Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Rules and Regulations 65565 

formulations (i.e., food contact surface 

sanitizing solutions) applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemption 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). 

VIII. 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: October 22, 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 § 180.940, add alphabetically the 

following entry to the table in paragraph 

(a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

D-Glucopyranose, oligomeric, decyl octyl glycosides ........................................................................................... 68515–73–1 None 

* * * * * * * 

* * * * * 

[FR Doc. 2013–26241 Filed 10–31–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0589; FRL–9401–8] 

Fomesafen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fomesafen in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 1, 2013. Objections and 

requests for hearings must be received 

on or before December 31, 2013, 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–2012–0589, 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 


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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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0589 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 December 31, 2013. 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– 

2012–0589, 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) 

and June 5, 2013 (78 FR 33785) (FRL– 

9386–2), EPA issued documents 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of pesticide petitions (PP 2E8061 and 

3E8167) by IR–4, IR–4 Project 

Headquarters, 500 College Road East, 

Suite 201W, Princeton, NJ 08540. The 

petitions requested that 40 CFR 180.433 

be amended by establishing tolerances 

for residues of the herbicide fomesafen, 

5-[2-chloro-4-(trifluoromethyl)phenoxy]- 

N-(methylsulfonyl)-2-nitrobenzamide, 

in or on cantaloupe; cucumber; pea, 

succulent; pumpkin; squash, summer; 

squash, winter; and watermelon all at 

0.025 parts per million (ppm); and 

soybean, vegetable, succulent at 0.05 

ppm (2E8061); and bean, lima, 

succulent at 0.05 ppm (3E8167). The 

documents referenced a summary of 

each petition prepared by Syngenta 

Crop Protections, LLC, the registrant, 

which are available in the docket, 

http://www.regulations.gov. One public 

comment was received on the notice of 

filing for PP 3E8167. EPA’s response to 

the comment is discussed in Unit IV.C. 

Based upon review of data supporting 

the petition, EPA corrected the 

commodity name for certain crops for 

which a tolerance was proposed as 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

Consistent with 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 fomesafen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fomesafen follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

In the subchronic and chronic 

fomesafen toxicity studies in rats and 

mice, food consumption, food 

efficiency, body weight, body weight 

gain, and histopathological changes in 

the liver were parameters that were 

most often affected. In addition, dogs 

and mice also showed hematological 

changes (e.g., decreased erythrocyte 

count, hemoglobin, or hematocrit). 

In the developmental studies, postimplantation loss was noted but no 

quantitative or qualitative evidence of 

increased susceptibility to fomesafen 


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was seen following in utero exposure to 

rat or rabbit fetuses in prenatal 

developmental studies or postnatally in 

rat 2-generation reproduction study. 

Acute neurotoxicity studies indicate 

fomesafen may cause neurotoxicity 

(decreased motor activity) at the same 

dose level as systemic toxicity. 

Although suppression of anti-sheep red 

blood cell immunoglobulin (SRBC IgM) 

response was noted in the 

immunotoxicity study, the selected 

endpoints for risk assessment are 

protective of this effect. 

Carcinogenicity was not observed in 

the rat chronic toxicity/carcinogenicity 

study. Although liver tumors were seen 

in the mouse carcinogenicity study, EPA 

classified fomesafen as ‘‘Not Likely to be 

Carcinogenic to Humans’’ because the 

mode of action for fomesafen-induced 

hepatocarcinogenesis in mice is 

unlikely to take place in humans. 

Fomesafen was not considered to be 

mutagenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fomesafen, as well as 

the no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies, can be found at http:// 

www.regulations.gov in document: 

‘‘Fomesafen Sodium: Human Health 

Risk Assessment for the Section 3 

Registration Action on Cantaloupe, 

Cucumber, Pea (Succulent), Pumpkin, 

Summer Squash, Winter Squash, 

Watermelon, Soybean (Succulent) and 

Lima Bean (Succulent),’’ dated July 18, 

2013 at page 27 in docket ID number 

EPA–HQ–OPP–2012–0589. 

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 fomesafen used for human 

risk assessment is shown in Table 1. of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOMESAFEN 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 = 100 mg/

kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1 mg/

kg/day 

aPAD = 1 mg/kg/day 

Acute neurotoxicity test in the rat. 

LOAEL = 250 mg/kg/day based on decreased body weight and 

motor activity (horizontal and vertical activity and time in central quadrant) in males. 

Chronic dietary (All populations) NOAEL= 0.25 mg/

kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.0025 mg/kg/day 

cPAD = 0.0025 mg/

kg/day 

Chronic toxicity/carcinogenicity in the rat. 

LOAEL = 5 mg/kg/day based on hyalinization of the liver in 

males. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. 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 fomesafen, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fomesafen tolerances in 40 CFR 180.433. 

EPA assessed dietary exposures from 

fomesafen 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. 

Such effects were identified for 

fomesafen. In estimating acute dietary 

exposure, EPA used Dietary Exposure 

Evaluation Model—Food Consumption 

Intake Database (DEEM–FCID), ver. 3.16 

which incorporates consumption data 

from the United States Department of 

Agriculture (USDA) 2003—2008 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEA). Acute 

analysis assumed 100 percent crop 

treated (PCT), DEEM 7.81 default 

concentration factors, tolerance-level 

residues for all existing and proposed 

crop uses. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used DEEM–FCID, ver. 3.16 which 

incorporates consumption data from 

USDA 2003—2008 NHANES/WWEA. 

As to residue levels in food, EPA 

analysis assumed 100 PCT and 

tolerance-level residues for all existing 

and proposed crop uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., a dietary 

exposure assessment for the purpose of 

assessing cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for fomesafen. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fomesafen in drinking water. These 

simulation models take into account 


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data on the physical, chemical, and fate/ 

transport characteristics of fomesafen. 

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. 

Screening model Tier II Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) was 

used to calculate surface water 

estimated drinking water concentrations 

(EDWCs). Groundwater EDWCs for 

fomesafen were calculated using Tier 1 

Pesticide Root Zone Model Ground 

Water (PRZM GW). Acute exposures are 

estimated to be 34.8 parts per billion 

(ppb) for surface water and 51.8 ppb for 

ground water. 

Chronic exposures for non-cancer 

assessments are estimated to be 13.1 

ppb for surface water and 32.3 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations are based on ground 

water EDWCs, which were highest 

among surface water and ground water 

EDWCs (representing worst case), were 

directly entered into the dietary 

exposure model. 

For acute dietary risk assessment, the 

water concentration value of 51.8 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 32.3 

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). 

Fomesafen 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 fomesafen to share 

a common mechanism of toxicity with 

any other substances, and fomesafen 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fomesafen 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. 

The pre- and postnatal database for 

fomesafen includes a prenatal 

developmental toxicity study in rabbits, 

two prenatal developmental toxicity 

studies in rats, and a 2-generation 

reproduction toxicity study in rats. The 

rabbit developmental study was 

classified as unacceptable because of 

bacterial infection in the colony; 

however, the study provided 

information to assess potential 

developmental toxicity in rabbits. There 

was no significant difference between 

the treated and control animals for 

developmental abnormalities in the 

rabbit study. In the two rat 

developmental studies (considered 

together), developmental effects 

(postimplantation loss) occurred at the 

same dose causing maternal toxicity 

(staining of the ventral fur and 

significantly decreased body weight 

gain (>10%)). In the rat reproduction 

study, offspring effects (increased 

incidence of liver hyalinization in 

males) occurred at the same dose 

causing parental effects (liver 

histopathology in males and females of 

both generations). 

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 fomesafen 

is complete. The developmental toxicity 

study in rabbits, classified unacceptable 

due to mortality from bacterial 

infections, showed no evidence of 

increased susceptibility of rabbit fetuses 

due to the treatment with fomesafen. 

Therefore, the lack of an acceptable 

developmental toxicity study in nonrodents was not considered a data gap. 

ii. There is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. In an acute neurotoxicity 

screening battery in rats, decreased 

motor activity (horizontal and vertical 

activity and time in central quadrant) 

was observed at the same dose that 

resulted in general systemic toxicity. In 

the subchronic neurotoxicity test, 

neither general systemic toxicity nor 

neurotoxicity was observed at the 

highest dose tested. All points of 

departure used in the risk assessment 

are protective of any potential 

neurotoxicity. 

iii. There is no evidence that 

fomesafen 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. The 2-generation 

reproduction study in rats did not show 

evidence of increased susceptibility to 

fomesafen. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Tolerance level residues and 100 PCT 

were assumed for all food commodities. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fomesafen in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by fomesafen. 

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 and water to 

fomesafen will occupy < 1% of the 

aPAD for all population subgroups, 

including 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 fomesafen from 


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food and water will utilize 77% of the 

cPAD for all infants (< 1 year old) the 

population group receiving the greatest 

exposure. There are no residential uses 

for fomesafen. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- or 

intermediate-term residential exposure 

plus chronic exposure from food and 

water (considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, fomesafen is not 

registered for any use patterns that 

would result in short- and intermediateterm residential exposure. Because there 

is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

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 fomesafen. 

4. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., fomesafen is 

not expected to pose a cancer risk to 

humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fomesafen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/

MS) method (GRM045.01A) is available 

to enforce the tolerance expression. The 

validated limit of quantitation (LOQ) of 

the method is 0.02 ppm. 

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 

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. 

Codex has not established maximum 

residue limits (MRLs) for residues of 

fomesafen. 

C. Response to Comments 

The Agency received an anonymous 

public comment objecting to the 

proposed fomesafen tolerance on lima 

bean because of the amounts of 

pesticides already consumed and 

carried by the American population. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, under the existing 

legal framework provided by section 

408 of the FFDCA, EPA is authorized to 

establish pesticide tolerances or 

exemptions where persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. 

D. Revisions to Petitioned-For 

Tolerances 

Petitioned-for tolerance levels in or on 

commodities were unchanged, however, 

the commodity name of certain 

proposed crops was changed to comply 

with current EPA commodity 

definitions, as follows: Winter, squash 

changed to squash, winter; vegetable, 

soybean, succulent to soybean, 

vegetable, succulent; and lima, bean to 

bean, lima, succulent. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the herbicide fomesafen, 

including its metabolites and 

degradates, in or on cantaloupe; 

cucumber; pea, succulent; pumpkin; 

squash, summer; squash, winter; and 

watermelon all at 0.025 ppm; soybean, 

vegetable, succulent at 0.05 ppm; and 

bean, lima, succulent at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 


ehiers on DSK2VPTVN1PROD with RULES
65570 Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Rules and Regulations 

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: October 17, 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 § 180.433, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.433 Fomesafen; tolerance for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

*****

Bean, lima, succulent ............... 0.05 

*****

Cantaloupe ............................... 0.025 

*****

Cucumber ................................. 0.025 

Pea, succulent .......................... 0.025 

*****

Pumpkin .................................... 0.025 

*****

Soybean, vegetable, succulent 0.05 

Squash, summer ...................... 0.025 

Squash, winter .......................... 0.025 

Commodity Parts per 

million 

*****

Watermelon .............................. 0.025 

* * * * * 

[FR Doc. 2013–25984 Filed 10–31–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2008–0918; FRL–9901–97] 

RIN 2070–AB27 

Modification of Significant New Uses 

of 1-Propene, 2,3,3,3-tetrafluoroAGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Under the Toxic Substances 

Control Act (TSCA), EPA is finalizing an 

amendment to the significant new use 

rule (SNUR) for the chemical substance 

identified as 1-Propene, 2,3,3,3- 

tetrafluoro-, which was the subject of 

premanufacture notice (PMN) P–07– 

601. This action amends the SNUR to 

allow the manufacture and processing 

for certain uses without requiring a 

significant new use notice (SNUN). EPA 

is finalizing this amendment based on 

review of newly submitted exposure 

and toxicity data. 

DATES: This final rule is effective 

December 2, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2008–0918 is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC. 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 OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Jim 

Alwood, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–8974; email address: 

alwood.jim@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, process, 

or use the chemical substance identified 

as 1-Propene, 2,3,3,3-tetrafluoro- (PMN 

P–07–601). Potentially affected entities 

may include, but are not limited to: 

• Manufacturers or processors of the 

subject chemical substance (NAICS 

codes 325 and 324110), e.g., chemical 

manufacturers and petroleum refineries. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical person listed under FOR

FURTHER INFORMATION CONTACT. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Chemical importers 

are subject to the TSCA section 13 (15 

U.S.C. 2612) import certification 

requirements promulgated at 19 CFR 

12.118 through 12.127, and 19 CFR 

127.28. Chemical importers must certify 

that the shipment of the chemical 

substance complies with all applicable 

rules and orders under TSCA. Importers 

of chemicals subject to a SNUR must 

certify their compliance with the SNUR 

requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export the chemical substance 

that is the subject of a proposed or final 

SNUR are subject to the export 

notification provisions of TSCA section 

12(b) (15 U.S.C. 2611(b)) (see § 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 


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