32146 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 

EPA-APPROVED GEORGIA NON-REGULATORY PROVISIONS—Continued 

Name of nonregulatory SIP provision Applicable geographic or 

nonattainment area 

State submittal date/ 

effective date EPA approval date Explanation 

Negative Declaration for Control of 

VOC Leaks from Synthetic Organic 

Chemical Polymer and Resin Manufacturing Equipment EPA–450/3–83– 

006, March 1984.

Atlanta 1997 8-Hour Ozone 

Nonattainment Area.

10/21/2009 ................ 09/28/2013 ................

Negative Declaration for Control of 

VOC Emissions from Air Oxidation 

Processes in Synthetic Organic 

Chemical Manufacturing Industry 

(SOCMI), EPA–450/3–84–015, December 1984.

Atlanta 1997 8-Hour Ozone 

Nonattainment Area.

10/21/2009 ................ 09/28/2013 ................

110(a)(1) and (2) Infrastructure Requirements for 1997 Fine Particulate 

Matter National Ambient Air Quality 

Standards.

Georgia ................................ 7/23/2008 .................. 4/12/2013 .................. Addressing element 110(a)(2) 

(D)(i)(II) prong 3 

only 

110(a)(1) and (2) Infrastructure Requirements for 2006 Fine Particulate 

Matter National Ambient Air Quality 

Standards.

110(a)(1) and (2) Infrastructure Requirements for 

1997 Fine Particulate Matter National Ambient Air 

Quality Standards.

10/21/2009 ................ 4/12/2013 .................. Addressing element 110(a)(2) 

(D)(i)(II) prong 3 

only 

1997 8-Hour Ozone Reasonable Further Progress Plan for Atlanta Area.Atlanta 1997 8-Hour Ozone 

Nonattainment Area.

10/21/2009 ................ 5/29/2013 ..................

[FR Doc. 2013–12467 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0780; FRL–9387–1] 

Triforine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of triforine in or 

on blueberry and tomato. Summit Agro 

North America Holding Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

29, 2013. Objections and requests for 

hearings must be received on or before 

July 29, 2013, 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–2011–0780, 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: 

Heather Garvie, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; email address: 

garvie.heather@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0780 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 July 29, 2013. 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 


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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32147 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2001–0780, 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.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of November 

9, 2011 (76 FR 69690) (FRL–9325–1), 

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 1E7911) by 

Summit Agro North America Holding 

Corporation, 600 Third Avenue, New 

York, NY 10016–2001. The petition 

requested that 40 CFR 180 be amended 

by establishing tolerances for residues of 

the fungicide triforine, piperazine-1,4- 

diylbis(2,2,2-trichloroethane-1,1- 

diyl)diformamide [also more commonly 

known as triforine, (N,N ́-[1,2- 

piperazinediylbis(2,2,2- 

trichloroethylidene)]bis[formamide])], 

in or on blueberry and tomato at 0.02 

and 0.5 parts per million (PPM), 

respectively. That document referenced 

a summary of the petition prepared by 

Landis International, Inc. on behalf of 

Summit Agro North America Holding 

Corporation, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerance for blueberry from 0.02 

ppm to 1.0 ppm. The reasons for this 

change are explained in Unit IV.D. 

There are no registered food uses for 

triforine in the United States. These 

tolerances were requested in connection 

with use of triforine on tomatoes and 

blueberries grown overseas. These 

tolerances will allow blueberries and 

tomatoes containing triforine residues to 

be imported into the United States. 

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 triforine 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with triforine follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. The principal 

toxic effects of triforine are changes in 

the liver and hematopoietic system 

following repeated oral dosing, and the 

dog is the most sensitive species for the 

hematopoietic effects. Liver effects 

include increased liver weights, 

cholesterol and alkaline phosphatase 

levels. Toxicity was not observed in a 

rat 21-day dermal toxicity study at dose 

levels greater than the limit dose. 

Triforine is not acutely toxic via the 

oral, dermal, and inhalation routes. No 

developmental or reproductive toxicity 

was observed at doses below the limit 

dose. Triforine does not demonstrate 

neurotoxic or immunotoxic potential. 

Although the mouse study showed that 

triforine was associated with common 

tumors in the mouse, the EPA has 

determined that quantification of risk 

using a non-linear approach; i.e., 

reference dose (RfD), for triforine will 

adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to triforine. 

That conclusion is based on the 

following considerations: (1) No 

carcinogenic response was seen in 

either sex in an acceptable rat cancer 

study; (2) the tumors found in the 

mouse are commonly seen in the mouse; 

(3) both tumors types were found only 

at the high dose, which was above the 

limit dose (males 1204, females 1507 

milligrams/kilogram (mg/kg/day)); (4) 

triforine is not mutagenic; (5) each 

tumor type was observed in one sex 

only; i.e., liver tumors in male mice and 

lung tumors in female mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by triforine as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Triforine. Human Health Risk 

Assessment to Support Petition for the 

Establishment of Permanent Tolerances 

without U.S. Registration for Blueberries 

and Tomatoes on pages 8 through 13 in 

docket ID number EPA–HQ–OPP–2011– 

0780. 

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 an 

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 


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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 triforine used for human 

risk assessment is shown in the 

following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TRIFORINE 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 (all populations) .. No hazard or appropriate acute endpoint was identified in the database. 

Chronic dietary (All populations) NOAEL= 22 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.22 

mg/kg/day.

cPAD = 0.22 mg/kg/ 

day 

Subchronic/Chronic oral toxicity (dog) 

LOAEL = 120 mg/kg/day, based on decreased RBC, hematocrit, hemoglobin values and siderosis in the liver, spleen, and 

bone marrow. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 22 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

<100.

Subchronic/chronic oral toxicity (dog) 

LOAEL = 120 mg/kg, based on decreased RBC, hematocrit, 

and hemoglobin values, increased spleen weight, and siderosis in the liver, spleen, and bone marrow. 

Incidental oral intermediateterm (1 to 6 months).NOAEL= 22 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

<100.

Subchronic/chronic oral toxicity (dog) 

LOAEL = 120 mg/kg, based on decreased RBC, hematocrit, 

and hemoglobin values, increased spleen weight, and siderosis in the liver, spleen, and bone marrow. 

Dermal short-term (all durations).No potential hazard via the dermal route based on the lack of systemic effects following repeat dermal exposure of rats at dose levels up to 1100 mg/kg/day which is greater than the limit dose. The endpoints of concern were all assessed in this study, and there is no developmental or reproductive concern at dose levels 

below the limit dose. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) 

study.

NOAEL= 22 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

<100.

Subchronic/chronic oral toxicity (dog) 

LOAEL = 120 mg/kg, based on decreased RBC, hematocrit, 

and hemoglobin values, increased spleen weight, and siderosis in the liver, spleen, and bone marrow. 

Inhalation intermediate-term (1 

to 6 months).

Inhalation (or oral) 

study.

NOAEL = 22 mg/kg/ 

day (inhalation absorption rate = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 

<100.

Subchronic/chronic oral toxicity (dog) 

LOAEL = 120 mg/kg, based on decreased RBC, hematocrit, 

and hemoglobin values, increased spleen weight, and siderosis in the liver, spleen, and bone marrow. 

Cancer (Oral, dermal, inhalation).EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account 

for all chronic toxicity, including carcinogenicity. 

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 triforine, EPA considered 

exposure under the petitioned-for 

tolerances. EPA assessed dietary 

exposures from triforine 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. No such effects were 

identified in the toxicological studies 

for triforine; therefore, a quantitative 

acute dietary exposure assessment was 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16. This software uses 

2003–2008 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). As to 

residues levels in food, EPA assumed 

tolerance level residues in the chronic 


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Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32149 

dietary assessment for these raw 

agricultural commodities (RACs). A 

processing study for tomatoes was 

submitted that showed no concentration 

of triforine residues in tomato paste and 

puree; therefore the RAC tolerance was 

used and the concentration factor were 

set to a value of ‘‘1’’ for all processed 

tomato products, with the exception of 

dried tomatoes. Empirical data are not 

available for this processed commodity, 

so the DEEM 7.81 default processing 

factor for dried tomatoes of 14.3 was 

included in the dietary risk assessment. 

In addition, the dietary assessment 

assumes that 100% of the blueberry, 

tomato, and tomato processed 

commodities consumed in the U.S. are 

imported, and further that all of the 

imports have been treated with triforine, 

effectively assuming 100 percent crop 

treated (PCT) for the two crops that are 

included in the dietary risk assessment. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

determined that although the mouse 

study showed that triforine was 

associated with common tumors in the 

mouse, quantification of risk using a 

non-linear approach for triforine would 

adequately account for all chronic 

effects, including potential 

carcinogenicity that could result from 

exposure to triforine. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for triforine. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. Since this petition requests 

tolerances without U.S. registration, 

establishing the requested tolerances 

will have no impact on domestic 

drinking water. However, for the 

purpose of this risk assessment, the 

most recent drinking water assessment 

dated March 5, 2008, which estimated 

residues resulting from the residential 

uses of triforine, was consulted. Along 

with the other risk assessments 

supporting this action, the drinking 

water assessment (DP 339605; K. Moore, 

3/5/08) can be found in the triforine 

docket, EPA–HQ–OPP–2011–0780. 

Modeled estimated drinking water 

concentrations from those uses are 

included in this risk assessment. 

Surface water estimated drinking water 

concentrations (EDWCs) are based on 

first index reservoir screening tool 

(FIRST) modeling and represent 

untreated surface water concentrations. 

For surface water, the modeled EDWC 

for annual average exposure was 0.84 

parts per billion (PPB). The one-in-10- 

year annual average concentration is 

used for chronic exposure assessments. 

Groundwater EDWCs are based on 

Screening Concentration in Ground 

Water (SCIGROW) modeling and 

represent the concentration that might 

be expected in shallow unconfined 

aquifers under sandy soils. For 

groundwater, the average exposure 

estimate is 0.43 ppb. The drinking water 

models and their descriptions are 

available at the EPA Internet site: 

http://www.epa.gov/oppefed1/models/ 

water/. The highest annual average 

EDWC from the surface water model of 

0.84 ppb was included in the chronic 

dietary risk assessment. 

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). Triforine 

is currently registered for the following 

uses that could result in residential 

exposures: ornamentals including roses, 

trees, herbaceous plants, and woody 

shrubs and vines. There are no new 

residential uses with this petition; 

however, in order to complete the 

aggregate risk assessment, the Agency 

updated the residential exposure 

assessment. Because triforine does not 

pose a hazard by the dermal route of 

exposure, the residential handler 

assessment includes only inhalation 

exposure. The residential handler 

exposure assessment does not identify 

any residential handler risk concerns, in 

spite of representing worst case 

inhalation exposures. For postapplication exposures, although a 

quantitative residential post-application 

exposure assessment was not 

performed, the Agency concluded that 

there is no concern for post-application 

exposures to triforine for the following 

reasons: 

i. Since no dermal endpoints of 

concern were identified, there is also no 

concern for post-application dermal 

exposures. 

ii. While the mouthing behaviors of 

children are also commonly addressed 

in post-application assessments, the 

Agency does not expect, based on the 

primary use pattern of triforine to 

control diseases on roses and other 

ornamental plants, children to routinely 

contact treated plants and engage in 

mouthing behaviors. 

iii. Triforine is relatively non-volatile 

which, coupled with the dilution 

expected outdoors and the small 

amounts of active ingredient used 

diminish the possibility of postapplication inhalation exposure. 

Moreover, the residential handler 

inhalation exposure assessment, which 

represents worst case inhalation 

exposures, and is considered protective 

of most post-application inhalation 

exposure scenarios. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http:// 

www.epa.gov/pesticides/science/ 

residential-exposure-sop.html. 

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 triforine to share 

a common mechanism of toxicity with 

any other substances, and triforine does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

triforine 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 

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 is no evidence of increased 

susceptibility following in utero 

exposure to triforine in either the rat or 

rabbit developmental toxicity study at 

dose levels up to the limit dose, and 

there is no evidence of increased 

susceptibility following in utero and/or 

pre-/post-natal exposure in the 2- 

generation reproduction study in rats at 

any dose levels, even those greater than 

the limit dose. 


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Triforine has been evaluated for 

potential developmental effects in the 

rat and rabbit (gavage administration). 

Maternal toxicity included decreased 

body weight and food consumption in 

rabbits at the limit dose, and maternal 

toxicity was not observed in rats at dose 

levels up to the limit dose. Decreased 

fetal body weight was observed in the 

rabbit at the limit dose, whereas there 

were no developmental effects in the rat 

at the limit dose (actual 840 mg/kg/day). 

Decreased fertility index and decreased 

testes weight was observed in F1 males 

in the 2-generation reproduction study 

only at a dose level greater than the 

limit dose. 

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 triforine is 

complete. 

ii. There is no indication that triforine 

is a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. As indicated in Unit III.D.2., there 

is no evidence that triforine 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 assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to triforine in 

drinking water. No risk is expected from 

the dermal route of exposure for 

children’s postapplication exposure. 

Because of the use pattern, no incidental 

oral exposure is expected for children 

and no quantitative exposure 

assessment was conducted. These 

assessments will not underestimate the 

exposure and risks posed by triforine. 

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 aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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, triforine 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 triforine from 

food and water will utilize <1% of the 

cPAD for the general U.S. population 

and all population subgroups. Based on 

the explanation in Unit III.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of triforine is not expected; therefore the 

chronic aggregate risk includes food and 

drinking water only. 

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). Triforine is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

triforine. The Agency conducted shortterm aggregate risk assessments only for 

adult males and adult females since 

there are no short-term residential 

exposures for children. There are no 

oral residential exposures for adults and 

triforine does not pose a dermal hazard, 

so only residential inhalation exposure 

is included in the aggregate assessment. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential inhalation exposures result 

in aggregate MOEs of 46,000. Because 

EPA’s level of concern for triforine is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. Residential 

intermediate-term exposure is not 

anticipated; therefore an intermediateterm aggregate risk assessment is not 

necessary. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

EPA has determined that quantification 

of risk using a non-linear approach for 

triforine will be protective of all chronic 

effects including potential 

carcinogenicity. There are no chronic 

aggregate risks of concern and, 

therefore, there are no cancer aggregate 

risks of concern. 

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 triforine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with electron 

capture detection) is 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. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has 

established MRLs for triforine in or on 

blueberry and tomato at 1.0 and 0.5 

ppm, respectively. These MRLs are the 

same as the tolerances being established 

for triforine in the United States. 

C. Response to Comments 

One comment was received in 

response to the notice filing. The 

commenter asked the Agency to deny 

the petition stating that * * * ‘‘toxic 

effects to red blood cells and iron 

deposition in the wrong places is 

enough reason to deny this product.’’ 

The comment also requested that all 

studies be verified by an independent 

lab. The Agency responds to this 

comment by stating that all toxicity 

studies required in accordance with 

new 40 CFR part 158 data requirements 

have been submitted. The studies 

available for consideration of triforine 

toxicity provide a comprehensive and 

complete database. The Agency has 

conducted a human health risk 

assessment with this database and has 

concluded that there are no risks of 

concern to human health from the 

requested use of triforine as 

demonstrated by the risk assessment. 

Only dietary exposure is expected for 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 32151 

the establishment of a tolerance on 

imported blueberries and tomatoes and 

adequate studies are available for 

consideration of this potential exposure 

scenario. All studies conducted on 

pesticide products to support 

applications for research or marketing 

should follow the Good Laboratory 

Practice (GLP) standards as stipulated in 

40 CFR part 160 under FIFRA. When a 

registrant utilizes the service of a 

laboratory to conduct a study, they must 

notify the laboratory that the study 

should be conducted in accordance with 

this part (§ 160.10). Every study that is 

submitted to the Agency must include a 

statement that the study was conducted 

in accordance with this part (§ 160.12). 

Submission of a false statement may for 

the basis for cancellations, suspension, 

etc. EPA may refuse to consider reliable 

any data from a study which was not 

conducted in accordance with this part 

(§ 160.17). The Agency’s Office of 

Enforcement and Compliance (OECA) 

conducts inspections of laboratory 

facilities for the purpose of compliance 

review to determine that the GLP 

regulations of FIFRA are being observed. 

This compliance review includes 

inspection of all raw data records, 

specimens and other entities as needed 

as stipulated in this part (§ 160.15). The 

toxicity studies used to assess the 

potential risks associated with exposure 

to triforine were conducted in 

compliance with 40 CR part 160, and 

included submission of all raw data as 

well as required GLP compliance 

statements. Further, Agency scientists 

conducted a thorough and independent 

review of these data during the 

registration process. The Agency has no 

objection to the establishment of 

tolerances without U.S. registrations for 

residues of triforine in or on blueberry 

and tomato. 

D. Revisions to Petitioned-for 

Tolerances 

The tolerance level for blueberry 

being established by the EPA differs 

from that proposed in the tolerance 

petition submitted by Summit Agro 

North America Holding Corporation. 

The Agency determined that the 

tolerance level of 1.0 ppm instead of 

0.02 ppm for blueberry is needed so as 

to harmonize with the established 

Codex Maximum Residue Limits (MRL). 

This tolerance level will allow for full 

harmonization of both the residue 

definition and the tolerance level 

between the United States and Codex. 

V. Conclusion 

Therefore, tolerances are established 

for residues of triforine, (N,N′-[1,2- 

piperazinediylbis(2,2,2- 

trichloroethylidene)]bis[formamide]), 

including its metabolites and 

degradates, in or on tomato and 

blueberry at 0.5 and 1.0 ppm, 

respectively. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 20, 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. Add § 180.1321 to read as follows: 

§ 180.1321 Triforine; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of triforine, 

including its metabolites and 

degradates. Compliance with the 

tolerance levels specified in the 

following table is to be determined by 

measuring only triforine (N,N′-[1,2- 

piperazinediylbis(2,2,2- 

trichloroehylidene)]bis[formamide]), in 

or on the following commodities. 

Commodity Parts per 

million 

Blueberry 1 ............................ 1.0 

Tomato 1 ............................... 0.5 

1There are no U.S. registrations for blueberry and tomato. 


tkelley on DSK3SPTVN1PROD with RULES
32152 Federal Register / Vol. 78, No. 103 / Wednesday, May 29, 2013 / Rules and Regulations 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2013–12461 Filed 5–28–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0558; FRL–9387–2] 

Guar Hydroxypropyltrimethylammonium Chloride; 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 guar 

hydroxypropyltrimethylammonium 

chloride (CAS Reg. No. 71329–50–5) 

when used as an inert ingredient 

(thickener/drift reduction agent) in 

pesticide formulations applied to 

growing crops. SciReg. Inc., on behalf of 

Rhodia Inc., submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of guar 

hydroxypropyltrimethylammonium 

chloride. 

DATES: This regulation is effective May 

29, 2013. Objections and requests for 

hearings must be received on or before 

July 29, 2013, 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–2012–0558, 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: 

William Cutchin, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7099; email address: 

cutchin.william@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/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–2012–0558 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 July 29, 2013. 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– 

2012–0558, 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.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Petition for Exemption 

In the Federal Register of September 

28, 2012 (77 FR 59581) (FRL–9364–6), 

EPA issued a notice pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

2E8017) by SciReg. Inc., 12733 

Director’s Loop, Woodbridge, VA 22192 

on behalf of Rhodia Inc. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of guar 

hydroxypropyltrimethylammonium 

chloride (CAS No. 71329–50–5) when 

used as an inert ingredient (thickener/ 

drift reduction agent) in pesticide 

formulations applied to growing crops 

under 40 CFR 180.920. That notice 

referenced a summary of the petition 

prepared by Rhodia, Inc. the petitioner, 

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 V.C. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 


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