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E. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks; Executive Order 

13211: Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use; and Executive 

Order 12898: Federal Actions To 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

As indicated previously, this action is 

not a ‘‘regulatory action’’ as defined by 

Executive Order 12866. As a result, this 

action is not subject to Executive Order 

13045 (62 FR 19885, April 23, 1997) and 

Executive Order 13211 (66 FR 28355, 

May 22, 2001). In addition, this order 

also does not require any special 

considerations under Executive Order 

12898 (59 FR 7629, February 16, 1994). 

F. National Technology Transfer and 

Advancement Act 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

Congressional Review Act, 5 U.S.C. 801 

et seq. does not apply because this 

action is not a rule as that term is 

defined in 5 U.S.C. 804(3). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Fenamiphos, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: February 24, 2012. 

Richard P. Keigwin, Jr., 

Director, Pesticide Re-evaluation Division, 

Office of Pesticide Programs. 

[FR Doc. 2012–5383 Filed 3–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0659; FRL–9336–6] 

Pyriofenone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyriofenone, 

(5-chloro-2-methoxy-4-methyl-3- 

pyridinyl)(2,3,4-trimethoxy-6- 

methylphenyl) methanone, including its 

metabolites and degradates, in or on 

grape and grape, raisin. ISK BioSciences 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 7, 2012. Objections and requests 

for hearings must be received on or 

before May 7, 2012, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0659. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Heather Garvie, Registration Division 

(7505P), 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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/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–2010–0659 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 May 7, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0659, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 


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Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

8, 2010 (75 FR 54629) (FRL–8843–3), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0E7731) by ISK 

BioSciences Corporation, 7470 Auburn 

Rd., Suite A, Concord, OH 44077. The 

petition requested that 40 CFR part 180 

be amended by establishing a tolerance 

for residues of the fungicide 

pyriofenone (5-chloro-2-methoxy-4- 

methyl-3-pyridinyl)(2,3,4-trimethoxy-6- 

methylphenyl) methanone, in or on 

grape at 0.2 parts per million (ppm). 

That notice referenced a summary of 

the petition prepared by ISK 

BioSciences Corporation, 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 modified the 

petitioned for tolerance for pyriofenone 

by increasing the tolerance level for 

grape and establishing a separate 

tolerance for grape, raisin. The reasons 

for these changes are explained in Unit 

IV.D. 

These are the first tolerances 

established for pyriofenone. There are 

no registered uses for pyriofenone in the 

United States. The tolerances were 

requested in connection with use of 

pyriofenone on grapes grown overseas. 

These tolerances will allow grapes and 

processed grape commodities 

containing pyriofenone residues to be 

imported to 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 pyriofenone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyriofenone 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 liver and 

kidney were affected by treatment with 

pyriofenone, and although more effects 

were noted with increasing duration of 

exposure, effects were generally not 

severe. These effects included increased 

liver weight, microscopic changes, and 

clinical chemistry changes in rats, mice, 

and/or dogs. Kidney effects included 

increased organ weight, microscopic 

changes, and clinical chemistry changes 

in rats and mice and an increased 

incidence of chronic nephropathy in 

rats. Clinical signs included vomiting 

and loose stools in dogs and peri-genital 

staining in mice. Also noted were skin 

changes in the 2-year rat study (atrophy 

of hair follicles or perifolliculitis) and 

increased cecal weight or distended 

cecum in rat studies. Mutagenicity and 

carcinogenicity testing was negative and 

the cancer classification for pyriofenone 

is ‘‘not likely to be carcinogenic to 

humans’’ and therefore there is no 

cancer risk associated with exposure to 

pyriofenone. 

No developmental or reproductive 

toxicity occurred in the rat studies. 

Abortions were noted in the rabbit 

developmental study and were 

associated with decreased maternal 

body weight gain and food 

consumption. There was no evidence of 

neurotoxicity and a developmental 

neurotoxicity study is not needed for 

pyriofenone. Immunotoxicity testing in 

rats and mice was negative. Pyriofenone 

has a low acute toxicity by the oral 

exposure route. Dermal toxicity, 

inhalation toxicity, and ocular irritation 

studies are not available because these 

exposure routes are not applicable to 

non-domestic uses. Specific information 

on the studies received and the nature 

of the adverse effects caused by 

pyriofenone as well as the no-observedadverse-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 ‘‘Pyriofenone. HumanHealth Risk Assessment for the 

Establishment of Tolerances for 

Pyriofenone Fungicide in/on Imported 

Grapes,’’ dated November 1, 2011 at pp. 

16–30 in docket ID number EPA–HQ– 

OPP–2010–0659. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. A summary of the 

toxicological endpoints for used for 

human risk assessment is shown in the 

Table of this unit. 

In risk assessments for import 

commodities, endpoints are typically 

selected for dietary exposure only. 

Endpoints for incidental oral, dermal, 

and inhalation exposures are not 


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selected for import tolerances due to 

lack of potential occupational or 

residential exposure. No adverse effects 

attributable to a single exposure were 

identified for pyriofenone; therefore, an 

acute dietary endpoint was not selected 

for pyriofenone. 

Consideration was given to selecting 

abortions/premature delivery from the 

rabbit developmental study as an 

endpoint for assessing acute dietary 

risk. Typically, abortions observed early 

in the pregnancy in a developmental 

toxicity study are assumed to be 

attributable to a single exposure and 

thus appropriate for acute dietary risk 

assessment. 

In the rabbit developmental toxicity 

study, abortions occurred in 2 does on 

gestation day 18 at the highest dose 

tested (300 milligram/kilogram/day (mg/ 

kg/day). In this case the abortions were 

determined not to be attributable to a 

single exposure since the abortions 

occurred late in gestation (GD 18) and 

prior to which both does had 

significantly lower-food consumption 

resulting in lower body weight or body 

weight gain. In the range-finding study, 

abortions and premature delivery seen 

in 2 does also showed an association to 

the lower body weight and food 

consumption. Thus, the potential 

nutrient deficiency and maternal 

toxicity resulting from loss in body 

weight and lower food consumption 

were assumed to result in the abortions/ 

premature delivery rather than the test 

compound. 

For the chronic dietary risk 

assessment, a NOAEL of 9 mg/kg/day 

was selected based on the increased 

incidence of chronic nephropathy seen 

in female rats at 46 mg/kg/day (LOAEL) 

in the 2-year carcinogenicity study. 

Typically, chronic nephropathy occurs 

as spontaneous lesions in geriatric rats 

and in some cases, exposure to a 

chemical may exacerbate this kidney 

lesion. In this case, however, chronic 

nephropathy was considered to be 

adverse because the incidences of this 

lesion was significantly increased in 

females at 46 mg/kg/day (30/35) and 

also at the next higher dose of 254 mg/ 

kg/day (36/45, p<0.005). In the chronic 

study with dogs, the effects (e.g., 

clinical signs, alterations in clinical 

pathology, organ weights, or 

histopathology) were determined to be 

not adverse since the findings were 

isolated, highly variable, and/or there 

was a lack of dose-response or a clear 

target organ for toxicity. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRIOFENONE 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 ............................ An acute dietary endpoint was not selected because toxicity from a single dose was not identified in the hazard 

database. 

Chronic dietary (All populations).NOAEL= 9 mg/kg/day ............

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.09 ................

mg/kg/day 

cPAD = 0.09 

mg/kg/day 

Chronic toxicity/carcinogenicity study—rat 

NOAEL = 9 mg/kg/day based on increased 

nephropathy seen in female rats at LOAEL 

= 46 mg/kg/day. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’. 

FQPA SF = FQPA Safety Factor. LOAEL = lowest observed adverse effect level. 

LOC = Level of Concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD = population adjusted dose (a 

= acute, c = chronic). RfD = reference dose. UFA = extrapolation from animal to human (intraspecies). UFH = potential variation in sensitivity 

among members of the human population (interspecies). 

Specific information on the 

toxicological endpoints for pyriofenone 

can be found at http:// 

www.regulations.gov in document 

‘‘Pyriofenone. Human-Health Risk 

Assessment for the Establishment of 

Tolerances for Pyriofenone Fungicide 

in/on Imported Grapes,’’ dated 

November 1, 2011 at pp.16–30 in docket 

ID number EPA–HQ–OPP–2010–0659. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyriofenone, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from pyriofenone 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 pyriofenone; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intakes by Individuals (CSFII). As 

to residue levels in food, EPA 

conducted an unrefined, screening-level 

chronic dietary risk assessment 

assuming tolerance level residues for 

grapes, raisins, and all other processed 

grape commodities; and 100% of all 

grapes are treated with pyriofenone. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyriofenone does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue information 

in the dietary assessment for 

pyriofenone. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. Pyriofenone is not registered for 

use in the United States; therefore, 

exposure to pyriofenone in drinking 

water is not expected. 

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). 

Pyriofenone 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 


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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 pyriofenone to 

share a common mechanism of toxicity 

with any other substances, and 

pyriofenone does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance assessment action, therefore, 

EPA has not assumed that pyriofenone 

has 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 the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on 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. 

The toxicological database for 

pyriofenone is complete with regard to 

pre- and postnatal toxicity, and there are 

no residual uncertainties. As the data 

summarized in Unit III.A. showed, 

pyriofenone exposure did not result in 

quantitative or qualitative increased 

sensitivity in the young. 

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 

pyriofenone is complete. 

ii. There is no indication that 

pyriofenone is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

pyriofenone 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 the 

assumptions of 100 PCT and tolerancelevel residues. This assessment will not 

underestimate the exposure and risks 

posed by pyriofenone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. For this action there is potential 

exposure to pyriofenone from food only. 

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, pyriofenone 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 pyriofenone 

from food only will utilize 1% of the 

cPAD for children (1–2 years old), the 

population group receiving the greatest 

exposure. There are no residential uses 

for pyriofenone. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

pyriofenone is not expected. 

3. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyriofenone is classified as ‘‘not likely 

to be carcinogenic to humans.’’ EPA 

does not expect pyriofenone to pose a 

cancer risk. 

4. 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 pyriofenone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

A liquid chromatography/mass 

spectrometry/mass spectrometry (LC/ 

MS/MS) method based on the proposed 

enforcement method (Method ISK 0341/ 

074208, Revision #4) was used to 

determine residues of pyriofenone in or 

on grapes (Raw Agricultural Commodity 

(RAC)) and its processed fractions for 

the crop field trial and grape processing 

studies associated with this petition. 

The validated limit of quantitation 

(LOQ) is 0.01 ppm. This method was 

adequately validated for data collection 

purposes and a successful independent 

laboratory validation study was 

conducted. Therefore, the LC/MS/MS 

method is acceptable for use as an 

enforcement method. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level MRL. 

The Codex has not established a MRL 

for pyriofenone. However, review of this 

tolerance on imported grapes is being 

conducted with Canada, and the U.S. 

and Canada are harmonized on the 

residue definition and recommended 

tolerances. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerance level for grape being 

established by EPA differs from that 


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proposed in the tolerance petition 

submitted by the ISK Biosciences 

Corporation. The Agency used the 

Organization for Economic Cooperation 

and Development tolerance calculation 

procedures to determine that the 

tolerance level of 0.30 ppm is needed. 

The petitioner did not propose a 

separate tolerance for grape, raisin, but 

processing studies showed that residues 

could concentrate, necessitating a 

higher tolerance of 0.50 ppm. Finally, 

EPA has revised the tolerance 

expression to clarify that: 

1. As provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

pyriofenone not specifically mentioned. 

2. Compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

(without U.S. registrations) for residues 

of the fungicide, pyriofenone, including 

its metabolites and degradates, in or on 

grape at 0.30 ppm and grape, raisin at 

0.50 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) of FFDCA 

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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: February 17, 2012. 

Steven Bradbury, 

Director, 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. Section 180.660 is added to subpart 

C to read as follows: 

§ 180.660 Pyriofenone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

pyriofenone, including its metabolites 

and degradates, in or on the following 

commodities listed in the table. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

pyriofenone, (5-chloro-2-methoxy-4- 

methyl-3-pyridinyl)(2,3,4-trimethoxy-6- 

methylphenyl) methanone, in or on the 

following commodities: 

Commodity Parts per 

million 

Grape 1 .......................................... 0.30 

Grape, raisin 1 ............................... 0.50 

1There are no U.S. registrations for grape 

and grape, raisin. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–5271 Filed 3–6–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2011–0108; FRL–9339–8] 

RIN 2070–AB27 

Modification of Significant New Uses 

of Tris Carbamoyl Triazine; Technical 

Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical correction. 

SUMMARY: EPA issued a final rule in the 

Federal Register of February 8, 2012 

concerning the modification of 

significant new uses of the chemical 

substance identified generically as tris 

carbamoyl triazine, which was the 

subject of premanufacture notice (PMN) 


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