Food Additives Permitted for Direct Addition to Food for Human Consumption; TBHQ, 34274-34276 [2015-14704]
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34274
Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
Country chart (see
Supp. No. 1 to part
738)
Control(s)
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CB applies to ‘‘technology’’ for items
controlled by
1C351, 1C353, or
1C354.
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CB Column 1.
List of Items Controlled
Related Controls: * * *
Related Definition: * * *
Items:
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15. In Supplement No. 1 to Part 774
(the Commerce Control List), Category
1—Special Materials and Related
Equipment, Chemicals,
‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN
1E351 is amended by revising the ECCN
heading and by revising the entry for
‘‘Country Chart—CB Column 1’’ in the
License Requirements section to read as
follows:
■
1E351 ‘‘Technology’’ according to the
General Technology Note for the
disposal of chemicals or microbiological
materials controlled by 1C350, 1C351,
1C353, or 1C354.
License Requirements
Reason for Control: NS, MT, NP, CB, RS, AT
Country chart (see
Supp. No. 1 to part
738)
Control(s)
CB applies to ‘‘technology’’ for items
controlled by
1C351, 1C353, or
1C354.
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CB Column 1.
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16. In Supplement No. 1 to Part 774
(the Commerce Control List), Category
2—Materials Processing, ECCN 2B350 is
amended by revising the ‘‘LVS’’
paragraph in the List Based License
Exceptions section and also, under the
List of Items Controlled section, by
revising paragraph g. in the ‘‘Items’’
paragraph, by redesignating the
Technical Note to 2B350.g as Technical
Note 2 to 2B350.g, by adding a
Technical Note 1 to 2B350.g
immediately preceding Technical Note
2, and by adding a Technical Note to
2B350.i immediately following
2B350.i.11, to read as follows:
asabaliauskas on DSK5VPTVN1PROD with RULES
■
2B350 Chemical manufacturing facilities
and equipment, except valves controlled
by 2A226 or 2A292, as follows (see List
of Items Controlled).
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List Based License Exceptions (See Part 740
for a Description of All License Exceptions)
LVS: $2,000 for all Country Group B
destinations, except those also listed under
VerDate Sep<11>2014
Country Group D:3 (see Supplement No. 1
to part 740 of the EAR).
GBS: * * *
CIV: * * *
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g. Valves, as follows:
g.1. Valves having both of the following
characteristics:
g.1.a. A nominal size greater than 1.0 cm
(3⁄8 in.); and
g.1.b. All surfaces that come in direct
contact with the chemical(s) being produced,
processed, or contained are made from
materials identified in Technical Note 1 to
2B350.g.
g.2. Valves, except for valves controlled by
2B350.g.1, having all of the following
characteristics:
g.2.a. A nominal size equal to or greater
than 2.54 cm (1 inch) and equal to or less
than 10.16 cm (4 inches);
g.2.b. Casings (valve bodies) or preformed
casing liners controlled by 2B350.g.3, in
which all surfaces that come in direct contact
with the chemical(s) being produced,
processed, or contained are made from
materials identified in Technical Note 1 to
2B350.g; and
g.2.c. A closure element designed to be
interchangeable.
g.3. Casings (valve bodies) and preformed
casing liners having both of the following
characteristics:
g.3.a. Designed for valves in 2B350.g.1 or
.g.2; and
g.3.b. All surfaces that come in direct
contact with the chemical(s) being produced,
processed, or contained are made from
materials identified in Technical Note 1 to
2B350.g.
Technical Note 1 to 2B350.g: All surfaces
of the valves controlled by 2B350.g.1, and the
casings (valve bodies) and preformed casing
liners controlled by 2B350.g.3, that come in
direct contact with the chemical(s) being
produced, processed, or contained are made
from the following materials:
a. Alloys with more than 25% nickel and
20% chromium by weight;
b. Nickel or alloys with more than 40%
nickel by weight;
c. Fluoropolymers (polymeric or
elastomeric materials with more than 35%
fluorine by weight);
d. Glass (including vitrified or enameled
coating or glass lining);
e. Tantalum or tantalum alloys;
f. Titanium or titanium alloys;
g. Zirconium or zirconium alloys;
h. Niobium (columbium) or niobium
alloys; or
i. Ceramic materials, as follows:
i.1. Silicon carbide with a purity of 80%
or more by weight;
i.2. Aluminum oxide (alumina) with a
purity of 99.9% or more by weight; or
i.3. Zirconium oxide (zirconia).
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i. * * *
Technical Note to 2B350.i: The seals
referred to in 2B350.i come into direct
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contact with the chemical(s) being processed
(or are designed to do so), and provide a
sealing function where a rotary or
reciprocating drive shaft passes through a
pump body.
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Dated: June 9, 2015.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2015–14471 Filed 6–15–15; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA–2014–F–0364]
Food Additives Permitted for Direct
Addition to Food for Human
Consumption; TBHQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the food additive regulations
by removing the upper bound of the
melting point range in the regulation for
the antioxidant tertiary
butylhydroquinone (TBHQ) and adding
a purity acceptance criterion. This
action is in response to a petition
submitted by Eastman Chemical
Company.
DATES: This rule is effective June 16,
2015. See section VIII for further
information on the filing of objections.
Submit either electronic or written
objections and requests for a hearing by
July 16, 2015. The Director of the
Federal Register approves the
incorporation by reference of certain
publications listed in the rule as of June
16, 2015.
ADDRESSES: You may submit either
electronic or written objections and
requests for a hearing identified by
Docket No. FDA–2014–F–0364, by any
of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written objections in the
following ways:
• Mail/Hand delivery/Courier (for
paper submissions): Division of Dockets
E:\FR\FM\16JNR1.SGM
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Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
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–2014–F–0364 for this
rulemaking. All objections received will
be posted without change to https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section.
Docket: For access to the docket to
read background documents or
objections received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1309.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with RULES
I. Background
In a notice published in the Federal
Register on April 8, 2014 (79 FR 19301),
we announced that we filed a food
additive petition (FAP 4A4803)
submitted by Eastman Chemical
Company, c/o Keller and Heckman LLP,
1001 G St. NW., Suite 500 West,
Washington, DC 20001 (petitioner). The
petition proposed to amend the food
additive regulations in § 172.185 (21
CFR 172.185) TBHQ by removing the
upper bound of the specified melting
point range (126.5 °C to 128.5 °C) and
by adding an acceptance criterion to
measure purity of the additive.
Specifically, the petition proposed to
allow the use of TBHQ with a melting
point that is 126.5 °C or higher. In
addition to this change in melting point
specification, the petition also proposed
to add an acceptance criterion for purity
of not less than 99.0 percent TBHQ, as
tested by the titration assay specified in
the most current edition of the Food
Chemicals Codex (FCC).
TBHQ is the chemical 2-(1,1dimethylethyl)-1,4-benzenediol
(Chemical Abstracts Service Registry
Number 1948–33–0). In the Federal
Register of November 30, 1972 (37 FR
25356), we issued a final rule that was
codified in 21 CFR 121.1244 to provide
for the safe use of TBHQ in food under
certain conditions, including a melting
point range for TBHQ of 126.5 °C–128.5
VerDate Sep<11>2014
16:14 Jun 15, 2015
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°C. An amendment to § 121.1244 was
issued in the Federal Register of
December 10, 1976 (41 FR 53981) to
recognize the name ‘‘TBHQ’’ as the
common name for tertiary
butylhydroquinone, and to add the
Chemical Abstracts Service Registry
Number and nomenclature in the
introductory text of § 121.1244. In the
Federal Register of March 15, 1977 (42
FR 14302 at 14495), TBHQ was
recodified from § 121.1244 to § 172.185.
No amendments to the TBHQ regulation
have been made since then.
II. Evaluation of Petition
The melting point range of 126.5 °C–
128.5 °C was originally included by
FDA in the regulation for TBHQ as part
of the chemical identity of the additive
and to ensure purity. The melting point
range describes the initial and final
temperatures at which the substance
melts. Data provided in the subject
petition show that TBHQ with an initial
melting point of 126.5 °C has a purity
of not less than 99 percent, which is
consistent with the petitioner’s
proposed acceptance criterion
specification. However, according to the
petitioner, analytical and manufacturing
variability can result in batches of
TBHQ that have a final melting point
greater than 128.5 °C, but are of suitably
high purity. Using the titration assay for
TBHQ in the FCC 9th Edition (the most
current edition), the petitioner analyzed
multiple samples of TBHQ with a final
melting point above 128.5 °C. All
samples had a purity of at least 99
percent. Based on their analysis of these
data, the petitioner concluded that,
while melting point has utility in
identifying TBHQ, a maximum melting
point specification limit is unnecessary
in the regulation to ensure purity. We
agree with the petitioner and have
concluded that the data provided
support their request to remove the
upper bound of the melting point range
specified in § 172.185(a), and add a
purity acceptance criterion of not less
than 99 percent determined using the
titration assay for TBHQ in the FCC
9th Edition or an equivalent method
(Ref. 1).
The petitioner did not propose any
modifications to the use or intended
technical effect of TBHQ as currently
permitted in § 172.185. As such, the
petitioner’s proposed amendments will
have no impact on dietary exposure of
TBHQ. Therefore, we did not reevaluate
the dietary exposure to TBHQ (Ref. 1).
The petitioner also stated that there are
no changes to the manufacturing
process and therefore no new
components will be introduced into the
diet.
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34275
No new toxicology studies were
submitted in support of the safety of the
petition request. The petitioner
referenced the toxicological data that
had been previously submitted and
evaluated when the regulation for TBHQ
was first issued (37 FR 25356). As part
of the safety evaluation for this petition,
we conducted an updated literature
search for new toxicological studies
related to the safety of TBHQ. Our
literature search did not reveal any new
safety issues with the regulated use of
TBHQ or any safety concerns regarding
TBHQ with a final melting point in
excess of 128.5 °C (Ref. 2).
III. Incorporation by Reference
FDA is incorporating by reference the
monograph for TBHQ in the FCC 9th
edition (the most current edition),
which was approved by the Office of the
Federal Register. You may purchase a
copy of the material from the United
States Pharmacopeial Convention,
12601 Twinbrook Pkwy., Rockville, MD
20852, 1–800–227–8772, https://
www.usp.org/.
The FCC is a compendium of
internationally recognized standards for
the purity and identity of food
ingredients. The FCC monograph for
TBHQ contains a description of a
titration assay, which is an analytical
method used to determine the purity of
TBHQ.
IV. Conclusion
Based on the data and information in
the petition and other relevant material,
we conclude that the proposed
amendments to remove the upper bound
of the melting point range in the
regulation for TBHQ and to add a purity
acceptance criterion are safe and
appropriate. Therefore, we are
amending the regulations in 21 CFR part
172 as set forth in this document.
V. Public Disclosure
In accordance with § 171.1(h) (21 CFR
171.1(h)), the petition and the
documents that we considered and
relied upon in reaching our decision to
approve the petition will be made
available for public disclosure (see FOR
FURTHER INFORMATION CONTACT). As
provided in § 171.1(h), we will delete
from the documents any materials that
are not available for public disclosure.
VI. Environmental Impact
We have considered the
environmental effects of this rule. As
stated in the April 8, 2014, Federal
Register notice of petition for FAP
4A4803 (79 FR 19301), we have
determined, under 21 CFR 25.30(i), that
this action is of a type that does not
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Federal Register / Vol. 80, No. 115 / Tuesday, June 16, 2015 / Rules and Regulations
individually or cumulatively have a
significant effect on the human
environment such that neither an
environmental assessment nor an
environmental impact statement is
required. We have not received any new
information or comments that would
affect that determination.
VII. Paperwork Reduction Act of 1995
This 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.
asabaliauskas on DSK5VPTVN1PROD with RULES
VIII. Objections
If you will be adversely affected by
one or more provisions of this
regulation, you may file with the
Division of Dockets Management (see
ADDRESSES) either electronic or written
objections. You must separately number
each objection, and within each
numbered objection you must specify
with particularity the provision(s) to
which you object, and the grounds for
your objection. Within each numbered
objection, you must specifically state
whether you are requesting a hearing on
the particular provision that you specify
in that numbered objection. If you do
not request a hearing for any particular
objection, you waive the right to a
hearing on that objection. If you request
a hearing, your objection must include
a detailed description and analysis of
the specific factual information you
intend to present in support of the
objection in the event that a hearing is
held. If you do not include such a
description and analysis for any
particular objection, you waive the right
to a hearing on the objection.
It is only necessary to send one set of
documents. Identify documents with the
docket number found in brackets in the
heading of this document. Any
objections received in response to the
regulation 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 https://
www.regulations.gov.
IX. Section 301(ll) of the Federal Food,
Drug, and Cosmetic Act
Our review of this petition was
limited to section 409 of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 348). This final
rule is not a statement regarding
compliance with other sections of the
FD&C Act. For example, the Food and
Drug Administration Amendments Act
of 2007, which was signed into law on
September 27, 2007, amended the FD&C
Act to, among other things, add section
301(ll) of the FD&C Act (21 U.S.C.
VerDate Sep<11>2014
16:14 Jun 15, 2015
Jkt 235001
331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery
for introduction into interstate
commerce of any food that contains a
drug approved under section 505 of the
FD&C Act (21 U.S.C. 355), a biological
product licensed under section 351 of
the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for
which substantial clinical investigations
have been instituted and their existence
has been made public, unless one of the
exemptions in section 301(ll)(1) to (4) of
the FD&C Act applies. In our review of
this petition, we did not consider
whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food
containing this additive. Accordingly,
this final rule should not be construed
to be a statement that a food containing
this additive, if introduced or delivered
for introduction into interstate
commerce, would not violate section
301(ll) of the FD&C Act. Furthermore,
this language is included in all food
additive final rules and therefore should
not be construed to be a statement of the
likelihood that section 301(ll) of the
FD&C Act applies.
X. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. FDA Memorandum from H. Lee, to E.
Anderson, June 18, 2014.
2. FDA Memorandum from A. Khan to E.
Anderson, August 6, 2014.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by
reference, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Director, Center for Food Safety and
Applied Nutrition, 21 CFR part 172 is
amended as follows:
PART 172—FOOD ADDITIVES
PERMITTED FOR DIRECT ADDITION
TO FOOD FOR HUMAN
CONSUMPTION
1. The authority citation for 21 CFR
part 172 continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
■
■
2. Amend § 172.185 as follows:
a. Revise paragraph (a);
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Sfmt 4700
b. Redesignate paragraphs (b) and (c)
as paragraphs (c) and (d), respectively;
and
■ c. Add new paragraph (b).
The revision and addition read as
follows:
■
§ 172.185
TBHQ.
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(a) The food additive has a melting
point of not less than 126.5 °C.
(b) The percentage of TBHQ in the
food additive is not less than 99.0
percent when tested by the assay
described in the Food Chemicals Codex,
9th ed. (2014), pp. 1192–1194, which is
incorporated by reference, or an
equivalent method. The Director of the
Office of the Federal Register approves
this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address:
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030 or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
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Dated: June 9, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2015–14704 Filed 6–15–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 526, and
528
[Docket No. FDA–2015–N–0002]
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
SUMMARY:
E:\FR\FM\16JNR1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Rules and Regulations]
[Pages 34274-34276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14704]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2014-F-0364]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; TBHQ
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulations by removing the upper bound of the melting
point range in the regulation for the antioxidant tertiary
butylhydroquinone (TBHQ) and adding a purity acceptance criterion. This
action is in response to a petition submitted by Eastman Chemical
Company.
DATES: This rule is effective June 16, 2015. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by July 16,
2015. The Director of the Federal Register approves the incorporation
by reference of certain publications listed in the rule as of June 16,
2015.
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2014-F-0364, by any
of the following methods:
Electronic Submissions
Submit electronic objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets
[[Page 34275]]
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-2014-F-0364 for this rulemaking. All objections
received will be posted without change to https://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section.
Docket: For access to the docket to read background documents or
objections received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1309.
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register on April 8, 2014 (79
FR 19301), we announced that we filed a food additive petition (FAP
4A4803) submitted by Eastman Chemical Company, c/o Keller and Heckman
LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001 (petitioner).
The petition proposed to amend the food additive regulations in Sec.
172.185 (21 CFR 172.185) TBHQ by removing the upper bound of the
specified melting point range (126.5 [deg]C to 128.5 [deg]C) and by
adding an acceptance criterion to measure purity of the additive.
Specifically, the petition proposed to allow the use of TBHQ with a
melting point that is 126.5 [deg]C or higher. In addition to this
change in melting point specification, the petition also proposed to
add an acceptance criterion for purity of not less than 99.0 percent
TBHQ, as tested by the titration assay specified in the most current
edition of the Food Chemicals Codex (FCC).
TBHQ is the chemical 2-(1,1-dimethylethyl)-1,4-benzenediol
(Chemical Abstracts Service Registry Number 1948-33-0). In the Federal
Register of November 30, 1972 (37 FR 25356), we issued a final rule
that was codified in 21 CFR 121.1244 to provide for the safe use of
TBHQ in food under certain conditions, including a melting point range
for TBHQ of 126.5 [deg]C-128.5 [deg]C. An amendment to Sec. 121.1244
was issued in the Federal Register of December 10, 1976 (41 FR 53981)
to recognize the name ``TBHQ'' as the common name for tertiary
butylhydroquinone, and to add the Chemical Abstracts Service Registry
Number and nomenclature in the introductory text of Sec. 121.1244. In
the Federal Register of March 15, 1977 (42 FR 14302 at 14495), TBHQ was
recodified from Sec. 121.1244 to Sec. 172.185. No amendments to the
TBHQ regulation have been made since then.
II. Evaluation of Petition
The melting point range of 126.5 [deg]C-128.5 [deg]C was originally
included by FDA in the regulation for TBHQ as part of the chemical
identity of the additive and to ensure purity. The melting point range
describes the initial and final temperatures at which the substance
melts. Data provided in the subject petition show that TBHQ with an
initial melting point of 126.5 [deg]C has a purity of not less than 99
percent, which is consistent with the petitioner's proposed acceptance
criterion specification. However, according to the petitioner,
analytical and manufacturing variability can result in batches of TBHQ
that have a final melting point greater than 128.5 [deg]C, but are of
suitably high purity. Using the titration assay for TBHQ in the FCC 9th
Edition (the most current edition), the petitioner analyzed multiple
samples of TBHQ with a final melting point above 128.5 [deg]C. All
samples had a purity of at least 99 percent. Based on their analysis of
these data, the petitioner concluded that, while melting point has
utility in identifying TBHQ, a maximum melting point specification
limit is unnecessary in the regulation to ensure purity. We agree with
the petitioner and have concluded that the data provided support their
request to remove the upper bound of the melting point range specified
in Sec. 172.185(a), and add a purity acceptance criterion of not less
than 99 percent determined using the titration assay for TBHQ in the
FCC 9th Edition or an equivalent method (Ref. 1).
The petitioner did not propose any modifications to the use or
intended technical effect of TBHQ as currently permitted in Sec.
172.185. As such, the petitioner's proposed amendments will have no
impact on dietary exposure of TBHQ. Therefore, we did not reevaluate
the dietary exposure to TBHQ (Ref. 1). The petitioner also stated that
there are no changes to the manufacturing process and therefore no new
components will be introduced into the diet.
No new toxicology studies were submitted in support of the safety
of the petition request. The petitioner referenced the toxicological
data that had been previously submitted and evaluated when the
regulation for TBHQ was first issued (37 FR 25356). As part of the
safety evaluation for this petition, we conducted an updated literature
search for new toxicological studies related to the safety of TBHQ. Our
literature search did not reveal any new safety issues with the
regulated use of TBHQ or any safety concerns regarding TBHQ with a
final melting point in excess of 128.5 [deg]C (Ref. 2).
III. Incorporation by Reference
FDA is incorporating by reference the monograph for TBHQ in the FCC
9th edition (the most current edition), which was approved by the
Office of the Federal Register. You may purchase a copy of the material
from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852, 1-800-227-8772, https://www.usp.org/.
The FCC is a compendium of internationally recognized standards for
the purity and identity of food ingredients. The FCC monograph for TBHQ
contains a description of a titration assay, which is an analytical
method used to determine the purity of TBHQ.
IV. Conclusion
Based on the data and information in the petition and other
relevant material, we conclude that the proposed amendments to remove
the upper bound of the melting point range in the regulation for TBHQ
and to add a purity acceptance criterion are safe and appropriate.
Therefore, we are amending the regulations in 21 CFR part 172 as set
forth in this document.
V. Public Disclosure
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.
VI. Environmental Impact
We have considered the environmental effects of this rule. As
stated in the April 8, 2014, Federal Register notice of petition for
FAP 4A4803 (79 FR 19301), we have determined, under 21 CFR 25.30(i),
that this action is of a type that does not
[[Page 34276]]
individually or cumulatively have a significant effect on the human
environment such that neither an environmental assessment nor an
environmental impact statement is required. We have not received any
new information or comments that would affect that determination.
VII. Paperwork Reduction Act of 1995
This 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.
VIII. Objections
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
It is only necessary to send one set of documents. Identify
documents with the docket number found in brackets in the heading of
this document. Any objections received in response to the regulation
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 https://www.regulations.gov.
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348).
This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, the Food and Drug Administration
Amendments Act of 2007, which was signed into law on September 27,
2007, amended the FD&C Act to, among other things, add section 301(ll)
of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act
applies. In our review of this petition, we did not consider whether
section 301(ll) of the FD&C Act or any of its exemptions apply to food
containing this additive. Accordingly, this final rule should not be
construed to be a statement that a food containing this additive, if
introduced or delivered for introduction into interstate commerce,
would not violate section 301(ll) of the FD&C Act. Furthermore, this
language is included in all food additive final rules and therefore
should not be construed to be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.
X. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. FDA Memorandum from H. Lee, to E. Anderson, June 18, 2014.
2. FDA Memorandum from A. Khan to E. Anderson, August 6, 2014.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
0
2. Amend Sec. 172.185 as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b) and (c) as paragraphs (c) and (d),
respectively; and
0
c. Add new paragraph (b).
The revision and addition read as follows:
Sec. 172.185 TBHQ.
* * * * *
(a) The food additive has a melting point of not less than 126.5
[deg]C.
(b) The percentage of TBHQ in the food additive is not less than
99.0 percent when tested by the assay described in the Food Chemicals
Codex, 9th ed. (2014), pp. 1192-1194, which is incorporated by
reference, or an equivalent method. The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the
United States Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address: https://www.usp.org). Copies may
be examined at the Food and Drug Administration's Main Library, 10903
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030 or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
Dated: June 9, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2015-14704 Filed 6-15-15; 8:45 am]
BILLING CODE 4164-01-P
