[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Proposed Rules]
[Pages 22442-22451]
[FR Doc No: 2013-08855]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 107

[Docket No. FDA-2013-N-0067]

Infant Formula: The Addition of Minimum and Maximum Levels of
Selenium to Infant Formula and Related Labeling Requirements

AGENCY: Food and Drug Administration.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulations on nutrient specifications and labeling for infant
formula to add the mineral selenium to the list of required nutrients
and to establish minimum and maximum levels of selenium in infant
formula.

DATES: Submit either electronic or written comments on the proposed
rule by July 1, 2013. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by May 16, 2013, (see the
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0067, by any of the following methods, except that comments on
information collection issues under the Paperwork Reduction Act of 1995
must be submitted to the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB) (see the ``Paperwork Reduction
Act of 1995'' section of this document):

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0067 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``How Do You Submit Comments on This
Rule?'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule:
Benson M. Silverman, Center for Food Safety and Applied Nutrition (HFS-
850), Food and Drug Administration, 5100 Paint Branch Pkwy, College
Park, MD 20740,<PHONE_NUMBER>.
    With regard to the information collection issues: Domini Bean,
Office of Information Management, Food and Drug Administration, 1350
Piccard Dr., PI50-400T, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the background of this proposed rule?

    Section 412(i) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 350a(i)) establishes requirements for the nutrient
content of infant formulas. Under section 412(i)(2) of the FD&C Act,
the Secretary of Health and Human Services (the Secretary) is
authorized to revise the list of required nutrients and the required
level for any required nutrient, which authority has been delegated to
the Commissioner of Food and Drugs (the Commissioner). The table in
section 412(i) of the FD&C Act and FDA regulations, 21 CFR 107.100,
specify that infant formulas must contain 29 nutrients; minimum levels
for each nutrient and maximum levels for 9 of the nutrients are also
specified.
    At the time FDA established nutrient specifications for infant
formula, selenium was not recognized as an essential nutrient and was
not one of the nutrients required by statute in infant formula. As
explained in detail in this document, selenium has subsequently been
recognized as an essential nutrient. Therefore, we are proposing to
amend the nutrient specifications for infant

formula in Sec.  107.100 to include selenium as a required nutrient and
to establish minimum and maximum values for selenium. We are also
proposing to amend the labeling requirements for infant formula in 21
CFR 107.10 to add selenium to the list of nutrients along with the
requirement to list the amount of selenium per 100 kilocalories in the
formula.
    Selenium is an essential trace element for humans that functions
largely through an association with proteins known as selenoproteins.
The known biological functions of selenium include defense against
oxidative stress, regulation of thyroid hormone action, and regulation
of the oxidation/reduction status of vitamin C and other molecules.
    Plant foods are the major dietary sources of selenium although
selenium is also found in some meats, seafood, and nuts. The selenium
content of a food depends on the selenium content of the soil where the
plant was grown or where the animal was raised. In the United States,
food distribution patterns across the country help prevent people
living in geographic areas with low-selenium levels in the soil from
having low dietary selenium intakes. Keshan disease, a cardiomyopathy
that occurs almost exclusively in children, has been linked to selenium
deficiency. Keshan disease occurs in areas of China where the
population has severe selenium deficiency. Chronic selenium toxicity
(selenosis) has also been observed in persons consuming diets
containing high levels of selenium. Reported characteristics include
hair and nail brittleness and loss, gastrointestinal upsets, skin rash,
garlic breath odor, fatigue, irritability, and nervous system
abnormalities. Acute selenium toxicity is rare and the few reports in
the literature of acute fatal or near fatal selenium poisoning have
occurred because of accidental or suicidal ingestion of selenium (Ref.
1).
    In the United States, selenium is not routinely added to food. An
exception is infant formula, a food that is intended to be the sole
source of nutrition for infants and therefore, must provide sufficient
amounts of all nutrients essential for infants. In 1989, the Food and
Nutrition Board of the National Research Council established a
Recommended Dietary Allowance (RDA) for selenium for infants 0 to 6
months of age of 10.0 micrograms per day ([mu]g/day), a level
extrapolated from adult values on the basis of body weight and with a
factor allowed for growth (Ref. 2). Although selenium is not currently
required in infant formula by Sec.  107.100, all U.S. manufacturers are
adding selenium to their infant formulas. Based on labeling
information, currently marketed infant formulas contain 1.8 [mu]g to
3.0 [mu]g selenium per 100 kilocalorie (kcal) of formula.

II. What levels of selenium are we proposing for infant formula?

    As discussed in more detail in this document, we are proposing 2.0
[mu]g selenium/100 kcal as the minimum level for selenium in infant
formulas and 7.0 [mu]g/100 kcal as the maximum level of selenium in
infant formulas

III. What scientific evidence did we consider for the proposed
requirement to add selenium to infant formulas?

    In order to add a selenium requirement and to establish minimum and
maximum levels of selenium in infant formula, we first identified and
reviewed three relevant technical reports on recommended nutrient
levels for formulas for term infants and nutrient needs of healthy term
infants: (1) The Life Sciences Research Office (LSRO) report
``Assessment of Nutrient Requirements for Infant Formulas'' (Ref. 3);
(2) ``Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and
Carotenoids'' (Ref. 1); and (3) ``Global Standard for the Composition
of Infant Formula: Recommendations of an ESPGHAN Coordinated
International Expert Group'' (Ref. 4). These reports are referred to as
the LSRO report, the Institute of Medicine (IOM) report, and the
European Society on Pediatric Gastroenterology, Hepatology, and
Nutrition (ESPGHAN) report, respectively, in the remainder of this
proposal. We also searched the published scientific literature from
1998 through 2012 for published studies not included in these reports
or not identified in a 2008 published study by Daniels et al. (Ref. 5).
(The Daniels et al. study is discussed in this section of the
document.)

A. Available Evidence for Setting a Minimum Level of Selenium in Infant
Formula

1. LSRO Report
    In 1998, Raiten et al. published a report summarizing the
scientific literature on the nutrient needs of healthy term infants,
with an emphasis on research studies published since 1983 (Ref. 3). The
report was prepared for FDA's Center for Food Safety and Applied
Nutrition and Health Canada's Health Protection Branch by the LSRO in
consultation with expert scientists and professional organizations
involved in the field of infant nutrition. The goal of the
deliberations of this LSRO Expert Panel was to provide recommendations
for nutrient content of infant formulas that could serve as the sole
source of nutrition for term infants throughout the first year of life.
    On the basis of the evidence for the dietary essentiality of
selenium, the LSRO Expert Panel recommended that selenium be included
as a required nutrient in infant formula. The Panel also recommended a
minimum selenium content of 1.5 [mu]g/100 kcal (10.0 [mu]g/liter (L)),
which) and a maximum level of 5.0 [mu]g/100 kcal (33.5 [mu]g/L). The
minimum value approximated the estimated value for the mean minus one
standard deviation (SD) for the selenium concentration in human milk in
countries in which selenium deficiency has not been recognized in
breast-fed infants. This recommended minimum level would provide an
estimated 7.5 [mu]g/day of selenium for young infants exclusively fed
infant formula,\1\ an amount below the 1989 RDA (10.0 [mu]g/day). The
LSRO Panel was aware that there were disparities between some of its
recommendations for nutrient levels in infant formulas and the 1989
RDAs; however, the history of use for a large population in which
selenium deficiency has not been reported was regarded as a reasonable
basis for recommending a minimum value for selenium in infant formula.
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    \1\ This estimate is based on a calculation used to convert
nutrient intake values (e.g., milligram (mg)/day) to formula
nutrient content values (e.g., mg/100 kcal) (Raiten, et al., 1998;
Koletzko, et al, 2006). The calculation is based on the following
assumptions: (1) The mean intake of formulas for infants 0 to 6
months of age is 750 milliliter (ml)/day; (2) a representative body
weight for infants over this period is 5 kilogram (kg); and (3) a
representative caloric intake of infants over this period is 500
kcal/day (or 100 kcal/kg/day).
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2. IOM Report
    In 2000, the IOM published Dietary Reference Intakes (DRI) for
selenium. The DRI concept evolved from the Recommended Dietary
Allowances reports that have been published periodically since 1941 by
the National Academies of Science. As described by the IOM (Ref. 1),
the term Dietary Reference Intake encompasses three nutrient-based
reference values in addition to the RDA. The RDA and the three
nutrient-based reference values were described by the IOM as follows:
     The Recommended Dietary Allowance (RDA) is the average
dietary intake level that is sufficient to meet the nutrient
requirements of nearly all (97 to 98 percent) healthy individuals in a
particular life stage and gender group.

The RDA is intended to be the goal for daily intake by individuals.
     The Estimated Average Requirement (EAR) is the daily
intake value that is estimated to meet the requirement, as defined by
the specified indicator of adequacy, in half of the healthy individuals
in a life stage and gender group. The EAR is used to set the RDA. If
the standard deviation (SD) of the EAR is available and the requirement
for the nutrient is normally distributed, the RDA is defined as the EAR
plus two SDs of the EAR.
     An Adequate Intake (AI) is established for a nutrient when
sufficient scientific evidence is not available to calculate an EAR. An
AI is based on experimentally-derived intake levels of approximations
of observed mean nutrient intakes by a group of healthy people. The AI
for children and adults is expected to meet or exceed the amount needed
to maintain a defined nutritional state or exceed the amount needed to
maintain a defined nutritional state or criterion of adequacy in
essentially all members of a specific healthy population because it is
set using healthy populations. Like the RDA, the AI is intended to be
the goal for individual intake and it is intended to cover the needs of
nearly all persons in a life stage group.
     The Tolerable Upper Intake Level (UL) is the highest daily
intake level of a nutrient that is likely to pose no risk of adverse
health effects in almost all individuals in a life stage group.
    At the time of its report, the IOM did not find sufficient evidence
to calculate an EAR for selenium for infants during the first year of
life and, therefore, did not have a basis to set an RDA for selenium
for infants. For this reason, the IOM set an AI for selenium for
infants 0 to 6 months of age, the age when the recommended sole source
of nutrition is human milk, infant formula, or a combination of the
two.
    The IOM's primary basis for deriving an AI for most nutrients for
the first 6 months of life was the average intake by full term infants
born to healthy, well-nourished mothers and exclusively fed human milk.
To derive the AI values for infants ages 0 to 6 months of age, the mean
intake of a nutrient was calculated based on the average concentration
of the nutrient in human milk from 2 to 6 months of lactation, using
agreed-upon values from several reported studies and an average volume
of milk intake. To calculate the AI for selenium, IOM used the average
concentration of selenium in human milk from mothers in the United
States and Canada (18.0 [mu]g/L) and an intake of 0.78 L/day, as
reported from differences in weights of full-term infants before and
after feedings. A reference weight of 7 kg for infants 2 to 6 months of
age, adapted from National Health and Nutrition Examination Survey
(NHANES) III 1988-1994 data (Ref. 6), was used by the IOM to calculate
the AI on a body weight basis. (Ref. 1). The IOM established a selenium
AI of 15.0 [mu]g/day (approximately 2.1 [mu]g/kg body weight/day) for
infants 0 to 6 months of age (IOM, 2000). Assuming a typical intake of
100 kcal/kg/day for infants 0 to 6 months of age, this approximates a
need for selenium, relative to energy consumption, of 2.1 [mu]g/100
kcal.
3. ESPGHAN Report
    In 2005, an International Expert Group (IEG) coordinated by the
Committee on Nutrition of the ESPGHAN prepared a report on nutrient
levels in infant formula, based on scientific analysis and taking into
account existing scientific reports on current infant formula nutrient
content (Ref. 4). The report was prepared at the request of the Codex
Committee on Nutrition and Foods for Special Dietary Uses for use by
that Committee in revising the Codex Standard for Infant Formula and
Formulas for Special Medical Purposes Intended for Infants (Codex Stan
72-1981) (Ref. 7). The goal of establishing minimum and maximum
nutrient values for the Codex standard was to ensure that infant
formulas adhering to the Standard would be safe and would meet infants'
normal nutritional requirements.
    The ESPGHAN IEG reported that their recommended minimum nutrient
values were based on scientific evidence of the amounts needed to meet
infants' nutritional requirements when such information was available.
When scientific information was lacking, an established history of
apparent safe use was taken into account. The IEG recommended a minimum
selenium value of 1 [mu]g/100 kcal for infant formula and they
indicated that the reported median selenium content of human milk and
values set for infant reference nutrient intakes formed the basis for
their recommendation. Further detail was not provided on how this
information was used by the IEG in making their recommendation.
4. Recent Published Literature
    One recent report in the published scientific literature also
provides important information on necessary infant selenium intake
levels. Daniels, et al. reported the results of a randomized, double-
blinded dose-response study of healthy term infants fed infant formula
containing selenium at three concentrations (6.0 [mu]g/liter, 13.0
[mu]g/liter, or 21.0 [mu]g/liter) and a breast-fed reference group
(Ref. 5). The concentrations of selenium in the study formulas
correspond to 0.9 [mu]g/100 kcal (low selenium control), 1.9 [mu]g/100
kcal, and 3.1 [mu]g/100 kcal, respectively. The mean concentration of
selenium in breast milk reported in this study was 11.0 [mu]g/liter
(1.6 [mu]g/100 kcal). Infants participating in the study consumed the
assigned infant formula or breast milk as the sole source of nutrition
from birth to 16 weeks of age.
    Consumption of formulas containing both of the higher levels of
selenium (1.9 [mu]g/100 kcal and 3.1 [mu]g/100 kcal) resulted in
changes in plasma and erythrocyte indicators of selenium status at the
end of the study that did not differ statistically from each other or
from the breast-fed control group. However, indicators of selenium
status for all of these groups differed statistically from the plasma
and erythrocyte indicators of selenium status in the infants fed the
control formula containing only 0.9 [mu]g selenium/100 kcal. A dose-
related increase in urinary selenium excretion in the formula-fed
groups was also reported. When infants consumed formulas containing
selenium at levels of 1.9 [mu]g/100 kcal or 3.1 [mu]g/100 kcal, there
were no statistically significant dose-related changes in plasma and
erythrocyte indicators of selenium status. However, there was a
statistically significant increase in urinary selenium excretion in the
infants fed the formula containing 3.1 [mu]g/100 kcal compared to the
infants fed the formula containing 1.9 [mu]g/100 kcal. This latter
finding, in combination with the finding of no dose-related changes in
the circulating indicators of selenium status, suggests that infants
fed the formula containing a level of 1.9 [mu]g selenium/100 kcal
received sufficient selenium to meet their nutritional needs and that
by virtue of the body's homeostatic mechanisms, it would appear that
much of the selenium intake above the level of 1.9 [mu]g selenium/100
kcal was eliminated from the body.

B. Available Evidence for Setting a Maximum Level for Selenium in
Infant Formula

1. LSRO Report
    The LSRO Expert Panel recommended a maximum selenium level for
infant formula of 5.0 [mu]g/100 kcal (33.5 [mu]g/L) (Ref. 3). This
recommendation was based on the upper limit of the range of selenium in
human milk, which was considered to represent a history of use for a
large population in which

selenium toxicity had not been reported. The LSRO report also indicated
that, on a body weight basis, this level is far below the intake
associated with the development of selenosis in adults.
2. IOM Report
    The IOM established an upper limit (UL) for selenium for infants 0
to 6 months of age relying on data on the concentration of selenium in
human milk, which is not associated with known adverse effects. The IOM
calculated an UL of 47.0 [mu]g/day or approximately 7.0 [mu]g/kg body
weight/day for infants 0 to 6 months of age, which approximates 7.0
[mu]g/100 kcal.
3. ESPGHAN Report
    The ESPGHAN IEG recommended a maximum level of 9 [mu]g/100 kcal for
selenium in infant formula. The IEG based their recommendations for
maximum nutrient values on scientific evidence regarding the absence of
adverse effects, when such information was available. When scientific
information was lacking, an established history of apparent safe use
was taken into account. Further detail was not provided on how this
information was used by the IEG in making its recommendation.

IV. Which products are subject to this proposed rule?

    Products that meet the statutory definition of ``infant formula''
in section 201(z) of the FD&C Act (21 U.S.C. 321(z)) (``a food which
purports to be or is represented for special dietary use solely as a
food for infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk'') are
subject to this proposed rule.

V. What does this proposed rule do?

    This proposed rule, if finalized, will add selenium to the list of
required nutrients for infant formulas and establish minimum and
maximum levels of selenium in FDA's nutrient specifications regulations
for infant formulas under Sec.  107.100(a). In addition, the proposed
rule would add selenium to the list of nutrients that must be listed in
the table of nutrition information required on infant formula labeling
by Sec.  107.10(a)(2).

A. Revision to Sec.  107.100(a) Nutrient Specifications

    We are proposing to mandate that selenium be added to infant
formula by requiring that this mineral be listed in the table of
nutrients for infant formulas in Sec.  107.100(a). We are also
proposing to establish minimum and maximum levels for selenium in
infant formula because evidence exists for both deficiency and toxicity
of selenium, and there is no room for error in production of a food
that serves as the sole source of nutrition for infants.
1. Proposed Minimum Level of Selenium in Infant Formulas
    After considering the scientific reports discussed previously in
this document and evidence published by Daniels, et al. after those
reports were completed, we are proposing 2.0 [mu]g selenium/100 kcal as
the minimum level for selenium in infant formulas. This proposed
minimum level is based on the IOM's AI for selenium for infants 0 to 6
months of age (2.1 [mu]g/day) (Ref. 1) and the level suggested by the
data in the study by Daniels, et al. (1.9 [mu]g/100 kcal) (Ref. 5),
rounded to the nearest whole microgram. As noted, the Daniels, et al.
study demonstrated that infants who consumed infant formula containing
1.9 [mu]g selenium/100 kcal had plasma and erythrocyte indicators of
selenium status that were statistically higher than those of infants
consuming formula containing less selenium (0.9 [mu]g/100 kcal) but
these levels did not differ from those of infants consuming infant
formula containing more selenium (3.1 [mu]g/100 kcal). Infants
consuming the formula containing 3.1 [mu]g/100 kcal of selenium also
had significantly higher urinary excretion of selenium. In the absence
of statistically significant changes in plasma and erythrocyte
indicators of selenium status, the substantially higher urinary
excretion of selenium of the infants fed the 3.1 [mu]g selenium formula
compared to that of the infants fed the 1.9 [mu]g selenium formula,
suggests that a selenium intake of 3.1 [mu]g/100 kcal is likely to be
greater than the amount needed to meet an infant's nutritional needs.
Thus, FDA tentatively concludes that 2.0 [mu]g selenium/100 kcal is an
appropriate required minimum for selenium in infant formulas.
    We also propose to correct a typographical error in the table that
appears in Sec.  107.100(a). In the second column of that table, each
abbreviation for ditto (``do'') will now be followed by a period.
2. Proposed Maximum Level of Selenium in Infant Formulas
    FDA is also proposing to set a maximum level for selenium in infant
formula of 7.0 [mu]g/100 kcal. This level is based on the UL for
infants 0 to 6 months of age established by the IOM (Ref. 1), and
defined as highest level of daily nutrient intake that is likely to
pose no risk of adverse health effects in the population of interest.
FDA is relying on the IOM's recommendation because the IOM report was
the most transparent in terms of the basis for its recommended UL.
Also, unlike the minimum level, there is no study that provides direct
evidence to establish a maximum level and thus, in proposing a maximum
level, the agency must rely on a recommendation for an intake level
that is likely to pose no risk of adverse health effects.
3. Comments Specifically Requested
    We find that there is scientific evidence sufficient to support the
minimum proposed level of 2.0 [mu]g selenium/100 kcal and the proposed
maximum level of 7.0 ug selenium/100 kcal, although there is less
evidence directly applicable to the proposed maximum level. While we
are interested in comments regarding the proposed minimum level for
selenium, we are particularly interested in comments regarding the
proposed maximum level of 7.0 [mu]g selenium/100 kcal, including
whether such a maximum level is needed and the scientific data or
information that form the basis of any comments.
    Although, in our judgment, it will be feasible for formula
manufacturers to achieve consistent production of infant formulas with
selenium levels that are at or above the proposed minimum level of 2.0
[mu]g/100 kcal while not exceeding the proposed maximum level of 7.0
[mu]g/100 kcal, we specifically request comments about whether the
proposed minimum and maximum selenium levels provide sufficient
flexibility and can be achieved from a practical manufacturing
standpoint. In addition, because unduly high levels of nutrients should
be avoided in products that serve as the sole source of nutrients for
infants, a population that is particularly vulnerable to nutritional
inadequacies and excesses, we are also particularly interested in
receiving comments about available means to ensure that nutrient levels
in infant formulas, including selenium, are not excessive.

B. Revision to Sec.  107.10(a)(2) Nutrient Information

    We are proposing to add selenium to the statement of the amounts of
nutrients required for infant formula labeling in Sec.  107.10(a)(2).
This additional mineral would be required to be listed between iodine
and sodium, as directed by Sec.  107.10(b)(5).

VI. What is the legal authority for this proposed rule?

    Section 412(i) of the FD&C Act contains a table of nutrients
(including

minimum and, in some cases, maximum levels for such nutrients) that are
required to be in an infant formula. Section 412(i)(2) of the FD&C Act
authorizes the Secretary to revise the statutory table of nutrients and
to revise the level of any required nutrient. The Secretary has
delegated this authority to the Commissioner. In the Federal Register
of October 31, 1985, FDA published a final rule revising the statutory
table of nutrients, which was published as Sec.  107.100. This proposed
rule, if finalized, would amend Sec.  107.100. Accordingly, the legal
authority for the proposed revision to Sec.  107.100, which revises the
statutory list of nutrients required for infant formula, is section
412(i)(2) of the FD&C Act.
    Additionally, this proposed rule, if finalized, would require the
addition of selenium to the statement of the amounts of nutrients
required for infant formula labeling in Sec.  107.10(a)(2). As noted
previously in this document, ``infant formula'' is defined as a food
for ``special dietary use'' under section 201(z) of the FD&C Act. Under
sections 403(j) and 701(e) of the FD&C Act (21 U.S.C. 343(j) and 21
U.S.C. 371(e)), the Secretary, and by delegation the Commissioner, may
prescribe regulations concerning the vitamin and mineral content of
foods for special dietary uses, in order to fully inform purchasers as
to the value of the food for such uses. As such, FDA has the authority
to revise the statement of the amounts of nutrients required for infant
formula labeling in Sec.  107.10(a)(2) under sections 201(z), 403(j),
412(i), and 701(e) of the FD&C Act. When the Agency issues a final rule
for the provisions in proposed Sec.  107.10(a)(2), it will provide an
opportunity for filing objections and requests for a formal evidentiary
public hearing under 21 CFR part 12.

VII. What is the environmental impact of this proposed rule?

    FDA has determined under 21 CFR 25.32(n) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, the Agency concludes that the proposed rule does not
contain policies that have federalism implications as defined in the
Executive order and, consequently, a federalism summary impact
statement is not required.

IX. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because only one firm is affected by this rule, and
it is considered large by Small Business Administration standards, the
Agency proposes to certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal Mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

X. Regulatory Impact Analysis

A. Need for This Regulation

    FDA is proposing to amend its infant formula nutrient requirement
regulations. If the proposed rule is finalized, infant formulas will be
required to contain selenium at a level not less than 2.0 [mu]g and not
more than 7.0 [mu]g for each 100 kilocalories of the infant formula in
the form prepared for consumption as directed on the container. This
regulation is needed because selenium is now recognized as an essential
nutrient for humans.
    Additionally, if finalized, this proposed rule will require that
infant formula manufacturers add selenium to the list of nutrients on
infant formula labels, and to list the amount of selenium per 100
kilocalories in the formula.
    Selenium is a trace mineral that is essential to good health but
required only in small amounts. Selenium is incorporated into proteins
to make selenoproteins, which are important antioxidant enzymes, the
natural by-products of oxygen metabolism that may contribute to the
development of chronic diseases such as cancer and heart disease. In
most countries throughout the world, plant foods are major dietary
sources of selenium. However, selenium is also found in some meats,
seafood, and nuts. In the United States, food distribution patterns
across the country help prevent people in geographic areas with low-
selenium levels in the soil from having low dietary selenium intakes.
Food is not generally fortified with selenium in the United States, but
an exception to this is infant formula.

B. Regulatory Options

    In formulating the analysis of this proposed rule, three options
were analyzed: (1) No new regulatory action (baseline); (2) require the
provisions of this proposed rule and make the provisions of the rule
effective 180 days after publication; and (3) require the provisions of
this proposed rule, but make the provisions of the rule effective 12
months after publication.
    Option 1: No New Regulatory Action (Baseline)
    The first option is no new regulatory action. We include it here
because OMB cost-benefit analysis guidelines recommend discussing
statutory requirements that affect the selection of regulatory
approaches. These guidelines also recommend analyzing the opportunity
cost of legal constraints that prevent the selection of the regulatory
action that best satisfies the philosophy and principles of Executive
Order 12866. There are zero costs and benefits associated with this
option, and it serves as the baseline against which other options will
be measured for assessing costs and benefits.

    Option 2: Finalize the proposed rule and make the provisions
effective 180 days after publication.

XI. Costs

    One cost of this proposal, if finalized, will be reformulation
costs resulting from firms adding selenium to infant formulas in order
to comply with this rule. Currently, there are five firms that produce
infant formula in the United States. Of these firms, only one will need
to add slightly more selenium to its infant formulas. Based on
information provided by the infant formula industry, it appears that
all other infant formula manufacturers already added selenium to their
infant formula products at a level within the range identified by the
proposed rule. Therefore, any reformulation cost of this proposal will
come from a single firm adding slightly more selenium to its infant
formula products that currently do not meet the proposed minimum level
of 2.0 [mu]g/100 kcal.
    Table 1 of this document outlines low, medium, and high cost
estimates based on a change in the formulation of infant formula. Costs
are estimated using a reformulation model, developed under contract
with Research Triangle Institute (RTI). This model provides estimates
of the costs of reformulation of the range of food, dietary supplement,
and cosmetic products under FDA's jurisdiction, including infant
formulas, and has been adjusted to reflect 2012 dollars. In this model,
the cost of the reformulation depends on the affected ingredient and
the likely response of manufacturers. The cost per infant formula
associated with reformulation is estimated to be a function of product
research, product development, coordinating activities, startup and
verification, and nutrient testing of finished product. To the extent
that any of these activities is not necessary for adding selenium to an
infant formula that already has selenium added, costs will be
overestimated. Table 1 of this document presents total estimated low,
medium, and high costs of reformulation for this proposed rule. The
totals are based on the reformulation of 46 separate infant formulas
manufactured by one firm, the current formulation of which would not
meet the requirements of this rule, if finalized. Therefore, the total
industry costs are each of the low, medium, and high costs multiplied
by 46.

           Table 1--Estimation of First-Year Costs of Infant Formula Reformulation, per Infant Formula
----------------------------------------------------------------------------------------------------------------
                            Variable                                    Low           Medium           High
----------------------------------------------------------------------------------------------------------------
Product Research................................................          $1,685         $16,853         $33,706
Product Development.............................................           4,598          13,023          28,259
Coordinating Activities.........................................           2,938           8,818          14,690
Startup and Verification........................................           1,442           7,207          15,890
Nutrient Testing of the Finished Product........................              15              15              15
                                                                 -----------------------------------------------
    Total Per Formula...........................................          10,678          45,916          92,560
    Total Industry Cost of Reformulation (Cost x 46 infant               497,188       2,112,136       4,257,760
     formulas)..................................................
----------------------------------------------------------------------------------------------------------------

    Another component of the costs of this option is cost related to
the relabeling of reformulated infant formula. The proposed rule
requires infant formula manufacturers to include selenium in the
nutrient content statement on containers of infant formula. All
manufacturers currently disclose selenium in the nutrient list as
specified under Sec.  107.10(b)(5). However, as noted previously in
this document, one manufacturer would be required to add more selenium
to its formulas under this proposal. Therefore, it is estimated that
the same firm that would be required to add more selenium to its
formulas under this proposal will also incur relabeling costs to comply
with this proposed rule.
    Table 2 of this document outlines low, medium, and high cost
estimates of relabeling based on a minor change to the infant formula
label and an effective date of 180 days after publication. Costs are
estimated using a relabeling model developed under contract by RTI.
This model estimates the costs of relabeling food, dietary supplements,
and cosmetic products under FDA's jurisdiction and these estimates have
been adjusted to reflect 2012 dollars. In this model, relabeling costs
depend on the type of change (major, minor, or extensive) and the
effective date of the rule. This model estimates that longer periods of
time before a rule becomes effective are associated with lower
relabeling costs because any change is more likely to be able to be
coordinated with a change in a label that may already be scheduled, and
will diminish the need to, for example, purchase and apply stickers to
packages affected by the change. The Agency acknowledges the
uncertainty in this estimation and how it may specifically apply to the
infant formula industry and requests comment regarding the extent to
which the effective date is likely to affect the cost of compliance
with this proposed rule.

             Table 2--Estimated First Year Relabeling Costs
------------------------------------------------------------------------
                     Low                         Medium         High
------------------------------------------------------------------------
$3,565,880..................................   $8,735,802   $23,619,959
------------------------------------------------------------------------

    The final component of cost is related to one firm assembling
information for submission to the Agency related to the reformulated
infant formulas, as required under section 412(d)(3) of the FD&C Act.
The addition of more selenium constitutes a change in the formulation
of these formulas that the Agency considers may affect whether the
formulas are adulterated; therefore, we are including the submission of
information about the change in the formulas before the first
processing of such formulas as a cost.
    It is estimated that a scientist from one firm will spend 10 hours
assembling the information to be submitted, which will address the 46
reformulated infant formulas. This is estimated as a one-time cost. It
is estimated that this scientist is paid a wage of $52.88; that is,
$35.25 plus 50 percent overhead. Therefore, 10 hours x $52.88 =
$528.80.

                                   Table 3--Summary of Total Cost of Option 1
----------------------------------------------------------------------------------------------------------------
                                             Low                         Medium                     High
----------------------------------------------------------------------------------------------------------------
Reformulation Cost............  $491,188....................  $2,112,136.................  $4,257,760.
First Year Relabeling Costs...  $3,467,560..................  $8,735,802.................  $23,619,959.
First Year Submission Costs...  $529........................  $529.......................  $529.
                               ---------------------------------------------------------------------------------
    Total Cost of Option 1....  $3.95 million...............  $10.85 million.............  $27.88 million.
----------------------------------------------------------------------------------------------------------------

As seen in table 3 of this document, the total cost of this option
ranges from $3.95 million to $27.88 million, with the majority of cost
coming from relabeling.

XII. Benefits

    The potential benefits from this proposed rule, if finalized, are
any cases of selenium deficiency that are avoided as a result of infant
formulas meeting the 2.0 [mu]g/100 kcal requirement. However, selenium
deficiency is extremely rare, occurring primarily in areas of the world
where the levels of selenium in the environment are low, such as China
(Ref. 1). Therefore, it is not possible to quantify benefits accrued as
a result of this rule and benefits will be discussed qualitatively.
    The consequences of selenium deficiency may be of greatest concern
in infants and children, who have relatively greater requirements for
selenium than adults due to their rapid growth (Ref. 1). According to
Daniels, et al. (2008), suboptimal selenium status is associated with a
range of negative health outcomes including thyroid and immune
dysfunction, viral infection, cardiovascular disease, inflammatory
conditions, infertility, and an increased risk of some cancers (Ref.
5). Overt selenium deficiency is manifested as Keshan disease, an
endemic fatal cardiomyopathy. Because infant formula may be an infant's
only source of nutrition, the potential for developing a deficiency is
averted if selenium is added to the formula.

XIII. Summary of Costs and Benefits of This Proposed Rule

    The total costs of this proposed rule, if finalized, consist of one
time reformulation costs, one time submission costs and one time
relabeling costs. The total cost ranges between about $4 million and
$28 million. Because the costs of this proposed rule are one time only
costs, no annual costs are estimated for this proposal. Furthermore,
because selenium deficiency is so rare, it is not possible to quantify
benefits from any final rule resulting from this proposal.
    Option 3: Finalize the proposed rule and make the provisions
effective 12 months after publication.
    In this option, firms are required to meet the requirements of the
proposed rule for infant formula, that is, have formulas contain
selenium at 2.0 [mu]g and not more than 7.0 [mu]g for each 100
kilocalories of the infant formula, and have manufacturers add selenium
to the list of nutrients on infant formula labels. However, under
Option 3, industry would have at least 12 months before they were
required to comply with the rule.

XIV. Costs of Option 3

    For this option, the primary costs of this proposed rule will be
reformulation costs resulting from the firm that needs to add slightly
more selenium to certain infant formulas in order to comply with any
final rule resulting from this proposal, along with relabeling and
submission costs. These costs are presented in 2012 dollars. In
contrast to Option 2, relabeling costs for this option are less,
because of the estimation of the cost model that, over a longer period
of time, any labeling change is more likely to be able to be
coordinated with a change in a label that may already be scheduled, and
will diminish the need to, for example, purchase and apply stickers to
packages affected by the change. As in Option 2, the Agency
acknowledges the uncertainty in this estimation and how it may
specifically apply to the infant formula industry and requests comment
regarding the extent to which the effective date is likely to affect
the cost of compliance with this proposed rule.

                                      Table 4--Summary of Costs of Option 3
----------------------------------------------------------------------------------------------------------------
                                                                        Low           Medium           High
----------------------------------------------------------------------------------------------------------------
Reformulation Cost..............................................        $491,188      $2,112,136      $4,257,760
One Time Submission Cost........................................             529             529             529
Relabeling Costs................................................         438,747         765,439       1,271,285
                                                                 -----------------------------------------------
    Total Cost of Option 3......................................         930,464       2,878,104       5,529,574
----------------------------------------------------------------------------------------------------------------

Therefore, the costs from this rule, as shown in table 4, range from
about $930,464 to about $5.5 million.

XV. Benefits of Option 3

    Benefits from this option are identical to Option 2, however, under
this option, benefits are delayed by 6 months. The potential benefits
from this proposed option are any cases of selenium deficiency avoided
as a result of infant formulas meeting the 2.0 ug/100kcal requirement.
As stated earlier, selenium deficiency is extremely rare, occurring
primarily in areas of the world where the levels of selenium in the
environment are low (Ref. 1).

XVI. Preliminary Regulatory Flexibility Analysis

    FDA has examined the economic implications of this proposed 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. FDA finds that, under the Regulatory Flexibility Act (5
U.S.C. 605(b)), this proposal, if finalized, will not have a
significant impact on a substantial number of small entities, as only
one firm is affected by this rule and it is considered large by Small
Business Administration standards.

XVII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given in this section of the
document with an estimate of the annual third-party disclosure burden.
Included in the burden estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
    FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Third-Party Disclosure Requirements for Selenium in Infant
Formula
    Description of Respondents: The respondents to this information
collection are manufacturers of infant formula marketed in the United
States.
    Description: The proposed rule, if finalized, would revise Sec.
107.10(a) to require that selenium be listed in the nutrient list on
the label for all infant formulas. In particular, in the nutrient list,
selenium would be required to be listed between iodine and sodium and
the amount per 100 calories declared; and, because selenium would be a
required ingredient in infant formula, selenium would also be required
to be declared in the formula's ingredient statement by its common or
usual name and positioned according to the descending order of its
predominance in the formula, under Sec.  101.4. The present version of
Sec.  107.10(a) is approved by OMB in accordance with the PRA and has
been assigned OMB control number 0910-0256. This proposed rule, if
finalized, would modify the information collection associated with the
present version of Sec.  107.10(a) by adding 23 hours to the burden
associated with the collection. A manufacturer not in compliance with
the new minimum and maximum levels for selenium in infant formula would
be required to make a one-time change to the nutrient list information
disclosed to consumers on the label of its infant formula, to account
for the required change in the amount of selenium in its products. The
nutrient information disclosed by manufacturers on the infant formula
label is necessary to inform purchasers of the value of the infant
formula. As discussed previously in this document, FDA has the
authority to revise the statement of the amounts of nutrients required
for infant formula labeling in Sec.  107.10(a)(2).
    FDA estimates the burden of this collection of information as
follows:

                                               Table 5--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of
            21 CFR section                Number of     disclosures per    Total annual        Average burden per         Total hours     Total capital
                                         respondents       respondent      disclosures             disclosure                                  cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   107.10 Nutrient labeling for                 1               46               46   0.5 (30 minutes)............              23         $765,439
 infant formula.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    FDA tentatively concludes that the additional burden to disclose
selenium in the ingredient statement resulting from the proposed
amendment of Sec.  107.10 would be negligible because all U.S. infant
formula manufacturers currently add selenium as an ingredient to their
infant formula products, and all manufacturers currently disclose the
selenium in the ingredient statement, as specified by Sec.  101.4.
Additionally, all manufacturers currently disclose selenium in the
nutrient list, as required by Sec.  107.10(b)(5). Only one manufacturer
produces infant formula that would not meet the requirements of this
rule, if finalized, and would thus need to be reformulated. Under
proposed Sec.  107.10(a)(2), this one manufacturer would need to make a
one-time labeling change to modify its nutrient list to account for the
addition of more selenium to its infant formula.
    The third-party disclosure burden consists of the setup time
required to design a revised label and incorporate it into the
manufacturing process. Based upon its knowledge of food and dietary
supplement labeling, FDA estimates that the affected manufacturer would
require less than 0.5 hour per product to modify the label's nutrient
list to reflect the addition of more selenium to the product. The
Regulatory Impact Analysis estimates that this manufacturer produces 46
separate infant formulas that would need to be reformulated, and thus
require relabeling. The one-time third-party disclosure burden for the
proposed rule is estimated in table 5 of this document.
    The final column of table 5 gives the estimated capital cost
associated with relabeling. This is the cost of designing a revised
label and incorporating it into the manufacturing process. The cost
stated in table 5, $765,439, is based on the estimate in the Regulatory
Impact Analysis under Option 3, which assumes that the proposed rule is
finalized with an effective date of 1 year after publication. These
costs are based on the estimation of the cost model that, over a longer
period of time, any labeling change is more likely to be able to be
coordinated with a change in a label that may already be scheduled, and
will diminish the need to, for example, purchase and apply stickers to
packages affected by the change. Additionally, because of the change in
formulation of its products that would be required if the rule is
finalized as proposed, a manufacturer would need to determine whether
they are required to make a one-time submission to FDA before the first
processing of its formulas, as required by section 412(d)(3) of the
FD&C Act. This reporting requirement is approved by OMB under OMB
control number 0910-0256. The current hour burden approved by OMB for
section 412(d) of the FD&C Act is 10 hours per report. Based on the
Agency's experience with infant formula submissions, FDA estimates that
the affected manufacturer will submit one report that will cover all 46
reformulated infant formulas. In a future request for extension of the
0910-0256 information collection, FDA will include the additional
report in its estimates.

    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title ``Third-Party Disclosure Requirements for
Selenium in Infant Formula.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this proposed rule to OMB for review. Interested persons
are requested to send comments regarding information collection by May
16, 2013, to the Office of Information and Regulatory Affairs, OMB.

XVIII. How do you submit comments on this rule?

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIX. References

    The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.

1. Food and Nutrition Board. Institute of Medicine. Dietary
Reference Intakes for Vitamin C, Vitamin E, Selenium, and
Carotenoids. Washington, DC: National Academy Press, p. 21-33; 292-
299; 315-316, 2000.
2. Food and Nutrition Board. National Research Council. Recommended
Dietary Allowances. 10th Edition. Washington, DC: National Academy
Press, p. 221, 1989.
3. Raiten, D. J., J. M. Talbot, and J. H. Waters, ``Assessment of
Nutrient Requirements for Infant Formulas,'' Journal of Nutrition,
128: 2059S-2249S, 1998.
4. Koletzko, B., S. Baker, G. Cleghorn, U. F. Neto, et al., ``Global
Standard for the Composition of Infant Formula. Recommendations of
an ESPGHAN Coordinated International Expert Group,'' Journal of
Pediatric Gastroenterology and Nutrition, 41:584-599, 2005.
5. Daniels, L., R.A. Gibson, K. Simmer, P. Van Dael, M. Makrides,
``Selenium Status of Term Infants Fed Selenium-Supplemented Formula
in a Randomized Dose-Response Trial,'' American Journal of Clinical
Nutrition, 88:70-76, 2008.
6. Centers for Disease Control and Prevention (CDC). National Center
for Health Statistics (NCHS). National Health and Nutrition
Examination Survey Data. Hyattsville, MD: U.S. Department of Health
and Human Services, Centers for Disease Control and Prevention,
2013.
7. Codex Alimentarius Commission, ``Standards for Infant Formulas
for Special Medical Purposes Intended for Infants, 72-1981,'' 1981.

List of Subjects in 21 CFR Part 107

    Exempt infant formulas, Food labeling, General provisions, Infant
formula, Infant formula recalls, Infants and children, Labeling,
Nutrition, Nutrient requirements, Reporting and recordkeeping
requirements, Signs and symbols.

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

PART 107--INFANT FORMULA

    The authority citation for 21 CFR part 107 continues to read as
follows:

    Authority: 21 U.S.C. 321, 343, 350a, 371.

0
1. In Sec.  107.10, revise paragraph (a)(2) to read as follows:

Sec.  107.10  Nutrient Information.

    (a) * * *
    (2) A statement of the amount of each of the following nutrients
supplied by 100 kilocalories:

------------------------------------------------------------------------
               Nutrients                      Unit of  measurement
------------------------------------------------------------------------
Protein...............................  Grams.
Fat...................................  Do.
Carbohydrate..........................  Do.
Water.................................  Do.
Linoleic acid.........................  Milligrams.
Vitamins:
  Vitamin A...........................  International Units.
  Vitamin D...........................  Do.
  Vitamin E...........................  Do.
  Vitamin K...........................  Micrograms.
  Thiamine (Vitamin B1)...............  Do.
  Riboflavin (Vitamin B2).............  Do.
  Vitamin B6..........................  Do.
  Vitamin B12.........................  Do.
  Niacin..............................  Do.
  Folic acid (Folacin)................  Do.
  Pantothenic acid....................  Do.
  Biotin..............................  Do.
  Vitamin C (Ascorbic acid)...........  Milligrams.
  Choline.............................  Do.
  Inositol............................  Do.
Minerals:
  Calcium.............................  Milligrams.
  Phosphorus..........................  Do.
  Magnesium...........................  Do.
  Iron................................  Do.
  Zinc................................  Do
  Manganese...........................  Micrograms.
  Copper..............................  Do.
  Iodine..............................  Do.
  Selenium............................  Do.
  Sodium..............................  Milligrams.
  Potassium...........................  Do.
  Chloride............................  Do.
------------------------------------------------------------------------

* * * * *
0
2. In Sec.  107.100, revise paragraph (a) to read as follows:

Sec.  107.100  Nutrient specifications.

    (a) An infant formula shall contain the following nutrients at a
level not less than the minimum specified and not more than the maximum
level specified for each 100 kilocalories of the infant formula in the
form prepared for consumption as directed on the container:

----------------------------------------------------------------------------------------------------------------
                  Nutrients                           Unit of measurement         Minimum level   Maximum level
----------------------------------------------------------------------------------------------------------------
Protein......................................  Grams...........................            1.8               4.5
Fat..........................................  do..............................            3.3               6.0
                                               Percent calories................           30                54
Linoleic acid................................  Milligrams......................          300     ...............
                                               Percent calories................            2.7   ...............
----------------------------------------------------------------------------------------------------------------
                                                    Vitamins
----------------------------------------------------------------------------------------------------------------
Vitamin A....................................  International Units.............          250               750
Vitamin D....................................  do..............................           40               100
Vitamin E....................................  do..............................            0.7   ...............

Vitamin K....................................  Micrograms......................            4     ...............
Thiamine (Vitamin B1)........................  do..............................           40     ...............
Riboflavin (Vitamin B2)......................  do..............................           60     ...............
Vitamin B6...................................  do..............................           35     ...............
Vitamin B12..................................  do..............................            0.15  ...............
Niacin \1\...................................  do..............................          250     ...............
Folic Acid (folacin).........................  do..............................            4     ...............
Pantothenic acid.............................  do..............................          300     ...............
Biotin \2\...................................  do..............................            1.5   ...............
Vitamin C (ascorbic acid)....................  Milligrams......................            8     ...............
Choline \2\..................................  do..............................            7     ...............
Inositol \2\.................................  do..............................            4     ...............
----------------------------------------------------------------------------------------------------------------
                                                    Minerals
----------------------------------------------------------------------------------------------------------------
Calcium......................................  do..............................           60     ...............
Phosphorus...................................  do..............................           30     ...............
Magnesium....................................  do..............................            6     ...............
Iron.........................................  do..............................            0.15              3.0
Zinc.........................................  do..............................            0.5   ...............
Manganese....................................  Micrograms......................            5     ...............
Copper.......................................  do..............................           60     ...............
Iodine.......................................  do..............................            5                75
Selenium.....................................  do..............................            2                 7
Sodium.......................................  Milligrams......................           20                60
Potassium....................................  do..............................           80               200
Chloride.....................................  do..............................           55               150
----------------------------------------------------------------------------------------------------------------
 \1\ The generic term ``niacin'' includes niacin (nicotinic acid) and niacinamide (nicotinamide).
 \2\ Required only for non-milk-based infant formulas.

* * * * *

    Dated: April 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08855 Filed 4-15-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 15, 2005 (Volume 70, Number 240)]
[Notices]
[Page 74314-74315]
[DOCID:fr15de05-63]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8008-9]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement and consent order; request for
public comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``Act''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed settlement, which would be entered as a consent order, to
address a lawsuit filed by South Jersey Environmental Justice Alliance
(``SJEJA''), New Jersey Public Interest Research Group, South Camden
Citizens in Action, and New Jersey Environmental Federation
(collectively the ``plaintiffs''): SJEJA v. Johnson, 05-6891 (RJH)
(S.D.N.Y.). On or about August 2, 2005, the plaintiffs filed a
complaint alleging that they had submitted a petition to EPA seeking an
objection to a Clean Air Act Title V permit issued by the New Jersey
Department of Environmental Protection to Camden County Energy Recovery
Associates for its facility in Camden, New Jersey, and that the
Administrator had failed to perform his nondiscretionary duty to
respond to the petition within sixty days of the date it was filed.
Under the terms of the proposed settlement and consent order, EPA has
agreed to respond to the petition by January 20, 2006, and the
plaintiffs have agreed to dismiss their suit with prejudice shortly
thereafter. In addition, EPA has agreed to pay the plaintiffs a
specified amount in settlement of the plaintiffs' claims for attorneys'
fees in this matter.

DATES: Written comments on the proposed settlement and consent order
must be received by January 17, 2006.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2005-0472, online at http://www.regulations.gov (EPA's preferred method); by e-mail to<EMAIL_ADDRESS>mailed to EPA Docket Center,

Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Wordperfect or ASCII file, avoiding the use of special
characters and any form of encryption, and may be mailed to the mailing
address above.

FOR FURTHER INFORMATION CONTACT: Amy Huang Branning, Air and Radiation
Law Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement and Consent
Order

    This proposed settlement and consent order would resolve a lawsuit
seeking a response to a petition to object to a Title V permit issued
by the New Jersey Department of Environmental Protection to Camden
County Energy Recovery Associates for its facility in Camden, New
Jersey (permit II-2005-01). Under the proposed settlement, if neither
EPA nor the Department of Justice withdraws its consent to the proposed
settlement following the thirty (30)-day comment period provided in
this Notice, the plaintiffs and EPA have agreed to jointly ask that the
Court enter this settlement as a consent order. The consent order, if
entered, would require that the Administrator issue a response to the
petition by January 20, 2006 and that the plaintiffs dismiss their
lawsuit ten (10) days after the Administrator provides notice of its
Order in the Federal Register. The consent order would also require
that EPA pay the plaintiffs a specified amount in settlement of their
claims for attorneys' fees. The proposed settlement and consent order
do not require the Administrator to respond to the petition in any
particular way.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will receive written comments relating to
the proposed settlement and consent order from persons who were not
named as parties or intervenors to the litigation in question. EPA or
the Department of Justice may withdraw or withhold consent to the
proposed settlement and consent order if the comments disclose facts or
considerations that indicate that such consent is inappropriate,
improper, inadequate, or inconsistent

with the requirements of the Act. Unless EPA or the Department of
Justice determine, based on any comment which may be submitted, that
consent to this proposed settlement and consent order should be
withdrawn, the terms of the proposed consent order will be affirmed.

II. Additional Information About Commenting on the Proposed Settlement
and Consent Order

A. How Can I Get a Copy of the Proposed Settlement?

    Direct your comments to the official public docket for this action
under Docket ID No. EPA-HQ-OGC-2005-0472 which contains a copy of the
proposed settlement. The official public docket is available for public
viewing at the Office of Environmental Information (OEI) Docket in the
EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
http://www.regulations.gov You may use the http://www.regulations.gov.
to submit or view public comments, access the index listing of the
contents of the official public docket, and to access those documents
in the public docket that are available electronically. Once in the
system, select ``search,'' then key in the appropriate docket
identification number.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,

unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and To Whom Do I Submit Comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the http://www.regulations.gov Web site to submit comments

to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://www.regulations.gov
, your e-mail address is automatically captured and

included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: December 8, 2005.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. 05-24077 Filed 12-14-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Proposed Rules]
[Pages 47909-47911]
[FR Doc No: 2019-19543]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0598; Airspace Docket No. 19-ASO-16]
RIN 2120-AA66

Proposed Amendment of the Class D and Class E Airspace; Meridian,
MS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class D airspace at Joe
Williams NOLF, Meridian, MS; Key Field, Meridian, MS; and NAS Meridian/
McCain Field, Meridian, MS; the Class E airspace area designated as an
extension to Class D airspace at Key Field; and the Class E airspace
extending upward from 700 feet above the surface at Key Field, Joe
Williams NOLF, and NAS Meridian/McCain Field. The FAA is proposing this
action as the result of the decommissioning of the Kewanee VHF
omnidirectional range (VOR) navigation aid, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR Minimum Operational Network (MON) Program. The names and
geographic coordinates of NAS Meridian/McCain Field and Joe Williams
NOLF, and the geographic coordinates of Key Field would also be updated
to coincide with the FAA's aeronautical database. Airspace redesign is
necessary for the safety and management of instrument flight rules
(IFR) operations at these airports.

DATES: Comments must be received on or before October 28, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0598; Airspace Docket No. 19-ASO-16, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11C, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for this Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class D airspace at Joe Williams NOLF, Meridian,
MS; Key Field, Meridian, MS; and NAS Meridian/McCain Field, Meridian,
MS; the Class E airspace area designated as an extension to Class D
airspace at Key Field; and the Class E airspace extending upward from
700 feet above the surface at Key Field, Joe Williams NOLF, and NAS
Meridian/McCain Field to support IFR operations at these airports.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-0598/
Airspace Docket No. 19-ASO-16.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11C, Airspace
Designations and Reporting Points, dated August 13, 2018, and effective
September 15, 2018. FAA Order 7400.11C is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11C lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by:
    Amending the Class D airspace at Joe Williams NOLF, Meridian, MS,
by updating the geographic coordinates of Joe Williams NOLF to coincide
with the FAA's aeronautical database, and would replace the outdated
term ``Airport/Facility Directory'' with ``Chart Supplement'';
    Amending the Class D airspace to within a 4.5-mile radius (reduced
from a 5.3-mile radius) of Key Field, Meridian, MS; updating the city
in the airspace legal description to Meridian, MS, (previously Meridian
Key Field, MS) to comply with changes to FAA Order 7400.2M, Procedures
for Handling Airspace Matters; removing the city listed with the
airport in the airspace legal description to comply with changes to FAA
Order 7400.2M; updating the geographic coordinates of Key Field to
coincide with the FAA's aeronautical database; and would replace the
outdated term ``Airport/Facility Directory'' with ``Chart Supplement'';
    Amending the Class D airspace to within a 5.3-mile radius
(previously a 5.8-mile radius) of NAS Meridian/McCain Field, Meridian,
MS; updating the city in the airspace legal description to Meridian,
MS, (previously Meridian NAS-McCain Field, MS) to comply with changes
to FAA Order 7400.2M; removing the city listed with the airport in the
airspace legal description to comply with changes to FAA Order 7400.2M;
updating the name and geographic coordinates of NAS Meridian/McCain
Field (previously NAS-McCain Field) to coincide with the FAA's
aeronautical database; adding an extension 1 mile each side of the
009[deg] bearing from the airport extending from the 5.3-mile radius to
5.5 miles north of the airport; adding an extension 1.5 miles each side
of the 189[deg] bearing from the airport extending from the 5.3-mile
radius to 6 miles from the airport; adding an extension 1.6 miles each
side of the Meridian TACAN 331[deg] radial extending from the 5.3-mile
radius to 5.6 miles northwest of the Meridian TACAN; and would replace
the outdated term ``Airport/Facility Directory'' with ``Chart
Supplement'';
    Amending the Class E airspace area designated as an extension to a
Class D airspace at Key Field by updating the city in the airspace
legal description to Meridian, MS, (previously Meridian/Key Field, MS)
to comply with changes to FAA Order 7400.2M; removing the city listed
with the airport in the airspace legal description to comply with
changes to FAA Order 7400.2M; updating the geographic coordinates of
Key Field and the Meridian VORTAC to coincide with the FAA's
aeronautical database; adding an extension 1 mile each side of the
009[deg] bearing from the airport extending from the 4.5-mile radius to
4.9-miles north of the airport; adding an extension 1 mile each side of
the 044[deg] bearing from the airport extending from the 4.5-mile
radius to 4.6 miles northeast of the airport; adding an extension 2.9
miles each side of the Meridian VORTAC 141[deg] radial extending from
the 4.5-mile radius to 11 miles southeast of the Meridian VORTAC;
adding an extension 1 mile each side of the 189[deg] bearing from the
airport extending from the 4.5-mile radius to 4.6 miles south of the
airport; adding an extension 1 mile each side of the 224[deg] bearing
from the airport extending from the 4.5-mile radius to 4.6 miles
southwest of the airport; removing the extension northwest of the
VORTAC; and would replace the outdated term ``Airport/Facility
Directory'' with ``Chart Supplement'';
    And amending the Class E airspace extending upward from 700 feet
above the surface to within a 7-mile radius (reduced from an 8-mile
radius) of Key Field; adding an extension 1 mile each side of the
009[deg] bearing from Key Field extending from the 7-mile radius to
12.5 miles north of the airport; adding an extension 3.4 miles each
side of the 009[deg] bearing from the Key Field: RWY 19-LOC extending
from the 7-mile radius of the airport to 11.1 miles north of the Key
Field: RWY 19-LOC; adding an extension within 2 miles each side of the
044[deg] bearing from the airport extending from the 7-mile radius of
the airport to 11.6 miles northeast of the airport; adding an extension
within 3.6 miles each side of the Meridian VORTAC 141[deg] radial
extending from the 7-mile radius of the airport to 13.9 miles southeast
of the Meridian VORTAC; adding an extension within 1 mile each side of
the 189[deg] bearing from the airport extending from the 7-mile radius
of the airport to 12.6 miles south of the airport; adding an extension
within 3.4 miles each side of the 189[deg] bearing from the Key Field:
RWY 01-LOC extending from the 7-mile radius of the airport to 11.2
miles south of the Key Field: RWY 01-LOC; amending the extension
northwest of the Meridian VORTAC to within 1.5 miles (reduced from 2.5
miles) each side of the Meridian VORTAC 311[deg] (previously 315[deg])
radial extending from the 7-mile radius of the airport to 14.3 miles
(increased from 7 miles) northwest of the Meridian VORTAC; within a 6.7
mile radius (decreased from a 7.4-mile radius) of Joe Williams NOLF,
Meridian, MS; within a 7.8-mile radius (decreased from an 8-mile
radius) of NAS Meridian/McCain Field; removing the extension ``. . .
within 4 miles each side of the 020[deg] bearing from lat.
32[deg]33'28'' N, long, 88[deg]33'33'' W, extending from the 8-mile
radius to 20 miles north of Meridian TACAN, and within a 25-mile radius
of the Meridian VORTAC, extending clockwise from the 341[deg] radial to
the 040[deg] radial, and within 8 miles north and 6 miles south of the
Kewanee VORTAC 273[deg] radial, extending from the VORTAC to long.
88[deg]45'00'' W''; adding an extension 6.7 miles either side of a line
from Joe William NOLF to NAS Meridian/McCain Field; updating the names
of Joe William NOLF (previously Joe Williams OLF), and NAS Meridian/
McCain Field (previously NAS-McCain Field) and the geographic
coordinates of Key Field, Joe Williams NOLF and NAS Meridian/McCain
Field to coincide with the FAA's aeronautical database; and removing
the Meridian TACAN and Kewanee VORTAC from the airspace legal
description.
    This action is the result of an airspace review caused by the
decommissioning of the Kewanee VOR, which provided navigation
information for the instrument procedures at these airports, as part of
the VOR MON Program.
    Class D and E airspace designations are published in paragraph
5000, 6004, and 6005, respectively, of FAA Order 7400.11C, dated August
13, 2018, and effective September 15, 2018, which is incorporated by
reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a

substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
 2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.11C, Airspace Designations and Reporting Points, dated August 13,
2018, and effective September 15, 2018, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO MS D Meridian, MS [Amended]

    Joe Williams NOLF, MS (Lat. 32[deg]47'56'' N, long.
88[deg]50'04'' W)
    That airspace extending upward from the surface to and including
3,000 feet MSL within a 4.2-mile radius of Joe Williams NOLF. This
Class D airspace area is effective during the specific dates and
times established by a Notice to Airmen. The effective date and time
will thereafter be continuously published in the Chart Supplement.

ASO MS D Meridian, MS [Amended]

    Key Field, MS (Lat. 32[deg]19'57'' N, long. 88[deg]45'07'' W)
    That airspace extending upward from the surface to and including
2,800 feet MSL within a 4.5-mile radius of Key Field. This Class D
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Char
Supplement.

ASO MS D Meridian, MS [Amended]

    NAS Meridian/McCain Field, MS (Lat. 32[deg]33'13'' N, long.
88[deg]33'19'' W)
    Meridian TACAN (Lat. 32[deg]34'42'' N, long. 88[deg]32'43'' W)
    That airspace extending upward from the surface to and including
2,800 feet MSL within a
    5.3-mile radius of NAS Meridian/McCain Field, and within 1 mile
each side of the 009[deg] bearing from the airport extending from
the 5.3 mile radius to 5.5 miles north of the airport; and within
1.5 miles each side of the 189[deg] bearing from the airport
extending from the 5.3-mile radius to 6 miles south of the airport;
and within 1.6 miles each side of the Meridian TACAN 331[deg] radial
extending from the 5.3-mile radius to 5.6 miles northwest the
Meridian TACAN. This Class D airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

ASO MS E4 Meridian, MS [Amended]

    Key Field, MS (Lat. 32[deg]19'57'' N, long. 88[deg]45'07'' W)
    Meridian VORTAC (Lat. 32[deg]22'42'' N, long. 88[deg]48'15'' W)
    That airspace extending upward from the surface within 1 mile
each side of the 009[deg] bearing from Key Field extending from the
4.5-mile radius of Key Field to 4.9 miles north of Key Field, and
within 1 mile each side of the 044[deg] bearing from Key Field
extending from the 4.5-mile radius of Key Field to 4.6 miles
northeast of Key Field, and within 2.9 miles each side of the
Meridian VORTAC 141[deg] radial extending from the 4.5-mile radius
of Key Field to 11 miles southeast of the Meridian VORTAC, and
within 1 mile each side of the 189[deg] bearing from Key Field
extending from the 4.5-mile radius of Key Field to 4.6 miles south
of Key Field, and within 1 mile each side of the 224[deg] bearing
from Key Field extending from the 4.5-mile radius of Key Field to
4.6 miles southwest of Key Field. This Class E airspace area is
effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter
be continuously published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO MS E5 Meridian, MS [Amended]

    Key Field, MS (Lat. 32[deg]19'57'' N, long. 88[deg]45'07'' W)
    Key Field: RWY 19-LOC (Lat. 32[deg]18'54'' N, long.
88[deg]45'25'' W)
    Meridian VORTAC (Lat. 32[deg]22'42'' N, long. 88[deg]48'15'' W)
    Key Field: RWY 01-LOC (Lat. 32[deg]20'52'' N, long.
88[deg]45'02'' W)
    Joe Williams NOLF, MS (Lat. 32[deg]47'56'' N, long.
88[deg]50'04'' W)
    NAS Meridian/McCain Field, MS (Lat. 32[deg]33'13'' N, long.
88[deg]33'19'' W)
    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Key Field, and within 1 mile each side of
the 009[deg] bearing from Key Field extending from the 7-mile radius
of Key Field to 12.5 miles north of Key Field; and within 3.4 miles
each side of the 009[deg] bearing from the Key Field: RWY 19-LOC
extending from the 7-mile radius of Key Field to 11.1 miles north of
the Key Field: RWY 19-LOC, and within 2 miles each side of the
044[deg] bearing from Key Field extending from the 7-mile radius of
Key Field to 11.6 miles northeast of Key Field, and within 3.6 miles
each side of the Meridian VORTAC 141[deg] radial extending from the
4.5-mile radius of Key Field to 13.9 miles southeast of the Meridian
VORTAC, and within 1 mile each side of the 189[deg] bearing from Key
Field extending from the 7-mile radius of Key Field to 12.6 miles
south of Key Field, and within 3.4 miles each side of the 189[deg]
bearing from the Key Field: RWY 01-LOC extending from the 7-mile
radius of Key Field to 11.2 miles south of the Key Field: RWY 01-
LOC, and within 1.5 miles each side of the Meridian VORTAC 311[deg]
radial extending from the 7-mile radius of Key Field to 14.3 miles
northwest of the Meridian VORTAC, and within a 6.7-mile radius of
Joe Williams NOLF, and within a 7.8-mile radius of NAS Meridian/
McCain Field, and within 6.7 miles each side of a line from Joe
Williams NOLF to NAS Meridian/McCain Field.

    Issued in Fort Worth, Texas, on September 4, 2019.
Steve Szukala,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2019-19543 Filed 9-10-19; 8:45 am]
 BILLING CODE 4910-13-P