26456 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

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) (Pub. L. 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: April 24, 2012. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.617 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Sugarcane, cane ........................ 0.06 

* * * * * 

* * * * * 

[FR Doc. 2012–10689 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0428; FRL–9346–5] 

Carfentrazone-ethyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of carfentrazoneethyl in or on crop group 18, non-grass 

animal feed (forage, hay, and seed). 

FMC Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 2012, 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–2011–0428. 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: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26457 

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 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0428 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 July 3, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0428, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 6, 2011 

(76 FR 39360) (FRL–8875–6), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1F7839) by FMC 

Corporation, 1735 Market St., 

Philadelphia, PA 19103. The petition 

requested that 40 CFR 180.515 be 

amended by establishing tolerances for 

residues of the herbicide, carfentrazoneethyl and its metabolite, carfentrazoneethyl chloropropionic acid, in or on 

alfalfa, forage at 5 parts per million 

(ppm); alfalfa, hay at 18 ppm; alfalfa, 

seed at 10 ppm; clover, forage at 5 ppm; 

clover, hay at 18 ppm; and clover, seed 

at 10 ppm. That notice referenced a 

summary of the petition prepared by 

FMC Corporation, the registrant, which 

is available in the docket, 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 individual alfalfa and 

clover tolerances to crop group 18 

tolerances. The reason for this change is 

explained in Unit IV.C. 

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 carfentrazoneethyl including exposure resulting from 

the tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with carfentrazone-ethyl 

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. 

Carfentrazone-ethyl was ranked low 

in acute oral toxicity in rats via the oral, 

dermal, and inhalation routes of 

exposure. It was minimally irritating to 

eyes, non-irritating to skin, and not a 

skin sensitizer. 

The proposed mode of action of 

carfentrazone-ethyl in target plants is 

through inhibition of the enzyme 

protoporphyrinogen oxidase (PPO) 

which is involved in chlorophyll 

biosynthesis. In mammals, PPO is also 

an important enzyme in heme 

biosynthesis and its inhibition can lead 

toxic effects where heme is utilized 

(e.g., red blood cells). Some of the 

toxicities reported for carfentrazoneethyl are consistent with this mode of 

action. The target tissues/organs 

identified are the blood and liver and 

the most sensitive species was the rat. 

Subchronic toxicity studies in rats, 

mice, and dogs demonstrated that the 

primary effects were on hematological 

parameters (decreased mean 

corpuscular hemoglobin (MCH) and 

mean corpuscular volume (MCV)). 

There was also increased urinary 

porphyrin excretion, increased liver 

weights, and liver histopathology 

findings consisting of hepatic pigment 

deposition, hepatocytomegaly, single 

cell necrosis, and cell mitosis. Similarly, 

chronic toxicity studies in rats and dogs 

demonstrated increased urinary 

porphyrin excretion and liver 

histopathology findings in rats and mice 

consisting of liver pigmentation and 

increases in red fluorescence. 

Fluorescence microscopy on liver 

sections also revealed red fluorescent 

granules consistent with porphyrin 

deposits in rats and mice. 


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There was no evidence of increased 

susceptibility in prenatal developmental 

toxicity studies (rats and rabbits) or the 

multigenerational reproductive toxicity 

study in rats. Carfentrazone-ethyl 

induced a significant increase in litter 

incidences of wavy and thickened ribs 

in rats at a dose (1,250 mg/kg/day) much 

higher than the dose (600 mg/kg/day) 

that caused maternal toxicity consistent 

with interference with porphyrin 

metabolism (i.e., staining of the 

abdominogenital area and of the cage 

pan liner). The rabbit prenatal 

developmental toxicity study did not 

yield any evidence of treatment-related 

prenatal developmental toxicity even at 

the highest dose tested (HDT) (300 mg/ 

kg/day). The offspring effects from the 

2-generation reproduction study 

consisted of decreased pup body weight 

in both sexes of the F2 generation at the 

HDT (343 mg/kg/day) and at which 

maternal toxicity was observed in the 

form of decreased body-weight gains, 

increased liver weights, liver and bile 

duct histopathology, and reductions in 

the mean cell volume (F0 and F1 males, 

F1 females), mean cell hemoglobin (F0

and F1 males, F1 females), hematocrit 

(F1 males), and hemoglobin (F1 males). 

There is no concern for neurotoxicity. 

The results of the acute neurotoxicity 

study indicate clinical signs (i.e., 

salivation) and mild decreases in motor 

activity only on the treatment day and 

the subchronic neurotoxicity showed no 

signs of neurotoxicity up to the limit 

dose (1,178 mg/kg/day for males and 

1,434 mg/kg/day for females). 

In a 21-day dermal toxicity study, 

carfentrazone-ethyl did not induce any 

type of dermal or systemic toxicity up 

to the limit dose of 1,000 mg/kg/day. 

There are no toxicity studies based on 

repeated inhalation exposures to 

carfentrazone-ethyl. A waiver of a 28- 

day inhalation toxicity study was 

previously accepted based on its 

relatively low volatility, low acute 

inhalation lethality, and the large 

inhalation MOEs associated with the 

requested applications. 

The mutagenic test battery 

demonstrated that carfentrazone-ethyl is 

not mutagenic. In accordance with the 

Draft Proposed Guidelines for 

Carcinogen Risk Assessment (April, 

1999), carfentrazone-ethyl is classified 

as a ‘‘not likely human carcinogen,’’ 

based on the lack of evidence for 

carcinogenicity in the mouse and rat. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by carfentrazone-ethyl as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Carfentrazone-ethyl. Section 3 

Registration for Application to the Nongrass Animal Feed Crop Group 18. 

Human-Health Risk Assessment’’ pp. 

30–32 in docket ID number EPA–HQ– 

OPP–2011–0428. 

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 carfentrazone-ethyl used 

for human risk assessment is shown in 

the Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CARFENTRAZONE-ETHYL FOR 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 infants and children).

NOAEL = 500 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 5 mg/kg/day 

aPAD = 5 mg/kg/day 

Acute neurotoxicity—rat. 

LOAEL = 1000 mg/kg/day based on clinical observations (salivation) and decreased motor activity. 

Chronic dietary (All populations) ..... NOAEL = 3 mg/kg/day ...

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.03 mg/ 

kg/day.

cPAD = 0.03 mg/kg/day 

Chronic toxicity—rat. 

LOAEL = 12 mg/kg/day based on liver histopathology (increases in microscopic red fluorescence and pigmentation) and increased urinary porphyrin levels in both sexes. 

Incidental oral short-term (1 to 30 

days) and intermediate term (1 to 

6 months).

NOAEL = 50 mg/kg/day

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 ........ Subchronic toxicity—dog. 

LOAEL = 150 mg/kg/day based on decreased 

body weight gain and increased urinary excretion of porphyrins. 

Dermal short-term (1 to 30 days) 

and intermediate-term (1 to 6 

months).

Dermal risk assessment is not required—No toxicity seen at the limit-dose (1,000 mg/kg/day) in a 21-day 

rat dermal toxicity study and low level of concern for developmental effects. 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26459 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CARFENTRAZONE-ETHYL FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation short-term (1 to 30 days) 

and intermediate term (1 to 6 

months).

Oral NOAEL = 50 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 ........ Subchronic toxicity—dog. 

LOAEL = 150 mg/kg/day based on decreased 

body weight gain and increased urinary excretion of porphyrins. 

Cancer (Oral, dermal, inhalation) .... Classification: ‘‘not likely to be carcinogen;’’ therefore, a quantitative cancer risk assessment is not necessary. 

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). 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 carfentrazone-ethyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing carfentrazone-ethyl tolerances 

in 40 CFR 180.515. EPA assessed dietary 

exposures from carfentrazone-ethyl in 

food as follows: 

i. Acute and chronic 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. Since such 

effects were identified for carfentrazoneethyl, both acute and chronic dietary 

risk assessments were conducted. In 

estimating acute and chronic dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance-level 

residues or, if necessary, tolerance-level 

residues adjusted to account for the 

residues of concern for risk assessment, 

100 PCT. 

ii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that carfentrazone-ethyl does 

not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk was not conducted. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for carfentrazone-ethyl in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of carfentrazone-ethyl. 

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 Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of carfentrazone-ethyl for 

acute exposures are estimated to be 126 

parts per billion (ppb) for surface water 

and 13 ppb for ground water. Chronic 

exposures for non-cancer assessments 

are estimated to be 48 ppb for surface 

water and 13 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 126 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 48 ppb was used to assess the 

contribution to drinking water. 

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). 

Carfentrazone-ethyl is currently 

registered for the following uses that 

could result in residential exposures: 

Golf courses, residential lawns, and 

aquatic areas. EPA assessed residential 

exposure with the assumption that 

homeowner handlers wear shorts, shortsleeved shirts, socks, and shoes, and 

that they complete all tasks associated 

with the use of a pesticide product 

including mixing/loading, if needed, as 

well as the application. Residential 

handler exposure scenarios for 

residential lawn applications are 

considered to be short-term only, due to 

the infrequent use patterns associated 

with homeowner products. Therefore, 

short-term inhalation risk was assessed 

for residential handlers; however, since 

no hazard was identified via the dermal 

route of exposure, a dermal risk 

assessment was not conducted for 

residential handlers. 

EPA uses the term ‘‘post-application’’ 

to describe exposure to individuals that 

occur as a result of being in an 

environment that has been previously 

treated with a pesticide. Carfentrazoneethyl can be used in many areas that can 

be frequented by the general population 

including home lawns, golf courses and 

aquatic recreational areas such as ponds 

and lakes that have been treated for 

removal of aquatic vegetation. As a 

result, individuals can be exposed by 

entering these areas if they have been 

previously treated. Therefore, short-term 

post-application exposure and risk were 

also assessed for carfentrazone-ethyl. 

The most conservative exposure 

scenario for adults, the aquatic exposure 

scenario (combined incidental oral and 

inhalation), was used to estimate postapplication risk. For children, the most 

conservative exposure scenario, the 

hand-to-mouth exposure in residential 

turf scenario (incidental oral), was used 

to estimate post-application risk. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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 carfentrazone-ethyl to share a 

common mechanism of toxicity with 

any other substances, and carfentrazoneethyl does not appear to produce a toxic 

metabolite produced by other 


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substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that carfentrazone-ethyl 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 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. 

As discussed in Unit III.A., based on the 

results of the rat/rabbit prenatal 

developmental toxicity studies and the 

rat 2-generation reproductive toxicity 

study, there is no evidence of increased 

pre- and/or postnatal sensitivity. 

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. Although an immunotoxicity study 

is currently lacking in the toxicity 

database for carfentrazone-ethyl, there is 

no evidence in the current database that 

the immune system organs are directly 

affected following carfentrazone-ethyl 

exposure. 

ii. There is no indication that 

carfentrazone-ethyl 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 

carfentrazone-ethyl results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

carfentrazone-ethyl 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 carfentrazone-ethyl. 

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 aPAD and 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 and water to 

carfentrazone-ethyl will occupy 1% of 

the aPAD for all infants (<1 year 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 carfentrazoneethyl from food and water will utilize 

69% of the cPAD for children 1–2 years 

old, 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 

carfentrazone-ethyl is not expected. 

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). Carfentrazone-ethyl 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 carfentrazone-ethyl. Using 

the exposure assumptions described in 

this unit for short-term exposures, EPA 

has concluded that children (1–2 years 

old) provide the most conservative 

short-term exposure scenario. Chronic 

dietary estimates (food + water) for this 

age group, combined with incidental 

oral exposure from turf use (hand-tomouth) results in aggregate MOEs of 

2,300. Because EPA’s level of concern 

for carfentrazone-ethyl is a MOE of 100 

or below, these MOEs are not of 

concern. 

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). 

Although intermediate-term residential 

exposures are not anticipated, the 

relevant short-/intermediate-term PODs 

are the same and, therefore, the shortterm risk assessment is protective of 

intermediate-term exposure. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

carfentrazone-ethyl is not expected to 

pose a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 

carfentrazone-ethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. This analytical enforcement 

method involves separate analyses for 

parent and the metabolite. The parent is 

analyzed by evaporation and 

reconstitution of the sample prior to 

analysis by LC/MS/MS GC/ECD. The 

metabolite is refluxed in the presence of 

acid and cleaned up with solid phase 

extraction prior to analysis by LC/MS/ 

MS. 

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 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26461 

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. 

There are no Codex, Canadian, or 

Mexican MRLs established for 

carfentrazone-ethyl in or on the 

requested crops. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the proposed uses and the 

submitted data, the Agency concludes 

that crop group 18 tolerances are 

appropriate for carfentrazone-ethyl, as 

opposed to individual tolerances on 

alfalfa and clover as proposed. These 

crop group tolerances are based on the 

submitted field trial data, which were 

conducted on the representative 

commodities for crop group 18, and the 

Organization for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedure. 

V. Conclusion 

Therefore, tolerances are established 

for residues of carfentrazone-ethyl, 

including its metabolites and 

degradates, as set forth in the regulatory 

text. Compliance with the tolerance 

levels is to be determined by measuring 

only the sum of carfentrazone-ethyl 

(ethyl-alpha-2-dichloro-5-[-4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4- 

fluorobenzenepropanoate) and its 

metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[-4-difluoromethyl)-4,5-dihydro-3- 

methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4- 

fluorobenzenepropanoic acid), 

calculated as the stoichiometric 

equivalent of carfentrazone-ethyl. 

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) (Pub. L. 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: April 25, 2012. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.515 is amended in 

paragraph (a) by revising the 

introductory text and by alphabetically 

adding the following entries to the table 

to read as follows: 

§ 180.515 Carfentrazone-ethyl; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

carfentrazone-ethyl, including its 

metabolites and degradates, in or on the 

commodities listed in the following 

table. Compliance with the following 

tolerance levels is to be determined by 

measuring only the sum of 

carfentrazone-ethyl (ethyl-alpha-2- 

dichloro-5-[-4-(difluoromethyl)-4,5- 

dihydro-3-methyl-5-oxo-1H -1,2,4- 

triazol-1-yl]-4-fluorobenzenepropanoate) 

and its metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro5-[-4-difluoromethyl)-4,5-dihydro-3- 

methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4- 

fluorobenzenepropanoic acid), 

calculated as the stoichiometric 

equivalent of carfentrazone-ethyl, in or 

on the following commodities: 


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26462 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Animal feed, nongrass, crop 

group 18, forage ..................... 2.0 

Animal feed, nongrass, crop 

group 18, hay .......................... 5.0 

Animal feed, nongrass, crop 

group 18, seed ........................ 15.0 

* * * * * 

* * * * * 

[FR Doc. 2012–10688 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0388; FRL–9346–6] 

Dimethomorph; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for residues of 

dimethomorph, (E,Z)-4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propenyl]morpholine in or 

certain commodities as discussed in this 

document. BASF Corporartion 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 2012, 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–2011–0388. 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–0388 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 July 3, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0388, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), 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 0F7800) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709. The petition 

requested that EPA amend 40 CFR part 

180 by raising tolerances for residues of 

the fungicide dimethomorph, in or on 

brassica, head and stem, subgroup 5A 

from 2.0 ppm to 5.0 ppm; brassica, leafy 

greens, subgroup 5B from 20.0 ppm to 

30.0 ppm; green onion, subgroup 3B 

from 2.0 ppm to 11.0 ppm. The petition 

also requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

the residues of the fungicide 

dimethomorph, in or on vegetable, leafy 

at 16 ppm (PP 0F7816). The notice 


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