[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
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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
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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.
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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)
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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)
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[[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.
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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.
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Long-Term Dermal (>6 months) N.A. No exposure under Residential N.A. N.A.
use pattern Occupational N.A.......
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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