Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 /Rules and Regulations 29949

1The percentage of elemental fluoride in any

compound is determined by dividing the molecular

weight of fluoride (∼619 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.

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Final Rule: Requirements for ChildResistant 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: Final rule.

SUMMARY: The Commission is issuing 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). For consistency, the

Commission is also modifying the oral

prescription drug exemption for sodium

fluoride preparations. Instead of

exempting drugs with no more than 264

mg of sodium fluoride per package as

the current rule does, the Commission

will exempt such drugs with either 50

mg or less of the equivalent of elemental

fluoride (110 mg or less of sodium

fluoride) per package or no more than

the equivalent of 0.5 percent elemental

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

Commission determines that childresistant 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: The rule will become effective

on March 2, 1999, and applies to

products packaged on or after that date.

FOR FURTHER INFORMATION CONTACT:

Laura Washburn, Office of Compliance,

Consumer Product Safety Commission,

Washington, D.C. 20207; telephone

(301) 504–0400 ext. 1452.

SUPPLEMENTARY INFORMATION:

A. Background

1. Household Products Containing

Fluoride

Fluorides are ingredients in such

household products as cleaning

solutions 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[1&3] 2

Many dental products also contain

fluorides, but at lower levels. 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 PPPA Requirements for

Fluoride-Containing 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). The

Commission based this exemption level

on the lack of serious adverse human

experience associated with such drugs

at that time and 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. As discussed below, the

Commission is revising the exemption

to a new level that is based on current

information concerning the toxicity of

fluoride and is consistent with the CR

requirement for fluoride-containing

household products.

4. The Proposed Rule

On November 20, 1997, the

Commission issued a notice of proposed

rulemaking (‘‘NPR’’) that would require

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 (w/v or w/w). The

Commission also proposed to adjust the

oral prescription drug exemption so that

it would be consistent. 62 FR 61928.

The Commission received four

comments in response to the proposed

rule.

One commenter noted that the

language of the revised exemption

needed to be clarified. The Commission

intended that products satisfying either

one of the criteria specified would

qualify for the exemption. Accordingly,

the Commission has clarified the final

rule so that it exempts sodium fluoride

drug preparations that contain no more

than 50 mg of the equivalent of

elemental fluoride (110 mg or less of

sodium fluoride) per package or no

more than the equivalent of 0.5 percent

elemental fluoride on a w/w or w/v

basis.

The Commission received a letter

from the American Dental Association

stating that it does not object to the

proposed rule. The third comment came

from the Art and Creative Materials

Institute, a non-profit association of

manufacturers of art and creative

materials, expressing support for the
29950 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 /Rules and Regulations

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.

proposed rule. The Chemical

Manufacturers Association also

commented in support of the proposed

rule.

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]

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.

Ocular exposure can result in serious

eye injury.[2]

Ingestion of fluoride can result in

mild to severe GI symptoms. Reports

suggest that ingesting 3 to 5 milligrams

of fluoride per kilogram of body weight

(mg/kg) 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

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 are not

identical 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 fluoridecontaining 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.[2]

Other reports gathered from the medical

literature are discussed in the notice of

proposed rulemaking and the

accompanying briefing package. 62 FR

61928.

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 files,

Death Certificate (‘‘DCRT’’) database,

and In-Depth-Investigation (‘‘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] In addition, 1997 NEISS

reports show six adults experienced

burns while using fluoride-containing

products. In 1997, NEISS had reports of

an additional five cases involving

children under 5 years old ingesting

products containing fluoride. For 1997,

NEISS also reported an additional three

cases of children under 5 years old

involving products that might have

contained fluoride.[7]

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. Three reports in the INDP files

involve children under 5 years old who

died after ingesting fluoride-containing

products. A 3-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 were six reports of

fluoride poisoning in children under 5

years of age from a wheel cleaning

product. 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]

Three deaths from fluoride-containing

products were documented in 1997 after

the staff had completed the briefing

package for the proposed rule. Two

involved children under 5 years old. In

one case, a 3-year-old female died from

cardiac arrest after ingesting the recalled

wheel cleaner described above. The

second death involved a 19-month-old

female who ingested a rust remover

with hydrofluoric acid and ammonium

bifluoride. Finally, a 38-year-old male

died from cardiac arrest after

unintentional ingestion of a rust

remover with ammonium bifluoride.[6]

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
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 /Rules and Regulations 29951

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 1996 AAPCC data report 136

exposures to products known to contain

HF involving children under 5 years

old. Four of these resulted in moderate

outcomes. There were no major

outcomes or deaths reported with this

age group in 1996.[7]

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]

The 1996 AAPCC data for all ages and

all routes of exposure show that for

1996 there were about 2944 exposures

to products containing HF. Of these, 742

resulted in moderate outcomes and 27

in major outcomes. Four deaths were

reported involving HF.[7]

D. Level of Regulation for Household

Products Containing Fluoride

The Commission is issuing 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 w/v basis for liquids or a

w/w basis for non-liquids.[1,2&5] This

is the same level as the Commission

proposed.

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 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 determined 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&5]

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

level for household products containing

fluoride, the Commission is revising the

level for the oral prescription drug

exemption to exempt products that have

either no more than the equivalent of 50

mg of elemental fluoride (110 mg

sodium fluoride) per package or no

more than a concentration of 0.5 percent

elemental fluoride on a w/v basis for

liquids or a w/w basis for nonliquids.[1,2&5]

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.[1] In its comment, the

American Dental Association confirmed

this.[5]

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 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 future

manufacturers.[1,2&5]

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 modifying

the existing exemption for such drugs

with sodium fluoride to reflect current

toxicity data and be consistent with the

level for fluoride-containing household

products.[1&2]

Pursuant to section 3(a) of the PPPA,

15 U.S.C. 1472(a), the Commission 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 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.[4,9]

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]
29952 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 /Rules and Regulations

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

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

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.[9]

Therefore, the Commission believes that

an effective date of 9 months after

publication of the final rule is

reasonable. The Commission proposed a

9 month effective date and received no

comments on this issue. If companies do

find that they need more time, they can

request a stay of enforcement for the

minimum period needed to obtain

adequate supplies of senior-friendly CR

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.

In connection with the proposed rule,

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]

Based on this assessment, the

Commission concluded 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. Despite making

a specific request in the NPR, the

Commission received no comments

concerning the potential impact on

small businesses, and the Commission

is unaware of any information that

would alter its conclusion that the rule

will not have a significant impact on a

substantial number of small entities.[8]

The Commission reached the same

conclusion concerning the proposed

modification in the level for exemption

of oral prescription drugs containing

sodium fluoride.[3] No additional

information was provided to alter the

Commission’s conclusion that the

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.[8]

I. Environmental Considerations

Also in connection with the proposed

rule and pursuant to the National

Environmental Policy Act, the Council

on Environmental Quality regulations

and CPSC procedures for environmental

review, the Commission assessed the

possible environmental effects

associated with the proposed PPPA

requirements for fluoride-containing

products.[3] The Commission

concluded that the proposed rule would

have no adverse effect on the

environment, and neither an

environmental assessment nor an

environmental impact statement would

be required. No additional information

alters this conclusion.[8]

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 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 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 rule does
Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 /Rules and Regulations 29953

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 amends 16 CFR part 1700

as follows:

PART 1700—[AMENDED]

1. The authority citation for part 1700

continues to read as follows:

Authority: 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 (the

introductory text of paragraphs (a) and

(10) are republished without change 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 or 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: May 27, 1998.

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.

5. Briefing memorandum from Jacqueline

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

‘‘Final Rule to Require Child-Resistant

Packaging for Household Products with

Fluoride,’’ May 6, 1998.

6. Memorandum from Susan C. Aitken,

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

‘‘Update on Injuries Due to Products

Containing Fluoride,’’ October 9, 1997.

7. Memorandum from Susan C. Aitken,

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

‘‘Injuries Due to Products Containing

Fluoride,’’ April 20, 1998.

8. Memorandum from Marcia P. Robins,

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

Rule: Child-Resistant Packaging for

Household Products Containing Fluorides,’’

April 8, 1998.

9. Memorandum from Charles Wilbur, EH,

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

Feasibility, Practicability, and

Appropriateness Determination for the Final

Rule to Require Special Packaging for

Products Containing Fluoride,’’ March 10,

1998.

[FR Doc. 98–14449 Filed 6–1–98; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Part 10

[T. D. 98–52]

RIN 1515–AC18

Procedural Change Regarding

American Shooks and Staves

AGENCY: Customs Service, Department

of the Treasury.

ACTION: Final rule.

SUMMARY: This document amends the

Customs Regulations by requiring the

submission of a Customs Form (CF)

4455, Certificate of Registration, rather

than a CF 3311, Declaration for Free

Entry of Returned American Products,

when shooks and staves produced in the

United States are exported from the

United States with the intention that

they will be returned to the United

States, exempt from duty, in the form of

complete boxes or barrels in use as

usual containers of merchandise. When

boxes or barrels made from the exported

American shooks and staves, for which

a CF 4455 has been submitted, are

imported, the importer of the boxes or

barrels must use the CF 4455 as well to

make such a claim. Shooks and staves

produced in the United States that are

exported and so returned are exempt

from customs duties provided their

identity is established by the proper

submission of the CF 4455. The

amendment helps to clarify the

procedures regarding the free entry of

such American produced shooks and

staves returned to the United States.

EFFECTIVE DATE: July 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas Wygant, Office of Field

Operations, 202–927–1167.

SUPPLEMENTARY INFORMATION:

Background

Section 10.5, Customs Regulations (19

CFR 10.5) provides that shooks and

staves produced in the United States

and returned in the form of complete

boxes or barrels in use as the usual

containers of merchandise are exempt

from any duties imposed by the tariff

laws upon similar containers made of

foreign shooks or staves, provided their

identity is established under the

regulations.

Paragraph (d) of § 10.5 provides that

an exporter of shooks or staves in

respect of which free entry is to be

claimed when returned as boxes or

barrels shall file a notice of intent to

export on a Customs Form (CF) 3311 in

triplicate with the director of the port of