EPA737-N-94-010
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
September 6, 1994 !
PESTICIDE REGULATION (PR) NOTICE 94-6 PESTICIDESANDTOXIC
SUBSTANCES
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDE, PRODUCTS
ATTENTION: Persons Responsible for Registration of Pesticide
.,-._,..,.._..., .__., ... Products :_ „-,,„,.„ ,„ ,.„_,,,„ :__-___,....„„ .. — - .
SUBJECT: Pesticide Products Registered for^Use on Humans to
Control Lice (Pediculicides) ,
This notice alerts pesticide registrants to a rule issued by
Food and Drug Administration (FDA) under the Federal Food, Drug and
Cosmetic Act (FFDCA) establishing conditions for safe and effective
use of pediculicide drug products (including pesticide products)
for "over-the-counter (OTC) human use. As a result of the FDA rule
pesticide products containing the active ingredients pyrethrins and
piperonyl butoxide and labeled solely for use- on humans as a
pediculicide (treatment -of head, pubic (crab) and body lice) will
no longer be regulated by EPA. Specifically, aerosol formulations
of pediculicides are exempt from regulation under FIFRA as of June
14, 1994 and non-aerosol formulations will be exempt from
regulation as of December 14, 1994. In addition this notice
discusses actions registrants may take prior to December 14, 1994
to prepare for compliance with the FDA rule and also remain in
compliance with FIFRA.
The FDA rule was published in the Federal Register of December
14, 1993 (58 FR 65451) . Upon the effective dates of _this rule_
~(i. e~. 7" \June" 14 ,' 1;9 94' and December" 14 ~, 19 9 4) r egul at dry 'j ur i s di c t i on"
for OTC human pediculicides will rest fully with the FDA. No
response to this notice is required unless a registrant wishes to
sell a product bearing FDA labeling prior to December 14, 1994
(See Section, III) .
I. BACKGROUND ' ,
There are certain pesticide products that , fall within the
statutory definition of "drug" in the FFDCA and-as such are also
subject to the jurisdiction of the FDA. In the Federal Register of
November 5, 1979 (44 FR 63749) EPA issued a final regulation to
clarify its policy regarding the registration of pesticide products
(which include pediculicide products) that are not new drugs.
Basically, EPA has jurisdiction over pesticide products marketed
OTC and used, as pediculicides under' FIFRA whereas FDA has
jurisdiction over pediculicide drug products under' FFDCA. 40 CFR
Printed on Recycled Paper
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Section 152.20(b) of EPA's regulations provides that a pesticide,
such as pyrethrins, is exempt from requirements of FIFRA if .the
product is offered solely for human use and also is a new drug
within the meaning of FFDCA section 201 (p) or is a product that has
been determined not to be a new drug by the Secretary of Health and
Human Services by a regulation establishing conditions for use of
the product.
Prior to December 14, 1993 FDA had not declared pediculicide
products containing pyrethrins to be new drugs- nor established
conditions for use of these products in a regulation. Therefore,
EPA had jurisdiction on such products. However, on December 14,
1993, FDA issued a final rule establishing conditions for use of
these products which effectively removed pediculicide drug products
containing pyrethrins and piperonyl butoxide from the requirements
of FIFRA. Upon the effective date of the final rule (i.e.,
December 14, 1994) regulatory jurisdiction of OTC human
pediculicides will rest fully with the Food and Drug
Administration. Firms that market non-aerosol OTC human
pediculicides must comply with the FDA final rule with respect to
labeling, formulation, etc., by that effective date. The only
acceptable OTC pediculicide products for human use under this final
rule are combinations of pyrethrum extract (0.17 to 0.33 percent)
with piperonyl butoxide (2 to 4 percent) in a nonaerosol dosage
form. Under the same rule, any aerosol OTC pediculicides may no
longer be marketed after June 14, 1994, unless they are the subject
of an approved New Drug Application.
According to Agency records there .are twenty-five (25)
products registered as pediculicides for use on humans, one of
which is an aerosol formulation.
II. DISCUSSION .,.-.'
On April 22, 1994, the Nonprescription Drug Manufacturers
Association (NDMA) submitted a petition entitled "Petition for the
Administrative Coordination of Transfer of Regulatory Authority
from EPA to FDA for OTC Pediculicide Products." NDMA also filed
the same petition with FDA requesting similar action. NDMA is a
trade association that Represents OTC pediculicide manufacturers.
Basically, the petition informed EPA that (1) firms subject to the
FDA rule needed at least one and one-half years from December 14,
1993 for a smooth transition from EPA to FDA regulation for OTC
pediculicide drug products; (2) firms needed EPA approval of a time
period effective as soon as possible and ending on December 14,
1994, during which time the production and shipment into interstate
commerce of OTC pediculicide products that bear FDA mandated
labeling would be deemed in qompliance with EPA regulations; and
(3) firms needed EPA to inform their field compliance authorities
and, state authorities of the regulatory status of these products
(i.e., EPA permitting future FDA mandated labeling during the
period of EPA compliance authority). . ,
In support of these actions, the, NDMA petition included a
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comparison of current EPA and .FDA required labeling. The
Comparison demonstrated that the labeling currently approved by EPA
was substantively the same as that which would be required by FDA
after December 14, 1994 with respect to information needed by the
user to use the product safely and effectively. Thus, use of FDA
mandated labeling prior to the administrative transfer date and
during the time of EPA authority over OTC pediculicide products
would not represent a safety or efficacy problem. In addition, EPA
allowance to permit FDA mandated labeling for OTC pediculicides
prior to December 14, 1994 would help significantly in minimizing
the possibility -of excess inventory after the compliance date of
the FDA final rule and assure that the OTC supply of available
product for lice infestation is fully available for the users
during the 1994 season.
The EPA has determined that currently EPA registered OTC
pediculicide products that bear FDA mandated labeling per the FDA
OTC final rule would be in compliance with Federal regulation until
December 14, 1994 provided certain actions are taken with respect
to the FDA label.
EPA will allow the use of FDA. mandated labeling provided:
• Registrants who want to market pediculicides with FDA
labeling prior to December 14, 1994 notify EPA in writing
that the labeling submitted in conjunction with their
registration is in full compliance with the FDA rule
published in the Federal Register of December 14, 1993
(58 FR 65451) ;
• Registrants submit such labeling along with their
notification;
• The labeling bears the current EPA Registration Number
and the misuse statement "It is a violation of Federal
Law to use this product in a manner inconsistent with its
labeling.» '
With respect to these changes and existing stocks, FDA does
not object to OTC pediculicide drug products conforming with the
final FDA rule and also containing EPA required labeling for a
period of 1 year after the effective date of the final rule on
pecember 14, 1994. ,
III. WHAT REGISTRANTS SHOULD DO
The following actions should be taken only if a registrant
wishes to market an EPA registered product bearing FDA labeling
prior to December 14, 1994:
A. Ensure that labeling .in conformance with the FDA final
rule bears the following:
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1. EPA Registration Number
2 The misuse statement "It is a violation of Federal
law to use this product in a manner inconsistent
with its labeling."
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B Submit a Notification (in accordance with the procedures
outlined in PR Notice 88-6} which states, "I certify that
the enclosed labeling is in compliance with the FDA final
rule published in the Federal Register in December_14,
1993 (58 FR 65451) and bears the label revisions
described in PR Notice 94-6 ." A copy of the labeling
should be enclosed.
IV. EFFECTIVE DATES
This notice is effective immediately.
V. MAILING ADDRESS
Registrants should send notifications and labeling to the
following address: , .
U. S. Postal Service Deliveries
Document Processing Desk (NOTIF)
Office of Pesticide Program (7504C) •
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, DC 20460-0001
Personal/Courier Service Deliveries (Mon.-
Fri., 8:00 a.m. to 4:30 p.m., except federal
holidays)
Document Processing Desk (NOTIF)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
VI. FOR FURTHER INFORMATION
If you have questions regarding this notice, contact George
LaRocca, Product Manager 13, Registration Division at (703) 305-
6100.
Sincer
son, Director-
ivision
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