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Commodity Parts per 

million 

* * * * * 

Animal feed, nongrass, crop 

group 18, forage ..................... 2.0 

Animal feed, nongrass, crop 

group 18, hay .......................... 5.0 

Animal feed, nongrass, crop 

group 18, seed ........................ 15.0 

* * * * * 

* * * * * 

[FR Doc. 2012–10688 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0388; FRL–9346–6] 

Dimethomorph; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for residues of 

dimethomorph, (E,Z)-4-[3-(4- 

chlorophenyl)-3-(3,4-dimethoxyphenyl)- 

1-oxo-2-propenyl]morpholine in or 

certain commodities as discussed in this 

document. BASF Corporartion 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 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–2011–0388. 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: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; email address: 

gibson.tamue@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–2011–0388 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 3, 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–2011–0388, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. 

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 July 20, 

2011 (76 FR 43231) (FRL–8880–1), 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 0F7800) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709. The petition 

requested that EPA amend 40 CFR part 

180 by raising tolerances for residues of 

the fungicide dimethomorph, in or on 

brassica, head and stem, subgroup 5A 

from 2.0 ppm to 5.0 ppm; brassica, leafy 

greens, subgroup 5B from 20.0 ppm to 

30.0 ppm; green onion, subgroup 3B 

from 2.0 ppm to 11.0 ppm. The petition 

also requested that 40 CFR part 180 be 

amended by establishing a tolerance for 

the residues of the fungicide 

dimethomorph, in or on vegetable, leafy 

at 16 ppm (PP 0F7816). The notice 


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referenced a summary of the petition 

prepared by BASF 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. 

In the Federal Register of October 27, 

2010 (75 FR 66092) (FRL–8848–3), 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 0F7751) by BASF 

Corporation, P.O. Box 13528, Research 

Triangle Park, NC 27709. The petition 

requested that EPA establish a tolerance 

for residues of the fungicide 

dimethomorph, in or on grape at 3.5 

ppm. The notice referenced a summary 

of the petition prepared by BASF 

Corporation, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. One comment was 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the proposed tolerance level and 

commodity definition for vegetable, 

bulb, group 3 and removed the 

established tolerance for the regional 

registration for grape. Tolerances for the 

national registration for grape and 

onion, bulb subgroup 3–07A were 

lowered. Tolerances for brassica, head 

and stem, subgroup 5A; brassica, leafy 

greens, subgroup 5B; vegetable, leafy 

except brassica, group 4; onion, green, 

subgroup 3–07B were raised. Tolerances 

for grape, raisin were established for 

domestic registrations and were also 

raised. EPA is also establishing 

rotational crop tolerances for wheat, 

forage; wheat, hay; and wheat, straw. 

EPA has made various changes to the 

commodity definitions and tolerance 

levels sought in the petition and also is 

establishing rotational crop tolerances. 

The reason for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *.’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for dimethomorph 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with dimethomorph 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. 

Dimethomorph has low acute toxicity 

via the oral and dermal routes of 

exposure. Chronic risk is regulated 

based on effects seen in body weight 

decrements and liver effects in the 

female rat. There was no evidence of 

increased incidence of any neoplasms at 

the limit dose tested in carcinogenicity 

studies tested in rats and mice. 

Dimethomorph is classified as ‘‘not 

likely’’ to be a human carcinogen based 

on the lack of evidence of 

carcinogenicity in carcinogenicity 

studies in rats and mice. The available 

data for dimethomorph does not show 

evidence of neurotoxicity. There is a 

subchronic neurotoxicity study 

available which demonstrated no 

neurotoxic effects in the study. In 

addition, neither the subchronic nor 

chronic toxicity studies in rats or dogs, 

nor the developmental toxicity studies 

indicated that the nervous system was 

affected by treatment with 

dimethomorph. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dimethomorph as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Dimethomorph: Human Health Risk 

Assessment to Support Amended Use 

on Grapes, Bulb Vegetables, Leafy 

Brassica Vegetables, and Leafy 

Vegetables,’’ pp. 35–38 in docket ID 

number EPA–HQ–OPP–2011–0388. 

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 dimethomorph used for 

human risk assessment is shown in the 

Table this unit. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIMETHOMORPH FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (Females 13–49 

years of age).

No endpoint attributable 

to a single dose was 

identified.

Not applicable ................. No study selected. 

Acute dietary (General population 

including infants and children).

No endpoint attributable 

to a single dose was 

identified.

Not applicable ................. No study selected. 

Chronic dietary (All populations) ..... NOAEL = 11 mg/kg/day

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.1 mg/kg/ 

day.

cPAD = 0.1 mg/kg/day 

Carcinogenicity study in rats. 

LOAEL = 46.3 mg/kg/day based on decreased 

body weight and increases in liver lesions in female rats. 

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

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. mg/kg/day = milligram/kilogram/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dimethomorph, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing dimethomorph tolerances in 40 

CFR 180.493. EPA assessed dietary 

exposures from dimethomorph 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 toxic effects attributable to 

a single dose were observed in the 

toxicological studies for dimethomorph; 

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 USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues and 

100 percent crop treated (PCT). Dietary 

Evaluation Exposure Model (DEEM) 

default processing factors were used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., 

dimethomorph has been classified as 

‘‘not likely’’ to be a human carcinogen. 

EPA has concluded that dimethomorph 

does not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for dimethomorph. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dimethomorph in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

dimethomorph. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST), and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

dimethomorph for acute exposures are 

estimated to be 81.1 parts per billion 

(ppb) for surface water and 0.264 ppb 

for ground water. 

For chronic exposures for non-cancer 

assessments are estimated to be 24.7 

ppb for surface water and 0.264 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For chronic dietary risk assessment, 

the water concentration of value 24.7 

ppb was used to assess the contribution 

to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Dimethomorph is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found dimethomorph to 

share a common mechanism of toxicity 

with any other substances, and 

dimethomorph does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that dimethomorph does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 


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provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available data did not provide 

evidence of any increased susceptibility 

in the offspring in either of the two 

developmental toxicity studies or in the 

2-generation reproduction study. In 

either of these two studies toxicity was 

not seen in the offspring occurring at 

doses lower than in the parent in any of 

the studies. Additionally, the effects 

seen in the young were qualitatively 

similar to those in the parents. 

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 

dimethomorph is complete. 

ii. There is no indication that 

dimethomorph is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

dimethomorph 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 unrefined chronic dietary risk 

assessment used tolerance level 

residues, included modeled drinking 

water estimates, assumed 100 PCT, and 

incorporated DEEM default processing 

factors. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to dimethomorph in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by dimethomorph. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. 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, dimethomorph 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 dimethomorph 

from food and water will utilize 27% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. There are no residential uses 

for dimethomorph and thus residential 

exposure to residues of dimethomorph 

is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Dimethomorph is not 

registered for any use patterns that 

would result in residential exposure. 

Therefore, the short-term aggregate risk 

is the sum of the risk from exposure to 

dimethomorph through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Dimethomorph is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to dimethomorph through 

food and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

dimethomorph is not expected to pose 

a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

dimethomorph residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

FAMS–002–04 which utilizes high 

pressure liquid chromatography with 

ultraviolet detection (HPLC/UV) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international 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 

dimethomorph in or on grape at 2 ppm; 

and grape, raisin at 5 ppm. These MRLs 

are different than the tolerances being 

established for dimethomorph in this 

action because the MRLs are based on 

residue data derived from Europe. 

C. Response to Comments 

One comment was received from a 

private citizen (in reference to tolerance 

petition 0F7751) who encouraged the 

Agency to continue to reduce the risk to 

human health and the environment 

from pesticide usage. The Agency 

recognizes that some individuals believe 

that pesticide use should not be 

permitted. However, under the existing 

legal framework provided by section 

408 of the Federal Food, Drug and 

Cosmetic Act (FFDCA), EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

the statute. 

D. Revisions to Petitioned-For 

Tolerances 

The crop group regulations (40 CFR 

180.41) were recently amended 

pertaining to Crop Group 3—Bulb 

Vegetables, and the revised Crop group 

is designated Crop group 3–07 Bulb 

Vegetable. The revised crop group now 

contains two subgroups: Bulb, subgroup 


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3–07A and onion, green, subgroup 3– 

07B. Because BASF proposed to modify 

its existing Crop Group 3 tolerance by 

adding a revised green onion tolerance, 

EPA has determined it is appropriate to 

establish both onion, bulb subgroup 3– 

07A and onion, green, subgroup 3–07B 

tolerances rather than a Crop Group 3 

tolerance and a green onion tolerance. 

Based on analysis of residue levels from 

crop field trail data and tolerance 

calculation procedures, EPA is setting 

the onion, bulb subgroup 3–07A 

tolerance at 0.6 ppm and the onion, 

green, subgroup 3–07B tolerance at 15 

ppm. EPA is removing the existing Crop 

Group 3 tolerance. 

Additionally, based on analysis of 

residue levels from crop field trail data 

and tolerance calculation procedures, 

EPA is raising tolerance levels for grape, 

raisin; brassica, head and stem, 

subgroup 5A; brassica, leafy greens, 

subgroup 5B; and vegetable, leafy, 

except brassica, group 4. For the same 

reason, EPA is lowering the tolerance 

for grape. Additionally, because the 

Agency is amending the BASF 

registration to allow use on grapes in the 

U.S., EPA is removing the footnote in 

the tolerance stating that such a 

registration does not exist. 

Subsequent to the filing of the 

petition, the petitioner requested that 

the Agency establish tolerances in cereal 

grain commodities (forage, hay and 

straw) that are rotated to fields 

following use dimethomorph on 

commodities covered by the tolerances 

established in this action. The Agency 

determined that rotated crop tolerances 

would be appropriate for wheat, forage; 

wheat, hay; and wheat, straw. 

V. Conclusion 

Therefore, amended tolerances are 

established for residues of 

dimethomorph, in or on brassica, head 

and stem, subgroup 5A at 6.0 ppm; 

brassica, leafy greens, subgroup 5B at 

30.0 ppm; onion, bulb subgroup 3–07A 

at 0.6 ppm; onion, green, subgroup 3– 

07B at 15.0 ppm; grape at 3.0 ppm; and 

grape, raisin at 7.0 ppm. A tolerance is 

established for residues of 

dimethomorph, in or on vegetable, leafy 

except brassica, group 4 at 30.0 ppm. 

This regulation also establishes 

tolerances for the indirect or inadvertent 

residues of dimethomorph, in or on 

wheat, forage at 0.15 ppm; wheat hay at 

0.15 ppm and wheat, straw at 0.4 ppm. 

Furthermore, this regulation removes 

established tolerances on vegetable, 

bulb, group 3 and footnote pertaining 

the lack of a registration for use on 

grapes. 

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) (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: April 25, 2012. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.493 is amended as 

follows: 

■ i. Remove the entry for ‘‘Vegetable, 

bulb, group 3’’; and footnote 1 from the 

table in paragraph (a); 

■ ii. By revising the entries for 

‘‘Brassica, head and stem, subgroup 

5A,’’ ‘‘Brassica, leafy greens, subgroup 

5B’’ and ‘‘Grape, raisin’’ and 

alphabetically adding new entries to the 

table in paragraph (a); 

■ iii. Remove ‘‘Grape’’ from the table in 

paragraph (c); 

■ iv. Revise paragraph (d) . 

The amendments read as follows: 

§ 180.493 Dimethomorph; tolerances for 

residues. 

(a) * * * 


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Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 26467 

Commodity Parts per 

million 

Brassica, head and stem, 

subgroup 5A ...................... 6.0 

Brassica, leafy greens, subgroup 5B ........................... 30.0 

* * * * * 

Grape .................................... 3.0 

Grape, raisin ......................... 7.0 

* * * * * 

Onion, bulb, subgroup 3–07A 0.6 

Onion, green, subgroup 3– 

07B .................................... 15.0 

* * * * * 

Vegetable, leafy (except 

Brassica) group 4 .............. 30.0 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 

fungicide dimethomorph, in or on the 

commodities in the following table. 

Compliance with the following 

tolerance levels specified in the 

following table is to be determined by 

measuring only dimethomorph (E,Z)-4- 

[3-(4-chlorophenyl)-3-(3,4- 

dimethoxyphenyl)acryloyl]morpholine 

calculated in or on the following 

commodities: 

Commodity Parts per million 

Wheat, forage ..................... 0 .15 

Wheat, hay ......................... 0 .15 

Wheat, straw ....................... 0 .4 

[FR Doc. 2012–10709 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0677; FRL–9345–3] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluoxastrobin 

in or on peanut and peanut, refined oil. 

Arysta LifeScience North America, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

4, 2012. Objections and requests for 

hearings must be received on or before 

July 3, 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–2009–0677. 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, 

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–2009–0677 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 3, 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–2009–0677, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. 

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. 


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