25396 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations 

timely notice of intent and extension 

request consistent with 98.234(f)(8)(ii) 

can automatically use best available 

monitoring method through June 30, 

2012, for the specific parameters 

identified in their notification of intent 

and best available monitoring methods 

request regardless of whether the best 

available monitoring methods request is 

ultimately approved. Owners or 

operators that submit a notice of intent 

but do not follow up with a best 

available monitoring methods request 

by March 30, 2012 cannot use best 

available monitoring methods in 2012. 

For 2012, when an owner or operator 

has submitted a notice of intent and a 

subsequent best available monitoring 

method extension request, use of best 

available monitoring methods will be 

valid, upon approval by the 

Administrator, until the date indicated 

in the approval or until December 31, 

2012, whichever is earlier. For reporting 

years after 2012, a new request to use 

best available monitoring methods must 

be submitted by June 30th of the year 

prior to the reporting year for which use 

of best available monitoring methods is 

sought. 

* * * * * 

[FR Doc. 2013–10184 Filed 4–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0132; FRL–9384–3] 

Glyphosate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of glyphosate in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

1, 2013. Objections and requests for 

hearings must be received on or before 

July 1, 2013, 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–2012–0132, 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: 

Andrew Ertman, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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://www.ecfr.gov/cgi-bin/textidx?&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–2012–0132 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 1, 2013. 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 Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0132, 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.html. 

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 Register of May 2, 2012 

(77 FR 25954) (FRL–9346–1), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 2E7979) by IR–4, 500 

College Rd. East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.364 be 

amended by establishing tolerances for 

residues of the herbicide glyphosate 

N-(phosphonomethyl) glycine in or on 

the raw agricultural commodity teff, 

forage and teff, hay at 100 parts per 

million (ppm) and oilseed crops, group 

20 at 40 ppm. The petition also 

requested amendments to the tolerances 

in 40 CFR 180.364 as follows: Vegetable, 

root and tuber, group 1, except sugar 

beet, from 0.2 ppm to 6.0 ppm; 

vegetable, bulb, group 3 at 0.2 ppm to 


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vegetable, bulb, group 3–07 at 0.2 ppm; 

okra at 0.5 ppm; vegetable, fruiting, 

group 8 at 0.1 ppm to vegetable, fruiting, 

group 8–10 at 0.1 ppm; fruit, citrus, 

group 10 at 0.5 ppm to fruit, citrus, 

group 10–10 at 0.5 ppm; fruit, pome, 

group 11 at 0.2 ppm to fruit, pome, 

group 11–10 at 0.2 ppm; cranberry, 

grape, juneberry, kiwifruit, lingonberry, 

salal, strawberry, and berry group 13 at 

0.2 ppm to berry and small fruit, group 

13–07 at 0.2 ppm. That document 

referenced a summary of the petition 

prepared by Monsanto, the registrant, 

which is available in the docket at 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for some 

commodities as well as the crops for 

which tolerances are being established. 

The reason for these changes is 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for glyphosate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with glyphosate 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. 

A chronic feeding/carcinogenicity 

study in rats found no systemic effects 

in any of the parameters examined 

(body weight, food consumption, 

clinical signs, mortality, clinical 

pathology, organ weights, and 

histopathology). A second chronic 

feeding/carcinogenicity study in rats 

tested at higher dietary levels, and a 

lowest-observed-adverse-effect level 

(LOAEL) was identified at 20,000 ppm 

(approximately 940 milligram/kilogram/ 

day (mg/kg/day)) based on decreased 

body-weight gains in females and 

increased incidence of cataracts and 

lens abnormalities, decreased urinary 

pH, increased absolute liver weight, and 

increased relative liver weight/brain 

weight in males. No evidence of 

carcinogenicity was found in mice or 

rats. In a chronic toxicity study in dogs, 

no systemic effects were found in all 

examined parameters. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat or rabbit fetuses to in utero exposure 

in developmental studies. A focal 

tubular dilation of the kidneys was 

observed in an older 3-generation 

reproductive study on rats at the 30-mg/ 

kg/day level (highest dose tested (HDT)); 

however, a 2-generation reproductive 

study on rats did not observe the same 

effect at the 1,500 mg/kg/day level 

(HDT), nor were any adverse 

reproductive effects observed at any 

dose level. A clear NOAEL was 

established and the chronic reference 

dose (cRfD) was set at a level well below 

this effect. Neurotoxicity has not been 

observed in any of the acute, 

subchronic, chronic, developmental, or 

reproductive studies performed with 

glyphosate. 

Neurotoxicity screening battery tests 

and an immunotoxicity study have been 

submitted to the Agency. Given the 

timing of the submission of these 

studies, the Agency has conducted 

preliminary reviews of these studies. 

The preliminary reviews show no 

effects up to the HDT for both the acute 

and subchronic durations for the 

neurotoxicity studies and no effects up 

to the HDT in the immunotoxicity 

study. EPA does not believe that further 

review will result in different 

conclusions concerning the neurotoxic 

or immunotoxic potential of glyphosate. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by glyphosate as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled ‘‘Glyphosate. Section 3 

Registration Concerning the Application 

of Glyphosate to Carrots, Sweet Potato, 

Teff, and Oilseeds (Crop Group (CG) 20) 

and to Update the CG Definitions for 

Bulb Vegetable (CG 3–07), Fruiting 

Vegetable (CG 8–10), Citrus Fruit (CG 

10–10), Pome Fruit (CG 11–10), and 

Berry (CG 13–07). Human-Health Risk 

Assessment’’ on pp. 26–28 in docket ID 

number EPA–HQ–OPP–2012–0132. 

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 

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 glyphosate used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of April 8, 2011 (76 

FR 19701) (FRL–8866–8). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to glyphosate, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 


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glyphosate tolerances in 40 CFR 

180.364. EPA assessed dietary 

exposures from glyphosate 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 glyphosate; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). This 

dietary survey was conducted from 2003 

to 2008. As to residue levels in food, 

EPA assumed tolerance level residues 

and 100 percent crop treated (PCT) for 

both proposed and existing 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that glyphosate 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. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for glyphosate. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The Agency used both a 

screening level water exposure model 

(surface water) as well as monitoring 

data (ground water) in the dietary 

exposure analysis and risk assessment 

for glyphosate in drinking water. The 

simulation model takes into account 

data on the physical, chemical, and fate/ 

transport characteristics of glyphosate. 

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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and monitoring 

data from the National Water-Quality 

Assessment Program (NAWQA), the 

estimated drinking water concentrations 

(EDWCs) of glyphosate for chronic 

exposures are estimated to be 8.11 parts 

per billion (ppb) for surface water and 

2.03 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 8.11 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). 

Glyphosate is currently registered for 

the following uses that could result in 

residential exposures: Turf (including 

golf courses and residential lawns) and 

for aquatic application. EPA assessed 

residential exposure using the following 

assumptions: 

Based on the registered residential use 

patterns, there is a potential for shortterm dermal and inhalation exposures to 

homeowners who mix and apply 

products containing glyphosate 

(residential handlers). However, since 

short- and intermediate-term dermal or 

inhalation endpoints were not selected, 

a quantitative exposure risk assessment 

was not completed. 

Based on the registered use patterns, 

children 1–2 years old may have shortterm post-application incidental oral 

exposures from hand-to-mouth behavior 

on treated lawns and swimmers (adults 

and children 3–6 years old) may have 

short-term post-application incidental 

oral exposures from aquatic uses. Based 

on the soil half-life for glyphosate, 

intermediate-term soil ingestion was 

also considered for children 1<2 years 

old. The incidental oral scenarios for the 

turf assessment (i.e., hand-to-mouth, 

object-to-mouth, and soil ingestion) 

should be considered inter-related and 

it is likely that they occur interspersed 

amongst each other across time. 

Combining these scenarios would be 

overly conservative because of the 

conservative nature of each individual 

assessment. Therefore, none of the 

incidental oral scenarios were 

combined. 

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 glyphosate to 

share a common mechanism of toxicity 

with any other substances, and 

glyphosate does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that glyphosate does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat or rabbit fetuses to in utero exposure 

in developmental studies. A focal 

tubular dilation of the kidneys was 

observed in an older 3-generation 

reproductive study on rats at the 30-mg/ 

kg/day level (HDT); however, a 2- 

generation reproductive study on rats 

did not observe the same effect at the 

1,500 mg/kg/day level (HDT), nor were 

any adverse reproductive effects 

observed at any dose level. A clear 

NOAEL was established and the cRfD 

was set at a level well below this effect. 

Therefore, the endpoints selected for 

risk assessment are protective of the 

effects seen in the 3-generation rat 

reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for glyphosate 

is complete. 


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ii. There is no indication that 

glyphosate is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. 

iii. As discussed in Unit III.D.2., there 

is no evidence that glyphosate results in 

increased susceptibility in in utero rats 

or rabbits in the prenatal developmental 

studies. 

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 surface water modeling used to 

assess exposure to glyphosate in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication incidental oral exposure of 

children. These assessments will not 

underestimate the exposure and risks 

posed by glyphosate. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, glypyhosate 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 glyphosate 

from food and water will utilize 13% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of glyphosate 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). 

Glyphosate 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 glyphosate. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2,000 for the general U.S. 

population and 450 for children 1–2 

years old. Because EPA’s level of 

concern for glyphosate is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Glyphosate is currently registered for 

uses that could result in intermediateterm residential exposure to children 1– 

2 years old, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to glyphosate. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 770 for children 

1–2 years old, the population subgroup 

of concern. Because EPA’s level of 

concern for glyphosate is a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

glyphosate 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 glyphosate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography (HPLC)) is available to 

enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

glyphosate in or on cotton seed at 40 

ppm, sunflower seed at 7 ppm, and rape 

seed at 20 ppm. The MRL for cotton 

seed is the same as the oilseed crop 

group tolerance and the MRL for rape 

seed is the same as the canola seed 

tolerance being established by this 

document. Based on the oilseed residue 

data, harmonization with the Codex 

sunflower seed tolerance is not possible. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has revised the 

petitioned-for tolerances as follows: 

The proposed increase in tolerance for 

vegetables, root and tuber, group 1, 

except sugar beet from 0.2 ppm to 6 

ppm cannot be done at this time due to 

inadequate residue data. Instead, the 

Agency is establishing individual 

tolerances for carrot at 5.0 ppm and 

sweet potato at 3.0 ppm and modifying 

the existing tolerance on vegetables, root 

and tuber, group 1, except sugar beet at 

0.20 ppm to read as ‘‘vegetables, root 

and tuber, group 1, except sugar beet, 

carrot, and sweet potato.’’ 

The petition requested a tolerance at 

40 ppm on the oilseed group 20. In 

order to maintain harmonization with 

both Canada and Codex the Agency is 

establishing a tolerance on the oilseed 

crop group 20, except canola at 40 ppm 

and is maintaining the existing canola 

seed tolerance at 20 ppm. 

The petition requested that the 

current tolerance for vegetable, fruiting, 

group 8 be updated to the new 

vegetable, fruiting, group 8–10. Okra is 

part of the new crop group, however, 


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and the currently established tolerance 

in or on crop group 8 is 0.1 ppm, 

whereas the okra tolerance is 0.5 ppm. 

Due to this difference, the Agency is 

updating crop group 8 to read 

‘‘vegetable, fruiting, group 8–10, except 

okra’’ and maintaining the existing okra 

tolerance at 0.5 ppm. 

Lastly, several of the tolerance values 

on the crop group conversions are being 

revised to reflect Agency policy 

concerning significant figures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of glyphosate N- 

(phosphonomethyl) glycine in or on the 

raw agricultural commodity teff, forage 

at 100 ppm; teff, hay at 100 ppm; 

oilseeds, group 20, except canola at 40 

ppm; vegetable, root and tuber, group 1, 

except carrot, sweet potato, and sugar 

beet at 0.20 ppm; carrot at 5.0 ppm; 

sweet potato at 3.0 ppm; vegetable, bulb, 

group 3–07 at 0.20 ppm; vegetable, 

fruiting, group 8–10 (except okra) at 

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

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

0.20 ppm; and berry and small fruit, 

group 13–07 at 0.20 ppm. 

In addition, due to the establishment 

of the tolerances in this document, the 

following tolerances are being removed 

as unnecessary: Vegetables, root and 

tuber, crop group 1, except sugar beet; 

vegetable, bulb, group 3; vegetable, 

fruiting, group 8; fruit, citrus, group 10; 

fruit, pome, group 11; berry group 13; 

borage, seed; cotton, undelinted seed; 

crambe, seed; flax, meal; flax, seed; 

jojoba seed; lesquerella, seed; 

meadowfoam, seed; mustard seed; 

rapeseed, seed; safflower, seed; sesame, 

seed; sunflower, seed; cranberry; grape; 

juneberry; kiwifruit; lingonberry; salal; 

and strawberry. 

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: April 19, 2013. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.364: 

■ a. Add alphabetically to the table in 

paragraph (a)(1) the following 

commodities. 

■ b. Remove from the table in paragraph 

(a)(1), the commodities berry group 13; 

borage, seed; cotton, undelinted seed; 

crambe, seed; cranberry; flax, meal; flax, 

seed; fruit, citrus, group 10; fruit, pome, 

group 11; grape; jojoba seed; juneberry; 

kiwifruit; lesquerella, seed; lingonberry; 

meadowfoam, seed; mustard seed; 

rapeseed, seed; safflower, seed; salal; 

sesame, seed; strawberry; sunflower, 

seed; vegetable, bulb, group 3; vegetable, 

fruiting, group 8; vegetable, root and 

tuber, group 1, except sugar beet. 

The additions read as follows: 

§ 180.364 Glyphosate; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Berry and small fruit, group 

13–07 .............................. 0 .20 

* * * * * 

Carrot .................................. 5 .0 

* * * * * 

Fruit, citrus, group 10–10 ... 0 .50 

Fruit, pome, group 11–10 ... 0 .20 

* * * * * 

Oilseeds, group 20, except 

canola .............................. 40 

* * * * * 

Sweet potato ....................... 3 .0 

* * * * * 

Teff, forage ......................... 100 

* * * * * 

Teff, hay .............................. 100 


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Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations 25401 

Commodity Parts per 

million 

* * * * * 

Vegetable, bulb, group 3– 

07 .................................... 0 .20 

* * * * * 

Vegetable, fruiting, group 

8–10 (except okra) .......... 0 .10 

Commodity Parts per 

million 

* * * * * 

Vegetables, root and tuber, 

group 1, except carrot, 

sweet potato, and sugar 

beet ................................. 0 .20 

* * * * * 

* * * * * 

[FR Doc. 2013–10316 Filed 4–30–13; 8:45 am] 

BILLING CODE 6560–50–P 


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