[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]



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.


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.


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.

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:


1. The authority citation for 21 CFR part 177 continues to read as 

    Authority: 21 U.S.C. 321, 342, 348, 379e.

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]