[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Rules and Regulations]
[Pages 42280-42286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19910]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300880; FRL-6086-9]
RIN 2070-AB78
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer in or on parsley. 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
parsley in California. This regulation establishes a maximum
permissible level for residues of azoxystrobin in this food commodity
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
tolerance will expire and is revoked on December 30, 2000.
DATES: This regulation is effective August 4, 1999. Objections and
requests for hearings must be received by EPA on or before October 4,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300880], 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-300880], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300880].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jacqueline E. Gwaltney,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 278 Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-6792,
gwaltney.jackie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing a tolerance for combined residues or
residues of the fungicide azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer, in or on parsley at 20 parts per million (ppm) for fresh and at
100 ppm for dry. This tolerance will expire and is revoked on December
30, 2000. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Public Law 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 in this preamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
[[Page 42281]]
II. Emergency Exemption for Azoxystrobin on Parsley and FFDCA
Tolerances
The State of California requested an exemption for the use of
azoxystrobin (Quadris flowable fungicide) on 3,000 acres of parsley to
control Septoria leaf blight disease caused by Septoria petroselini.
After crop harvest the pathogen does not survive in the fields during
the winter months and must therefore be reintroduced into parsley
fields each season if disease is to reoccur. This is a seed borne-
disease. When contaminated seeds are planted, the pathogen is
reintroduced. The reintroduced pathogen spreads in the field through
rain splash or sprinkler irrigation. During spring, the parsley growing
areas have mild temperatures and high humidity favoring disease
development. Disease severity is weather dependent and can vary from
season to season. The most logical way of controlling this would be to
eradicate this pathogen from the seeds. The spring seasons of 1995 and
1998 were wet and humid favoring disease development. In spite of using
registered alternatives (copper fungicides and neem oil), California
growers experienced significant losses due to high disease pressure. It
is clearly documented that the registered alternatives are not
effective in controlling the disease under high disease pressure.
During 1999, the spring season was wet and conditions were favorable
for the development of disease. It is expected that parsley growers in
California will suffer significant losses during the 3rd and 4th
parsley cutting without the use of azoxystrobin. EPA has authorized
under FIFRA section 18 the use of azoxystrobin on parsley for control
of septoria blight/septoria leaf spot 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 azoxystrobin in or on
parsley. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on December 30,
2000, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
parsley 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 azoxystrobin
meets EPA's registration requirements for use on parsley 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 azoxystrobin 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
azoxystrobin, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
azoxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer on parsley at fresh parsley at 20 ppm and dried parsley at 100
ppm 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 and the Agency's selection of
toxicological endpoints upon which to assess risk caused by
azoxystrobin are discussed below.
1. Acute toxicity. The Agency evaluated the existing toxicology
data base for azoxystrobin and did not identify an acute dietary
endpoint. Therefore, a risk assessment is not required.
2. Short- and intermediate-term toxicity. The Agency evaluated the
existing toxicology data base for short- and intermediate-term dermal
and inhalation exposure and determined that this risk assessment is not
required. Note: From a 21-day dermal toxicity study the no observed
adverse effect level (NOAEL) was 1,000 milligrams/kilograms/day (mg/kg/
day) at the highest dose tested (HDT) (Acute inhalation toxicity
category III).
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for azoxystrobin at 0.18 mg/kg/day. This RfD is based on on a chronic
toxicity study in rats with a NOAEL of 18.2 mg/kg/day. Reduced body
weights and bile duct lesions were observed at the lowest effect level
(LEL) of 34 mg/kg/day. An Uncertainty Factor (UF) of 100 was used to
account for both the interspecies extrapolation and the intraspecies
variability.
4. Carcinogenicity. The EPA has determined that azoxystrobin should
be classified as ``Not Likely'' to be a human carcinogen according to
the proposed revised Cancer Guidelines. This classification is based on
the lack of evidence of carcinogenicity in long-term rat and mouse
feeding studies.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.507(a)) for the combined residues of azoxystrobin and R230310
in or on a variety of raw agricultural commodities at levels ranging
from 0.010 ppm in tree nuts to 20 ppm in rice hulls. Included in these
tolerances are numerous ones for animal commodities which were
established in conjunction with tolerances for rice and wheat
[[Page 42282]]
commodities. Time-limited tolerances range from 0.1 ppm in soybeans to
30 ppm in spinach.
2. Acute risk. No toxicological effects which could be attributed
to a single dietary exposure were observed, including developmental and
neurotoxic effects in the appropriate studies. Therefore, no acute
endpoint has been assigned.
3. Chronic risk. In conducting this chronic dietary risk
assessment, EPA has made very conservative assumptions: 100% of parsley
and all other commodities having azoxystrobin tolerances will contain
azoxystrobin residues, and those residues will be at the level of the
tolerance. Default concentration factors have been removed (i.e., set
to 1) for the following commodities: grapes-juice, grapes-raisins,
tomatoes-juice, tomatoes-puree, and potatoes-white (dry). Concentration
factors were removed because data which were previously submitted show
no concentration of residues into raisins, grape juice, tomato juice
and puree or potatoes. The default ratio between grape juice and juice
concentrate was retained. (Chronic RfD = 0.18 mg/kg/day)
The Novigen DEEM (Dietary Exposure Evaluation Model) system was
used for this chronic dietary exposure analysis. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1991. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function of dietary exposure.
The existing azoxystrobin tolerances (published, pending, and
including the necessary section 18 tolerances result in a theoretical
maximum residue contribution (TMRC) that is equivalent to the following
percentages of the Chronic RfD. As the 10x safety factor was removed,
the chronic RfD is equal to the PAD (population-adjusted dose). As a
result, the exposure given as a percentage of the total allowable
exposure is reported as %PAD.
Table 1.--Summary: Chronic Exposure Analysis by the DEEM System
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Percent Reference
Population Subgroup Exposure (mg/kg/ Dose\1\ (%Chronic
day) PAD/RfD)
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U.S. Population (total)........... .012246 6.8%
All Infants (<1 year="" old).........="" 0.014830="" 8.2%="" nursing="" infants=""><1 year="" old).....="" 0.003917="" 2.2%="" non-nursing="" infants=""><1 year="" old).="" 0.019422="" 10.8%="" children="" (1-6="" years="" old)..........="" 0.022035="" 12.2%="" children="" (7-12="" years="" old).........="" 0.012990="" 7.2%="" non-hispanic="" blacks...............="" 0.016444="" 9.1%="" non-hispanic/non-white/non-black..="" 0.021015="" 11.7%="" females="" 20+="" (not="" pregnant="" or="" 0.012325="" 6.8%="" nursing).........................="" females="" 13+="" (nursing).............="" 0.014238="" 7.9%="" seniors="" 55+.......................="" 0.013489="" 7.5%="" ------------------------------------------------------------------------="" \1\="" percentage="" reference="" dose="" (%="" chronic="" pad)="Exposure" x="" 100%="" (as="" rfd="PAD" in="" this="" case)="" chronic="" pad="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (total);="" (2)="" those="" for="" infants="" and="" children;="" and="" (3)="" the="" other="" subgroups="" (except="" regions="" and="" seasons)="" for="" which="" the="" percentage="" of="" the="" chronic="" pad="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (total).="" section="" 408(b)(2)(e)="" authorizes="" epa="" to="" use="" available="" data="" and="" information="" on="" the="" anticipated="" residue="" levels="" of="" pesticide="" residues="" in="" food="" and="" the="" actual="" levels="" of="" pesticide="" chemicals="" that="" have="" been="" measured="" in="" food.="" if="" epa="" relies="" on="" such="" information,="" epa="" must="" require="" that="" data="" be="" provided="" 5="" years="" after="" the="" tolerance="" is="" established,="" modified,="" or="" left="" in="" effect,="" demonstrating="" that="" the="" levels="" in="" food="" are="" not="" above="" the="" levels="" anticipated.="" following="" the="" initial="" data="" submission,="" epa="" is="" authorized="" to="" require="" similar="" data="" on="" a="" time="" frame="" it="" deems="" appropriate.="" as="" required="" by="" section="" 408(b)(2)(e),="" epa="" will="" issue="" a="" data="" call-in="" for="" information="" relating="" to="" anticipated="" residues="" to="" be="" submitted="" no="" later="" than="" 5="" years="" from="" the="" date="" of="" issuance="" of="" this="" tolerance.="" 4.="" from="" drinking="" water.="" azoxystrobin="" is="" persistent="" and="" mobile.="" there="" is="" no="" established="" maximum="" contaminant="" level="" for="" residues="" of="" azoxystrobin="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" azoxystrobin="" in="" drinking="" water="" have="" been="" established.="" epa="" has="" estimated="" the="" concentration="" of="" azoxystrobin="" in="" surface="" water="" based="" on="" geneec="" (generic="" estimated="" environmental="" concentration)="" modeling="" and="" in="" ground="" water="" based="" on="" screening="" concentration="" in="" ground="" water="" (sci-grow)="" modeling.="" 5.="" chronic="" risk.="" estimated="" environmental="" concentrations="" (eecs)="" using="" geneec="" for="" azoxystrobin="" on="" bananas,="" grapes,="" peaches,="" peanuts,="" pecans,="" tomatoes,="" and="" wheat="" are="" listed="" in="" the="" swat="" team="" second="" interim="" report="" (june="" 6,="" 1997).="" the="" highest="" eec="" for="" azoxystrobin="" in="" surface="" water="" (39="">g/L)
is from the application of azoxystrobin to grapes. The EEC for ground
water is 0.064 g/L resulting from use on turf. For purposes of
risk assessment, the maximum EEC for azoxystrobin in drinking water (39
g/L) should be used for comparison to the back-calculated
human health drinking water levels of comparison (DWLOC) for the
chronic (non-cancer) endpoint. These DWLOCs for various population
categories are summarized in the following table.
Table 2.--Drinking Water Levels of Comparison for Chronic Exposure\1\
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Max. Water
Population Category\2\ Chronic RfD (mg/ Food Exposure (mg/ Exposure\3\ (mg/ DWLOC4,5,6(g/
kg/day) kg/day) kg/day) L)
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U.S. Population (total)........ 0.18 0.012246 0.168 5,900
Females 13+ (nursing).......... 0.18 0.014238 0.166 5,000
[[Page 42283]]
Non-nursing Infants............ 0.18 0.019422 0.161 1,600
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\1\ Values are expressed to 2 significant figures.
\2\ Within each of these categories, the subgroup with the highest food exposure was selected.
\3\ Maximum Water Exposure (Chronic) (mg/kg/day) = Chronic RfD (mg/kg/day) - Food Exposure (mg/kg/day).
\4\ DWLOC(g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) * water
consumed daily (L/day)].
\5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+
years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
\6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
The estimated maximum concentrations of azoxystrobin in surface
water and ground water are less than EPA's levels of comparison for
azoxystrobin in drinking water as a contribution to chronic aggregate
exposure. Therefore, taking into account the present uses and uses
proposed in this section 18 and the fact that GENEEC can substantially
overestimate (by up to 3X) true pesticide concentrations in drinking
water, EPA concludes with reasonable certainty that residues of
azoxystrobin in drinking water (when considered along with other
sources of chronic exposure for which EPA has reliable data) would not
result in an unacceptable estimate of chronic (non-cancer) aggregate
human health risk at this time.
EPA bases this determination on a comparison of estimated average
concentrations of azoxystrobin in surface and ground water to back-
calculated DWLOCs for azoxystrobin in drinking water. These levels of
comparison in drinking water were determined after EPA considered all
other non-occupational human exposures for which it has reliable data,
including all current uses, and the use considered in this action. The
estimate of azoxystrobin in surface water is derived from a water
quality model that uses conservative assumptions (health-protective)
regarding the pesticide transport from the point of application to
surface and ground water. Because EPA considers the aggregate risk
resulting from multiple exposure pathways associated with a pesticide's
uses, levels of comparison in drinking water may vary as those uses
change. If new uses are added in the future, EPA will reassess the
potential impacts of azoxystrobin in drinking water as a part of the
chronic (non-cancer) aggregate risk assessment process.
6. From non-dietary uses. Azoxystrobin (Heritage formulation) is
registered for residential use on ornamental turf. Short-term exposure
may occur for residential handlers and for postapplication activities.
Because the TES Committee (November 12, 1996) did not select applicable
acute dietary or short-term dermal or inhalation endpoints, a short-
term risk assessment is not required. No toxicity was observed at the
limit dose (1,000 mg/kg body wt/day) in a 21-day dermal study and an
acute inhalation study indicated low toxicity. Intermediate-term and
chronic exposures are not expected for residential use.
7. 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. This risk assessment is not applicable since no
indoor and outdoor residential exposure uses are currently registered
for azoxystrobin.
C. Aggregate Cancer Risk for U.S. Population
1. Short- and intermediate-term aggregate risk. There are no
applicable endpoints for short-term exposure (TES Committee, November
12, 1996); therefore, a short-term aggregate risk assessment is not
required. Intermediate-term exposure is not expected for registered
residential uses; therefore, an intermediate-term risk assessment is
not required.
2. Chronic aggregate risk. Using the conservative TMRC exposure
assumptions described above, and taking into account the completeness
and reliability of the toxicity data, EPA has estimated the exposure to
azoxystrobin from food will utilize 11.7% of the chronic PAD for the
most highly exposed adult population subgroup (Non-Hispanic/non-white/
non-black). The exposure to azoxystrobin from food for infants and
children will utilize from 2.2% to 12.2% of the chronic PAD. EPA
generally has no concern for exposures below 100% of the chronic PAD
because the chronic PAD represents the level at which daily aggregate
oral exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to azoxystrobin in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
chronic PAD. Chronic exposures are not expected for residential uses.
EPA concludes that there is a reasonable certainty that no harm will
result to adults, infants, or children from chronic aggregate exposure
to azoxystrobin residues.
D. 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 azoxystrobin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for 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 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.
[[Page 42284]]
ii. Developmental toxicity studies-- a. Rabbit. In the
developmental toxicity study in rabbits, developmental NOEL was 500 mg/
kg/day, at the HDT. Because there were no treatment-related effects,
the developmental LEL was 500 mg/kg/day. The maternal NOEL
was 150 mg/kg/day. The maternal LEL of 500 mg/kg/day was based on
decreased body weight gain during dosing.
b. Rat. In the developmental toxicity study in rats, the maternal
(systemic) NOAEL was not established. The maternal LEL of 25 mg/kg/day
at the lowest dose tested (LDT) was based on increased salivation. The
developmental (fetal) NOAEL was 100 mg/kg/day (HDT).
iii. Reproductive toxicity study. In the reproductive toxicity
study in rats, the parental (systemic) NOAEL was 32.3 mg/kg/day. The
parental LEL of 165.4 mg/kg/day was based on decreased body weights in
males and females, decreased food consumption and increased adjusted
liver weights in females, and cholangitis. The reproductive NOAEL was
32.3 mg/kg/day. The reproductive LEL of 165.4 mg/kg/day was based on
increased weanling liver weights and decreased body weights for pups of
both generations.
iv. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology data base for azoxystrobin is complete with respect to
current toxicological data requirements. The results of these studies
indicate that infants and children are not more sensitive to exposure,
based on the results of the rat and rabbit developmental toxicity
studies and the 2-generation reproductive toxicity study in rats. The
additional 10X safety factor to account for sensitivity of infants and
children was removed by an ad hoc FQPA Safety Factor Committee.
v. Conclusion. Therefore, the tolerance is established for combined
residues or residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer in parsley at fresh parsley at 20 ppm and dried parsley at 100
ppm ppm. The results of these studies indicate that infants and
children are not more sensitive to exposure, based on the results of
the rat and rabbit developmental toxicity studies and the 2-generation
reproductive toxicity study in rats. The additional 10X safety factor
to account for sensitivity of infants and children was removed by an ad
hoc FQPA Safety Factor Committee.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
azoxystrobin from food will utilize 2 to 5% of the RfD for infants and
children. 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
azoxystrobin 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
azoxystrobin residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
1. Plants. The nature of the residue in plants is adequately
understood. The HED Metabolism Assessment Review Committee (MARC) met
on November 10, 1998 and determined that the residue of concern in
plants is azoxystrobin and its Z isomer, R230310. The Committee based
this determination on the results of metabolism studies done on grapes,
peanuts, and wheat. In all three studies the major residues were
azoxystrobin and R230310. EPA will translate these data to parsley for
this section 18.
2. Animals. As there are no animal feed items associated with this
section 18, the nature of the residue in animals is not of concern.
B. Analytical Enforcement Methodology
An adequate analytical method is available for enforcement of the
proposed tolerances. Method RAM 243 (GC/NPD) can be used for parsley.
The limit of quantitation for spinach was 0.01 ppm. This method has
been validated by the Agency's Analytical Chemistry Laboratory and will
be submitted to the Food and Drug Administration for inclusion in the
Pesticide Analytical Manual II.
C. Magnitude of the Residues
1. Plants. IR-4 performed five field trials on spinach. In each
trial, six applications were made at an application rate of 0.25 lb ai/
A. The PHI was either 6 or 7 days. This use pattern is the same as that
proposed for parsley.
2. Animals. There are no animal feed items associated with
parsley; therefore, the magnitude of the residue in animals is not
relevant to this petition.
D. Rotational Crop Restrictions
Rotational crop data were submitted in pesticide petition #6F4762.
Based on this information, a 45-day plantback interval is appropriate
for all crops other than those with azoxystrobin tolerances.
E. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for azoxystrobin on parsley. Thus, harmonization is not an issue
for this section 18 request.
V. Conclusion
Therefore, the tolerance is established for combined residues or
residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer in fresh parsley at 20 ppm and dried parsley at 100 ppm.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(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 4, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697,
[[Page 42285]]
tompkins.jim@epa.gov. Requests for waiver of tolerance objection fees
should be sent to James Hollins, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300880] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any prior consultation
as specficed by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an
[[Page 42286]]
effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 22, 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. 346a, 321q and 371.
2. In Sec. 180.507 (b), by revising two commodities in the table
to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
* * * * *
(b)* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
* * * * *
Parsley, dried................................. 20.0 12/30/00
Parsley, fresh................................. 100.0 12/30/00
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-19910 Filed 8-3-99; 8:45 am]
BILLING CODE 6560-50-F
