[Federal Register Volume 62, Number 85 (Friday, May 2, 1997)]
[Rules and Regulations]
[Pages 24045-24051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11507]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300479; FRL-5713-2]
RIN 2070-AB78
Paraquat; 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 the herbicide paraquat in or on the food commodities
sorghum grain, sorghum forage, sorghum stover, sorghum aspirated grain
fractions, corn grain, corn forage, corn fodder, corn flour, and
poultry byproducts in connection with EPA's granting of an emergency
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of paraquat on sorghum and corn in Louisiana. This
regulation establishes maximum permissible levels for residues of
paraquat in these foods pursuant to the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
The tolerances will expire and are revoked on April 14, 1998.
DATES: This regulation becomes effective May 2 1997. Objections and
requests for hearings must be received by EPA on or before July 1,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300479], 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-300479], must also be submitted to: Public
Response and Program Resources Branch, Field Operations Division
(7506C), 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. 1132, CM #2, 1921 Jefferson
Davis Highway, 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: opp-docket@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All copies of objections and hearing requests in electronic form must
be identified by the docket number [OPP-300479]. No Confidential
[[Page 24046]]
Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and hearing requests on this rule may
be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Pat Cimino, Registration
Division (7505W), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA, (703) 308-8328, e-mail: cimino.pat@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, pursuant to section 408(e) and (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
and (l)(6), is establishing tolerances for residues of paraquat (1,1'-
dimethyl-4,4'-bipyridinium-ion), in or on grain sorghum at 5.0 part per
million (ppm), sorghum stover at 10.0 ppm, sorghum forage at 3.0 ppm,
aspirated sorghum grain fractions at 50.0 ppm, corn grain at 0.05 ppm,
corn forage at 3.0 ppm, corn fodder at 10.0 ppm, corn flour at 0.10 ppm
and poultry byproducts at 0.02 ppm. These tolerances will expire and be
revoked by EPA on April 14, 1998. After April 14, 1998, EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the 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, 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 below 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) 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, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemption for Paraquat on Sorghum and Corn and FFDCA
Tolerances
On August 6, 1996, the Louisiana Department of Agriculture Forestry
used its authority to declare the existence of a crisis situation
within the state, thereby authorizing use under FIFRA section 18 of
paraquat on sorghum and corn as a harvest aid for control of weeds.
Louisiana stated that above average rainfall has resulted in regrowth
and flushes of weeds in corn and sorghum rendering harvest difficult to
impossible in the state. This could result in an economic disaster for
Louisiana corn and sorghum producers.
As part of its assessment of these crisis declarations, EPA
assessed the potential risks presented by residues of paraquat in or on
sorghum and corn. In doing so, EPA considered the new safety standard
in FFDCA section 408(b)(2), and EPA decided to allow the crisis uses
only after concluding that the necessary tolerances under FFDCA section
408(l)(6) would clearly be consistent with the new safety standard and
with FIFRA section 18. These tolerances for paraquat will permit the
marketing of corn and sorghum treated in accordance with the provisions
of the section 18 emergency exemptions. Consistent with the need to
move quickly on the emergency exemptions and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment under section 408(e)
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on April 14, 1998, under FFDCA section 408(l)(5),
residues of paraquat not in excess of the amounts specified in the
tolerances remaining in or on sorghum and corn after that date will not
be unlawful, provided the pesticide is applied during the term of, and
in accordance with all the conditions of, the emergency exemptions. EPA
will take action to revoke these tolerances earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
EPA has not made any decisions about whether paraquat meets the
requirements for registration under FIFRA section 3 for use on sorghum
and corn, or whether permanent tolerances for paraquat for sorghum and
corn would be appropriate. This action by EPA does not serve as a basis
for registration of paraquat by a State for special local needs under
FIFRA section
[[Page 24047]]
24(c). Nor does this action serve as the basis for any State other than
Louisiana to use this product on this crop under section 18 of FIFRA
without following all provisions of section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemptions
for paraquat, contact the Agency's Registration Division at the address
provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, which
provides a dose that causes adverse effects (threshold effects) and
doses causing no observed effects (the ``no-observed effect level'' or
``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or margin of exposure calculation based on the
appropriate NOEL) will be carried out based on the nature of the
carcinogenic response and the Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. Dietary exposure
to residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100 percent
of every crop considered in the analysis is treated with the pesticide
being evaluated. If the TMRC exceeds the RfD or poses a lifetime cancer
risk that is greater than approximately one in a million, EPA attempts
to derive a more accurate exposure estimate for the pesticide by
evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances and that the entire crop may not have been
treated with the pesticide.
IV. Aggregate Risk Assessments, Cumulative Risk Discussion, 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. Paraquat is already registered by EPA for use on various
food and feed crops (see 40 CFR 180.205 for specific tolerances).
Tolerances exist for most of the food or feed crops affected by these
emergency exemptions [0.05 ppm (Non-Detectable) levels for corn (grain,
fodder and forage) and sorghum (grain and forage)]; however, they were
established for use patterns (primarily as pre-plant herbicide use for
reduced-tillage soil conservation farming practices) with much longer
pre harvest intervals (PHI) than these emergency exemption harvest-aid/
desiccant use patterns.
The pesticide residues from the emergency exemption harvest aid/
desiccant use pattern exceed the established tolerances, therefore, new
tolerance levels are required. Tolerances exist for meat, milk, poultry
and eggs to address the potential for secondary residues resulting from
the use of treated commodities as feed. Secondary residues in animal
commodities from this section 18 use, resulting from the use of sorghum
or corn as feed, are not expected to exceed existing tolerances with
the exception of poultry byproducts. The existing tolerance for poultry
byproducts is 0.01 ppm. Residues in poultry byproducts are not expected
to exceed 0.02 ppm as a result of these emergency exemption uses.
EPA has sufficient data to assess the hazards of paraquat and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for time-limited tolerances for residues of paraquat in or
on grain sorghum at 5.0 part per million (ppm), sorghum stover at 10.0
ppm, sorghum forage at 3.0 ppm, aspirated sorghum grain fractions at
50.0 ppm, corn grain at 0.05 ppm, corn forage at 3.0 ppm, corn fodder
at 10.0 ppm, corn flour at 0.10 ppm and poultry byproducts at 0.02 ppm.
Concentration is not expected in other corn processed commodities
(grits, oil, meal, and starch). The Agency's assessment of the dietary
exposures and risks associated with establishing these tolerances
follows.
A. Toxicological Profile
1. Chronic toxicity. The RfD of 0.0045 milligrams per kilogram per
day (mg/kg/day) was established by the Agency based on a 1-year dog
feeding study with a NOEL of 15 ppm (0.45 mg/kg/day) and an uncertainty
factor of 100. Chronic pneumonitis was observed at the next dose of
paraquat tested, 30 ppm (0.93 mg/kg/day, expressed as paraquat cation).
2. Acute toxicity. Based on the proposed and existing use patterns
and tolerances and available toxicological data, there are no acute
dietary exposure endpoints of concern for paraquat.
3. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified paraquat as Group ``E'' for carcinogenicity (evidence of
noncarcinogenicity for humans).
[[Page 24048]]
B. Aggregate Exposure
Tolerances have been established (40 CFR 180.205) for the residues
of paraquat in or on various food commodities ranging from 0.01 ppm in
milk to 30.0 ppm in bean straw.
Other potential sources of exposure of the general population to
residues of pesticides besides food are residues in drinking water and
residues from non-occupational sources such as indoor and outdoor
residential uses. There are no indoor or outdoor residential uses
registered for paraquat.
There are no acute dietary exposure or cancer risk endpoints of
concern for these uses of paraquat. Aggregate risk has been assessed
from chronic exposure to food and drinking water.
1. Dietary/food risk assessment considerations. For the purpose of
assessing potential chronic dietary exposure from paraquat, EPA assumed
tolerance levels for all uses and percent of crop treated refinements
for some commodities to estimate the Anticipated Residue Contribution
(ARC) from the proposed and existing food uses of paraquat. The use of
percent of crop treated data for some of the existing food uses in this
analysis results in a more refined estimate of exposure than the TMRC.
Percent of crop treated estimates are derived from Federal and private
market survey data and are considered to be reliable data. Typically, a
range of estimates are supplied and the upper end of this range is
assumed for the exposure assessment. By using this upper end estimate
of percent crop treated, the Agency is reasonably certain that exposure
is not understated for any significant subpopulation group.
2. Drinking water considerations. Review of terrestrial field
dissipation data by the Environmental Fate and Effects Division
indicates that paraquat is persistent and very soluble in water but has
a high affinity to bind to sediment. As noted in ``Pesticides in
Groundwater Database'' (EPA 734-12-92-001, Sept 1992), 971 wells were
sampled in 5 states from 1983 to 1990. Eleven of the 971 wells
exhibited positive hits, up to 0.1 milligram per liter (mg/L) (ppm).
However, the two wells that exhibited concentrations at 0.1 mg/L were
in Missouri, with a detection limit which was also 0.1 mg/L. The next
highest concentration of paraquat was 0.018 mg/L from a well in
Virginia, where the detection limit of the analytical method was
0.00001 mg/L 9. Based on the poor analytical methodology used, the
Agency believes that the Missouri data are unreliable. There is no
established Maximum Concentration Level for residues of paraquat in
drinking water. The following health advisory levels for paraquat in
drinking water have been established: children (short-term exposure)
0.1 mg/L; children (longer-term exposure) 0.05 mg/L; adult
(intermediate-term exposure) 0.2 mg/L; and adult (lifetime exposure)
0.03 mg/L.
Because the Agency lacks sufficient water-related exposure data to
complete a comprehensive drinking water risk assessment for many
pesticides, EPA has commenced and nearly completed a process to
identify a reasonable yet conservative bounding figure for the
potential contribution of water related exposure to the aggregate risk
posed by a pesticide. In developing the bounding figure, EPA estimated
residue levels in water for a number of specific pesticides using
various data sources. The Agency then applied the estimated residue
levels, in conjunction with appropriate toxicological endpoints (RfD's
or acute dietary NOEL's) and assumptions about body weight and
consumption, to calculate, for each pesticide, the increment of
aggregate risk contributed by consumption of contaminated water. While
EPA has not yet pinpointed the appropriate bounding figure for
consumption of contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause paraquat to exceed
the RfD if the tolerance being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with paraquat in water, even at the higher levels
the Agency is considering as a conservative upper bound for RfD
exposure considerations, would not prevent the Agency from determining
that there is a reasonable certainty of no harm if the tolerance is
granted.
3. Non-dietary, non-occupational considerations. Paraquat is not
registered for indoor or outdoor residential use.
C. 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical-specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether paraquat 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,
paraquat 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 paraquat has a common mechanism of toxicity
with other substances.
D. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. As discussed above, there are no acute dietary
exposure or cancer risk endpoints of
[[Page 24049]]
concern for these uses of paraquat and based on currently available
methodologies, no common mechanism of toxicity with other substances
has been assumed. The safety for the U.S. population from this use has
been determined using the aggregate risk assessment from chronic
exposure to food and drinking water.
Based on the completeness and reliability of the toxicity data and
the ARC dietary exposure assumptions, the Agency has concluded that
chronic dietary risk from food accounts for 10% of the RfD. Despite the
potential for exposure to paraquat in drinking water, EPA does not
expect the aggregate exposure to exceed 100% of the RfD, even at the
higher levels the Agency is considering as a conservative upper bound
for RfD exposure considerations. EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to paraquat residues.
2. Infants and children. Safety for infants and children from this
use has been determined from: Consideration of the special
susceptibilities of infants and children to pesticide residues
including neurological differences between infants and children and
adults, and effects of in utero exposure to pesticides and; aggregate
risk assessment from chronic exposure to food and drinking water. As
discussed above, there are no acute dietary exposure for these uses of
paraquat and based on currently available methodologies, no common
mechanism of toxicity with other substances has been assumed. A
detailed explanation of the risk assessment follows:
i. Special susceptibility of infants and children considerations.
In assessing the potential for additional sensitivity of infants and
children to residues of paraquat, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-year
reproductive toxicity study in rats. The developmental toxicity studies
are designed to evaluate adverse effects on the developing organism
resulting from pesticide exposure during pre-natal development to one
or both parents. Reproductive toxicity studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
The results of the rat and mouse developmental studies have been
used to assess the potential for additional pre-natal sensitivity to
infants and children. In the rat developmental study, the maternal
(systemic) NOEL and the developmental (fetus) NOEL are both 1 mg/kg/
day. The LOELs are 5 mg/kg/day for both maternal (mother) and
developmental (fetus) effects. The maternal NOEL and LOEL were based on
clinical signs of thin and hunched appearance and decreased body weight
gains. Developmental toxicity was manifested as decreases in fetal body
weight and delayed ossification in forelimb and hindlimb digits. The
developmental results at 5 mg/kg/day do not indicate any severe effects
in comparison to the maternal effects at the LOEL, which would
necessitate an acute dietary risk assessment for females 13+.
From the mouse developmental study, the maternal (systemic) and
developmental (fetus) NOELs were established at 1 mg/kg/day with the
LOELs set at 5 mg/kg/day. Maternal toxicity was observed at 5 mg/kg/day
and above as reduction in body weight gain. Developmental toxicity was
observed at 5 mg/kg/day as partially ossified 4th sternebrae. The
developmental effects at the LOEL of 5 mg/kg/day do not demonstrate any
special pre-natal sensitivity.
In both developmental toxicity studies, maternal (mother) and
developmental (fetus) NOEL/LOEL levels and effects at the LOEL suggest
that there is no special pre-natal sensitivity for infants and children
from exposure to paraquat residues in the diet.
The results of the 2-generation rat reproduction study have been
used to assess the potential for additional post-natal sensitivity. In
the rat reproduction study the parental (systemic) NOEL was 1.25 mg/kg/
day and the LOEL was 3.75 mg/kg/day based on increased incidence of
alveolar histiocytosis. No reproductive effects were observed;
therefore, the pup NOEL was considered to be >7.5 mg/kg/day, the
highest dose tested. This result indicates that there are no special
pre- or post- natal sensitivities to paraquat residues for infants and
children.
ii. Safety factor considerations. FFDCA section 408 provides that
EPA shall apply an additional safety factor for infants and children in
the case of threshold effects to account for pre- and post-natal
toxicity and the completeness of the data base unless EPA concludes,
based on reliable evidence, that a different safety factor is
protective of infants and children. EPA believes that reliable data
support using a different safety factor (usually 100x) and not the
additional safety 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 traditional safety
factors. Based on current toxicological data requirements, the data
base for paraquat relative to pre- and post-natal toxicity is complete.
As described above, NOEL/LOEL levels and effects at the LOEL, from the
developmental and the reproductive studies, suggest that there is no
special pre- or post-natal sensitivity for infants and children from
exposure to paraquat residues in the diet. The Agency has concluded
that reliable data support use of the standard uncertainty factor as
protecting the safety of infants and children and that an additional
tenfold margin of exposure is unnecessary.
iii. Chronic risk. Based on ARC exposure estimates for food, as
described above, EPA has concluded that the percentage of the RfD that
will be utilized by dietary (food only) exposure to residues of
paraquat ranges from 15% for children 7 to 12 years old, up to 31% for
non-nursing infants. Despite the potential for exposure to paraquat in
drinking water, EPA does not expect the aggregate exposure to exceed
100% of the RfD, even at the higher levels the Agency is considering as
a conservative upper bound for RfD exposure considerations. EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to paraquat residues.
V. Other Considerations
The nature of the residue in plants and animals is adequately
understood for these tolerances. Codex maximum residue levels (MRL) are
established for residues of paraquat for corn grain at 0.1 ppm and for
sorghum grain at 0.5 ppm. The proposed tolerances for corn grain at
0.05 ppm and sorghum grain at 5.0 ppm differ from the Codex MRLs based
on field residue data generated in the United States for these uses
(Pesticide Petitions 5F1625 and 5H5088 for corn grain and 5F1591 for
sorghum grain). These data indicate that use of the pesticide according
to good agricultural practices and under the terms of the FIFRA
emergency exemption will not result in residues in corn grain greater
than 0.05 ppm or in sorghum grain greater than 5.0 ppm. Differences in
use patterns and pre-harvest intervals may account for the differences
between the Codex MRLs and the tolerance values generated from the
pesticide residue trials in the United States. For purposes of these
section 18 uses, the time-limited tolerances will be established at
0.05 ppm for corn grain and 5.0 ppm for sorghum grain. Harmonization of
the U.S. tolerances with the Codex MRLs will be addressed if permanent
tolerances and registrations are requested. Adequate enforcement
[[Page 24050]]
methodology, method I of PAM, Vol. II (spectrophotometric), is
available to enforce the tolerance expression. The method is available
to anyone who is interested in pesticide residue enforcement from: By
mail, Calvin Furlow, Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Crystal Mall #2, Rm. 1128, 1921
Jefferson Davis Highway, Arlington, VA (703) 305-5805.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18
emergency exemptions are established for residues of paraquat in or on
grain sorghum at 5.0 part per million (ppm), sorghum stover at 10.0
ppm, sorghum forage at 3.0 ppm, aspirated sorghum grain fractions at
50.0 ppm, corn grain at 0.05 ppm, corn forage at 3.0 ppm, corn fodder
at 10.0 ppm, corn flour at 0.10 ppm and poultry byproducts at 0.02 ppm.
These tolerances will expire and be revoked by EPA on April 14, 1998.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by July 1, 1997, 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 above (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). 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.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
number [OPP-300479] (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 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above 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 rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply.
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
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 General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 17, 1997.
Stephen L. Johnson,
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:
[[Page 24051]]
Authority: 21 U.S.C. 346a and 371.
2. Section 180.205 is amended as follows:
a. In paragraph (a) by adding a paragraph heading, and new entries
in alphabetical order to the table.
b. By redesignating paragraph (b) as paragraph (c) and adding a new
paragraph (b).
c. In newly designated paragraph (c) by adding a paragraph heading.
d. By adding and reserving paragraph (d).
e. By revising the phrase ``raw agricultural'' to read ``food''
throughout the section.
Sec. 180.205 Paraquat; tolerances for residues
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hops, dried................................................ 0.2
* * * * *
Mint, hay, spent........................................... 3.0
Sunflower, seed hulls...................................... 6.0
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the desiccant, defoliant, and herbicide
paraquat (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from
applications of either the bis (methyl sulfate) or the dichloride salt
(both calculated as the cation) in connection with use of the pesticide
under section 18 emergency exemptions granted by EPA in or on the
following food commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Sorghum grain.............................. 5.0 4/14/98
Sorghum stover............................. 10.0 4/14/98
Sorghum forage............................. 3.0 4/14/98
Sorghum, aspirated grain fractions......... 50.0 4/14/98
Corn grain................................. 0.05 4/14/98
Corn forage................................ 3.0 4/14/98
Corn fodder................................ 10.0 4/14/98
Corn flour................................. 0.10 4/14/98
Poultry, mbyp.............................. 0.02 4/14/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. * * *
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-11507 Filed 5-1-97; 8:45 am]
BILLING CODE 6560-50-F
