Final Rule: 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

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

Final Rule: 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: Final rule.

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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-to-volume (``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 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: 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

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\1\ The 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\ x 100 =

45%).

\2\ Numbers in brackets refer to documents listed at the end of

this notice.

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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

[[Page 29950]]

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 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.[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-

year-old 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

[[Page 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]

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\3\ Major outcome--The patient exhibited signs or symptoms which

were life-threatening or resulted in significant residual disability

or disfigurement.

\4\ Moderate 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.

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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 non-

liquids.[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]

[[Page 29952]]

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 fluoride-

containing 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 senior-friendly 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

fluoride-containing 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 fluoride-containing

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 fluoride-containing 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

[[Page 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):

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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