[Federal Register Volume 60, Number 68 (Monday, April 10, 1995)]
[Rules and Regulations]
[Pages 17992-18005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8628]



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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700


Requirements for Child-Resistant Packaging; Requirements for 
Products Containing Lidocaine or Dibucaine

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: Under the Poison Prevention Packaging Act of 1970, the 
Commission issues a rule requiring child-resistant packaging for 
products containing more than 5.0 milligrams (mg) of lidocaine in a 
single package or more than 0.5 mg of dibucaine in a single package. 
These requirements are issued because the Commission has determined 
that child-resistant packaging is required to protect children under 5 
years of age from serious personal injury and serious illness resulting 
from ingesting such substances. Lidocaine and dibucaine are used in 
prescription drugs and over-the-counter drug products that are applied 
to the skin or mucous membranes to provide an anesthetic effect.

DATE: The rule shall be effective on April 10, 1996 and shall apply to 
subject products that are packaged on or after that date.<SUP>1

    \1\The Commission approved unanimously (3-0) the motion of 
Chairman Ann Brown to require special packaging for all products 
containing more than .5 mg of dibucaine in a single package. The 
Commission voted 2-1 to require special packaging for all products 
containing more than 5 mg of lidocaine in a single package (Chairman 
Brown and Commissioner Jacqueline Jones-Smith voting for and 
Commissioner Mary Sheila Gall voting against).
    The Commission then voted unanimously (1) that the regulation on 
lidocaine and dibucaine not be considered a final regulation until 
it is published in the Federal Register; (2) that the final 
regulation be published in the Federal Register on April 8, 1995, or 
as soon thereafter as practicable; and (3) to approve the most 
recent draft Federal Register notice that had been forwarded to the 
Commission.
    Each Commissioner filed a separate statement concerning this 
matter. Copies of the Commissioners' statements can be obtained from 
the Commission's Office of the Secretary. [[Page 17993]] 
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FOR FURTHER INFORMATION CONTACT: Michael Bogumill, Division of 
Regulatory Management, Office of Compliance and Enforcement, Consumer 
Product Safety Commission, Washington, DC 20207; telephone (301)504-
0621 ext. 1368.

SUPPLEMENTARY INFORMATION:

A. Background

    Relevant statutes and regulations. The Poison Prevention Packaging 
Act of 1970 (the ``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 packaging,'' is defined as packaging that 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. It does not mean, however, packaging 
which all such children cannot open, or obtain a toxic or harmful 
amount from, within a reasonable time.
    Under the PPPA, effectiveness standards have been established for 
special packaging (16 CFR 1700.15), as has a procedure for evaluating 
its effectiveness (Sec. 1700.20). Regulations were issued requiring 
special packaging for a number of household products (Sec. 1700.14). 
The findings that the Commission must make in order to issue a standard 
requiring child-resistant (``CR'') packaging for a product are 
discussed below in Section E of this notice. For the purposes of the 
PPPA, the amount of a substance ``in a single package'' that requires 
the product to be in CR packaging refers to the total amount in a 
single retail unit of the substance.
    One of the categories of products for which CR packaging is 
required is prescription drugs intended for oral administration to 
humans, with specified exemptions. 16 CFR 1700.14(a)(10). Drugs that 
are applied topically (for example, ointments, creams, sprays, 
suppositories, mouthwash, etc.) are not covered by the oral 
prescription drug standard. Where prescription drugs are subject to a 
special packaging standard, section 4(b) of the PPPA allows such 
products to be sold in non-CR packaging only when (1) directed by the 
prescribing medical practitioner or (2) requested by the purchaser. 15 
U.S.C. 1473(b).
    For nonprescription (over-the-counter, or ``OTC'') products subject 
to special packaging standards, section 4(a) of the PPPA allows the 
manufacturer or packer to package a single size of the product in non-
CR packaging only if (1) the manufacturer (or packer) also supplies the 
substance in CR packages and (2) the non-CR packages bear conspicuous 
labeling stating: ``This package for households without young 
children.'' 15 U.S.C. 1473(a). If the package is too small to 
accommodate this label statement, the package may bear a label stating: 
``Package not child-resistant.'' 16 CFR 1700.5(b). The right of the 
manufacturer or packer to market a single size of the product in 
noncomplying packaging under these conditions is termed the ``single-
size exemption.''
    The Commission may restrict the right to market a single size in 
noncomplying packaging if the Commission finds that the substance is 
not also being supplied in popular size packages that comply with the 
standard. 15 U.S.C. 1473(c). In this case, the Commission may, after 
giving the manufacturer or packer an opportunity to comply with the 
purposes of the PPPA and an opportunity for a hearing, order that the 
substance be packaged exclusively in CR packaging. To issue such an 
order, the Commission must find that the exclusive use of special 
packaging is necessary to accomplish the purposes of the PPPA.
    Previous Commission activities. [9]<SUP>2 In 1985, the Commission's 
staff reviewed ingestion data for topical prescription drugs to assess 
the need for CR packaging. Lidocaine, a local anesthetic, was 
identified as a topical drug that presented a potential ingestion 
hazard to young children. Local anesthetics are used to produce 
temporary loss of feeling to a limited area of the body by decreasing 
the transmission of nerve impulses in that area.

    \2\Numbers in brackets indicate the number of a relevant 
document as listed in Appendix 1 to this notice. When a reference 
document that is cited in a document listed in Appendix 1 is 
referred to, both the number of the Appendix 1 document and the 
designation of the reference document as given in the Appendix 1 
document are given, e.g., [1, Ref. A].
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    In 1985, many manufacturers of 2-percent viscous prescription 
lidocaine drugs were voluntarily using CR packaging on products 
intended to be dispensed directly to the consumer. The Commission 
directed the staff to pursue voluntary action to address the ingestion 
hazard presented by lidocaine-containing drugs and to continue to 
monitor data on topical prescription drugs. In 1986, the staff sent 
letters to the known manufacturers of 2-percent viscous prescription 
lidocaine products requesting that the manufacturers (1) use CR 
packaging on all consumer-ready packages of 2-percent viscous lidocaine 
products, and (2) label 2-percent viscous lidocaine products intended 
to be repackaged by the pharmacist to advise the pharmacist to dispense 
the drug in CR packaging.
    In 1990, the staff updated its review of the toxicity of lidocaine. 
The scope of the review was expanded to include other topical local 
anesthetics marketed for consumer use, and to include OTC products as 
well as prescription products. The review showed that two local 
anesthetics, lidocaine and dibucaine, have caused serious adverse 
effects, including death, following accidental ingestion by young 
children.
    After considering the available information, the Commission, on 
August 4, 1992, proposed a CR packaging requirement for products 
containing (1) more than 5.0 milligrams (mg) of lidocaine in a single 
package or (2) more than 0.5 mg dibucaine in a single package. 57 Fed. 
Reg. 34274.

B. Lidocaine

    Product forms, dosage and packaging. Lidocaine is an ingredient in 
a wide variety of preparations used as anesthetics, general 
antiseptics, and burn remedies, and for skin care. It is used also in 
preparations meeting the provisions of the Food and Drug 
Administration's (FDA's) OTC monograph for male genital desensitizing 
products (57 Fed. Reg. 27654; June 19, 1992; 21 CFR 348). Lidocaine 
preparations are available as creams, ointments, gels, jellies, viscous 
[[Page 17994]] solutions, liquids, sprays, aerosols, and injectables. 
Tube packaging, used for creams, ointments, and some gels, protects its 
contents from contamination and moisture and enables the administration 
of a controlled volume of medication to smaller areas. Aerosol, spray, 
and squeeze bottles permit liquids to be applied to cover larger areas.
    OTC liquid lidocaine preparations contain 1.5 to 2.5 percent 
lidocaine hydrochloride. The liquid preparations typically are packaged 
in squeeze or pump bottles or aerosol sprays and are labeled for 
external use only. Creams and ointments contain 0.5 to 2.5 percent 
lidocaine and typically are packaged in tubes. These products are 
recommended for children 2 years of age and older.
    Approximately 12.1 million units of lidocaine-containing products 
were sold to consumer outlets in 1992. More than half (6.2 million) of 
these products were cream and ointment formulations available in tubes. 
In addition, the Commission's staff estimates that less than 0.4 
million bottles of consumer-ready prescription viscous lidocaine were 
sold in 1992.
    Prescription preparations intended for consumer use include a 2-
percent viscous solution and at least two combination lidocaine creams. 
The prescription 2-percent lidocaine viscous liquids, in 100 ml bottles 
(3\1/2\ fluid oz), are available from 15 suppliers at estimated 
wholesale costs to pharmacies ranging from $2.28 to $4.40. One supplier 
also markets a 450 ml bottle of 2-percent viscous lidocaine that, 
according to a company spokesperson, is for pharmacy repackaging into 
smaller containers and dispensing as prescribed by physicians.
    One combination cream, a lidocaine/hydrocortisone formulation, is 
marketed in a 1-oz tube; its estimated wholesale cost to pharmacies is 
$32.33. The other combination is a lidocaine/prilocaine-based cream, 
marketed in unit dose and 30-gm (slightly over 1 oz) tubes (cost 
unknown). The unit-dose, when used by the consumer, is intended to have 
its entire contents applied at home about 1 hour before a medical 
procedure that will be performed in a professional setting. The 
preparation is used also in professional settings.
    The prescription 2-percent viscous solution of lidocaine is used 
for anesthesia of irritated or inflamed mucous membranes of the mouth 
and throat. Care must be taken following the oral use of viscous 
lidocaine because swallowing may be impaired. It is recommended that 
food not be ingested for 1 hour following oral use because of the 
potential for aspiration. For adults, it is recommended for mouth pain 
that one 15 ml tablespoon be swished around the mouth and spit out; for 
throat pain, the same amount can be gargled and either spit out or 
swallowed. The maximum recommended single adult dose is 4.5 milligrams/
kilogram (mg/kg), not to exceed 300 mg. (A kilogram equals 
approximately 2.2 lb.) Although this form of lidocaine is applied to 
the mouth, or even swallowed, it is not considered to be a ``drug for 
human use that is in a dosage form intended for oral administration'' 
that already is required to be in CR packaging by 16 CFR 
1700.14(a)(10). This is because its action is caused by topical 
application to the affected area and not by systemic action following 
ingestion.
    For children under 3 years of age, it is recommended that \1/4\ 
teaspoonful be applied to the affected area with a cotton-tipped 
applicator. For children 3 years old and older, the dose is prescribed 
based on the weight and age of the child. The dose interval for 
children should be at least 3 hours, so as not to exceed 4 doses in a 
12-hour period.
    Previously, the Commission was aware of 7 marketers of trade name 
OTC pharmaceuticals containing lidocaine; 16 marketers are now known. 
Some marketers represent recently introduced preparations. Also, some 
preparations have been recently withdrawn from the market. Creams, 
ointments and some gel preparations are available in small (\1/2\- and/
or 1-oz) tubes at estimated wholesale costs of $2.02 to $5.74. One 
supplier markets a preparation in a 35-gm tube (1.25 oz) at an 
estimated wholesale cost of $10.19. Liquid (and some gel) lidocaine 
preparations are available in aerosol, spray pump, and spray and 
squeeze bottle containers. Estimated wholesale costs for \1/4\-16 oz 
liquids and gels range from $1.74 to $5.46. One new marketer supplies a 
preparation for burn injuries in a foil packet containing \1/8\ oz of 
gel. The preparation is currently promoted for use in the workplace 
rather than in the home; the company plans to introduce this product 
into the consumer market in the future.
    Some lidocaine preparations, although dispensed through pharmacies, 
are intended for use in a professional setting such as a doctor's or 
dentist's office. According to pharmaceutical company spokespersons, 
these preparations include prescription lidocaine fluids such as 2 
percent, 4 percent, and 5 percent liquid solutions; 2 percent jellies; 
5 percent ointments; 4 percent viscous liquids; 10 percent oral sprays; 
5 percent ophthalmologic solutions and drops; and prefilled syringes 
containing lidocaine solutions. Products that are not customarily 
consumed, used, or stored by individuals in or about the household are 
not required to comply with PPPA regulations.
    Table 1 shows estimated 1992 total market sales of prescription and 
OTC consumer-use preparations containing lidocaine for each of five 
therapeutic categories in which lidocaine products are sold. Total 
sales of lidocaine preparations in 1992 are estimated at $36.6 million, 
about 12 percent of sales of all preparations in the five categories 
reviewed.
    Based on IMS America data, the Commission's staff estimates 1992 
unit sales of consumer-ready prescription 2-percent viscous lidocaine 
bottles at under 0.4 million bottles, a decrease of about 50 percent 
from the 1989 estimate of 0.8 million bottles. About 98 percent of 
prescription 2-percent viscous lidocaine preparations were marketed in 
consumer-ready 100 ml bottles in 1989 and in 1992. Many marketers and 
pharmacists are voluntarily providing CR packaging for these 
preparations.
    Market shares of lidocaine-containing preparations (Table 2) show 
slight increases since 1989 in three categories: OTC Topical 
Anesthetics (up 1 percent); General Antiseptics (up 3 percent); and 
Burn Remedies (up 2 percent). The 9 percent increase in the market 
share of lidocaine preparations in the Topical Anti-infectives category 
is most likely due to new product introductions of combination 
antibiotic/anesthetic ointments and creams. The 1992 market share of 
prescription cortisone/lidocaine preparations remains unchanged from 
1989.

   Table 1.--Estimated Sales: Total Market\1\ Lidocaine Preparations--  
                          Topical Dosage Forms                          
------------------------------------------------------------------------
                                                            1992        
                                                   ---------------------
                                                               Lidocaine
                                                    All preps    preps  
                                                     Sales ($   Sales ($
                                                    millions)  millions)
------------------------------------------------------------------------
Topical Anesthetics:                                                    
(OTC).............................................      97.7        2.0 
(Prescription)\2\.................................       3.3        3.3 
General Antiseptics (OTC Only)....................      33.0        8.9 
Burn Remedies (OTC Only)..........................      25.1        9.2 
Topical Anti-infectives (OTC Only)................     135.4       13.1 
Hydrocortisone Combinations (Prescription Only)...       7.2         .1 
                                                   ---------------------
[[Page 17995]]                                                          
                                                                        
      Total.......................................     301.7      36.6  
------------------------------------------------------------------------
Source: IMS America, Ltd. and CPSC Directorate for Economic Analysis.   
\1\Extrapolated from IMS America, Ltd. data to estimate total sales to  
  drug stores, food stores, and mass merchandise outlets. Includes data 
  provided by pharmaceutical company spokespersons.                     
\2\Includes only prescription 2-percent Viscous Lidocaine; all other    
  prescription preparations in the category are for professional use.   


  Table 2.--Estimated Market Shares by Category; Lidocaine Preparations 
                              1992 and 1989                             
------------------------------------------------------------------------
                                                        1992 (%  1989 (%
                                                         Share)   Share)
------------------------------------------------------------------------
Topical Anesthetics (OTC).............................        2        1
General Antiseptics (OTC Only)........................       27       24
Burn Remedies (OTC Only)..............................       37       35
Topical Anti-infectives (OTC Only)....................       10        1
Hydrocortisone Combinations (prescription Only).......        2       2 
------------------------------------------------------------------------
Source: IMS America and CPSC Directorate for Economic Analysis.         

    Toxicity. [1] The toxicity of lidocaine has been demonstrated in 
animals and humans. Adverse effects have been observed in humans 
following both therapeutic usage and accidental overdosage. Lidocaine 
is readily absorbed through mucous membranes and abraded skin. The OTC 
preparations warn against using large quantities over raw or blistered 
areas or puncture wounds. The first-aid spray preparations warn against 
use near the mouth, eyes, ears, or other sensitive areas.
    Absorption of lidocaine results in systemic side effects occurring 
most commonly in the cardiovascular and central nervous systems. 
Adverse effects range from minor effects, such as disorientation, 
dizziness, numbness, and drowsiness, to major effects, including 
convulsions, coma, and respiratory arrest. The blood level of lidocaine 
that is associated with toxic effects is a concentration of over 6 
micrograms/milliliter (<greek-m>g/ml). Major adverse effects occur with 
blood levels over 10 <greek-m>g/ml.
    Animal toxicity studies have been carried out with lidocaine using 
several different species and routes of exposure. Oral LD<INF>50 values 
for the rat and mouse are 317 mg/kg and 220 mg/kg, respectively. [1, 
Ref. Y] The median convulsive dose was calculated to be 75 percent of 
the lethal dose in one study. Id. The intravenous LD<INF>50 values were 
calculated to be 20-34 mg/kg in various mice studies and 25 mg/kg in 
the rat. Id. Although these animal data clearly demonstrate the high 
toxicity associated with lidocaine, the human experience data described 
below are more relevant for extrapolation to toxicity in children.
    The staff is aware of nine deaths attributed to the accidental or 
intentional overdose of lidocaine:
    The CPSC Death Certificate file contains a report of a three-year-
old child who died in 1980 after the accidental ingestion of lidocaine. 
[4a] The causes of death were listed as cardiac arrhythmia and 
degenerative brain effects.
    A second death certificate reports the 1981 death of a 2-year-old 
child after accidental overdose of a combination of two drugs, 
lidocaine and meperidine (a narcotic analgesic). Additional information 
is not available on this case. [4a]
    The CPSC Reported Incident File contains the report of the death of 
an 11-month-old child, in 1984, from accidental ingestion of lidocaine. 
In this case, the child removed the CR closure from the product. [4b]
    The FDA Adverse Reaction Reporting System reports an accidental 
death, in 1979, of a 13-month-old girl who ingested a Canadian viscous 
lidocaine product. The blood lidocaine concentration was 20 <greek-m>g/
ml. [4c]
    A case reported in the literature describes the death, in 1986, of 
a 13-month-old boy. The boy had blood lidocaine levels of 19.5 
<greek-m>g/ml, remained unconscious, and was mechanically ventilated 
for 54 days. The child had suffered respiratory arrest at home prior to 
hospitalization. [1, Ref. Z]
    A case investigated by CPSC staff involved the death in 1990 of a 
14-month-old girl who ingested an unknown amount of 2-percent viscous 
lidocaine. Prior to the ingestion, the lidocaine had been applied to a 
diaper rash. The child's mother had placed the bottle in the crib while 
changing the child's diaper. The bottle had a CR closure, but it may 
not have been properly resecured. The mother did not believe the drug 
was hazardous, because she had been told by the pediatrician to rub 
lidocaine on the child's gums to ease teething pain. The toxicology 
report revealed high levels of lidocaine in the blood (12 <greek-m>g/
ml) and liver. [16, Ref. 1]
    Another death in 1990 involved a 15-year-old girl who drank up to 
480 ml of an OTC first-aid liquid containing 2.5 percent lidocaine. The 
cause of death was aspiration of gastric contents secondary to 
lidocaine intoxication. The serum lidocaine level was 18 <greek-m>g/ml. 
[16, Ref. 2]
    Two adult deaths due to intentional overdose of lidocaine are also 
reported in the literature. In these two cases, the blood lidocaine 
levels were 40 <greek-m>g/ml and 53 <greek-m>g/ml, respectively. [1, 
Ref. S]
    The following cases reported in the literature describe non-fatal 
adverse effects observed in young children following therapeutic 
administration or accidental ingestion of lidocaine:
    A 22-month-old child, weighing 10 kg, ingested 20 to 25 ml 
(approximately 50 mg/kg) of 2-percent viscous lidocaine. The child 
arrived at the hospital convulsing and not breathing. The child was 
successfully resuscitated, and the seizures were controlled. The child 
was discharged after 2 days with no long-term effects. [1, Ref. AA]
    A 3\1/2\-year-old child was given one tablespoon of 2-percent 
viscous lidocaine (approximately 21 mg/kg) for a sore throat. The dose 
was repeated 4 hours later. The child developed seizures and had a 
lidocaine blood level of 10.6 <greek-m>g/ml. The child was transferred 
to Pediatric Intensive Care in respiratory distress. The child was 
alert approximately 10 hours following the initial seizure and was 
discharged the following day. [1, Ref. BB]
    A 15-month-old boy developed seizures following the prescribed use 
of lidocaine. The child's lidocaine blood level was 4.9 <greek-m>g/ml. 
[1, Ref. BB]
    A mother used a finger to apply 2-percent viscous lidocaine to an 
11-month-old child's gums for teething pain, five or six times a day 
for a week. The child developed seizures and had a blood lidocaine 
level of 10 <greek-m>g/ml. The child was treated in the intensive care 
unit and recovered after 4 days. [1, Ref. CC] Many articles in the 
medical literature warn physicians about the hazards of prescribing 
lidocaine for teething pain and related symptoms in young children.
    A 5-month-old boy weighing 6.5 kg suffered seizures and required 48 
hours of hospitalization after 1 day of treatment with oral viscous 
lidocaine. [24, p. 3 & n. 2] The 3.8 <greek-m>g/ml serum lidocaine 
level, measured 4 hours after arrival at the emergency room, was in the 
high therapeutic range. The infant [[Page 17996]] required intubation 
to maintain respiration.
    In another case, a 2-year-old drank from a bottle of viscous 
lidocaine, choked, and began convulsing within 10 to 15 seconds. [24, 
p. 3 & n. 3] Aspiration of lidocaine resulted in its rapid absorption. 
Serum lidocaine levels were 0.5 <greek-m>g/ml 4 hours after the 
ingestion. The child remained hospitalized for 14 days with intubation 
and respiratory support.
    FDA's Adverse Reaction Reporting System contains reports of two 
children (5 months old and 1 year old) who developed seizures after 
being administered viscous lidocaine. [5]
    For the period 1978 through April 1990, the CPSC's Children and 
Poisoning (``CAP'') data base shows four ingestions of prescription 
viscous lidocaine and three ingestions of OTC lidocaine products by 
children under age 5. [6] All seven children were treated in National 
Electronic Injury Surveillance System (``NEISS'') hospital emergency 
rooms and released. Information on the amount of product ingested or 
adverse effects suffered by the children is not available.
    Data collected by the FDA National Clearinghouse for Poison Control 
Centers from 1980 through 1984 [7] show 176 accidental ingestions of 
OTC lidocaine products, 18 of which exhibited toxic symptoms. These 
data also include 28 ingestions of prescription viscous lidocaine 
products, with 10 showing toxic symptoms. Details of the amount of 
product ingested or specific toxic symptoms are not available. This 
data base was discontinued after 1984.
    For the years 1989 through 1991, the American Association of Poison 
Control Centers (``AAPCC'') reported 2,422 ingestions of lidocaine-
containing products, 341 of which are known to have produced symptoms 
related to the exposure. Children under age 6 were involved in 1,898 of 
these ingestions. [23]
    In addition to the cases noted above, several cases of accidental 
lidocaine poisoning in adults are reported in the literature. The 
reported cases demonstrate extreme variability in the development of 
toxicity of lidocaine, with children appearing to be more sensitive to 
the central nervous system side effects of the drug.
    Level for Regulation. The maximum level of lidocaine that does not 
produce serious side effects in children is not known. The recommended 
maximum single total dose of lidocaine for children is 5.0 mg/kg, which 
is approximately 50 mg in a 10 kilogram (kg) child. However, as noted 
above, toxic effects were reported at therapeutic dose levels. The 
staff lacks sufficient information to establish that the reported cases 
involving toxic effects at therapeutic doses involved oral exposures 
(the route of administration most relevant to accidental ingestion) or 
that the proper therapeutic dose was not exceeded. It is possible, 
however, that a child who accidentally ingests a lidocaine preparation 
will already have received an intentional therapeutic dose of the 
preparation. In addition, the systemic toxicity of the drug is not the 
only hazard it presents; there is the risk of serious injury or illness 
caused by aspiration of substances that are swallowed while the mouth 
and throat are anesthetized by the drug. These considerations make it 
difficult to establish a package size that would not cause serious 
toxic effects if the contents are ingested by a small child.
    Therefore, the Commissions staff recommended that the recommended 
maximum dose of lidocaine for a 10-kg child be reduced by a factor of 
10 (referred to as an ``uncertainty factor'') in order to arrive at a 
level that would not cause serious injury or illness in young children. 
[1, 9, 24] After considering the comments on the proposal and other 
available information, the Commission accepted this recommendation. 
Therefore, products containing more than 5.0 mg of lidocaine in a 
single package will be subject to CR packaging standards.

C. Dibucaine

    Product form, dosage and packaging. Dibucaine is used for temporary 
relief of painful sunburn, minor burns, scrapes, scratches, 
nonpoisonous insect bites, and external hemorrhoidal pain. OTC 
dibucaine preparations are marketed in 30-gm (slightly over 1 oz), 1-
oz, 1.5-oz, and 2-oz tubes. It is used also in a few prescription 
preparations. It is also marketed in a 16-oz jar whose contents, 
according to the supplier, are used as the basis for a pharmacist-
compounded and repackaged preparation. It is estimated that 
approximately 0.9 million tubes of dibucaine were sold to consumer 
outlets in 1992.
    In 1994, the 13 suppliers of OTC dibucaine distributed 16 products, 
each in tubes of 25 grams (nearly 1 oz) or more. This reflects a 
decrease of over 50 percent in the estimated number of suppliers of 
generic OTC dibucaine since 1989, when there were 28 such suppliers. 
The 3 suppliers of prescription dibucaine preparations listed by 
Redbook in 1989 were not listed in 1992 or 1994.
    Table 3 shows CPSC staff estimates of 1992 total market sales for 
OTC dibucaine preparations in the two categories in which dibucaine 
preparations are sold: OTC anti-hemorrhoidal and topical anesthetics. 
The market share of dibucaine-containing preparations reported in the 
topical anesthetics category remains at less than 1 percent, similar to 
the 1989 estimate. In the anti-hemorrhoidal category, dibucaine-
containing preparations have an estimated 3 percent market share, down 
from 5 percent in 1989. Overall sales of dibucaine-containing 
preparations were an estimated $4.4 million.

  Table 3.--Estimated Sales: Total Market;\1\ Dibucaine Preparations--  
                          Topical Dosage Forms                          
------------------------------------------------------------------------
                                                            1992        
                                                   ---------------------
                                                        All    Dibucaine
                                                      preps      preps  
                                                     Sales($    Sales($ 
                                                    millions)  millions)
------------------------------------------------------------------------
Topical Anesthetics (OTC).........................      97.7         .1 
Anti-hemorrhoidal (OTC)...........................     161.3       4.3  
------------------------------------------------------------------------
Source: IMS America, Ltd. and CPSC Directorate for Economic Analysis    
\1\Extrapolated from IMS America, Ltd. data to estimate total sales to  
  drug stores, food stores, and mass merchandise outlets. Includes data 
  provided by a pharmaceutical company spokesperson.                    

    The recommended dose for adults is to not exceed 1 ounce 
(equivalent to no more than 300 mg of dibucaine) in 24 hours. The 
recommended dose for a child, 2 years of age or older, is not to exceed 
\1/4\ ounce (equivalent to no more than 80 mg of dibucaine) in 24 
hours.
    Toxicity. Dibucaine is one of the most potent and toxic local 
anesthetics. Dibucaine produces serious systemic effects on both the 
central nervous system and the cardiovascular system. Adverse effects 
can include convulsions, depression of heart muscle contractility, and 
death. Dibucaine is readily absorbed through the mucous membranes and 
should not be used around the eyes or mouth. Systemic absorption may 
occur following the application of large amounts of dibucaine to large 
areas of abraded or damaged skin, or following rectal administration. 
The FDA disapproved the use of dibucaine in sore-throat and mouth 
medicines because of the possibility of systemic toxicity from 
dibucaine absorbed through the mucous membranes of the mouth and 
throat. [1, Ref. K]
[[Page 17997]]

    The toxicity of dibucaine has been demonstrated in animals and 
humans. Animal studies indicate that dibucaine is lethal at three mg/kg 
in dogs, and one mg/kg in monkeys. [1, Ref. J] The toxic dose of 
dibucaine in humans is not known. However, the suggested maximum adult 
dose is 25 mg of dibucaine. [1, Refs. H, P]
    The staff is aware of eight deaths of young children resulting from 
ingestion of dibucaine local anesthetics and of one death resulting 
from the rectal use of a dibucaine ointment:
    During the 23-year period of 1951 through 1973, one manufacturer 
received reports of 11 cases of acute intoxications of young children 
from dibucaine topical preparations. [1, Refs. J, L] Ten of the cases 
involved accidental ingestion; one case involved the rectal use of 
dibucaine ointment in a 2-month-old infant. Four of the children who 
ingested the products died, as did the 2-month-old infant. Additional 
details of the incidents were not provided.
    The CPSC Death Certificate File contains the report of a 2-year-old 
child who died in 1987 after accidentally ingesting a dibucaine cream 
used primarily for treating hemorrhoids. The child was found staggering 
by his mother, was lethargic, had seizures, and could not be 
resuscitated from respiratory arrest. The child had a dibucaine blood 
level of 1.3 <greek-m>g/ml. [4d]
    A second death certificate reports the death in 1988 of a 21-month-
old child who accidentally ingested 22.5 grams of a dibucaine 
hemorrhoid ointment. Cardiorespiratory arrest and convulsions 
developed. The child could not be resuscitated after suffering cardiac 
arrest. [1, Ref. N; 4e]
    CPSC has obtained a medical examiner's death report of an 18-month-
old who died on July 10, 1994, after ingestion of a 1-percent dibucaine 
ointment. The victim may have ingested up to \1/2\ oz of the product. 
The victim's father found the child suffering seizures in the family's 
kitchen. The victim was taken to a medical center and then transferred 
to a major children's hospital. The child was pronounced dead 
approximately 7 hours after the ingestion. [25]
    Because of deaths reported from oral ingestion of dibucaine 
products, a warning was added to the labels of dibucaine products, 
stating:
    ``Should not be swallowed. Swallowing can be hazardous, 
particularly to children. In the event of accidental ingestion, consult 
a physician or poison control center immediately.''
    For the period of 1978 through February 1990, the CPSC CAP data 
base shows two ingestions of dibucaine products by children under age 
5. [6] Both children were treated in NEISS hospital emergency rooms and 
released. Information on the amount of product ingested or adverse 
effects suffered is not available.
    Data from the FDA National Clearinghouse for Poison Control Centers 
from 1980 through 1984 show 113 ingestions of dibucaine products. Six 
of those individuals exhibited toxic symptoms. [7] This data base was 
discontinued after 1984.
    The AAPCC National Data Collection System supplied to CPSC reports 
general data on the ingestion of topical local anesthetics, but does 
not contain specific information on the identity of the individual 
compounds involved. Lidocaine and dibucaine creams and ointments 
comprise only about 5 percent of the topical local anesthetics market. 
For the 5-year period 1984 through 1988, 10,330 cases of accidental 
ingestion of topical local anesthetics by children under age 5 were 
reported through that data system. [8] Of these cases, 883 exhibited 
minor-to-moderate symptoms and 10 were life-threatening or resulted in 
disability. The two cases that resulted in death were attributed to 
dibucaine, and are described above. Specific information on dibucaine 
ingestions was available for the years 1989 through 1991. The AAPCC 
received a total of 495 poison exposure cases involving dibucaine, 433 
of which involved children under age 6. [23]
    A review of the literature revealed one case in which a 12-month-
old infant ingested a combination of three gm of boric acid and 300 mg 
of dibucaine. The child developed seizures, and also vomited due to the 
effects of the boric acid. The child was hospitalized and recovered 
fully after aggressive and intensive treatment. [1, Ref. M]
    Level for Regulation. The high potency and toxicity of dibucaine 
are well known; however, an absolute level of safety for this drug is 
difficult to determine. Most cases of reported deaths contain little 
information about the concentration of the drug or the amount consumed. 
Ingestion of dibucaine, however, results in the same types of toxicity 
as does ingestion of lidocaine. The differences between the two 
compounds are in the potency and duration of action. Dibucaine is 
approximately 10 times more potent than lidocaine. Therefore, a 
correction factor of 10 was applied to the level for regulation derived 
for lidocaine to arrive at 0.5 mg as the level for regulation. [24]
    This level of regulation for dibucaine is also supported by a case 
reported in the medical literature in which a 3-year-old child ingested 
8 lozenges containing 1 mg of dibucaine each. The child died 8 hours 
later. The total dosage was approximately 0.5-0.8 mg/kg. [22] The 
author states that the child may have been sensitive to dibucaine.

D. Other Economic Considerations

    [27] The total combined market for lidocaine and dibucaine 
(including OTC products and prescription viscous lidocaine) in 1992 
totaled an estimated 13.4 million packages available to the consumer. 
This market declined 18 percent from the estimated 16.3 million 
packages reported in 1989. Decreases were reported in all formulations, 
most notably an estimated decline of 50 percent in the number of 
packages of consumer-ready viscous lidocaine.

    Most lidocaine and dibucaine preparations are OTC products sold in 
packages that are not CR. The prescription creams/ointments in tubes 
are also in non-CR packaging.

    Table 4 shows 1992 estimated total consumer-use units and market 
share by packaging type for the six categories in which IMS reports 
sales of lidocaine or dibucaine. Within the six categories, lidocaine 
or dibucaine preparations may not be marketed in specific package 
types. For example, there are no dibucaine preparations in spray 
packages. Additionally, there are no suppositories, pads, or wipes 
containing lidocaine or dibucaine. Units of prescription bottles used 
for 2-percent viscous lidocaine, discussed earlier, are excluded from 
this table. Lidocaine-containing preparations in all package forms 
amount to about 9 percent of topical anesthetic units. Nevertheless, 
lidocaine in spray packages dominates the market for spray topical 
anesthetic preparations (83 percent), and lidocaine in aerosol packages 
represents more than half (56 percent) of the topical anesthetics 
aerosol market. Lidocaine formulations packaged in tubes (creams, 
ointments, and gels) and bottles (liquids and gels) comprise 7 and 8 
percent of units in their respective topical anesthetic package 
categories. Dibucaine-containing preparations, packaged only in tubes, 
represent about 1 percent of all tubes.

                                                                        
[[Page 17998]]                                                          
   Table 4.--Estimated 1992 Units;\1\ Consumer-Use Topical Anesthetics  
         Containing Lidocaine, Dibucaine, Other By Package Type         
------------------------------------------------------------------------
                                                            1992        
                                                  ----------------------
                   Package type                                  Market 
                                                      Units      share  
                                                   (millions)  (percent)
------------------------------------------------------------------------
Spray/Lidocaine..................................        2.5         83 
Spray/Dibucaine..................................  ..........  .........
Spray/Other......................................         .5         17 
Aerosol/Lidocaine................................        1.9         56 
Aerosol/Dibucaine................................  ..........  .........
Aerosol/Other....................................        1.5         44 
Tube/Lidocaine...................................        6.2          7 
Tube/Dibucaine...................................         .9          1 
Tube/Other.......................................       82.9         92 
Bottle/Lidocaine.................................        1.5          8 
Bottle/Dibucaine.................................  ..........  .........
Bottle/Other.....................................       16.9         92 
Suppository/Lidocaine............................  ..........  .........
Suppository/Dibucaine............................  ..........  .........
Suppository/Other................................       18.4        100 
Pad or Wipe/Lidocaine............................  ..........  .........
Pad or Wipe/Dibucaine............................  ..........  .........
Pad or Wipe/Other................................         .8        100 
Unknown/Other....................................        2.3   .........
                                                  ----------------------
      Total Lidocaine............................       12.1          9 
      Total Dibucaine............................         .9          1 
      Total Other................................      123.3        90  
------------------------------------------------------------------------
Source: IMS America, Ltd. and CPSC Directorate for Economic Analysis    
\1\Extrapolated from IMS America, Ltd. data to estimate total sales to  
  drug stores, food stores, and mass merchandise outlets for the six IMS
  categories in which lidocaine and dibucaine preparations are reported.
  Includes data provided by pharmaceutical company spokespersons.       


    Table 5.--Estimated Units by Package Type;\1\ Lidocaine/Dibucaine   
                       Preparations 1992 and 1989                       
------------------------------------------------------------------------
                                                   1992       1989 Units
                Package type                 Units(millions)  (millions)
------------------------------------------------------------------------
Tubes......................................          7.1            7.6 
Prescription bottles.......................           .4             .8 
Aerosols...................................          1.9            3.2 
Spray/Bottles..............................          4.0            4.7 
      Total................................         13.4          16.3  
------------------------------------------------------------------------
Source: IMS America, Ltd. and CPSC Directorate for Economic Analysis.   
                                                                        
\1\Extrapolated from IMS America, Ltd. data to estimate total unit sales
  to drug stores, food stores, and mass merchandise outlets.            

    The following discussion of the economic impact of this rule is 
organized by the type of packaging. As noted above, lidocaine creams, 
ointments, gels, viscous solutions, and liquids are packaged in tubes, 
bottles and various spray containers. Dibucaine formulations are 
available only in creams and ointments and are packaged only in tubes.
    Prescription viscous lidocaine packaged in prescription bottles. 
Most, if not all, suppliers of prescription 2-percent viscous lidocaine 
formulations dispensed in bottles are voluntarily using CR packaging in 
response to the Commission's 1986 request. CR packages for prescription 
bottles are readily available at low incremental cost. Therefore, the 
rule is not expected to have an adverse economic impact on businesses 
of any size that market viscous lidocaine in prescription bottles.
    Lidocaine or dibucaine creams, ointments, and gels packaged in 
tubes. In 1992, an estimated 51 percent of lidocaine preparations (6.2 
million units) and 100 percent of dibucaine preparations (0.9 million 
units) were packaged in tubes containing 2 oz or less. There are 
currently no commercially available CR packages to substitute for the 
small pharmaceutical tubes used to package creams, ointments, and some 
gels. Therefore, the PPPA requirement for topical anesthetics 
containing lidocaine or dibucaine will affect all marketers of the 
preparations packaged in tubes.
    The Commission's staff identified nine marketers of OTC lidocaine 
preparations packaged in tubes. Four marketers that are considered 
``small businesses'' account for about 11 percent of the lidocaine/tube 
preparation market. Dibucaine, available only in tubes, is marketed by 
16 suppliers. Fifteen of these suppliers market generic and/or private-
label products as part of extensive product lines. Specific sales data 
for the individual small marketers were not reported. However, a 
pharmaceutical company spokesperson reports the aggregate market share 
of small marketers is quite small. [27]
    Under this rule, each marketer of lidocaine/dibucaine preparations 
packaged in tubes will have to consider one of three possible marketing 
options: development of acceptable CR packaging; reformulation to 
eliminate lidocaine or dibucaine as an ingredient; or withdrawal from 
the tube segment of the topical anesthetic market. Each marketer will 
probably choose the least costly alternative. These options are 
discussed below.
    Reformulation: Marketers can reformulate to non-lidocaine/ 
dibucaine preparations and supply them in tube sizes comparable to 
those they are now using. Since many marketers have tube filling 
operations, this would enable the use of existing filling equipment. 
However, reformulation may result in the loss of a market ``niche'' 
held by a specific preparation. There also are potential costs 
associated with reformulation. For example, there may be research and 
development costs, costs to obtain FDA approval (if required), and 
additional marketing costs to regain market share. With this option, 
consumers would forego the use of the original preparations.
    Develop CR packaging: Marketers can work with package manufacturers 
to develop CR multi-dose tubes compatible with specific lidocaine or 
dibucaine formulations. The Commission concludes that the development 
of CR packaging for these tubes is technically feasible, practicable 
and appropriate based on existing technology. [26] A pharmaceutical 
trade association contacted several major developers and suppliers of 
CR closures and provided the Commission with cost and time estimates to 
develop a CR tube package. The information supplied by the trade 
association stated that the development cost estimates ranged from 
$145,000 to $585,000 and that development would take 27-36 months. 
Additional time would be needed for stability testing of the 
preparation in the new package. Increased costs of up to $4.40 per tube 
are estimated if development is done on an individual company basis. 
Since marketers sell most lidocaine and dibucaine creams and ointments 
to pharmacies at prices ranging from less than $1.00 to about $6.00, 
the potential incremental cost of the tube might outweigh the cost of 
certain preparations provided by small marketers. [24]
    Discontinue marketing: Some marketers may be unable to absorb the 
costs associated with the development of CR packaging for tubes while 
maintaining a competitive price for their products. The alternative 
option, reformulation, may lead to the loss of a market ``niche.'' As a 
result, some firms may decide to withdraw the lidocaine/dibucaine tubes 
from the market. Based on 1992 estimated total sales of all lidocaine 
and dibucaine preparations ($41 million), with tubes accounting for 
about 53 percent of units sold, the potential loss of sales may be 
about $22 million if all such products were withdrawn. For small firms 
that have extensive product lines, abandoning lidocaine or dibucaine 
preparations may not be very disruptive, particularly if unit sales are 
low. For a few small companies with limited product lines or a niche 
preparation, withdrawal could result in disruption and financial loss. 
One small firm estimated lidocaine preparations represent 30 percent of 
sales, of which one-third is attributed to a preparation packaged in a 
tube. The other two small firms marketing [[Page 17999]] lidocaine in 
tubes would have less than 1 percent and less than 3 percent of their 
respective markets affected if these products are withdrawn. Thus 
lidocaine in tubes represents between less than 1 percent to 10 percent 
of these companies' total sales. As in the reformulation option, 
consumers would experience a loss of utility if manufacturers adopt 
this option. However, preparations with similar therapeutic qualities 
to any preparations withdrawn are available in the marketplace.
    OTC Lidocaine liquids and gels packaged in bottles, pump sprays, 
metered sprays, and aerosol sprays. OTC lidocaine preparations in 
bottles and spray packages represented about 45 percent (5.9 million 
units) of lidocaine shipments in 1992. Ten marketers of these 
preparations have been identified. The preliminary economic assessment 
discussed the availability and incremental costs of CR packaging for 
these preparations. The lack of comments regarding the economic effects 
of the proposal for bottle and spray packages confirms the Commission's 
initial finding that costs to provide special packaging are 
comparatively low and likely not to have a substantial effect on 
marketers.

E. Comments on the Proposal

    Ten comments were received on the proposal. The comments focused on 
several areas, including the level of drug for regulation, contentions 
that there is a lack of information to include all products with 
lidocaine and dibucaine, and the lack of a CR tube for creams and 
ointments. One commenter supported the rule. The Commission's responses 
to the comments are explained below.
    Scope of the proposed regulation. Comment: Several commenters 
indicated that the Commission had insufficient information to require 
CR packaging of all products containing lidocaine and dibucaine. The 
Nonprescription Drug Manufacturers Association (NDMA) stated that the 
Commission had not demonstrated that a significant number of children 
have been harmed by the accidental ingestion of OTC lidocaine and 
dibucaine. The NDMA contracted with Pegus Research to analyze poison 
exposures to OTC products containing topical anesthetics. The study 
examined poisoning incidents associated with OTC products containing 
lidocaine, dibucaine, and benzocaine.
    Response: The staff's review of the toxicity of lidocaine and 
dibucaine was included in the February 27, 1992, briefing package for 
the proposed rule and updated in a supplemental package dated May 27, 
1992. The documents described nine deaths attributed to the accidental 
or intentional overdose of lidocaine and several medical case reports 
of adverse effects following therapeutic administration or accidental 
ingestion of lidocaine. Six of these deaths were children under 5 years 
of age. The majority of the cases where the formulation is known 
involved 2-percent viscous lidocaine (a prescription drug). One death 
followed an intentional ingestion by a 15-year-old of an OTC product 
containing 2.5 percent lidocaine. The staff toxicity review described 
the deaths of six children (two known to be under 5 years of age) 
following the ingestion of dibucaine. An additional death of an 18-
month-old girl following the ingestion of dibucaine ointment was 
reported recently.
    While the data do not indicate whether any of the accidental deaths 
of children associated with lidocaine involved OTC formulations, these 
products contain amounts of lidocaine similar to the prescription 
viscous formulation. Young children are being exposed to OTC topical 
anesthetic products containing lidocaine or dibucaine. This is verified 
by the NDMA-sponsored study. The CPSC staff's analysis indicates that 
the proportion of children under 6 exposed to lidocaine or dibucaine is 
significantly larger than the proportion of children in this age group 
exposed to other substances.
    The Commission concurs with the conclusion of the NDMA-sponsored 
analysis that the lidocaine and dibucaine poisonings generally do not 
have severe outcomes. However, four deaths from these compounds were 
documented from 1987 to the present, attesting to the toxicity of these 
substances.
    Cream and ointment products are included in the rule because 
details from the three most recent deaths following ingestion of 
dibucaine (1987, 1988, 1994) specified that dibucaine was in a cream or 
ointment formulation. These deaths demonstrate the toxicity of 
dibucaine and the potential for toxicity from cream and ointment 
formulations in general.
    Comment: A manufacturer of a male genital desensitizing agent 
containing lidocaine indicated that the Commission had not considered 
this product class and therefore it should not be covered in the rule.
    Response: At the time of the proposal, the staff was unaware of the 
FDA's monograph for male genital desensitizing agents. Because the 
ingestion cases do not specify the formulation of the OTC lidocaine 
products, the staff cannot determine if any poisoning exposures are 
attributed to this class of products. However, the rule should not 
exempt these products, since the potential for injury and death from 
these lidocaine-containing products is equivalent to other OTC 
lidocaine spray products. The amount of lidocaine in one metered spray 
of this product exceeds the 5 mg regulated amount. Tests of a similar 
metered-spray package have shown that 48 of the 50 children in the test 
for child resistance actuated the spray and that, on average, each of 
the 48 actuated the spray over 90 times each during the 10-minute test. 
[30]
    Inhalation and aspiration of aerosol and spray products can result 
in absorption from the lungs. The local anesthetic drugs are also 
readily absorbed through mucous membranes of the mouth and throat, 
therefore, an ``ingestion'' does not have to occur to result in 
toxicity. Aerosol and spray product formulations are included in the 
proposed rule because a child can access a potentially harmful dose. 
There is a documented case of a child spraying himself with another 
topical anesthetic (benzocaine 20 percent). The child experienced 
cardiac arrest resulting in death.
    Comment: One commenter indicated that the rule should be clarified 
to exempt formulations of lidocaine intended for administration by 
injection. The commenter contended that lidocaine for injection 
purposes does not fit the definition of a household substance as 
described in the PPPA regulations.
    Response: The Commission disagrees with the commenter's contention 
that the PPPA does not apply to injectable prescription pharmaceutical 
products. The definition of ``household substance'' in section 2(2) of 
the PPPA includes drugs and other hazardous substances that are 
``customarily produced or distributed for sale for consumption or use, 
or customarily stored, by individuals in or about the household.'' 15 
U.S.C. 1471(2). However, the PPPA does not extend to products used 
exclusively in hospitals, in nursing homes, or by medical 
professionals, because such items are not customarily consumed, used, 
or stored by individuals in or about the household. If the injectable 
lidocaine preparations truly are for professional use only and are not 
available to the consumer for use or storage at home, it is not 
necessary to separately state an exemption of these products.
    However, if lidocaine injectable formulations were customarily 
available [[Page 18000]] for home consumer use (as is the case with 
insulin), the products would not be exempted. Injectable lidocaine is a 
liquid formulation that could be accessed by children if available in 
the home. The commenter provided no rationale for excluding these 
products in that case.
    The staff is aware of other lidocaine-containing prescription 
products that may be used exclusively by physicians, dentists, and in 
hospital settings. A company supplied the staff with information about 
the usage of these products during a meeting on October 15, 1992. The 
products include creams, jellies, and liquids. The liquids are 
available in prefilled syringes, ampules, sprays, and bottles. As 
discussed above, if these products are for professional use only and 
are not obtained by consumers for use or storage at home, the 
requirements of the PPPA do not apply.
    Regulated levels of lidocaine and dibucaine. Comment: Several 
comments were received regarding the proposed amount (level) of the two 
drug products that should be regulated. One commenter questioned the 
use of a 10-fold uncertainty factor for lidocaine. Another commenter 
questioned the use of an additional 10-fold factor for dibucaine.
    Response: The level for regulation of lidocaine- and dibucaine-
containing products is based on the maximum recommended single 
therapeutic dose of lidocaine (5 mg/kg or 50 mg for a 10 kg child). A 
10-fold uncertainty factor was used to arrive at the 5 mg level of 
lidocaine.
    It is true that a 10-fold uncertainty factor applied to a 
recommended therapeutic dose provides a more stringent level for 
regulation than that normally used by CPSC staff. Applying the 
uncertainty factor to the therapeutic dose is justified for lidocaine 
and dibucaine, however, for the following reasons: (1) Toxicity can 
occur at therapeutic doses of lidocaine and dibucaine; (2) children are 
particularly susceptible to the toxic effects of repeated therapeutic 
doses of these drugs; (3) since these drugs are used on children as 
well as adults, an accidental exposure could occur following a previous 
therapeutic dose of the drugs; (4) the metabolites of lidocaine and 
dibucaine are potentially toxic, especially to young children; and (5) 
risks of aspirating food or liquids are associated with oral exposure 
to these drugs, even at nonlethal and therapeutic doses. These reasons 
support the level chosen for regulating lidocaine.
    The level for regulation of dibucaine was derived from the level 
for lidocaine, based on the relative difference in potency of the two 
drugs. Dibucaine is approximately 10 times more potent than lidocaine; 
therefore, the staff applied an additional 10-fold factor to the 5 mg 
level for lidocaine to arrive at a 0.5 mg level for dibucaine. While 
the commenter questioned the use of the additional 10-fold correction 
factor for dibucaine, the commenter agreed that dibucaine is 
approximately 10 times more potent than lidocaine.
    The commenter suggested an alternative level derived from ingestion 
cases reported to the company. The commenter considers the cases to be 
confidential information, so they are not discussed here in detail. 
However, in addition to the cases discussed by the commenter, there was 
a death of a 3-year-old child following the ingestion of 8 lozenges, 
containing 1 mg of dibucaine each, that was reported in the medical 
literature in 1955. The child died 8 hours later from respiratory 
failure. The total dosage was approximately 0.5-0.8 mg/kg. The authors 
speculated that the child may have been sensitive to this drug product; 
however, dibucaine is very potent and readily absorbed from mucous 
membranes. The FDA later disapproved the use of dibucaine as an active 
ingredient in oral health-care products. The level of regulation being 
adopted for dibucaine (0.5 mg) is supported by this reported literature 
case. The Commission believes that these are appropriate levels for 
regulating lidocaine and dibucaine.
    Comment: One commenter indicated that a 10-fold correction factor 
was not necessary for metered spray products because a child cannot 
spray enough to obtain a toxic blood level. The commenter indicated 
that the male genital desensitizing agent packages ``already are child 
resistant in that the drug product is dispensed in a metered spray.'' 
The commenter estimates that only \1/3\ of each spray would be absorbed 
by a child. The commenter states that any risk of aspiration is 
unsupported.
    Response: Metered sprays are tested for child-resistance as 
described in 16 CFR 1700.20 for unit packaging. The commenter provided 
no test results describing how many sprays a child can access during 
the test period. It should be noted that each spray of the commenter's 
product contains 7.68 mg of lidocaine per spray, an amount greater than 
the recommended level for regulation. This product contains 150 sprays 
per container. The FDA monograph for these preparations restricts the 
dosage to 10 mg of lidocaine per spray. Thus each spray of a male 
genital desensitizing agent can contain two times the proposed level 
for regulation for lidocaine. The commenter did not supply data to 
support its estimate of the access and absorption of the product.
    The commenter also contended that the 10-fold uncertainty factor 
for lidocaine was established because of the Commission's concern for 
the aspiration hazard for sprays. This is not the case. Aspiration 
following oral usage of local anesthetics is documented in the medical 
literature and in CPSC injury records and is not limited to aerosol 
products. [24, Refs. 3, 7]
    Comment: Commenters stated that the 5-mg level for lidocaine and 
the 0.5 mg level for dibucaine were below the therapeutic 
concentrations recommended by the FDA for cream and ointment 
preparations.
    Response: The level for regulation does not affect or restrict the 
concentration of the product. The Commission's rule simply requires 
that products containing more than the regulated level must have CR 
packaging. The comment about the regulated levels being below the 
therapeutic concentrations can be interpreted as a complaint that the 
level is too restrictive and that all lidocaine- and dibucaine-
containing products would require CR packaging. However, this is not 
the case, since the PPPA allows a manufacturer or packager to package 
an OTC product in one size of non-CR packaging if the manufacturer also 
supplies the products in CR packages and the non-CR package is labeled 
properly. The amount of product in the noncomplying package is not 
restricted.
    Effectiveness of Requiring CR Packaging. Comment: One commenter 
supported the rule but stated that CR packaging would have prevented 
only a few of the deaths. This commenter stressed the need for enhanced 
educational activity. In addition, several commenters indicated that 
the viscous lidocaine responsible for two of the deaths was already in 
CR packaging. Other commenters indicated that the rule would have a 
limited effect, since no deaths have occurred in the past several 
years.
    Response: Several of the deaths described in the toxicity review 
were accidental or intentional overdose cases. The purpose of 
discussing these cases is to illustrate the toxicity of the products. 
The results of the study of ingestion cases indicate that children are 
accessing products containing lidocaine and dibucaine. There were 676 
ingestions of lidocaine-containing products and 110 ingestions of 
dibucaine-containing products by children under 5 years of age reported 
to poison control centers in 1992. [29] [[Page 18001]] While most of 
these children did not experience major effects, each of the ingestions 
had the potential to result in serious injury or death. For example, 
with dibucaine, a company reported four deaths of children who 
accidently ingested dibucaine products from 1951 to 1973. Two more 
deaths were reported in 1987 and 1988, more than 10 years after the 
last reported death. The death reported in 1994 demonstrates that the 
risk of injury from dibucaine continues to exist. CR packaging 
requirements may prevent future deaths from products containing these 
ingredients.
    No information is available as to whether the ``CR'' packaging, 
used voluntarily by several companies, actually meets the criteria of 
the PPPA regulations. A requirement for CR packaging of these products, 
instead of voluntary usage, would permit CPSC to enforce the PPPA 
requirements for these products.
    CR packaging has saved many lives, but CR packaging is not child 
proof. The Commission agrees that education is an important part of 
poison prevention. The Commission acts as the secretariat for the 
Poison Prevention Week Council, which promotes the poison prevention 
message.
    Development of CR Tubes. Closures that can be put on the small 
tubes that are in current production to make them child resistant are 
not currently commercially available. The following discussion 
addresses some general comments related to packaging for the cream and 
ointment products.
    Comment: One manufacturer supplied limited test results of a 1-inch 
diameter plastic squeeze tube with a European 18-mm ASTM type IA 
closure. The company reported that the package was closed at 7 inch-
torque-pounds (ITP). Twenty children were tested, and eleven children 
were able to open the package during the test period. None of the 
children used teeth to open the package. The commenter contended that 
these test data show that CR tubes are not technically feasible.
    Response: The staff indicated in the proposed rule that special 
packaging for tubes could be achieved by using commercially available 
22-mm closure bottle threads on a suitable laminated plastic tube. This 
would allow the use of a ``senior friendly'' ASTM type IA continuous 
threaded closure to be used to obtain child-resistance. The staff is 
unaware of any data from protocol tests conducted on a tube with the 
22-mm ASTM type IA closure.
    The child-resistance function of the European closure used by this 
commenter is unknown. This closure has never been tested by the 
Commission on any package. It is difficult to know whether the failures 
in the test were associated with the closure itself or a problem with 
the combination of the closure and tube. The package tested had a small 
diameter closure, and 7 ITP is a very low closing force. Both of these 
factors make the package more accessible to children. The larger 
closure size (22 mm) proposed by the CPSC's staff is harder for 
children to remove and easier to put on at higher forces. These data do 
not change the Commission's view that a plastic tube can be made CR 
using a 22-mm ASTM type IA closure and existing technology. See also 
Section E.2, below.
    Comment: Commenters indicated that unit packaging is not 
appropriate for products containing lidocaine and dibucaine because the 
FDA does not define a dose for lidocaine- and dibucaine-containing 
creams and ointments. Commenters indicated that people use varying 
amounts of these products depending on the indication for use and the 
potential for partial use exists. In addition, the NDMA stated that one 
of their members attempted to package in a foil pouch and could not 
achieve stability of the product.
    Response: The Commission is aware of the lack of a defined dose for 
lidocaine and dibucaine. The Commission agrees that nonreclosable 
packaging for many of the creams and ointments may not be possible due 
to this variation in the definition of single use and the potential for 
residual product in the package. It is difficult to package a unit 
amount for these products that will not result in potential harm to 
children if it is not completely used. A package cannot be marketed 
containing less than the regulated amount, because this level is below 
the therapeutic level required by the FDA.
    The technical finding of appropriateness includes shelf life and 
stability. Neither the NDMA, its member companies, nor other commenters 
supplied data to document the lack of stability in pouches. The staff 
is aware of a lidocaine-containing product packaged in foil pouches. 
This product is currently used in industrial settings, although the 
company advertises the potential for home use. The Commission 
recognizes that not all formulations are equivalent; different 
ingredients have different stability properties. However, the 
Commission believes that suitable pouch materials can be found for any 
lidocaine- or dibucaine-containing product. Because of the problem of 
hazardous residual amounts, however, the amount packaged would have to 
be extremely small. Therefore, pouches or other unit-dose packages may 
not be a practical way to market these products to comply with the 
regulation.
    Comment: Bottles and jars are unsuitable for cream and ointment 
formulations of hemorrhoidal relief use products, and anesthetic first 
aid products due to preservation and contamination issues.
    Response: Other creams, such as cosmetic cold creams, are packaged 
in jars. However, the usage of these products differs substantially 
from the usages of lidocaine- or dibucaine-containing products. Since 
lidocaine- and dibucaine-containing products are used in the anal area 
(hemorrhoidal preparations) or on open wounds (first aid preparations), 
the Commission agrees that contamination is possible if individuals 
reenter the container for more product without washing their hands 
thoroughly. This limits the appropriateness of jars and bottles for 
these products.
    Comment: Plastic or laminate tubes are not a viable alternative. 
One commenter reported that it cannot achieve stability of the 
lidocaine product in plastic or laminate tubes.
    Response: Metal tubes currently are used for packaging many 
lidocaine-containing products and all the dibucaine-containing 
products. The proposed rule indicated that manufacturers may have to 
change from a metal tube to a plastic tube to achieve child-resistance. 
No commenter supplied data to support the claim that stability cannot 
be attained in plastic or laminate tubes. One manufacturer currently 
markets a lidocaine-based cream product in a plastic tube. Although the 
different vehicles in different formulations have different stability 
properties, development testing will determine which plastics or 
laminates are compatible with any particular formulation.
    Comment: Tubes cannot be made CR because children will bite through 
the tube, thereby gaining access to the tube's contents. The NDMA cited 
the opinion of Dr. Alexander Perritt, president of Perritt 
Laboratories, a CR package testing laboratory.
    Response: One NDMA member supplied limited child test data to the 
Commission staff. The company tested a plastic tube with a CR closure 
that allegedly meets the different European child-resistance standards 
on other types of packaging. While many of the 20 children tested in 
these tests opened the tube package, none did so with their teeth. 
There is no reason to conclude that tubes cannot be made sufficiently 
strong to withstand the teeth of children under age 5. [[Page 18002]] 
    Additional information on the technical feasibility of plastic 
tubes is in Section E.2 of this notice.

E. Statutory Considerations

    1. Hazard to children. Pursuant to section 3(a) of the PPPA, 15 
U.S.C. 1472(a), the Commission finds that because of the toxic nature 
of lidocaine and dibucaine preparations, described above, and the 
accessibility of such preparations to children in the home, the degree 
and nature of the hazard to children in the availability of such 
substances, by reason of their packaging, is such that special 
packaging is required to protect children from serious personal injury 
or serious illness resulting from handling, using, or ingesting these 
substances.
    2. Technical feasibility, practicability, and appropriateness. [26] 
In issuing a standard for special packaging under the PPPA, the 
Commission is required by section 3(a)(2) of the PPPA, 15 U.S.C. 
1472(a)(2), to find that the special packaging is ``technically 
feasible, practicable, and appropriate.'' Technical feasibility exists 
when technology exists or readily can be developed and implemented by 
the effective date to produce packaging conforming to the standards. 
Practicability means that special packaging complying with the 
standards can utilize modern mass production and assembly line 
techniques. Appropriateness exists when packaging complying with the 
standards will adequately protect the integrity of the substance and 
not interfere with the intended storage or use.
    A. Technical feasibility. Lidocaine and dibucaine prescription and 
OTC products are presently packaged in tubes, spray containers, 
aerosols, and prescription containers. Most of the current packaging 
appears to be non-CR. The manufacturers of most viscous lidocaine-based 
non-oral prescription drugs have voluntarily packaged these drugs in 
consumer-ready CR prescription containers, even though they are not now 
required to do so under the PPPA regulations. [2, Ref. 3] For those 
manufacturers using non-CR packaging, various types and designs of non-
tube CR packaging can be obtained.
    CR packaging for OTC and prescription tubes can be accomplished by 
using commercially available bottle threads on plastic tubes. [2, Ref. 
4] This would allow the use of readily available CR continuous-threaded 
closures on the tube. The Commission is aware of tubes now on the 
market that use bottle threads that could be outfitted with existing 
push-and-turn continuous-threaded CR closures. However, the Commission 
does not know that such CR tubes are available in all the sizes 
currently used or lidocaine and dibucaine products. Therefore, it may 
be necessary for the manufacturers of these products to develop and 
test such packaging and incorporate it into their production lines. For 
those manufacturers using metal tubes, a change to a plastic tube, with 
appropriate stability testing, may be necessary.<SUP>3

    \3\ There are other potential designs for making metal tubes CR. 
[26] Those designs are not being relied upon to make the technical 
feasibility finding in this proceeding, however, because they were 
not discussed in the proposal and, therefore, not made available for 
public comment.
    One alternative CR package design that can be adapted to the 
existing metal tubes involves modifying a hinged snap cap. A 
continuous-threaded cap with a hinged snap cap can be permanently 
attached to the threads of the tube. The snap cap can be modified by 
providing a slot to allow opening of the package with a tool. This 
design, if developed, should be both CR and senior friendly. 
Moreover, it can be adapted to existing metal tubes and be mass 
produced without degrading the integrity of the product.
    In addition, two prototype closures were made for metal tubes in 
the past. While these were never developed commercially, the 
prototypes illustrate different approaches that can be used to 
achieve CR tube packaging.
    Furthermore, a company has indicated that metal tubes can be 
provided with threads that can accommodate existing continuous-
threaded closures known to be child resistant on other package 
types. [31, 33]
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    The Commission's determination that plastic tubes for these 
products are technically feasible has been confirmed by additional 
information. One cap manufacturer has notified the Commission that it 
has two cap designs that should be suitable. [37] One of these is 
currently commercially available in stock sizes as small as 20 mm, 
including the 22 mm size relied on in the proposal. This cap is child-
resistant under the Commission's current regulations and meets the 
proposed senior-friendly requirements that may be adopted in the future 
(see Section I of this notice). The other cap is a squeeze-and-turn 
model that currently is not available in sizes below 28 mm. However, 
the manufacturer indicated that a development program for smaller sizes 
would require 3 months to produce prototypes, with full commercial 
availability in an additional 6 months.
    Another manufacturer submitted information showing steps leading to 
a child-resistant plastic tube with appropriate stability 
characteristics that could be distributed commercially within a 52-week 
period. [35]
    Technical feasibility for lidocaine prescription drug products and 
OTC spray containers that are presently in non-CR packaging is 
demonstrated by: (1) Many manufacturers are voluntarily using CR 
packaging (ASTM type IA closures on bottles) for prescription 2-percent 
viscous lidocaine consumer-ready preparations. (2) CR packaging for OTC 
products that are dispensed by spraying is also commercially available. 
Similar CR packaging designs have passed the proposed protocols for 
``senior friendly'' packaging. (See section I below.)
    CR packaging for aerosol and mechanical pump packaging is 
technically feasible and commercially available. The staff has 
information that this type of packaging can be made senior friendly. 
Additional time to develop suitable packaging may be necessary for some 
products containing lidocaine, due to the small size of the package. 
For example, male genital desensitizing agents containing lidocaine are 
available in metered spray packaging containing less than \1/2\ oz. An 
overcap can be made for this product that would require the use of a 
tool to remove. It is unknown whether this feature would be senior 
friendly on this small package. If not, it may be necessary to use an 
alternative type of package, such as a larger diameter aerosol with a 
CR and senior-friendly overcap. Manufacturers of these products and 
other products available in small mechanical pumps or aerosols may need 
more than 1 year to develop senior-friendly CR packaging for these 
small packages. However, as noted above, larger diameter packages can 
be used, and such packages could be available within 1 year.
    There are numerous continuous-threaded special packaging designs 
that can replace the non-CR continuous-threaded closures presently 
being used with viscous lidocaine prescription medication and OTC spray 
packaging.
    CR packaging for aerosols also can be obtained, and a number of 
commercially available designs could be used. Therefore, the Commission 
concludes that there are numerous package designs that meet the 
requirements of 16 CFR 1700.15(b) that are suitable for use with the 
forms of these products.
    b. Practicability. Companies that are presently using CR packaging 
for viscous prescription drug products containing 2-percent lidocaine 
have implemented assembly line and mass production techniques in their 
manufacturing processes. This shows that it is practicable to package 
2-percent viscous lidocaine-containing products in special packaging. 
No major problems from the manufacturing standpoint are anticipated in 
the change from non-CR to CR packaging, except for the multiple-dose 
tube-type packaging, [[Page 18003]] which may require the use of a 
contract packager.
    The manufacturers of non-tube CR packaging do not anticipate any 
problems with supplying CR closures and containers. The major suppliers 
of CR packaging and materials indicate that they can supply more than 
the 6.2 million non-tube units estimated to be needed for lidocaine and 
dibucaine products.
    In most cases, manufacturers can incorporate CR packaging into 
their existing packaging lines. If there were any problems in modifying 
or obtaining new equipment, i.e., capping, etc., a contract packager 
could be used in the interim to package lidocaine- and dibucaine-
containing products. Many existing designs suitable for use with the 
products that are the subject of the regulation are currently being 
used in the packaging of other products, or can be readily developed. 
Special packaging for this product is therefore practicable in that it 
is adaptable to modern mass production and assembly line techniques. 
The Commission anticipates no major supply or procurement problems for 
the packagers of these products or the manufacturers of CR closure and 
capping equipment.
    c. Appropriateness. Information available to the staff indicates 
that the CR packaging of lidocaine- and dibucaine-containing products 
is appropriate. Some companies are presently voluntarily using special 
packaging for their viscous prescription drug products containing 2-
percent lidocaine. Other companies can utilize existing CR packaging 
designs and materials that are not detrimental to the integrity of the 
substance and do not interfere with its storage or use. Product shelf-
life and integrity would not be expected to change, as it is 
anticipated that the same packaging materials could be used in contact 
with the product.
    In the case of the multiple-dose CR tube packaging, however, it may 
be necessary, for example, to change from a metal tube to a plastic 
tube in order to provide a suitable mating surface for a CR cap. A 
major product manufacturer contacted by the Commission's staff 
indicated that it could find an appropriate multilayer plastic tube to 
replace the metal tube, but that the suitability of the new tube would 
have to be confirmed by protocol and product stability testing.
    The Commission concludes, therefore, that special packaging is 
appropriate because it is available in forms that are not detrimental 
to the integrity of the substance and that do not interfere with its 
storage or use.
    Accordingly, the Commission finds that special packaging is 
technically feasible, practicable, and appropriate.
    3. Reasonableness. In establishing a special packaging standard, 
section 3(b) of the PPPA requires the Commission to consider the 
available data concerning whether the standard is reasonable. 15 U.S.C. 
1472(b). However, the Commission is not required to make a positive 
finding that the standard is reasonable. S. Rep. No. 91-845, 91st 
Cong., 2d Sess. 10 (1970).
    After considering the available data, the Commission concludes that 
there are no data that warrant a conclusion that the proposed rule is 
not reasonable.
    4. Other considerations. Section 3(b) of the PPPA also requires the 
Commission, in establishing a special packaging standard, to consider:
    a. Available scientific, medical, and engineering data concerning 
special packaging and concerning childhood accidental ingestions, 
illness, and injury caused by household substances;
    b. The manufacturing practices of industries affected by the PPPA; 
and
    c. The nature and use of the household substance. 15 U.S.C. 
1472(b).
    The Commission has considered these items in making the various 
determinations in this notice.

F. Effective Date

    The PPPA provides that no regulation shall take effect sooner than 
180 days or later than one year from the date such regulation is 
final,<SUP>4 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. The Commission concludes that 
production of CR packaging can be fully implemented within a year from 
the publication of this rule. Therefore, the final rule will become 
effective April 10, 1996, as to all products subject to the rule that 
are packaged on or after that date.

    \4\ The Commission voted on September 28, 1994, to issue this 
rule, and, at that time, the Commission directed that the rule would 
become final on its date of publication in the Federal Register. The 
Commission also directed that the date of publication would be April 
8, 1995, or as soon thereafter as practicable.
---------------------------------------------------------------------------

    This 1-year effective date may not allow adequate time to modify or 
replace all multiple-dose tubes, aerosols, and mechanical pumps if 
unusual difficulties are encountered, if the initial design intended to 
be CR is found to be unsuitable, or if data on the stability of the 
package contents need to be approved by the FDA. Where necessary, 
affected parties using any type of package can apply to the Commission 
for a temporary exemption for the minimum period required to market 
their products in CR packaging. Applications for such exemptions should 
describe the efforts since the issuance of the final rule to implement 
complying package designs, explain why such efforts were diligent yet 
unsuccessful, and explain why additional efforts within a limited 
period should result in a complying package.

G. Regulatory Flexibility Act Certification

    When an agency undertakes a rulemaking proceeding, the Regulatory 
Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601 et seq.) generally 
requires the agency to prepare initial and final regulatory flexibility 
analyses describing the impact of the rule on small businesses and 
other small entities. The purpose of the Regulatory Flexibility Act, as 
stated in section 2(b) (5 U.S.C. 602 note), is to require agencies, 
consistent with their objectives, to fit the requirements of 
regulations to the scale of the businesses, organizations, and 
governmental jurisdictions subject to the regulations. 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 initial certification indicated that the incremental costs for 
CR packaging for lidocaine preparations in aerosols and squeeze and 
spray bottles were comparatively low and likely to have a minimal 
effect on small businesses. Since the proposal, the staff has not 
received any additional information regarding adverse impacts on small 
business from comments on the proposed rule or from any other source. 
Therefore, the Commission concludes that the action to require CR 
packaging for topical anesthetics containing lidocaine packaged in 
aerosols, squeeze, and spray bottles will not have a significant 
economic effect on a substantial number of small entities.
    The initial certification indicated also that packaging industry 
spokespersons were unaware of any appropriate types of CR packages for 
the small pharmaceutical tubes now used to package lidocaine and 
dibucaine creams and ointments (and some gels). The analysis concluded 
that if costs associated with the use of alternate packaging were 
prohibitive to small manufacturers, they may drop the product from 
their lines. Since the proposal, the staff has received additional 
information regarding [[Page 18004]] adverse impacts of the proposed 
rule on small businesses.
    Industry representatives have confirmed that there are no known CR 
closures commercially available for the small pharmaceutical tubes 
currently used to package creams, ointments, and some gels. Although CR 
unit-dose sachets are available, specific chemical formulations used in 
various preparations are reported to be incompatible with the materials 
used for the sachets. Since there is no alternative packaging currently 
commercially available, some small businesses advise that a PPPA 
requirement for creams and ointments containing lidocaine or dibucaine 
will result in the withdrawal of their products from the market. For a 
few small companies, particularly those with limited product lines or a 
niche preparation, withdrawal could result in disruption and financial 
loss, as discussed in Section D of this notice.
    The Commission concludes that the action to require CR packaging 
for topical anesthetics containing lidocaine or dibucaine cream and 
ointment formulations may have an adverse effect on a few small 
businesses, but the number of businesses subject to such effects is not 
likely to be substantial.
    For the reasons given above, the Commission certifies that the rule 
will not have a significant economic impact on a substantial number of 
small entities.

H. 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 assessed the 
possible environmental effects associated with the proposed PPPA 
packaging requirements for topical drug preparations containing 
lidocaine or dibucaine and presented its findings in the Preliminary 
Economic Assessment (Revised April 1992). Re-assessment of the possible 
environmental effects confirms the original determination that the rule 
will have no significant effects on the environment. There is little 
likelihood that CR unit dose tubes or sachets will replace the 
currently used multi-dose tubes. But even if unit dose packaging was 
available, the amount of additional packaging used would be relatively 
insignificant. Since there appears to be no alternative packaging for 
preparations packaged in tubes, the proposal will affect only 
preparations packaged in bottles and various forms of spray containers. 
Manufacturers of affected products will have time to use up existing 
closure inventories and will not need to dispose of them in bulk. The 
rule will not significantly increase the number of CR packages in use 
and, in any event, the manufacture, use, and potential disposal of the 
CR packages present the same potential environmental effects as do the 
currently used packages.
    Therefore, because this rule has no adverse effect on the 
environment, neither an environmental assessment nor an environmental 
impact statement is required.

I. Possible Changes to the PPPA Test Protocol

    For the purpose of determining whether a package is CR, the current 
regulations provide that a package must be capable of resisting opening 
by 85 percent of a panel of 200 children after a 5-minute test and by 
80 percent of the panel after an additional 5-minute test. In order to 
determine that the package can be used by adults, the package must also 
be able to be opened and, if appropriate, properly closed within 5 
minutes by 90 percent of a panel of 100 persons of ages from 18 to 45 
years.
    On October 5, 1990, the Commission proposed to amend its 
requirements under the PPPA. 55 FR 40856. In its proposal, the 
Commission concluded that, if CR packages were easier to use, more 
people would purchase and properly use CR packaging. Accordingly, the 
Commission proposed to substitute a panel of 100 older adults, of ages 
from 60 to 75 years for the panel of 18- to 45-year-olds. The 
Commission also solicited comment on allowing a 5-minute 
familiarization period in the adult test, during which the subject must 
open the package, before the 1-minute test. 56 FR 9181 (March 5, 1991). 
Other amendments, intended to simplify the current child test 
procedures, add a procedure for determining whether the package was 
adequately resecured by the adults, and to ensure that the tests 
produced more consistent results, were also proposed.
    The Commission received a number of comments on the proposed rule, 
and contracted for additional testing to obtain information to address 
the comments on the proposed 5-minute/1-minute test. On March 21, 1994, 
the Commission published a Federal Register notice outlining the new 
information obtained, describing possible changes to the proposed test 
procedure, and requesting comment on these matters. 59 Fed. Reg. 13264. 
The possible changes to the test procedure included:
    1. Dividing the 60-75-year-olds into 3 age groups and distributing 
the participants in the groups to reduce variability.
    2. Modifying the sequential testing scheme for older adults to 
provide more certainty about passing or failing ``borderline'' 
packages. This involves testing sequential panels of 100 seniors, up to 
400 subjects, until a statistically valid determination is made.
    3. Adopting the 5-minute/1-minute older adult test on which comment 
was sought previously.
    The additional data also resulted in other minor changes to the 
proposal and provided information that the Commission can use to 
address other comments that did not warrant any changes.
    The Commission may vote later this year on whether to issue these 
revisions to the PPPA protocol. Manufacturers of lidocaine- and 
dibucaine-containing products are urged to consider changing to CR 
packaging that not only meets the current PPPA requirements but will 
meet the new procedures that may be adopted. This would eliminate any 
need to change packaging twice in a relatively short period of time.

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Toxic substances.

J. Conclusion

    For the reasons given above, the Commission amends 16 CFR 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 by adding new paragraphs (a)(23) and 
(a)(24) and the introductory text of paragraph (a) is republished to 
read as follows:


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 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:
* * * * * [[Page 18005]] 
    (23) Lidocaine. Products containing more than 5.0 mg of lidocaine 
in a single package (i.e., retail unit) shall be packaged in accordance 
with the provisions of Sec. 1700.15(a) and (b).
    (24) Dibucaine. Products containing more than 0.5 mg of dibucaine 
in a single package (i.e., retail unit) shall be packaged in accordance 
with the provisions of Sec. 1700.15(a) and (b).

    Dated: April 3, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.

Appendix 1--List of References

(This Appendix will not be printed in the Code of Federal Regulations.)

    1. Memorandum from CPSC's Directorate for Health Sciences, dated 
June 21, 1990 (toxicity).
    2. Memorandum from CPSC's Directorate for Health Sciences, dated 
July 24, 1989 (technical feasibility, practicability, and 
appropriateness).
    3. Memorandum from CPSC's Directorate for Economic Analysis, 
dated December 10, 1991 (a. economic information; b. regulatory 
flexibility analysis; and c. environmental assessment).
    4. Death and injury data:
    a. CPSC Death Certificate File, 1981, lidocaine.
    b. CPSC Injury or Potential Injury Incident File, 1984, 
lidocaine.
    c. FDA Drugs and Biologics Adverse Reaction Reporting System 
Data Base, 1979, lidocaine.
    d. CPSC Death Certificate File, 1987, dibucaine.
    e. CPSC Death Certificate File, 1988, dibucaine.
    5. FDA Drugs and Biologics Adverse Reaction Reporting System 
Data Base.
    6. CPSC National Electronic Injury Surveillance System Data 
Base--1978 through April 1990.
    7. National Clearinghouse for Poison Control Centers Data Base 
1980-1984.
    8. AAPCC National Data Collection System 1984-1988.
    9. Briefing package, OS #3309, ``Draft Proposed Rules--Special 
Packaging Standards For Topical Anesthetics,'' February 27, 1992.
    10. Briefing package, ``Supplemental Information--Special 
Packaging Standards For Topical Anesthetics,'' May 27, 1992.
    11. Log of Meeting with Ciba Consumer Pharmaceuticals, April 8, 
1992.
    12. Memorandum from CPSC's Directorate for Economic Analysis, 
``Market Sketch: Topical Preparations Containing Lidocaine and 
Dibucaine,'' Oct. 2, 1990 (revised April 23, 1992).
    13. Memorandum from CPSC's Directorate for Economic Analysis, 
``Supplemental Information on Lidocaine and Dibucaine,'' April 23, 
1992.
    14. Memorandum from CPSC's Directorate for Health Sciences, 
``The Amount of Lidocaine and Dibucaine in Marketed Products,'' 
April 27, 1992.
    15. Memorandum from CPSC's Directorate for Economic Analysis, 
``Amended Economic Data: Proposal to Require Child-Resistant 
Packaging for Topical Preparations Containing Lidocaine or 
Dibucaine,'' dated April 27, 1992 (with revised preliminary economic 
assessment).
    16. Memorandum from CPSC's Directorate for Health Sciences, 
``Additional Human Experience Data for Lidocaine and Dibucaine,'' 
April 27, 1992.
    17. Memorandum from CPSC's Directorate for Health Sciences, 
``Supplemental Information on Lidocaine and Dibucaine,'' May 28, 
1992.
    18. Log of Meeting with NDMA Lidocaine/Dibucaine Task Force, 
October 15, 1992.
    19. Comments on proposed rule (10). On file in the Office of the 
Secretary.
    20. Log of meeting with Ciba Consumer Pharmaceuticals, January 
11, 1994.
    21. Log of Meeting with NDMA Lidocaine/Dibucaine Task Force, May 
25, 1994.
    22. McClenahan, W., Fatal Poisoning with Dibucaine Hydrochloride 
(Nuporal) Lozenges, Journal of American Medical Association, 158(7), 
565, 1955.
    23. Memorandum from Terry L. Kissinger, EPHA, ``Response to 
Comments and analysis of Available Data Regarding Child-resistant 
Packaging for Topical Anesthetics Containing Lidocaine or 
Dibucaine,'' April 29, 1994.
    24. Memorandum from Susan C. Aitken, Ph.D., HSPS, ``Health 
Sciences Staff Responses to Comments on Proposed Packaging Standards 
for Lidocaine and Dibucaine,'' July 19, 1994.
    25. Memorandum from Terry L. Kissinger, EPHA, ``Recent Death 
Involving Ingestion of a Dibucaine-Containing Product,'' July 27, 
1994.
    26. Memorandum from Charles J. Wilbur, HSPS, ``PPPA Final Rule 
Lidocaine and Dibucaine Technical Feasibility, Practicability, and 
Appropriateness,'' July, 1994.
    27. Memorandum from Marcia P. Robins, ECSS, ``Final Economic 
Assessments: Proposal to Require Child-resistant Packaging for 
Topical Anesthetics Containing Lidocaine or Dibucaine,'' June 15, 
1994, (and telephone conversation 10/1/93).
    28. Letter from Vincent De Stefano (Ciba Consumer 
Pharmaceuticals) to Ann Brown, June 10, 1994.
    29. Poison Control Centers Toxic Exposure Surveillance System, 
1992.
    30. Wilbur, Charles J., Laboratory Report, form 221, Non-CR 
Finger Mechanical Pump Spray with Overcap, 2 fl. oz., S-400-0802, 
CPSC, August 2, 1994 (Confidential).
    31. Memorandum to file, Mike Gidding, CEAL, ``Memorandum of 
visit to Teledyne Corporation,'' August 4, 1994.
    32. Letter from Andrew S. Krulwich and Julie Jacobs, counsel to 
Combe, Inc., to Eric A. Rubel, General Counsel, in support of 
exemption for OTC topical lidocaine preparations, September 8, 1994.
    33. Memorandum from Suzanne Barone, HS, to the Commission, 
``Supplemental Information on Lidocaine and Dibucaine,'' September 
9, 1994.
    34. Vote sheet from the Office of the General Counsel to the 
Commission, with revised Federal Register notice, September 9, 1994.
    35. Log of meeting and attached material submitted by a 
manufacturer--FOR OFFICIAL USE ONLY.
    36. Letter from John B. Dubeck, Keller and Heckman, on behalf of 
Pound International, Inc., September 12, 1994.
    37. Letter from Jeffrey C. Minnette, Sunbeam Plastics, September 
16, 1994.
    38. Memorandum from Marcia Robins, ECSS, to Suzanne Barone, 
Ph.D., Project Manager, HS, ``Lidocaine/Dibucaine'' (about share of 
revenue for lidocaine in tubes for three small companies), September 
19, 1994.
    39. Letter from Andrew S. Krulwich and Julie Jacobs, Wiley, Rein 
& Fielding, on behalf of Combe, Inc., September 20, 1994.
    40. Tape recordings of Commission briefing on September 21, 1994 
(portion containing discussion of confidential data is for official 
use only).
    41. Letter from John Dubeck, Keller and Heckman, representing 
Pound International, September 26, 1994 (non-confidential version).
    42. Additional data from AAPCC, September 27, 1994.
    43. Revised draft Federal Register notice, September 27, 1994.
    44. Tape recording of Commission meeting on September 28, 1994.
    45. Separate statements of the Commissioners.
[FR Doc. 95-8628 Filed 4-7-95; 8:45 am]
BILLING CODE 6335-01-P