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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II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 20, 

2011 (76 FR 43236) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP #1F7871) by Arysta 

LifeScience North America, LLC, 15401 

Weston Parkway, Suite 150, Cary, NC 

27513. The petition requested that 40 

CFR 180.609 be amended by revising 

tolerances for residues of the fungicide 

fluoxastrobin in or on peanut and 

peanut oil, from 0.01 and 0.03 to 0.02 

and 0.06 parts per million (ppm) 

respectively. That notice referenced a 

summary of the petition prepared by 

Arysta LifeScinece North America, LLC, 

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 

corrected the commodity definition for 

peanut oil. The reason for this change is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fluoxastrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluoxastrobin 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 most recent 

human health risk assessment for 

fluoxastrobin was conducted for use on 

the squash/cucumber crop subgroup 9B. 

Since that time, no new toxicology data 

have been submitted to the Agency and 

the hazard characterization and toxicity 

endpoints for risk assessment remain 

unchanged. Specific information on the 

studies received and the nature of the 

adverse effects caused by fluoxastrobin 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in the final rule that established a 

tolerance for residues of fluoxastrobin in 

or on squash/cucumber subgroup 9B. 

This rule was published in the Federal 

Register of August 17, 2011 (76 FR 

50893) (FRL–8884–4). 

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 fluoxastrobin used for 

human risk assessment is shown in 

Table 1 of the final rule published in the 

Federal Register of August 17, 2011. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluoxastrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluoxastrobin tolerances in 40 

CFR 180.609. EPA assessed dietary 

exposures from fluoxastrobin 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 fluoxastrobin; 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 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA conducted a 

conservative dietary exposure 

assessment for fluoxastrobin. The 

assumptions of this dietary assessment 

included tolerance level residues and 

100 percent crop treated (PCT). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluoxastrobin 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 information in the 

dietary assessment for fluoxastrobin. 

Tolerance level residues and/or 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. Based on laboratory studies, 

fluoxastrobin persists in soils for several 

months to several years and is slightly 

to moderately mobile in soil. 

The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluoxastrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluoxastrobin. Further information 


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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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluoxastrobin for chronic exposures for 

non-cancer assessments are estimated to 

be 52.9 parts per billion (ppb) for 

surface water and 0.23 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 53 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). 

Fluoxastrobin is currently registered for 

the following uses that could result in 

residential exposures: Spot treatment 

and/or broadcast control of diseases on 

turf, including lawns and golf courses. 

EPA assessed residential exposure using 

the following assumptions: Because of 

the potential for application four times 

per year, exposure duration is expected 

to be short-term and intermediate-term. 

A short-term dermal endpoint was not 

identified; therefore, only intermediateterm dermal risks as well as short- and 

intermediate-term inhalation risks were 

assessed. Homeowner residential 

applicators are expected to be adults. 

There is also the potential for 

homeowners and their families (of 

varying ages) to be exposed as a result 

of entering areas that have previously 

been treated with fluoxastrobin. 

Exposure might occur on areas such as 

lawns used by children or recreational 

areas such as golf courses used by adults 

and youths. Potential routes of exposure 

include dermal (adults and children) 

and incidental oral ingestion (children). 

Since no acute hazard has been 

identified, an assessment of episodic 

granular ingestion was not conducted. 

While it is assumed that most 

residential use will result in short-term 

(1 to 30 days) post-application 

exposures, it is believed that 

intermediate-term exposures (greater 

than 30 days up to 180 days) are also 

possible. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/science/residential-exposuresop.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 fluoxastrobin to 

share a common mechanism of toxicity 

with any other substances, and 

fluoxastrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fluoxastrobin 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 Safety 

Factor (FQPA 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 database for evaluating in utero or 

postnatal susceptibility includes 

developmental toxicity studies in both 

rats and rabbits and a 2-generation 

reproduction study in the rat. The data 

provide no indication of increased 

susceptibility of rats or rabbits to 

prenatal and postnatal exposure to 

fluoxastrobin. 

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 

fluoxastrobin is complete with the 

exception of an acceptable functional 

immunotoxicity study. The Agency does 

have an immunotoxicity study for 

fluoxastrobin but it has deficiencies that 

make it unacceptable at this time. The 

study may be acceptable if additional 

information is submitted. Nonetheless, 

the Agency does not believe that 

conducting a new immunotoxicity study 

will result in a lower NOAEL than the 

regulatory dose for risk assessment. 

First, the available data do not indicate 

that fluoxastrobin results in primary 

immune system effects; a NOAEL for 

decreased spleen weight in the absence 

of histopathological findings (male rats) 

was 53 milligrams/kilogram/day (mg/ 

kg/day). In addition, there was no 

indication of a functional effect on the 

immune system in the unacceptable 

mouse immunotoxicity study at doses as 

high as 2,383 mg/kg/day. Finally, the 

registrant recently submitted a new 

immunotoxicity study. The Agency has 

not fully reviewed the study at this 

time, but a preliminary screen indicates 

that fluoxastrobin does not appear to 

significantly affect the immune system 

and would not provide a Point of 

Departure lower than that currently 

used for risk assessment. For all of these 

reasons, the Agency therefore believes 

that no additional safety factor is 

needed to account for the deficiencies in 

the first immunotoxicity study. 

ii. There is no indication that 

fluoxastrobin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

iii. There is no evidence that 

fluoxastrobin 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. 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to fluoxastrobin in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by fluoxastrobin. 

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 


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26470 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Rules and Regulations 

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, fluoxastrobin 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 fluoxastrobin 

from food and water will utilize 47% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of fluoxastrobin is not 

expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure take into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Fluoxastrobin is 

currently registered for uses that could 

result in both short- and intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures of adults and children to 

fluoxastrobin. Because all short- and 

intermediate-term quantitative hazard 

assessments (via the dermal and 

incidental oral routes) for fluoxastrobin 

are based on the same endpoint, a 

screening-level, conservative aggregate 

risk assessment was conducted that 

combined the short-term incidental oral 

and intermediate-term exposure 

estimates (i.e., the highest exposure 

estimates) in the risk assessments for 

adults. The Agency believes that most 

residential exposure will be short-term, 

based on the use pattern. 

There is potential short- and 

intermediate-term exposure to 

fluoxastrobin via the dietary (which is 

considered background exposure) and 

residential (which is considered 

primary) pathways. For adults, these 

pathways lead to exposure via the oral 

(background), and dermal and 

inhalation (primary) routes. For 

children, these pathways lead to 

exposure via the oral (background), and 

incidental oral and dermal (primary) 

routes. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short- and intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs of 630 for 

adults; 170 for children (1–2 years old). 

Because EPA’s level of concern for 

fluoxastrobin is a MOE of 100 or below, 

these MOEs are not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluoxastrobin is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluoxastrobin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry) is 

available to enforce the tolerance 

expression. Method No. 00604 is 

available for plant commodities and 

Method No. 00691 is available for 

animal commodities. 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 U.N. 

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. 

There are currently no established 

Mexican, Canadian, or Codex MRLs or 

tolerances for fluoxastrobin in/on 

peanuts. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed commodity term has 

been revised to agree with the Agency’s 

Food and Feed Commodity Vocabulary. 

The petitioned for commodities were 

peanut and peanut oil. The correct 

commodity definitions are peanut and 

peanut, refined oil. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluoxastrobin, in or on 

peanut and peanut, refined oil at s 0.02 

and 0.06 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 


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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 180.609 is amended by 

revising the following entries in the 

table in paragraph (a)(1) to read as 

follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Peanut ............................... 0.02 

* * * * * 

Peanut, refined oil ............. 0.06 

* * * * * 

* * * * * 

[FR Doc. 2012–10704 Filed 5–3–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket DOT–OST–2010–0026] 

RIN 2105–AE14 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs: 6-acetylmorphine (6–AM) 

Testing 

AGENCY: Office of the Secretary, DOT. 

ACTION: Interim final rule. 

SUMMARY: The Department is amending 

certain provisions of its drug testing 

procedures for 6-acetylmorphine (6– 

AM), a unique metabolite of heroin. 

Laboratories and Medical Review 

Officers (MROs) will no longer be 

required to consult with one another 

regarding the testing for the presence of 

morphine when the laboratory confirms 

the presence of 6–AM. This rule is 

intended to streamline the laboratory 

process for analyzing and reporting 6– 

AM positive results and will facilitate 

MRO verification of 6–AM positive 

results. 

DATES: The rule is effective July 3, 2012. 

Comments to this interim final rule 

should be submitted by June 4, 2012. 

Late-filed comments will be considered 

to the extent practicable. 

ADDRESSES: To ensure that you do not 

duplicate your docket submissions, 

please submit them by only one of the 

following means: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for submitting 

comments. 

• Mail: Docket Management Facility, 

U.S. Department of Transportation, 1200 

New Jersey Ave. SE., West Building 

Ground Floor Room W12–140, 

Washington, DC 20590–0001; 

• Hand Delivery: West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Ave. SE., between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–366–9329; 

Instructions: You must include the 

agency name and docket number DOTOST–2010–0026 or the Regulatory 

Identification Number (2105–AE14) for 

the rulemaking at the beginning of your 

comments. All comments received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

FOR FURTHER INFORMATION CONTACT: 

Bohdan Baczara, U.S. Department of 

Transportation, Office of Drug and 

Alcohol Policy and Compliance, 1200 

New Jersey Avenue SE., Washington, 

DC 20590; 202–366–3784 (voice), 202– 

366–3897 (fax), or 

bohdan.baczara@dot.gov (email). 

SUPPLEMENTARY INFORMATION: 

Background 

For its drug testing regulation, the 

Department of Transportation (DOT) is 

required by the Omnibus Transportation 

Employee Testing Act of 1991 (Omnibus 

Act) to incorporate the laboratory testing 

protocols and standards established by 

the U.S. Department of Health and 

Human Services (HHS). The Omnibus 

Act requires that we utilize HHScertified laboratories and that we follow 

the HHS Mandatory Guidelines for 

identifying the specific drugs for which 

we test and the scientific methodologies 

the laboratories must use for testing. 

Because of these requirements and to 

create consistency with certain aspects 

of the new HHS Mandatory Guidelines 

effective October 1, 2010 [73 FR 71858], 

the DOT published its final rule on 

August 16, 2010 [75 FR 49850], also 

effective October 1, 2010, to harmonize 

with many aspects of the revised 

Mandatory Guidelines. 

One item with which the DOT 

harmonized was the laboratory testing 

for 6-acetylmorphine (6–AM) without a 

morphine marker. 6–AM is a unique 

metabolite produced when a person 

uses the illicit drug heroin. Prior to the 

October 1, 2010 rulemaking, both HHS 

and DOT regulations required the 

laboratory to first test for morphine, and 

if it detected morphine at the HHS/DOT 

cutoff of 2000ng/mL, the lab would then 

test for 6–AM. 


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