Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 19701 

■ 2. Add § 165.T01–0992 to read as 

follows: 

§ 165.T01–0992 Safety Zone; Repair of 

High Voltage Transmission Lines to Logan 

International Airport; Saugus River, 

Saugus, MA. 

(a) General. A temporary safety zone 

is established for the event described in 

paragraph (a)(1): 

(1) Repair of high voltage 

transmission lines to Logan 

International Airport; Saugus River, 

Saugus, MA. 

(i) All waters of the Saugus River, 

from surface to bottom, within a 250- 

yard radius of position 42°26′ 42′′ N; 

070°58′ 14′′ W. 

(ii) Effective Period. This rule is 

effective May 9, 2011 to October 10, 

2011. 

(iii) Enforcement Period. This rule 

will be enforced during a consecutive 48 

hour period to begin each day at 9 a.m. 

and end at 2 p.m. with notice of the 

enforcement of this safety zone to be 

made by all means to affect the widest 

publicity among the affected segments 

of the public, including publication of a 

Notice of Enforcement in the Federal 

Register, in the Local Notice to 

Mariners, and in the Safety Marine 

Information Broadcast. 

(b) Regulations. 

(1) In accordance with the general 

regulations in Section 165.23 of this 

part, entry into, transiting or anchoring 

within this regulated area is prohibited 

unless authorized by the COTP Boston, 

or his designated on-scene 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP Boston or the 

designated on-scene representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port Boston is any 

Coast Guard commissioned, warrant, or 

petty officer who has been designated 

by the Captain of the Port Boston to act 

on his behalf. The on-scene 

representative will be aboard either a 

Coast Guard or Coast Guard Auxiliary 

vessel. The COTP or the designated on 

scene representative may be contacted 

by telephone at 617–223–5750 or on 

VHF Channel 16. 

(4) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain within the regulated area may do 

so if they obtain permission from the 

COTP or the designated representative 

by contacting the COTP Sector Boston 

by telephone at 617–223–5750 or VHF 

radio channel 16. 

Dated: March 25, 2011. 

John N. Healey, 

Captain, U.S. Coast Guard, Captain of the 

Port Boston. 

[FR Doc. 2011–8372 Filed 4–7–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0988; FRL–8866–8] 

Glyphosate (N-(phosphonomethyl) 

glycine); Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation replaces the 

established tolerance for residues of 

glyphosate in or on sweet corn, grain 

with corn, sweet, kernel plus cob with 

husk removed and reduces the 

established tolerance for residues of 

glyphosate and N-acetyl-glyphosate in 

or on poultry, meat. Monsanto Company 

requested these tolerances under the 

Federal Food, Drug and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

8, 2011. Objections and requests for 

hearings must be received on or before 

June 7, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0988. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0415; e-mail address: 

kable.davis@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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–2009–0988 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 June 7, 2011. Addresses for mail 


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and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0988, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of March 24, 

2010 (75 FR 14154–14157) (FRL–8815– 

6), EPA issued a notice pursuant to 

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

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

pesticide petition (PP 9F7644) by 

Monsanto Company, 1300 I St., NW., 

Suite 450 East, Washington, DC 20052. 

The petition requested that 40 CFR part 

180 be amended by replacing the 

established tolerances for residues of the 

herbicide, glyphosate, in or on sweet 

corn, grain with the following: Corn, 

sweet, kernel plus cob with husk 

removed at a tolerance level of 3.0 parts 

per million (ppm) and corn, sweet, 

forage at a tolerance level of 9.0 ppm. 

The petition also requested a reduction 

in the established tolerance for residues 

of glyphosate and its metabolite (Nacetyl-glyphosate) in or poultry meat 

from 4.0 ppm to 0.1 ppm, as they 

believe the tolerance level was 

inadvertently increased when the 

poultry tolerances were moved from 40 

CFR 180.364 (a)(1) to (a)(2). There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA is revising 

the requested actions in several 

respects. EPA has concluded that a 

tolerance for residues of glyphosate in 

or on corn, sweet, kernel plus cob with 

husk removed should be set at 3.5 ppm, 

not 3.0 ppm. Since the proposed forage 

tolerance is less than the currently 

established tolerance for this 

commodity, EPA has concluded that a 

revision to the currently established 

forage tolerance is unnecessary. EPA is 

also modifying the tolerance expression 

for 40 CFR 180.364(a)(1) and (a)(2) to 

clarify the coverage of the tolerance and 

the compounds to be measured in 

determining compliance with tolerance 

levels. The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 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. 

Glyphosate is of low acute toxicity 

following oral, dermal, and inhalation 

exposure. It is a mild eye irritant, slight 

skin irritant, and is not a dermal 

sensitizer in guinea pigs. Inhalation risk 

assessments are not required based on 

the low toxicity of the formulation 

products (toxicity category III or IV) and 

the physical characteristics of the 

technical product. An acute dose and 

endpoint for assessing acute risk have 

not been selected for any population 

subgroups because no effect that could 

be attributed to a single exposure (dose) 

was observed in oral toxicity studies 

including the developmental toxicity 

studies in rats and rabbits. 

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). In a second chronic 

feeding/carcinogenicity study in rats 

tested at higher dietary levels, a lowestobserved-adverse-effect level (LOAEL) 

was identified at 940-milligrams/ 

kilograms/day (mg/kg/day) & 1,183-mg/ 

kg/day (male/female) 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 rats or 

mice. In a chronic toxicity study in 

dogs, no systemic effects were found. 

Acceptable developmental toxicity 

studies in the rat and rabbit are 

available, as is an acceptable 2- 

generation reproduction study in the rat. 

No significant reproductive and 

developmental toxic effects were found. 

A focal tubular dilation of the kidneys 

was observed in a 3-generation 

reproductive study on rats at the 30-mg/ 

kg/day high dose treatment level 

(HDTL), however a 2-generational 

reproductive study on rats did not 

observe the same effect at the 1,500-mg/ 

kg/day HDTL, nor were any adverse 

reproductive effects observed at any 

dose level. EPA concluded that the focal 

tubular dilation of the kidneys at the 30- 

mg/kg/day level was a spurious rather 

than a glyphosate-related effect. 

In a prenatal developmental toxicity 

study in rats, maternal (systemic) effects 

observed included mortality, increased 

clinical signs, and reduced body-weight 

gain at the HDTL (3,500-mg/kg/day). 

Developmental (fetal) effects were 

observed only in the high-dose group 


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and included decreases in total 

implantations/dam and nonviable 

fetuses/dam, increased number of litters 

and fetuses with unossified sternebrae, 

and decreased mean fetal body weights. 

In a prenatal developmental toxicity 

study in rabbits, maternal (systemic) 

effects observed included mortality and 

clinical signs of toxicity at the HDTL 

(350-mg/kg/day). In the rabbits, 

developmental toxicity was not 

observed at any dose. On the basis of 

developmental studies in rats and 

rabbits and reproductive findings in 

rats, glyphosate exhibited no evidence 

of increased susceptibility of offspring. 

Neurotoxicity has not been observed 

in any of the acute, subchronic, chronic, 

developmental, or reproductive studies 

performed with glyphosate. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by glyphosate as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Glyphosate. Section 3 

Registration for Application of the 

Potassium Salt of Glyphosate to 

Glyphosate-Tolerant Sweet Corn. 

Human-Health Risk Assessment,’’ pp. 

26–27 in docket ID number EPA–HQ– 

OPP–2009–0988. 

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 (LOC) 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 the NOAEL 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) 

(a = acute c = chronic) 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 glyphosate used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR GLYPHOSATE 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 ............................ An endpoint of concern (effect) attributable to a single dose was not identified in the database. 

Chronic dietary (All populations).NOAEL= 175 ..........................

mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 1.75 mg/kg/day 

cPAD = 1.75 mg/kg/day.

Developmental Toxicity Study—Rabbit: Maternal LOAEL = 350 mg/kg/day based on 

diarrhea, nasal discharge and death in maternal animals. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 175 ..........................

mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = < 100 ............ Developmental Toxicity Study—Rabbit: Maternal LOAEL = 350 mg/kg/day based on 

diarrhea, nasal discharge and death in maternal animals. 

Incidental oral intermediateterm (1 to 6 months).NOAEL= 175 ..........................

mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = < 100 ............ Developmental Toxicity Study—Rabbit: Maternal LOAEL = 350 mg/kg/day based on 

diarrhea, nasal discharge and death in maternal animals. 

Dermal short-term (1 to 30 

days) Dermal intermediateterm (1 to 6 months).

None ....................................... None ....................................... Based on the lack of toxicity up to the highest dose tested (1,000 mg/kg/day) in the 

21 day dermal toxicity study in rabbits and 

the lack of concern for developmental and 

reproductive effects, the quantification of 

dermal risks was not conducted. 

Inhalation short-term (1 to 30 

days) Inhalation (1 to 6 

months).

None ....................................... None ....................................... Based on the lack of toxicity up to the highest concentration tested (0.36 mg/L) in the 

28-day inhalation toxicity study in rats, and 

the physical characteristics of the technical, 

the quantification of inhalation risks was 

not conducted. 

Cancer (Oral, dermal, inhalation).None ....................................... None ....................................... No evidence of carcinogenicity. 

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. UFS = use of a short-term study for long-term risk assessment. UFDB = to account 

for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. 

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 

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. 


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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 the food consumption data 

from the United States Department of 

Agriculture Continuing Survey of Food 

Intake by Individuals (USDA CSFII) 

(1994–1996 and 1998). The chronic 

analysis assumed tolerance-level 

residues, 100 percent crop treated 

(PCT), and Dietary Exposure Evaluation 

Model (DEEM (version 7.81)) default 

processing factors and incorporated 

glyphosate drinking water monitoring 

data. 

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. 

2. Dietary exposure from drinking 

water. The Agency used monitoring data 

from the United States Geological 

Survey (USGS) National Water-Quality 

Assessment Program (NAWQA) to 

calculate drinking water exposure. For 

chronic dietary risk assessment, the 

water concentration of value 13.5 parts 

per million (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). 

The sweet corn use is not anticipated 

to result in residential exposure. 

However, residential exposure is 

anticipated from the registered 

broadcast and spot treatment to 

residential lawns, gardens, and 

recreational areas including parks and 

golf courses. Based on the registered 

residential use patterns, there is a 

potential for short-term and 

intermediate-term dermal and 

inhalation exposures to homeowners 

who mix and apply products containing 

glyphosate. Since short- and 

intermediate-term dermal and 

inhalation endpoints were not selected, 

no residential handler/applicator 

exposure assessment was conducted. 

Post-application dermal and inhalation 

exposure assessments were not 

conducted since short- and 

intermediate-term dermal and 

inhalation endpoints were not selected. 

Based on registered use patterns, 

toddlers may have short-term postapplication incidental oral exposure 

from hand-to-mouth, object to mouth, 

and soil ingestion behavior on treated 

lawns and swimmers may have shortterm post-application incidental oral 

exposures from treated surface water. 

Exposures and risks from these 

scenarios were assessed because an 

applicable endpoint was identified. 

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 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rats or rabbit fetuses to in utero 

exposure in developmental studies. A 

focal tubular dilation of the kidneys was 

observed in a 3-generation reproductive 

study on rats at the 30-mg/kg/day 

HDTL, however a 2-generational 

reproductive study on rats did not 

observe the same effect at the 1,500-mg/ 

kg/day HDTL, nor were any adverse 

reproductive effects observed at any 

dose level. A clear NOAEL was 

established and the chronic reference 

dose was set at a level well below (∼17- 

fold) this effect. Therefore, the 

endpoints selected for risk assessment 

are protective of the effects seen in the 

3-generation rat reproduction study. 

There are no residual uncertainties for 

pre- or postnatal toxicity. 

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 is complete 

with the exception of recently-required 

studies on acute and subchronic 

neuorotoxicity and immunotoxicity. 

There is no evidence of neurotoxicity in 

any of the toxicology studies. 

Accordingly, although an acute and 

subchronic neurotoxicity studies are 

now required as part of new data 

requirements, EPA does not believe that 

conducting these studies will result in 

a lower POD than that currently used for 

overall risk assessment, and therefore, a 

database uncertainty factor is not 

needed to account for lack of these 

studies. 

ii. The toxicology database for 

glyphosate does not show any evidence 

of treatment-related effects on the 

immune system. The overall weight of 

evidence suggests that this chemical 

does not directly target the immune 

system. Accordingly, although an 

immunotoxicity study is required as a 

part of the new data requirements in the 

40 CFR part 158 for conventional 

pesticide registration, EPA does not 

believe that conducting a functional 

immunotoxicity study will result in a 

lower POD than that currently use for 

overall risk assessment, and therefore, a 

data base uncertainty factor is not 

needed to account for lack of this study. 

iii. There is no quantitative or 

qualitative evidence of increased 

susceptibility of rats or rabbit fetuses to 

in utero exposure in developmental 

studies. 

iv. The dietary exposure analysis of 

exposure to glyphosate in food is 

conservative as it assumed tolerance 

level residues and 100 PCT. EPA made 

conservative (protective) assumptions in 

the water modeling used to assess 

exposure to glyphosate in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 


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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 aPAD and 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, glyphosate 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 12% 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. 

Short-term incidental oral exposure 

may occur to young children (swimmer 

and turf non-dietary ingestion) and 

adults (swimmers). For young children, 

short-term aggregate exposure includes 

chronic dietary (food and water) and 

incidental oral ingestion exposure 

resulting from the turf use (highest 

exposure of all possible scenarios). For 

adults, short-term aggregate exposure 

includes chronic dietary exposure (food 

and water) and incidental oral ingestion 

exposure resulting from the aquatic use 

(highest exposure of all possible 

scenarios). See Table 6.0.1 in the 

document titled ‘‘Glyphosate. Section 3 

Registration for Application of the 

Potassium Salt of Glyphosate to 

Glyphosate-Tolerant Sweet Corn. 

Human-Health Risk Assessment’’ in 

docket ID number EPA–HQ–OPP–2009– 

0988 for a summary of the short-term 

aggregate exposures and risk estimates 

(the populations included represent 

those with the highest dietary 

exposures). For glyphosate, the LOC is 

for MOEs below 100. Since the aggregate 

MOEs are ≥720, short-term aggregate 

exposure to glyphosate does not pose a 

risk of concern. 

4. Intermediate-term risk. Since the 

short-/intermediate-term incidental oral 

endpoints are identical, the short-term 

risk assessments are protective of 

intermediate-term exposure. 

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) equipped with 

a fluorescence detector method; LOQ = 

0.05 ppm) is available to enforce the 

tolerance expression. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established any 

MRLs for sweet corn commodities; 

however, it has established an MRL for 

residues of glyphosate, per se, in/on 

poultry, meat at 0.05 ppm. The U.S. 

tolerance of 0.10 ppm for poultry, meat 

is necessarily higher than the Codex 

MRL to account for residues of both 

gyphosate and its metabolite N-acetyl 

glyphosate. N-acetyl glyphosate is found 

in genetically modified (GMO) 

glyphosate-resistant commodities, 

including corn and soybeans; that are 

used as feed items for poultry in the 

U.S. Therefore, it is included in the U.S. 

tolerance expression for poultry but not 

the Codex expression, accounting for 

the difference in the established MRLs. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has concluded that a tolerance 

for residues of glyphosate in or on corn, 

sweet, kernel plus cob with husk 

removed at 3.5 ppm is needed because 

the highest residue from the field trials 

was 3.1 ppm. Since the proposed forage 

tolerance (9 ppm) is less than the 

currently established tolerance for this 

commodity (100 ppm), EPA has 

concluded that a revision to the 

currently established tolerance is 

unnecessary. 

Finally, EPA is revising the tolerance 

expressions in 40 CFR 180.364(a)(1) and 

40 CFR 180.364(a)(2) to clarify the 

chemical moieties that are covered by 

the tolerances and specify clearly how 

compliance with the tolerances is to be 

measured. 

V. Conclusion 

Therefore this regulation changes the 

established tolerance for residues of 

glyphosate in or on corn, sweet, grain (at 

0.1 ppm) to 3.5 ppm for residues of 

glyphosate in or on corn, sweet, kernel 

plus cob with the husk removed. This 

regulation reduces the established 

tolerance for residues of glyphosate and 

N-acetyl-glyphosate in or on poultry, 

meat from 4.0 ppm to 0.10 ppm. This 

regulation also changes the tolerance 

expression for 40 CFR 180.364(a)(1) and 

(a)(2). 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
19706 Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Rules and Regulations 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 29, 2011. 

G. Jeffery Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.364 is amended by: 

i. Revising the introductory text in 

paragraph (a)(1), and in the table, revise 

the entry for corn, sweet, grain 0.1 ppm; 

to corn, sweet, kernel plus cob with 

husk removed at 3.5 ppm; and 

ii. Revising the introductory text in 

paragraph (a)(2), and in the table, revise 

the entry for poultry, meat 4.0 ppm to 

0.10 ppm. The revisions read as follows: 

§ 180.364. Glyphosate; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of glyphosate, 

including its metabolites and 

degradates, in or on the commodities 

listed below resulting from the 

application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

dimethylamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only glyphosate (N- 

(phosphonomethyl)glycine). 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, kernel plus cob 

with husk removed ................ 3.5 

* * * * * 

(2) Tolerances are established for 

residues of glyphosate, including its 

metabolites and degradates, in or on the 

commodities listed below resulting from 

the application of glyphosate, the 

isopropylamine salt of glyphosate, the 

ethanolamine salt of glyphosate, the 

dimethylamine salt of glyphosate, the 

ammonium salt of glyphosate, and the 

potassium salt of glyphosate. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only glyphosate (N- 

(phosphonomethyl)glycine) and its 

metabolite N-acetyl-glyphosate (Nacetyl-N-(phosphonomethyl)glycine; 

calculated as the stoichiometric 

equivalent of glyphosate). 

Commodity Parts per 

million 

* * * * * 

Poultry, meat ............................ 0.10 

* * * * * 

* * * * * 

[FR Doc. 2011–8428 Filed 4–7–11; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL MARITIME COMMISSION 

46 CFR Parts 520 and 532 

[Docket No. 10–03] 

RIN 3072–AC38 

Non-Vessel-Operating Common Carrier 

Negotiated Rate Arrangements; 

Correction 

April 5, 2011. 

AGENCY: Federal Maritime Commission. 

ACTION: Final rule; correction. 

SUMMARY: The Federal Maritime 

Commission is correcting a final rule 

that appeared in the Federal Register on 

March 2, 2011, exempting licensed nonvessel-operating common carriers that 

enter into negotiated rate arrangements 

from the tariff rate publication 

requirements of the Shipping Act of 

1984. This correction clarifies that the 

negotiated rate arrangement must be 

agreed to prior to receipt of the cargo 

and removes the requirement that nonvessel-operating common carriers 

indicate their intention to move cargo 

under negotiated rate arrangements on 

their Form FMC–1 on file with the 

Commission. 

DATES: Effective April 18, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Legal Information: Elisa Holland, 202– 

523–5740, generalcounsel@fmc.gov; 


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