[Federal Register Volume 64, Number 19 (Friday, January 29, 1999)]
[Rules and Regulations]
[Pages 4572-4577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2206]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300772; FRL-6050-6]
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 or residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z
isomer in or on strawberries. 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 strawberries in Florida. 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 July 30, 2000.
DATES: This regulation is effective January 29, 1999. Objections and
requests for hearings must be received by EPA on or before March 30,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300772], 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-300772], 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 (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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
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-300772]. 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: Jacqueline E. Gwaltney,
Registration Division (7505C), Office of
[[Page 4573]]
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-
6792, e-mail: Gwaltney.Jackie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 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 a tolerance for
combined residues or residues of the fungicide azoxystrobin and its Z
isomer, in or on strawberry at 0.05 part per million (ppm). This
tolerance will expire and is revoked on July 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 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 tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Azoxystrobin on Strawberry and FFDCA
Tolerances
The Florida Department of Agriculture and Consumer Services
requested an emergency exemption on September 28, 1998 for the control
of anthracnose on strawberries. Anthracnose adversely affect the plants
in a variety of ways. It can cause plant losses (crown rot, root rot,
anthracnose of the stolon and petiole, but rot, and leaf spots) and
fruit losses (anthracnose fruit rot and flower blight).
The two factors that have brought about this emergency condition
include variety shift and lack of efficacy of previously effective
fungicides. No single variety has all the desirable characteristics.
Among these desirable characteristics important to Florida growers are:
season-long production, early and late production, disease resistance,
insect and mite resistance, etc.
EPA has authorized under FIFRA section 18 the use of azoxystrobin
on strawberry for control of anthracnose in Florida. 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
strawberry. 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 July 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
strawberries 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 strawberry 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 Florida 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 above.
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
[[Page 4574]]
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
or residues of azoxystrobin on strawberry 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, 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 azoxystrobin are
discussed below.
1. Acute toxicity. The Agency evaluated the existing toxicology
database 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 database for short- and intermediate-term
dermal and inhalation exposure and determined that this risk assessment
is not required.
3. Chronic toxicity. EPA has established the reference dose (RfD)
for azoxystrobin at 0.18 milligrams/kilogram/day (mg/kg/day). This RfD
is based on a chronic toxicity study in rats with a no observed
adversed effect level (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 Agency 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. Permanent tolerances have been
established (40 CFR 180.507(a)) for the combined residues of
azoxystrobin and its Z isomer, in or on a variety of raw agricultural
commodities at levels ranging from 0.01 ppm in pecans to 1.0 ppm in
grapes. In addition, time-limited tolerances have been established (40
CFR 180.507(b) at levels ranging from 0.006 ppm in milk to 20 ppm in
rice hulls) in conjunction with previous section 18 requests. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from azoxystrobin 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 Agency did not conduct an acute
risk assessment because no toxicological endpoint of concern was
identified during review of available data.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made very conservative assumptions -- 100% of
strawberry commodities and all other commodities having azoxystrobin
tolerances will contain azoxystrobin residues and those residues would
be at the level of the tolerance with the exception of grapes-raisins,
grape-juice, tomatoes-juice, and tomatoes-puree -- which result in an
overestimation of human dietary exposure. Thus, in making a safety
determination for this tolerance, The Agency is taking into account
this conservative exposure assessment.
The existing azoxystrobin tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in a
Theoretical Maximum Residue Contribution (TMRC) that is equivalent to
the following percentages of the RfD:
------------------------------------------------------------------------
Population Sub-Group TMRC (mg/kg/day) % RFD
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U.S. Population (48 States)..... 0.0036 2.0%
All Infants (<1 year="" old).......="" 0.0011="" 5.9%="" nursing="" infants=""><1 year="" old)...="" 0.0034="" 1.9%="" non-nursing="" infants=""><1 year="" 0.0014="" 7.6%="" old).="" children="" (1-6="" years="" old)........="" 0.0083="" 4.6%="" children="" (7-12="" years="" old).......="" 0.0050="" 2.8%="" u.s.="" population="" (summer="" season).="" 0.0039="" 2.2%="" u.s.="" population="" (spring="" season).="" 0.0042="" 2.3%="" northeast="" region................="" 0.0041="" 2.3%="" western="" region..................="" 0.0038="" 2.1%="" hispanics.......................="" 0.0042="" 2.3%="" non-hispanics="" blacks............="" 0.0038="" 2.1%="" non-hispanics="" (other="" than="" black="" 0.0068="" 3.8%="" or="" white).="" females="" (13+/nursing)...........="" 0.0045="" 2.5%="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" 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.="" i.="" acute="" exposure="" and="" risk.="" an="" assessment="" was="" not="" appropriate="" since="" no="" toxicological="" endpoint="" of="" concern="" was="" identified="" during="" review="" of="" the="" available="" data.="" ii.="" chronic="" exposure="" and="" risk.="" based="" on="" the="" chronic="" dietary="" (food)="" exposure="" estimates,="" chronic="" drinking="" water="" levels="" of="" concern="" (dwloc)="" for="" azoxystrobin="" were="" calculated="" and="" are="" summarized="" in="" table="" 1.="" the="" highest="" eec="" for="" azoxystrobin="" in="" surface="" water="" is="" from="" the="" application="" of="" azoxystrobin="" on="" grapes="" (39="">g/L) and is substantially lower
than the DWLOCs calculated. Therefore, chronic exposure to azoxystrobin
residues in drinking water do not exceed EPA level of concern.
Table 1. Drinking Water Levels of Concern
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TMRC [Food Max Water
Chronic RfD (mg/kg/ Exposure] (mg/kg/ Exposure\1\ (mg/kg/ DWLOC \2\,\3\,\4\
day) day) day) (g/L)
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U.S. Population (48 States)..... 0.18 0.0036 0.18 6200
Females (13 + years old, not 0.18 0.0045 0.18 5300
pregnant or nursing).
Non-nursing Infants (< 1="" year="" 0.18="" 0.014="" 0.17="" 1700="" old).="" ----------------------------------------------------------------------------------------------------------------="" \1\="" maximum="" water="" exposure="" (mg/kg/day)="Chronic" rfd="" (mg/kg/day)="" -="" tmrc="" from="" dres="" (mg/kg/day)="" \2\="" dwloc="">g/L) = Max water exposure (mg/kg/day) * body wt (kg) /[(10-3 mg/g) *water consumed
daily (L/day)]
[[Page 4575]]
\3\ HED Default body wts for males, females, and children are 70 kg, 60 kg, and 10 kg respectively.
\4\ HED Default Daily Drinking Rates are 2 L/Day for Adults and 1 L/Day for children
3. From non-dietary exposure. Azoxystrobin is not currently
registered for any residential 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.''
EPA does not have, at this time, available data to determine
whether Azoxystrobin 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,
Azoxystrobin 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 Azoxystrobin 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).
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. This is not applicable since no toxicological end-
point of concern was identified during review of the available data.
2. Chronic 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 3.8% of the RfD for the U.S.
population. 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, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. Under current EPA guidelines, the
registered non-dietary uses of azoxystrobin do not constitute a chronic
exposure scenario. EPA concludes that there is a reasonable certainty
that no harm will result from chronic aggregate exposure to
azoxystrobin residues. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to
azoxystrobin residues.
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. This risk assessment is not applicable since no
indoor and outdoor residential exposure uses are currently registered
for azoxystrobin.
4. Aggregate cancer risk for U.S. population. The Agency determined
that azoxystrobin should be classified as ``Not Likely'' to be a human
carcinogen according to the proposed revised Cancer Guidelines. The
Agency has therefore not conducted a cancer risk assessment.
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 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 two-
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 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 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
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. Rabbit - In the
developmental toxicity study in rabbits, developmental NOAEL was 500
mg/kg/day, at the highest dose tested (HDT). Because there were no
treatment-related effects, the developmental LEL was 500
mg/kg/day. The maternal NOAEL 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 -- Rat - 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. Pre- and post-natal sensitivity. The pre- and post-natal
toxicology data base for azoxystrobin is complete with respect to
current toxicological data requirements.
v. Conclusion. 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 the Agency.
2. Acute risk. Not applicable, no end-point.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
azoxystrobin from food will utilize 1.9% to 5.6% of
[[Page 4576]]
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.
4. Short- or intermediate-term risk. Not applicable, no end-point.
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 azoxystrobin
residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
1. The nature of the residue in grapes is adequately understood.
These data are being translated for strawberries for this section 18
temporary tolerance.
2. The qualitative nature of the residue in animals is adequately
understood for the purposes of this section 18 request. A ruminant
metabolism study has been submitted, however the animal metabolism data
have not been reviewed by the Office of Pesticide Program's Metabolism
Assessment Review Committee. The residues of concern in ruminants
appears to be different from that of plants. Unidentified metabolite
compounds,designated metabolites 2, 20, and 28, appear to be the major
components of the residue inruminant tissues. For the purposes of these
time-limited tolerances for emergencyexemptions only, the residues of
concern in animal tissues are azoxystrobin and its Z-isomer.
3. As strawberry commodities are not considered to be major poultry
feed items, the natureand the magnitude of residues in poultry and eggs
are not of concern for the this section18.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703) 305-5229.
V. Conclusion
Therefore, the tolerance is established for combined residues or
residues of azoxystrobin in strawberry at 0.05 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 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 March 30, 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 above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
VII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300772] (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, CM #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
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/exemption from the
tolerance requirement under FFDCA section 408(l)(6). 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
[[Page 4577]]
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 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
under FFDCA section 408(l)(6), such as the tolerance/exemption 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 acations 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 to 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 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 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 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: January 20, 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 and 371.
2. In Sec. 180.507, paragraph (b) by alphabetically inserting the
following commodity to the table to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million RevocationDate
------------------------------------------------------------------------
* * * * *
Strawberries.................... 10.0 7/30/00
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-2206 Filed 1-28-99; 8:45 am]
BILLING CODE 6560-50-F
