Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Proposed Rules 8989

borrower to RUS and the annual

auditor’s report on the borrower’s

operations. However, RUS may inspect

the borrower’s records at any time

during the year to determine borrower

compliance. If a borrower’s most recent

annual financial and statistical report

shows the aggregate of the borrower’s

investments, loans and guarantees to be

below the 15 percent level, that in no

way relieves the borrower of its

obligation to comply with its RUS

mortgage, RUS loan contract, and this

subpart with respect to Administrator

approval of any additional investment,

loan or guarantee that would cause the

aggregate to exceed the 15 percent level.

§ 1717.658 Effect of this subpart on RUS

loan contract and mortgage.

(a) Nothing in this subpart shall affect

any provision, covenant, or requirement

in the RUS mortgage, RUS loan contract,

or any other agreement between a

borrower and RUS with respect to any

matter other than the prior approval by

RUS of investments, loans, and

guarantees made by the borrower. Also,

nothing in this subpart shall affect any

rights which supplemental lenders have

under the RUS mortgage, or under their

loan contracts or other agreements with

their borrowers, to limit investments,

loans and guarantees by their borrowers

to levels below 15 percent of total utility

plant.

(b) RUS reserves the right to change

the provisions of the RUS mortgage and

loan contract relating to RUS approval

of investments, loans and guarantees

made by the borrower, on a case-by-case

basis, in connection with providing

additional financial assistance to a

borrower after [Date 30 days after the

final rule is published in the Federal

Register].

Dated: February 7, 1995.

Bob J. Nash,

Under Secretary, Rural Economic and

Community Development.

[FR Doc. 95–3665 Filed 2–15–95; 8:45 am]

BILLING CODE 3410–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 111, 170, and 310

[Docket Nos. 91P–0186 and 93P–0306]

Iron-Containing Supplements and

Drugs; Label Warning Statements and

Unit-Dose Packaging Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Supplemental proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a

supplemental proposed rule to set forth

its legal authority, after the passage of

the Dietary Supplement Health and

Education Act (DSHEA), to require unitdose packaging of iron-containing

dietary supplements that contain 30

milligrams (mg) or more iron per dosage

unit. On October 6, 1994, the agency

proposed this packaging requirement as

part of a broader proposal to require

unit-dose packaging of all ironcontaining products in solid oral dosage

form containing 30 mg or more iron per

dosage unit and to require label warning

statements on all iron-containing

products in solid oral dosage form. The

agency’s authority to establish the

labeling requirements and the packaging

requirements for iron-containing

products other than dietary

supplements (i.e., iron-containing

drugs) is unaffected by the DSHEA. To

ensure that there is adequate time to

comment on this supplemental

proposed rule, as well as on the issues

raised by the initial proposal, FDA is

reopening the comment period for this

rulemaking until April 17, 1995.

DATES: Written comments to the initial

proposal (published at 59 FR 51030,

October 6, 1994) and this supplemental

proposal by April 17, 1995. The agency

is proposing that any final rule that may

be issued based upon this proposal

become effective 180 days after its

publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

N. Hathcock, Center for Food Safety and

Applied Nutrition (HFS–465), Food and

Drug Administration, 8301 Muirkirk

Rd., Laurel, MD 20708, 301–594–6006.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 6,

1994 (59 FR 51030), FDA issued a

proposal on actions that it tentatively

concluded were necessary to stem the

recent epidemic of pediatric poisonings

from accidental overdoses of ironcontaining products. The available

evidence shows that since the mid

1980’s, there has been an upsurge in

reported accidental pediatric poisonings

from ingestion of iron-containing

products (59 FR 51030). This upsurge in

poisonings, and the many resultant

injuries and deaths of children, have

created a dilemma with respect to how

to ensure that iron sources are available

while still minimizing the risks to

children.

To protect children, FDA proposed

two new requirements: First, to ensure

that consumers are fully informed about

the consequences of consuming ironcontaining products, FDA proposed to

require a warning statement about the

adverse effects of acute, high-dose iron

ingestion by children to be included in

the labeling of all iron-containing

products in solid oral dosage form. FDA

found that the fact that poisonings

continue to occur, even though there

have been at least 37 deaths from

accidental iron ingestion, strongly

suggests that many adults are not aware

of the potential for serious harm or

death in young children from accidental

ingestion of iron-containing products.

Support for this finding is provided by

statements made by the parents of the

victims in several of the poisoning

incidents, described in the case reports

obtained from the U.S. Consumer

Product Safety Commission (CPSC).

FDA proposed that this requirement

apply to iron-containing drugs and

dietary supplements based on its

authority under sections 201(n),

403(a)(1), 502(a), and 701(a) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 321(n), 343(a)(1),

352(a), and 371(a)). Under section

403(a)(1) of the act, a food is

misbranded if its labeling is false or

misleading in any particular. Section

502(a) of the act establishes the same

rule for drugs. Section 201(n) of the act

states:

If an article is alleged to be misbranded

because the labeling or advertising is

misleading, then in determining whether the

labeling or advertising is misleading there

shall be taken into account (among other

things) not only representations made or

suggested by statement, word, design, device,

or any combination thereof, but also the

extent to which the labeling or advertising

fails to reveal facts material in the light of

such representations or material with respect

to consequences which may result from the

use of the article to which the labeling or

advertising relates under the conditions of

use prescribed in the labeling or advertising

thereof or under such conditions of use as are

customary or usual.

These statutory provisions, combined

with section 701(a) of the act, which

grants the agency authority to issue

regulations for the efficient enforcement

of the act, clearly authorize FDA to issue

a regulation designed to ensure that

persons using iron-containing drugs and

dietary supplements will receive

information that is material with respect

to consequences that may result from

the use of the product.
8990 Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Proposed Rules

The circumstances involved with the

iron poisonings parallel in many

significant respects those that led the

agency to require a warning on protein

products. The use of iron-containing

products in households where children

are present is in no way an unusual

practice. Multi-vitamin/mineral

supplements with iron are taken

routinely by children, and products of

this type specifically intended for use

by children are widely available and

commonly sold. Iron supplements and

iron-containing drug products are

frequently recommended by physicians

for pregnant women (often with a

prescription) and other women of childbearing age to meet their dietary

requirement (these groups require more

iron than other adults). Yet, the

evidence on poisonings and deaths

shows that the presence of ironcontaining products in households with

young children can lead to accidental

injury or death if the children gain

access to the products. Thus, FDA

tentatively concluded that a warning

about the risk of accidental pediatric

poisoning from iron-containing

products in solid oral dosage form is

necessary in the labeling of all ironcontaining products.

Second, FDA proposed to require that

all iron-containing drugs and dietary

supplements in solid oral dosage form

that contain 30 mg or more iron per

dosage unit be packaged in unit-dose

packaging. In the proposal, FDA

tentatively concluded that full

compliance with CPSC’s child resistant

packaging requirements, even if there

are warning statements in labeling of

iron-containing products and

appropriate educational programs, is not

adequate to ensure the safe use of

certain iron-containing drugs and

dietary supplements if bottle and

closure packaging were to continue as

the predominant means of packaging

such products. FDA recognizes that

each of these measures either has been

successful in limiting the number of

poisonings or can be reasonably

expected to be effective in reducing the

number of poisonings. However, given

the potentially fatal outcome that can

result from pediatric iron poisoning,

FDA stated that it is not persuaded that

these measures are adequate to ensure

the safety of the use of certain ironcontaining drugs and dietary

supplements. To reduce the incidence

of pediatric iron poisonings to a level

that would permit the agency to

conclude that the use of these products

is safe, or generally recognized as safe

(GRAS), FDA tentatively concluded that

it was necessary to require a specific

type of physical barrier to access dietary

supplements that contain 30 mg or more

of iron. Therefore, FDA tentatively

concluded that an additional packaging

requirement was necessary.

FDA proposed this packaging

requirement for iron-containing dietary

supplements based on its authority

under the act, with the provisions

available at that time, to ensure that

food ingredients are safe. In particular,

the act requires, in sections 402 and 409

(21 U.S.C. 342 and 348), that the safety

of each food ingredient be established,

either because the ingredient is GRAS,

or because it is listed under the food

additive or other relevant provisions,

before it is added to food.

Section 409(a) of the act deems a food

additive to be unsafe unless its use

conforms to the conditions specified in

the listing regulation. These conditions

include, but are not limited to,

specifications as to the particular food

or classes of food to which the additive

may be added, the manner in which the

additive may be added to such food, and

any directions or other labeling or

packaging requirements for such

additive deemed necessary to assure the

safety of such use (section 409(c)(1)(A)

of the act). Thus, under the act, the

agency is authorized to specify

packaging requirements for a food

additive when it finds that use of such

packaging is necessary to ensure the safe

use of the additive.

Section 201(s) of the act provides an

exemption to the ‘‘food additive’’

definition for substances that are GRAS

under the conditions of their intended

use. FDA has issued regulations

delineating conditions under which the

use of certain substances is GRAS. In

the proposal, FDA tentatively concluded

that those conditions could include

packaging. Thus if a dietary supplement

contained an iron salt whose use would

be GRAS except for the fact that its

packaging would not ensure that its use

would be safe, the product would be

considered to contain an unsafe food

additive and thus to be adulterated.

FDA proposed the packaging

requirement for iron-containing drugs

based on its authority under section

501(a)(2)(B) of the act (21 U.S.C.

351(a)(2)(B)). This section states that a

drug shall be deemed to be adulterated

if the methods used in, or the facilities

or controls used for, its manufacture,

processing, packing, or holding do not

conform to, or are not operated or

administered in conformity with,

current good manufacturing practice

(CGMP) to assure that such drug meets

the requirements of the act as to safety

and has the identity and strength, and

meets the quality and purity

characteristics, which it purports or is

represented to possess.

Under section 501(a)(2)(B) of the act,

manufacturers are responsible for

preventing intentional misuse of a drug

product. For example, in 1982, in

response to a series of capsule

tamperings, FDA issued a regulation

(§ 211.132), under the authority of this

section, that requires tamper-resistant

packaging for all over-the-counter (OTC)

human drug products except

dermatologics, dentifrices, and insulin

(47 FR 50442, November 5, 1982). The

agency’s action assured greater package

integrity and product security beyond

the point of manufacture.

The recent data available to FDA

demonstrate that the current manner of

holding iron-containing drug products

until their use by the intended

consumer fails to ensure that the drug

products will be safe because large

numbers of children are ingesting such

products and suffering serious injuries

or death. Existing technology permits

additional safeguards, such as childresistant blister packs, to be used for

holding iron-containing drug products.

Given the known dangers and the ability

to minimize or eliminate such dangers

through the use of existing technology,

FDA tentatively concluded that CGMP

dictates that unit-dose packaging be

used.

II. The Dietary Supplement Health and

Education Act

On October 25, 1994, President

Clinton signed into law the DSHEA

(Pub. L. 103–417). The DSHEA contains

two provisions that bear on FDA’s

packaging proposal with respect to

dietary supplements. First, section 3(b)

of the DSHEA added section 201(s)(6) to

the act. This provision excludes

minerals, such as iron, that are used in

dietary supplements from the definition

of a ‘‘food additive.’’ Second, section 9

of the DSHEA added section 402(g) to

the act. Under this provision, a dietary

supplement is adulterated unless it has

been prepared, packed, and held under

conditions that comply with the CGMP

(section 402(g)(1) of the act). Under

section 402(g)(2), the Secretary (and, by

delegation, FDA) is authorized to

prescribe CGMP’s for dietary

supplements by regulation.

The DSHEA does not bear on any

aspect of this rulemaking other than the

proposed packaging requirement for

dietary supplements. Dietary

supplements are deemed to be food and

thus are subject to sections 201(n),

403(a), and 701(a) of the act (see section

201(ff) of the act). Thus, the proposed

labeling requirement for iron-containing

dietary supplements is not affected by
Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Proposed Rules 8991

the DSHEA. Moreover, the DSHEA does

not bear on how drugs are regulated.

Thus, the proposed requirements for

iron-containing drugs are also

unaffected by the new law. Even with

the DSHEA, however, FDA continues to

have authority to require that dietary

supplements that contain 30 mg or more

of iron per dosage unit be unit-dose

packed.

III. Discussion

A. Effect of Section 201(s)(6) of the Act

In the proposal, FDA explained the

basis for its tentative conclusion that it

had authority to impose packaging

requirements on iron-containing dietary

supplements, FDA stated:

Should FDA determine that a particular

type of packaging is necessary to ensure the

safe use of iron substances in dietary

supplements, either as GRAS substances or

as listed food additives, then any use of iron

substances in dietary supplements that does

not involve use of that type of packaging

would constitute a use of an unapproved

food additive and render the dietary

supplements adulterated under the act.

See 59 FR 51047.

This argument is deprived of its legal

validity by new section 201(s)(6) of the

act. The use of iron ingredients in

dietary supplements is not subject to

section 409 of the act, even if the

conditions of use of the iron ingredients

are not those that are GRAS. Thus, FDA

cannot rely on section 409 of the act for

authority to require unit-dose packaging

of dietary supplements.

B. Effect of Section 402(g) of the Act

While, on the one hand, the DSHEA

deprives the agency of the authority that

it relied on in the proposal to require

unit-dose packaging, on the other it

added a new provision to the act that

gives the agency authority to establish

such a requirement.

Section 402(g)(2) of the act provides

that CGMP’s for dietary supplements

shall be modeled after the CGMP’s for

food. The current food CGMP

regulations provide that food is to be

packaged in a way that ensures that it

is safe and sanitary (§§ 110.5(a)(2) and

110.80(b)(13)). As explained in the

preamble to the October 6, 1994,

proposal, FDA has tentatively

concluded that unit-dose packaging is

necessary to ensure the safety of dietary

supplements that contain 30 mg or more

of iron per dosage unit.

As discussed in the proposal, the

recent data available to FDA

demonstrate that iron-containing

products with 30 mg or more iron per

dosage unit are associated with a

significant number of pediatric illnesses

and deaths. As FDA stated with respect

to drugs in the proposal, to ensure that

these products are safe, CGMP requires

that manufacturers respond to this new

information, and take advantage of

advances in technology, to alter, adapt,

or change their manufacturing processes

to ensure that all possible measures

have been taken to eliminate known

dangers from their products.

Existing technology permits

safeguards, specifically unit-dose

packaging, to be used for ironcontaining products, including dietary

supplements. Unit-dose packaging

limits a child’s ability to gain access to

enough dosage units to provide a

harmful amount of iron. Given the

known dangers posed by dietary

supplements that contain 30 mg or more

iron per dosage unit, and the ability to

minimize or eliminate such dangers

through the use of unit-dose packaging,

FDA tentatively concludes that the

CGMP dictates that unit-dose packaging

be used for these products.

Thus, FDA tentatively concludes that,

to ensure that dietary supplements that

contain 30 mg of iron or more per

dosage unit are safe, CGMP requires that

they be packaged in unit-dose

packaging.

The agency will consider conducting

a more complete rulemaking on what

CGMP requirements for dietary

supplements under section 402(g) of the

act are. However, considering the

hazard presented to young children by

iron-containing products, FDA

tentatively concludes that it is

appropriate to effect this aspect of its

CGMP authority in advance of any

broader rulemaking.

To reflect the shift in the agency’s

authority with respect to packaging of

dietary supplements, FDA is codifying

the proposed CGMP requirements for

iron-containing dietary supplements in

new part 111, rather than in part 170 (21

CFR part 170). Proposed § 170.55 is

being removed in this supplemental

proposal and replaced by § 111.1. The

agency is also making conforming

amendments to part 101 to reflect new

part 111 rather than part 170. For the

convenience of the reader, FDA is

republishing the amendments to parts

101 and 310 in their entirety. Thus, the

codified portion of this document will

also reflect the changes proposed in the

October 6, 1994, proposed rule and

thereby supersedes that codified

material.

In proposing the unit-dose packaging

requirement under new part 111, the

agency is removing the provision from

the packaging regulation in the original

proposal that also would have required

the proposed warning labels as a

condition of safe use (i.e., as food

additives or GRAS ingredients) for iron

and iron salts in iron-containing

supplements. The authority for this

requirement was also derived from

section 409 of the act, which permits the

agency to consider any necessary

labeling requirements in establishing

conditions of safe use for a food

additive. New section 201(s)(6) of the

act also invalidates the legal authority

that FDA relied upon for this proposed

provision because the use of iron

ingredients in dietary supplements is no

longer subject to section 409 of the act.

IV. Comments

Because of the change in the law and

issuance of this supplemental proposal,

FDA will allow an additional 60 days

for comment on the entire proposed

action. This additional time will

provide an opportunity for the

submission of all views on the issues in

the rulemaking.

Interested persons may, on or before

April 17, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one 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 office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

V. Environmental Impact

The agency previously considered the

environmental effects of its action to

require unit-dose packaging for ironcontaining products, in the proposed

rule that was published in the Federal

Register of October 6, 1994 (59 FR

51030). The changes in legal authority

being proposed in this document will

not affect the agency’s previously

proposed requirement for unit-dose

packaging for iron-containing products

and, therefore, will not affect the

agency’s previous determination that

there is no significant impact on the

human environment and that an

environmental impact statement is not

required.

VI. Analysis of Impacts

FDA previously examined the impact

of the proposed rule as published in the

Federal Register of October 6, 1994 (59

FR 51030), in accordance with

Executive Order 12866 and the

Regulatory Flexibility Act, and

determined that it is not an

economically significant rule. The

discussion of the legal authority

contained in this supplemental

proposed rule does not alter the
8992 Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Proposed Rules

agency’s conclusions. The rule will

result in total costs of approximately

$53 million and discounted benefits of

between $315 million and $653 million

over the next 20 years (discounted at 7

percent).

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting

and recordkeeping requirements.

21 CFR Part 111

Current good manufacturing practices,

Dietary supplements.

21 CFR Part 170

Administrative practice and

procedure, Food additives, Reporting

and recordkeeping requirements.

21 CFR Part 310

Administrative practice and

procedure, Drugs, Labeling, Medical

Devices, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, the codified text as

proposed in the Federal Register of

October 6, 1994 (59 FR 51030), is

republished in its entirety and is

thereby superseded by this document. It

is further proposed that Title 21,

Chapter I be amended as follows:

PART 101—FOOD LABELING

1. The authority citation for 21 CFR

part 101 continues to read as follows:

Authority: Secs. 4, 5, 6 of the Fair

Packaging and Labeling Act (15 U.S.C. 1453,

1454, 1455); secs. 201, 301, 402, 403, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348, 371).

2. Section 101.17 is amended by

adding a new paragraph (e) to read as

follows:

§ 101.17 Food labeling warning and notice

statements.

* * * * *

(e) Dietary supplements containing

iron or iron salts. (1) The labeling of any

dietary supplement in solid oral dosage

form (e.g., tablets or capsules) that

contains iron or iron salts for use as an

iron source shall bear the following

statement:

(i) If the product is packaged in unitdose packaging as defined in § 111.1 of

this chapter:

WARNING—Keep away from children.

Keep in original package until each use.

Contains iron, which can harm or cause

death to a child. If a child accidentally

swallows this product, call a doctor or poison

control center immediately.

(ii) If the product contains less than

30 milligrams of iron per dosage unit

and is packaged by the manufacturer in

other than unit-dose packaging as

defined in § 111.1 of this chapter, e.g.,

a container with a child-resistant

closure, its label shall bear the following

statement:

WARNING—Close tightly and keep away

from children. Contains iron, which can

harm or cause death to a child. If a child

accidentally swallows this product, call a

doctor or poison control center immediately.

(2) The statement required by

paragraph (e)(1)(i) of this section shall

appear prominently and conspicuously

on the immediate container labeling in

such a way that the warning is intact

until all of the dosage units to which it

applies are used. The statement required

by paragraph (e)(1)(ii) of this section

shall appear prominently and

conspicuously on the immediate

container labeling. In all cases where

the immediate container is not the retail

package, the warning statement shall

also appear prominently and

conspicuously on the principal display

panel of the retail package. In addition,

the warning statement shall appear on

any labeling that contains warnings.

3. Part 111 is added to read as follow:

PART 111—CURRENT GOOD

MANUFACTURING PRACTICE FOR

DIETARY SUPPLEMENTS

Authority: Secs. 201, 402, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 371).

§ 111.1 Iron and iron salts in dietary

supplements.

The use of iron and iron salts as iron

sources in dietary supplements offered

in solid oral dosage form (e.g., tablets or

capsules), and containing 30 milligrams

or more of iron per dosage unit, is safe

and in accordance with current good

manufacturing practice only when such

supplements are packaged in unit-dose

packaging. ‘‘Unit-dose packaging’’

means a method of packaging a product

into a nonreusable container designed to

hold a single dosage unit intended for

administration directly from that

container, irrespective of whether the

recommended dose is one or more than

one of these units. The term ‘‘dosage

unit’’ means the individual physical

unit of the product (e.g., tablets or

capsules).

PART 170—FOOD ADDITIVES

3. The authority citation for 21 CFR

part 170 continues to read as follows:

Authority: Secs. 201, 401, 402, 408, 409,

701 of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 341, 342, 346a, 348, 371).

§ 170.55 [Removed]

4. Section 170.55 Iron and iron salts

in dietary supplements not in

conventional food form (as proposed in

at 59 FR 51030, October 6, 1994) is

removed.

PART 310—NEW DRUGS

5. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 512–516, 520, 601(a), 701, 704,

705, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 360b–360f, 360j, 361(a),

371, 374, 375, 379e; secs. 215, 301, 302(a),

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 242(a), 262, 263b–

263n).

6. New § 310.518 is added to subpart

E to read as follows:

§ 310.518 Drug products containing iron or

iron salts.

Drug products containing elemental

iron or iron salts as an active ingredient

in solid oral dosage form (e.g., capsules

or tablets) shall meet the following

requirements:

(a) Packaging. If the product contains

30 milligrams or more of iron per dosage

unit, it shall be packaged in unit-dose

packaging. ‘‘Unit-dose packaging’’

means a method of packaging a product

into a nonreusable container designed to

hold a single dosage unit intended for

administration directly from that

container, irrespective of whether the

recommended dose is one or more than

one of these units. The term ‘‘dosageunit’’ means the individual physical

unit of the product, e.g., tablets or

capsules.

(b) Labeling. (1) If the product is

packaged by the manufacturer in unitdose packaging, its label shall bear the

following statement:

WARNING—Keep away from children.

Keep in original package until each use.

Contains iron, which can harm or cause

death to a child. If a child accidentally

swallows this product, call a doctor or poison

control center immediately.

(2) If the product contains less than 30

milligrams of iron and is packaged by

the manufacturer in other than unitdose packaging, e.g., a container with a

child-resistant closure, its label shall

bear the following statement:

WARNING—Close tightly and keep away

from children. Contains iron, which can

harm or cause death to a child. If a child

accidentally swallows this product, call a

doctor or poison control center immediately.

(3) The statement required by

paragraph (b)(1) of this section shall

appear prominently and conspicuously

on the immediate container labeling in
Federal Register / Vol. 60, No. 32 / Thursday, February 16, 1995 / Proposed Rules 8993

such a way that the warning is intact

until all of the dosage units to which it

applies are used. The statement required

by paragraph (b)(2) of this section shall

appear prominently and conspicuously

on the immediate container labeling. In

all cases where the immediate container

is not the retail package, the warning

statement shall also appear prominently

and conspicuously on the principal

display panel of the retail package. In

addition, the warning statement shall

appear on any labeling that contains

warnings.

Dated: February 10, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95–3970 Filed 2–15–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Chapter I

[CGD 95–009]

Chemical Transportation Advisory

Committee (CTAC) Subcommittee on

Hazardous Substances Response Plan

Meeting

AGENCY: Coast Guard, DOT.

ACTION: Notice of meeting.

SUMMARY: The Hazardous Substances

Response Plan Subcommittee of CTAC

will meet to develop response plan

criteria for hazardous substances to be

considered under proposed

requirements for tank vessels and

marine transportation related facilities

under the Oil Pollution Act of 1990

(OPA 90). The meeting will be open to

the public.

DATES: The meeting will be held on

March 13, 1995, from 9 a.m. to 4 p.m.

Written material should be submitted no

later than March 3, 1995.

ADDRESSES: The meeting will be held in

Room 2415, U.S. Coast Guard

Headquarters, 2100 Second Street SW.,

Washington, DC 20593–0001. Written

material should be submitted to Ms.

Margaret K. Doyle, Chemical Carriers’

Association, 1700 North Moore Street,

Suite 1805, Arlington, VA 22209.

FOR FURTHER INFORMATION CONTACT:

Ms. Margaret K. Doyle, Chemical

Carriers’ Association, 1700 North Moore

Street, Suite 1805, Arlington, VA 22209,

telephone (703) 528–6900, or Lieutenant

Rick Raksnis, Commandant (G–MTH–1),

U.S. Coast Guard, 2100 Second Street

SW., Washington, DC 20593–0001,

telephone (202) 267–1217.

SUPPLEMENTARY INFORMATION: Notice of

this meeting is given pursuant to the

Federal Advisory Committee Act, 5

U.S.C. App. 2, section 1 et seq. OPA 90

requires owners or operators of tank

vessels and marine transportation

related onshore facilities to prepare and

submit response plans for a worst case

discharge or release of oil or a

hazardous substance. The Coast Guard

has begun preliminary work to develop

vessel and facility response plan

regulations for hazardous substances.

This Subcommittee was recently

established to evaluate the regulatory

approach to assess the appropriateness

of the planned requirements for this

rulemaking. Attendance is open to the

public. With advance notice, and at the

Chairman’s discretion, members of the

public may make oral presentations

during the meeting. Persons wishing to

make oral presentations should notify

Ms. Doyle, listed above under

ADDRESSES, no later than three days

before the meeting. Written material

may be submitted at any time for

presentation to the Subcommittee.

However, to ensure advance distribution

to each Subcommittee member, persons

submitting written material are asked to

provide 30 copies of Ms. Doyle no later

than March 3, 1995.

Dated: February 7, 1995.

N.W. Lemley,

Acting Chief, Office of Marine Safety, Security

and Environmental Protection.

[FR Doc. 95–3834 Filed 2–15–95; 8:45 am]

BILLING CODE 4910–14–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[AK6–1–6887b, AK5–1–6437b, AK3–1–

5851b; FRL–5147–9]

Approval and Promulgation of State

Implementation Plans: Alaska

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: The EPA proposes to approve

regulations from three submittals

received from the Alaska Department of

Environmental Conservation (ADEC):

submittal dated July 17, 1990 requesting

our action to address out-of-date

sections found in 40 CFR 52.73–5296

relating to Alaska state implementation

plan (SIP) deficiencies, and including

the applicable Alaska statutes to support

their request; submittal dated October

15, 1991 requesting approval of

amendments to regulations dealing with

Air Quality Control, 18 AAC 50, for

inclusion into Alaska’s SIP to assure

compliance with Federal ambient air

quality standards for airborne

particulate matter, and submittal dated

March 24, 1994 requesting approval of

additional amendments to 18 AAC 50,

Air Quality Control, for inclusion into

Alaska’s SIP to assure compliance with

new source review permitting

requirements, the 1990 Clean Air Act

Amendments (the Act), for sources

located in nonattainment areas for either

carbon monoxide or particulate matter.

In the Final Rules Section of this

Federal Register, the EPA is approving

these SIP revisions as a direct final rule

without prior proposal because the

Agency views this as a noncontroversial

revision amendment and anticipates no

adverse comments. A detailed rationale

for the approval is set forth in the direct

final rule. If no adverse comments are

received in response to this proposed

rule, no further activity is contemplated

in relation to this rule. If the EPA

receives adverse comments, the direct

final rule will be withdrawn and all

public comments received will be

addressed in a subsequent final rule

based on this proposed rule. The EPA

will not institute a second comment

period on this document.

DATES: Comments on this proposed rule

must be received in writing by March

20, 1995.

ADDRESSES: Written comments should

be addressed to Montel Livingston,

Environmental Protection Specialist

(AT–082), Air Programs Section, at the

EPA Regional Office listed below.

Copies of the documents relevant to this

proposed rule are available for public

inspection during normal business

hours at the following locations. The

interested persons wanting to examine

these documents should make an

appointment with the appropriate office

at least 24 hours before the visiting day.

U.S. Environmental Protection Agency,

Region 10, Air Programs Section, 1200

6th Avenue, Seattle, WA 98101.

The Alaska Department of

Environmental Conservation, 410

Willoughby, Suite 105, Juneau, Alaska

99801–1795.

FOR FURTHER INFORMATION CONTACT:

Montel Livingston, Air Programs Branch

(AT–082), EPA, 1200 6th Avenue,

Seattle, WA 98101, (206) 553–0180.

SUPPLEMENTARY INFORMATION: See the

information provided in the Direct Final

action which is located in the Rules

Section of this Federal Register.