[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32146-32152]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12461]


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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.

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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/text-idx?&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

[[Page 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[acute]-
[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

[[Page 32148]]

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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  No hazard or appropriate acute endpoint was identified in the database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 22 mg/kg/day.  Chronic RfD = 0.22   Subchronic/Chronic oral toxicity
                                   UFA = 10x...........   mg/kg/day.           (dog)
                                   UFH = 10x...........  cPAD = 0.22 mg/kg/   LOAEL = 120 mg/kg/day, based on
                                   FQPA SF = 1x........   day.                 decreased RBC, hematocrit,
                                                                               hemoglobin values and siderosis
                                                                               in the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= 22 mg/kg/day.  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 30 days).                         UFA = 10x...........                        (dog)
                                   UFH = 10x...........                       LOAEL = 120 mg/kg, based on
                                   FQPA SF = 1x........                        decreased RBC, hematocrit, and
                                                                               hemoglobin values, increased
                                                                               spleen weight, and siderosis in
                                                                               the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term  NOAEL= 22 mg/kg/day.  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 (1 to 6 months).                  UFA = 10x...........                        (dog)
                                   UFH = 10x...........                       LOAEL = 120 mg/kg, based on
                                   FQPA SF = 1x........                        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     Inhalation (or oral)  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 days).                             study.                                     (dog)
                                   NOAEL= 22 mg/kg/day.                       LOAEL = 120 mg/kg, based on
                                   UFA = 10x...........                        decreased RBC, hematocrit, and
                                   UFH = 10x...........                        hemoglobin values, increased
                                   FQPA SF = 1x........                        spleen weight, and siderosis in
                                                                               the liver, spleen, and bone
                                                                               marrow.
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term (1    Inhalation (or oral)  LOC for MOE = <100.  Subchronic/chronic oral toxicity
 to 6 months).                      study.                                     (dog)
                                   NOAEL = 22 mg/kg/day                       LOAEL = 120 mg/kg, based on
                                    (inhalation                                decreased RBC, hematocrit, and
                                    absorption rate =                          hemoglobin values, increased
                                    100%).                                     spleen weight, and siderosis in
                                   UFA = 10x...........                        the liver, spleen, and bone
                                   UFH = 10x...........                        marrow.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
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

[[Page 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 non-occupational, 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 post-application 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 post-application 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.

[[Page 32150]]

    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 
short-term 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 intermediate-term 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

[[Page 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 (Sec.  160.10). Every study 
that is submitted to the Agency must include a statement that the study 
was conducted in accordance with this part (Sec.  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 (Sec.  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 (Sec.  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]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Add Sec.  180.1321 to read as follows:


Sec.  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.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Blueberry \1\...........................................             1.0
Tomato \1\..............................................             0.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations for blueberry and tomato.


[[Page 32152]]

    (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]
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