[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Rules and Regulations]
[Pages 27186-27192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12247]
[[Page 27186]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300853; FRL-6078-4]
RIN 2070-AB78
Sulfosulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
sulfosulfuron: 1-(4,6-dimethoxypyrimidin-2yl)-3-[(2-ethanesulfonyl-
imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea and its metabolites converted
to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine and calculated as
sulfosulfuron in or on wheat grain at 0.02 parts per million (ppm),
wheat straw at 0.1 ppm, wheat hay at 0.3 ppm, wheat forage at 4.0 ppm,
milk at 0.006 ppm, fat and meat of cattle, goat, swine, horse, and
sheep at 0.005 ppm, and meat by-products of cattle, goat, swine, horse,
and sheep at 0.05 ppm. Monsanto Company requested this tolerance under
the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: This regulation is effective May 19, 1999. Objections and
requests for hearings must be received by EPA on or before July 19,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300853], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300853], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epa.gov. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300853]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 237, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-5697,
Tompkins.jim@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 23, 1998
(63 FR 71126) (FRL-6047-7), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP) 7F4840 for
tolerance by Monsanto Company. This notice included a summary of the
petition prepared by the Monsanto Company, the registrant. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide sulfosulfuron in
or on wheat grain at 0.02 part per million (ppm), wheat straw at 0.1
ppm, wheat hay at 0.3 ppm, wheat forage at 4.0 ppm, milk at 0.006 ppm,
fat and meat of cattle, goat, swine, horse, and sheep at 0.005 ppm, and
meat by-products of cattle, goat, swine, horse, and sheep at 0.05 ppm.
I. Background and Statutory Findings
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
Sulfosulfuron and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for residues of 1-
(4,6-dimethoxypyrimidin-2yl)-3-[(2-ethanesulfonyl-imidazo[1,2-
a]pyridine-3-yl)sulfonyl]urea and its metabolites converted to 2-
(ethylsulfonyl)-imidazo[1,2-a]pyridine and calculated as sulfosulfuron
on wheat grain at 0.02 parts per million (ppm), wheat straw at 0.1 ppm,
wheat hay at 0.3 ppm, wheat forage at 4.0 ppm, milk at 0.006 ppm, fat
and meat of cattle, goat, swine, horse, and sheep at 0.005 ppm, and
meat by-products of cattle, goat, swine, horse, and sheep at 0.05 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by sulfosulfuron are
discussed in this unit.
1. Several acute toxicity studies place technical sulfosulfuron in
Toxicity Categories III or IV. Technical sulfosulfuron is not a dermal
sensitizer.
[[Page 27187]]
2. In a rat subchronic oral toxicity study, sulfosulfuron was
administered in the diet for 13 weeks at a dose levels of 0, 20, 200,
2,000, 6,000, or 20,000 ppm (equivalent to average daily intake of 0,
1.2, 12.1, 123.2, 370.3 or 1,277.5 miligrams/kilograms/day (mg/kg/day)
for males and 0, 1.5, 14.6, 144.3, 447.5 or 1,489.1 mg/kg/day for
females). The systemic toxicity lowest observed adverse effect level
(LOAEL) is 20,000 ppm (1,277.5 mg/kg/day), based on decreased body
weight/weight gain in males, possible decreased weight gain in pregnant
females during gestation days 14-21, and possible renal lesions related
to formulation of calculi. The no observed adverse effect level (NOAEL)
is 6,000 ppm (370.3 mg/kg/day).
3. In a dog subchronic oral toxicity study, sulfosulfuron was
administered by gelatin capsule at dose levels of 0, 30, 100, 300, or
1,000 mg/kg/day for 90 days. The systemic toxicity LOAEL is 300 mg/kg/
day, based on lesions in the urinary bladder in females occurring
subsequent to urinary crystal formation and on abnormal urinary
crystals in males and females. The NOAEL for systemic toxicity is 100
mg/kg/day.
4. In a 28-day rat dermal study, sulfosulfuron was applied dermally
at dose levels of 0,100, 300 or 1,000 mg/kg/day for 5 days/week for 4
weeks. The NOAEL is 1,000 mg/kg/day the highest dose tested
for males and females.
5. In a 1-year dog chronic feeding study, sulfosulfuron was
administered by gelatin capsule at dose levels of 0, 5, 20, 100 or 500
mg/kg/day, 5 days/week, for 1 year. The LOAEL is 500 mg/kg/day based on
the presence of abnormal urinary crystals and bladder pathology
secondary to formation of urinary tract calculi in males. The NOAEL is
100 mg/kg/day.
6. In a rat chronic feeding/ carcinogenicity study, sulfosulfuron
was administered in the diet at dose levels of 0, 50, 500, 5,000 and
20,000 ppm (females only) for 22 months. Surviving males at 20,000 ppm
were sacrificed on day 259 due to excessive mortality. The average
daily intake of test material was 0, 2.4, 24.4 or 244.2 mg/kg/day(males
up to 5,000 ppm); 1,178.3 mg/kg/day, males at 20,000 ppm until day 259)
and 3.1, 30.4, 314.1 or 1,296.5 mg/kg/day for females. The LOAEL is
5,000 ppm (244.2 mg/kg/day), based on increased incidence of urinary
tract gross/microscopic lesions, mineralization in several tissues
(males), abnormal urine crystals and possibly decreased albumin (males,
termination). The NOAEL is 500 ppm (24.4 mg/kg/day) Transitional cell
papilloma and carcinoma of the urinary bladder occurred at 1,296.5 mg/
kg/day (5,000 ppm) in females. These tumors were determined to be
treatment related.
7. In a mouse carcinogenicity study, sulfosulfuron was administered
in the diet at dose levels of 0, 30, 700, 3,000, or 7,000 ppm (0, 4.0,
93.4, 393.6 or 943.5 mg/kg/day to males or 0, 6.5 153.0 634.9 or
1,388.2 mg/kg/day to females) for 18 months. The LOAEL is 3,000 ppm
(393.6 mg/kg/day), based on gross and microscopic effects related to
urinary calculus formation in the urinary bladder of males. The NOAEL
is 700 ppm (93.4 mg/kg/day) Benign mesenchymal tumors of the urinary
bladder occurred in males at 943.5 mg/kg/day (7,000 ppm). These tumors
also occurred in one male at 393.6 mg/kg/day (3,000 ppm), one control
female and one female at 1,388.2 mg/kg/day (7,000 ppm). Incidences of
renal tubular adenoma were observed in one male and one female at 943.5
and 1,388.2 mg/kg/day or 7,000 ppm. The mesenchymal tumors and adenoma
in females were determined to be treatment related.
8. In a 2-generation rat reproduction study, sulfosulfuron was
administered in the diet at dose levels of 0, 50, 500, 5,000 or 20,000
ppm during premating (equivalent to average daily intake for P adults
of 0, 3.1, 31.6, 312.1 or 1,312.8 mg/kg/day, males and 0, 3.6, 36.2.
363.2 or 1,454.1 mg/kg/day, females; for F1a adults, 0, 3.1, 31.1,
315.8, 1,378.8 mg/kg/day, males and 0, 3.7, 37.7, 377.8 or 1,598.0 mg/
kg/day, females). The reproductive toxicity NOAEL is 20,000
ppm (1,312.8 mg/kg/day) and the LOAEL is > 20,000 ppm. The parental
systemic toxicity LOAEL is 20,000 ppm based on decreased parental body
weight and/or weight gain during premating, gestation and lactation,
mortality (males) and increased incidence of urinary tract pathology
related calculus formation. The parental systemic NOAEL is 5,000 ppm
(312.1 mg/kg/day). The offspring toxicity LOAEL is 20,000 ppm (1,312.8
mg/kg/day) based on decreased body weight gain in postweaning
adolescent rats, and the offspring NOAEL is 5,000 ppm (312.1 mg/kg/
day).
9. In a rat developmental study, sulfosulfuron was administered by
gavage at dose levels of 0, 100, 300, and 1000 mg/kg/day to females
from day 6 through 15 of gestation. The NOAELs for maternal and
developmental toxicity were greater than 1,000 mg/kg/day, the highest
dose tested.
10. In a rabbit developmental study, sulfosulfuron was administered
by gavage at dose levels of 0, 50, 250, or 1,000 mg/kg/day from day 7
through 19 of gestation. The NOAEL for maternal toxicity is greater
than 1,000 mg/kg/day the highest dose tested. No LOAEL for
developmental toxicity was observed in this study.
11. In an acute rat oral neurotoxicity screening study,
sulfosulfuron was administered by gavage at dose levels of 0, 125, 500,
or 2,000 mg/kg/day. No treatment-related effects on clinical signs,
body weight, food consumption, functional observational battery
parameters, motor activity, gross pathology or neuropathology were
observed. The NOAEL is 2,000 mg/kg/day. The LOAEL > 2,000
mg/kg/day.
12. In a rat subchronic neurotoxicity study, sulfosulfuron was
administered in the diet at dose levels of 0, 200, 2,000, 20,000 ppm
(corresponding to average daily doses of 0, 12, 122, or 1,211 mg/kg/day
in males and 0, 14, 141, or 1,467 mg/kg/day in females). The NOAEL is
20,000 ppm (1,211 mg/kg/day), based on marginal reductions in body
weight/weight gain of males. The LOAEL is > 20,000 ppm (> 1,211 mg/kg/
day).
13. Mutagenicity data included a gene mutation bacterial reverse
gene mutation with Salmonella (negative for inducing reverse gene
mutation); an in vitro mammalian forward gene mutation with Chinese
hamster ovary cells ( negative for inducing forward gene mutations at
the HGPRT locus in Chinese hamster ovary (CHO) with and without S9
activation); in vitro chromosome aberration study on human
lymphocytes (did not induce structural chromosome damage); and an in
vivo structural chromosome aberration micronucleus test (negative).
14. Based on the results of the rat metabolism study, more than 90%
of the administered radioactivity was excreted by 72-hours post-dosing.
Between 77% to 87% was excreted in the urine in all low dose groups.
Feces was the major route of elimination at the high dose. In all dose
groups minimal radioactivity was retained in the tissue. Metabolism of
sulfosulfuron in all groups was minimal and most was excreted
unmetabolized.
B. Toxicological Endpoints
1. Acute toxicity. A dose and endpoint were not selected for the
acute dietary risk assessment because there were no effects
attributable to a single dose (exposure) observed in oral toxicity
studies including developmental toxicity studies in the rat and rabbit
(up to 1,000 mg/kg/day) and an acute neurotoxicity study in rat (up to
2,000 mg/kg). The acute oral, dermal and inhalation toxicity of
sulfosulfuron is very low.
2. Short- and intermediate-term toxicity. No short- or
intermediate-term dermal or inhalation endpoints were
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identified. No dermal or systemic toxicity was seen following dermal
applications in the 28-day dermal toxicity study with rats up to 1,000
mg/kg/day.
Based on the low acute inhalation toxicity (Toxicity Category IV,
no mortality at 3.0 mg/liter (l), the formulation of the product as
wettable granules and the low application rates from the proposed use
patterns, there is minimal concern for potential inhalation exposure
and risk.
3. Chronic toxicity. EPA has established the RfD for sulfosulfuron
at 0.24 mg/kg/day. This Reference Dose (RfD) is based on the rat
chronic toxicity/carcinogenicity study NOAEL of 24.0 mg/kg/day and an
uncertainty factor of 100.
4. Carcinogenicity. In accordance with the Agency's Proposed
Guidelines for Carcinogenic Risk Assessment (April 10, 1996), the HED
Cancer Assessment Review Committee (CARC) classified sulfosulfuron as a
likely human carcinogen. The weight-of-evidence for this classification
are as follows: (i) occurrence of rare transitional cell papilloma and
carcinoma of the urinary bladder in female rats; (ii) occurrence of
rare benign mesenchymal tumors of the urinary bladder in male as well
as one renal adenoma in both male and female mice; and (iii) the
relevancy of the observed tumors to human exposure. The Committee
recommended that a linear low-dose approach (Q1*) for human
risk characterization and extrapolation of risk should be based on the
incidence of benign mesenchymal bladder tumors in male mice. The unit
risk, Q1* (mg/kg/day), of sulfosulfuron based upon male
mouse urinary bladder mesenchymal tumor rates is 1.03 x
10-3 (mg/kg/day)-1 in human equivalents.
C. Exposures and Risks
1. From food and feed uses. No tolerances have been established for
sulfosulfuron. Risk assessments were conducted by EPA to assess
exposures from sulfosulfuron as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. An acute risk from the proposed use is
not expected because no effect attributed to a single dose (exposure)
were observed in oral toxicology studies including developmental
toxicity in the rat and the rabbit and an acute neurotoxicity study in
the rat. The Agency concludes with reasonable certainly that
sulfosulfusulfuron does not elicit an acute toxicological response.
ii. Chronic exposure and risk. A chronic dietary exposure analysis
was performed using the RfD of 0.24 mg/kg/day based on a chronic
toxicity NOAEL of 24.0 mg/kg/day and an uncertainly factor of 100,
assuming tolerance level residues and 100 % crop treated information to
estimate the Theoretical Maximum Residue Contribution (TMRC) for the
general population and 28 subgroups. The TMRC for the all population
subgroups represent <1% of="" the="" rfd.="" this="" is="" a="" highly="" conservative="" risk="" estimate="" since="" no="" refinements="" for="" percent="" crop="" treated="" or="" anticipated="" residues="" were="" made.="" iii.="" carcinogenicity="" exposure="" and="" risk.="" a="" cancer="" exposure="" analysis="" was="" performed="" (deem)="" software,="" usda="" 1989-91="" nationwide="" continuing="" surveys="" for="" food="" intake="" by="" individuals="" (csfii)="" using="" tolerance="" level="" residues="" and="" 100%="" crop="" treated="" information="" to="" estimate="" the="" lifetime="" cancer="" risk="" for="" the="" general="" population.="" the="" lifetime="" risk="" was="" 8.45="" x="">-8 for a 70-year exposure. The lifetime risk was 1.05 x
10-7 for infants, 2.55 x 10-7 for childern (1-
6) and 1.47 x 10-7 for childern (7-12). The Agency
considers risks in the range of 1 x 10-6 as negligible
risk. The cancer dietary risk associated with sulfosulfuron is below
the Agency`s level of concern.
2. From drinking water. Tier I estimated environmental
concentrations (EEC) were calculated for both surface water ((Generic
expected environmental concentration) GENEEC model) and ground water
((Screening Concentration in GROund water) SCI-GROW). Tier I models
represent the most conservative estimates of potential residues in
drinking water. Drinking water levels of comparison (DWLOCs) for acute
and chronic dietary risk from drinking water were calculated for both
surface and ground water. Estimated environmental concentrations (EECs)
for surface and ground water were 1.73 parts per billion (ppb) and
0.295 ppb, respectively.
A DWLOC is a theoretical upper limit on a pesticide's concentration
in drinking water in light of total aggregate exposure to a pesticide
in food, drinking water, and through residential uses. A DWLOC will
vary depending on the toxic endpoint, with drinking water consumption,
and body weights. Different populations will have different DWLOCs. OPP
uses DWLOCs internally in the risk assessment process as a surrogate
measure of potential exposure associated with pesticide exposure
through drinking water. In the absence of monitoring data for
pesticides, it is used as a point of comparison against conservative
model estimates of a pesticide's concentration in water. DWLOC values
are not regulatory standards for drinking water. They do have an
indirect regulatory impact through aggregate exposure and risk
assessments.
i. Acute exposure and risk. An acute risk from the proposed use is
not expected because no effect attributed to a single dose (exposure)
were observed in oral toxicology studies including developmental
toxicity in the rat and the rabbit and an acute neurotoxicity study in
the rat.
ii. Chronic exposure and risk. The DWLOC s calculated for adults
and children were 8,400 ppb and 2,400 ppb, respectively. These are
higher than the EEC s of 1.73 ppb for surface water and 0.295 ppb for
ground water.
iii. For cancer exposure to sulfosulfuron, the adult DWLOC is 27
ppb, which is above the EECs of 1.73 ppb for surface water and 0.0295
ppb for ground water.
3. From non-dietary exposure. Based on the proposed use of
sulfosulfuron on turf at playgrounds, parks, and residential areas by
professional applicators, potential for residential exposure exists,
from post-application scenarios.
i. Acute exposure and risk. An acute risk from the proposed use is
not expected because no effects attributed to a single dose (exposure)
were observed in oral toxicology studies including developmental
toxicity in the rat and the rabbit and an acute neurotoxicity study in
the rat.
ii. Chronic exposure and risk. A chronic exposure is not expected
for use of sulfosulfuron on agricultural, and non-agricultural areas,
because exposure does not continuously (daily) occur more than 180
days.
iii. Short- and intermediate-term exposure and risk. No short-term
or intermediate term dermal or inhalation endpoints were identified.
The Agency concludes that exposures form residential uses of
sulfosulfuron are not expected to pose undue risk.
iv. Cancer exposure and risk. Post-application exposures resulting
from the proposed application of sulfosulfuron to recreational areas,
parks, and residential areas (lawns) are not expected to pose an undue
cancer risk.
A typical cancer risk for a residential adult was calculated for a
Tc = 1,000 cm2/hr (high activity for 1 hr.) and for a Tc =
500 cm2/hr (low activity for 1 hr.). An average is usually
used for cancer assessments. This assessment is based on conservative
assumptions (due to the assessment using 50 years of exposure, and
utilizing an estimated 20% (default) of dislodgeable foliar residues
(DFR) from the turf; which is
[[Page 27189]]
derived from the maximum application rate). An average of 14 days of
DFRs was used for this cancer assessment; this would be considered a
10% decrease each day (from dilution by rain, and mowing of the grass)
of the 20% residue for at least 14 days, and then taking the mean value
of this 14 day exposure. The Life time Average Daily Dose (LADD) = 6.0
x 10-5 mg/kg/day for a Tc = 1,000 cm2/hr (high
activity for 1 hr.) and for a Tc = 500 cm2/hr (low activity
for 1 hr.) is equal to 3.0 x 10-5 mg/kg/day. The cancer
risks are 6.0 x 10-8 (for Tc =1,000 cm2/hr,
high activity) and 3.0 x 10-8 (for Tc = 500
cm2/hr (low activity for 1 hr.)). The highest residential
calculated level of cancer risk on day zero for a Tc =1,000
cm2/hr (high activity for 1 hr.) is equal to 1.2 x
10-7, and for a Tc = 500 cm2/hr (low activity for
1 hr.) is equal to 6.0 x 108. This risk is considered
minimal.
The cancer risk assessment for dermal post-application exposure for
toddlers is based on conservative assumptions (due to the assessment
using 12 years of exposure at maximum rate, for 14 days a year without
a 10 % dissipation each day after day zero, and a high transfer
coefficient (Tc); default for toddlers = 8,700 cm2/hr (high
activity for 2 hrs, Tier I.). It also utilizes dislodgeable foliar
residues (DFR) derived from the maximum application rate and an
estimated 20 % (upper percentile, default) of this residue remaining on
the turf). The calculated level of cancer risk is 1.0 x
106. This is considered as a worst case scenario for
toddlers, because the toddler default Tc = 8,700 cm22/hr
(high activity for 2 hrs, Tier I.), and an average of exposure over
time is usually used for cancer assessments (which would be considered
much less due to a 10% decrease each day, from dilution by rain and
mowing of the grass, of the 20% residue for at least 14 days, and then
taking the mean value of this 14 day exposure). This risk is considered
minimal.
Although it is likely that toddlers also would be exposed to
sulfosulfuron from incidental ingestion of grass, soil, or hand-to-
mouth transfer, no risk assessment was performed for these scenarios
because no relevant oral toxicological endpoints have been identified.
There was no acute dietary endpoint identified for sulfosulfuron.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether sulfosulfuron has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
sulfosulfuron does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that sulfosulfuron has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. An acute risk from the proposed use is not expected
because no effects attributed to a single dose (exposure) were observed
in oral toxicology studies including developmental toxicity in the rat
and the rabbit and an acute neurotoxicity study in the rat.
2. Chronic risk. Using the theoretical maximum residue contribution
exposure assumptions described in this unit, EPA has concluded that
aggregate exposure to sulfosulfuron from food will utilize <1% of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" sulfosulfuron="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" sulfosulfuron="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" short-="" term="" and="" intermediate-term="" dermal="" and="" inhalation="" is="" not="" a="" concern="" due="" to="" the="" lack="" of="" significant="" toxicological="" effects="" observed="" with="" sulfosulfuron="" under="" these="" exposure="" scenarios.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" the="" cancer="" aggregate="" risk="" which="" includes="" food,="" water,="" and="" the="" lifetime="" average="" daily="" dose="" from="" post="" application="" exposure="" for="" the="" general="" population="" is="" 2.05="" x="">-7 which is lower than the Agency`s negligible risk of 1
x 10-6.
Aggregrate cancer risk for infants and childern. The aggregrate
cancer risk for infants and childern which includes food, water, and
lifetime average daily dose from post-application exposure is 1.1 x
10-6 which is considered negibile risk.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to sulfosulfuron residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of Sulfosulfuron, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not
[[Page 27190]]
raise concerns regarding the adequacy of the standard MOE/safety
factor.
ii. Pre- and post-natal sensitivity. The developmental and
reproductive toxicity data did not indicate increased susceptibility to
in utero and/or postnatal exposure.
iii. Conclusion. There is a complete toxicity database for
Sulfosulfuron and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures.
Based on these data, there is no indication that the developing
fetus or neonate is more sensitive than adult animals. Acceptable acute
and subchronic neurotoxicity studies in rats have been submitted to the
Agency. There were no data gaps for the assessment of the neurotoxic
potential of sulfosulfuron. There was no evidence of neurotoxicity in
other studies (including a rat 90-day feeding toxicity study, rat 2-
year chronic toxicity/carcinogenicity study, dog oral (capsule) 90-day
study and a dog 1 year oral (capsule) toxicity study, conducted on
sulfosulfuron. The Agency believes that reliable data support the use
of the standard 100-fold uncertainly factor, and that a tenfold (10x)
uncertainty factor to protect the safety of infants and children should
not be retained.
2. Acute risk. There are no acute toxicological endpoints for
sulfosulfuron. The Agency concludes that establishment of the proposed
tolerances would not pose an unacceptable aggregate risk.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to Sulfosulfuron from
food will utilize < 1%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" sulfosulfuron="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" intermediate-term="" risk.="" short-term="" and="" intermediate-="" term="" dermal="" and="" inhalation="" risk="" is="" not="" a="" concern="" due="" to="" lack="" of="" significant="" toxicological="" effects="" observed="" with="" sulfosulfuron="" under="" these="" exposure="" scenarios.="" 5.="" aggregrate="" cancer="" risk="" for="" infants="" and="" childern.="" the="" aggregrate="" cancer="" risk="" for="" infants="" and="" childern="" which="" includes="" food,="" water,="" and="" lifetime="" average="" daily="" dose="" from="" post-application="" exposure="" is="" 1.1="" x="">-6 which is considered negibile risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to Sulfosulfuron
residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The guideline requirement for an animal metabolism study is
satisfied. Sulfosulfuron is rapidly excreted, primarily unmetabolized.
Excretion at low dose occurred primarily in the urine, whereas at high
dose, a large percentage of the administered dose was excreted in the
feces. Sulfosulfuron was not retained in tissues to any significant
extent.
The nature of the residue in plants is understood. The sulfonyl
urea bond is cleaved in soil prior to uptake by wheat and Pd-
metabolites are taken up less readily than Im-metabolites. Metabolite
formation appears to occur by demethylation and cleavage of sulfonyl
urea bond.start
B. Analytical Enforcement Methodology
An interim adequate enforcement methodology (example - gas
chromatography) is available to enforce the tolerance expression. The
method is undergoing modification to improve the method. The improved
method, when available, may be requested from: Calvin Furlow, PIRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm. 101FF, CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5229. The interim method is available from the
Analytical Chemistry Lab, BEAD (7503C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,
(703) 305-2905.
C. Magnitude of Residues
Residues of 1-(4,6-dimethoxypyrimidin-2yl)-3-[(2-ethanesulfonyl-
imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea and its metabolites that are
converted to 2-(ethylsulfonyl)-imidazol[1,2-a]pyridine and calculated
as sulfosulfuron are not expected to exceed on wheat grain 0.02 ppm,
wheat straw 0.1 ppm, wheat hay 0.3 ppm, wheat forage 4.0 ppm, milk
0.006 ppm, fat and meat of cattle, goat, swine, horse, and sheep 0.005
ppm, and meat by-products of cattle, goat, swine, horse, and sheep at
0.05 ppm.
D. International Residue Limits
No Codex or Mexican MRLs are established for sulfosulfuron.
Canadian MRLs exist for sulfosulfuron on wheat grain at 0.02 mg/kg;
milk at 0.006 mg/kg, meat and fat of cattle, goat, swine, horse , sheep
and poultry at 0.005 mg/kg, eggs at 0.0005 mg/kg; and meat by products
of cattle, goat, swine, horse, sheep and poultry at 0.05 mg/kg. The
Canadian MRLs are the same as the United States tolerances. No Canadian
MRLs exist for wheat straw, wheat hay, and wheat forage. These
tolerances are necessary to support use patterns in the United States.
E. Rotational Crop Restrictions
Based on the results of the confined accumulation in rotational
crops study, the appropriate plantback intervals are: 30 days for leafy
and root crops. Limited rotational field trials are required to
determine the appropriate rotation intervals for all other crops
(except wheat).
IV. Conclusion
Therefore, the tolerances are established for residues of
sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2yl)-3-[(2-ethanesulfonyl-
imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea and its metabolites converted
to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine and calculated as
sulfosulfuron, in wheat grain at 0.02 ppm, wheat straw at 0.1 ppm,
wheat hay at 0.3 ppm, wheat forage at 4.0 ppm, milk at 0.006 ppm, fat
and meat of cattle, goat, swine, horse, and sheep at 0.005 ppm, and
meat by-products of cattle, goat, swine, horse, and sheep at 0.05 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by July 19, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
[[Page 27191]]
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information 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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300853] (including any comments and data submitted
electronically). 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 public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any special considerations as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR
[[Page 27192]]
27655, May 19, 1998), EPA may not issue a regulation that is not
required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments. If the mandate is unfunded,
EPA must provide OMB, in a separately identified section of the
preamble to the rule, a description of the extent of EPA's prior
consultation with representatives of affected tribal governments, a
summary of the nature of their concerns, and a statement supporting the
need to issue the regulation. In addition, Executive Order 13084
requires EPA to develop an effective process permitting elected
officials and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 6, 1999.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.552 is added to subpart C to read as follows:
Sec. 180.552 Sulfosulfuron; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-
ethanesulfonyl-imidazo[1,2-a]pyridine-3-yl) sulfonyl]urea and its
metabolites converted to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine and
calculated as sulfosulfuron in or on the raw agricultural commodities.
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Cattle, fat.................................................... 0.005
Cattle, meat................................................... 0.005
Cattle, meat by-products....................................... 0.05
Goat, fat...................................................... 0.005
Goat, meat..................................................... 0.005
Goat, meat by-products......................................... 0.05
Horse, fat..................................................... 0.005
Horse, meat.................................................... 0.005
Horse, meat by-products........................................ 0.05
Milk........................................................... 0.006
Sheep, fat..................................................... 0.005
Sheep, meat.................................................... 0.005
Sheep, meat by-products........................................ 0.05
Swine, fat..................................................... 0.005
Swine, meat.................................................... 0.005
Swine, meat by-products........................................ 0.05
Wheat, forage.................................................. 4.0
Wheat, grain................................................... 0.02
Wheat, hay..................................................... 0.3
Wheat, straw................................................... 0.1
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-12247 Filed 5-18-99; 8:45 am]
BILLING CODE 6560-50-F
