[Federal Register Volume 81, Number 54 (Monday, March 21, 2016)]
[Notices]
[Pages 15099-15100]
[FR Doc No: 2016-06287]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14623-001]

Advanced Hydropower, Inc.; Notice of Surrender of Preliminary
Permit

    Take notice that Advanced Hydropower, Inc., permittee for the
proposed Macon County Hydropower Project, filed a letter on March 9,
2016, requesting that its preliminary permit be surrendered. The permit
was issued on January 23, 2015, and would have expired on December 31
2017.\1\ The project would have been located on the Cullasaja River, in
Macon County, North Carolina.
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    \1\ 150 FERC ] 62,064 (2015).
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    The preliminary permit for Project No. 14623 will remain in effect
until the

close of business, April 13, 2016. But, if the Commission is closed on
this day, then the permit remains in effect until the close of business
on the next day in which the Commission is open.\2\ New applications
for this site may not be submitted until after the permit surrender is
effective.
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    \2\ 18 CFR 385.2007(a)(2) (2015).

    Dated: March 14, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-06287 Filed 3-18-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Rules and Regulations]
[Pages 23262-23273]
[FR Doc No: 2014-09492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket Nos. FDA-2007-0601, FDA-2004-N-0382, FDA-2005-P-0371, and FDA-
2006-P-0224 (formerly Docket Nos. 2004N-0217, 2005P-0189, and 2006P-
0137, respectively)]
RIN 0910-ZA28

Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid,
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this rule to prohibit certain nutrient content claims for
foods, including conventional foods and dietary supplements, that
contain omega-3 fatty acids, based on our determination that such
nutrient content claims do not meet the requirements of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action
in response to three notifications submitted to us. One notification
concerning nutrient content claims for alpha-linolenic acid (ALA),
docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) was
submitted collectively by Alaska General Seafoods, Ocean Beauty
Seafoods, Inc., and Trans-Ocean Products, Inc. (the seafood processors
notification); a second notification concerning nutrient content claims
for ALA, DHA, and EPA was submitted by Martek Biosciences Corp. (the
Martek notification); and a third notification concerning nutrient
content claims for DHA and EPA was submitted by Ocean Nutrition Canada,
Ltd. (the Ocean Nutrition notification). The final rule prohibits the
nutrient content claims for DHA and EPA set forth in the three
notifications and the nutrient content claims for ALA set forth in the
seafood processors notification. FDA is taking no regulatory action at
this time with respect to the nutrient content claims for ALA set forth
in the Martek notification and, therefore, these claims will be allowed
to remain on the market.

DATES: This rule is effective January 1, 2016.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115) amended the FD&C Act to provide, among other things,
for the filing of notifications as an alternative to the petition
process for nutrient content claims set forth in section 403(r)(4) of
the FD&C Act (21 U.S.C. 343(r)(4)). ``Nutrient content claims'' are
labeling claims that characterize the level of a nutrient in a food.
(See section 403(r)(1)(A) of the FD&C Act.) We have stated that the
Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535), which
created section 403(r)(1)(A) of the FD&C Act, has three basic
objectives: (1) To make available nutrition information that can assist
consumers in selecting foods that can lead to healthier diets, (2) to
eliminate consumer confusion by establishing definitions for nutrient
content claims that are consistent with the terms defined by the
Secretary of Health and Human Services (the Secretary), and (3) to
encourage product innovation through the development and marketing of
nutritionally improved foods (58 FR 2302, January 6, 1993). Under the
notification process that FDAMA established in section 403(r)(2)(G) of
the FD&C Act, a nutrient content claim is based on an authoritative
statement published either by a scientific body of the U.S.

Government that has official responsibility for public health
protection or research directly relating to human nutrition, or by the
National Academy of Sciences (NAS) or any of its subdivisions.
    Section 403(r)(2)(G) of the FD&C Act requires that a notification
for a prospective nutrient content claim be submitted to FDA at least
120 days before a food bearing the claim may be introduced into
interstate commerce. The notification must contain specific information
including: (1) The exact wording of the prospective nutrient content
claim, (2) a concise description of the basis upon which the notifier
relied for determining that the requirements for an authoritative
statement in section 403(r)(2)(G)(i) of the FD&C Act have been
satisfied, (3) a copy of the authoritative statement that serves as the
basis for the claim, and (4) a balanced representation of the
scientific literature relating to the nutrient level for the claim. The
claim must be an accurate representation of the authoritative statement
and must be stated in a manner that enables the public to comprehend
the information provided by the claim and to understand the relative
significance of such information in the context of the total daily
diet. Furthermore, the authoritative statement that is the basis for
the nutrient content claim must be currently in effect and identify the
nutrient level to which the claim refers.
    In the Federal Register of November 27, 2007 (72 FR 66103), we
published a proposed rule that would prohibit all of the nutrient
content claims for the omega-3 fatty acids DHA and EPA set forth in:
(1) The seafood processors notification submitted on January 16, 2004,
(2) the Martek notification submitted on January 21, 2005, and (3) the
Ocean Nutrition notification submitted on December 9, 2005. The seafood
processors notification set forth ``high'' \1\ nutrient content claims
for both DHA and EPA,\2\ whereas the Martek notification set forth a
``high'' nutrient content claim only for DHA \3\ and the Ocean
Nutrition notification set forth a ``high'' nutrient content claim for
DHA and EPA combined.\4\ The proposed rule would take this action
because the nutrient content claims for DHA and EPA set forth in the
three notifications are not based on an authoritative statement that
identifies a nutrient level to which the claims refer, as required by
the FD&C Act.
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    \1\ Nutrient content claims are defined in Sec.  101.54 (21 CFR
101.54). ``High'' is defined as 20 percent or more of the Reference
Daily Intake (RDI) or the Daily Reference Value (DRV) per reference
amount customarily consumed (RACC) (Sec.  101.54(b)). ``Good
source'' is defined as 10 to19 percent of the RDI or DRV per RACC
(Sec.  101.54(c)). ``More'' is defined as 10 percent or more of the
RDI or DRV per RACC than an appropriate reference food (Sec.
101.54(e)). Synonyms for each of these terms are also set forth in
the regulations; for example, the terms ``rich in'' and ``excellent
source of'' are considered to be equivalent to the term ``high''
(Sec.  101.54(b)).
    \2\ The seafood processors notification specified that one of
the following two statements would accompany these claims:
    ``Contains -- mg of [DHA/EPA] per serving, which is -- % of the
Daily Value for [DHA/EPA] (130 mg).''
    ``Contains -- % of the Daily Value for [DHA/EPA] per serving.
The Daily Value for [DHA/EPA] is 130 mg.'' As indicated in the
notification, use of [DHA/EPA] is intended to mean that either EPA
or DHA can be used as the subject of the claim.
    \3\ The Martek notification proposed the following exact wording
for these claims: `` `Excellent source of DHA.' (`High in DHA,'
`Rich in DHA') Contains -- mg of DHA per serving, which is -- % of
the 160 mg Daily Value for DHA.'' [Products would need to contain at
least 32 mg of DHA per RACC to qualify for the claim.]
    \4\ The Ocean Nutrition notification proposed the following
exact words for these claims: `` `Excellent source of Omega-3 EPA
and DHA.' (`High in Omega-3 EPA and DHA;' `Rich in Omega-3 EPA and
DHA'). Contains -- mg of EPA and DHA combined per serving, which is
-- % of the 160 mg Daily Value for a combination of EPA and DHA.''
FDA notes that this claim language was incorrectly written in the
proposed rule, where it was written as `` `Excellent source of
Omega-3 EPA and DHA.' (`High in Omega-3 EPA and DHA;' `Rich in
Omega-3 EPA and DHA'). Contains -- mg of EPA and DHA combined per
serving, which is -- % of the 160 mg EPA and DHA combined per
serving, which is -- % of the 160 mg Daily Value for a combination
of EPA and DHA.''
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    The proposed rule also would prohibit the nutrient content claims
for ALA set forth in the seafood processors notification \5\ because
the claims were based on a reference value that was determined by a
different approach than reference values already established for other
nutrients (i.e., Daily Values (DVs)). In the report entitled ``Dietary
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids,
Cholesterol, Protein, and Amino Acids'' from the Institute of Medicine
(IOM) of the NAS (``the IOM report'') (Ref. 1), the IOM identified
several age-gender group specific adequate intake levels (AIs) for ALA,
including 1.6 grams per day (g/day) for males 14 and more years of age
and 1.1 g/day for females 14 and more years of age. (See also 72 FR
66103 at 66106.) The seafood processors calculated a population-
weighted AI to use as the reference value for their claims. This
approach differs from our approach, under which reference values are
set by using the population-coverage approach. (See 58 FR 2206 at 2210
through 2211, January 6, 1993.) Under a ``population-coverage
approach,'' we would use the highest Recommended Daily Allowance (RDA)
or AI for adults and children 4 or more years of age (excluding values
for pregnant and lactating women) to serve as the label reference
value. (See, e.g., 72 FR 62149 at 62150, November 2, 2007.) In
contrast, the seafood processors calculated a population-weighted
reference value--they looked at the various AIs that the IOM identified
for different age and gender groups (excluding children under 4 years
of age and pregnant and lactating women) and averaged out all of those
numbers, taking into account the predominance of the various groups
within the population, to arrive at their label reference value. The
difference, in brief, is that we essentially take the highest number to
use as the label reference value, while the seafood processors would
take an average of the various numbers to use as their reference value.
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    \5\ The seafood processors notification proposed ``high,''
``good source,'' and ``more'' claims for ALA. The notification
specified that one of the following two statements would accompany
``high'' and ``good source'' claims for ALA:
    ``Contains -- mg of ALA per serving, which is -- % of the Daily
Value for ALA (1.3 g).''
    ``Contains -- % of the Daily Value for ALA per serving. The
Daily Value for ALA is 1.3 g.''
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    In the proposed rule, we tentatively determined that the seafood
processors notification's use of a different methodology to set the
reference values does not enable the public to comprehend the
information provided in the ALA claim and to understand the relevant
significance of such information in the context of the daily diet. We
indicated that we would not take regulatory action at this time on the
ALA claims set forth in the Martek notification,\6\ which used a
population-coverage approach that is consistent with the approach that
FDA has used in determining DVs to date (see 58 FR 2206 at 2211). We
expressed no conclusions as to whether the ALA claims in the Martek
notification are supported by an authoritative statement that satisfies
the

requirements of section 403(r)(2)(G) of the FD&C Act. Because the
proposed rule would neither prohibit nor modify the nutrient content
claims for ALA set forth in the Martek notification, we indicated that
we would allow these claims to remain on the market at this time (see
72 FR 66103 at 66104).
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    \6\ The Martek notification proposed ``high,'' ``good source,''
and ``more'' claims for ALA. The notification proposed the following
exact words for these claims:
    `` `Excellent source of ALA.' (`High in ALA,' `Rich in ALA')
Contains -- mg of ALA per serving, which is -- % of the 1.6 g Daily
Value for ALA.'' [Products would need to contain at least 320 mg of
ALA per RACC to qualify for the claim.]
    `` `Good source of ALA.' (`Contains ALA,' `Provides ALA')
Contains -- mg of ALA per serving, which is -- % of the 1.6 g Daily
Value for ALA'' [Products would need to contain at least 160 mg of
ALA per RACC to qualify for the claim.]
    `` `More ALA.' (`Fortified with ALA,' `Enriched with ALA,'
`Added ALA,' `Extra ALA,' `Plus ALA') Contains -- % more of the
Daily Value for ALA per serving than [reference food]. This product
contains -- mg of ALA which is -- % of the Daily Value for ALA (1.6
g).'' [Products would need to contain at least 160 mg or more ALA
per RACC than an appropriate reference food and would comply with
the requirements for relative claims found at 21 CFR 101.13(j).]
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II. Summary of Comments and Agency's Responses

    We invited comments on the proposed rule. The comment period closed
on February 11, 2008. We received 19 comments, each containing one or
more issues. The comments were from manufacturers, trade associations,
and health-related organizations. One comment raised issues that were
outside the scope of this rulemaking, and we will not discuss it in
this document. We discuss the remaining comments and our responses in
part II. For ease of reading, we preface each comment discussion with a
numbered ``Comment,'' and each response by a corresponding numbered
``Response.'' We have numbered each comment to help distinguish among
different topics. The number assigned is for organizational purposes
only and does not signify the comment's value, importance, or the order
in which it was received.
    (Comment 1) Several comments stated that the nutrient content
claims for DHA and EPA should be permitted because the statements from
the IOM report that were used as the basis for these claims are
authoritative statements that identify a nutrient level, as required by
the statute. Specifically, the comments pointed to the following
statements from the IOM report:
     [EPA] and [DHA] contribute approximately 10 percent of the
total n-3 fatty acid intake and therefore this percent contributes
toward the AI for [ALA].
     Small amounts of EPA and DHA can contribute towards
reversing an n-3 fatty acid deficiency . . . and can therefore
contribute toward the AI for [ALA]. EPA and DHA contribute
approximately 10 percent of the total n-3 fatty acid intake and
therefore this percent contributes toward the AI for [ALA].
     The AMDR [Acceptable Macronutrient Distribution Range] for
[ALA] is set at 0.6 to 1.2 percent of energy. Ten percent of this range
can be consumed as [EPA] and/or [DHA].
     Approximately 10 percent of the AMDR for n-3 fatty acids
([ALA]) can be consumed as EPA and/or DHA (0.06 to 0.12 percent of
energy).
    The comments asserted that these statements permit a calculation of
a value for DHA and EPA that can be considered a ``nutrient level.''
The comments further asserted that our position regarding the term
``nutrient level'' goes beyond what the statute requires and is unduly
restrictive. These comments characterized our position as interpreting
the term ``nutrient level'' to refer to reference values that are
similar in type to Dietary Reference Intakes (DRI) or other types of
defined intake levels that serve as reference values for the basis of
nutrient content claims. Based on these contentions, the comments
asserted that the proposed rule was contrary to Congressional intent in
that we are imposing standards of traditional rulemaking on a process
that Congress intended to be an expedited process of information
dissemination. If Congress had intended otherwise, at least one comment
stated, it could have explicitly indicated that a specific type of
reference value be required; however, Congress did not do so.
    (Response) We disagree. We consider the term ``nutrient level'' as
used in section 403(r)(2)(G)(i) of the FD&C Act, to mean a reference
value that is similar to a label reference value for use in nutrition
labeling, i.e., that reflects a recommended or defined intake level
that could serve as a basis for setting a DV that could be used to
characterize a given level of a nutrient (here, DHA or EPA) for
purposes of nutrition labeling. To date, our regulations have
established two types of DVs: RDIs and DRVs (72 FR 66103 at 66104
through 66105). However, contrary to what some comments suggest, the
proposed rule would not have the statutory term ``nutrient level''
refer only to RDIs and DRVs. Instead, we proposed that the term refers
to values that could serve as a basis for setting a DV, in that they
could be used to characterize a given level of a nutrient for the
purposes of nutrition labeling (72 FR 66103 at 66109). DVs are intended
to help consumers understand the relative significance of information
about the amount of certain nutrients in a food in the context of a
total daily diet and to help consumers compare the nutritional values
of food products. Permitting nutrient content claims on the basis of
statements that do not identify the nutrient level to which the claims
refer results in inconsistent and conflicting claims that can confuse
consumers. Congress required that an authoritative statement identify
the ``nutrient level to which the claim refers'' (section 403(r)(2)(G)
of the FD&C Act) to help ensure consistency among different products
from different manufacturers.
    Our use of ``nutrient level'' to mean a reference value that
reflects a recommended or defined intake level that could serve as a
basis for setting a DV is in keeping with the plain meaning of the word
``level,'' both alone and in the statutory context in which the term is
used. The Oxford English Dictionary defines ``level'' in relevant part
as, ``A position (on a real or imaginary scale) in respect of amount,
intensity, extent, or the like; the relative amount or intensity of any
property, attribute, or activity. Freq. preceded by a sb. denoting the
property, etc., referred to, as danger, energy, noise level.'' (See
Level Definition, The Oxford English Dictionary (Second Edition 1998)
(emphasis in the original).) Section 403(r)(2)(G) of the FD&C Act
states, in relevant part: ``A claim of the type described in
subparagraph (1)(A) for a nutrient . . . shall be authorized and may be
made with respect to a food if . . . a scientific body . . . has
published an authoritative statement . . . which identifies the
nutrient level to which the claim refers.'' The word ``level'' is
preceded by the word ``nutrient'' to denote the property referred to.
The nutrient level serves to identify ``[a] position . . . in respect
of amount,'' in the words of the dictionary definition; in other words,
the authoritative statement must identify a specific amount of the
nutrient in question. This nutrient level is the thing ``to which the
claim refers,'' and our use of the ``nutrient level'' as a reference
value is consistent with the plain meaning. The statutory phrase ``the
nutrient level'' indicates that a single, precise nutrient level must
be identified by the authoritative statement.
    Moreover, the meaning of the phrase ``nutrient level'' is further
clarified by the statutory context in which the phrase appears, as well
as related statutory provisions regarding how nutrient content claims
function. Section 403(r)(2)(G) of the FD&C Act describes one way that
claims ``of the type described in [403(r)(1)(A)]'' can be made. The
type of claim described in section 403(r)(1)(A) of the FD&C Act is a
claim that ``characterizes the level of any nutrient . . .,'' i.e., a
nutrient content claim. Such claims characterize the specific amount of
a nutrient that is found in one serving of a specific product by using
terms such as ``good source.'' In general, such claims can only be made
``if the characterization of the level made in the claim uses terms
which are defined in regulations of the Secretary.'' (Section
403(r)(2)(A)(i) of the FD&C Act.) We defined terms such as ``good
source'' in a way that ties each

term's meaning to the DV that has been established by regulation for
the nutrient in question--for example, ``good source'' claims can be
made for foods that contain 10 to 19 percent of the DV for the relevant
nutrient per reference amount customarily consumed (Sec.  101.54(c)).
With respect to ``a nutrient, for which the Secretary has not
promulgated a regulation,'' Section 403(r)(2)(G) of the FD&C Act allows
for the possibility that a nutrient content claim can still be made, if
an authoritative statement ``identifies the nutrient level to which the
claim refers.'' We do not require that this nutrient level be an RDI or
a DRV, but the nutrient level must be a single reference value or else
it would be impossible to know when the definition for a term such as
``good source'' had been met. Moreover, for a nutrient content claim to
provide a meaningful characterization of the level of the nutrient, the
reference value must be such that it helps consumers understand the
relative significance of information about the amount of the nutrient
in a food in the context of a total daily diet; Congress emphasized the
importance of this goal in section 403(r)(2)(G)(iv) of the FD&C Act. We
have determined that a reference value that reflects a recommended or
defined intake level that could serve as a basis for setting a DV
serves this purpose and is a ``nutrient level.'' Therefore, the meaning
of ``nutrient level'' in section 403(r)(2)(G)(i) of the FD&C Act is a
reference value that is similar to a label reference value for use in
nutrition labeling, i.e., that reflects a recommended or defined intake
level that could serve as a basis for setting a DV that could be used
to characterize a given level of a nutrient for purposes of nutrition
labeling.
    According to section 403(r)(2)(G)(i) of the FD&C Act, an
authoritative statement that identifies the nutrient level to which the
claim refers can be provided by a scientific body of the U.S.
Government with official responsibility for public health protection or
research directly relating to human nutrition or the NAS or any of its
subdivisions, such as the IOM. The IOM provides authoritative
statements on recommended or defined nutrient intake levels in the form
of DRIs. DRIs include the Estimated Average Requirement, RDA, AI, and
Tolerable Upper Intake Level. The IOM report does not establish any of
these for DHA and EPA. The statements in the IOM report that use the
terms ``approximately 10 percent'' do not identify a nutrient level for
DHA and/or EPA. The statements describe the approximate contribution
that DHA and EPA can make toward meeting the AI for ALA, but they do
not reflect a recommended or defined intake level of DHA and/or EPA
that could serve as a basis for setting a DV that could be used to
characterize a given level of DHA and/or EPA. In fact, the three
notifications reflect different readings of the IOM's statement: the
seafood processors notification states that 10 percent of their
proposed reference value for ALA results in a reference value for DHA
or EPA; the Ocean Nutrition notification states that 10 percent of its
proposed reference value for ALA results in a reference value for EPA
and DHA combined; and the Martek notification states that 10 percent of
its proposed reference value for ALA results in a reference value for
DHA alone. (The three notifications also differ in that the Martek
notification and the Ocean Nutrition notification conclude that 160
milligrams (mg)/day is the nutrient level that is obtained by dividing
by 10, while the seafood processors notification arrives at 130 mg/day,
also by dividing by 10. This difference stems from a dispute as to
whether 1.6 g/day is the appropriate nutrient level to use in nutrient
content claims for ALA, or whether 1.3 g/day is the appropriate level.
Because we find that none of the submitted claims for DHA and/or EPA is
based on an authoritative statement that identifies a nutrient level
for DHA and/or EPA, we do not reach the issue of addressing this
discrepancy in the numbers.) The discrepancy in how the three
notifications read the IOM's statements underscores the fact that the
statements in the IOM report do not identify a nutrient level for DHA
or EPA. Moreover, the statements in the IOM report are explicitly
approximate, whereas the statutory and regulatory structure requires
that a ``nutrient level'' be a single, precise reference value.
Finally, we note that these statements do not appear to meet the
National Research Council Governing Board of NAS' definition of an
authoritative statement, in that they do not ``appear explicitly as
findings, conclusions, or recommendations'' (see Docket No. FDA-2004-N-
0382) (Ref. 2)).
    We note that nutrient content claims may be based on authoritative
statements from various sources and are not limited to authoritative
statements from the IOM. Authoritative statements on defined nutrient
intake levels from the IOM are provided in the form of DRIs and are
only one source of such statements. Authoritative statements from other
entities described in section 403(r)(2)(G)(i) of the FD&C Act that
include nutrient levels that reflect a recommended or defined intake
level that could serve as a basis for setting a DV also may be used as
the basis for nutrient content claims. Absent such a statement, the
FD&C Act allows interested persons to submit a petition for a nutrient
content claim (section 403(r)(4) of the FD&C Act; 21 CFR 101.69).
    (Comment 2) Several comments asserted that the FD&C Act does not
require us to use a specific approach to determine a reference nutrient
value (i.e., population-coverage versus population-weighted). One
comment noted that IOM recommended the use of a population-weighted
approach for setting nutrient references values in its 2003 report
entitled ``Dietary Reference Intakes: Guiding Principles for Nutrition
Labeling and Fortification'' (hereinafter ``the IOM report on Guiding
Principles'') (Ref. 3). Finally, the comments requested that we not act
on current ALA nutrient content claims until after completing the
rulemaking initiated by our Advance Notice of Proposed Rulemaking
(ANPRM) on the Revision of Reference Values and Mandatory Nutrients (72
FR 62149) (``DV ANPRM'') which sought public comment on what new
reference values we should use to calculate the DVs in the Nutrition
Facts label and what factors we should consider in establishing these
new reference values.
    (Response) We disagree with the comments. The FD&C Act requires
that a claim based on an authoritative statement have a nutrient level
identified in the statement and be stated in a manner that enables the
public to comprehend the information provided and to understand the
relative significance of such information in the context of the daily
diet (section 403(r)(2)(G)(iv) of the FD&C Act). Using two different
approaches to set a reference value for ALA (i.e., the population-
weighted approach used in the seafood processors notification and the
population-coverage approach used in the Martek notification) will
result in inconsistent and conflicting nutrient content claims on food
labels. Such inconsistencies make meaningful product-to-product
comparisons impossible. To enable the public to comprehend the
information provided in nutrient content claims and to understand the
relative significance of that information in the context of the daily
diet, as required by section 403(r)(2)(G)(iv) of the FD&C Act,
qualifying ALA levels for nutrient content claims in food labeling must
be based on a single nutrient value

determined using the same approach for reference values for other
nutrients, which is currently the population-coverage approach
established in the 1993 final rule for determining DVs (58 FR 2206).
Therefore, to prevent inconsistent and conflicting claims on food
labels, we are not taking regulatory action at this time with respect
to ALA claims based on the population-coverage approach, but are
prohibiting claims based on the population-weighted approach.
    We also disagree that we should not act on current ALA nutrient
content claims until we have completed the rulemaking initiated by the
DV ANPRM. The concurrent use of two different approaches to set a
reference value for ALA will result in inconsistent and conflicting
nutrient content claims on food labels. Because it may be some time
before any rulemaking related to the DV ANPRM is finalized, we are
taking action now to prevent inconsistent and conflicting claims by
prohibiting ALA claims based on the population-weighted approach.
    (Comment 3) Several comments asserted that nutrient content claims
constitute commercial speech and that, by not allowing the claims to
appear on labeling, we would violate the First Amendment. One comment
also noted, with respect to the claims regarding DHA and EPA, that we
have not done an analysis on each claim to determine if the claims we
propose to prohibit would be misleading and whether they could be cured
by disclaimers, nor have we identified any safety concerns or provided
evidence of consumers being misled by these nutrient content claims.
Moreover, a number of comments stated that the FD&C Act allows us to
modify claims to provide more information regarding the basis of the
claims (for example through use of a disclosure or disclaimer) if any
of the claims are found to be misleading, yet we have not done so. For
all of these reasons, the comments asserted that prohibiting these
claims could violate the First Amendment.
    (Response) FDA disagrees. As the preamble to the proposed rule
explained (72 FR 66103 at 66104), the 1993 regulations that implemented
the Nutrition Labeling and Education Act of 1990 (NLEA) created a
procedure under which a person who wishes to make a nutrient content
claim not already defined by regulation may petition us to authorize
that claim under section 403(r)(4) of the FD&C Act (Sec.  101.69).
Under that process, the petitioner must set forth an explanation of the
reasons why the proposed claim meets the requirements of the FD&C Act
and a summary of the scientific data supporting those reasons. (See
section 403(r)(4)(B) of the FD&C Act.) We can either deny the petition
or issue a proposed rule to take the action requested in the petition.
If we issue a proposed rule, the rulemaking must be completed within
540 days of the date the petition was received. (See section
403(r)(4)(A)(i) of the FD&C Act).) The U.S. Court of Appeals for the
Second Circuit upheld this statutory scheme and our implementation of
it as constitutional. Nutritional Health Alliance v. Shalala, 144 F.3d
220 (2d Cir. N.Y. 1998).
    FDAMA created an alternate, expedited notification process to allow
certain nutrient content claims to be made without going through the
petition process. (See H. Rept. 105-306 (1997) (``It is the Committee's
intention that the FDA will use this authority primarily for the
purpose of expediting review of petitions for health and nutrient
content claims based on authoritative statements.'').) When the
requirements of FDAMA's expedited notification process (as set out in
section 403(r)(2)(G) of the FD&C Act) have been met, the claim can be
made; preapproval by FDA is not required. If the requirements of
section 403(r)(2)(G) of the FD&C Act have not been met, FDAMA's
expedited path is not available. In such situations, the petition
process outlined under section 403(r)(4) of the FD&C Act is the proper
vehicle for submitting a proposed nutrient content claim to us. (See H.
Rept. 105-306 (1997) (``The Committee emphasizes that this provision
maintains the full range of existing FDA enforcement powers with
respect to claims made in violation of the statutory requirements.'').)
    The petition process set forth in section 403(r)(4) of the FD&C Act
relates only to two types of labeling claims: ``nutrient content
claims,'' which are claims of the type described in section
403(r)(1)(A) of the FD&C Act; and ``health claims,'' which are claims
of the type described in section 403(r)(1)(B) of the FD&C Act. FDAMA's
alternate, expedited route also applies only to these two types of
claims. (See sections 403(r)(2)(G) through (r)(2)(H) and 403(r)(3)(C)
through (r)(3)(D) of the FD&C Act.) (This rulemaking concerns only
nutrient content claims.) There are numerous other types of claims that
can be made on food and supplement labeling, including many types of
claims that can lawfully be made about the presence of DHA or EPA. (See
72 FR 66103 at 66109.) Under Sec.  101.13(i)(3) (21 CFR 101.13(i)(3)),
the label or labeling of a food may contain a statement about the
amount or percentage of a nutrient if the statement does not,
explicitly or implicitly, characterize the level of the nutrient in the
food and is not false or misleading in any respect. For example, a
conventional food or a dietary supplement may bear a statement such as
``X mg of EPA and DHA omega-3 fatty acids per serving.'' Also, under
Sec.  101.13(q)(3)(ii)(A), dietary supplements are permitted to bear
simple percentage claims (e.g., 40 percent EPA and DHA omega-3 fatty
acids), and under 21 CFR 101.14(q)(3)(ii)(B), they are permitted to
bear comparative percentage claims (e.g., ``four times the EPA and DHA
omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil
(20 mg)''). Furthermore, in 2003, we announced our intention to
exercise our enforcement discretion with respect to the following
qualified health claim, which companies can use to describe to
consumers the potential health benefits of consuming EPA and DHA:
``Supportive but not conclusive research shows that consumption of EPA
and DHA omega-3 fatty acids may reduce the risk of coronary heart
disease. One serving of [name of food] provides [x] grams of EPA and
DHA omega-3 fatty acids. [See nutrition information for total fat,
saturated fat and cholesterol content.]'' See Letter Responding to
Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3
Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No.
2003Q-0401) (available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072932.htm); see also
Letter Responding to Health Claim Petition dated June 23, 2003
(Wellness petition): Omega-3 Fatty Acids and Reduced Risk of Coronary
Heart Disease (Docket No. 2003Q-0401) (available at http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072936.htm).
    Section 403(r)(2)(G) of the FD&C Act takes place within this
broader labeling context. Nutrient content claims, such as the ones
about DHA, EPA, and ALA that the notifiers here seek to make, are just
one, very specific, statutorily-defined type of labeling claim. When a
company wishes to make such a claim about a nutrient for which FDA has
not identified a nutrient level, the company generally must use the
process set forth in section 403(r)(4) of the FD&C Act; this process
has been upheld as constitutional. (See Nutritional Health Alliance v.
Shalala, 144 F.3d 220 (2d Cir. N.Y. 1998).) FDAMA creates an alternate,
expedited route, but only in

situations where all of the requirements of section 403(r)(2)(G) of the
FD&C Act have been met.
    Our application of section 403(r)(2)(G) of the FD&C Act to the
notifications concerning EPA and DHA and the notifications concerning
ALA is constitutional, as explained herein:

A. DHA and EPA

    With respect to the proposed claims regarding DHA and EPA, our
response to comment 1 explains that the notifiers have not met the
requirement of section 403(r)(2)(G)(i) of the FD&C Act that each
proposed claim be based on an authoritative statement that identifies a
nutrient level to which the proposed claim refers. We therefore find
that these claims may not be used in food labeling.
    When we establish by regulation particular definitions for terms
(such as ``good source''), the use of such terms without complying with
the established definitions is inherently misleading, and therefore not
protected by the First Amendment, see Central Hudson Gas & Elec. Corp.
v. Public Serv. Comm'n of New York, 447 U.S. 557, 563 (1980); see also
In re R.M.J., 455 U.S. 191, 203 (1982), because such use implies that
the definitions and other statutory and regulatory requirements have
been met, which they have not. See, e.g., Am. Acad. of Pain Mgmt v.
Joseph, 353 F.3d 1099, 1108 (9th Cir. 2004) (finding that the use of
the term ``board certified'' is inherently misleading when its use does
not conform to the statutory definition of that term); see also United
States v. Articles of Food * * * Clover Club Potato Chips, 67 F.R.D.
419, 424 (D. Idaho 1975) (``Freedom of [s]peech does not include the
freedom to violate the labeling provisions of the Federal Food, Drug,
and Cosmetic Act.''). Furthermore, insofar as the proposed claims state
or imply that a daily value for DHA or EPA has been established, the
claims are false, and are not afforded First Amendment protection. See
Central Hudson, 447 U.S. at 563; see also In re R.M.J., 455 U.S. at
203.
    The comments seem to suggest that, even if we find that the
proposed DHA and EPA claims are not based on an authoritative statement
that identifies a nutrient level as required by statute, the First
Amendment nonetheless requires us to allow the claims to appear and to
use a disclaimer to cure the flaw. The comments did not indicate what
the disclaimer would be, and indeed, we conclude that there is no
disclaimer that could cure the fundamental flaw of the proposed DHA and
EPA claims: namely, that the claims are not based on an authoritative
statement that identifies a nutrient level, as required by statute. Cf.
Wallach v. Crawford, 2005 U.S. Dist. LEXIS 43700 (S.D. Cal. Mar. 29,
2005) (``A disclaimer regime simply cannot provide the same protection
that Congress envisioned. . ..''). One comment seemed to suggest that
consumer research could help identify an appropriate disclaimer.
However, the statute does not permit the use of FDAMA's expedited
process unless an authoritative statement identifying a nutrient level
has been made. We have concluded that the statutory threshold has not
been met, and that these claims cannot be permitted under the FD&C Act.
These conclusions are not amenable to further exploration through
consumer research. Cf. Alliance for Natural Health U.S. v. Sebelius,
786 F.Supp.2d 1, 14 (D.D.C. 2011) (``Pearson [v. Shalala], 164 F.3d 650
(D.C. Cir. 1999)] does not require the FDA to make an empirical showing
of the inefficacy of a disclaimer before prohibiting a claim'' that is
``unprotected commercial speech that can be prohibited under the
threshold step of the Central Hudson analysis.'').

B. ALA

    One comment stated that we would violate the First Amendment by
prohibiting the ALA claims proposed in the seafood processors
notification.
    We disagree. Under section 403(r)(2)(G)(iv) of the FD&C Act, ``The
claim must be an accurate representation of the authoritative statement
and must be stated in a manner that enables the public to comprehend
the information provided by the claim and to understand the relative
significance of such information in the context of the total daily
diet.'' (See section 403(r)(2)(G)(iv) of the FD&C Act.) As we discussed
in more detail under Comment 2, we have determined that the proposed
ALA claims that are based on population-weighted AIs do not enable the
public to understand the claims' relative significance in the context
of the total daily diet because using two different approaches to set a
reference value for ALA will result in inconsistent and conflicting
nutrient content claims on food labels. The claims therefore do not
conform to the requirements of the FD&C Act and, like the DHA and EPA
claims discussed previously, cannot be made.
    Furthermore, the ALA claims that are based on population-weighted
AIs are inherently misleading, and thus not entitled to First Amendment
protection, see Central Hudson, 447 U.S. at 563, and In re R.M.J., 455
U.S. at 203, because the use of two different daily values for ALA
would result in inconsistent and contradictory nutrient content claims.
Consumers cannot make meaningful product-to-product comparisons based
on such claims.
    The ALA claims take place against a backdrop where all other food
labeling references to nutrient levels are based on the population-
coverage approach. In most situations, the reference value that results
from the population-coverage approach will be higher than the reference
value that results from the population-weighted approach; thus, by
using the latter method, a company can in effect hold itself to a lower
standard when making claims such as ``good source'' or ``high.'' For
example, by using population-weighted AIs, a company taking the seafood
processors' approach could claim, at the point of sale, that the
reference value for ALA is 1.3 g/day, even while companies taking
Martek's approach, which uses the population-coverage approach, are
claiming, based on the same IOM report, that the reference value for
ALA is 1.6 g/day. Furthermore, on the label of a product that contained
0.3 g of ALA, those taking the seafood processors' approach would
declare the product to be ``high'' in ALA, because 0.3 g is
approximately 23 percent of 1.3 g; however, those taking Martek's
approach would declare an identical product to only be a ``good
source'' of ALA, because 0.3 g is only 18.75 percent of 1.6 g. The
presence of these conflicting claims is inherently misleading. More
generally, the claim proposed by the seafood processors is inherently
misleading in the context of FDA's current labeling regime, which
relies solely on the population-coverage approach, because the seafood
processors' claim would create contradictory information about the
meaning of ``good source'' when used to characterize the level of a
nutrient.
    Even if a disclaimer or other modification were to explain that a
given claim arose as a result of a certain statistical method for
computing nutrient levels, this would not change the fact that terms
such as ``high'' or ``good source'' would have two different meanings
under this hypothetical regime. This is precisely what Congress sought
to avoid when it passed the NLEA, and it is what we sought to avoid
when we issued regulations under that statute, defining terms such as
``high'' and ``good source.'' See, e.g., 136 Cong. Rec. H5836-01, H5840
(July 30, 1990) (statement of Rep. Waxman); 136 Cong. Rec. H12951-02,
H12953-54 (October 26, 1990) (statement of Rep. Madigan). (See also 56
FR 60421 at 60423, (November 27, 1991) (``Inconsistent use of the same
term on various products

could lead to consumer confusion and nonuniformity in the marketplace.
To ensure that consumers are not misled and are given reliable
information, Congress found, and FDA agrees, that it is appropriate for
the Agency to establish specific definitions to standardize the terms
used by manufacturers to describe the nutrient content of foods.'');
see also 58 FR 2302. The purpose of FDA-regulated nutrient content
claims is to provide the public with meaningful information about the
content of a product within the context of the total daily diet. This
purpose is only served if terms such as ``high,'' ``good source,'' and
the other terms defined at Sec.  101.54 (21 CFR 101.54) are given a
consistent meaning for all nutrients that are the subject of such
claims, so that consumers have meaningful information to compare.
    We therefore conclude that the ALA claims that are based on a
population-weighted approach are inherently misleading, and thus not
entitled to First Amendment protection. But even if the seafood
processors' proposed claims were not inherently misleading, prohibiting
the claims would still be permissible under the First Amendment. Though
we have concluded that the claims are inherently misleading, this
section nonetheless goes on to analyze this point.
    In Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of New
York, 447 U.S. 557 (1980), the Supreme Court laid out a four-part test
to analyze whether a Government restriction on commercial speech is
constitutional. The first step under Central Hudson is to determine
whether or not the speech at issue is protected by the First Amendment.
If the speech is found to be protected by the First Amendment--which we
do not find to be the case here, but which is a scenario that we are
nonetheless analyzing--the second requirement of Central Hudson is that
``the State must assert a substantial interest to be achieved'' by the
proposed action. Central Hudson, 447 U.S. at 564. Here, the Government
has a substantial interest in promoting the public health, preventing
inconsistent and contradictory labeling claims (and thereby preventing
consumer confusion), and maintaining the integrity of the food label so
that consumers will have access to meaningful information that they can
understand in the context of a total daily diet and that will enable
them to make meaningful product-to-product comparisons so they can
select foods that can lead to healthier diets (see Pearson, 164 F.3d at
656; Rubin v. Coors Brewing Co., 514 U.S. 476, 485 (1995); Fleminger v.
U.S. Dep't of Health and Human Servs., 854 F. Supp. 2d 192, 208 (D.
Conn. 2012); and 58 FR 2302).
    The next question under Central Hudson is whether the government
action ``directly advances the governmental interest asserted.''
Central Hudson, 447 U.S. at 566. The need for consistent labeling
claims that would help consumers select healthier foods is the precise
issue that Congress sought to address when passing the portions of the
NLEA that address nutrient content claims. See, e.g., 136 Cong. Rec.
H5836-01, H5840 (July 30, 1990) (statement of Rep. Waxman) (``[Under
the NLEA,] content claims would have to be consistent with terms
defined by . . . the Food and Drug Administration. Today, companies use
terms such as `low' and `light' differently and inconsistently. . . .
The bill would correct this deceptive and misleading state of affairs
by requiring that terms such as `light' have a single meaning.'') and
id. at H5843 (statement of Rep. Madigan) (``Consumers today are
confronted with a variety of labels that provide them with disjointed
and confusing information. . . . In the past few years, important
scientific evidence has been repeatedly reported that clearly links
dietary habits to good health. For this reason, the need to provide
consumers with better information about the foods they eat is
important.''); see also 136 Cong. Rec. H12951-02, H12953-54 (October
26, 1990) (statement of Rep. Madigan) (``[T]he bill requires that
content claims such as light, low, et cetera, would have to be
consistent with terms defined by the FDA. This is to address the
current problem of companies using these terms differently and
inconsistently.''). Requiring that all nutrient levels be computed in
the same way so that words such as ``high'' will have a consistent
meaning directly advances the goals of preventing inconsistent and
contradictory claims in food labeling, maintaining the integrity of the
food label, and promoting public health. The result is labels that
contain meaningful information that the consumer can understand in the
context of a total daily diet. Such labels allow consumers to make
meaningful product-to-product comparisons and to select foods that can
lead to healthier diets.
    The final question under Central Hudson is ``whether the fit
between the government's ends and the means chosen to accomplish those
ends `is not necessarily perfect, but reasonable.' '' See Pearson, 164
F.3d at 656, quoting Fox, 492 U.S. at 480. The Government's approach
here is narrowly tailored to advance the Government's interest in
preventing inconsistent and contradictory claims, maintaining the
integrity of the food label, and promoting the public health, while not
unnecessarily infringing speech. Nutrient content claims are not
prohibited, but instead are permitted under a range of circumstances.
Nutrient content claims based on an authoritative statement may be
used, provided that the relevant nutrient reference level is not based
on an approach that results in inconsistent and contradictory
information. In this situation, we are taking no regulatory action at
this time with regard to a nutrient content claim for ALA that uses the
population-coverage approach to determine the nutrient level; that
claim may therefore be used. The comments have advanced no argument to
explain why the use of multiple, inconsistent statistical methods that
generate inconsistent and contradictory claims would be preferable for
consumers. Such claims would, in fact, impede the ability of consumers
to make meaningful product-to-product comparisons, and therefore to
make informed purchasing decisions. We also note that, in addition to
the population coverage-based ALA claims about which we are taking no
action at this time, other opportunities exist for companies to make
labeling statements regarding ALA in their products; for example,
labeling that simply states the amount of a nutrient may be made in
accordance with Sec.  101.13(i).
    Moreover, we have concluded that no disclaimer could cure the
fundamental contradiction and inconsistency resulting from the proposed
ALA claims that are based on the population-weighted approach. No
disclaimer would cure the fundamental flaw presented here: that the use
of two different daily values for ALA would render the nutrient content
claims that were based on those reference values inconsistent with one
another, and would therefore impede consumers' ability to make
meaningful product-to-product comparisons based on those claims. A
disclaimer cannot bring clarity to a situation where a fundamental
contradiction remains. See Resort Car Rental System, Inc. v. FTC, 518
F.2d 962, 964 (9th Cir.) (per curiam), cert denied, 423 U.S. 827
(1975); Continental Wax Corp. v. FTC, 330 F.2d 475, 480 (2d Cir. 1964);
United States v. Millpax, Inc., 313 F.2d 152, 154 & n.1 (7th Cir.
1963); Pasadena Research Labs v. United States, 169 F.2d 375, 383-84
(9th Cir. 1948). Labeling that states the amount of a nutrient may be
made under Sec.  101.13(i);

the purpose of nutrient content claims is to use words such as ``high''
and ``good source,'' which, because they are defined by regulation,
place that type of information in the context of the total daily diet.
This purpose is only served if the terms defined at Sec.  101.54 are
given a consistent meaning.
    (Comment 4) A number of comments suggested that FDA should
establish, through notice and comment rulemaking, DVs for DHA and EPA
for use in nutrient content claims and requested that FDA continue to
allow the current claims for DHA and EPA until DVs can be established.
    (Response) We disagree that we should continue to allow these
claims, pending a rulemaking to establish DVs for DHA and EPA, for the
reasons set forth in this final rule for prohibiting such claims. Under
section 403(r)(4) of the FD&C Act and Sec.  101.69, interested persons
can submit a petition for the authorization of nutrient content claims.
    (Comment 5) A number of comments stated that we did not respond to
the notifications in a timely manner and that, as a consequence, many
manufacturers would be affected financially by a prohibition of certain
omega-3 nutrient content claims. Several comments stated that there
could be a possible negative health impact in removing omega-3 claims
that have existed for some time in the marketplace, including increased
consumer confusion regarding recommended intakes of omega-3 fatty
acids. Other comments requested that, because the omega-3 nutrient
content claims have been lawful and in use in the marketplace for some
time, FDA should provide a transition period to phase them out (e.g., 1
year) if the Agency decides to prohibit certain omega-3 nutrient
content claims.
    (Response) We disagree with the comments asserting that we did not
act in a timely manner. Section 403(r)(2)(G)(ii) of the FD&C Act,
permits a food bearing a nutrient content claim based on an
authoritative statement to be introduced into interstate commerce 120
days after notifying FDA. The claim may be made until we issue a
regulation prohibiting the claim, modifying the claim, or finding that
the requirements of the FD&C Act have not been met, or a district court
of the United States determines that the requirements of the FD&C Act
have not been met (section 403(r)(2)(H) of the FD&C Act). We received
three separate notifications for omega-3 fatty acids over a 2-year
period ending in December 2005. Because the notifications addressed the
same issue, we conducted a collective review of the notifications and
determined that all three notifications should be addressed in the same
rulemaking, rather than separately. In June 2004, we publicly announced
our intention to issue rulemaking to prohibit some of the nutrient
content claims (see Docket No. FDA-2004-N-0382) (Ref. 4) and, less than
2 years after the receipt of the final notification, we issued the
proposed rule.
    We agree with the comments requesting a transition period. In this
final rule, we conclude that certain omega-3 fatty acid nutrient
content claims set forth in the three notifications do not meet the
requirements of section 403(r)(2)(G) of the FD&C Act and, therefore,
are prohibited from use in food labeling. We are providing a period for
transition, and this rule will become effective on the next uniform
compliance date for labeling regulations. The next uniform compliance
date is January 1, 2016, and it applies to food labeling regulations
issued between January 1, 2013, and December 31, 2014.

III. Summary of the Final Rule

    Given the information discussed in the preamble to the omega-3
proposed rule and the absence of contrary information in the comments,
and under our authority under section 403(r)(2)(H)(i)(I) of the FD&C
Act, FDA is adopting as a final rule, without change, the proposal to
prohibit the nutrient content claims for DHA and EPA set forth in the
seafood processors notification, the Martek notification, and the Ocean
Nutrition notification and the nutrient content claims for ALA set
forth in the seafood processors notification. We express no conclusions
as to whether the ALA claims in the Martek notification are supported
by an authoritative statement that satisfies the requirements of
section 403(r)(2)(G) of the FD&C Act. We are taking no regulatory
action at this time with respect to the nutrient content claims for ALA
set forth in the Martek notification and, therefore, these claims,
which are set forth in table 1, will be allowed to remain on the market
at this time.

                        Table 1--Nutrient Claims
------------------------------------------------------------------------
                                         Conditions for making the claim
     Nutrient content claim for ALA                    \1\
------------------------------------------------------------------------
High...................................  >= 320 mg of ALA per RACC (>=
                                          20% of 1.6 g/day)
Good Source............................  >= 160 mg of ALA per RACC (>=
                                          10% of 1.6 g/day)
More...................................  >= 160 mg of ALA more per RACC
                                          than an appropriate reference
                                          food (>= 10% of 1.6 g/day)
------------------------------------------------------------------------
\1\ Nutrient content claims must comply with all applicable FDA
  regulations regarding the making of such claims.

IV. Analysis of Impacts

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive 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). We have
concluded that this final rule is not a significant regulatory action
under the Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. We have concluded that this final rule may 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 $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This final regulatory impact analysis revises the initial
regulatory impact analysis set forth in the proposed rule (72 FR 66103)
in response to comments on the proposed rule. Except for the revisions
that we indicate in this section of the document, the analysis for the

final rule is the same as the analysis for the proposed rule.

A. Benefit-Cost Analysis

1. The Need for This Rule

    We discuss any comments on the legal and regulatory need for this
rule in section II of this document.
2. Options
    In the analysis for the proposed rule, we analyzed the following
two regulatory options: (1) Take no new regulatory action and (2)
prohibit the DHA and EPA claims and the ALA claims based on a reference
value of 1.3 g/day, but allow the ALA claims based on a reference value
of 1.6 g/day.
a. Option 1: Take No New Regulatory Action
    We did not receive any comments on the selection of this option as
the baseline.
b. Option 2: Take the Regulatory Actions as Described in the Proposed
Rule
    (Comment 6) One comment asserted that the economic analysis for the
proposed rule did not fulfill the requirements of Executive Order 12866
because we said that we could not estimate the public health impacts of
eliminating nutrient content claims for DHA and EPA because we had not
yet conducted a review of the scientific evidence concerning the health
effects of consuming DHA and EPA at various levels. The comment
suggested that we review the relevant scientific evidence to complete
the analysis. The comment also noted that we previously reviewed at
least some of the scientific evidence relating to cardiovascular
effects in the context of qualified health claims for DHA and EPA. The
comment said that, on that basis alone, FDA could present a more
detailed analysis of potential health costs than it presented in the
analysis for the proposed rule.
    Other comments said that eliminating existing nutrient content
claims for DHA and EPA would generate public health costs. These
comments linked DHA and/or EPA to preventing cardiovascular disease,
reducing cardiac mortality including sudden death in patients with no
sign of cardiovascular conditions and cardiovascular events in
hypercholesterolemic patients, growth, neurodevelopment including brain
and eye development in infants, intelligence quotients, and improved
mental acuity and overall quality of life for consumers facing age-
related cognitive decline, including Alzheimer's disease. The comments
also noted possible links to the prevention and treatment of arthritis,
inflammatory and autoimmune diseases, and cancer. One comment noted
that current average intake of DHA and EPA is estimated to be 100 to
200 mg/day in the United States, which is below the intake recommended
by various organizations.
    (Response) In the analysis for the proposed rule, we said that we
could not determine whether eliminating existing nutrient content
claims for DHA and EPA would have any impact on consumer health because
we had not yet conducted a review of the scientific evidence on the
health effects of consuming DHA and EPA at different levels. The
information presented in these comments suggests that eliminating
nutrient content claims for DHA and EPA could lead to health costs.
However, because we have not yet conducted a comprehensive review of
the scientific evidence, we cannot revise the analysis of the final
rule to account for these potential effects.
    (Comment 7) A number of comments addressed the relative merits of
nutrient content claims, qualified health claims, and quantitative
statements. One comment stated that qualified health claims are a poor
substitute for nutrient content claims and that eliminating nutrient
content claims would reduce opportunities for firms to communicate with
consumers about EPA and DHA. The comment looked at health claims
appearing on new omega-3 fatty acid and DHA and/or EPA products in the
Mintel Global New Products Database between June 2006 and November 2007
and found that 24 percent were nutrient content claims, 56 percent were
quantitative statements, and 20 percent were structure function claims.
The comment suggested that nutrient content claims and quantitative
statements predominated because they are relatively simple and easy to
understand. One comment said that qualified health claims and
quantitative statements do not enable consumers to consider the
relative significance of the claims and statements in the context of
the total daily diet. This comment said that without nutrient content
claims, consumers would be unable to determine if quantitative content
differences are significant or to readily identify foods that contain
meaningful levels of omega-3 fatty acids. Finally, the comment noted
that removing nutrient content claims would significantly diminish the
incentives for firms to innovate and to improve the nutritional
properties of food. One comment noted that we permit qualified health
claims on products regardless of the level of DHA or EPA in those
products. The comment said that we did not consider the potential
health costs generated by consumers switching to products having
potentially lower levels of DHA and/or EPA. One comment said that
prohibiting DHA and EPA claims after they have appeared for several
years would lead consumers to question the dietary value of these
nutrients. One comment said that allowing quantitative statements about
the level of DHA and/or EPA in products without providing some context
of the significance of those levels would confuse consumers.
    (Response) Our analysis for the proposed rule did not claim that
the availability of qualified health claims implied that eliminating
nutrient content claims for DHA and EPA would have no impact on product
innovation, consumption of these substances, or consumer health. We
said that eliminating nutrient content claims for DHA and EPA might
result in reduced consumption of DHA and EPA under two scenarios.
First, consumers might reduce their consumption of these nutrients if
they choose not to purchase and consume products that do not have the
relevant nutrient content claims on the label. Second, producers may
choose not to reformulate products with higher levels of DHA and/or EPA
if they cannot use nutrient content claims to communicate these higher
levels to consumers. However, we did not consider potentially reduced
consumption resulting from the following mechanisms discussed in some
comments: consumers switching to products with qualified health claims
that may have lower levels of DHA and/or EPA, consumers who choose not
to consume products with DHA and/or EPA because they question the
dietary value of these nutrients due to the disappearance of nutrient
content claims, and consumers who become confused about the
significance of particular levels of DHA and EPA due to the
disappearance of nutrient content claims. Therefore, we revise our
analysis to include these additional pathways by which this final rule
may reduce consumption of omega-3 fatty acids, but we still reach the
same conclusion: Because we have yet to conduct a review of the
scientific evidence concerning the health effects of consuming EPA and
DHA at different levels, we cannot determine whether the loss of these
claims would have any impact on consumer health, either beneficial or
detrimental.
    (Comment 8) Some comments said that FDA did not present a
statistically representative portrait of the number of products
containing DHA and/or EPA and instead relied on products that we found
in grocery stores in the

Washington, DC metropolitan area and on Internet grocery stores.
    (Response) We did not present our estimates in the analysis for the
proposed rule as a statistically representative portrait of the number
of products containing DHA and/or EPA. Constructing a statistically
representative portrait would be very costly and would not be
worthwhile because it would not change the conclusions of the analysis.
We have estimated that this rule will generate very small costs that
are considerably below the cutoff for classifying a rule as significant
under Executive Order 12866, so performing a statistically
representative study would probably not change the status of this rule
under that Executive Order. In addition, we were unable to quantify
benefits, so obtaining more precise cost estimates would not allow the
Agency to revise its analysis of net benefits.
    (Comment 9) One comment said that we only considered seafood, eggs,
pasta, and dietary supplement products, and we excluded many of the
emerging categories of foods that firms enrich with omega-3 fatty
acids. The comment said that these emerging categories are categories
that contain foods that traditionally do not contain omega-3 fatty
acids. According to this comment, food manufacturers tend to rely
heavily on nutrient content claims to communicate the benefits of DHA
and EPA enrichment over other products within these categories. The
comment stated that some of these categories include fresh and shelf-
stable milks, spoonable yogurts, yogurt drinks, fermented milk drinks,
cheeses, butters, fat-based spreads, juices, juice smoothies, soy
milks, packaged breads, meats from grass-fed animals, packaged meats,
baby foods, chocolate confections, cooking oils, packaged soups, ice
creams, nutritional bars, and frozen pizzas. One comment said that
firms are currently making nutrient content claims involving ALA, DHA,
and EPA on dairy products. The comment said that we did not account for
the costs associated with these products in the analysis for the
proposed rule. One comment stated that we underestimated the number of
products and labels affected by the proposed rule. The comment noted
that, in the analysis for the proposed rule, we said that we found 113
qualifying dietary supplements in the Dietary Supplements Sales
Information database, but that when we searched a single retailer,
Amazon.com, we turned up 2,224 dietary supplement labels (stock keeping
units or SKUs) containing ``fish oil.'' The comment said that we also
underestimated the number of SKUs for eggs and seafood.
    (Response) We were unable to locate information on products bearing
omega-3 nutrient content claims in the specific product categories
mentioned in this comment. However, we did locate data indicating that
firms introduced 369 new food and beverage products bearing omega-3
claims in the United States from 1999 to 2014 (Ref. 5). We do not know
how many of these products remain on the market, nor do we know how
many of these products bear one or more of the relevant nutrient
content claims. Therefore, this number represents the maximum number of
such products currently on the market.
    In the preamble to the proposed rule, we identified only one
conventional food product that firms enriched with omega-3 fatty acids.
We estimated that two such products probably existed on the market, and
estimated a label change cost of $17,000, or $8,500 per product. If we
apply this cost to 369 products, we get an estimated cost of
approximately $3 million. Therefore, in this final rule, we have
revised the previous estimate of the total cost of labeling changes
from $0.08 million to approximately $3 million.
    (Comment 10) One comment said that firms launched a significant
number of products enriched with DHA and EPA in part because they were
able to communicate some of the benefits of DHA and EPA using nutrient
content claims. This comment said that we did not consider the loss of
sales that would result if these firms were unable to communicate the
relative enrichment levels of DHA and EPA in these products, but that
we instead only considered the cost of relabeling these products. One
comment stated that we did not account for the loss of the return on
investment in product development.
    (Response) Once the final rule becomes effective, firms will retain
some ability to communicate levels of omega-3 fatty acid content to
consumers by using amount or percentage statements and qualified health
claims. These statements might not be as effective as express nutrient
content claims (e.g., ``high'') in encouraging consumers to buy these
products. Therefore, sales of these products and the return on
investment for developing these products may decline. We would classify
these effects as distributive impacts rather than social costs because
we have based our rule on the notion that these nutrient content claims
lack the scientific support that an authoritative statement would
provide. Therefore, consumer demand based on these nutrient content
claims does not represent the true demand for these products and
prohibiting these nutrient content claims will not generate social
costs for consumers. However, some firms may lose sales and profits and
some firms may gain sales and profits. We cannot estimate this
distributive impact because we do not know how much money firms have
spent developing these products or the impact of eliminating nutrient
content claims for DHA and/or EPA on the sales of these products.
However, we revised the analysis by noting that firms that produce
products or that planned to produce products bearing these nutrient
content claims may lose profits, while firms producing competing
products may gain profits.
    (Comment 11) One comment said that we were rejecting the nutrient
content claims presented in the seafood processors notification based
on our approach to calculating a nutrient reference value. This comment
noted that we had published the DV ANPRM (72 FR 62149) inviting
comments on what new reference values we should use to calculate the
DVs in the Nutrition Facts label and what factors we should consider in
establishing such new reference values. The comment noted that if we
change our position on setting reference values, then we might need to
reverse our position on the nutrient content claims in the seafood
processors notification, which would generate additional label changes
and also confuse consumers.
    (Response) Even if we were to establish, in the future, a
population-weighted approach for DVs that would allow the nutrient
content claims in the seafood processors notification and thus allow
firms to make additional label changes, we can infer that any such
label changes would be associated with positive net benefits. Firms
that were using the nutrient content claims in the seafood processors
notification and that stopped using those claims because of this final
rule might be able to resume using those claims. However, because such
label changes would be voluntary, manufacturers would not choose to
make them unless consumers valued the changes at least enough to cover
the cost of such changes. Manufacturers are not likely to voluntarily
make nutrient content claims if the addition would confuse consumers
and negatively impact sales. We would not allow such label changes if
we determined them to be false or misleading; therefore, we would infer
that any additional value consumers placed on such products is related
to the value of the new information. In addition, changes in product
labeling are not particularly

unusual, so it is unlikely that many consumers would be confused if the
nutrient content claims on particular products disappeared and later
reappeared.
    (Comment 12) One comment said that a single label change can cost
dairy processors up to $5,000 per label for a new label design and new
printing plates. The comment noted that firms would also need to
dispose of obsolete packaging and that, in the past, companies have
estimated these costs in the tens to hundreds of thousands of dollars,
depending on the number of SKUs.
    (Response) In the analysis for the proposed rule, we estimated the
cost of changing labels using a model developed for us for that
purpose. The model included designing new labels, producing new
printing plates, and disposing of obsolete packaging. We estimated
costs per SKU of between $2,300 and $8,400. This figure implies that a
large company producing many SKUs could face costs of tens to hundreds
of thousands of dollars for disposing of obsolete packaging. Therefore,
this comment is consistent with the analysis for the proposed rule.

B. Benefits

    (Comment 13) One comment said that there is no scientific evidence
supporting health benefits of 160 mg of DHA and/or EPA per day but
that, on the contrary, the science supports much higher levels. This
comment said that to allow the use of an ``excellent source'' claim for
this level of these nutrients might cause consumers to lose confidence
in package claims.
    (Response) Some consumers may have experienced a reduction in their
confidence in package claims based on the discrepancy between nutrient
content claims describing products with 160 mg of DHA and/or EPA as an
excellent source of these nutrients and the level of these nutrients
recommended by some scientific organizations. These consumers may
experience increased confidence in package claims when this discrepancy
is eliminated. Increased confidence in package claims could lead to
health benefits from better dietary choices based on package claims. We
do not have sufficient information to estimate this potential benefit.

C. Regulatory Flexibility Analysis

    We have 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. We find that this final rule may have a significant
economic impact on a substantial number of small entities.
    The Regulatory Flexibility Act requires that FDA present a succinct
statement of a rule's objectives. We discussed the legal and regulatory
need for this rule in section II of this document and in section III in
the preamble of the proposed rule (72 FR 66103 at 66107). The intent of
this rule is to eliminate certain nutrient content claims that do not
have the scientific justification that an authoritative statement would
provide or that are not stated in a manner that enables the public to
comprehend the information provided in the claim and to understand the
relative significance of the information in the context of a total
daily diet. In so doing, the rule enables consumers to identify
suitable products.
    In the analysis for the proposed rule, we said that the proposed
rule would not have a significant effect on a substantial number of
small entities. We based that conclusion on our review of the labels in
the marketplace. However, one comment on the benefit-cost analysis in
the proposed rule suggested that we had overlooked a number of
products. Based on that comment, we estimated a new range of
potentially affected products in the final benefit-cost analysis. The
new range of potentially affected products suggests that the final rule
might have a significant effect on a substantial number of small
entities.
    In the benefit-cost analysis for this rule, we estimated that the
final rule would affect a maximum of 369 products. We were not able to
identify the firms that produce these products. However, in the
analysis for the proposed rule, we estimated that four products were
associated with four manufacturers. Therefore, we assume that 369
products may be associated with 369 manufacturers. We also were not
able to identify these products, although the comments indicated that
they include products from the following categories: seafood, pasta,
eggs, fresh and shelf-stable milks, spoonable yogurts, yogurt drinks,
fermented milk drinks, cheeses, butters, fat-based spreads, juices,
juice smoothies, soy milks, packaged breads, meats from grass-fed
animals, packaged meats, baby foods, chocolate confections, cooking
oils, packaged soups, ice creams, nutritional bars, and frozen pizzas.
    The Small Business Administration (SBA) publishes size standards
for small businesses. The SBA size definition for firms producing these
products defines a small firm to be any firm with 500 or fewer
employees. We do not know how many employees work at the firms that
produce the specified products because we cannot identify those firms.
However, the vast majority of these firms probably meet the SBA
definition of a small business because nearly all (97 percent) of food
manufacturing plants have 500 or fewer employees.
1. Options
    FDA considers the following option to reduce the burden of this
rule on small entities: give small firms more time to comply with this
rule.
    Option 1: Give small firms more time to comply with this rule
    This rule will become effective on the next uniform compliance date
for labeling regulations. The next uniform compliance date is January
1, 2016, and it applies to food labeling regulations that FDA issues
between January 1, 2013, and December 31, 2014. Using the next uniform
compliance date always provides firms with at least 1 year and as much
as 3 years to make any necessary labeling changes. In the analysis for
the proposed rule (72 FR 66103 at 66109), we based our cost estimates
on firms having 2 years to change product labels. Providing more time
to change labels reduces the cost of changing those labels because more
firms would be able to make the changes during regularly scheduled
label changes. In the analysis for the proposed rule, we noted that our
labeling cost model estimates that firms will redesign 67 percent of
product labels in any 2-year period and all product labels in any 3-
year period. Therefore, if we changed the compliance date for small
firms so that they had at least 3 years to comply, then we would reduce
the cost for these firms to zero. To avoid inconsistent labeling on
products produced by small firms and by other firms, we would need to
set the same compliance date for all firms. This option would delay the
benefits of this rule. Therefore, we have chosen not to give small
firms more time to comply with the final rule.

V. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of the
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.

VI. Paperwork Reduction Act of 1995

    We conclude that labeling provisions of this 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).

VII. Federalism

    We analyzed this final rule in accordance with the principles set
forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State law
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts ``any requirement respecting any claim of the type described
in section 403(r)(1) [21 U.S.C. 343(r)(1)] made in the label or
labeling of food that is not identical to the requirement of section
403(r) [21 U.S.C. 343(r)]. . . .'' Section 403A(a)(5) of the FD&C Act
(21 U.S.C. 343-1(a)(5)). However, this statutory provision does not
preempt any State requirement respecting a statement in the labeling of
food that provides for a warning concerning the safety of the food or
component of the food (Pub. L. 101-535, Section 6 (1990)). This final
rule prohibits certain nutrient content claims for certain omega-3
fatty acids in the label or labeling of food under section 403(r) of
the FD&C Act.

VIII. 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 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but FDA is not responsible for any
subsequent changes to Web sites after this document publishes in the
Federal Register.)

    1. ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids.'' Institute
of Medicine, National Academy of Sciences, 2005.
    2. Letter from the Institute of Medicine of the National
Academies to FDA/CFSAN. Docket No. FDA-2004-N-0382; Document ID FDA-
2004-N-0382-0035.
    3. ``Dietary Reference Intakes: Guiding Principles for Nutrition
Labeling and Fortification.'' Institute of Medicine, National
Academy of Sciences, 2003.
    4. Letter from FDA/CFSAN to Advocates for Better Children's
Diets. Docket No. FDA-2004-N-0382; Document ID FDA-2004-N-0382-0004.
    5. Data from Mintel Global New Products Database, Mintel Group,
Ltd., http://www.mintel.com, accessed January 29, 2014.

    Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09492 Filed 4-25-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: September 11, 2008 (Volume 73, Number 177)]
[Rules and Regulations]
[Page 52788-52789]
[DOCID:fr11se08-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0900]

Safety Zone; Milwaukee Harbor, Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Milwaukee Harbor Safety Zone
in Milwaukee Harbor from 8:30 p.m. through 8:45 p.m. on September 29,
2008. This action is necessary to protect vessels and people from the
hazards associated with fireworks displays. This safety zone will
restrict vessel traffic from portions of the Captain of the Port Lake
Michigan Zone.

DATES: The regulation in 33 CFR 165.935 will be enforced from 8:30 p.m.
through 8:45 p.m. on September 29, 2008.

FOR FURTHER INFORMATION CONTACT: Petty Officer Eric Vogel, Prevention
Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414)
747-7154.

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zone,
Milwaukee Harbor, Milwaukee, WI, 33 CFR 165.935 for the following
event: Milwaukee Brewers Rally Monday, on September 29, 2008, from 8:30
p.m. through 8:45 p.m.
    All vessels must obtain permission from the Captain of the Port or
his designated representative to enter, move within, or exit the safety
zone. Vessels and persons granted permission to enter the safety zone
shall obey all lawful orders or directions of the Captain of the

Port or his designated representative. While within a safety zone, all
vessels shall operate at the minimum speed necessary to maintain a safe
course.
    This notice is issued under authority of 33 CFR 165.935 Safety
Zone, Milwaukee Harbor, Milwaukee, WI, and 5 U.S.C. 552(a). In addition
to this notice in the Federal Register, the Coast Guard will provide
the maritime community with advance notification of these enforcement
periods via broadcast Notice to Mariners or Local Notice to Mariners.
    The Captain of the Port or designated representative may be
contacted via U.S. Coast Guard Sector Lake Michigan on channel 16, VHF-
FM.

    Dated: August 27, 2008.
Bruce C. Jones,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. E8-21223 Filed 9-10-08; 8:45 am]

BILLING CODE 4910-15-P


STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS

DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 17

ODORS

Effective 22 February 1977

Last Amended   19 July 2007

AUTHORITY:	These regulations are authorized pursuant to R.I. Gen. Laws
§ 42-17.1-2(s) and 23-23, as amended, and have been promulgated
pursuant to the procedures set forth in the R.I. Administrative
Procedures Act, R.I. Gen. Laws Chapter 42-35.

RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT

OFFICE OF AIR RESOURCES

AIR POLLUTION CONTROL REGULATION NO. 17

ODORS

17.1	Definitions

Unless otherwise expressly defined in this section, the terms used in
this regulation shall be defined by reference to the Rhode Island Air
Pollution Control General Definitions Regulation.

17.2	Prohibitions

No person shall emit or cause to be emitted into the atmosphere any air
contaminant or combination of air contaminants which creates an
objectionable odor beyond the property line of said person.

17.3	Odor Evaluations

A staff member of the Department shall determine by personal observation
if an odor is objectionable, taking into account its nature,
concentration, location, duration and source.

General Provisions

Purpose

The purpose of this regulation is to prohibit the release of an air
contaminant which may create an objectionable odor beyond the source’s
property line.

Authority

These regulations are authorized pursuant to R.I. Gen. Laws §
42-17.1-2(s) and 23-23, as amended, and have been promulgated pursuant
to the procedures set forth in the R.I. Administrative Procedures Act,
R.I. Gen. Laws Chapter 42-35

Application

The terms and provisions of this regulation shall be liberally construed
to permit the Department to effectuate the purposes of state law, goals
and policies.

Severability

If any provision of this regulation or the application thereof to any
person or circumstance, is held invalid by a court of competent
jurisdiction, the validity of the remainder of the regulation shall not
be affected thereby.

Effective Date

The foregoing regulation, "Odors”, as amended, after due notice, is
hereby adopted and filed with the Secretary of State this ____29th_ day
of __June_________, 2007_ to become effective twenty (20) days
thereafter, in accordance with the provisions of Chapters 23-23, 42-35,
42-17.1, 42-17.6, of the General Laws of Rhode Island of 1956, as
amended.

W. Michael Sullivan, PhD., Director

Department of Environmental Management

Notice Given on:	February 21, 2007

Public Hearing held:	     March 23, 2007

Filing Date:	June 29, 2007

Effective Date:  July 19, 2007

Page   PAGE  1  of 2


[Federal Register Volume 81, Number 134 (Wednesday, July 13, 2016)]
[Notices]
[Page 45340]
[FR Doc No: 2016-16495]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 15Bc3-1 and Form MSDW; SEC File No. 270-93, OMB Control No.
3235-0087.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and
Exchange Commission (``Commission'') is soliciting comments on the
existing collection of information provided for in Rule 15Bc3-1 (17 CFR
15Bc3-1) and Form MSDW (17 CFR 249.1110) under the Securities Exchange
Act of 1934 (17 U.S.C. 78a et seq.). The Commission plans to submit
this existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Rule 15Bc3-1 provides that a notice of withdrawal from registration
with the Commission as a bank municipal securities dealer must be filed
on Form MSDW. The Commission uses the information submitted on Form
MSDW in determining whether it is in the public interest to permit a
bank municipal securities dealer to withdraw its registration. This
information is also important to the municipal securities dealer's
customers and to the public, because it provides, among other things,
the name and address of a person to contact regarding any of the
municipal securities dealer's unfinished business.
    Based upon past submissions, the staff estimates that, on an annual
basis, approximately five bank municipal securities dealers will file a
notice of withdrawal from registration with the Commission as a bank
municipal securities dealer on Form MSDW. The staff estimates that the
average number of hours necessary to comply with the notice
requirements set out in Rule 15Bc3-1 and Form MSDW is 0.5 per
respondent, for a total burden of 2.5 hours per year. The staff
estimates that the average internal compliance cost per hour is
approximately $343. Therefore, the estimated total cost of compliance
for the respondents is approximately $858.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimate
of the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: July 6, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-16495 Filed 7-12-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Page 18414]
[FR Doc No: 2022-06627]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94504; File No. SR-OCC-2022-801]

Self-Regulatory Organizations; the Options Clearing Corporation;
Notice of Extension of Review Period of Advance Notice Concerning the
Options Clearing Corporation's Margin Methodology for Incorporating
Variations in Implied Volatility

March 24, 2022.
    On January 24, 2022, the Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission (``Commission'')
advance notice SR-OCC-2022-801 (``Advance Notice'') pursuant to Section
806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and
Consumer Protection Act, entitled Payment, Clearing and Settlement
Supervision Act of 2010 (``Clearing Supervision Act'') \1\ and Rule
19b-4(n)(1)(i) \2\ under the Securities Exchange Act of 1934
(``Exchange Act'') \3\ to change quantitative models related to certain
volatility products.\4\ The Advance Notice was published for public
comment in the Federal Register on February 11, 2022.\5\ The Commission
received a comment regarding the changes proposed in the Advance
Notice.\6\
---------------------------------------------------------------------------

    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
    \3\ 15 U.S.C. 78a et seq.
    \4\ See Notice of Filing infra note 5, at 87 FR 8063.
    \5\ Securities Exchange Act Release No. 94166 (Feb. 7, 2022), 87
FR 8063 (Feb. 11, 2022) (File No. SR-OCC-2022-801) (``Notice of
Filing''). On January 24, 2022, OCC also filed a related proposed
rule change (SR-OCC-2022-001) with the Commission pursuant to
Section 19(b)(1) of the Exchange Act and Rule 19b-4 thereunder
(``Proposed Rule Change''). 15 U.S.C. 78s(b)(1) and 17 CFR 240.19b-
4, respectively. In the Proposed Rule Change, which was published in
the Federal Register on February 11, 2022, OCC seeks approval of
proposed changes to its rules necessary to implement the Advance
Notice. Securities Exchange Act Release No. 94165 (Feb. 7, 2022), 87
FR 8072 (Feb. 11, 2022) (File No. SR-OCC-2022-001). The comment
period for the related Proposed Rule Change filing closed on March
4, 2022.
    \6\ Since the proposal contained in the Advance Notice was also
filed as a proposed rule change, all public comments received on the
proposal are considered regardless of whether the comments are
submitted on the Proposed Rule Change or the Advance Notice.
Comments on the Proposed Rule Change are available at https://www.sec.gov/comments/sr-occ-2022-001/srocc2022001.htm.
---------------------------------------------------------------------------

    Section 806(e)(1)(G) of the Clearing Supervision Act provides that
OCC may implement the changes if it has not received an objection to
the proposed changes within 60 days of the later of (i) the date that
the Commission receives the Advance Notice or (ii) the date that any
additional information requested by the Commission is received,\7\
unless extended as described below.
---------------------------------------------------------------------------

    \7\ 12 U.S.C. 5465(e)(1)(G).
---------------------------------------------------------------------------

    Pursuant to Section 806(e)(1)(H) of the Clearing Supervision Act,
the Commission may extend the review period of an advance notice for an
additional 60 days, if the changes proposed in the advance notice raise
novel or complex issues, subject to the Commission providing the
clearing agency with prompt written notice of the extension.\8\
---------------------------------------------------------------------------

    \8\ 12 U.S.C. 5465(e)(1)(H).
---------------------------------------------------------------------------

    Here, as the Commission has not requested any additional
information, the date that is 60 days after OCC filed the Advance
Notice with the Commission is March 25, 2022. However, the Commission
finds the issues raised by the Advance Notice complex because OCC
proposes to change three models within its margin methodology, in part,
to build the foundation for a single, consistent framework to model
equity volatility products in margin and stress testing.\9\ Therefore,
the Commission finds it appropriate to extend the review period of the
Advance Notice for an additional 60 days under Section 806(e)(1)(H) of
the Clearing Supervision Act.\10\
---------------------------------------------------------------------------

    \9\ See Notice of Filing, 87 FR 8063.
    \10\ 12 U.S.C. 5465(e)(1)(H).
---------------------------------------------------------------------------

    Accordingly, the Commission, pursuant to Section 806(e)(1)(H) of
the Clearing Supervision Act,\11\ extends the review period for an
additional 60 days so that the Commission shall have until May 24, 2022
to issue an objection or non-objection to advance notice SR-OCC-2022-
801.
---------------------------------------------------------------------------

    \11\ Id.
    \12\ 17 CFR 200.30-3(a)(94).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-06627 Filed 3-29-22; 8:45 am]
BILLING CODE 8011-01-P