[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Rules and Regulations]
[Pages 6118-6120]
[FR Doc No: 2018-02749]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0952; Product Identifier 2017-CE-028-AD; Amendment
39-19189; AD 2018-03-16]
RIN 2120-AA64

Airworthiness Directives; Stemme AG Gliders

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2017-10-11 for
Stemme AG Model Stemme S10-VT gliders (type certificate previously held
by Stemme GmbH & Co. KG). This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and address an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as certain
propeller front transmission gear wheels having insufficient material
strength because of improper heat treatment during manufacturing. We
are issuing this AD to require actions to address the unsafe condition
on these products and to add Stemme AG Model Stemme S 12 gliders to the
Applicability section.

DATES: This AD is effective March 20, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 20,
2018.

ADDRESSES: You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0952; or in person at Docket Operations, U.S. Department of
Transportation, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    For service information identified in this AD, contact STEMME AG,
Flugplatzstrasse F2, Nr. 6-7, D-15344 Strausberg, Germany; telephone:
+49 (0) 3341 3612-0, fax: +49 (0) 3341 3612-30; internet: https://www.stemme.com. You may view this referenced service information at the
FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for Docket No. FAA-2017-0952.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Stemme AG Model Stemme
S10-VT gliders (type certificate previously held by Stemme GmbH & Co.
KG) and all Stemme AG Model Stemme S 12 gliders equipped with a certain
front gearbox, part number 11AG. That NPRM was published in the Federal
Register on October 10, 2017 (82 FR 46938), and proposed to supersede
AD 2017-10-11, Amendment 39-18885 (82 FR 24239, May 26, 2017) (``AD
2017-10-11'').
    Since we issued AD 2017-10-11, we have type certificated Stemme AG
Model Stemme S 12 gliders in the United States and have determined
those model gliders should also be included in the applicability of AD
2017-10-11. In addition, Stemme AG has issued new service information
with procedures for addressing the unsafe condition.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
and the FAA's response to the comment.

Request for Manufacturer To Be Responsible for All Associated Cost

    Taylor Ray stated that the manufacturer should be responsible for
replacing the front gearbox on the affected gliders at no cost to the
owners/operators. We infer that the commenter is referring to the cost
for both parts and labor.
    Taylor Ray stated that since the unsafe condition resulted from the
manufacturing process, the manufacturer should be responsible for
fixing the unsafe condition.
    We neither agree nor disagree since the FAA does not get involved
in who pays for the cost of mitigating an unsafe condition. The primary
concern the FAA has when issuing an AD is addressing unsafe conditions
on various aircraft flying in the United States. While we provide
information related to the estimated labor and parts cost associated
with each AD, we do not control warranty coverage for owner/operators
of the affected aircraft nor can

we mandate the manufacturer to cover all associated costs. We have
contacted Stemme AG about this issue. The following is the response we
received: ``All costs will be paid by Stemme AG (parts + work) for
customers who are affected within the one-year warranty. Customers who
are out of the one-year warranty will receive parts for free, but
unfortunately, they have to pay for the necessary work (approx. 10
working hours).'' Based on this response from Stemme AG, we revised the
Cost of Compliance section in this AD. We changed the number of
estimated work-hours per product to replace the front gearbox from 19
to 10, updated the total cost on U.S. operators and cost per product
based on this change, and added standard warranty information.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for changes stated above. We have determined
that these changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Stemme AG has issued STEMME Service Bulletin Dok. Nr.: P062-980010,
Issue: 01, dated June 14, 2017, and STEMME Procedural Specification
Dok. Nr.: P320-900060, dated June 14, 2017. In combination, the service
information describes procedures for replacing the front gearbox. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section of this AD.

Differences Between This AD and the Service Information

    The service information for this AD allows the owner/operator to do
certain maintenance tasks. Also, the service information specifies
certain maintenance tasks be done by Stemme AG. However, for this AD,
we do not allow the owner/operator to do any maintenance tasks; all
maintenance tasks must be done by an appropriately certified mechanic
or maintenance shop. In addition, we do not require any maintenance
tasks be done specifically by Stemme AG; any appropriately certified
mechanic or maintenance shop may do the tasks required by this AD.

Costs of Compliance

    According to the U.S. registry, we have a total of 51 of both
glider types registered, but there are still only 14 serial numbers of
the part number 11AG front gearbox. Therefore, the most gliders that
will be affected remains 14. According to Stemme AG, there are a total
of 4 of the affected front gearboxes on both glider types of U.S.
registry (2 for each model).
    It will take an estimated 10 work-hours per product to comply with
the basic requirements of this AD. The average labor rate is $85 per
work-hour. Required parts will cost about $2,000 per product.
    Based on these figures, if we consider the costs for all 14
affected gearboxes, then we estimate the cost of this AD on U.S.
operators to be $39,990, or $2,850 per product.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0952; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
the NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-18885 (82 FR
24239, May 26, 2017), and adding the following new AD:

2018-03-16 Stemme AG: Amendment 39-19189; Docket No. FAA-2017-0952;
Product Identifier 2017-CE-028-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective March 20,
2018.

(b) Affected ADs

    This AD replaces AD 2017-10-11, Amendment 39-18885 (82 FR 24239,
May 26, 2017) (``AD 2017-10-11'').

(c) Applicability

    This AD applies to Stemme AG Model Stemme S10-VT gliders (type
certificate previously held by Stemme GmbH & Co. KG), all serial
numbers, and Stemme AG Model Stemme S 12 gliders, all serial
numbers, that are:
    (1) Equipped with a front gearbox, part number (P/N) 11AG, with
a serial number listed in table 1 to paragraph (c) of this AD; and
    (2) are certificated in any category.

                   Table 1 to Paragraph (c) of This AD--Affected P/N 11AG (Front Gearbox) S/Ns
----------------------------------------------------------------------------------------------------------------

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       80058/0814             80059/0915             80060/0915             80061/1115             80062/1215
       80063/0116             80064/0416             80065/0616             80066/0716             80067/0916
       80068/1016             80069/0117             80070/0217             80071/0217      ....................
----------------------------------------------------------------------------------------------------------------

    Note 1 to paragraph (c) of this AD: Page 2 of Stemme AG Service
Bulletin No. P062-980010, dated April 21, 2017, provides a pictorial
of where the serial number of the affected gearboxes are located.

(d) Subject

    Air Transport Association of America (ATA) Code 61: Propellers/
Propulsors.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and address an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as certain
propeller front transmission gear wheels having insufficient
material strength because of improper heat treatment during
manufacturing. We are issuing this AD to add a model glider to the
Applicability, paragraph (c) of this AD, and to prevent failure of
the propeller front transmission gear wheels. This failure could
cause loss of power between the engine and the propeller, which
could result in reduced control.

(f) Actions and Compliance

    Unless already done, do the following actions:
    (1) For Model Stemme S10-VT gliders: Before further flight after
June 15, 2017 (the effective date of AD 2017-10-11), replace the
front gearbox following STEMME Procedural Specification Dok. Nr.:
P320-900060, as specified in STEMME Service Bulletin Dok. Nr.: P062-
980010, Issue: 01, both dated June 14, 2017.
    (2) For Model Stemme S 12 gliders: Before further flight after
March 20, 2018 (the effective date of this AD), replace the front
gearbox following STEMME Procedural Specification Dok. Nr.: P320-
900060, as specified in STEMME Service Bulletin Dok. Nr.: P062-
980010, Issue: 01, both dated June 14, 2017.
    (3) As of March 20, 2018 (the effective date of this AD), do not
install a front gear box listed in table 1 of paragraph (c) of this
AD.
    (4) The service information for this AD allows the owner/
operator to do certain maintenance tasks. Also, the service
information specifies certain maintenance tasks be done by Stemme
AG. However, for this AD, we do not allow the owner/operator to do
any maintenance tasks; all maintenance tasks must be done by an
appropriately certified mechanic or maintenance shop. In addition,
we do not require any maintenance tasks be done specifically by
Stemme AG; any appropriately certified mechanic or maintenance shop
may do the tasks required by this AD.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Small Airplane Standards Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax: (816) 329-
4090; email: [email protected].
    (i) Before using any approved AMOC on any airplane to which the
AMOC applies, notify your appropriate principal inspector (PI) in
the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (ii) AMOCs approved for AD 2017-10-11, Amendment 39-18885 (82 FR
24239, May 26, 2017) are approved as AMOCs for the corresponding
provisions of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, Small Airplane
Standards Branch, FAA; or the European Aviation Safety Agency
(EASA).

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2017-0072-E, dated April 26, 2017, and Stemme AG Service Bulletin
No. P062-980010, dated April 21, 2017, for related information. You
may examine the MCAI on the internet at http://www.regulations.gov
by searching for and locating Docket No. https://www.regulations.gov/document?D=FAA-2017-0952-0002.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) STEMME Service Bulletin Dok. Nr.: P062-980010, Issue: 01,
dated June 14, 2017.
    (ii) STEMME Procedural Specification Dok. Nr.: P320-900060,
dated June 14, 2017.
    (3) For Stemme AG service information identified in this AD,
contact STEMME AG, Flugplatzstrasse F2, Nr. 6-7, D-15344 Strausberg,
Germany; telephone: +49 (0) 3341 3612-0, fax: +49 (0) 3341 3612-30;
internet: https://www.stemme.com.
    (4) You may view this service information at FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
816-329-4148. In addition, you can access this service information
on the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0639.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on February 5, 2018.
Melvin J. Johnson,
Deputy Director, Policy & Innovation Division, Aircraft Certification
Service.
[FR Doc. 2018-02749 Filed 2-12-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 29, 2008 (Volume 73, Number 189)]
[Rules and Regulations]
[Page 56477-56487]
[DOCID:fr29se08-17]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2004-P-0205] (formerly Docket No. 2004P-0464)

Food Labeling: Health Claims; Calcium and Osteoporosis, and
Calcium, Vitamin D, and Osteoporosis

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
labeling regulation authorizing a health claim on the relationship
between calcium and a reduced risk of osteoporosis to include vitamin D
so that, in addition to the claim for calcium and osteoporosis, an
additional claim can be made for calcium and vitamin D and
osteoporosis; eliminate the requirement that the claim list sex, race,
and age as specific risk factors for the development of osteoporosis;
eliminate the requirement that the claim does not state or imply that
the risk of osteoporosis is equally applicable to the general U.S.
population, and that the claim identify the populations at particular
risk for the development of osteoporosis; eliminate the requirement
that the claim identify the mechanism by which calcium reduces the risk
of osteoporosis and instead make it optional; eliminate the requirement
that the claim include a statement that a total dietary intake greater
than 200 percent of the recommended daily intake (2,000 milligrams (mg)
of calcium) has no further benefit to bone health when the food
contains 400 mg or more of calcium per reference amount customarily
consumed or per total daily recommended supplement intake; and allow
reference for the need of physical activity in either of the health
claims to be optional rather then required. This final rule is, in
part, in

response to a health claim petition submitted by The Beverage Institute
for Health and Wellness, LLC.

DATES: This final rule is effective January 1, 2010.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 5, 2007 (72 FR 497), FDA
published a proposed rule (the calcium and vitamin D proposed rule) to
amend Sec.  101.72 (21 CFR 101.72), which authorizes a health claim
regarding the relationship between calcium and osteoporosis. The agency
proposed the following five amendments: (1) Inclusion of vitamin D so
that, in addition to the claim for calcium and osteoporosis, an
additional claim can be made for calcium and vitamin D and
osteoporosis; (2) elimination of the requirement in Sec.
101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific
risk factors for the development of osteoporosis; (3) elimination of
the requirement in Sec.  101.72(c)(2)(i)(B) that the claim does not
state or imply that the risk of osteoporosis is equally applicable to
the general U.S. population, and that the claim identify the
populations at particular risk for the development of osteoporosis; (4)
elimination of the requirement in Sec.  101.72(c)(2)(i)(C) that the
claim identify the mechanism by which calcium reduces the risk of
osteoporosis and instead make it optional; and (5) elimination of the
requirement in Sec.  101.72(c)(2)(i)(E) that the claim include a
statement that reflects the limit of the benefits derived from dietary
calcium intake, when the level of calcium in the food exceeds a set
threshold level. FDA issued this proposed rule in response to a health
claim petition submitted on July 12, 2004, by the Beverage Institute
for Health and Wellness under section 403(r)(4) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)) (Ref. 1).
Section 403(r)(3)(B)(i) of the act states that the Secretary of Health
and Human Services (Secretary) (and, by delegation, FDA) shall issue a
regulation authorizing a health claim only if the Secretary determines,
based on the totality of publicly available scientific evidence
(including evidence from well-designed studies conducted in a manner
which is consistent with generally recognized scientific procedures and
principles), that there is significant scientific agreement, among
experts qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence (see also 21
CFR 101.14(c)). Section 403(r)(4) of the act sets out the procedures
that FDA is to follow upon receiving a health claim petition. FDA filed
the petition for comprehensive review in accordance with section
403(r)(4) of the act on October 20, 2004.

II. Summary of Comments and the Agency's Response

    FDA solicited comments on the calcium and vitamin D proposed rule.
The comment period closed on March 21, 2007. The agency received 27
responses, each containing one or more comments, to the calcium and
vitamin D proposed rule. The comments were from trade associations,
health-related organizations, academia, and consumers. Most of the
comments supported the proposed amendments. A few comments expressed
personal opinions on the use of health claims and labeling in general.
These comments did not raise any issues about the calcium and vitamin D
proposed rule, and therefore, we consider these to be outside the scope
of this rulemaking and do not discuss them in this document. Another
comment asserted that the standard of significant scientific agreement
was not met and provided some citations and studies as support for its
assertion. However, the studies that were submitted were not the type
of studies that could resolve a question about the relationship between
vitamin D and calcium, or calcium only, and osteoporosis that is the
subject of the claim. The remaining comments and the agency's responses
are discussed below.
    (Comment 1) FDA received two comments opposing the elimination of
the requirement in Sec.  101.72(c)(2)(i)(A) that the claim list sex,
race, and age as specific risk factors for the development of
osteoporosis. One of these comments did not give a reason for its
opposition to the elimination of this requirement. The comment also
asserted that high levels of calcium will inhibit the intake of
manganese, and that the primary cause of osteoporosis in the United
States is manganese deficiency. The other comment stated that the
``published docket'' did not provide adequate support to eliminate
references to age, sex, race, and the need for an adequate level of
exercise. The comment noted that studies have linked calcium and
vitamin D to bone health only in specific demographic categories.
    (Response) The comment opposing the elimination of listing sex,
race, and age as specific risk factors in the claim language failed to
provide any explanation, data, or evidence to support its opposition to
eliminating the listing of these risk factors in the claim. Without
such explanation, data, or evidence, FDA has no basis upon which to
revise its analysis. As such, FDA will continue to rely on the analysis
as set forth in the calcium and vitamin D proposed rule (72 FR 497 at
506-507). As to the comment's concern about manganese, the agency is
not aware of, nor did the comment provide, any data or evidence to
substantiate the statement that high levels of calcium intake will
inhibit the intake of manganese or that the primary cause of
osteoporosis in the United States is manganese deficiency.
    FDA disagrees with the comment that information in the docket does
not provide adequate evidence to eliminate the requirement that the
claim reference age, sex, and race. The information in the record of
this proceeding demonstrates that benefits of adequate calcium and
vitamin D in reducing the risk of osteoporosis is not confined to any
particular subpopulation in the United States. The scientific evidence
from both the 2004 Surgeon General's Report on Bone Health and
Osteoporosis and the 2000 National Institutes of Health (NIH) Consensus
Statement concludes that osteoporosis occurs in all populations and at
all ages (72 FR 497 at 506). Moreover, both the 2000 NIH Consensus
Statement and the 2004 Surgeon General's Report on Bone Health and
Osteoporosis conclude that achieving and maintaining optimal bone
health is a process that is important in both men and women throughout
the lifespan and is not a specific need to any particular subpopulation
in the United States (72 FR 497 at 506-507). Given that the risk of
osteoporosis applies to the general U.S. population, the benefits of
adequate calcium and vitamin D in terms of reducing risk of disease
apply to both sexes at all ages and race categories. Accordingly,
because these benefits do not apply only to specific demographic
groups, the language of the health claim in question should not state
or suggest otherwise. For this reason, FDA is eliminating the
requirement that the calcium and osteoporosis health claim or the
calcium, vitamin D, and osteoporosis health claim list sex, race, and
age as specific risk factors for the development of osteoporosis.
    In any discussion about osteoporosis and bone health, it is
important to recognize the difference between risk of bone disease,
including osteoporosis, and the prevalence of the disease in various
subpopulations in the United

States. Risk measures the probability that a disease will occur whereas
prevalence measures the number of cases of a disease that are
documented in a given population or subpopulation. Both the 2000 NIH
Consensus Statement and the 2004 Surgeon General's Report on Bone
Health and Osteoporosis state that all populations in the United States
are at risk of osteoporosis, although the prevalence of the disease is
not equally distributed among all subpopulations. Specifically,
osteoporosis is most prevalent in White postmenopausal women. However,
as noted, the disease often goes unrecognized in other age and ethnic
groups as well as in men (72 FR 497 at 508).
    In sum, while the prevalence of osteoporosis varies in different
subpopulations in the United States, all populations are at risk of
osteoporosis and, in fact, the disease does occur in all populations.
Thus, the benefits of calcium or calcium and vitamin D on reducing the
risk of bone diseases, including osteoporosis, apply to both sexes at
all ages and in all race categories (72 FR 497 at 507). For this
reason, FDA is eliminating the requirement that the calcium and
osteoporosis health claim or the calcium, vitamin D, and osteoporosis
health claim list sex, race, and age as specific risk factors for the
development of osteoporosis.
    Importantly, however, although this final rule eliminates the
requirement that the claim reference age, sex, and race for the
development of osteoporosis, Sec.  101.72(d)(4) allows the claim to
include optional information related to the prevalence of osteoporosis.
In particular, the claim could include information about the number of
people in the United States, including the number of people in certain
subpopulations in the United States, who have osteoporosis or low bone
density. For example, under Sec.  101.72(d)(4), a claim could include a
statement that, according to the National Osteoporosis Foundation, 20
percent of non-Hispanic Caucasian and Asian women aged 50 and older are
estimated to have osteoporosis.
    (Comment 2) FDA received two comments opposing the elimination of
the requirement in Sec.  101.72(c)(2)(i)(C) that the calcium and
osteoporosis health claim identify the mechanism by which calcium
reduces the risk of osteoporosis. One comment did not give a reason for
its opposition to the elimination of this requirement. The other
comment noted that building a strong bone matrix relies on proper
mineral balance and that science is continually evolving to elucidate
the specific mechanisms involved. This comment further stated that
although calcium is required to develop and sustain proper bone health
and to prevent osteoporosis, the scientific community recognizes that
calcium alone is not adequate, and a balance of normal minerals and
hormones are also critical for bone health. Thus, this comment
suggested that there is not enough scientific evidence either to
eliminate or make optional the requirement in Sec.  101.72(c)(2)(i)(C)
because incomplete information is not accurate information.
    (Response) The comment opposing elimination of the requirement in
Sec.  101.72(c)(2)(i)(C) failed to provide any explanation, data, or
evidence to support its position. Without any explanation, data, or
evidence provided in the comment, we have no basis upon which to revise
our analysis or to alter our conclusion to eliminate the requirement
that the health claim identify the mechanism by which calcium reduces
the risk of osteoporosis; thus we will continue to use the analysis as
set forth in the calcium and vitamin D proposed rule (72 FR 497 at 508-
509).
    FDA agrees with the comment that stated: Building a strong bone
matrix relies on proper mineral balance and that science is continually
evolving to elucidate specific mechanism(s) involved. Calcium is an
important nutrient for achieving and maintaining good skeletal health.
FDA discussed the findings that many nutrients are involved in bone
health, and tentatively concluded in the proposed rule that a well-
balanced diet is important for bone health throughout life (72 FR 497
at 507). Thus, the agency proposed that the claim make clear the
importance of calcium intake or calcium and vitamin D intake in a
healthful well-balanced diet over a lifetime. Conveying the information
about calcium intake in the context of a healthful, well-balanced diet
recognizes that calcium alone is not sufficient for bone health.
Furthermore, results from a 1995 health claims report showed that
consumers had learned elsewhere that calcium intake is related to bone
health and that they thought the food label was not the right means for
conveying this information (72 FR 497 at 509). This consumer awareness
of calcium's ability to ``build and maintain good bone health,'' as
well as the observation that the food label is not necessarily the most
appropriate means to convey this information, prompted the agency to
request comment in the calcium and vitamin D proposed rule on whether
to make information of the mechanism by which calcium reduces the risk
of osteoporosis optional in the health claim. Therefore, for the
reasons set forth previously in this document, FDA is eliminating the
requirement that the claims identify the mechanism by which calcium
reduces the risk of osteoporosis, and instead is making such
information optional. FDA is also revising the language from the
proposed rule for use of the optional statement about slowing the rate
of bone loss, by removing the following phrase: ``When reference is
made to persons with a family history of the disease, post-menopausal
women, and elderly men and women * * *'' so the language now reads:
``The claim may also state that adequate intake of calcium, or when
appropriate, adequate intake of calcium and vitamin D, is linked to
reduced risk of osteoporosis through the mechanism of slowing the rate
of bone loss for persons with a family history of the disease, post-
menopausal women, and elderly men and women.'' This change makes the
use of the optional language related to the mechanism of slowing the
rate of bone loss consistent with the final rule to remove reference to
specific targeted populations as to risk of osteoporosis, but allows
reference to family history of the disease, post-menopausal women, and
elderly men and women in the context of the mechanism of slowing the
rate of bone loss.
    (Comment 3) Several comments opposed the elimination of the
conditional requirement in Sec.  101.72(c)(2)(i)(E) that the calcium
and osteoporosis health claim include a statement that a total dietary
intake greater than 200 percent of the recommended daily intake (2,000
mg of calcium) has no further known benefit to bone health. Some of the
comments were concerned that eliminating this requirement could
potentially mislead consumers because there will be nothing on the
label to remind them that ``more is not always better when it comes to
nutrients, especially in the form of supplements or fortification.''
One comment stated that withholding this information could encourage
consumers to over consume calcium products while other comments were
concerned that withholding this information could be potentially
harmful for those individuals who may be taking high doses of
supplemental calcium, along with high amounts of vitamin D. One comment
highlighted its concern regarding the elimination of this conditional
requirement by pointing out that the Institute of Medicine (IOM) of the
National Academy of Sciences (NAS) has found that the toxic effects of
excess calcium

increased the risk of kidney stone formation and that this condition
affected 12 percent of individuals in the United States, as well as
renal insufficiency and decreased absorption of other essential
minerals (iron, zinc, magnesium and phosphorus) (72 FR 497 at 502).
Another comment questioned how FDA could be assured that cumulative
vitamin D intake from all dietary sources would remain `at non-toxic
levels' (e.g., less than the Tolerable Upper Intake Level (UL) for
vitamin D) when supplementation is encouraged in a variety of foods,
including staples such as milk, cereal, and bread.
    (Response) FDA's decision to eliminate the conditional requirement
was made, in part, in response to the IOM's 1997 report on ``Dietary
Reference Intakes (DRIs) for Calcium, Phosphorus, Magnesium, Vitamin D
and Fluoride,'' which was not available at the time the calcium and
osteoporosis health claim was authorized in 1993 (72 FR 497 at 510).
IOM conducted a major review of bone-related nutrients to determine the
level of nutrient intake for normal, healthy individuals that would
prevent the development of a chronic condition (e.g., osteoporosis)
associated with calcium (Ref. 2). IOM set the UL for calcium at 2,500
mg per day for all individuals ages 1 and above. The UL, as defined by
IOM, is the highest level of nutrient intake that is likely to pose no
risks of adverse effects to all individuals in the general population.
When IOM set the UL for calcium it divided the lowest- observed-
adverse-effect level (LOAEL) of calcium by an uncertainty factor of two
to take into account the relatively high prevalence of kidney (renal)
stones in the U. S. population, which is 12 percent, and the potential
increased risk of hypercalciuria and depletion of other minerals among
susceptible individuals (72 FR 497 at 502). An increased risk of kidney
stone formation from toxic effects of excess calcium, as noted in one
of the comments, was addressed when IOM established the UL for calcium.
    Furthermore, inclusion of the conditional requirement was based, in
part, on a concept that calcium was a threshold nutrient, which means
that there is a level of calcium intake below which bone health is
jeopardized and above which no further benefit to bone health occurs
(72 FR 497 at 510). Neither IOM in its 1997 report, the 2000 NIH
Consensus Statement, nor the 2004 Surgeon General's Report on Bone
Health and Osteoporosis discusses a threshold level of calcium beyond
which no further bone benefit occurs; instead these reports discuss
scientific evidence that is useful for establishing a desirable level
of intake for calcium as well as intake levels of calcium that pose no
risk of adverse health effects (72 FR 497 at 510).
    Moreover, contrary to concerns expressed by some of the comments,
the lack of calcium in the American diet is more of a concern than the
potential over consumption of the nutrient. For example, the 2005
Dietary Guidelines for Americans identified calcium as a ``nutrient of
concern'' due to low calcium consumption in the U.S. population (Ref.
3).
    FDA also notes that a ``high'' level of calcium and vitamin D is at
least 20 percent of the Reference Daily Intake (RDI) of calcium and
vitamin D per reference amount customarily consumed (RACC). Since the
RDI for calcium is 1,000 mg per day and the RDI for vitamin D is 400 IU
(10 micrograms per day ([mu]g per day)), 20 percent of the RDI for
calcium (200 mg per day) is well below the UL of 2,500 mg per day
intake level of calcium that poses no risk of adverse health effects
and 20 percent of the RDI for vitamin D (80 IU (2 [mu]g per day) is
well below the 2,000 IU (50 [mu]g per day) intake level of vitamin D
that poses no risk of adverse health effects.
    To evaluate potential maximum intake levels of calcium and vitamin
D in the United States, FDA examined the most recent nationally
representative data available from the National Health and Nutrition
Examination Survey on median intake values for calcium and vitamin D
and common dietary supplement products that contain calcium, or calcium
and vitamin D in the calcium and vitamin D proposed rule (72 FR 497 at
500 to 502). Results from this evaluation suggested that consumers who
choose foods that bear the calcium, or the calcium and vitamin D, and
osteoporosis health claim would be able to incorporate such foods into
the diet in a manner that would likely keep their total intake of
calcium well below the UL of 2,500 mg per day and their total intake of
vitamin D below the UL of 2,000 IU per day (72 FR 497 at 502). Further,
FDA determined that consumers who choose conventional foods that bear
the calcium or the additional calcium and vitamin D claim and that
consume up to 1,500 mg of calcium per day from supplements (the maximum
daily intake of calcium suggested in commonly found supplements) and
that consume up to 400 IU of vitamin D per day from supplements (the
most common daily intake of vitamin D suggested in supplements) would
also likely keep their total intake of calcium and vitamin D below the
ULs of calcium and vitamin D (id.). None of the comments questioned
these findings. Finally, the agency is not aware of any basis for why
the elimination of the conditional requirement would be misleading or
encourage over-consumption of calcium products.
    For these reasons, FDA is eliminating the conditional requirement
in Sec.  101.72(c)(2)(i)(E), as proposed.
    (Comment 4) One comment noted that retaining in Sec.  101.72(e) and
(f) physical activity as part of the calcium and osteoporosis health
claim as well as the calcium, vitamin D and osteoporosis health claim,
might have the unintended consequence of leading consumers to believe
that the benefits to bone health (or reduced risk of osteoporosis) of
consuming adequate amounts of calcium or calcium and vitamin D can only
be achieved by regularly engaging in physical activity.
    (Response) FDA agrees with this comment. The agency's tentative
decision to retain physical activity as part of the calcium and
osteoporosis claim as well as the calcium, vitamin D and osteoporosis
health claim was based primarily on the 2000 NIH Consensus Statement
and the 2004 Surgeon's General Report (72 FR 497 at 507), which
indicate that physical activity is beneficial to bone health and can
have an additive effect on increasing bone mineral density (BMD) in
conjunction with adequate intake of calcium and vitamin D. On the other
hand, several studies show that consuming adequate levels of calcium
and vitamin D supports bone health and reduces the risk of osteoporosis
in the absence of physical activity (Refs. 4 to 12). Since consumption
of adequate amounts of calcium and vitamin D reduces the risk of
osteoporosis without physical activity, FDA will not require physical
activity to remain as part of the claim language for the calcium and
osteoporosis or the calcium, vitamin D and osteoporosis health claim.
However, since the importance of physical activity to bone health is
well established, FDA will allow optional reference to physical
activity in the health claim.
    Given the information discussed in the preamble to the calcium and
vitamin D proposed rule and the absence of contrary information in the
comments, FDA is adopting the following amendments to Sec.  101.72: (1)
Inclusion of vitamin D so that, in addition to the claim for calcium
and osteoporosis, a claim can be made for calcium and vitamin D and
osteoporosis; (2) elimination of the requirement in Sec.
101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific
risk factors for the development of osteoporosis; (3)

elimination of the requirement in Sec.  101.72(c)(2)(i)(B) that the
claim does not state or imply that the risk of osteoporosis is equally
applicable to the general U.S. population, and that the claim identify
the populations at particular risk for the development of osteoporosis;
(4) elimination of the requirement in Sec.  101.72(c)(2)(i)(C) that the
claim identify the mechanism by which calcium reduces the risk of
osteoporosis, and instead make it optional; (5) elimination of the
conditional requirement in Sec.  101.72(c)(2)(i)(E) that the claim
include a statement that a total dietary intake greater than 200
percent of the recommended daily intake (2,000 milligrams (mg) of
calcium) has no further benefit to bone health, when the level of
calcium in the food exceeds a set threshold level; and (6) elimination
of the provision in Sec.  101.72(c)(2)(i)(A) about physical activity,
and instead make it optional. Therefore, FDA is not including the term
``physical activity'' in some of the model health claims as proposed.
Moreover, FDA is revising Sec.  101.72(e) and (f) by removing the term
``regular exercise'' in the model health claims.

III. Analysis of Economic Impacts

A. Final Regulatory Impact Analysis

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies 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). The agency believes that
this final rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant economic impact
of a rule on small entities. The final rule amends the current calcium
and osteoporosis health claim language and will require changes to the
claim language on products currently bearing the health claim. Thus,
the only mandatory costs of this final rule will be the costs to update
the current wording of the calcium and osteoporosis health claim on
those products that currently bear the claim. Based on FDA's 2001 Food
Label and Package Survey (FLAPS) (see discussion in section III.A.2
``Background'' of this document), very few products bear the calcium
and osteoporosis health claim. Therefore, because of the limited use of
the current calcium and osteoporosis health claim, the agency certifies
that the final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``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 $130 million, using the most current (2007) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount and has determined that this final rule does not
constitute a significant rule under the Unfunded Mandates Reform Act.
1. Need for This Regulation
    Current regulations do not permit food producers to claim health
benefits for products by linking the intake of vitamin D, when combined
with the intake of calcium, with a reduced risk of osteoporosis.
However, current regulations do permit food producers to claim health
benefits for products by linking calcium intake with a reduced risk of
osteoporosis only if they also list the specific risk factors and at-
risk subpopulations for osteoporosis, the mechanism by which calcium
reduces the risk of osteoporosis, and the limit of the benefits of
dietary calcium at certain levels.
    Health claims can inform consumers about diet-disease relationships
and encourage producers to produce more healthful foods. This final
rule will allow producers to make more nutrition information related to
osteoporosis available to consumers (linking the intake of calcium and
vitamin D to the risk of osteoporosis), while eliminating other
information currently required to be given to consumers when claiming
health benefits relating to the relationship between calcium intake and
the risk of osteoporosis.
2. Background
    Osteoporosis represents a major public health problem in the United
States. This disease affects more than 10 million individuals and
causes approximately 1.5 million fractures annually. Every year, these
lead to more than 2.6 million physician office visits, over 800,000
emergency room visits, and more than 500,000 hospitalizations, and the
placement of nearly 180,000 people into nursing homes. The direct care
expenditures for osteoporotic fractures alone range from 12 to 18
billion dollars each year (measured in 2002 dollars) (Ref. 13). The
indirect health costs of osteoporosis, such as pain, suffering, and
lost mobility, are also large. Average calcium and vitamin D intakes
are below recommended levels for many consumers (Refs. 13, 14 and 15).
Even though many consumers are not achieving recommended intakes of
calcium, producers have rarely placed the calcium and osteoporosis
health claim on products that qualify for the claim. FDA's 2001 FLAPS
(the most recently available data) showed only 1 out of the 87 shelf-
stable juice products surveyed, a fortified orange juice, bearing the
calcium and osteoporosis health claim. None of the 10 milk products
surveyed bore the claim (Ref. 16).
3. Regulatory Options
    FDA identified four regulatory options for this final rule: (1)
Take no new regulatory action; (2) reduce the required language in the
existing calcium and osteoporosis health claim; (3) expand the existing
calcium and osteoporosis health claim to include vitamin D; or (4)
reduce the required language in the existing calcium and osteoporosis
health claim and include vitamin D as an option to the claim, as
described in this final rule.
4. Changes in Market Behavior in Response to Options
    This final rule will require that any food manufacturers wishing
their products' labels to make the calcium, or calcium and vitamin D,
and osteoporosis health claim be redesigned. Labels must be redesigned
in order for a food to carry the health claim since information on
populations at particular risk for osteoporosis would no longer be
required or allowed for the claim (see Sec.  101.72(c)(2)(A) and
(c)(2)(B)).
    Manufacturers that wish to continue making a calcium and
osteoporosis health claim on their products will not need to
reformulate their products under the final rule. The nature of the food
eligible to make a calcium and osteoporosis health claim remains food
that meets or exceeds a ``high'' level of calcium (as defined in 21 CFR
101.54(b)). Manufacturers wishing to take advantage of the expanded
calcium, vitamin D, and osteoporosis health

claim may voluntarily choose to reformulate their products. If some
producers choose to reformulate their products to take advantage of the
calcium, vitamin D, and osteoporosis health claim, they reveal that
they expect the private benefit that the claims give them to exceed the
expense of making the claims. If this is not the case, no producer will
voluntarily choose to use the claims. Likewise, consumers who choose to
purchase the products with the amended health claims reveal that they
value the products more highly than other alternatives, including not
purchasing the products.
    We considered five potential effects in estimating the relative
public health benefits of the options: (1) The extent to which the
option encourages producers to use the health claims on their food
labels; (2) the extent to which the option encourages producers to
reformulate their products to make the health claims; (3) the extent to
which the option provides information to consumers; (4) potential risk-
risk tradeoffs (where the action taken to reduce the risk posed by one
hazard causes an increase in the risk posed by another hazard) with
each option; and (5) the availability of information on the
relationship between osteoporosis and calcium and vitamin D to
consumers who do not consume dairy products.
    a. Producer responses. There are four likely responses to this
final rule from producers: (1) Make no changes (i.e., continue not
making the calcium or calcium and vitamin D health claim; (2) create
new product labels to continue making the calcium and osteoporosis
health claim (for products already making the existing claim); (3) add
the health claims to their products that qualify for the health claims
(increase usage of the claim due to the new wording requirements); and
(4) reformulate their products (by fortifying with calcium or vitamin
D, for example) to qualify for the health claims.
    Several factors affect whether producers choose to use health
claims, including the flexibility of the health claims and how
appealing the health claims are to consumers. Revising the existing
calcium and osteoporosis health claim language to make it shorter will
make it more appealing to put the health claims on labels. Package
space is limited, so more flexible and shorter claims are easier to
use. Also, Wansink, et al. (2004) found that shorter health claims on
the front of the package led to more favorable beliefs about the
product and a more positive image of the product among consumers (Ref.
17).
    Approving a calcium, vitamin D, and osteoporosis health claim
should encourage the manufacturers of foods that are eligible for
fortification with vitamin D to do so because they will be able to
publicize the relationship between calcium, vitamin D, and osteoporosis
on their labels. If producers fortify more products with vitamin D,
consumers can get more vitamin D in their diet without making changes
in their dietary choices.
    b. Consumer responses. Providing information about the relationship
between calcium, vitamin D, and osteoporosis on food packages provides
a number of benefits to consumers, including: (1) Informing them about
the nutrient-disease relationship; (2) helping them identify products
that are high in calcium and vitamin D; and (3) helping them make
dietary choices that reduce their risk of osteoporosis. The extent to
which consumers realize these benefits will depend on the consumer's
knowledge of the relationship between calcium, vitamin D, and bone
health; how many products bear the calcium or calcium and vitamin D
health claims; how many consumers read the health claims; and how much
they change their behavior to include such products in their diets.
There is evidence that consumers who read nutrition information on
packages eat healthier diets (Refs. 18 and 19). However, there is a
great deal of uncertainty about how much consumers change their
behavior in response to label information.
    c. Risk-risk tradeoffs. A potential concern is that allowing these
osteoporosis health claims on juice drinks will result in consumers
switching away from milk to juice drinks, which are higher in calories,
for dietary sources of calcium and vitamin D. Table 1 of this document
presents the caloric and nutrient profile of non-fat and low-fat milk
products and an orange juice drink product as reported in the U.S.
Department of Agriculture (USDA) National Nutrient Database for
Standard Reference. Orange juice drinks are higher in calories and
contain less of some important nutrients than either non-fat or low-fat
milk (table 1 of this document).

Table 1--Profiles of Selected Nutrients in Non-fat and Low-fat Milk and Orange Juice Drink (per 8-ounce serving)
----------------------------------------------------------------------------------------------------------------
                                                                           (2) Non-fat Milk    (3) Low-fat Milk
                      Nutrient                         (1) Orange Juice   (Skim), With Added   (1%), With Added
                                                             Drink             Vitamin A           Vitamin A
----------------------------------------------------------------------------------------------------------------
Energy, kilocalorie (kcal)                                       134                  83                 102
----------------------------------------------------------------------------------------------------------------
Protein, gram (g)                                                  0.5                 8.25                8.22
----------------------------------------------------------------------------------------------------------------
Total Fat, g                                                       0                   0.2                 2.37
----------------------------------------------------------------------------------------------------------------
Saturated Fat, g                                                   0                   0.286               1.545
----------------------------------------------------------------------------------------------------------------
Carbohydrate, g                                                   33.36               12.14               12.18
----------------------------------------------------------------------------------------------------------------
Total Dietary Fiber, g                                             0.5                 0                   0
----------------------------------------------------------------------------------------------------------------
Total Sugars, g                                                   23.29               12.46               12.69
----------------------------------------------------------------------------------------------------------------
Calcium, mg                                                        5                 306                 290
----------------------------------------------------------------------------------------------------------------
Iron, mg                                                           0.27                0.07                0.07
----------------------------------------------------------------------------------------------------------------
Magnesium, mg                                                      7                  27                  27
----------------------------------------------------------------------------------------------------------------
Phosphorus, mg                                                    10                 247                 232
----------------------------------------------------------------------------------------------------------------

Potassium, mg                                                    104                 382                 366
----------------------------------------------------------------------------------------------------------------
Sodium, mg                                                         5                 103                 107
----------------------------------------------------------------------------------------------------------------
Zinc, mg                                                           0.05                1.03                1.02
----------------------------------------------------------------------------------------------------------------
Copper, mg                                                         0.045               0.032               0.024
----------------------------------------------------------------------------------------------------------------
Manganese, mg                                                      0.017               0.007               0.007
----------------------------------------------------------------------------------------------------------------
Selenium, [mu]g                                                    0                   7.6                 8.1
----------------------------------------------------------------------------------------------------------------
Vitamin C, mg                                                     37.3                 0                   0
----------------------------------------------------------------------------------------------------------------
Thiamin, mg                                                        0.945               0.11                0.049
----------------------------------------------------------------------------------------------------------------
Riboflavin, mg                                                     1.07                0.446               0.451
----------------------------------------------------------------------------------------------------------------
Niacin, mg                                                        12.44                0.23                0.227
----------------------------------------------------------------------------------------------------------------
Pantothenic acid, mg                                               0.149               0.874               0.881
----------------------------------------------------------------------------------------------------------------
Vitamin B-6, mg                                                    1.244               0.091               0.09
----------------------------------------------------------------------------------------------------------------
Folate, [mu]g                                                     10                  12                  12
----------------------------------------------------------------------------------------------------------------
Vitamin B-12, [mu]g                                                0                   1.3                 1.07
----------------------------------------------------------------------------------------------------------------
Vitamin A, IU                                                    109                 499                 478
----------------------------------------------------------------------------------------------------------------
Vitamin D, IU                                                      0                 101.46              126.77
----------------------------------------------------------------------------------------------------------------
Cholesterol, mg                                                    0                   5                  12
----------------------------------------------------------------------------------------------------------------

    The likelihood of consumers switching from non-fat or low-fat milk
or to higher caloric juice drinks because of this rule is expected to
be small because non-fat and low-fat milk and juice drinks that are
eligible can already make the existing calcium and osteoporosis health
claim. Permitting the same set of products to make the final, simpler
calcium and osteoporosis health claim should not change the relative
appeal of the claim to producers of one type of beverage over another.
The allowance of the new calcium, vitamin D, and osteoporosis health
claim could expand the set of products making an osteoporosis health
claim; however, the relative appeal of the new claim (calcium and
vitamin D) to producers of non-fat and low-fat milk and juice drinks
should be similar to the appeal of the existing calcium and
osteoporosis health claim.
    There is little evidence to support that consumers would switch
from non-fat or low-fat milk to juice drinks as a result of this final
rule. As stated in the Surgeon General's Report on Bone Health and
Osteoporosis, consuming adequate levels of calcium and vitamin D
throughout life are critically important to an individual's bone
health. However, the report's review of national surveys suggests that
the average calcium intake of individuals is far below the levels
recommended for optimal bone health. One reason cited by the report for
these low levels of calcium intake relates to current lifestyle and
food preferences, which have resulted in reduced intake of dairy
products and other naturally occurring calcium-rich foods. The report
also posits that for some individuals lactose intolerance\1\ may also
play a role in not consuming adequate levels of calcium. Given this
information on the current preference and tolerance for dairy products,
expanding the calcium and osteoporosis health claim to include vitamin
D as a result of this final rule should only lead to an increase in the
overall consumption of these essential, under consumed nutrients.
---------------------------------------------------------------------------

    \1\Lactose intolerance is a condition in which individuals
cannot metabolize lactose, the main sugar found in milk and other
calcium-rich dairy products. Information in the Surgeon General's
2004 Report on Bone Health and Osteoporosis indicates that an
estimated 30 to 50 million Americans are affected by lactose
intolerance, although to varying degrees.
---------------------------------------------------------------------------

    In addition, according to the American Beverage Association, U.S.
sales of calcium-fortified orange juice have grown dramatically over
recent years, reaching nearly $1 billion in 2003 (Ref. 20), while
overall sales of juice have not grown. Therefore, FDA expects that the
nutritional profile of diets would most likely improve as a consequence
of changes in consumption resulting from this final rule. Switching
from unfortified to fortified juices would increase needed consumption
of calcium and vitamin D.
5. Benefits and Costs of Regulatory Options
    The simplification of the current health claim for calcium and
osteoporosis, along with the additional health claim for calcium,
vitamin D, and osteoporosis should increase and expand the current
usage of the health claim and therefore improve the U.S. population's
intake of these two important nutrients. Therefore, all the options
considered below would improve public health relative to the baseline
of taking no new regulatory action. In our analysis of the benefits and
costs of the options, we compare

the benefits and costs of each option with each other option based on
their relative effects on consumer and producer behavior.
Option 1: Take no new regulatory action.
    This option would result in no change to the current situation.
This is the baseline for comparison of options and entails no costs or
benefits.
Option 2: Reduce the required language in the existing calcium and
osteoporosis health claim.
    Compared with Option 1, this option would increase the appeal of
the claim for producers, increase the use of the claim on products, and
thereby provide consumers with more information on the calcium and
osteoporosis diet-disease relationship. It could encourage more
reformulation of products to fortify with calcium than has occurred
with the existing claim. Like Option 1, this option provides consumers
with no information about the relationship of vitamin D to
osteoporosis.
    With this option, manufacturers of some products making the current
calcium and osteoporosis health claim may have to re-label their
products to reflect the updated wording provided by the claim. The
potential costs associated with a required label change will vary
depending on when the new effective compliance date is established.
Table 2 of this document shows the possible range of costs by product
type of having to re-label to be in compliance with the revised calcium
and osteoporosis health claim. The product re-labeling costs were
estimated using the FDA Labeling Cost Model (Ref. 21). The costs of re-
labeling included are administrative, graphic, prepress, engraving, and
inventory costs. Re-labeling costs are shown for both a 12-month and
24-month compliance period.

                                                      Table 2.--Cost of Label Changes for Option 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              12 Months to Comply, Cost Per Label SKU         24 Months to Comply, Cost Per Label SKU
       NAICS Codes                    Product            -----------------------------------------------------------------------------------------------
                                                             Low Cost        Med Cost        High Cost       Low Cost        Med Cost        High Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
311421                     Fruit Juices                           $7,478         $10,186         $15,282          $5,455          $7,595         $11,897
311411
--------------------------------------------------------------------------------------------------------------------------------------------------------
311514                     Non-fat and Low-fat Milk,             $11,216         $14,086         $20,437          $7,127          $9,236         $14,327
311511                      fluid, dry, powered,
                            condensed, flavored
--------------------------------------------------------------------------------------------------------------------------------------------------------
311513                     Low-fat Cheese, multiple               $6,611          $8,759         $13,758          $5,106          $6,999         $11,489
                            types
--------------------------------------------------------------------------------------------------------------------------------------------------------
311511                     Yogurt-like products                   $4,554          $6,490         $10,857          $4,140          $5,900          $9,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
325412                     Dietary Supplements                    $9,728         $13,345         $22,834          $8,540         $11,739         $20,266
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average cost of label change regardless of product type           $7,917         $10,573         $16,633          $6,074          $8,294         $13,572
--------------------------------------------------------------------------------------------------------------------------------------------------------

Option 3: Expand the existing calcium and osteoporosis health claim to
include vitamin D.
    Failing to shorten the existing calcium and osteoporosis health
claim will not make the health claim as appealing to producers and
consumers as Option 2, leading to less claim use and reformulation and
less information provided to consumers than Option 2. This option would
provide consumers with more information on vitamin D than Option 2,
should producers decide to voluntarily re-label and/or reformulate
their products to make use of the added vitamin D language.
Option 4: Reduce the required language in the existing calcium and
osteoporosis health claim and include vitamin D as an option to the
claim, as described in this final rule.
    Like Option 2, this option would increase the appeal of the calcium
and osteoporosis health claim for producers and thereby provide
consumers with more information on the calcium and osteoporosis diet-
disease relationship. Also like Option 2, producers of products with
existing calcium and osteoporosis health claim labeling will have to
revise their labeling in order to comply with the revised claim
language. Like Option 3, this option would provide consumers with more
information on vitamin D than Option 2 because the new, simplified
calcium and osteoporosis health claim can now contain information about
vitamin D as well. It could also encourage more reformulation of
products to fortify with vitamin D than would Option 2 and as many
products to fortify with calcium as Option 2.
Summary
    FDA is unable to quantify the benefits of this final rule due to
uncertainty about the degrees of changes in consumer and producer
behavior. However according to information compiled in the Surgeon
General's 2004 Report on Bone Health and Osteoporosis, there are about
1.5 million osteoporotic fractures in the United States each year that
carry annual direct care expenditures of 12 to 18 billion dollars per
year (2002 dollars). These fractures cause more than half a million
hospitalizations, over 800,000 emergency room encounters, more than 2.6
million physician office visits, and the placement of nearly 180,000
individuals into nursing homes annually (Ref. 13). The direct costs of
other complications from osteoporosis, and the indirect costs of these
fractures and other osteoporotic ailments (e.g., the value of
functional disability to the patient, the value of the pain and
suffering to the patient, the costs experienced by the care giver) if
calculated, would add substantially to the annual costs of this
disease. Any increase in calcium and vitamin D intake by consumers
insufficient in these nutrients as a result of this final rule could
possibly lower the incidence of osteoporosis and therefore the annual
costs associated with the disease.
    Table 3 of this document provides a summary of the effects of the
rule, and which options create the smallest and largest behavior
changes for consumers and producers. All options should produce
positive net benefits, with the largest net benefit arising from Option
4, the final rule. With Option 4, the largest number of products and
labels would

change, leading to the largest reduction in the risk of osteoporosis.

                 Table 3.--Summary of Effects of Options
------------------------------------------------------------------------
              Effect                  Largest Effect    Smallest Effect
------------------------------------------------------------------------
Encouraging producer use of the              Option 4           Option 1
 claims
------------------------------------------------------------------------
Encouraging fortification                    Option 4           Option 1
------------------------------------------------------------------------
Informing consumers                          Option 4           Option 1
------------------------------------------------------------------------
Informing consumers who do not buy           Option 4           Option 1
 dairy products about alternative
 food sources for vitamin D
------------------------------------------------------------------------

B. Small Entity Analysis (or Initial Regulatory Flexibility Analysis)

    FDA has examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA does not
believe that this final rule will have a significant economic impact on
a substantial number of small entities because the only mandatory costs
of this rule are the costs to update the current wording of the calcium
and osteoporosis health claim for manufacturers of products that
currently make the claim and wish to continue doing so. Also previously
mentioned, FDA's 2001 Food Label and Package Survey showed only 1 out
of 87 shelf-stable juice products surveyed bore the current calcium and
osteoporosis health claim while none of the 10 milk products surveyed
bore the claim. This implies that not many products eligible to bear
the current claim would need to be re-labeled as a result of this final
rule.
    In addition, FDA establishes uniform compliance dates for final
food labeling regulations in 2-year intervals. Therefore, companies
whose products currently make the calcium and osteoporosis health claim
and wish to continue doing so will have between 1 and 2 years to use
existing label inventory and expense the costs of designing revised
labeling. FDA estimates that on average, the cost to re-label a product
according to the revised health claim language will be $7,900 to
$16,600 per product if the compliance period is 12 months; and $6,100
to $13,600 per product if the compliance period is 24 months. In the
calcium and vitamin D proposed rule, FDA requested comments on whether
the rule would have a significant impact on a substantial number of
small entities. FDA received no comments on the issue of significant
impacts on any size business. Manufacturers that wish to begin using
the revised calcium and osteoporosis health claim or the new calcium,
vitamin D, and osteoporosis health claim will only do so if the
benefits of labeling their products to inform consumers of the claim
outweigh the costs of doing so.

IV. Environmental Impact

    FDA has determined under 21 CFR 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.

V. Paperwork Reduction Act

    FDA concludes that the labeling provisions of this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food
labeling health claims on the association between calcium and
osteoporosis or calcium, vitamin D, and osteoporosis is a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public.'' (5 CFR
1320.3(c)(2)).

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the 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 authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act (21 U.S.C.
343-1(a)(5)) 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--* * * (5) any
requirement respecting any claim of the type described in section
403(r)(1) made in the label or labeling of food that is not identical
to the requirement of section 403(r) * * *.''
    This final rule amends the existing food labeling regulations on
health claims for calcium and osteoporosis. Although this rule has a
preemptive effect in that it precludes States from issuing any health
claim labeling requirements for calcium and osteoporosis or calcium,
vitamin D, and osteoporosis that are not identical to those required by
this final rule, this preemptive effect is consistent with what
Congress set forth in section 403A of the act. Section 403A(a)(5) of
the act displaces both State legislative requirements and State common
law duties. Riegel v. Medtronic, 128 S. Ct. 999 (2008).
    FDA believes that the preemptive effect of the final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.''' On
February 17, 2006, FDA's Division of Federal and State Relations
provided notice by fax and e-mail transmission to State health
commissioners, State agriculture commissioners, food program directors,
and drug program directors as well as FDA field personnel, of FDA's
intended amendments to the calcium and osteoporosis health claim (21
CFR 101.72). FDA received no comments in response to this notice.

    In addition, the agency sought input from all stakeholders through
publication of the proposed rule in the Federal Register on January 5,
2007 (72 FR 497). FDA received no comments from any States on the
proposed rulemaking.
    In conclusion, the agency believes that it has complied with all of
the applicable requirements under the Executive order and has
determined that the preemptive effects of this rule are consistent with
Executive Order 13132.

VII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
    1. The Beverage Institute for Health and Wellness, ``Petition
for Vitamin D, Calcium and Osteoporosis,'' (Docket No. 2004P-0464,
CP1), July 12, 2004.
    2. Standing Committee on the Scientific Evaluation of Dietary
Reference Intakes, Food and Nutrition Board, Institute of Medicine,
``Dietary Reference Intakes for Calcium, Phosphorus, Magnesium,
Vitamin D and Fluoride,'' Chapter 4, National Academy Press,
Washington, DC, 1997.
    3. U.S. Department of Health and Human Services and U.S.
Department of Agriculture. ``Dietary Guidelines for Americans,
2005,'' 6th ed., Washington, DC: U.S. Government Printing Office,
chapter 2, January 2005.
    4. Baeksgaard, L., K. P. Andersen, and L. Hyldstrup, ``Calcium
and Vitamin D Supplementation Increases Spinal BMD in Healthy,
Postmenopausal Women,'' Osteoporosis International, 8:255-260, 1998.
    5. Chapuy, M. C., M. E. Arlot, F. Duboeuf, et al., ``Vitamin D3
and Calcium to Prevent Hip Fractures in Elderly Women,'' The New
England Journal of Medicine, 327:1637-1642, 1992.
    6. Chapuy, M. C., M. E. Arlot, P. D. Delmas, et al., ``Effect of
Calcium and Cholecalciferol Treatment for Three Years on Hip
Fractures in Elderly Women,'' British Medical Journal, 308:1081-
1082, 1994.
    7. Dawson-Hughes, B., G. E. Dallal, E. A. Krall, S. Harris, L.
J. Sokoll, and G. Falconer, ``Effect of Vitamin D Supplementation on
Wintertime and Overall Bone Loss in Healthy Postmenopausal Women,''
Annuals of Internal Medicine, 115:505-512, 1991.
    8. Dawson-Hughes, B., S. S. Harris, E. A. Krall, et al.,
``Effect of Calcium and Vitamin D Supplementation on Bone Density in
Men and Women 65 Years of Age or Older,'' The New England Journal of
Medicine, 337:670-676, 1997.
    9. Dawson-Hughs, B., S. S. Harris, E. A. Krall, et al., ``Effect
of Withdrawal of Calcium and Vitamin D Supplements on Bone Mass in
Elderly Men and Women,'' American Journal of Clinical Nutrition,
72:745-750, 2000.
    10. Krieg, M. A., A. F. Jacquet, M. Bremgartner, et al.,
``Effect of Supplementation with Vitamin D3 and Calcium on
Quantitative Ultrasound of Bone in Elderly Institutionalized Women:
A Longitudinal Study,'' Osteoporosis International, 9:483-488, 1999.
    11. Sosa, M., P. L[aacute]inez, A. Arbelo, et al., ``The Effect
of 25-dihydroxyvitamin D on the Bone Mineral Metabolism of Elderly
Women with Hip Fracture,'' Rheumatology, 39:1263-1268, 2000.
    12. Jackson, R. D., et al., ``Calcium Plus Vitamin D
Supplementation and the Risk of Fractures, The Women's Health
Initiative,'' The New England Journal of Medicine, 354:669-683,
2006.
    13. ``Bone Health and Osteoporosis: A Report of the Surgeon
General,'' Rockville, MD: U.S. Department of Health and Human
Services, Office of the Surgeon General, Executive Summary, 2004.
    14. Calvo, M. S., S. J. Whiting, and C. N. Barton, ``Vitamin D
Fortification in the United States and Canada: Current Status and
Data Needs,'' American Journal of Clinical Nutrition,
80(suppl):1710S-1716S, 2004.
    15. Moore, C., M. M. Murphy, D. R. Keast, et al., ``Vitamin D
Intake in the United States,'' Journal of the American Dietetic
Association, 104(6):980-983, 2004.
    16. U.S. Food and Drug Administration, Center for Food Safety
and Applied Nutrition, Office of Nutritional Products, Labeling, and
Dietary Supplements, ``Food Label and Package Survey 2000-2001,''
http://www.cfsan.fda.gov/~dms/lab-flap.html, August 2004.
    17. Wansink B., S. T. Sonka, and C. M. Hasler, ``Front-Label
Health Claims: When Less is More,'' Food Policy, 29(6):659-667,
2004.
    18. Kim, S., R. M. Nayga, Jr., and O. Capps Jr., ``The Effect of
Food Label Use on Nutrient Intakes: An Endogenous Switching
Regression Analysis,'' Journal of Agricultural and Resource
Economics, 25(1):215-231, 2000.
    19. Neuhouser, M. L., A. R. Kristal, and R. E. Patterson, ``Use
of Food Nutrition Labels Associated With Lower Fat Intake,'' Journal
of the American Dietetic Association, 99(1):45-50, 53, 1999.
    20. American Beverage Association, Press Release, September 17,
2004 (http://www.ameribev.org/news-detail/index.aspx?nid=32).
    21. ``Food and Drug Administration Labeling Cost Model,''
Health, Social, and Economics Research, Research Triangle Park, NC,
January 2003 (http://www.cfsan.fda.gov/~dms/lab-flap.html).

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
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 to read as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR 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 101.72 is revised to read as follows:

Sec.  101.72  Health claims: calcium, vitamin D, and osteoporosis.

    (a) Relationship between calcium, vitamin D, and osteoporosis. An
inadequate intake of calcium or calcium and vitamin D contributes to
low peak bone mass, which has been identified as one of many risk
factors in the development of osteoporosis. Peak bone mass is the total
quantity of bone present at maturity, and experts believe that it has
the greatest bearing on whether a person will be at risk of developing
osteoporosis and related bone fractures later in life. Another factor
that influences total bone mass and susceptibility to osteoporosis is
the rate of bone loss after skeletal maturity. Vitamin D is required
for normal absorption of calcium and to prevent the occurrence of high
serum parathyroid hormone (PTH) concentration, which stimulates
mobilization of calcium from the skeleton and can lower bone mass.
Calcium, along with vitamin D and several other nutrients, is required
for normal bone mineralization. While vitamin D is required for optimal
bone mineralization, it is more effective when calcium intake is
adequate. An adequate intake of calcium and vitamin D is thought to
exert a positive effect during adolescence and early adulthood in
optimizing the amount of bone that is laid down. However, the upper
limit of peak bone mass is genetically determined. The mechanism
through which adequate intakes of calcium and vitamin D and optimal
peak bone mass reduce the risk of osteoporosis is thought to be as
follows. All persons lose bone with age. Hence, those with higher bone
mass at maturity take longer to reach the critically reduced mass at
which bones can fracture easily. The rate of bone loss after skeletal
maturity also influences the amount of bone present at old age and can
influence an individual's risk of developing osteoporosis. Maintenance
of adequate intakes of calcium and vitamin D later in life is thought
to be important in reducing the rate of bone loss particularly in the
elderly and in women during the first decade following menopause, but a
significant protective effect is also seen among men and younger women.

    (b) Significance of calcium or calcium and vitamin D. Adequate
calcium intake, or adequate calcium and vitamin D intake, is not the
only recognized risk factor in the development of osteoporosis, which
is a multifactorial bone disease. Maintenance of adequate calcium and
vitamin D intakes throughout life is necessary to achieve optimal peak
bone mass and to reduce the risk of osteoporosis in later life.
However, vitamin D is most effective in this regard when calcium intake
is adequate. Increasing intake of calcium has been shown to have
beneficial effects on bone health independent of dietary vitamin D.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim
associating calcium or, when appropriate, calcium and vitamin D with a
reduced risk of osteoporosis may be made on the label or labeling of a
food described in paragraphs (c)(2)(ii) and (d)(1) of this section,
provided that:
    (A) The claim makes clear the importance of adequate calcium
intake, or when appropriate, adequate calcium and vitamin D intake,
throughout life, in a healthful diet, are essential to reduce
osteoporosis risk. The claim does not imply that adequate calcium
intake, or when appropriate, adequate calcium and vitamin D intake, is
the only recognized risk factor for the development of osteoporosis;
    (B) The claim does not attribute any degree of reduction in risk of
osteoporosis to maintaining an adequate dietary calcium intake, or when
appropriate, an adequate dietary calcium and vitamin D intake,
throughout life.
    (ii) Nature of the food. (A) The food shall meet or exceed the
requirements for a ``high'' level of calcium as defined in Sec.
101.54(b);
    (B) The calcium content of the product shall be assimilable;
    (C) Dietary supplements shall meet the United States Pharmacopeia
(USP) standards for disintegration and dissolution applicable to their
component calcium salts, except that dietary supplements for which no
USP standards exist shall exhibit appropriate assimilability under the
conditions of use stated on the product label;
    (D) A food or total daily recommended supplement intake shall not
contain more phosphorus than calcium on a weight per weight basis.
    (d) Optional information. (1) The claim may include the term
``vitamin D'' if the food meets or exceeds the requirements for a
``high'' level of vitamin D as defined in Sec.  101.54(b);
    (2) The claim may include information from paragraphs (a) and (b)
of this section.
    (3) The claim may make reference to physical activity.
    (4) The claim may include information on the number of people in
the United States, including the number of people in certain
subpopulations in the United States, who have osteoporosis or low bone
density. The sources of this information must be identified, and it
must be current information from the National Center for Health
Statistics, the National Institutes of Health, or the National
Osteoporosis Foundation.
    (5) The claim may state that the role of adequate calcium intake,
or when appropriate, the role of adequate calcium and vitamin D intake,
throughout life is linked to reduced risk of osteoporosis through the
mechanism of optimizing peak bone mass during adolescence and early
adulthood. The phrase ``build and maintain good bone health'' may be
used to convey the concept of optimizing peak bone mass. The claim may
also state that adequate intake of calcium, or when appropriate,
adequate intake of calcium and vitamin D, is linked to reduced risk of
osteoporosis through the mechanism of slowing the rate of bone loss for
persons with a family history of the disease, post-menopausal women,
and elderly men and women.
    (e) Model health claims. The following model health claims may be
used in food labeling to describe the relationship between calcium and
osteoporosis:
Adequate calcium throughout life, as part of a well-balanced diet, may
reduce the risk of osteoporosis.
Adequate calcium as part of a healthful diet, along with physical
activity, may reduce the risk of osteoporosis in later life.
    (f) Model additional health claims for calcium and vitamin D. The
following model health claims may be used in food labeling to describe
the relationship between calcium, vitamin D, and osteoporosis:
Adequate calcium and vitamin D throughout life, as part of a well-
balanced diet, may reduce the risk of osteoporosis.
Adequate calcium and vitamin D as part of a healthful diet, along with
physical activity, may reduce the risk of osteoporosis in later life.

    Dated: September 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22730 Filed 9-26-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31864-31865]
[FR Doc No: 2019-14204]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-419-000.
    Applicants: Tuscarora Gas Transmission Company.
    Description: Report Filing: Tuscarora Refund Report RP19-419.
    Filed Date: 6/14/19.
    Accession Number: 20190614-5023.
    Comments Due: 5 p.m. ET 7/5/19.

    Docket Numbers: RP19-1332-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Contracts
Expiring to be effective 8/1/2019.
    Filed Date: 6/26/19.
    Accession Number: 20190626-5101.
    Comments Due: 5 p.m. ET 7/8/19.

    Docket Numbers: RP19-1333-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Emera
contracts eff 7-1-19 to be effective 7/1/2019.
    Filed Date: 6/26/19.
    Accession Number: 20190626-5105.
    Comments Due: 5 p.m. ET 7/8/19.

    Docket Numbers: RP19-1334-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Chevron to
Eco Energy 8958085 eff 7-1-19 to be effective 7/1/2019.
    Filed Date: 6/27/19.
    Accession Number: 20190627-5015.
    Comments Due: 5 p.m. ET 7/9/19.

    Docket Numbers: RP19-1335-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Boston to SFE
799462 eff 7-1-19 to be effective 7/1/2019.
    Filed Date: 6/27/19.
    Accession Number: 20190627-5016.
    Comments Due: 5 p.m. ET 7/9/19.

    Docket Numbers: RP19-1336-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Seminole
9214212 eff 7-1-19 to be effective 7/1/2019.
    Filed Date: 6/27/19.
    Accession Number: 20190627-5023.
    Comments Due: 5 p.m. ET 7/9/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/

docs-filing/efiling/filing-req.pdf. For other information, call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 27, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-14204 Filed 7-2-19; 8:45 am]
 BILLING CODE 6717-01-P