17660 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

1Numbers in parentheses identify documents

listed at the end of this notice.

the general public who attend the

conference may have an opportunity to

make a brief oral statement presenting

their views on issues raised in the Rule

Review. Oral statements of views by

members of the general public will be

limited to a few minutes in length. The

time allotted for these statements will be

determined on the basis of the time

allotted for discussion of the issues by

the selected parties, as well as by the

number of persons who wish to make

statements.

Written submissions of views, or any

other written or visual materials, will

not be accepted during the conference.

The discussion will be transcribed and

the transcription placed on the public

record.

The conference will be held in the

early fall over the course of two

consecutive days. A forthcoming

announcement will provide the exact

dates and location. Parties interested in

participating must notify Commission

staff by August 11, 1995.

List of Subjects in 16 CFR Part 436

Advertising, Business and industry,

Franchising, Trade practices.

Authority: 15 U.S.C. 41–58.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 95–8619 Filed 4–6–95; 8:45 am]

BILLING CODE 6750–01–P

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Poison Prevention Packaging

Requirements; Proposed Exemption of

Certain Iron-Containing Dietary

Supplement Powders

AGENCY: Consumer Product Safety

Commission.

ACTION: Proposed rule.

SUMMARY: The Commission proposes to

amend its regulations to exempt from

child-resistant packaging requirements

those dietary supplement powders that

have no more than the equivalent of

0.12 percent weight-to-weight elemental

iron. The Commission proposes this

exemption because there are no known

poisoning incidents with these

products, and the dry powdered form

deters children from ingesting them in

harmful amounts.

DATES: Comments on the proposed rule

must be received by the Commission no

later than June 21, 1995.

ADDRESSES: Comments should be

mailed, preferably in five (5) copies, to

the Office of the Secretary, Consumer

Product Safety Commission,

Washington, D.C. 20207, or delivered to

the Office of the Secretary, Consumer

Product Safety Commission, Room 502,

4330 East-West Highway, Bethesda,

Maryland 20814; telephone (301) 504–

0470.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Ferrante, Ph.D., Project

Manager, Directorate for Health

Sciences, Consumer Product Safety

Commission, Washington, D.C. 20207;

telephone (301) 504–0477.

SUPPLEMENTARY INFORMATION:

A. Background

Although iron is essential for good

health, in large doses it can be toxic. For

this reason, in 1978, the Consumer

Product Safety Commission (‘‘the

Commission’’) required child-resistant

packaging (‘‘CRP’’) for drugs and dietary

supplements that contain iron. 16 CFR

1700.14(a)(12) and (13). The

Commission issued these rules under

the Poison Prevention Packaging Act

(‘‘PPPA’’), 15 U.S.C. 1471–1476, which

authorizes the Commission to require

CRP to protect children under 5 years of

age from poisoning hazards posed by

harmful household substances.

Specifically, CRP is required for

dietary supplements ‘‘that contain an

equivalent of 250 milligrams or more of

elemental iron, from any source, in a

single package in concentrations of

0.025 percent or more on a weight-tovolume basis for liquids and 0.05

percent or more on a weight-to-weight

basis for nonliquids.’’ 16 CFR

1700.14(a)(13). This requirement does

not apply if iron is present only as a

colorant. Id.

On May 11, 1994, Nutritech, Inc.,

petitioned the Commission to exempt

unflavored, unsweetened iron powders

from CRP requirements for dietary

supplements containing iron. Nutritech

manufactures an unsweetened,

unflavored vitamin, mineral, and amino

acid powder intended to be mixed with

fruit juice. The petitioner stated that

CRP is unnecessary for this dietary

supplement because: (i) The substance

alone is unpalatable; (ii) due to the

powder consistency of this substance, a

child would not consume a toxic

amount without gagging; and (iii) to

Nutritech’s knowledge, there have been

no poisoning incidents involving this

product in its 22 year history.(1) 1 The

Commission published a notice in the

Federal Register soliciting comments on

the petition, 59 FR 39747, and has

received no responses.

B. Toxicity Data

The minimum toxic and lethal doses

of iron are not well defined. Generally,

doses of elemental iron from 20 to 60

milligrams per kilogram of body weight

(‘‘mg/kg’’) may produce mild symptoms

of poisoning, 60 mg/kg is the minimal

dose for serious toxicity, and

approximately 180 to 250 mg/kg is

considered a lethal dose. However,

fatalities of young children have been

reported at lower doses.(2)(3)

According to the relevant scientific

and medical literature, where

information on the formulation was

available, the majority of pediatric

poisoning incidents involved solid

iron—in the form of tablets or

capsules—with the remaining cases

involving liquid preparations. Among

the reported ingestion incidents,

fatalities and serious cases of toxicity

usually involve ingestion of adult

preparations (such as prenatal vitamins)

that contain 60 mg or more of elemental

iron per tablet. The literature search did

not identify a single case of pediatric

poisoning involving powdered iron

formulations.(2)(3)

Recently, the Food and Drug

Administration (‘‘FDA’’) published

proposed labeling and packaging

requirements for iron-containing dietary

supplements and drugs. 59 FR 51030

(October 6, 1994). Based on its review

of iron poisonings involving children

under 6 years of age, the FDA decided

to limit its proposed rules to products

in solid oral dosage forms (capsules and

tablets) and not include liquid or

powder products.(2)

The Commission’s own 1994 study of

pediatric iron poisonings and fatalities

found that the majority of serious

outcomes involved products in solid or

capsule forms. The report showed that

all 36 of the in-depth investigations of

iron ingestion deaths of children under

5 years old occurring between 1986 and

1993 involved solid capsule or tablet

formulations. In 1993, 57 hospital

emergency room cases documented

through NEISS involved ingestion of

iron capsules or tablets by children

under 5 years old, and one involved

liquid iron. As noted, there were no

known pediatric poisonings that

involved powdered formulations. This

study was based on data from the

Commission’s National Electronic Injury

Surveillance System (‘‘NEISS’’), indepth investigations, the National

Center for Health Statistics (‘‘NCHS’’)

and the American Association of Poison

Control Centers (‘‘AAPCC’’).(2)
Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules 17661

Due to the subcategories that AAPCC

uses to classify iron ingestion incidents,

the data do not specifically address

powdered iron-containing formulations.

However, for these AAPCC cases,

powdered formulations can be ruled out

of all iron related fatalities involving

children under 5 years old, and 98.4

percent of cases with serious symptoms,

that were reported to the AAPCC

between 1989 and 1992. (The remaining

1.2% of cases did not specify the

physical form of the ingested product.)

The formulations of the iron-containing

products involved in pediatric deaths is

unavailable from NCHS death certificate

data.(2)

For powdered dietary supplements

containing 18 mg of elemental iron per

tablespoon (0.12% weight-to-weight), a

10 kg child would have to consume 11,

33, and 100 tablespoons to reach the

respective minimal (20mg/kg), serious

(60mg/kg), and lethal (180 mg/kg)

toxicity levels. This assumes none of the

product is spilled during

consumption.(2)

C. Human Factors Data

Poisoning incidents involving

ingestion of large amounts of any

powdered substance are relatively rare.

Rather, children are more likely to

ingest large quantities in the form of

liquids or solids, such as tablets and

capsules. One reason for this distinction

is the physical difficulty children have

handling and swallowing powders.

Eating a dry powder is difficult and

time-consuming. Only small amounts

can be eaten at a time to allow the

powder to absorb sufficient saliva so the

powder can be swallowed. Attempts to

swallow too much at once or to swallow

too soon will likely result in aspirating

the powder and stimulate coughing,

which would limit the amount ingested.

Because of the time it takes to ingest a

powder, it is questionable that a young

child could eat a full tablespoon of

powder at one time. The length of time

required to successfully ingest powders

may increase the opportunity for an

adult to intervene.(2)(3)

Children’s motivation is also a factor

in poisoning incidents. Curiosity is the

most common motivation among young

children. Those less than 3 years old

explore through manipulative and oral

activity. The youngest at-risk children

(less than 24 months) reportedly ingest

substances like dirt or powdered

detergent by grasping a handful of the

substance and then opening their hands

and using their palms to push the

substance into their mouths. This often

results in spilling much of the

substance.(3)

Exploratory behavior among children

3 to 4 years old may be somewhat more

controlled than for younger children.

For example, in a study examining

powdered aspirin, children 42 to 51

months of age had difficulty picking up

the fine aspirin powder, and when

asked to taste it, they did so by putting

their fingers in the powder and licking

their fingers or by licking the powder

directly on the table. This behavior may

tend to limit the amount ingested.(3)

In role-playing activities, children

may use a powdered substance in

imitation of adult behavior. They may

mix it with a liquid and drink it or use

the powder to substitute for some other

food item (e.g., cake mix). However,

incomplete mixing of the product will

result in a grainy or lumpy mixture

which may cause gagging. Repeated

ingestion is unlikely following such an

experience. It is unlikely that a child

could effectively dissolve and ingest

toxic amounts of powder with 0.12

percent weight-to-weight iron.(3)

Hunger is another potential

motivation. The primary risk of

poisoning from these iron-containing

supplements would be to a starved,

unattended child with no other

available source of nutrition. However,

it is unlikely that a child would have

the time and perseverance to ingest a

quantity of iron (11 tablespoons) that

would be potentially toxic (20 mg/kg).

This is especially true since these

products are expensive, purchased by a

select population of nutrition

enthusiasts, and are probably stored

near other foods that would be more

appealing to children.(3)

The relative palatability of a

substance may influence toxic

ingestions. Although flavor plays little

or no role in determining whether a

product is ingested, it does influence

the quantity ingested. The unpleasant

taste of the petitioner’s product may

deter ingestion of toxic levels. Flavored

products may pose a somewhat greater

risk. However, the other factors

discussed above would likely limit the

toxic dose ingested of both flavored and

unflavored powdered iron

supplements.(3)

D. Economic Data

According to the Food and Drug

Administration, a dietary supplement is

‘‘a food, not in conventional form, that

supplies a component to supplement

the diet by increasing the total dietary

intake of that component,’’ Dietary

Supplement Health and Education Act

of 1994, Public Law 103–417. These are

distinct from fortified foods, such as

infant formulas and meal replacements,

which are intended to serve as the sole

item of a meal. The ingredients in

dietary supplements and fortified foods

may be similar, but the marketing

emphasis and health claims are

different.(4)

The petitioner markets two

unsweetened, unflavored protein

powder supplements that are sold in

individual serving packets or in

canisters. Each recommended serving of

1 tablespoon contains 18 mg of iron and

is mixed with juice for consumption.

The following table shows the available

container sizes and the total iron

content of each.

Size Servings Total iron content (mg)

5.29 oz. ........................................................................................................................................................... 10 180.

15.9 oz. ........................................................................................................................................................... 30 540.

2.2 lb. .............................................................................................................................................................. 66 1188.

25 packets ...................................................................................................................................................... 25 450 (18 mg per packet).

Sweetened or flavored supplements

make up the major part of the powder

dietary supplement market. Many are

marketed as ‘‘sports nutritionals’’ for

fitness enthusiasts. These products are

packaged in cartons, canisters, packets,

jugs, and pails in various sizes and

strengths of iron. Unit and dollar sales

of powdered nutritional products are

not available. A spokesperson for the

Council for Responsible Nutrition

(‘‘CRN’’), an industry group, estimates

the retail market for protein powders

(including both supplements and

fortified foods) at $2 billion. CRN

attributes the larger market share

(percent unknown) to flavored powders

marketed as sports nutritionals and diet

supplements.(4)

D. Action on the Petition

As discussed above, the relevant

literature and data show no cases of

child poisonings due to iron-containing

powders. In addition, it is unlikely that

young children would ingest toxic
17662 Federal Register / Vol. 60, No. 67 / Friday, April 7, 1995 / Proposed Rules

amounts of iron-containing supplement

powders which are difficult for children

to handle without spilling or to swallow

without gagging. A child would have to

ingest approximately 11 tablespoons of

petitioner’s product (20 mg/kg in a 10 kg

child) in order to produce a minimally

toxic dose. Approximately 100

tablespoons would be required for a

lethal dose. Most of the factors that

make toxic ingestions of petitioner’s

unflavored product unlikely would also

apply to flavored supplement powders.

After considering the available

information, the Commission

preliminarily concludes that the degree

and nature of the hazard to children

presented by the availability of dietary

supplement powders with no more than

the equivalent of 0.12 percent weight-toweight elemental iron are such that

special packaging is not required to

protect children from serious personal

injury or serious illness resulting from

handling, or ingesting such substance.

Accordingly, the Commission voted to

grant the petition and proposes to

amend 16 CFR 1700.14(a)(13) to exempt

from requirements for child resistant

packaging those dietary supplement

powders with no more than the

equivalent of 0.12 percent weight toweight-elemental iron.

E. Regulatory Flexibility Certification

Under the Regulatory Flexibility Act

(Public Law 96–354, 5 U.S.C. 601 et

seq.), when an agency issues proposed

and final rules, it must examine the

rules’ potential impact on small

businesses. The Act requires agencies to

prepare and make available for public

comment an initial regulatory flexibility

analysis if a proposed rule would have

a significant impact on a substantial

number of small businesses, small

organizations, and small governmental

jurisdictions.

The exemption proposed below, to

exempt powdered iron-containing

dietary supplements from CRP

requirements, will give manufacturers of

these products the option of packaging

products using any packaging they

choose. As far as CPSC is aware,

powdered iron-containing dietary

supplements are not currently packaged

in CRP. The Commission’s Compliance

staff is exercising its enforcement

discretion regarding these products

pending completion of this rulemaking.

Thus, the proposed exemption will

bring no change in the current

packaging of products subject to the

exemption. Accordingly, the

Commission concludes that this

exemption will not have any significant

economic effect on a substantial number

of small entities.

F. Environmental Considerations

The Commission’s regulations at 16

CFR 1021.5(c)(3) state that rules

exempting products from child-resistant

packaging requirements under the PPPA

normally have little or no potential for

affecting the human environment. The

Commission does not foresee any

special or unusual circumstances

surrounding this proposed rule.

Therefore, exempting these products

from the PPPA requirements will have

little or no effect on the human

environment. For this reason, the

Commission concludes that no

environmental assessment or impact

statement is required in this proceeding.

G. Effective Date

Since the proposed rule provides for

an exemption, no delay in the effective

date is required. 5 U.S.C. 553(d)(1).

Accordingly, the rule shall become

effective upon publication of the final

rule in the Federal Register.

List of Subjects in 16 CFR Part 1700

Consumer protection, Infants and

children, Packaging and containers,

Poison prevention, Toxic substances.

Conclusion

For the reasons given above, the

Commission amends Title 16 of the

Code of Federal Regulations to read as

follows:

PART 1700—[AMENDED]

1. The authority citation for part 1700

continues to read as follows:

Authority: Pub. L. 91–601, secs. 1–9, 84

Stat. 1670, 15 U.S.C. 1471–76, Secs. 1700.1

and 1700.14 also issued under Pub. L. 92–

573, sec. 30(a), 88 Stat. 1231, 15 U.S.C.

2079(a).

2. Section 1700.14(a)(13) is revised to

read as follows:

§ 1700.14 Substances requiring special

packaging.

(a) * * *

(13) Dietary supplements containing

iron. Dietary supplements, as defined in

§ 1700.1(a)(3), that contain an

equivalent of 250 mg or more of

elemental iron, from any source, in a

single package in concentrations of

0.025 percent or more on a weight-tovolume basis for liquids and 0.05

percent or more on a weight-to-weight

basis for nonliquids (e.g., powders,

granules, tablets, capsules, wafers, gels,

viscous products, such as pastes and

ointments, etc.) shall be packaged in

accordance with the provisions of

§ 1700.15 (a), (b), and (c), except for the

following:

(i) Preparations in which iron is

present solely as a colorant; and

(ii) Powdered preparations with no

more than the equivalent of 0.12 percent

weight-to-weight elemental iron.

* * * * *

Dated: April 3, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

Reference Documents

The following documents contain

information relevant to this rulemaking

proceeding and are available for inspection at

the Office of the Secretary, Consumer

Product Safety Commission, Washington,

Room 502, 4330 East-West Highway,

Bethesda, Maryland 20814.

1. Briefing Memorandum with attached

briefing package, March 14, 1995.

2. Memorandum from Sandra E. Inkster,

Ph.D., HSPS, to Jacqueline N. Ferrante, Ph.D.,

HSPS, ‘‘Review of Iron Toxicity: Relevance to

a Petition Requesting Exemption for

Powdered, Iron-Containing Dietary

Supplements,’’ February 15, 1995.

3. Memorandum from Catherine A.

Sedney, EPHF, to Jacqueline N. Ferrante,

Ph.D., HSPS, ‘‘Petition to Exempt IronContaining Supplement Powders from PPPA

Requirements,’’ February 16, 1995.

4. Memorandum from Marcia P. Robins,

EPSS, to Jacqueline N. Ferrante, Ph.D., HSPS,

‘‘Preliminary Market Information: Petition for

Exemption from Child-Resistant Packaging

Requirements for Powdered Iron-Containing

Dietary Supplements,’’ March 10, 1995.

[FR Doc. 95–8522 Filed 4–6–95; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF ENERGY

Federal Energy Regulatory

Commission

18 CFR Part 35

[Docket Nos. RM95–8–000 and RM94–7–

001]

Promoting Wholesale Competition

Through Open Access Nondiscriminatory Transmission Services

by Public Utilities, Recovery of

Stranded Costs by Public Utilities and

Transmitting Utilities; Proposed

Rulemaking and Supplemental Notice

of Proposed Rulemaking

March 29, 1995.

AGENCY: Federal Energy Regulatory

Commission.

ACTION: Notice of proposed rulemaking

and supplemental notice of proposed

rulemaking.

SUMMARY: The Federal Energy

Regulatory Commission (Commission) is

proposing to require that public utilities

owning and/or controlling facilities

used for the transmission of electric

energy in interstate commerce have on