[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Proposed Rules]
[Page 54526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23671]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2015-F-2712]
Adisseo France S.A.S.; Filing of Food Additive Petition (Animal
Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; petition for rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that Adisseo France S.A.S. has filed a petition proposing that the food
additive regulations be amended to provide for the safe use of silicon
dioxide as a carrier for selenomethionine hydroxy analogue at a level
not to exceed 95 percent of the selenomethionine hydroxy analogue in
its packaged form.
DATES: The food additive petition was filed on June 18, 2015.
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: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-6729, [email protected].
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a
food additive petition (FAP 2291) has been filed by Adisseo France
S.A.S., Immeuble Antony Parc II, 10 Place du G[eacute]n[eacute]ral de
Gaulle, 92160 Antony, France. The petition proposes to amend Title 21
of the Code of Federal Regulations (CFR) in part 573 (21 CFR part 573)
Food Additives Permitted in Feed and Drinking Water of Animals to
provide for the safe use of silicon dioxide as a carrier for
selenomethionine hydroxy analogue at a level not to exceed 95 percent
of the selenomethionine hydroxy analogue in its packaged form. In an
earlier notice of petition (80 FR 48471, August 13, 2015), the use of
silicon dioxide was omitted.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.
Dated: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23671 Filed 10-29-18; 8:45 am]
BILLING CODE 4164-01-P