[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Rules and Regulations]
[Pages 536-537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-32112]
[[Page Unknown]]
[Federal Register: January 5, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0439]
21 CFR Part 100
Misleading Containers; Nonfunctional Slack-Fill
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revoking a
regulation that implements section 403(d) of the Federal Food, Drug,
and Cosmetic Act (the act) by defining the circumstances in which a
food is misbranded, and that became final by operation of law on May
10, 1993. In addition, the agency is replacing this revoked regulation
with one that was included in a final rule that published in the
Federal Register of December 6, 1993 (58 FR 64123).
EFFECTIVE DATE: January 5, 1994.
FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION: The Nutrition Labeling and Education Act of
1990 (the 1990 amendments) (Pub. L. 101-535) became law on November 8,
1990. Section 6 of the 1990 amendments established a procedure under
which FDA was given 30 months from the date of their enactment to
promulgate final rules implementing that section. Pursuant to that
procedure, FDA published a proposal on January 6, 1993 (58 FR 2957)
(the misleading container proposal), to amend its regulations by
implementing new Sec. 100.100 (21 CFR 100.100) to define the
circumstances in which a food is misbranded under section 403(d) of the
act (21 U.S.C. 343(d)).
Section 6(b)(3)(D)(ii) of the 1990 amendments provides that, if the
final rule to implement section 403(d) of the act is not promulgated
within 30 months of the date of passage of the 1990 amendments
(November 8, 1990), then the regulation proposed to implement that
section is to be considered a final regulation. Further, section 6
provides that States and their political subdivisions shall be
preempted with respect to section 403(d) of the act at that time.
The 30-month period established by the 1990 amendments expired on
May 9, 1993. Because FDA was unable to publish a final rule, in the
proceeding instituted in January 1993, by May 9, 1993, FDA published a
document in the Federal Register of May 12, 1993 (58 FR 27932) (the May
12, 1993, regulation), announcing that the regulation that FDA had
proposed in the misleading container proposal was considered to be a
final regulation by operation of law, effective May 10, 1993. This
document did not conclude the rulemaking begun in January, 1993,
however. Rather, the May 12, 1993, regulation was part of a separate
proceeding that is compelled under section 6(b)(3)(D)(ii) of the 1990
amendments (see H. Rept. 101-538, 101st Cong., 2d sess. 18 and 136
Congressional Record 5842 on the effect of this ``hammer'' provision).
In the Federal Register of December 6, 1993 (58 FR 64123), FDA
published a final rule on the circumstances in which containers are
misleading and thus would misbrand the food under section 403(d) of the
act. This final rule concluded the proceeding that the agency
instituted with the misleading container proposal. In the May 12, 1993,
document, FDA stated that when it issued such a final rule, it would
act to supersede the regulation that had become final by operation of
law. Thus, the agency proposed to withdraw the May 10, 1993, regulation
in the Federal Register of December 6, 1993 (58 FR 64208).
FDA explained that it was proposing to do so for two reasons.
First, the May 10, 1993, regulation did not have the benefit of public
comment. Thus, the regulation included in the December 6, 1993, final
rule (the December 6, 1993 regulation), which was the product of notice
and comment rulemaking, is better able than the May 10, 1993,
regulation to ensure adequate implementation of section 403(d) of the
act and to facilitate compliance. Second, FDA tentatively found that
because of the minor differences between the May 10, 1993, regulation
and the December 6, 1993, regulation, replacing the former with the
latter will not result in any hardship to manufacturers who have relied
on the May 10, 1993, regulation.
FDA gave interested persons 10 days to comment on its proposal to
withdraw the May 10, 1993, regulation. It also proposed to make any
final rule that issues in this proceeding effective on the date of its
publication in order to ensure that the supersession of the May 10,
1993, regulation proceeded as expeditiously as possible and with a
minimum of confusion or ambiguity.
The comment period on the proposal to withdraw the May 10, 1993,
regulation closed on December 17, 1993. FDA received no comments on
this proposed action. Therefore, FDA advises that the May 10, 1993,
regulation, which became final by operation of law, is withdrawn. FDA
advises that it is replacing that regulation with the December 6, 1993,
regulation.
Environmental Impact
In the December 6, 1993, proposal (58 FR 64208 at 64209), FDA
stated that it had determined under 21 CFR 25.24(a)(ii) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment, and that as a result,
neither an environmental assessment nor an environmental impact
statement is required. FDA received no comments on the conclusion;
therefore FDA restates it here.
Economic Impact
In the December 6, 1993, proposal (58 FR 64208 at 64209), FDA
incorporated the conclusion from the December 6, 1993, final rule on
slack-fill that the agency's action in replacing the May 10, 1993,
regulation would not have any significant economic effects. The agency
received no comments on this conclusion and consequently is restating
it here.
List of Subject in 21 CFR Part 100
Administrative practice and procedure, Food labeling, Foods.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
100 is amended as follows:
PART 100--GENERAL
1. The authority citation for 21 CFR part 100 continues to read as
follows:
Authority: Secs. 201, 301, 307, 402, 403, 409, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 337, 342,
343, 348, 371).
Sec. 100.100 [Removed]
2. Subpart F consisting of Sec. 100.100 Misleading containers (as
published in the Federal Register of May 12, 1993 (58 FR 27932), is
removed.
3. For the convenience of the reader, FDA is republishing without
change new subpart F, consisting of Sec. 100.100 (as published in the
Federal Register of December 6, 1993 (58 FR 64136) to read as follows:
Subpart F--Misbranding for Reasons Other Than Labeling
Sec. 100.100 Misleading containers.
In accordance with section 403(d) of the act, a food shall be
deemed to be misbranded if its container is so made, formed, or filled
as to be misleading.
(a) A container that does not allow the consumer to fully view its
contents shall be considered to be filled as to be misleading if it
contains nonfunctional slack-fill. Slack-fill is the difference between
the actual capacity of a container and the volume of product contained
therein. Nonfunctional slack-fill is the empty space in a package that
is filled to less than its capacity for reasons other than:
(1) Protection of the contents of the package;
(2) The requirements of the machines used for enclosing the
contents in such package;
(3) Unavoidable product settling during shipping and handling;
(4) The need for the package to perform a specific function (e.g.,
where packaging plays a role in the preparation or consumption of a
food), where such function is inherent to the nature of the food and is
clearly communicated to consumers;
(5) The fact that the product consists of a food packaged in a
reusable container where the container is part of the presentation of
the food and has value which is both significant in proportion to the
value of the product and independent of its function to hold the food,
e.g., a gift product consisting of a food or foods combined with a
container that is intended for further use after the food is consumed;
or durable commemorative or promotional packages; or
(6) Inability to increase level of fill or to further reduce the
size of the package (e.g., where some minimum package size is necessary
to accommodate required food labeling (excluding any vignettes or other
nonmandatory designs or label information), discourage pilfering,
facilitate handling, or accommodate tamper-resistant devices).
(b) [Reserved]
Dated: December 30, 1993.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 93-32112 Filed 12-30-93; 2:40 pm]
BILLING CODE 4160-01-F
