[Federal Register Volume 62, Number 168 (Friday, August 29, 1997)]
[Rules and Regulations]
[Pages 45748-45754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23094]



[[Page 45748]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185 and 186

[OPP-300542; FRL-5739-8]
RIN 2070-AB78


Paraquat; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes time-limited tolerances for 
paraquat (1,1'-dimethyl-4,4'-bipyridinium-ion) in or on dry peas and 
mustard seed. This action is in response to EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on dry peas in Idaho, 
Oregon and Washington, and mustard seed in Washington. This regulation 
establishes maximum permissible levels for residues of paraquat 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. The tolerances will expire and are revoked on November 15, 
1998.

DATES: This regulation is effective August 29, 1997. Objections and 
requests for hearings must be received by EPA on or before October 28, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300542], 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-300542], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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 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 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 control 
number [OPP-300542]. No Confidential 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 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) 308-9357, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, 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 
the herbicide/desiccant/defoliant paraquat, in or on dry peas at 0.3 
parts per million (ppm) and mustard seed at 5.0 ppm. These tolerances 
will expire and are revoked on November 15, 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 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, 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) 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 tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Paraquat on Dry Peas and Mustard Seed 
and FFDCA Tolerances

    The Idaho Department of Agriculture requested a regional emergency 
exemption for use of paraquat dichloride (Gramoxone Plus Herbicide) for 
desiccation of weeds infesting green peas grown for seed and dry peas 
in Idaho, Oregon and Washington in March, 1997. Unusually cold, wet 
weather delayed the pea planting season resulting in late pea emergence 
and higher incidence of weed infestations in fields. Continued moist, 
cool weather has contributed to weeds remaining green at harvest. Weeds 
plug harvesting equipment delaying harvest and the

[[Page 45749]]

delays result in downgraded or unmarketable peas due to shattered pods, 
bleached and sloughed seed coats and sprouting. There are currently no 
registered pesticides or alternative methods of control which can 
provide desiccation of weeds and permit harvest of the crops. After 
having reviewed the submission, EPA concurs that emergency conditions 
exist for these states.
    The Washington Department of Agriculture requested a specific 
exemption for use of paraquat (Gramoxone Extra Herbicide) for 
desiccation of weeds in mustard seed grown for processing (condiment). 
An early season freeze coupled with continuous cool, early season 
growing conditions stunted this years' mustard crop and allowed weeds, 
predominantly Russian thistle, to become established in the crop. 
Affected growers will be unable to harvest infested mustard fields 
without the use of a desiccant harvest aid. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this state.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of paraquat in or on 
dry peas and mustard seed. In doing so, EPA considered the new 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 
new 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 these tolerances will expire and are 
revoked on Nov 15, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on dry peas and mustard seed after that date will not 
be unlawful, provided the pesticide is applied in a manner that was 
lawful under FIFRA. 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 paraquat meets EPA's 
registration requirements for use on dry peas and mustard seed or 
whether permanent tolerances for these uses would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of paraquat by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any State other than Idaho, Oregon, and Washington for dry 
peas and Washington for mustard seed to use this pesticide on these 
crops 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 exemption 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. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal 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. EPA generally uses the 
RfD to evaluate the chronic risks posed by pesticide exposure. For 
shorter term risks, EPA calculates a margin of exposure (MOE) by 
dividing the estimated human exposure into the NOEL from the 
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be 
unacceptable. This 100-fold MOE is based on the same rationale as the 
100-fold uncertainty factor.
    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 MOE 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.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide

[[Page 45750]]

applications. However, since enaction of FQPA, this assessment has been 
expanded to include both dietary and non-dietary sources of exposure, 
and will typically consider exposure from food, water, and residential 
uses when reliable data are available. In this assessment, risks from 
average food and water exposure, and high-end residential exposure, are 
aggregated. High-end exposures from all three sources are not typically 
added because of the very low probability of this occurring in most 
cases, and because the other conservative assumptions built into the 
assessment assure adequate protection of public health. However, for 
cases in which high-end exposure can reasonably be expected from 
multiple sources (e.g. frequent and widespread homeowner use in a 
specific geographical area), multiple high-end risks will be aggregated 
and presented as part of the comprehensive risk assessment/
characterization. Since the toxicological endpoint considered in this 
assessment reflects exposure over a period of at least 7 days, an 
additional degree of conservatism is built into the assessment; i.e., 
the risk assessment nominally covers 1-7 days exposure, and the 
toxicological endpoint/NOEL is selected to be adequate for at least 7 
days of exposure. (Toxicity results at lower levels when the dosing 
duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    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, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). 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. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
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% of the crop is treated by pesticides that have 
established tolerances. 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.
    Percent of crop treated estimates are derived from federal and 
private market survey 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 of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup non-nursing 
infants (less than 1 year old) was not regionally based.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the hazards of paraquat 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for time-limited tolerances for paraquat (1,1'-
dimethyl-4,4'-bipyridinium-ion) on dry peas at 0.3 ppm and mustard seed 
at 5.0 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by paraquat are 
discussed below.
    1. 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.
     2. Short - and intermediate - term toxicity. Short- and 
intermediate-term aggregate exposure takes into account chronic dietary 
food and water (considered to be a background exposure level) plus 
indoor and outdoor residential uses. There are no indoor residential 
uses of paraquat and based on the nature of the non-food outdoor uses, 
the Agency does not expect significant exposure from the registered 
outdoor residential uses (spot treatment of vegetation for ornamental 
crop production) of paraquat. Therefore, a short- and intermediate-term 
aggregate risk assessment has not been performed.
    3. Chronic toxicity. EPA has established the RfD for paraquat at 
0.0045 milligrams/kilogram/day (mg/kg/day). This RfD is based on a one 
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).
    4. 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.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.205) for the herbicide/desiccant/defoliant paraquat (1,1'-
dimethyl-4,4'-bipyridinium-ion) , in or on a variety of plant raw 
agricultural commodities ranging from 0.05 ppm in broccoli to 30 ppm in 
bean straw, and animal commodities ranging from 0.01 ppm (non-
detectable residues) in milk and eggs to 0.30 ppm for cattle kidney. 
Risk assessments were conducted by EPA to assess dietary exposures and 
risks from paraquat 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

[[Page 45751]]

a one day or single exposure. 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.
    ii. Chronic exposure and risk. 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.
    2. From drinking water. 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 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. 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 exposure 
from 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, would not prevent the Agency 
from determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    3. From non-dietary exposure. Paraquat is registered for use in 
federal conservation reserve programs and for weed control in 
ornamental crop production; however, the Agency does not expect 
significant exposure from these registered outdoor non-food uses.
    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.'' 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.

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. No acute toxicity effect of concern was identified 
by the Agency, so this risk assessment is not required.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to paraquat from 
dietary (food only) sources will utilize 10 % of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is non-nursing infants less than 1 year old. The chronic risk 
for infants and children is discussed below. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Despite the 
potential for exposure to paraquat in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% of the RfD. EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to paraquat residues.

[[Page 45752]]

    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. There are no indoor residential uses for paraquat 
and based on the nature of the outdoor non-food uses, the Agency does 
not expect significant exposure from the registered outdoor residential 
uses (spot treatment of vegetation for ornamental crop production) of 
paraquat. Therefore, a short- and intermediate-term aggregate risk 
assessment has not been performed.

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 paraquat, EPA considered data from 
developmental toxicity studies in the rat and mouse and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development 
to one or both parents. 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 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.
    ii. Developmental toxicity studies-- a. Rats. The maternal NOEL was 
1 mg/kg/day. The maternal LOEL of 5 mg/kg/day (expressed as paraquat 
cation) was 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 NOEL and LOEL were 1 mg/kg/day and 5 mg/kg/day, 
respectively.
    b. Mice. The maternal NOEL was 1 mg/kg/day expressed as paraquat 
cation). The maternal LOEL of 5 mg/kg/day was based on a reduction in 
body weight gain. The NOEL for developmental toxicity was also 1 mg/kg/
day. The LOEL of 5 mg/kg/day was based on partially ossified 4th 
sternebrae.
    iii. Reproductive toxicity study--Rats. The NOEL for systemic 
toxicity in the adults was 25 ppm (1.25 mg/kg/day). The LOEL of 75 ppm 
(3.75 mg/kg/day), expressed as paraquat cation, was based on the 
increased incidence of alveolar histiocytosis in the parents. The 
reproductive/developmental toxicity NOEL was considered to be > 150 ppm 
(7.5 mg/kg/day, expressed as paraquat cation) at the highest dose 
tested since no reproductive effects were presented in this study.
    iv. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicology data base for paraquat is complete with respect to current 
toxicological data requirements.
    In the rat developmental study, the maternal (systemic) NOEL and 
the developmental NOEL are both 1 mg/kg/day. The LOELs are 5 mg/kg/day 
for both maternal and developmental effects. The developmental results 
at 5 mg/kg/day do not indicate any severe effects compared to the 
maternal effects at the LOEL. In the mouse developmental study, the 
maternal (systemic) and developmental NOELs were established at 1 mg/
kg/day with the LOELs set at 5 mg/kg/day. The developmental effects at 
the LOEL of 5 mg/kg/day do not demonstrate any special pre-natal 
sensitivity for infants and children which would require an additional 
safety factor.
    In both studies, maternal and developmental NOEL/LOEL levels and 
effects at the LOEL suggest that there is no increased sensitivity for 
infants and children from exposure to paraquat residues in the diet.
    In the rat reproduction study the parental (systemic) NOEL was 1.25 
mg/kg/day. The pup NOEL was considered to be > 7.5 mg/kg/day at the 
highest dose tested which suggests that there is no increased post-
natal sensitivity to paraquat.
    v. Conclusion. The effects observed in the mouse and rat 
developmental studies and the rat reproductive study did not 
demonstrate any special pre- or post-natal sensitivity for infants and 
children.
    The Agency concludes that reliable data support use of the standard 
100-fold uncertainty factor and that an additional uncertainty factor 
is not needed to protect infants and children.
    2. Acute risk. No acute effect endpoint of concern was identified 
by the Agency so this risk assessment is not required.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that the percentage of the RfD that 
will be utilized from dietary (food only) exposure to paraquat ranges 
from 12% for nursing infants to 31% for non-nursing infants less than 1 
year old. EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Under current guidelines, the registered 
residential uses (weed control in ornamental crop production) do not 
fall under a chronic scenario. Despite the potential for exposure to 
paraquat in drinking water and from non-dietary, non-occupational 
exposure, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD. 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

A. Metabolism In Plants and Animals

    The qualitative nature of the residue in plants and animals has 
been determined. The residue of concern is the parent compound, 
paraquat, only, as specified in 40 CFR 180.205.

B. Analytical Enforcement Methodology

    Method I of PAM, Vol. II (spectrophotometric), is adequate for 
tolerance enforcement purposes. In addition, the Agency concluded that 
Method 1B adequately recovers paraquat cation residues from samples of 
potatoes and soybeans treated with radiolabeled paraquat.

C. Magnitude of Residues

    Residues of paraquat are not expected to exceed 0.3 ppm in/on dry 
peas and 5.0 ppm in/on mustard seed as a result of these section 18 
uses. For the purposes of the dried pea section 18 requests only, the 
Agency is willing to accept the proposed prohibition for feeding the 
pea byproducts. No animal feed items are associated with the proposed 
use on mustard seed.

[[Page 45753]]

D. International Residue Limits

     No CODEX, Canadian, and/or Mexican MRLs/tolerances have been 
established for residues of paraquat on peas or mustard seed.

E. Rotational Crop Restrictions.

     As noted in the residue chemistry chapter of the Paraquat 
Reregistration Eligibility Document, no plantback restrictions or field 
rotational crop studies are required.

VI. Conclusion

    Therefore, tolerances are established for paraquat (1,1'-dimethyl-
4,4'-bipyridinium-ion) in/on dry peas at 0.3 ppm and mustard seed at 
5.0 ppm in 40 CFR 180.205. In addition, Sec. 180.205 was restructured 
in a final rule published in the Federal Register on May 2, 1997 (62 FR 
24045)(FRL-5713-2) to combine the tolerances for food and feed 
commodities and raw agricultural commidities into the same section. At 
that time the food and feed additive tolerances in Secs. 185.4700 and 
186.4700 were combined with the tolerances in Sec. 180.205(a). 
Therefore, Secs. 185.4700 and 186.4700 are no longer necessary and are 
removed in this rule.

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 October 28, 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 
Confidential Business Information (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 
control number [OPP-300542] (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 Information and Records 
Integrity Branch, Information Resources and Services 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 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a time limited tolerance on EPA's own 
initiative, under FFDCA section 408(d). 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 specified 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 these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the time limited 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 has 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.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory

[[Page 45754]]

Enforcement Fairness Act of 1996, the Agency has 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 this rule in today's 
Federal Register. This 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 185

    Environmental protection, Food additives, Pesticides and pests.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticides and pests.


    Dated: August 18, 1997.

James Jones,

Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I, parts 180, 185, and 186 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. In Sec. 180.205, the table in paragraph (b) is amended by 
ordering alphabetically the existing entries, and by adding 
alphabetically entries for ``peas, (dry),'' and ``mustard, seed,'' to 
read as follows:


Sec. 180.205  Paraquat; tolerances for residues.

*       *       *       *        *
    (b) *      *      *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Peas (dry)......................  0.3                 November 15, 1998 
Mustard, seed...................  5.0                 November 15, 1998 
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

*       *       *       *        *

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority : 21 U.S.C. 346a and 348.

Sec. 185.4700 [Removed]

    b. Section 185.4700 is removed.

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:
    Authority : 21 U.S.C. 346a and 348.

Sec. 186.4700 [Removed]

    b. Section 186.4700 is removed.

[FR Doc. 97-23094 Filed 8-28-97; 8:45 am]
BILLING CODE 6560-50-F