[Federal Register Volume 64, Number 163 (Tuesday, August 24, 1999)]
[Rules and Regulations]
[Pages 46129-46130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21851]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 176
[Docket No. 96F-0145]
Indirect Food Additives: Paper and Paperboard Components
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of
tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. 55566-30-8) as
a slimicide for use in the manufacture of paper and paperboard that
contact food. This action responds to a petition filed by Albright &
Wilson, Ltd.
DATES: This regulation is effective August 24, 1999; submit written
objections and requests for a hearing by September 23, 1999.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Vivian M. Gilliam, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3094.
SUPPLEMENTARY INFORMATION:
In a notice published in the Federal Register of May 20, 1996 (61
FR 25228), FDA announced that a food additive petition (FAP 5B4472) had
been filed by Albright & Wilson, Ltd., c/o Delta Analytical Corp., 7910
Woodmont Ave., suite 1000, Bethesda, MD 20814. The petition proposed to
amend the food additive regulations in Sec. 176.300 Slimicides (21 CFR
176.300) to provide for the safe use of
tetrakis(hydroxymethyl)phosphonium sulfate as a slimicide in the
manufacture of paper and paperboard intended to contact food. Albright
and Wilson, Ltd. is currently represented by Lewis & Harrison, 122 C
St. NW., suite 740, Washington, DC 20001. (Formerly represented by
Delta Analytical Corp., 7910 Woodmont Ave., suite 1000, Bethesda, MD
20814.)
When the petition was filed on May 20, 1996, it contained an
environmental assessment (EA). In the notice of filing, the agency
announced that it was placing the EA on display at the Dockets
Management Branch for public review and comment (61 FR 25228). No
comments were received. On July 29, 1997 (62 FR 40569), FDA published
revised regulations under part 25 (21 CFR part 25), which became
effective on August 28, 1997. On January 7, 1999, the petitioner
submitted a claim of categorical exclusion under new Sec. 25.32(q), in
accordance with the procedures in Sec. 25.15(a) and (d). Because the
agency had not completed its review of the earlier submitted EA, the
agency reviewed the claim of categorical exclusion under Sec. 25.32(q)
for the final rule and has determined that this action is a type that
does not individually or cumulatively have a significant effect on the
human environment. Therefore, neither an EA nor an environmental impact
statement is required.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that: (1) The proposed
use of tetrakis(hydroxymethyl)phosphonium sulfate as a slimicide in the
manufacture of paper and paperboard that contact food is safe; (2) the
additive will achieve its intended technical effect; and therefore,(3)
the regulation in Sec. 176.300(c) should be amended as set forth below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above. As provided in Sec. 171.1(h),
the agency will delete from the documents any materials that are not
available for public disclosure before making the documents available
for inspection.
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may at
any time on or before September 23, 1999, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for
[[Page 46130]]
which a hearing is requested shall include a detailed description and
analysis of the specific factual information intended to be presented
in support of the objection in the event that a hearing is held.
Failure to include such a description and analysis for any particular
objection shall constitute a waiver of the right to a hearing on the
objection. Three copies of all documents shall be submitted and shall
be identified with the docket number found in brackets in the heading
of this document. Any objections received in response to the regulation
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
List of Subjects in 21 CFR Part 176
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 176 is amended as follows:
PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
1. The authority citation for 21 CFR part 176 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 346, 348, 379e.
2. Section 176.300 is amended by alphabetically adding an entry to
the table in paragraph (c) to read as follows:
Sec. 176.300 Slimicides.
* * * * *
(c) * * *
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List of Substances Limitations
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* * *
Tetrakis(hydroxymethyl)phosphonium Maximum use level of 84 mg/kg in
sulfate (CAS Reg. No. 55566-30-8) the pulp slurry. The additive may
also be added to water, which when
introduced into the pulp slurry,
results in a concentration in the
pulp slurry not to exceed 84 mg/
kg.
* * * *
* * *
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Dated: August 12, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-21851 Filed 8-23-99; 8:45 am]
BILLING CODE 4160-01-F
