59106 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

EPA APPROVED ALABAMA REGULATIONS—Continued 

State citation Title/subject State 

effective date EPA approval date Explanation 

Section 335– 

3–14–.04.

Air Permits Authorizing Construction in Clean Air Areas 

[:prevention of Significant 

Deterioration (PSD)].

May 23, 

2011.

9–26–12 ..................................

[Insert citation of publication]. 

As of [Insert date of publication in FEDERAL

REGISTER] Section 335–3–14–.04 does not 

include Alabama’s revision to adopt the 

PM2.5 SILs threshold and provisions (as 

promulgated in the October 20, 2010 PM2.5

PSD Increment-SILs-SMC Rule at 40 CFR 

1.166(k)(2) and the term ‘‘particulate matter 

emissions’’ (as promulgated in the May 16, 

2008 NSR PM2.5 Rule (at 40 CFR 

51.166(b)(49)(vi)). 

* * * * * * * 

Chapter No. 335–3–17 Conformity of Federal Actions to State Implementation Plans 

Section 335– 

3–17.01.

Transportation Conformity ....... May 23, 

2011.

9–26–12 ..................................

[Insert citation of publication]. 

Section 335– 

3–17–.02.

General Conformity ................. May 23, 

2011.

9–26–12 ..................................

[Insert citation of publication]. 

* * * * * * * 

* * * * * 

[FR Doc. 2012–23586 Filed 9–25–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0813; FRL–9363–6] 

Glufosinate Ammonium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of glufosinate 

ammonium in or on multiple 

commodities which are identified and 

discussed later in this document. 

Interregional Research Project Number 4 

(IR–4) and Bayer CropScience requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 26, 2012 except for the 

addition of the tolerance for Fruit, stone, 

group 12–12 to the table in § 180.473 (a), 

which is effective October 22, 2012. 

Objections and requests for hearings 

must be received on or before November 

26, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0813, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; email address: 

jackson.sidney@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0813 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 November 26, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59107 

may be disclosed publicly by EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0813, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-for Tolerance 

In the Federal Registers of January 6, 

2010 (75 FR 864) (FRL–8801–5) and 

March 19, 2010 (75 FR 13277) (FRL– 

8813–2), EPA issued notices pursuant to 

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

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

pesticide petitions; (PP 9E7604) by 

Interregional Research Project Number 4 

(IR–4), IR–4 Project Headquarters, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08540 and (PP 9F7655) by 

Bayer CropScience LP, 2 T. W. 

Alexander Drive, Research Triangle 

Park, NC 27709, respectively. The 

petitions requested that 40 CFR 180.473 

be amended by establishing tolerances 

for residues of the herbicide glufosinate 

ammonium, butanoic acid, 2-amino-4- 

(hydroxymethylphosphinyl)- 

monoammonium salt, and its 

metabolites, 2-acetylamino-4- 

methylphosphinico-butanoic acid and 

3-methylphosphinico-propionic acid, 

calculated as the stoichiometric 

equivalent of 2-amino-4- 

(hydroxymethylphosphinyl), in or on 

corn, sweet, forage at 4.0 parts per 

million (ppm); corn, sweet, kernel plus 

cob with husks removed at 0.2 ppm; 

corn, sweet, stover at 6.0 ppm (PP 

9E7604); citrus, fruit (crop group 10) at 

0.05 ppm; olives at 0.05 ppm; pome, 

fruit (crop group 11) at 0.10 ppm; and 

stone fruit (crop group 12) at 0.10 ppm 

(PP 9F7655). These notices referenced a 

summary of the petition prepared by 

Bayer CropScience LP, 2 T. W. 

Alexander Drive, Research Triangle 

Park, NC 27709, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices of filing. 

Based upon review of the data 

supporting the petition, EPA is: (1) 

Correcting certain crop definitions to 

comply with current Agency policies; 

(2) establishing tolerance levels for 

certain commodities other than the 

proposed levels; (3) removing the 

proposed tolerance for plum, prune, 

dried; (4) modifying the crop group 

tolerances requested to the revised and 

expanded citrus fruit group 10–10, 

pome fruit group 11–10 and stone fruit 

group 12–12; and 5) revising 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 FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for glufosinate 

ammonium including exposure 

resulting from the tolerances established 

by this action. EPA’s assessment of 

exposures and risks associated with 

glufosinate ammonium follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Technical grade glufosinate 

ammonium has low toxicity in the oral, 

dermal, inhalation studies and is not an 

eye or dermal irritant or a dermal 

sensitizer. 

Subchronic toxicity studies in rats 

showed inhibition of glutamate 

synthetase and lead the Agency to 

conclude that the changes in brain 

glutamine synthetase activity are of 

significant concern for possible 

neurotoxicity and/or expression of 

clinical signs. Observed alterations in 

liver and kidney glutamate synthetase 

are considered an adaptive response. 

The primary effects in the mouse 

subchronic study were increased liver 

and kidney weights with increases in 

serum aspartate amino transferase and 

alkaline phosphatase. 

Additional toxicity testing was 

conducted with the L-isomer of 

glufosinate ammonium, and degradates 

glufosinate propanoic acid (MPP), and 

2-acetamido-4-methylphosphinicobutanoic acid (NAG). These compounds, 

tested in subchronic rat, mouse, and dog 

studies, and in developmental toxicity 

studies in rat and rabbit, are generally 

less toxic than the parent compound. 

However, L-isomer of glufosinate 

ammonium was found to be slightly 

more toxic than the racemic parent 

compound. This finding is not concern 

since this isomer is included in the 

toxicity testing of the parent compound 

at the levels in the technical material. 

In chronic studies in the rat, 

inhibition of brain glutamine 

synthetase, increased mortality, and 

increased occurrence of retinal atrophy 

were noted, as were increased liver and 

kidney weights. In the mouse, increased 

mortality was noted, as were changes in 

glucose levels consistent with changes 

in glutathione levels. Increased 

mortality and electrocardiogram 

alterations were observed in dogs. The 

developmental toxicity study in the rat 

produced dilated renal pelvis and/or 

hydroureter in the fetuses at levels that 

produced significant increases in 

hyperactivity and vaginal bleeding in 

dams. In the rabbit, decreased fetal body 

weight and increased mortality were 

observed at 20 milligrams/kilogram/day 

(mg/kg/day), while in rabbit dams, 

decreased food consumption, body 

weight, and body weight gain were 

observed at 20 mg/kg/day. Since 

increased fetal mortality was observed 

in the presence of less severe maternal 

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59108 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

toxicity in the rabbit developmental 

study, there is evidence of qualitative 

increased susceptibility in fetuses. 

The reproductive toxicity study in 

rats indicated postnatal developmental 

toxicity at the highest dose tested in the 

form of decrease in viable pups. No 

parental toxicity was seen at the highest 

dose tested. Since pup mortality was 

observed in the absence of parental 

toxicity, there is evidence of 

quantitative increased susceptibility in 

offspring. 

There were indications of 

neurotoxicity in several studies. Of 

particular concern is that the 

developmental neurotoxicity study 

demonstrated alterations in brain 

morphometrics in the adult offspring 

exposed in utero or during lactation at 

dose levels not associated with maternal 

toxicity. Retinal atrophy was observed 

in a rat oral study. In the 90-day dietary 

neurotoxicity study, increases in the 

incidence of decreased exploratory 

activity, decreased alertness, and 

decreased startle response, increased 

incidence of fearfulness, increased pain 

response and meiosis were reported. 

The subchronic dermal toxicity study 

indicated aggressive behavior, a high 

startle response and piloerection. The 

28-day subchronic inhalation study 

demonstrated tono-clonic convulsions 

at the high dose in at least some males. 

However, in a 37-day dietary 

neurotoxicity study, there was no 

evidence of neurotoxicity at doses up to 

143.3 mg/kg/day. There was no 

evidence of neurotoxicity in two acute 

neurotoxicity studies at doses up to 500 

mg/kg/day. Also, there was no evidence 

of neurotoxicity in White Leghorn hens 

following an acute dose of up to 10,000 

mg/kg. Changes in glutamine synthetase 

levels were observed in liver, kidney, 

and brain in rats. The altered 

electrocardiograms seen in the dog 

studies imply a possible neuromuscular 

effect. 

There is no concern for 

immunotoxicity based on an adequate 

database. 

There is no concern for mutagenic 

activity in several available studies 

including: Salmonella E. Coli, in vitro 

mammalian cell gene mutation assays, 

mammalian cell chromosome aberration 

assays, in vivo mouse bone marrow 

micronucleus assays, and unscheduled 

DNA synthesis assays. 

Glufosinate ammonium was classified 

as ‘‘not likely to be a human 

carcinogen.’’ There was no evidence of 

a treatment-related increase in tumors in 

either rats or mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by glufosinate ammonium 

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

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Glufosinate Ammonium. 

Updated Human Health Risk 

Assessment for the Proposed New Use 

of Glufosinate Ammonium in/on Citrus 

Fruit (Crop Group 10), Pome Fruit (Crop 

Group 11), Stone Fruit (Crop Group 12), 

Olives and Sweet Corn’’, dated July 25, 

2012 at page number 34 in docket ID 

number EPA–HQ–OPP–2009–0813. 

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 glufosinate ammonium 

used for human risk assessment is 

shown in the following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR GLUFOSINATE AMMONIUM 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 (General Population, including Infants and Children).No endpoint attributable to a single exposure was identified for the general population, including infants and children. 

Acute dietary (Females 13–50 years of 

age).

NOAEL = 6.3 mg/ 

kg/day.

UFA = 10x .............

UFH = 10x .............

FQPA SF = 1x ......

aRfD = 0.063 mg/ 

kg/day.

aPAD = 0.063 mg/ 

kg/day.

Developmental Toxicity Study in Rabbits. 

LOAEL = 20 mg/kg/day based on increased fetal deaths. 

Chronic dietary (All populations) ............ NOAEL = 6 mg/kg/ 

day.

UFA = 10x .............

UFH = 10x .............

FQPA SF = UFL = 

10x.

cRfD = cPAD = 

0.006 mg/kg/day.

‘‘Weight of evidence’’ approach from four studies. Rat 

subchronic and chronic studies with the LOAEL based 

on inhibition of brain glutamate synthetase. A dog 

chronic study with the LOAEL based on altered electrocardiogram and mortality. The rat developmental 

neurotoxicity study with a LOAEL (without a NOAEL, 

basis for UFL) based on altered morphometrics in the 

offspring as adults. 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59109 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR GLUFOSINATE AMMONIUM FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—Continued 

Exposure/Scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Dermal short-term (1 to 30 days) ........... LOAEL= 14 mg/kg/ 

day (LDT).

UFA=10x ...............

UFH=10x ...............

FQPA SF= UFL= 

10x.

LOC for MOE = 

1,000.

Developmental Neurotoxicity Study in Rats 

LOAEL = 14 mg/kg/day based on brain morphometric 

changes at PND 72. No NOAEL identified. 

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. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to glufosinate ammonium, 

EPA considered exposure under the 

petitioned-for tolerances as well as all 

existing glufosinate ammonium 

tolerances in 40 CFR 180.473. EPA 

assessed dietary exposures from 

glufosinate ammonium 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. 

Such effects were identified for 

glufosinate ammonium for females 13 

through 50 years old. In estimating 

acute dietary exposure assessment of 

glufosinate ammonium, EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database DEEM–FCIDTM, Version 

3.10, which incorporates consumption 

data from USDA’s National Health and 

Nutrition Examination Survey/‘‘What 

We Eat in America’’ (NHANES/WWEIA) 

dietary survey conducted in 2003–2008. 

The 2003–2008 data are based on the 

reported consumption of individuals 

over two non-consecutive survey days. 

As to residue levels in food, EPA 

assumed tolerance level residues for all 

established and recommended 

tolerances along with default processing 

factors, and 100 percent crop treated 

(PCT) assumptions. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA also used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database DEEM–FCIDTM, Version 3.10. 

As to residue levels in food, EPA used 

anticipated residues based on average 

residue levels from field trial studies. 

The DEEM default processing factors 

were used for all commodities except 

apple juice, pear juice, grape juice, and 

raisins, for which factors derived from 

the processing studies were used in the 

assessment. One hundred percent crop 

treated values were used for all 

proposed new uses and some registered 

uses. Average PCT estimates were used 

in the chronic dietary analysis for crops 

that are currently registered for 

glufosinate ammonium if available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that glufosinate ammonium 

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)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

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 average 

PCT for existing uses as follows: 

Almond: 15%; blueberry: 5%; field 

corn, 5%; grape, 15%; pecan, 1%; 

potato, 10%; soybean, 1%; walnut, 10%; 

canola, 25%; cotton, 5%; filbert, 10%; 

pistachio, 20%; and rice, 1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/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 

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59110 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

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 glufosinate ammonium may be 

applied in a particular area. 

2. Dietary exposure from drinking 

water. The Agency used refined 

drinking water exposure models in the 

dietary exposure analysis and risk 

assessment for glufosinate ammonium. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

glufosinate ammonium. 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. 

Environmental fate studies indicate 

glufosinate ammonium is relatively 

stable and is very mobile. The main 

degradation pathway in water and soil 

is via microbial action, metabolizing 

primarily to CO2, glufosinate propanoic 

acid (MPP), 2-methylphosphinico acetic 

acid (MPA), and 2-acetamido-4- 

methylphosphinico-butanoic acid 

(NAG). EPA recently reconsidered the 

appropriate residues of concern for 

drinking water to be used in risk 

assessment and determined that only 

the parent, glufosinate ammonium is the 

residue of concern for drinking water. 

Though MPA is a major degradate in 

some studies, a 90-day rat feeding study 

showed no effects at the highest dose 

tested which is about 100-fold higher 

than the NOAEL of the parent. Based on 

the rabbit developmental studies NAG is 

considered slightly less toxic than the 

parent. However, it was only observed 

as a major degradate during photolysis 

in soil; therefore, its exposure is 

significantly lower to that of the parent 

in drinking water. The parent 

glufosinate ammonium and MPP show 

different toxicities and therefore should 

not be aggregated. Moreover, the Agency 

has determined that the acute 

concentrations of MPP are not likely to 

be significantly greater than that of 

glufosinate in drinking water. However, 

given the minimal fate data available for 

MPP that indicates MPP does not 

degrade in aerobic aquatic 

environments, it is unclear if this will 

be true for chronic concentrations of 

MPP and glufosinate. Since MPP is 

considered less toxic than the parent 

compound and should not be aggregated 

with the parent, EPA concluded that if 

estimated drinking water concentrations 

(EDWCs) of MPP are not significantly 

greater than those for glufosinate, the 

risk assessment for the parent will be 

protective of any toxicity associated 

with exposure to MPP in drinking 

water. 

Previous analyses for glufosinate 

ammonium demonstrated that the 

maximum acute and chronic EDWCs 

result from surface water estimates 

arising from the rice use; the surface 

water values for rice are nearly an order 

of magnitude higher than any surface or 

ground water values for any other use of 

glufosinate ammonium. Therefore, a 

comprehensive refinement of the 

drinking water assessment for the rice 

use of glufosinate ammonium, should be 

protective of other uses. 

The Agency estimated acute EDWCs 

for glufosinate ammonium and MPP 

using the Tier I Rice Model and 

Pesticide Flooded Application Model 

(PFAM) [version 0.70] without the index 

reservoir. To estimate chronic EDWCs, 

the acute concentrations from PFAM 

without the index reservoir were 

assumed to degrade over a 365-day 

period, using aerobic aquatic 

degradation half-lives; thus allowing 

calculation of average concentrations 

over a one-year period. This method 

results in chronic values approximately 

76% and 3% lower than the acute 

values for glufosinate-ammonium and 

MPP, respectively. 

The EDWCs for surface water are 

expected to be 390 parts per billion 

(ppb) for glufosinate and 183 ppb for 

MPP for acute exposures. The EDWCs 

for surface water are expected to be 95 

ppb for glufosinate and 177 ppb for MPP 

for chronic exposures. The maximum 

chronic EDWC for rice for MPP is 

approximately 2X higher than the 

corresponding value for glufosinate: 177 

and 95 ppb, respectively. Since MPP is 

considered less toxic than the parent 

compound and should not be aggregated 

with the parent, EPA concluded that if 

the EDWCs for MPP are not significantly 

greater than those for glufosinate, the 

risk assessment for the parent will be 

protective of any toxicity associated 

with exposure to MPP in drinking 

water. Given the estimated EDWCs for 

MPP concentrations are not likely to be 

more than twice the corresponding 

levels of glufosinate in drinking water, 

EPA concluded a quantitative risk 

assessment for MPP in drinking water is 

not needed. Accordingly, for purposes 

of acute and chronic dietary analyses, 

the recommended glufosinate EDWCs 

are 390 and 95 ppb, respectively. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 390 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 95 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). 

Glufosinate ammonium is currently 

registered for the following uses that 

could result in residential exposures: 

spot treatments of lawns and turf. EPA 

assessed residential exposure using the 

following assumptions: 

Residential handler exposure is 

expected to be short-term. Intermediateterm exposures are not likely because of 

the intermittent nature of applications 

by homeowners. Dermal and inhalation 

exposures are possible for applications 

from mixing/loading/applying liquids 

with a hose-end sprayer, a backpack 

sprayer, and a sprinkler can and 

applications for manually pressurized 

handgun. However, only the dermal 

route of exposure was included in the 

aggregate analysis since potential 

dermal risks are higher than potential 

inhalation risks and the EPA 

determined it is not appropriate to 

aggregate the dermal and inhalation 

exposures since the toxicity endpoints 

are different. 

The Agency did not quantify postapplication exposures. Post-application 

exposure is expected to be minimal. 

Any exposure to children via incidental 

non-dietary ingestion (i.e., hand-tomouth, object-to-mouth (turfgrass), and 

soil ingestion) after application to 

treated turf is expected to be low since 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59111 

treatments to lawns and turf are limited 

to spot treatments. 

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 glufosinate 

ammonium to share a common 

mechanism of toxicity with any other 

substances, and glufosinate ammonium 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that glufosinate ammonium 

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. 

The reproductive toxicity study in rats 

indicated postnatal developmental 

toxicity at the highest dose tested in the 

form of decrease in viable pups. No 

parental toxicity was seen at the highest 

dose tested. Since pup mortality was 

observed in the absence of parental 

toxicity, there is evidence of 

quantitative increased susceptibility in 

offspring. Although in the rat 

developmental toxicity study dilated 

renal pelvis and hydroureter were 

observed in fetuses at 250 mg/kg/day, 

significant toxicity in the dams occurred 

at lower doses (vaginal bleeding and 

hyperactivity in the dams at 50 mg/kg/ 

day), doses at which no developmental 

effects were observed. Therefore, no 

increased sensitivity was seen in this 

study. 

Since increased fetal mortality was 

observed in the presence of less 

significant maternal toxicity in the 

rabbit developmental study, there is 

evidence of qualitative increased 

susceptibility in fetuses. Finally, the 

developmental neurotoxicity study 

demonstrated alterations in brain 

morphometrics in the adult offspring 

exposed in utero or during lactation at 

dose levels not associated with maternal 

toxicity. This shows quantitative 

sensitivity in the young. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA safety 

factor were reduced to 1X for acute 

dietary exposure. For all other exposure 

scenarios where the developmental 

neurotoxicity study or the 28-day 

inhalation study is used as an endpoint 

for risk assessment, EPA is retaining a 

10X FQPA safety factor. That decision is 

based on the following findings: 

i. Although all required studies for 

glufosinate ammonium have been 

submitted, the glufosinate ammonium 

database has a completeness issue in 

that the developmental neurotoxicity 

and the 28-day inhalation studies used 

for risk assessment did not demonstrate 

NOAELs, and LOAELs were used as 

endpoints. Therefore, the 10X FQPA 

safety factor was retained for use of a 

LOAEL to extrapolate a NOAEL. EPA 

has reduced the 10X safety factor when 

relying on a LOAEL in circumstances 

that suggest that the LOAEL is 

approaching a NOAEL (e.g., very 

minimal effects seen at the LOAEL). 

EPA, however has no reliable data 

supporting selection of a different safety 

factor value other than the default value 

of 10X for glufosinate ammonium. 

ii. Although there were indications of 

neurotoxicity in several studies, the 

PODs and safety factors chosen for risk 

assessment are protective for these 

effects. The developmental 

neurotoxicity study showed altered 

brain morphometrics at the LOAEL, and 

this study is used in the weight-of-the 

evidence decision-making process for 

selection of an endpoint. Applying the 

10X FQPA Safety Factor for the LOAEL 

to NOAEL extrapolation, as well as the 

10X inter- and intra-species uncertainty 

factors, to this LOAEL will be protective 

against possible neurotoxicity as 

indicated in the laboratory animal 

studies. 

iii. Although there is evidence that 

glufosinate ammonium results in 

increased qualitative or quantitative 

susceptibility in the developmental 

neurotoxicity study (rats), a prenatal 

developmental study (rabbits), and in 

the 2-generation reproduction study 

(rats), the PODs selected for risk 

assessment are protective for these 

effects because they are either based on 

clear NOAELs for the effects in young 

animals or they are based on a LOAEL 

adjusted by a 10X safety factor to 

account for the lack of a NOAEL in that 

study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. The 

chronic dietary exposure analysis was 

performed using anticipated residues 

from field trial data, processing factors, 

and PCT information. With limited 

monitoring data available, upper-bound 

assumptions were used to determine 

exposure through drinking water 

sources. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to glufosinate 

ammonium in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by glufosinate 

ammonium. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

glufosinate ammonium will occupy 

39% of the aPAD for females 13–49 

years old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to glufosinate 

ammonium from food and water will 

utilize 98% of the cPAD for all infants 

(<1 year old) the population group 

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59112 Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 

receiving the greatest exposure. Based 

on the explanation in Unit III.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of glufosinate ammonium 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). 

Glufosinate ammonium 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 

glufosinate ammonium. 

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 1,800 for the general 

population for mixer/loader/applicators. 

Because EPA’s level of concern for 

glufosinate ammonium is an MOE of 

1,000 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). 

An intermediate-term adverse effect 

was identified; however, glufosinate 

ammonium is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for glufosinate ammonium. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

glufosinate ammonium 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 glufosinate 

ammonium residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two analytical methods have been 

validated by EPA for enforcement of the 

currently established tolerances: (1) 

Method HRAV–5A for the 

determination of glufosinate ammonium 

and glufosinate propanoic acid in/on 

apple, grape, almond, soybean seed, 

corn grain, and corn forage, and (2) 

Method BK/01/99 for determination of 

glufosinate ammonium, N-acetylglufosinate, and glufosinate propanoic 

acid in/on canola seed and sugar beet 

root. 

Based on the similarity in the two 

methods and the results from the 

petition method validations (PMVs), 

EPA concludes that method BK/01/99 is 

a suitable method for enforcement of 

sweet corn, stone fruit, pome fruit, 

citrus fruit, and olive tolerances. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established MRLs 

for glufosinate ammonium in or on 

olives and sweet corn commodities. 

However, for glufosinate ammonium in 

or on citrus fruit, pome fruit, and stone 

fruit, Codex has set MRLs of 0.1, 0.05, 

and 0.05 ppm, respectively. EPA is 

establishing tolerances in this action for 

citrus fruit, pome fruit, and stone fruit, 

at 0.15, 0.25, and 0.25 ppm, 

respectively. EPA cannot harmonize 

these tolerance values with the Codex 

MRLs because the lower MRLs could be 

exceeded with the uses petitioned-for in 

this action. 

C. Revisions to Petitioned-for Tolerances 

EPA modified/revised certain IR–4 

proposed tolerances for glufosinate 

ammonium residues. Higher tolerance 

levels were established for citrus, pome 

fruit, stone fruit, and olives because 

EPA concluded that it was appropriate 

to sum the full level of quantification 

(LOQ) for each of the three residues of 

concern in situations where < LOQ 

residue levels were found. Sweet corn 

tolerances were amended based on 

results from the Organization for 

Economic Co-operation and 

Development (OECD) tolerance 

calculation procedures the corn, sweet, 

K+CWHR tolerance proposed at 0.2 ppm 

will be established at 0.30 ppm, corn, 

sweet, forage tolerance proposed at 4.0 

ppm will be established at 1.5 ppm. A 

separate prune tolerance was 

established as residues in this processed 

commodity are covered by the stone 

fruit group tolerance. 

Additionally, EPA was petitioned for 

tolerances on citrus fruit group 10, 

pome fruit group 11, and stone fruit 

group 12. In the Federal Register of 

December 8, 2010 (75 FR 76284) (FRL– 

8853–8) and Wednesday, August 22, 

2012, EPA issued final rules that revised 

the crop grouping regulations. As part of 

those actions, EPA expanded and 

revised the existing citrus fruit group, 

pome fruit group, and stone fruit group. 

The revised crop groups are designated 

as citrus fruit group 10–10, pome fruit 

group 11–10, and stone fruit group 12– 

12. As noted in the two crop group 

rulemakings, it is EPA policy to attempt 

to conform petitions for crop group 

tolerances filed prior the finalization of 

amendments to crop groups to the crop 

groups, as revised. This was possible in 

this case because the representative 

commodities for the crop groups did not 

change and the increased exposure as a 

result of the expanded crop groups 

could be assessed as part of review of 

the petition. Therefore, consistent with 

this policy, EPA has assessed and is 

establishing a tolerance on citrus fruit 

group 10–10, pome fruit group 11–10, 

and stone fruit group 12–12. 

Finally, 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 glufosinate ammonium 

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. 

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Federal Register / Vol. 77, No. 187 / Wednesday, September 26, 2012 / Rules and Regulations 59113 

V. Conclusion 

Therefore, tolerances are established 

for residues of glufosinate ammonium 

(butanoic acid, 2-amino-4- 

(hydroxymethylphosphinyl) 

monoammonium salt) and its 

metabolites, 2-(acetylamino)-4- 

(hydroxymethyl phosphinyl) butanoic 

acid, and 3-(hydroxymethylphosphinyl) 

propanoic acid, expressed as 2-amino-4- 

(hydroxymethylphosphinyl)butanoic 

acid equivalents in or on corn, sweet, 

forage at 1.5 ppm; corn, sweet, kernels 

plus cob with husks removed at 0.30 

ppm; corn, sweet, stover at 6.0 ppm; 

fruit, citrus, group 10–10 at 0.15 ppm; 

fruit, pome, group 11–10 at 0.25 ppm; 

fruit, stone, group 12–12 at 0.25 ppm; 

and olive at 0.15 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: September 19, 2012. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticides 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 180.473 is amended as 

follows: 

■ i. Revise the introductory text in 

paragraphs (a) and (d). 

■ ii. Add alphabetically the following 

commodities to the table in paragraph 

(a). 

The revised and added text reads as 

follows: 

§ 180.473 Glufosinate ammonium; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

glufosinate ammonium, 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 the sum of glufosinate 

ammonium, butanoic acid, 2-amino-4- 

(hydroxymethylphosphinyl) 

monoammonium salt, and its 

metabolites, 2-(acetylamino)-4- 

(hydroxymethyl phosphinyl)butanoic 

acid, and 3- 

(hydroxymethylphosphinyl)propanoic 

acid, expressed as 2-amino-4- 

(hydroxymethylphosphinyl)butanoic 

acid equivalents: 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, forage ................ 1 .5 

Corn, sweet, kernels plus cob 

with husks removed ............ 0 .30 

Corn, sweet, stover ................ 6 .0 

* * * * * 

Fruit, citrus, group 10–10 ....... 0 .15 

Fruit, pome, group 11–10 ....... 0 .25 

Fruit, stone, group 12–12 ....... 0 .25 

* * * * * 

Olive ........................................ 0 .15 

* * * * * 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of glufosinate 

ammonium, including its metabolites 

and degradates, in or on the 

commodities in the table below, as a 

result of the application of glufosinate 

ammonium to crops listed in paragraph 

(a) of this section. Compliance with the 

tolerance levels specified below is to be 

determined by measuring the sum of 

glufosinate ammonium, butanoic acid, 

2-amino-4-(hydroxymethylphosphinyl) 

monoammonium salt, and its 

metabolite, 3- 

(hydroxymethylphosphinyl) propanoic 

acid, expressed as 2-amino-4- 

(hydroxymethylphosphinyl)butanoic 

acid equivalents. 

* * * * * 

[FR Doc. 2012–23738 Filed 9–25–12; 8:45 am] 

BILLING CODE 6560–50–P 

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