Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Rules and Regulations 71459 

* * * * * 

[FR Doc. 2011–29777 Filed 11–17–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0780; FRL–9326–4] 

Prohexadione Calcium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of prohexadione 

calcium in or on sweet cherry. BASF 

Corporation requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 18, 2011. Objections and 

requests for hearings must be received 

on or before January 17, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0780. 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: Rose 

Mary Kearns, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; email address: 

kearns.rosemary@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–2010–0780 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 January 17, 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–2010–0780, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of October 27, 

2010 (75 FR 66092) (FRL–8848–3), 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 0F7765) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR 180.547 be 

amended by establishing tolerances for 

residues of the plant growth regulator 

prohexadione calcium, calcium, 3- 

oxido-5-oxo-4-propionylcyclohex-3- 

enecarboxylate, in or on sweet cherries 

at 0.50 parts per million (ppm). That 

notice referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing for these 

changes are explained in Unit IV.D. 

Based upon review of the data 

supporting the petition, EPA has 

lowered the tolerance from 0.5 ppm to 

0.4 p.m. The reason 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 


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71460 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Rules and Regulations 

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 including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with prohexadione calcium 

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. Prohexadione 

calcium is not acutely toxic by the oral, 

dermal, and inhalation routes. It is 

moderately irritating to the eyes and 

skin and is not a dermal sensitizer. 

Following subchronic dietary 

exposures, no treatment-related effects 

were seen at doses up to the limit dose 

in mice, fore-stomach hyperplasia was 

seen only at very high doses in rats, and 

kidneys were the target organ for 

toxicity in the dogs. Following repeated 

dermal exposures for 28-days, no 

toxicity was seen at the limit dose of 

1,000 milligrams/kilogram/day (mg/kg/ 

day). There was no evidence of 

neurotoxicity following acute or 

subchronic exposure to rats. 

Following chronic dietary exposures, 

toxicity was seen only at high doses in 

dogs, rats, and mice. There was no 

evidence of carcinogenicity in male and 

female mice or male and female rats. 

In the rat developmental toxicity 

study, no treatment-related maternal or 

developmental toxicity was seen at the 

limit dose. Three rabbit developmental 

toxicity studies are also available. In one 

study, maternal toxicity manifested as 

increased mortality, abortions, and 

decreases in body-weight gain was seen 

at the highest dose tested. However, no 

developmental toxicity was seen at the 

dose that caused maternal toxicity. The 

abortions were attributed to the 

maternal toxicity (i.e., mortality and 

decreased body-weight gain) and not to 

toxicity of the test material. In the 

second developmental toxicity study in 

rabbits, no maternal or developmental 

toxicity was seen at the highest dose 

tested. In the third study, maternal 

toxicity, manifested as premature 

deliveries, was seen as a dose where no 

developmental toxicity was seen. In the 

reproductive toxicity study with rats, 

parental toxicity (minimal mortality) 

occurred at a dose lower than the dose 

that caused decreases in body weight of 

the offspring. No reproductive toxicity 

was seen at the highest dose tested in 

this study. These results indicate no 

quantitative or qualitative increase in 

susceptibility of rats and rabbits to in 

utero and/or post-natal exposure to 

prohexadione calcium. 

Prohexadione calcium was noncarcinogenic in both the rat and mouse. 

Prohexadione calcium has been 

classified as ‘‘not likely to be 

caricinogenic to humans’’ 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 prohexadione calcium 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in the 

document Notice of Filing for 

Prohexadione Calcium at 66092 in 

docket ID number EPA–HQ–OPP–2010– 

0780. (See pages 8012 in the HED Risk 

Assessment in the docket number for 

this rule). 

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 prohexadione calcium 

used for human risk assessment is 

shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROHEXADIONE CALCIUM FOR USE IN HUMAN

HEALTH RISK ASSESSMENT

Exposure/scenario Dose used in risk 

assessment, UFs 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary .......................... N/A ........................................ N/A ........................................ An appropriate endpoint attributable to a single 

dose (exposure) was not seen in the toxicity 

database. 

Chronic dietary ....................... NOAEL = 20 mg/kg/day ........

UFA = 10X 

UFH = 10X FQPA SF = 1X 

Chronic RfD cPAD= 0.2 mg/ 

kg/day.

Chronic toxicity dog LOAEL = 200 mg/kg/day 

based on histopathological changes in the kidneys (dilated basophilic tubules) and increased 

urinary volumn and NA+ ion concentrations. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROHEXADIONE CALCIUM FOR USE IN HUMAN

HEALTH RISK ASSESSMENT—Continued 

Exposure/scenario Dose used in risk 

assessment, UFs 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Incidental oral short-term (1 

to 30 days)- and Intermediate (1–6 Months)-Term.

NOAEL= 80 mg/kg/day .........

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 (Residential).90 day oral toxicity dog LOAEL = 400 mg/kg/day 

based on moderate cortical areas of dilated 

basophilic tubules in the kidneys and decreased potassium levels. 

Short (1–30 days)- and intermediate (1 to 6 months)— 

Term Dermal (Occupational/Residential).

Oral Maternal NOAEL = 40 

Estimated absorption rate 

25%.

LOC for MOE = 100 (Occupational/Residential.Prenatal developmental Toxicity—rabbit LOAEL 

= 200 mg/kg/day based on increased mortality, abortions, and decreased maternal 

body-weight gain. 

Short-term (1 to 30 days)- 

and Intermediate (1–6 

months)—Term Inhalation.

Oral Maternal NOAEL = 40 

mg/kg/day (inhalation-absorption rate = 100%).

LOC for MOE = 100 ............. Prenatal developmental toxicity—rabbit LOAEL = 

200 mg/kg/day based on increased mortality, 

abortions, and decreased maternal bodyweight gain. 

Cancer (oral, dermal, inhalation.Not likely human carcinogen N/A ........................................ No evidence of carcinogenic potential. 

1 UF = uncertainty factor, UFA = extrapolation from animal to human (interspecies), UFH = potential variation in sensitivity among members of 

the human population (intraspecies), FQPA SF = FQPA Safety Factor, NOAEL = no-observed adverse-effect level, LOAEL = lowest-observed 

adverse-effect level, PAD = population-adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure; LOC = level of 

concern; NA = not applicable. 2 25% Dermal-absorption factor—Derived from HIARC report 112600HA.002. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to prohexadione calcium, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing prohexadione calcium 

tolerances in 40 CFR 180.547. EPA 

assessed dietary exposures from 

prohexadione calcium 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 prohexadione 

calcium therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA assumed Dietary 

Exposure Evaluation Model (DEEM) TM

(ver.7.81) default processing factors, 100 

percent crop treated (PCT), and 

tolerance level residues for all 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that prohexadione calcium 

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 prohexadione calcium. 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 prohexadione calcium in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of prohexadione calcium. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppfed1/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 

prohexadione calcium for acute 

exposures are estimated to be 52.4 parts 

per billion for surface water and .158 

ppb for ground water. 

For chronic exposures for non cancer 

assessments are estimated to be 9.1 ppb 

for surface water and 0.0158 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary assessment, the 

water concentration value of 52.4 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 9.1 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). 

Prohexadione calcium is currently 

registered for the following uses that 

could result in residential exposures: 

Residential lawns, ornamentals, athletic 

fields, parks, and golf courses. There is 

a potential for exposure in residential 

settings during the application process 

for homeowners who use products 

containing prohexadione calcium. There 

is also a potential for exposure of adults 

and children from entering 

prohexadione calcium-treated areas. 

EPA assessed residential exposure using 

the following assumptions: It has been 

determined that exposure to pesticide 

handlers is likely during the residential 

use of prohexadione calcium on lawns 

and ornamentals. Intermediate term 

exposures are not likely because of the 

intermittent nature of applications by 

homeowners. Adults were also assessed 

for potential short-term postapplication 

dermal exposure from contact with 

treated residential and recreational turf 

(home lawns, recreational fields, and 

golf courses). Youths, ages 10–12 years 

old, were selected as a representative 

population to assess postapplication 

dermal exposure from contact with 

treated residential and recreational turf 

(home lawns, fields, and golf courses). 

Children, ages 3–6 years old, were 

selected as a representative population 

to assess for postapplication dermal and 

incidental oral (hand-to-mouth, objectVerDate Mar<15>2010 16:24 Nov 17, 2011 Jkt 226001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\18NOR1.SGM 18NOR1

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to-mouth, and soil ingestion) exposure 

to residential turf/home lawns. For all 

residential scenarios, the short-term risk 

estimates (MOEs) do not exceed the 

Agency’s LOC. 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 prohexadione 

calcium to share a common mechanism 

of toxicity with any other substances, 

and prohexadione calcium does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

prohexadione calcium does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence (quantitative or 

qualitative) evidence of increased 

susceptibility following in utero 

exposures to rats and rabbits and 

following pre-and post-natal exposures 

to rats. In the developmental study in 

rats, no maternal or developmental 

toxicity was seen up to the limit dose. 

Additionally, three developmental 

studies in rabbits were available, and no 

developmental toxicity was seen in 

these studies. The abortions seen in one 

study were not due to treatment, but 

rather due to the severe maternal 

toxicity (deaths and decreased bodyweight gain) observed in the dose. In the 

reproductive toxicity, offspring toxicity 

was seen at a dose higher than the dose 

that caused parental/systemic toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

prohexadione calcium is complete. 

ii. There is no evidence of 

neurotoxcity following acute and 

subchronic exposures and there was no 

evidence of increased susceptibility 

following in utero and pre/post natal 

exposures. Therefore, a developmental 

neurotoxicity study is not required. 

iii. The toxicology database for 

prohexadione calcium does not show 

any evidence of treatment-related effects 

on the immune system. The overall 

weight of evidence suggests that this 

chemical does not directly target the 

immune system. In addition, 

prohexadione calcium does not belong 

to a class of chemicals (e.g., the 

organotins, heavy metals, halogenated 

aromatic hydrocarbons) that would be 

expected to be immunotoxic. Although 

an immunotoxicity study is now 

required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registration, HED 

does not believe that conducting this 

study will result in a lower point of 

departure (POD) than that currently 

used for overall risk assessment; 

therefore, a database uncertainty factor 

(UFDB) is not needed to account for lack 

of these studies 

iv. There are no residual uncertainties 

for pre- and post-natal toxicity. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary exposure analysis is 

conservative in that tolerance-level 

residues, 100% crop treated, and 

modeled drinking water estimates were 

assumed. The residential exposure 

analysis is conservative since it is based 

on the residential Standard Operating 

Procedures (SOPs). The dietary and 

residential risk assessments are thus 

conservative and are not expected to 

underestimate risk. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

prohexadione calcium in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks exposed by prohexadione calcium. 

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, prohexadione 

calcium is not expected to pose an acute 

risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit or 

chronic exposure, EPA has concluded 

that the chronic exposure to 

prohexadione calcium from food and 

water will utilize 14% 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 prohexadione calcium 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). Prohexadione calcium 

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 prohexadione calcium. 

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 340 or higher for all 

populations. Because EPA’s level of 

concern for prohexadione calcium is a 

MOE of 100 or below, these MOEs are 

not of concern. 


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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). 

Because no intermediate-term adverse 

effect was identified, prohexadione 

calcium is not expected to pose a 

intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

prohexadione calcium 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 

prohexadione calcium residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. A liquid chromatography 

with tandem mass spectrometry (LC/ 

MS/MS) method (BASF Method 564/0) 

is available for the enforcement of the 

proposed tolerances or sweet cherries. 

EPA has determined that BASF Method 

564/0 is a suitable enforcement method 

for fruit commodities, as defined in SOP 

No. ACB–019 (9/15/08). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@ 

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for prohexadione calcium. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has determined that the tolerance 

level for prohexadione calcium residues 

in or on sweet cherry should be lowered 

from 0.50 ppm as requested in the 

petition to 0.40 ppm based on a review 

of the current prohexadione calcium 

database and utilizing the 

internationally (OECD) harmonized 

spreadsheet for calculating pesticide 

tolerances. 

Additonally, the Agency is modifying 

the tolerance expression for 

prohexadione calcium to clarify that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of prohexadione calcium not 

specifically mentioned; and 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, a tolerance is established 

for residues of prohexadione calcium, 

calcium 3-oxido-5-oco-4- 

propionylcyclohex-3-enecarboxylate, in 

or on sweet cherry at 0.40 ppm. The 

tolerance expression is also being 

revised to include metabolites and 

degradates. 

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, 

Agricultural commodities, Pesticides 


emcdonald on DSK5VPTVN1PROD with RULES
71464 Federal Register / Vol. 76, No. 223 / Friday, November 18, 2011 / Rules and Regulations 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 28, 2011. 

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. Section 180.547 is amended by: 

■ i. Revising the introductory text to 

paragraph (a) and; 

■ ii. Alphabetically adding the 

commodity Cherry, sweet, to the table in 

paragraph (a) to read as follows: 

§ 180.547 Prohexadione calcium, 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of the growth 

regulator, prohexadione calcium, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

prohexadione calcium (calcium 3-oxido5-oxo-4-propionylcyclohex-3- 

enecarboxylate)’’ in or on the following 

commodities. 

Commodity Parts per 

million 

* * * * * 

Cherry, sweet ........................... 0.40 

* * * * * 

* * * * * 

[FR Doc. 2011–29751 Filed 11–17–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 212 and 252 

RIN 0750–AH46 

Defense Federal Acquisition 

Regulation Supplement; Transition to 

the System for Award Management 

(DFARS Case 2011–D053) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is issuing a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement for 

the transition of the Integrated 

Acquisition Environment systems to the 

new System for Award Management 

architecture. 

DATES: Effective date: November 18, 

2011. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Julian E. Thrash, (703) 602–0310. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Integrated Acquisition 

Environment (IAE) is an electronic 

Government initiative that aggregates 

Federal acquisition content by 

providing one Web site for regulations, 

systems, resources, opportunities, and 

training. The Web site at https:// 

www.acquisition.gov was designed to 

create an easily navigable resource that 

is both more efficient and transparent. 

The transition of the IAE to the new 

System for Award Management (SAM) 

architecture has begun. Phase One will 

transition the Central Contractor 

Registration (CCR), the Excluded Parties 

List System (EPLS), and Online 

Representations and Certifications 

Application (ORCA) to the new SAM 

architecture. This rule provides the first 

step in updating the DFARS for these 

changes by updating Web address in the 

DFARS for two references to ORCA to 

show that the application is now 

available through https:// 

www.acquisition.gov. Future DFARS 

cases are anticipated to actually change 

the names of the systems to SAM once 

the transition is complete, as well as to 

begin the transition of the remaining 

IAE systems. 

A related FAR case, 2011–021, 

Transition to the System for Award 

Management, is revising the Federal 

Acquisition Regulation references for 

the CCR, EPLS, and ORCA databases as 

being accessible through https:// 

www.acquisition.gov. 

DoD has issued this rule as a final rule 

because this rule is administrative as it 

only updates existing Web page 

addresses does not have a significant 

cost or administrative impact on 

contractors or offerors. Therefore, public 

comment is not required in accordance 

with 41 U.S.C. 1707. 

II. DFARS Changes 

This rule makes the following DFARS 

changes to reflect that the relevant 

database references for ORCA shown in 

the DFARS references are accessible 

through the new Web site, https:// 

www.acquisition.gov: 

• 212.301 Solicitation provisions and 

contract clauses for the acquisition of 

commercial items; and 

• 252.204–7007 Alternate A, Annual 

Representations and Certifications. 

III. Executive Orders 12866 and 13563 

Executive Orders (E.O.s) 12866 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. This is not a significant 

regulatory action and, therefore, was not 

subject to review under section 6(b) of 

E.O. 12866, Regulatory Planning and 

Review, dated September 30, 1993. This 

rule is not a major rule under 5 U.S.C. 

804. 

IV. Regulatory Flexibility Act 

The Regulatory Flexibility Act does 

not apply to this rule because this final 

rule does not constitute a significant 

DFARS revision within the meaning of 

FAR 1.501–1 and 41 U.S.C. 1707 and 

does not require publication for public 

comment. 

V. Paperwork Reduction Act 

The rule does not contain any 

information collection requirements that 

require the approval of the Office of 

Management and Budget under the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). 

List of Subjects in 48 CFR Parts 212 and 

252 

Government procurement. 

Mary Overstreet, 

Editor, Defense Acquisition Regulations 

System. 

Therefore, 48 CFR parts 212 and 252 

are amended as follows: 

■ 1. The authority citation for 48 CFR 

parts 212 and 252 continue to read as 

follows: 

Authority: 41 U.S.C. 1303 and 48 CFR 

chapter 1. 

PART 212–ACQUISITION OF 

COMMERCIAL ITEMS 

■ 2. Amend section 212.301 paragraph 

(f) introductory text by removing the 

Internet address ‘‘https://orca.bpn.gov’’ 

and adding in its place ‘‘https:// 

www.acquisition.gov/’’. 


emcdonald on DSK5VPTVN1PROD with RULES