[Federal Register Volume 60, Number 69 (Tuesday, April 11, 1995)]
[Rules and Regulations]
[Pages 18349-18352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8772]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 176 and 178
[Docket No. 93N-0420]
Indirect Food Additives: Paper and Paperboard Components;
Adjuvants, Production Aids, and Sanitizers; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to correct an error in nomenclature for a food additive.
The amendment adds alkyl mono- and disulfonic acids, sodium salts
(produced from n-alkanes in the range of C10-C18 with not
less than 50 percent C14-C16) as a component of paper and
paperboard in contact with food, as an antistatic agent, and as an
emulsifier and/or surface active agent. Additionally, because certain
sections contain multiple entries for the additive, FDA is amending its
food additive regulations so that all uses of the additive will be
combined under single entries in those sections of the regulations.
DATES: Effective April 11, 1995; written objections and requests for a
hearing by May 11, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Andrew Zajac, Center for Food Safety
and Applied Nutrition (HFS-216), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3095.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 21, 1994
(59 FR 3322), FDA published a proposed rule to correct an error in
nomenclature for a food additive regulated in Secs. 176.170, 176.180,
178.3130, and 178.3400 (21 CFR 176.170, 176.180, 178.3130, and
178.3400). The agency proposed to add alkyl mono- and disulfonic acids,
sodium salts (produced from n-alkanes in the range of C10-C18
with not less than 50 percent C14-C16) to those sections and
to remove: (1) The listing ``n-alkylsulfonate (alkyl group is in the
range C10-C18 with not less than 50 percent C14-
C16)'' from Sec. 176.170; (2) the listing ``petroleum sulfonates''
from the list of substances in Sec. 176.180; (3) the listings for
``sodium n-alkylsulfonate (alkyl group in the range of C10-
C18 with not less than 50 percent C14-C16)'' and
``sodium sec-alkyl mono- and disulfonates (alkyl group in the range of
C10-C18 with not less than 50 percent C14-C16)''
from Sec. 178.3130; and (4) the listings for ``n-alkylsulfonate (alkyl
group is in the range C10-C18 with not less than 50 percent
C14-C16)'' and ``sodium sec-alkyl mono- and disulfonates
(alkyl group in the range of C10-C18 with not less than 50
percent C14-C16)'' from Sec. 178.3400.
FDA received no comments on its proposal. The agency is, therefore,
adopting the proposal as a final rule without any changes.
The agency has previously considered the environmental effects of
this rule, as announced in the proposed rule (59 FR 3322, January 21,
1994). No new information or comments have been received that would
affect the agency's previous determination that this action will not
have a significant impact upon the human environment and that neither
an environmental assessment nor an environmental impact statement is
required.
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined
[[Page 18350]] by the Executive Order and so is not subject to review
under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because no current activity is prohibited by this
final rule, the compliance costs to firms are zero. Likewise, because
no increase in the health risks faced by consumers will result from
this final rule, total costs are also zero. The agency certifies that
the final rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
Furthermore, in accordance with the Regulatory Flexibility Act, the
agency previously considered the potential effects that this rule would
have on small entities, including small businesses, and has determined
that no significant economic impact on a substantial number of small
entities would derive from this action. FDA has not received any new
information or comments that would alter its previous determination.
Any person who will be adversely affected by this regulation may at
any time on or before May 11, 1995, 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 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
21 CFR Parts 176 and 178
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 parts 176 and 178 are 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: Secs. 201, 402, 406, 409, 721 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
2. Section 176.170 is amended in the table in paragraph (b)(2) by
removing the entry for ``n-Alkylsulfonate (alkyl group is in the range
C10-C18 with not less than 50 percent C14-C16)''
and by alphabetically adding a new entry under the headings ``List of
substances'' and ``Limitations'' to read as follows:
Sec. 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
* * * * *
(b) * * *
(2) * * *
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
* * * *
* * *
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-
alkanes in the range of C10-C18
with not less than 50 percent C14-
C16)..
1. As emulsifiers for vinylidene
chloride copolymer coatings and
limited to use at levels not to
exceed 2 percent by weight of the
coating solids.
2. As emulsifiers for vinylidene
chloride copolymer or homopolymer
coatings at levels not to exceed a
total of 2.6 percent by weight of
coating solids. The finished
polymer contacts food only of
types identified in paragraph (c)
of this section, Table 1, under
Types I, II, III, IV, V, VIA, VIB,
VII, VIII, and IX and under
conditions of use E, F, and G
described in Table 2 of paragraph
(c) of this section.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
3. Section 176.180 is amended in the table in paragraph (b)(2) by
removing the entry for ``Petroleum sulfonates'' and by alphabetically
adding a new entry under the heading ``List of substances'' to read as
follows:
Sec. 176.180 Components of paper and paperboard in contact with dry
food.
* * * * *
(b) * * *
(2) * * *
[[Page 18351]]
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
* * * *
* * *
Alkyl mono- and disulfonic acids,
sodium salts (produced from n-
alkanes in the range of C10-C18
with not less than 50 percent C14-
C16)..
* * * *
* * *
------------------------------------------------------------------------
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
4. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
5. Section 178.3130 is amended in the table in paragraph (b) by
removing the entries for ``Sodium n-alkylsulfonate (alkyl group in the
range of C10-C18 with not less than 50 percent C14-
C16)'' and ``Sodium sec-alkyl mono- and disulfonates (alkyl group
in the range of C10-C18 with not less than 50 percent
C14-C16)'' and by alphabetically adding a new entry under the
headings ``List of substances'' and ``Limitations'' to read as follows:
Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
* * * * *
(b) * * *
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-
alkanes in the range of C10-C18
with not less than 50 percent C14-
C16)..
1. As antistatic agents at levels
not to exceed 0.1 percent by
weight of polyolefin films that
comply with Sec. 177.1520 of this
chapter: Provided, that the
finished olefin polymers contact
foods of Types I, II, III, IV, V,
VIA, VIB, VII, VIII, and IX
described in Table 1 of Sec.
176.170(c) of this chapter, and
under conditions of use E, F, and
G described in Table 2 of Sec.
176.170(c) of this chapter.
2. As antistatic agents at levels
not to exceed 3.0 percent by
weight of polystyrene or rubber-
modified polystyrene complying
with Sec. 177.1640(c) of this
chapter under conditions of use B
through H described in Table 2 of
Sec. 176.170(c) of this chapter.
* * * *
* * *
------------------------------------------------------------------------
6. Section 178.3400 is amended in the table in paragraph (c) by
removing the entries for ``n-Alkylsulfonate (alkyl group is in the
range C10-C18 with not less than 50 percent C14-
C16)'' and ``Sodium sec-alkyl mono- and disulfonates (alkyl group
in the range of C10-C18 with not less than 50 percent
C14-C16)'' and by alphabetically adding a new entry under the
headings ``List of substances'' and ``Limitations'' to read as follows:
Sec. 178.3400 Emulsifiers and/or surface active agents.
* * * * *
(c) * * *
[[Page 18352]]
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Alkyl mono- and disulfonic acids, For use only:
sodium salts (produced from n-
alkanes in the range of C10-C18
with not less than 50 percent C14-
C16)..
1. As provided in Sec. 176.170 of
this chapter.
2. At levels not to exceed 2
percent by weight of polyvinyl
chloride and/or vinyl chloride
copolymers complying with Sec.
177.1980 of this chapter.
3. As emulsifiers in vinylidene
chloride copolymer or homopolymer
coatings at levels not to exceed a
total of 2.6 percent by weight of
coating solids. The finished
polymer contacts food only of the
Types I, II, III, IV, V, VIA, VIB,
VII, VIII, and IX as identified in
Table 1 of Sec. 176.170(c) of this
chapter, and limited to conditions
of use E, F, and G described in
Table 2 of Sec. 176.170 of this
chapter.
4. As emulsifiers and/or surface-
active agents at levels not to
exceed 3.0 percent by weight of
polystyrene or rubber-modified
polystyrene complying with Sec.
177.1640(c) of this chapter under
conditions of use B through H
described in Table 2 of Sec.
176.170(c) of this chapter.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Dated: April 3, 1995.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Intitiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 95-8772 Filed 4-10-95; 8:45 am]
BILLING CODE 4160-01-F
