14086 Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Rules and Regulations 

Dated: March 11, 2010. 

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 §180.910, in the table add 

alphabetically the following inert 

ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * ** *

Ammonium salts 

of fatty acids 

(C8-C18 saturated) (CAS 

Reg. No. 5972– 

76–9, 63718– 

65–0, 16530– 

70–4, 32582– 

95–9, 2437–23– 

2, 191799–95– 

8, 16530–71–5, 

93917–76–1, 

5297–93–8, 

94266–36–1, 

1002–89–7) 

Surfactant 

* * * * ** *

[FR Doc. 2010–6495 Filed 3–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0092; FRL–8814–2] 

Clopyralid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clopyralid in 

or on Swiss chard and bushberry 

subgroup 13-07B. This regulation 

additionally amends an existing 

tolerance in or on strawberry. 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

March 24, 2010. Objections and requests 

for hearings must be received on or 

before May 24, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0092. 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: 

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; e-mail 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 

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

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gpo/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0092 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before May 24, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0092, 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). 

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Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Rules and Regulations 14087 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 8, 

2009 (74 FR 15971) (FRL–8407–4), 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 8E7481) 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 

combined residues of the herbicide 

clopyralid, (3,6-dichloro-2- 

pyridinecarboxylic acid), in or on Swiss 

chard at 5.0 parts per million (ppm) and 

bushberry subgroup 13-07B at 6.0 ppm. 

This petition additionally requested that 

EPA establish a tolerance with regional 

restrictions in or on strawberry, annual 

at 4.0 ppm. That notice referenced a 

summary of the petition prepared on 

behalf of IR-4 by Dow AgroSciences, the 

registrant, which is available to the 

public in the docket, 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 revised 

the proposed tolerance levels on Swiss 

chard and bushberry subgroup 13-07B. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of clopyralid on 

Swiss chard at 3.0 ppm; bushberry 

subgroup 13-07B at 0.50 ppm; and 

strawberry at 4.0 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

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 

(HDT). 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 

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 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document: 

‘‘Human Health Risk Assessment to 

Evaluate New Uses on Swiss Chard, 

Bushberry Subgroup (13-07B), and 

Strawberry (Regional Restriction),’’ at 

pages 26–30 in docket ID number EPA– 

HQ–OPP–2009–0092. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

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dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for clopyralid used for human 

risk assessment can be found at http:// 

www.regulations.gov in the document: 

‘‘Human Health Risk Assessment to 

Evaluate New Uses on Swiss Chard, 

Bushberry Subgroup (13-07B), and 

Strawberry (Regional Restriction),’’ at 

pages 16–18 in docket ID number EPA– 

HQ–OPP–2009–0092. 

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. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues, Dietary Exposure Evaluation 

Model (DEEM) default processing 

factors, and 100 percent crop treated 

(PCT) for all proposed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues, DEEM 

default processing factors, and 100 PCT 

for all proposed commodities. 

iii. Cancer. Based on the evidence 

discussed in Unit III.A., EPA has 

determined that clopyralid is ‘‘not likely 

to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for clopyralid. Tolerance level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for 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), and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

clopyralid for surface water are 

estimated to be 45.0 parts per billion 

(ppb) for acute exposures and 11.9 ppb 

for chronic exposures. For ground 

water, the EDWC is estimated to be 0.39 

ppb for both acute exposures and 

chronic exposures for non-cancer 

assessments. 

The Agency also considered available 

surface and ground water monitoring 

data from the United States Geological 

Survey (USGS) National Water Quality 

Assessment Data Warehouse (http:// 

water.usgs.gov/nawqa/) for clopyralid. 

Groundwater concentrations as high as 

13 ppb have been detected in Alabama 

and surface water concentrations of up 

to 42 ppb have been detected in North 

Carolina, Illinois, and Ohio. Clopyralid 

is a persistent chemical that partitions 

to water. Degradation is driven by 

aerobic aquatic metabolism, though this 

pathway is not directly characterized 

through a guideline study. The 

degradation behavior for clopyralid best 

fits second-order kinetics, though firstorder kinetics are used to derive and 

parameterize FIRST and SCIGROW 

models. In this case, second-order 

kinetics provide a substantially larger 

half-life estimate than first-order 

kinetics. These modeling limitations 

likely account for the higher 

concentrations in groundwater from the 

monitoring data versus the groundwater 

EDWCs. Peak surface water 

concentrations from monitoring data are 

slightly below the EDWC (45.0 ppb) 

used to estimate the contribution to 

drinking water for the acute dietary risk 

assessment. Therefore, EPA believes 

45.0 ppb is a reasonable, high end 

estimate to be used in risk assessment. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 45.0 ppb was 

used to assess the contribution to 

drinking water. The EDWC of 11.9 ppb 

was used to assess the contribution to 

drinking water for chronic dietary risk 

assessment. 

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 residential turf, which could 

result in residential exposures. EPA 

assessed residential exposure using the 

following assumptions: Short-term 

inhalation exposure for adults applying 

clopyralid to residential turf by pushtype spreaders, low-pressure hand 

sprayers, and garden hose end sprayers; 

short-term postapplication exposure for 

toddlers from incidental oral contact 

with treated turf (hand-to-mouth 

exposure); short-term postapplication 

incidental oral ingestion of granules 

from treated turf; and intermediate-term 

postapplication exposure for toddlers 

from incidental oral contact with treated 

turf (hand-to-mouth exposure). 

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. 

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 

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Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Rules and Regulations 14089 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act safety 

factor (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 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 except for immunotoxicity, 

acute neurotoxicity, and subchronic 

neurotoxicity testing. Recent changes to 

40 CFR part 158 require acute and 

subchronic neurotoxicity testing 

(OPPTS Guideline 870.6200), and 

immunotoxicity testing (OPPTS 

Guideline 870.7800) for pesticide 

registration; however, the existing data 

are sufficient for endpoint selection for 

exposure/risk assessment scenarios, and 

for evaluation of the requirements under 

the FQPA. There are no clinical or 

micropathological indications of 

neurotoxicity or immunotoxicity in the 

available subchronic and chronic 

studies in multiple species. Although 

hydrocephalus was observed in the 

rabbit developmental toxicity study, it 

was only observed at a dose that also 

caused severe maternal toxicity, 

including mortality. The endpoints 

selected for risk assessment are 

considered adequately protective of 

prenatal and/or postnatal toxicity; 

therefore, an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity or 

neurotoxicity. 

ii. In the rabbit developmental 

toxicity study, neuropathology 

(hydrocephalus) was observed at the 

HDT. However, the concern for this 

effect is considered low because it 

occurred at a dose that caused severe 

maternal toxicity, including 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 from in utero exposure to 

rats or rabbits in the prenatal 

developmental studies or exposure to 

young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residue data. Based on 

both modeling and monitoring data, 

EPA made reasonable (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 exposure of 

children as well as 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 pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to clopyralid will 

occupy 9% of the aPAD for children 1 

to 2 years old, the population group 

receiving the greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to clopyralid from 

food and water will utilize 23% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of 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. While there is 

potential for toddlers to ingest granular 

formulations of clopyralid directly from 

treated turf, due to the episodic nature 

of granule ingestion, this source of 

exposure was not included in the shortterm aggregate assessment. Therefore, 

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 5,500 for adult handlers from 

inhalation exposure and 1,700 for 

children 1 to 2 years old from incidental 

oral (hand-to-mouth) exposure. The 

LOC is for MOEs lower than 100. 

Therefore, the aggregate MOEs for shortterm exposure are not of concern to 

EPA. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

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14090 Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Rules and Regulations 

exposure to food and water (considered 

to be a background exposure level). 

Clopyralid is currently registered for 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure to clopyralid through food and 

water with intermediate-term exposures 

for clopyralid. Using the exposure 

assumptions described in this unit for 

intermediate-term exposures, EPA has 

concluded the combined intermediateterm food, water, and residential 

exposures result in an aggregate MOE of 

390 for children 1 to 2 years old from 

incidental oral (hand-to-mouth) 

exposure. The LOC is for MOEs lower 

than 100. Therefore, the aggregate MOE 

for intermediate-term exposure is not of 

concern to EPA. 

5. Aggregate cancer risk for U.S. 

population. Based on the adequate 

cancer studies in rats and mice, EPA has 

concluded that 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 

There are no Codex or Mexican 

maximum residue limits (MRLs) for 

residues of clopyralid in or on the 

requested commodities. There are 

Canadian MRLs for residues of 

clopyralid at 1.0 ppm on strawberry and 

0.1 ppm on blueberry. While the 

Canadian MRL for strawberry 

harmonizes with the existing U.S. 

tolerance for strawberry at 1.0 ppm, the 

revised U.S. tolerance on strawberry at 

4.0 ppm cannot be harmonized with the 

Canadian MRL because the residue field 

trial data supporting the revised 

tolerance resulted in residues that were 

higher than 1.0 ppm. Additionally, the 

U.S. tolerance on bushberry subgroup 

13-07B (at 0.50 ppm) cannot be 

harmonized with the Canadian MRL on 

blueberry (at 0.1 ppm) because residue 

field trial data supporting the U.S. 

tolerance resulted in residues that were 

higher than 0.1 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the residue field 

trial data supporting the petition, EPA 

revised the proposed tolerances on 

Swiss chard from 5.0 ppm to 3.0 ppm 

and bushberry subgroup 13-07B from 

6.0 ppm to 0.50 ppm. The Agency 

revised the tolerance levels based on 

analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

Additionally, EPA revised the 

introductory text in paragraph (a) to 

clarify in the tolerance expression (1) 

that, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of clopyralid 

not specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clopyralid, (3,6-dichloro2-pyridinecarboxylic acid), in or on 

Swiss chard at 3.0 ppm; bushberry 

subgroup 13-07B at 0.50; and strawberry 

at 4.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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, 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 75, No. 56 / Wednesday, March 24, 2010 / Rules and Regulations 14091 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 12, 2010. 

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 as follows: 

i. Revise the introductory text. 

ii. In the table, revise the entry for 

‘‘Strawberry’’, and add alphabetically 

‘‘Bushberry subgroup 13-07B’’ and 

‘‘Swiss chard’’ to read as follows: 

§ 180.431 Clopyralid; tolerances for 

residues. 

(a) General.. Tolerances are 

established for residues of the herbicide 

clopyralid, including its metabolites and 

degradates, in or on the commodities in 

the table below from its application in 

the acid form or in the form of its salts. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only clopyralid, (3,6- 

dichloro-2-pyridinecarboxylic acid), in 

or on the following commodities: 

Commodity Parts per million 

* * * * * 

Bushberry subgroup 13- 

07B .............................. 0.50 

* * * * * 

Strawberry ...................... 4.0 

Swiss chard .................... 3.0 

* * * * * 

* * * * * 

[FR Doc. 2010–6498 Filed 3–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2010–0003] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: 

Kevin C. Long, Acting Chief, 

Engineering Management Branch, 

Mitigation Directorate, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–2820, or (e-mail) 

kevin.long@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. The BFEs and 

modified BFEs are made final in the 

communities listed below. Elevations at 

selected locations in each community 

are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This final rule involves no policies that 

have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This final rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

■ Accordingly, 44 CFR part 67 is 

amended as follows: 

PART 67—[AMENDED] 

■ 1. The authority citation for part 67 

continues to read as follows: 

Authority: 42 U.S.C. 4001 et seq.; 

Reorganization Plan No. 3 of 1978, 3 CFR, 

1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 

3 CFR, 1979 Comp., p. 376. 

§ 67.11 [Amended] 

■ 2. The tables published under the 

authority of § 67.11 are amended as 

follows: 

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