[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: [email protected].
    Copies of objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Copies of objections and hearing requests will also be 
accepted on disks in WordPerfect 5.1 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: [email protected].
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:
    [email protected].


    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