Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Rules and Regulations 73663 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0640; FRL–9936–71] 

Saflufenacil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of saflufenacil in 

or on pomegranate. BASF Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

November 25, 2015. Objections and 

requests for hearings must be received 

on or before January 25, 2016, 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–2014–0640, 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), 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: 

Susan Lewis, Director, 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 number EPA–HQ– 

OPP–2014–0640 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 January 25, 2016. 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– 

2014–0640, 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 February 

11, 2015, (80 FR 7559) (FRL–9921–94), 

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) 4F8305 by BASF 

Corporation, 26 Davis Drive, 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, in or on pomegranate at 

0.03 parts per million (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. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed 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 


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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. 

The effects observed following 

repeated oral exposures to saflufenacil 

are consistent with the proposed mode 

of toxicity involving inhibition of 

protoporphyrinogen oxidase (PPO) in 

mammals, resulting in disruption of 

heme biosynthesis. Toxicological effects 

from subchronic and chronic toxicity 

studies in rats, mice and dogs consisted 

of decreased hematological parameters 

(RBC, Ht, MCV, MCH, and MCHC) at 

approximately the same dose level (13– 

39 mg/kg/day), except in the case of the 

dog, where the effects were seen at a 

slightly higher dose (50–100 mg/kg/

day). In line with the absorption, 

distribution, metabolism, and excretion 

(ADME) findings suggesting that male 

rats achieve a greater systemic exposure 

than females, males were the most 

sensitive sex in mice and rats, with 

LOAELs approximately 3–4X lower than 

their female counterparts. The 

hematological effects resulting from oral 

exposures to saflufenacil occurred 

around the same dose level from shortthrough long-term exposures without 

increasing in severity. Toxic effects 

were also seen in the liver (increased 

organ weight, centrilobular fatty change, 

lymphoid infiltrate) in mice, the spleen 

(increased organ 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 a progression in severity. 

Evidence for increased pre- and/or 

postnatal susceptibility was noted from 

the developmental toxicity studies in 

the rat and rabbit and in the 2- 

generation reproduction study in the rat. 

Decreased fetal body weights and 

increased skeletal variations occurred at 

doses (20 mg/kg/day) that were not 

maternally toxic in the developmental 

study in rats. Similarly, in rabbits, 

increased liver porphyrins in fetuses 

were observed at doses (200 mg/kg/day) 

that were not maternally toxic. In the 2- 

generation reproductive toxicity study 

in rats, there was evidence of increased 

qualitative susceptibility based on an 

increased number of stillborn pups, 

decreased pup viability and lactation 

indices, decreased pre-weaning bodyweight and/or body-weight gain, and 

changes in hematological parameters at 

the same dose level as less severe 

maternal effects consisting of 

decrements in food intake, body-weight, 

body-weight gain, and changes in organ 

weights and hematological parameters 

indicative of anemia. 

In an acute neurotoxicity (ACN) study 

in rats, a decrease in motor activity was 

observed on the day of dosing at the 

limit dose (2,000 mg/kg/day) in males 

only. However, the finding was not 

accompanied by any neuropathological 

changes and was considered a reflection 

of a mild and transient general systemic 

toxicity and not a substance-specific 

neurotoxic effect. In the subchronic 

neurotoxicity (SCN) study, systemic 

toxicity (anemia) was seen at 1,000 ppm 

(66.2 mg/kg/day) and 1,350 ppm (101 

mg/kg/day) in males and females, 

respectively. There was no evidence of 

neurotoxicity or neuropathology in 

either the acute or subchronic 

neurotoxicity study. 

In a 28-day dermal toxicity study in 

rats, saflufenacil did not induce any 

type of dermal or systemic toxicity up 

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

Based on the results of acute toxicity 

studies, saflufenacil was ranked low for 

acute toxicity via the oral, dermal, and 

inhalation route of exposure. It was not 

classified as a dermal irritant or dermal 

sensitizer. 

In a 28-day immunotoxicity study in 

mice, saflufenacil failed to induce 

toxicity specific to the immune system 

at the highest dose tested (i.e., 52 mg/ 

kg bw/day). 

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 Pomegranate’’ pgs. 26– 

30 in docket ID number EPA–HQ–OPP– 

2014–0640. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for saflufenacil used for 

human risk assessment is shown in 

Table 1 of this unit. 


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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 bw ......

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 5 mg/kg ...........................

aPAD = 5 mg/kg 

Acute Neurotoxicity Study (rat). LOAEL 

= 2,000 mg/kg bw based on decreased motor activity representing 

mild and transient systemic toxicity 

in males. 

Chronic dietary (All populations).NOAEL = 4.6 mg/kg/day ......

UFA =10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.046mg/kg/day ............

cPAD = 0.046 mg/kg/day 

Chronic/Carcinogenicity (mouse). 

LOAEL = 13.8 mg/kg bw/day based 

on decreased red blood cells, hemoglobin, hematocrit, and porphyria observed in the satellite group. 

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 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 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 

used an unrefined approach by 

assuming that 100% of the crop is 

treated and that residues are present at 

the tolerance-level or at tolerance-levels 

adjusted to account for the residues of 

concern for risk assessment for all foods. 

EPA also used default processing factors 

using the Dietary Exposure Evaluation 

Model (DEEM) 7.8. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the same conservative 

assumptions that were used for the 

acute dietary assessment noted above. 

iii. 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. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for saflufenacil. Tolerance-level residues 

and/or 100% CT 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://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Tier 1 Rice Model and 

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. 

The EDWCs for 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:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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 


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safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

As discussed in III.A., there is evidence 

of increased pre- and/or postnatal 

susceptibility in the developmental 

toxicity studies in the rat and rabbit and 

in the 2-generation reproduction study 

in the rat. 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 are also well 

characterized and being used for 

assessing risks. The point of departure 

for risk assessments would be protective 

of the developmental and offspring 

effects. 

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 was no evidence of 

neurotoxicity or neuropathology in the 

acute and subchronic neurotoxicity 

study. The decrease in motor activity 

observed in the acute neurotoxicity 

study on the day of dosing at the limit 

dose (2,000 mg/kg/day) in males is 

considered a reflection of a mild and 

transient general systemic toxicity and 

not a substance-specific neurotoxic 

effect. No neurotoxic effects were seen 

in the sub-chronic neurotoxicity study. 

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 are also well 

characterized and being used for 

assessing risks. The POD for risk 

assessments would be protective of the 

developmental and offspring effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT 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 less than 1% of 

the aPAD for all infants (<1-year old), 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to saflufenacil 

from food and water will utilize 20% of 

the cPAD for all infants (<1-year old) the 

population group receiving the greatest 

exposure. There are no residential uses 

for saflufenacil. 

3. Short-term and intermediate-term 

risk. Short-term aggregate exposure 

takes into account short-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water. Since there 

are no registered or proposed residential 

uses for saflufenacil that would result in 

short or intermediate-term residential 

exposures, 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 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 methodology 

(liquid chromatography/mass 

spectroscopy/mass spectroscopy (LC/

MS/MS) Method D0603/02) is available 

to enforce the tolerance expression. 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. The Codex has not 

established a MRL for saflufenacil on 

pomegranate. Therefore, harmonization 

of MRLs and U.S. tolerances is not an 

issue at this time. 

C. Response to Comments 

EPA received two comments to the 

docket, EPA–HQ–OPP–2014–0640; 

however, only one of these public 

submissions was in response to the 

Notice of Filing for PP# 4F8305, while 

the remaining comment pertained to an 

unrelated petition in the Federal 

Register notice. For PP# 4F8305, the 

commenter stated that they are in 

support of actions to set tolerance levels 

for pesticides on the food we eat and 

that we are taking a step in the right 

direction by making it safer for human 

consumption by placing more 

regulations on pesticide chemicals. 

EPA agrees with the commenter and 

will continue to regulate pesticides 


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under the legal framework provided by 

the Federal Insecticide, Fungicide, 

Rodenticide Act (FIFRA) and Section 

408 of the Federal Food, Drug and 

Cosmetic Act (FFDCA), which allows 

EPA to assess the risk of pesticides and 

set tolerance levels for those pesticides 

on food commodities as deemed 

necessary to protect human health while 

still providing tools for growers so that 

they can meet the ever-growing food 

demands of this country and others. 

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, in or on 

pomegranate at 0.03 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: November 17, 2015. 

Susan Lewis, 

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, add alphabetically the 

entry to the table in paragraph (a)(1) to 

read as follows: 

§ 180.649 Saflufenacil; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

* * * * * 

Pomegranate ........................ 0.03 

* * * * * 

* * * * * 

[FR Doc. 2015–29889 Filed 11–24–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 80 

[Docket No. CDC–2015–0062; NIOSH–286] 

RIN 0920–AA55 

Occupational Safety and Health 

Research and Related Activities: 

Removal of Regulations Regarding 

Administrative Functions, Practices, 

and Procedures 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Final rule. 

SUMMARY: With this action, the 

Department of Health and Human 

Services (HHS) removes its regulations 

pertaining to fees for direct training in 

occupational safety and health 

conducted by the National Institute for 

Occupational Safety and Health 

(NIOSH) in the Centers for Disease 

Control and Prevention (CDC). As a part 

of the retrospective review conducted 

by all Federal agencies, HHS has 

determined that these regulations are no 

longer in use by NIOSH and should be 

removed. 

DATES: This rule is effective on 

November 25, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 1090 

Tusculum Ave., MS: C–46, Cincinnati, 

OH 45226; telephone (855)818–1629 

(this is a toll-free number); email 

NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Public Participation 

In a notice of proposed rulemaking 

published on August 13, 2015 (80 FR 

48473), HHS invited interested persons 

or organizations to submit written 

views, recommendations, and data 

regarding the removal of part 80. We 

received no comments on this rule. 


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