[Federal Register Volume 64, Number 76 (Wednesday, April 21, 1999)]
[Rules and Regulations]
[Pages 19484-19489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9709]
[[Page 19484]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300832; FRL-6073-1]
RIN 2070-AB78
Fludioxonil; 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 fludioxonil 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. This regulation establishes a
maximum permissible level for residues of fludioxonil 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 May 31, 2000.
DATES: This regulation is effective April 21, 1999. Objections and
requests for hearings must be received by EPA on or before June 21,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300832], 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-300832], 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-300832].
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
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for
residues of the fungicide fludioxonil, in or on strawberries at 2.0
part per million (ppm). This tolerance will expire and is revoked on
May 31, 2000. EPA will publish a document in the Federal Register to
remove the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (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 in this preeamble 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 Fludioxonil on Strawberries and FFDCA
Tolerances
According to the Applicant, gray mold caused by Botrytis cinerea is
one of the most severe problems limiting strawberry production in
Florida. Gray mold affects both flowers and fruit, resulting in
marketable yield losses. Historically, gray mold has been controlled
with bloom sprays of Rovral (iprodione) then weekly applications of
captan until harvest. This schedule has provided good control of gray
mold, especially for relatively resistant varieties, such as Oso
Grande.
However, a shift toward the usage of certain varieties of
strawberries which have specific desirable attributes (i.e.,
[[Page 19485]]
production, pest resistance or tolerance, etc.) but are more
susceptible to gray mold, the development of gray mold strains with
resistance to iprodione, and limitation of iprodione use on
strawberries recently instituted as part of the iprodione
reregistration has resulted in a situation where growers expect heavy
losses without the requested product, Switch (which contains the active
ingredients cyprodinil and fludioxonil). EPA has authorized under FIFRA
section 18 the use of fludioxonil on strawberries for control of gray
mold 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 fludioxonil in or on
strawberries. 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 May 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
strawberries after that date will not be unlawful, provided the
pesticide is applied at a time and 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 fludioxonil meets EPA's
registration requirements for use on strawberries 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 fludioxonil 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
fludioxonil, 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
fludioxonil and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of fludioxonil on strawberries at 2.0 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 fludioxonil are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. No endpoint was identified for acute dietary
exposure. The Agency has concluded that the toxicology database does
not suggest the need for this assessment.
2. Short- and intermediate-term toxicity. No toxicological
endpoints of concern were identified for acute oral exposure, short-
term dermal exposure or inhalation exposure for all time periods. Risk
assessments for these exposure scenarios were not conducted.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for fludioxonil at 0.03 milligrams/kilogram/day (mg/kg/day). This RfD
is based on a no observed adverse effects level (NOAEL) of 3.3 mg/kg/
day, taken from a chronic feeding study in dogs, and an uncertainty
factor of 100. The effect observed at the lowest effect level (LEL) of
35.5 mg/kg/day was decreased body weight gain in females.
4. Carcinogenicity. Fludioxonil has been classified as a Group D-
not classifiable as to human carcinogenicity- chemical by the Cancer
Peer Review Committee. The Group D classification was based on the
statistically significant increase in liver tumors in female rats for
combined adenoma/carcinoma only, the lack of a tumorigenic response in
male rats or in either sex of the mouse, and the need for additional
mutagenicity studies.
C. Exposures and Risks
1. From food and feed uses. A tolerance has been established (40
CFR 180.516) for the residues of fludioxonil, in or on potatoes at 0.02
ppm. Fludioxonil is currently registered for use as a seed treatment on
potatoes, popcorn, field and sweet corn, and sorghum, as well as for
use in greenhouses on nonfood crops. Additionally, time-limited
tolerances have been established for residues of fludioxonil on
apricots, nectarines, peaches and plums. Risk assessments were
conducted by EPA to assess dietary exposures and risks from fludioxonil
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. In reviewing the toxicity data base, no
toxicological endpoints were identified which could be attributable to
a single dietary exposure. Therefore a risk assessment for this
exposure scenario is not required.
ii. Chronic exposure and risk. Tolerance level residues and 100%
crop treated were assumed to calculate theoretical maximum residue
contribution (TMRCs) for the United States (U.S.) population and
population subgroups from residues on published and proposed uses.
Chronic exposure from food uses of fludioxonil represents 4% of the RfD
for the U.S. population and 22% of the RfD for non-nursing infants
(<1yr), the="" subgroup="" most="" highly="" exposed.="" 2.="" from="" drinking="" water.="" fludioxonil="" is="" not="" expected="" to="" impact="" ground="" or="" surface="" water="" resources.="" available="" data="" suggest="" fludioxonil="" has="" a="" relatively="" low="" potential="" to="" leach="" to="" groundwater="" and="" move="" in="" runoff="" to="" aquatic="" environments.="" there="" is="" no="" established="" maximum="" contaminant="" level="" (mcl)="" for="" residues="" of="" fludioxonil="" in="" drinking="" water.="" no="" [[page="" 19486]]="" health="" advisory="" levels="" for="" fludioxonil="" in="" drinking="" water="" have="" been="" established.="" the="" agency="" has="" calculated="" drinking="" water="" levels="" of="" comparison="" (dwlocs)="" for="" chronic="" exposure="" to="" fludioxonil="" in="" surface="" and="" groundwater.="" the="" dwlocs="" are="" calculated="" by="" subtracting="" from="" the="" rfd="" the="" respective="" chronic="" dietary="" exposure="" attributable="" to="" food="" to="" obtain="" the="" acceptable="" exposure="" to="" fludioxonil="" in="" drinking="" water.="" default="" body="" weight="" (70="" kg="" for="" males,="" 60="" kg="" for="" females,="" and="" 10="" kg="" for="" non-nursing="" infants="">< 1="" year="" old)="" and="" default="" drinking="" water="" consumption="" estimates="" (2="" l/day="" for="" adults,="" 1="" l/day="" for="" non-nursing="" infants)="" are="" then="" used="" to="" calculate="" the="" actual="" dwlocs.="" the="" dwloc="" represents="" the="" concentration="" level="" in="" surface="" water="" or="" groundwater="" at="" which="" aggregate="" exposure="" to="" the="" chemical="" is="" not="" of="" concern.="" using="" generic="" expected="" environmental="" concentration="" (geneec)="" (surface="" water)="" and="" screening="" concentration="" in="" ground="" water(sci-grow)="" (groundwater)="" models,="" the="" agency="" has="" calculated="" chronic="" tier="" i="" estimated="" environmental="" concentrations="" (eecs)="" for="" fludioxonil="" for="" use="" in="" human="" health="" risk="" assessments.="" these="" values="" represent="" the="" upper="" bound="" estimates="" of="" the="" concentrations="" of="" fludioxonil="" that="" might="" be="" found="" in="" surface="" and="" ground="" water="" assuming="" the="" maximum="" application="" rate="" allowed="" on="" the="" label="" of="" the="" highest="" use="" pattern.="" the="" eecs="" from="" these="" models="" are="" compared="" to="" the="" dwlocs="" to="" make="" the="" safety="" determination.="" i.="" acute="" exposure="" and="" risk.="" in="" reviewing="" the="" toxicity="" data="" base,="" no="" toxicological="" endpoints="" were="" identified="" which="" could="" be="" attributable="" to="" a="" single="" dietary="" exposure.="" therefore="" a="" risk="" assessment="" for="" this="" exposure="" scenario="" was="" not="" conducted.="" ii.="" chronic="" exposure="" and="" risk.="" using="" the="" sci-grow="" model,="" the="" maximum="" long-term="" estimated="" concentration="" in="" groundwater="" is="" not="" expected="" to="" exceed="" 0.08="" parts="" per="" billion="" (ppb).="" the="" chronic="" estimated="" concentration="" in="" surface="" water,="" using="" the="" geneec="" model,="" is="" 7.8="" ppb.="" the="" dwloc="" for="" the="" most="" sensitive="" adult="" subgroup,="" non-hispanic="" females="" other="" than="" black="" or="" white="" was="" calculated="" to="" be="" 850="" ppb;="" dwlocs="" for="" all="" other="" adult="" population="" groups="" are="" even="" higher.="" as="" even="" the="" upper="" bound="" concentrations="" of="" fludioxonil="" in="" groundwater="" and="" surface="" water="" are="" not="" expected="" to="" exceed="" the="" calculated="" dwloc,="" the="" agency="" concludes="" with="" reasonable="" certainty="" that="" chronic="" exposure="" to="" fludioxonil="" in="" drinking="" water="" is="" not="" of="" concern.="" 3.="" from="" non-dietary="" exposure.="" fludioxonil="" is="" currently="" not="" registered="" for="" use="" on="" non-food="" sites="" that="" would="" result="" in="" non-="" occupational,="" non-dietary="" exposure;="" therefore,="" no="" such="" exposure="" is="" expected.="" 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="" fludioxonil="" 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,="" fludioxonil="" 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="" fludioxonil="" 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.="" in="" reviewing="" the="" toxicity="" data="" base,="" no="" toxicological="" endpoints="" were="" identified="" which="" could="" be="" attributable="" to="" a="" single="" dietary="" exposure.="" therefore="" a="" risk="" assessment="" for="" this="" exposure="" scenario="" was="" not="" conducted.="" 2.="" chronic="" risk.="" using="" the="" tmrc="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fludioxonil="" from="" food="" will="" utilize="" 4%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-="" nursing="" infants="" less="" than="" 1="" year="" in="" age="" (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="" fludioxonil="" in="" surface="" water="" and="" groundwater="" do="" not="" exceed="" chronic="" dwlocs="" calculated="" by="" the="" agency.="" 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.="" no="" toxicological="" endpoints="" of="" concern="" were="" identified="" for="" acute="" oral="" exposure,="" short-term="" dermal="" exposure="" or="" inhalation="" exposure="" for="" all="" time="" periods.="" risk="" assessments="" for="" these="" exposure="" scenarios="" were="" not="" conducted.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" fludioxonil="" has="" been="" classified="" as="" a="" group="" d-="" not="" classifiable="" as="" to="" human="" carcinogenicity-="" chemical="" by="" the="" cancer="" peer="" review="" committee.="" the="" group="" d="" classification="" was="" based="" on="" the="" statistically="" significant="" increase="" in="" liver="" tumors="" in="" female="" rats="" for="" combined="" adenoma/carcinoma="" only,="" the="" lack="" of="" a="" tumorigenic="" response="" in="" male="" rats="" or="" in="" either="" sex="" of="" the="" mouse,="" and="" the="" need="" for="" additional="" mutagenicity="" studies.="" 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="" fludioxonil="" 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="" fludioxonil,="" 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="" 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="" [[page="" 19487]]="" 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="" (systemic)="" noael="" was="" 100="" mg/kg/day,="" based="" on="" reduction="" in="" mean="" body="" weight="" gain="" in="" dams="" during="" gestation="" period="" at="" the="" lowest="" observed="" effects="" level="" (loel)="" of="" 1,000="" mg/kg/day.="" the="" developmental="" (fetal)="" noael="" was="" 100="" mg/kg/day,="" based="" on="" increased="" fetal="" and="" litter="" incidence="" of="" dilated="" renal="" pelvis="" and="" dilated="" ureter="" at="" the="" loel="" of="" 1,000="" mg/kg/day.="" in="" the="" rabbit="" developmental="" toxicity="" study,="" the="" maternal="" (systemic)="" noael="" was="" 10="" mg/kg/day,="" based="" on="" decreased="" body="" weight="" gains="" and="" food="" efficiency="" at="" the="" loel="" of="" 100="" mg/kg/day.="" the="" developmental="" (pup)="" noael="" was="" 300="" mg/kg/day,="" the="" highest="" dose="" tested.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" parental="" (systemic)="" noael="" was="" 22.13="" mg/kg/="" day="" (males)="" and="" 24.24="" mg/kg/day="" (females),="" based="" on="" clinical="" signs="" and="" decreased="" body="" weight,="" body="" weight="" gain="" and="" food="" consumption="" at="" the="" loel="" of="" 221.6="" mg/kg/day="" (males)="" and="" 249.7="" mg/kg/day="" (females).="" the="" reproductive/developmental="" (pup)="" noael="" was="" 22.13="" mg/kg/day="" (males)="" and="" 24.24="" mg/kg/day="" (females),="" based="" on="" reduced="" pup="" weights="" at="" the="" loel="" of="" 221.6="" mg/kg/day="" (males)="" and="" 249.7="" mg/kg/day="" (females).="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" fludioxonil="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" there="" are="" no="" pre-="" or="" post-="" natal="" 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="" database="" for="" fludioxonil="" and="" exposure="" data="" is="" complete="" or="" is="" estimated="" based="" on="" data="" that="" reasonably="" accounts="" for="" potential="" exposures.="" 2.="" acute="" risk.="" in="" reviewing="" the="" toxicity="" data="" base,="" no="" toxicological="" endpoints="" were="" identified="" which="" could="" be="" attributable="" to="" a="" single="" dietary="" exposure.="" therefore="" a="" risk="" assessment="" for="" this="" exposure="" scenario="" was="" not="" conducted.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" fludioxonil="" from="" food="" will="" utilize="" 22%="" of="" the="" rfd="" for="" non-nursing="" infants="" less="" than="" one,="" the="" subgroups="" 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="" groundwater="" or="" surface="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" 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.="" no="" toxicological="" endpoints="" of="" concern="" were="" identified="" for="" acute="" oral="" exposure,="" short-term="" dermal="" exposure="" or="" inhalation="" exposure="" for="" all="" time="" periods.="" risk="" assessments="" for="" these="" exposure="" scenarios="" were="" not="" conducted.="" 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="" fludioxonil="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" based="" on="" a="" metabolism="" study="" submitted="" for="" seed="" treatment="" use="" on="" potatoes.="" the="" residue="" of="" concern="" is="" the="" parent="" compound,="" fludioxonil,="" only.="" there="" are="" no="" livestock="" feed="" items="" associated="" with="" the="" proposed="" use="" on="" strawberries.="" therefore,="" the="" nature="" of="" the="" residue="" in="" animals="" is="" not="" germane="" to="" these="" section="" 18="" requests="" or="" to="" the="" establishment="" of="" this="" tolerance.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" (gc/npd)="" 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,="" (703)="" 305-5229.="" c.="" magnitude="" of="" residues="" residues="" of="" fludioxonil="" are="" not="" expected="" to="" exceed="" 2.0="" ppm="" in/on="" strawberries="" as="" a="" result="" of="" the="" proposed="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" there="" are="" no="" feed="" items="" associated="" with="" the="" strawberry="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex="" residue="" limits="" established="" for="" fludioxonil,="" and="" no="" canadian="" or="" mexican="" residue="" limits="" for="" fludioxonil="" use="" on="" strawberries.="" e.="" rotational="" crop="" restrictions="" no="" crops="" may="" be="" planted="" for="" at="" least="" 30="" days="" following="" the="" last="" application="" of="" fludioxonil.="" the="" crop="" rotation="" restriction="" for="" cyprodinil,="" the="" other="" active="" ingredient="" in="" switch="" 62.5="" wg,="" prohibits="" planting="" any="" crop="" other="" than="" strawberries.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" fludioxonil="" in="" strawberries="" at="" 2.0="" 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="" june="" 21,="" 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.
[[Page 19488]]
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-300832] (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) (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
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an 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
[[Page 19489]]
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: April 2, 1999.
Donald Stubbs,
Acting 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. Section 180.516, is amended by alphabetically adding the
following commodity to the table in paragraph (b) to read as follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Strawberry...................... 2.0 5/31/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-9709 Filed 4-20-99; 8:45 am]
BILLING CODE 6560-50-F
