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