4542 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 

(115) On July 31, 2003, the State of 

Colorado submitted revisions to 

Colorado’s 5 CCR 1001–3, Regulation 1, 

that deleted Sections II.A.6, A.7, A.9 

and C.3, regarding, respectively, alfalfa 

dehydrating plant drum dryers, wigwam 

burners, the static firing of Pershing 

missiles and a notice regarding waste 

materials. The State also deleted 

emission limitations for alfalfa plant 

drum dyers by removing Section III.C.2. 

Colorado’s deletion of Sections II. A6, 

A.7 and A.9 and Section III.C.2 will 

cause a numbering change of 

subsequent paragraphs within Sections 

II.A and III.C. EPA is adopting the new 

numbering scheme for sections II.A. and 

III C. Section II.C.2.d. regarding 

agricultural open burning is modified to 

include the burning of diseased animal 

carcasses to prevent a public health 

emergency. Section III.A.1.d is modified 

for incorporation of new State’s method 

for calculating emissions from multiple 

fuel burning units ducted to a common 

stack. Section V is added regarding 

emission standards for electric arc 

furnaces, except for the director’s 

discretion provision provided for in 

Section V.A.2. Sections VI.A.3.e, 

VI.A.3.f, VI.B.4.e, and VI.B.4.g(ii) are 

modified regarding the methods used 

for the averaging of emissions over a 24 

hour period. 

(i) Incorporation by reference. 

(A) 5 CCR 1001–3, Regulation 1, 

Emission Control for Particulates, 

Smokes, Carbon Monoxide and Sulfur 

Oxides, Section II, Smoke and Opacity, 

Section II.C.2.d, effective March 2, 2002. 

(B) 5 CCR 1001–3, Regulation 1, 

Emission Control for Particulates, 

Smokes, Carbon Monoxide and Sulfur 

Oxides, Section III, Particulate Matter, 

Fuel Burning Equipment, Section 

III.A.1.d, effective September 30, 2001. 

(C) 5 CCR 1001–3, Regulation 1, 

Emission Control for Particulates, 

Smokes, Carbon Monoxide and Sulfur 

Oxides, Section V, Emission Standard 

for Existing Iron and Steel Plant 

Operations, effective September 30, 

2001. 

(1) The submittal contains Section 

V.A.2 with the language: 

‘‘Emissions from gas-cleaning device 

shall not exceed a mass emission rate of 

0.00520 gr/dscf of filterable particulates 

maximum two-hour average, as 

measured by EPA Methods 1–4 and the 

front half of Method 5 (40 CFR 60.275, 

and Appendix A, Part 60), or by other 

credible method approved by the 

Division. This particulate emissions 

standard does not include condensable 

emissions, or the back half emissions of 

Method 5’’. The language ‘‘or by other 

credible method approved by the 

Division’’ is disapproved. The language 

‘‘Appendix A, Part 60’’ is changed to 

‘‘appendices A1 through A3, Part 60’’ in 

order to comply with the current 

nomenclature of Part 60. 

(D) 5 CCR 1001–3, Regulation 1, 

Emission Control for Particulates, 

Smokes, Carbon Monoxide and Sulfur 

Oxides, Section VI, Sulfur Dioxide 

Emission Regulations, Sections VI.A.3.e, 

VI.A.3.f, VI.B.4.e, and VI.B.4.g(ii), 

effective September 30, 2001. 

(1) Sections VI.B.4.e and VI.B.4.g(ii) 

list an emission rate of 0.7 lbs. sulfur 

dioxide, for the sum of all SO2

emissions from a given refinery per 

barrel of oil processed, per day. This 

emission rate is disapproved. The 

emission rate remains unchanged at 0.3 

lbs. All remaining language within 

Sections VI.B.4.e and VI.B.4.g(ii) is 

approved. 

[FR Doc. 2011–1497 Filed 1–25–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0713; FRL–8855–1] 

Mefenoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mefenoxam in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes the individual tolerance on 

lingonberry, as it will be superseded by 

inclusion in bushberry subgroup 

13–07B. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 26, 2011. Objections and 

requests for hearings must be received 

on or before March 28, 2011, 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–2009–0713. 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: 

Laura Nollen, Registration Division 

(7509P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@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://www.gpoaccess.gov/ecfr. 


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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 4543 

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–2009–0713 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 March 28, 2011. 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–2009–0713, 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. 

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 

Tolerances 

In the Federal Register of October 7, 

2009 (74 FR 51597) (FRL–8792–7), 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 9E7591) by IR–4, 

500 College Road East, Suite 201 W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.546 be 

amended by establishing tolerances for 

residues of the fungicide mefenoxam, 

(R)- and (S)-2-[(2,6-dimethyl(phenyl)- 

methoxyacetylamine]-propionic acid 

methyl ester, and its metabolites 

containing the 2,6 dimethylaniline 

moiety, and N -(2-hydroxy methyl-6- 

methylphenyl)-N-(methoxyacetyl)- 

alanine methyl ester, each expressed as 

mefenoxam equivalents, in or on bean, 

snap, succulent at 0.35 parts per million 

(ppm); caneberry subgroup 13–07A at 

0.80 ppm; bushberry subgroup 13–07B 

at 2.0 ppm; onion, bulb, subgroup 3– 

07A at 3.0 ppm; onion, green, subgroup 

3–07B at 10.0 ppm; and spinach at 8.0 

ppm. The notice additionally requested 

to remove the individual tolerance for 

lingonberry at 2.0 ppm, as it will be 

superseded by inclusion in bushberry 

subgroup 13–07B. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 by Syngenta 

Crop Protection, Inc., 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 revised 

the proposed tolerance levels for several 

commodities. EPA has also revised the 

tolerance expression for all established 

commodities to be consistent with 

current Agency policy. The reasons for 

these changes are 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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 mefenoxam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with mefenoxam 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. 

Mefenoxam, is the R-enantiomer of 

metalaxyl which is a racemic mixture 

that contains approximately 50% each 

of the R- and S-enantiomers. EPA 

conducted a side-by-side comparison of 

the available toxicity data for 

mefenoxam and metalaxyl and 

concluded that mefenoxam has similar 

toxicity to that of metalaxyl. Therefore, 

metalaxyl data may be used to support 

the registration of mefenoxam. 

The database for mefenoxam/ 

metalaxyl indicates that the liver is the 

major target organ. Liver effects 

observed in oral studies in rats, mice, 

and dogs include increased liver 

enzymes (alanine amino-transferase, 

aspartate amino-transferase, and 

alkaline phosphatase), increased 

incidence of pathological observations 

in the liver (hepatocyte hypertrophy, 

vacuolation of hepatocytes, and fatty 

infiltration) and increased relative and 

absolute liver weights. In guideline 

studies, the dog appears to be the most 

sensitive species. 

The developmental toxicity studies in 

rat and rabbit and the multigeneration 

reproduction study did not show 

metalaxyl/mefenoxam to be a 

developmental or reproductive toxicant. 

There was no indication of increased 

susceptibility in pups following 

prenatal and postnatal exposures to 

mefenoxam. In the rat and rabbit 

developmental toxicity studies, in 

which animals were administered 

metalaxyl by gavage at relatively high 

doses, both rat and rabbit dams 

exhibited clinical signs (ataxia, body 

tremors, reduced activity, and righting 

reflex). These clinical signs are believed 

to result from metalaxyl/mefenoxam 

induced bradycardia mediated through 

alpha-adrenoreceptors and not from 

neurotoxicity. 

Metalaxyl has been classified as ‘‘not 

likely to be carcinogenic to humans’’ 

based on the results of a carcinogenicity 


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4544 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 

study in mice and the combined chronic 

toxicity and carcinogenicity studies in 

rats. Based on the classification of 

metalaxyl, mefenoxam is also 

considered ‘‘not likely to be 

carcinogenic to humans.’’ Mutagenicity 

studies do not indicate increased 

mutagenic potential following exposure 

to metalaxyl/mefenoxam. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mefenoxam 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 

‘‘Mefenoxam. Human Health Risk 

Assessment for Proposed Uses on Snap 

Beans and the Caneberry Subgroup, 

Expanded Uses on the Bulb and Green 

Onion Subgroups and the Bushberry 

Subgroup, and Amended Use on 

Spinach.’’ at pages 51–53 in docket ID 

number EPA–HQ–OPP–2009–0713. 

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 mefenoxam used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM 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 13–50 years of 

age and the general population including infants and children).

None. No appropriate endpoint attributable to a single dose was identified. 

Chronic dietary (All populations) ............ NOAEL = 7.41 mg/kg/day, UFA = 10x, 

UFH = 10x, FQPA SF = 1x.

Chronic RfD = 

0.074 mg/kg/day.

cPAD = 0.074 mg/ 

kg/day.

6-Month Feeding (Metalaxyl) Study in 

Dog, LOAEL = 39 mg/kg/day, based 

on increased liver weights and clinical chemistry (alkaline phosphatase). 

Incidental oral short-term (1 to 30 days) NOAEL = 50 mg/kg/day, UFA = 10x, 

UFH = 10x, FQPA SF = 1x.

LOC for MOE = 

100.

Developmental Toxicity in Rat 

(Metalaxyl), LOAEL = 250 mg/kg/ 

day based on clinical signs of toxicity including post-dosing convulsions. 

Incidental oral intermediate-term (1 to 6 

months).

NOAEL = 7.41 mg/kg/day, UFA = 10x, 

UFH = 10x, FQPA SF = 1x.

LOC for MOE = 

100.

6-Month Feeding (Metalaxyl) Study in 

Dog, LOAEL = 39 mg/kg/day based 

on increased liver weights and clinical chemistry (alkaline phosphatase). 

Inhalation short-term (1 to 30 days) ....... Inhalation (or oral) study NOAEL = 50 

mg/kg/day (inhalation absorption 

rate = 100%), UFA = 10x, UFH = 

10x, FQPA SF = 1x.

LOC for MOE = 

100.

Developmental Toxicity in Rat 

(Metalaxyl), LOAEL = 250 mg/kg/ 

day based on clinical signs of toxicity including post-dosing convulsions. 

Cancer (Oral, dermal, inhalation) ........... Classification: ‘‘Not likely to be carcinogenic to humans’’ based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies. 

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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mefenoxam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing mefenoxam tolerances in 40 

CFR 180.546 and metalaxyl tolerances 

in 40 CFR 180.408. EPA assessed dietary 

exposures from mefenoxam/metalaxyl 

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 


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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 4545 

for mefenoxam; 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 U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance-level 

residues for most commodities. 

Additional factors derived from 

available residue chemistry data were 

applied to the tolerance values for leafy 

vegetables, grain seed (including dried 

beans), with the exception of flour 

cereal grains, nut commodities, 

succulent snap beans, and caneberries 

to address concerns regarding the 

adequacy of the residue analytical 

method to determine all metalaxyl/ 

mefenoxam residues of concern, 

including metabolites, in plant and 

animal commodities. This was 

accomplished by calculating parent and 

metabolite to parent ratios to residue 

levels of concern for risk assessment 

purposes. 

Additionally, EPA used DEEM default 

processing factors except where specific 

mefenoxam/metalaxyl tolerances exist 

for processed commodities or where 

metabolism and processing data are 

available to establish specific processing 

factors. Tolerances were used for dried 

apricot, tomato paste, tomato puree, and 

potato processed commodities and a 

data-derived processing factor was 

applied for fruit juices based on 

available metabolism and processing 

data. Finally, the dietary assessment 

incorporated average percent crop 

treated (PCT) information, when 

available, for mefenoxam because it 

showed higher estimates than 

metalaxyl. One hundred PCT was used 

for all other commodities, including the 

proposed uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that mefenoxam 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. Section 

408(b)(2)(F) of FFDCA states that the 

Agency may use data on the actual 

percent of food treated for assessing 

chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Almond, 1% Honeydew, 5% 

Apple, 1% 5% Lemon, 5% 

Artichoke; 5% Lettuce, 10% 

Asparagus, 10% Onion, 30% 

Avocado, 2.5% Orange, 5% 

Blueberry, 1% Peach, 1% 

Broccoli, 10% Peanut, 1% 

Cabbage, 10% Pea, green, 2.5% 

Cantaloupe, 10% Pepper, 15% 

Tomato, 15% Potato, 20% 

Carrot, 35% Pumpkin, 5% 

Cauliflower, 5% Rice, 1% 

Celery, 5% Soybean, 10% 

Cherry, 1% Squash, 10% 

Cotton, 5% Strawberry, 10% 

Cucumber, 10% Sugar beet, 1% 

Dry bean and pea, 1% Sweet corn, 1% 

Garlic, 15% Tangerine, 10% 

Grapefruit, 5% Walnut, 1% 

Grape, 1% Watermelon, 

15% 

In most cases, EPA uses available data 

from the USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6-7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which mefenoxam may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metalaxyl/mefenoxam in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of mefenoxam. 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 Tier II Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) and 

Tier I Screening Concentration in 

Ground Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of mefenoxam for chronic 

exposures for non-cancer assessments 

are estimated to be 36.7 parts per billion 

(ppb) for surface water and 1.72 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 36.7 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). 

Mefenoxam is currently registered for 

the following uses that could result in 

residential exposures: Residential turf 

and ornamentals and recreational turf, 


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4546 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 

such as golf courses and athletic fields. 

EPA assessed residential exposure using 

the following assumptions: Exposure to 

adults may occur from handling 

mefenoxam, and to children from 

postapplication contact with treated 

areas. Therefore, adult handlers were 

assessed for short-term inhalation 

exposure resulting from residential 

application of mefenoxam; 

intermediate-term handler exposure is 

not expected. For children, short- and 

intermediate-term postapplication oral 

exposures (hand-to-mouth, object-tomouth, and incidental ingestion of soil) 

were assessed. Dermal toxicity 

endpoints were not identified for any 

mefenoxam use pattern and chronic 

residential exposure is not expected; 

therefore, these exposure scenarios were 

not assessed. It was also determined that 

postapplication mefenoxam exposures 

to adults and children at recreational 

use sites would be similar to those 

assessed for residential use sites and, 

therefore, a separate recreational 

exposure assessment is not necessary. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

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 mefenoxam to 

share a common mechanism of toxicity 

with any other substances, and 

mefenoxam does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that mefenoxam does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence that mefenoxam 

results in increased susceptibility from 

in utero exposure to rats or rabbits in the 

prenatal developmental studies or 

exposure to young rats in the 2- 

generation reproduction study. 

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 

mefenoxam is complete except for 

immunotoxicity, acute neurotoxicity, 

and subchronic neurotoxicity testing. 

Recent changes to 40 CFR part 158 

require acute and subchronic 

neurotoxicity testing (OPPTS Guideline 

870.6200), and immunotoxicity testing 

(OPPTS Guideline 870.7800) for 

pesticide registration. However, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. The 

available studies do not indicate 

potential for immunotoxicity, as 

evidenced by the lack of effects seen in 

the spleen, thymus, or hematological 

parameters. Also, metalaxyl and 

mefenoxam do not belong to a class of 

compounds (e.g., the organotins, heavy 

metals, or halogenated aromatic 

hydrocarbons) that would be expected 

to be toxic to the immune system. 

ii. With respect to neurotoxicity, 

clinical signs (ataxia, body tremors, 

reduced activity, and righting reflex) 

were observed in maternal animals in 

rat and rabbit developmental studies at 

relatively high doses (≥ 150 mg/kg/day), 

where metalaxyl was administered by 

gavage only. These clinical signs were 

unlikely neurotoxically mediated, but 

rather resulted from the bradycardia 

mediated through alphaadrenoreceptors. Therefore, there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

mefenoxam 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. Although one additional field trial 

with residue decline measures is needed 

to complete the geographic distribution 

for caneberry crops, there are no 

uncertainties in the exposure database 

due to the fact that: (1) There is no 

significant difference in residues in 

blackberry/raspberry samples from field 

trials conducted in four regions 

including the major production region 

(∼70%) and relatively low production 

(6–15%) in the remaining regions; and 

(2) existing decline data indicate that 

residues decline with increasing 

sampling intervals. 

The chronic dietary food exposure 

assessment was somewhat refined, 

using estimated average PCT data, when 

available, and 100 PCT for all other 

commodities. The assessment was also 

performed based on tolerance-level 

residues or additional factors to address 

concerns regarding the adequacy of the 

residue analytical method in some 

commodities and DEEM default 

processing factors unless specific 

tolerances were established for 

processed commodities or metabolism 

and processing data were available to 

establish specific processing factors. 

These assumptions are based on reliable 

data which will not underestimate 

potential dietary exposures. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

mefenoxam 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 mefenoxam. 

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 


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Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 4547 

selected. Therefore, mefenoxam 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 mefenoxam 

from food and water will utilize 60% 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 mefenoxam 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). Mefenoxam is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

mefenoxam. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2,500 for the general U.S. 

population; 920 for children 3–5 years 

old; and 880 for children 1–2 years old. 

Because EPA’s level of concern for 

mefenoxam is a MOE of 100 or below, 

these MOEs are not of concern. 

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). 

Mefenoxam is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to mefenoxam. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 150 for children 

3–5 years old and 140 for children 

1–2 years old. Because EPA’s level of 

concern for mefenoxam is a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mefenoxam 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 mefenoxam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For the purposes of this tolerance 

action, adequate enforcement 

methodologies including a gas-liquid 

chromatography with alkali flameionization detection (GLC/AFID) 

(Method AG–348) and a GLC with 

nitrogen-phosphorus detection (NPD) 

(Method AG–395) are available to 

enforce the tolerance expression for 

plant commodities. However, the 

Agency determined that the current 

residue analytical methods available for 

tolerance enforcement will not 

adequately recover all of the metalaxyl/ 

mefenoxam residues of concern in the 

revised tolerance expression. For this 

action, therefore, the Agency applied 

additional factors derived from available 

residue chemistry data to certain 

commodities to account for all residues 

of concern for dietary risk assessments, 

as previously described in Unit III.C.ii. 

Neither Method AG–348 nor Method 

AG–395 distinguish between the R- and 

S-enantiomers of metalaxyl/mefenoxam; 

however, a confirmatory high 

performance liquid chromatography 

method with mass spectrometric 

detection that utilizes a chiral column 

(chiral LC/MS), Method 456–98, is 

available for the enantioselective 

determination of the D- and Lenantiomers of metalaxyl in crops. 

Therefore, EPA has determined for 

future actions that the multiresidue 

method Protocol D, which completely 

recovers metalaxyl/mefenoxam per se, is 

an adequate enforcement method for the 

determination of metalaxyl/mefenoxam 

per se in plant and livestock 

commodities; and analysis using a 2,6– 

DMA common moiety method, 

including recovery data for parent, 

CGA-62826, and CGA-94689, can be 

used in order to refine dietary risk 

assessments. 

Method AG–;348 may be found in 

PAM Vol. II; Method AG–395 and 

Method 456–98 have been submitted for 

inclusion in PAM Vol. II; and 

Multiresidue method Protocol D may be 

found in PAM, Vol. I Section 302. 

Methods not published in PAM may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail 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. 

Pending revocation of Codex MRLs 

for metalaxyl, Codex MRLs for 

metalaxyl-m (mefenoxam) have not been 

advanced to final status. Therefore, 

there are currently no Codex MRLs 

established for residues of mefenoxam 

in or on the commodities associated 

with this petition. However, with the 

adoption of the revised tolerance 

expression, the U.S. tolerance 

expression will be harmonized with the 

tolerance expression for Codex. 

Canadian MRLs for mefenoxam 

(metalaxyl-m) are covered by MRLs 

established for metalaxyl, and Canadian 

MRLs have been established for residues 

of metalaxyl in or on spinach at 10 ppm, 

bulb onion at 3.0 ppm, green onion at 

10 ppm, bean at 0.2 ppm, raspberry at 

0.2 ppm, and blueberry at 2.0 ppm. The 

Canadian MRLs are harmonized with 

U.S. tolerance levels in or on the 

commodities associated with this 

petition, with the exception of 

caneberry subgroup 13–07A, which is 

being established at 0.70 ppm (the 

Canadian MRL for raspberry is 0.2 

ppm). The U.S. tolerance on caneberry 

subgroup 13–07A cannot be harmonized 

with the Canadian MRL on raspberry at 

this time because the field trial data 

supporting the U.S. tolerance result in 

residues above 0.2 ppm. Additionally, 

with the adoption of the revised 

tolerance expression for mefenoxam, the 

U.S. tolerance expression will not be in 

harmonization with Canadian MRLs. 

C. Revisions to Petitioned-for Tolerances 

Based on analysis of the residue field 

trial data supporting the petition, EPA 

revised the proposed tolerances on 

bean, snap, succulent from 0.35 ppm to 


Emcdonald on DSK2BSOYB1PROD with RULES
4548 Federal Register / Vol. 76, No. 17 / Wednesday, January 26, 2011 / Rules and Regulations 

0.20 ppm; caneberry subgroup 13–07A 

from 0.80 ppm to 0.70 ppm; and 

spinach from 8.0 ppm to 10 ppm. The 

Agency revised these tolerance levels 

based on analysis of the residue field 

trial data using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

Additionally, EPA has revised the 

tolerance expression to clarify: (1) That, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of mefenoxam not 

specifically mentioned; and (2) that 

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 

for residues of mefenoxam, including its 

metabolites and degradates, in or on 

bean, snap, succulent at 0.20 ppm; 

caneberry subgroup 13–07A at 0.70 

ppm; bushberry subgroup 13–07B at 2.0 

ppm; onion, bulb, subgroup 3–07A at 

3.0 ppm; onion, green, subgroup 3–07B 

at 10 ppm; and spinach at 10 ppm. 

Compliance with the specified tolerance 

levels is to be determined by measuring 

only metalaxyl (methyl N-(2,6- 

dimethylphenyl)-N-(methoxyacetyl)-DLalaninate). Additionally, this regulation 

deletes the individual tolerance in or on 

lingonberry at 2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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: January 13, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.546 is amended by 

revising paragraph (a) introductory text; 

removing the entry for ‘‘Lingonberry’’ 

from the table; and alphabetically 

adding the following commodities to the 

table in paragraph (a) to read as follows: 

§ 180.546 Mefenoxam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of mefenoxam, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

metalaxyl (methyl N-(2,6- 

dimethylphenyl)-N-(methoxyacetyl)-DLalaninate). 

Commodity Parts per 

million 

* * * * * 

Bean, snap, succulent ............ 0 .20 

Bushberry subgroup 13–07B .. 2 .0 

Caneberry subgroup 13–07A 0 .70 

* * * * * 

Onion, bulb, subgroup 3–07A 3 .0 

Onion, green, subgroup 3– 

07B ...................................... 10 

* * * * * 

Spinach ................................... 10 

* * * * * 

* * * * * 

[FR Doc. 2011–1655 Filed 1–25–11; 8:45 am] 

BILLING CODE 6560–50–P 


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