Misleading Containers; Nonfunctional Slack-Fill

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