[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Notices]
[Page 67344-67346]
[DOCID:fr28no07-86]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2007-29019]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 27 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). The exemptions will enable these individuals to operate
commercial motor vehicles (CMVs) in interstate commerce without meeting
the prescribed vision standard. The Agency has concluded that granting
these exemptions will provide a level of safety that is equivalent to,
or greater than, the level of safety maintained without the exemptions
for these CMV drivers.

DATES: The exemptions are effective November 28, 2007. The exemptions
expire on November 30, 2009.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Chief, Physical
Qualifications Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue, SE., Room W64-
224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5
p.m. Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78; Apr. 11, 2000).
This information is also available at http://Docketinfo.dot.gov.

Background

    On October 15, 2007, FMCSA published a notice of receipt of
exemption applications from certain individuals, and requested comments
from the public (72 FR 58362). That notice listed 27 applicants' case
histories. The 27 individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 27 applications on their merits
and made a determination to grant exemptions to all of them. The
comment period closed on November 14, 2007.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing standard
red, green, and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision standard,
but have adapted their driving to accommodate their vision limitation
and demonstrated their ability to drive safely. The 27 exemption
applicants listed in this notice are in this category. They are unable
to meet the vision standard in one eye for various reasons, including
amblyopia, retinal detachment, macular scar, cataract, retinoblastoma,
and loss of vision due to trauma. In most cases, their eye conditions
were not recently developed. All but two of the applicants were either
born with their vision impairments or have had them since childhood.
The two individuals who sustained their vision conditions as adults
have had them for periods ranging from 4 to 24 years.
    Although each applicant has one eye which does not meet the vision
standard in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV. All these
applicants satisfied the testing standards for their State of
residence. By meeting State licensing requirements, the applicants
demonstrated their ability to operate a commercial vehicle, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 27 drivers have been
authorized to drive a CMV in intrastate

commerce, even though their vision disqualified them from driving in
interstate commerce. They have driven CMVs with their limited vision
for careers ranging from 3 to 42 years. In the past 3 years, three of
the drivers had convictions for traffic violations and none of them was
involved in a crash.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the October 15, 2007
notice (72 FR 58362).

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision standard in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered not only the medical reports about the applicants' vision,
but also their driving records and experience with the vision
deficiency. To qualify for an exemption from the vision standard, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at docket number FMCSA-98-3637.
    We believe we can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively. (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly. (See Bates and Neyman, University of California
Publications in Statistics, April 1952.) Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes. (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971) A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 27 applicants, one of the applicants had a traffic violation for
speeding, and one applicant was involved in two crashes. The applicants
achieved this record of safety while driving with their vision
impairment, demonstrating the likelihood that they have adapted their
driving skills to accommodate their condition. As the applicants' ample
driving histories with their vision deficiencies are good predictors of
future performance, FMCSA concludes their ability to drive safely can
be projected into the future.
    We believe the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision standard in
49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 27 applicants listed in the notice of October
15, 2007 (72 FR 58362).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 27 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the standard in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    Advocates for Highway and Auto Safety (Advocates) expressed
opposition to FMCSA's policy to grant exemptions from the FMCSRs,
including the driver qualification standards. Specifically, Advocates:
(1) Objects to the manner in which FMCSA presents driver information to
the public and makes

safety determinations; (2) objects to the Agency's reliance on
conclusions drawn from the vision waiver program; (3) claims the Agency
has misinterpreted statutory language on the granting of exemptions (49
U.S.C. 31136(e) and 31315); and finally (4) suggests that a 1999
Supreme Court decision affects the legal validity of vision exemptions.
    The issues raised by Advocates were addressed at length in 64 FR
51568 (September 23, 1999), 64 FR 66962 (November 30, 1999), 64 FR
69586 (December 13, 1999), 65 FR 159 (January 3, 2000), 65 FR 57230
(September 21, 2000), and 66 FR 13825 (March 7, 2001). We will not
address these points again here, but refer interested parties to those
earlier discussions.

Conclusion

    Based upon its evaluation of the 27 exemption applications, FMCSA
exempts Christopher L. Bagby, Robert W. Bequeaith, William R. Braun,
Lloyd K. Brown, Kecia D. Clark-Welch, Earl S. Cooper, Tommy R. Crouse,
Ben W. Davis, Charles A. DeKnikker, Sr., Everett E. Denny, Nigel L.
Farmer, Earl M. Frederick, Jr., Lorne H. Geiken, John E. Halcomb,
Michael A. Hershberger, Patrick J. Hogan, Jr., Donald W. Holt, Judy L.
Marshall, Mark A. Massengill, Todd A. McBrain, Amilton T. Monteiro,
Dennis D. Moore, David G. Oakley, John S. Olsen, Thomas J. Prusik, Glen
W. Sterling, Calvin D. Tubergen, from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)).
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: November 19, 2007.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E7-23107 Filed 11-27-07; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 100 (Wednesday, May 24, 2023)]
[Notices]
[Pages 33662-33663]
[FR Doc No: 2023-11066]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0020]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 10 individuals
for an exemption from the hearing requirement in the Federal Motor
Carrier Safety Regulations (FMCSRs) to operate a commercial motor
vehicle (CMV) in interstate commerce. If granted, the exemptions would
enable these hard of hearing and deaf individuals to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before June 23, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2023-0020 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2023-0020) in the keyword box and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click on the ``Comment'' button. Follow
the online instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET
Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical

Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001,<PHONE_NUMBER>, [email protected]. Office
hours are 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal
holidays. If you have questions regarding viewing or submitting
material to the docket, contact Dockets Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2023-0020), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov/docket?D=FMCSA- 2023-0020. Next, sort the results by ``Posted (Newer-
Older),'' choose the first notice listed, click the ``Comment'' button,
and type your comment into the text box on the following screen. Choose
whether you are submitting your comment as an individual or on behalf
of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2023-0020) in the keyword box and click ``Search.'' Next,
sort the results by ``Posted (Newer-Older),'' choose the first notice
listed, and click ``Browse Comments.'' If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
on the ground floor of the DOT West Building, 1200 New Jersey Avenue
SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    Under U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes also allow the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The 10 individuals listed in this notice have requested an
exemption from the hearing requirement in 49 CFR 391.41(b)(11).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting the exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971),
respectively).
    On February 1, 2013, FMCSA announced in a Notice of Final
Disposition titled, ``Qualification of Drivers; Application for
Exemptions; National Association of the Deaf,'' (78 FR 7479), its
decision to grant requests from 40 individuals for exemptions from the
Agency's physical qualification standard concerning hearing for
interstate CMV drivers. Since that time the Agency has published
additional notices granting requests from hard of hearing and deaf
individuals for exemptions from the Agency's physical qualification
standard concerning hearing for interstate CMV drivers.

III. Qualifications of Applicants

Lori Greenidge

    Lori Greenidge, 51, holds a class O driver's license in Nebraska.

Lucas Grimm

    Lucas Grimm, 19, holds a class C driver's license in Pennsylvania.

Bradley Hannah

    Bradley Hannah, 57, holds a class DM driver's license in Kentucky.

Ryan Ketchner

    Ryan Ketchner, 41, holds a class C driver's license in Texas.

Jerry Lacouture

    Jerry Lacouture, 58, holds a class C driver's license in Texas.

Matthew Loschen

    Matthew Loschen, 40, holds a driver's license in Michigan.

Edgar Pacheo

    Edgar Pacheo, 32, holds a class D driver's license in Arizona.

Nicholas Romano

    Nicholas Romano, 55, holds a class D driver's license in
Massachusetts.

Chadwick Savoy

    Chadwick Savoy, 47, holds a class R driver's license in
Mississippi.

Rebecca Yeater

    Rebecca Yeater, 45, holds a class E driver's license from Florida.

IV. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated under the DATES
section of the notice.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-11066 Filed 5-23-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Rules and Regulations]
[Pages 76892-76894]
[FR Doc No: 2011-31687]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 730, 734, 736, 742, 744, and 745

[Docket No. 111031662-1691-01]
RIN 0694-AF44

Updated Statements of Legal Authority To Reflect Continuation of
Emergency Declared in Executive Order 12938

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This rule updates the Code of Federal Regulations (CFR) legal
authority citations for the Export Administration Regulations (EAR) to
replace citations to the President's Notice of November 4, 2010,
Continuation of Emergency Regarding Weapons of Mass Destruction, with
citations to the President's Notice of November 9, 2011 on the same
subject. BIS is making these changes to keep the CFR's legal authority
citations for the EAR current.

DATES: Effective Date: December 9, 2011.

ADDRESSES: Comments concerning this rule should be sent to
<EMAIL_ADDRESS>or to Regulatory Policy Division, Bureau of
Industry and Security, Room H2099B, U.S. Department of Commerce,
Washington, DC 20230. Please refer to regulatory identification number
(RIN) 0694-AF44 in all comments, and in the subject line of email
comments.

FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy
Division, Bureau of Industry and Security, telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    In Executive Order 12938 of November 14, 1994 (59 FR 59099, 3 CFR,
1994 Comp., p. 950), the President declared a national emergency with
respect to the unusual and extraordinary threat to the national
security, foreign policy and economy of the United States posed by the
proliferation of nuclear, biological and chemical weapons and the means
of delivering such weapons. That emergency has been continued in effect
through successive annual presidential notices. The authority for parts
730, 734, 736, 742, 744 and 745 of the EAR (15 CFR parts 730, 734, 736,
742, 744 and 745) rests in part on E.O. 12938, as amended, and on the
successive annual notices continuing the emergency. This rule revises
the authority citations in those parts of the

CFR to cite the notice of November 9, 2011, which is the most recent
such annual Presidential notice, and to remove the citation to the
notice of November 4, 2010 on the same topic.
    BIS is making these revisions so that title 15 of the CFR will cite
the current authority for the parts mentioned above. This rule is
purely procedural, and makes no changes other than to revise CFR
authority citations paragraphs. It does not change the text of any
section of the EAR, nor does it alter any right, obligation or
prohibition that applies to any person under the EAR.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). This rule
does not impose any regulatory burden on the public and is consistent
with the goals of Executive Order 13563. This rule has been determined
not to be a significant rule for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C.
3501 et seq., unless that collection of information displays a
currently valid Office of Management and Budget (OMB) Control Number.
This rule does not involve any collection of information.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. The Department finds that there is good cause under 5 U.S.C.
553(b)(3)(B) to waive the provisions of the Administrative Procedure
Act requiring prior notice and the opportunity for public comment
because they are unnecessary. This rule only updates legal authority
citations and is nondiscretionary. This rule does not alter any right,
obligation or prohibition that applies to any person under the EAR.
Because these revisions are not substantive changes, it is unnecessary
to provide notice and opportunity for public comment. In addition, the
30-day delay in effectiveness required by 5 U.S.C. 553(d) is not
applicable because this rule is not a substantive rule. Because neither
the Administrative Procedure Act nor any other law requires that notice
of proposed rulemaking and an opportunity for public comment be given
for this rule, the analytical requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) are not applicable.

List of Subjects

15 CFR Part 730

    Administrative practice and procedure, Advisory committees,
Exports, Reporting and recordkeeping requirements, Strategic and
critical materials.

15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and
patents, Research, Science and technology.

15 CFR Part 736

    Exports.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Part 745

    Administrative practice and procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping requirements.

    Accordingly, the EAR (15 CFR parts 730-774) is amended as follows:

PART 730--[AMENDED]

0
1. The authority citation for 15 CFR part 730 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151
note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s),
185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C.
1824a; 50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42
FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p.
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854,
58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O.
12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR
54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p.
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224,
66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, 3
CFR, 2004 Comp., p. 168; Notice of January 13, 2011, 76 FR 3009
(January 18, 2011); Notice of August 12, 2011, 76 FR 50661 (August
16, 2011); Notice of November 9, 2011, 76 FR 70319 (November 10,
2011).

PART 734--[AMENDED]

0
2. The authority citation for 15 CFR part 734 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61
FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 12, 2011, 76 FR 50661 (August 16, 2011);
Notice of November 9, 2011, 76 FR 70319 (November 10, 2011).

PART 736--[AMENDED]

0
3. The authority citation for 15 CFR part 736 is revised to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp.,
p. 168; Notice of August 12, 2011, 76 FR 50661 (August 16, 2011);
Notice of November 9, 2011, 76 FR 70319 (November 10, 2011).

PART 742--[AMENDED]

0
4. The authority citation for 15 CFR part 742 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058,
43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3
CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential
Determination 2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003;
Notice of August 12, 2011, 76 FR 50661 (August 16, 2011); Notice of
November 9, 2011, 76 FR 70319 (November 10, 2011).

PART 744--[AMENDED]

0
5. The authority citation for 15 CFR part 744 is revised to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of January 13, 2011, 76 FR 3009

(January 18, 2011); Notice of August 12, 2011, 76 FR 50661 (August
16, 2011); Notice of November 9, 2011, 76 FR 70319 (November 10,
2011).

PART 745--[AMENDED]

0
6. The authority citation for 15 CFR part 745 is revised to read as
follows:

    Authority:  50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3
CFR, 1994 Comp., p. 950; Notice of November 9, 2011, 76 FR 70319
(November 10, 2011).

    Dated: December 5, 2011.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2011-31687 Filed 12-8-11; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91716-91722]
[FR Doc No: 2016-29997]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2013-P-0047]
RIN 0910-AH43

Food Labeling: Health Claims; Dietary Saturated Fat and
Cholesterol and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
regulation authorizing a health claim on the relationship between
dietary saturated fat and cholesterol and risk of coronary heart
disease (CHD) to permit raw fruits and vegetables that fail to comply
with the ``low fat'' definition and/or the minimum nutrient content
requirement to be eligible to bear the claim. We are taking this action
in response to a petition submitted by the American Heart Association
(the petitioner). The amendment expands the use of this health claim to
certain fruits and vegetables that are currently ineligible for the
health claim.

DATES: This interim final rule is effective December 19, 2016.
Interested persons may submit either electronic or written comments by
March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-P-0047 for ``Food Labeling: Health Claims; Dietary Saturated
Fat and Cholesterol and Risk of Coronary Heart Disease.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on http://www.regulations.gov. Submit both
copies to the Division of Dockets Management. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    This interim final rule amends the regulation authorizing a health
claim on the relationship between dietary saturated fat and cholesterol
and risk of coronary heart disease (CHD). The interim final rule
permits raw fruits and vegetables that fail to comply with the ``low
fat'' definition and/or the minimum nutrient content requirement to be
eligible to bear the claim. Health claims, in general, must meet
certain nutrient requirements that we establish to ensure that health
claims are used on foods with nutritional value. For example, except
where provided for in other regulations, foods bearing a health claim
must contain one or more of vitamin A, vitamin C, iron, calcium,
protein, or fiber at or above 10 percent of the Reference Daily Intake
(RDI) or Daily Reference Value (DRV), before any nutrient addition
(Sec.  101.14(e)(6) (21 CFR 101.14(e)(6)). Additionally, for foods
bearing health claims related to CHD, the food often must be a ``low
fat'' food (see e.g., Sec. Sec.  101.75(c)(2)(ii) and
101.81(c)(2)(iii)(D)). An unintended consequence of these general
requirements is that some foods that are generally considered to
contribute to a healthy diet are ineligible to bear certain health
claims. A small number of fruits and vegetables, for example, are
ineligible to bear the dietary saturated fat and cholesterol and risk
of CHD health claim because they do not meet the requirement to have 10
percent of the RDI or DRV of certain nutrients and/or they do not meet
the definition of a ``low fat'' food. However, consumption of fruits
and vegetables is encouraged by dietary recommendations, and low
saturated fat and low cholesterol fruits and vegetables should not be
excluded

from bearing this health claim. To address this unintended consequence,
this interim final rule includes provisions that exempt raw fruits and
vegetables from:
    (1) Needing to meet the 10 percent nutrient content requirement in
Sec.  101.14(e)(6).
    (2) Needing to meet the definition for a ``low fat'' food in Sec.
101.62.
    The Nutrition Labeling and Education Act of 1990 (the 1990
amendments) (Pub. L. 101-535) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by clarifying, among other things, FDA's
authority to regulate health claims on food labels and in food
labeling. Using that authority, in 1993 we issued Sec.  101.75, which
authorizes a health claim about the relationship between diets low in
saturated fat and cholesterol and a reduced risk of CHD (58 FR 2739,
January 6, 1993).
    Section 403(r)(4) of the FD&C Act (21 U.S.C. 343(r)(4)) establishes
a mechanism for any person to petition us to issue a regulation
relating to a claim that characterizes the level of any nutrient or the
relationship of any nutrient to a disease or a health-related
condition. We received a petition, under section 403(r)(4) of the FD&C
Act, requesting that we amend the dietary saturated fat and cholesterol
and risk of CHD health claim to permit raw fruits and vegetables, as
well as single-ingredient or mixtures of frozen or canned fruits and
vegetables that contain no added fat or sugars, which fail to comply
with the ``low fat'' definition and/or the minimum nutrient content
requirement, to be eligible to bear the claim. This interim final rule
responds to that petition.

Summary of the Major Provisions of the Regulatory Action in Question

    Under the interim final rule, raw fruits and vegetables are exempt
from needing to meet the minimum nutrient content requirement of the
general principles for health claims and from the requirement
specifically included in the dietary saturated fat and cholesterol and
risk of CHD health claim that a food meet the definition for ``low
fat'' to be eligible to bear the claim. Current FDA regulations, at
Sec.  101.75(c)(1), state that all requirements set forth in Sec.
101.14 must be met. The interim final rule revises Sec.  101.75(c)(1)
to provide an exemption for raw fruits or vegetables from meeting the
minimum nutrient content requirement in Sec.  101.14(e)(6).
    Current FDA regulations, at Sec.  101.75(c)(2)(ii), establish
requirements regarding the nature of the food, except for fish and game
meats; the food must meet all nutrient content requirements of Sec.
101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low
fat'' food. We are amending Sec.  101.75(c)(2)(ii) to provide an
exemption from meeting the nutrient content requirements of Sec.
101.62 for ``low fat'' if the food is a raw fruit or vegetable.

I. Background

A. The Nutrition Labeling and Education Act of 1990

    The 1990 amendments amended the FD&C Act in a number of important
ways. Among other changes, the 1990 amendments clarified our authority
to regulate health claims on food labels and in food labeling. Under
this authority, we issued several regulations, including Sec.  101.14,
Health claims: General requirements (58 FR 2478 at 2533), which sets
forth general principles for the authorization and use of health
claims, and Sec.  101.70, Petitions for health claims (58 FR 2478 at
2534), which sets forth a process for petitioning us to authorize
health claims about substance-disease relationships, and sets out the
types of information that any such petition must include. Among other
provisions, the general principles for health claims include
requirements for determining the eligibility of a food to bear a health
claim. Examples include disqualifying nutrient levels (Sec.
101.14(a)(4)), which are specific nutrient thresholds not to be
exceeded by a food bearing a health claim as required by Sec.
101.14(e)(3), and also a minimum nutrient content requirement (Sec.
101.14(e)(6)) to ensure that a food bearing a health claim provide
meaningful nutritive value as determined by meeting specific nutrient
content levels.

B. Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart
Disease Health Claim

    When implementing the 1990 amendments, we also conducted a review
of evidence for a relationship between dietary saturated fat and
cholesterol and risk of CHD. Based on the totality of the publicly
available scientific evidence, we concluded that there was significant
scientific agreement among qualified experts that diets low in
saturated fat and cholesterol may reduce the risk of CHD. Therefore, we
authorized a health claim about the relationship between diets low in
saturated fat and cholesterol and a reduced risk of CHD (Sec.  101.75;
58 FR 2739 at 2757, January 6, 1993). Among the specific requirements
included in Sec.  101.75 are requirements that, in addition to the
general requirements set forth in Sec.  101.14, foods must meet all of
the nutrient content requirements in Sec.  101.62 for a ``low saturated
fat,'' ``low cholesterol,'' and ``low fat'' food in order to be
eligible to bear the health claim, except that fish and game meats
(i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may
meet the requirements for ``extra lean'' in Sec.  101.62.

II. Petition and Grounds

    We received a petition from the American Heart Association (Docket
No. FDA-2013-P-0047) on October 1, 2012, under section of 403(r)(4) of
the FD&C Act. The petition requested that we amend the dietary
saturated fat and cholesterol and risk of CHD health claim (Sec.
101.75) to permit raw fruits and vegetables, as well as single-
ingredient or mixtures of frozen or canned fruits and vegetables that
contain no added fat or sugars, which fail to comply with the ``low
fat'' definition and/or the minimum nutrient content requirement, to be
eligible to bear the claim. In addition, the petition requested that we
issue an interim final rule by which fruits and vegetables that fail to
comply with the ``low fat'' definition and/or the minimum nutrient
content requirement could be eligible to bear the claim before
publication of a final rule. Section 403(r)(4) of the FD&C Act
establishes a mechanism for any person to petition us to issue a
regulation relating to a claim that characterizes the level of any
nutrient or the relationship of any nutrient to a disease or a health-
related condition. On January 10, 2013, we notified the petitioner that
we had completed our initial review of the petition, that the petition
had been filed for further action in accordance with section 403(r)(4)
of the FD&C Act, and that the filing date was January 9, 2013. Under
the FD&C Act, if we do not act, by either denying the petition or
issuing a proposed regulation to authorize the health claim, within 90
days of the date of filing for further action, the petition is deemed
to be denied unless an extension is mutually agreed upon by us and the
petitioner (21 U.S.C. 343(r)(4)(A)(i) andSec.  101.70(j)(3)(iii)). On
April 9, 2013, we mutually agreed with the petitioner to extend the
deadline to October 7, 2013. Later, through subsequent agreements, we
mutually agreed to extend the deadlines several times, with the last
deadline being March 17, 2017.
    The petitioner explained that some of our requirements for the
dietary saturated fat and cholesterol and risk of CHD health claim
prevent a number of fruits and vegetables from being eligible to bear
the claim. The minimum nutrient content requirement for all

health claims requires that, to be eligible to bear a health claim, a
food contains 10 percent or more of the Reference Daily Intake or the
Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein,
or fiber per reference amount customarily consumed (RACC) prior to any
nutrient addition (see Sec.  101.14(e)(6)). Although most fruits and
vegetables meet this minimum requirement for one or more of the
described nutrients, a small number of fruits and vegetables do not
meet the minimum nutrient content requirement. For example, grapes,
plums, beets, and cucumbers do not contain 10 percent of the RDI or DRV
of vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC.
Additionally, the dietary saturated fat and cholesterol and risk of CHD
health claim requires that a food bearing the claim meet all of the
nutrient content requirements of Sec.  101.62 for ``low saturated
fat,'' ``low cholesterol,'' and ``low fat'' (Sec.  101.75(c)(2)(ii)).
Again, most fruits and vegetables meet the requirement for ``low fat,''
but at least one fruit, avocados, does not meet the requirement and
therefore is not eligible to bear the claim, even though the fruit
meets the requirements for ``low saturated fat'' and ``low
cholesterol.''
    The petition requested that fruits and vegetables, as a category of
foods, be exempted from meeting the minimum nutrient content
requirement and the ``low fat'' requirement for the dietary saturated
fat and cholesterol and risk of CHD health claim. The petition asserted
that, based on the scientific evidence, fruits and vegetables as a
group contribute to reduced risk of CHD regardless of their inherent
fat content or their ability to meet 10 percent of the RDI or DRV of
vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC. The
petition described the scientific evidence relating consumption of
fruits and vegetables and risk of CHD, including large observational
studies (e.g., the Women's Health Study) (Ref. 1) and intervention
studies on fruit and vegetable intake and surrogate endpoints for CHD
risk (e.g., low-density lipoprotein concentration) (Ref. 2).
Additionally, the petition detailed the numerous current public health
recommendations, such as the Dietary Guidelines for Americans (DGA)
2010, published by the U.S. Department of Health and Human Services
(HHS) and the U.S. Department of Agriculture (USDA) (Ref. 3) and the
National Cholesterol Education Program (NCEP) of the National Heart
Lung and Blood Institute (NHLBI) of the National Institutes of Health
(NIH) (Ref. 4), which consistently encourage fruit and vegetable
consumption as an integral part of a healthful diet, regardless of the
specific nutrient contents of individual fruits and vegetables.
    The petition requested the following specific changes in the
regulation governing the dietary saturated fat and cholesterol and risk
of CHD health claim:
     Modify Sec.  101.75(c)(2)(ii) to create a new paragraph
(A) and remove ``low fat'' food from the list of nutrient content
requirements in Sec.  101.62 a food must meet.
     Modify Sec.  101.75(c)(2)(ii) to create a new paragraph
(B) that provides an exemption to the nutrient content requirements of
Sec.  101.62 for a ``low fat'' food if it is a raw fruit or vegetable,
or is a single-ingredient or mixture of frozen or canned fruits and
vegetables that contains no fats or sugars in addition to the fats or
sugars inherently present in the fruit or vegetable product.
     Modify Sec.  101.75(c)(1) to exempt raw fruits and
vegetables, or single-ingredient or mixtures of frozen or canned fruits
and vegetables from meeting the requirement of Sec.  101.14(e)(6).
    In addition, the petition requested that we issue an interim final
rule under section 403(r)(7)(A) of the FD&C Act, stating that the
evidence is compelling and the potential to encourage fruit and
vegetable consumption is important for public health and that issuing
an interim final rule would allow affected fruit and vegetable products
to become eligible to bear these health claims as expeditiously as
possible.

III. Decision To Amend the Health Claim

A. Current Dietary Recommendations for Fruit and Vegetable Intake

    The DGA, issued every 5 years by USDA and HHS, sets forth the
Federal Government's official recommendations regarding healthy eating
and construction of a healthful diet (Ref. 5). The 2015-2020 DGA is the
most recent version. At the core of the 2015-2020 DGA, as stated in
Chapter 1 (``Key Elements of Healthy Eating Patterns''), ``is the
importance of consuming overall healthy eating patterns, including
vegetables, fruits, grains, dairy, protein foods, and oils--eaten
within an appropriate calorie level and in forms with limited amounts
of saturated fats, added sugars, and sodium.'' Key recommendations of
the 2015-2020 DGA are to ``Shift to consume more vegetables'' and
``Shift to consume more fruits.'' For example, Chapter 2 (``Shifts
Needed to Align With Healthy Eating Patterns'') of the 2015-2020 DGA
discusses intakes and states that ``For most individuals, following a
healthy eating pattern would include an increase in total vegetable
intake from all vegetable subgroups, in nutrient-dense forms, and an
increase in the variety of different vegetables consumed over time.''
Chapter 2 likewise states that ``To help support healthy eating
patterns, most individuals in the United States would benefit from
increasing their intake of fruits, mostly whole fruits, in nutrient-
dense forms.''
    We note that the recommendations in the 2015-2020 DGA regarding
fruits and vegetables are directed at intakes of fruit and vegetables
as a group. Particularly, in the discussions on fruit and vegetable
intake throughout the report, the 2015-2020 DGA considers fruits and
vegetables as a category of foods when discussing the associations
between fruit and vegetable intake and reduced risk of cardiovascular
disease or other chronic diseases (Ref. 5). Our reliance on dietary
recommendations in this rulemaking and in previous health claim
regulations is based on provisions of the 1990 amendments that direct
us to issue health claim regulations that take into account the role of
the nutrients in food in a way that will enhance the chances of
consumers maintaining healthy dietary practices (see section
403(r)(3)(A) and (r)(3)(B) of the FD&C Act and previous health claim
regulations for plant sterol/stanol esters and reduced risk of CHD
(Sec.  101.83) and soluble fiber from certain foods and risk of CHD
(Sec.  101.81)). Thus, general eligibility requirements that establish
which types of foods are able to bear health claims have been typically
determined based on the current dietary recommendations and guidelines
at the time. The requirements are established to include foods and
categories of foods that are encouraged to be consumed for their
benefits to health, while restricting foods whose consumption is not
encouraged from bearing health claims (see 58 FR 2478 at 2490).

B. Low Fat

    Our regulations authorizing CHD-related health claims (Sec. Sec.
101.75, 101.81, 101.82, and 101.83) require, with a few exceptions,
that foods bearing such claims meet: (1) The ``low fat'' criterion
defined by Sec.  101.62(b)(2); (2) the ``low saturated fat'' criterion
defined by Sec.  101.62(c)(2); and (3) the ``low cholesterol''
criterion defined by Sec.  101.62(d)(2).
    The term ``low fat'' may be used on the label or in the labeling of
food, except meal products as defined in Sec.  101.13(l) and main dish
products as

defined in Sec.  101.13(m), provided that the food has a reference
amount customarily consumed greater than 30 grams (g) or greater than 2
tablespoons and contains 3 g or less of fat per reference amount
customarily consumed; or the food has a reference amount customarily
consumed of 30 g or less or 2 tablespoons or less and contains 3 g or
less of fat per reference amount customarily consumed and per 50 g of
food (for dehydrated foods that must be reconstituted before typical
consumption with water or a diluent containing an insignificant amount,
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount
customarily consumed, the per 50-g criterion refers to the ``as
prepared'' form) (Sec.  101.62(b)(2)).
    The term ``low saturated fat'' may be used on the label or labeling
of foods, except meal products as defined in Sec.  101.13(1) and main
dish products as defined in Sec.  101.13(m), provided that the food
contains 1 g or less of saturated fatty acids per reference amount
customarily consumed and not more than 15 percent of calories from
saturated fatty acids (Sec.  101.62(c)(2)).
    The term ``low cholesterol,'' under Sec.  101.62(d)(2), may be used
on the label or in the labeling of foods, except meal products as
defined in Sec.  101.13(l) and main dish products as defined in Sec.
101.13(m), provided that, for foods that have a reference amount
customarily consumed greater than 30 g or greater than 2 tablespoons
and contain 13 g or less of total fat per reference amount customarily
consumed and per labeled serving, the food contains 20 milligrams or
less of cholesterol per reference amount customarily consumed or the
food contains 2 g or less of saturated fatty acids per reference amount
customarily consumed.
    The petition noted that a fruit such as an avocado exceeds the 3 g
total fat per RACC criterion of the ``low fat'' definition and
therefore would never be able to bear the health claim for diets low in
saturated fat and cholesterol and reduced risk of CHD. According to our
nutrient data on the 20 most frequently consumed fruits (Sec. Sec.
101.42 through 101.45 and appendix C to part 101), avocados contain 4.5
g total fat per RACC and do, indeed, exceed 3 g total fat per RACC.
Barring an exemption to the ``low fat'' requirement, avocados (and any
other fruit or vegetable with a total fat content in excess of the
criteria for ``low fat'') are not eligible to bear the dietary
saturated fat and cholesterol and risk of CHD health claim.
    In the 1993 final rule authorizing the dietary saturated fat and
cholesterol and risk of CHD health claim (58 FR 2739), we established
``low fat'' as a qualifying criterion for eligibility for the claim
asserting that ``while total fat is not as strongly or directly linked
to increased risk of CHD . . . it may have significant indirect
effects.'' We discussed how ``low fat foods generally help individuals
in reducing their intake of saturated fat and cholesterol'' and how
excess calories, of which fat contributes more per gram than the other
energy nutrients, is associated with two health-related conditions
(obesity and diabetes) that are risk factors for heart disease (58 FR
2739 at 2742). In support of these determinations, we noted that, ``Low
fat diets are recommended in all Federal Government and National
Academy of Sciences' dietary guidelines for reducing the risk of heart
disease'' (58 FR 2739 at 2742).
    Since we published the final rule for the dietary saturated fat and
cholesterol and risk of CHD health claim in 1993, the science related
to intake of total fat has evolved, and the current dietary
recommendations no longer contain a recommendation encouraging the
consumption of diets low in total fat. Beginning with the 2000 DGA,
recommendations for total fat intake shifted from recommending diets
low in fat to diets moderate in total fat (Ref. 6). The recommendations
reflected a shift in focus to types of fat consumed (i.e., saturated
versus unsaturated fat) and their relation to effects on blood
cholesterol concentrations. The recommendations for moderate fat intake
continued through the 2005 DGA (Ref. 7) with even more discussion on
types of fat in the diet (e.g., polyunsaturated and monounsaturated
fats) and their influence on cardiovascular disease. The discussion on
total fat intake in the 2010 DGA (Ref. 3) focused on the importance of
staying within the Institute of Medicine (IOM) of the National
Academies of Science Acceptable Macronutrient Distribution Range (AMDR)
for total fat intake of 20 to 35 percent of energy for adults and an
AMDR of 25 to 35 percent of energy for children age 4 to 18 years (Ref.
8). The AMDRs are associated with reduced risk of chronic diseases,
such as cardiovascular disease, while providing for adequate intake of
essential nutrients (Ref. 8).
    The 2015-2020 DGA does not focus on total fat intake, but instead
makes recommendations about types of fat. Chapter 1 (``Key Elements of
Healthy Eating Patterns'') states that ``[a] healthy eating pattern
limits . . . [s]aturated fats and trans fats . . .'' and contains a key
recommendation to ``[c]onsume less than 10 percent of calories per day
from saturated fats. . . .'' In this same chapter, the 2015-2020 DGA
notes that ``[t]he recommendation to limit intake of calories from
saturated fats to less than 10 percent per day is a target based on
evidence that replacing saturated fats with unsaturated fats is
associated with reduced risk of cardiovascular disease'' (Ref. 5, page
15).
    As a result of the modifications in the dietary recommendations for
total fat intake over the years, we have exempted certain foods at
times from needing to meet the ``low fat'' requirement to be eligible
to make a health claim related to CHD if those foods are consistent
with dietary recommendations. For example, whole oats are exempt from
meeting the ``low fat'' requirement to be eligible for ``Soluble Fiber
from Certain Foods and Risk of Coronary Heart Disease'' health claim
(Sec.  101.81). In providing the exemption, we discussed that
consumption of whole oats was consistent with the recommendations
regarding fat intake in the 2005 DGA and that consumption of foods such
as whole oats was helpful in reducing the risk of CHD (73 FR 23947 at
23951, May 1, 2008).
    We find that not imposing a ``low fat'' requirement for raw fruits
and vegetables is consistent with the 2015-2020 DGA recommendations to
increase intake of fruits and vegetables to help support healthy eating
patterns (Ref. 5), as well as the 2015-2020 DGA emphasis on types of
fat rather than total fat when discussing CHD risk (Refs. 5 and 7). We
note that the fruits and vegetables that we are exempting from meeting
the definition of ``low fat'' must still comply with general health
claim requirements in order to be eligible to bear the claim,
including, but not limited to, the requirement in Sec.  101.14(e)(3)
that the level of fat must not exceed the disqualifying nutrient level
for total fat in Sec.  101.14(a)(4).

C. Minimum Nutrient Content

    In the 1993 final rule on the general requirements for health
claims (58 FR 2478), we established the minimum nutrient content
requirement for eligibility of foods to bear health claims. We stated
that foods bearing health claims should be those consistent with
dietary guidelines and that the value of health claims should not be
trivialized or compromised by their use on foods of little or no
nutritional value. We also stated that claims intended to promote the
consumption of food that is incompatible with dietary guidelines would
be misleading to consumers (58 FR 2478 at 2521). We developed an
approach that would limit health claims to foods that contribute
certain nutrients

to the diet and, thus, are sources of more than calories (58 FR 2478 at
2521). We concluded that a food must contain one or more of vitamin A,
vitamin C, iron, calcium, protein, or fiber at or above 10 percent of
the RDI or DRV, prior to any nutrient addition, noting that most foods
consistent with dietary guidelines met this criterion. Therefore, we
added Sec.  101.14(e)(6) to state that, except for dietary supplements
that are not in conventional food form, the food must contain 10
percent or more of the Reference Daily Intake or the Daily Reference
Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per
reference amount customarily consumed before any nutrients are added.
We adopted this requirement in light of Congressional intent that
health claims be used to help Americans maintain a balanced and
healthful diet consistent with dietary guidelines (58 FR 2478 at 2521).
    We later published technical amendments to the health claim
regulations acknowledging that certain food products that had limited
nutritional value may be determined to be appropriate foods to bear a
health claim (58 FR 44036, August 18, 1993). We noted that we intended
to address such situations in the regulations authorizing specific
health claims, such as through an exception to the general requirements
expressed in Sec.  101.14(e)(6) (58 FR 44036).
    Thus, we have recognized that exemptions to the minimum nutrient
content requirement may be necessary in certain situations to help
consumers construct overall daily diets that conform to current dietary
guidelines and that otherwise promote good health. Multiple such
exemptions have already been granted. For example, on August 23, 1996,
we exempted noncariogenic carbohydrate sweeteners (carbohydrate
sweeteners that do not promote the development of tooth decay) from the
minimum nutrient content requirement to be eligible for the ``dietary
noncariogenic carbohydrate sweeteners and dental caries'' health claim
(Sec.  101.80) (61 FR 43433 at 43436). We reiterate that the minimum
nutrient content requirements of Sec.  101.14(e)(6) are important, but
that an exemption from the minimum nutrient content requirements for
fruits and vegetables as a group is warranted for these products to be
eligible to bear the health claims authorized in Sec.  101.75, given
current dietary guideline recommendations. The value of these health
claims will not be trivialized or compromised by their use on fruits
and vegetables because current dietary guidelines emphasize that
increased intake of fruits and vegetables is an integral part of
creating healthful diets and reducing the risk of chronic disease.

D. Conclusion

    We agree with the petitioner that some current requirements for the
dietary saturated fat and cholesterol and risk of CHD health claim
prevent a number of fruits and vegetables from being eligible to bear
the claim. We also agree that fruits and vegetables as a group appear
to contribute to a reduced risk of CHD regardless of their inherent fat
content or their ability to meet 10 percent of the RDI or DRV of
vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC. We
previously have exempted foods from needing to meet individual
requirements for health claim eligibility when, as here, consumption of
the foods is consistent with contemporary science-based dietary
recommendations. We conclude that raw fruits and vegetables should be
exempt from needing to meet the minimum nutrient content requirement of
the general principles for health claims and from the requirement
specifically included in the dietary saturated fat and cholesterol and
risk of CHD health claim that a food meet the definition for ``low
fat'' to be eligible to bear the claim.
    Although the petition requested that a ``single-ingredient or
mixture of frozen or canned fruits and vegetables that contains no fats
or sugars in addition to the fats or sugars inherently present in the
fruit or vegetable product'' also be exempt from the low fat and
minimum nutrient content requirements, we are not including these types
of products in the exemptions at this time. We are able to easily
determine which foods fall into the category of raw fruits and
vegetables. With single-ingredient or mixtures of canned or frozen
fruit and vegetable products, however, the categories are very broadly
described, and it is difficult to know all of the types of products
that may become included in an exemption. There are many food products
that could conceivably be considered ``fruit or vegetable products,''
including products with varying degrees of processing, with numerous
possibilities of ingredients in a ``mixture,'' or with a number of
packaging variations. We determine that providing an exemption for raw
fruits and vegetables will affect the public health positively, but it
is unclear if all single-ingredient and mixtures of frozen or canned
fruits and vegetables that contain no fats or sugars in addition to the
fats or sugars inherently present in the fruit or vegetable product
would have similar effects. Therefore, we decline to extend any
exemptions to this category of fruit and vegetable products at this
time. However, we invite comments on this issue. If we receive
information related to the possible iterations of canned and frozen
fruit and vegetable products and also on their effects on health, we
may consider expanding the foods included in the exemption in the
future. Indeed, the petition encouraged FDA to proceed with exemptions
solely for raw fruits and vegetables if the canned and frozen products
required additional consideration.

IV. Description of Amendments to Sec.  101.75

    We are revising Sec.  101.75(c) to: (1) Provide an exemption at
Sec.  101.75(c)(1) for raw fruits or vegetables from meeting the
minimum nutrient content requirement in Sec.  101.14(e)(6), and (2)
revise Sec.  101.75(c)(2)(ii) to provide an exemption from meeting the
nutrient content requirements of ``low fat'' if the food is a raw fruit
or vegetable.

V. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the interim final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We have developed a comprehensive Economic Analysis of
Impacts that assesses the impacts of the interim final rule. We believe
that this interim final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this interim final rule concerns voluntary claims, we
certify that the interim final rule will not have a significant
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in

the aggregate, or by the private sector, of $100,000,000 or more
(adjusted annually for inflation) in any one year.'' The current
threshold after adjustment for inflation is $146 million, using the
most current (2015) Implicit Price Deflator for the Gross Domestic
Product. This interim final rule would not result in an expenditure in
any year that meets or exceeds this amount.

B. Summary of Benefits and Costs of the Interim Final Rule

    This interim final rule amends the regulation authorizing a health
claim on the relationship between dietary saturated fat and cholesterol
and risk of CHD by expanding its use to raw fruits and vegetables that
do not meet the ``low fat'' definition (Sec.  101.62(b)(2)) and/or the
minimum nutrient content requirement (Sec.  101.14(e)(6)). We believe
that a business will only incur the additional costs of analyzing the
health claim requirements and relabeling a previously ineligible
product if the additional revenue it anticipates to generate by
attracting more customers to its products is greater than these
additional costs. This implies zero net costs from this interim final
rule to such businesses, as well as to any businesses that decide not
to include new CHD health claims on previously ineligible and now
eligible fruits and vegetables.
    We have very little data on the current consumer usage of CHD
claims on labels and labeling, how these practices would change in
response to this interim final rule, or how the consumers will respond
to new CHD claims on raw fruits and vegetables that were previously
ineligible for such claims. Because of this data gap, we acknowledge
that we do not have sufficient evidence at this point to quantify the
benefits and the administrative and labeling costs of this interim
final rule. Industry will only use a new CHD health claim on the label
and labeling of a previously ineligible product if it believes
consumers are willing to pay more for such product or buy more of it
due to the new CHD claim. If consumers value such new CHD health
information, we expect there to be changes in consumer behavior that
would result in public health benefits from the reduced annual number
of CHD cases. The benefits therefore will only be realized, and labels
will only be changed, if the new CHD information on labels and labeling
increases consumer demand for the previously ineligible and now
eligible for a CHD health claim fruits and vegetables. Otherwise, the
firms will not use the CHD health claim on their labels for these
fruits and vegetables.
    The full analysis of economic impacts is available in the docket
for this interim final rule (Ref. 9) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VI. The Paperwork Reduction Act of 1995

    This interim final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.

VII. Analysis of Environmental Impact

    We have determined under Sec.  25.32(p) 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.

VIII. Federalism

    We analyzed this interim final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the interim final rule will have a preemptive effect on State law.
Section 4(a) of the Executive order requires Agencies to ``construe . .
. a Federal statute to preempt State law only where the statute
contains an express preemption provision or there is some other clear
evidence that the Congress intended preemption of State law, or where
the exercise of State law conflicts with the exercise of Federal
authority under the Federal statute.'' Section 403A(a) of the FD&C Act
provides that no State or political subdivision of a State may directly
or indirectly establish under any authority or continue in effect as to
any food in interstate commerce any requirement respecting any claim of
the type described in section 403(r)(1) of the FD&C Act made in the
label or labeling of food that is not identical to the requirement of
section 403(r) of the FD&C Act.
    This interim final rule amends the existing food labeling
regulations on health claims for dietary saturated fat and cholesterol
and risk of CHD (Sec.  101.75) in the label or labeling of food under
section 403(r) of the FD&C Act. Although this interim final rule has a
preemptive effect in that it precludes States from issuing any health
claim labeling requirements for dietary saturated fat and cholesterol
and the risk of CHD, this preemptive effect is consistent with what
Congress set forth in section 403A(a) of the FD&C Act. Section
403A(a)(5) of the FD&C Act displaces both State legislative
requirements and State common law duties.
    We have complied with all of the applicable requirements under
Executive Order 13132 and have determined that the preemptive effects
of this interim final rule are consistent with Executive Order 13132.

IX. Issuance of an Interim Final Rule and Immediate Effective Date

    We are issuing this rule as an interim final rule, effective
immediately, with an opportunity for public comment. Section 403(r)(7)
of the FD&C Act authorizes us to make proposed regulations issued under
section 403(r) of the FD&C Act effective upon publication pending
consideration of public comment and publication of a final regulation,
if the Agency determines that such action is necessary for public
health reasons. This authority enables us to act promptly on petitions
that provide for information that is necessary to: (1) Enable consumers
to develop and maintain healthy dietary practices; (2) enable consumers
to be informed promptly and effectively of important new knowledge
regarding nutritional and health benefits of food; or (3) ensure that
scientifically sound nutritional and health information is provided to
consumers as soon as possible. Proposed regulations made effective upon
publication under this authority are deemed to be final Agency action
for purposes of judicial review. The legislative history indicates that
such regulations should be issued as interim final rules (H. Conf.
Rept. No. 105-399, at 98 (1997)).
    The petition requested that we issue an interim final rule amending
Sec.  101.75 to indicate that the evidence is compelling and the
potential to encourage fruit and vegetable consumption is important for
public health. It noted that we have used this authority to issue
interim final rules for health claims a number of times (e.g., 65 FR
54685, September 8, 2000) and using an interim final rule would be
consistent with our past practices.
    We are satisfied that all three criteria in section 403(r)(7)(A) of
the FD&C Act have been met for the amendment to the dietary saturated
fat and cholesterol and risk of CHD health claim to permit raw fruits
and vegetables that fail to comply with the ``low fat'' definition and/
or the minimum nutrient content requirement, to be eligible to bear the
claim. First, we conclude that these amendments for eligibility for
foods to bear these health claims could help enable consumers to
develop and maintain healthy dietary practices. Second, these
amendments to this health claim will enable consumers

to be informed promptly and effectively of important new knowledge
regarding nutritional and health benefits of food. Third, these
amendments to this health claim will ensure that scientifically sound
nutritional and health information regarding the benefits of fruit and
vegetable intake and reduction of CHD risk can be provided to consumers
as soon as possible. The past few editions of the DGA have been moving
away from a focus on total fat and have instead communicated to
consumers the need to focus on type of fat consumed instead of total
amount of fat. Recent editions of the DGA have also encouraged
increased intake of fruits and vegetables for a healthful diet. Prompt
issuance of an interim final rule that reflects the current
recommendations is necessary for consumers to be able to have the most
current information on nutrition and diet. Consumers will be better
able to construct healthful diets if they have prompt access to
information that is consistent with the current recommendations on fat
content and on consumption of fruits and vegetables. Therefore, we are
using the authority in section 403(r)(7)(A) of the FD&C Act to issue an
interim final rule amending the general requirements for the health
claim for dietary saturated fat and cholesterol and risk of CHD and to
make the interim final rule effective immediately.
    This regulation is effective upon publication in the Federal
Register. We invite public comment on this interim final rule. We will
consider modifications to this interim final rule based on comments
made during the comment period. We will address comments and confirm or
amend the interim final rule in a final rule.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
    1. Liu, S., J.E. Manson, I.M. Lee, et al. ``Fruit and Vegetable
Intake and Risk of Cardiovascular Disease: The Women's Health Study.''
The American Journal of Clinical Nutrition, 72: 922-928, 2000.
    2. Appel, L.J., T.J. Moore, E. Obarzanek, et al. ``A Clinical Trial
of the Effects of Dietary Patterns on Blood Pressure.'' DASH
Collaborative Research Group. The New England Journal of Medicine, 336:
1117-1124, 1997.
    3. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. ``Dietary Guidelines for Americans, 2010. 7th
Edition,'' 2010. Available at http://health.gov/dietaryguidelines/2010/.
    4. ``Third Report of the National Cholesterol Education Program
(NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III) final report.''
Circulation, 106: 3143-3421, 2002.
    5. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. ``2015-2020 Dietary Guidelines for Americans, 8th
Edition,'' December 2015. Available at http://health.gov/dietaryguidelines/2015/guidelines/.
    6. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. ``Nutrition and Your Health, Dietary Guidelines for
Americans,'' 2000. Available at http://health.gov/dietaryguidelines/2000.asp.
    7. U.S. Department of Health and Human Services and U.S. Department
of Agriculture. ``Dietary Guidelines for Americans, 2005. 6th
Edition,'' 2005. Available at http://health.gov/dietaryguidelines/dga2005/document/default.htm.
    8. Institute of Medicine (IOM) of the National Academies. ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids (Macronutrients).'' Chapter 8,
``Dietary Fats: Total Fat and Fatty Acids,'' 2002.
    9. FDA/CFSAN, Food Labeling: Health Claims; Dietary Saturated Fat
and Cholesterol and Risk of Coronary Heart Disease, Regulatory Impact
Analysis, FDA-2013-P-0047.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

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

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.75 is amended by revising paragraphs (c)(1) and
(c)(2)(ii) to read as follows:

Sec.  101.75   Health claims: dietary saturated fat and cholesterol and
risk of coronary heart disease.

* * * * *
    (c) * * *
    (1) All requirements set forth in Sec.  101.14 shall be met, except
Sec.  101.14(e)(6) with respect to a raw fruit or vegetable.
    (2) * * *
    (ii) Nature of the food. (A) The food shall meet all of the
nutrient content requirements of Sec.  101.62 for a ``low saturated
fat'' and ``low cholesterol'' food.
    (B) The food shall meet the nutrient content requirements of Sec.
101.62 for a ``low fat'' food, unless it is a raw fruit or vegetable;
except that fish and game meats (i.e., deer, bison, rabbit, quail, wild
turkey, geese, and ostrich) may meet the requirements for ``extra
lean'' in Sec.  101.62.
* * * * *

    Dated: December 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29997 Filed 12-16-16; 8:45 am]
 BILLING CODE 4164-01-P