38976 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 

[FR Doc. 2015–16632 Filed 7–7–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0346; FRL–9927–25] 

Prohexadione Calcium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of prohexadione 

calcium in or on strawberry and 

watercress. Inter-Regional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

8, 2015. Objections and requests for 

hearings must be received on or before 

September 8, 2015, 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–2014–0346, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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). 

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. 

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–2014–0346 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 September 8, 2015. 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– 

2014–0346, 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 August 1, 

2014 (79 FR 44729) (FRL–9911–67), 

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 4E8264) by IR–4, 

IR–4 Project Headquarters, Rutgers, The 

State University of New Jersey, 500 

College Road East, Suite 201 W, 

Princeton, NJ 08450. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide prohexadione 

calcium, calcium 3-oxido-5-oxo-4- 

propionylcyclohex-3-enecarboxylate, in 

or on strawberry at 0.3 parts per million 

(ppm) and watercress at 2.0 ppm. That 

document referenced a summary of the 

petition prepared by BASF Corporation, 

the registrant, which is available in the 

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

comment was received on the notice of 

filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

amended the tolerance for watercress 

from what the petitioner requested. The 

reason for this change is explained in 

Unit IV.D. 

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 


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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38977 

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 prohexadione 

calcium 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. 

The most sensitive effect in the 

prohexadione toxicity database by oral 

exposure is kidney toxicity in dogs both 

for subchronic and chronic durations. 

Minor hematological changes (decreased 

white blood cell counts in males), and 

fore-stomach hyperplasia were seen 

only at very high doses in rodents. No 

dermal toxicity was observed up to the 

limit dose of 1,000 milligram/kilogram/ 

day (mg/kg/day). There was no evidence 

of neurotoxicity in either of the 

neurotoxicity screening batteries up to 

or exceeding the limit dose. 

In rats and rabbits, no increased 

quantitative or qualitative pre- or 

postnatal susceptibility was observed. In 

rats, no maternal or developmental 

toxicity was observed up to the limit 

dose (1,000 mg/kg/day). Three 

developmental studies in rabbits are 

available in the toxicological database 

for prohexadione calcium. In one study, 

late abortions occurred during GD 24–29 

at 200 mg/kg/day, with increased 

mortality in maternal animals (GD 15– 

24) also noted at this dose. In another 

rabbit developmental study, two 

premature deliveries (on GD 24 and 26) 

were noted at the highest dose tested 

(350 mg/kg/day) with no developmental 

effects observed. No maternal or 

developmental effects were seen in a 

third rabbit developmental study up to 

150 mg/kg/day. In the 2-generation 

reproductive toxicity study with rats, 

parental toxicity (minimal mortality) 

occurred at a dose well below the dose 

that caused decreases in offspring body 

weight (3, 850 mg/kg/day). 

Prohexadione calcium is classified as 

not likely to be carcinogenic to humans 

based on 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 

document Prohexadione Calcium. 

Section 3 Registration for Use on 

Strawberry and Watercress. Human 

Health Risk Assessment on pages 11–14 

in docket ID number EPA–HQ–OPP– 

2014–0346. 

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 (U/SF) 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 nonthreshold 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/risk

assess.htm. 

A summary of the toxicological 

endpoints for prohexadione calcium 

used for human risk assessment is 

shown in the Table of this unit. Since 

the assessment in 2011, (November 18, 

2011) (76 FR 71459) (FRL–9326–4), the 

Agency has reevaluated the endpoints 

and determined that the previously 

identified dermal endpoints are no 

longer appropriate. 

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

RISK ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors 

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

Acute dietary (All populations).No endpoint attributable to a single dose and appropriate for the U.S. general population was seen in the 

prohexadione calcium toxicological database; therefore, an acute dietary point of departure for the general 

U.S. population was not established. 

Chronic dietary (All populations).NOAEL = 20 mg/kg/day ....

UFA = 10x .........................

UFH = 10x .........................

FQPA SF = 1x ...................

Chronic RfD = cPAD = 

0.20 mg/kg/day.

Chronic toxicity—Dog. LOAEL = 200 mg/kg/day based 

on histopathological changes in the kidneys (dilated 

basophilic tubules) and increased urinary volume 

and sodium concentration. 

Incidental oral short-term (1 

to 30 days) and intermediate-term.

(1 to 6 months) ....................

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

UFA = 10x .........................

UFH = 10x .........................

FQPA SF = 1x ...................

LOC for MOE = 100 .......... 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. 


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38978 Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 

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

RISK ASSESSMENT—Continued 

Exposure/scenario Point of departure and uncertainty/safety factors 

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

Dermal short-term (1 to 30 

days) and intermediateterm (1 to 6 months).

Short-term and intermediate-term dermal endpoints were not selected since there were no adverse dermal or systemic effects observed in the 28-day dermal study in rats. There was also no evidence of increased quantitative or qualitative pre- or postnatal sensitivity in the prohexadione calcium database. Therefore no concern 

for any duration of dermal exposure and no dermal endpoints are required 

Inhalation short-term (1 to 

30 days) and intermediate-term (1 to 6 

months).

NOAEL= 40 mg/kg/day .....

UFA = 10x .........................

UFH = 10x .........................

FQPA SF = 1x ...................

Inhalation assumed equivalent to oral.

LOC for MOE = 100 .......... Prenatal Developmental Toxicity—Rabbit. Maternal 

LOAEL = 200 mg/kg/day based on increased mortality, and abortions. 

Cancer (Oral, dermal, inhalation).‘‘Not likely to be carcinogenic to humans’’ based upon lack of evidence of carcinogenicity in rats and mice. No 

evidence of carcinogenic potential, therefore, cancer risk assessment is not required. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 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 USDA Nationwide Health and 

Nutrition Examination Survey, What We 

Eat In America (NHANES/WWEIA) 

conducted from 2003–2008. As to 

residue levels in food, the chronic 

dietary analysis assumed Dietary 

Exposure Evaluation Model (DEEM) 

(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 or PCT 

information in the dietary assessment 

for prohexadione calcium. Tolerancelevel 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/oppefed1/models/

water/index.htm. 

Based on the Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) model, the 

estimated drinking water concentrations 

(EDWCs) of prohexadione calcium for 

chronic exposures for non-cancer 

assessments are estimated to be 170 

parts per billion (ppb) for surface water 

and 0.137 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 170 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. EPA 

assessed residential exposure using the 

following assumptions: Short-term 

residential handler exposures may 

result from adults applying 

prohexadione calcium to residential 

lawns and ornamentals. The Agency 

assessed inhalation exposures for adult 

handlers applying manually-pressurized 

handwand applications to bedding 

plants. Short-term exposure is also 

possible for post-application incidental 

oral exposures of children 1–<2 years 

old. The Agency assessed hand-tomouth exposures and incidental soil 

ingestions from applications to turf for 

children. Intermediate- and long-term 

exposures are not expected since there 

are no registered or proposed uses of 

prohexadione calcium that result in 

intermediate- or long-term residential 

exposures. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://

www.epa.gov/pesticides/science/

residential-exposure-sop.html. 

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 


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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Rules and Regulations 38979 

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 

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 are available to EPA support the 

choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

There are no residual uncertainties for 

prenatal and postnatal toxicity and there 

is no evidence of increased qualitative 

or quantitative susceptibility of any 

kind for fetuses and offspring in both 

rats and rabbits. 

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 indication that 

prohexadione calcium is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

prohexadione calcium results in 

increased susceptibility in in utero rats 

or rabbits in the prenatal developmental 

studies or in young rats in the 2- 

generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT, 

tolerance-level residues, and DEEM (Ver 

7.81) default processing factors. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to prohexadione calcium in drinking 

water. EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed 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 for 

chronic exposure, EPA has concluded 

that chronic exposure to prohexadione 

calcium from food and water will utilize 

19% 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 14,000 for adults and 2,100 for 

children. Because EPA’s level of 

concern for prohexadione calcium 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, prohexadione 

calcium is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term 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 intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for prohexadione calcium. 

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 

(BASF Analytical Method D9601 and 

564/0) is available to enforce the 

tolerance expression for residues of 

prohexadione calcium in watercress and 

strawberry samples. 

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 


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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 prohexadione calcium in/on 

strawberries and watercress. 

C. Response to Comments 

One comment was received in 

response to the notice of filing of IR–4’s 

petition. The commenter stated this use 

should be denied due to toxicity to bees 

and that all use of chemicals should be 

stopped. The comment primarily 

appears directed to the registration of 

the pesticide under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), but to the extent the 

comment is directed at the present 

tolerance action, the Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that pesticides should be banned 

on agricultural crops. However, the 

existing legal framework provided by 

section 408 of FFDCA states that 

tolerances may be set when persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. This citizen’s comment 

appears to be directed at the underlying 

statute and not EPA’s implementation of 

it; the citizen has made no contention 

that EPA has acted in violation of the 

statutory framework. As to bees the EPA 

will consider impacts to the 

environment and non-target species 

under the authority of FIFRA. 

D. Revisions to Petitioned-For 

Tolerances 

The tolerance on watercress has been 

revised from what was proposed in the 

initial petition. EPA is increasing the 

proposed tolerance for residues in/on 

watercress from 2 ppm to 4.0 ppm based 

on the available watercress field trial 

data and the OECD tolerance calculation 

procedure. 

V. Conclusion 

Therefore, tolerances are established 

for residues of prohexadione calcium, 

calcium 3-oxido-5-oxo-4- 

propionylcyclohex-3-enecarboxylate, in 

or on strawberry at 0.30 ppm and 

watercress at 4.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: June 22, 2015. 

Daniel J. Rosenblatt, 

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 § 180.547, add alphabetically the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.547 Prohexadione calcium; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Strawberry ................................ 0.30 

Watercress ................................ 4.0 

* * * * * 

[FR Doc. 2015–16419 Filed 7–7–15; 8:45 am] 

BILLING CODE 6560–50–P 


tkelley on DSK3SPTVN1PROD with RULES