[Federal Register Volume 64, Number 27 (Wednesday, February 10, 1999)]
[Rules and Regulations]
[Pages 6542-6549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3247]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[OPP-300781; FRL-6055-6]
RIN 2070-AB78
3,7-Dichloro-8-quinoline carboxylic acid; Pesticide Tolerances
for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of 3,7-dichloro-8-quinoline carboxylic acid in or on wheat
forage, grain, straw, milled fractions, and aspirated grain fractions;
sorghum grain, grain forage, and grain fodder (stover); fat of cattle,
goats, hogs, horses, poultry and sheep; and meat byproducts of cattle,
goats, hogs, horses, and sheep. This action is in connection with
crisis exemptions declared under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
wheat and sorghum. This regulation establishes a maximum permissible
level for residues of 3,7-dichloro-8-quinoline carboxylic acid in these
food commodities pursuant to section 408(l)(6) of the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996. These tolerances will expire and are revoked on May 30, 2000.
DATES: This regulation is effective February 10, 1999. Objections and
requests for hearings must be received by EPA on or before April 12,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300781], 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-300781], 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, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of electronic 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
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300781].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, 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: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9364, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing tolerances for
residues of the herbicide 3,7-dichloro-8-quinoline carboxylic acid in
or on wheat forage at 5 ppm, grain at 4 ppm, straw at 1 ppm, milled
fractions at 40 ppm, aspirated grain fractions at 800 ppm; sorghum,
grain at 4 ppm, grain forage at 5 ppm, grain fodder (stover) at 1 ppm;
fat of cattle, goats, hogs, horses, and sheep at 0.6 ppm; fat of
poultry at 0.2 ppm ; and meat byproducts of cattle, goats, hogs,
horses, and sheep at 1.5 part per million (ppm). These tolerances will
expire and are revoked on May 30, 2000. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things,
[[Page 6543]]
FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New 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. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for 3,7-Dichloro-8-Quinoline Carboxylic
Acid on Wheat and Sorghum and FFDCA Tolerances
On May 28, 1998, the North Dakota Department of Agriculture availed
itself of the authority to declare the existence of a crisis situation
within the state, thereby authorizing use under FIFRA section 18 of
3,7-dichloro-8-quinoline carboxylic acid on wheat for control of
volunteer flax. Hail and unusually highwinds struck last fall in the
affected area which caused the seeds of flax plants to fall onto the
ground before they were harvested. After germination in the spring, the
subsequent crop of wheat was found to be severely infested. No other
options for control of flax in wheat are available. On June 22, 1998,
the Nebraska Department of Agriculture availed itself of the authority
to declare the existence of a crisis situation within the state,
thereby authorizing use under FIFRA section 18 of 3,7-dichloro-8-
quinoline carboxylic acid on sorghum for the control of annual weeds.
Extreme heavy rains prevented many producers from cultivating their
crops, which resulted in a greater-than-normal weed cover.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of 3,7-dichloro-8-quinoline
carboxylic acid in or on wheat forage, grain, straw, milled fractions,
and aspirated grain fractions; sorghum grain, grain forage, and grain
fodder (stover); fat of cattle, goats, hogs, horses, poultry and sheep;
and meat byproducts of cattle, goats, hogs, horses, and sheep. In doing
so, EPA considered the safety standard in FFDCA section 408(b)(2), and
EPA decided that the necessary tolerance under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although this tolerance will expire
and is revoked on May 30, 2000, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on wheat forage, grain, straw, milled
fractions, and aspirated grain fractions; sorghum grain, grain forage,
and grain fodder (stover); fat of cattle, goats, hogs, horses, poultry
and sheep; and meat byproducts of cattle, goats, hogs, horses, and
sheep after that date will not be unlawful, provided the pesticide is
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether 3,7-dichloro-8-quinoline
carboxylic acid meets EPA's registration requirements for use on wheat
and sorghum or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as a basis for registration of 3,7-dichloro-8-
quinoline carboxylic acid by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than North Dakota and Nebraska to use this pesticide on
these crops under section 18 of FIFRA without following all provisions
of EPA's regulations implementing section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for 3,7-dichloro-8-quinoline carboxylic acid, contact the Agency's
Registration Division at the address provided under the ADDRESSES
section.
III. Aggregate Risk Assessment and Determination of Safety
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).
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 3,7-
dichloro-8-quinoline carboxylic acid (quinclorac) and to make a
determination on aggregate exposure, consistent with section 408(b)(2),
for time-limited tolerances for residues of 3,7-dichloro-8-quinoline
carboxylic acid on wheat forage at 5 ppm, grain at 4 ppm, straw at 1
ppm, milled fractions at 40 ppm, aspirated grain fractions at 800 ppm;
sorghum, grain at 4 ppm, grain forage at 5 ppm, grain fodder (stover)
at 1 ppm; fat of cattle, goats, hogs, horses, and sheep at
[[Page 6544]]
0.6 ppm; fat of poultry at 0.2 ppm ; and 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 tolerances
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 3,7-dichloro-8-
quinoline carboxylic acid are discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. For acute dietary risk assessment, EPA used the
no observed adverse effect level (NOAEL) of 200 milligrams/kilograms/
day (mg/kg/day), based on increased incidence of fetal resorptions,
decrease in the number of live fetuses, and reduced fetal body weight
at the lowest observed effect level (LOEL) of 600 mg/kg/day, from the
developmental toxicity study in rabbits and an uncertainty factor of
100 (10X for inter-species extrapolation and 10X for intra-species
variability). This risk assessment will evaluate acute dietary risk for
females 13+ years, the population subgroup of concern, but not to the
general population (including infants and children). 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. EPA did not select
either a dose or endpoint for short- and intermediate term dermal
exposure since no dermal or systemic toxicity was observed in a dermal
toxicity study in New Zealand White rabbits after 21 repeated dermal
applications of quinclorac at 0, 10, 200, or 1,000 mg/kg/day, 6 hours/
day, 7 days/week. The dose of 1,000 mg/kg/day is the limit dose.
Therefore, EPA did not conduct a risk assessment for short- and
intermediate-term exposure.
3. Chronic toxicity. EPA has established the RfD for 3,7-dichloro-
8-quinoline carboxylic acid at 0.4 mg/kg/day. This RfD is based on a
carcinogenicity study in mice with a NOAEL of 37.5 mg/kg/day and an
uncertainty factor of 100 based on decreased body weights in male and
female mice at the LOEL of 150 mg/kg/day.
4. Carcinogenicity. After considering an equivocal increase of
acinar cell adenomas of the pancreas in male Wistar rats, 3,7-Dichloro-
8-quinoline carboxylic acid has been 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 rice grain (5 ppm); rice straw (12 ppm); fat and meat of
cattle, goats, hogs, horses, poultry, and sheep (0.05 ppm); meat-
byproducts (mbyp) of cattle, goats, hogs, and horses (0.05 ppm); mbyp
of poultry and sheep (0.1 ppm); eggs (0.05 ppm); and, milk (0.05 ppm).
Risk assessments were conducted by EPA to assess dietary exposures and
risks from 3,7-dichloro-8-quinoline carboxylic acid 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. The acute dietary (food only) risk
assessment was conducted via Dietary Exposure Evaluation Model (DEEM),
using the theoretical maximum residue contribution (TMRC), which
assumes tolerance level residues and 100% crop-treated. Using the
formula, % Acute RfD Occupied = (High-End Exposure Acute RfD)
x 100%, the high-end (99.9 percentile) exposure estimate of 0.256735
mg/kg/day for females 13+/nursing, (the subpopulation in the females
13+ years of age subgroup with the highest exposure), occupies 13% of
the acute RfD. This result should be viewed as a very conservative risk
estimate; refinement using anticipated residue values and percent crop-
treated data would result in a lower estimate of acute dietary
exposure.
ii. Chronic exposure and risk. The chronic analysis for 3,7-
dichloro-8-quinoline carboxylic acid is a conservative estimate of
dietary exposure with all residues at proposed or published tolerance
levels, and 100% of the commodities assumed to be treated. A risk
assessment for chronic dietary exposure from food and feed uses was
made for all subpopulations. The percent of the RfD occupied ranged
from 2% for nursing infants to 34% for children 1-6 years old.
2. From drinking water. Quinclorac is rather persistent in soils
and prone to leach into groundwater. There is no entry for quinclorac
in EPA's Pesticides in Ground Water Database. No established Maximum
Contaminant Level or health advisory levels have been established for
residues of quinclorac in drinking water.
i. Acute exposure and risk. For purposes of acute risk assessment,
the maximum estimated environmental concentration (EEC) for 3,7-
dichloro-8-quinoline carboxylic acid in drinking water (26.8 ppb in
surface water, GENEEC peak value) was used for comparison to the back-
calculated human health Drinking Water Level of Comparison (DWLOC) for
acute dietary exposure (52,000 g/L for the only population of
concern, females (13+ years/nursing). The estimated peak concentration
in surface water (26.8 g/L) is significantly less than EPA's
level of concern for 3,7-dichloro-8-quinoline carboxylic acid in
drinking water as a contribution to acute aggregate exposure.
ii. Chronic exposure and risk. For purposes of chronic risk
assessment, the maximum EEC for 3,7-dichloro-8-quinoline carboxylic
acid in drinking water (25.4 ppb in surface water, rather than 13.8 in
ground water, GENEEC average 56-day concentration) was used for
comparison to the back-calculated human health DWLOCs for chronic
dietary exposure (12,000 g/L for U.S. population; 2,700
g/L for infants/children). The estimated average concentration
in surface water (25.4 g/L) is significantly less than EPA's
level of concern for 3,7-dichloro-8-quinoline carboxylic acid in
drinking water as a contribution to chronic aggregate exposure and does
not result in an unacceptable level of chronic aggregate human health
risk estimate at this time.
3. From non-dietary exposure. There are no registered uses which
will result in non-dietary, non-occupational exposure to 3,7-dichloro-
8-quinoline carboxylic acid.
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 3,7-dichloro-8-quinoline carboxylic acid 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, 3,7-dichloro-8-quinoline carboxylic acid does not appear to
produce a toxic metabolite
[[Page 6545]]
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that 3,7-dichloro-8-quinoline
carboxylic acid has a common mechanism of toxicity with other
substances. For more 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. Using the conservative TMRC exposure assumptions
already described, and taking into account the completeness and
reliability of the toxicity data, EPA has calculated that the high end
exposure to 3,7-dichloro-8-quinoline carboxylic acid residues in food
will utilize 13% of the acute RfD for females 13+ years of age/nursing,
the most highly exposed subpopulation of the females 13+ subgroup,
which is the only subgroup of concern for acute dietary risk. The DWLOC
was back-calculated as described previously, and residues of 3,7-
dichloro-8-quinoline carboxylic acid which may be present in drinking
water are far below the DWLOC for females 13+ years of age/nursing.
Thus, EPA does not expect the acute aggregate exposure (food plus
water) to exceed 100% of the acute RfD. EPA generally has no concern
for acute exposures below 100% of the acute RfD, when the FQPA safety
factor has been removed, as is the case here. Based on all these
considerations, EPA concludes that there is a reasonable certainty that
no harm will result to the U.S. adult population from acute aggregate
exposure to 3,7-dichloro-8-quinoline carboxylic acid residues.
2. Chronic risk. Using the conservative TMRC exposure assumptions
already described, and taking into account the completeness and
reliability of the toxicity data, EPA has calculated that dietary
exposure to 3,7-dichloro-8-quinoline carboxylic acid residues in food
will utilize 17% of the chronic RfD for non-hispanic others which, for
3,7-dichloro-8-quinoline carboxylic acid, is the most highly
chronically exposed subgroup of the U.S. adult population. DWLOCs were
back-calculated as described previously, and residues of 3,7-dichloro-
8-quinoline carboxylic acid which may be present in drinking water are
far below the DWLOCs for U.S. adult populations, including non-hispanic
others. Thus, EPA does not expect the chronic aggregate exposure (food
plus water) to exceed 100% of the chronic RfD. EPA generally has no
concern for chronic exposures below 100% of the chronic RfD (when the
FQPA safety factor has been removed, as is the case here) because the
chronic RfD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. Under current EPA guidelines, non-dietary uses of 3,7-
dichloro-8-quinoline carboxylic acid do not constitute a chronic
exposure scenario, and thus are not a factor in chronic aggregate risk.
Based on all these considerations, EPA concludes that there is a
reasonable certainty that no harm will result to the U.S. adult
population from chronic aggregate exposure to 3,7-dichloro-8-quinoline
carboxylic acid residues.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential uses that may result in non-dietary, non-occupational
exposure. Such exposure to 3,7-dichloro-8-quinoline carboxylic acid is
not expected and endpoints for short- and intermediate-term exposures
have not been selected. Thus, short- and/or intermediate-term risk
assessments are not required.
4. Aggregate cancer risk for U.S. population. After considering an
equivocal increase of acinar cell adenomas of the pancreas in male
Wistar rats, 3,7-Dichloro-8-quinoline carboxylic acid was 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
from aggregate exposure to 3,7-dichloro-8-quinoline carboxylic acid
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 3,7-dichloro-8-quinoline carboxylic acid, 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
during 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 MOE and 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. In
the case of 3,7-dichloro-8-quinoline carboxylic acid, for purposes of
these section 18 exemption uses, the FQPA 10X safety factor to protect
infants and children in cases of enhanced susceptibility was removed
for the following reasons: (a) the toxicology data base is complete;
(b) there is no evidence of susceptibility in rat or rabbit
developmental studies, or in the rat 2-generation reproduction study;
(c) in the standard toxicity tests there is no indication of
neurotoxicity that would warrant follow-up testing; (d) non-dietary,
non-occupational exposures are not expected; and, (e) only limited
dietary exposure is expected from these section 18 uses on wheat and
grain sorghum. EPA concludes that reliable data support use of a 100-
fold margin of exposure/uncertainty factor, for the purposes of these
section 18 exemptions, to protect infants and children.
ii. Developmental toxicity studies-- a. Rats. In a developmental
toxicity study, 3,7-dichloro-8-quinoline carboxylic acid 3,7 (96.5%
a.i.), was administered to twenty-five female Wistar rats by gavage at
dose levels of 0, 24.4, 146, and 438 mg/kg/day from gestational days 6-
15, inclusive.
Maternal toxicity, observed at 438 mg/kg/day, was manifested as
increased mortality, decreased food consumption (10-15%) and increased
water consumption (31-54%) during the dosing and/or gestation period.
The maternal LOEL is 438 mg/kg/day. The maternal NOAEL is 146 mg/kg/
day.
No developmental toxicity was observed. The LOEL for developmental
[[Page 6546]]
toxicity is >436 mg/kg/day. The developmental NOEL is 436
mg/kg/day.
b. Rabbits. In a developmental toxicity study, 3,7-dichloro-8-
quinoline carboxylic acid (98.3% a.i.), was administered to fifteen
female Himalayan rabbits by gavage at dose levels of 0, 70, 200, or 600
mg/kg/day from gestational days 7-19, inclusive.
Maternal toxicity, observed at 200 mg/kg/day, was manifested as
decreased body weight gain (36%) and food consumption (13%) during the
dosing period. Additional findings noted at 600 mg/kg/day included
increased mortality, water consumption (7% over entire gestation),
increased incidence of clinical signs (reduced/no defecation, diarrhea,
apathy and poor general state) and discoloration of the kidney. The
maternal LOEL is 200 mg/kg/day. The maternal NOAEL is 70 mg/kg/day.
Developmental toxicity, observed at 600 mg/kg/day, consisted of
increased rate of resorption and post-implantation loss, a decrease in
the number of live fetuses, and reduced fetal body weight. The NOAEL
for developmental toxicity is 200 mg/kg/day.
iii. Reproductive toxicity study-- Rats. In a 2-generation
reproduction study, 3,7-dichloro-8-quinoline carboxylic acid
(97.3% a.i.) was administered to Wistar rats (24/sex/group)
at dietary levels of 0, 1,000, 4,000, or 12,000 ppm (0, 40, 160 or 480
mg/kg/day, respectively).
Evidence of toxicity was observed in the male and female parental
rats of both generations at 12,000 ppm (480 mg/kg/day). It consisted of
reduced body weight during the premating (both sexes) and lactation
period. In addition, increased incidence of interstitial nephritis was
noted among females. The LOEL for parental systemic toxicity is 12,000
ppm (480 mg/kg/day) based on decreased body weight during premating and
lactation. There were no other systemic effects that could be
attributed to treatment, nor was there any indication, at any treatment
level, of an effect on the reproductive performance of the adults.
Treatment-related effects were observed in F1 and
F2 offspring at 12,000 ppm (480 mg/kg/day) which consisted
of reduced pup viability, delay in growth and physical development
(pinna unfolding, eye opening), and reduction in pup survival.
Additionally, decreases in body weights of F1 and
F2 pups were noted throughout lactation.
Systemic LOEL = 480 mg/kg/day for males and females, based upon
decreased body weight during premating and lactation. Systemic NOAEL =
160 mg/kg/day for males and females.
Developmental LOEL = 480 mg/kg/day, based on decreased pup
viability, and pup weight, and delay in development (pinna unfolding
and eye opening). Developmental NOAEL = 160 mg/kg/day.
Reproductive LOEL = >480 mg/kg/day, based on lack of reproductive
effects. Reproductive NOAEL = 480 mg/kg/day.
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal toxicity for 3,7-dichloro-8-
quinoline carboxylic acid is complete with respect to current data
requirements. 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. For purposes of these section 18 exemption requests,
the FQPA 10X safety factor to protect infants and children in cases of
enhanced susceptibility was removed, based on reasons given above.
2. Acute risk. This risk assessment was not conducted. EPA did not
identify an appropriate endpoint which was applicable to infant and
children population subgroups.
3. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to 3,7-dichloro-8-quinoline
carboxylic acid from food will utilize 34% of the RfD for children (1-6
years), the most highly exposed subpopulation of the infant and
children subgroups. DWLOCs were back-calculated as described
previously, and residues of 3,7-dichloro-8-quinoline carboxylic acid
which may be present in drinking water are well below the DWLOCs for
this population subgroup. Thus, EPA does not expect the chronic
aggregate exposure (food plus water) to exceed 100% of the chronic RfD.
EPA generally has no concern for exposures below 100% of the RfD (when
the FQPA safety factor has been removed, as is the case here) because
the chronic RfD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. Under current EPA guidelines, non-dietary uses of 3,7-
dichloro-8-quinoline carboxylic acid do not constitute a chronic
exposure scenario, and thus are not a factor in chronic aggregate risk.
Based on all these considerations, EPA concludes that there is a
reasonable certainty that no harm will result to infants and children
from chronic aggregate exposure to 3,7-dichloro-8-quinoline carboxylic
acid residues.
4. Short- or intermediate-term risk. These risk assessments were
not conducted. EPA did not identify endpoints for short- and
intermediate-term exposures.
5. 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 3,7-dichloro-8-
quinoline carboxylic acid residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in/on rice is adequately understood. For
purposes of these section 18s only, the nature of the residues in/on
wheat and grain sorghum is considered to be adequately understood (by
translation from rice). The residue-of-concern is 3,7-dichloro-8-
quinoline carboxylic acid. The nature of the residue in animals is
adequately understood. The residue-of-concern in animal commodities is
3,7-dichloro-8-quinoline carboxylic acid.
B. Analytical Enforcement Methodology
GLC/ECD is available BASF Method A8902, rice; BASF Method 268/1,
animal and poultry tissues to enforce the tolerance expression. These
methods have both undergone agency method trial validation and were
found to be adequate to enforce the tolerances on rice and animal
commodities, with a limit of determination of 0.05 ppm.
Recovery data submitted indicate that BASF Method A8902 is also
suitable for wheat. The method should also be adequate for grain
sorghum for purposes of this use.
The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202, (703-305-5229).
C. Magnitude of Residues
Residues of 3,7-dichloro-8-quinoline carboxylic acid are not
expected to exceed the following levels as a result of this proposed
section 18 use:
------------------------------------------------------------------------
------------------------------------------------------------------------
Grain sorghum, forage...................................... 5 ppm
Grain sorghum, grain....................................... 4 ppm
Grain sorghum, stover...................................... 1 ppm
Wheat, forage.............................................. 5 ppm
Wheat, grain............................................... 4 ppm
Wheat, straw............................................... 1 ppm
------------------------------------------------------------------------
[[Page 6547]]
Residues of 3,7-dichloro-8-quinoline carboxylic acid are not
expected to exceed the following concentrations in wheat grain
processed fractions as a result of this section 18 use:
------------------------------------------------------------------------
------------------------------------------------------------------------
Wheat, milled fractions.................................... 40 ppm
Aspirated grain fractions.................................. 800 ppm
------------------------------------------------------------------------
Residues of 3,7-dichloro-8-quinoline carboxylic acid in animal
commodities are not expected to exceed the following concentrations as
a result of these section 18 uses:
------------------------------------------------------------------------
------------------------------------------------------------------------
Fat of cattle, goats, hogs, horses, and sheep.............. 0.6 ppm
Fat of poultry............................................. 0.2 ppm
Meat by-products of cattle, goats, hogs, horses, and sheep. 1.5 ppm
------------------------------------------------------------------------
These time-limited tolerances are higher than the existing
permanent tolerances (0.05 ppm) for residues (as specified in 40 CFR
180.463). The existing permanent tolerances for 3,7-dichloro-8-
quinoline carboxylic acid residues in meat of cattle, goats, hogs,
horses, poultry, and sheep (0.05 ppm); meat by-products of poultry (0.1
ppm); milk (0.05 ppm); and eggs (0.05 ppm) are sufficient for these
section 18 uses.
D. International Residue Limits
There are no Codex or Mexican maximum residue limits (MRLs)
established for 3,7-dichloro-8-quinoline carboxylic acid residues on
wheat or grain sorghum.
E. Rotational Crop Restrictions
Restrictions for 3,7-dichloro-8-quinoline carboxylic acid use on
wheat specify a plantback interval of not less than 10 months after
application for all crops except flax and lentils, which have a 24-
month interval. Similarly, restrictions for use on grain sorghum state
a 10-month post-application interval for plantback of all crops except
flax, peas, lentils, and sugar beets (24-month interval). Rotational
crop tolerances are not needed with these plantback intervals.
V. Conclusion
Therefore, the tolerances are established for residues of 3,7-
dichloro-8-quinoline carboxylic acid in wheat forage at 5 ppm, grain at
4 ppm, straw at 1 ppm, milled fractions at 40 ppm, aspirated grain
fractions at 800 ppm; sorghum, grain at 4 ppm, grain forage at 5 ppm,
grain fodder (stover) at 1 ppm; fat of cattle, goats, hogs, horses, and
sheep at 0.6 ppm; fat of poultry at 0.2 ppm ; and meat byproducts of
cattle, goats, hogs, horses, and sheep at 1.5 part per million (ppm).
VI. 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 April 12, 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
rulemaking. 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, Crystal Mall #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
anobjection 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300781] (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 Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #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
[[Page 6548]]
address in ADDRESSES at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. 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 prior consultation as
specficed by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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(l)(6), 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 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.
IX. 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
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: January 22, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.463 is amended to read as follows:
i. By designating the existing text as paragraph (a)(1) and adding
a heading to newly designated (a).
ii. By adding paragraph (b).
ii. By adding and reserving paragraphs (c) and (d) with headings to
read as follows:
Sec. 180.463 3,7-Dichloro-8-quinoline carboxylic acid; tolerances for
residues.
(a) General. (1) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide 3,7-dichloro-8-quinoline
carboxylic acid in connection with use of the pesticide under FIFRA
section 18 emergency exemptions granted by EPA.
[[Page 6549]]
The tolerances are specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cattle, fat..................... 0.6............... 5/30/00
Cattle, mbyp.................... 1.5............... 5/30/00
Goats, fat...................... 0.6............... 5/30/00
Goats, mbyp..................... 1.5............... 5/30/00
Hogs, fat....................... 0.6............... 5/30/00
Hogs, mbyp...................... 1.5............... 5/30/00
Horses, fat..................... 0.6............... 5/30/00
Horses, mbyp.................... 1.5............... 5/30/00
Poultry, fat.................... 0.2............... 5/30/00
Sheep, fat...................... 0.6............... 5/30/00
Sheep, mbyp..................... 1.5............... 5/30/00
Sorghum, grain fodder (stover).. 1................. 5/30/00
Sorghum, grain forage........... 5................. 5/30/00
Sorghum, grain, grain........... 4................. 5/30/00
Wheat, aspirated grain fractions 800............... 5/30/00
Wheat, forage................... 5................. 5/30/00
Wheat, grain.................... 4................. 5/30/00
Wheat, milled fractions......... 40................ 5/30/00
Wheat, straw.................... 1 5/30/00
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 371.
Sec. 186.1860 [Partially Redesignated and Removed]
b. Section 186.1860 is amended as follows:
i. By transferring the text of Sec. 186.1860 to Sec. 180.463, and
redesignating it as paragraph (a)(2).
ii. By removing the remainder of Sec. 186.1860.
[FR Doc. 99-3247 Filed 2-9-99; 8:45 am]
BILLING CODE 6560-50-F