Federal Register / Vol. 78, No. 245 / Friday, December 20, 2013 / Rules and Regulations 76987 

1The Judges proposed two accounting 

provisions—§ 385.12(e) and § 385.22(d)—each of 

which would have required the licensee’s statement 

of account to ‘‘set forth each step of its calculations 

with sufficient information to allow the copyright 

owner to assess the accuracy and manner in which 

the licensee determined the payable royalty pool 

and per-play allocations (including information 

sufficient to demonstrate whether and how a 

minimum royalty or subscriber-based royalty floor 

pursuant to § 385.13 does or does not apply) and, 

for each offering reported, also indicate the type of 

licensed activity involved and the number of plays 

of each musical work (including an indication of 

any overtime adjustment applied) that is the basis 

of the per-work royalty allocation being paid.’’ 77 

FR 29259, 29267 (May 17, 2012). The language of 

proposed § 385.22(d) mirrored that in § 385.12(e), 

except for non-substantive conforming language 

needed for its inclusion in proposed Subpart C. 

2Today’s amendment concerns only proposed 

§ 385.12(e) because this section was adopted 

initially by the Judges in 2009. See 74 FR 4510 (Jan. 

26, 2009). Proposed § 385.22(d) was part of a newly 

proposed Subpart C, see 77 FR 29259 (May 17, 

2012), and was not adopted in the final rule 

published on November 13, 2013. 

3The Judges provided a copy of this technical 

amendment to the participants of this proceeding 

prior to its submission to the Federal Register for 

publication. 

LIBRARY OF CONGRESS 

Copyright Royalty Board 

37 CFR Part 385 

[Docket No. 2011–3 CRB Phonorecords II] 

Adjustment of Determination of 

Compulsory License Rates for 

Mechanical and Digital Phonorecords 

AGENCY: Copyright Royalty Board, 

Library of Congress. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Copyright Royalty Judges 

are making a technical amendment to 

the regulations regarding the rates and 

terms for the section 115 statutory 

license for the use of musical works in 

physical phonorecord deliveries, 

permanent digital downloads, ringtones, 

interactive streaming, limited 

downloads, limited offerings, mixed 

service bundles, music bundles, paid 

locker services, and purchased content 

locker services. The technical 

amendment corrects a clerical error 

regarding an accounting provision in the 

final rule. 

DATES: Effective: January 1, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Richard Strasser, Senior Attorney, or 

Gina Giuffreda, Attorney Advisor. 

Telephone: (202) 707–7658 or email at 

crb@loc.gov. 

SUPPLEMENTARY INFORMATION: On 

November 13, 2013, the Copyright 

Royalty Judges (Judges) published in the 

Federal Register final regulations 

setting the rates and terms for the 

section 115 statutory license for the use 

of musical works in physical 

phonorecord deliveries, permanent 

digital downloads, ringtones, interactive 

streaming, limited downloads, limited 

offerings, mixed service bundles, music 

bundles, paid locker services, and 

purchased content locker services. 78 

FR 67938. In the preamble to the final 

rule, the Judges stated that they could 

not adopt an accounting provision 

proposed in § 385.12(e) 1 because of a 

finding by the Register of Copyrights 

(Register) that adoption by the Judges of 

such a provision ‘‘represent[ed] an 

encroachment on the Register’s 

[exclusive] authority regarding 

statements of account’’ kept under the 

section 115 statutory license. See Id. at 

67940, citing 78 FR 28772 (May 16, 

2013). Due to an inadvertent oversight, 

however, no instruction reflecting the 

removal of § 385.12(e) appeared in the 

regulatory text.2 The Judges now correct 

this error. 

Section 803(c)(4) of the Copyright Act 

authorizes the Judges to issue ‘‘an 

amendment to a written determination 

to correct any technical or clerical errors 

in the determination’’ and directs that 

such amendment ‘‘be set forth in a 

written addendum to the determination 

that shall be distributed to the 

participants and shall be published in 

the Federal Register.’’ 17 U.S.C. 

803(c)(4).3 The Judges make this 

correction by today’s notice pursuant to 

their continuing jurisdiction under 

section 803(c)(4) of the Copyright Act. 

List of Subjects in 37 CFR Part 385 

Copyright, Phonorecords, Recordings. 

Final Regulations 

For the reasons set forth in the 

preamble, the Copyright Royalty Judges 

amend Part 385 of Chapter III of title 37 

of the Code of Federal Regulations as 

follows: 

PART 385—RATES AND TERMS FOR 

USE OF MUSICAL WORKS UNDER 

COMPULSORY LICENSE FOR MAKING 

AND DISTRIBUTING OF PHYSICAL 

AND DIGITAL PHONORECORDS 

■ 1. The authority citation for part 385 

continues to read as follows: 

Authority: 17 U.S.C. 115, 801(b)(1), 

804(b)(4). 

§ 385.12 [Amended] 

■ 2. Section 385.12 is amended by 

removing paragraph (e). 

Dated: November 18, 2013. 

Suzanne M. Barnett, 

Chief Copyright Royalty Judge. 

Approved by: 

James H. Billington, 

Librarian of Congress. 

[FR Doc. 2013–30346 Filed 12–19–13; 8:45 am] 

BILLING CODE 1410–72–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0980; FRL–9903–57] 

Mandipropamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances in or on multiple 

commodities and removes several 

established tolerances for residues of 

mandipropamid, which are identified 

and discussed later in this document. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

December 20, 2013. Objections and 

requests for hearings must be received 

on or before February 18, 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 docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0980, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 


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SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2012–0980 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 18, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0980, 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 

27, 2013 (78 FR 13295) (FRL–9380–2), 

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 2E8126) by IR–4, 

500 College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.637 be 

amended by establishing tolerances for 

residues of the fungicide 

mandipropamid, 4-chloro-N-[2-[3- 

methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-alpha-(2- 

propynyloxy)-benzeneacetamide, in or 

on basil, dried at 200 parts per million 

(ppm); basil, fresh at 30 ppm; bean, 

succulent at 0.90 ppm; cowpea, forage at 

15 ppm; fruit, small, vine climbing, 

subgroup 13–07F, except fuzzy kiwifruit 

at 2.0 ppm; ginseng at 0.3 ppm; onion, 

bulb, subgroup 3–07A at 0.1 ppm; 

onion, green, subgroup 3–07B at 7.0 

ppm; and vegetable, fruiting, group 8–10 

at 1.0 ppm. The petition additionally 

requested to remove the established 

tolerances in or on grape at 1.4 ppm; 

onion, dry bulb at 0.05 ppm; onion, 

green at 4 ppm; okra at 1.0 ppm; and 

vegetable, fruiting, group 8 at 1.0 ppm, 

upon establishment of the associated 

proposed tolerances. That document 

referenced a summary of the petition 

prepared on behalf of IR–4 by Syngenta 

Crop Protection, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that the proposed tolerances 

should not be established on succulent 

bean or cowpea forage, and that a 

tolerance should be established on snap 

bean. The Agency has also determined 

that the proposed tolerances in or on 

small vine climbing fruit subgroup 13– 

07F, bulb onion subgroup 3–07A and 

green onion subgroup 3–07B should be 

revised. EPA has also revised the 

commodity terminology for fresh and 

dried basil and determined that the 

tolerance expression should be revised 

for all commodities. Finally, EPA 

determined that the time-limited 

tolerance on fresh basil should be 

removed. 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 mandipropamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with mandipropamid 

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. 


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Subchronic and chronic studies 

indicate that the liver is the primary 

target organ for mandipropamid. Liver 

effects were identified in subchronic 

studies with rats, mice, and dogs. Liver 

effects included increased plasma 

albumin, total protein, cholesterol, and 

gamma-glutamyl transferase, as well as 

periportal hypertrophy in rats; increased 

liver enzymes, increased pigment in 

hepatocytes and Kupffer cells, and 

centrilobular hepatocyte vacuolation in 

dogs; increased eosinophilia in rats and 

mice; and increased liver weights in 

rats, mice and dogs. In the chronic dog 

study, increases in microscopic pigment 

in the liver and increased liver enzymes 

were observed. No liver effects were 

observed in chronic rat and mouse 

studies up to the highest doses tested. 

Instead, nephrotoxicity was observed in 

the chronic rat study and decreased 

body weight and food utilization was 

observed in the chronic mouse study. 

The findings of liver toxicity and 

nephrotoxicity are consistent with the 

results from metabolism studies where 

the tissues with the highest levels of 

radioactivity were the liver followed by 

the kidney. 

No evidence of neurotoxicity was 

observed in the acute or subchronic 

neurotoxicity screening battery. No 

systemic or dermal toxicity was 

observed following dermal exposure for 

28 days, up to the limit dose. No 

immunotoxicity was observed up to the 

highest dose tested in the mouse 

immunotoxicity study. 

No evidence of increased quantitative 

or qualitative susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits or in a 2-generation 

reproduction study in rats. The only 

effects observed in fetuses or pups were 

in the 2-generation reproduction study, 

where decreased pup body weight was 

observed in the presence of maternal 

toxicity (decreased body weight, body 

weight gain, and food utilization). In 

addition, there was a delay in preputial 

separation in F1 males which was 

considered to be the result of lower 

body weights. 

There was no evidence of tumors in 

the carcinogenicity study in mice or in 

the chronic/carcinogenicity study in rats 

and there was no evidence that 

mandipropamid was mutagenic or 

clastogenic. Therefore, mandipropamid 

is classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mandipropamid as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Mandipropamid: Human Health Risk 

Assessment For New Uses On Basil, 

Ginseng and Snap Beans, as Well as 

Crop Group Expansions for Fruiting 

Vegetable; Small Fruit, Vine Climbing, 

Except Fuzzy Kiwifruit; and Bulb Onion 

and Green Onion Subgroups.’’ at pages 

33–38 in docket ID number EPA–HQ– 

OPP–2012–0980. 

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 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for mandipropamid used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANDIPROPAMID 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 and females 13–49 years old).No endpoint attributable to a single exposure was identified. 

Chronic dietary (All populations) ......... NOAEL=5 mg/kg/day ....

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 mg/

kg/day.

cPAD = 0.05 mg/kg/day 

Chronic Toxicity Study, Dogs LOAEL = 40 mg/kg/

day based on increased incidence and severity 

of microscopic pigment in the liver and increased alkaline phosphatase activity in both 

sexes as well as increased alanine 

aminotransferase activity in males. 

Cancer (Oral, dermal, inhalation) ........ Classified as not likely to be carcinogenic to humans. 

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

milligrams/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 mandipropamid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing mandipropamid tolerances in 

40 CFR 180.637. EPA assessed dietary 

exposures from mandipropamid 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 


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occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for mandipropamid; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16, which uses food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, ‘‘What We Eat in 

America’’ (NHANES/WWEIA) from 

2003 through 2008. As to residue levels 

in food, EPA used tolerance-level 

residues with the exception of 

subgroups 13–07F, 3–07A, and 3–07B, 

for which EPA used residue levels 

higher than the tolerance levels being 

established here; and tuberous and corm 

vegetable subgroup 1C, which was 

assessed at 0.026 ppm, in order to 

account for the SYN 500003 metabolite 

for this commodity. EPA assessed 

tolerances for subgroups 13–07F, 3– 

07A, and 3–07B using levels that were 

proposed by the petitioner and that 

were harmonized with Codex maximum 

residue levels. However, for reasons 

discussed in Unit IV.B., EPA is 

harmonizing these tolerance levels with 

the lower Canadian maximum residue 

levels (MRLs). The Agency also 

assumed 100 percent crop treated (PCT) 

estimates for all commodities and 

utilized default DEEM–FCID TM (ver. 

7.81) processing factors, with the 

exception of chemical-specific 

processing factors for grape wine and 

sherry. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that mandipropamid 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 mandipropamid. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for mandipropamid in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

mandipropamid. 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 First Index Reservoir 

Screening Tool (FIRST) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of 

mandipropamid for chronic exposures 

for non-cancer assessments are 

estimated to be 9.0 parts per billion 

(ppb) for surface water and 79 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration value of 79 ppb was 

used to assess the contribution from 

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). 

Mandipropamid 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 mandipropamid to share a 

common mechanism of toxicity with 

any other substances, and 

mandipropamid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that mandipropamid 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 (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. 

There were no treatment-related effects 

observed in dams or fetuses in the 

developmental toxicity studies in rats or 

rabbits up to the limit dose of 1,000 

milligrams/kilogram/day (mg/kg/day). 

In the rat 2-generation reproductive 

study, decreased pup weight occurred 

only in the presence of comparable 

maternal toxicity (decreased body 

weight, body weight gain, and food 

utilization). Therefore, there is no 

increased quantitative or qualitative 

susceptibility to rat or rabbit offspring 

exposed in utero and/or postnatally to 

mandipropamid, and there are no 

residual uncertainties with respect to 

prenatal or postnatal exposure. 

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 

mandipropamid is complete. 

ii. There is no indication that 

mandipropamid is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

mandipropamid 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 dietary food exposure assessment 

was performed based on 100 PCT and 

tolerance-level residues for all 

commodities, with the exception of 

tuberous and corm vegetable subgroup 

1C, which was assessed for the tolerance 

level plus the metabolite. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

mandipropamid in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by mandipropamid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 


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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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, mandipropamid is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

mandipropamid from food and water 

will utilize 46% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

There are no residential uses for 

mandipropamid. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Short- and intermediate-term adverse 

effects were identified; however, 

mandipropamid is not registered for any 

use patterns that would result in shortor intermediate-term residential 

exposures. Short- and intermediate-term 

risk is assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short- and 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for 

mandipropamid. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mandipropamid 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 

mandipropamid residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

a high performance liquid 

chromatography with tandem mass 

spectrometric detection (LC/MS/MS), 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 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 established MRLs for 

mandipropamid in or on bell and 

nonbell pepper at 1 ppm, bulb onion at 

0.1 ppm, grape at 2 ppm, and spring 

onions at 7.0 ppm. The tolerances are 

harmonized with the U.S. tolerances 

established in or on fruiting vegetable 

group 8–10 (including pepper) at 1.0 

ppm. However, the tolerances in or on 

small vine climbing fruit except fuzzy 

kiwifruit subgroup 13–07F (including 

grape) at 1.4 ppm, bulb onion subgroup 

3–07A at 0.05 ppm, and green onion 

subgroup 3–07B at 4 ppm are not 

harmonized with associated Codex 

MRLs on these commodities because it 

has been determined that the major 

export market for these commodities is 

Canada. Therefore, in order to maintain 

harmonization of U.S. tolerances and 

Canadian MRLs for these commodities, 

EPA is establishing these subgroup 

tolerances at the levels that align with 

the Canadian MRLs. There are no Codex 

MRLs on the other commodities 

associated with this action. 

C. Revisions to Petitioned-for Tolerances 

Based on the data supporting the 

petition, EPA has revised basil, fresh to 

basil, fresh leaves and basil, dried to 

basil, dried leaves in order to correct the 

commodity terminology. EPA also 

determined that the following proposed 

tolerances should be amended in order 

to harmonize with Canadian MRLs on 

associated commodities: Small vine 

climbing fruit except fuzzy kiwifruit 

subgroup 13–07F from 2.0 ppm to 1.4 

ppm; bulb onion subgroup 3–07A from 

0.1 ppm to 0.05 ppm; and green onion 

subgroup 3–07B from 7.0 ppm to 4.0 

ppm. Additionally, while EPA was 

petitioned for a tolerance on succulent 

bean, no field trial data were conducted 

on a succulent shelled bean cultivar in 

order to support the tolerance. Instead, 

the petitioner submitted snap bean data, 

which EPA determined is sufficient to 

support a tolerance of mandipropamid 

in or on bean, snap at 0.90 ppm. Snap 

beans are a subset of the larger 

succulent shelled bean definition, as 

defined in 40 CFR 180.1(g). 

Additionally, the Agency determined 

that the proposed tolerance in or on 

cowpea, forage cannot be established at 

this time because the use lacks a 

validated livestock analytical 

enforcement method for residues of 

mandipropamid. EPA also determined 

that the time-limited tolerance in or on 

fresh basil at 20 ppm should be 

removed, as it will be superseded by a 

permanent tolerance on fresh basil 

leaves at 30 ppm. Finally, the Agency 

has revised the tolerance expression to 

clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

mandipropamid not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only mandipropamid. 

V. Conclusion 

Therefore, tolerances are established 

for residues of mandipropamid, 4- 

chloro-N-[2-[3-methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)benzeneacetamide, in or 

on basil, dried leaves at 200 ppm; basil, 

fresh leaves at 30 ppm; bean, snap at 

0.90 ppm; fruit, small vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 1.4 ppm; ginseng at 0.30 ppm; onion, 

bulb, subgroup 3–07A at 0.05 ppm; 

onion, green, subgroup 3–07B at 4.0 

ppm; and vegetable, fruiting, group 8–10 

at 1.0 ppm. This regulation additionally 

removes the established tolerances in or 

on grape at 1.4 ppm; onion, dry bulb at 

0.05 ppm; onion, green at 4 ppm; okra 


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76992 Federal Register / Vol. 78, No. 245 / Friday, December 20, 2013 / Rules and Regulations 

at 1.0 ppm; and vegetable, fruiting, 

group 8 at 1.0 ppm. Finally, this 

regulation removes the time-limited 

tolerance in or on basil, fresh at 20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

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 16, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.637: 

■ a. Revise the introductory text in 

paragraph (a). 

■ b. Remove ‘‘Grape’’, ‘‘Okra’’, ‘‘Onion, 

dry bulb’’, ‘‘Onion green’’, and 

‘‘Vegetable, fruiting, group 8’’ from the 

table in paragraph (a). 

■ c. Add ‘‘Basil, dried leaves’’, ‘‘Basil, 

fresh leaves’’, ‘‘Bean, snap’’, ‘‘Fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F’’, 

‘‘Ginseng’’, ‘‘Onion, bulb, subgroup 3– 

07A’’, ‘‘Onion, green, subgroup 3–07B’’, 

and ‘‘Vegetable, fruiting, group 8–10’’ to 

the table in paragraph (a). 

■ d. Revise the introductory text in 

paragraph (b). 

■ e. Remove ‘‘Basil, fresh’’ from the 

table in paragraph (b). 

The amendments read as follows: 

§ 180.637 Mandipropamid; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

mandipropamid, including its 

metabolites and degradates, in or on the 

commodities listed in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only mandipropamid (4- 

chloro-N-[2-[3-methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)benzeneacetamide) in or 

on the commodity. 

Commodity Parts per 

million 

Basil, dried leaves ................ 200 

Basil, fresh leaves ................ 30 

Bean, snap ........................... 0.90 

* * * * * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F .................... 1.4 

Ginseng ................................ 0.30 

* * * * * 

Onion, bulb, subgroup 3–07A 0.05 

Onion, green, subgroup 3– 

07B .................................... 4.0 

* * * * * 

Vegetable, fruiting, group 8– 

10 ...................................... 1.0 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of mandipropamid, 

including its metabolites and 

degradates, in or on the commodities 

listed in the table below resulting from 

use of the pesticide pursuant to FFIFRA 

section 18 emergency exemptions. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only mandipropamid (4- 

chloro-N-[2-[3-methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)benzeneacetamide) in or 

on the commodity. The tolerances 

expire on the date specified in the table. 

* * * * * 

[FR Doc. 2013–30348 Filed 12–19–13; 8:45 am] 

BILLING CODE 6560–50–P 


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