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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.
TABLE OF CONTENTS
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DATES:
ADDRESSES:
Electronic Submissions
Written Submissions
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
II. Evaluation of Petition
III. Incorporation by Reference
IV. Conclusion
V. Public Disclosure
VI. Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Objections
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
X. References
List of Subjects in 21 CFR Part 172
PART 172FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
DATES:
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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:
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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 DocketsManagement (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:
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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:
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I. Background
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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-(1,1-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 C-128.5 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
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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.
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
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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
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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.
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