[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]


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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.

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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: http://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 http://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 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 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, http://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 http://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 http://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: http://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: http://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