United Stales OPA 136/8
Environmental Protection December 1978
Agency
Pesticides
The Federal
Pesticide Act
of 1978
-------
A New, On September 30, 1978 President Car
More Workable signed into law the Federal Pesticide , of
Law 1978, amending the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA)
That was the final step in a process which
had begun some 18 months previously with
the submission of Administration proposals
to the Congress Congress and the U S
Environmental Protection Agency (EPA),
which has chief responsibility for ad-
ministering FIFRA, have worked together to
refine this legislation to make government's
regulation of pesticides more efficient,
more effective, less costly and less time
consuming
The amendments build and improve upon
all the major areas covered by the previous
law
Registration (premarket clearance) of
pesticides to prevent unreasonable hazards
to humans or the environment.
Classification of pesticides for general or
restricted use
Certification of users of restricted use
pesticides
Informative and accurate labeling of
pesticide products
Enforcement of FIFRA to ensure proper
pesticide practices
The most significant and far-reaching of the
amendments bear upon the registration
process, particularly in regard to the kinds
of information required to register a prod-
uct, the sharing of information between
registrants, and the review and validation of
the data base supporting some 35,000 pes-
ticide products now on the market
The cornerstone of the new; more effi-
cient approach authorized in the amended
law is a program of generic pesticide
registration In the past, registration en-
tailed an examination of risk of each
product one at a time. However, generic
registration of pesticides entails a single,
comprehensive evaluation of risks and
benefits of the technical material common
to numerous products based on all data
relevant to the registration decision. The
new system will demand less time and
money both from EPA and the registrant
Development of pesticide generic stan
dards will take time and until such stan
dards are developed and the complete new
The
Registration
Process
-------
reregistration program is put in place. Con-
gress has authorized a program for EPA to
grant conditional registrations. Conditional
registration will allow EPA to process ap-
plications for registration of new products
which are like ones already registered, and
thus permit the new products to enter the
market on an equal footing with others
already registered and in turn provide con-
sumers with a wider range of comparable
products. Ultimately, all products will be
reviewed comprehensively when reregis-
tered under generic pesticide registration
standards.
New uses of "old" chemicals and new
chemicals will also be eligible for condi-
tional registration if EPA determines that
enough information is available to evaluate
unique hazards that may be posed by the
new uses. The Agency is also authorized to
issue conditional registration of new
chemicals if the public interest would be
served by a registration, and if risks during
the period required to complete and submit
additional studies are not unreasonable.
In the future, conditional registration will
be useful for allowing time to meet new
data requirements or in some special cases,
for permitting early registration of brand
new chemicals
Solving In addition to authorizing generic and con-
Data Problems ditional registration, the new law clarifies
many matters relating to use of data'
'compensation by one registrant for use
of data owned by another registrant;
'exclusive use of data submitted for
registration of new pesticide chemicals,
protection of specified trade secrets;
'several issues pertaining to efficacy
data, and registration data for "minor
uses"
All data submitted from 1970 on are eligible
for compensation for a period of 15 years
following the submission of the data. This
means that subsequent applicants must of-
fer to pay compensation to data originators
in order to rely on their data. If registrants
cannot agree on fair compensation, the
-------
dispute will be settled by binding arbitr
tion. Previously the Agency was respoi
ble for settling disputes over compensation.
The new law will also give 10 years "ex-
clusive use" of data to the original
registrant after a new chemical is first
registered. That means that no one can use
that data for 10 years without the ex-
press permission of the data developer
This aspect of the law rewards innovation
in the industry, and may be especially
useful in encouraging development of bio-
logical pesticides and other compounds for
which patent protection was difficult to
achieve in the past.
The amended law provides that the basic
health and safety data underlying pesticide
registrations are open to the public and
thus the public will have access to the in-
formation on which EPA's regulatory deci-
sions are based. Other data, however, are
now specifically protected from public dis-
closure. EPA or other government workers,
including those under contract to the
government, who wrongfully disclose such
data are subject to imprisonment or a firu
Data as to the efficacy of a pesticide ^
have generally been required for registra-
tion EPA now has relatively broad discre-
tion to waive submission of efficacy data
That will simplify the registration process
for the registrant and reduce Federal man-
power required to register and reregister
pesticides, This new policy is more or less
an experiment in permitting the market-
place to police efficacy. If it does
not stand the test of time, EPA will recon-
sider the new approach as appropriate. In
any case the agency will continue to con-
sider efficacy when performance of the
product bears upon public health.
The new law also gives States broader
authority and responsibility for registering
pesticides. States automatically have
authority to register products for use within
a State for "special local needs." Formerly,
States had that authority only with EPA ap-
proval. EPA may disapprove State registra-
tion if the use is dissimilar from Federal
registration, if an imminent health hazard
exists or if the State has authorized use on
crops for which no tolerance, or a I Iowa bU'
residue level, on crops, has been estab- 1
lished by EPA.
-------
1
Cla nation Congress has amended two other separate
anc but related areas in FIFRA classification
Certification of pesticides and applicator certification.
In order to make full use of the state~~pro-
grams for training and certification of ap-
plicators to use "restricted use" pesticides,
EPA is authorized to classify uses by regu-
lation, apart from the registration process.
This will help realize the objectives of the
applicator certification program, since
almost all States have worked hard to train
and certify applicators to handle the
restricted products Restriction of use also
gives EPA an option short of cancellation
to reduce pesticide risks. Also in connec-
tion with the training and certification pro-
grams, EPA is authorized to pay up to 50%
of the costs for each State program.
Some Special For users of all pesticides the new amend-
Issues ments have clarified an issue of broad con-
cern: the legality of pesticide uses or prac-
tices not addressed in the label directions.
Several important pesticide use practices
have been specifically excluded from the
definition of "use inconsistent with the
label", and the Agency may identify other
uses which will be considered consistent
through not in literal accord with the label.
Pesticide exporters must now comply with
special label requirements including a re-
quirement that pesticides not registered for
use in this country must be labelled, "not
registered for use in the U.S.". Importers
must also sign a statement acknowledging
that they know such products are not
registered in the United States, a copy of
which must be sent to an appropriate of-
ficial in the importing country.
Congress has required EPA to study and
report on-
the feasibility of charging fees to cover
the registration
method of pesticide application including -
the advisability of ultra-low volume applica-
tion
the problems of minor uses of pesticides.
-------
Enforcement Violations of FIFRA, like those of an
may come to the attention of the govt,,.i-
ment through various avenues com-
plaints, accident reports, general inspec-
tions of areas where pesticides are made ot
used, specific investigations where viola-
tions are suspected. Among the most com-
mon violations are misuse of a product
through failure to follow labeling directions,
deliberate misuse, misbranding, mislabelling
and selling adulterated or unregistered
pesticides. Violations may involve penalties
under FIFRA ranging from fines of small
amounts of money to imprisonment.
The new amendments set up a three tier
penalty structure for applicators. Pesticide
registrants, dealers, retailers and commer-
cial applicators {those applicators, other
than private applicators, using restricted
use pesticides) are subject to civil penalties
of up to $5,000 for their first violation.
Those applicators in the business of ap-
plying pesticides, using only general use
pesticides could be fined up to $500 for
first offense violations. Private applicators
(generally farmers who use restricted
pesticides) and others such as homeo^Wrs
would first receive a warning letter. As
before in assessing fines, EPA must take in-
to account the size of business the appro-
priateness of the penalty to the violation,
and the ability of the person to pay.
The new amendments transfer to States
the primary responsibility for prosecuting
pesticide use violations. The responsibility
will be transferred to a state if it has
entered into a cooperative enforcement
agreement with EPA or if the Agency has
determined that the state has pesticide use
laws, regulations, and implementing pro-
cedures.
Regardless of transfer of responsibility, if
a state is unwilling or unable to effectively
act upon a violation, EPA may act. In addi-
tion, EPA could revoke all or part of the
State's responsibility for pesticide use en-
forcement if the Agency found that the
State's program was deficient. Also, in the
event of an emergency where the State
was not capable of quickly responding,
EPA could step in.
-------
For users of pesticides, the best rule to
promote safety and avoid violations of
FIFRA is: Read and follow label directions.
If you have any question about FIFRA or
safe pesticide practices contact:
EPA Region 1 JFK
Federal Bldg. Boston
MA 02203 Connec-
ticut, Maine. Massachu-
setts, New Hampshire,
Rhode Intend, Vermont ซ
617-223-7210
EPA Region 2*28
Federal Plaza * New
York NY 10007 New
Jersey, New York, Puer-
to Rico, Virgin Islands *
212-264-2525
EPA Region 3 6th
end Walnut Streets
Philadelphia PA 1910S
Delaware, Maryland,
Pennsylvania, Virginia,
West Virginia, District of
Columbia 215-597-9814
EPA Region 4 346
CcwrtJand Street NE
Atlanta OA 30303
Alabama, Georgia,
Florida, Mississippi,
North Carolina, South
Carolina, Tennessee,
Kentucky 4G4-881-4727
EPA Region 6 230 S.
Dearborn Chicago IL
60604 ป Illinois, Indiana,
Ohio, Michigan, Wiscon-
sin, Minnesota
312-353-2000
EPA Region 6 1201
Elm Street Dallas TX
75270 ฎ Arkansas, Loui-
siana, Oklahoma, Texas,
New Mexico
214-767-2600
EPA Region 7 1735
Baltimore Avenue
Kansas City MO 64103
Iowa, Kansas,
Missouri, Nebraska
816-374-5493
EPA Region 8 * 1880
Lincoln Street *
Denver CO 80203 * Col-
orado, Utah, Wyoming,
Montana, North Dakota,
South Dakota
303-837-3895
EPA Region 9 * 215
Fremont Street San
Francisco CA 94105
Arizona, California,
Nevada, Hawaii, Guam,
American Samoa, Trust
Territories of the Pacific
415-556-2320
EPA Region 10 1200
Sixth Avenue Seattle
WA 98101 Alaska.
Idaho, Oregon, Washing-
ton 206-442-1220
-------
EPA is charged by Congress to protect the Nation's land, air and v
systems. Under a mandate of national environmental laws focusse
and water quality, solid waste management and the control of toxic
substances, pesticides, noise and radiation, the Agency strives to for-
mulate and implement actions which lead to a compatible balance be-
tween human activities and the ability of natural systems to support and
nurture life.
m j> -g m ti
"TJtO ^ ~ O o
>(T| ^ < O yi
~ ~
------- |