001 R78103 12/4/78
5414
EPA REGULATION OF BIOLOGICAL PESTICIDES
A great deal of interest has recently been expressed in
biological pest control agents and the degree to which the
Environmental Protection Agency's policies and practices act
as a stimulus or obstacle to the development and use of
these products.
The vast majority of the more than one thousand pesticide
active ingredients regulated by the EPA are man-made organic
chemicals. There is, however, a class of pesticides which
is inherently different from those products which function
as pesticides through their innate toxicity. The pesticides
which function by modes of action other than innate toxicity
include true biological agents, living or reproduced biologi-
cal entities such as viruses, bacteria, fungi, and protozoans
and naturally occurring biochemicals such as plant growth
regulators, insect pheromones, and hormones. At this time
"biological" pesticides account for less than 1 percent of
all pesticide products registered by the EPA.
During the last decade there has been an upsurge in com-
mercial and governmental activity in the development and use
of biologicals. EPA and other agencies (e.g., USDA) have
sought to stimulate this area of technological innovation
by research efforts and by utilization of such materials
in governmental pest control programs. The need to design
registration requirements specific to this category of
pesticides has been identified as a high priority by a
number of scientific groups, including the National Academy
of Sciences. Because of the recent interest in the develop-
ment and regulation of biological pesticides, this paper has
been prepared to provide a short history of the subject and
the Agency's expectations for future policies and direction.
BACKGROUND
EPA is responsible for administering the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), which provides
authority to regulate the marketing of pesticides and requires,
among other things, that such products be registered with
the Agency. Under the amended FIFRA, the registration of
any pesticide is contingent upon the availability of data
adequate to demonstrate that the product will not pose the
risk of unreasonable adverse effects on man or the environ-
ment when used in accordance with its label directions or
in accordance with commonly recognized practice. The
recently enacted 1978 amendments to the Act do not change
this fundamental mandate. Under FIFRA, "pesticides" are
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defined as "any substance or mixture of substances intended
.for preventing/ destroying, repelling, or mitigating any
pest." Biological agents therefore, clearly fall under this
definition. Generally, biologicals can be divided into
three categories:
(1) classical biological controls, including parasite
and predator species;
(2) naturally occurring biochemicals that may attract,
retard, or destroy pests—for example, pheronones,
hormones, and plant growth regulators;
(3) micro-organisms such as viruses, bacteria, protozoa,
and fungi, which have replicative potential.
While all three of these categories could be regulated as
pesticides under FIFRA, EPA had decided informally to
exempt from regulation the kinds of parasites and predators
in category (1) above. These pest control agents are
.recognized as posing no known human health hazards- Their
.ecological-effects are currently monitored under the various
pest control authorities of the U.S. Department of Agriculture
and the U.S. Department of the Interior.
The. other two categories, however, are subject to the
registration provisions of the Act. These products must
fund_ergo Agency review before marketing to insure, that
-they meet the statutory standard of not posing" any
'."unreasonable adverse effects" oh man or. the environment.
REGISTRATION OF BIOLOGICAL'PESTICIDES
EPA recognizes that registration requirements for testing
.and data under the existing Agency guidelines are oriented
toward the more traditional pest control chemicals and are
jgenerally not applicable to biological agents..- Becaus.e of
the wide variety of biological pesticides, however, there
"is potentially great variance in the testing and data .
necessary for EPA to be able to decide that an agent can
be used safely. Thus, registration of biological pesticide
agents has been handled on a case-by-case basis. Informal
guidance on registration requirements has been developed
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and published in books and professional journals; however,
most registrants have had to consult with EPA on which
data requirements are most appropriate to their particular
biological control agent.
Although the volume of applications for registration of
biological control agents has remained low and all submitted
have received registration, it may well be that the lack
of guidelines for registration of biologicals has introduced
such a large degree of uncertainty into the registration
process that potential registrants are "scared off" and do
not even attempt to register and market their products.
Furthermore, the lack of guidelines may result in the
imposition of unnecessary data requirements that are both
costly and time consuming to the registrant. EPA recognizes
that registration guidelines which are specific to biological
pesticides are desirable and would alleviate uncertainty
over data requirements. Consequently, in order to improve
the registration process for these compounds, the Agency
will:
(1) Develop guidelines specifying data requirements
for registration. These are scheduled to be
published for public comment on a staggered
schedule beginning in July 1979. Final
guidelines will be promulgated in 1980.
(2) Complete the development of efficacy guidelines
under contract with the American Institute of
Biological Sciences for pheromones, hormones,
and viruses.
(3) Continue the panel of virology experts developing
agreed protocols, areas of protocol research
needs, and risk information for viral pest control.
(4) Establish a panel of university, USDA, environ-
mentalists, and industry experts to provide
recommendations on risk assessment data require-
ments for insect hormones and pheromones.
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(5) Draft regulations clearly excluding non-microbial
biological control agents from FIFRA regulation.
(6) Publish a general policy statement explaining the
Agency position on regulation of biological pesti-
cides in the Federal Register.
DATA REQUIREMENTS FOR BIOLOGICAL PESTICIDES
There is no reason to assume that a biological agent will not
result in adverse effects simply because it is biological,
just as more traditional pesticides cannot be judged
harmful simply because they do not occur naturally. Clearly,
EPA must determine whether biologicals cause any health or
environmental hazards, and this consideration must be
reflected in any new registration guidelines for them. The
Agency will be careful, however, to require only data relevant
to adequate scientific assessment of the compound's potential
risk in accord with the nature of the pesticide.
Viruses, for example, may undergo some alternations which
could potentially pose a hazard to humans or other organisms.
The forthcoming biological pesticide registration guidelines
will outline generally what kinds of hazard information will
be needed in this regard, and will describe how EPA will use
the data. Waivers for exempting a product from a particular
data requirement will be"set forth in the guidelines, and
attention will also be paid to assessing a -compound's potential
for exposure to humans, wildlife, "and the environment. '- EPA
will require few data for registration in cases where a
material is of a class determined by scientific evidence and
judgment to be relatively innocuous, and where the potential
for exposure is low. . - . . . -_----
Recently enacted amendments to the FIFRA .include two pro-
visions which may lessen the amount of data required for
registration and should allow biological pesticide products
to be marketed more quickly. The Administrator of EPA is
now authorized to waive efficacy data in support of regis-
tration, consequently, the amount of efficacy data that"the
manufacturer must develop to satisfy EPA regulatory require-
ments will be reduced. The Federal Pesticide Act of
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1978 also authorizes EPA to change over from the present
product-by-product registration system to a broad, generic
standard or chemical—rather than product specific registration
scheme. Because generic standard building will take a
number of years to fully accomplish, EPA has been authorized
during the transition period to issue conditional registrations,
That is, the Agency may issue registrations based on less
than the full complement of supporting data, on the condition
that the missing data will be developed and submitted in
a timely manner during reregistration of all products
containing the same active ingredients. EPA plans to begin
issuing conditional registrations as soon as possible for
old and new uses of products identical or similar to
previously registered pesticides. New active ingredients
can be conditionally registered if the Administrator finds
that registration is in the public interest and there is
enough hazard data available to determine that the risks
of use of the compound during the period of time required
to complete the data base are not unreasonable.
COST OF REGISTRATION REQUIREMENTS
The costs of EPA testing requirements to an applicant for
registration are a critical factor in the decision to
pursue registration since the applicant must have a
reasonable prospect of recouping this investment. EPA will
consider the economic impact of the requirements imposed
on the marketing of biologicals in development of guidelines
for their registration. As a first step in this direction,
on June 20, 1977, the Agency announced a policy of waiving
fees for tolerances (the legal limits of pesticide residues
that may remain in or on raw agricultural commodities,
processed food, or feed) for innovative pesticides when
the need can be demonstrated by the applicant.
While guidelines might remedy the uncertainty in EPA
registration requirements, and could reduce the costs of
registration through more suitable data requirements, it
should be noted that the ambiguity which presently exist
in EPA registration requirements is only one of the several
factors that may operate against introducing biologicals
to the market.
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The very specificity of many biological pesticides that
makes them so environmentally desirable usually results in
a restricted market, and therefore, usually limits potential
profits. The biological pesticides that have been registered
to date include products which have more general application
and thus may provide a better return for the developer's
investment. Such agents include those for use against
relatively major pests or for limited portions of major
crops (such as Gossyplure for cotton pest control and Altosid,
a growth regulator, for mosquito control) and those which
have a broader activity spectrum like Bacillus thuringiensis
which is effective against a number of moth and butterfly
larvae.
The'costs of research into the properties of such products
are not limited to developing the data required for EPA
registration. This is also true for more traditional
chemical pesticide products. It is estimated that research
and development costs over a 7- to 8-year period between
discovery and registration of a pesticide amount to between
two and ten million dollars. Of that total R&D expenditure,
approximately one-tenth, or between $200,000 and $1,0.00-, 000
can be attributed to meeting EPA registration requirements.
In the case of both biologicals and traditional pesticide
chemicals, minor market uses suffer due to low anticipated
return from this large pre-market investment. The traditional
chemicals usually penetrate one or more major markets to . -
carry the cost of the minor uses. -.".".""-"
In the specific case of biologicals, there has also been
question in the past about the applicability of patent
protection for the agents. However, patent protection was
recently granted by the courts to a developer of a new" life
form and the method of producing it. For some' of the biologi-
cal agents, this will be added incentive to producers to
register and market them. . . ._
More importantly, one of the recent amendments to FIFRA
provides for exclusive use of data and will protect the
original data submitter from competition for a period of
10 years after initial registration of a new pesticide
active ingredient. This provision could have a favorable
effect on the market situation for biologicals.
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PROCESSING TIME FOR REGISTRATION
Length of time required for EPA review of applications
for registration has the potential for frustrating would-be
applicants. Under the current system of negotiating data
requirements with each registrant, EPA has shortened its
processing time of registering biologicals. As both EPA
and potential registrants have gained more experience in
this area, the system has been streamlined. A recent
registration action on Gossyplure, a pheremone registered
to the Conrel Corporation for pink bollworm control, was
accomplished quite expeditiously:
• an experimental use permit was issued in early
1977;
• formal application for registration was received
by EPA in September 1977;
• following an expedited review of the application,
Gossyplure was registered in February 1978.
The 5 months required to review this application is
substantially less than the 19-month average for review
of applications for more traditional pesticides. (The
review period includes the time from formal submission of an
application for registration to approval of the registration,
including time when the applicant may be developing missing
data.)
REGISTRATIONS
The following table displays the biological agents and
compounds, including pheromones and juvenile hormones
that have been registered by EPA and its predecessor
agency.
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NEW GENERATION PESTICIDE SUMMARY
PESTICIDE
USE PATTERN
REGISTRATION STATUS
I. BIOLOGICAL AGENTS
Bacillus thuringiensis
Virus of H.zea (NPV)
Virus of tussock Moth
Bacillus popilleae
Virus of Gypsy Moth
Colleotrichum gloediosporiodes
(Mold)
Nosema locusteae (Protozoan)
Hirsutella thompsonii (Mold)
Phytophthora citropthora (Mold)
Bacillus sphaericus
Virus of Autographa californica
Sawfly-Virus
Lepidopteran Larvae
Many crops
Heliothis Species,Cotton
Forest Use
Japanese Beetle, Lawns
Forest Use (hard woods)
Weed Control (rice)
Locust, Rangeland
Citrus Mites
Citrus, Milkweed Vine
Mos qui toe s (Larvae)
Broad Spectrum
Lepidopteran"Larvae
Forest Use
Registered 1962
Registered 1974
Registered 1977
Registered 1975
Registered 1978
EUP (Expt'l Use Permit)
EUP
EUP
EUP
Field Research
Field. Research
«
Field Research
II. CHEMICAL AGENTS
Altosid (Juvenile Hormone Analog) Diptera(Mo'squitoes~,Flies)~Re~gisteretf 1972
Gossyplufe (Pheromone) Pink Bollworm, Cotton Registered 1978
Disparloxe (Pheromone)
Multilure (Pheromone)
Gypsy Moth, Forest EUP
Pine Bark Beetle, Forest EUP
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