Environmental Impact Considerations, Food Additives, and Generally Recognized As Safe Substances; Technical Amendments, 59247-59250 [2011-24455]
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Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Rules and Regulations
orders otherwise, to the Director of
Market Oversight or his designee, in
consultation with the General Counsel
or his designee, the authority reserved
to the Commission under paragraph (m)
of this section. The Director of the
Division of Market Oversight may
submit to the Commission for its
consideration any matter which has
been delegated pursuant to this
paragraph (o).
3. Appendix D to Part 30 is revised to
read as follows:
■
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Appendix D to Part 30—Commission
Certification With Respect to Foreign
Futures and Options Contracts on a
Non-Narrow-Based Security Index
06:33 Sep 24, 2011
Jkt 223001
Issued in Washington, DC, on September
16, 2011 by the Commission.
David A. Stawick,
Secretary of the Commission.
[FR Doc. 2011–24609 Filed 9–23–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 25, 173, 175, 177, 178,
182, and 184
In its analysis of a request for certification
by a foreign board of trade relating to a
security index futures contract traded on that
foreign board of trade pursuant to § 30.13, the
Commission will evaluate the contract to
ensure that it complies with the three criteria
of section 2(a)(1)(C)(ii) of the Act.
(1) Because security index futures contracts
are cash settled, the Commission also
evaluates the contract terms and conditions
relating to cash settlement. In that regard, the
Commission examines, among other things,
whether the cash price series is reliable,
acceptable, publicly available and timely;
that the cash settlement price is reflective of
the underlying cash market; and that the cash
settlement price is not readily susceptible to
manipulation. In making its determination,
the Commission considers the design and
maintenance of the index, the method of
index calculation, the nature of the
component security prices used to calculate
the index, the breadth and frequency of index
dissemination, and any other relevant factors.
(2) In considering the susceptibility of an
index to manipulation, the Commission
examines several factors, including the
structure of the primary and secondary
markets for the component equities, the
liquidity of the component stocks, the
method of index calculation, the total
capitalization of stocks underlying the index,
the number, weighting and capitalization of
individual stocks in the index, and the
existence of surveillance sharing agreements
between the board of trade and the securities
exchange(s) on which the underlying
securities are traded.
(3) To verify that the index is not narrowbased, the Commission considers the number
and weighting of the component securities
and the aggregate value of average daily
trading volume of the lowest weighted
quartile of securities. Under the Act, a
security index is narrow-based if it meets any
one of the following criteria:
(i) The index is composed of fewer than 10
securities;
(ii) Any single security comprises more
than 30% of the total index weight;
(iii) The five largest securities comprise
more than 60% of the total index weight; or
(iv) The lowest-weighted securities that
together account for 25% of the total weight
of the index have an aggregate dollar value
of average daily trading volume of less than
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US$30 million (or US$50 million if the index
includes fewer than 15 securities).
[Docket No. FDA–2011–N–0011]
Environmental Impact Considerations,
Food Additives, and Generally
Recognized As Safe Substances;
Technical Amendments
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending
certain regulations regarding
environmental impact considerations,
food additives, and generally recognized
as safe (GRAS) substances to correct
minor errors in the Code of Federal
Regulations (CFR). This action is
editorial in nature and is intended to
provide accuracy and clarity to the
Agency’s regulations.
DATES: This rule is effective October 3,
2011.
FOR FURTHER INFORMATION CONTACT:
Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS–
206), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 240–402–1256.
SUPPLEMENTARY INFORMATION: FDA is
amending certain regulations in parts
25, 173, 175, 177, 178, 182, and 184 (21
CFR parts 25, 173, 175, 177, 178, 182,
and 184). Minor errors were
inadvertently published in the CFR
affecting certain regulations regarding
environmental impact considerations
(part 25), food additives (parts 173, 175,
177, and 178), and GRAS substances
(parts 182 and 184). This action makes
the needed corrections.
The final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
Publication of this document
constitutes final action of these changes
under the Administrative Procedure Act
SUMMARY:
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59247
(5 U.S.C. 553). These amendments are
merely correcting nonsubstantive errors.
FDA therefore, for good cause, finds
under 5 U.S.C. 553(b)(3)(B) and (d)(3)
that notice and public comment are
unnecessary. The changes addressed in
this document are as follows:
1. The Agency is correcting
typographical errors. Two chemical
names are corrected:
Polytetrafluoroethylene in § 175.105 and
dialkyl (C8–C18) dimethylammonium
chloride in § 177.2600. Two chemical
formulas are corrected: N,N-B-is(2hydroxyethyl) alkylamine, where the
alkyl groups (C14–C18) are derived from
tallow in § 178.3130, and MnCl2 in
§ 184.1446.
2. The Agency is also correcting five
Chemical Abstract Service registry
numbers (CAS Reg. Nos.) that are
incorrectly listed: 123–93–5 in
§ 173.375, 1302–78–9 in § 184.1155,
7758–99–8 in § 184.1261, 10024–66–5
in § 184.1449, and 10025–69–1 in
§ 184.1845.
3. The Agency is updating citations.
The two citations in 21 CFR 182.99 are
updated to 40 CFR 180.910 and 40 CFR
180.920 due to a recent U.S.
Environmental Protection Agency
regulation. A citation in § 25.32 is
updated. Section 25.32(p) refers to a
petition pertaining to the label
declaration of ingredients as described
in § 101.103 (21 CFR 101.103). However,
FDA revoked § 101.103 on June 3, 1996
(61 FR 27771 at 27779) because it
duplicated the procedures in 21 CFR
10.30 for citizen petitions.
4. The Agency is amending tables in
§§ 175.300 and 177.1210.
5. Finally, the Agency is updating
§ 184.1165. Under § 184.1165(a), both nbutane and iso-butane are described as
odorless. However, the Food Chemicals
Codex, 7th Edition (2010) 1 does not use
the word ‘‘odorless’’ to describe the
gases. Therefore, the Agency is
amending its description by removing
the word ‘‘odorless.’’
List of Subjects
21 CFR Part 25
Environmental impact statements,
Foreign relations, Reporting and
recordkeeping requirements.
21 CFR Part 173
Food additives.
21 CFR Part 175
Adhesives, Food additives, Food
packaging.
1 Food Chemicals Codex, 7th Edition, pp. 115 and
529, Rockville, MD: United States Pharmacopeial
Convention, 2010.
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Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Rules and Regulations
21 CFR Part 177
Food additives, Food packaging.
2. Section 25.32 is amended by
revising paragraph (p) to read as
follows:
■
21 CFR Part 178
Food additives, Food packaging.
§ 25.32 Foods, food additives, and color
additives.
21 CFR Part 182
Food ingredients, Food packaging,
Spices and flavorings.
*
21 CFR Part 184
Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 25,
173, 175, 177, 178, 182, and 184 are
amended as follows:
PART 25—ENVIRONMENTAL IMPACT
CONSIDERATIONS
1. The authority citation for 21 CFR
part 25 continues to read as follows:
■
Authority: 21 U.S.C. 321–393; 42 U.S.C.
262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR
parts 1500–1508; E.O. 11514, 35 FR 4247, 3
CFR, 1971 Comp., p. 531–533 as amended by
E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp.,
p. 123–124 and E.O. 12114, 44 FR 1957, 3
CFR, 1980 Comp., p. 356–360.
*
*
*
*
(p) Issuance, amendment, or
revocation of a regulation in response to
a reference amount petition as described
in § 101.12(h) of this chapter, a nutrient
content claim petition as described in
§ 101.69 of this chapter, a health claim
petition as described in § 101.70 of this
chapter, or a petition pertaining to the
label declaration of ingredients as
described in § 10.30 of this chapter.
*
*
*
*
*
PART 173—SECONDARY DIRECT
FOOD ADDITIVES PERMITTED IN
FOOD FOR HUMAN CONSUMPTION
3. The authority citation for 21 CFR
part 173 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348.
4. Section 173.375 is amended by
revising the introductory text to read as
follows:
■
§ 173.375
Cetylpyridinium chloride.
Cetylpyridinium chloride (CAS Reg.
No. 123–93–5) may be safely used in
food in accordance with the following
conditions:
*
*
*
*
*
PART 175—INDIRECT FOOD
ADDITIVES: ADHESIVES AND
COMPONENTS OF COATINGS
5. The authority citation for 21 CFR
part 175 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 379e.
§ 175.105
[Amended]
6. Section 175.105 is amended in the
table in paragraph (c)(5), in the
‘‘Substances’’ column, by removing the
entry for ‘‘Polytretrafluoroethylene’’ and
by adding in its place the entry for
‘‘Polytetrafluoroethylene.’’
■ 7. Section 175.300 is amended by
revising Table 2 in paragraph (d) to read
as follows:
■
§ 175.300 Resinous and polymeric
coatings.
*
*
*
(d) * * *
*
*
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR POLYMERIC COATINGS,
USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Extractant
Condition of use
Types of food
(see Table 1)
Water
(time and temperature)
Heptane1,2
(time and temperature)
A. High temperature heat-sterilized (e.g.,
over 212 °F).
I, IV–B ....................................
250 °F, 2 hr ...........
................................
III, IV–A, VII ...........................
II .............................................
III, VII .....................................
II, IV–B ...................................
150 °F, 2 hr ...........
................................
120 °F, 30 min.
................................
III, IV–A ..................................
V .............................................
II, IV–B, VI–B .........................
III, IV–A ..................................
V .............................................
VI–A .......................................
II, IV–B, VI–B .........................
do ...........................
212 °F, 30 min .......
do ...........................
Fill boiling, cool to
100 °F.
do ...........................
................................
150 °F, 2 hr ...........
do ...........................
................................
................................
120 °F, 24 hr .........
III, IV–A ..................................
V, VII ......................................
VI–A .......................................
I, II, III, IV–A, IV–B, VI–B,VII
do ...........................
................................
................................
70 °F, 48 hr ...........
70 °F, 30 min .........
do ...........................
................................
................................
VI–A .......................................
I, II, III, IV–B, VII ....................
................................
70 °F, 24 hr ...........
................................
................................
I, II, IV–B ................................
212 °F, 30 min .......
................................
III, IV–A, VII ...........................
do ...........................
120 °F, 30 min .......
B. Boiling water-sterilized ...............................
C. Hot filled or pasteurized above 150 °F .....
D. Hot filled or pasteurized below 150 °F ......
E. Room temperature filled and stored (no
thermal treatment in the container).
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F. Refrigerated storage (no thermal treatment in the container).
G. Frozen storage (no thermal treatment in
the container).
H. Frozen storage: Ready-prepared foods intended to be reheated in container at time
of use:
1. Aqueous or oil in water emulsion of
high or low fat.
2. Aqueous, high or low free oil or fat ....
1
2
120 °F, 15 min .......
do ...........................
................................
100 °F, 30 min .......
do ...........................
................................
................................
Heptane extractant not to be used on wax-lined containers.
Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
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8% alcohol
(time and temperature)
150 °F, 2 hr.
120 °F, 24 hr.
70 °F, 48 hr.
Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Rules and Regulations
*
*
*
*
Authority: 21 U.S.C. 321, 342, 348, 379e.
*
9. Section 177.1210 is amended by
revising Table 4 of paragraph (c) to read
as follows:
■
PART 177—INDIRECT FOOD
ADDITIVES: POLYMERS
59249
§ 177.1210 Closures with sealing gaskets
for food containers.
*
*
*
(c) * * *
*
*
8. The authority citation for 21 CFR
part 177 continues to read as follows:
■
TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM
CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Extractant
Conditions of use
Types of food
(see Table 3)
A. High temperature heat-sterilized (e.g.,
over 212 °F).
B. Boiling water-sterilized ...............................
C. Hot filled or pasteurized above 150 °F .....
D. Hot filled or pasteurized below 150 °F ......
E. Room temperature filled and stored (no
thermal treatment in the container).
F. Refrigerated storage (no thermal treatment).
G. Frozen storage (no thermal treatment in
the container).
1Heptane
Heptane1 (time and
temperature)
I, IV–B ....................................
250 °F, 2 hr ...........
................................
III, IV–A, VII ...........................
II .............................................
III, VII .....................................
II, IV–B ...................................
150 °F, 2 hr ...........
................................
120 °F, 30 min .......
................................
III, IV–A ..................................
V .............................................
II, IV–B, VI–B .........................
III, IV–A ..................................
V .............................................
VI–A .......................................
II, IV–B, VI–B .........................
do ...........................
212 °F, 30 min .......
do ...........................
Fill boiling, cool to
100 °F.
do ...........................
................................
150 °F, 2 hr ...........
do ...........................
................................
................................
120 °F, 24 hr .........
III, IV–A ..................................
V .............................................
VI–A .......................................
I, II, III, IV–A, IV–B, VI–B,VII
do ...........................
................................
................................
70 °F, 48 hr ...........
70 °F, 30 min .........
do ...........................
................................
70 °F, 30 min .........
120 °F, 24 hr.
VI–A .......................................
I, II, III, IV–B, VII ....................
................................
70 °F, 24 hr ...........
................................
................................
70 °F, 48 hr.
120 °F, 15 min .......
do ...........................
................................
100 °F, 30 min .......
do ...........................
................................
................................
150 °F, 2 hr.
extractant not applicable to closure-sealing gaskets overcoated with wax.
§ 177.2600
[Amended]
10. Section 177.2600 is amended in
paragraph (c)(4)(ix) by removing the
entry for ‘‘Dialkyl (C8–C18’’ and by
adding in its place the entry for ‘‘Dialkyl
(C8–C18) dimethylammonium chloride
for use only as a flocculating agent in
the manufacture of silica.’’
■
PART 178—INDIRECT FOOD
ADDITIVES: ADJUVANTS,
PRODUCTION AIDS, AND SANITIZERS
11. The authority citation for 21 CFR
part 178 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 379e.
§ 178.3130
[Amended]
12. Section 178.3130 is amended in
the table in paragraph (b), in the ‘‘List
of Substances’’ column, by removing the
entry for ‘‘N,N-Bis(2-hydroxyethyl)
alkylamine, where the alkyl groups (C1–
C18) are derived from tallow.’’ and by
adding in its place the entry for ‘‘N,NBis(2-hydroxyethyl) alkylamine, where
the alkyl groups (C14–C18) are derived
from tallow.’’
■
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8% alcohol
(time and temperature)
Water (time and
temperature)
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PART 182—SUBSTANCES
GENERALLY RECOGNIZED AS SAFE
13. The authority citation for 21 CFR
part 182 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 371.
14. Section 182.99 is revised to read
as follows:
■
§ 182.99 Adjuvants for pesticide
chemicals.
Adjuvants, identified and used in
accordance with 40 CFR 180.910 and 40
CFR 180.920, which are added to
pesticide use dilutions by a grower or
applicator prior to application to the
raw agricultural commodity, are exempt
from the requirement of tolerances
under section 409 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348).
PART 184—DIRECT FOOD
SUBSTANCES AFFIRMED AS
GENERALLY RECOGNIZED AS SAFE
15. The authority citation for 21 CFR
part 184 continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 371.
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16. Section 184.1155 is amended by
revising the first sentence of paragraph
(a) to read as follows:
■
§ 184.1155
Bentonite.
(a) Bentonite (Al2O34SiO2nH2O, CAS
Reg. No. 1302–78–9) is principally a
colloidal hydrated aluminum silicate.
* * *
*
*
*
*
*
17. Section 184.1165 is amended by
revising the first sentence of paragraph
(a) to read as follows:
■
§ 184.1165
n-Butane and iso-butane.
(a) n-Butane and iso-butane (empirical
formula C4H10, CAS Reg. Nos. 106–97–
8 and 75–28–5, respectively) are
colorless, flammable gases at normal
temperatures and pressures. * * *
*
*
*
*
*
■ 18. Section 184.1261 is amended by
revising the first sentence of paragraph
(a) to read as follows:
§ 184.1261
Copper sulfate.
(a) Copper sulfate (cupric sulfate,
CuSO4·5 H2O, CAS Reg. No. 7758–99–8)
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usually is used in the pentahydrate
form. * * *
*
*
*
*
*
■ 19. Section 184.1446 is amended by
revising the first sentence of paragraph
(a) to read as follows:
§ 184.1446
Manganese chloride.
(a) Manganese chloride (MnCl2, CAS
Reg. No. 7773–01–5) is a pink,
translucent, crystalline product. * * *
*
*
*
*
*
■ 20. Section 184.1449 is amended by
revising the first sentence of paragraph
(a) to read as follows:
§ 184.1449
Manganese citrate.
(a) Manganese citrate (Mn3(C6H5O7)2,
CAS Reg. No. 10024–66–5) is a pale
orange or pinkish white powder. * * *
*
*
*
*
*
■ 21. Section 184.1845 is amended by
revising the fourth sentence of
paragraph (a) to read as follows:
§ 184.1845 Stannous chloride (anhydrous
and dehydrated).
(a) * * * Dihydrated stannous
chloride (SnCl2·2H2O, CAS Reg. No.
10025–69–1) is the chloride salt of
metallic tin that contains two molecules
of water. * * *
*
*
*
*
*
Dated: September 19, 2011.
Susan Bernard,
Acting Director, Office of Regulations, Policy
and Social Sciences, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2011–24455 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2011–0386–201151; FRL–
9471–1]
Approval and Promulgation of Air
Quality Implementation Plans; North
Carolina: Clean Smokestacks Act
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is approving a State
Implementation Plan (SIP) revision
submitted by the State of North Carolina
for the purpose of establishing systemwide emission limitations from the
North Carolina Clean Smokestacks Act
(CSA) into the North Carolina SIP. On
August 21, 2009, the State of North
Carolina, through the North Carolina
Department of Environment and Natural
Resources (NC DENR), Division of Air
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SUMMARY:
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06:33 Sep 24, 2011
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Quality (DAQ), submitted an attainment
demonstration for the HickoryMorganton-Lenoir and GreensboroWinston Salem-High Point 1997 fine
particulate matter (PM2.5) nonattainment
area. That submittal included a request
that the system-wide emission
limitations from the North Carolina CSA
be incorporated into the State’s federally
approved SIP. EPA has determined that
the CSA portion of this SIP revision is
approvable pursuant to the Clean Air
Act (CAA or Act).
DATES: This rule will be effective
October 26, 2011.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R04–OAR–
2011–0386. All documents in the docket
are listed on the https://
www.regulations.gov Web site. Although
listed in the index, some information is
not publicly available, i.e., Confidential
Business Information or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy at
the Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960. EPA
requests that if at all possible, you
contact the person listed in the FOR
FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional
Office’s official hours of business are
Monday through Friday, 8:30 to 4:30
excluding federal holidays.
FOR FURTHER INFORMATION CONTACT: Joel
Huey or Nacosta C. Ward, Regulatory
Development Section, Air Planning
Branch, Air, Pesticides and Toxics
Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303–8960. Mr. Huey
may be reached by phone at (404) 562–
9104. Mr. Huey can also be reached via
electronic mail at huey.joel@epa.gov.
Ms. Ward may be reached by phone at
(404) 562–9140 or via electronic mail at
ward.nacosta@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. What is the background of North Carolina’s
CSA?
II. This Action
III. Final Action
IV. Statutory and Executive Order Reviews
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V. Statutory and Executive Order Reviews
I. What is the background of North
Carolina’s CSA?
In June 2002, the General Assembly of
North Carolina, Session 2001, passed
Session Law 2002–4, also known as
Senate Bill 1078. This legislation,
entitled ‘‘An Act to Improve Air Quality
in the State by Imposing Limits on the
Emission of Certain Pollutants from
Certain Facilities that Burn Coal to
Generate Electricity and to Provide for
Recovery by Electric Utilities of the
Costs of Achieving Compliance with
Those Limits,’’ requires significant
actual emission reductions from coalfired power plants in North Carolina.
The State expected that emission
reductions from the CSA would have
significant health benefits for the
citizens of North Carolina and other
states.
North Carolina’s CSA includes a
schedule of system-wide limitations (or
caps) on emissions of nitrogen oxides
(NOx) and sulfur dioxide (SO2) from
coal-fired power plants in the State, the
first of which became effective in 2007.
The State expects the resulting emission
reductions will serve as a significant
step towards meeting the 1997 PM2.5
and 8-hour ozone national ambient air
quality standards (NAAQS), among
other NAAQS, improving visibility in
the mountains and other scenic vistas,
and reducing acid rain. EPA notes that
all areas in the State that were
designated nonattainment for the 1997
PM2.5 and 8-hour ozone NAAQS are
currently attaining the standards.
Although the Hickory-Morganton-Lenoir
and Greensboro-Winston Salem-High
Point nonattainment areas for the 1997
PM2.5 NAAQS have not yet been
redesignated to attainment, EPA
determined that these areas had
attaining data based on the three-year
period 2006–2008.1 Also, although the
Charlotte 1997 8-hour ozone
nonattainment area is still designated
nonattainment, EPA has issued a
proposed determination that the Area
has attaining data based on the 2008–
2010 design value period. See 76 FR
20293 (April 12, 2011). North Carolina
has identified the CSA as part of its plan
to attain and maintain the NAAQS.
Because North Carolina is relying on
1 EPA’s determination that the HickoryMorganton-Lenoir and Greensboro-Winston SalemHigh Point PM2.5 nonattainment areas have attained
the 1997 PM2.5 NAAQS is not equivalent to the
redesignation of the areas to attainment. The
designation status of the areas remains
nonattainment for the 1997 PM2.5 NAAQS until
such time as EPA determines that the areas meet all
of the CAA requirements for redesignation to
attainment. See 75 FR 54 (January 4, 2010) and 75
FR 230 (January 5, 2010), respectively.
E:\FR\FM\26SER1.SGM
26SER1
]]>Agencies
[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Rules and Regulations]
[Pages 59247-59250]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24455]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 25, 173, 175, 177, 178, 182, and 184
[Docket No. FDA-2011-N-0011]
Environmental Impact Considerations, Food Additives, and
Generally Recognized As Safe Substances; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is amending certain
regulations regarding environmental impact considerations, food
additives, and generally recognized as safe (GRAS) substances to
correct minor errors in the Code of Federal Regulations (CFR). This
action is editorial in nature and is intended to provide accuracy and
clarity to the Agency's regulations.
DATES: This rule is effective October 3, 2011.
FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1256.
SUPPLEMENTARY INFORMATION: FDA is amending certain regulations in parts
25, 173, 175, 177, 178, 182, and 184 (21 CFR parts 25, 173, 175, 177,
178, 182, and 184). Minor errors were inadvertently published in the
CFR affecting certain regulations regarding environmental impact
considerations (part 25), food additives (parts 173, 175, 177, and
178), and GRAS substances (parts 182 and 184). This action makes the
needed corrections.
The final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Publication of this document constitutes final action of these
changes under the Administrative Procedure Act (5 U.S.C. 553). These
amendments are merely correcting nonsubstantive errors. FDA therefore,
for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that
notice and public comment are unnecessary. The changes addressed in
this document are as follows:
1. The Agency is correcting typographical errors. Two chemical
names are corrected: Polytetrafluoroethylene in Sec. 175.105 and
dialkyl (C8-C18) dimethylammonium chloride in
Sec. 177.2600. Two chemical formulas are corrected: N,N-B-is(2-
hydroxyethyl) alkylamine, where the alkyl groups (C14-
C18) are derived from tallow in Sec. 178.3130, and
MnCl2 in Sec. 184.1446.
2. The Agency is also correcting five Chemical Abstract Service
registry numbers (CAS Reg. Nos.) that are incorrectly listed: 123-93-5
in Sec. 173.375, 1302-78-9 in Sec. 184.1155, 7758-99-8 in Sec.
184.1261, 10024-66-5 in Sec. 184.1449, and 10025-69-1 in Sec.
184.1845.
3. The Agency is updating citations. The two citations in 21 CFR
182.99 are updated to 40 CFR 180.910 and 40 CFR 180.920 due to a recent
U.S. Environmental Protection Agency regulation. A citation in Sec.
25.32 is updated. Section 25.32(p) refers to a petition pertaining to
the label declaration of ingredients as described in Sec. 101.103 (21
CFR 101.103). However, FDA revoked Sec. 101.103 on June 3, 1996 (61 FR
27771 at 27779) because it duplicated the procedures in 21 CFR 10.30
for citizen petitions.
4. The Agency is amending tables in Sec. Sec. 175.300 and
177.1210.
5. Finally, the Agency is updating Sec. 184.1165. Under Sec.
184.1165(a), both n-butane and iso-butane are described as odorless.
However, the Food Chemicals Codex, 7th Edition (2010) \1\ does not use
the word ``odorless'' to describe the gases. Therefore, the Agency is
amending its description by removing the word ``odorless.''
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\1\ Food Chemicals Codex, 7th Edition, pp. 115 and 529,
Rockville, MD: United States Pharmacopeial Convention, 2010.
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List of Subjects
21 CFR Part 25
Environmental impact statements, Foreign relations, Reporting and
recordkeeping requirements.
21 CFR Part 173
Food additives.
21 CFR Part 175
Adhesives, Food additives, Food packaging.
[[Page 59248]]
21 CFR Part 177
Food additives, Food packaging.
21 CFR Part 178
Food additives, Food packaging.
21 CFR Part 182
Food ingredients, Food packaging, Spices and flavorings.
21 CFR Part 184
Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
25, 173, 175, 177, 178, 182, and 184 are amended as follows:
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS
0
1. The authority citation for 21 CFR part 25 continues to read as
follows:
Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C.
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR,
1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR,
1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980
Comp., p. 356-360.
0
2. Section 25.32 is amended by revising paragraph (p) to read as
follows:
Sec. 25.32 Foods, food additives, and color additives.
* * * * *
(p) Issuance, amendment, or revocation of a regulation in response
to a reference amount petition as described in Sec. 101.12(h) of this
chapter, a nutrient content claim petition as described in Sec. 101.69
of this chapter, a health claim petition as described in Sec. 101.70
of this chapter, or a petition pertaining to the label declaration of
ingredients as described in Sec. 10.30 of this chapter.
* * * * *
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
0
3. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
0
4. Section 173.375 is amended by revising the introductory text to read
as follows:
Sec. 173.375 Cetylpyridinium chloride.
Cetylpyridinium chloride (CAS Reg. No. 123-93-5) may be safely used
in food in accordance with the following conditions:
* * * * *
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
0
5. The authority citation for 21 CFR part 175 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
Sec. 175.105 [Amended]
0
6. Section 175.105 is amended in the table in paragraph (c)(5), in the
``Substances'' column, by removing the entry for
``Polytretrafluoroethylene'' and by adding in its place the entry for
``Polytetrafluoroethylene.''
0
7. Section 175.300 is amended by revising Table 2 in paragraph (d) to
read as follows:
Sec. 175.300 Resinous and polymeric coatings.
* * * * *
(d) * * *
Table 2--Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and
Beverages
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extractant
Types of food (see ----------------------------------------------------------------------------------------------
Condition of use Table 1) Heptane\1,2\ (time and 8% alcohol (time and
Water (time and temperature) temperature) temperature)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B.............. 250 [deg]F, 2 hr.............. .............................. .............................
sterilized (e.g., over 212
[deg]F).
III, IV-A, VII....... do............................ 150 [deg]F, 2 hr.............. .............................
B. Boiling water-sterilized....... II................... 212 [deg]F, 30 min............ .............................. .............................
III, VII............. do............................ 120 [deg]F, 30 min............
C. Hot filled or pasteurized above II, IV-B............. Fill boiling, cool to 100 .............................. .............................
150 [deg]F. [deg]F.
III, IV-A............ do............................ 120 [deg]F, 15 min............ .............................
V.................... .............................. do............................ .............................
D. Hot filled or pasteurized below II, IV-B, VI-B....... 150 [deg]F, 2 hr.............. .............................. .............................
150 [deg]F.
III, IV-A............ do............................ 100 [deg]F, 30 min............ .............................
V.................... .............................. do............................ .............................
VI-A................. .............................. .............................. 150 [deg]F, 2 hr.
E. Room temperature filled and II, IV-B, VI-B....... 120 [deg]F, 24 hr............. .............................. .............................
stored (no thermal treatment in
the container).
III, IV-A............ do............................ 70 [deg]F, 30 min............. .............................
V, VII............... .............................. do............................ .............................
VI-A................. .............................. .............................. 120 [deg]F, 24 hr.
F. Refrigerated storage (no I, II, III, IV-A, IV- 70 [deg]F, 48 hr.............. .............................. .............................
thermal treatment in the B, VI-B,VII.
container).
VI-A................. .............................. .............................. 70 [deg]F, 48 hr.
G. Frozen storage (no thermal I, II, III, IV-B, VII 70 [deg]F, 24 hr.............. .............................. .............................
treatment in the container).
H. Frozen storage: Ready-prepared
foods intended to be reheated in
container at time of use:
1. Aqueous or oil in water I, II, IV-B.......... 212 [deg]F, 30 min............ .............................. .............................
emulsion of high or low fat.
2. Aqueous, high or low free III, IV-A, VII....... do............................ 120 [deg]F, 30 min............ .............................
oil or fat.
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\1\ Heptane extractant not to be used on wax-lined containers.
\2\ Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
[[Page 59249]]
* * * * *
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
0
8. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
0
9. Section 177.1210 is amended by revising Table 4 of paragraph (c) to
read as follows:
Sec. 177.1210 Closures with sealing gaskets for food containers.
* * * * *
(c) * * *
Table 4--Test Procedures With Time-Temperature Conditions for Determining Amount of Extractives From Closure-Sealing Gaskets, Using Solvents Simulating
Types of Foods and Beverages
--------------------------------------------------------------------------------------------------------------------------------------------------------
Extractant
Types of food (see ----------------------------------------------------------------------------------------------
Conditions of use Table 3) Heptane\1\ (time and 8% alcohol (time and
Water (time and temperature) temperature) temperature)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B.............. 250 [deg]F, 2 hr.............. .............................. .............................
sterilized (e.g., over 212
[deg]F).
III, IV-A, VII....... do............................ 150 [deg]F, 2 hr.............. .............................
B. Boiling water-sterilized....... II................... 212 [deg]F, 30 min............ .............................. .............................
III, VII............. do............................ 120 [deg]F, 30 min............ .............................
C. Hot filled or pasteurized above II, IV-B............. Fill boiling, cool to 100 .............................. .............................
150 [deg]F. [deg]F.
III, IV-A............ do............................ 120 [deg]F, 15 min............ .............................
V.................... .............................. do............................ .............................
D. Hot filled or pasteurized below II, IV-B, VI-B....... 150 [deg]F, 2 hr.............. .............................. .............................
150 [deg]F.
III, IV-A............ do............................ 100 [deg]F, 30 min............ .............................
V.................... .............................. do............................ .............................
VI-A................. .............................. .............................. 150 [deg]F, 2 hr.
E. Room temperature filled and II, IV-B, VI-B....... 120 [deg]F, 24 hr............. .............................. .............................
stored (no thermal treatment in
the container).
III, IV-A............ do............................ 70 [deg]F, 30 min............. .............................
V.................... .............................. do............................ .............................
VI-A................. .............................. .............................. 120 [deg]F, 24 hr.
F. Refrigerated storage (no I, II, III, IV-A, IV- 70 [deg]F, 48 hr.............. 70 [deg]F, 30 min............. .............................
thermal treatment). B, VI-B,VII.
VI-A................. .............................. .............................. 70 [deg]F, 48 hr.
G. Frozen storage (no thermal I, II, III, IV-B, VII 70 [deg]F, 24 hr.............. .............................. .............................
treatment in the container).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
Sec. 177.2600 [Amended]
0
10. Section 177.2600 is amended in paragraph (c)(4)(ix) by removing the
entry for ``Dialkyl (C8-C18'' and by adding in
its place the entry for ``Dialkyl (C8-C18)
dimethylammonium chloride for use only as a flocculating agent in the
manufacture of silica.''
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
0
11. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
Sec. 178.3130 [Amended]
0
12. Section 178.3130 is amended in the table in paragraph (b), in the
``List of Substances'' column, by removing the entry for ``N,N-Bis(2-
hydroxyethyl) alkylamine, where the alkyl groups (C1-
C18) are derived from tallow.'' and by adding in its place
the entry for ``N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl
groups (C14-C18) are derived from tallow.''
PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE
0
13. The authority citation for 21 CFR part 182 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
0
14. Section 182.99 is revised to read as follows:
Sec. 182.99 Adjuvants for pesticide chemicals.
Adjuvants, identified and used in accordance with 40 CFR 180.910
and 40 CFR 180.920, which are added to pesticide use dilutions by a
grower or applicator prior to application to the raw agricultural
commodity, are exempt from the requirement of tolerances under section
409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348).
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
0
15. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
0
16. Section 184.1155 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 184.1155 Bentonite.
(a) Bentonite
(Al2O34SiO2nH2O, CAS Reg.
No. 1302-78-9) is principally a colloidal hydrated aluminum silicate. *
* *
* * * * *
0
17. Section 184.1165 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 184.1165 n-Butane and iso-butane.
(a) n-Butane and iso-butane (empirical formula
C4H10, CAS Reg. Nos. 106-97-8 and 75-28-5,
respectively) are colorless, flammable gases at normal temperatures and
pressures. * * *
* * * * *
0
18. Section 184.1261 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 184.1261 Copper sulfate.
(a) Copper sulfate (cupric sulfate, CuSO4[middot]5
H2O, CAS Reg. No. 7758-99-8)
[[Page 59250]]
usually is used in the pentahydrate form. * * *
* * * * *
0
19. Section 184.1446 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 184.1446 Manganese chloride.
(a) Manganese chloride (MnCl2, CAS Reg. No. 7773-01-5)
is a pink, translucent, crystalline product. * * *
* * * * *
0
20. Section 184.1449 is amended by revising the first sentence of
paragraph (a) to read as follows:
Sec. 184.1449 Manganese citrate.
(a) Manganese citrate
(Mn3(C6H5O7)2,
CAS Reg. No. 10024-66-5) is a pale orange or pinkish white powder. * *
*
* * * * *
0
21. Section 184.1845 is amended by revising the fourth sentence of
paragraph (a) to read as follows:
Sec. 184.1845 Stannous chloride (anhydrous and dehydrated).
(a) * * * Dihydrated stannous chloride
(SnCl2[middot]2H2O, CAS Reg. No. 10025-69-1) is
the chloride salt of metallic tin that contains two molecules of water.
* * *
* * * * *
Dated: September 19, 2011.
Susan Bernard,
Acting Director, Office of Regulations, Policy and Social Sciences,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2011-24455 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P
