 22, 2011.
Lisa P. Jackson,
Administrator.

    For the reasons stated in the preamble, Title 40, Chapter I, Part
49 of the Code of Federal Regulations is amended as follows:

PART 49--[AMENDED]

0
1. The authority citation for Part 49 continues to read as follows:

    Authority:  42 U.S.C. 7401, et seq.

PART 49--INDIAN COUNTRY: AIR QUALITY PLANNING AND MANAGEMENT

0
2. Revise the part heading for part 49 as set forth above. Sec. Sec.
49.22-49.24 [Redesignated]

0
3. Redesignate Sec.  49.22 in subpart A as Sec.  49.5511 in subpart L.

0
4. Redesignate Sec.  49.23 in subpart A as Sec.  49.5512 in subpart L.

0
5. Redesignate Sec.  49.24 in subpart A as Sec.  49.5513 in subpart L.

0
6. Add and reserve new Sec. Sec.  49.22-49.24 in subpart A.

[FR Doc. 2011-10321 Filed 4-28-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Proposed Rules]
[Page 70251-70255]
[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://www.regulations.gov.

Follow the instructions for submitting comments.
     Agency Web site: 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:<PHONE_NUMBER>.
     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://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://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,<PHONE_NUMBER>.

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

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

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

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

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://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


[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Rules and Regulations]
[Page 44881]
[FR Doc No: 2013-17915]

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 DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0651]

Drawbridge Operation Regulation; York River, Between Yorktown and
Gloucester Point, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the operation of the Coleman Memorial
Bridge (US 17/George P. Coleman Memorial Swing Bridge) across the York
River, mile 7.0, between Gloucester Point and Yorktown, VA. This
deviation is necessary to facilitate maintenance work on the moveable
spans on the Coleman Memorial Bridge. This temporary deviation allows
the drawbridge to remain in the closed to navigation position.

DATES: This deviation is effective from 7 a.m. on August 18, 2013 to 5
p.m. August 25, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0651] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Jim Rousseau, Bridge
Administration Branch Fifth District, Coast Guard; telephone (757) 398-
6557, email<EMAIL_ADDRESS>If you have questions on
reviewing the docket, call Barbara Hairston, Program Manager, Docket
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
who owns and operates this swing bridge, has requested a temporary
deviation from the current operating regulation set out in 33 CFR
117.1025, to facilitate maintenance of the moveable spans on the
structure.
    Under the regular operating schedule, the Coleman Memorial Bridge,
mile 7.0, between Gloucester Point and Yorktown, VA, opens on signal
except from 5 a.m. to 8 a.m. and 3 p.m. to 7 p.m. Monday through
Friday, except Federal holidays the bridge shall remain closed to
navigation. The Coleman Memorial Bridge has vertical clearances in the
closed position of 60 feet above mean high water.
    Under this temporary deviation, the drawbridge will be closed to
navigation from 7 a.m. to 5 p.m. on Sunday August 18, 2013; with an
inclement weather date from 7 a.m. to 5 p.m. on Sunday August 25, 2013.
The bridge will operate under normal operating schedule at all other
times. Emergency openings cannot be provided. There are no alternate
routes for vessels transiting this section of the York River. The York
River is used by a variety of vessels including military, tugs, and
recreational vessels. The Coast Guard has carefully coordinated the
restrictions with these waterway users.
    Vessels able to pass under the bridge in the closed position may do
so at anytime and are advised to proceed with caution. The bridge will
not be able to open for emergencies and there is no immediate alternate
route for vessels to pass transiting this section of the York River but
vessels may pass before 7 a.m. and after 5 p.m. The Coast Guard will
also inform additional waterway users through our Local and Broadcast
Notices to Mariners of the closure periods for the bridge so that
vessels can arrange their transits to minimize any impacts caused by
the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: July 12, 2013.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2013-17915 Filed 7-24-13; 8:45 am]
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