Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Rules and Regulations 76561 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0431; FRL–9402–4] 

Endothall; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of endothall in or 

on apple and apple, pomace. United 

Phosphorus, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 18, 2013. Objections and 

requests for hearings must be received 

on or before February 18, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0431, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 703–305–5447; email address: 

Rossi.Lois@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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– 

OPP–2012–0431 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 18, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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 (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0431, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 25, 

2012 (77 FR 43562) (FRL–9353–6), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2F8023) by United 

Phosphorus, Inc., 630 Freedom Business 

Center, Suite 402 King of Prussia, PA 

19406. The petition requested that 40 

CFR 180.293 be amended by 

establishing tolerances for residues of 

the herbicide, endothall, mono (N,Ndimethylalkylamine) salt of endothall, 

and the dipotassium salt of endothall, in 

or on apples at 0.05 parts per million 

(ppm), and apple, pomace at 0.15 ppm. 

That document referenced a summary of 

the petition prepared by United 

Phosphorus, Inc., the registrant, which 

is available in the docket, EPA–HQ– 

OPP–2012–0431 at http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed definition for apple 

pomace to ‘‘apple, wet pomace’’ and 

updated the current tolerance 

expression so that metabolites and 

degradates of endothall are included. 

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. . . .’’ 


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Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for endothall 

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 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. 

Endothall is a caustic chemical with 

toxicity being the result of a direct 

degenerative effect on tissue. By acute 

exposure, endothall is a skin sensitizer 

and an extreme irritant by the acute oral 

and ocular routes of administration. The 

most sensitive effect of endothall 

following chronic oral administration is 

direct irritation of the gastrointestinal 

system. This effect was evident in 

several species and in several studies. 

The dog is particularly sensitive to 

endothall toxicity. Endothall caused 

gastric epithelial hyperplasia in dogs 

treated with an oral dose of 6.5 mg/kg/ 

day for 52 weeks (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). Besides gastric 

irritant effects, decreased body weight 

in the dog was also a sensitive effect 

following 13 weeks of endothall 

administration. The decreased body 

weights were most likely attributable to 

the constant and direct irritation of the 

gastric lining. 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. Proliferative 

lesions of the gastric epithelium were 

observed in F1 parental male and female 

rats treated orally with 2 mg/kg/day 

endothall in a 2-generation reproduction 

study (a NOAEL was not identified). In 

a developmental rat study, pregnant rats 

exhibited decreased body weight and 

decreased body weight was also noted 

in a 90-day dietary study in the rat. 

Dermally, endothall destroys the 

stratum corneum and then the 

underlying viable epidermis. In the 21- 

day dermal rat study, systemic toxicity 

(hematology and clinical chemistry 

alterations) was 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 dose levels lower 

than those associated with systemic 

toxicity. 

Acute inhalation toxicity of endothall 

is low; however, nasal and pulmonary 

toxicity were evident in the 5-day and 

28-day inhalation toxicity studies in the 

rat including rales, labored respiration, 

pale lungs (gross necropsy), increased 

absolute and relative lung weights, 

subacute inflammation, alveolar 

proteinosis, and nasal hemorrhage 

inflammation, erosion, and ulceration. 

Endothall does not cause pre-natal 

toxicity following in utero exposure to 

rats nor pre-and postnatal toxicity 

following exposures to rats for two 

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. The hazard 

data for endothall indicate no evidence 

of quantitative or qualitative increased 

susceptibility of rat fetuses exposed in 

utero to endothall in the developmental 

toxicity studies. In addition, no 

evidence of quantitative or qualitative 

increased susceptibility of rat fetuses or 

neonates was observed in the 2- 

generation reproduction study. 

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-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Endothall. Human Health Risk 

Assessment to support proposed Use on 

Apples’’ at 30–34 in docket ID number 

EPA–HQ–OPP–2012–0431. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). 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 

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 is shown in Table 1. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ENDOTHALL USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (General population including Females 13– 

50 years of age, infants and 

children).

An appropriate endpoint attributable to a single dose was not available from any study, including the prenatal 

development toxicity study in rats. An acute RfD was not established. 

Chronic dietary (All populations) LOAEL = 2 mg/kg/day (NOAEL 

not determined).

UF = 300x 

FQPA SF = 3x 

Chronic RfD = 0.007 mg/kg/day 

cPAD = 0.007 mg/kg/day 

Rat 2-generation reproduction study proliferative lesions of the gastric epithelium 

(both sexes) 

Incidental oral short-term (1 to 

30 days).

Offspring NOAEL = 9.4 mg/kg/ 

day.

Residential LOC for MOE = 

100.

Rat 2-generation reproduction study 

LOAEL = 60 mg/kg/day based on decreased pup body weight (both sexes) 

on Day 0 F1 and F2 generations Body 

Weights were also similarly decreased 

in the dams throughout the study. 

Dermal short-term (1 to 30 

days) And Intermediate-term 

(1 to 6 months).

In the 21 day dermal toxicity study, severe dermal effects were observed at 30 mg/kg/day (lowest dose tested). The NOAEL for dermal irritation was not established due to Erythema, edema and fissuring and sloughing 

off of skin at the lowest tested (30 mg/kg/day) endothall is caustic dermally because it is an acid. Since undiluted endothal is so toxic at the portal of entry (e.g., skin), quantification of systemic toxicity and risk is not 

necessary to show that direct exposure to endothall poses unacceptable risk. Protection against any potential 

dermal effects from direct exposure is addressed with precautionary labeling recommending the use of gloves 

and other personal protection which limits contact of the material with the handler’s body. The 30 mg/kg/day 

dose from the 21 day dermal study was used as a point of reference in assessing potential risk to swimmers 

from dermal exposure. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) study 

NOAEL = 0.001 mg/kg/day 

(inhalation absorption rate = 

100%).

UFA = 3xcx 

UFH = 10xx 

FQPA SF = 1x 

LOC for MOE = 30 ................... Subchronic inhalation toxicity study 

LOAEL = 0.005 based on clinical signs 

(rales and labored respiration) observed 

acutely (0–1 hr post dosing and prior to 

next exposure). 

Cancer (Oral, dermal, inhalation).Classified as a ‘‘Not Likely’’ human carcinogen 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use 

of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. 

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 such effects were identified in the 

toxicological studies for endothall; 

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–FID) Version 3.16 which uses 

food consumption data from the U.S. 

Department of Agriculture‘s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA), conducted from 

2003–2008. As to residue levels in food, 

EPA used average percent crop treated 

(PCT) estimates for endothall, average 

field trial residues for all existing and 

new uses, and DEEM 7.81 default and 

crop specific processing factors and 

conservative drinking water estimates to 

obtain accurate residue data. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that endothall does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Percent crop treated (PCT) 

information. 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. 


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The Agency estimated the PCT for 

new and existing uses as follows: Apple 

62%, apple fresh market 76%, apple 

processing 37%, apple juice 40%, barley 

for grain 36%, corn for grain 19%, dry 

beans 32%, grape 95%, grape fresh 

market 99%, grape processing 94%, 

green peas 43%, oats for grain 7%, 

peanut for nuts 42%, rice 100%, 

sorghum for grain 15%, soybean for 

beans 9%, strawberry 90%, strawberry 

fresh market 88%, strawberry 

processing 100%, sugar beet for sugar 

37%, sugarcane for sugar 54%, 

watermelon 33%, and wheat for grain 

14%. 

Because endothall will be applied to 

water in irrigation canals, EPA estimates 

the percent crop treated for endothall by 

estimating the percent of the crop that 

is irrigated. This will serve as an upper 

bound for crops that may be exposed to 

endothall in irrigation water. EPA uses 

two methods to estimate percent crop 

irrigated. The first method, where data 

on irrigated production is 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, sugar 

beets, sugarcane, and wheat. For these 

crops, data on irrigated production is 

from the 2007 Census of Agriculture. 

Where data on irrigated production are 

not available, EPA estimates the percent 

crop irrigated by determining the 

percentage of United States 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 are 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. Data on the share of the 

crop grown in the 17 western states are 

from USDA/NASS data. 

These estimates are conservative 

because they are the equivalent of 

assuming 100% of irrigated crops are 

irrigated with water from endothalltreated canals. This assumption is being 

made despite the fact that all irrigation 

canals may not be treated with 

endothall, even in some areas with 

surface water delivery systems and 

other areas with crops (even in the 

heavily irrigated areas of the West), not 

being irrigated. 

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 Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for endothall in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of endothall. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Simple 

First-Order Degradation the estimated 

drinking water concentrations (EDWCs) 

of endothall for chronic exposures for 

non-cancer assessments are estimated to 

be 31 ppb for surface water and ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). A product 

containing endothall is currently 

registered for uses that could result in 

residential exposures which include 

aquatic applications on ponds, lakes 

and garden pools. There is a potential 

for exposure from registered uses for 

homeowners who apply endothall 

products to control aquatic weeds and 

algae in ponds and garden pools. For 

residential handlers, exposure scenarios 

are only considered to be short-term in 

nature due to the episodic uses 

associated with homeowner products. 

There is also a potential for exposure to 

adults and children from contacting 

water treated with endothall through 

swimming, wading, water skiing, etc. 

Only short-term exposures are expected 

since these scenarios are expected to be 

only episodic. 

Endothall registered use patterns and 

current labeling indicate three likely 

residential handler exposure scenarios: 

(1) applying granules by hand for 

treating garden pools, (2) applying 

granules by cup for treating ponds and 

lakes, and (3) applying granules by 

spoon for treating ponds and lakes. For 

post-application exposures, the Agency 

quantitatively assessed inhalation and 

incidental oral (water ingestion) from 

the aquatic use (adult and children). 

Since endothall is caustic dermally 

because it is an acid the Agency 

determined quantification of systemic 

toxicity and risk resulting from dermal 

exposure is not appropriate. Though 

swimmers could be exposed to 

endothall, EPA did not conduct a formal 

quantitative assessment for this scenario 

because the maximum concentration of 

endothall in swimming water is 5 ppm, 

and this dilutes out very rapidly. In 

comparison, in the dermal toxicity 

study, the concentration that caused 

irritation was substantially higher (2000 

ppm). Therefore exposures to endothall 

in water would not likely result in any 

irritation to the skin. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

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 


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mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site 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 Safety Factor (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 was no indication of increased 

susceptibility of rats or mice in utero 

and or postnatal exposure in the 

developmental and reproductive 

toxicity studies. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 3X. That decision is 

based on the following findings: 

i. The toxicity database for endothall 

is complete, with the exception of the 

immunotoxicity study, which is a 

toxicology data requirement of the 

revised 40 CFR Part 158. However, 

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 and 

the available studies showed no 

evidence of potential immunotoxicity. 

ii. 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. 

iii. There is no evidence that 

endothall results in increased 

susceptibility in utero in rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

in the endothall database in regard to 

dietary (food and drinking water) and 

residential exposures. Though the 

chronic dietary exposure and risk 

assessment was partially refined by 

using percent crop treated data, the 

dietary food assessment is still very 

conservative since field trial rather than 

monitoring data were used as the 

residue input, and default as well as 

measured processing factors were used 

for some commodities. Also, the 

drinking water inputs were based on 

modeled surface water values from the 

scenario which provides the highest 

estimated environmental concentration 

and will not underestimate chronic 

exposure to residues of endothall 

present in drinking water. Residential 

exposure estimates are based on 

conservative, health-protective 

assumptions that also ensure exposures 

are not underestimated. 

v. Although all of the above factors 

support the conclusion that removal of 

the FQPA factor would be safe for 

children, an additional 3X FQPA factor 

is being retained because a LOAEL 

established in the two-generation 

reproduction study was used for 

assessing chronic dietary risks. A 3X 

factor (as opposed to a 10X) was 

determined to be adequate since the 

severity of the lesions were minimal to 

mild indicating that LOAEL did not far 

exceed the NOAEL. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and therefore no acute dietary endpoint 

was selected. Endothall is not expected 

to pose an acute dietary 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 90% of the 

cPAD for infants (1–2 years old) which 

is the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

endothall is not expected. 

3. Short-term risk: Short-term 

aggregate exposure takes into account 

adult and children’s post-application 

inhalation and oral exposure (from 

swimming in water bodies treated with 

endothall) combined with the chronic 

dietary exposure from the mostly highly 

exposed adult (General US population) 

and children’s (all children 1–2 years 

old) subpopulations respectively, to 

determine aggregate exposure and risk. 

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 that 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 1200 and 210 for the most 

highly exposed subgroups of adults and 

children, respectively. 

Because EPA’s level of concern for 

endothall is a MOE of 100 or below, 

these MOEs are not of concern. As 

discussed in Unit III.C.3., the risk to 

swimmers from dermal exposure to 

endothall is very low. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

endothall is not expected to pose a 

cancer risk to humans. 

5. 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 

(GC with microcoulometric nitrogen 

detection and a confirmatory HPLC/

MSD method) 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; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 


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76566 Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Rules and Regulations 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for endothall. 

C. Response to Comments 

There were no comments on the 

petition to establish endothall tolerance 

on apples and apple pomace. The 

comment posted in the Endothall 

Docket, EPA–HQ–OPP–2012–0431–0005 

was published within the incorrect 

docket and is irrelevant to this action. 

D. Revisions to Petitioned-For 

Tolerances 

The proposed commodity definition 

for apple pomace is being revised to 

‘‘apple, wet pomace’’ to reflect the 

Agency’s correct commodity definition. 

In addition EPA is revising the tolerance 

expression in 40 CFR 180.293(a)(1) for 

food commodities to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover ‘‘residues of endothall, 

including its metabolites and 

degradates,’’ and that compliance with 

the tolerance levels will be determined, 

for food commodities, by measuring 

only endothall (7-oxabicyclo [2.2.1] 

heptanes-2,3-dicarboxylic acid) and its 

mono-methyl ester. EPA has determined 

that it is reasonable to make this change 

final without prior proposal and 

opportunity for comment, because 

public comment is not necessary, in that 

the change has no substantive effect on 

the tolerance, but rather is merely 

intended to clarify the legal effect of 

tolerances as Provided in FFDCA 

section 408(a)(3). 

V. Conclusion 

Therefore, tolerances are established 

for residues of endothall and its monomethyl ester, in or on apple at 0.05 ppm 

and apple, wet pomace at 0.15 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action 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 9, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.293 revise paragraph (a)(1) 

introductory text and add, 

alphabetically, the following 

commodities to the table to read as 

follows: 

§ 180.293 Endothall; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for the residues of endothall, 

including its metabolites and 

degradates, in or on the commodities in 

the table, below. Compliance with the 

tolerance levels specified, below, is to 

be determined by measuring only 

endothall (7-oxabicylco [2.2.1] 

heptanes-2,3-dicarboxylic acid) and its 

mono-methyl ester. 

Commodity Parts per 

million 

Apple ......................................... 0.05 

Apple, wet pomace ................... 0.15 

* * * * * 

* * * * * 

[FR Doc. 2013–29963 Filed 12–17–13; 8:45 am] 

BILLING CODE 6560–50–P 


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