Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52215 

Commodity Parts per 

million 

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Pea, dry, seed ...................... 0.06 

Pea, field, hay ....................... 15 

Pea, field, vines .................... 4 

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* * * * * 

[FR Doc. 2014–20928 Filed 9–2–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0622 and EPA–HQ– 

OPP–2014–0124; FRL–9912–91] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

and revises 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 

September 3, 2014. Objections and 

requests for hearings must be received 

on or before November 3, 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 for this action, 

identified by docket identification (ID) 

numbers EPA–HQ–OPP–2013–0622 and 

EPA–HQ–OPP–2014–0124, 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), West William 

Jefferson Clinton 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; main 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 numbers EPA–HQ– 

OPP–2013–0622 and EPA–HQ–OPP– 

2014–0124 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 November 3, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0622 and EPA–HQ–OPP–2014– 

0124, 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 October 25, 

2013 (78 FR 63938) (FRL–9901–96), 

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 3F8192) 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, 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-dihydro-1(2H)- 

pyrimidinyl)-4-fluorobenzoyl]-N′- 

isopropylsulfamide and N-[4-chloro-2- 

fluoro-5-({[(isopropylamino)sulfonyl

]amino}carbonyl)phenyl]urea, 

calculated as the stoichiometric 

equivalent of saflufenacil, in or on grass, 

forage at 15 parts per million (ppm); 

grass, hay at 20 ppm; grass, seed 

screenings at 0.9 ppm; and grass, straw 

at 1.5 ppm and revising the livestock 

commodity tolerances for (cattle, goat, 

horse, and sheep): Fat from 0.01 ppm to 

0.05 ppm; liver from 2.5 ppm to 45 

ppm; and meat byproducts, except liver 

from 0.05 ppm to 0.5 ppm; hog, fat from 

0.01 ppm to 0.05 ppm; hog, liver from 

0.80 ppm to 45 ppm; and hog, meat 

byproducts, except liver from 0.02 ppm 

to 0.5 ppm. 

The same Federal Register document 

of October 25, 2013, also announced 


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52216 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 

BASF Corporation’s filing of a pesticide 

petition (PP 3F8185) that requested 40 

CFR 180.649 be amended by revising 

tolerances for saflufenacil and its 

metabolites in or on barley, grain from 

0.10 ppm to 1.0 ppm; barley, straw from 

0.10 ppm to 15.0 ppm; barley, bran from 

0.10 ppm to 1.53 ppm; wheat, grain 

from 0.10 ppm to 0.6 ppm; and wheat, 

straw from 0.10 ppm to 6.0 ppm, 

included under the existing tolerances 

for ‘‘Grain, cereal, group 15’’ and 

‘‘Grain, cereal, forage, fodder and straw 

group 16.’’ In addition, BASF 

Corporation requested to amend the 

existing commodity definition, ‘‘Grain, 

cereal, forage, fodder and straw group 

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

straw, group 16, except barley, rice and 

wheat straw’’ as well as amend the 

commodity definition, ‘‘Grain, cereal, 

group 15’’ to ‘‘Grain, cereal, group 15, 

except barley and wheat.’’ 

Finally, in the Federal Register of 

February 25, 2014 (79 FR 10458) (FRL– 

9906–77), 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 4F8229) by 

BASF Corporation. The petition 

requested that 40 CFR 180.649 be 

amended by establishing tolerances for 

residues of the herbicide 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-dihydro1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N′- 

isopropylsulfamide and N-[4-chloro-2- 

fluoro-5-({[(isopropylamino)sulfonyl]

amino}carbonyl)phenyl]urea, calculated 

as the stoichiometric equivalent of 

saflufenacil in or on olive at 0.03 ppm. 

These documents referenced summaries 

of the petitions prepared by BASF 

Corporation, the petitioner, which are 

available in the dockets, http://

www.regulations.gov. There were no 

comments received in response to these 

notices of filings. 

Based upon review of the supporting 

data, EPA has made modifications to the 

proposed tolerances which include: 

1. Rounding the proposed tolerance 

for barley, bran. 

2. Revising the commodity definition 

for crop group 16. 

3. Decreasing the proposed tolerances 

for grass, seed screenings and grass, 

straw. 

4. Increasing the existing tolerance for 

residues in or on grain, aspirated 

fractions. 

5. Making several changes to the 

proposed livestock tolerances. 

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. In the Federal 

Register of February 21, 2014 (79 FR 

9861) (FRL–9905–87), EPA published a 

final rule establishing tolerances for 

residues of the herbicide saflufenacil 

and its metabolites in or on sugarcane, 

fish, and shellfish commodities based 

on EPA’s conclusion that aggregate 

exposure to saflufenacil is safe for the 

general population, including infants 

and children. Since that rulemaking, 

there have been no additional tolerance 

actions for saflufenacil, nor has the 

toxicity profile for saflufenacil changed. 

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 are discussed in that 

rulemaking which can be found in the 

docket under 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 the NOAEL and the 

lowest dose at which the LOAEL are 

identified. Uncertainty/safety factors 

(UFs) are used in conjunction with the 

POD to calculate a safe exposure level— 

generally referred to as a populationadjusted 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 discussed in Unit III.B. of 

the February 21, 2014 Federal Register 

final rule. 

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 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 acute 

dietary exposure, EPA used food 


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consumption information from the 

United States Department of Agriculture 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (USDA NHANES/WWEIA, 

2003–2008). As to residue levels in 

food, EPA assumed 100 percent crop 

treated (PCT), Dietary Exposure 

Evaluation Model (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. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA NHANES/WWEIA, 

2003–2008. As to residue levels in food, 

EPA made the same assumptions 

(adjusted tolerance-level residues and 

100 PCT) as in the acute dietary 

exposure assessment. 

iii. Cancer. As indicated in the 

February 21, 2014 Federal Register final 

rule preamble for saflufenacil, 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. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for saflufenacil. Tolerance-level residues 

(or higher) 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 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 safety factor 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 

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. 


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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 20% of 

the cPAD for infants less than 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. 

There are MRLs established for 

residues of saflufenacil, measuring the 

levels of the parent only and not 

residues of the metabolites, as follows: 

0.01 ppm in or on cereal grains, which 

includes barley, corn, and wheat; 0.05 

ppm for maize fodder (dry), sorghum 

straw and fodder, dry; 0.05 ppm for 

barley straw and fodder, dry; 0.05 ppm 

for wheat straw and fodder, dry; 0.01 

mammalian fats (except milk fats), 

which includes cattle, goat, hog, horse, 

and sheep; and 0.3 edible offal 

mammalian, which includes cattle, goat, 

hog, horse, and sheep. 

Harmonization between the Codex 

MRLs for cereal grains and the U.S. 

tolerances for barley, grain and wheat, 

grain and between the Codex MRL for 

barley straw and fodder, dry and the 

U.S. tolerance for barley, straw and 

between the Codex MRL for wheat straw 

and fodder, dry and the U.S. tolerance 

for wheat, straw is not possible as the 

U.S. use pattern (harvest-aide/

burndown application) results in 

significantly higher residues than the 

Codex use pattern (pre-emergence 

application). The higher residues 

translate into higher residues of 

saflufenacil in animal byproducts than 

are covered by the corresponding Codex 

MRLs for livestock commodities under 

the Codex use pattern; therefore, U.S. 

tolerances for livestock commodities 

cannot be harmonized with Codex 

MRLs for corresponding livestock 

commodities. 

The U.S. tolerances for crop groups 15 

and 16 are not harmonized with the 

Codex MRLs for cereal grains and straw 

and fodder because the compliance with 

the Codex MRLs involve measurement 

of residues of the parent only and not 

the metabolites, whereas the U.S. 

tolerance requires measurement of both, 

in order to be harmonized with 

Canadian tolerances. 

C. Revisions to Petitioned-for Tolerances 

EPA is making several revisions to the 

petitioned-for tolerances. These include 

the following. First, the petitioned value 

for barley bran is being rounded from 

1.53 ppm to 1.5 ppm to be consistent 

with the current Organization for 

Economic Cooperation and 

Development (OECD) tolerancecalculation procedure. Second, the 

commodity definition ‘‘Grain, cereal, 

forage, fodder, and straw group 16 

(except barley, wheat and rice straw)’’ is 

being revised to ‘‘Grain, cereal, forage, 

fodder and straw group 16 (except 

barley and wheat straw)’’ as the new use 

pattern (harvest aid/desiccant) was not 

proposed for rice. Third, the petitioner 

requested tolerance values for grass 

straw and seed screenings were based 

on data from trials in which the samples 

were harvested at a significantly shorter 

preharvest interval (PHI) than that listed 

on the label. Additional residue data 

reflecting the actual PHI listed on the 

label showed lower residue levels; 

therefore, the tolerance values for grass 

straw and seed screenings are being 

decreased. Fourth, the existing tolerance 

of 10 ppm for residues in or on grain, 

aspirated fractions is being increased to 

50 ppm as a result of the new tolerances 

for cereal grains and based on available 

residues data. Finally, EPA is making 

several revisions to the proposed 

livestock tolerances which include: 

1. Decreasing the proposed tolerances 

for cattle, goat, sheep, hog and horse fat 

from 0.05 ppm to 0.04 ppm and meat 

byproducts (except liver) from 0.05 ppm 

to 0.03 ppm. 

2. Increasing the tolerances proposed 

for cattle, goat, sheep and horse liver 

from 45 ppm to 50 ppm. 

3. Decreasing the tolerance proposed 

for hog liver from 45 ppm to 2.0 ppm. 

4. Establishing tolerances for cattle, 

goat, sheep and horse meat at 0.02 ppm. 


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Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52219 

5. Retaining the currently established 

tolerances for hog, fat or hog, meat 

byproducts (except liver), instead of 

increasing them as requested. 

The tolerances being set for residues 

in livestock differ from the petitionedfor tolerances due to differences in 

calculation methods of the maximum 

reasonably balanced diets (MRBDs) with 

the results of the ruminant feeding 

study. It also appears that the petitioner 

over-estimated residues in hog 

commodities as a result of using the 

cattle MRDB. 

V. Conclusion 

Therefore, tolerances are established 

for residues of saflufenacil, including its 

metabolites and degradates, as set forth 

in the regulatory text. Compliance with 

the plant 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-dihydro1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N’- 

isopropylsulfamide and N-[4-chloro-2- 

fluoro-5-({[(isopropylamino)

sulfonyl]amino}carbonyl)phenyl]urea, 

calculated as the stoichiometric 

equivalent of saflufenacil. Compliance 

with the livestock tolerances is to be 

determined by measuring only 

saflufenacil, 2-chloro-5-[3,6-dioxo-4- 

(trifluoromethyl)-3,6-dihydro-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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 25, 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. Remove the commodities ‘‘Grain, 

aspirated fractions,’’ ‘‘Grain, cereal, 

forage, fodder and straw group 16,’’ and 

‘‘Grain, cereal, group 15’’ in the table in 

paragraph (a)(1). 

■ b. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). 

■ c. Revise the following commodities 

in the table in paragraph (a)(2). 

The amendments read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Barley, bran ........................ 1 .5 

Barley, grain ....................... 1 .0 

Barley, straw ....................... 15 

* * * * * 

Grain, aspirated grain fractions ................................. 50 

Grain, cereal, forage, fodder 

and straw group 16 (except barley and wheat 

straw) .............................. 0 .10 

Grain, cereal, group 15 (except barley and wheat 

grain) ............................... 0 .03 

* * * * * 

Grass, forage ...................... 15 

Grass, hay .......................... 20 

Grass, seed screenings ...... 0 .15 

Grass, straw ....................... 0 .15 

* * * * * 

Olive .................................... 0 .03 

* * * * * 

Wheat, grain ....................... 0 .60 

Wheat, straw ....................... 6 .0 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

Cattle, fat ............................ 0 .04 


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52220 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 

Commodity Parts per 

million 

Cattle, liver .......................... 50 

Cattle, meat ........................ 0 .02 

Cattle, meat byproducts, except liver .......................... 0 .30 

* * * * * 

Goat, fat .............................. 0 .04 

Goat, liver ........................... 50 

Goat, meat .......................... 0 .02 

Goat, meat byproducts, except liver .......................... 0 .30 

* * * * * 

Hog, liver ............................ 2 .0 

* * * * * 

Horse, fat ............................ 0 .04 

Horse, liver ......................... 50 

Horse, meat ........................ 0 .02 

Horse, meat byproducts, 

except liver ...................... 0 .30 

* * * * * 

Sheep, fat ........................... 0 .04 

Sheep, liver ......................... 50 

Sheep, meat ....................... 0 .02 

Sheep, meat byproducts, 

except liver ...................... 0 .30 

* * * * * 

[FR Doc. 2014–20947 Filed 9–2–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 271 

[EPA–R06–RCRA–2013–0624 FRL 9915–99– 

Region 6] 

Texas: Final Authorization of State 

Hazardous Waste Management 

Program Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The State of Texas has 

applied to the Environmental Protection 

Agency (EPA) for Final authorization of 

the changes to its hazardous waste 

program under the Resource 

Conservation and Recovery Act (RCRA). 

EPA has determined that these changes 

satisfy all requirements needed to 

qualify for Final authorization, and is 

authorizing the State’s changes through 

this direct final action. The EPA is 

publishing this rule to authorize the 

changes without a prior proposal 

because we believe this action is not 

controversial and do not expect 

comments that oppose it. Unless we 

receive written comments which oppose 

this authorization during the comment 

period, the decision to authorize Texas’ 

changes to its hazardous waste program 

will take effect. If we receive comments 

that oppose this action, we will publish 

a document in the Federal Register 

withdrawing this rule before it takes 

effect, and a separate document in the 

proposed rules section of this Federal 

Register will serve as a proposal to 

authorize the changes. 

DATES: This final authorization will 

become effective on November 3, 2014 

unless the EPA receives adverse written 

comment by October 3, 2014. If the EPA 

receives such comment, it will publish 

a timely withdrawal of this direct final 

rule in the Federal Register and inform 

the public that this authorization will 

not take effect. 

ADDRESSES: Submit your comments by 

one of the following methods: 

1. Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

2. Email: patterson.alima@epa.gov. 

3. Mail: Alima Patterson, Region 6, 

Regional Authorization Coordinator, 

State/Tribal Oversight Section (6PD–O), 

Multimedia Planning and Permitting 

Division, EPA Region 6, 1445 Ross 

Avenue, Dallas, Texas 75202–2733. 

4. Hand Delivery or Courier. Deliver 

your comments to Alima Patterson, 

Region 6, Regional Authorization 

Coordinator, State/Tribal Oversight 

Section (6PD–O), Multimedia Planning 

and Permitting Division, EPA Region 6, 

1445 Ross Avenue, Dallas, Texas 75202– 

2733. 

Instructions: Do not submit 

information that you consider to be CBI 

or otherwise protected through 

regulations.gov, or email. The Federal 

regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means the EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to the EPA without 

going through regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, the EPA recommends that 

you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If the EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

the EPA may not be able to consider 

your comment. Electronic files should 

avoid the use of special characters, any 

form of encryption, and be free of any 

defects or viruses. You can view and 

copy Texas’ application and associated 

publicly available materials from 8:30 

a.m. to 4 p.m. Monday through Friday 

at the following locations: Texas 

Commission on Environmental Quality, 

(TCEQ) 12100 Park S. Circle, Austin 

Texas 78753–3087, (512) 239–6079 and 

EPA, Region 6, 1445 Ross Avenue, 

Dallas, Texas 75202–2733, phone 

number (214) 665–8533. Interested 

persons wanting to examine these 

documents should make an 

appointment with the office at least two 

weeks in advance. 

FOR FURTHER INFORMATION CONTACT: 

Alima Patterson, Region 6 Regional 

Authorization Coordinator, State/Tribal 

Oversight Section (6PD–O), Multimedia 

Planning and Permitting Division, (214) 

665–8533, EPA Region 1445 Ross 

Avenue, Dallas, Texas 75202–2733, and 

Email address patterson.alima@epa.gov. 

SUPPLEMENTARY INFORMATION: 

A. Why are revisions to State programs 

necessary? 

States which have received final 

authorization from the EPA under RCRA 

section 3006(b), 42 U.S.C. 6926(b), must 

maintain a hazardous waste program 

that is equivalent to, consistent with, 

and no less stringent than the Federal 

program. As the Federal program 

changes, States must change their 

programs and ask the EPA to authorize 

the changes. Changes to State programs 

may be necessary when Federal or State 

statutory or regulatory authority is 

modified or when certain other changes 

occur. Most commonly, States must 

change their programs because of 

changes to the EPA’s regulations in 40 

Code of Federal Regulations (CFR) parts 

124, 260 through 268, 270, 273, and 279. 

B. What decisions have we made in this 

rule? 

We conclude that the State of Texas’ 

application to revise its authorized 

program meets all of the statutory and 

regulatory requirements established by 

RCRA. Therefore, we grant the State of 

Texas Final Authorization to operate its 

hazardous waste program with the 

changes described in the authorization 

application. The State of Texas has 

responsibility for permitting treatment, 

storage, and disposal facilities within its 

borders (except in Indian Country) and 

for carrying out the aspects of the RCRA 

program described in its revised 

program application, subject to the 

limitations of the Hazardous and Solid 

Waste Amendments of 1984 (HSWA). 

New Federal requirements and 

prohibitions imposed by Federal 

regulations that the EPA promulgates 

under the authority of HSWA take effect 

in authorized States before they are 


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