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Final Rule.
SUMMARY
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits. This action is in response to a color additive petition (CAP) submitted by E. & J. Gallo Winery.
TABLE OF CONTENTS
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DATES:
ADDRESSES:
Electronic Submissions
Written Submissions
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
II. Safety Evaluation
A. Determination of Safety
B. Safety of the Petitioned Use of the Color Additive
III. Conclusion
IV. Public Disclosure
V. Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
VIII. Objections
IX. References
List of Subjects in 21 CFR Part 73
PART 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
DATES:
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This rule is effective November 2, 2015. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by October 30, 2015.
ADDRESSES:
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You may submit either electronic or written objections and requests for a hearing, identified by Docket No. FDA-2015-C-1154, 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 or submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name and Docket No. FDA-2015-C-1154 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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Salome Bhagan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-3041.
SUPPLEMENTARY INFORMATION:
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I. Background
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In a notice published in the Federal Register on April 22, 2015 (80 FR 22449), we announced that we filed a color additive petition (CAP 5C0302) to amend the color additive regulations in 73.350 Mica-based pearlescent pigments (21 CFR 73.350).
CAP 5C0302 was submitted by E. & J. Gallo Winery, c/o Keller and Heckman LLP, Three Embarcadero Center, Suite 1420, San Francisco, CA 94111 (petitioner). In CAP 5C0302, E. & J. Gallo Winery proposed to amend the color additive regulations in 73.350 to increase the maximum permitted alcohol content of distilled spirits to which mica-based pearlescent pigments may be added from 23 percent to 25 percent alcohol by volume, and to remove the current limitation for distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. The term distilled spirits is defined by the Alcohol and Tobacco Tax and Trade Bureau as ethyl alcohol, hydrated oxide of ethyl, spirits of wine, whisky, rum, brandy, gin, and other distilled spirits, including all dilutions and mixtures thereof, for nonindustrial use. The term does not include mixtures containing wine, bottled at 48 degrees of proof or less, if the mixture contains more than 50 percent wine on a proof gallon basis (27 CFR 5.11).
Mica-based pearlescent pigments prepared from titanium dioxide and mica are currently approved under 73.350(c)(1)(i) for use as a color additive in amounts up to 1.25 percent, by weight, in cereals, confections and frostings, gelatin deserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. They are also approved under 73.350(c)(1)(ii) in amounts up to 0.07 percent, by weight, in: Distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis ( 73.350(c)(1)(ii)(A)); cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, and cocktails ( 73.350(c)(1)(ii)(B)); and non-alcoholic cocktail mixes and mixers, such as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, and beverages that are typically consumed without added alcohol (e.g., fruit juices, fruit juice drinks, and soft drinks) ( 73.350(c)(1)(ii)(C)). The pigments also are approved under 73.350(c)(1)(iii) in egg decorating kits used for coloring the shells of eggs in amounts consistent with good manufacturing practice. Mica-based pearlescent pigments prepared from titanium dioxide on mica, iron oxide on mica, and titanium dioxide and iron oxide on mica are approved for use as a color additive in ingested drugs under 73.1350 (21 CFR 73.1350). Mica-based pearlescent pigments formed by depositing titanium or iron salts from a basic solution onto mica, followed by calcination to produce titanium dioxide or iron oxides on mica, are approved for use in contact lenses under 73.3128 (21 CFR 73.3128). The color additive that is mica-based pearlescent pigments prepared from titanium dioxide and mica will be referred hereinafter in this final rule as mica-based pearlescent pigments.
II. Safety Evaluation
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A. Determination of Safety
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establishes that the color additive is safe for that use. FDA's color additive regulations in 21 CFR 70.3(i) define safe to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. To establish with reasonable certainty that a color additive intended for use in food is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare an individual's estimated daily intake (EDI) of the additive from all sources to an acceptable daily intake (ADI) established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the additive. We typically use the EDI for the 90th percentile consumer of a color additive as ameasure of high chronic dietary exposure.
B. Safety of the Petitioned Use of the Color Additive
During our safety review of the use of mica-based pearlescent pigments proposed in CAP 5C0302, we considered the exposure to the color additive from its petitioned use and from the currently permitted uses in food and ingested drugs under 73.350 and 73.1350, respectively. In estimating the cumulative estimated dietary intake (CEDI) of these pigments, we determined that the exposure to mica-based pearlescent pigments from the use in egg decorating kits used for coloring the shells of boiled eggs and in contact lenses ( 73.350(c)(1)(iii) and 73.3128, respectively) is negligible and, therefore, does not contribute to the exposure.
The petitioner estimated the eaters-only exposure to mica-based pearlescent pigments from the proposed use in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume at 0.14 grams per person per day (g/p/d) at the mean and 0.31 g/p/d at the 90th percentile for the U.S. population (Ref. 1). (An eaters-only exposure is the total of the amount of food consumed per day averaged over the number of days in the survey period by individuals consuming the food at least once during the survey period.) We conclude that the petitioner's exposure estimates are sufficiently conservative to account for the petitioned use of mica-based pearlescent pigments. Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that provided for the safe use of mica-based pearlescent pigments as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs, we estimated the CEDI for the use of mica-based pearlescent pigments in food ( 73.350) and ingested drugs ( 73.1350) to be 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the U.S. population (80 FR 32303 at 32305, June 8, 2015). Since the petitioned use of mica-based pearlescent pigments will generally substitute for currently-permitted uses of mica-based pearlescent pigments in other alcoholic beverages with no change in the maximum use level of 0.07 percent by weight, we have determined that the petitioned use of mica-based pearlescent pigments will not result in an increase in consumer exposure to these pigments. Therefore, we conclude that our previous CEDI for mica-based pearlescent pigments of 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the U.S. population will remain unchanged (Ref. 1).
To support the safety of the proposed use of mica-based pearlescent pigments in food, the petitioner referenced the safety determination made by FDA for previously filed petitions (70 FR 42271, July 22, 2005); (71 FR 31927, June 2, 2006); and (78 FR 35115, June 12, 2013); including our previously established ADI for mica-based pearlescent pigments of 1.8 g/p/d based on a 2-year rat carcinogenicity bioassay (71 FR 31927 at 31928). Because there is no increase in the intake of mica-based pearlescent pigments beyond a level that has already been established as safe, FDA has no concerns regarding the petitioned use of mica-based pearlescent pigments in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume (Ref. 2).
III. Conclusion
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Based on the data and information in the petition and other relevant material, FDA concludes that the petitioned use of mica-based pearlescent pigments prepared from titanium dioxide and mica as a color additive at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in part 73 as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), we conclude that certification of mica-based pearlescent pigments prepared from titanium dioxide and mica is not necessary for the protection of the public health.
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