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

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.

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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-to-volume (``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 [email protected].

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

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\1\ The 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 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.

[[Page 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 over-the-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 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).

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

[[Page 61930]]

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 2\1/2\-year-old 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-year-old 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-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]

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. 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]

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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 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

[[Page 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 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 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

[[Page 61932]]

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 senior-friendly 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 fluoride-containing 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 fluoride-containing 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

[[Page 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):

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 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 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: 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