[Federal Register: March 26, 2004 (Volume 69, Number 59)]
[Rules and Regulations]
[Page 15667-15669]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr04-10]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 1996F-0176]
Indirect Food Additives: Polymers; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending its food
additive regulations to correctly reflect all materials that are
permitted for use as films/layers of laminated articles intended for
use with food. The current requirements for polymer films/layers are
incomplete due to an inadvertent error. This document is
[[Page 15668]]
editorial in nature and amends the regulations to correct this error.
DATES: This rule is effective March 26, 2004. Submit written or
electronic comments by April 26, 2004.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has discovered that an error has become incorporated into the
agency's regulations in part 177 (21 CFR part 177). In the Federal
Register of August 25, 1999 (64 FR 46271), FDA published a final rule
with an inadvertent error. In this final rule, Sec. 177.1390 was
amended, and existing paragraph (c)(1)(i)(f) was not redesignated as
paragraph (c)(1)(i)(g). Because Sec. 177.1390(c)(1)(i)(g) was not
added to the agency's regulations, the regulations are incorrect.
Accordingly, Sec. 177.1390 is being amended to correct this error.
To the extent that 5 U.S.C. 553 applies to this action, the
agency's implementation of this action without opportunity for public
comment comes within the good cause exception in 5 U.S.C. 553(b)(3)(B)
in that obtaining public comment is impracticable, unnecessary, and
contrary to public interest. This amendment to the food additive
regulations corrects an inadvertent omission in the Code of Federal
Regulations (CFR). The purpose of this final rule is to update the
regulations in part 177 to correctly reflect all materials that are
permitted for use as films/layers of laminated articles intended for
use with food. In accordance with 21 CFR 10.40(e)(1), FDA is providing
an opportunity for comment on whether the regulation should be
subsequently modified or revoked.
II. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 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). Under the Regulatory
Flexibility Act, if a rule has a significant economic impact on a
substantial number of small entities, an agency must analyze regulatory
options that would minimize any significant impact of the rule on small
entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995
requires that agencies prepare a written statement of anticipated costs
and benefits before proposing any rule that may result in an
expenditure in any one year by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million(adjusted
annually for inflation).
The agency concludes that this final rule is consistent with the
principles set out in Executive Order 12866 and in these two statutes.
FDA has determined that the final rule is not a significant regulatory
action as defined by the Executive order and so is not subject to
review under the Executive order.
The Unfunded Mandates Reform Act of 1995 does not require FDA to
prepare a statement of costs and benefits for this final rule, because
the final rule is not expected to result in any 1-year expenditure that
would exceed $100 million adjusted for inflation. The current inflation
adjusted statutory threshold is $112.3 million.
The purpose of this final rule is to update the regulations in part
177 to correctly reflect all materials that are permitted for use as
films/layers of laminated articles intended for use with food. Because
this rule simply adds an additional permitted use that was
inadvertently omitted from Sec. 177.1390, this rule does not impose
any additional costs on industry. Consequently, the agency certifies
that this 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.
III. Paperwork Reduction Act of 1995
The final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
IV. Environmental Impact
The agency has 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. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
VI. Opportunity for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 177
Food additives, Food packaging.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
0
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
0
2. Section 177.1390 is amended by adding paragraph (c)(1)(i)(g) to read
as follows:
Sec. 177.1390 Laminate structures for use at temperatures of 250
[deg]F and above.
* * * * *
(c) * * *
(1) * * *
(i) * * *
(g) Polymeric resins that comply with an applicable regulation in
this chapter which permits food type and time/temperature conditions to
which the
[[Page 15669]]
container will be exposed, including sterilization processing.
* * * * *
Dated: March 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6738 Filed 3-25-04; 8:45 am]
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