Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Rules and Regulations 75059 

Service continues to encourage mailers 

to use one of the various merchandise 

return services products for return 

merchandise, instead of using Business 

Reply Mail, which is primarily intended 

for use with letter and flat sized pieces. 

The Postal Service currently offers a 

Merchandise Return Service (MRS) webtool (API) interface that permits all 

mailers to create their MRS labels with 

the required IMpb. The Postal Service 

will continue to consider additional 

enhancements for all return services to 

make it easier for companies of all sizes 

to do business with us. 

III. Features of the Final Rule 

The Postal Service continues to 

enhance its operational capability to 

scan IMpbs, encoded with routing and 

tracking information, via automated 

mail processing equipment and 

Intelligent Mail scanning devices, and to 

provide tracking information to the 

mailers. Full implementation of the 

Postal Service’s package visibility 

strategy relies on the availability of 

piece-level information provided 

through the widespread use of IMpb. 

Recent changes to mailing standards 

now require the use of IMpb on all 

commercial parcels (excluding parcels 

paid for using BRM service). The Postal 

Service now advances its package 

visibility strategy by requiring a unique 

IMpb on cartons, parcels, or Priority 

Mail pieces of any shape, preprinted or 

with labels affixed to be returned using 

BRM service. 

For the purposes of this requirement, 

a BRM carton is defined as a parcelshaped mailpiece with a BRM label 

either printed directly on the mailpiece 

or affixed by the end user prior to 

mailing. BRM permit holders would not 

be required to submit shipping 

manifests to support these mailpieces. 

BRM labels would be required to use a 

unique Mailer ID (MID) for BRM parcels 

and a concatenated IMpb construct that 

includes the ZIP+4®routing code. The 

barcodes must be unique for 180 days. 

BRM cartons and parcels will use IMpb 

service type codes for Merchandise 

Return Service for Priority Mail or FirstClass Mail®, based on the product used. 

The Postal Service will provide an 

exception process—for mailers of small 

BRM cartons and parcels lacking 

sufficient label space to apply an IMpb 

barcode meeting the 3⁄4-inch height 

requirement—to submit barcodes of at 

least 1⁄2-inch in height for USPS testing 

and approval. This exception process 

will be administered by the National 

Customer Service Center (NCSC), as part 

of the normal package barcode approval 

process. At this time, no other changes 

would be made to the BRM standards in 

DMM 505.1 applicable to all other mail 

shapes. 

Noncompliant Mailpieces: The Postal 

Service will assess a per-piece IMpb 

non-compliance fee on all BRM parcels 

not bearing an IMpb and returned using 

Priority Mail. The proposed effective 

date for the per-piece fee on First-Class 

Mail parcels being returns using BRM 

would be predicated on the Postal 

Service filing a notice with, and 

receiving approval from, the Postal 

Regulatory Commission. Thus, the noncompliance fee starts immediately with 

Priority Mail pieces only. 

List of Subjects in 39 CFR Part 111 

Administrative practice and 

procedure, Postal Service. 

For the reasons stated in the 

preamble, 39 CFR part 111 is amended 

as follows: 

PART 111—[AMENDED] 

■ 1. The authority citation for 39 CFR 

part 111 continues to read as follows: 

Authority: 5 U.S.C. 552(a); 13 U.S.C. 301– 

307; 18 U.S.C. 1692–1737; 39 U.S.C. 101, 

401, 403, 404, 414, 416, 3001–3011, 3201– 

3219, 3403–3406, 3621, 3622, 3626, 3632, 

3633, and 5001. 

■ 2. Revise the following sections of 

Mailing Standards of the United States 

Postal Service, Domestic Mail Manual 

(DMM), as follows: 

Mailing Standards of the United States 

Postal Service, Domestic Mail Manual 

(DMM) 

* * * * * 

505 Return Services 

1.0 Business Reply Mail (BRM) 

* * * * * 

1.4 General Information 

1.4.1 Description 

[Insert a new fourth sentence in 1.4.1 

to read as follows:] 

* * * All BRM labels intended for 

use on cartons, mailpieces meeting the 

physical characteristics of a parcel in 

DMM 201, or a Priority Mail item of any 

shape, must meet the standards under 

1.7.10. 

* * * 

* * * * * 

1.7 Mailpiece Characteristics 

* * * * * 

[Insert new 1.7.10 to read as follows:] 

1.7.10 Labels for Parcels 

BRM labels intended for use on 

cartons, mailpieces meeting the physical 

standards of a parcel under DMM 201, 

or a Priority Mail item of any shape, 

must also bear an IMpb prepared under 

708.5.0 and meet the technical 

standards in the Parcel Labeling Guide 

available on RIBBS. 

* * * * * 

1.8 Format Elements 

1.8.1 General 

[Revise the text of the first and second 

sentences of 1.8.1 to read as follows:] 

Except for BRM labels for parcels as 

provided under 1.7.10, all pieces of 

BRM are subject to these format 

elements. For all other BRM pieces, an 

Intelligent Mail barcode (IMb) is not 

required, except for QBRM prices; if an 

IMb is used, it must be printed and 

placed as provided under 1.9 and as 

shown in Exhibit 1.8.1. * * * 

* * * * * 

Stanley F. Mires, 

Attorney, Federal Requirements. 

[FR Doc. 2014–29479 Filed 12–16–14; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0662; FRL–9918–99] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluopyram in 

or on multiple commodities that are 

identified and discussed later in this 

document. Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 17, 2014, except for the 

amendment to § 180.661 in amendatory 

instruction number 3, which is effective 

June 17, 2015. Objections and requests 

for hearings must be received on or 

before February 17, 2015, 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–2013–0662, 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 


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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, 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2013–0662 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 February 17, 2015. 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– 

2013–0662, 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 May 23, 

2014 (79 FR 29729) (FRL–9910–29), 

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 3F8190) by Bayer 

CropScience, P.O. Box 12014, 2 T.W. 

Alexander Dr., Research Triangle Park, 

NC 27709. The petition requested that 

40 CFR 180.661 be amended by 

establishing tolerances for residues of 

the fungicide fluopyram, N-[2-[3-chloro5-(trifluoromethyl)-2-pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the following commodities: Beef, 

byproducts at 0.70 parts per million 

(ppm); beef, fat at 0.10 ppm; beef, meat 

at 0.10 ppm; grain, cereal, forage, group 

16 at 1.5 ppm; cotton, gin by-products 

at 0.80 ppm; cotton, seed at 0.01 ppm; 

egg at 0.15 ppm; grain, cereal group 15, 

except rice at 0.03 ppm; grain, cereal, 

fodder, hay and straw, group 16 at 2.0 

ppm; hog, fat at 0.05 ppm; hog, meat at 

0.10 ppm; hog, meat byproducts at 0.70 

ppm; milk at 0.10 ppm; peanuts at 0.09 

ppm; poultry, fat at 0.10 ppm; poultry, 

meat at 0.10 ppm; poultry, meat 

byproducts at 0.20 ppm; and soybean, 

seed at 0.04 ppm. That document 

referenced a summary of the petition 

prepared by Bayer CropScience, 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. 

Based upon review of the data 

supporting the petition, EPA is issuing 

some tolerances that vary from the 

fluopyram tolerances as requested. The 

reasons for these changes are explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fluopyram 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluopyram 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 


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concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Decreased body weight and liver 

effects were the common and frequent 

findings in the fluopyram subchronic 

and chronic oral toxicity studies in rats, 

mice, and dogs, and they appeared to be 

the most sensitive effects. Liver effects 

were characterized by increased liver 

weight, hepatocellular hypertrophy, 

hepatocellular vacuolation, increased 

mitosis and hepatocellular necrosis. 

Thyroid effects were found at dose 

levels similar to those that produced 

liver effects in rats and mice; these 

effects consisted of follicular cell 

hypertrophy, increased thyroid weight 

and hyperplasia at dose levels greater 

than or equal to 100 milligrams/

kilogram/day (mg/kg/day). Changes in 

thyroid hormone levels were also seen 

in a subchronic toxicity study. In male 

mice, there was an increased incidence 

of thyroid adenomas. 

Although increased liver tumors were 

observed in female rats in the 

carcinogenicity study, EPA has 

concluded that fluopyram is ‘‘Not Likely 

to be Carcinogenic to Humans’’ at doses 

that do not induce cellular proliferation 

in the liver or thyroid glands. This 

classification was based on convincing 

evidence that non-genotoxic modes of 

action for liver tumors in rats and 

thyroid tumors in mice have been 

established and that the carcinogenic 

effects have been demonstrated as a 

result of a mode of action dependent on 

activation of the CAR/PXR receptors. 

Moreover, fluopyram is not genotoxic or 

mutagenic. 

Fluopyram is not a developmental 

toxicant, nor did it adversely affect 

reproductive parameters. No evidence of 

qualitative or quantitative susceptibility 

was observed in developmental studies 

in rats and rabbits or in a multigeneration study in rats. 

In an acute neurotoxicity study, 

transient decreased motor activity was 

seen only on the day of treatment, but 

no other findings demonstrating 

neurotoxicity were observed. In 

addition, no neurotoxicity was observed 

in the subchronic neurotoxicity study in 

the presence of other systemic adverse 

effects. Fluopyram did not produce 

treatment-related effects on the immune 

system. 

Fluopyram has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. Fluopyram is not a skin or 

eye irritant or sensitizer under the 

conditions of the murine lymph node 

assay. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluopyram 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 

entitled ‘‘Fluopyram: Human Health 

Risk Assessment for Proposed New Use 

as a Soil/In-Furrow Treatment for 

Cotton and Peanut, and as a Seed 

Treatment to Cotton and Soybean, Plus 

a Proposal for Amended Inadvertent 

Tolerances for the Crop Group 15 Cereal 

Grains and Crop Group 16 Forage, 

Fodder, and Straw of Cereal Grains’’ in 

docket ID number EPA–HQ–OPP–2013– 

0662. 

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. 

The details for selecting toxicity 

endpoints and points of departure for 

various exposure scenarios can be found 

at http://www.regulations.gov in the 

document entitled ‘‘Fluopyram: Human 

Health Risk Assessment for Proposed 

New Use as a Soil/In-Furrow Treatment 

for Cotton and Peanut, and as a Seed 

Treatment to Cotton and Soybean, Plus 

a Proposal for Amended Inadvertent 

Tolerances for the Crop Group 15 Cereal 

Grains and Crop Group 16 Forage, 

Fodder, and Straw of Cereal Grains’’ in 

docket ID number EPA–HQ–OPP–2013– 

0662. 

A summary of the toxicological 

endpoints for fluopyram used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPYRAM 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 (Females 13–50 

years of age).

An endpoint attributable to a single dose exposure has not been identified for this subpopulation. 

Acute dietary (General population including infants and 

children).

NOAEL = 50 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.50 

mg/kg/day.

aPAD = 0.50 mg/kg/

day 

Acute Neurotoxicity Study in Rats. 

LOAEL = 100 mg/kg/day based on decreased motor and locomotor activity in females. The LOAEL in males was 125 mg/

kg/day. 

Chronic dietary (All populations) NOAEL = 1.2 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.012 

mg/kg/day.

cPAD = 0.012 mg/

kg/day 

Combined Chronic/Carcinogenicity in Rats. 

LOAEL = 6.0 mg/kg/day based on follicular cell hypertrophy in 

the thyroid, and increased liver weight with gross pathological and histopathological findings. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPYRAM 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).Classification: Not likely to be carcinogenic to humans at doses that do not induce cellular proliferation in the 

liver or thyroid glands. 

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

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluopyram, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluopyram tolerances in 40 CFR 

180.661. EPA assessed dietary 

exposures from fluopyram 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 fluopyram. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey/What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA included 

tolerance residue levels, the assumption 

of 100 percent crop treated (PCT), and 

processing factors (empirical and 

default). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/

WWEIA. As to residue levels in food, 

EPA included average field-trial residue 

levels, the assumption of 100 PCT, and 

processing factors (empirical and 

default). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluopyram does not pose 

a cancer risk to humans at doses that do 

not induce cellular proliferation in the 

liver or thyroid glands. The chronic RfD 

is derived using the NOAEL of 1.2 

mg/kg/day as the ‘‘point of departure’’ 

which is below the dose of 11 

mg/kg/day that caused cell proliferation 

in the liver (i.e., a key event in tumor 

formation) and the subsequent liver 

tumors at a higher dose (89 mg/kg/day). 

Therefore, the Agency believes the 

chronic assessment will be protective of 

any cancer risk; therefore, a separate 

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 fluopyram. Tolerance level residues 

or average field-trial residues and 100 

PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluopyram in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluopyram. 

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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of fluopyram 

for acute exposures are estimated to be 

19.4 parts per billion (ppb) for surface 

water and 87.5 ppb for ground water. 

The chronic exposures for non-cancer 

assessments are estimated to be 4.9 ppb 

for surface water and 76.8 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 87.5 ppb was used to assess the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 76.8 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). 

Fluopyram 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 fluopyram to share a common 

mechanism of toxicity with any other 

substances, and fluopyram does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fluopyram 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. 

The available developmental toxicity 

studies in rats and rabbits and the multigeneration reproduction in rats 


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demonstrate no evidence of increased 

susceptibility in the developing or 

young animals, which were exposed 

during prenatal or postnatal periods. 

Decreased fetal body weight was 

observed at levels equal to or greater 

than the maternal LOAEL in both rat 

and rabbit developmental studies. 

Likewise, body-weight effects were seen 

in offspring at levels equal to the 

parental LOAEL in the rat 2-generation 

reproductive toxicity study. 

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 fluopyram 

is complete. 

ii. The fluopyram toxicology database 

did not demonstrate evidence of 

neurotoxicity. Although transient 

decreases in motor and locomotor 

activities in the acute neurotoxicity 

study on the day of treatment and 

limited use of hind-limbs and reduced 

motor activity in the rat chronic/

carcinogenicity study were seen, there 

were no other associated 

neurobehavioral or histopathology 

changes found in other studies in the 

fluopyram toxicity database. The effects 

seen in the chronic/carcinogenicity 

study were in the presence of increased 

mortality and morbidity such as general 

pallor and appearance. Therefore, the 

reduced motor activity and limited use 

of hind-limbs seen in these two studies 

were judged to be the consequence of 

the systemic effects and not direct 

neurotoxicity. Therefore, there is no 

need for a developmental neurotoxicity 

study or additional uncertainty factors 

(UFs) to account for neurotoxicity. 

iii. There is no evidence that 

fluopyram results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary exposure 

assessment was performed using 

tolerance level residues or average fieldtrial residues for all crops. Both acute 

and chronic assessments assumed 100 

PCT and incorporated empirical or 

default processing factors. The dietary 

exposure assessment also assumed that 

all drinking water will contain 

fluopyram at the highest EDWC levels 

modeled by the Agency for ground or 

surface water. Residential exposures are 

not expected. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluopyram in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by fluopyram. 

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 

fluopyram will occupy 4.4% of the 

aPAD for children 1–2 years 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 fluopyram from 

food and water will utilize 38% of the 

cPAD for all infants, the population 

group receiving the greatest exposure. 

There are no residential uses for 

fluopyram. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of fluopyram is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because there are no 

residential uses, short-term residential 

exposures are not likely to occur, and 

therefore fluopyram is not expected to 

pose a short-term aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because there are no residential uses, 

intermediate-term residential exposures 

are not likely to occur, and therefore 

fluopyram is not expected to pose an 

intermediate-term aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A. and the lack 

of a chronic risk, fluopyram is not 

expected to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluopyram 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The German multi-residue method 

DFG Method S 19, a gas 

chromatography with mass selective 

detection (GC/MSD) method, is 

adequate for the enforcement of 

tolerances for fluopyram residues in or 

on crop commodities, and a high 

performance liquid chromatography 

method with tandem mass spectrometry 

detection (HPLC/MS/MS), Method 

01079, is adequate for the enforcement 

of tolerances for residues of fluopyram 

and its metabolite, AE C656948- 

benzamide, in livestock commodities. 

The validated limit of quantitation 

(LOQ) is 0.01 ppm for each analyte in 

each matrix. The enforcement methods 

for plant commodities (DFG Method 

S19) and livestock commodities 

(Method 01079) are deemed adequate as 

enforcement methods. Adequate HPLC/ 

MS/MS methods were used for data 

collection for crop and livestock 

commodities. Thus, adequate 

enforcement methodologies (DFG 

Method S 19 and Method 01079) are 

available to enforce the tolerance 

expression. 

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. As required by FFDCA section 

408(b)(4), EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex) in its 

tolerance decisions. 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 MRL for peanut is 0.03 

mg/kg, which is lower than the U.S. 

tolerance as amended for peanuts at 

0.09 ppm. The U.S. peanut tolerance 

cannot be harmonized at 0.03 because 

following the approved label directions 

could result in residues above 0.03 ppm. 


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75064 Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Rules and Regulations 

There are Codex MRLs for the 

livestock commodities that are higher 

than the U.S. tolerances for livestock 

commodities. The lowering of the 

tolerances for the cereal grains (group 

15), and cereal grains forages, stovers, 

and straws (group 16), all as rotational 

crops, resulted in considerably less 

fluopyram in the livestock diets than 

under the previous tolerances. As a 

result, the tolerances for the livestock 

commodities were lowered. Calculated 

values were adjusted slightly to 

harmonize with Canada for all livestock 

commodity tolerances/MRLs but could 

not be harmonized with Codex MRLs, 

which are generally higher (5X–60X), 

because they are based on a different 

residue definition, do not reflect the 

North American Free Trade Agreement 

(NAFTA) plant commodity use patterns, 

and do not consider the Maximum 

Reasonably Based Diet. 

C. Response to Comments 

Two comments were received in 

response to the notice of filing of Bayer 

CropScience’s application. Both 

commenters objected to the increase of 

chemical residues generally and one 

commenter expressed additional 

concerns about the carcinogenic effects 

of chemicals in general on humans. The 

Agency understands the commenters’ 

concerns regarding toxic chemicals and 

their potential effects on humans. 

Pursuant to its authority under the 

FFDCA, and as discussed further in this 

preamble, EPA conducted a 

comprehensive assessment of 

fluopyram, which included an 

assessment on the carcinogenic 

potential of fluopyram. Based on its 

assessment of the available data, the 

Agency has concluded that fluopyram is 

not likely to be a carcinogen and that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to residues of fluopyram. 

D. Revisions to Petitioned-For 

Tolerances 

EPA is establishing tolerances for 

cotton gin byproducts and for cereal 

grain forage group 16 that differ from 

the petitioned-for tolerances. The 

petitioned-for tolerances differ from the 

tolerances for cotton gin byproducts and 

for cereal grain forage group 16. The 

petition requested a tolerance of 0.80 

ppm for cotton gin byproducts, but 

based on residue data provided and 

using the Organization for Economic 

Cooperation and Development (OECD) 

statistical calculation, EPA is 

establishing a tolerance level of 0.70 

ppm. The petition also requested two 

different tolerances for the cereal grain 

forage, fodder, stover, and straw group 

16: 1.5 ppm for forage and 2.0 ppm for 

hay, fodder, and straw. Only one 

tolerance is possible for the group, so 

the Agency is establishing the tolerance 

at 2.0 ppm to cover residues within that 

crop group. 

EPA is establishing tolerances for fat, 

meat, and meat byproducts of cattle, 

hog, and poultry; egg; and milk lower 

than the petition requested based on a 

recalculation of the livestock dietary 

burdens and adjusted upwards to 

harmonize with Canada. The Agency is 

revising the commodity terms to ‘‘cattle, 

fat’’; ‘‘cattle, meat’’; and ‘‘cattle, meat 

byproducts’’ to be consistent with the 

food commodity vocabulary used for 

tolerances. 

E. Trade Considerations 

A few of the tolerance actions result 

in reductions of existing tolerance 

levels; therefore, EPA is delaying the 

effective date of the following tolerance 

actions for 6 months to allow a 

reasonable interval for producers in 

exporting member countries of the 

World Trade Organization’s Sanitary 

and Phytosanitary Measures Agreement 

to adapt to the requirements of these 

modified tolerances. The tolerance 

actions subject to the 6-month delay are 

effective June 17, 2015 are as follows: 

Modifying tolerances in § 180.661(a)(2) 

for cattle, fat at 0.05 ppm; cattle, meat 

at 0.05 ppm; cattle, meat byproducts at 

0.40 ppm; egg at 0.06 ppm; hog, fat at 

0.02 ppm; hog, meat at 0.02 ppm; hog, 

meat byproducts at 0.03 ppm; milk at 

0.06 ppm; poultry, fat at 0.03 ppm; 

poultry, meat at 0.03 ppm; and poultry, 

meat byproducts at 0.10 ppm; modifying 

tolerances in § 180.661(d) for grain, 

cereal, group 15, except rice at 1.5 ppm 

to grain, cereal, except rice, group 15 at 

0.03 ppm; establishing tolerances in 

§ 180.661(d) for grain, cereal, forage, 

fodder and straw, group 16 at 2.0 ppm; 

and removing tolerances from 

§ 180.661(d) for grain, cereal, forage, 

fodder and straw, group 16, except rice; 

forage at 4.0 ppm; grain, cereal, forage, 

fodder and straw, group 16, except rice; 

hay, straw and stover at 7.0 ppm; and 

soybean, seed at 0.10 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopyram, N-[2-[3- 

chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the following commodities: Cattle, fat at 

0.05 ppm; cattle, meat at 0.05 ppm; 

cattle, meat byproducts at 0.40 ppm; 

cotton, gin byproducts at 0.70 ppm; 

cotton, undelinted seed at 0.01 ppm; egg 

at 0.06 ppm; grain, cereal, except rice, 

group 15 at 0.03 ppm; grain, cereal, 

forage, fodder and straw, group 16 at 2.0 

ppm; hog, fat at 0.02 ppm; hog, meat at 

0.02 ppm; hog, meat byproducts at 0.03 

ppm; milk at 0.06 ppm; peanuts at 0.09 

ppm; poultry, fat at 0.03 ppm; poultry, 

meat at 0.03 ppm; poultry, meat 

byproducts at 0.10; and soybean, seed at 

0.04 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 


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Federal Register / Vol. 79, No. 242 / Wednesday, December 17, 2014 / Rules and Regulations 75065 

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: December 9, 2014. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.661 (effective December 17, 

2014): 

■ a. Add alphabetically ‘‘Cotton, gin byproducts’’; ‘‘Cotton, undelinted seed’’; 

and ‘‘Soybean, seed’’ to the table in 

paragraph (a)(1). 

■ b. Revise the entry for ‘‘Peanut’’ in the 

table in paragraph (a)(1). 

■ c. Remove the entries ‘‘Cotton, gin 

byproducts’’ and ‘‘Cotton, undelinted 

seed,’’ in the table in paragraph (d). 

The additions and revision read as 

follows: 

§ 180.661 Fluopyram; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Cotton, gin byproducts ............. 0.70 

Cotton, undelinted seed ........... 0.01 

* * * * * 

Peanut ...................................... 0.09 

* * * * * 

Soybean, seed .......................... 0.04 

* * * * * 

* * * * * 

■ 3. In § 180.661 (effective June 17, 

2015): 

■ a. Revise in the table in paragraph 

(a)(2) the following entries listed in the 

table below. 

■ b. Add alphabetically ‘‘Grain, cereal, 

except rice, group 15’’ and ‘‘Grain, 

cereal, forage, fodder and straw, group 

16’’ to the table in paragraph (d). 

■ c. Remove the entries ‘‘Grain, cereal, 

forage, fodder and straw, group 16, 

except rice; forage’’; ‘‘Grain, cereal, 

forage, fodder and straw, group 16, 

except rice; hay, straw and stover’’; and 

‘‘Grain, cereal, group 15, except rice’’ in 

the table in paragraph (d). 

The additions and revisions read as 

follows: 

§ 180.661 Fluopyram; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

Cattle, fat .................................. 0.05 

Cattle, meat .............................. 0.05 

Cattle, meat byproducts ........... 0.40 

Egg ........................................... 0.06 

* * * * * 

Hog, fat ..................................... 0.02 

Hog, meat ................................. 0.02 

Hog, meat byproducts .............. 0.03 

* * * * * 

Milk ........................................... 0.06 

Poultry, fat ................................ 0.03 

Poultry, meat ............................ 0.03 

Poultry, meat byproducts .......... 0.10 

* * * * * 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

* * * * * 

Grain, cereal, except rice, 

group 15 ................................ 0.03 

Grain, cereal, forage, fodder 

and straw, group 16 .............. 2.0 

Commodity Parts per 

million 

* * * * * 

[FR Doc. 2014–29480 Filed 12–16–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0352; FRL–9919–35] 

Natamycin; Amendment to an 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the biochemical 

pesticide natamycin in or on 

pineapples. DSM Food Specialties B.V. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an amendment to 

the exemption from the requirement of 

a tolerance. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of 

natamycin in or on pineapple. 

DATES: This regulation is effective 

December 17, 2014. Objections and 

requests for hearings must be received 

on or before February 17, 2015, 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–2014–0352, 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: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 


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