[Federal Register Volume 63, Number 174 (Wednesday, September 9, 1998)]
[Rules and Regulations]
[Pages 48116-48124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24150]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300703; FRL-6024-7]
RIN 2070-AB78
Herbicide Safener HOE-107892; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of the inert ingredient, herbicide safener HOE-107892 and its
metabolites HOE-113225, HOE-109453, and HOE-094270 in or on barley
grain, barley hay, barley straw, and the processed by-products of
barley grain: pearled barley, bran, and flour. 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 fenoxaprop formulated with HOE-107892 on barley.
This regulation establishes maximum permissible levels for residues of
HOE-107892 and its metabolites HOE 113225, HOE-109453, and HOE-094270
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. These tolerances will expire and be revoked on February 1,
2000.
DATES: This regulation is effective September 9, 1998. Objections and
requests for hearings must be received by EPA on or before November 9,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300703], 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-300703], 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 requeststo Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300703]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: 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: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the herbicide safener HOE-107892 and its metabolites HOE
113225, HOE-109453, and HOE-094270, in or on barley grain at 0.05 part
per million (ppm), barley hay at 0.5 ppm, barley straw at 1.0 ppm, and
the processed by-products of barley grain: pearled barley at 0.1 ppm,
bran at 0.4 ppm, and flour at 0.1 ppm. These tolerances will expire and
be revoked on February 1, 2000. EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is
[[Page 48117]]
``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 tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for the Herbicide Safener HOE-107892 on
Barley and FFDCA Tolerances
The applicant requested the use of fenoxaprop formulated with the
herbicide safener HOE-107892 (trade name Puma) to control trifluralin-
resistant foxtail in barley fields. The applicant stated that resistant
foxtail has gradually become a problem over the years with the end
result being a significant drop in barley yields. The registered
alternatives currently available are not adequate to control the
problem and growers could be expected to experience significant
economic losses without the authorized use of this formulation of
fenoxaprop. EPA has authorized under FIFRA section 18 the use of
fenoxaprop formulated with the herbicide safener HOE-107892 on barley
for control of foxtail in North Dakota. 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 HOE-107892 in or on barley
grain, barley hay, barley straw, and the processed by-products of
barley grain: pearled barley, bran, and flour. In doing so, EPA
considered the new 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 new 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 be revoked on February 1, 2000, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on barley grain, barley hay, barley straw,
and the processed by-products of barley grain: pearled barley, bran,
and flour 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 levels that were 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 herbicide safener indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether HOE-107892
meets EPA's registration requirements for use on barley 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 HOE-107892 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 North Dakota to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for HOE-107892, contact the Agency's
Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same
[[Page 48118]]
rationale as the 100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. 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 percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (children 1-6
years old) was not regionally based.
IV. Aggregate Risk Assessment and Determination of Safety
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 HOE-
107892 and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for time-limited tolerances for residues of
HOE-107892 and its metabolites HOE 113225, HOE-109453, and HOE-094270
on barley grain at 0.05 ppm, barley hay at 0.5 ppm, barley straw at 1.0
ppm, and the processed by-products of barley grain: pearled barley at
0.1 ppm, bran at 0.4 ppm, and flour at 0.1 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 HOE-107892 are
discussed below.
1. Acute toxicity. For acute dietary risk assessment, a reference
dose (RfD)
[[Page 48119]]
was established for females, ages 13+, the population subgroup of
concern. The Agency used a No Observable Effect Level (NOEL) of 100 mg/
kg/day, based on increased preimplantation loss (indicative of
initiation of dosing too early, which appeared after a single dose) at
the Lowest Observable Effect Level (LOEL) of 250 mg/kg/day, from a
developmental toxicity study in rabbits. Using an uncertainty factor of
100 for intra- and inter-species differences, the Acute RfD for oral
exposure was calculated to be 1 mg/kg/day (100 mg/kg/day 100).
The Agency determined that the 10X factor required by FQPA for
protection of infants and children from exposure to HOE-107892 should
be reduced to 3X for the purposes of this section 18 only. Application
of the additional 3X safety factor for enhanced susceptibility of
infants and children to the acute RfD results in an acceptable acute
dietary exposure (food plus water) of 33.3% or less of the acute RfD
for the population subgroup, females, 13+ years.
2. Short - and intermediate - term toxicity. For short-term dermal
Margin of Exposure (MOE) calculations, the Agency used the maternal/
developmental NOEL of 100 mg/kg/day from a developmental study in the
rabbit. At the LOEL of 250 mg/kg/day, there were decreases in body-
weight gain during days 6 to 13 accompanied by reduced food efficiency
index and food consumption and a higher rate of abortions starting on
gestation day 16. An acceptable MOE is 100.
An endpoint for inhalation exposure was not found. The acute
LC50 is > 1.32 mg/L for the technical material and the acute
LC50 for an end-use formulation of which HOE-107892 is 2.6%
by weight is > 5.14 mg/L (LC50 = concentration lethal to 50%
of animals after a 4-hour exposure). It appears unlikely that there
will be a significant risk from inhalation.
For intermediate-term dermal MOE calculations, the Agency used a
NOEL of 80.5 mg/kg/day from a subchronic feeding study in the dog. At
the LOEL of 341.0 mg/kg/day, there were increases in alkaline
phosphatase (ALP) activities and absolute/relative liver weights; a
focal liver lesion characterized by hemorrhage, necrosis, and
inflammation; slight anemia and decreases in food consumption and body
weight gains. An acceptable MOE is 100.
An endpoint for inhalation exposure was not found. The acute
LC50 is > 1.32 mg/L for the technical material and the acute
LC50 for an end-use formulation of which HOE-107892 is 2.6%
by weight is > 5.14 mg/L. It appears unlikely that there will be a
significant risk from inhalation.
3. Chronic toxicity. EPA has established the RfD for HOE-107892 at
0.51 milligrams/kilogram/day (mg/kg/day). This RfD is based on a
chronic feeding study in dogs with a NOEL of 51.4 mg/kg/day and an
uncertainty factor of 100. An LOEL of 260 mg/kg/day is based on
increased alkaline phosphatase and absolute/relative liver weights and
grade 1 (minimal) intrahepatic cholestasis in the liver.
The results from a 2-generation reproduction study in the rat
support the NOEL from the chronic feeding study in the dog with a NOEL
of 57.3 mg/kg/day and an LOEL of 305.9 mg/kg/day based on decreased
mean body weight and mean body weight gain in the parents and
offspring.
4. Carcinogenicity. In a rat study, there were no treatment related
effects, including tumors. The NOEL is >5,000 ppm (highest dose tested:
HDT). The doses employed in this study were not sufficient to produce
any systemic effects and appeared to be inadequate to test the
carcinogenic potential of the test material. This study is classified
as unacceptable because it appears that the animals could have
tolerated a higher dose level.
In the mouse study, there were no treatment related effects in
mortality, clinical signs, feed consumption, and gross necropsy
findings. Increases in liver weights and hepatocellular hypertrophy
were detected at several dose levels. At the terminal sacrifice,
Harderian gland adenocarcinoma showed a positive trend in both sexes
with the incidences exceeding the maximum percentages for historical
controls (2%) at some dose levels. However, although there was a
positive trend, the incidences were not dose-related (0/50, 0/50, 2/50,
1/50 and 2/50 in males and 0/50, 1/50, 0/50, 0/50 and 2/50 in females).
A complete assessment of the toxicological significance of these tumors
will be conducted when this chemical is considered for full
registration. The dose levels employed in this study were adequate to
characterize the carcinogenic potential of HOE-107892 in NMRI mice.
The mouse and rat cancer studies with the safener have not been
reviewed and classified by either the Cancer Peer Review Committee or
the HIARC. It is not known at this time whether or not the Harderian
gland adenocarcinomas mentioned in the mouse study are toxicologically
significant and whether or not a cancer risk assessment is appropriate
for this chemical. Therefore, for the purposes of this section 18, a
cancer risk assessment was not conducted.
B. Exposures and Risks
1. From food and feed uses. No permanent tolerances have been
established for the residues of HOE-107892. A section 18 for HOE-107892
on durum wheat in North Dakota, South Dakota, and Montana was granted
in 1996 and the appropriate time-limited tolerances were established.
For the purposes of that section 18 only, it was assumed that there
would be no quantifiable residues of HOE-107892 in wheat grain or
straw. It was further assumed that there would be no quantifiable
residues in meat, milk, poultry, or eggs resulting from the use. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from HOE-107892 as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. The acute RfD is 1 mg/kg bw/day.
Application of the 3X safety factor for enhanced susceptibility of
infants and children to the Acute RfD results in an acceptable acute
dietary exposure (food plus water) of 33.3% or less of the acute RfD
for the population subgroup of concern, females, age 13+ years. For
this population subgroup, there is an acceptable acute dietary exposure
(food only) of <1% of="" the="" acute="" rfd.="" this="" acute="" dietary="" (food)="" risk="" assessment="" used="" the="" tmrc="" which="" assumes="" tolerance="" level="" residues="" and="" 100%="" crop-treated.="" the="" dietary="" exposure="" evaluation="" model="" (deem)="" software="" was="" used="" for="" this="" acute="" dietary="" exposure="" analysis.="" for="" females="" (13-50="" yrs),="" the="" exposure="" values="" of="" 0.00028="" was="" determined="" to="" utilize=""><1 percent="" of="" the="" acute="" rfd.="" these="" results="" should="" be="" viewed="" as="" a="" very="" conservative="" risk="" estimate;="" refinement="" using="" anticipated="" residue="" values="" and="" percent="" crop-="" treated="" information="" in="" conjunction="" with="" monte="" carlo="" analysis="" would="" result="" in="" a="" lower="" estimate="" of="" acute="" dietary="" exposure.="" ii.="" chronic="" exposure="" and="" risk.="" in="" conducting="" this="" chronic="" dietary="" risk="" assessment,="" epa="" has="" made="" very="" conservative="" assumptions:="" 100%="" of="" all="" commodities="" (including="" barley)="" which="" have="" hoe-107892="" tolerances="" (at="" the="" present="" time,="" time-limited="" tolerances)="" contain="" mefenpyr-diethyl="" residues,="" and="" these="" residues="" are="" present="" at="" the="" level="" of="" the="" tolerance.="" by="" making="" these="" assumptions,="" an="" overestimation="" of="" human="" dietary="" exposure="" results.="" thus,="" in="" making="" a="" safety="" determination="" for="" this="" [[page="" 48120]]="" tolerance,="" epa="" is="" taking="" into="" account="" this="" conservative="" exposure="" assessment.="" the="" time-limited="" hoe-107892="" tolerances,="" including="" the="" necessary="" section="" 18="" tolerance(s),="" result="" in="" a="" theoretical="" maximum="" residue="" contribution="" (tmrc)="" that="" is="" equivalent="" to="" the="" following="" percentages="" of="" the="" chronic="" rfd:="" ------------------------------------------------------------------------="" population="" subgroup="" tmrc(mg/kg/day)="" %="" chronic="" rfd="" ------------------------------------------------------------------------="" u.s.="" population="" (48="" states).......="" 0.000023=""><1% nursing="" infants=""><1 year="" old).....="" 0.000004=""><1% non-nursing="" infants=""><1 year="" old).="" 0.000008=""><1% children="" (1-6="" years="" old)..........="" 0.000038=""><1% children="" (7-12="" years="" old).........="" 0.000027=""><1% females="" (13-50="" years="" old).........="" 0.000016=""><1% ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" u.s.="" population="" (48="" states);="" (2)="" infants="" and="" children="" (4="" subgroups)="" and="" (3)="" females="" (13-50="" years).="" there="" are="" no="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" hoe-107892="" is="" not="" persistent="" and="" not="" mobile.="" even="" though="" sorption="" to="" soil="" is="" relatively="" low="" (median="" koc="" of="" approximately="" 600),="" its="" short="" half-life="" of="" about="" one="" week="" or="" less="" and="" low="" use="" rate="" imply="" that="" it="" has="" little="" potential="" to="" leach="" to="" ground="" water="" or="" runoff="" to="" surface="" water.="" under="" favorable="" conditions,="" there="" could="" be="" runoff="" into="" surface="" water,="" primarily="" via="" dissolution="" in="" runoff="" water,="" for="" several="" days="" post-application.="" there="" are="" no="" established="" maximum="" contaminant="" levels="" for="" residues="" of="" hoe-107892="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" hoe-107892="" in="" drinking="" water="" have="" been="" established.="" i.="" ground="" water.="" the="" agency="" used="" its="" sci-grow="" (screening="" concentration="" in="" ground="" water)="" screening="" model="" and="" environmental="" fate="" data="" to="" determine="" the="" eecs="" of="" hoe-107892="" in="" ground="" water.="" sci-grow="" is="" an="" empirical="" model="" based="" upon="" actual="" ground="" water="" monitoring="" data="" collected="" for="" the="" registration="" of="" a="" number="" of="" pesticides="" that="" serve="" as="" benchmarks="" for="" the="" model.="" the="" current="" version="" of="" sci-grow="" appears="" to="" provide="" realistic="" estimates="" of="" pesticide="" concentrations="" in="" shallow,="" highly="" vulnerable="" ground="" water="" sites="" (i.e.,="" sites="" with="" sandy="" soils="" and="" depth="" to="" ground="" water="" of="" 10="" to="" 20="" feet).="" the="" sci-grow="" ground="" water="" screening="" concentration="" is="" 0.00006="" ppb.="" ii.="" surface="" water.="" the="" agency="" used="" its="" geneec="" (generic="" estimated="" environmental="" concentration)="" screening="" model="" and="" environmental="" fate="" data="" to="" determine="" the="" eecs="" of="" hoe-107892="" in="" surface="" water.="" geneec="" simulates="" a="" 1="" hectare="" by="" 2="" meter="" deep="" edge-of-the-field="" farm="" pond="" which="" receives="" pesticide="" runoff="" from="" a="" treated="" 10="" hectare="" field.="" geneec="" can="" substantially="" overestimate="" (by="" a=""> 3 fold factor) true
pesticide concentrations in drinking water. It has certain limitations
and is not the ideal tool for use in drinking water risk assessments.
However, it can be used in screening calculations and does provide an
upper bound on the concentration of pesticide that can be found in
drinking water. Since GENEEC can substantially overestimate true
drinking water concentrations, it will be necessary to refine the
GENEEC estimate when the level of concern is exceeded. In those
situations where the level of concern is exceeded and the GENEEC value
is a substantial part of the total exposure, the Agency can use a
variety of methods to refine the exposure estimates.
Using the GENEEC model and available environmental fate data, EPA
calculated the following Tier 1 Estimated EECs for HOE-107892:
- GENEEC Peak EEC(ppb): 0.29 ppb
- Average 4 day EEC (ppb): 0.28 ppb
- Average 21 day EEC(ppb): 0.23 ppb
- Average 56 day EEC (ppb): 0.15 ppb.
iii. Acute exposure and risk. Based on the acute dietary (food)
exposure estimates, acute drinking water level of concern (DWLOC) for
HOE-107892 was calculated to be 9,900 (g/L) for the
subpopulation group of concern (females 13 years and older).
iv. Chronic risk. Based on the chronic dietary (food) exposure
estimates, chronic drinking water levels of concern (DWLOC) for HOE-
107892 were calculated and are summarized below:
- U.S. Population (48 States): 18,000
- Females 13 + years, nursing: 15,000
- Children (1-6 years old): 5,100
It is current Agency policy that the following subpopulations be
addressed when calculating drinking water levels of concern: U.S.
population (48 States), any other adult populations whose %RfD is
greater than that of the U.S. population, and the Female and Infant/
Children subgroups (1 each) with the highest food exposure. The
subgroups which are listed above are those which fall into these
categories.
3. From non-dietary exposure. HOE-107892 currently has no
registered residential uses.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
[[Page 48121]]
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether HOE-107892 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, HOE-
107892 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 HOE-107892 has a common mechanism of toxicity with
other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk-- U.S. adult population. Toxicological effects
applicable to the general U.S. adult population that could be
attributed to a single exposure (dose) were not observed in oral
toxicity studies in animal species. Therefore, a dose and endpoint were
not identified for acute dietary risk assessment for this population.
Females 13 years and older: The population subgroup of concern is
females 13+ years. Using TMRC, EPA concluded that the high-end exposure
estimate of 0.00028 mg/kg/day, results in an acceptable acute dietary
risk estimate (food only) of <1% of="" the="" acute="" rfd="" for="" the="" population="" of="" concern:="" females,="" 13+="" years.="" for="" acute="" exposure,="" based="" on="" an="" adult="" female="" body="" weight="" of="" 60="" kg="" and="" 2l="" consumption="" of="" water="" per="" day,="" epa's="" dwloc="" for="" acute="" exposure="" to="" hoe-107892="" for="" females,="" 13="" years="" and="" older,="" is="" 9,900="" ppb.="" the="" peak="" eec="" (acute)="" value="" of="" 0.29="" ppb="" is="" lower="" than="" the="" acute="" dwlocs="" for="" females,="" 13="" years="" and="" older="" (9900="" ppb).="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" the="" acute="" exposure="" to="" mefenpyr-diethyl="" (hoe-107892)="" in="" drinking="" water="" is="" less="" than="" our="" level="" of="" concern="" and="" that="" the="" acute="" aggregate="" risk="" estimate="" (food="" and="" water)="" is="" less="" than="" our="" level="" of="" concern.="" 2.="" chronic="" risk.="" using="" the="" conservative="" tmrc="" exposure="" assumptions="" described="" above,="" and="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data,="" the="" agency="" has="" calculated="" that="" chronic="" dietary="" exposure="" to="" hoe-107892="" from="" food="" will="" utilize=""><1% of="" the="" rfd="" for="" the="" u.s.="" population.="" epa's="" dwloc="" for="" chronic="" exposure="" to="" hoe-107892="" is="" 18,000="" ppb="" for="" the="" us="" population="" and="" 15,000="" for="" nursing="" females="" 13="" years="" and="" older.="" the="" chronic="" eec,="" geneec="" 56-day,="" value="" of="" 0.15="" ppb="" is="" lower="" than="" these="" chronic="" dwlocs.="" therefore,="" epa="" concludes="" with="" reasonable="" certainty="" that="" exposure="" to="" hoe-107892="" in="" drinking="" water="" is="" less="" than="" the="" level="" of="" concern="" and="" that="" the="" chronic="" aggregate="" risk="" (food="" and="" water)="" is="" less="" than="" the="" level="" of="" concern.="" there="" are="" no="" residential="" exposures.="" under="" current="" agency="" guidelines,="" the="" proposed="" and="" current="" uses="" of="" hoe-107892="" under="" the="" existing="" temporary="" tolerances="" do="" not="" constitute="" a="" chronic="" dermal="" or="" inhalation="" exposure="" scenario.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" hoe-107892="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" uses.="" there="" are="" no="" residential="" uses.="" therefore,="" short-="" and="" intermediate-term="" aggregate="" risk="" assessments="" are="" not="" required.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" although="" there="" is="" a="" question="" concerning="" a="" positive="" statistical="" trend="" in="" harderian="" gland="" tumors="" in="" mice="" exposed="" to="" hoe-107892="" in="" the="" diet="" over="" a="" lifetime="" and="" the="" incidences="" exceed="" historical="" control="" incidences,="" these="" tumors="" were="" not="" dose-related="" and="" there="" is="" no="" statistically="" significant="" increase="" using="" a="" pairwise="" comparison="" at="" any="" dose="" level.="" it="" is="" unlikely="" that="" they="" will="" be="" toxicologically="" significant="" when="" officially="" reviewed="" by="" either="" the="" hiarc="" or="" the="" cprc.="" therefore,="" for="" the="" purposes="" of="" this="" section="" 18,="" which="" allows="" for="" a="" limited="" use="" over="" a="" limited="" period="" of="" time,="" a="" cancer="" risk="" assessment="" will="" not="" be="" conducted.="" 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="" hoe-107892,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" a="" 10-fold="" 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="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" margin="" of="" exposure="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" in="" either="" case,="" epa="" generally="" defines="" the="" level="" of="" appreciable="" risk="" as="" exposure="" that="" is="" greater="" than="" 1/100="" of="" the="" no="" observed="" effect="" level="" in="" the="" animal="" study="" appropriate="" to="" the="" particular="" risk="" assessment.="" this="" 100-fold="" uncertainty="" (safety)="" factor/margin="" of="" exposure="" (safety)="" is="" designed="" to="" account="" for="" inter-species="" extrapolation="" and="" intra-species="" variability.="" the="" agency="" believes="" that="" reliable="" data="" support="" using="" the="" 100-fold="" margin/factor,="" rather="" than="" the="" 1,000-fold="" margin/factor,="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines,="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children,="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound,="" or="" the="" quality="" of="" the="" exposure="" data="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" margin/="" factor.="" ii.="" developmental="" toxicity="" studies.="" in="" a="" developmental="" toxicity="" study="" in="" rats,="" the="" maternal="" noel="" is="" the="" limit="" dose,="" 1,000="" mg/kg/day.="" there="" were="" no="" treatment-related="" effects="" in="" developmental="" parameters.="" the="" developmental="" noel="" is="" also="" the="" limit="" dose,="" 1,000="" mg/kg/day.="" in="" an="" embryotoxicity="" and="" post-natal="" development="" study="" hoe-107892="" was="" tested="" at="" the="" limit="" dose="" of="" 1,000="" mg/kg/day.="" mean="" maternal="" body-="" weight="" gain="" was="" significantly="" lower="" during="" treatment="" and="" was="" accompanied="" by="" a="" significant="" reduction="" in="" food="" efficiency="" and="" food="" consumption.="" there="" was="" also="" a="" treatment-related="" impairment="" in="" fetal="" body="" weight="" and="" body-weight="" gain.="" based="" on="" the="" results="" of="" the="" study,="" the="" noel="" for="" maternal,="" fetal="" and="" neonatal="" toxicity="" is="">< 1,000="" mg/kg/="" day.="" in="" a="" developmental="" toxicity="" study="" in="" rabbits="" there="" was="" a="" significant="" decrease="" in="" body-weight="" gain="" observed="" at="" 250="" mg/kg/day="" during="" the="" first="" week="" of="" treatment="" which="" was="" accompanied="" by="" significantly="" reduced="" food="" efficiency="" index="" and="" food="" consumption.="" there="" was="" also="" a="" higher="" rate="" of="" abortions="" and="" an="" increased="" preimplantation="" loss.="" the="" noel="" for="" teratogenicity="" was="" 250="" mg/kg/="" [[page="" 48122]]="" day,="" the="" highest="" dose="" tested.="" the="" noel="" for="" maternal="" toxicity="" is="" 100="" mg/="" kg/day.="" based="" on="" the="" higher="" rate="" of="" abortions="" observed="" in="" the="" dams="" at="" 250="" mg/kg/day,="" the="" noel="" for="" fetotoxicity="" is="" also="" 100="" mg/kg/day.="" iii.="" reproductive="" toxicity="" study.="" in="" a="" 2-generation="" reproduction="" study="" in="" rats,="" the="" noel="" for="" general="" toxicity="" (i.e.,="" for="" parents="" and="" offspring)="" was="" determined="" to="" be="" 57.3="" mg/kg="" bw/day="" based="" on="" decreased="" mean="" body="" weight="" and="" mean="" body="" weight="" gain="" and="" an="" increase="" in="" the="" severity="" (but="" not="" in="" the="" incidence)="" of="" splenic="" extramedullary="" hematopoiesis.="" the="" reproductive="" noel="" was="" set="" at="" 305.9="" mg/kg/day="" (hdt),="" since="" there="" were="" no="" adverse="" treatment-related="" effects="" on="" reproductive="" parameters="" evident="" at="" any="" dose="" level="" tested.="" iv.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" data="" base="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" hoe-107892="" is="" complete="" with="" respect="" to="" current="" data="" requirements.="" based="" on="" the="" developmental="" study="" data="" discussed="" above,="" hoe-107892="" does="" not="" appear="" to="" have="" an="" extra="" sensitivity="" for="" pre-natal="" effects.="" the="" fqpa="" safety="" factor="" of="" 10x="" was="" reduced="" to="" 3x="" for="" the="" purposes="" of="" this="" section="" 18="" only="" until="" the="" entire="" database="" is="" completely="" reviewed.="" the="" factor="" of="" 3x="" is="" only="" to="" be="" applied="" to="" the="" acute="" dietary="" endpoint="" for="" the="" females="" 13+="" years="" population="" subgroup;="" the="" factor="" of="" 10x="" is="" to="" be="" removed="" for="" the="" chronic="" dietary="" endpoint="" for="" all="" population="" subgroups.="" the="" rationale="" was="" as="" follows:="" ``there="" is="" no="" increased="" sensitivity="" in="" rats="" and="" rabbits="" in="" developmental="" and="" reproduction="" studies="" in="" rats="" and="" rabbits,="" however,="" in="" the="" absence="" of="" an="" opp="" toxicologist's="" review="" of="" the="" rabbit="" developmental="" study,="" the="" summary="" description="" of="" the="" rabbit="" developmental="" study="" indicates="" that="" there="" may="" an="" increased="" severity="" of="" effect="" in="" the="" offspring="" (increased="" preimplantation="" loss="" and="" abortions)="" relative="" to="" effects="" in="" the="" dams="" at="" the="" same="" dose="" (decreases="" in="" food="" consumption,="" food="" efficiency="" and="" weight="" gain).''="" 2.="" acute="" risk.="" toxicological="" effects="" applicable="" to="" children="" and/or="" infants="" that="" could="" be="" attributed="" to="" a="" single="" exposure="" (dose)="" were="" not="" observed="" in="" oral="" toxicity="" studies="" in="" several="" animal="" species.="" therefore,="" a="" dose="" and="" endpoint="" were="" not="" identified="" for="" acute="" dietary="" risk="" assessment="" for="" this="" population="" subgroup.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" hoe-="" 107892="" from="" food="" will="" utilize=""><1% 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.="" epa's="" dwloc="" for="" chronic="" exposure="" to="" hoe-107892="" is="" 5,100="" ppb="" for="" children,="" ages="" 1-6,="" the="" subgroup="" with="" the="" highest="" food="" exposure="" of="" all="" the="" infant="" and="" children="" subgroups.="" the="" chronic="" eec,="" geneec="" 56-="" day,="" value="" of="" 0.15="" ppb="" is="" lower="" than="" this="" chronic="" dwloc.="" therefore,="" the="" agency="" concludes="" with="" reasonablecertainty="" that="" exposure="" to="" hoe-107892="" in="" drinking="" water="" is="" less="" than="" our="" level="" of="" concern="" for="" infants="" and="" children="" and="" that="" the="" chronic="" aggregate="" risk="" (food="" and="" water)="" is="" less="" than="" the="" level="" of="" concern.="" 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="" uses.="" there="" are="" no="" residential="" uses.="" short-="" and="" intermediate-term="" endpoints="" were="" not="" identified="" for="" infants="" and="" children.="" therefore,="" short-="" and="" intermediate-term="" aggregate="" risk="" assessments="" are="" not="" required.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" parent="" hoe-107892="" and="" metabolites="" hoe-113225,="" hoe-109453,="" and="" hoe-094270.="" for="" the="" purposes="" of="" this="" section="" 18="" only,="" the="" residues="" of="" concern="" in="" poultry="" and="" ruminants="" are="" hoe-107892="" and="" metabolites="" hoe-113225,="" hoe-109453,="" and="" hoe-094270.="" b.="" analytical="" enforcement="" methodology="" adequate="" enforcement="" methodology="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" the="" method="" involves="" extraction,="" methylation,="" separation="" by="" gas="" chromoatography="" (gc),="" and="" detection="" by="" mass="" spectroscopy="" (ms).="" c.="" magnitude="" of="" residues="" as="" a="" result="" of="" this="" section="" 18="" use,="" residues="" of="" mefenpyr-diethyl="" (hoe-107892)="" and="" its="" regulated="" metabolites="" (hoe-113225,="" 109453,="" and="" 094270)="" are="" not="" expected="" to="" exceed="" the="" following="" levels:="" 0.05="" ppm="" in="" grain,="" 0.5="" ppm="" in="" hay,="" and="" 1.0="" ppm="" in="" straw.="" in="" addition,="" residues="" of="" hoe-107892="" and="" its="" regulated="" metabolites="" are="" not="" expected="" to="" exceed="" the="" following="" levels="" in="" processed="" by-products="" of="" barley="" grain:="" 0.1="" ppm="" in="" pearled="" barley,="" 0.4="" ppm="" in="" bran,="" and="" 0.1="" ppm="" in="" flour.="" the="" tolerance="" levels="" on="" processed="" barley="" by-products="" are="" based="" on="" the="" tolerance="" level="" for="" barley="" grain="" and="" theoretical="" concentration="" factors.="" epa="" does="" not="" expect="" detectable="" residues="" in="" livestock="" commodities="" as="" a="" result="" of="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" maximum="" residue="" limits="" (mrls)="" for="" hoe-107892="" on="" barley.="" thus,="" harmonization="" is="" not="" an="" issue="" for="" this="" section="" 18="" request.="" e.="" rotational="" crop="" restrictions="" for="" this="" section="" 18="" only,="" a="" 60="" day="" plant="" back="" interval="" will="" be="" required="" for="" all="" crops="" other="" than="" wheat="" and="" barley.="" this="" decision="" is="" based="" on="" results="" of="" laboratory="" environmental="" fate="" studies="" and="" the="" long="" phi="" which="" is="" stipulated.="" within="" 1-month="" of="" application="" of="" hoe-107892,="" 14c="" activity="" from="" both="" mefenpyr="" diethyl="" and="" a="" major="" metabolite,="" hoe-="" 113225,="" decreased="" to="" less="" than="" 6%="" of="" the="" original="" activity.="" a="" second="" major="" metabolite,="" hoe-094270,="" had="" a="" longer="" residence="" time="" in="" soil.="" it="" reached="" maximum="" activity="" of="" about="" 72%="" after="" 30-60="" days="" of="" incubation,="" and="" has="" a="" much="" longer="" estimated="" dt50="" (time="" required="" for="" compound="" to="" decay="" to="" 50%="" of="" the="" initial="" quantity)="" of="" 100-200="" days.="" in="" this="" section="" 18="" a="" 60="" day="" phi="" is="" stipulated.="" in="" effect,="" hoe-107892="" automatically="" has="" 60="" days="" to="" decay="" before="" re-planting="" can="" be="" done.="" for="" the="" purposes="" of="" this="" section="" 18="" only,="" epa="" is="" willing="" to="" allow="" rotation="" to="" any="" crops="" 60="" days="" after="" application.="" for="" section="" 3="" registration,="" actual="" rotational="" crop="" data="" will="" need="" to="" be="" reviewed="" to="" determine="" an="" appropriate="" plant="" back="" interval="" for="" crops="" other="" than="" wheat="" and="" barley.="" vi.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" hoe-107892="" and="" its="" metabolites="" hoe="" 113225,="" hoe-109453,="" and="" hoe-094270="" in="" barley="" grain="" at="" 0.05="" ppm,="" barley="" hay="" at="" 0.5="" ppm,="" barley="" straw="" at="" 1.0="" ppm,="" and="" the="" processed="" by-products="" of="" barley="" grain:="" pearled="" barley="" at="" 0.1="" ppm,="" bran="" at="" 0.4="" ppm,="" and="" flour="" at="" 0.1="" ppm.="" vii.="" 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(e)="" 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="" [[page="" 48123]]="" 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="" november="" 9,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300703]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any 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 prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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).
Executive Order 12875. Under Executive Order 12875, entitled
Enhancing Intergovernmental Partnerships (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 the Office of Management and Budget
(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.
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 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
[[Page 48124]]
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.
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 19, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.509 is amending paragraph (b) by alphabetically
adding the following entries to the table to read as follows:
Sec. 180.509 HOE-107892 (mefenpyrdiethyl; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Barley, bran.................... 0.4 2/1/00
Barley, flour................... 0.1 2/1/00
Barley, grain................... 0.05 2/1/00
Barley, hay..................... 0.5 2/1/00
Barley, pearled................. 1.0 2/1/00
Barley, straw................... 0.1 2/1/00
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-24150 Filed 9-8-98; 8:45 am]
BILLING CODE 6560-50-F
