Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17579 

Commodity Parts per 

million 

Expiration/ 

Revokation 

Date 

Bermuda 

grass, forage 10 12/31/11 

Bermuda 

grass, hay 25 12/31/11 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–7745 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0141; FRL–8808–9] 

Aminopyralid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of aminopyralid, 

including its metabolites and 

degradates, in or on corn, field, forage; 

corn, field, grain; and corn, field, stover. 

Dow AgroSciences requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

7, 2010. Objections and requests for 

hearings must be received on or before 

June 7, 2010, 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–2009–0141. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left-side 

navigation menu. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2009–0141 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before June 7, 2010. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0141, 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. Petition for Tolerance 

In the Federal Register of May 6, 2009 

(74 FR 20947) (FRL–8412–7), 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 8F7455) by Dow 

AgroSciences, 9330 Zionsville Rd., 

Indianapolis, IN 46268. The petition 

requested that 40 CFR 180.610 be 

amended by establishing tolerances for 

combined residues of the herbicide 

aminopyralid, 4-amino-3,6-dichloro-2- 

pyridinecarboxylic acid, and its glucose 

conjugate, expressed as total parent, in 

or on corn, forage at 0.30 parts per 

million (ppm); corn, grain at 0.20 ppm; 

and corn, stover at 0.20 ppm. That 

notice referenced a summary of the 

petition prepared by Dow AgroSciences, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Comments were 

WReier-Aviles on DSKGBLS3C1PROD with RULES

17580 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

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 petition, EPA has revised 

the corn commodity terminology and 

tolerance expression for aminopyralid. 

The reasons 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 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 the petitioned-for 

tolerances for residues of aminopyralid, 

including its metabolites and 

degradates, on corn, field, forage at 0.30 

ppm; corn, field, grain at 0.20 ppm; and 

corn, field, stover at 0.20 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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 toxicology database for 

aminopyralid includes toxicity studies 

conducted with the acid (XDE-750) and 

the triisopropanolammonium (TIPA) 

salt (GF-871). The acute toxicity data 

indicate that both the acid and salt have 

low toxicity via oral, dermal, and 

inhalation routes of exposure; and that 

neither is a skin irritant or skin 

sensitizer. The TIPA salt is not irritating 

to the eye; however, aminopyralid acid 

is severely irritating to the eye. 

Longer term studies indicate that the 

stomach, ileum, and cecum are targets 

for aminopyralid. In a subchronic 

feeding study in rats (XDE-750), 

hyperplasia of the mucosal epithelium 

of the ileum and cecum was observed at 

the highest dose tested (HDT) of 1,000 

milligrams/kilograms/day (mg/kg/day). 

Chronic exposure in rats (XDE-750) also 

resulted in hyperplasia of the mucosal 

epithelium, along with cecal 

enlargement and decreased body 

weights at a lower dose of 500 mg/kg/ 

day. Hypertrophy and hyperplasia of the 

mucosal epithelium were seen after 

subchronic exposure in dogs (XDE-750) 

at the HDT of 929 mg/kg/day. 

Thickening of the stomach mucosa 

(females), hyperplasia and hypertrophy 

of the mucosal epithelium, slight 

lymphoid hyperplasia of the gastric 

mucosa, and very slight/slight chronic 

mucosal inflammation were observed in 

dogs after chronic exposure at the HDT 

of 967 mg/kg/day. No adverse effects 

were observed in subchronic or chronic 

feeding studies in mice. 

Stomach effects were also observed in 

a developmental toxicity study in 

rabbits conducted with the acid (XDE750). Ulcers and erosions were seen in 

the glandular mucosa of the stomach at 

500 mg/kg/day in maternal animals. 

Other effects noted were decreased body 

weights and incoordinated gait. No 

developmental effects were seen in 

fetuses at 500 mg/kg/day. The high dose 

group was removed from the study 

because of the severity of the clinical 

signs that were observed (incoordinated 

gait, significant body weight losses, and 

decreased food intake). In another 

developmental rabbit study conducted 

with the TIPA salt (GF-871), severe 

inanition (exhaustion from lack of food), 

body weight loss, decreased fecal 

output, and incoordinated gait were 

observed at 260 mg/kg/day. At 520 mg/ 

kg/day, decreased fetal body weights 

were observed. No effects were noted in 

developmental toxicity studies in rats 

with XDE-750 or GF-871 or a 

reproduction study in rats with XDE750. There was no qualitative or 

quantitative evidence of increased 

susceptibility of fetuses or offspring in 

any of the developmental and 

reproduction toxicity studies conducted 

with aminopyralid. 

No systemic toxic effects were 

observed in a 28–day dermal toxicity 

study in rats with XDE-750; however, 

dermal toxicity was indicated by slight 

epidermal hyperplasia in males at 1,000 

mg/kg/day. 

In an acute neurotoxicity study in rats 

(XDE-750), fecal soiling in males and 

urine soiling in females were observed 

at 2,000 mg/kg/day. No adverse effects 

were observed in a chronic 

neurotoxicity study in rats up to 1,000 

mg/kg/day. 

Aminopyralid is classified as ‘‘not 

likely to be carcinogenic to humans.’’ No 

increase in any tumors was found in 

carcinogenicity studies in rats and mice. 

Aminopyralid was negative in all 

mutagenicity studies, except for an in 

vitro chromosome aberration assay in 

Sprague Dawley rats. In this assay, XDE750 induced chromosome aberrations, 

but only at cytotoxic concentrations. 

The clastogenic response was induced 

secondarily to toxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by aminopyralid 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 the document 

‘‘Aminopyralid. Human Health Risk 

Assessment for the Proposed Use on 

Field Corn (PP#8F7455)’’ at page 40 in 

docket ID number EPA–HQ–OPP–2009– 

0141. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17581 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

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 greater than that 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 aminopyralid used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document ‘‘Aminopyralid: Human 

Health Risk Assessment for the 

Proposed Use on Field Corn 

(PP#8F7455)’’ at page 20 in docket ID 

number EPA–HQ–OPP–2009–0141. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to aminopyralid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing aminopyralid tolerances in 40 

CFR 180.610. EPA assessed dietary 

exposures from aminopyralid 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 aminopyralid; 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 Survey of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed that residues are 

present in all commodities at the 

tolerance level and that 100% of 

commodities are treated with 

aminopyralid. The Dietary Exposure 

Evaluation Model (DEEM)(tm) 7.81 

default concentration factors were used 

to estimate residues of aminopyralid in 

processed commodities. 

iii. Cancer. Based on the results of 

carcinogenicity studies in rats and mice, 

EPA classified aminopyralid as ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, an exposure assessment to 

evaluate cancer risk is unnecessary for 

this chemical. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for aminopyralid. Tolerance level 

residues and 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 aminopyralid in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

aminopyralid. 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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

aminopyralid for chronic exposures for 

non-cancer assessments (the only 

dietary exposure scenario of concern for 

aminopyralid) are estimated to be 1.937 

parts per billion (ppb) for surface water 

and 0.63 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 1.937 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). 

Aminopyralid is currently registered 

for the following uses that could result 

in residential exposures: Natural 

recreation areas, such as wildlife 

management areas, campgrounds, 

trailheads and trails. EPA assessed 

residential exposure using the following 

assumptions: 

Aminopyralid is not applied by 

homeowners to residential or 

recreational settings; therefore, only 

post-application residential exposures 

were considered. A dermal endpoint of 

concern has not been identified for 

aminopyralid and postapplication 

inhalation exposure following treatment 

of recreation areas is expected to be 

negligible for adults and children. There 

is, however, the potential for short-term 

postapplication oral exposure of 

children playing in areas treated with 

aminopyralid. EPA assessed the 

following incidental oral exposure 

scenarios: Hand-to-mouth transfer of 

residues; object-to-mouth transfer of 

residues; and ingestion of soil 

containing aminopyralid residues. 

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 aminopyralid to 

share a common mechanism of toxicity 

with any other substances, and 

aminopyralid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that aminopyralid 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 website 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 

Factors (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 prenatal and postnatal toxicity 

database for aminopyralid includes 

harmonized guideline rat and rabbit 

developmental toxicity studies for both 

the acid and TIPA salt of aminopyralid 

and a two-generation reproduction 

toxicity study in rats conducted using 

aminopyralid acid. As discussed in Unit 

III.A (Toxicological Profile), there is no 

WReier-Aviles on DSKGBLS3C1PROD with RULES

17582 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

quantitative or qualitative evidence of 

increased susceptibility of fetuses or 

offspring in any of these studies. 

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 

aminopyralid is adequate to assess preand postnatal toxicity. In accordance 

with 40 CFR part 158 Toxicology Data 

requirements, an immunotoxicity study 

(guideline 870.7800) is required for 

aminopyralid. In the absence of specific 

immunotoxicity studies, EPA has 

evaluated the available aminopyralid 

data to determine whether an additional 

uncertainty factor is needed to account 

for potential immunotoxicity. The 

toxicology database for aminopyralid 

does not show any evidence of 

treatment-related effects on the immune 

system. The overall weight-of-evidence 

suggests that this chemical does not 

directly target the immune system, and 

the Agency does not believe that 

conducting a functional immunotoxicity 

study will result in a lower POD than 

that currently used for overall risk 

assessment. Therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for the lack of this study. 

ii. No evidence of neurotoxicity was 

observed in acute or chronic 

neurotoxicity studies. Incoordinated 

gait, along with a lack of ambulatory 

movement, was observed in 

developmental toxicity studies (XDE750 and GF-871) in rabbits at 500 mg/ 

kg/day. However, the incoordination 

was transient (complete resolution 

within 2 hours postdosing) and 

considered to be a result of frank 

toxicity, rather than a neurotoxic event. 

Additionally, no signs of neurotoxicity 

were observed in other toxicity studies, 

and no evidence of quantitative or 

qualitative susceptibility was observed 

in developmental toxicity studies in rats 

or rabbits or a reproduction study in 

rats. Based on these findings, EPA has 

concluded that there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

aminopyralid results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

offspring in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to aminopyralid 

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 aminopyralid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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, aminopyralid 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 aminopyralid 

from food and water will utilize <1% of 

the cPAD for the general U.S. 

population and all population 

subgroups, including children 1 to 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 aminopyralid 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). Aminopyralid 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 

aminopyralid. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of between 25,000 

and 33,000 for children’s population 

subgroups. The aggregate MOEs include 

dietary exposures from food and 

drinking water as well as 

postapplication incidental oral exposure 

of children and toddlers playing in 

recreational areas treated with 

aminopyralid. Although short-term 

residential postapplication exposure of 

adults could result from the use of 

aminopyralid, inhalation exposures are 

expected to be negligible and a dermal 

endpoint of concern has not been 

identified for aminopyralid. Therefore, 

the short-term aggregate risk for adults 

is the sum of the risk from exposure to 

aminopyralid through food and water, 

which has already been addressed, 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). 

Aminopyralid 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 aminopyralid 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 a lack of evidence 

for carcinogenicity in mice and rats 

following long-term dietary 

administration, aminopyralid is not 

expected to pose a cancer risk. 

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 

aminopyralid residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

Liquid Chromatography/Mass 

Spectrometry/Mass Spectrometry (LC/ 

MS/MS), Method GRM 07.07, 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; e-mail address: 

residuemethods@epa.gov. 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17583 

B. International Residue Limits 

No Codex, Canadian or Mexican 

MRLs have been established for corn 

commodities. 

C. Response to Comments 

EPA received comments from an 

anonymous submitter objecting to 

pesticides and other ‘‘toxic’’ chemicals 

generally and recommending against 

any tolerances greater than zero for this 

product. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, the existing legal 

framework provided by section 408 of 

the FFDCA contemplates that tolerances 

greater than zero may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. This 

submitter’s comments appear to be 

directed at the underlying statute and 

not EPA’s implementation of it; the 

citizen has made no contention that 

EPA has acted in violation of the 

statutory framework. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the commodity terms 

‘‘corn, forage,’’ ‘‘corn, grain,’’ and ‘‘corn, 

stover,’’ to read ‘‘corn, field, forage,’’ 

‘‘corn, field, grain,’’ and ‘‘corn, field, 

stover’’ to agree with the Agency’s Food 

and Feed Commodity Vocabulary. 

EPA is also revising the tolerance 

expression for existing tolerances and 

the new tolerances on corn commodities 

to clarify the chemical moieties that are 

covered by the tolerances and specify 

how compliance with the tolerances is 

to be measured. Plant tolerances are 

currently expressed in terms of ‘‘free and 

conjugated residues of the herbicide 

aminopyralid, 2-pyridine carboxylic 

acid, 4-amino-3,6-dichloro-, calculated 

as aminopyralid.’’ Livestock tolerances 

are currently expressed in terms of 

‘‘residues of the herbicide 

aminopyralid.’’ The tolerance expression 

for plants is being revised to make clear 

that the tolerances cover residues of 

aminopyralid, 4-amino-3,6-dichloro-2- 

pyridinecarboxylic acid, including its 

metabolites and degradates. Compliance 

with the tolerances is to be determined 

by measuring only free and conjugated 

aminopyralid. Similarly, the tolerance 

expression for livestock commodities is 

being revised to clarify that the 

tolerances cover residues of 

aminopyralid, including its metabolites 

and degradates, but that compliance 

with the tolerance levels will be 

determined by measuring only 

aminopyralid. 

EPA has determined that it is 

reasonable to make these changes final 

without prior proposal and opportunity 

for comment, because public comment 

is not necessary, in that the changes 

have no substantive effect on the 

tolerances, but rather are merely 

intended to clarify the existing tolerance 

expressions. 

V. Conclusion 

Therefore, tolerances are established 

for residues of aminopyralid, 4-amino3,6-dichloro-2-pyridinecarboxylic acid, 

including its metabolites and 

degradates, in or on corn, field, forage 

at 0.30 ppm; corn, field, grain at 0.20 

ppm; and corn, field, stover at 0.20 

ppm. Compliance with these tolerance 

levels is to be determined by measuring 

only free and conjugated aminopyralid. 

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) (Public Law 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: March 26, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

WReier-Aviles on DSKGBLS3C1PROD with RULES

17584 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

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 180.610 is amended by 

revising the introductory text in 

paragraphs (a)(1) and (a)(2) and 

alphabetically adding commodities to 

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

follows: 

§ 180.610 Aminopyralid; tolerances for 

residues. 

(a) * * * (1) Tolerances are established 

for residues of the herbicide 

aminopyralid, 4-amino-3,6-dichloro-2- 

pyridinecarboxylic acid, 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 free and conjugated 

aminopyralid. 

Commodity Parts per million 

Corn, field, forage .................................................................................................... 0.30 

Corn, field, grain ...................................................................................................... 0.20 

Corn, field, stover .................................................................................................... 0.20 

*** * *

(2) Tolerances are established for 

residues of the herbicide aminopyralid, 

4-amino-3,6-dichloro-2- 

pyridinecarboxylic acid, 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 aminopyralid. 

* * * * * 

[FR Doc. 2010–7749 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

[CC Docket No. 02–6; FCC 09–105] 

Schools and Libraries Universal 

Service Support Mechanism 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) addresses matters related 

to the eligibility of products and 

services under the schools and libraries 

universal service support mechanism, 

also known as the E-rate program. First, 

in the Report and Order, the 

Commission modifies its rules to 

expressly include interconnected voice 

over Internet protocol (VoIP) and text 

messaging as eligible services under the 

E-rate program. Second, in the process 

of releasing the list of services that will 

be eligible for discounts for E-rate 

funding year 2010, the Commission 

clarifies the E-rate program eligibility of 

video on-demand servers, ethernet, web 

hosting, wireless local area network 

(LAN) controllers, and virtualization 

software. It also finds that telephone 

broadcast messaging, unbundled 

warranties, power distribution units, 

softphones, interactive white boards, 

and e-mail archiving are ineligible for 

E-rate program funding. 

DATES: Effective May 7, 2010. 

FOR FURTHER INFORMATION CONTACT: Cara 

Voth, Wireline Competition Bureau, 

Telecommunications Access Policy 

Division, (202) 418–7400 or TTY: (202) 

418–0484. 

SUPPLEMENTARY INFORMATION: This is a 

synopsis of the Commission’s Report 

and Order in CC Docket No. 02–6, FCC 

09–105, adopted December 1, 2009, and 

released December 2, 2009. The 

complete text of this document is 

available for inspection and copying 

during normal business hours in the 

FCC Reference Information Center, 

Portals II, 445 12th Street, SW., Room 

CY–A257, Washington, DC 20554. The 

document may also be purchased from 

the Commission’s duplicating 

contractor, Best Copy and Printing, Inc., 

445 12th Street, SW., Room CY–B402, 

Washington, DC 20554, telephone (800) 

378–3160 or (202) 863–2893, facsimile 

(202) 863–2898, or via the Internet at 

http://www.bcpiweb.com. It is also 

available on the Commission’s Web site 

at http://www.fcc.gov. 

People with Disabilities: To request 

materials in accessible formats for 

people with disabilities (braille, large 

print, electronic files, audio format), 

send an e-mail to fcc504@fcc.gov or call 

the Consumer & Governmental Affairs 

Bureau at 202–418–0530 (voice), 202– 

418–0432 (tty). 

Synopsis of the Report and Order 

I. Introduction 

1. In the Report and Order, we 

conclude that interconnected VoIP 

service is eligible for E-rate support and 

should continue to be an eligible service 

under the E-rate program. We also 

conclude that text messaging is eligible 

for E-rate support. In response to the 

2010 ESL Public Notice, we clarify the 

E-rate program eligibility of video ondemand servers, ethernet, web hosting, 

wireless local area network (LAN) 

controllers, and virtualization software. 

We find that telephone broadcast 

messaging, unbundled warranties, 

power distribution units, softphones, 

interactive white boards, and e-mail 

archiving are ineligible for E-rate 

program funding. Finally, we release the 

Eligible Services List (ESL) for E-rate 

funding year 2010. 

II. Background 

2. Under the E-rate program, eligible 

schools, libraries, and consortia that 

include eligible schools and libraries 

may receive discounts for eligible 

telecommunications services, Internet 

access, and internal connections. 

Section 254 of the Communications Act 

of 1934, as amended (the Act), gives the 

Commission the authority to designate 

‘‘telecommunications services’’ and 

certain additional services eligible for 

support under the E-rate program. The 

Commission may also designate services 

eligible for E-rate support as part of its 

authority to enhance, to the extent 

technically feasible and economically 

reasonable, access to advanced 

telecommunications and information 

services for all public and non-profit 

elementary and secondary school 

classrooms and libraries. 

3. Since the initial implementation of 

the E-rate program in 1998, and 

consistent with the Commission’s rules 

and requirements, USAC has developed 

procedures and guidelines to ensure 

that E-rate funding is provided only for 

eligible services. Initially, the 

Commission directed USAC, in 

consultation with the Commission, to 

determine whether particular services 

fell within the eligibility criteria 

established under the Act and the 

Commission’s rules and policies. USAC 

began to update and post to its Web site 

on an annual basis a list of services and 

products eligible to receive discounts 

under the E-rate program, now known 

as the ESL. In consultation with the 

Wireline Competition Bureau (Bureau), 

USAC updated the list to reflect any 

WReier-Aviles on DSKGBLS3C1PROD with RULES