[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: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
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.J[email protected].

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
------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                                          TMRC [Food           Max Water
                                  Chronic RfD (mg/kg/  Exposure] (mg/kg/  Exposure\1\ (mg/kg/  DWLOC \2\,\3\,\4\
                                         day)                day)                day)           (g/L)
----------------------------------------------------------------------------------------------------------------
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).
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\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:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

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