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Flufenacet (Bayer). April 2, 1997. Pesticide Tolerance Petition. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/April/Day-02/p8397.htm
[Federal Register: April 2, 1997 (Volume 62, Number 63)]
[Notices]
[Page 15690-15698]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap97_dat-75]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-723; FRL-5593-9]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various agricultural commodities.
DATES: Comments, identified by the docket control number PF-723, must
be received on or before May 2, 1997.
ADDRESSES: By mail submit written comments to: Public Response and
Program Resources Branch, Field Operations Divison (7505C), Office of
Pesticides Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential
business information should be submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: The product manager listed in the
table below:
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Office location/
Product Manager telephone number Address
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Connie Welch (PM 21).......... Rm. 227, CM #2, 703- 1921 Jefferson
305-6226, e- Davis Hwy,
mail:welch.connie@epa Arlington, VA
mail.epa.gov.
Cynthia Giles-Parker (PM 22).. Rm. 229, CM #2, 703- Do.
305-5540, e-mail:
giles-
parker.cynthia@epamai
l.epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various raw
agricultural commodities under section 408 of the Federal Food, Drug,
and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these
petitions contain data or information regarding the elements set forth
in section 408(d)(2); however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports grantinig of the petition. Additional data may be needed
before EPA rules on the petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number PF-723 (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official
[[Page 15691]]
record is located at the address in ``ADDRESSES'' at the beginning of
this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (insert docket number) and appropriate
petition number. Electronic comments on this proposed rule may be filed
online at many Federal Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 24, 1997.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Below summaries of the pesticide petitions are printed. The
summaries of the petitions were prepared by the petitioners. The
petition summary announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
1. Bayer's Corporation
PP 6F4631
EPA has received a pesticide petition (PP 6F4631) from Bayer
Corporation, 8400 Hawthorne Road, Kansas City, MO 64120-0013, proposing
pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. 346a(d), to amend 40 CFR Part 180 by establishing tolerances
for residues of the herbicide, FOE 5043, N-(4-Fluorophenyl)-N-(1-
methylethyl)-2[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide
in or on the raw agricultural commodities, field corn grain at 0.05
parts per million (ppm), field corn forage at 0.4 ppm, field corn
stover (fodder) at 0.4 ppm, soybean seed at 0.1 ppm, milk at 0.01 ppm,
meat at 0.05 ppm, and meat byproducts at 0.05 ppm. The proposed
analytical method is gas chromatography/mass spectrometry with selected
ion monitoring. (PM 22)
1. Chemical uses. FOE 5043 use on field corn and soybeans provides
selective weed control for a wide spectrum of annual grasses and small-
seeded broadleaf weeds, with exceptional strength on barnyard grass,
large crabgrass, fall panicum and foxtail species. Application
technique: Products containing FOE 5043 can be applied preplant
surface, preplant incorporated, or preemergence for control of emerging
weeds. Applications can be made up to 45 days before planting.
Applications may be made using standard low pressure ground herbicide
boom sprayers equipped with suitable nozzles and screens. The products
containing FOE 5043 may be applied either as a single or a split
application. Application rates range from 0.442 to 0.884 pounds active
ingredient (a.i.) of FOE 5043 per acre depending on the soil texture
and soil organic matter content. Tank mix combinations with selected
products may provide additional weed control.
2. FOE 5043 Safety. Bayer has submitted over 65 separate toxicology
studies in support of tolerances for FOE 5043. Among the submissions, a
finding of particular interest was the observation that in the long-
term data compiled for FOE 5043, provided no indications of a potential
to induce either carcinogenic or reproductive signs of toxicity. In
addition, developmental no-observed-adverse effects levels (NOAELs) of
25 milligrams body weight per day (mg/kg bwt/day) were established for
both the rat and rabbit.
The following mammalian toxicity studies have been conducted to
support the tolerance of AXIOM DF (contains FOE 5043 and metribuzin):
i. A rat acute oral study with an LD50 of 2,347 mg/kg (male)
and 2,027 mg/kg (female).
ii. A rabbit acute dermal with an LD50 of > 2,000 mg/kg.
iii. A rat acute inhalation with an LD50 of > 977 mg/m3.
iv. A primary eye irritation study in the rabbit which showed mild
irritation.
v. A primary dermal irritation study which showed no irritation.
vi. A primary dermal sensitization study which showed no
sensitization.
The following mammalian toxicity studies, derived from exposure to
the technical form of the chemical, have been conducted to support the
tolerance of FOE 5043:
i. A rat acute oral study with an LD50 of 1,617 mg/kg (male)
and 589 mg/kg (female).
ii. A rat acute dermal LD50 of 2,000 mg/kg bwt.
iii. A rat acute inhalation LC50 of 3,740 mg/m3 (male and
female).
iv. A primary eye irritation study in the rabbit which showed no
irritation.
v. A primary dermal irritation study which showed no irritation.
vi. A primary dermal sensitization study which showed no
sensitization.
vii. An acute neurotoxicity study with a no-observed effect level
(NOEL) for FOB, motor and locomotor activity of 75 mg/kg bwt/day for
males and females.
viii. A 90-day feeding study in the rat with a NOEL of 1.7 mg/kg
bwt/day.
ix. A 90-day subchronic neurotoxicity study in the rat with a
neurotoxicity and overall NOEL of 120 ppm.
x. A 24-months chronic feeding/oncogenicity study in the rat with
an overall NOEL of 1.2 mg/kg bwt/day in males and females based on
liver, kidney, hematologic and thyroid effects. There was no evidence
of an oncogenic response.
xi. A 90-day feeding study in dogs with a NOEL of 50 ppm, based on
liver hematology, and thyroid effects.
xii. A 12-month feeding study in dogs with a NOEL of 40 ppm, based
on hematology and thyroid effects.
xiii. A mouse oncogenicity study which provided no evidence of
oncogenicity.
xiv. An oral teratology study in the rat with maternal and
developmental NOAELs of 25 mg/kg bwt/day.
xv. An oral teratology study in the rabbit with maternal and fetal
NOELs of 5 and 25 mg/kg bwt/day respectively.
xvi. An two-generation reproduction study in the rat with a NOEL
for reproductive and parental toxicity of 500 and 20 ppm, respectively.
xvii. Ames assay: Negative
xviii. Unscheduled DNA synthesis: Negative
xix. Mouse Micronucleus Assay: Negative.
3. Threshold effects-- chronic effects. Based on the available
chronic toxicity data, Bayer believes the Reference Dose (RfD) for FOE
5043 should be 0.0114 mg/kg/day. The RfD for FOE 5043 is based on a 1
year chronic toxicity study in the dog with a threshold No Observed
Effect Level (NOEL) of 1.14 mg/kg/day and an uncertainty factor of 100.
Acute toxicity. EPA recently proposed a tiered approach to estimate
acute dietary exposure. The methods proposed by the EPA were reviewed
and supported by the FIFRA Scientific Advisory Panel (SAP, 1995). EPA's
Tier 1 method is based on the assumption that residue concentrations do
not vary. The analysis assumes that all residues have the same
magnitude, typically the highest field trial residue or tolerance
value. This value is assumed for all
[[Page 15692]]
points along the consumption distribution, resulting in a distribution
of dietary exposure.
For the acute analysis for FOE 5043, a Tier 1 analysis was
conducted for the overall U.S. population, infants, children 1 to 6
years of age, females 13 years and older, and males 13 years and older.
Using the NOEL of 138 mg/kg derived from the acute oral toxicity study
in rats, the following margins of exposure were calculated (margins of
exposure of 100 or more are considered satisfactory):
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Population Group Margin of Exposure
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U.S. Population-All Seasons............... 94,741
Infants................................... 64,986
Children 1 to 6........................... 76,494
Women 13 to 50 years old.................. 191,418
Men 13 years and older.................... 109,805
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4. Non-threshold Effects-- carcinogenicity. Using the Guidelines
for Carcinogen Risk Assessment, Bayer believes FOE 5043 to be in Group
E for carcinogenicity--no evidence of carcinogenicity--based on the
results of carcinogenicity studies in three species. There was no
evidence of carcinogenicity in an 18-month feeding study in mice, a 2-
year feeding study in rats, or a 1-year feeding study in dogs at the
dose levels tested. The doses tested are adequate for identifying a
cancer risk. Thus, a cancer risk assessment should not be necessary for
FOE 5043.
5. Aggregate Exposure. For purposes of assessing the potential
dietary exposure under the proposed tolerances for FOE 5043, the
estimated aggregate exposure was based on the Theoretical Maximum
Residue Concentrations (TMRC) and the proposed tolerances (The TMRC is
a worst case estimate of dietary exposure since it is assumed that 100
% of all crops for which tolerances are established are treated and
that pesticide residues are present at the tolerance levels.).
Registration for FOE 5043 and AXIOM are currently being sought on field
corn and soybeans. FOE 5043 and AXIOM are not registered for any uses.
Tolerances are proposed (pesticide petition number 6F 4631) for FOE
5043 on the following Raw Agricultural Commodities (RAC); field corn
grain (0.05 ppm), forage (0.4 ppm) and stover (fodder) (0.4 ppm),
soybean seed (0.1 ppm), milk (0.01 ppm), meat (0.05 ppm), and meat
byproducts (0.05 ppm). The TMRC is obtained by multiplying the
tolerance level for these commodities by consumption data which
estimates the amounts of corn and soybean products eaten by various
human population subgroups. Tolerances are proposed for milk, meat and
meat byproducts because residues for FOE 5043 can be transferred from
corn and soybean based feeds through livestock to humans.
This dietary exposure estimate assumes that 100% of these crops are
treated with FOE 5043 and that the residues of FOE 5043 found in these
crops would occur at the proposed tolerance levels. These assumptions
result in an overestimate of exposure. In making a safety determination
for these tolerances this conservative exposure estimate has been taken
into account.
Other potential sources of exposure of the general population to
residues of FOE 5043 are residues in drinking water and exposure from
non-occupational sources. In ongoing ground water monitoring studies,
trace levels of FOE 5043 residues (less that 1 part per billion (ppb)
total residues) have been detected in ground water. These studies are
being performed at sites with vulnerable shallow aquifers and large
amounts of irrigation are being applied monthly. The highest residue
level detected is well below the anticipated life-time Health Advisory
Level of 84 ppb. If residues of FOE 5043 do occur in ground water used
for drinking water they will be far below the level which causes
concern. Based on the available data, no significant residues of FOE
5043 are anticipated to occur in surface water used for drinking water.
Since registration is not being sought for any residential or homeowner
uses no other potential for exposure to FOE 5043 residues exists.
The toxicological profile for FOE 5043 is fundamentally
characterized by structural- and functional-related alterations in
thyroid, hematologic and hepatic parameters. These sort of changes are
not uncommon among herbicides. Since residues of FOE 5043 and its
degradates will occur in raw agricultural commodities and processed
foods in the high parts per billion or low parts per million range
there is no compelling evidence that suggests a cumulative effect
(i.e., potentiated, additive, or synergistic response) might occur or
be anticipated in the human following exposure to multiple chemical
agents with similar toxicological profiles and/or mechanisms of
toxicity.
6. Determination of safety for U.S. population--Reference dose
(RfD). Using the conservative exposure assumptions described above,
based on the completeness and reliability of the toxicity data, the
aggregate exposure to FOE 5043 will utilize 2.1% of the RfD for the
U.S. population. EPA generally has no concern for exposures below 100 %
of the RfD. Therefore, based on the completeness and reliability of the
toxicity data and the conservative exposure assessment, Bayer concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to residues of FOE 5043, including all anticipated
dietary exposure and all other non-occupational exposures.
7. Determination of Safety for Infants and Children. The
possibility of FOE 5043 induced developmental toxicity was suggested in
preliminary and non-definitive toxicity studies using rats (> 175 mg/kg
bwt/day) and rabbits (> 125 mg/kg bwt/day). However NOAELs for
developmental effects were ultimately established in the definitive
studies. Those values, as mentioned previously, were 25 mg/kg bwt/day
in the rat and 25 mg/kg bwt/day in the rabbit.
Reference Dose (RfD). Using the conservative exposure assumptions
described previously, Bayer has concluded that the percent of the RfD
utilized by aggregate exposure to residues of FOE 5043 ranges from 1.1
% for non-nursing infants, up to 5.2 % for children 1 to 6 years old.
EPA generally has no concern for exposure below 100 % of the Reference
Dose. Therefore, based on the completeness and reliability of the
toxicity data and the conservative exposure assessment, Bayer concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the residues of FOE
5043, including all anticipated dietary exposure and all other non-
occupational exposures.
8. Estrogenic Effects. No specific tests have been conducted with
FOE 5043 to determine whether the pesticide may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects.
9. Chemical Residue. The qualitative nature of the residues in
plants and animals is adequately understood for the purposes of
registration. Residues of FOE 5043 do concentrate slightly (1.6x) in
the processed commodity of corn grits. No tolerance has been proposed
for residue of FOE 5043 in corn grits because anticipated residues are
less than two times the limit of quantitation for the analytical
method. There are no Codex maximum residue levels established for
residues of FOE 5043 on any crop. Bayer has submitted a practical
analytical method for detecting and measuring levels of FOE 5043 in or
on food with a limit of detection that allows monitoring of food with
residues at or above the proposed tolerance levels. EPA will provide
information on
[[Page 15693]]
this method to FDA. The method is available to anyone who is interested
in pesticide residue enforcement from the EPA's Field Operations
Division, Office of Pesticide Programs.
Fifty-five separate residue trials have been conducted with FOE
5043 on corn and soybeans. Analysis of these trials shows that the
maximum total combined residue for FOE 5043 and its major metabolites
in any commodity will be at/below 9.75 ppm. Residues occurred at this
level in soybean dry hay. However, no tolerances have been proposed for
residues of FOE 5043 on soybean hay because the proposed labels for
products containing FOE 5043 do not allow livestock to be fed with FOE
5043 treated soybean hay.
Tolerances have been requested for residues of FOE 5043 and its
major metabolites on field corn grain (0.05 ppm), forage (0.4 ppm) and
stover (fodder) (0.4 ppm) and soybean seed (0.1 ppm), milk (0.01 ppm),
meat (0.05 ppm), and meat byproducts (0.05 ppm).
The proposed tolerance levels are adequate to cover residues likely
to be present from the proposed use of FOE 5043. Therefore, no special
processing to reduce the residues will be necessary.
There is no need for tolerances in poultry or eggs since there is
no reasonable expectation of residues in these materials based on the
results of poultry metabolism studies, as well as the corn and soybean
metabolism and rotational crop studies. Calculated transfer factors are
extremely low and maximum expected residues in poultry and eggs would
be in the low parts per billion or high parts per trillion range. The
anticipated residues in poultry tissues and eggs resulting from feeding
poultry FOE 5043 treated corn and or soybeans would be far below the
limit of quantitation of the analytical residue method.
No FOE 5043 food additive tolerances are proposed for field corn
starch (wet milling), field corn refined oil (wet milling), field corn
flour (dry milling) and field corn refined oil (dry milling) because no
residues were detected above the limit of quantitation in this
processed commodity.
Additionally, no FOE 5043 food additive tolerances are proposed in
field corn grits (dry milling) field corn meal (dry milling), soybean
meal, soybean hulls, and soybean refined oil because the measured
concentration, when adjusted for the exaggerated application rate, was
less that two times the limit of quantitation.
No feed additive tolerances are proposed for FOE 5043 in the
aspirated grain fractions of corn and soybeans. With pre-plant and or
pre-emergent modes of application for AXIOM DF and FOE 5043 DF, no
residues were expected on the seed surface in the corn and soybean
magnitude of residue studies. Therefore, no aspirated grain fractions
were collected for analysis. A tolerance has not been proposed for
soybean forage because feeding soybean hay and forage (silage) to
livestock animals is not permitted by the proposed label.
Also, no feed additive tolerances are proposed for soybean meal or
hulls since the measured concentration in the soybean processing study
for these feeds, when adjusted for the exaggerated application rate,
was less that two times the limit of quantitation.
No tolerances are proposed for corn milled by-products. Table II
(September 1995) advises use residue data for corn dry-milled processed
commodities having the highest residues, excluding oils. No residues
were detected in the dry-milled processed commodities above the limit
of quantitation.
10. Environmental Fate. Laboratory studies indicate that FOE 5043
residue has the potential to be moderately mobile in soil. However the
results of field dissipation studies performed in Wisconsin and North
Carolina, both corn and/or soybean producing states, indicate that
downward movement of FOE 5043 residue is limited, with no quantifiable
residues being found below 18 inches. These studies were conducted
under conditions conducive to downward movement of FOE 5043 and
degradates (very high sand content, low organic matter, and large
volumes of applied irrigation).
FOE 5043 has been found to be stable to chemical hydrolysis in the
pH range of environmental concern. The compound is also stable in water
and soil when exposed to artificial sunlight.
Microbial degradation is the principal means of dissipation in
soil. Half-lives for aerobic microbial degradation range from 10 to 34
days in varying soil types at the anticipated field application rate.
Degradation of FOE 5043 in soil under aerobic conditions occurs by
cleavage of the thiadiazole ring to form 3-trifluoromethyl-1,3,4-
thiadiazol-2(3H)one (FOE thiadone) and the corresponding alcohol, N-(4-
flurophenyl)-2-hydroxy-N-(1-methylethyl)acetamide. The FOE thiadone is
further metabolized to CO2, and the alcohol is subsequently oxidized to
[4-flurophenyl)(1-methylethyl)amino]oxoacetic acid. Another major
degradation product of FOE 5043 is 4-fluoro-N-methylethylaniline-
sulfoacetamide which is proposed to form through the oxidation of a
cysteine conjugate intermediate. (PM 22)
[FR Doc. 97-8397 Filed 4-1-97; 8:45 am]
BILLING CODE 6560-50-F