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

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:
    [email protected].


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

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