Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33731 

country, and EPA notes that it will not 

impose substantial direct costs on tribal 

governments or preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by August 5, 2013. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Ozone, 

Intergovernmental relations, 

Incorporation by reference, Nitrogen 

dioxides, Reporting and recordkeeping 

requirements, and Volatile organic 

compounds. 

Dated: May 22, 2013. 

A. Stanley Meiburg, 

Acting Regional Administrator, Region 4. 

40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart S—Kentucky 

■ 2. Section 52.920 (e) is amended by 

adding a new entry at the end of the 

table for the ‘‘MVEB Update for the 1997 

8-hour Ozone Maintenance Plan for 

Northern Kentucky’’ to read as follows: 

§ 52.920 Identification of plan. 

* * * * * 

(e) * * * 

EPA APPROVED KENTUCKY NON–REGULATORY PROVISIONS

Name of non-regulatory SIP 

provision 

Applicable geographic or 

nonattainment area 

State submittal 

date/effective date EPA approval date Explanation 

* * * * * * * 

MVEB Update for the 1997 

8-hour Ozone Maintenance 

Plan for Northern Kentucky.

Boone, Campbell, and Kenton Counties, KY.8/9/12 6/5/13 [Insert citation of publication].

[FR Doc. 2013–13186 Filed 6–4–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0887; FRL–9388–1] 

Propamocarb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of propamocarb in 

or on succulent lima bean. Interregional 

Research Project Number 4 (IR–4) 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective June 

5, 2013. Objections and requests for 

hearings must be received on or before 

August 5, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2008–0887, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 


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33732 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2008–0887 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 August 5, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2008–0887, 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 CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

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

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of April 13, 

2009 (74 FR 16866) (FRL–8396–6), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 8E7473) by IR–4, Rutgers 

University, 500 College Rd. East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.499 be 

amended by establishing a tolerance for 

residues of the fungicide propamocarb 

hydrochloride (propamocarb HCl), 

propyl[3- 

(dimethylamino)propyl]carbamate 

monohydrochloride, in or on succulent 

lima bean at 2.0 parts per million (ppm). 

That document referenced a summary of 

the petition prepared on behalf of IR–4 

by Bayer CropScience, the registrant, 

which is available 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 tolerance expression for all 

established commodities to be 

consistent with current Agency policy. 

The reason for this change is explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for propamocarb 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with propamocarb 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. 

In all species tested for toxicity to 

propamocarb, decreased body weights, 

body-weight gains, and food 

consumption were observed following 

subchronic and chronic durations of 

exposure. Effects indicative of toxicity 

were noted in the digestive and 

gastrointestinal (GI) tracts in dogs, 

including chronic erosive gastritis and 

vacuolization of the salivary glands, 

stomach, and duodenum. Ocular effects 

were noted in rats (opacity of the eye 

and yellow colored eyes in females) and 

in dogs (vacuolization of the lacrimal 

gland, retinal degeneration, and 

hyporeflectivity of the inner eye tissue 

below the lens). Respiratory tract effects 

were also noted in dogs, including 

vacuolization of the cells of the trachea 

and lung. In rats, there were signs of 

neurotoxicity including decreased 

motor activities in females following 

acute exposure and vacuolization of the 

ventricles of the brain that produce 

cerebral spinal fluid noted for 

subchronic and chronic durations. 

There were no signs of immunotoxicity 

in the guideline immunotoxicity study 

for propamocarb. 

Fetal effects due to propamocarb 

treatment were noted at doses which 

also caused maternal toxicity. Effects in 

the rat included increased fetal death 

and post-implantation loss, increases in 

minor skeletal anomalies, and increased 

incidences of small fetuses. There were 

also inter-atrial septal defects, and 

hemorrhage in the ears, upper GI tract, 

and nasopharynx/sinuses. Maternal 

effects consisted of decreased absolute 

body weights, body-weight gains and 

food consumption, and mortality. In 

rabbits, the only developmental effect 

was an increase in post-implantation 

loss. Maternal effects consisted of 

increased abortions, and body-weight 

decrements. 

Additionally, in the rat 2-generation 

reproduction studies, parental and 

offspring effects occurred at the same 


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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33733 

dose. Parental effects were similar to the 

effects observed in the rat subchronic 

and chronic studies in addition to 

clinical signs including salivation, 

reddish material around the mouth, and 

urine staining. Offspring effects 

consisted of pup deaths, decreased 

viability and lactation indices and litter 

size, and decreased pup body weights 

and body weight gains. Reproductive 

effects consisted of increased 

vacuolization and decreased weight of 

the epididymides, decreased sperm 

counts and motility, and abnormal 

sperm morphology. 

Propamocarb has been classified as 

‘‘not likely to be carcinogenic to 

humans’’ by all routes of exposure, 

based upon lack of evidence of 

carcinogenicity in rats and mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propamocarb 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 

entitled ‘‘Propamocarb Hydrochloride 

(Propamocarb-HCl). Section 3 Request 

for use on Lima Beans (Succulent). 

Human-Health Risk Assessment’’ at pp. 

32–37 in docket ID number EPA–HQ– 

OPP–2008–0887. 

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 propamocarb used for 

human-health risk assessment is shown 

in Table 1 of this unit. 

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

ASSESSMENT

Exposure/scenario POD and UFs/SFs RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (Females 13–49 

years of age).

NOAEL = 150 mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 1.5 mg/kg/day. .........

aPAD = 1.5 mg/kg/day. 

Developmental Toxicity Study— 

Rabbit. 

LOAEL = 300 mg/kg/day based 

on decreased body weight gain 

and decreased motor activity. 

Acute dietary (General population 

including infants and children).

NOAEL = 200 mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Acute RfD = 2 mg/kg/day. ............

aPAD = 2 mg/kg/day. 

Acute Neurotoxicity Screening 

Battery—Rat. 

LOAEL = 2,000 mg/kg/day based 

on decreased body weight gain 

and decreased motor activity. 

Chronic dietary (All populations) .... NOAEL = 12 mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.12 mg/kg/day. ....

cPAD = 0.12 mg/kg/day. 

Carcinogenicity Study—Mouse. 

LOAEL = 95 mg/kg/day based on 

decreased body weight and 

body weight gain in females. 

Dermal short-term (1 to 30 days) .. Dermal (or oral) study 

NOAEL = 150 mg/kg/day. 

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 ..................... 2-Generation Reproduction Toxicity Study—Rat. 

LOAEL = 406.69 mg/kg/day for 

males and 467.13 mg/kg/day 

for females based on decreased body weights. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Not likely to be carcinogenic to humans.’’ 

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). POD = points of departure. 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 propamocarb, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing propamocarb tolerances in 40 

CFR 180.499. EPA assessed dietary 

exposures from propamocarb in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for propamocarb. In estimating acute 

dietary exposure, EPA used Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEM–FCID) Version 3.16, 

which uses food consumption data from 

the U.S. Department of Agriculture’s 


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33734 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA), 

conducted from 2003–2008. As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT) and 

tolerance-level residues for all 

commodities. In addition, DEEM 

version 7.81 default processing factors 

were used, when appropriate. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used DEEM–FCID Version 3.16. As 

to residue levels in food, EPA assumed 

100 PCT and tolerance-level residues for 

all commodities. In addition, DEEM 

version 7.81 default processing factors 

were used, when appropriate. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that propamocarb does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for propamocarb. Tolerance level 

residues and/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 propamocarb in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

propamocarb. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

propamocarb for surface water are 

estimated to be 8,762 parts per billion 

(ppb) for acute exposures and 1,067 ppb 

for chronic exposures for non-cancer 

assessments. For ground water, the 

EDWC is estimated to be 15.6 ppb for 

acute and chronic exposures for noncancer assessments. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 8,762 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 1,067 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). 

Propamocarb is currently registered for 

use on golf course turf, which may 

result in residential exposure. EPA 

assessed residential exposure using the 

following assumptions: Chemicalspecific turf transferable residue (TTR) 

data for propamocarb were used to 

assess potential short-term dermal postapplication exposures to adult and 

youth golfers. Post-application oral and 

inhalation exposures, as well as 

residential handler exposures, are not 

expected based on the current use 

patterns for propamocarb. Intermediateterm residential exposures are not 

expected based on the current use 

patterns; however, the short-term 

aggregate assessment would be 

protective of any potential intermediateterm exposures, as the short- and 

intermediate-term PODs are the same. 

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.’’ Although a 

carbamate, propamocarb is not an Nmethyl carbamate and does not cause 

cholinesterase inhibition. Therefore, it 

was not included in the N-methyl 

carbamate cumulative risk assessment. 

EPA has not found propamocarb to 

share a common mechanism of toxicity 

with any other substances, and 

propamocarb does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that propamocarb does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no increased quantitative 

prenatal sensitivity due to propamocarb 

treatment. Effects in developing rats 

occurred at the same dose as maternal 

effects and included increased fetal 

death and post-implantation loss, 

increases in minor skeletal anomalies, 

and an increased incidence of small 

fetus. Effects in maternal rats at that 

dose consisted of decreased absolute 

body weights, body weight gains, food 

consumption, and mortality. In rabbits, 

the only developmental effect was an 

increase in post-implantation loss in the 

presence of maternal effects (increased 

abortions, and body weight decrements). 

In the rat 2-generation reproduction 

studies, parental effects were similar to 

the effects observed in the rat 

subchronic and chronic studies, in 

addition to clinical signs including 

salivation, reddish material around the 

mouth, and urine staining. Offspring 

effects consisted of pup deaths, 

decreased viability and lactation indices 

and litter size, and decreased pup body 

weights and body weight gains. 

Reproductive effects at the same dose as 

parental effects consisted of increased 

vacuolization and decreased weight of 

the epididymides, decreased sperm 

counts and motility, and abnormal 

sperm morphology. 

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 

propamocarb is complete. 

ii. There are two guideline acute 

neurotoxicity studies and two 

subchronic neurotoxicity studies for 

propamocarb HCl. The effects of these 

studies are well characterized, and 


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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33735 

include decreased motor activities in 

females following acute exposure. 

However, the endpoints selected are 

protective of these effects, as the rat 

acute oral neurotoxicity study was used 

to select the endpoint for the aRfD of 2.0 

mg/kg/day for the general U.S. 

population, including infants and 

children. The lack of quantitative 

increased fetal sensitivity should 

remove concern for a developmental 

neurotoxicity study (DNT). 

iii. There is no evidence that 

propamocarb results in increased 

quantitative susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

Although there are qualitative effects 

observed in both developmental studies, 

as well as in one of the 2-generation 

reproduction studies, EPA has 

determined that no additional UF is 

necessary to account for these effects 

because: 

a. The effects are well characterized. 

b. Clear NOAELs were established. 

c. The developmental rabbit and rat 2- 

generation reproduction studies are 

being used in endpoint selection. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to propamocarb 

in drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children. 

Incidental oral exposure is not expected 

for children. These assessments will not 

underestimate the exposure and risks 

posed by propamocarb. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposures, the acute dietary 

exposure from food and water to 

propamocarb will occupy 34% of the 

aPAD selected for females 13–49 years 

old; and 75% of the aPAD for infants 

less than 1 year old, the population 

group receiving the greatest exposure for 

the general U.S. population, including 

infants and children. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to propamocarb 

from food and water will utilize 50% of 

the cPAD for infants less than 1 year 

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 

propamocarb 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). Propamocarb 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 propamocarb. 

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 310 for adult male golfers, 280 

for golfers aged 11 to less than 16 years 

old, and 240 for golfers aged 6 to less 

than 11 years old. Because EPA’s level 

of concern for propamocarb 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, propamocarb 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 

propamocarb. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

propamocarb 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 propamocarb 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography with 

nitrogen-phosphorus detection (GC/ 

NPD) method (Analytical Method No. 

XAM–34) is available to enforce 

tolerance expression on plant 

commodities. The method may be found 

in the Pesticide Analytical Method 

(PAM) Vol. II. 

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 propamocarb. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency has revised the tolerance 

expression to clarify that: 

1. As provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

propamocarb not specifically 

mentioned. 

2. 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 propamocarb (propyl N- 

[3-(dimethylamino)propyl]carbamate) in 

or on bean, lima, succulent at 2.0 ppm. 


TKELLEY on DSK3SPTVN1PROD with RULES
33736 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 28, 2013. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.499, revise the section 

heading, paragraph (a) introductory text, 

and paragraph (c) to read as follows: 

§ 180.499 Propamocarb; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residues of 

propamocarb, including its metabolites 

and degradates, in or on the 

commodities specified in the following 

table resulting from the application of 

the hydrochloride salt of propamocarb. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only propamocarb (propyl N- 

[3-(dimethylamino)propyl]carbamate): 

* * * * * 

(c) Tolerance with regional 

registrations. Tolerances with regional 

registrations are established for the 

residues of propamocarb, including its 

metabolites and degradates, in or on the 

commodities specified in the following 

table resulting from the application of 

the hydrochloride salt of propamocarb. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only propamocarb (propyl N- 

[3-(dimethylamino)propyl]carbamate): 

Commodity Parts per 

million 

Bean, lima, succulent ........... 2.0 

* * * * * 

[FR Doc. 2013–13190 Filed 6–4–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0204; FRL–9387–9] 

Imidacloprid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of imidacloprid in 

or on fish and fish-shellfish, mollusc 

requested by the Interregional Research 

Project Number 4 (IR–4) under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). In addition, this regulation 

establishes time-limited tolerances for 

residues of imidacloprid in or on 

sugarcane, cane and sugarcane, 

molasses. This action is associated with 

the use of the pesticide on sugarcane 

under a crisis exemption granted by 

EPA under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). The time-limited 

tolerances expire on December 31, 2015. 

DATES: This regulation is effective June 

5, 2013. Objections and requests for 

hearings must be received on or before 

August 5, 2013, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0204, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 


TKELLEY on DSK3SPTVN1PROD with RULES