[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Proposed Rules]
[Page 34615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15535]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / 
Proposed Rules  

[[Page 34615]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2017-F-3717]


Juice Products Association; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Juice Products 
Association, proposing that the food additive regulations be amended to 
replace the current Recommended Daily Intake (RDI) percentage values of 
calcium in fruit juices and fruit juice drinks in the regulation for 
vitamin D3 with absolute values and to update the 
specifications for vitamin D3.

DATES: The food additive petition was filed on June 1, 2017.

ADDRESSES: For access to the docket, 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that 
we have filed a food additive petition (FAP 7A4818), submitted on 
behalf of the Juice Products Association by Hogan Lovells US LLP, 
Columbia Square, 555 Thirteenth Street NW., Washington, DC 20004. The 
petition proposes to amend the food additive regulations in Sec.  
172.380 (21 CFR 172.380) Vitamin D3 by replacing the current 
RDI percentage values of calcium in fruit juices and fruit juice drinks 
specified in Sec.  172.380(c)(1) and (2) with absolute values and to 
update the specifications for vitamin D3 established in 
Sec.  172.380(b) by incorporating by reference the most recent edition 
of the Food Chemicals Codex.
    These proposed changes would allow manufacturers of fruit juices 
and fruit juice drinks that are fortified with calcium to maintain the 
absolute level of added calcium at 330 milligrams (mg) and 130 mg, 
respectively, as established in our regulations at Sec.  172.380(c)(1) 
and (2).
    We have determined under 21 CFR 25.30(i) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment because the amendments are 
administrative in nature and permit manufacturers of fruit juices and 
fruit juice drinks that are fortified with calcium to maintain current 
calcium fortification levels in these products. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

    Dated: July 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15535 Filed 7-25-17; 8:45 am]
 BILLING CODE 4164-01-P