**Summary of OMB Briefing Notes/Questions**

**November 14, 2004**

# 40 CFR Part 158 Data Requirements: Biochemical and Microbial Pesticides

## The following people/Agency and issues were identified as requiring follow-up: 

## 

## 1. Burleson Smith/USDA - How many Bt pesticides have been registered prior to 1984? In other words, what portion of the early microbials were Bt's? The Agency estimated that about half of those registered were Bt pesticides but promised to get back to him with details. Burleson also asked how toxins isolated from microbial pesticides would be evaluated, i.e. as microbial pesticides or conventional chemical pesticides. The Agency responded that isolated toxins often had to be evaluated as conventional pesticides because the testing protocols for microbial pesticides would not be relevant for purified toxins.

In checking the actual microbials registered up to 1984, we find the
following list. Of ten registrations, three are Bt's. However, under the
policies existing at that time, additional isolates/registrations of Bt
have been registered under these groups. In fact, at the time of the
1961 registration, microbial taxonomy did not recognize subspecies of Bt
-- the designation "kurstaki" was added later. In addition, "subsp
Berliner" is no longer an acceptable name for Bt subspecies. In
actuality, pre 1984 registrations included several different isolates
under the three named in the list. It is a bit difficult at this point
in time to positively identify exactly how many different isolates of Bt
were registered by 1984 under these three names, but the best guess
would be around 8 which would have a ratio of about 8 to a total of 14
different registered microbial isolates -- a little more than half.
Fortunately, the Bt reregistration process will give separate
registration identification to each different Bt registered active
ingredient and our computer database will be revised to reflect each
registration on a one to one basis.

**Bts**

**1948 B. popilliae & B. lentimorbus (mixed)**

**1961 B. thuringiensis subsp kurstaki\***

**1981 B. thuringiensis subsp israelensis\***

**1984 B. thuringiensis subsp Berliner\***

**Others**

**1975 Heliothis NPV baculovirus**

**1976 Douglas fir tussock moth NPV**

**1978 Gypsy moth NPV**

**1979 Agrobacterium radiobacter K84**

**1980 Nosema locustae**

**1982 Colletotrichum gloeosporioides f.sp. aeschynomene**

**1983 Phytophthora palmivora MWV**

With respect to isolated toxins from microbials, our concern is a
broader issue than just for Bt pesticides. Actually, for Bt, the
products are almost an isolated toxin, since the insecticidal
delta-endotoxin is produced in a crystal at the time the bacterium turns
into a spore so you get a relative large amount of toxin along with each
spore in the final product. However, purified microbial toxins are
usually treated as a conventional pesticide because the protocols for
testing living microorganisms address endpoints like pathogenicity and
infectivity and assess the persistence of the living microbial in the
test system. Thus these tests are not appropriate to assess the chemical
toxin itself. A representative toxin from a microorganism would be an
antibiotic such as Streptomycin, used to control the bacteria and fungi
causing plant diseases.

**2. Burleson Smith/USDA** - Is phytotoxicity/pathogenicity data being
required as part of Tier IV?

In general, phytotoxicity effects **testing is** available, if needed,
at the Tier I (885.4300), II (885.5200, to determine exposure) and Tier
IV (850.2500 -- field test) levels for microbials**.**

**3. Burleson Smith/USDA** - How many PR notices have been issued since
1984 concerning biochemical and microbial pesticides?

The following PR notices have been issued which address biochemical and
microbial pesticides:

Pesticide Registration (PR) Notice 97-1, Agency Actions under the
Requirements of the Food Quality Protection Act., January 31, 1997. This
is available at the following website:
<http://www.epa.gov/opppmsd1/PR_Notices/pr97-1.html>

Pesticide Registration (PR) Notice 97-3, Guidelines for Expedited Review
of Conventional Pesticides under the Reduced-Risk Initiative and for
Biological Pesticides. September 4, 1997:
<http://www.epa.gov/opppmsd1/PR_Notices/pr97-3.html>

In addition, a large number of PR Notices addressing pesticides
generically (i.e. without regard to pesticide type) has been issued
since 1984. Few PR Notices are specific to type of pesticide.

## 4. Burleson Smith/USDA - Non target insect testing -- 885.4340 -- how many species does this cover- we have a test cost of \$10,500, does that address one species or multiples species? Are we testing for insects close to the target or further away? 

The 885.4340 guideline identifies three possible species to be tested.
If the Agency does require this study then all three species are
required to be tested, thus performing this test on three species would
increase the average cost of the study by a multiple of three,
approximately.

The Agency has confirmed that the average cost of \$10,500 is applicable
to only one species, therefore, assuming a multiple of three, the range
of test costs would be \$21,000 (low) to \$42,000 (high), with an
average of \$31,500. The economic analysis will be revised to reflect
this change.

While required at a higher frequency for microbials than biochemicals,
the non-target insect study is estimated as a negative incremental cost
in the economic analysis. Taking into consideration the anticipated
burden reduction and negative incremental cost, this increase in
estimated average cost would not alter the overall economic impact.
Non-target testing is often waived based on available scientific
literature.

***Specific Issues:***

1.  **Al Jennings/ USDA -** We appreciate consultations with APHIS. Do
    we need something more formal to avoid problems?

The Agency continues to collaborate with USDA for Biochemical and
Microbial Pesticide Registration activities. The Plant Protection
Quarantine Division (PPQ)/USDA follows the Agency's FR announcements of
microbial pesticide applications and when it is a potential plant
pathogen, the Agency notifies USDA. Conversely, Bob Flanders/USDA,
responsible for their science review group, contacts EPA if there are
any pesticide issues they believe would be of interest to EPA. The
Agency notifies USDA on issues of mutual interests. We have also
coordinated with the Biotechnology Group on genetically engineered
microbial pesticides. We will continue to formalize the process as
opportunities arise. We plan to ask for specific comment on this issue
in the proposed rule as a result of this question.

2.  **Al Jennings/ USDA** - Stakeholder consultation.

We should ask USDA as one of the stakeholders because they are involved
in biopesticide development. USDA wants to be involved before the final
rule. Dr. Jennings was disappointed that they were not consulted when
industry and academia were consulted. We agreed that next time we could
make sure they were at the table earlier in the process.