78740 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

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 almond hulls for pendimethalin. 

C. Revisions to Petitioned-For 

Tolerances 

Although the petitioner requested that 

EPA establish a new tolerance for 

residues of pendimethalin on almond 

hulls, there is already a tolerance for 

almond hulls at 0.4 ppm. Therefore, 

EPA is simply revising that existing 

tolerance, rather than establishing a new 

tolerance. 

V. Conclusion 

Therefore, 40 CFR 180.361 is 

amended by revising the established 

tolerance for the combined residues of 

the herbicide pendimethalin and its 

metabolite, in or on almond, hulls from 

0.4 ppm to 6.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule modifies a tolerance 

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 16, 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 § 180.361, in the table in 

paragraph (a), revise the tolerance level 

for ‘‘Almond, hulls’’ to read as follows: 

§ 180.361 Pendimethalin; tolerances for 

residues.(a) * * * 

Commodity Parts per 

million 

* * * * * 

Almond, hulls ............................ 6.0 

* * * * * 

* * * * * 

[FR Doc. 2013–30575 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0509; FRL–9903–53] 

Isopyrazam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of isopyrazam in 

or on apple and peanut for which there 

are no accompanying United States 

registrations. Syngenta Crop Protection, 

Inc., requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 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–2012–0509, 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. 


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FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0509 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 25, 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– 

2012–0509, 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.html. 

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 September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

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 2E8039) by 

Syngenta Crop Protection, Inc., 410 

Swing Rd., P.O. Box 18300, Greensboro, 

NC 27419–8300. The petition requested 

that 40 CFR 180.654 be amended by 

establishing tolerances for residues of 

the fungicide isopyrazam, in or on apple 

at 0.6 parts per million (ppm) and 

peanut at 0.01 ppm. That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc., the registrant, which is available in 

the docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition EPA has 

proposed a higher tolerance level for 

apple. The reason for this change is 

explained in Unit IV.D. 

There are no registered food uses for 

isopyrazam in the United States. These 

tolerances were requested in connection 

with use of isopyrazam on apples and 

peanuts grown outside the United 

States. These tolerances will allow 

apples and peanuts containing 

isopyrazam residues to be imported into 

the United States. 

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 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 isopyrazam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with isopyrazam 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. 

Subchronic and chronic oral toxicity 

studies in the rat, mouse, and dog 

demonstrate that the primary target 

organ for isopyrazam is the liver 

(increased organ weight and 

centrilobular hepatocyte hypertrophy). 

Liver toxicity is usually accompanied by 

reductions in bodyweight and food 

consumption. 

Isopyrazam did not cause 

reproductive toxicity. Effects seen in the 

offspring (bodyweight gain during 

lactation and increase liver weight at 

weaning) in the rat reproduction study 


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occurred at the same doses that cause 

general toxicity in the parents. 

Developmental effects described as 

small eyes and/or microphthalmia were 

observed in both the Himalayan and 

New Zealand rabbit strains. However, in 

the Himalayan strain, the intraocular 

abnormalities occur in the absence of 

maternal toxicity while in the New 

Zealand the ocular abnormalities 

occurred at doses that were maternally 

toxic. Developmental effects observed in 

the rat (increased post-implantation 

loss, reduced fetal weight and a slight 

retardation of ossification) occurred at 

doses that also produced maternal 

toxicity (mortality, decreased body 

weights, body weight gains, and food 

consumption). 

No evidence of specific neurotoxicity 

was seen in acute and subchronic oral 

neurotoxicity studies in rats. Clinical 

signs seen in two subchronic dog 

studies (side-to-side head wobble, 

ataxia, reduced stability) are consistent 

with neurotoxic effects. However 

detailed and specific neuropathological 

analyses were not conducted for the dog 

studies (i.e., functional observational 

battery, motor activity, detailed 

histopathology with special stains). 

Consequently, there is uncertainty 

regarding whether the effects seen in the 

dog studies are in fact signs of 

neurotoxicity. However, clear no 

observed adverse effect levels 

(NOAELs)/lowest adverse effect levels 

(LOAELs) were established for both 

subchronic dog studies. The point of 

departure selected for the acute dietary 

assessment is based on clinical signs 

seen on day 2 in one of four males in 

the subchronic dog study. This study 

provides the lowest NOAEL in the 

database (most sensitive endpoint) for a 

single dose effect. The dose used for the 

chronic dietary risk assessment is eight 

times lower than the dose at which 

clinical effects were seen at four weeks 

in the second subchronic dog study. 

There is no evidence of 

immunotoxicity based on a 28-day 

dietary immunotoxicity study in rats. 

The LOAEL for immunotoxicity was not 

identified and the NOAEL for 

immunotoxicity was 1,356 milligrams/ 

kilograms (mg/kg). 

Isopyrazam is classified as ‘‘Likely to 

be Carcinogenic to Humans’’ based on 

increased incidence of uterine 

endometrial adenocarcinomas and liver 

hepatocellular adenomas in female rats 

and increased incidence of thyroid 

follicular cell adenomas and/or 

carcinomas in male rats. Isopyrazam is 

not carcinogenic in the mouse. There is 

no evidence of genotoxicity, 

mutagenicity, or clastogenicity in the in 

vivo and in vitro studies. There are no 

structural relationships with other 

known carcinogens. A linear low-dose 

approach (Q1*) was used to extrapolate 

experimental animal tumor data for the 

quantification of human cancer risk. 

Isopyrazam is of low acute toxicity by 

the oral, dermal, and inhalation routes 

and is not a skin or eye irritant. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by isopyrazam as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Human Health Risk Assessment for the 

Establishment of Tolerances with No 

U.S. Registrations for Isopyrazam in/on 

Imported Apple and Peanut’’ at pp. 14– 

18 in docket ID number EPA–HQ–OPP– 

2012–0509. 

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 used for 

human risk assessment is shown in 

Table 1 of this unit. 

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

ASSESSMENT

Exposure/scenario Point of departure 

(mg/kg/day) 

Uncertainty/ 

FQPA safety factors 

RfD, PAD, level 

of concern for 

risk 

assessment 

(mg/kg/day) 

Study and toxicological effects 

Acute Dietary .......................

(All populations) ..................

NOAEL= 30 ........ UFA = 10x ..........

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.30 

aPAD = 0.30 ......

Subchronic Toxicity—Dog. LOAEL = 100 mg/kg/day 

based on clinical signs (side-to-side head wobble) 

in male dogs. 

Chronic Dietary (All populations).NOAEL = 5.5 ...... UFA = 10x ..........

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.055.

cPAD = 0.055 

Chronic Toxicity/Carcinogenicity—Rats. LOAEL = 

27.6 mg/kg/day based on decreased body weight 

and body weight gain in females; increased 

incidences of hepatocellular hypertrophy, pigment 

in centrilobular hepatocytes, eosinophilic foci of altered hepatocytes, vacuolation of centrilobular 

hepatocytes, bile duct hyperplasia, and bile duct fibrosis in both sexes; and brown pigment in the kidney in females. 


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

ASSESSMENT—Continued 

Exposure/scenario Point of departure 

(mg/kg/day) 

Uncertainty/ 

FQPA safety factors 

RfD, PAD, level 

of concern for 

risk 

assessment 

(mg/kg/day) 

Study and toxicological effects 

Cancer (All routes) .............. Classification: CARC classified isopyrazam as ‘‘Likely to be Carcinogenic to Humans’’ based on increased liver 

and uterine endometrial epithelial tumors in female rats and increased thyroid follicular cell tumors in male rats. A 

cancer slope factor (Q1*) of 0.00629 (mg/kg/day)-1 was calculated based on an increase in increase in liver tumors 

in female rats. 

CARC = Cancer Assessment Review Committee. Food Quality Protection Act Safety Factor = FQPA SF. LOAEL = lowest observed adverse

effect level. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = 

chronic). Point of Departure = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. Q1* = Linear low-dose approach. RfD = 

reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among 

members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to isopyrazam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing isopyrazam tolerances in 40 

CFR 180.654. EPA assessed dietary 

exposures from isopyrazam 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. In estimating acute dietary 

exposure, EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, maximum residues of 

isopyrazam (as the sum of its syn-isomer 

and anti-isomer) plus its tertiary alcohol 

metabolite (CSCD460260; as the sum of 

its syn-isomer (CSCD459488; free and 

conjugated) and anti-isomer 

(CSCD459489; free and conjugated)) 

from field trials reflecting maximum use 

rates and 100 percent crop treated (PCT) 

assumptions were used. Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors were used for 

all processed commodities including 

dried apple (8.0), apple juice/cider (1.3), 

dried banana/plantain (3.9), and peanut 

butter (1.89). In the absence of peanut 

processing data, the maximum 

theoretical concentration factor was 

used for peanut oil (2.8). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 2003– 

2008 NHANES/WWEIA. As to residue 

levels in food, EPA used the same 

residue levels, processing factors and 

PCT assumptions as in the acute dietary 

exposure analysis. 

iii. Cancer. Isopyrazam is classified as 

‘‘Likely to be Carcinogenic to Humans’’ 

based on increased liver and uterine 

endometrial epithelial tumors in female 

rats and increased thyroid follicular cell 

tumors in male rats. In the absence of 

mode of action data, a linear low dose 

extrapolation for cancer risk assessment 

was used. A cancer slope factor (Q1*) of 

0.00629 (mg/kg/day)¥1 was used for the 

quantification of human cancer risk. In 

evaluating cancer risk, EPA used the 

same residue levels, processing factors, 

and PCT assumptions as the acute and 

chronic dietary exposure analyses. 

iv. Anticipated residue and PCT 

information. While EPA did not use 

PCT information in the dietary 

assessment for isopyrazam, anticipated 

residues were used. Maximum residues 

from field trials conducted at the 

maximum use rates were used to 

estimate residues of isopyrazam (as the 

sum of its syn-isomer and anti-isomer) 

plus its tertiary alcohol metabolite 

(CSCD460260; as the sum of its synisomer (CSCD459488; free and 

conjugated) and anti-isomer 

(CSCD459489; free and conjugated)). 

Analyses assumed 100 PCT and used 

DEEM default processing factors. In the 

absence of peanut processing data, the 

maximum theoretical concentration 

factor was used as a processing factor 

for peanut oil (2.8). 

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. 

2. Dietary exposure from drinking 

water. An assessment of residues in 

drinking water is not needed for 

isopyrazam because there is no drinking 

water exposure associated with the 

existing (banana) and proposed uses 

(apple and peanut) which are all nondomestic. 

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). 

Isopyrazam is not registered for any 

specific use patterns that would result 

in residential exposure. 

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 isopyrazam to 

share a common mechanism of toxicity 

with any other substances, and 

isopyrazam does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that isopyrazam 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 


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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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There are no residual uncertainties for 

pre- and/or post natal susceptibility 

even though qualitative susceptibility 

was observed in the range-finding 

developmental studies in rabbits. 

Developmental effects (eye 

abnormalities) were observed in the 

absence of maternal toxicity in two 

range finding developmental toxicity 

studies in the Himalayan rabbit. 

However, the eye effects were only 

observed at relatively high doses (200– 

400 mg/kg/day) with clear NOAELs/

LOAELs established for the 

developmental effects. Developmental 

effects observed in the rat (reduced fetal 

weight and a slight retardation of 

ossification) occurred only at doses that 

also produced maternal toxicity 

(mortality, decreased body weights, 

body weight gains, and food 

consumption). There was no evidence of 

increased susceptibility in a 

2-generation reproduction study 

following pre- or postnatal exposure to 

isopyrazam. There was also no evidence 

of neuropathology or abnormalities in 

the development of the fetal nervous 

system from the available toxicity 

studies conducted with isopyrazam. 

Clear NOAELs/LOAELs were 

established for the developmental 

effects observed in rats and rabbits as 

well as for the offspring effects 

(increased liver weights) seen in the 2- 

generation reproduction study and a 

dose-response relationship for the 

effects of concern is well characterized. 

The dose used for the acute dietary risk 

assessment (30 mg/kg/day), based on 

effects seen in the subchronic dog study, 

is protective of the developmental 

effects seen in rats (44.5 mg/kg/day) and 

rabbits (200 mg/kg/day). Based on these 

considerations, there are no residual 

uncertainties for pre- and/or postnatal 

susceptibility 

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 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

isopyrazam is complete. 

ii. As discussed in Unit III.D.2, there 

are no residual uncertainties for preand/or postnatal susceptibility and thus, 

it is unnecessary to retain the 10X FQPA 

SF to adequately protect infants and 

children. 

iii. The dietary risk assessment is 

based on parent plus metabolite 

residues and will not underestimate 

dietary exposure to isopyrazam. For the 

acute, chronic and cancer dietary 

analyses, maximum residues of parent 

plus metabolite and 100 PCT 

assumptions were used for all treated 

commodities. There are no residual 

uncertainties identified in the exposure 

databases. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to isopyrazam will 

occupy 4.2% of the aPAD for children 

1–2 years old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to isopyrazam 

from food will utilize 6.1% of the cPAD 

for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Isopyrazam is not 

registered in the United States. Shortand intermediate-term risk is assessed 

based on short- and intermediate-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short- or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD, no 

further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for isopyrazam. 

4. Aggregate cancer risk for U.S. 

population. Using the exposure 

assumptions discussed in this unit for 

cancer exposure, the cancer dietary risk 

estimate for the U.S. population is 2 × 

10¥6. 

EPA generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 10¥6) or less to be 

negligible. The precision that can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the 

logarithmic scale; for example, risks 

falling between 3 × 10¥7 and 3 × 10¥6

are expressed as risks in the range of 

10¥6. Considering the precision with 

which cancer hazard can be estimated, 

the conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described above, cancer risk 

should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10¥6 until the calculated 

risk exceeds approximately 3 × 10¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. For isopyrazam, 

EPA’s exposure assessment assumes 

maximum residues of concern from 

field trials reflecting the maximum use 

rates, default processing factors, the 

maximum theoretical concentration for 

residues in peanut oil and 100 PCT, 

which is highly conservative. 

Accordingly, EPA has concluded the 

cancer risk from exposure to isopyrazam 

falls within the range of 1 × 10¥6 and is 

thus negligible. 

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 isopyrazam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement 

Methodology. 

Adequate enforcement methodology 

(Method GRM006.01B) is available to 

enforce the tolerance expression. The 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78745 

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). MRLs established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

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. 

No Codex or MRLs have been 

established for residues of isopyrazam 

in or on apple or peanut commodities. 

C. Response to Comments 

EPA received a comment to the notice 

of filing which said that no residues of 

isopyrazam should be permitted on 

food. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned on 

agricultural crops. However, the existing 

legal framework provided by FFDCA 

section 408 states that tolerances may be 

set when persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. This citizen’s comment appears 

to be directed at the underlying statute 

and not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

For the purposes of harmonization 

with a pending European Union MRL 

for residues of isopyrazam in or on 

pome fruit (0.7 mg/kg), EPA is 

establishing a tolerance of 0.70 ppm in 

or on apple in lieu of the 0.6 ppm as 

requested by the petitioner. This 

increase to the proposed tolerance is 

supported by the data reviewed for the 

petition. No changes were made to the 

proposed tolerance for peanut. 

V. Conclusion 

Therefore, tolerances are established 

for residues of isopyrazam in or on 

apple at 0.70 ppm and peanut at 0.01 

ppm. The Agency is also revising the 

tolerance expression to clarify that 

determining compliance with the 

tolerance requires measuring both the 

syn-isomer and the anti-isomers of 

isopyrazam. This change is supported 

by the available enforcement method 

which sums the two isomers for the 

tolerance detection. The tolerance 

expression revision will not impact the 

current banana tolerance. 

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 tolerances 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 19, 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 § 180.654: 

■ a. Revise the introductory text in 

paragraph (a). 

■ b. Add alphabetically the 

commodities ‘‘Apple’’ and ‘‘Peanut’’ to 

the table in paragraph (a). 

■ c. Revise footnote one to the table in 

paragraph (a). 


tkelley on DSK3SPTVN1PROD with RULES
78746 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

The additions and revisions read as 

follows: 

§ 180.654 Isopyrazam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

isopyrazam, including its metabolites 

and degradates, in or on the 

commodities listed in the following 

table. Compliance with the tolerance 

levels specified in the following table is 

to be determined by measuring only 

isopyrazam (3-(difluoromethyl)-1- 

methyl-N-[1,2,3,4-tetrahydro-9-(1- 

methylethyl)-1,4-methano-naphthalen5-yl]-1H-pyrazole-4-carboxamide), as 

the sum of its syn-isomer (3- 

(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 

9RS)-1,2,3,4-tetrahydro-9-(1- 

methylethyl)-1,4-methanonaphthalen-5- 

yl]-1H-pyrazole-4-carboxamide) and 

anti-isomer (3-(difluoromethyl)-1- 

methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4- 

tetrahydro-9-(1-methylethyl)-1,4- 

methano-naphthalen-5-yl]-1H-pyrazole4-carboxamide) in or on the commodity. 

Commodity Parts per 

million 

Apple 1 ......................................... 0.70 

* * * * * 

Peanut 1 ...................................... 0.01 

1There are no U.S. registrations for use of 

isopyrazam on apple, banana, or peanut. 

* * * * * 

[FR Doc. 2013–30874 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0777; FRL–9904–15] 

Extension of Tolerances for 

Emergency Exemptions (Multiple 

Chemicals) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation extends timelimited tolerances for the pesticides 

listed in this document. These actions 

are in response to EPA’s granting of 

emergency exemptions under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of these pesticides. In addition, the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) requires EPA to establish a 

time-limited tolerance or exemption 

from the requirement for a tolerance for 

pesticide chemical residues in food that 

will result from the use of a pesticide 

under an emergency exemption granted 

by EPA. 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 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–2013–0777 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, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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 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–2013–0777 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

received by the Hearing Clerk on or 

before February 25, 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– 

2013–0777 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. Background and Statutory Findings 

EPA published final rules in the 

Federal Register for each chemical 

listed. The initial issuance of these final 

rules announced that EPA, on its own 

initiative, under FFDCA section 408, 21 

U.S.C. 346a, was establishing timelimited tolerances. 


tkelley on DSK3SPTVN1PROD with RULES