[Federal Register Volume 64, Number 58 (Friday, March 26, 1999)]
[Rules and Regulations]
[Pages 14626-14632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7435]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300820; FRL-6069-5]
RIN 2070-AB78
Quinclorac; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
quinclorac, 3,7-dichloro-8-quinoline carboxylic acid in or on wheat and
sorghum. BASF Corporation 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 March 26, 1999. Objections and
requests for hearings must be received by EPA on or before May 26,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300820], 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-300820], 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-300820]. No Confidential Business
[[Page 14627]]
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: Joanne I. Miller,
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, 703 305-6224, miller.joanne
@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 2, 1998
(63 FR 66535) (FRL-6043-2), 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) 7F4870 for a
tolerance by BASF Corporation, P.O. Box 13528, Research Triangle Park,
NC 27709-3528. This notice included a summary of the petition prepared
by BASF Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.463 be amended by
establishing tolerances for residues of the herbicide quinclorac 3,7-
dichloro-8-quinoline carboxylic acid, in or on the raw agricultural
commodities wheat and sorghum as follows: 0.5 part per million (ppm)
(wheat grain), 0.1 ppm (wheat straw), 1.0 ppm (wheat forage), 0.5 ppm
(wheat hay), 0.75 ppm (wheat germ), 6.0 ppm (sorghum, grain, grain),
3.0 ppm (sorghum, grain, forage), 1.0 ppm (sorghum, grain, stover) and
1,200 ppm (aspirated grain fractions). Based on the estimated dietary
burden from the established tolerances and the proposed uses in this
petition the following revised tolerances are also established: fat of
cattle, goats, hogs, horses and sheep at 0.7 ppm and the meat
byproducts of cattle, goats, hogs, horses and sheep at 1.5 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
quinclorac and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for tolerances for residues of 3,7-
dichloro-8-quinoline carboxylic acid on the raw agricultural
commodities wheat and sorghum as follows: 0.5 ppm (wheat grain), 0.1
ppm (wheat straw), 1.0 ppm (wheat forage), 0.5 ppm (wheat hay), 0.75
ppm (wheat germ), 6.0 ppm (sorghum, grain, grain), 3.0 ppm (sorghum,
grain, forage), 1.0 ppm (sorghum, grain, stover) and 1,200 ppm
(aspirated grain fractions). Based on the estimated dietary burden from
the established tolerances and the proposed uses in this petition the
following revised tolerances are also established: fat of cattle,
goats, hogs, horses and sheep at 0.7 ppm and the meat byproducts of
cattle, goats, hogs, horses and sheep at 1.5 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 quinclorac are
discussed in this unit.
1. Acute toxicology studies place technical-grade quinclorac in
Toxicity Category III for all routes of exposure. It is a dermal
sensitizer.
2. A 21-day dermal toxicity study in NZ White rabbits was conducted
at doses of 0, 200 or 1,000 milligrams/kilograms/day (mg/kg/day). No
dermal or systemic toxicity was seen following 21 daily dermal
applications of quinclorac at doses of 0, 200, or 1,000 mg/kg/day. The
no observed adverse effect level (NOAEL) is greater than 1,000 mg/kg/
day.
3. A 13-week feeding study in mice was conducted at doses of 0,
4,000, 8,000, or 16,000 ppm; equivalent to 0, 1,000, 2,202 or 4,555 mg/
kg/day for males and 0, 1,467, 2,735 or 5,953 mg/kg/day for females.
The lowest observed adverse effect level (LOAEL) is 1,000 mg/kg/day for
males and 1,467 mg/kg/day for females based on decreased body weight
gains in males and females (17.6 and 18.7%, respectively).
4. A 13-week feeding study in mice was conducted at doses of 0 or
500 ppm (equivalent to 0 or 75 mg/kg/ day). The NOAEL is 75 mg/kg/day.
5. A 3-month feeding study in rats was conducted at doses of 0,
1,000, 4,000, or 12,000 ppm ( 0, 76.8, 302.3 or 929.9 mg/kg/day in
males and 0, 86.7, 358, or 1,035.4 mg/kg/day in females). The NOAEL is
302 mg/kg/day(male); 358 mg/kg/day (female). The LOAEL is 930 mg/kg/day
(male); 1035 mg/kg/day (female), based on decreased body weight gain,
food consumption, and increased water intake in males and females,
increased SGOT, SGPT and focal chronic interstitial nephritis in males.
6. A 1-year feeding study in dogs was conducted at doses of 0,
1,000, 4,000, or 12,000 ppm (0, 34, 142, or 513 mg/kg/day in males and
0, 35, 140, or 469 mg/kg/day in females). The NOAEL is 142 mg/kg/day
(male); 140 mg/kg/day (female). The LOAEL is 513 mg/kg/day (male); 469
mg/kg/day (female), based on reduced body weight gain, increased liver
and kidney weights, reduced food efficiency, reduced HgB, RBC, MCH, and
MCV, and kidney degeneration.
7. A 2-year chronic/carcinogenicity study in rats at doses of 0,
1,000, 4,000, 8,000 or 12,000 ppm (0, 56, 186, 385, or 487 mg/kg/day in
males and 0, 60, 235, 478, or 757 mg/kg/day in females). The NOAEL is
385 mg/kg/day (male); 478 mg/kg/day (female). The LOAEL is 487 mg/kg/
day (male); 757 mg/kg/day (female), based on decreased body weight in
females and increased incidence of pancreatic acinar cell hyperplasia
in males.
[[Page 14628]]
8. An 18-month carcinogenicity study in mice was conducted at doses
of 0, 250, 1,000, 4,000, or 8,000 ppm ( 0, 37.5, 150, 600, or 1200 mg/
kg/day). The NOAEL is 37.5 mg/kg/day and the LOAEL is 150 mg/kg/day
based on decreased body weight in both sexes.
9. A developmental toxicity study in rats was conducted at gavage
doses of 0, 24.4, 146, or 438 mg/kg/day during gestation. The maternal
toxicity NOAEL is 146 mg/kg/day. The maternal toxicity LOAEL is 438 mg/
kg/day, based on increased mortality, decreased food consumption, and
increased water consumption. The developmental toxicity NOAEL is equal
to or greater than 438 mg/kg/day.
10. A developmental toxicity study in rabbits was conducted at
gavage doses of 0, 70, 200, or 600 mg/kg/day during gestation. The
maternal toxicity NOAEL is 70 mg/kg/day. The maternal toxicity LOAEL is
200 mg/kg/day, based on decreased body weight gains and food
consumption. The developmental toxicity NOAEL is 200 mg/kg/day. The
developmental toxicity LOAEL is 600 mg/kg/day, based on increased
resorption rate, post-implantation loss, decreased number of live
fetuses, and reduced fetal body weight.
11. A 2-generation reproduction study in rats was conducted at
dietary levels of 0, 1,000, 4,000, or 12,000 ppm (0, 50, 200, 600 mg/
kg/day). The parental toxicity NOAEL is 200 mg/kg/day. The parental
toxicity LOAEL is 600 mg/kg/day, based on reduced body weight in both
sexes during premating and lactating periods. The reproductive toxicity
NOAEL is equal to or greater than 600 mg/kg/day. The developmental
toxicity NOAEL is 200 mg/kg/day. The developmental toxicity LOAEL is
600 mg/kg/day, based on decreased pup weight and viability, and
developmental delays.
12. A metabolism (biodisposition) study in rats was conducted at
single oral doses of 15 or 600 mg/kg; and multiple doses of unlabeled
quinclorac for 14 days followed by 14C quinclorac.
Quinclorac was rapidly absorbed and eliminated in the urine. Urinary
elimination accounted for 91 to 98% of the dose, with 1 to 4% in the
feces. None was demonstrated in the expired air.
13. Biliary excretion studies in rats were conducted at single oral
doses of 15 or 600 mg/kg. Biliary excretion was significant (11.5 to
14.5% of the dose) in 600 mg/kg treated rats but was reabsorbed from
the intestine and eliminated in the urine.
14. A plasma level study was conducted at single oral doses of 15,
100, 600, or 1,200 mg/kg; and a multiple dosing study at 15 and 600 mg/
kg/day for 7 days. Mean 14C residues were detected in plasma
30 minutes after dosing in single dose animals at 15, 100, and 600 mg/
kg or 15 mg/kg/day for 7 days. Most of this radioactivity was the
parent compound. Peak plasma levels of radioactivity in animals
receiving 1,200 mg/kg and 600 mg/kg/day for 7 days were noted at 7 to
48 hours post-dosing.
15. Tissue level studies were conducted at daily oral doses of 15
mg/kg or 1,200 mg/kg for 7 days. In both studies, the highest
concentration of radioactivity in tissues was found 30 minutes after
administration of the final dose.
B. Toxicological Endpoints
1. Acute toxicity. For acute dietary risk assessment, an acute
Reference Dose (RfD) of 2.0 mg/kg/day has been selected, based on the
developmental NOAEL of 200 mg/kg/day, from the rabbit developmental
toxicity study and an uncertainty factor of 100 (10X for inter-species
differences and 10X for intra-species variability). The endpoint is
based on increased incidence of fetal resorptions, decrease in the
number of live fetuses, and reduced fetal body weight at the LOAEL of
600 mg/kg/day. The population subgroup at risk is females of child-
bearing age (13+years). For the general population, no appropriate
endpoint attributable to a single exposure was identified from the oral
toxicity studies, including the rat and rabbit developmental toxicity
studies.
2. Short- and intermediate-term toxicity. Short and intermediate-
term toxicity endpoints are not established since no dermal or systemic
toxicity was observed in a 21-day dermal toxicity study in New Zealand
White rabbits.
3. Chronic toxicity. EPA has established the chronic RfD for
quinclorac at 0.4 mg/kg/day. This RfD is based on decreased body
weights in male and female mice observed in the mouse carcinogenicity
study with a NOAEL of 37.5 mg/kg/day.
4. Carcinogenicity. After considering an equivocal increase of
acinar cell adenomas of the pancreas in male Wistar rats, quinclorac is
classified as ``Group D --not classifiable as to human
carcinogenicity''.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.463) for the residues of 3,7-dichloro-8-quinoline carboxylic
acid, in or on a variety of raw agricultural commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
quinclorac 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 dietary risk assessment was
performed for quinclorac. The analysis was conducted using the acute
RfD of 2.0 mg/kg/day, based on increased incidence of fetal resorptions
and post-implantation loss, decreased number of live fetuses and
reduced fetal body weight observed in the rabbit developmental toxicity
study. For the population subgroup of concern, females 13 years and
older, the estimated 95th percentile of exposure occupies 0.4% of the
acute RfD. The analysis is conservative since it assumes that 100% of
wheat and sorghum - derived foods contain residues at the tolerance
levels (0.5 and 6.0 ppm, respectively); tolerance level residues on all
commodities with established quinclorac tolerances; and, 100% crop-
treated.
ii. Chronic exposure and risk. A chronic dietary risk assessment
was performed for quinclorac. The analysis used the chronic RfD of 0.4
mg/kg/day and assumed that 100% of wheat and sorghum - derived foods
contain residues at tolerance levels (0.5 and 6.0 ppm, respectively);
tolerance level residues on all commodities with established quinclorac
tolerances; and, 100% crop-treated. Based on these assumptions, no more
than 2% of the chronic RfD was occupied by any population subgroup.
2. From drinking water. No Maximum Contaminant Level or health
advisory levels have been established for residues of quinclorac in
drinking water. EPA used its SCI-GROW (Screening Concentration in
Ground Water) screening model and environmental fate data to determine
the estimated environmental concentration (EEC) for quinclorac in
ground water. The GENEEC (Generic Estimated Environmental
Concentration) screening model and environmental fate data were used to
determine the EECs for quinclorac in surface water. EECs in ground
water reflecting the maximum yearly application rate of 0.75 pounds of
active ingredient per acre were 21 parts per billion (ppb;ug/L). EECs
in surface water were 40 ppb for acute exposure scenarios and 38 ppb
for chronic exposure scenarios. The computer generated EECs represent
conservative estimates and should be used only for screening.
i. Acute exposure and risk. EPA has calculated a drinking water
level of comparison (DWLOC) for acute
[[Page 14629]]
exposure to quinclorac in drinking water for the relevant population
subgroup, females 13+ years of age. The DWLOC is 60,000 ug/L.
To calculate the DWLOCs for acute exposure relative to an acute
toxicity endpoint, the acute dietary food exposure from the DEEM
(Dietary Exposure Evaluation Model) analysis was subtracted from the
ratio of the acute RfD to obtain the acceptable acute exposure to
quinclorac in drinking water. DWLOCs were then calculated using default
body weights and drinking water consumption figures.
For purposes of risk assessment, EPA used 40 ppb as the estimated
maximum concentration of quinclorac in drinking water. The estimated
maximum concentrations in water are less than EPA's level of concern
(60,000 ppb) for quinclorac residues in drinking water as a
contribution to acute aggregate exposure. Therefore, taking into
account the use proposed in this action, EPA concludes with reasonable
certainty that residues of quinclorac in drinking water (when
considered along with other sources of exposure for which EPA has
reliable data) would not result in unacceptable levels of aggregate
human health risk at this time.
ii. Chronic exposure and risk. EPA has calculated drinking water
levels of comparsion (DWLOCs) for chronic exposure to quinclorac in
drinking water. For chronic (non-cancer) exposure to quinclorac in
drinking water, the drinking water levels of comparison are 14,000 ug/L
and 3,900 ug/L for the U.S. population and the subgroup children (1-6
years old), respectively.
To calculate the DWLOCs for chronic (non-cancer) exposure relative
to a chronic toxicity endpoint, the chronic dietary food exposure (from
the DEEM analysis) was A subtracted from the chronic RfD to obtain the
acceptable chronic (non-cancer) exposure to quinclorac in drinking
water. DWLOCs were then calculated using default body weights and
drinking water consumption figures.
The estimated average concentration of quinclorac in drinking water
is 38 ppb. The DWLOCs are 14,000 ppb for the U.S. population and 3,900
ppb for the subgroup, children (1-6 years old). The estimated average
concentration of quinclorac in drinking water is less than EPA's level
of concern for quinclorac in drinking water as a contribution to
chronic aggregate exposure. Therefore, taking into account the use
proposed in this action, EPA concludes with reasonable certainty that
residues of quinclorac in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time.
3. From non-dietary exposure. Quinclorac is currently registered
for use on the following residential non-food sites: residential lawns.
The residential use on lawns poses the potential for dermal exposure
for both children and adults and for oral exposure (incidental and/or
hand-to-mouth ingestion) for children. However, since there was no
observed dermal or systemic toxicity in a rabbit 21-day dermal study
with quinclorac, short-, intermediate- or long-term dermal or
inhalation endpoints are not being established. An acute dietary
endpoint (applicable to the general population, including infants and
children) is not being established since there was no observed toxicity
in the database, from a single exposure. Thus, residential exposure
risk assessments were not conducted.
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 quinclorac 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,
quinclorac 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 quinclorac 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. Adult
Population
1. Acute risk. For the population subgroup of concern, females 13+
years old, the acute dietary (food) exposure does not exceed 0.4% of
the acute RfD. The drinking water level of comparison (DWLOC) for acute
exposure to quinclorac residues is 60,000 ug/L for females (13+ years).
The maximum estimated environmental concentration (EEC) of quinclorac
in drinking water (40 ug/L) is less than EPA's level of concern for
quinclorac in drinking water as a contribution to acute aggregate
exposure. EPA concludes with reasonable certainty that residues of
quinclorac in drinking water will not contribute significantly to the
aggregate acute human health risk and that the acute aggregate exposure
from quinclorac in food and water will not exceed the Agency's level of
concern for acute dietary exposure.
2. Chronic risk. Using the TMRC exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to quinclorac from
food will utilize no more than 1% of the RfD for the U.S. adult
population. The major identifiable subgroup with the highest aggregate
exposure, infants or children 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 quinclorac in drinking water and
from non-dietary, non-occupational exposure, EPA does not expect the
aggregate exposure to exceed 100% of the RfD.
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. The residential use on lawns poses the potential
for dermal exposure for both children and adults and for oral exposure
(incidental and/or hand-to-mouth ingestion) for children. However, risk
assessments were not required for short- and intermediate-term
aggregate exposures due to a lack of observed toxicity in the
quinclorac database.
4. Aggregate cancer risk for U.S. population. Quinclorac is
classified as a ``Group D -- not classifiable as to human
carcinogenicity'' chemical.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the adult U.S. population from aggregate exposure to quinclorac
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 quinclorac, EPA considered data from
developmental toxicity studies in the rat
[[Page 14630]]
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
during gestation. Reproduction studies provide information relating to
pre-and post-natal effects from exposure to the pesticide, information
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 raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Pre- and post-natal sensitivity. There are no pre- or post-
natal toxicity concerns for infants and children, based on the results
of the rat and rabbit developmental toxicity studies and the 2-
generation rat reproductive toxicity study.
iii. Conclusion. There is a complete toxicity database for
quinclorac and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures. Taking into account
the completeness of the data base and the toxicity data regarding pre-
and post-natal sensitivity, EPA concludes, based on reliable data, that
use of the standard margin of safety will be safe for infants and
children without addition of another tenfold factor.
2. Acute risk. Fetuses are addressed by examining exposure to the
mother and those exposures are acceptable.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to quinclorac from food
will utilize no more than 2% 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 quinclorac in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD.
4. 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 quinclorac residues.
III. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants (sorghum grain, wheat, rice),
ruminants, and poultry is adequately understood. The residue of concern
is quinclorac per se.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (gas liquid chromotography with an
electron capture detector) is available to enforce the tolerance
expression. The method 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.
C. Magnitude of Residues
Residues of quinclorac 3,7-dichloro-8-quinoline carboxylic acid are
not expected to exceed the following tolerances on the raw agricultural
commodities wheat and sorghum as follows: 0.5 ppm (wheat grain), 0.1
ppm (wheat straw), 1.0 ppm (wheat forage), 0.5 ppm (wheat hay), 0.75
ppm (wheat germ), 6.0 ppm (sorghum, grain, grain), 3.0 ppm (sorghum,
grain, forage), 1.0 ppm (sorghum, grain, stover) and 1200 ppm
(aspirated grain fractions). Based on the estimated dietary burden from
the established tolerances and the proposed uses in this petition the
following revised tolerances are also established fat of cattle, goats,
hogs, horses and sheep at 0.7 ppm and the meat byproducts of cattle,
goats, hogs, horses and sheep at 1.5 ppm.
D. International Residue Limits
There are no Codex or Mexican maximum residue limits (MRLs)
established for quinclorac residues on wheat or sorghum grain. Canada
has an established MRL of 0.5 ppm for residues of quinclorac on
``wheat''. The tolerance BASF is proposing on wheat grain is in harmony
with this MRL.
E. Rotational Crop Restrictions
The label restrictions are: Do not plant any crop other than wheat
or sorghum grain for 309 days (10 months) following application. For
flax, peas, lentils, and sugar beets, do not replant for 24 months.
IV. Conclusion
Therefore, the tolerances are established for residues of 3,7-
dichloro-8-quinoline carboxylic acid in the raw agricultural
commodities wheat and sorghum as follows: 0.5 ppm (wheat grain), 0.1
ppm (wheat straw), 1.0 ppm (wheat forage), 0.5 ppm (wheat hay), 0.75
ppm (wheat germ), 6.0 ppm (sorghum, grain, grain), 3.0 ppm (sorghum,
grain, forage), 1.0 ppm (sorghum, grain, stover) and 1200 ppm
(aspirated grain fractions). Based on the estimated dietary burden from
the established uses in this petition the following revised tolerances
are also established fat of cattle, goats, hogs, horses and sheep at
0.7 ppm and the meat byproducts of cattle, goats, hogs, horses and
sheep at 1.5 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 May 26, 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
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
[[Page 14631]]
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-300820] (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/exemption 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 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
[[Page 14632]]
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: March 15, 1999.
James Jones,
Director, Registration Division, 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), 346a and 371.
2. Section 180.463 is amended as follows:
a. By revising the section title to read as set forth below:
b. By alphabetically adding the entries aspirated grain fractions;
sorghum, grain, forage; sorghum, grain, grain; sorghum, grain, stover;
wheat forage; wheat germ; wheat grain; wheat hay; and wheat straw to
the table in paragraph (a)(1) and;
c. By revising the entries for cattle, fat; cattle, mbyp; goats,
fat; goats, mbyp; hogs, fat; hogs, mbyp; horses, fat; horses, mbyp; and
sheep, fat; and sheep, mbyp to the table in paragraph (a)(1) as set
forth below:
Sec. 180.463 Quinclorac; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
quinclorac (3,7-dichloro-8-quinoline carboxylic acid) in or the
following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Aspirated grain fractions................. 1200
* * * * *
Cattle, fat............................... 0.7
Cattle, mbyp.............................. 1.5
* * * * *
Goats, fat................................ 0.7
Goats, mbyp............................... 1.5
* * * * *
Hogs, fat................................. 0.7
Hogs, mbyp................................ 1.5
* * * * *
Horses, fat............................... 0.7
Horses, mbyp.............................. 1.5
* * * * *
Sheep, fat................................ 0.7
Sheep, mbyp............................... 1.5
* * * * *
Sorghum, grain, forage.................... 3.0
Sorghum, grain, grain..................... 6.0
Sorghum, grain, stover.................... 1.0
Wheat forage.............................. 1.0
Wheat germ................................ 0.75
Wheat grain............................... 0.5
Wheat hay................................. 0.5
Wheat straw............................... 0.1
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-7435 Filed 3-25-99; 8:45 am]
BILLING CODE 6560-50-F
