Federal Register / Vol. 77, No. 106 / Friday, June 1, 2012 / Rules and Regulations 32401 

number EPA–HQ–OPP–2006–0848, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Tony Kish, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308-9443; email address: 

kish.tony@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by the action. If you have 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

II. What does this technical amendment 

do? 

EPA issued a final rule in the Federal 

Register of October 24, 2007 (72 FR 

60266) (FRL–8152–9), establishing 

tolerances for residues of the fungicide 

fenamidone in or on various 

commodities. In Units II., III., and V., of 

the preamble, the text correctly listed 

the tolerance level for the commodity 

‘‘strawberry’’ at 0.02 parts per million 

(ppm). The table in § 180.579(d), of the 

regulatory text, incorrectly listed the 

tolerance level for ‘‘strawberry’’ at 0.15. 

This technical amendment corrects that 

error. 

III. Why is this action issued as a final 

rule? 

Section 553 of the Administrative 

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

553(b)(3)(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 this technical amendment 

final without prior proposal and 

opportunity for comment, because this 

action merely corrects a typographical 

error. EPA finds that this constitutes 

good cause under 5 U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

executive order reviews apply to this 

action? 

No. For a detailed discussion 

concerning the statutory and executive 

order reviews, refer to Unit VI. of the 

October 24, 2007 final rule. 

V. 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 this 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: May 24, 2012. 

Losi Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR part 180 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 180.579 is amended by 

revising the entry for ‘‘Strawberry’’ in 

paragraph (d) to read as follows: 

§ 180.579 Fenamidone; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

*****

Strawberry ................................ 0.02 

[FR Doc. 2012–13354 Filed 5–31–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0802; FRL–9350–4] 

2,6-Diisopropylnaphthalene (2,6-DIPN) 

and Its Metabolites and Degradates; 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

tolerances for residues of 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

it’s metabolites and degradates in or on 

certain commodities discussed in this 

document. Loveland Products, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective June 

1, 2012. Objections and requests for 

hearings must be received on or before 

July 31, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0802, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Andrew Bryceland, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6928; email address: 

bryceland.andrew@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 


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pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0802 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 July 31, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). In addition to filing an 

objection or hearing request with the 

Hearing Clerk as described in 40 CFR 

part 178, please submit a copy of the 

filing that does not contain any CBI for 

inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit a copy of your non-CBI 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2009–0802, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

II. Summary of Petition for Tolerance 

In the Federal Register of May 4, 2012 

(77 FR 26477) (FRL–9348–3), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 9F7626) by Loveland 

Products, Inc., 7251 W. 4th St., Greeley, 

Colorado 80634. The petition requested 

that 40 CFR 180.590 be amended by 

establishing tolerances for residues of 

the insecticide 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates, 2,6- 

DIPN and its metabolites and 

degradates, in or on potato, granules/ 

flakes at 5.5 parts per million (ppm); 

potato, wet peel at 6.0 ppm; potato, 

whole at 2.0 ppm; cattle, fat at 0.2 ppm; 

cattle, meat at 0.02 ppm; cattle, meat 

byproducts, except fat at 0.02 ppm; goat, 

fat at 0.2 ppm; goat, meat at 0.02 ppm; 

goat, meat byproducts, except fat at 0.02 

ppm; horse, fat at 0.2 ppm; horse, meat 

at 0.02 ppm; horse, meat byproducts, 

except fat at 0.02 ppm; milk, fat at 0.02 

ppm; sheep, fat at 0.2 ppm; sheep, meat 

at 0.02 ppm and sheep, meat 

byproducts, except fat at 0.02 ppm. One 

comment was submitted. An 

anonymous commenter (EPA–HQ–OPP– 

2009–0802–0003) generally expressed 

opposition to EPA granting this 

tolerance specifically because ‘‘it is time 

to stop allowing so many toxic 

chemicals to poison earth, which end 

up in American bodies causing cancer 

and other killing deseases and even in 

breast milk’’. After conducting a 

comprehensive assessment of the data 

and information submitted by the 

petitioner, EPA has concluded there is 

a reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of 2,6-DIPN. Thus, 

under the standard in FFDCA section 

408(b)(2), a tolerance is appropriate. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerance expressions such 

that only the parent need be included in 

the tolerance expression for livestock 

commodities. The reason for these 

changes are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

it’s metabolites and degradates 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

it’s metabolites and degradates 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 

B. Toxicological Endpoints 

1. Acute toxicity. While EPA’s 

complete discussion and analysis of 

acute toxicity of 2,6-DIPN can be found 

in the Federal Register of August 8, 

2003 (68 FR 47246) (FRL–7321–6), in 


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summary, 2,6-DIPN is classified as 

Toxicity Category IV for the oral route 

of exposure (median lethal dose (LD50) 

> 5,000 milligrams per kilogram (mg/ 

kg)). 

2. Short- and intermediate-term 

toxicity. While EPA’s complete 

discussion and analysis of short- and 

intermediate-term toxicity of 2,6-DIPN 

can be found in the Federal Register of 

August 8, 2003, a summary is provided 

here. The subchronic toxicity study 

submitted and reviewed suggests the 

endpoint selection (value/dose at which 

an effect was observed) is the 104 

milligrams per kilogram per day (mg/kg/ 

day) no observed adverse effect level 

(NOAEL) based on reduced body 

weight, weight gain, and food 

consumption. Although the 

developmental toxicity study indicated 

a lower NOAEL (50 mg/kg/day) for the 

same toxicity, the maternal lowest 

observed adverse effect level (LOAEL) of 

150 mg/kg/day is between the 

subchronic NOAEL of 104–121 mg/kg/ 

day and the LOAEL of 208–245 mg/kg/ 

day. The NOAEL of 50 mg/kg/day may 

have been appropriate for use in 

characterization of risks for the 

subpopulation of women of 

childbearing age; however, the response 

at 50 mg/kg/day in the developmental 

study was minimal, and the 

observations for toxic effects were more 

thoroughly documented in the 

subchronic study. 

3. Chronic toxicity. EPA has 

established the reference dose (RfD) for 

2,6-DIPN at 1 mg/kg/day. This RfD is 

based on results from the subchronic 

and developmental toxicity studies 

described in the Federal Register of 

September 1, 2006 (71 FR 52011) (FRL– 

8081–9). In support of these tolerances, 

the RfD remains unchanged. 

4. Carcinogenicity. No new study 

results suggest that 2,6-DIPN is 

carcinogenic. See EPA’s complete 

discussion and analysis in the Federal 

Register of August 8, 2003. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by 2,6-Diisopropylnaphthalene (2,6- 

DIPN) and its metabolites and 

degradates as well as the NOAEL and 

the LOAEL from the toxicity studies are 

discussed in the final rule published in 

the Federal Register of August 8, 2003. 

C. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

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

gov/pesticides/factsheets/riskassess.

htm. 

A summary of the toxicological 

endpoints for 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates used for 

human risk assessment is discussed in 

Unit III. of the final rule published in 

the Federal Register of December 16, 

2009 (74 FR 66574) (FRL–8798–5). 

D. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 2,6-Diisopropylnaphthalene 

(2,6-DIPN) and its metabolites and 

degradates, EPA considered exposure 

under the petitioned-for tolerances as 

well as all existing 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates 

tolerances in 40 CFR 180.590. EPA 

assessed dietary exposures from 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates 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 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

anticipated residue and/or percent crop 

treated (PCT) were not used. 

Acute dietary 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. In the case of 2,6-DIPN, the 

toxicity database did not indicate an 

acute endpoint, but the 100 mg/kg/day 

NOAEL from the subchronic toxicity 

study (rounded from 104 mg/kg/day) 

was used to evaluate potential acute 

dietary exposure as a conservative basis 

for risk characterization. Also, if the 50 

mg/kg/day NOAEL from the 

developmental toxicity study had been 

used to establish an acute RfD, this 

choice would have been inconsistent 

with the use of the 100 mg/kg/day 

NOAEL since it implies that exposure to 

repeated daily doses at 100 mg/kg/day 

is potentially less hazardous than a 

single dose at 50 mg/kg/day. Given the 

minimal nature of the responses in the 

subchronic and developmental toxicity 

studies, and the fact that the NOAEL 

from the developmental study is only 

appropriate to the subgroup of females 

13–49 years of age, using the 100 mg/ 

kg/day RfD for the acute and chronic 

dietary assessments is more appropriate 

for assessing risk for other subgroups 

and the general population. Therefore, a 

conservative interpretation of these 

endpoints indicated the need for an 

acute dietary exposure assessment. The 

100 mg/kg/day endpoint was also 

interpreted as requiring a chronic 

dietary exposure assessment. 

Acute and chronic dietary exposure 

assessments for 2,6-DIPN were 

conducted using the Dietary Exposure 

Evaluation Model software (DEEMTM

version 1.30), which incorporates 

consumption data from the United 

States Department of Agriculture’s 

Continuing Surveys of Food Intakes by 

Individuals (CSFII, 1994–1996/1998). 

For acute exposure assessments, 

individual 1-day food consumption data 

define an exposure distribution, which 

is expressed as a percentage of the acute 

population adjusted dose (aPAD) (for 

2,6-DIPN, aPAD = 0.1 mg/kg/day). For 

chronic exposure and risk assessment, 

an estimate of the residue level in each 

food or food-form (e.g., orange or orange 

juice) on the commodity residue list is 

multiplied by the average daily 

consumption estimate for the food or 

food-form. The resulting residue 

consumption estimate for each food or 

food-form is summed with the residue 

consumption estimate for all other food 

or food-forms on the commodity residue 

list to arrive at the total estimated 

exposure. Exposure estimates are 

expressed as mg/kg body weight/day 

and as a percent of the 2,6-DIPN chronic 


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population adjusted dose (cPAD) (0.1 

mg/kg/day). These procedures are 

performed for each population 

subgroup. 

EPA determines whether quantitative 

cancer exposure and risk assessments 

are appropriate for a food-use pesticide 

based on the weight of the evidence 

from cancer studies and other relevant 

data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or 

nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

nonlinear approach is used and a cancer 

RfD is calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. 

Based on the data summarized in Unit 

III.A., EPA has concluded that 2,6-DIPN 

does not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iii. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for 2,6-Diisopropylnaphthalene (2,6- 

DIPN) and its metabolites and 

degradates. Tolerance level residues 

and/or 100 PCT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. Because 2,6-DIPN treatment of 

stored (i.e., post-harvest) potato occurs 

inside (in warehouses, for example), no 

concern from exposure through water is 

expected regarding acute and chronic 

dietary risk assessment. For this reason, 

the dietary risk assessment did not 

include drinking water values. 

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). 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates is not 

registered for any specific use patterns 

that would result in residential 

exposure. 

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 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates to share 

a common mechanism of toxicity with 

any other substances, and 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates 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. 

E. 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 were no observed prenatal and 

postnatal effects. 

3. Conclusion. Based on the risk 

assessments and in consideration of 

residue data, EPA concludes that there 

is a reasonable certainty that no harm 

will result to the U.S. population, 

including infants and children, from 

aggregate exposure to residues of 2,6- 

DIPN, including its metabolites and 

degradates, within the existing tolerance 

limits resulting from post-harvest 

applications, undertaken in accordance 

with good agricultural practices and 

EPA-approved labeling, to potatoes. 

Such exposure includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. In arriving at this 

conclusion, EPA has retained the 

tenfold margin of safety in order to 

adequately account for potential preand post-natal toxicity and 

completeness of the data with respect to 

exposure and toxicity to infants and 

children. 

F. 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, 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

it’s metabolites and degradates is not 

expected to pose an acute risk. 

2. Chronic risk. There are no 

residential uses for 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates. 

3. Short-term risk. Because no shortterm adverse effect was identified, 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates is not 

expected to pose a short-term risk. 

4. Intermediate-term risk. Because no 

intermediate-term adverse effect was 

identified, 2,6-Diisopropylnaphthalene 

(2,6-DIPN) and its metabolites and 

degradates is not expected to pose a 

intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

2,6-DIPN 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 2,6- 

Diisopropylnaphthalene (2,6-DIPN) and 

its metabolites and degradates residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Loveland Products, Inc. has proposed 

a liquid chromatographic/ultraviolet 

(LC/UV) detection analytical method for 

enforcement of tolerances for residues of 

2,6-DIPN in potatoes and potato peels. 

While tolerances are set for livestock 


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Federal Register / Vol. 77, No. 106 / Friday, June 1, 2012 / Rules and Regulations 32405 

commodities, no analytical method is 

being required for livestock 

commodities based on a re-evaluation of 

the cattle feeding study and the existing 

ruminant metabolism study which was 

conducted in goats at a feeding level 

two times the Maximum Reasonable 

Dietary Burden (MRDB). The parent 

compound DIPN and the metabolites 

M27 and M29 were quantifiable in all 

edible livestock matrices. In the cattle 

feeding study DIPN was quantifiable at 

exaggerated feeding levels, and at the 

MRDB in fat. The results of the 

metabolism and feeding studies indicate 

that fat will likely have the highest 

residues of any of the livestock matrices, 

and USDA monitors fat for pesticide 

residues accessed 5/10/12). Therefore, 

the parent will be an adequate marker 

for misuse, particularly with regard to 

fat which is the commodity most likely 

to have residues and most likely to be 

monitored. Accordingly, the residue 

definition for the tolerance expression 

can be modified to include the parent 

compound only. 

The method (entitled, ‘‘Liquid 

Chromatographic Analysis for the 

Determination of 2,6- 

Diisopropylnaphthalene (DIPN) in 

Potatoes and Liquid Chromatographic 

Analysis for the Determination of 2,6- 

Diisopropylnaphthalene (DIPN) in 

Potato Peels’’ (Platte Report Number 

CARDC–1298–DIPN)) was used for the 

determination of residues of 2,6-DIPN in 

potatoes and potato peels. 

The method includes instructions and 

chromatograms for analysis of samples 

of potatoes and potato peels. Briefly, 

samples are extracted with acetonitrile. 

The extracts are partitioned with 

hexane. The acetonitrile part is 

discarded. The hexane part is rotoevaporated to dryness. The residues are 

reconstituted in hexane and purified 

using a Florisil column. The residues 

are roto-evaporated to dryness and 

reconstituted in acetonitrile. The 

samples are filtered through Acrodisc®

LC polyvinylidene difluoride (PVDF) 

0.45 micrometer (mm) filters and 

analyzed by high performance liquid 

chromatography (HPLC) with ultraviolet 

(UV) detection at 254 nanometers (nm) 

using a Zorbax ODS column. 

The validated limit of quantitation 

(LOQ) is 0.01 ppm for 2,6-DIPN in 

potatoes and 0.02 ppm in potato peels. 

The reported limits of detection (LODs) 

were 0.001 ppm for 2,6-DIPN in 

potatoes and potato peels. The method 

does not include instructions for 

confirmatory analysis. Method 

validation data for the LC/UV method 

demonstrated adequate method 

recoveries of residues of 2,6-DIPN. 

Potato samples were fortified with 2,6- 

DIPN at levels of 0.01 ppm, 0.02 ppm, 

0.05 ppm, and 50 ppm. Samples were 

analyzed at the limit of quantitation of 

0.01 ppm. Overall, recovery ranges (and 

CVs) from these matrices were 77.9– 

123.2 (13.9%) for 2,6-DIPN. Potato peel 

samples were fortified with 2,6-DIPN at 

levels of 0.02 ppm, 0.05 ppm, and 0.2 

ppm. Samples were analyzed at the 

limit of quantitation of 0.02 ppm. 

Overall, recovery ranges (and CVs) from 

these matrices were 83.2–96.1 (5.3%) for 

2,6-DIPN. 

Acceptable independent laboratory 

validation is available for this method 

using potato and potato peel samples. 

As described in this unit, an adequate 

enforcement methodology (liquid 

chromatographic/ultraviolet detection 

analytical method) is available to 

enforce the tolerance expression for 

potatoes and potato peels only. 

The radiovalidation data for HPLC/ 

UV(CARDC–1298–DIPN) for the 

determination of residues of 2,6-DIPN in 

potatoes and potato peels adequately 

recovered residues of 2,6-DIPN from 

samples of whole potato and potato 

peels with the treatment of the active 

ingredient. Multiresidue testing for 2,6- 

DIPN showed that the multiresidue 

methods are not adequate for 

enforcement purposes since 2,6-DIPN 

was not recovered through any of the 

protocols. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

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 2,6-Diisopropylnaphthalene (2,6- 

DIPN) and its metabolites and 

degradates. 

C. Revisions to Petitioned-For 

Tolerances 

Time-limited tolerances for 2,6-DIPN 

are set to expire on May 18, 2012 (40 

CFR 180.590). In consideration of 

whether or not the continued use of the 

active ingredient when used on potatoes 

would impose further risks to human 

health, EPA has reviewed newly 

submitted data/information 

multiresidue testing for 2,6-DIPN and 

radiovalidation of the analytical method 

and multiresidue testing method for 

determination of 2,6-DIPN in potato and 

potato peels as well as re-evaluated 

existing data/information in support of 

a full tolerance without time limitations. 

Receipt of this information satisfied the 

conditions of registration. 

In the previous time limited tolerance, 

EPA determined that an acceptable 

revised enforcement analytical method 

for 2,6-Diisopropylnaphthalene (2,6- 

DIPN) and two metabolites (M27 and 

M29) in livestock commodities must be 

submitted. EPA also determined that 

radiovalidation data for 2,6-DIPN and its 

metabolites (M27 and M29) must also be 

submitted. These data have already been 

generated and final reports of these 

studies are anticipated to be submitted 

to the Agency by or before December 

2012. Although EPA has requested 

additional data, EPA has revisited its 

original decision that the tolerance 

expression include two of the 

metabolites in addition to the parent 

compound. Based on this re-evaluation, 

EPA has decided to limit the tolerance 

expression to DIPN only. Feeding 

studies demonstrate that DIPN is 

quantifiable in all animal commodities. 

The highest residues are found in fat, 

and residues in fat were quantifiable 

without use of exaggerated feeding 

studies. Fat is also the commodity most 

frequently monitored for tolerance 

violative residues. Accordingly, EPA 

concludes that limiting the tolerance 

expression to parent only will be 

appropriate as a tolerance level for 

monitoring compliance with label 

application instructions for DIPN (the 

basis on which the safety determination 

for this tolerance was made). 

(Memorandum from C. Ollinger EPA/ 

OPP/HED to L. Hollis EPA/OPP/BPPD 

dated May 11, 2012). 

V. Conclusion 

Therefore, the tolerances for residues 

of 2,6-Diisopropylnaphthalene (2,6- 

DIPN) and its metabolites and 

degradates, are amended, in or on 

potato, granules/flakes at 5.5 parts per 

million (ppm); potato, wet peel at 6.0 


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32406 Federal Register / Vol. 77, No. 106 / Friday, June 1, 2012 / Rules and Regulations 

ppm; potato, whole at 2.0 ppm; cattle, 

fat at 0.2 ppm; cattle, meat at 0.02 ppm; 

cattle, meat byproducts, except fat at 

0.02 ppm; goat, fat at 0.2 ppm; goat, 

meat at 0.02 ppm; goat, meat 

byproducts, except fat at 0.02 ppm; 

horse, fat at 0.2 ppm; horse, meat at 0.02 

ppm; horse, meat byproducts, except fat 

at 0.02 ppm; milk, fat at 0.02 ppm; 

sheep, fat at 0.2 ppm; sheep, meat at 

0.02 ppm and sheep, meat byproducts, 

except fat at 0.02 ppm. 

Modification of the residue definition 

based on re-examination of existing data 

as described in Unit IV.A. and D., also 

require modification of the tolerance 

level. Residues in milk, skim milk, 

cream, meat, liver, and kidney will be 

below the limit of quantitation (LOQ) of 

0.02 ppm. Therefore, the tolerance may 

be set at 0.02 ppm. Residues are likely 

to be quantifiable in fat. HED 

recommends a level of 0.2 ppm. This is 

based on the maximum residue of 0.095 

from the 8.9 ppm feeding level (0.6x the 

MRDB) extrapolated to the 1x feeding 

level, (equal to 0.158 ppm) and rounded 

up to 0.2 ppm. The existing tolerances 

for DIPN residues on hog commodities 

may be revoked, since potatoes are no 

longer considered a major feed item for 

swine (memorandum from C. Ollinger 

(EPA/OPP/HED to L. Hollis EPA/OPP/ 

BPPD dated May 11, 2012). 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). Since tolerances and exemptions 

that are established on the basis of a 

petition under FFDCA section 408(d), 

such as the tolerance in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 16, 2012. 

Keith A. Matthews, 

Director, Biopesticides and Pollution 

Prevention 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 180.590, paragraph (a) is 

revised to read as follows: 

§ 14;180.590 2,6-Diisopropylnaphthalene 

(2,6-DIPN); tolerances for residues. 

(a) General. Tolerances are 

established for residues of the growth 

inhibitor 2,6-DIPN, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 2,6- 

Diisopropylnaphthalene. 

Commodity Parts per 

million 

Cattle, fat .................................... 0 .2 

Cattle, meat ................................ 0 .02 

Cattle, meat byproducts, except 

fat ............................................ 0 .02 

Goat, fat ...................................... 0 .2 

Goat, meat .................................. 0 .02 

Goat, meat byproducts, except 

fat ............................................ 0 .02 

Horse, fat .................................... 0 .2 

Horse, meat ................................ 0 .02 

Horse, meat byproducts, except 

fat ............................................ 0 .02 

Milk, fat ....................................... 0 .02 

Potato, granules/flakes ............... 5 .5 

Potato, wet peel .......................... 6 .0 

Potato, whole .............................. 2 .0 

Sheep, fat ................................... 0 .2 

Sheep, meat ............................... 0 .02 

Sheep, meat byproducts, except 

fat ............................................ 0 .02 

* * * * * 

[FR Doc. 2012–13203 Filed 5–31–12; 8:45 am] 

BILLING CODE 6560–50–P 


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