Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Rules and Regulations 9861 

Inert ingredients Limits Uses 

*******

a-alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-whydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of 

di- and monohydrogen phosphate esters and the corresponding ammonium, 

calcium, magnesium, monoethanolamine, potassium, sodium and zinc salts of 

the phosphate esters; minimum oxyethylene content averages 2 moles; minimum oxypropylene content is 0 moles (CAS Reg. Nos. 9004–80–2, 9046–01– 

9, 26982–05–8, 31800–89–2, 37280–82–3, 39464–66–9, 39341–09–8, 39341– 

65–6, 39464–69–2, 42612–52–2, 50643–20–4, 50668–50–3, 51884–64–1, 

52019–36–0, 57486–09–6, 58318–92–6, 59112–71–9, 60267–55–2, 61837– 

79–4, 62362–49–6, 63747–86–4, 63887–55–8, 66272–25–1, 67711–84–6, 

67786–06–5, 67989–06–4, 68070–99–5, 68071–17–0, 68071–35–2, 68071– 

37–4, 68130–44–9, 68130–45–0, 68130–46–1, 68130–47–2, 68186–29–8, 

68186–36–7, 68186–34–5, 68186–37–8, 68238–84–6, 68311–02–4, 68311– 

04–6, 68389–72–0, 68413–78–5, 68425–73–0, 68425–75–2, 68439–39–4, 

68458–48–0, 68511–15–9, 68511–36–4, 68511–37–5, 68551–05–3, 68585– 

15–9, 68585–16–0, 68585–17–1, 68585–36–4, 68585–39–7, 68603–24–7, 

68607–14–7, 68610–64–0, 68610–65–1, 68649–29–6, 68649–30–9, 68650– 

84–0, 68815–11–2, 68855–46–9, 68856–03–1, 68890–90–4, 68890–91–5, 

68891–12–3, 68891–13–4, 68891–26–9, 68908–64–5, 68909–65–9, 68909– 

67–1, 68909–69–3, 68921–24–4, 68921–60–8, 68954–87–0, 68954–88–1, 

68954–92–7, 68987–35–9, 69029–43–2, 69980–69–4, 70247–99–3, 70248– 

14–5, 70903–63–8, 71965–23–6, 71965–24–7, 72480–27–4, 72623–67–7, 

72623–68–8, 72828–56–9, 72828–57–0, 73018–34–5, 73038–25–2, 73050– 

08–5, 73050–09–6, 73361–29–2, 73378–71–9, 73378–72–0, 73559–42–9, 

73559–43–0, 73559–44–1, 73559–45–2, 74499–76–6, 76930–25–1, 78330– 

22–0, 78330–24–2, 91254–26–1, 93925–54–3, 96416–89–6, 103170–31–6, 

103170–32–7, 106233–09–4, 106233–10–7, 108818–88–8, 110392–49–9, 

111798–26–6, 111905–50–1, 116671–23–9, 117584–36–8, 119415–05–3, 

121158–61–0, 121158–63–2, 125139–13–1, 125301–86–2, 125301–87–3, 

126646–03–5, 129870–77–5, 129870–80–0, 130354–37–9, 136504–88–6, 

143372–50–3, 143372–51–4, 154518–39–5, 154518–40–8, 155240–11–2, 

160498–49–7, 160611–24–5, 171543–66–1, 210493–60–0, 246159–55–7, 

251298–11–0, 261627–68–3, 317833–96–8, 422563–19–7, 873662–29–4, 

936100–29–7, 936100–30–0, 1072943–56–6, 1187742–89–7, 1187743–35–6).

Not to exceed 30% of pesticide formulation.Surfactants, related adjuvants of 

surfactants 

* * * * * * * 

[FR Doc. 2014–03733 Filed 2–20–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0775 and EPA–HQ– 

OPP–2013–0008; FRL–9905–87] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of saflufenacil in 

or on multiple commodities which are 

identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 21, 2014. Objections and 

requests for hearings must be received 

on or before April 22, 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 dockets in this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0775 and 

EPA–HQ–OPP–2013–0008, are 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 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 


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9862 Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Rules and Regulations 

proper receipt by EPA, you must 

identify the docket ID number EPA– 

HQ–OPP–2012–0775 and/or EPA–HQ– 

OPP–2013–0008 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 April 22, 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– 

2012–0775 and/or EPA–HQ–OPP–2013– 

0008, 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 November 

7, 2012 (77 FR 66781) (FRL–9367–5) 

(EPA–HQ–OPP–2012–0775), 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 2E8065) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.649 be amended by 

establishing tolerances for residues of 

the herbicide, saflufenacil, including its 

metabolites and degradates, in or on 

sugarcane, cane at 0.03 parts per million 

(ppm); sugarcane, molasses at 0.075 

ppm; and sugarcane, refined sugar at 

0.045 ppm. That document referenced a 

summary of the petition prepared by 

BASF 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. 

In the Federal Register of February 

27, 2013 (78 FR 13295) (FRL–9380–2) 

(EPA–HQ–OPP–2013–0008), 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 2F8139) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.649 be amended by 

establishing tolerances for residues of 

the herbicide, saflufenacil, including its 

metabolites and degradates, in or on 

crayfish at 0.01 ppm. In the Federal 

Register of December 30, 2013 (78 FR 

79359) (FRL–9903–69) (EPA–HQ–OPP– 

2013–0008) EPA issued a document 

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

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

to the original pesticide petition (PP 

2F8139) by BASF Corporation, 26 Davis 

Dr., P.O. Box 13528, Research Triangle 

Park, NC 27709–3528. The revised 

petition requested that 40 CFR 180.649 

be amended by establishing tolerances 

for residues of the herbicide, 

saflufenacil, including its metabolites 

and degradates, in or on fish-freshwater 

finfish and fish-shellfish crustacean at 

0.01 ppm instead of ‘‘crayfish at 0.01 

ppm’’ based on the Agency’s evaluation 

of the data supporting the original 

petition. That document referenced a 

summary of the petition prepared by 

BASF 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. 

In the Federal Register of June 5, 2013 

(78 FR 33785) (FRL–9386–2) (EPA–HQ– 

OPP–2013–0008), 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 2F8129) by BASF 

Corporation, 26 Davis Dr., P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR 180.649 be amended by 

amending tolerances for residues of the 

herbicide, saflufenacil, including its 

metabolites and degradates, in or on 

rice, straw at 0.30 ppm and amend the 

current commodity definition ‘‘Grain, 

cereal, forage, fodder and straw group 

16’’ to ‘‘Grain, cereal, forage, fodder and 

straw group 16 (except rice straw).’’ 

That document referenced a summary of 

the petition prepared by BASF 

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 petitions, EPA has 

determined that the tolerance level of 

0.03 ppm requested for sugarcane, cane 

is increased to 0.05 ppm; and the 

tolerance level of 0.075 ppm requested 

for sugarcane, molasses is increased to 

0.08 ppm. Additionally, tolerances 

requested for sugarcane, refined sugar 

and rice, straw are not being established 

at this time. The reasons for these 

changes are 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 saflufenacil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with saflufenacil 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. 

Saflufenacil has low acute toxicity via 

all routes of exposure. Subchronic and 


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Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Rules and Regulations 9863 

chronic toxicity studies in rats, mice, 

and dogs identified the hematopoietic 

system as the primary target of 

saflufenacil. Consistent with its 

proposed mode of toxicity involving 

protoporphyrinogen IX oxidase (PPO) 

inhibition and subsequent disruption of 

heme biosynthesis, decreased 

hematological parameters were seen at 

about the same dose level [lowestobserved adverse-effect levels (LOAELs) 

of 13–39 milligram/kilogram/day (mg/

kg/day)] across species, except in the 

case of the dog, where the effects were 

seen at a slightly higher dose (LOAELs 

of 50–100 mg/kg/day). These effects 

occurred around the same dose level 

from short- through long-term exposures 

without increasing in severity. In line 

with findings that male rats achieve a 

greater systemic exposure than females, 

males were the most sensitive sex in 

mice and rats. Effects were also seen in 

the liver (increased weight, 

centrilobular fatty change, lymphoid 

infiltrate) in mice, the spleen (increased 

spleen weight and extramedullary 

hematopoiesis) in rats, and in both of 

these organs (increased iron storage in 

the liver and extramedullary 

hematopoiesis in the spleen) in dogs. 

These effects also occurred around the 

same dose level from short- through 

long-term exposures without increasing 

in severity. 

Increased fetal susceptibility was 

observed in the developmental toxicity 

studies in the rat and rabbit and in the 

2-generation reproduction study in the 

rat. Developmental effects (decreased 

fetal body weights and increased 

skeletal variations in rats and increased 

liver porphyrins in rabbits) occurred at 

doses that were not maternally toxic, 

indicating increased quantitative 

susceptibility. In the 2-generation 

reproductive toxicity study in rats, the 

reported offspring effects were more 

severe than the maternal effects at the 

same dose level, indicating evidence for 

increased qualitative susceptibility. An 

increased number of stillborn pups, 

decreased viability and lactation 

indices, decreased pre-weaning body 

weight and/or body-weight gain, and 

changes in hematological parameters 

occurred at the same dose level as 

maternal decrements in food intake, 

body weight, body-weight gain, and 

changes in hematological parameters 

and organ weights indicative of anemia. 

There is no evidence of neurotoxicity 

or immunotoxicity in the saflufenacil 

database. 

Saflufenacil was weakly clastogenic 

in the in vitro chromosomal aberration 

assay in V79 cells in the presence of S9 

activation; however, the response was 

not evident in the absence of S9 

activation. It was neither mutagenic in 

bacterial cells nor clastogenic in rodents 

in vivo. Carcinogenicity studies in rats 

and mice showed no evidence of 

increased incidence of tumors at the 

tested doses. Saflufenacil is classified as 

‘‘not likely carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by saflufenacil as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Saflufenacil. Human-Health Risk 

Assessment in Support of Tolerances for 

Residues in/on Fish, Crayfish, and 

Imported Sugarcane’’ at p. 26 in docket 

ID numbers EPA–HQ–OPP–2012–0775 

and EPA–HQ–OPP–2013–0008. 

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 saflufenacil used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SAFLUFENACIL 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 

Acute RfD = 5.0 mg/ 

kg/day.

aPAD = 5.0 mg/kg/day 

Acute Neurotoxicity Study (rat). 

LOAEL = 2,000 mg/kg/day based on decreased motor activity representing mild and transient systemic toxicity in male rats. 

FQPA SF = 1X 

Chronic dietary (All 

populations).

NOAEL= 4.6 mg/kg/ 

day.

Chronic RfD = 0.046 

mg/kg/day.

Chronic/Carcinogenicity (mouse). 

LOAEL = 13.8 mg/kg/day based on decreased red blood cells, hemoglobin, hematocrit, and porphyria observed in the satellite 

group. 

UFA = 10X 

UFH = 10X 

cPAD = 0.046 mg/kg/ 

day.

FQPA SF = 1X 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SAFLUFENACIL 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 

Cancer (Oral, dermal, 

inhalation).

Not likely carcinogenic to humans based on the lack of tumors in the mouse and rat carcinogenicity studies and lack of 

mutagenicity. 

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

milligram/kilogram/day. 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 saflufenacil, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing saflufenacil tolerances in 40 

CFR 180.649. EPA assessed dietary 

exposures from saflufenacil 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. Such effects 

were identified for saflufenacil. 

In estimating both acute and chronic 

dietary exposure, EPA used the Dietary 

Exposure Evaluation Model—Food 

Consumption Intake Database (DEEM) 

which incorporates food consumption 

information from the United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA; 2003– 

2008). As to residue levels in food, EPA 

assumed 100 percent crop treated (PCT), 

DEEM 7.81 default processing factors, 

and tolerance-level or higher (i.e., 

tolerance levels adjusted to take into 

account metabolite levels) residues for 

all foods. 

ii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that saflufenacil does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iii. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for saflufenacil. Tolerance level residues 

and/or 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 saflufenacil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of saflufenacil. 

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 

Tier II Pesticide Root Zone Model 

Ground Water (PRZM GW), the 

estimated drinking water concentrations 

(EDWCs) of saflufenacil for acute 

exposures are estimated to be 133 parts 

per billion (ppb) for surface water and 

69.2 ppb for ground water. Chronic 

exposures for non-cancer assessments 

are estimated to be 120 ppb for surface 

water and 51.5 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 133 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 120 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). 

Saflufenacil 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 saflufenacil to share a common 

mechanism of toxicity with any other 

substances, and saflufenacil does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

saflufenacil 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 

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. 

Increased fetal susceptibility was 

observed in the developmental toxicity 

studies in the rat and rabbit and in the 

2-generation reproduction study in the 

rat. Developmental effects (decreased 

fetal body weights and increased 

skeletal variations in rats and increased 

liver porphyrins in rabbits) occurred at 

doses that were not maternally toxic in 

the developmental studies, indicating 

increased quantitative susceptibility. In 

the 2-generation reproductive toxicity 

study in rats, the reported offspring 

effects were more severe than the 

maternal effects at the same dose level, 

indicating evidence for increased 

qualitative susceptibility. An increased 

number of stillborn pups, decreased 

viability and lactation indices, 

decreased pre-weaning body weight 

and/or body-weight gain, and changes 


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Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Rules and Regulations 9865 

in hematological parameters occurred at 

the same dose level as maternal 

decrements in food intake, body weight, 

body-weight gain, and changes in 

hematological parameters and organ 

weights indicative of anemia. 

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 

saflufenacil is complete. 

ii. There is no indication that 

saflufenacil is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. The concern for increased 

susceptibility following prenatal or 

postnatal exposure is low because clear 

NOAELs/LOAELs were established for 

the developmental effects seen in rats 

and rabbits as well as for the offspring 

effects seen in the 2-generation 

reproductive toxicity study. Further, the 

dose-response relationship for the 

effects of concern is also well 

characterized and being used for 

assessing risks. None of the effects in 

the developmental or reproduction 

studies were attributable to a single 

exposure and, therefore, are not of 

concern for acute risk assessment. The 

chronic point of departure used for risk 

assessment is protective of any 

developmental and offspring effects 

observed in these studies. 

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 saflufenacil 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by saflufenacil. 

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 

saflufenacil will occupy <1% of the 

aPAD for infants less than 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 saflufenacil 

from food and water will utilize 18% of 

the cPAD for infants <1-year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for saflufenacil. 

3. Short and intermediate-term risk. 

Short and intermediate-term aggregate 

exposure takes into account short and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 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-term risk for 

saflufenacil. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

saflufenacil 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 saflufenacil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods 

‘‘D0603/02’’ and ‘‘L0073/01’’ (liquid 

chromatography/mass spectroscopy/ 

mass spectroscopy (LC–MS/MS)) are 

available to enforce the tolerance 

expression. These methods 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. The Codex has not 

established a MRL for saflufenacil. 

C. Revisions to Petitioned-for Tolerances 

EPA has increased the tolerance level 

requested by BASF Corporation in 

petition 2E8065 for sugarcane, cane 

from 0.03 ppm to 0.05 ppm based on the 

residue data for sugarcane and use of 

the Organization for Economic Cooperation and Development (OECD) 

tolerance calculation procedures. Also, 

based on the residue data for sugarcane 

and to account for concentrations of 

residues during processing, a tolerance 

of 0.08 ppm is required for residues in 

or on sugarcane, molasses. Residues did 

not concentrate in refined sugar, so the 

tolerance proposed for this commodity 

will not be established at this time. In 

addition, the proposed tolerances for 

rice straw in PP 2F8129 will not be 

established since rice straw is not a 

significant livestock item. Therefore, the 

associated request for a change in the 

commodity definition is not necessary. 

V. Conclusion 

Therefore, tolerances are established 

for residues of saflufenacil, 2-chloro-5- 

[3,6-dihydro-3-methyl-2,6-dioxo-4- 

(trifluoromethyl)-1(2H)-pyrimidinyl]-4- 

fluoro-N-[[methyl(1- 

methylethyl)amino]sulfonyl]benzamide, 

and its metabolites and degradates in or 

on sugarcane, cane at 0.05 ppm and 

sugarcane, molasses at 0.08 ppm. Also, 

tolerances are established for residues of 

the parent, saflufenacil, in fishfreshwater finfish and fish-shellfish, 

crustacean at 0.01 ppm. Compliance 

with the sugarcane, cane and sugarcane, 

molasses tolerances is to be determined 

by measuring the sum of saflufenacil, 2- 

chloro-5-[3,6-dihydro-3-methyl-2,6- 

dioxo-4-(trifluoromethyl)- 1(2H)- 

pyrimidinyl]-4-fluoro-N -[[methyl(1- 

methylethyl)amino]sulfonyl]benzamide, 

and its metabolites N-[2-chloro-5-(2,6- 

dioxo-4-(trifluoromethyl)-3,6-dihydroVerDate Mar<15>2010 13:18 Feb 20, 2014 Jkt 232001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\21FER1.SGM 21FER1

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9866 Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Rules and Regulations 

1(2H)-pyrimidinyl)-4-fluorobenzoyl]-Nisopropylsulfamide and N-[4-chloro-2- 

fluoro-5 ({[(isopropylamino)sulfonyl]

amino}carbonyl)phenyl]urea calculated 

as the stoichiometric equivalent of 

saflufenacil; compliance with the fishfreshwater finfish and fish-shellfish, 

crustacean tolerances are to be 

determined by measuring only 

saflufenacil, 2-chloro-5-[3,6-dihydro-3- 

methyl-2,6-dioxo-4-(trifluoromethyl)- 

1(2H)-pyrimidinyl]-4-fluoro-N- 

[[methyl(1- 

methylethyl)amino]sulfonyl]benzamide. 

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: February 11, 2014. 

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 § 180.649: 

■ a. Add alphabetically the following 

commodities and footnote 2 to the table 

in paragraph (a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(2). 

The amendments read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

Sugarcane, cane 2 .................... 0.05 

Sugarcane, molasses 2 ............. 0.08 

*****

* * * * * 2No U.S. registration as of February 

21, 2014. 

(2) * * * 

Commodity Parts per 

million 

*****

Fish-freshwater finfish .............. 0.01 

Fish-shellfish, crustacean ......... 0.01 

*****

* * * * * 

[FR Doc. 2014–03734 Filed 2–20–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 001005281–0369–02] 

RIN 0648–XD137 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; 2014 

Commercial Accountability Measure 

and Closure for Coastal Migratory 

Pelagic Resources of the Gulf of 

Mexico and South Atlantic 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS implements an 

accountability measure (AM) to close 

the hook-and-line component of the 

commercial sector for king mackerel in 

the southern Florida west coast 

subzone. This closure is necessary to 

protect the Gulf of Mexico (Gulf) king 

mackerel resource. 

DATES: This rule is effective 12:01 a.m., 

local time, February 21, 2014, through 

June 30, 2014. 


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