

[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Rules and Regulations]               
[Page 47101-47106]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au06-16]                         


[[Page 47101]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0018; FRL-8080-7]

 
Endothall; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of endothall and its monomethyl ester in or on fish. Cerexagri, Inc. 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 16, 2006. Objections and 
requests for hearings must be received on or before October 16, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0018. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne Miller, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6224; e-mail address: miller.joanne@epa.gov.

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 entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm



C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0018 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 October 16, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0018, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of February 11, 2005 (70 FR 7260) (FRL-
7696-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9F6015) by Cerexagri, Inc., 630 Freedom Business Center, Suite 402, 
King of Prussia, PA 19406. The petition requested that 40 CFR 180.293 
be amended by establishing a tolerance for residues of the herbicide 
endothall, 7-oxabicyclo[2,2,1] heptane-2,3-dicarboxylic acid, in or on 
fish/shellfish at 0.25 parts per million (ppm). That notice included a 
summary of the petition prepared by Cerexagri, Inc., the registrant. 
Comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit IV.C. On June 8, 2006, Cerexagri, Inc. 
submitted a revised petition to the Agency. The petition was requested 
establishing a tolerance for endothall in or on fish at 0.1 ppm.

[[Page 47102]]

    The endothall tolerance under 40 CFR 180.293 is being revised per 
the Endothall RED, to be expressed in terms of endothall per se and its 
monomethyl ester. Tolerances that are currently established for 
residues in/on undelinted cotton seed, hops, potato, and rice grain and 
straw will not change in value.
    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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....''
    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 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for combined residues of endothall 
and its monomethyl ester on fish at 0.1 ppm. EPA's assessment of 
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. Specific information on the studies received and the nature 
of the toxic effects caused by endothall and its monomethyl ester as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at http://www.epa.gov/oppsrrd1/REDs/endothall_red.pd.


B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for endothall and its 
monomethyl ester used for human risk assessment is shown in Table 1 of 
this unit:

  Table 1.--Summary of Toxicological Dose and Endpoints for Endothall and its monomethyl ester for Use in Human
                                                 Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA Safety
          Exposure/Scenario                Interspecies and     Factor (SF) and LOC for  Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of                                                    An appropriate endpoint
 age)                                                                                     attributable to a
                                                                                          single dose was not
                                                                                          available from any
                                                                                          study, including the
                                                                                          prenatal developmental
                                                                                          toxicity study in
                                                                                          rats. An acute
                                                                                          reference dose (RfD)
                                                                                          was not established.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      LOAEL= 2 milligrams/     FQPA SF = 1              Rat 2-generation
                                        kilogram (mg/kg)/day    Chronic population        reproduction study
                                       UF = 300...............   adjusted dose (cPAD) =  LOAEL 2 mg/kg/day based
                                       Chronic RfD = 0.007 mg/   chronic RfD / FQPA SF.   on proliferative
                                        kg/day.                 = 0.007 mg/kg/day......   lesions of the gastric
                                                                                          epithelium (both
                                                                                          sexes)
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1 to 30    Offspring                Residential LOC for      Rat 2-generation
 days) (Residential)                   NOAEL = 9.4 mg/kg/day..   Margin of Exposure       reproduction study
                                                                 (MOE) = 100             LOAEL 60 mg/kg/day
                                                                Occupational = Not        based on decreased pup
                                                                 Applicable (N.A.).       body weight (both
                                                                                          sexes) on Day 0 F1 and
                                                                                          F2 generations
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1   LOAEL= 2 mg/kg/day       Residential LOC for MOE  Rat 2-generation
 to 6 months) (Residential)                                      = 300                    reproduction study
                                                                Occupational = N.A.....  LOAEL 2 mg/kg/day based
                                                                                          on proliferative
                                                                                          lesions of the gastric
                                                                                          epithelium (both
                                                                                          sexes)
----------------------------------------------------------------------------------------------------------------

[[Page 47103]]


Short-Term Dermal (1 to 30 days)                                                         No dermal assessments
 (Residential)                                                                            were conducted, since
                                                                                          endothall is a severe
                                                                                          dermal irritant and
                                                                                          repeated dermal
                                                                                          exposure is highly
                                                                                          unlikely to occur.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 to 6                                                         No dermal assessments
 months) (Residential)                                                                    were conducted, since
                                                                                          endothall is a severe
                                                                                          dermal irritant and
                                                                                          repeated dermal
                                                                                          exposure is highly
                                                                                          unlikely to occur.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (>6 months)           N.A. No exposure under   Residential N.A.         N.A.
                                        use pattern             Occupational N.A.......
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Offspring                Residential LOC for MOE  Rat 2-generation
                                       NOAEL = 9.4 mg/kg/day     = 100                    reproduction study
                                        (inhalation absorption  Occupational LOC for     LOAEL 60 mg/kg/day
                                        rate = 100%).            MOE = 100.               based on decreased pup
                                                                                          body weight (both
                                                                                          sexes) on Day 0 F1 and
                                                                                          F2 generations
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 to 6   LOAEL= 2 mg/kg/day       Residential LOC for MOE  Rat 2-generation
 months) and Long-Term Inhalation (>6                            = 300                    reproduction study
 months)                                                        Occupational LOC for     LOAEL 2 mg/kg/day based
                                                                 MOE = 300.               on proliferative
                                                                                          lesions of the gastric
                                                                                          epithelium (both
                                                                                          sexes)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N.A....................  N.A....................  Chronic/Onco Rat
                                                                                         Negative for
                                                                                          carcinogenicity
                                                                                         Carcinogenicity Mice
                                                                                         Negative for
                                                                                          carcinogenicity
                                                                                         Not likely carcinogenic
                                                                                          to humans
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.293) for the residues of endothall, in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from endothall and its 
monomethyl ester in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    No such effects were identified in the toxicological studies for 
endothall and its monomethyl ester; therefore, a quantitative acute 
dietary exposure assessment is unnecessary. In conducting the acute 
dietary exposure assessment EPA used the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), 
which incorporates food consumption data as reported by respondents in 
the United States Department of Agricultural (USDA) 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), 
and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the acute exposure assessments: No 
toxicological endpoint was identified for acute oral exposure. 
Therefore no acute dietary exposure assessment was performed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID\TM\, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: For the chronic analyses, tolerance-level 
residues were assumed for all food commodities with current or proposed 
endothall tolerances, and it was assumed that all the crops included in 
the analysis were treated. Percent Crop Treated (PCT) and/or 
anticipated residues were not used in the chronic risk assessment.
    iii. Cancer. Endothall is considered not likely to be carcinogenic 
to humans.
    2. Dietary exposure from drinking water. This assessment assumes an 
endothall concentration of 100 parts per billion (ppb) as the average 
concentration in drinking water. This concentration is the Maximum 
Contaminant Level (MCL) for endothall. Actual monitoring data for 
endothall suggest the average concentration of endothall in drinking 
water are well below the MCL. Monitoring data for finished water are 
available from the National Contaminant Occurrence Database (NCOD) for 
both surface water and ground water. Detectable residues of endothall 
were found in only 7 of 27,494 or 0.025% of ground water samples and 8 
of 5,112 or 0.15% of surface water samples. Although these few values 
are above the established Maximum Contaminant Level (MCL) for endothall 
of 100 ppb, greater than 99% of ground water and surface water samples 
contained concentration below the limit of detections (10 ppb). Using 
this data the mean concentration of endothall would be expected to be 
10 ppb in both ground water and surface water. Although the MCL is 
likely to overestimate average (i.e., chronic) residues of endothall in 
drinking water,

[[Page 47104]]

EPA believes it provides a reasonable high-end estimate of potential 
drinking water concentrations from the aquatic uses of endothall. 
Consequently, the MCL of 100 ppb was used in the dietary risk 
assessment.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
endothall and its monomethyl ester for acute exposures are estimated to 
be 7.1 ppb for surface water and 0.086 ppb for ground water. The EECs 
for chronic exposures are estimated to be 2.5 ppb for surface water and 
0.086 ppb for ground water. The EECs for chronic exposures (cancer) are 
estimated to be 2.4 ppb for surface water and 0.086 ppb for ground 
water.
    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). Endothall and its 
monomethyl ester is currently registered for use on the following 
residential non-dietary sites: Ponds and garden pools. The risk 
assessment was conducted using the following residential exposure 
assumptions: Homeowners may potentially be exposed to endothall by 
applying home-use formulations. There is potential for exposure to 
adults and children from incidental oral and dermal exposure during 
recreational activities in public waters treated with endothall.
    As a result, risk assessments were completed for both residential 
handlers and post-application scenarios. Residential applications are 
only expected to occur over short-periods of time. For residential 
post-application exposures, exposures on the day of application after 
an application to a public water body are of the greatest concern. The 
Agency identified incidental oral exposure (from swallowing water while 
swimming) and the potential for dermal irritation while swimming as 
possible post-application exposure scenarios. The Agency conducted an 
assessment, using the SWIM modeling program, to assess incidental 
exposures. Risks were calculated using MOEs, where and MOE greater than 
or equal to 100 is below EPA's LOC.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to endothall and its 
monomethyl ester and any other substances and endothall and its 
monomethyl ester 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 endothall and its monomethyl ester 
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 policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.


D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA 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 based on reliable data 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 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional UFs and/or special FQPA 
safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is not a concern for 
prenatal and/or postnatal toxicity resulting from exposure to endothall 
in rats (rabbit- not yet determined). There was no quantitative or 
qualitative evidence of increased susceptibility following prenatal 
exposure to rats in the developmental toxicity study and prenatal/
postnatal exposure to rats in the 2-generation reproduction study. Due 
to the lack of a prenatal developmental study in rabbits, 
susceptibility could not be ascertained in a second (non-rodent) 
species.
    There are no concerns for residual uncertainty for prenatal 
toxicity in the available developmental study, or the 2-generation rat 
toxicity study. In evaluating the toxicological database for endothall, 
the primary effects are the point of entry effects (i.e., dermal). In 
addition, the weight of evidence suggests that endothall will be of no 
developmental concern. The rabbit developmental study is being required 
as a confirmatory study.
    3. Conclusion. Based on the above data base (which is considered 
adequate), no special FQPA safety factor (i.e. 1X) is required since 
there are no residual uncertainties for prenatal toxicity. In deriving 
uncertainty for use in the risk assessment, the conventional 10x factor 
for interspecies extrapolation and 10x for intraspecies extrapolation 
were used for all scenarios. The data base was complete enough and 
there was no evidence of prenatal or postnatal susceptibility in the 
studies submitted and evaluated to date. Therefore, the FQPA 10X factor 
was reduced to 1X. The exposure scenarios in which the hazard value was 
based on a LOAEL (intermediate term inhalation for both occupational 
and residential settings) an additional UF of 3X was used to 
approximate a NOAEL.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Due to the lack of an acute Rfd and acute dietary 
exposure/risk, an acute aggregate risk assessment was not performed.
    2. Chronic risk. There are no long term residential uses of 
endothall. Aggregated chronic exposures to endothall through food plus 
drinking water were calculated in DEEM\TM\. The results for directly 
treated crops, irrigated crops and drinking water from aquatic uses of 
endothall were 33% of the cPAD (0.002297 mg/kg/day) for the general 
population. The most highly exposed population subgroup was infants at 
103% cPAD (0.007234 mg/kg/day). This risk estimate is the result of 
conservative assumptions (using the MCL of 100 ppb, likely to 
overestimate chronic residues of endothall in drinking waters).
    3. Short-term risk. A risk assessment for aggregate exposures (food 
+ drinking water + residential) was conducted for the short term 
exposure scenario because residential uses of endothall are expected to 
be only episodic. Food

[[Page 47105]]

exposures are based on treated crops and irrigated crops. Drinking 
water exposures are based on aquatic uses of endothall. Although 
endothall has terrestrial uses, as well as aquatic uses, the aquatic 
uses result in the highest estimates of potential drinking water 
exposures. Residential handler exposures for adults are based on 
granular applications of endothall with a belly grinder to lakes or 
ponds. Residential post-application exposures for adults and children 
are based on swimming.
    For adults, estimated dietary exposures via food and drinking water 
were combined with inhalation exposures during application to a pond or 
lake and potential post-application exposures during swimming. The 
Agency notes the handler scenario aggregated for adults is the exposure 
scenario resulting in the lowest MOE (highest risk estimate) for 
residential handlers. For children, estimated dietary exposures via 
food and drinking water were combined with potential post-application 
exposures during swimming. The short term aggregate risk estimate (MOE) 
for adults is 310, for children, it is 250. The MOEs are not a risk 
concern. Therefore, there are no short term aggregate (food + drinking 
water + residential) risk concerns for endothall.

                            Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Endothall and its monomethyl ester
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Short Term Scenario
                                                                   -------------------------------------------------------------------------------------
                                                                                                            Residential
                            Population                                 Target     MOE food + -----------------------------------------   Aggregate MOE
                                                                     Aggregate     water\2\                                  MOE       (food + water and
                                                                       MOE\1\                 MOE oral\3\   MOE dermal  inhalation\4\   residential)\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child (3-5 years old)                                                       100        2,770          280         N.A.          N.A.                 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults (50+ years old)                                                      100        4,250          900         N.A.           470                 310
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Target MOE of 100 based on using UF of 10X for interspecies extrapolation and 10X for intraspecies variability.
\2\ MOE food + water, which incorporated the dietary exposures for treated crops, irrigated crops and aquatic uses, = ( short-term oral NOAEL)/(chronic
  dietary exposure). Short-term NOAEL = 9.4 mg/kg/day from the 2-generation reproduction rat study, chronic dietary (food+ water) exposure = 0.003395,
  Children 3-5 years old, and 0.002211, Adults 50+ years old.
\3\ MOE oral = (short-term oral NOAEL)/(Oral postapplication exposure of Swimmers) Short-term NOAEL = 9.4 mg/kg/day from the 2-generation reproduction
  rat study, Oral daily postapplication exposure of swimmers = 0.0341 mg/kg/day, Children 6-10 years old; 0.0107 mg/kg/day, Adults (see Table 6.3.2.2).
\4\ MOE inhalation = [(inhalation NOAEL)/(high-end inhalation residential handler exposure)] Short-term inhalation NOAEL = 9.4 mg/kg/day from the 2-
  generation reproduction rat study.
\5\ Aggregate MOE (food + water and residential) = 1/[ [(1/MOE food+ water) + (1/MOE oral) + (1/MOE dermal) + (1/MOE inhalation)]]

    4. Intermediate-term risk. Due to the episodic residential use of 
Endothall, no intermediate term aggregate (dietary + residential) risk 
assessment was performed.
    5. Aggregate cancer risk for U.S. population. Endothall is 
considered not likely to be carcinogenic to humans.
    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 endothall and its monomethyl ester residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An improved high performance liquid chromotography-mass 
spectrometry detection (HPLC-MSD) method has been submitted as a 
confirmatory enforcement method for plants and fish. A gas 
chromatography method with microcoulometric nitrogen detection is 
listed as Method I in the Pesticide Analytical Manual (PAM, Volume II) 
for the determination of endothall residues in/on crop commodities.
    Adequate enforcement methodology (specify method; example--gas 
chromatography) is available to enforce the tolerance expression. The 
method may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.


B. International Residue Limits

    No International tolerances have been set for endothall.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing conducted on animals have absolutely no validity and are 
cruel to the test animals. B. Sachau's comments contained no scientific 
data or evidence to rebut the Agency's conclusion that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to endothall, including all anticipated dietary exposures and all other 
exposures for which there is reliable information. EPA has responded to 
B. Sachau's generalized comments on numerous previous occasions.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
endothall, 7-oxabicyclo[2,2,1] heptane-2,3-dicarboxylic acid and its 
monomethyl ester, in or on fish at 0.1 ppm, and the endothall tolerance 
in 40 CFR 180.293 is revised to be expressed in terms of endothall per 
se and its monomethyl ester.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. 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). Because this rule has been 
exempted from review under Executive Order 12866 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). 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) (Public Law 
104-4). Nor does it require any

[[Page 47106]]

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 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 petition under 
section 408(d) of FFDCA, 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. 
The Agency hereby certifies that this rule will not have significant 
negative economic impact on a substantial number of small entities. 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 section 408(n)(4) of FFDCA. 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.

VII. Congressional Review Act

    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 3, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.293, paragraph (a)(1) is amended by revising the 
introductory text and alphabetically adding the commodity ``fish'' to 
the table to read as follows:


Sec.  180.293  Endothall; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues 
of Endothall, 7-oxabicyclo [2, 2, 1] heptane-2, 3-dicarboxylic acid and 
its monomethyl ester in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Fish.................................................                0.1
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-13293 Filed 8-15-06; 8:45 am]

BILLING CODE 6560-50-S
