[Federal Register Volume 64, Number 46 (Wednesday, March 10, 1999)]
[Rules and Regulations]
[Pages 11782-11789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5963]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300795; FRL-6062-5]
RIN 2070-AB78
Metolachlor; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerances for the
combined residues of metolachlor and its metabolites determined as the
derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed
as the parent compound in or on tomatoes, tomato puree, and tomato
paste. This action is in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
[[Page 11783]]
Rodenticide Act authorizing use of the pesticide on tomatoes. This
regulation establishes maximum permissible levels for residues of
metolachlor in these food commodities 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 tolerances will expire and are
revoked on April 1, 2001.
DATES: This regulation is effective March 10, 1999. Objections and
requests for hearings must be received by EPA on or before May 10,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300795], 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-300795], 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-300795].
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: Andrew Ertman, 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. 280, (CM #2), 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9367;
ertman.andrew@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
combined residues of the herbicide metolachlor and its metabolites
determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound, in or on tomatoes
at 0.1 part per million (ppm), tomato puree at 0.3 ppm, and tomato
paste at 0.6 ppm. These tolerances will expire and are revoked on April
1, 2001. EPA will publish a document in theFederal Register to remove
the revoked tolerances 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 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 Metolachlor on Tomatoes and FFDCA
Tolerances
Eastern black nightshade (Solanum nigrum) is a common annual weed
found in tomato fields. Currently registered herbicides for use on
tomatoes have little or no effect in controlling eastern black
nightshade. Chloramben (amiben) is the most effective herbicide for
this weed, but has not been manufactured since 1991 and grower's
reserves of the herbicide have been depleted. Hand hoeing is utilized,
but it does not provide complete control and is very expensive. The
Applicant stated that since this weed population is ubiquitous and hand
hoeing does not provide complete control, the weed population is
increasing and threatening the economic viability of the tomato
industry in their state. EPA has authorized under FIFRA section 18 the
use of metolachlor on tomatoes for control of nutsedge and nightshade
in Virginia. 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
[[Page 11784]]
metolachlor in or on tomatoes, tomato paste, and tomato puree. In doing
so, EPA considered the safety standard in FFDCA section 408(b)(2), and
EPA decided that the necessary tolerances 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 these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on April 1, 2001, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on tomatoes, tomato paste, and tomato puree
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 these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether metolachlor
meets EPA's registration requirements for use on tomatoes or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of metolachlor by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Virginia 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
metolachlor, 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
metolachlor and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of metolachlor and its metabolites determined as the
derivatives, 2-[(2-ethyl-6- methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3- morpholinone, each
expressed as the parent compound on tomatoes at 0.1 ppm, tomato puree
at 0.3 ppm, and tomato paste at 0.6 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 metolachlor are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. EPA has determined that available data do not
indicate that there is potential for adverse effects after a single
dietary exposure. Therefore, acute risk assessments were not conducted.
2. Short - and intermediate - term toxicity. For intermediate-term
dermal risk assessment, the no observed adverse effect level (NOAEL) of
100 miligrams/kilogram/day (mg/kg/day) from the 21-day dermal toxicity
study in rats is to be used. At the lowest effect level (LEL) of 1,000
mg/kg/day, there were dose-related increases in minor histopathological
alterations of the skin, in total bilirubin (females), in absolute and
relative liver weights (males), and in relative kidney weights
(females). An inhalation exposure intermediate-term hazard was not
identified. The EPA has determined that the available data do not
indicate the potential for adverse effects from short-term dermal or
inhalation exposures.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for metolachlor at 0.10 mg/kg/day. This RfD is based on the results
from the 1-year feeding study in dogs, with a NOAEL of 9.7 mg/kg/day,
and an uncertainty factor of 100, based on decreased body weight gain
at the lowest observed effect level (LOEL) of 33 mg/kg/day.
4. Carcinogenicity. Under the EPA Guidelines for Carcinogen Risk
Assessment, metolachlor has been classified as a Group C Chemical
(possible human carcinogen), based on increased incidence of adenomas
and combined adenomas/carcinomas in female rats. The structural
relationship of metolachlor to acetochlor and alachlor was of concern
to the OPP Carcinogenicity Peer Review Committee (CPRC). However, in
light of new information on the relative metabolism of these chemicals,
and since there was no supportable mutagenicity concern, the CPRC
recommended the Margin of Exposure (MOE) approach for estimation of
risk, using the NOAEL of 15.7 mg/kg/day from the 2-year rat feeding
study.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.368) for the combined residues of metolachlor and its
metabolites determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3- morpholinone, each expressed as the parent
compound, in or on a variety of raw agricultural commodities, ranging
from 0.02 ppm in various animal commodities, to 30 ppm in peanut forage
and hay. Risk assessments were conducted by EPA to assess dietary
exposures and risks from metolachlor 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. EPA has determined that available data
do not indicate that there is potential for adverse effects after a
single dietary exposure. Therefore, acute risk assessment is not
required.
ii. Chronic exposure and risk. In conducting this chronic dietary
(food only) risk assessment, the Agency used percent of crop treated
data for selected crops, and assumed tolerance level residues in all
commodities having metolachlor tolerances. These assumptions result in
an overestimate of human dietary exposure, and thus this risk estimate
should be viewed as conservative; further refinement using anticipated
residue levels and additional percent crop treated values would result
in lower exposure estimates. Based on the given
[[Page 11785]]
assumptions, EPA has calculated that dietary exposure to metolachlor
will utilize 1.1% of the RfD for the overall U.S. population. The major
identifiable subgroups with the highest exposure are non-nursing
infants <1 year="" old="" and="" children="" 1="" to="" 6="" years="" old,="" both="" at="" 2.3%="" of="" the="" rfd.="" this="" is="" further="" discussed="" below="" in="" the="" section="" on="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposure="" 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="" metolachlor="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" metolachlor="" residues.="" section="" 408(b)(2)(f)="" states="" that="" the="" agency="" may="" use="" data="" on="" the="" actual="" percent="" of="" food="" treated="" (pct)="" for="" assessing="" chronic="" dietary="" risk="" only="" if="" the="" agency="" can="" make="" the="" following="" findings:="" that="" the="" data="" used="" are="" reliable="" and="" provide="" a="" valid="" basis="" to="" show="" what="" percentage="" of="" the="" food="" derived="" from="" such="" crop="" is="" likely="" to="" contain="" such="" pesticide="" residue;="" that="" the="" exposure="" estimate="" does="" not="" underestimate="" exposure="" for="" any="" significant="" subpopulation="" group;="" and="" if="" data="" are="" available="" on="" pesticide="" use="" and="" food="" consumption="" in="" a="" particular="" area,="" the="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" the="" population="" in="" such="" area.="" in="" addition,="" the="" agency="" must="" provide="" for="" periodic="" evaluation="" of="" any="" estimates="" used.="" to="" provide="" for="" the="" periodic="" evaluation="" of="" the="" estimate="" of="" percent="" crop="" treated="" as="" required="" by="" the="" section="" 408(b)(2)(f),="" epa="" may="" require="" registrants="" to="" submit="" data="" on="" pct.="" the="" agency="" used="" percent="" crop="" treated="" data="" for="" selected="" crops,="" and="" assumed="" tolerance="" level="" residues="" in="" all="" commodities="" having="" metolachlor="" tolerances.="" the="" agency="" believes="" that="" the="" 3="" conditions,="" discussed="" in="" section="" 408="" (b)(2)(f)="" in="" this="" unit="" concerning="" the="" agency's="" responsibilities="" in="" assessing="" chronic="" dietary="" risk="" findings,="" have="" been="" met.="" the="" pct="" estimates="" are="" derived="" from="" federal="" and="" private="" market="" survey="" data,="" which="" are="" reliable="" and="" have="" a="" valid="" basis.="" typically,="" a="" range="" of="" estimates="" are="" supplied="" and="" the="" upper="" end="" of="" this="" range="" is="" assumed="" for="" the="" exposure="" assessment.="" by="" using="" this="" upper="" end="" estimate="" of="" the="" pct,="" the="" agency="" is="" reasonably="" certain="" that="" the="" percentage="" of="" the="" food="" treated="" is="" not="" likely="" to="" be="" underestimated.="" the="" regional="" consumption="" information="" and="" consumption="" information="" for="" significant="" subpopulations="" is="" taken="" into="" account="" through="" epa's="" computer-based="" model="" for="" evaluating="" the="" exposure="" of="" significant="" subpopulations="" including="" several="" regional="" groups.="" use="" of="" this="" consumption="" information="" in="" epa's="" risk="" assessment="" process="" ensures="" that="" epa's="" exposure="" estimate="" does="" not="" understate="" exposure="" for="" any="" significant="" subpopulation="" group="" and="" allows="" the="" agency="" to="" be="" reasonably="" certain="" that="" no="" regional="" population="" is="" exposed="" to="" residue="" levels="" higher="" than="" those="" estimated="" by="" the="" agency.="" other="" than="" the="" data="" available="" through="" national="" food="" consumption="" surveys,="" epa="" does="" not="" have="" available="" information="" on="" the="" regional="" consumption="" of="" food="" to="" which="" metolachlor="" may="" be="" applied="" in="" a="" particular="" area.="" 2.="" from="" drinking="" water.="" environmental="" fate="" studies="" indicate="" that="" metolachlor="" appears="" to="" be="" moderately="" persistent="" and="" ranges="" from="" being="" mobile="" to="" highly="" mobile="" in="" different="" soils.="" data="" collected="" from="" around="" the="" u.s.="" provides="" evidence="" that="" metolachlor="" leaches="" into="" ground="" water,="" occasionally="" at="" levels="" that="" exceed="" the="" lifetime="" health="" advisory="" (ha)="" level="" of="" 100="" parts="" per="" billion="" (ppb).="" metolachlor="" is="" not="" yet="" formally="" regulated="" under="" the="" safe="" drinking="" water="" act;="" therefore,="" no="" enforcement="" maximum="" contaminant="" level="" (mcl)="" has="" been="" established="" for="" it.="" metolachlor="" also="" has="" relatively="" high="" health="" advisory="" levels="" (1-10="" day="" ha="" level="" of="" 2,000="" ppb="" and="" lifetime="" ha="" level="" of="" 100="" ppb).="" based="" on="" available="" data,="" it="" appears="" highly="" unlikely="" that="" maximum="" or="" short-term="" average="" metolachlor="" concentrations="" will="" exceed="" the="" 1-10="" day="" ha="" levels="" of="" 2,000="" ppb,="" or="" that="" annual="" average="" metolachlor="" concentrations="" will="" exceed="" the="" lifetime="" ha="" of="" 100="" ppb="" anywhere.="" additionally,="" to="" mitigate="" risk,="" additional="" label="" restrictions="" are="" being="" required="" under="" the="" reregistration="" process,="" designed="" to="" minimize="" ground="" and="" surface="" water="" contamination.="" chronic="" exposure="" and="" risk.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfd's="" or="" acute="" dietary="" noael's)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" metolachlor="" to="" exceed="" the="" rfd="" if="" the="" tolerance="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" metolachlor="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerance="" is="" granted.="" 3.="" from="" non-dietary="" exposure.="" metolachlor="" is="" currently="" registered="" for="" use="" on="" a="" number="" of="" residential="" non-food="" sites="" including="" ornamental="" plants="" and="" grasses,="" highway="" rights="" of="" way,="" and="" recreational="" areas.="" no="" indoor="" uses="" are="" registered.="" i.="" acute="" exposure="" and="" risk.="" epa="" generally="" will="" not="" include="" residential="" or="" other="" non-dietary="" exposures="" as="" a="" component="" of="" the="" acute="" exposure="" assessment.="" theoretically,="" it="" is="" also="" possible="" that="" a="" residential,="" or="" other="" non-dietary,="" exposure="" could="" be="" combined="" with="" the="" acute="" total="" dietary="" exposure="" from="" food="" and="" water.="" however,="" the="" agency="" does="" not="" believe="" that="" aggregate="" multiple="" exposure="" to="" large="" amounts="" of="" pesticide="" residues="" in="" the="" residential="" environment="" via="" multiple="" products="" and="" routes="" for="" a="" one="" day="" exposure="" is="" a="" reasonably="" probable="" event.="" it="" is="" highly="" unlikely="" that,="" in="" one="" day,="" an="" individual="" would="" have="" multiple="" high-end="" exposures="" to="" the="" same="" pesticide="" by="" treating="" their="" lawn="" and="" garden,="" treating="" their="" house="" via="" crack="" and="" crevice="" application,="" swimming="" in="" a="" pool,="" and="" be="" maximally="" exposed="" by="" the="" food="" and="" water="" consumed.="" additionally,="" the="" concept="" of="" an="" acute="" exposure="" as="" a="" single="" exposure="" does="" not="" allow="" for="" including="" post-application="" exposures,="" in="" which="" residues="" decline="" over="" a="" period="" of="" days="" after="" application.="" therefore,="" the="" agency="" believes="" that="" residential="" exposures="" are="" more="" appropriately="" included="" in="" the="" short-term="" exposure="" scenario="" discussed="" below.="" ii.="" chronic="" exposure="" and="" risk.="" the="" agency="" has="" concluded="" that="" a="" chronic="" residential="" exposure="" scenario="" does="" not="" exist="" for="" non-="" occupational="" uses="" of="" metolachlor.="" iii.="" short-="" and="" intermediate-term="" exposure="" and="" risk.="" there="" are="" residential="" uses="" of="" metolachlor="" and="" epa="" acknowledges="" that="" there="" may="" be="" short="" and="" intermediate-term="" non-occupational="" [[page="" 11786]]="" exposure="" scenarios.="" the="" epa="" has="" identified="" a="" toxicity="" endpoint="" for="" intermediate-term="" residential="" risks.="" however,="" no="" acceptable="" reliable="" exposure="" data="" to="" assess="" the="" potential="" risks="" are="" available="" at="" this="" time.="" based="" on="" the="" high="" level="" of="" the="" intermediate-term="" toxicity="" endpoint="" (noael="" of="" 100="" mg/kg/day,="" and="" loel="" of="" 1,000="" mg/kg/day),="" the="" agency="" does="" not="" expect="" the="" intermediate-term="" aggregate="" risk="" to="" exceed="" the="" level="" of="" concern.="" a="" short-term="" non-dietary="" toxicity="" endpoint="" was="" not="" identified="" for="" metolachlor.="" 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="" metolachlor="" 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,="" metolachlor="" 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="" metolachlor="" 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.="" the="" available="" data="" for="" metolachlor="" do="" not="" indicate="" the="" potential="" for="" adverse="" effects="" from="" acute="" dietary="" exposures.="" therefore,="" an="" acute="" aggregate="" risk="" assessment="" was="" not="" conducted.="" 2.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" metolachlor="" from="" food="" will="" utilize="" 1.1%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" non-nursing="" infants=""><1 year="" old,="" and="" children="" 1="" to="" 6="" years="" old,="" both="" at="" 2.3%="" of="" the="" rfd;="" this="" is="" further="" 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.="" despite="" the="" potential="" for="" exposure="" to="" metolachlor="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" 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.="" based="" on="" the="" low="" percentage="" of="" the="" rfd="" occupied="" by="" the="" chronic="" dietary="" exposure=""><3% for="" all="" population="" subgroups)="" and="" the="" high="" level="" of="" the="" intermediate-term="" toxicity="" endpoint="" (noael="" and="" loel="" of="" 100="" and="" 1,000="" mg/kg/day,="" respectively),="" in="" the="" best="" scientific="" judgment="" of="" epa,="" the="" intermediate-term="" aggregate="" risk="" will="" not="" exceed="" the="" agency's="" level="" of="" concern.="" despite="" the="" potential="" for="" exposure="" to="" metolachlor="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" since="" a="" short-term="" toxicity="" endpoint="" was="" not="" identified="" for="" metolachlor,="" a="" short-term="" aggregate="" risk="" assessment="" was="" not="" conducted.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" based="" on="" the="" cprc="" recommendation="" that="" the="" moe="" approach="" be="" used="" to="" assess="" cancer="" risk,="" a="" quantitative="" cancer="" risk="" assessment="" was="" not="" performed.="" based="" on="" the="" aggregate="" chronic="" dietary="" analysis="" (food="" only),="" the="" calculated="" moes="" for="" the="" u.s.="" population="" and="" infants/children="" are="" 15,000="" and="" 6,800,="" respectively.="" other="" than="" dietary="" exposure,="" no="" chronic="" exposure="" scenarios="" have="" been="" identified="" from="" registered="" uses="" of="" metolachlor.="" the="" epa="" believes="" that="" the="" potential="" additional="" exposure="" in="" drinking="" water="" would="" not="" significantly="" lower="" the="" chronic="" dietary="" moes.="" the="" epa="" has="" not="" yet="" established="" what="" an="" adequate="" moe="" should="" be="" for="" chemicals="" having="" a="" non-linear="" mechanism="" for="" carcinogenicity.="" at="" this="" time,="" and="" for="" the="" purpose="" of="" this="" action="" only,="" the="" agency="" concludes="" that="" the="" moes="" given="" above="" are="" adequate="" to="" ensure="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" to="" the="" u.s.="" population="" or="" to="" infants="" and="" children,="" will="" result="" from="" aggregate="" exposure="" to="" residues="" of="" metolachlor.="" when="" the="" agency="" reaches="" a="" conclusion="" on="" the="" science="" policy="" issue="" of="" adequate="" moes="" for="" non-linear="" carcinogens,="" it="" is="" possible="" that="" the="" risk="" assessment="" for="" metolachlor="" may="" need="" to="" be="" revised.="" 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="" metolachlor="" 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="" metolachlor,="" 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="" 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="" 300="" mg/kg/day;="" mortality,="" increased="" salivation,="" lacrimation,="" convulsions,="" reduced="" body="" weight="" gain,="" and="" reduced="" food="" consumption="" were="" observed="" at="" the="" lel="" of="" 1,000="" mg/kg/day.="" the="" developmental="" noael="" was="" also="" 300="" mg/kg/day,="" with="" reduced="" mean="" fetal="" body="" weight,="" reduced="" number="" of="" implantations,="" and="" a="" slight="" increase="" in="" resorptions,="" seen="" at="" the="" lel="" of="" 1,000="" mg/kg/day.="" in="" the="" rabbit="" developmental="" study,="" the="" maternal="" noael="" was="" 120="" mg/="" kg/day,="" with="" lacrimation,="" miosis,="" reduced="" food="" consumption,="" and="" decreased="" body="" weight="" gain="" seen="" at="" the="" lel="" of="" 360="" mg/kg/day.="" no="" developmental="" effects="" were="" [[page="" 11787]]="" observed="" at="" the="" levels="" tested,="" and="" therefore="" the="" developmental="" noael="" was="" greater="" than="" 360="" mg/kg/day="" the="" highest="" dose="" tested="" (hdt).="" iii.="" reproductive="" toxicity="" study.="" in="" the="" 2-generation="" rat="" reproductive="" study,="" the="" reproductive/developmental="" toxicity="" noael="" of="" 23="" mg/kg/day="" was="" less="" than="" the="" parental="" (systemic)="" toxicity="" noael="" of="">76
mg/kg/day HDT. The reproductive/developmental NOAEL was based on
decreased pup body weight during late lactation.
iv. Pre- and post-natal sensitivity. Based on current toxicological
data requirements, the database for metolachlor relative to pre- and
post-natal toxicity is complete. The developmental toxicity NOAELs of
300 mg/kg/day (in rats) and >360 mg/kg/day (HDT tested in rabbits)
demonstrate that there is not increased sensitivity to metolachlor by
the developing fetus (pre-natal) in the presence of maternal toxicity.
There was developmental toxicity in rats at 1,000 mg/kg/day (but not in
rabbits). The developmental NOAELs are more than 30- and 37-fold higher
in the rats and rabbits, respectively, than the NOAEL of 9.7 mg/kg/day
from the 1-year feeding study in dogs, which is the basis of the RfD.
In the 2-generation reproductive toxicity study in rats, the
reproductive/developmental toxicity NOAEL of 23 mg/kg/day was less than
the parental (systemic) toxicity NOAEL of >76 mg/kg/day. The
reproductive/developmental NOAEL was based on decreased pup body weight
during late lactation and the NOAEL occurred at a level which is below
the NOAEL for parental toxicity (>76 mg/kg/day). This finding suggests
that pups are more sensitive to metolachlor than adult animals. For
purposes of this section 18 only, an additional 3-fold uncertainty
factor was added to the RfD for infants and children.
v. Conclusion. The TMRC value for the most highly exposed infant
and children subgroups (non-nursing infants <1 year="" old,="" and="" children="" 1="" to="" 6="" years="" old)="" occupies="" 6.9%="" of="" the="" rfd="" for="" both="" groups="" (with="" the="" additional="" 3-fold="" safety="" factor).="" this="" estimate="" should="" be="" viewed="" as="" conservative,="" since="" it="" is="" based="" on="" percent="" of="" crop="" treated="" data="" for="" selected="" crops="" and="" tolerance="" level="" residues="" for="" all="" commodities.="" refinement="" of="" the="" dietary="" risk="" assessment="" by="" using="" additional="" percent="" crop="" treated="" and="" anticipated="" residue="" data="" would="" reduce="" dietary="" exposure="" estimates.="" therefore,="" this="" risk="" assessment="" is="" an="" over-estimate="" of="" dietary="" risk.="" 2.="" acute="" risk.="" the="" available="" data="" for="" metolachlor="" do="" not="" indicate="" the="" potential="" for="" adverse="" effects="" from="" acute="" dietary="" exposures.="" therefore,="" no="" acute="" risk="" assessment="" was="" conducted.="" 3.="" chronic="" risk.="" using="" the="" exposure="" assumptions="" described="" in="" this="" unit,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" metolachlor="" from="" food="" ranges="" from="" 6.9%="" for="" non-nursing="" infants=""><1 year="" old,="" down="" to="" 1.8%="" for="" nursing="" infants=""><1 year="" old="" (using="" an="" additional="" 3="" fold="" safety="" factor)="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" metolachlor="" in="" drinking="" water="" and="" from="" non-="" dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 4.="" short-="" or="" 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.="" a="" short-term="" non-dietary="" toxicity="" endpoint="" was="" not="" identified="" for="" metolachlor.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" the="" percent="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" aggregate="" exposure="" to="" residues="" of="" metolachlor="" is="" 6.9%="" (using="" an="" additional="" 3="" fold="" safety="" factor)="" for="" non-="" nursing="" infants=""><1 year="" old="" and="" children="" 1="" to="" 6="" years="" old="" (the="" most="" highly="" exposed="" population="" subgroups).="" based="" on="" the="" low="" percentage="" of="" the="" rfd="" occupied="" by="" the="" chronic="" dietary="" exposure="" and="" the="" high="" level="" of="" the="" intermediate-term="" toxicity="" endpoint="" (noael="100" mg/kg/day="" and="" loel="1,000" mg/kg/day),="" in="" the="" best="" scientific="" judgment="" of="" epa,="" the="" intermediate-term="" aggregate="" risk="" will="" not="" exceed="" the="" agency's="" level="" of="" concern.="" despite="" the="" potential="" for="" exposure="" to="" metolachlor="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 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="" metolachlor="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" and="" animals="" is="" adequately="" understood.="" tolerances="" for="" residues="" of="" metolachlor="" in="" or="" on="" food/feed="" commodities="" are="" currently="" expressed="" in="" terms="" of="" the="" combined="" residues="" (free="" and="" bound)="" of="" the="" herbicide="" metolachlor="" ([2-chloro-n-(2-ethyl-6-="" methylphenyl)-n-(2-methoxy-1-methylethyl)acetamide])="" and="" its="" metabolites,="" determined="" as="" the="" derivatives,="" 2-[(2-ethyl-6-="" methylphenyl)amino]-1-propanol="" and="" 4-(2-ethyl-6-methylphenyl)-2-="" hydroxy-5-methyl-3-morpholinone,="" each="" expressed="" as="" the="" parent="" compound="" (40="" cfr="" sec.="" 180.368)="" b.="" analytical="" enforcement="" methodology="" adequate="" methods="" for="" purposes="" of="" data="" collection="" and="" enforcement="" of="" tolerances="" for="" metolachlor="" residues="" are="" available.="" methods="" for="" determining="" the="" combined="" residues="" of="" metolachlor="" and="" its="" metabolites,="" as="" the="" derivatives="" cga-37913="" and="" cga-49751,="" are="" described="" in="" pam,="" vol.="" ii,="" as="" method="" i="" (plants;="" gas="" chromatograpy="" (gc)="" with="" nitrogen="" phosphorus="" detection="" (npd))="" and="" method="" ii="" (animals;="" gc-mass="" spectroscopy).="" c.="" magnitude="" of="" residues="" residues="" of="" metolachlor="" are="" not="" expected="" to="" exceed="" 10="" ppm="" in/on="" forage="" and="" 0.2="" ppm="" in/on="" the="" hay="" of="" grass="" grown="" for="" seed,="" as="" a="" result="" of="" this="" section="" 18="" use.="" secondary="" residues="" in="" animal="" commodities="" are="" not="" expected="" to="" exceed="" existing="" tolerances="" as="" a="" result="" of="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" established="" codex,="" canadian,="" or="" mexican="" residue="" limits="" for="" metolachlor="" on="" grass="" commodities.="" e.="" rotational="" crop="" restrictions="" rotational="" crop="" restrictions="" are="" stated="" on="" the="" dual="" magnum="" product="" label.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" combined="" residues="" of="" metolachlor="" and="" its="" metabolites,="" each="" expressed="" as="" the="" parent="" compound="" in="" tomatoes="" at="" 0.1="" ppm,="" tomato="" puree="" at="" 0.3="" ppm,="" and="" tomato="" paste="" at="" 0.6="" ppm.="" vi.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" [[page="" 11788]]="" any="" person="" may,="" by="" may="" 10,="" 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-300795] (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. 3501et
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
[[Page 11789]]
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: February 26, 1999.
Peter Caulkins,
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), 346a and 371.
2. In Sec. 180.368, paragraph (b), by revising the following
commodities in the table to read as follows:
Sec. 180.368 Metolachlor.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
Tomato paste.................... 0.6 4/1/01
Tomato puree.................... 0.3 4/1/01
Tomatoes........................ 0.1 4/1/01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-5963 Filed 3-9-99; 8:45 am]
BILLING CODE 6560-50-F
