Federal Register / Vol. 77, No. 182 / Wednesday, September 19, 2012 / Rules and Regulations 58045 

FIRE SUPPRESSION AND EXPLOSION PROTECTION SECTOR—ACCEPTABLE SUBJECT TO NARROWED USE LIMITS

End-Use Substitute Decision Conditions Further information 

Streaming .................. C7 Fluoroketone as a 

substitute for Halon 

1211.

Acceptable subject to 

narrowed use limits.

For use only in nonresidential applications.Use of this agent should be in accordance with the latest edition of 

NFPA Standard 10 for Portable Fire Extinguishers. 

For operations that fill canisters to be used in streaming applications, EPA recommends the following: 

—Adequate ventilation should be in place; 

—All spills should be cleaned up immediately in accordance with 

good industrial hygiene practices; and 

—Training for safe handling procedures should be provided to all 

employees that would be likely to handle containers of the agent 

or extinguishing units filled with the agent. 

See additional comments 1, 2, 3, 4. 

Additional comments: 

1—Should conform to relevant OSHA requirements, including 29 CFR 1910, Subpart L, Sections 1910.160 and 1910.162. 

2—Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the area. 

3—The agent should be recovered from the fire protection system in conjunction with testing or servicing, and recycled for later use or destroyed. 

4—EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other occupational safety and health standard with respect to halon substitutes. 

[FR Doc. 2012–23138 Filed 9–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0569; FRL–9361–5] 

Clopyralid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clopyralid in 

or on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes several established individual 

tolerances, as they will be superseded 

by inclusion in subgroup tolerances. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

September 19, 2012. Objections and 

requests for hearings must be received 

on or before November 19, 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–2011–0569, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

Nollen.Laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://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–2011–0569 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 19, 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 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–2011–0569, 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 


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Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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 

Tolerances 

In the Federal Register of August 26, 

2011 (76 FR 53372) (FRL–8884–9), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7882) by IR–4, 500 

College Road East, Suite 201W., 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.431 be 

amended by establishing tolerances for 

residues of the herbicide clopyralid, 

(3,6-dichloro-2-pyridinecarboxylic 

acid), in or on apple at 0.05 parts per 

million (ppm); brassica, leafy greens, 

subgroup 5B at 5.0 ppm; rapeseed 

subgroup 20A, except gold of pleasure, 

seed at 3.0 ppm; rapeseed subgroup 

20A, except gold of pleasure, meal at 6.0 

ppm; and rapeseed subgroup 20A, 

except gold of pleasure, forage at 3.0 

ppm. That notice referenced a summary 

of the petition prepared on behalf of IR– 

4 by Dow AgroSciences, the registrant, 

which is available in the docket, 

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

no comments received in response to 

the notice of filing. 

Additionally, in the Federal Register 

of July 25, 2012 (77 FR 43562) (FRL– 

9353–6), EPA issued a notice pursuant 

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

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

pesticide petition (PP 2E8013) by IR–4. 

The petition requested that 40 CFR 

180.431 be amended by establishing 

tolerances for residues of the herbicide 

clopyralid, (3,6-dichloro-2- 

pyridinecarboxylic acid), in or on teff, 

forage at 9.0 ppm; teff, grain at 3.0 ppm; 

teff, straw at 9.0 ppm; and teff, hay at 

9.0 ppm. That notice referenced a 

summary of the petition prepared on 

behalf of IR–4 by Dow AgroSciences, the 

registrant, which is available in docket 

ID number EPA–HQ–OPP–2012–0309, 

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 

determined that the proposed tolerance 

on rapeseed subgroup 20A, except gold 

of pleasure, forage is not necessary. 

Additionally, EPA has determined that 

several established tolerances should be 

removed. Finally, the Agency 

determined that the proposed tolerance 

on rapeseed subgroup 20A, except gold 

of pleasure, meal should be established 

as a tolerance on rapeseed, meal. 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 clopyralid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clopyralid 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. 

Clopyralid has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. It is not a dermal irritant 

or sensitizer, but it is a severe eye 

irritant in its acid form. No consistent 

mammalian target organ was identified 

in the clopyralid toxicological studies 

submitted to the Agency. Effects were 

noted in various organs and systems in 

different species, including increases in 

liver weight, changes in clinical 

chemistry and blood cell parameters, 

skin lesions, and decreases in body 

weight gain. 

In subchronic mouse studies, 

decreased body weights were observed 

in males and females. Following chronic 

exposure, effects in dogs included 

reductions in red blood cell parameters, 

increased liver weight (males), and 

vacuolated adrenal cortical cells 

(females). Additionally, skin lesions and 

clinical chemistry changes (decreased 

serum glucose, protein, and albumin) 

were observed at the highest dose 

tested. In the rat, epithelial hyperplasia, 

thickening of the limiting ridge of the 

stomach, and decreased body weight 

were observed following chronic 

exposure. There were no clinical 

indications of neurotoxicity or 

immunotoxicity in the subchronic or 

chronic toxicity studies. 

No developmental toxicity was 

observed in the rat at doses that caused 

maternal mortality and decreased body 

weight gains. In the rabbit 

developmental toxicity study, decreased 

fetal body weights and hydrocephalus 

were observed at a dose that caused 

severe maternal toxicity including a 

high rate of mortality, clinical signs of 

toxicity, decreased body weight gains, 

and gastric mucosal lesions. 

Reproductive toxicity was not observed 

in the rat, but mean pup weight 

reductions and relative liver weight 

increases were observed at doses that 

caused parental toxicity (decreased 

body weight/weight gain and food 

consumption and gastric lesions). 

There was no evidence of 

carcinogenic potential in the rat and 

mouse 2-year carcinogenicity studies. 

Further, there were no positive findings 

for mutagenicity or clastogenicity 

observed in a battery of mutagenicity 

studies (including bacterial reverse gene 

mutation, in vitro and in vivo hostmediated assays in Salmonella and 

Saccharomyces, in vivo chromosomal 

aberrations, unscheduled DNA 

synthesis, and dominant lethal activity 

studies). Based on the results of these 

studies, EPA has determined that 

clopyralid is ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by clopyralid as well as 

the no-observed-adverse-effect-level 


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Federal Register / Vol. 77, No. 182 / Wednesday, September 19, 2012 / Rules and Regulations 58047 

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

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Clopyralid. Human Health Risk 

Assessment for New Uses on Apples, 

Teff, Brassica Leafy Greens, and 

Rapeseed’’ at pages 32–35 in docket ID 

number EPA–HQ–OPP–2011–0569. 

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 clopyralid used for human 

risk assessment is shown in Table 1 of 

this unit. EPA notes that in the last final 

rule for clopyralid, published in the 

Federal Register of March 24, 2010 (75 

FR 14086) (FRL–8814–2), the Agency 

identified an acute dietary toxicological 

POD based on decreased maternal body 

weight in the rat developmental toxicity 

study. However, upon reevaluation of 

the toxicological database for clopyralid, 

EPA determined that the effect is not the 

result of a single dose, and is not 

appropriate for an acute dietary 

endpoint. Additionally, while the last 

final rule included endpoints and points 

of departure for intermediate-term 

residential scenarios, including 

postapplication incidental oral exposure 

for children, the Agency has reevaluated 

this scenario and has determined that 

for clopyralid, residential exposure to 

children on turf is not likely to occur 

over an intermediate-term duration (i.e., 

1 month to 6 months). Further, 

intermediate-term exposures are not 

expected for residential handlers, based 

on the use pattern. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CLOPYRALID FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age and general 

population, including infants 

and children).

An appropriate endpoint for a single exposure was not identified. 

Chronic dietary (All populations) NOAEL = 15 mg/kg/day ...........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.15 mg/kg/day

cPAD = 0.15 mg/kg/day 

2-Year Combined Chronic Toxicity/Carcinogenicity (oral)—rat LOAEL = 150 

mg/kg/day based on increased epithelial 

hyperplasia and thickening of the limiting ridge of the stomach in both sexes. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 75 mg/kg/day UFA = 

10x.

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ................. Developmental Toxicity (oral)—rat LOAEL 

= 250 mg/kg/day based on decreased 

body weight gain and food consumption 

during gestation days 6–9. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) study 

NOAEL = 75 mg/kg/day.

(inhalation absorption rate = 

100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ................. Developmental Toxicity (oral)—rat LOAEL 

= 250 mg/kg/day based on decreased 

body weight gain and food consumption 

during gestation days 6–9. 

Cancer (Oral, dermal, inhalation).‘‘Not likely to be carcinogenic to humans.’’ Cancer risk is not of concern. 

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). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to clopyralid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

clopyralid tolerances in 40 CFR 180.431. 

EPA assessed dietary exposures from 

clopyralid 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 clopyralid; 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 USDA 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 


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Individuals (CSFII). As to residue levels 

in food, EPA assumed tolerance-level 

residues, 100 percent crop treated (PCT) 

estimates, and DEEMTM ver. 7.81 default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that clopyralid 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 or PCT 

information in the dietary assessment 

for clopyralid. Tolerance level residues 

or 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for clopyralid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of clopyralid. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) model, the 

estimated drinking water concentration 

(EDWC) of clopyralid for chronic 

exposures is estimated to be 11.9 parts 

per billion (ppb) for surface water. The 

Agency also considered available 

monitoring data from the United States 

Geological Survey (USGS) National 

Water Quality Assessment Data 

Warehouse (http://water.usgs.gov/ 

nawqa/) for clopyralid. For ground 

water monitoring data, the peak 

observed value for detectable levels of 

clopyralid was 0.5288 ppb (Oregon) 

with a nationwide mean value of 0.065 

ppb. Therefore, the EDWC of clopyralid 

for chronic exposures is estimated to be 

0.5288 ppb for ground water. 

For chronic dietary risk assessment, 

the water concentration of value 11.9 

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). 

Clopyralid is currently registered for 

use on lawns, turf, and ornamentals in 

residential and public areas, which 

could result in residential exposures. 

EPA assessed residential exposure using 

the following assumptions: Short-term 

inhalation exposure for adult residential 

handlers and short-term postapplication 

exposure for children from incidental 

oral contact with treated turf (hand-tomouth, object-to-mouth and soil 

ingestion). Although dermal exposure is 

anticipated from residential use of 

clopyralid, risks via the dermal route of 

exposure are not of concern for 

clopyralid; therefore, dermal risks were 

not quantitatively assessed for 

residential exposure. 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 clopyralid to share 

a common mechanism of toxicity with 

any other substances, and clopyralid 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that clopyralid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

prenatal and/or postnatal qualitative or 

quantitative susceptibility in the 

available studies in the toxicology 

database, including the rat and rabbit 

developmental toxicity studies and a 2- 

generation reproduction toxicity study 

in rats. In the developmental rat study, 

no developmental effects were seen at 

doses that caused maternal toxicity. In 

the rabbit developmental study, 

hydrocephalus and decreased mean 

fetal weight were observed at a dose that 

caused severe maternal toxicity, 

including mortality. In the 2-generation 

reproduction study, decreased pup 

weights and increased relative liver 

weights were observed at the same level 

that resulted in parental toxicity 

(decreased body weights, body weight 

gains and food consumption and slight 

focal hyperkeratotic changes in the 

gastric squamous mucosa). 

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 clopyralid 

is complete. EPA has waived the 

requirement of a 28-day inhalation 

toxicity study in rats (OCSPP Guideline 

870.3465) based on the low volatility 

and low acute inhalation toxicity for 

clopyralid, as well as the selection of 

conservative and adequately protective 

points of departure from oral studies for 

clopyralid. As the 28-day inhalation 

toxicity study was not required, oral 

studies were considered for use with 

route-to-route extrapolation for the 

short-term adult handler inhalation 

exposure assessment. For short-term 

inhalation exposure, the maternal 

toxicity NOAEL of 75 mg/kg/day from 

the rat developmental toxicity study 

was selected based on mortality, 

decreased maternal body weight gain, 

and decreased food consumption at the 

LOAEL of 250 mg/kg/day. This study 

was chosen because it was of the 

appropriate duration and route, and it 

provided the most sensitive NOAEL. 

This endpoint is protective of potential 

pre- and postnatal toxicity because 

developmental toxicity in the rabbit was 

only seen in the presence of significant 

maternal toxicity (maternal/ 

developmental NOAEL = 250 mg/kg/ 

day), and developmental toxicity in the 

rat was not observed up to a maternally 

toxic dose. As such, it is considered to 

be a conservative endpoint for this 

exposure scenario. 

ii. In the rabbit developmental 

toxicity study, neuropathology 

(hydrocephalus) was observed at the 

highest dose tested. However, the 

concern for this effect is considered low 

because it occurred at a dose that caused 

severe maternal toxicity, including a 


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Federal Register / Vol. 77, No. 182 / Wednesday, September 19, 2012 / Rules and Regulations 58049 

high rate of mortality and decreased 

body weight gain and food 

consumption. Further, there was no 

evidence of neurotoxicity in the rat 

developmental or reproduction studies 

or in the available subchronic or chronic 

studies; therefore, there is no need for 

a developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

clopyralid results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to clopyralid in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by clopyralid. 

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, clopyralid 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 clopyralid from 

food and water will utilize 25% 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 clopyralid 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). Clopyralid 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 

clopyralid. 

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 5,300 for the general 

population and 1,700 for children 1–2 

years old. Because EPA’s level of 

concern for clopyralid 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). An 

intermediate-term adverse effect was 

identified; however, clopyralid is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm 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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

clopyralid. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

clopyralid 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 clopyralid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodology is available in The 

Pesticide Analytical Manual Vol. II to 

enforce the tolerance expression for 

plant commodities: a gas 

chromatography/electron-capture 

detection (GC/ECD) method. 

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 a MRL 

for clopyralid in or on the commodities 

associated with these petitions. 

C. Revisions to Petitioned-for Tolerances 

Based on the data supporting the 

petitions, EPA has determined that the 

proposed tolerance on rapeseed 

subgroup 20A, except gold of pleasure, 

forage at 3.0 ppm is not necessary 

because the commodity is not a 

significant livestock feed item. 

Additionally, the Agency has 

determined that the established 

tolerances in or on crambe, seed; flax, 

seed; mustard, seed; and rapeseed, seed 

should be removed because they are 

superseded by inclusion in rapeseed, 

subgroup 20A, except gold of pleasure 

at 3.0 ppm. EPA is also removing the 

established tolerance on mustard greens, 

as it is superseded by inclusion in 

brassica, leafy greens, subgroup 5B. 

Finally, the Agency determined that the 

proposed tolerance on rapeseed 

subgroup 20A, except gold of pleasure, 

meal at 6.0 ppm should be established 

on rapeseed, meal at 6.0 ppm. The EPA 

may establish an individual tolerance 

on a processed commodity that is a 

member of rapeseed subgroup 20A. 

However, the Agency will not establish 

a subgroup tolerance for processed 

foods prepared from crops covered by a 

group tolerance, as outlined in 40 CFR 

180.40, paragraph (f). Therefore, a 

separate tolerance for the processed 

commodity is appropriate. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clopyralid, (3,6-dichloroVerDate Mar<15>2010 19:23 Sep 18, 2012 Jkt 226001 PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 E:\FR\FM\19SER1.SGM 19SER1

srobinson on DSK4SPTVN1PROD with RULES
58050 Federal Register / Vol. 77, No. 182 / Wednesday, September 19, 2012 / Rules and Regulations 

2-pyridinecarboxylic acid), in or on 

apple at 0.05 ppm; brassica, leafy 

greens, subgroup 5B at 5.0 ppm; 

rapeseed, subgroup 20A, except gold of 

pleasure at 3.0 ppm; rapeseed, meal at 

6.0 ppm; teff, forage at 9.0 ppm; teff, 

grain at 3.0 ppm; teff, hay at 9.0 ppm; 

and teff, straw at 9.0 ppm. This 

regulation additionally removes 

established tolerances in or on crambe, 

seed; flax, seed; mustard greens; 

mustard, seed; and rapeseed, seed. 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 10, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.431, paragraph (a) is 

amended by removing the commodities 

‘‘Crambe, seed’’; ‘‘Flax, seed’’; ‘‘Mustard 

greens’’; ‘‘Mustard, seed’’; and 

‘‘Rapeseed, seed’’ from the table and by 

adding, alphabetically, the following 

commodities to the table to read as 

follows: 

§ 180.431 [Amended] 

(a) * * * 

Commodity Parts per 

million 

Apple ........................................... 0 .05 

* * * * * 

Brassica, leafy greens, subgroup 

5B ............................................ 5 .0 

* * * * * 

Rapeseed, meal ......................... 6 .0 

Rapeseed, subgroup 20A, except gold of pleasure .............. 3 .0 

* * * * * 

Teff, forage ................................. 9 .0 

Teff, grain ................................... 3 .0 

Teff, hay ...................................... 9 .0 

Teff, straw ................................... 9 .0 

* * * * * 

* * * * * 

[FR Doc. 2012–22754 Filed 9–18–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 32 

Refuge-Specific Hunting and Sport 

Fishing Regulations 

CFR Correction 

§ 32.29 [Corrected] 

■ In Title 50 of the Code of Federal 

Regulations, parts 18 to 199, revised as 

of October 1, 2011, on page 320, in 

§ 32.29, under Savannah National 

Wildlife Refuge, the second paragraph 

A.1. is removed. 

[FR Doc. 2012–23169 Filed 9–18–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 32 

Refuge-Specific Hunting and Sport 

Fishing Regulations 

CFR Correction 

§ 32.37 [Corrected] 

■ In Title 50 of the Code of Federal 

Regulations, Parts 18 to 199, revised as 

of October 1, 2011, on page 345, in 

§ 32.37, under Black Bayou Lake 

National Wildlife Refuge, the second 

paragraph B.1. and the second 

paragraph C.1. are removed. 

[FR Doc. 2012–23170 Filed 9–18–12; 8:45 a.m.] 

BILLING CODE 1505–01–P 


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