[Federal Register Volume 66, Number 177 (Wednesday, September 12, 2001)]
[Rules and Regulations]
[Pages 47394-47403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22526]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301163; FRL-6798-2]
RIN 2070-AB70


Bromoxynil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of bromoxynil in or on timothy, hay and timothy, forage. This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on timothy. This regulation 
establishes a maximum permissible level for residues of bromoxynil in 
these commodities. These tolerances will expire and are revoked on June 
30, 2003.

DATES: This regulation is effective September 12, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301163, 
must be received by EPA on or before November 13, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301163 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6463; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

[[Page 47395]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301163. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for residues of the insecticide 
bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, in or on timothy, hay at 
0.50 part per million (ppm) and timothy, forage at 0.10 ppm. These 
tolerances will expire and are revoked on June 30, 2003. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by the Food Quality Protection Act (FQPA). EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Bromoxynil on Timothy and FFDCA 
Tolerances

    On May 4, 2001, the Nevada Department of Agriculture availed 
themselves of the authority to declare a crisis exemption for use of 
bromoxynil in fields planted with both timothy and alfalfa to control 
weeds. Very recent overplanting of aging alfalfa fields with timothy 
revealed a problem with weed control in that no registered herbicides 
are available for use on alfalfa and timothy that do not damage the 
other crop. Bromoxynil, which is registered for use on alfalfa, does 
not damage timothy. The crisis declaration was made because alfalfa 
growth had reached a point where applications would be ineffective if 
done any later in the season. EPA has authorized under FIFRA section 18 
the use of bromoxynil on timothy for control of weeds in Nevada.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bromoxynil in or on 
timothy, hay and timothy, forage. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on June 30, 2003, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on timothy, 
hay and timothy, forage after that date will not be unlawful, provided 
the pesticide is applied in a manner that was lawful under FIFRA, and 
the residues do not exceed a level that was authorized by this 
tolerance at the time of that application. EPA will take action to 
revoke this tolerance

[[Page 47396]]

earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether bromoxynil 
meets EPA's registration requirements for use on timothy or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of bromoxynil 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 Nevada to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing section 18 as identified in 40 CFR part 166. 
For additional information regarding the emergency exemption for 
bromoxynil, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
bromoxynil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
residues of bromoxynil in or on timothy, hay at 0.50 ppm and timothy, 
forage at 0.10 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for bromoxynil used for human risk assessment is shown in the 
following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Bromoxynil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk           Concern for        Study and Toxicological
                                            Assessment, UF           RiskAssessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   NOAEL = 4 mg/kg/day      FQPA SF = 10             Developmental toxicity
 age                                   UF = 100...............  aPAD = acute RfD          study where bromoxynil
                                       Acute RfD = 0.04 mg/kg/    FQPA SF.        phenol was
                                        day.                    = 0.004 mg/kg/day......   administered to rats.
                                                                                         LOAEL = 5 mg/kg/day
                                                                                          based on an increased
                                                                                          incidence of
                                                                                          supernumerary ribs in
                                                                                          rats from a
                                                                                          developmental toxicity
                                                                                          study.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL = 8 mg/kg/day      FQPA SF = 1              13-Week range-finding
 including infants and children        UF =100................  aPAD = acute RfD          study in which
                                       Acute RfD = 0.08 mg/kg/    FQPA SF.        bromoxynil phenol was
                                        day.                    = 0.08 mg/kg/day.......   administered orally to
                                                                                          dogs.
                                                                                         LOAEL = 12 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of panting
                                                                                          on day 1, suggestive
                                                                                          of a compensatory
                                                                                          reaction to the
                                                                                          effects of the test
                                                                                          material, which at
                                                                                          higher doses is
                                                                                          expressed as elevated
                                                                                          body temperature.
----------------------------------------------------------------------------------------------------------------

[[Page 47397]]

 
Chronic Dietary all populations        NOAEL= 1.5 mg/kg/day     FQPA SF = 1              12-Month chronic oral
                                        UF = 100..............  cPAD = chronic RfD        toxicity study in dogs
                                       Chronic RfD = 0.015 mg/    FQPA SF.        using bromoxynil
                                        kg/day.                 = 0.015 mg/kg/day......   phenol as the test
                                                                                          material. Threshold
                                                                                          NOAEL/LOAEL of 1.5 mg/
                                                                                          kg/day based on
                                                                                          slightly decreased
                                                                                          body weight gain in
                                                                                          males. At the next
                                                                                          higher dose level (7.5
                                                                                          mg/kg/day), the
                                                                                          following effects were
                                                                                          observed in both males
                                                                                          and females: decreased
                                                                                          body weight gain;
                                                                                          increased salivation,
                                                                                          panting, liquid feces,
                                                                                          and pale gums;
                                                                                          decreased
                                                                                          erythrocytes,
                                                                                          hemoglobin, and packed
                                                                                          cell volume; increased
                                                                                          urea nitrogen; and
                                                                                          increased liver
                                                                                          weights.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Bromoxynil phenol has    10-\6\                   The weight-of-the-
                                        been classified as a                              evidence determination
                                        Group C, possible                                 was based primarily on
                                        human carcinogen. A                               results in two mouse
                                        low dose extrapolation                            carcinogenicity
                                        model (Q1*) is applied                            studies.
                                        for quantification of
                                        human risk. Q1* = 1.03
                                        x 10-\1\ (mg/kg/day)-
                                        \1\
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.324) for the residues of bromoxynil, in or on a 
variety of raw agricultural commodities including alfalfa, barley, 
corn, flax, garlic, mint, oats, onions, rye, sorghum, wheat, and 
cotton. Tolerances have also been established on fat, meat, and meat-
by-products of cattle, goats, hogs, horses, poultry, and sheep as well 
as eggs and milk. Risk assessments were conducted by EPA to assess 
dietary exposures from bromoxynil in food as follows.
    Bromoxynil is currently registered for use on alfalfa. The 
aggregate risks associated with the use of bromoxynil on alfalfa have 
been assessed previously (Reregistration Eligibility Decision (RED) 
document, Decmeber 1998). No residue data are available for bromoxynil 
on timothy. As the use directions for timothy-alfalfa stands are the 
same as for alfalfa alone, the state has proposed to translate the 
existing residue data for alfalfa (a member of Crop Group 18, Nongrass 
Animal Feeds) to timothy (a member of Crop Group 17; Grass Forage, 
Fodder and Hay). This translation would generally not be possible as 
the timothy, forage tolerance would be based on 0-day preharvest 
interval (PHI) data whereas the PHI for alfalfa, forage is 30 days. 
However, as the cultural practices for timothy-alfalfa stands is the 
same as that for alfalfa alone, for the emergency exemption only, the 
Agency is willing to translate the existing alfalfa residue data to 
timothy. Based upon the alfalfa residue data, the following tolerances 
are thus appropriate for timothy, hay at 0.50 ppm and timothy, forage 
at 0.10 ppm.
    There are no human food items associated with timothy and 
therefore, the use of bromoxynil on timothy will not increase the 
potential for secondary residues in livestock (since the residues in 
timothy will not exceed those on alfalfa, a more significant feed 
item), the dietary risk associated with bromoxynil will not be effected 
by this use. The potential for residues in drinking water will not be 
effected as the use rate for timothy-alfalfa stands is the same as for 
alfalfa alone. Thus, revised risk assessments were not conducted for 
this action. The information discussed below was previously discussed 
in the December 1998 RED document.
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. In 1998, an acute (probabilistic) dietary analysis 
including the cotton use was performed by Novigen Sciences, Inc. for 
Rhone Poulenc. The assessment used the consumption data from the USDA 
1989-1992 nationwide Continuing Survey of Food Intakes by Individuals 
(CSFII).
    The acute dietary risk assessment was conducted as a probabilistic 
risk assessment, assuming single day exposure. In the assessment, each 
person-day of food consumption was matched with randomly selected 
residue values for this assessment from field trails submitted in 
support of the chemical. Percent crop treated data were included in the 
assessment as zeroes to account for portions of the crop to which 
bromoxynil was not applied. This process was repeated one thousand 
times for each person-day in consumption data base. The assessment 
assumed that the treated commodities were evenly distributed in the 
food supply. Secondary residues in meat and milk from consumption of 
treated feed items were included in the form of a probabilistic 
assessment, varying residues in the diet in accordance with the data 
from the field trials. The assumptions for the dietary exposure were 
reviewed and found to be acceptable. The assessments assumed that 10% 
of the cotton crop would be treated.
    Anticipated residues in blended commodities (such as grains, 
cottonseed and mint oil) were used, without an adjustment for percent 
crop treated; however, tolerance level residues were used for onions, 
garlic, fat, meat by-products, and meat of cattle, goats, hogs, horses, 
sheep, and poultry, and eggs. Milk is a blended commodity, and 
therefore an anticipated residue was used.
    ii. Chronic/cancer exposure. In conducting this chronic dietary 
risk

[[Page 47398]]

assessment the Dietary Risk Evaluation System (DRES) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1989-1992 nationwide CSFII and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: Field trial residues in raw agricultural 
commodities (RACs) consumed by people were nondetectable; anticipated 
residues were based on 1/2 the limit of quantitation (LOQ), and were 
further refined by percent crop treated data. Field trial residues from 
all forages (i.e., sorghum, wheat, oat, corn, alfalfa), and all hays 
were averaged, and the additional refinement for percent crop treated 
was applied. Although forages and hays contained detectable bromoxynil 
residues, the averages used were significantly lower than tolerance-
level residues.
    The contribution of cotton gin products (gin trash) to the dietary 
burden for ruminants was assumed to be 5% of the diet for beef cattle 
and 1% for dairy cattle. It was assumed that 10% of cotton was treated. 
The only commodities which contribute significantly to exposure to 
bromoxynil and/or DBHA in the diet for the general U.S. population (or 
any subpopulation) are meat, milk, poultry, and eggs, based on 
secondary residues resulting from consumption of livestock feed items.
    iii. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a Data Call-In for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings:
     Condition 1, that the data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain such pesticide residue.
     Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group.
     Condition 3, if data are available on pesticide use and 
food consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows: 10% of the cereal 
grains (wheat, corn, oats, barley, rye, sorghum, including processed 
commodities) treated; 62% of onions treated; 100% garlic treated; 71% 
of the peppermint and spearmint treated, and 10% of the cotton treated. 
Refer to the December 1998 RED docucment for additional information.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which bromoxynil may 
be applied in a particular area.
    2. Dietary exposure from drinking water--i. Ground water. 
Bromoxynil octanoate does not exhibit the mobility or persistence 
characteristics of pesticides that are normally found in ground water. 
Bromoxynil phenol (which bromoxynil octanoate readily degrades to) has 
the potential to leach to ground water under certain conditions; 
however, it rapidly degrades under aerobic and anaerobic conditions 
reducing the likelihood of ground water contamination. Limited 
monitoring information for bromoxynil in ground water is available. The 
``Pesticides in Ground Water Database'' (EPA 1992) reports sampling for 
bromoxynil in 107 wells in four counties in Oregon between 1985 and 
1987. The well samples in each area (public water supply and domestic) 
were selected based on suspected vulnerability, susceptibility to 
contamination, and availability of information on well construction and 
depth. No additional information on the details of the monitoring was 
available. No detections of bromoxynil were reported.
    Additional monitoring data from the United States Geological Survey 
(USGS) National Water Quality Program (NAQWA) represent the highest 
quality data and most recent data available (1993-1994). The program 
was carefully designed to obtain monitoring data for surface and ground 
waters from diffuse (non-point) sources. For ground water, one 
detection of bromoxynil (concentration not specified) was reported from 
a total of 2,245 samples. Clearly, these compounds (bromoxynil phenol 
and octanoate) are not considered candidates for restricted use due to 
ground water concerns and the potential for ground water contamination 
(and exposure) from bromoxynil is extremely low.
    DBHA, a cotton metabolite, is not expected to be found in ground 
water.
    ii. Surface water. Environmental fate studies indicate that 
bromoxynil (phenol and octanoate) should not persist in surface waters, 
although water monitoring data from the USGS NAWQA program show that 
bromoxynil has been detected in 1.1% of surface water samples. Modeled 
estimated environmental concentrations (EECs)

[[Page 47399]]

were based on the cotton use and not the small grains, corn or other 
uses of bromoxynil because, it has been the Agency's experience, that 
using cotton as opposed to these crops results in a higher estimated 
surface water exposure. Cotton represents the most conservative use for 
surface water exposure (i.e., the highest possible exposure scenario).
    A Tier II analysis based on the PRZM-EXAMS model (Pesticide Root 
Zone Model Version 2.3 plus Exposure Analysis Modeling System Version 
2.94) was conducted for the cotton use. PRZM-EXAMS uses data on the 
physical-chemical properties of the pesticide plus soil and topographic 
characteristics, weather data, and water quality parameters for the 
modeled site. The model uses this information to estimate runoff from a 
10 hectare agricultural field into an immediately adjacent 1 hectare by 
2 meter deep pond. PRZM-EXAMS considers reduction in dissolved 
pesticide concentrations due to adsorption of pesticide to soil or 
sediment, incorporation, degradation in soil before wash off to a water 
body, direct deposition of spray drift into the water body, and 
degradation of the pesticide within the water body.
    Water monitoring data from the USGS NAWQA Program were reported 
during the 1993-1995 period from 7 of 20 river basins throughout the 
U.S. The NAWQA Program examined drainage basins that were primarily 
agricultural use. The percentage of detections was 1.1% from a total of 
1,925 surface water samples. Analysis of the 20 detections >0.03 parts 
per billion (ppb) yielded a median value of 0.105 ppb with a mean of 
0.53 ppb. The maximum concentration was one data point at 6.1 ppb (12.2 
ppb when accounting for 50% recovery) measured in the South Platte 
River Study Unit, CO. For urban land use, bromoxynil was not detected 
in surface waters. It is important to note the laboratory recoveries 
were approximately 50%. Apparently the laboratory recoveries did not 
vary considerably from the 50% level.
    Based on model estimates (using PRZM-EXAMS), the maximum or peak 
estimated concentration for bromoxynil was 12.3 ppb and the maximum 
estimated long-term mean was 0.24 ppb (using 36 years of weather data). 
These values represent what might be expected in a small water body 
near a cotton field highly prone to runoff. The maximum peak estimated 
concentration for bromoxynil from the model correlates with the highest 
value detected in the USGS monitoring data, when this measured value 
has been corrected for an analytical recovery rate of 50%.
    To estimate a reasonable high end exposure for the human health 
risk assessment, EPA focused on the calculated time-weighted annual 
mean concentrations of bromoxynil at each of 11 USGS monitoring sites, 
which the EPA views as located in watersheds likely to have bromoxynil 
use. (These values were not corrected for the analytical recovery rate 
of 50%.) These time-weighted annual mean concentrations ranged from 
0.011 ppb to 0.18 ppb, with 10 out of the 11 sites with time-weighted 
annual mean concentrations below 0.05 ppb. Six of the 10 sites had time 
weighted annual mean concentrations at or below 0.014 ppb. The highest 
annual time-weighted mean (0.18 ppb) was located in a relatively small 
watershed (approximately 100 square miles) in a relatively small water 
body, and the calculated annual mean value at this site was 
significantly influenced by the presence of a single high value (the 
highest value found in all of the available monitoring data). Based on 
this information, EPA believes that 0.05 ppb is a reasonable high end 
estimate for purposes of estimating drinking water exposure.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Bromoxynil is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether bromoxynil 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, 
bromoxynil 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 bromoxynil has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base on toxicity and exposure unless EPA 
determines that a different margin of safety will be safe for infants 
and children. Margins of safety are incorporated into EPA risk 
assessments either directly through use of a margin of exposure (MOE) 
analysis or through using uncertainty (safety) factors in calculating a 
dose level that poses no appreciable risk to humans.
    The bromoxynil data submitted to the Agency for review are 
sufficient for the assessment of hazard to the developing organism. A 
total of 11 developmental and 3 reproductive toxicity studies were 
available for review. These include oral prenatal developmental 
toxicity studies (three in rats, two in rabbits, and one in mice with 
the phenol; one in rats with the octanoate), dermal prenatal 
developmental toxicity studies (one each in rats and rabbits with both 
the phenol and the octanoate), and two dietary two-generation 
reproduction studies in rats (one with the phenol; one with the 
octanoate) and one dermal reproduction study. Developmental toxicity 
was observed, following in utero exposure to bromoxynil, in multiple 
studies, by two routes of exposure, and in three species. The induction 
of supernumerary ribs was shown to be the most sensitive indicator of 
developmental toxicity in fetal rats, mice, and (in certain studies) 
rabbits. Upon consideration of the data base in its entirety, the 
Agency determined that the developmental NOAEL, for the induction of 
supernumerary ribs, resulting from prenatal exposure to bromoxynil 
(phenol) is 4 mg/kg/day via the oral route and 10 mg/kg/day via the 
dermal route. The developmental LOAELs for bromoxynil phenol were 5 mg/
kg/day by the oral route and 50 mg/kg/day by the dermal route. Other 
forms of developmental toxicity, including resorptions and 
malformations, were routinely observed in bromoxynil studies at higher 
dose levels.
    It was determined that the FQPA safety factor should be retained 
for the subpopulation consisting of females 13+ for acute dietary 
exposures. This

[[Page 47400]]

decision was based upon concerns emanating from the toxicological 
profile, including evidence of increased susceptibility of fetuses to 
bromoxynil exposure, the steep dose response curve, and the 
demonstrated severe developmental effects at doses above the LOAEL.
    The population of concern is the developing fetus and the endpoint 
of concern is supernumerary ribs. This endpoint, a developmental 
anomaly, results from in utero exposure; therefore the population 
subgroup of concern is females 13+ years old. Although some systems in 
infants and children continue developing, it is unlikely that 
supernumerary ribs, even though observed across multiple species, would 
result from postnatal exposure. A 10-fold safety factor, as required by 
FQPA, will provide additional protection for infants and children and 
ensure a reasonable certainty of no harm to this sensitive 
subpopulation.

D. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure and dietary exposure from drinking water, the 
acute aggregate exposure from food and water to bromoxynil will occupy 
<1% of the aPAD for the U.S. population, 11% of the aPAD for females 13 
years and older, 2% of the aPAD for all infants and 2% of the aPAD for 
children 1-6 years old. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in the following Table 2:

                      Table 2.--Aggregate Risk Assessment for Acute Exposure to Bromoxynil
----------------------------------------------------------------------------------------------------------------
                                                      Estimated Exposure  Estimated Exposure
       Population Subgroup           aPAD (mg/kg)      from Food (mg/kg   from Water (mg/kg/   % aPAD (Food and
                                                            bw/day)              day)               Water)
----------------------------------------------------------------------------------------------------------------
 U.S. population                  0.08                0.000137            0.00035             <1%
----------------------------------------------------------------------------------------------------------------
Females 13+ years                 0.004               0.000082            0.00035             11%
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)          0.08                0.000288            0.0012              2%
----------------------------------------------------------------------------------------------------------------
All infants                       0.08                0.000219            0.0012              2%
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure and dietary exposure from drinking water, EPA 
has concluded that exposure to bromoxynil from food and water will 
utilize <1% of the cPAD for the U.S. population, <1% of the cPAD for 
all infants, and <1% of the cPAD for children 1-6 years old. There are 
no residential uses for bromoxynil that result in chronic residential 
exposure to bromoxynil. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 3:

              Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bromoxynil
----------------------------------------------------------------------------------------------------------------
                                                      Estimated Exposure  Estimated Exposure
       Population Subgroup           cPAD (mg/kg)      from Food (mg/kg   from Water (mg/kg/   % cPAD (Food and
                                                            bw/day)              day)               Water)
----------------------------------------------------------------------------------------------------------------
U.S. population                   0.015               0.000015            0.0000014           <1%
----------------------------------------------------------------------------------------------------------------
Females 13+ years                 0.015               0.000012            0.0000016           <1%
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)          0.015               0.000032            0.000005            <1%
----------------------------------------------------------------------------------------------------------------
All Infants                       0.015               0.000036            0.000005            <1%
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Bromoxynil is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which were previously addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Bromoxynil is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which were previously addressed.
    5. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions described in this unit for chronic/cancer exposure and 
dietary exposure from drinking water, EPA has concluded that exposure 
to bromoxynil from food and water resulted in an estimated aggregate 
cancer risk to the U.S. population of 1.7 x 10-\6\. 
Bromoxynil is not registered for use on any sites that would result in 
residential exposure. Therefore, the aggregate cancer risk is the sum 
of the risk from food and water only.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to bromoxynil residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methodology is available for data collection 
and tolerance enforcement for bromoxynil per se in plants. Method I in 
PAM, Vol. II, is a GLC/MCD that has undergone a successful EPA method 
validation on

[[Page 47401]]

wheat grain. This method involves alkaline hydrolysis in methanolic KOH 
to convert residues to bromoxynil, cleanup by liquid-liquid 
partitioning, methylation using diazomethane, further cleanup on a 
Florisil column, and determination by GLC/MCD. Method Ia is the same 
method, but uses GC/ECD for determination of methylated bromoxynil.
    Method A is a GC/MCD or ECD method for the analysis of bromoxynil 
residues in livestock tissues and is essentially the same as Method I. 
Method B is a GC/ECD method that is also similar to Method I, with 
modifications to the cleanup procedures.

B. International Residue Limits

    There are no established or proposed Codex maximum residue levels 
for bromoxynil residues; no compatibility questions exist with respect 
to U.S. tolerances and Codex.

VI. Conclusion

    Therefore, the tolerance is established for residues of bromoxynil, 
3,5-dibromo-4-hydroxybenzonitrile, in or on timothy, hay at 0.50 ppm 
and timothy, forage at 0.10 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301163 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
13, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301163, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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

[[Page 47402]]

Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review 
or any other Agency action under Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This action does not involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a FIFRA section 18 
exemption under FFDCA section 408, such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. In addition, the Agency has determined that this action will not 
have a substantial direct effect on States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in Executive Order 13132, entitled Federalism (64 FR 43255, 
August 10, 1999). Executive Order 13132 requires EPA to develop an 
accountable process to ensure ``meaningful and timely input by State 
and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.
    Because this rule has been exempted from review under Executive 
Order 11866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001).

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 this final rule in the Federal Register. This final 
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 28, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.324 is amended by adding text to paragraph (b) to 
read as follows:


Sec. 180.324  Bromoxynil, tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide bromoxynil, 3,5-dibromo-4-
hydroxybenzonitrile in connection with use of the pesticide under 
section 18 emergency exemptions granted by EPA. The tolerances will 
expire and are revoked on the date specified in the following table:

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Timothy, hay......................           0.50 ppm            6/30/03
Timothy, forage...................           0.10 ppm            6/30/03
------------------------------------------------------------------------


[[Page 47403]]

* * * * *
[FR Doc. 01-22526 Filed 9-11-01; 8:45 am]
BILLING CODE 6560-50-S