61928 Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules

1The percentage of elemental fluoride in any

compound is determined by dividing the molecular

weight of fluoride (∼ 19 grams/mole) by the

molecular weight of the compound (e.g., the

molecular weight of sodium fluoride = 42 grams/

mole). Sodium fluoride contains 45% elemental

fluoride (19/42 × 100 = 45%).

2Numbers in brackets refer to documents listed

at the end of this notice.

SIAP, GPS RWY 25 SIAP, and GPS RWY

29 SIAP and other IFR operations at

Tracy Municipal Airport, Tracy, CA.

Class E airspace designations are

published in paragraph 6005 of FAA

Order 7400.E dated September 10, 1997,

and effective September 16, 1997, which

is incorporated by reference in 14 CFR

71.1. The Class E airspace designation

listed in this document would be

published subsequently in this Order.

The FAA has determined that this

proposed regulation only invovles an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current.

Therefore, this proposed regulation—(1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034; February 26, 1979); and (3)

does not warrant preparation of a

Regulatory Evaluation as the anticipated

impact is so minimal. Since this is a

routine matter that will only affect air

traffic procedures and air navigation, it

is certified that this proposed rule

would not have a significant economic

impact on a substantial number of small

entities under the criteria of the

Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR part 71 as

follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9E, Airspace

Designations and Reporting Points,

dated September 10, 1997, and effective

September 16, 1997, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

AWP CA E5 Tracy, CA [Revised]

Tracy Municipal Airport, CA

(Lat. 37°41′15′′ N, long. 121°26′29′′ W)

Manteca VORTAC

(Lat. 37°50′01′′ N, long. 121°10′17′′ W)

That airspace extending upward from 700

feet above the surface within a 6.4-mile

radius of Tracy Municipal Airport and within

2.2 miles each side of the Manteca VORTAC

237° radial, extending from the 6.4-mile

radius to 4.9 miles southwest of the Manteca

VORTAC and within 1.8 miles each side of

the 117° bearing from the Tracy Municipal

Airport, extending from the 6.4-mile radius

to 8.4 miles southeast of the Tracy Municipal

Airport and within 1.8 miles each side of the

326° bearing from the Tracy Municipal

Airport, extending from the 6.4-miles radius

to 7.7 miles northwest of the Tracy

Municipal Airport, excluding that portion

within the Stockton, CA, Class E and

Livermore, CA, Class E airspace areas, and

excluding that airspace within Restricted

Area R2531A.

* * * * *

Issued in Los Angeles, California, on

November 7, 1997.

Michael Lammes,

Acting Manager, Air Traffic Division,

Western-Pacific Region.

[FR Doc. 97–30353 Filed 11–19–97; 8:45 am]

BILLING CODE 4910–13–M

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Requirements for Child-Resistant

Packaging; Household Products With

More Than 50 mg of Elemental Fluoride

and More Than 0.5 Percent Elemental

Fluoride; and Modification of

Exemption for Oral Prescription Drugs

With Sodium Fluoride

AGENCY: Consumer Product Safety

Commission.

ACTION: Proposed rule.

SUMMARY: The Commission is proposing

a rule to require child-resistant (‘‘CR’’)

packaging for household products

containing more than the equivalent of

50 mg of elemental fluoride and more

than the equivalent of 0.5 percent

elemental fluoride (on a weight-tovolume (‘‘w/v’’) or weight-to-weight

(‘‘w/w’’) basis). Examples of such

products are some rust removers, toilet

cleaners, metal cleaners and etching

products. Dental products, such as

toothpaste, contain lower levels of

fluoride and would not be affected. For

consistency, the Commission is also

proposing to modify the oral

prescription drug exemption for sodium

fluoride preparations. Instead of

allowing drugs with no more than 264

mg of sodium fluoride per package to be

in non-CR packaging as the current rule

does, the Commission proposes to allow

such drugs with only 50 mg or less of

the equivalent of elemental fluoride

(110 mg or less of sodium fluoride) per

package and no more than the

equivalent of 0.5 percent elemental

fluoride on a w/v or w/w basis. The

Commission has preliminarily

determined that child-resistant

packaging is necessary to protect

children under 5 years of age from

serious personal injury and serious

illness resulting from handling or

ingesting a toxic amount of elemental

fluoride. The Commission takes this

action under the authority of the Poison

Prevention Packaging Act of 1970.

DATES: Comments on the proposal

should be submitted no later than

February 3, 1998.

ADDRESSES: Comments should be

mailed 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 20814–4408, telephone

(301)504–0800. Comments may also be

filed by telefacsimile to (301) 504–0127

or by email to cpsc-os@cpsc.gov.

FOR FURTHER INFORMATION CONTACT:

Jacqueline Ferrante, Ph.D., Division of

Health Sciences, Directorate for

Epidemiology and Health Sciences,

Consumer Product Safety Commission,

Washington, D.C. 20207; telephone

(301)504–0477 ext. 1199.

SUPPLEMENTARY INFORMATION:

A. Background

1. Household Products Containing

Fluoride

Many types of household products

may contain fluoride in one form or

another. Fluorides are ingredients in

cleaning products for metal, tile, brick,

cement, wheels, radiators, siding,

toilets, ovens and drains. Fluorides are

also found in rust and water stain

removers, silver solder and other

welding fluxes, etching compounds,

laundry sour, air conditioner coil

cleaners and floor polishes. The

fluorides that may be ingredients in

these products and are potentially toxic

are hydrofluoric acid (‘‘HF’’),

ammonium bifluoride, ammonium

fluoride, potassium bifluoride, sodium

bifluoride, sodium fluoride and sodium

fluosilicate.1 [3] 2

Many dental products also contain

fluorides, but at lower levels.
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules 61929

Prescription dental products are

available with fluoride contents of

0.125–0.5 mg/ml for drops, 0.5–1 mg per

tablet, 1 mg per lozenge, 0.1–0.9 mg/g

for topical rinses (0.01–0.09 percent and

5 mg/g (0.5 percent) for topical gels.

Prescription vitamin preparations are

also available containing 0.25 to 1 mg

elemental fluoride per ml. The highest

concentration of elemental fluoride in

any such dental product available overthe-counter (‘‘OTC’’) is 0.15 percent for

pastes and powders and 0.5 percent for

liquids or gels. In contrast, some

household products, particularly metal

cleaners and rust removers containing

hydrofluoric acid and/or soluble

fluoride salts, can have as much as 57

percent elemental fluoride. In general,

the concentrations of elemental fluoride

in household cleaners and surface

preparation agents are 10 to 1,000-fold

higher than concentrations found in

dental products.[2]

2. Relevant Statutory and Regulatory

Provisions

The Poison Prevention Packaging Act

of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476,

authorizes the Commission to establish

standards for the ‘‘special packaging’’ of

any household substance if (1) the

degree or nature of the hazard to

children in the availability of such

substance, by reason of its 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 and (2) the

special packaging is technically feasible,

practicable, and appropriate for such

substance.

Special packaging, also referred to as

‘‘child-resistant (CR) packaging,’’ is (1)

designed or constructed to be

significantly difficult for children under

5 years of age to open or obtain a toxic

or harmful amount of the substance

contained therein within a reasonable

time and (2) not difficult for ‘‘normal

adults’’ to use properly. 15 U.S.C.

1471(4). Household substances for

which the Commission may require CR

packaging include (among other

categories) foods, drugs, or cosmetics as

these terms are defined in the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

321). 15 U.S.C. 1471(2)(B). The

Commission has performance

requirements for special packaging. 16

CFR 1700.15, 1700.20.

Section 4(a) of the PPPA, 15 U.S.C.

1473(a), allows the manufacturer or

packer to package a nonprescription

product subject to special packaging

standards in one size of non-CR

packaging only if the manufacturer (or

packer) also supplies the substance in

CR packages of a popular size, and the

non-CR packages bear conspicuous

labeling stating: ‘‘This package for

households without young children.’’ 15

U.S.C. 1473(a), 16 CFR 1700.5.

3. Existing Requirements for FluorideContaining Products

The Commission currently requires

CR packaging for oral prescription drugs

with fluoride, but it exempts those in

liquid or tablet form that contain no

more than 264 mg of sodium fluoride

(equivalent to 120 mg fluoride) per

package. 16 CFR 1700.14(10)(vii). In

1977, the Commission first exempted

aqueous solutions of sodium fluoride at

that level. In 1980, in response to a

petition, the Commission extended the

exemption to include liquid and tablet

forms. When it issued the exemption,

the Commission believed that drugs

with sodium fluoride below that level

would not cause serious personal injury

or illness to children under 5 years of

age. The Commission based this

decision on the lack of serious adverse

human experience associated with such

drugs at that time. The level was also

partly based on a recommendation by

the American Dental Association that no

more than 264 mg of sodium fluoride

should be dispensed at one time. 45 FR

78630. Also at that time, the Food and

Drug Administration (‘‘FDA’’) had

determined that an acutely toxic dose of

sodium fluoride for a 25 pound (∼ 11.4

kg) child was in the range of 50 to 250

mg/kg (equivalent to ∼ 23 to 113 mg/kg

of elemental fluoride) (42 FR 62363). As

discussed below, the Commission is

proposing a new level that is based on

current information concerning the

toxicity of fluoride and would be

consistent with the proposed CR

requirement for fluoride-containing

household products.

The FDA limits OTC packages of

toothpaste and tooth powder to no more

than 276 mg total elemental fluoride per

package. 21 CFR 310.545. However,

preventative treatment rinses and gels

sold OTC must contain no more than

120 mg total elemental fluoride per

package. 21 CFR 355.10.

B. Toxicity of Fluoride

Most available toxicity information on

fluoride relates to acute toxicity of

hydrofluoric acid (‘‘HF’’). However,

other water soluble fluoride-containing

compounds can cause fluoride

poisoning. The fluoride ion is

systemically absorbed almost

immediately. It is highly penetrating

and reactive and can cause both

systemic poisoning and tissue

destruction. Fluoride ions, once

separated from either HF or fluoride

salts, penetrate deep into tissues,

causing burning at sites deeper than the

original exposure site. The process of

tissue destruction can continue for

days.[2]

Systemic fluoride poisoning after

ingestion or inhalation occurs very

rapidly as the fluoride is absorbed into

the gastrointestinal (‘‘GI’’) tract and

lungs. Systemic fluoride poisoning can

also result from dermal exposure if the

exposure is massive or the skin barrier

has been destroyed, as with severe

burns. Fluoride absorption can produce

hyperkalemia (elevated serum

potassium), hypocalcemia (lowered

serum calcium), hypomagnesemia

(lowered serum magnesium), and

metabolic and respiratory acidosis.

These disturbances can then bring on

cardiac arrhythmia, respiratory

stimulation followed by respiratory

depression, muscle spasms,

convulsions, central nervous system

(‘‘CNS’’) depression, possible

respiratory paralysis or cardiac failure,

and death. Fluoride may also inhibit

cellular respiration and glycolysis, alter

membrane permeability and excitability,

and cause neurotoxic and adverse GI

effects.[2]

When exposure is through inhalation,

fluorides can cause severe chemical

burns to the respiratory system.

Inhalation can result in difficulty

breathing (dyspnea), bronchospasms,

chemical pneumonitis, pulmonary

edema, airway obstruction, and

tracheobronchitis. The severity of burns

from dermal absorption can vary

depending on the concentration of

fluoride available, duration of the

exposure, the surface area exposed, and

the penetrability of the exposed tissue.

Dermal exposure to 6 to 10 percent HF

is the lowest concentration range known

to cause skin injury in humans.

Destruction of tissue under the skin may

occur, as may decalcification and

erosion of bone. Death from systemic

fluoride toxicity has resulted from

dermal exposure to 70 percent HF over

2.5 percent of the body surface.[2]

Ocular exposure can result in serious

eye injury. Exposure to concentrations

of 0.5 percent can lead to mild

conjunctivitis and greater

concentrations can lead to progressively

severe results such as immediate

corneal necrosis (20 percent solution).

Ingestion of fluoride can result in

mild to severe GI symptoms. Reports

suggest that ingesting 3 to 5 milligrams

per kilogram of fluoride causes

vomiting, diarrhea, and abdominal pain.

Ingestion of more than 5 mg/kg may

produce systemic toxicity. A

retrospective poison control center

study of fluoride ingestions reported
61930 Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules

3Major outcome—The patient exhibited signs or

symptoms which were life-threatening or resulted

in significant residual disability or disfigurement.

4Moderate outcome—The patient exhibited signs

and symptoms that were more pronounced, more

prolonged, or more of a systemic nature. Usually

some form of treatment was required. Symptoms

were not life-threatening and the patient had no

residual disability or disfigurement.

that symptoms, primarily safely

tolerated GI symptoms that tended to

resolve within 24 hours, developed

following ingestions of 4 to 8.4 mg/kg of

fluoride.[2]

According to the medical literature, a

safely tolerated dose (‘‘STD’’) and a

certainly lethal dose (‘‘CLD’’) were

determined from 600 fluoride poisoning

deaths. The CLD was determined to be

32 to 64 mg/kg and the STD was

estimated at one fourth that, or 8 to 16

mg/kg. These values were statistically

determined and do not correspond to

the actual lowest toxic or lethal levels

of fluoride. The lowest documented

lethal dose for fluoride is 16 mg/kg in

a 3-year-old child. There were

complicating factors in this death. The

child may have taken other medications

and he suffered from Crohn’s disease

(an inflammatory disorder of the GI

tract) that may have contributed to his

death.[2]

C. Injury Data

Medical Literature

There are many reports in the medical

literature of deaths and injuries

involving fluoride-containing products.

A retrospective study conducted by the

American Association of Poison Control

Centers (‘‘AAPCC’’) of hydrofluoric acid

burns from rust stain removers applied

to clothing found 619 such cases in

1990. Five of these required

hospitalization. Some of the burns

occurred even after the clothing had

been washed.[2]

Other reports included that of a 14-

month-old child who developed

hypocalcemia and hyperfluoridemia

(elevated blood fluoride level) and went

into cardiac arrest after exposure to a

rust remover containing HF. A 21⁄2-yearold child developed respiratory failure

and repeated episodes of ventricular

tachycardia (rapid heart beat) and

fibrillation after ingesting a laundry sour

(used in laundry operations to

neutralize alkalis or decompose

hypochlorite bleach) with sodium

fluosilicate. A 28-year-old man died

after accidentally drinking floor polish

that contained fluosilicate. A 56-yearold man died after ingesting a spoonful

of glass etching cream (20% ammonium

bifluoride and 13% sodium bifluoride).

He had severe burns in his esophagus

and stomach, and he suffered cardiac

arrest 5 hours after the ingestion.[2]

CPSC Databases

CPSC has several databases for poison

incidents. The staff reviewed cases from

1988 to May 1997 in the National

Electronic Injury Surveillance System

(‘‘NEISS’’), the Injury or Potential Injury

Incident (‘‘IIPI’’) files, Death Certificate

(‘‘DCRT’’) database, and In-DepthInvestigation (‘‘INDP’’) files. From 1988

to 1996, NEISS had reports of 31

incidents involving products

documented to contain fluoride. Two of

these were accidental ingestions by

children under 5 years old. Most other

injuries involved chemical burns of the

hands.[2]

The INDP files contain numerous

injury reports. For example, a 50-yearold woman was using a water stain

remover with 6 percent HF when it

leaked through her rubber gloves and to

her skin. She developed intense pain 4

hours later when the fluoride ion

penetrated through to the bones of her

forearm. Four months after the incident

she had only partial use of her arm and

hand. In another case, an 18-year-old

man developed second and third degree

burns on his hands after exposure to an

automobile water spot remover with HF.

His fingers became permanently flexed

from damage to the muscle and

connective tissue. A 20-year-old male

died of cardiac arrest after ingesting one

to two ounces of a wheel cleaner with

fluoride.[2]

Three reports in the INDP files

involve children under 5 years old who

died after ingesting fluoride-containing

products. A three-year-old child

ingested an unknown product with HF.

The second case involved a 2-year-old

child who ingested a toilet bowl stain

remover that contained 15.9 percent

ammonium bifluoride. The most recent

case was an 18-month-old child who

ingested an unknown amount of air

conditioner coil cleaner with 8 percent

HF and 8 percent phosphoric acid.[2]

Since 1995, there have been six

additional reports of fluoride poisoning

in children under 5 years of age from

the wheel cleaning product involved in

the death of the 20-year-old man

described above. The product contains

ammonium bifluoride and ammonium

fluoride salts, reportedly containing at

least 15 percent fluoride. Before

December, 1996, it was marketed for

household use in non-CR packaging.

Since that date it has been packaged in

CR packaging, and in September 1997 it

was recalled by the manufacturer.[2]

AAPCC Data

The staff reviewed AAPCC ingestion

data involving children under 5 years

old and products known to, or that may,

contain fluoride. (The actual number of

fluoride exposures cannot be

determined because some products that

contain fluoride are not identified as

such and therefore may be coded to

generic categories such as acidic

cleaning products or other unknown

cleaning products.) From 1993 to 1995,

there were no reported fatalities in this

age group. Out of a total of 499

exposures to products known to contain

HF, there were 2 major 3 outcomes and

24 moderate 4 outcomes. The AAPCC

data also show 23 major outcomes and

188 moderate outcomes for other acid

household products. Some of these may

have contained fluoride. The frequency

of injury for dental treatments was

much lower than that for household

products containing HF. Of

approximately 23,000 exposures to such

dental products, there were 34 moderate

outcomes, and the only documented

major outcome was a miscoded incident

where the child experienced an allergic

reaction to the product rather than

systemic toxicity from an overdose.[2]

The staff also compiled data from

AAPCC annual reports for all ages and

all routes of exposure for the years 1985

to 1995. During this time period, there

were about 25,000 exposures to

products containing HF. Of these, 2,881

resulted in moderate outcomes and 275

in major outcomes. There were also

injuries from dental products, fluoride

mineral/electrolyte products, and

vitamins with fluoride. A total of 18

deaths were reported in the HF category.

Two deaths involved children under 5

years old. One ingested an ammonium

bifluoride toilet stain remover

(described above) and the other child

died after ingesting a toilet cleaner with

HF. Generally, these AAPCC data

suggest that household products with

HF pose a more serious risk of injury

than other classes of fluoride products.

Moderate to serious outcomes

developed in 12.8 percent of the

exposures to HF compared to only 0.4

percent of the exposures to anticaries

products.[2]

D. Level of Regulation for Household

Products Containing Fluoride

The Commission is proposing a rule

that requires special packaging for

household products containing more

than the equivalent of 50 mg of

elemental fluoride and more than the

equivalent of 0.5 percent elemental

fluoride on a weight-to-volume (‘‘w/v’’)

basis for liquids or a weight-to-weight

(‘‘w/w’’) basis for non-liquids.[1&2] The

Commission is especially interested in

obtaining information and receiving
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules 61931

comments on the uses and marketing

patterns of glass etching creams.

There is no well defined lethal dose

for fluoride. In the medical literature,

one source cites a minimum lethal dose

in humans of 71 mg/kg and another

specifies a lethal oral dose in the range

of 70 to 140 mg/kg. The staff considers

these values too high based on

documented cases of fluoride toxicity.

There is one documented death from

ingestion of 16 mg/kg fluoride, but as

discussed above, other medical factors

may have contributed to that death.

Most evidence suggests that the lower

limit of the calculated certainly lethal

dose (CLD) of 32 mg/kg is a reasonable

estimate for a minimum lethal dose.[2]

Similarly, there is no established toxic

dose for fluoride. Generally, greater than

6 percent HF can cause dermal burns

and more than 0.5 percent can lead to

serious eye injury. Several reports

suggest ingestion of 3 to 5 mg/kg

produces symptoms and that more than

5 mg/kg (50 mg in a 10 kg child) can

produce systemic toxicity. Additionally,

some medical professionals advise

medical observation following

ingestions of more than 5 to 8 mg/kg.

Based on this information, the

Commission proposes a level for

regulation that would include all

household products with more than 50

mg of elemental fluoride and more than

0.5 percent elemental fluoride on a w/

v basis for liquids or a w/w basis for

non-liquids. There is no evidence that

50 mg or less of elemental fluoride or

concentrations less than 0.5 percent

cause serious systemic toxicity or

serious burns. [1&2]

E. Level of Regulation for Oral

Prescription Drugs Containing Sodium

Fluoride

Based on the toxicity information

discussed above, the Commission

believes that the current exemption for

oral prescription drugs with no more

than 264 mg of sodium fluoride should

be modified. To be consistent with the

proposed level for household products

containing fluoride, the Commission is

proposing that the level for the oral

prescription drug exemption be changed

to allow no more than the equivalent of

50 mg of elemental fluoride (110 mg

sodium fluoride) per package and no

more than a concentration of 0.5 percent

elemental fluoride on a w/v basis for

liquids or a w/w basis for non-liquids.

The proposed level provides a safety

factor to protect sensitive

individuals.[1&2]

The Commission does not believe that

changing the level of exemption for

prescription drugs containing sodium

fluoride will impact any of the currently

exempted dental products with more

than 50 mg of fluoride because these

products have 0.5 percent or less

fluoride. There is no evidence that any

of these products have caused serious

injury. The Commission proposes

modifying the exemption level so that it

is consistent with the regulated level

proposed for household products

containing fluoride.[1]

F. Statutory Considerations

1. Hazard to Children

As noted above, the toxicity data

concerning children’s ingestion of

fluoride demonstrate that fluoride can

cause serious illness and injury to

children. Moreover, it is available to

children in common household

products. Although some products

currently use CR packaging, others do

not. The Commission preliminarily

concludes that a regulation is needed to

ensure that products subject to the

regulation will be placed in CR

packaging by any current as well as new

manufacturers.[1&2]

The same hazard posed to children by

toxic amounts of fluoride in household

products also exists from such levels of

fluoride in oral prescription drugs.

Therefore, the Commission is proposing

to modify the existing exemption for

such drugs with sodium fluoride to

reflect current toxicity data and be

consistent with the proposed level for

fluoride-containing household

products.[1&2]

Pursuant to section 3(a) of the PPPA,

15 U.S.C. 1472(a), the Commission

preliminarily finds that the degree and

nature of the hazard to children from

handling or ingesting fluoride is such

that special packaging is required to

protect children from serious illness.

The Commission bases this finding on

the toxic nature of these products,

described above, and their accessibility

to children in the home.

2. Technical Feasibility, Practicability,

and Appropriateness

In issuing a standard for special

packaging under the PPPA, the

Commission is required to find that the

special packaging is ‘‘technically

feasible, practicable, and appropriate.’’

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

feasibility may be found when

technology exists or can be readily

developed and implemented by the

effective date to produce packaging that

conforms to the standards. Practicability

means that special packaging complying

with the standards can utilize modern

mass production and assembly line

techniques. Packaging is appropriate

when complying packaging will

adequately protect the integrity of the

substance and not interfere with its

intended storage or use.[4]

Some OTC fluoride-containing

household products are packaged in

containers with non-CR continuous

threaded closures. The Commission also

is aware of such products packaged in

aerosols and mechanical pumps.

Various types and designs of senior

friendly CR packaging can be readily

obtained that would be suitable for

fluoride-containing products.[3&4]

Two manufacturers currently use

senior-friendly continuous threaded CR

packaging for their fluoride-containing

household products. Another

manufacturer uses a senior-friendly

trigger mechanical pump mechanism for

its product. This shows that these types

of CR packages are technically feasible,

practicable and appropriate for fluoridecontaining products. The Commission

knows of at least one fluoride product

that uses a non-CR aerosol package. The

manufacturer of another regulated

product is currently using a seniorfriendly CR aerosol overcap. Thus, this

kind of CR packaging could be used for

fluoride-containing products. Finally,

various designs of senior-friendly snap

type reclosable CR packaging that would

be appropriate for non-liquid fluoridecontaining products are available. Thus,

appropriate senior-friendly CR

packaging is available for products

marketed in continuous threaded, snap,

aerosols, and trigger spray packaging.[4]

Therefore, the Commission concludes

that CR packaging for fluoridecontaining products is technically

feasible, practicable, and appropriate.

3. Other Considerations

In establishing a special packaging

standard under the PPPA, the

Commission must consider the

following:

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).

The Commission has considered these

factors with respect to the various

determinations made in this notice, and

preliminarily finds no reason to

conclude that the rule is unreasonable

or otherwise inappropriate.

G. Effective Date

The PPPA provides that no regulation

shall take effect sooner than 180 days or

later than one year from the date such
61932 Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules

final regulation is issued, except that,

for good cause, the Commission may

establish an earlier effective date if it

determines an earlier date to be in the

public interest. 15 U.S.C. 1471n.

Senior-friendly special packaging is

currently commercially available for

most types of CR packaging. Aerosol

and mechanical pump packages should

be commercially available in seniorfriendly CR designs within nine months

of a final rule.[1,4 & 5] Thus, the

Commission proposes that a final rule

would take effect nine months after

publication of the final rule.

Currently available information

indicates that full commercial

availability for senior-friendly

mechanical pump packages and aerosol

overcap packages could take from 9 to

12 months from the date a final rule is

issued. If comments on this proposal

indicate that manufacturers using

mechanical pump packages and aerosol

overcap packages need more than 9

months to comply with the rule, the

Commission may (1) specify a 1-year

effective date for these types of packages

only, or (2) provide that manufacturers

may request a stay of enforcement so

they can market their products in

conventional packaging for the

minimum period needed to obtain an

adequate supply of senior-friendly

packaging.

A final rule would apply to products

that are packaged on or after the

effective date.

H. Regulatory Flexibility Act

Certification

When an agency undertakes a

rulemaking proceeding, the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq.,

generally requires the agency to prepare

proposed and final regulatory flexibility

analyses describing the impact of the

rule on small businesses and other small

entities. Section 605 of the Act provides

that an agency is not required to prepare

a regulatory flexibility analysis if the

head of an agency certifies that the rule

will not have a significant economic

impact on a substantial number of small

entities.

The Commission’s Directorate for

Economic Analysis prepared a

preliminary assessment of the impact of

a rule to require special packaging for

household products containing fluoride

with more than 50 mg elemental

fluoride and more than 0.5 percent

elemental fluoride (w/v or w/w). The

staff also considered the impact of a rule

modifying the current exemption for

oral prescription drugs containing

sodium fluoride so that it would be

consistent with the level proposed for

household products.[3]

This assessment reports that the staff

is aware of 25 suppliers of products that

are in categories of products that may

contain fluorides. Fourteen of these

companies may be small businesses. It

is unclear which of these products

actually contain fluorides and are

marketed directly to consumers rather

than commercial markets. The staff is

also aware of 40 suppliers of automotive

and household cleaning chemicals and

products. Some of these products may

contain fluoride.[3] The Commission

requests comments from companies that

supply fluoride-containing household

products. The Commission is

particularly interested in comments and

information on the likely effect of this

proposed rule on small businesses.

Several consumer products containing

fluoride are already in CR packaging.

For example, senior friendly packaging

is used by a small business marketer of

a fluoride-containing rust remover

packaged in a plastic container with a

continuous turn closure. Another small

business, marketing a fluoridecontaining glass etching cream, also

uses senior-friendly CR packaging.

However, the small business marketer of

another glass etching product is not

currently using CR packaging. A variety

of types of senior friendly CR packaging

that would be suitable for such products

are readily available at prices

competitive with non-CR packaging.

Similarly, of the three known marketers

of fluoride-containing wheel cleaners,

one (a large manufacturer) is using CR

packaging, while another (a small

business) is not. Senior-friendly trigger

sprays like those used for this product

are available. The incremental cost of a

CR trigger is not likely to be large

relative to the retail cost of the

product.[3]

Based on this assessment, the

Commission concludes that the

proposed requirement for fluoridecontaining household products would

not have a significant impact on a

substantial number of small businesses

or other small entities.

Furthermore, the proposed

modification in the level for exemption

of oral prescription drugs containing

sodium fluoride is not likely to affect

any currently available prescription

drugs, and if such drugs should become

available in the future appropriate CR

packaging is readily available at prices

competitive with non-CR packaging.

Therefore, the Commission concludes

that the proposed modification to the

exemption for oral prescription drugs

containing sodium fluoride would not

have a significant impact on a

substantial number of small businesses

or other small entities.

I. Environmental Considerations

Pursuant to the National

Environmental Policy Act, and in

accordance with the Council on

Environmental Quality regulations and

CPSC procedures for environmental

review, the Commission has assessed

the possible environmental effects

associated with the proposed PPPA

requirements for fluoride-containing

products.

The Commission’s regulations state

that rules requiring special packaging

for consumer products normally have

little or no potential for affecting the

human environment. 16 CFR

1021.5(c)(3). Nothing in this proposed

rule alters that expectation. Therefore,

because the rule would have no adverse

effect on the environment, neither an

environmental assessment nor an

environmental impact statement is

required.

J. Executive Orders

According to Executive Order 12988

(February 5, 1996), agencies must state

in clear language the preemptive effect,

if any, of new regulations.

The PPPA provides that, generally,

when a special packaging standard

issued under the PPPA is in effect, ‘‘no

State or political subdivision thereof

shall have any authority either to

establish or continue in effect, with

respect to such household substance,

any standard for special packaging (and

any exemption therefrom and

requirement related thereto) which is

not identical to the [PPPA] standard.’’

15 U.S.C. 1476(a). A State or local

standard may be excepted from this

preemptive effect if (1) the State or local

standard provides a higher degree of

protection from the risk of injury or

illness than the PPPA standard; and (2)

the State or political subdivision applies

to the Commission for an exemption

from the PPPA’s preemption clause and

the Commission grants the exemption

through a process specified at 16 CFR

Part 1061. 15 U.S.C. 1476(c)(1). In

addition, the Federal government, or a

State or local government, may establish

and continue in effect a non-identical

special packaging requirement that

provides a higher degree of protection

than the PPPA requirement for a

household substance for the Federal,

State or local government’s own use. 15

U.S.C. 1476(b).

Thus, with the exceptions noted

above, the proposed rule requiring CR

packaging for household products

containing fluoride above the regulated

level and modifying the exemption level

for oral prescription drugs with sodium

fluoride would preempt non-identical
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Proposed Rules 61933

state or local special packaging

standards for such fluoride containing

products.

In accordance with Executive Order

12612 (October 26, 1987), the

Commission certifies that the proposed

rule does not have sufficient

implications for federalism to warrant a

Federalism Assessment.

List of Subjects in 16 CFR Part 1700

Consumer protection, Drugs, Infants

and children, Packaging and containers,

Poison prevention, Toxic substances.

For the reasons given above, the

Commission proposes to amend 16 CFR

part 1700 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. 1670–74, 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 is amended to

revise paragraph (a)(10)(vii) and to add

paragraph (a)(27) to read as follows

(although unchanged, the introductory

text of paragraphs (a) and (10) are

included below for context):

§ 1700.14 Substances requiring special

packaging.

(a) Substances. The Commission has

determined that the degree or nature of

the hazard to children in the availability

of the following substances, by reason of

their packaging, is such that special

packaging meeting the requirements of

§ 1700.20(a) is required to protect

children from serious personal injury or

serious illness resulting from handling,

using, or ingesting such substances, and

the special packaging herein required is

technically feasible, practicable, and

appropriate for these substances:

* * * * *

(10) Prescription drugs. Any drug for

human use that is in a dosage form

intended for oral administration and

that is required by Federal law to be

dispensed only by or upon an oral or

written prescription or a practitioner

licensed by law to administer such drug

shall be packaged in accordance with

the provisions of § 1700.15 (a), (b), and

(c), except for the following:

* * * * *

(vii) Sodium fluoride drug

preparations including liquid and tablet

forms, containing not more than 110

milligrams of sodium fluoride (the

equivalent of 50 mg of elemental

fluoride) per package and not more than

a concentration of 0.5 percent elemental

fluoride on a weight-to-volume basis for

liquids or a weight-to-weight basis for

non-liquids and containing no other

substances subject to this

§ 1700.14(a)(10).

* * * * *

(27) Fluoride. Household substances

containing more than the equivalent of

50 milligrams of elemental fluoride per

package and more than the equivalent of

0.5 percent elemental fluoride on a

weight-to-volume basis for liquids or a

weight-to-weight basis for non-liquids

shall be packaged in accordance with

the provisions of § 1700.15 (a), (b) and

(c).

Dated: November 17, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

List of Relevant Documents

1. Briefing memorandum from Jacqueline

Ferrante, Ph.D., EH, to the Commission,

‘‘Proposed Rule to Require Child-Resistant

Packaging for Household Products with

Fluoride,’’ September 30, 1997.

2. Memorandum from Susan C. Aitken,

Ph.D., EH, to Jacqueline Ferrante, Ph.D., EH,

‘‘Toxicity of Household Products Containing

Fluoride,’’ August 4, 1997.

3. Memorandum from Marcia P. Robins,

EC, to Jacqueline Ferrante, Ph.D., EH,

‘‘Market Data, Economic Considerations and

Environmental Effects of a Proposal to

Require Child-Resistant Packaging for

Household Products Containing Fluoride,’’

June 20, 1997.

4. Memorandum from Charles Wilbur, EH,

to Jacqueline Ferrante, Ph.D., EH, ‘‘Technical

Feasibility, Practicability, and

Appropriateness Determination for the

Proposed Rule to Require Child-Resistant

Packaging for OTC Products Containing

Fluoride,’’ June 27, 1997.

[FR Doc. 97–30555 Filed 11–19–97; 8:45 am]

BILLING CODE 6355–01–P

SECURITIES AND EXCHANGE

COMMISSION

17 CFR Parts 230, 240 and 270

[Release Nos. 33–7475, 34–39321, IC–22884;

File No. S7–27–97]

RIN 3235–AG98

Delivery of Disclosure Documents to

Households

AGENCY: Securities and Exchange

Commission.

ACTION: Proposed rule.

SUMMARY: The Commission is proposing

for public comment a new rule under

the Securities Act of 1933 to enable

issuers and broker-dealers to satisfy the

Act’s prospectus delivery requirements,

with respect to two or more investors

sharing the same address, by sending a

single prospectus, subject to certain

conditions. The Commission is

proposing similar amendments to the

rules under the Securities Exchange Act

of 1934 and the Investment Company

Act of 1940 that govern the delivery of

annual and (in the case of investment

companies) semiannual reports to

shareholders. The proposed rule and

rule amendments seek to provide greater

convenience for investors and cost

savings for issuers by reducing the

amount of duplicative information that

investors receive.

DATES: Comments must be received on

or before February 2, 1998.

ADDRESSES: Comments should be

submitted in triplicate to Jonathan G.

Katz, Secretary, Securities and Exchange

Commission, 450 5th Street, N.W., Stop

6–9, Washington, D.C. 20549.

Comments also may be submitted

electronically at the following E-mail

address: rule-comments@sec.gov. All

comment letters should refer to File No.

S7–27–97; this file number should be

included on the subject line if E-mail is

used. Comment letters will be available

for public inspection and copying in the

Commission’s Public Reference Room,

450 5th Street, N.W., Washington, D.C.

20549. Electronically submitted

comment letters also will be posted on

the Commission’s Internet web site

(http://www.sec.gov).

FOR FURTHER INFORMATION CONTACT:

Marilyn Mann, Senior Counsel, at (202)

942–0690, Office of Regulatory Policy,

Division of Investment Management,

Stop 10–2, or Elizabeth M. Murphy,

Special Counsel, at (202) 942–2900,

Office of Chief Counsel, Division of

Corporation Finance, Stop 4–2,

Securities and Exchange Commission,

450 5th Street, N.W., Washington, D.C.

20549.

SUPPLEMENTARY INFORMATION: The

Commission today is requesting public

comment on proposed rule 154 under

the Securities Act of 1933 (15 U.S.C.

77a) (the ‘‘Securities Act’’) and

proposed amendments to rules 14a–3

(17 CFR 240.14a–3), 14c–3 (17 CFR

240.14c–3) and 14c–7 (17 CFR 240.14c–

7) under the Securities Exchange Act of

1934 (15 U.S.C. 78a) (the ‘‘Exchange

Act’’), and rules 30d–1 (17 CFR

270.30d–1) and 30d–2 (17 CFR 270.30d–

2) under the Investment Company Act

of 1940 (15 U.S.C. 80a) (the ‘‘Investment

Company Act’’).

Table of Contents

I. Discussion

A. Delivery of Prospectuses to a Household

1. Scope of Rule and General Conditions

2. Householding Without Written Consent

3. Revocation of Consent