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cyprodinil Pesticide Tolerance for Emergency Exemption 6/99

 

[Federal Register: June 30, 1999 (Volume 64, Number 125)]
[Rules and Regulations]               
[Page 35032-35037]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn99-24]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300876; FRL-6086-3]
RIN 2070-AB78

 
Cyprodinil; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of cyprodinil in or on caneberries. 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 caneberries. This regulation establishes a maximum 
permissible level for residues of cyprodinil 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 31, 2000.

DATES: This regulation is effective June 30, 1999. Objections and 
requests for hearings must be received by EPA on or before August 30, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300876], 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-300876], 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@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-300876]. 
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: Stephen Schaible, 
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. 271, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9362, 
schaible.stephen@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 residues of the 
fungicide cyprodinil, in or on caneberries at 10 parts per million 
(ppm). This tolerance will expire and is revoked on December 31, 2000. 
EPA will publish a document in the Federal Register to remove the 
revoked

[[Page 35033]]

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.

II. Emergency Exemption for Cyprodinil on Caneberries and FFDCA 
Tolerances

    According to the Applicants, weather conditions favorable to gray 
mold disease development, combined with pathogen resistance to existing 
registered fungicides, has contributed to an emergency condition for 
caneberry growers in the States of Washington and Oregon. The States 
claim that registered pesticides either do not provide an adequate 
level of economic control of gray mold fruit rot or are limited in the 
number of applications needed for season-long control. EPA has 
authorized under FIFRA section 18 the use of the product Switch 62.5 
WG, containing the active ingredients cyprodinil and fludioxonil, on 
caneberries for control of gray mold in Oregon and Washington. After 
having reviewed the submission, EPA concurs that emergency conditions 
exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of cyprodinil in or on 
caneberries. 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 31, 
2000, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
caneberries 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 cyprodinil 
meets EPA's registration requirements for use on caneberries 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 cyprodinil by a State for special local needs 
under FIFRA section 24(c). Nor does this tolerance serve as the basis 
for any States other than Oregon and Washington 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 cyprodinil, 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 
cyprodinil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of cyprodinil on caneberries at 10 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 cyprodinil are 
discussed in this unit.

[[Page 35034]]

B. Toxicological Endpoint

    1. Acute toxicity. No effects that could be attributed to a single 
exposure (dose) were observed in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits. Therefore, a dose 
and endpoint were not identified for acute dietary risk assessment.
    2. Short - and intermediate-term toxicity. A no observed adverse 
effect level (NOAEL) of 25 milligrams/kilograms/day (mg/kg/day) was 
selected from the 21-day dermal rat study. The effect observed at the 
lowest observed adverse effect level (LOAEL) of 125 mg/kg/day in this 
study was hunched posture in females.
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for cyprodinil at 0.03 mg/kg/day. This RfD is based on a NOAEL of 2.7 
mg/kg/day and an uncertainty factor of 100. The NOAEL was taken from 
the chronic rat study; at the LOAEL of 35.6 mg/kg/day, effects observed 
were histopathological alterations in the liver (spongiosis hepatis) in 
males.
    4. Carcinogenicity. Cyprodinil is classified as a ``not likely'' 
human carcinogen, based on the lack of evidence of carcinogenicity in 
mice and rats at doses that were judged to be adequate to assess the 
carcinogenic potential.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.532) for the residues of cyprodinil, in or on a variety of raw 
agricultural commodities. Mention any tolerances of special relevance 
and meat, milk, poultry and egg tolerances, if applicable. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from cyprodinil 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 1-day or single exposure. This risk assessment is not required. No 
effects that could be attributed to a single exposure (dose) were 
observed in oral toxicity studies including the developmental toxicity 
studies in rats and rabbits. Therefore, a dose and endpoint were not 
identified for acute dietary risk assessment.
    ii. Chronic exposure and risk. Tolerance level residues and 100% 
crop treated were assumed to calculate dietary exposure for the United 
States (U.S.) population and population subgroups from residues on 
published and proposed uses. Chronic exposure from food uses of 
cyprodinil represents 6% of the RfD for the U.S. population and 21% of 
the RfD for nursing infants (<1yr), the subgroup most highly exposed.
     2. From drinking water. Cyprodinil is considered to be persistent 
in water and mobile in most soils; under most conditions though, 
cyprodinil will have a low potential for movement into ground water at 
high concentrations. There is potential for cyprodinil to contaminate 
surface water as runoff and as a sorbed species through erosion of soil 
particles. There is no established Maximum Contaminant Level (MCL) for 
residues of cyprodinil in drinking water. No health advisory levels for 
cyprodinil in drinking water have been established.
    The Agency has calculated drinking water levels of comparison 
(DWLOCs) for chronic exposure to cyprodinil in surface and ground 
water. A DWLOC is a theoretical upper limit on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food, drinking water, and through residential uses. 
Toxicity endpoints, default body weight (70 kg for males, 60 kg for 
females, and 10 kg for nursing infants < 1 year old) and default 
drinking water consumption estimates (2 liter (L)/day for adults, 1 L/
day for nursing infants) are used to calculate the actual DWLOCs. The 
DWLOC represents the concentration level in surface water or ground 
water at which aggregate exposure to the chemical is not of concern.
    Using the Screening Concentration in Ground Water (SCI-GROW) 
screening model, the Agency calculated an Estimated Environmental 
Concentration (EEC) of cyprodinil in ground water for use in human 
health risk assessments. This value represents an upper bound estimate 
of the concentration of cyprodinil that might be found in ground water 
assuming the maximum application rate allowed on the label of the 
highest use pattern.
    The Agency used its Pesticide Root Zone Model (PRZM)-EXAMS model to 
estimate EECs for cyprodinil in surface water. PRZM-EXAMS is a more 
refined Tier II assessment. The EECs from these models are compared to 
the DWLOCs to make the safety determination.
    i. Acute exposure and risk. This risk assessment is not required. 
No effects that could be attributed to a single exposure (dose) were 
observed in oral toxicity studies including the developmental toxicity 
studies in rats and rabbits. Therefore, a dose and endpoint were not 
identified for acute dietary risk assessment.
    ii. Chronic exposure and risk. Using the SCI-GROW model, the 
maximum long-term estimated concentration in ground water is not 
expected to exceed 0.04 parts per billion (ppb). The chronic estimated 
concentration in surface water, using the PRZM-EXAMS model, is 51 ppb. 
The DWLOC for the U.S. population was calculated to be 990 ppb; the 
DWLOC for the most sensitive subgroup, nursing infants < 1 year old, 
was 220 ppb. As concentrations of cyprodinil in ground water and 
surface water do not exceed the calculated DWLOCs, the Agency concludes 
with reasonable certainty that chronic exposure to cyprodinil in 
drinking water is not of concern.
    3. From non-dietary exposure. Cyprodinil is currently not 
registered for use on residential, non-food sites; therefore, no non-
occupational, non-dietary exposure is expected.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether cyprodinil 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, 
cyprodinil 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 cyprodinil has a common mechanism of toxicity 
with other substances. For more information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. This risk assessment is not required. No effects 
that could be attributed to a single exposure (dose) were observed in 
oral toxicity studies including the developmental toxicity studies in 
rats and rabbits. Therefore, a dose and endpoint were not identified 
for acute dietary risk assessment.
    2. Chronic risk. Using the Theoreticl Maximus Residue Contribution 
(TMRC) exposure assumptions described in this unit, EPA has concluded 
that aggregate

[[Page 35035]]

exposure to cyprodinil from food will utilize 6 of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is nursing infants < 1 year old (discussed below). EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Estimated chronic environmental concentrations of cyprodinil in 
surface water and ground water do not exceed chronic DWLOCs calculated 
by the Agency; therefore, EPA does not expect the aggregate exposure to 
exceed 100% of the RfD.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure.
    There are no residential uses of this chemical registered. This 
risk assessment is therefore not required.
    4. Aggregate cancer risk for U.S. population. Cyprodinil is 
classified as a ``not likely'' human carcinogen, based on the lack of 
evidence of carcinogenicity in mice and rats at doses that were judged 
to be adequate to assess the carcinogenic potential. This risk 
assessment is not required.
    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 cyprodinil residues.

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

    1. Safety factor for infants and children -- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of cyprodinil, 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 pre-and postnatal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
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. In the rat developmental 
study, the maternal NOAEL was 200 mg/kg/day, based on decreased body 
weight, body weight gain, and food consumption at the LOAEL of 1,000 
mg/kg/day. The developmental NOAEL was 200 mg/kg/day, based on 
increased incidence of skeletal variations (primarily absent or reduced 
ossification of the metacarpal) and on decreased mean fetal weight at 
the LOAEL of 1,000 mg/kg/day. In the rabbit developmental toxicity 
study, the maternal NOAEL was 150 mg/kg/day, based on decreased body 
weight gain at the LOAEL of 400 mg/kg/day. The developmental NOAEL was 
150 mg/kg/day and the LOAEL was 400 mg/kg/day, based on increased 
incidence of 13th rib.
    iii. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the parental NOAEL was 81 mg/kg/day, based on 
decreased parental female premating body weight gain at the LOAEL of 
326 mg/kg/day. The Agency considers significant increases in kidney and 
liver weight at the 326 mg/kg/day dose as supportive evidence of 
toxicity. The reproductive/developmental NOAEL was 81 mg/kg/day and the 
LOAEL was 326 mg/kg/day, based on decreased F<INF>1</INF> and 
F<INF>2</INF> pup weight during lactation and continuing into adulthood 
for F<INF>1</INF> rats.
    iv. Pre- and postnatal sensitivity. The toxicological data base for 
evaluating pre- and postnatal toxicity for cyprodinil is complete with 
respect to current data requirements. There are no pre- or postnatal 
toxicity concerns for infants and children, based on the results of the 
rat and rabbit developmental toxicity studies and the 2-generation rat 
reproductive toxicity study.
    v. Conclusion. There is a complete toxicity data base for 
cyprodinil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The Agency 
determined that for cyprodinil, the 10x factor to account for enhanced 
sensitivity of infants and children should be removed.
    2. Acute risk. This risk assessment is not required. No effects 
that could be attributed to a single exposure (dose) were observed in 
oral toxicity studies including the developmental toxicity studies in 
rats and rabbits. Therefore, a dose and endpoint were not identified 
for acute dietary risk assessment.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to cyprodinil from food 
will utilize 21 of the RfD for nursing infants < 1 year old, the infant 
and children subgroup most highly exposed. 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. Because the 
chronic DWLOCs are not exceeded by estimated chronic environmental 
concentrations in ground water or surface water, EPA does not expect 
the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. There are no residential uses 
for this chemical; this risk assessment is not required.
    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 cyprodinil residues.

IV. Other Considerations

A. Metabolism In Plants and Animals

     The nature of the residue in plant is understood based on 
metabolism studies in stone fruit, pome fruit, wheat, tomatoes and 
potatoes. The residue of concern is parent cyprodinil only. There are 
no animal feed items associated with the proposed use; data on the 
nature of the residue in animals are not required for the section 18 
action or the establishment of this tolerance.

B. Analytical Enforcement Methodology

     Adequate enforcement methodology High Performance Liquid 
Chromotography (HPLC) is available to enforce the tolerance expression; 
OPP concludes that the method will be suitable for enforcement purposes 
once revisions recommended by the Analytical Chemistry Laboratory (ACL) 
are incorporated. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection

[[Page 35036]]

Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Rm 101FF, CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5229.

C. Magnitude of Residues

     Residues of cyprodinil are not expected to exceed 10 ppm in 
caneberries as a result of the proposed section 18 use.

D. International Residue Limits

     There are no Codex, Canadian, or Mexican residue limits 
established for cyprodinil on caneberries. Therefore, no compatibility 
problems exist for the proposed tolerance.

E. Rotational Crop Restrictions

     As caneberries are not considered to be a rotated crop, no 
rotational crop data are required.

V. Conclusion

     Therefore, the tolerance is established for residues of cyprodinil 
in caneberries at 10 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 August 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 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, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
(703) 305-5697, 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-300876] (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 Rm. 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 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 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

[[Page 35037]]

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 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: June 11, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 321(q), 346(a) and 371.


    2. In Sec. 180.532, by alphabetically adding the commodity 
``caneberries'' to the table in paragraph (b) to read as follows:


Sec. 180.532  Cyprodinil; tolerances for residues.

    (b) *        *        *


------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Caneberries.....................  10                  12/31/00
                  *        *        *        *        *
------------------------------------------------------------------------

*        *        *        *        *

[FR Doc. 99-16542 Filed 6-29-99; 8:45 am]
BILLING CODE 6560-50-F