Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45629 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican Maximum Residue Limits 

(MRLs) for difenoconazole. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy) phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole, 

in or on almond at 0.05 parts per 

million (ppm), almond, hulls at 5.0 

(ppm), and cantaloupe at 1.0 (ppm), 

cucumber at 1.0 (ppm), and watermelon 

at 1.0 (ppm). These tolerances expire 

and are revoked on December 31, 2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) 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, 

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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances 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 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. 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: July 25, 2008. 

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 180.475 is amended by 

adding text to paragraph (b) to read as 

follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the fungicide difenoconazole 

in or on the specified agricultural 

commodities, resulting from use of the 

pesticide pursuant to FIFRA section 18 

emergency exemptions. The tolerances 

expire and are revoked on the date 

specified in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Almond .............. 0.05 12/31/11 

Almond, hulls .... 5.0 12/31/11 

Cantaloupe ....... 1.0 12/31/11 

Cucumber ......... 1.0 12/31/11 

Watermelon ...... 1.0 12/31/11 

* * * * * 

[FR Doc. E8–17937 Filed 8–5–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0221; FRL–8367–5] 

Dodine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dodine in or 

on bananas and peanuts. Agriphar S.A. 

c/o Ceres International LLC requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 6, 2008. Objections and requests 

for hearings must be received on or 

before October 6, 2008, 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–2007–0221. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 


yshivers on PROD1PC62 with RULES
45630 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

Mary L. Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354 e-mail address: 

waller.mary@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr.] 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–0221 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 October 6, 2008. 

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–2007–0221, 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’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 Tolerance 

In the Federal Register of May 9, 2007 

(72 FR 26372) (FRL–8121–5), 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 7F7185) by 

Agriphar S.A. c/o Ceres International 

LLC, 1087 Heartsease Dr., West Chester, 

PA 10382. The petition requested that 

40 CFR 180.172 be amended by 

establishing tolerances for residues of 

the fungicide dodine, ndodecylguanidine acetate, in or on 

bananas at 0.50 parts per million (ppm) 

and on peanuts at 0.03 ppm. That notice 

referenced a summary of the petition 

prepared by Agriphar S.A. c/o Ceres 

International LLC, the registrant, which 

is available to the public in the docket, 

http://www.regulations.gov. Comments 

were 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 

lowered the tolerance for peanuts from 

0.03 ppm to 0.013 ppm. 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 

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 dodine on 

bananas at 0.50 ppm and on peanuts at 


yshivers on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45631 

0.013 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Technical dodine has moderate 

toxicity via the acute oral, dermal and 

inhalation routes of exposure. It is a 

severe eye irritant and causes severe 

dermal irritation; it is not a skin 

sensitizer. A definitive target organ has 

not been identified for dodine. The most 

common effects observed in subchronic 

and chronic oral and inhalation studies 

were decreases in food consumption, 

body weight and/or body weight gain. 

There is no evidence of neurotoxicity. 

Effects from dermal exposure were 

limited to dermal lesions. There is no 

evidence of increased susceptibility 

(quantitative or qualitative) in pups 

versus adults based on rat and rabbit 

developmental studies and the rat 

multi-generation reproduction study. A 

weight of evidence evaluation of the 

carcinogenic potential of dodine was 

performed, and based on the results it 

was concluded that there is no evidence 

of carcinogenicity after exposure to 

dodine. All toxicological endpoints 

chosen for risk assessment were based 

on body weight effects plus, in the case 

of inhalation, reduced food 

consumption. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by dodine as well as the 

no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Dodine: Human Health Risk Assessment 

for Proposed Use Bananas and Peanuts, 

pages 12 and 44 in docket ID number 

EPA–HQ–OPP–2007–0221. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

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. 

A summary of the toxicological 

endpoints for dodine used for human 

risk assessment can be found at http:// 

www.regulations.gov in document 

Dodine: Human Health Risk Assessment 

for Proposed Use Bananas and Peanuts, 

page 17 in docket ID number EPA–HQ–

OPP–2007–0221. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to dodine, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing dodine 

tolerances in (40 CFR 180.172). EPA 

assessed dietary exposures from dodine 

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 dodine; 

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 1994–1996 and 1998 

(CSFII). As to residue levels in food, 

EPA assumed that tolerance level 

residues were used for all crops. In 

terms of extent of usage, percent crop 

treated information was used for pome 

fruit, stone fruit, strawberry, pecan and 

walnut. One hundred percent crop 

treated was assumed for banana and 

peanut crops. 

iii. Cancer. There was equivocal 

evidence of carcinogenicity in a mouse 

carcinogenicity study. However, based 

on a weight of evidence evaluation of 

the carcinogenic potential of dodine, the 

Agency concluded that there is no 

evidence of carcinogenicity after 

exposure to dodine. Factors bearing on 

this weight of the evidence 

determination are described in Dodine: 

Human Health Risk Assessment for 

Proposed Use Bananas and Peanuts, 

pages 20–21 in docket ID number EPA–

HQ–OPP–2007–0221. EPA principally 

relied on the fact that the only evidence 

of cancer was a finding of statistically 

significant liver tumors (primarily 

adenomas) in female mice at the highest 

dose tested and no evidence of 

genotoxicity was found. There was no 

evidence of cancer in male mice or rats. 

iv. Percent crop treated (PCT) 

information. Section 408(b)(2)(F) of 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT. 

The Agency used PCT information as 

follows: 

The Agency used the following PCT 

information for the currently registered 

uses of dodine: 10% PCT for pears and 

quinces; 5% PCT for apples, crabapples, 

loquats, cherries, walnuts and pecans; 

and 1% PCT for strawberries, apricots, 

nectarines, peaches, and plums. 


yshivers on PROD1PC62 with RULES
45632 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6 years. EPA uses an average PCT 

for chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which dodine may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for dodine in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of dodine. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST), and Screening 

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

water concentrations (EDWCs) of dodine 

for chronic exposures for non-cancer 

assessments are estimated to be 4.0 parts 

per billion (ppb) for surface water and 

<0.08 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 4.0 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). 

Dodine is not registered for any 

specific use patterns that would result 

in residential exposure. However, a 

closely related chemical, 

dodecylguanidine hydrochloride (DGH) 

is used as an antimicrobial in 

household, industrial, and commercial 

products having residential and nonoccupational exposure potential. DGH is 

used as a bacteriostat in paints and in 

absorbent material in disposal diapers. 

Dodine and DGH have similar chemical 

compositions and properties and are 

therefore considered bio-equivalents. 

Residential painters may have shortterm dermal and inhalation exposure as 

a result of using DGH treated paint. 

Infants < 1–year old may have short-, 

intermediate, and long term dermal 

exposure as a result of wearing DGH 

impregnated diapers. Inhalation 

exposure of infants and children is 

expected to be negligible. Although 

small children may have short-term post 

application oral exposure as a result of 

accidental ingestion of paint chips 

which contain DGH, the Agency does 

not believe that this would occur on a 

regular basis. 

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 dodine to share a 

common mechanism of toxicity with 

any other substances, and dodine does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that dodine 

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. 

There is no evidence (quantitative or 

qualitative) of increased susceptibility 

and no residual uncertainties with 

regard to prenatal and/or postnatal 

toxicity following in utero exposure to 

rats or rabbits and prenatal and/or 

postnatal exposure to rats. In a rat 

developmental toxicity study, decreased 

body weight gain and food consumption 

were observed at ≥ 45 milligrams/ 

kilograms/day (mg/kg/day) in maternal 

animals. No treatment-related effects 

were observed in fetuses up to 90 mg/ 

kg/day. In a rabbit developmental 

toxicity study, dams demonstrated 

decreased food consumption at 80 mg/ 

kg/day; however, this finding was not 

considered adverse. No treatmentrelated effects were observed in fetuses 

up to 80 mg/kg/day. In a 2–generation 

reproduction toxicity study in rats, 

decreases in parental body weight, body 

weight gain and food consumption were 

noted in both generations of rats at 53 

mg/kg/day. Additionally at 53 mg/kg/ 

day, the offspring of both generations 

demonstrated decreased body weight 

after postnatal day 4 which continued 

through pre-mating. 

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: 


yshivers on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 45633 

i. The toxicity database for dodine is 

complete. 

ii. EPA concluded that dodine is not 

a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. Possible neurological 

clinical signs (excessive salivation and 

hunched posture/hypoactivity) were 

observed in chronic studies in rats and 

mice but were not dose-related or 

statistically significant. Excessive 

salivation in the chronic study in dogs 

showed a treatment related dose 

response. However, the effect was not 

consistent with a neurological adverse 

effect since it was seen prior to dosing 

and was a persistent finding throughout 

the study. In addition, no evidence of 

neuropathology was observed in the 

available studies. Therefore, it was 

determined that there was no evidence 

of neurotoxicity. Based on the weight of 

evidence, the Agency determined that a 

developmental neurotoxicity study is 

not required. 

iii. There is no evidence that dodine 

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 Agency 

recommended tolerance-level residues 

and health-protective modeling 

assumptions. Although PCT estimates 

were used for crops with existing 

tolerances, the use of tolerance values 

for residue levels will likely 

overestimate actual exposures. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to dodine in drinking water. EPA used 

similarly conservative assumptions to 

assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by dodine. 

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, dodine 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 dodine from 

food and water will utilize 20% of the 

cPAD for (children 1-2 years of age) the 

population group receiving the greatest 

exposure. Although dodine is not 

currently registered for any use patterns 

that would result in residential 

exposure, DGH is currently registered 

for uses that could result in long-term 

residential post-application exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure to dodine through food and 

water with long-term residential postapplication exposure to DGH. EPA has 

concluded that the combined long-term 

food, water, and dermal exposure for 

infants wearing diapers containing DGH 

treated material results in aggregate 

MOEs as follows: 300 when using a 5% 

transfer factor and 100 when using a 

30% transfer factor. The Agency 

believes that a transfer factor of 30% is 

an overestimate of exposure in 

determining the amount of DGH 

transferred to infants from diapers based 

on a transfer study using dodine-treated 

paper exposed to extreme conditions. 

Additionally, the Agency has requested 

an impregnated diaper migration study 

as confirmatory data. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Although dodine is not registered for 

any use patterns that would result in 

residential exposure, DGH is currently 

registered for uses that could result in 

short- and intermediate-term residential 

exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure to dodine 

through food and water with short- and 

intermediate-term residential exposures 

to DGH. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the short- and intermediateterm combined food, water, and 

residential exposures aggregated result 

in aggregate MOEs of 4,500 for adult 

males handling paint and 4,600 for 

adult females handling paint do not 

exceed the Agency’s level of concern. 

EPA has concluded that the combined 

intermediate-term food, water, and 

dermal exposure for infants wearing 

diapers containing DGH treated material 

results in aggregate MOEs of 640 when 

using a 5% transfer factor and 120 when 

using a 30% transfer factor. For the 

reasons stated in Unit III.E.2. the 

Agency believes the risks do not exceed 

the Agency’s level of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on its weight of the 

evidence calculation, the Agency 

believes that there is no cancer risk 

associated with the use of dodine. 

5. 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 dodine 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry) is 

available to enforce the tolerance 

expression. 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian, or 

Mexican maximum residue limits for 

dodine on bananas or peanuts. 

C. Response to Comments 

There was one favorable comment 

from Del Monte in favor of establishing 

the tolerance for use of dodine on 

bananas in order to control black 

sigatoka disease. 

D. Revisions to Petitioned-For 

Tolerances 

The proposed tolerance of 0.03 ppm 

for residues of dodine on peanuts was 

revised to 0.013 ppm because the 

tolerances were proposed in terms of 

dodine free base, and the Agency 

recalculated the residue results in terms 

of dodine using a molecular weight 

conversion factor of 1.258. 


yshivers on PROD1PC62 with RULES
45634 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

V. Conclusion 

Therefore, tolerances are established 

for residues of dodine, ndodecylguanidine acetate, in or on 

bananas at 0.50 ppm and on peanuts at 

0.013 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

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 

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: July 25, 2008. 

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 180.172 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.172 Dodine; tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

*****

Banana ..................................... 0.50 

*****

Peanut ...................................... 0.013 

*****

* * * * * 

[FR Doc. E8–17934 Filed 8–5–08; 8:45 am] 

BILLING CODE 6560–50–S 


yshivers on PROD1PC62 with RULES