[Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
[Rules and Regulations]
[Pages 63714-63720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30411]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300949; FRL-6392-9]
RIN 2070-AB78


Paraquat; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of paraquat (1,1'-di-methyl-4,4'-bipyridinium-ion) in or on 
artichokes. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
artichokes. This regulation establishes a maximum permissible level for 
residues of paraquat in this food commodity. The tolerance will expire 
and is revoked on December 31, 2000.

DATES: This regulation is effective November 22, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300949, 
must be received by EPA on or before January 21, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300949 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number:(703) 308-9364; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
              Categories                NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                   111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under

[[Page 63715]]

the ``Federal Register--Environmental Documents.'' You can also go 
directly to the Federal Register listings at http://www.epa.gov/
fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300949. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings 

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing a tolerance for residues of the herbicide paraquat, in or 
on artichokes at 0.05 part per million (ppm). This tolerance will 
expire and is revoked on December 31, 2000. EPA will publish a document 
in the Federal Register to remove the revoked tolerance from the Code 
of Federal Regulations.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Paraquat on Artichokes and FFDCA 
Tolerances

    Simazine has been used in the past to control common chickweed, 
mustard, Bermuda buttercup, certain grasses and older weeds in 
artichokes. With the imminent cancellation of simazine on artichokes, 
the industry purchased all existing stocks. However, growers are 
expected to deplete the existing stocks of simazine, labeled for 
artichokes by September of 1999. EPA has authorized under FIFRA section 
18 the use of paraquat on artichokes for control of weeds in 
California. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of paraquat in or on 
artichokes. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although this tolerance will 
expire and is revoked on December 31, 2000, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on artichokes after that 
date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by this tolerance at the time of that 
application. EPA will take action to revoke this tolerance earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether paraquat meets 
EPA's registration requirements for use on artichokes or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of paraquat by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any State other than California to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing section 18 as identified in 40 CFR part 166. 
For additional information regarding the emergency exemption for 
paraquat , contact the Agency's Registration Division at the address 
provided under ``FOR FURTHER INFORMATION CONTACT.''

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of paraquat 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a time-limited tolerance for residues of 
paraquat on artichokes at 0.05 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,

[[Page 63716]]

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 in 
this unit.

B. Toxicological Endpoint

    1. Acute toxicity. An acute reference dose (acute RfD) of 0.03 
milligrams per kilogram per day (mg/kg/day) has been identified for 
females 13+ years old and the general population including infants and 
children. For females 13+ the acute RfD is based on the maternal no 
observable adverse effects level (NOAEL) of 3 milligrams/kilogram/day 
(mg/kg/day) derived from the combined results of two developmental 
studies in rats. The effects of concern are delayed ossification of the 
forelimb and hindlimb digits. The maternal NOAEL of 3 mg/kg/day has 
also been identified as the endpoint of concern for the acute RfD for 
the general population including infants and children. The effects of 
concern are based on clinical signs of toxicity, decreased body weight 
gain, and respiratory distress and histopatholgy of the lungs An 
uncertainty factor (UF) of 100 (10x for inter-species extrapolation and 
10x for intra-species variability) is appropriate. The 10x FQPA Safety 
factor to account for enhanced sensitivity of infants and children as 
required by FFDCA section 408 (b)(2)(C) was reduced to 1x for acute 
exposures. The acute Population Adjusted Dose (aPAD) is a modification 
of the acute RfD to accommodate the FQPA Safety Factor. The aPAD is 
equal to the acute RfD divided by the FQPA Safety Factor. Therefore, 
for females 13+ years old and the general population including infants 
and children the dietary aPAD is 0.03 mg/kg/day.
    2. Short- and intermediate-term toxicity. The NOAEL of 3.0 mg/kg/
day derived from the combined results of two developmental studies in 
rats was identified as the short- and intermediate-term endpoints for 
dermal exposures. At lowest observable adverse effects level (LOAEL) of 
5.0 mg/kg/day, there were clinical signs of toxicity, decreased body 
weight gain, and lung histopathology. A 0.3% dermal absorption rate 
should be used in risk assessments.
    3. Chronic toxicity. EPA has established the chronic RfD for 
paraquat at 0.0045 mg/kg/day. The chronic RfD is based on the NOAEL of 
0.45 mg/kg/day from a one year oral study in dogs. At the LOAEL of 0.93 
mg/kg/day the effects were chronic pneumonitd. An UF of 100 (10x for 
inter-species extrapolation and 10x for intra-species variability is 
appropriate. The 10x FQPA Safety factor to account for enhanced 
sensitivity of infants and children as required by FFDCA section 408 
(b)(2)(C) is not applicable because the endpoint used in deriving the 
chronic RfD is based on chronic pneumonitd (not developmental or 
neurotoxic effects) in adult dogs after chronic exposure and thus are 
not relevant for enhanced sensitivity to infants and children. The 
chronic Population Adjusted Dose (cPAD) is a modification of the 
chronic RfD to accommodate the FQPA Safety Factor. The cPAD is equal to 
the chronic RfD divided by the FQPA Safety Factor. Hence for chronic 
exposures, the cPAD and chronic RfD are the same (0.0045 mg/kg/day).
     4. Carcinogenicity. Paraquat is classified as Group E (no evidence 
of carcinogenicity in humans).

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.205) for the residues of paraquat, in or on a variety of raw 
agricultural commodities. Tolerances have also been established for 
fat, kidney, meat, and meat byproducts for cattle, goats, hogs, horses, 
poultry and sheep as well as tolerances for eggs and milk. 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 a one day or single exposure. The Dietary Exposure Evaluation Model 
(DEEMTM) analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-91 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. At the 95th percentile exposure 
level, assuming 100 percent crop treated and tolerance level residues 
for all commodities, 13 percent of the aPAD was utilized for the U.S. 
Population and 23 percent of the aPAD was utilized for children (1-6 
years old), the subgroup with the highest exposure. The results of this 
analysis indicate that the acute dietary risk associated with existing 
uses and the proposed use of paraquat is below the Agency's level of 
concern.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment the DEEMTM analysis evaluated the individual 
food consumption as reported by respondents in the USDA 1989-91 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. Assuming 
tolerance level residues for all commodities and 100 percent crop 
treated values, 31 percent of the cPAD was utilized for the U.S. 
Population and 69 percent of the cPAD was utilized for children (1-6 
years old), the subgroup with the highest exposure. The results of this 
analysis indicate that the chronic dietary risk associated with 
existing uses and the proposed use of paraquat is below the Agency's 
level of concern.
    2. From drinking water. Paraquat dichloride binds strongly to soil 
clay particles and it did not leach from the surface in terrestrial 
field dissipation studies. There were, however, detections of paraquat 
in drinking water wells from two states cited in the Pesticides in 
Ground Water Database (1991). These detections are not considered to be 
representative of normal paraquat use. Therefore, paraquat is not 
expected to be a groundwater contaminant or concern based on normal use 
patterns.
    Due to its persistent nature, paraquat could potentially be found 
in surface water systems associated with soil particles carried by 
erosion, however, paraquat is immobile in most soils, and at very high 
application rates (50-1000X), there was no desorption of paraquat from 
soils. Therefore, based on paraquat's normal use patterns and unique 
environmental fate characteristics, exposures to paraquat in drinking 
water are not expected to be obtained from surface water sources.
    3. From non-dietary exposure. Paraquat is not registered on any use 
sites which would result in non-dietary, non-occupational exposure. 
Therefore, EPA expects only dietary and occupational exposure from the 
use of paraquat.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether 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

[[Page 63717]]

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. For more 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances 
(62 FR 62961, November 26, 1997).

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

    1. Acute risk. Acute aggregate exposure takes into account acute 
dietary food and water exposures plus other indoor and outdoor non-
occupational exposure. Since paraquat is not registered on any use 
sites which would result in non-dietary, non-occupational exposure and 
exposure to ground or surface water is not expected, the only non-
occupational exposure to paraquat is expected through consumption of 
food. Therefore acute aggregate risk to paraquat is assumed to be the 
same as estimated risk from food and feed uses: at the 95th percentile 
exposure level, assuming 100 percent crop treated and tolerance level 
residues for all commodities, 13 percent of the aPAD was utilized for 
the U.S. Population.
    2. Chronic risk. Chronic-term aggregate exposure takes into account 
chronic dietary food and water plus other indoor and outdoor non-
occupational exposure. Since there are no non-dietary, non-occupational 
exposures expected from the use of this chemical and paraquat is not 
expected to reach ground or surface water, the only non-occupational 
exposure to paraquat is anticipated through consumption of food. 
Therefore chronic aggregate risk to paraquat is expected be the same as 
the estimated risk from food and feed uses: assuming tolerance level 
residues for all commodities and 100 percent crop treated values, 31 
percent of the cPAD was utilized for the U.S. Population.
    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. Paraquat is not registered on any use sites which 
would result in non-dietary, non-occupational exposure. Therefore no 
short- and intermediate-term aggregate risk assessments are needed.
    4. Aggregate cancer risk for U.S. population. Paraquat is 
classified as Group E (no evidence of carcinogenicity in humans).
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to paraquat residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of paraquat, EPA considered data from 
developmental toxicity studies in the rat and mice and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans. EPA believes that reliable data 
support using the standard MOE and uncertainty factor (usually 100 for 
combined interspecies and intraspecies 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. In a developmental study in 
rats, the maternal NOAEL is 8 mg/kg/day (HDT). No LOAEL was identified 
and there were no maternal or developmental effects observed in the 
study.
    In another developmental study in rats, the maternal NOAEL is 1 mg/
kg/day based on thin and hunched appearance, decreased body weight 
gain, and histological changes in the lungs and kidneys of non-
survivors at 5 mg/kg/day (LOAEL). The developmental NOAEL is 1 mg/kg/
day based on delayed ossification in the fore- and hindlimb digits at 5 
mg/kg/day (LOAEL). (The overall maternal and developmental NOAEL for 
the rat is considered 3 mg/kg/day based on the results from two 
developmental studies.)
    In a developmental study in mice, the maternal NOAEL is 5 mg/kg/day 
based on statistically significant decreases in body weight gain at 10 
mg/kg/day (LOAEL). The developmental NOAEL is 5 mg/kg/day based on 
statistically significant decreases in body weight gain at 10 mg/kg/day 
(LOAEL).
    In another developmental study in mice, the maternal NOAEL is 15 
mg/kg/day based clinical signs, death, decreased body weight gain, 
decreased body weight, increased organ weight (lung w/ trachea, 
kidney), dark red lung lobes, and possible decrease in pregnancy rate 
at 25 mg/kg/day (LOAEL). The developmental NOAEL is 15 mg/kg/day based 
on decreased mean fetal weight, retarded ossification of occipital, 
increased number with extra 14th ribs, increased number with unossified 
astragalus in the hindlimb, and an increased number with  6 
caudal centra.
    iii. Reproductive toxicity study. In a 2-generation reproductive 
study in rats, the NOAEL for paternal toxicity is 1.25 mg/kg/day based 
on increased incidence of alveolar histiocytes, discolored lungs, 
fibrosis, edema at the LOAEL of 3.75 mg/kg/day. There were no 
reproductive effects seen in this study therefore, the reproductive 
NOAEL/LOAEL is 7.5 mg/kg/day (HDT).
    iv. Prenatal and postnatal sensitivity. The Agency has determined 
that there is no indication of additional sensitivity to young rats or 
mice following pre-and/or postnatal exposure to paraquat.
    v. Conclusion. There is a complete toxicity data base for paraquat 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. Data provided no 
indication of increased sensitivity of rats or mice to in utero and/or 
postnatal exposure to paraquat. Based on this, EPA concludes that 
reliable data support the use of the standard 100-fold uncertainty 
factor, and that an additional uncertainty factor is not needed to 
protect the safety of infants and children.
    2. Acute risk. Acute aggregate exposure takes into account acute 
dietary food and water exposures plus other indoor and outdoor non-
occupational exposures. Since paraquat is not registered on any use 
sites which would result in non-dietary, non-

[[Page 63718]]

occupational exposure and is not expected in ground or surface water, 
the only non-occupational exposure to paraquat is expected through 
consumption of food. Therefore acute aggregate risk to paraquat is 
assumed to be the same as estimated risk from food and feed uses; at 
the 95th percentile exposure level, assuming 100 percent crop treated 
and tolerance level residues for all commodities, 23 percent of the 
aPAD was utilized for utilized for children, 1-6 years old, the major 
identifiable subgroup with the highest aggregate exposure.
    3. Chronic risk. Chronic-term aggregate exposure takes into account 
chronic dietary food and water plus other indoor and outdoor non-
occupational exposure. Since there are no non-dietary, non-occupational 
exposures expected from the use of this chemical and paraquat is not 
expected to reach ground or surface water, the only non- occupational 
exposure to paraquat is expected through consumption of food. Therefore 
chronic aggregate risk to paraquat is assumed to be the same as the 
estimated risk from food and feed uses; assuming tolerance level 
residues for all commodities and 100 percent crop treated values, 69 
percent of the cPAD was utilized for children, 1-6 years old, the major 
identifiable subgroup with the highest aggregate exposure.
    4. Short- or 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. Paraquat is not registered on any use sites which 
would result in non-dietary, non-occupational exposure. Therefore no 
short- and intermediate-term aggregate risk assessments are needed.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to paraquat residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of the residue in plants and animals has is 
understood. 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 0.05 ppm in/on 
artichokes as a result of this section 18. No animal feed items are 
associated with the proposed use.

D. International Residue Limits

    No CODEX, Canadian, and/or Mexican MRLs/tolerances have been 
established for residues of paraquat on artichoke. Therefore, there are 
no issues of international harmonization associated with this action.

E. Rotational Crop Restrictions

     Artichokes are a perennial crop and are not normally rotated; 
therefore, a discussion of rotational crop requirements is not germane 
to this petition.

VI. Conclusion

    Therefore, the tolerance is established for residues of paraquat in 
artichokes at 0.05 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300949 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before January 
21, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of

[[Page 63719]]

Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-300949, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or 
by courier, bring a copy to the location of the PIRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [email protected]. Please use an ASCII file format and avoid the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); 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 or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

IX. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: November 4, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

     Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. In Sec. 180.205, the table to paragraph (b) is amended by adding 
alphabetically an entry for ``artichokes'' to read as follows:


Sec. 180.205   Paraquat; tolerances for residues.

*        *         *         *         *
    (b) Section 18 emergency exemptions. ***

[[Page 63720]]



 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
                  *        *        *        *        *
Artichokes......................  0.05                12/31/00
                  *        *        *        *        *
------------------------------------------------------------------------

 *         *         *         *         *         

[FR Doc. 99-30411 Filed 11-19-99; 8:45 am]
BILLING CODE 6560-50-F