New York State Department of Environmental Conservation
Division of Solid & Hazardous Materials
Bureau of Pesticides Management
Pesticide Product Registration Section
625 Broadway, Albany, New York 12233-7257
Phone 518-402-8768 FAX 518-402-9024
August 10, 2001
RETURN RECEIPT REQUESTED
Ms. Laura L. Whatley, Ph.D.
State Registration Specialist
PO Box 13528
Research Triangle Park, NC 27709-3528
Dear Dr. Whatley:
Re: Registration of a Major Change in Labeling for the Active
Ingredient Pyridaben, Contained in the Pesticide Product Pyramite
Miticide/Insecticide (EPA Reg. No. 7969-125)
The New York State Department of Environmental Conservation
(the Department) has reviewed your application, received July 25, 2000, and
additional information, received September 8, 2000, to register the
above-mentioned product in New York State. Pyramite Miticide/Insecticide
contains the active ingredient pyridaben which is currently registered in
New York State for control of mites and whiteflies on ornamental plants,
flowers and foliage (non-food) crops in greenhouses; and for use to control
mites on apples, pears and almonds. The new Pyramite Miticide/Insecticide
label adds the use of pyridaben on grapes, apricots, cherries, nectarines,
peaches, pistachio, plums, prunes and the tree nut group.
The application was deemed complete for purposes of review on
September 13, 2000 and a registration decision date was set for February 20,
2001. However, during the review of the application, an error was discovered
in the "Environmental Hazards" section of the Pyramite label. The bee
precautionary statements were inadvertently deleted by the registrant
from the Environmental Hazards section. The comment letter, which accompanied
the United States Environmental Protection Agency (USEPA) stamped "ACCEPTED
with COMMENTS" label dated June 28, 2000, listed eight revisions which were to
be made to the label. During the revision of the label, the bee precautionary
statements were inadvertently removed. BASF submitted the revised label to the
USEPA. The USEPA stamped the label "ACCEPTED" on October 17, 2000 without
noting the omission of the bee precautionary statements.
BASF Corporation waived the February 20, 2001 registration
decision date, on February 16, 2001, in order to allow time for the review
and acceptance of the corrected label by the USEPA.
The Department has reviewed the information supplied to date
in support of registration of the major change in labeling application of
Pyramite Miticide/Insecticide (EPA Reg. No. 7969-125).
The New York State Department of Health (DOH) stated that
according to the registrant, acute toxicity studies were not conducted with
the Pyramite formulated product (60% pyridaben); acute toxicity studies
conducted with SanMite (75% pyridaben) were cited. Neither pyridaben nor
SanMite was highly toxic in acute exposure studies by the oral or dermal
routes. These materials were not irritating to the skin and were not reported
to be skin sensitizers. However, SanMite caused significant eye irritation and
damage, and also was quite potent following acute inhalation exposures. Pyridaben
was not oncogenic, or teratogenic nor did it cause reproductive effects and
was negative in several genotoxicity studies. However, in a rabbit dermal
and a rat oral development toxicity study, pyridaben caused some developmental
effects (retarded fetal growth and incomplete skeletal ossification) at doses
greater than those that caused maternal effects. The USEPA established a
reference dose (RfD) of 0.005 milligrams per kilogram per day (mg/kg/day),
based in a no-observed-effect level of 0.5 mg/kg/day in a one-year dog feeding
study (decreased body weight gain) and an uncertainty factor of 100. A current
search of the toxicological literature did not find any significant new
information on the toxicity of pyridaben.
The USEPA established tolerances for pyridaben residues in or
on apples at 0.5 parts per million (ppm), wet pomace at 0.75 ppm, almond hulls
at 4.0 ppm, apricots at 0.05 ppm, cherries at 0.05 ppm, grapes at 1.5 ppm,
nectarines at 2.5 ppm, pears at 0.75 ppm, plums at 2.5 ppm, prunes at 2.5
ppm and the tree nut group at 0.05 ppm. The USEPA estimated that the chronic
dietary exposure to these residues would be up to 64 percent of the chronic
Population Adjusted Dose (equivalent to the RfD) for the most highly exposed
subgroup, non-nursing infants less than one year old. This chronic exposure
analysis is based on the assumption that 100 percent of crops are treated and
contain anticipated tolerance residue levels.
There are no chemical-specific federal or State drinking
water/groundwater standards for pyridaben. Based on its chemical structure,
pyridaben falls under the
50 microgram per liter general New York State drinking water standard
for an "unspecified organic contaminant" (10 NYCRR Part 5 - Public Water Systems).
Based on the RfD of 0.005 mg/kg/day and the DEC Water Quality Regulation
procedures for deriving surface and groundwater standards and guidance values
from non-oncogenic effects (6 NYCRR Part 702.5) an ambient water quality value
for pyridaben of 35 micrograms per liter can be calculated.
According to data from laboratory animals exposed to SanMite,
Pyramite has the potential to cause significant eye irritation and damage and
to be quite toxic following acute inhalation. However, Pyramite is contained
in water-soluble packages and its label requires applicators and other handlers
to wear personal protective equipment which includes waterproof gloves,
protective eyewear and a dust/mist filtering respirator. These factors mitigate
the exposure potential of Pyramite to workers. The registrant submitted a
worker exposure assessment for application of pyridaben to apple trees. From
this assessment, margins of exposure ranging from about 400 to 22,000 were
calculated for workers wearing personal protective equipment. Generally,
margins of exposure of 100-fold or greater are considered adequate by the
In a previous review of Pyramite and its active ingredient
pyridaben, the DOH noted that if the registrant applied for registration of
additional food crop uses in the future, exposure could increase and possibly
become an issue of concern. However, as indicated as above, the estimated
dietary exposure did not exceed the chronic Population Adjusted Dose for the
most highly exposed subgroup, non-nursing infants. In fact, current estimates
of exposure decreased from previous estimates for those crops for which
tolerances have been established due to the generation of new data that
indicate lower residue levels (some tolerances were lowered accordingly).
Based on current evaluations, registration of Pyramite Miticide/Insecticide
in New York State should not pose a significant risk to public health.
The Department's Division of Fish, Wildlife & Marine Resources'
Bureau of Habitat (BOH) completed a technical review of Pyramite for use on
apples, pears, and almonds on March 3, 1998. The reviewer concluded that
Pyramite, when used as labeled, should not adversely impact New York State
fish or wildlife resources. The current submission adds use on apricot,
cherry, nectarine, peach, plum, prune, grapes, pistachio, and the tree nut
crop group. Inclusion of the stone fruits and grapes in the allowed uses
will result in approximately forty thousand additional acres on which Pyramite
may be applied. The application rates and intervals between applications for
the new uses are identical to those for the previously registered use patterns.
As such the previous BOH assessment is applicable to the new uses as well.
Therefore, the use of Pyramite Miticide/Insecticide as labeled should not
adversely impact the fish and wildlife resources of New York State.
The Department's groundwater staff stated that pyridaben is
stable under hydrolysis at pH's 5, 7 and 9. Aqueous photolysis is a major
degradation route, with a calculated half-life of 5.3 minutes. Three major
degradates were found; an unidentified degradate reached 16% of applied
radioactivity after 30 minutes, then decreased to 2% after two hours.
Another unidentified degradate reached 28% at 40 minutes, then decreased
to <=10% after two hours. The degradate B-3 reached approximately 20% of
the applied radioactivity at 30 minutes, and increased to 27% after six
hours. Because this is a foliar application that works by contact, aqueous
photolysis is not expected to be a major component of degradation. B-3 was
not looked for in the field dissipation studies, probably because aqueous
photolysis was not a major degradate mechanism in the field studies. Soil
photolysis had a calculated half-life of 11 days with no major degradates.
The aerobic metabolism half-life was 86 days in sandy loam, and
the anaerobic metabolism was almost non-existent. The study started out under
aerobic conditions, and gradually reached anaerobic conditions in a nitrogen
atmosphere. There were many minor degradates as the study started, and
degradation ceased as the study reached anaerobic conditions. The
adsorption-desorption study indicated that the parent material has a
Koc of 34,900 in sand, sandy loam, two silt loams and a clay loam soil.
During the aged leaching study, the parent was found to be slightly mobile,
but the degradate P-14 (found at 7%) was shown to leach (9-14 is a degradate
of the degradate P-1). A separate adsorption-desorption study was made
available for this degradate, indicating that the Koc for sand is 54.9 and
for sandy loam is 14.8. The terrestrial field dissipation studies generally
confirmed the laboratory data, with first-order half-lives ranging from eight
to 14 days. Only trace levels of PB-14 were found in the 0-6" soil column
(<=2, 85% of applied). Even though PB-14 was found to be very mobile, the
concentrations found were low enough that the USEPA did not believe the
degradate would have an impact on groundwater.
Modeling was conducted using sandy Riverhead soil type and
an 86-day half-life, and the Koc's listed above. The parent pyridaben was
not projected to leach at all. For P-14 a value of 31.7 ppb was projected
which approaches the drinking water standard set for pyridaben of 35 ppb.
The model was run using two applications at the maximum application rate
(0.05 lb. active ingredient/acre) 90 days apart, and assumes that the entire
application is applied to bare ground. Given foliar interception, the impact
to groundwater from the degradate P-14 would be negligible. However, grapes
are considered a major crop in our State and are grown extensively on Long
Island. The ground between grape arbors is usually bare and it is possible
for product to reach the bare ground during application.
Long Island has a vulnerable sole-source drinking-water
aquifer and the Department has concerns regarding the potential for groundwater
contamination as a result of the addition of grapes to the Pyramite
Miticide/Insecticide label. The label contains the following statement:
"Pyramite is not for sale, distribution, or use in Nassau and Suffolk counties
in New York State. In the remainder of the state, read and follow all applicable
directions, restrictions and precautions on this label."
Since this product is not for use in Nassau and Suffolk Counties,
this product when used as labeled, is not expected to impact the groundwater in
New York State.
Therefore, the Department hereby accepts for general use
registration in New York State the major change in labeling for Pyramite
Miticide/Insecticide (EPA Reg. No. 7969-125).
Enclosed are your New York State stamped "ACCEPTED"
label and a copy of the Certificate of Registration.
If you have any questions, please contact Ms. Jeanine Broughel,
of my staff, at
Maureen P. Serafini
Bureau of Pesticides Management
cc: w/enc. - N. Kim/D. Luttinger - NYS Dept. of Health
R. Zimmerman/ R. Mungari - NYS Dept. of Ag. & Markets
G. Good/W. Smith - Cornell University, PMEP