Biologically Based Technologies for Pest Control Page: 94

                                
94 I Biologically Based Technologies for Pest Control

the micromanagement of such features as the
thickness of plastic bags (0.1270 millimeters) for
seeds, the particular taxonomic groups listed to
be regulated, and specifications for the submis-
sion of samples to three museums. Other provi-
sions, however, suggested a much looser, more
fluid approach to APHIS's regulatory oversight
responsibilities; examples are the lack of clear
standards on purity; the lack of specific protocols
for host-specificity testing, and the absence of
any reference to pre- and postrelease monitoring
of nontarget effects.
That the proposed regulation failed to incor-
porate any provisions for postrelease monitoring,
even for higher risk releases, suggests a possible
reluctance by APHIS to confront the impacts of
its permitting activities. Over time, without any
monitoring, standards for successive applications
cannot benefit from knowledge gained about the
impact of prior releases (235). Until now PPQ
did not even maintain in a usable form the basic
records and databases on past releases. The PPQ
form 526 database was unable to locate prece-
dented permitting decisions except by the appli-
cant's name (299). The computerized NIDR
system instituted in early 1994 for environmental
assessment data was redesigned in summer 1995
to enable PPQ to locate precedented permitting
decisions by organism (360).
I Environmental Protection Agency
In the early 1980s EPA developed special data
requirements for biologically based products, but
not until fall 1994 did the agency separate out its
regulatory review of microbial pesticides and
biochemicals from that for conventional chemi-
cal pesticides.
Today the regulated community generally
gives EPA high marks for its actions on the reg-
istration of microbial pesticides and pheromones.

The new Biopesticides and Pollution Prevention
Division (BPPD) has consolidated the agency's
BBT-related activities, streamlined the data
requirements, and provided registrants with
faster, less costly, more accommodating registra-
tion services. Critics charge, however, that the
agency is waiving too many environmental data
requirements and should pay closer attention to
the effects on ecosystems and on insects and
other nontarget organisms. EPA's protocols for
host-specificity testing, moreover, focus almost
entirely on commercial species such as agricul-
tural crops and honeybees, with little regard for
native organisms. Finally, a major challenge lies
ahead for the agency as genetically engineered
microbial pesticides raise unprecedented risk
considerations that may require different regula-
tory approaches.
Statutory Responsibilities
Although EPA oversees the use of pesticides
marketed in the United States, the agency has
exempted from its jurisdiction all BBTs except
those derived from microbes used in pesticide
formulations (e.g., bacteria, algae, fungi, viruses,
and protozoans) or biochemicals (including pher-
omones). A further exemption covers phero-
mones used in traps. BBTs remaining within
EPA's jurisdiction are shown in table 4-2.
This arrangement derives from section 25(b)
of the Federal Insecticide, Fungicide and Roden-
ticide Act, which authorizes EPA to exempt pes-
ticides that are adequately regulated by other
federal agencies or are of a character not requir-
ing regulation under FIFRA6. Detailed testing
protocols to accompany the regulatory require-
ments listed in 40 CFR Part 158 have been
spelled out by EPA in its nonregulatory Pesticide
Testing Guidelines, Subdivision M (393,394).7

6 In 40 CFR Part 152, Subpart B, EPA exempts all BBTs except eucaryotic and procaryotic microorganisms (cellular organisms with and
without a distinct nucleus, respectively) and viruses.
7 Biologically based pesticides are also regulated under the food additive provisions of the Federal Food, Drug and Cosmetic Act
(FFDCA). Section 402 designates as adulterated any food or feed that contains residues of any pest control agent unless such residue is cov-
ered by a tolerance under sections 408 or 409 or an exemption from tolerance. To date, however, all microbial pesticides and most biochem-
ical pesticides registered for use on food crops have been exempted from the requirement of a tolerance (223).