47440 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations 

DATES: Effective date: October 16, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Marilyn Redman at 301–837–3174. 

SUPPLEMENTARY INFORMATION: The 

location of NARA’s Kansas City regional 

archives has changed. This document 

updates 36 CFR Part 1253 with the new 

location information. Also, NARA is 

changing the hours for our Kansas City 

location and existing New York City 

location. 

NARA published a proposed rule on 

June 12, 2009, in the Federal Register 

(74 FR 27956) for a 60 day public 

comment period. We notified several of 

our constituent groups by e-mail and 

provided a notice about the proposed 

rule on our Web site, http:// 

www.archives.gov. The public comment 

period closed on August 11, 2009; we 

received one public comment. The 

commenter remarked only about the 

change in hours and agreed that the 

change made sense if that would assist 

visitors. The commenter added that it 

would be helpful to have one night 

during the week or longer hours on 

Saturday for those who cannot visit 

during conventional business hours. 

The comment does not specify whether 

the concern relates to either, or to both, 

research locations. If a need for 

additional hours becomes evident in the 

future, and available resources support 

extending our hours, we will further 

explore the matter. As a result, we have 

made no changes in this final rule. 

This rule is not a significant 

regulatory action for the purposes of 

Executive Order 12866 and has not been 

reviewed by the Office of Management 

and Budget (OMB). As required by the 

Regulatory Flexibility Act, it is hereby 

certified that this rule will not have a 

significant impact on a substantial 

number of small entities because this 

rule applies to individual researchers. 

This rule does not have any federalism 

implications. This rule is not a major 

rule as defined in 5 U.S.C. Chapter 8, 

Congressional Review of Agency 

Rulemaking. 

List of Subjects in 36 CFR Part 1253 

Archives and records. 

■ For the reasons set forth in the 

preamble, NARA amends part 1253 of 

title 36, Code of Federal Regulations, as 

follows: 

PART 1253—LOCATIONS OF 

RECORDS AND HOURS OF USE 

■ 1. The authority citation for part 1253 

continues to read as follows: 

Authority: 44 U.S.C. 2104(a). 

■ 2. Amend § 1253.7 by revising 

paragraphs (c) and (g) as follows: 

§ 1253.7 Regional Archives. 

* * * * * 

(c) NARA—Northeast Region (New 

York City) is located at 201 Varick 

Street, 12th Floor, New York, NY 

10014–4811 (entrance on Houston 

Street, between Varick and Hudson). 

The hours are 9 a.m. to 5 p.m., Monday 

through Friday. The telephone number 

is 212–401–1620 or Toll Free 1–866– 

840–1752. 

* * * * * 

(g) NARA—Central Plains Region 

(Kansas City) is located at 400 West 

Pershing Road, Kansas City, MO 64108. 

The hours are 8 a.m. to 4 p.m., Tuesday 

through Saturday. The telephone 

number is 816–268–8000. 

* * * * * 

Dated: September 11, 2009. 

Adrienne C. Thomas, 

Acting Archivist of the United States. 

[FR Doc. E9–22403 Filed 9–15–09; 8:45 am] 

BILLING CODE 7515–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0624; FRL–8431–1] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on coffee, green bean imported and 

amends the tolerance for banana, 

imported. BASF, Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation is also a removing tolerance 

for cucumber, and one tolerance for 

vegetable, root, subgroup 1A, except 

sugar beet, garden beet, radish, and 

turnip which are superceded with 

higher tolerances formerly published in 

the Federal Register of March 28, 2008 

(73 FR 16553) (FRL–8354–4). 

DATES: This regulation is effective 

September 16, 2009. Objections and 

requests for hearings must be received 

on or before November 16, 2009, 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–2008–0624. 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: 

Bryant Crowe, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0025; e-mail address: 

crowe.bryant@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations 47441 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0624 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before November 16, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0624, 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. Petition for Tolerances 

In the Federal Register of November 

5, 2008 (73 FR 65849) (FRL–8385–1), 

EPA issued a notice pursuant to section 

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

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

pesticide petitions (PP 8E7366, PP 

8E7367) by BASF Corporation, P.O. Box 

13528, 26 Davis Drive, Research 

Triangle, NC 27709. The petitions 

requested that 40 CFR 180.589 be 

amended by increasing the tolerance for 

residues of the fungicide boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro(1,1′-biphenyl))-2-yl, in or on 

banana from 0.2 parts per million (ppm) 

to 0.5 ppm (PP 8E7366), and 

establishing a tolerance for coffee, green 

bean at 0.05 ppm (PP 8E7367). That 

notice referenced a summary of the 

petitions prepared by BASF 

Corporation, the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. One 

comment was received from a private 

citizen. EPA’s response to comment is 

discussed in Unit IV.C. 

Additionally, in this action EPA is 

correcting an error in a prior tolerance 

rulemaking for boscalid (73 FR 16553) 

(March 28, 2008). In that action, EPA 

amended the boscalid tolerances for 

cucumber and vegetable, root, subgroup 

1A , except sugar beet, garden beet, 

radish, and turnip by increasing the 

level of each of those tolerances. 

Inadvertently, however, the revised 

tolerance levels were added to the CFR 

without removing the prior tolerances. 

This action removes the prior 

tolerances. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of boscalid on 

banana, imported at 0.40 ppm, and 

coffee, green bean, imported at 0.05 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances follow. 

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. 

Boscalid has low acute toxicity via the 

oral, dermal, and inhalation routes of 

exposure and is not an eye or skin 

irritant. Dermal sensitization could not 

be determined because the skin 

sensitization study was inadequate. The 

target organs for boscalid are the thyroid 

and liver. 

An acute endpoint was not selected 

because no adverse effects attributable 

to a single exposure to boscalid were 

seen in the database, including the 

developmental toxicity studies. The 

chronic dietary, incidental oral, dermal, 

and inhalation endpoints were all 

selected from three co-critical studies: 

The chronic rat study, the rat 

carcinogenicity study, and a 1-year 

feeding study in dogs. The dose selected 

for regulation of oral, dermal, and 

inhalation risk at all durations, for all 

populations, is the ‘‘no- observedadverse-effect level’’ of 21.8 milligrams/ 

kilogram/day (mg/kg/day) based on 

thyroid and hepatic toxicity seen in rats 

and dogs at higher dose levels. 

Boscalid is classified as exhibiting 

‘‘suggestive evidence of 

carcinogenicity.’’ Evidence of 

carcinogenicity was seen in males 

(significant trend, and pair-wise at the 

high dose) and in females (trend only) 

in rats or mice or both; however, in both 

sexes no malignancies were seen. Only 

benign tumors were observed, and these 

occurred at dose levels above the dose 

level used to establish the chronic 

population adjusted dose (cPAD). 

Additionally, there is no concern for 

mutagencity. EPA has concluded that 

the cPAD is protective of any tumor 

response seen in the boscalid cancer 

studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by boscalid as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedVerDate Nov<24>2008 16:10 Sep 15, 2009 Jkt 217001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\16SER1.SGM 16SER1

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adverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the ‘‘Boscalid – 

Human Health Risk Assessment of the 

Proposed Food Use of the Fungicide on 

Imported Coffee’’ on pages 16–21 in 

docket ID number EPA–HQ–OPP–2008– 

0624. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which the NOAEL in 

the toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

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

pesticides/factsheets/riskassess.htm; 

http://www.epa.gov/oppfead1/trac/ 

science, and http://www.epa.gov/ 

pesticides/trac/science/aggregate.pdf. 

A summary of the toxicological 

endpoints for boscalid used for human 

risk assessment can be found at http:// 

www.regulations.gov in the ‘‘Boscalid – 

Human Health Risk Assessment of the 

Proposed Food Use of the Fungicide on 

Imported Coffee’’ on pages 6–7 in 

docket ID number EPA–HQ–OPP–2008– 

0624. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to boscalid, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

boscalid tolerances in (40 CFR part 

180.589). EPA assessed dietary 

exposures from boscalid 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 boscalid; therefore, a quantitative 

acute dietary exposure assessment was 

not conducted. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. As to residue 

levels in food, EPA made the following 

assumption for the chronic exposure 

assessments: The assessment was based 

on tolerance level residues for existing 

uses, recommended tolerance levels for 

banana and coffee, and 100% crop 

treated assumptions. 

iii. Cancer. For the reasons set forth 

in Unit II.A., EPA has concluded that 

the cPAD is protective of any cancer 

effects with boscalid. EPA’s estimate of 

chronic exposure as described above is 

relied upon to evaluate whether any 

exposure could exceed the cPAD and 

thus pose a cancer risk. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for boscalid in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of boscalid. 

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. 

The current requests for an increased 

tolerance in banana, and a new use on 

coffee, do not affect the estimated 

drinking water concentrations (EDWCs) 

because both requests are for tolerances 

on imported commodities. As a result, 

the EDWCs used in the previous 

assessment ‘‘Boscalid - Human Health 

Risk Assessment to support proposed 

new uses on fresh herbs (herbs subgroup 

19A), avocado, black sapote, canistel, 

mamey sapote, mango, papaya, 

sapodilla, star apple and cotton’’ on 

page 15 in docket ID number EPA–HQ– 

OPP–2008–0624 at http:// 

www.regulations.gov were used in this 

assessment as well. The EDWCs were 

based on the turf use. 

Based on the First Index Reservoir 

Screening Tool (FIRST), and Screening 

Concentration in Ground Water (SCIGROW) models, the EDWCs of boscalid 

for chronic exposures for non-cancer 

assessments are estimated to be 29.6 

ppb for surface water and 0.63 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 0.029 ppm 

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). 

Boscalid is currently registered for the 

following uses that could result in 

residential exposures: Golf course turf, 

strawberries, caneberries, and tree fruit 

grown at ‘‘U-pick’’ farms and orchards. 

EPA assessed residential exposure using 

the following assumptions: Dermal postapplication exposure for golfers exposed 

to treated turf. The duration of exposure 

is anticipated to be short-term. 

Based on the low vapor pressure of 

boscalid (7 x 10-9 hPa), the outdoor 

nature of the uses, and the weight of 

evidence from available residue studies, 

the Agency does not anticipate postapplication inhalation exposures from 

the currently approved uses of boscalid. 

In addition, U-pick activities are 

considered to be one-time (<1 day) 

events. As no adverse effects were seen 

in the boscalid toxicity database 

resulting from a single exposure to the 

chemical a post-application exposure 

assessment is not required for this 

scenario. 

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.’’ 


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EPA has not found boscalid to share 

a common mechanism of toxicity with 

any other substances, and boscalid does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

boscalid 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 website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

In the 2-generation reproduction study 

in rats, body weight effects were seen in 

the mid-and-high doses in the second 

generation male pups. However, the 

degree of concern is low for the 

quantitative evidence of susceptibility 

seen in this study, since the body 

weight effects were seen in only one sex 

and only after dosing for two 

generations. There is a clear NOAEL for 

the body weight effects seen in the rat 

2-generation reproduction study and 

EPA is regulating based on a POD below 

where these effects are seen. 

In the developmental neurotoxicity 

study, transient body weight effects 

were seen in one sex at postnatal days 

1–4 with the animals recovering by 

postnatal day 11. Body weight effects 

were also seen in the high dose, which 

was the limit dose. The degree of 

concern for these effects are low since 

the effects are either transient in nature 

or occurred at the limit dose and EPA 

is regulating based on a POD below 

where these effects are seen. 

While qualitative sensitivity was seen 

in the rabbit developmental study, the 

fetal effects were seen only at the limit 

dose in the presence of maternal 

toxicity. Further, since EPA is regulating 

based on a POD which is an order of 

magnitude below where these effects are 

seen in the rabbit developmental study, 

EPA concludes that the qualitative 

sensitivity evidenced in the fetuses in 

the rabbit developmental study does not 

require retention of the 10X children’s 

safety factor. 

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 boscalid is 

adequate for risk assessment, however 

an immunotoxicity study (OPPTS 

Guideline 870.7800) in rats and/or mice 

is required under the new 40 CFR part 

158 data regulations. No indication of 

immunotoxicity was observed in the 

toxicity database; therefore, an 

additional 10X database uncertainty 

factor (UF) is not warranted. 

ii. There is no indication that boscalid 

is a neurotoxic chemical and there is no 

need for additional UFs to account for 

neurotoxicity. There is no evidence of 

neurotoxicity in the acute subchronic, 

or developmental neurotoxicity studies. 

The toxicity studies for boscalid 

demonstrate that, in general, the 

chemical has low mammalian toxicity, 

and the database reveals no 

reproductive, developmental, or 

developmental neurotoxicity concerns. 

iii. Data involving the testing of young 

animals did show increased quantitative 

sensitivity in the young with regard to 

body weight effects, and qualitative 

sensitivity was seen in one 

developmental study. However, clear 

NOAELs were identified for all of these 

effects. Moreover, the body weight 

effects at the LOAELs in these studies 

were either transient or inconsistent, 

and qualitative sensitivity occurred at 

the limit dose in the presence of 

maternal toxicity. Additionally, EPA is 

regulating based on a POD below where 

these effects are seen. EPA concludes 

that there are no residual uncertainties 

for pre- and/or post-natal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA has conservatively estimated 

human exposure to boscalid, relying on 

worst case exposures in food (assuming 

all registered crops contain residues at 

the tolerance level), and conservative 

models, as well as pesticide-specific 

data, in estimating exposure from 

residues in drinking water, and from 

residential uses. These assessments will 

not underestimate the exposure and 

risks posed by boscalid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, boscalid 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 boscalid from 

food and water will utilize 33% of the 

cPAD for children 1 to 2 years of age, 

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 

boscalid 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). Boscalid is currently 

registered for use(s) 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 

boscalid. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 950 for the U.S. 

population, 1,200 for females 13–49 

years old, and 1,300 for youth 13–19 

years old. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 


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47444 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations 

(considered to be a background 

exposure level). Because no 

intermediate term, non-occupational 

exposures are anticipated from the use 

of boscalid, an intermediate-term 

aggregate risk assessment is not required 

for boscalid. 

5. Aggregate cancer risk for U.S. 

population. Boscalid is classified as 

exhibiting ‘‘suggestive evidence of 

carcinogenicity.’’ Evidence of 

carcinogenicity was seen in males 

(significant trend, and pair-wise at the 

high dose) and in females (trend only); 

however, in both sexes no malignancies 

were seen. Only benign tumors were 

observed, and these occurred at dose 

levels above the dose level used to 

establish the cPAD. Additionally, there 

is no concern for mutagencity. 

Quantification of human cancer risk is 

not required. Aggregate cancer exposure 

and risk are not of concern. Therefore, 

an aggregate risk assessment was not 

conducted. 

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 boscalid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

high performance liquid 

chromatography/ultra violet (HPLC/ 

UV), and liquid chromatography/mass 

spectrometry/tandem mass spectrometry 

(LC/MS/MS) are available to enforce the 

tolerance expressions. The methods may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

The Codex Alimentarius Commission 

has established a MRL for residues of 

boscalid in or on banana at 0.2 ppm, 

which is equivalent to the current U.S. 

tolerance. However, the recommended 

U.S. tolerance is higher than the Codex 

MRL. In the submitted field trials, 

residues above the Codex MRL were 

observed. As a result, it is not possible 

to harmonize the banana tolerance with 

the Codex MRL. There is a Codex 

Maximum Residue for the residues of 

boscalid in/on coffee beans at 0.05 ppm. 

C. Response to Comments 

One anonymous public comment was 

received on November 5, 2008. The 

commenter claimed that there was 

suggestive evidence of carcinogenic 

effects from boscalid but that EPA had 

not assessed these effects. In response, 

EPA notes that, for the reasons set forth 

in Unit II.A., EPA has concluded that 

boscalid cPAD provides an adequate 

margin of safety with regard to the 

benign tumors seen in cancer studies 

with boscalid. 

D. Revisions to Petitioned-For 

Tolerances 

The petition requested that 40 CFR 

180.589 be amended by increasing the 

tolerance for residues of boscalid in or 

on banana from 0.2 ppm to 0.5 ppm. 

Based on the output from the tolerance 

spreadsheet, the Agency recommends in 

favor of the establishment of an import 

tolerance of 0.40 ppm. 

Section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(B), provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the Agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making today’s technical correction 

final without prior proposal and 

opportunity for comment, because EPA 

is correcting an error in a prior tolerance 

rulemaking for boscalid (73 FR 16553) 

(March 28, 2008). In that action, EPA 

amended the boscalid tolerances for 

cucumber and vegetable, root, subgroup 

1A , except sugar beet, garden beet, 

radish, and turnip by increasing the 

level of each of those tolerances. 

Inadvertently, however, the revised 

tolerance levels were added to the CFR 

without removing the prior tolerances. 

This action removes the prior 

tolerances. EPA finds that this 

constitutes good cause under 5 U.S.C. 

553(b)(B). 

V. Conclusion 

Therefore, tolerances are amended for 

residues of boscalid, in or on banana, 

imported at 0.40 ppm, and established 

for coffee, green bean, imported at 0.05 

ppm. Additionally, the duplicate 

boscalid tolerances for cucumber at 0.20 

ppm, and vegetable, root, subgroup 1A, 

except sugar beet, garden beet, radish, 

and turnip at 0.7 ppm are removed 

correcting the error in which these 

superceded tolerances were not deleted 

despite their amendment. 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 


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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations 47445 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 25, 2009. 

Lois A. Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.589, the table to paragraph 

(a)(1) is amended by alphabetically 

adding an entry for ‘‘coffee, green bean, 

imported’’, by revising the entry for 

‘‘banana, import’’ and by removing the 

entry for ‘‘cucumber’’ with the limit of 

0.20 ppm and the entry for ‘‘vegetable, 

root, subgroup 1A, except sugar beet, 

garden beet, radish, and turnip’’ with 

the limit of 0.7 ppm. The added and 

revised entries read as follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a)* * *(1) * * * 

Commodity Parts per 

million 

*****

Banana, import \1\ .................... 0.40 

*****

Coffee, green bean, import \1\ .. 0.05 

*****

1No US registrations as of September 16, 

2009. 

* * * * * 

[FR Doc. E9–22163 Filed 9–15–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0002; FRL–8434–1] 

Acetochlor; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acetochlor, 

including its metabolites and 

degradates, in or on cotton, gin 

byproducts; cotton, undelinted seed; 

soybean, meal; and soybean, seed. 

Monsanto Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation also removes the existing 

tolerance for indirect or inadvertent 

residues of acetochlor on soybean, seed. 

DATES: This regulation is effective 

September 16, 2009. Objections and 

requests for hearings must be received 

on or before November 16, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0002. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA′s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office′s e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 


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