Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Proposed Rules 8659

Issued in Renton, Washington, on February

20, 1997.

James V. Devany,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–4719 Filed 2–25–97; 8:45 am]

BILLING CODE 4910–13–C

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Household Products Containing

Petroleum Distillates and Other

Hydrocarbons; Advance Notice of

Proposed Rulemaking; Request for

Comments and Information

AGENCY: Consumer Product Safety

Commission.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Consumer Product Safety

Commission (‘‘CPSC’’ or ‘‘Commission’’)

has reason to believe that child-resistant

packaging may be needed to protect

children from serious illness or injury

from products that contain either

petroleum distillates or other

hydrocarbons or combinations of these

ingredients. This advance notice of

proposed rulemaking (‘‘ANPR’’) initiates

a rulemaking proceeding under the

Poison Prevention Packaging Act

(‘‘PPPA’’). Existing PPPA standards

require child-resistant packaging for

some products that contain petroleum

distillates or other hydrocarbons. The

Commission desires information on a

variety of issues concerning products

containing petroleum distillates or other

hydrocarbons as it considers the

possibility of requiring child-resistant

packaging for additional consumer

products that contain these substances.

The Commission solicits written

comments from interested persons

concerning the risks of injury or illness

associated with household products

containing petroleum distillates and

other hydrocarbons, the regulatory

alternatives discussed in this notice,

other possible means to address these

risks, and the economic impacts of the

various regulatory alternatives.

DATES: Written comments and

submissions in response to this notice

must be received by the Commission by

May 12, 1997.

ADDRESSES: Comments should be

mailed, preferably in five copies, to the

Office of the Secretary, Consumer

Product Safety Commission,

Washington, DC 20207–0001, or

delivered to the Office of the Secretary,

Consumer Product Safety Commission,

Room 502, 4330 East-West Highway,

Bethesda, Maryland 20814; telephone

(301) 504–0800. Comments should be

captioned ‘‘ANPR for Petroleum

Distillates.’’

FOR FURTHER INFORMATION CONTACT:

Suzanne Barone, Directorate for

Epidemiology and Health Sciences,

Consumer Product Safety Commission,

Washington, DC 20207; telephone (301)

504–0477, ext. 1196.

SUPPLEMENTARY INFORMATION:

I. Background

1. Introduction. Petroleum distillates

are a group of hydrocarbon-based

chemicals that are refined from crude

oil. Petroleum distillates include

gasoline, naphtha, mineral spirits,

kerosene, paraffin wax, and tar. They

are the primary ingredient in many

consumer products, including certain

furniture polishes, paint solvents,

adhesives, and automotive chemicals.

As explained below, the presence of

such petroleum distillates in products

may contribute to the products’ toxicity.

A number of consumer products

contain hydrocarbons that are not

petroleum distillates, but that can cause

similar toxic effects. These other

hydrocarbons include substances such

as benzene, toluene, xylene, pine oil,

turpentine, and limonene.
8660 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Proposed Rules

1Liquids with high viscosity are thick and more

like syrup, while liquids with low viscosities are

thin and more watery. See Table 1.

2The Commission voted 2–1 to approve

publication of this ANPR. Voting to approve were

Chairman Ann Brown and Commissioner Thomas

Moore. Commissioner Mary Sheila Gall voted to

develop a Request for Information for publication

in the Federal Register and to utilize other available

information sources instead of an ANPR.

Commissioner Gall also issued a statement

concerning this vote. The statement is available

from the Office of the Secretary.

The toxicity of petroleum distillates

and other hydrocarbons affects the

respiratory system. Aspiration of small

amounts of these chemicals directly into

the lung, or into the lung during

vomiting of an ingested chemical, can

cause chemical pneumonia, pulmonary

damage, and death. Petroleum distillates

with low viscosity, such as gasoline,

kerosene, and mineral seal oil, possess

the greatest potential for aspiration.1

As explained below, all household

products that contain 10 percent or

more of petroleum distillates, or of

benzene, toluene, xylene, or turpentine,

are required to have hazard warnings by

regulations under the Federal

Hazardous Substances Act (‘‘FHSA’’).

Some other products that contain

hydrocarbons may be required to be

labeled by more general FHSA

requirements. Some, but not all, of these

products are also required to be in

child-resistant packaging under PPPA

regulations.

The purpose of this notice is to

commence a rulemaking proceeding to

examine whether additional products

containing petroleum distillates or other

hydrocarbons should be in childresistant packaging.2

II. The Possible Need for Additional

Regulation

1. Poisoning information. The

Commission evaluated pediatric

poisoning cases associated with product

classes that are known to include

products that contain hydrocarbons, and

that are not currently required to be in

child-resistant packaging. Such product

areas include adhesives, automotive

chemicals, workshop chemicals, metal

polishes, spot removers, cleaning fluids,

shoe polishes, and lubricants. The CPSC

staff reviewed data from various

sources, including the National

Electronic Injury Surveillance System

(‘‘NEISS’’), and the American

Association of Poison Control Centers’

(‘‘AAPCC’’) Toxic Exposure

Surveillance System (‘‘TESS’’).

According to NEISS, between 1990

and 1994 there was an annual estimated

average of about 2,300 emergency room

visits of children under 5 years of age

associated with exposure to product

categories that are not required to be in

child-resistant packaging and that

include products containing petroleum

distillates. About 5 percent of these

cases resulted in hospitalization.

Between October 1994 and May 1996,

a CPSC contractor conducted telephone

investigations on incidents reported

through NEISS that were treated in

hospital emergency rooms and involved

children under 5 years of age who had

been exposed to products in the

categories described above. The

telephone investigations produced 43

cases for analysis. Of these, 18 involved

petroleum distillates and 25 involved

products containing the hydrocarbon

pine oil. Most of the incidents occurred

in the child’s home. About 50 percent

of the victims accessed the product from

its normal storage area rather than from

another location. Seventy-nine percent

of the incidents involved products in

the original packaging. Most of these

containers were reported to be nonchild-resistant.

In 1994, the Poison Control Centers

(‘‘PCC’s) reported 5,791 exposures of

children under 5 years of age that were

attributed to product categories that

included only products that contain

petroleum distillates or other

hydrocarbons. Of these, 1130 cases

reported symptoms, most of which were

minor (exhibited some symptoms that

were minimally bothersome to the

patient, i.e. the symptoms usually

resolved rapidly and usually involved

skin or mucous membranes). Ninetythree of these cases reported moderate

outcomes (exhibited symptoms that

were more pronounced, more

prolonged, or of more of a systemic

nature than minor symptoms). In

addition, 7 cases reported major

symptoms (life-threatening or resulted

in significant residual disability or

disfigurement). A number of other PCC

product categories may also include

products that contain petroleum

distillates or other hydrocarbons.

The Commission is aware of 10

reported deaths since 1973 of children

under 5 following exposure to products

that contained petroleum distillates and

for which child-resistant packaging is

not currently required. Six of these

reports indicated that the deaths were

caused by chemical pneumonitis or

aspiration.

The death and injury data discussed

above suggest that the safety of young

children could be improved if

additional products that contain

petroleum distillates and other

hydrocarbons are required to be

packaged in child-resistant packaging.

2. Existing regulatory requirements.

a. Applicable requirements under the

Federal Hazardous Substances Act

(‘‘FHSA’’). The CPSC regulates the

labeling of hazardous household

products under the FHSA, 15 U.S.C.

1261–1278. Currently, FHSA regulations

require specified aspiration hazard

labeling for products containing 10

percent or more by weight of benzene,

toluene, xylene, or petroleum distillates

such as kerosene, mineral seal oil,

naphtha, gasoline, mineral spirits,

Stoddard solvent, and ‘‘related’’

distillates. 16 CFR 1500.14(a)(3), (b)(3).

The label must bear the signal word

‘‘DANGER,’’ the statement of hazard

‘‘Harmful or fatal if swallowed,’’ and the

statement ‘‘Call physician

immediately.’’ 16 CFR 1500.14(b)(3). A

similar labeling requirement applies to

products containing 10 percent or more

of turpentine because of the aspiration

hazard. See 16 CFR 1500.14(b)(5).
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Proposed Rules 8661

3 Saybolt Universal Seconds is a measure of

viscosity. The higher the SUS, the more viscous the

liquid.

In addition, section 2(p)(1) of the

FHSA requires any household product

that is ‘‘toxic’’ to bear specified hazard

labeling. 15 U.S.C. 1261(p)(1). Any

product that presents an aspiration risk

from hydrocarbons is required to bear

the labeling specified by section 2(p)(1),

regardless of whether a regulation

specifically applies to that product.

b. Applicable requirements under the

Poison Prevention Packaging Act

(‘‘PPPA’’). The CPSC also regulates the

packaging of many household products

containing petroleum distillates or other

hydrocarbons under the PPPA, 15

U.S.C. 1471–1476. PPPA regulations

require that products be sold in childresistant packaging.

Currently, some consumer products

containing 10 percent or more by weight

of petroleum distillates, and with a

viscosity less than 100 Saybolt

Universal Seconds (‘‘SUS’’) at 100°F, are

subject to the PPPA’s child-resistant

packaging standards. 3 The particular

types of petroleum distillate products

that require child-resistant packaging

under the PPPA include (1) prepackaged

liquid kindling and illuminating

preparations (e.g., lighter fluid) (16 CFR

1700.14(a)(7)), (2) prepackaged solvents

for paint or other similar surface-coating

materials (e.g., varnishes)(16 CFR

1700.14(a)(15)), and (3) nonemulsion

liquid furniture polish (16 CFR

1700.14(a)(2)). Child-resistant packaging

is also required for certain solvents

containing 10 percent or more of

benzene, toluene, or benzene, and with

a viscosity less than 100 SUS at 100°F.

16 CFR 1700.14(a)(15). In addition,

products containing 10 percent or more

of turpentine are required to be in childresistant packaging. 16 CFR

1700.14(a)(6).

c. Varying scope of the FHSA and

PPPA regulations. While FHSA labeling

regulations apply generically to

products that contain 10 percent or

more petroleum distillates or other

hydrocarbons, only certain specified

products are required to be in childresistant packaging under the current

PPPA regulations. Therefore, a number

of household products containing

petroleum distillates or other

hydrocarbons are not required to be in

child-resistant packaging. For example,

cleaning solvents, automotive

chemicals, shoe care products, and floor

care products may contain large

amounts of various petroleum

distillates. These products are not

required to be sold in child-resistant

packaging, but some of them are

required to be labeled under the FHSA.

See 16 CFR 1500.14(a)(3), (b)(3).

In addition, there are some anomalies

under the current PPPA regulations

concerning which products are required

to be in child-resistant packaging. For

example, the existing standards require

child-resistant packaging of

prepackaged kerosene for use as lamp

fuel. 16 CFR 1700.14(a)(7). However, a

gun cleaning solvent that contains over

90 percent kerosene does not have this

requirement. Mineral spirits used as a

paint solvent require child-resistant

packaging, 16 CFR 1700.14(a)(15), but

such packaging is not required for spot

removers containing 75 percent mineral

spirits or water repellents containing 95

percent mineral spirits. Yet, all of these

consumer products are required by the

FHSA to be labeled ‘‘Harmful or fatal if

swallowed.’’ 16 CFR 1500.14(b)(3).

A rule to require child-resistant

packaging of all household products

that contain petroleum distillates and

have specified characteristics would

create a more consistent regulatory

approach and afford greater protection

against poisonings.

III. Issues to be Considered During the

Rulemaking

During this rulemaking, the

Commission will consider the following

major issues.

1. Viscosity and percentage

composition. As noted above, the

PPPA’s child-resistant packaging

standards currently apply to certain

specified consumer products containing

10 percent or more by weight of

petroleum distillates, and with a

viscosity less than 100 SUS at 100 °F.

Products associated with chemical

pneumonia and death have had

viscosities below this level. Again,

liquids with low viscosities are more

likely to be aspirated than more syruplike liquids with high viscosities.

The Commission’s staff collected a

limited number of household products

that contain petroleum distillates and

measured their viscosities. The results

are listed in Table 1.

TABLE 1.—THE VISCOSITIES OF PRODUCTS CONTAINING PETROLEUM DISTILLATES

Product

PPPA

Regulated (yes

or no)

Viscosity

(SUS

@100

°F) 4

Motor oil (10W–30) ... N ≈325

Heavy Mineral Oil ..... N 180

Baby Oil .................... N ≈70

Furniture Polish ......... Y ≈40

Gasoline Treatment .. N ≈35

Carburetor Cleaner ... N <32 5

Degreaser ................. N <32 4

Lighter Fluid .............. Y <32 4

4The staff measured the viscosity at 100 °F

using a Brookfield viscometer calibrated in

centistokes (cs). The value was converted to

SUS using Table 1 of ASTM D 2161–93,

Standard Practice for Conversion of Kinematic

Viscosity to Saybolt Universal Viscosity or to

Saybolt Furol Viscosity. 5There are no equivalent viscosities measured in SUS for viscosities less than 1.8 cs.

The viscosity of 1.83 cs is equivalent to 32

SUS.

The staff’s initial laboratory analysis,

summarized in Table 1, shows that

lighter weight oils, including some baby

oils, would be included in a regulation

that required child-resistant packaging

of all products containing at least 10

percent petroleum distillates with a

viscosity less than 100 SUS at 100 °F.
8662 Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Proposed Rules

6Reyes De La Rocha, S. et al. Lipoid pneumonia

secondary to baby oil aspiration: a case report and

review of the literature. Pediatric Emergency Care,

1:74, 1985.

7Nierenberg, D.W., et al. Mineral Spirits

Inhalation Associated with Hemolysis, Pulmonary

Edema, and Ventricular Fibrillation. Arch Intern

Med, 151:14337, 1991. Rodriguez de la Vega, A. et

al. Kerosene-induced Asthma. Annals of Allergy,

64:362, 1990. Glynn, K.P. and Gale, N., Exogenous

Lipoid Pneumonia due to Inhalation of Spray

Lubricant, Chest, 97:1265, 1990.

8 Id. (Glynn, 1990).

9Schiller-Scotland, C.F, et al. Experimental data

for total disposition in the respiratory tract of

children. Toxicol. Lett., 72: 137, 1994.

10S. Rep. 845, 91st Cong., 2d Sess. 10 (1970).

11 Id.

12 Id.

There are reported cases of lipoid

pneumonia and deaths from aspiration

of lubricants, including baby oil, a spray

lubricant, chain saw oil, and trumpet

valve oil.6

The Commission will consider

whether a viscosity criterion should be

included in any regulation requiring

child-resistant packaging for products

containing petroleum distillates or other

hydrocarbons. If such a criterion is to be

included, the Commission will also

consider at what level it should be set.

2. Other hydrocarbons. The CPSC’s

FHSA regulations for petroleum

distillates require labeling of some

products containing other

hydrocarbons, including products that

contain 10 percent or more by weight of

benzene, toluene, or xylene. 16 CFR

1500.14(a)(3), (b)(3). FHSA labeling is

required because these substances have

an aspiration hazard similar to

petroleum distillates.

A number of household products

contain low-viscosity hydrocarbons

other than petroleum distillates. These

hydrocarbons include benzene, toluene,

xylene, and terpenes. For example,

terpene hydrocarbons derived from

wood or fruit are in products such as

turpentine, pine oil, and limonene. Pine

oil and limonene are found in cleaning

products and spot removers, as well as

disinfectants. (Products marketed as

disinfectants are not regulated by the

CPSC; they are regulated as pesticides

by the Environmental Protection Agency

(‘‘EPA’’).) Although pine oil and

limonene cleaning products and spot

removers require FHSA labeling, they

are not currently required to be in childresistant packaging.

The Commission will consider

whether there is a need for a special

packaging standard applicable to

products containing hydrocarbons other

than petroleum distillates.

3. Aerosols. The PPPA regulation for

furniture polish excludes products in

aerosol form. The rationale for

excluding aerosol furniture polishes was

that aerosols would be addressed

separately. 36 FR 18012 (September 8,

1971). However, there has been no

further regulatory action on aerosol

furniture polishes.

The child-resistant packaging

requirements for paint solvents and

kindling and illuminating preparations

do not specifically exempt aerosol

products. See 16 CFR 1700.14(a)(7),

(a)(15). However, the Commission is not

aware of any paint solvent or liquid

kindling or illuminating fluid sold in an

aerosol form.

CPSC exposure data on aerosol

products are limited.7 Inhalation of a

spray lubricant has been associated with

lipoid pneumonia.8 The NEISS case

investigation study, described above,

identified 4 percent of the cases as

involving products in aerosol form.

However, none of the people in these

aerosol cases was hospitalized.

The cases described in the medical

literature that resulted from the

inhalation of petroleum distillates from

aerosols or vapors involved prolonged

or repeated exposure of adults.

However, children are subject to greater

inhalation risks than are adults, for

equal exposure levels.9

The Commission will consider

whether aerosol products should be

included within any regulation

applicable to products containing

petroleum distillates and other

hydrocarbons.

4. Restricted flow. The PPPA

regulation for liquid furniture polish

includes an additional requirement that

no more than 2 milliliters of product

shall be obtained when the container is

shaken, squeezed, or activated once. 16

CFR 1700.14(a)(2). This requirement

was included, in part, because an open

container of polish may be moved and

used multiple times throughout the

house before the container is closed. 37

FR 5613 (March 17, 1972). Furniture

polish is the only PPPA-regulated

substance with a restricted-flow

requirement.

The Commission will consider

whether other products should be

subject to a restricted flow requirement.

IV. Rulemaking Procedure

In order to issue a regulation under

the PPPA, the Commission would have

to find that ‘‘the degree or nature of the

hazard to children in the availability of

(petroleum distillates and other

hydrocarbons), by reason of (their)

packaging, is such that special

packaging is required to protect children

from serious personal injury or serious

illness resulting from handling, using,

or ingesting such substance.’’ 15 U.S.C.

1472(a)(1). The Commission would also

have to find that child-resistant

packaging ‘‘is technically feasible,

practicable, and appropriate’’ for

products containing petroleum

distillates or other hydrocarbons. 15

U.S.C. 1472(a)(2).

According to the PPPA’s legislative

history, ‘‘technically feasible’’ means

that technology exists to produce

packaging that conforms to the

standards.10 ‘‘Practicable’’ means that

special packaging complying with the

standards can utilize modern mass

production and assembly line

techniques.11 ‘‘Appropriate’’ means that

packaging complying with the standards

will adequately protect the integrity of

the substance and not interfere with its

intended storage or use.12

In addition to the required findings,

the Commission is required to consider,

but not necessarily make formal

findings on, (a) the reasonableness of

the standard, (b) available scientific,

medical, and engineering data

concerning special packaging and

concerning childhood accidental

ingestions, illness, and injury caused by

household substances, (c) the

manufacturing practices of industries

affected by the PPPA, and (d) the nature

and use of the household substance. 15

U.S.C. 1472(b).

A rulemaking proceeding under the

PPPA is subject to the requirements of

the Administrative Procedure Act.

Therefore, the proceeding can be

commenced by publication of a notice

of proposed rulemaking (‘‘NPR’’),

without having previously published an

ANPR. However, in this proceeding, the

Commission is publishing an ANPR in

order to obtain additional information

before deciding whether to propose a

special packaging standard for products

that contain petroleum distillates or

other hydrocarbons.

V. Comments Requested Concerning the

Scope of a Rule

The Commission is seeking

information on issues relevant to

defining the scope of any child-resistant

packaging requirement for products

containing low-viscosity petroleum

distillates and other hydrocarbons.

These issues include the following:

1. What, if any, viscosity and/or

percentage composition should be used

as a threshold for requiring products

that contain petroleum distillates to be

in child-resistant packaging?

2. Should aerosol products be

included in a requirement for the childresistant packaging of products

containing petroleum distillates or other
Federal Register / Vol. 62, No. 38 / Wednesday, February 26, 1997 / Proposed Rules 8663

hydrocarbons? The Commission seeks

information on the possible effects to a

young child of a single acute exposure

to an aerosol product containing

petroleum distillates.

3. Should PPPA regulation extend

only to petroleum distillates or should

such regulation also extend to other

hydrocarbons, such as benzene, toluene,

xylene, turpentine, pine oil, and

limonene?

4. Should restricted flow be an

additional requirement for certain

products?

VI. Additional Requests for Information

The Commission believes that

information on the following issues

would also be helpful as it considers

whether child-resistant packaging

should be required for the entire class

of consumer products that present an

aspiration hazard because they contain

petroleum distillates or other

hydrocarbons.

1. Chemical properties. Information

concerning the chemical properties of

individual consumer products that

contain petroleum distillates or other

hydrocarbons will be used to compare

products that do not currently require

child-resistant packaging with those that

do. The Commission requests

information about the form (e.g., liquid

or aerosol), formulation (including the

amount of each component), and

viscosity of each product.

2. Users and use patterns. The

Commission would like information

about consumer use patterns for various

types of products containing petroleum

distillates or other hydrocarbons. The

Commission requests information

concerning: The intended use of the

product (e.g., as a shoe waterproofer,

carpet cleaner, upholstery spot

remover); the location(s) where it is

used (e.g., in a garage, a kitchen, a

bathroom); the frequency of use (e.g.,

daily, monthly, seasonally); how long a

package of the product is retained in the

home (e.g., used just once or stored for

long periods between uses); and the

location(s) where it is stored when not

in use. In addition, is the product used

by consumers (more than occasionally)

or is the product only used in the home

by workers, such as repair or cleaning

persons?

3. Current packaging and labeling.

Information about the packaging of

products that contain petroleum

distillates will be used to assess the

technical feasibility, practicability, and

appropriateness of child-resistant

packaging. The Commission requests

information describing current

packaging, such as packaging sizes,

container material, closure material,

closure design, and ASTM classification

if the package is child-resistant.

Information is also requested about

whether the product has labels with

warnings and instructions for use.

4. Economic information. Economic

information will be used to evaluate the

impact of requiring child-resistant

packaging for all products containing

petroleum distillates or other

hydrocarbons. The Commission requests

information about sales of these

products and about the range of

wholesale and retail prices. Further, the

Commission seeks comments on the

expected cost of providing childresistant packaging for these products.

In addition, the Commission requests

information about the potential impact

that such child-resistant packaging

requirements would have on businesses,

especially small businesses.

5. Incident information. Although the

Commission monitors data on

ingestions by young children of

products that contain petroleum

distillates and other hydrocarbons, the

Commission seeks additional

information about such poisoning

incidents. This information will be used

to assess the extent of injury from

different product formulations. The

Commission requests information

concerning the details of scenarios

resulting in poisoning incidents, and the

outcome of the incident.

Comments should be mailed,

preferably in five copies, to the Office of

the Secretary, Consumer Product Safety

Commission, Washington, DC 20207–

0001, or delivered to the Office of the

Secretary, Consumer Product Safety

Commission, Room 502, 4330 East-West

Highway, Bethesda, Maryland 20814;

telephone (301) 504–0800. All

comments and submissions should be

received no later than May 12, 1997.

VII. Trade Secret or Proprietary

Information

Any person responding to this notice

who believes that any information

submitted is trade secret or proprietary

should identify all such information at

the time of submission. The

Commission’s staff will receive and

handle such information confidentially

and in accordance with section 6(a) of

the Consumer Product Safety Act

(‘‘CPSA’’), 15 U.S.C. 2055(a). Such

information will not be placed in a

public file and will not be made

available to the public simply upon

request. If the Commission receives a

request for disclosure of the information

or concludes that its disclosure is

necessary to discharge the

Commission’s responsibilities, the

Commission will inform the person who

submitted the information and provide

that person an opportunity to present

additional information and views

concerning the confidential nature of

the information. 16 CFR 1015.18(b).

The Commission’s staff will then

make a determination of whether the

information is trade secret or

proprietary information that cannot be

released. That determination will be

made in accordance with applicable

provisions of the CPSA; the Freedom of

Information Act (‘‘FOIA’’), 5 U.S.C.

552b; 18 U.S.C 1905; the Commission’s

procedural regulations at 16 CFR part

1015 governing protection and

disclosure of information under

provisions of FOIA; and relevant

judicial interpretations. If any part of

information that has been submitted

with a claim that the information is a

trade secret or proprietary is found to be

disclosable, the person submitting the

material will be notified in writing and

given at least 10 calendar days from the

receipt of the letter to seek judicial

relief. 15 U.S.C. 2055(a) (5) and (6); 16

CFR 1015.19(b).

Dated: February 21, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–4783 Filed 2–25–97; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N–0038]

RIN 0910–AA01

Sunscreen Drug Products for Over-theCounter Human Use; Amendment to

the Tentative Final Monograph;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking;

correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice of proposed rulemaking that

appeared in the Federal Register of

September 16, 1996 (61 FR 48645). The

document proposed to amend the

tentative final monograph (proposed

rule) for over-the-counter (OTC)

sunscreen drug products. The document

was published with an error. This

document corrects that error.