[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: [email protected]. 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, [email protected]. 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:
    [email protected].


    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