Document ID: EPA-HQ-OPP-2008-0730-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Endothall
Posted Date: 2009-12-18T05:00Z

[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Rules and Regulations]               
[Page 67090-67098]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de09-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0730; FRL-8804-8]

 
Endothall; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for indirect or 
inadvertent combined residues of endothall in or on multiple 
commodities identified and discussed elsewhere in this document. The 
Interregional Research Project Number 4 (IR-4) in cooperation with the 
registrant, United Phosphorus, Inc., requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 18, 2009. Objections and 
requests for hearings must be received on or before February 16, 2010, 
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-2008-0730. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@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 those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods & Guidelines'' on the left-side navigation menu.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-

[[Page 67091]]

OPP-2008-0730 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 as required by 40 CFR part 178 on or before February 16, 
2010.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0730, 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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73644) (FRL-
8386-9), 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 
8E7419) by the IR-4, IR-4 Project Headquarters, 500 College Road East, 
Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 
180.293 be amended by establishing tolerances for combined residues of 
the herbicide endothall, mono (N,N-dimethylalkylamine) salt of 
endothall, and the dipotassium salt of endothall, in or on Vegetable 
Root, and Tuber Group 1 at 2 ppm (parts per million); Vegetable, Leaves 
of Root and Tuber, Group 2 at 3.5 ppm; Vegetable, Bulb, Group 3-07 at 2 
ppm; Vegetable, Leafy, except Brassica, Group 4 at 3.5 ppm; Vegetable, 
Brassica, Leafy, Group 5 at 0.1 ppm; Turnip, greens at 0.1 ppm; 
Vegetable, Legume, Group 6 at 3 ppm; Vegetable, Fruiting, Group 8 at 
0.05 ppm; Okra at 0.05 ppm; Vegetable, Cucurbit, Group 9 at 1.1 ppm; 
Fruit, Citrus, Group 10 at 0.05 ppm; Fruit, Pome, Group 11 at 0.05 ppm; 
Fruit, Stone, Group 12 at 0.25 ppm; Berry and Small Fruit Group 13-07 
at 0.6 ppm; Nut, Tree, Group 14, at 0.05 ppm; Pistachio at 0.05 ppm; 
Almond, hulls at 10 ppm; Grain, Cereal, Group 15 at 2.5 ppm; Grain, 
Cereal, Forage, Fodder and Hay, Group 16, forage at 3.5 ppm, Grain, 
Cereal, Forage, Fodder and Hay, Group 16, hay at 5 ppm, Grain, Cereal, 
Forage, Fodder and Hay, Group 16, stover at 11 ppm, Grain, Cereal, 
Forage, Fodder and Hay, Group 16, straw at 6 ppm, Grain, aspirated 
fractions at 24 ppm; Grass, Forage, Fodder, and Hay, Group 17, forage 
at 3 ppm, Grass, Forage, Fodder and Hay, hay at 19 ppm; Nongrass Animal 
Feed, Group 18 forage at 3.5 ppm, Nongrass Animal Feed, Group 18 hay at 
8 ppm; Grape at 0.9 ppm, Peppermint, tops at 7 ppm, Spearmint, tops at 
7 ppm; and Rice, grain at 1.7 ppm and Rice, straw at 4.5 ppm. That 
notice referenced a summary of the petition prepared by United 
Phosphorus, Inc., the registrant, on behalf of IR-4 which is available 
to the public in the docket, http://www.regulations.gov. This petition 
for tolerances was filed in conjunction with an application under the 
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA'') for use 
of endothall in irrigation water and thus the broad request for 
tolerances. There were no comments received in response to the notice 
of filing.
    Based upon review of the data supporting the petition as well as 
the proposed use to irrigation canals, EPA has determined that 
virtually all crops as well as most food and feed commodities could 
potentially be exposed to residues in endothall-laden irrigation water 
with EPA approval of this use. In consideration of these factors, the 
Agency is revising the proposed tolerances to include inadvertent 
endothall residues on any food commodities not otherwise listed at 5.0 
ppm and any feed commodities not otherwise listed at 10.0 ppm. 
Additionally, based on the residue data submitted, EPA has revised 
proposed tolerance levels for certain food and feed commodities. 
Finally, EPA is not establishing certain petitioned-for tolerances 
after determining they are not needed. The reasons for these changes 
are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with endothall follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Endothall is a caustic chemical with toxicity being the result of a 
direct degenerative effect on tissue. By acute dermal application and 
inhalation exposure, it has mild toxicity. Dermally, it destroys the 
stratum corneum and then the underlying viable epidermis. Endothall is 
a skin sensitizer. Endothall is an extreme irritant by the acute oral, 
and ocular routes of administration. Orally, endothall attacks the 
digestive tract. In the eye irritation study, endothall was shown to be 
extremely irritating to the eye and was also lethal to 4 of 6 rabbits 
tested.
    In the 21-day dermal rat study, systemic toxicity (hematology and 
clinical chemistry alterations) were noted at a dose level that was one 
order of magnitude greater than that causing dermal irritation. 
Available studies clearly demonstrate that local irritation (portal of 
entry effect) is the most sensitive and initial effect, occurring at

[[Page 67092]]

dose levels lower than those associated with systemic toxicity. In 
dogs, gastric irritation developed at a dose level that was one order 
of magnitude lower than doses associated with clinical signs of 
toxicity (subdued behavior, poor condition, thin appearance and 
distended abdomen). In the rat, gastric irritation was noted at a dose 
level that was 1 to 2 orders of magnitude lower than doses resulting in 
kidney lesions. Besides gastric irritant effects, decreased body weight 
was also a sensitive effect following endothall administration. The 
decreased body weights were most likely attributable to the constant 
and direct irritation of the gastric lining. In a developmental rat 
study, pregnant rats exhibited decreased body weight and decreased body 
weight was noted in a 90-day dietary study in the rat. Body weight loss 
occurred in dogs following a 13 week oral treatment with endothall.
    Endothall does not cause prenatal toxicity following in utero 
exposure to rats nor prenatal or postnatal toxicity following exposures 
to rats for 2-generations. In the developmental mouse study, there was 
severe maternal toxicity (i.e., greater than 30% mortality) at the 
highest dose tested; at this dose level, a slight increase in vertebral 
and rib malformations was observed in the offspring indicating that 
these effects were most likely secondary to severe maternal toxicity.
    Available studies showed no evidence of neurotoxicity and do not 
indicate potential immunotoxicity. Endothall does not belong to the 
class of compounds (e.g., the organotins, heavy metals, or halogenated 
aromatic hydrocarbons) that would be expected to be toxic to the immune 
system. Endothall is classified as ``not likely to be carcinogenic to 
humans'' based on lack of evidence of carcinogenicity in mice or rats. 
It has no mutagenic potential.
    Specific information on the studies received and the nature of the 
adverse effects caused by endothall 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.regulations.gov in document ``Endothall: Revised Human Health Risk 
Assessment for the Section 3 Registration Action to Support a New Use 
of Endothall in Irrigation Canals with No Required Holding Period 
before that Water Can Be Used on Crops,'' dated 11/09/2009, page 16 in 
docket ID number EPA-HQ-OPP-2008-0730-0004.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for endothall used for 
human risk assessment can be found at http://www.regulations.gov in 
document entitled; ``Endothall: Revised Human Health Risk Assessment 
for the Section 3 Registration Action to Support a New Use of Endothall 
in Irrigation Canals with No Required Holding Period before that Water 
Can Be Used on Crops,'' dated 11/09/2009, page 21 in docket ID number 
EPA-HQ-OPP-2008-0730-0004.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to endothall, EPA considered exposure under the petitioned-for 
tolerances as well as all existing endothall tolerances in 40 CFR 
180.293. EPA assessed dietary exposures from endothall 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 1-day or single exposure.
    No systemic toxicity resulting from a single exposure was 
identified. An acute Reference Dose (RfD) was not established for any 
population subgroup because an appropriate endpoint attributable to a 
single endothall dose was not available from any study, including the 
prenatal developmental toxicity study in the rat or the mouse. 
Therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database DEEM-FCID(\TM\), Version 2.03 which 
incorporates consumption data from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII).
    Analyses were performed to support the use of endothall in 
irrigation canals with no holding period before the water may be used 
on crops. The resulting chronic exposure assessment for food is 
refined, using average residues from the field trials, and estimating 
residues in meat, milk, poultry and eggs (MMPE), and using average 
residues in the livestock feeds. The exposure estimate also includes an 
adjustment for the percent of the harvested crop that has been 
irrigated for some crops. Despite this refinement, the results remain 
very conservative for several reasons. First, the field residue trials 
were performed under highly conservative conditions. Second, the manner 
of taking percent of the crop irrigated into consideration was very 
conservative. For most commodities EPA assumed 100% of the crop would 
be irrigated. For the remaining crops, EPA used two different methods 
to estimate the percent of the crop that was irrigated. Where EPA had 
reliable data on the percent of a crop that is irrigated, EPA assumed 
that percentage of that crop is irrigated with endothall-treated water 
(i.e., assuming that 100% of irrigation water is treated

[[Page 67093]]

with endothall). Where EPA did not have adequate data on the percent of 
a crop that is irrigated, EPA assumed that all crops grown in the 
western U.S. are irrigated with endothall-treated water. Endothall is 
unlikely to be used in treatment of irrigation water outside of the 
western U.S. This is a very conservative assumption because all of the 
crops grown in the western U.S. are not irrigated.
    The average residue values used in the dietary exposure assessment 
were taken from 18 sets of field trials submitted by IR-4. Processing 
factors were taken from the appropriate processing studies submitted 
with these field trials. Because this assessment needed to cover all 
possible crops that might be irrigated in the U.S., the appropriate 
crop residues and processing studies were translated within each extant 
crop group, and in addition appropriate residue values were translated 
to other orphan crops outside of those crop groups as needed. For 
similar reasons appropriate processing factors were sometimes 
translated to similarly processed commodities. DEEM default 
concentration factors were used for any applicable processed 
commodities where no applicable processing factors could reasonably be 
translated, but default factors did exist. For certain crops no formal 
default values have been established, so the processing factors for 
these crops were left at 1.0, to be consistent with other contemporary 
assessments.
    iii. Cancer. Endothall is considered ``not likely to be 
carcinogenic to humans'' based on lack of evidence of carcinogenicity 
in mice and rat studies. Endothall showed no mutagenic potential based 
on results from in vitro mammalian cell gene mutation assay in Chinese 
hamster ovary (CHO) cells and bacterial gene mutation assay (Salmonella 
typhimurium). Therefore, a dietary exposure assessment for the purpose 
of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) 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. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Apple, fresh market 78%, apple, processing 44%, apple, juice 49%, 
apple, canned 14%, barley 36%, corn 19%, dry edible beans 32%, grape, 
fresh market 99%, grape, processing 94%, green peas 11%, oats 7%, 
peanuts 42%, sorghum 15%, soybeans 9%, sugarbeets 37%, sugarcane 54%, 
strawberry, fresh market 89% and wheat 14%, and watermelon 39%.
    EPA is establishing tolerances on multiple commodities to support 
the application of the aquatic herbicide endothall to be used in 
irrigation canals without a holding period. For a new agricultural 
pesticide use, EPA typically estimates PCT by comparison with the 
amount of use of other pesticides for the same crop or site. That 
approach is inappropriate for the new use for endothall, because the 
use is on irrigation canals rather than crops and EPA does not have 
data on the frequency of use of aquatic herbicides on irrigation 
canals.
    Instead, EPA has estimated PCT for endothall by estimating the 
percent crop irrigated which serves as an upperbound for crops that may 
be exposed to endothall in irrigation water. EPA used two methods to 
estimate percent crop irrigated. The preferred method, used where 
reliable data on irrigated production are available, is an estimate of 
the share of total production that is irrigated. Estimates from this 
method are provided for barley, corn, dry edible beans, oats, peanuts, 
rice, sorghum, soybeans, sugarbeets, sugarcane, and wheat. Where data 
on irrigated production are not available, EPA estimated the percent 
crop irrigated by determining the percentage of U.S. production of a 
crop that is grown in 17 western states where endothall may be used. 
The 17 western states are Arizona, California, Colorado, Idaho , 
Kansas, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, 
Oregon, South Dakota, Texas, Utah, Washington, and Wyoming. These 
states are the states where large scale water projects predominate, and 
where other chemicals are used in canals for weed control. These types 
of irrigation projects are relatively rare in other parts of the 
country.
    Use of these estimates in the exposure assessment is conservative, 
because it is the equivalent of assuming 100% of irrigated crops have 
irrigated with water from endothall-treated canals. In fact, even in 
areas with surface water delivery systems, all irrigation canals may 
not be treated with endothall. Additionally, some crops, even in the 
heavily irrigated areas of the West, are not irrigated, such as dryland 
grain production.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, 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 reliable information on the regional consumption of 
food to which endothall may be applied in a particular area.
    2. Dietary exposure from drinking water. The maximum potential 
exposure of endothall in drinking water sources is expected to result 
from the direct application of endothall to drinking water reservoirs 
to control aquatic

[[Page 67094]]

weeds. EPA assumed that the entire reservoir would be treated at the 
maximum rates, with no more than 10% of the reservoir treated at one 
time as stated on the label, so that 10 treatments were applied 7 days 
apart to treat the entire reservoir. Since the label specified that the 
community water system (CWS) could not supply treated drinking water 
unless the endothall residues were below 0.1 ppm (100 [micro]g/L), EPA 
assumed 100 [micro]g/L (0.1 ppm) as the acute (peak) exposure and the 
constant exposure during the treatment period and then modeled residue 
decline by degradation after the final treatment. This resulted in a 
chronic (annual average) concentration of 31 [micro]g/L (0.031 ppm) for 
endothall. This represents the likely high-end chronic exposure from 
endothall from the use expected to generate the highest exposures 
(treatment of a reservoir).
    Additional information on the drinking water exposure assessment 
can be found at http://www.regulations.gov in document entitled; 
``Drinking Water Assessment for the IR-4 Tolerance Petition for the Use 
of Endothall-treated Irrigation Water on a Variety of Crops,'' dated 9/
09/2009 in docket ID number EPA-HQ-OPP-2008-0730.
    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 is currently registered for the following uses that could 
result in residential exposures. There is a potential for exposure from 
registered uses in residential for homeowners who apply endothall 
products to control aquatic weeds and algae in ponds and garden pools. 
There is also a potential for exposure to adults and children from 
contacting water treated with endothall through swimming, wading, water 
skiing, etc. The Agency conducted risk assessments for both residential 
handler and post-application scenarios.
    For residential handlers, exposure scenarios are only considered to 
be short-term in nature due to the episodic uses associated with 
homeowner products. In ponds and garden pools use patterns and under 
current product labeling, two likely residential exposure scenarios 
exist including; 1) loading/applying granules with a bellygrinder and 
2) applying granules by hand. The quantitative exposure/risk assessment 
developed for residential handlers is based on these two scenarios.
    In residential post-application scenarios, exposures to adults and 
children may be expected following applications of endothall to ponds 
and lakes. Only short-term exposures are expected since these scenarios 
are expected to be only episodic.
    Of the possible post-application exposures, swimming in treated 
water is considered by EPA to be worse-case and is used as a surrogate 
for all other possible post-application exposures, such as wading, 
water skiing, etc. The Agency considered residential post-application 
exposure for different segments of the population using the Swimmer 
Exposure Assessment Model (SWIMODEL). Details on the SWIMODEL used in 
this assessment may be found at: http://www.epa.gov/oppad001/
swimodel.htm.
    Risks were calculated using the MOE approach, where a MOE of >100 
is considered a level that does not pose a concern.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found endothall to share a common mechanism of toxicity 
with any other substances, and endothall does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that endothall does not 
have 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 EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility following prenatal 
exposure to rats in the developmental toxicity study. Endothall does 
not cause prenatal toxicity following in utero exposure to rats nor 
prenatal or postnatal toxicity following exposures to rats for 2-
generations reproduction studies. Due to high mortality observed in a 
range finding study in rabbits even at low doses, a developmental 
toxicity study in this species was not conducted (i.e., acute direct 
irritative effects of the chemical could interfere with developmental 
toxicity in this susceptible species). A developmental toxicity study 
in mice showed no evidence for enhanced susceptibility in this species.
    EPA concluded that there is not a concern for prenatal and/or 
postnatal toxicity resulting from exposure to endothall in rats. In the 
developmental mouse study, there was severe maternal toxicity (i.e., 
greater than 30% mortality) at the highest dose tested; at this dose 
level, a slight increase in vertebral and rib malformations was 
observed in the offspring indicating that these effects were likely 
secondary to severe maternal toxicity.
    3. Conclusion. For chronic and intermediate-term risk assessments, 
EPA is retaining an additional safety factor for the protection of 
infants and children because it is relying on a LOAEL in the 2-
generation reproduction study in assessing the risk of endothall. For 
short-term risk assessments, EPA has determined that reliable data show 
that the safety of infants and children would be adequately protected 
if the FQPA SF were reduced to 1X. Based on the following factors, EPA 
has determined that an additional factor of 3X will be safe for infants 
and children for chronic and intermediate-term risk assessments and 
that a 1X factor will be safe for short-term risk assessments:
    i. Despite the fact that a NOAEL was not identified in the 2-
generation reproduction study for chronic and intermediate-term effects 
and EPA is relying on a LOAEL from that study, a 3X factor (as opposed 
to a 10X) was determined to be adequate because: The gastric lesions 
(most sensitive effect) are due to the direct irritant properties of 
endothall (i.e., portal effects) and not as a result of frank systemic 
toxicity;the severity of the lesions were minimal to mild; and there 
was no apparent dose-response for this effect.

[[Page 67095]]

    Therefore, EPA is confident that the POD for chronic dietary and 
intermediate inhalation exposure risks will not underestimate risks 
following exposure to endothall. A NOAEL for short-term effects was 
identified in the 2-generation reproduction study and is being used as 
the POD for assessing short-term risks of endothall.
    ii. The toxicity database for endothall is complete except for 
acute and subchronic neurotoxicity studies and immunotoxicity testing. 
Recent changes to 40 CFR part 158 make these studies (OPPTS Guideline 
870.7800) required for pesticide registration; however, the available 
data for endothall do not show potential for neurotoxicity or 
immunotoxicity. Although neurotoxicity studies have not yet been 
submitted, there are no concerns for neurotoxicity. The EPA does not 
expect that these studies will demonstrate a potential neurotoxic 
effect that is more sensitive than direct local irritation (the most 
sensitive effect identified in the data base). The available acute 
subchronic and chronic studies showed no evidence of neurotoxicity. 
However, irritation was identified as the initial and most sensitive 
effect. In the absence of specific immunotoxicity studies, EPA has 
evaluated the available endothall toxicity database to determine 
whether an additional database uncertainty factor is needed to account 
for potential immunotoxicity. The available studies do not indicate 
potential immunotoxicity, and endothall does not belong to the class of 
compounds (e.g., the organotins, heavy metals, or halogenated aromatic 
hydrocarbons) that would be expected to be toxic to the immune system. 
Based on the available data, the required immunotoxicity study is not 
expected to provide a POD lower than that currently used (i.e., direct 
local irritation - the most sensitive effect) for overall risk 
assessments. Consequently, the EPA believes the existing data are 
sufficient for endpoint selection for exposure/risk assessment 
scenarios and for evaluation of the requirements under the FQPA, and an 
additional database uncertainty factor does not need to be applied.
    iii. There is no indication that endothall is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iv. There is no evidence that endothall results in increased 
susceptibility in in utero rats or mice in the prenatal developmental 
studies or in young rats in the 2-generation reproduction study.
    v. There are no residual uncertainties identified in the exposure 
databases. While the chronic dietary exposure estimates are refined 
(average field trial residues and adjustment of the percent of the 
harvested crop that has been irrigated) the results are very 
conservative because the field trials were performed under highly 
conservative conditions, and it was assumed that 100% of all irrigation 
canals in the U.S. are treated at the maximum rate for endothall. 
Further, it was assumed that this maximally treated water is applied to 
the crops on the day of harvest, and all consumers are chronically 
exposed to simultaneous inadvertent residues of endothall through all 
possible food and water sources. For most commodities EPA assumed 100% 
of the crop would be irrigated. For the remaining crops, EPA used two 
different methods to estimate the percent of the crop that was 
irrigated which were very conservative estimates. Therefore, the 
estimated dietary exposure (food and drinking water) will not 
underestimate the potential risks for infants and children. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to endothall in drinking water. EPA 
used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by endothall.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
endothall is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
endothall from food and water will utilize 84% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest exposure. 
The general U.S. population subgroup was exposed at a maximum of 32% of 
the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Endothall is currently registered for uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to endothall.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs. 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. 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 290, and for children, 
it is 240. The LOC for short-term exposures is for MOEs < 100. 
Therefore, there are no short term aggregate (food + drinking water + 
residential) risk concerns for endothall.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Endothall is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
endothall.

[[Page 67096]]

    5. Aggregate cancer risk for U.S. population. Endothall is 
considered not likely to be carcinogenic to humans. EPA does not expect 
endothall to pose a cancer risk.
    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, or to infants and children from aggregate 
exposure to endothall residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) with 
microcoulometric nitrogen detection) is listed as Method I in the 
Pesticide Analytical Manual (PAM, Volume II) for the determination of 
endothall residues (total common moiety) in plant commodities, with a 
limit of quantitation (LOQ) of 0.1 ppm. A second liquid chromatography/
mass spectrometry(LC/MS) method (Method No. KP218R0) is also available 
for determining residues of endothall and its monomethyl ester in fish 
and in plant commodities. The LOQ is 0.05 ppm for fish, and range from 
0.01-0.10 ppm for plant commodities.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for endothall on plant or animal commodities.

C. Revisions to Petitioned-For Tolerances

    The Agency revised the proposed tolerance levels for the following 
commodities: Almond, hulls from 10 to 15 ppm; animal feed, nongrass, 
group 18, forage from 3.5 to 4.0 ppm; animal feed, nongrass, group 18, 
hay from 8.0 to 10.0 ppm; fruit, stone, group 12 from 0.25 to 0.3 ppm; 
grain, aspirated fractions from 24.0 to 35.0 ppm; grain, cereal, group 
15, except corn from 1.9 to 4.0 ppm; grape from 0.9 to 1.0 ppm; grass, 
forage, fodder, and hay group 17, forage from 3.0 to 3.5 ppm; grass, 
forage, fodder, and hay group 17, hay from 19.0 to 18.0 ppm; 
peppermint, tops from 7.0 to 5.0 ppm; spearmint, tops from 7.0 to 5.0 
ppm; vegetable, bulb, group 3 at 2.0 to bulb, group 3-07 at 0.5 ppm; 
vegetable, cucurbit, group 9 from 1.1 to 1.5 ppm; vegetable, leafy, 
except brassica, group 4 from 3.5 to 2.0 ppm; vegetable, leaves of root 
and tuber, group 2 from 3.5 to 3.0 ppm; and vegetable, root and tuber, 
group 1 from 2.0 to 1.0 ppm. For proposed tolerances for cereal, 
forage, fodder and straw, group 16, stover at 11.0 ppm; and cereal, 
forage, fodder and straw, group 16, except stover at 6.0 ppm, the 
Agency established a single tolerance for both as ``grain, cereal, 
forage, fodder and straw, group 16'' at 10 ppm.
    The Agency revised the tolerance levels based on available data on 
maximum endothall residues in subject crop and/or representative crop 
including analysis of the residue field trial data using the Agency's 
Tolerance Spreadsheet in accordance with the Agency's Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data.
    Using the same resources and procedures, the Agency established 
tolerances for the following additional commodities: Apple, wet pomace 
at 0.15 ppm; beet, sugar, molasses at1.5 ppm; cattle, fat at 0.01 ppm; 
cattle, kidney at 0.20 ppm; cattle, liver at 0.1; cattle, meat at 0.03 
ppm; corn, field, grain at 0.07 ppm; corn, pop, grain at 0.07 ppm; egg 
at 0.05 ppm; feed commodities not otherwise listed at 10.0 ppm; food 
commodities not otherwise listed at 5.0 ppm; goat, fat at 0.005; goat, 
kidney at 0.15 ppm; goat, fat at 0.015 ppm; goat, liver at 0.05 ppm; 
goat meat at 0.015 ppm; grape, raisin at 5.0 ppm; herb and spice, group 
19 at 5.0 ppm; hog, fat at 0.005; hog, liver at 0.05; hog, kidney at 
0.10; hog, meat at .01 ppm; milk at 0.03 ppm; pea and bean, succulent 
shelled , subgroup 6B; pea and bean , dried shelled , subgroup, 6C at 
0.2 ppm; poultry, fat at 0.015 ppm; poultry, liver at 0.05 ppm; 
poultry, meat byproducts at 0.20 ppm; poultry, meat at 0.015 ppm; rice, 
hull at 8.0 ppm; sheep, fat at 0.005 ppm; sheep, kidney at 0.15 ppm; 
sheep, liver 0.05; sheep, meat 0.015 ppm; soybean, hulls at 0.5 ppm; 
soybean, seed at 0.2 ppm; tomato, paste at 0.1 ppm; tomato, puree at 
0.1 ppm; brassica, head and stem subgroup 5A at 0.1 ppm; brassica, 
leafy, group 5B at 2.0 ppm; vegetable, foliage of legume group 7 at 4.0 
ppm; vegetable, legume, edible, podded, subgroup 6A; and wheat, milled 
byproducts at 5.0 ppm. Some of these tolerances are being added because 
processing data indicated that residues in the processed food may 
exceed the raw commodity tolerance (grape, raisin; wheat, milled 
byproducts). The other tolerances are being added because use of an 
aquatic herbicide such as endothall in irrigation water may 
theoretically result in residues in these crops. The available data 
support these tolerances.
    EPA has also determined that individual tolerances are not 
necessary for certain petitioned-for commodities. Proposed tolerances 
for cereal, forage, fodder and straw, group 16, hay; cereal, forage, 
fodder and straw, group 16, straw; and cereal, forage, fodder and 
straw, group 16, forage are combined into forage, hay and straw and, 
therefore individual tolerances are not required. Proposed tolerances 
for rice, grain and rice, straw are not needed as these commodities are 
covered by the tolerances for cereal grains and cereal grain straw. The 
Agency rejected a proposed tolerance for vegetable, legume group 6 and 
established separate tolerances for soybeans and the various legume 
subgroups including vegetable, legume, edible podded, subgroups 6A; pea 
and bean, succulent shelled, subgroup 6B; and pea and bean, dried 
shelled, subgroup 6C. Likewise, tolerances were established for 
brassica, head and stem subgroup 5A and brassica, leafy, group 5B in 
place of a proposed tolerance for vegetable, brassica, group 5.
    The Agency established a tolerance for cattle, fat; cattle meat; 
cattle liver and cattle kidney based upon calculations for dairy cattle 
using metabolism data even though no tolerance was proposed by IR-4 for 
cattle meat products. Tolerances were also established for cereal, 
forage, fodder and straw, group 16.
    No tolerance was petitioned for on corn, field, grain or corn, pop, 
grain. However, a 0.7 ppm tolerance is established for each based on 
tolerance spreadsheet for corn grain. Also, a tolerance is established 
for corn, sweet, kernel plus cob with husks removed at 0.3 ppm based on 
maximum residues in sweet corn K+CWHR of 0.17 ppm based on available 
data.
    Additionally, the Agency has determined that the tolerances should 
be established in Sec.  180.293(d) for direct and inadvertant residues 
and the tolerance expression should read: Tolerances are established 
for the indirect or inadvertant combined residues of the herbicide, 
endothall (7 -oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in 
potable water from use of its potassium, sodium, di-N, N -
dimethylalkylamine, and mono-N-N, -dimethylalkylamine salts.

V. Conclusion

    Therefore, tolerances are established for the indirect or 
inadvertent combined residues of endothall (7-oxabicyclo[2.2.1] 
heptane-2,3-dicarboxylic acid) in water, potable from use of its 
potassium, sodium, di-N,N-dimethylalkylamine, and mono- N-N, -
dimethylalkylamine salts as algacides or herbicides to control aquatic 
plants in canals, lakes, ponds, and other potable water sources that 
may lead to endothall residues in or on almond, hulls at 15.0 ppm; 
animal feed, nongrass, group 18, forage at 4.0 ppm;

[[Page 67097]]

animal feed, nongrass, group 18, hay at 10 ppm; apple, wet pomace at 
0.15 ppm; beet, sugar at 1.5 ppm; bushberry subgroup 13-07B at 0.6 ppm; 
caneberry subgroup 13-07A at 0.6 ppm; cattle, fat at 0.01 ppm; cattle, 
kidney at 0.20 ppm; cattle, liver at 0.10 ppm; cattle, meat at 0. 03 
ppm; grain, cereal, forage, fodder and straw, group 16 at 10.0 ppm; 
corn, field, grain at 0.07 ppm; corn, pop, grain at 0.07 ppm; corn, 
sweet, kernel plus cob with husks removed at 0.3 ppm; citrus, dried 
pulp at 0.1 ppm; egg at 0.05 ppm; feed commodities not otherwise listed 
at 10.0 ppm; food commodities not otherwise listed at 5.0 ppm; fruit, 
citrus group 10 at 0.05 ppm; fruit, pome, group 11 at 0. 05 ppm; fruit, 
stone, group 12 at 0.3 ppm; goat, fat at 0.005 ppm; goat, kidney at 
0.15 ppm; goat, liver at 0.05 ppm; goat, meat at 0.015 ppm; grain, 
aspirated fractions at 35.0 ppm; grain, cereal, group 15, except corn 
at 35.0 ppm; grape at 1.0 ppm; grape, raisin at 5.0 ppm; grass, forage, 
fodder, and hay group 17, forage at 3.5 ppm; grass, forage, fodder, and 
hay group 17, hay at 18.0 ppm; herb and spice, group 19 at 5.0 ppm; 
hog, fat at 0.005 ppm; hog, liver at 0.05 ppm; hog, kidney at 0.10 ppm; 
hog, meat at 0.01 ppm; milk at 0.03 ppm; nut, tree, group 14 at 0.05 
ppm; okra at 0.05 ppm; pea and bean, succulent shelled, subgroup 6B at 
2.0 ppm; pea and bean, dried shelled, subgroup 6C at 0.2 ppm; 
peppermint, tops at 5.0 ppm; pistachio at 0. 05 ppm; poultry, fat at 
0.015 ppm; poultry, liver at 0.05 ppm; poultry, meat byproducts at 0.28 
ppm; poultry, meat at 0.15 ppm; rice, hull at 8.0 ppm; sheep, fat at 
0.005 ppm; sheep, kidney at 0.15 ppm; sheep, liver at 0.05 ppm; sheep, 
meat at 0.015 ppm; soybean hulls at 0.5 ppm; soybean, seed at 0.2 ppm; 
tomato, paste at 0.1 ppm; tomato, puree at 0.1 ppm; brassica, head and 
stem subgroup 5A at 0.1 ppm; brassica, leafy, group 5B at 2.0 ppm; 
vegetable, bulb, group 3-07 at 0.5 ppm; vegetable, cucurbit, group 9 at 
1.5 ppm; vegetable, foliage of legume, group 7 at 4.0 ppm; vegetable, 
fruiting, group 8 at 0. 05 ppm; vegetable, leafy, except brassica, 
group 4 at 2.0 ppm; vegetable, leaves of root and tuber, group 2 at 3.0 
ppm; vegetable, legume, edible, podded, subgroup 6A at 2.0 ppm; 
vegetable, root and tuber, group 1 at 1.0 ppm; and wheat, milled 
byproduct at 5.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: December 11, 2009.
Daniel J. Rosenblatt,
Acting 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 is amended by revising paragraph (d) to read as 
follows:

Sec.  180.293  Endothall; Tolerances for residues.

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent combined residues of the herbicide, 
endothall (7 - oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in 
potable water from use of its potassium, sodium, di-N, N -
dimethylalkylamine, and mono- N-N, -dimethylalkylamine salts as 
algicides or herbicides to control aquatic plants in canals, lakes, 
ponds, and other potable water sources that may lead to endothall 
residues in or on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................               15.0
Animal feed, nongrass, group 18, forage..............                4.0
Animal feed, nongrass, group 18, hay.................                 10
Apple, wet pomace....................................               0.15

[[Page 67098]]

Beet, sugar, molasses................................                1.5
Brassica, head and stem subgroup 5A..................                0.1
Brassica, leafy, subgroup 5B.........................                2.0
Bushberry subgroup 13-07B............................                0.6
Caneberry subgroup 13-07A............................                0.6
Cattle, fat..........................................               0.01
Cattle, kidney.......................................               0.20
Cattle, liver........................................               0.10
Cattle, meat.........................................               0.03
Corn, field, grain...................................               0.07
Corn, pop, grain.....................................               0.07
Corn, sweet, kernel plus cob with husks removed......                0.3
Citrus, dried pulp...................................                0.1
Egg..................................................               0.05
Feed commodities not otherwise listed................               10.0
Food commodities not otherwise listed................                5.0
Fruit, citrus group 10...............................               0.05
Fruit, pome, group 11................................               0.05
Fruit, stone, group 12...............................                0.3
Goat, fat............................................              0.005
Goat, kidney.........................................               0.15
Goat, liver..........................................               0.05
Goat, meat...........................................              0.015
Grain, aspirated fractions...........................               35.0
Grain cereal, forage, fodder and straw, group 16.....               10.0
Grain, cereal, group 15, except corn.................                4.0
Grape................................................                1.0
Grape, raisin........................................                5.0
Grass, forage, fodder, and hay group 17, forage......                3.5
Grass, forage, fodder, and hay group 17, hay.........               18.0
Herb and spice, group 19.............................                5.0
Hog, fat.............................................              0.005
Hog, liver...........................................               0.05
Hog, kidney..........................................               0.10
Hog, meat............................................               0.01
Milk.................................................               0.03
Nut, tree, group 14..................................               0.05
Okra.................................................               0.05
Pea and bean, succulent shelled, subgroup 6B.........                2.0
Pea and bean, dried shelled, subgroup 6C.............                0.2
Peppermint, tops.....................................                5.0
Pistachio............................................               0.05
Poultry, fat.........................................              0.015
Poultry, liver.......................................               0.05
Poultry, meat byproducts.............................               0.20
Poultry, meat........................................              0.015
Rice, hulls..........................................                8.0
Sheep, fat...........................................              0.005
Sheep, kidney........................................               0.15
Sheep, liver.........................................               0.05
Sheep, meat..........................................              0.015
Soybean, hulls.......................................                0.5
Soybean, seed........................................                0.2
Spearmint, tops......................................                5.0
Tomato, paste........................................                0.1
Tomato, puree........................................                0.1
Vegetable, bulb, group 3-07..........................                0.5
Vegetable, cucurbit, group 9.........................                1.5
Vegetable, foliage of legume, group 7................                4.0
Vegetable, fruiting, group 8.........................               0.05
Vegetable, leafy, except brassica, group 4...........                2.0
Vegetable, leaves of root and tuber, group 2.........                3.0
Vegetable, legume, edible, podded, subgroup 6A.......                2.0
Vegetable, root and tuber, group 1...................                1.0
Wheat, milled byproducts.............................                5.0
------------------------------------------------------------------------

[FR Doc. E9-30150 Filed 12-17-09; 8:45 am]

BILLING CODE 6560-50-S