68692 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

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: November 1, 2012. 

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 180.940 is amended by 

adding the entry ‘‘Xylenesulfonic acid, 

sodium salt’’ to the table in paragraph 

(a) and removing the entry for 

‘‘Xylenesulfonic acid’’ in the table in 

paragraph (c) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Xylenesulfonic acid, sodium 

salt.

1300–72–7 When ready for use, the end-use concentration is not to exceed 500 ppm. 

* * * * * 

[FR Doc. 2012–27406 Filed 11–15–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1029; FRL–9368–2] 

1,4-Dimethylnaphthalene; Amendment 

to an Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing exemption from the 

requirement of a tolerance for residues 

of the plant growth regulator, 1,4- 

dimethylnaphthalene (1,4-DMN) by 

expanding the current exemption to 

include all sprouting root and tuber 

vegetables (EPA Crop Group 01) and all 

bulb vegetables (EPA Crop Group 03). 

On behalf of D-I-1-4, Inc., a division of 

1,4Group, Inc., Technology Sciences 

Group, Inc. (TSG) submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

that EPA amend the existing exemption 

from the requirement of a tolerance for 

1,4-DMN. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1,4- 

DMN under the FFDCA. 

DATES: This regulation is effective 

November 16, 2012. Objections and 

requests for hearings must be received 

on or before January 15, 2013, 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–2011–1029, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Colin G. Walsh, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0298; email address: walsh.

colin@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 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. 

To access the OCSPP test guidelines 

referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2011–1029 in the subject line on 


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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 68693 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 15, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–1029, 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), (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. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Background and Statutory Findings 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

tolerance petition (PP 1F7920) by TSG, 

Agent, 712 Fifth Street, Suite A, Davis, 

CA 95616, on behalf of D-I-1-4, Inc., a 

division of 1,4Group, Inc., P.O. Box 860, 

Meridian, ID 83680. The petition 

requested that 40 CFR 180.1142 be 

amended by expanding the current 

exemption to include all sprouting root, 

tuber, and bulb crops, thus establishing 

an exemption from the requirement of a 

tolerance for residues of the plant 

growth regulator, 1,4-DMN, when 

applied postharvest to all sprouting 

root, tuber, and bulb crops in 

accordance with good agricultural 

practices. This notice referenced a 

summary of the petition prepared by the 

petitioner TSG, on behalf of D-I-1-4, 

Inc., a division of 1,4Group, Inc., which 

is available in the docket via http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require 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 * * *.’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that 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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability, and the 

relationship of this information 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. 

EPA established a tolerance 

exemption for 1,4-DMN in a Final Rule 

published in the Federal Register on 

February 8, 1995, (60 FR 7456–7457) 

(FRL–4932–4), which supported the 

plant growth regulator postharvest use 

on potatoes. The toxicological data 

submitted to support the previous 

tolerance exemption included the 

following: Acute (six-pack) toxicity, 

three mutagenicity studies, and a report 

of no hypersensitivity incidents for 1,4- 

DMN. The mutagenicity studies 

included an Ames test, an in vitro test 

for unscheduled DNA synthesis, and an 

in vivo micronucleus assay. All of the 

studies/information submitted to 

support the previous tolerance 

exemption indicated a lack of toxicity 

hazards for mammals, and EPA 

concluded that there is a reasonable 

certainty of no harm to humans, 

including infants and children, from the 

proposed food uses of 1,4-DMN. This 

amendment proposes to expand the 

tolerance exemption when applied 

postharvest to all sprouting root, tuber, 

and bulb crops in accordance with good 

agricultural practices. In support of this 

expansion of the tolerance exemption, 

new data have been generated by the 

petitioner and reviewed by EPA to 

address the developmental toxicity 

(OCSPP Guideline No. 870.3700) data 

requirement (the study was not 

submitted for the previous tolerance 

exemption). In addition, the petitioner 

submitted the following studies that 

were not required by EPA for this 

expansion of the tolerance exemption: 

In vivo unscheduled DNA synthesis, in 

vitro skin absorption, dermal 

sensitization, one-generation 

reproductive toxicity, and a combined 

chronic toxicity/carcinogenicity (OCSPP 

Guideline Nos. 870.5550, 870.7600, 

870.2600, 870.3800, and 870.4300, 

respectively). The developmental data 

are required when the use of the 

substance under widespread and 

commonly recognized practices may 

reasonably be expected to result in 

significant exposure to humans, 

specifically females of child-bearing age. 

The rest of the toxicological profile as 

stated in the February 8, 1995 issue of 

the Federal Register, and referenced 

herein, has not changed. The data 

submitted for the previous tolerance 

exemption include the acute toxicity 

(six-pack) studies, three mutagenicity 

studies, and a report of no 

hypersensitivity incidents for 1,4-DMN. 

A copy of the February 8, 1995 final rule 

document (60 FR 7456–7457) and risk 

assessments cited herein (Refs. 1 and 2) 

are located under docket ID number 

EPA–HQ–OPP–2011–1029. 

As discussed in the Federal Register 

of February 8, 1995 (60 FR 7456) and 

risk assessments (Refs. 1 and 2), 1,4- 

DMN is naturally occurring and has a 

nontoxic mode of action. 1,4-DMN is 


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found naturally occurring in potatoes 

(60 FR 7456) and detected in various 

other crops including cocoa, coffee, 

apples, corn, raisins, tomatoes, apricots, 

peaches, pear juice, eggplants, green 

peppers, star fruit, tea, radishes, 

oranges, cinnamon, poppies, and red 

beans (Ref. 1). When conditions are 

right for sprouting, the potato 

metabolizes 1,4-DMN to a low enough 

level so that sprouting can occur. 1,4- 

DMN is applied to postharvest sprouting 

root, tuber, and bulb stored crops at a 

level, generally 20 parts per million 

(ppm) up to 4 applications during a 

storage season, to continue to inhibit 

sprouting. 

As stated previously in this Unit, new 

toxicity data have been submitted in 

support of the request by the petitioner 

to expand the current tolerance 

exemption to cover all sprouting root, 

tuber, and bulb crops. These data 

include: (1) A prenatal developmental 

toxicity study and (2) additional data 

not required by EPA, but used to further 

support the developmental data and this 

expansion of the tolerance exemption. 

All new data, coupled with the data 

submitted to support the previous 

tolerance exemption (60 FR 7456), 

confirm the minimal human health 

hazard effects, as reported in the 

original assessment of the tolerance 

exemption, associated with dietary 

exposures of 1,4-DMN and fully 

demonstrate the lack of mammalian 

toxicity. Summaries of the new 

toxicological data submitted in support 

of the expansion of the tolerance 

exemption follow. 

A. Developmental Toxicity 

A new developmental study (Master 

Record Identification (MRID) Number 

48590905) was performed for 1,4-DMN 

to support the expansion of the 

tolerance exemption. 1,4-DMN was 

administered by oral gavage to female 

rabbits at the dose levels of 0, 25, 80, or 

250 milligrams/per/day (mg/kg/day) (23 

rabbits per test group) over gestation 

days 6 through 28. No treatment-related 

clinical signs were noted during the 

study, and gross necropsy findings were 

limited to those rabbits that underwent 

abortion (Ref. 1). The gross necropsy 

findings consisted of changes in the 

gastrointestinal tract (dilatation of 

stomach and/or intestines) and were 

likely related to the lack of eating prior 

to and during the abortion. Mean food 

consumption was significantly reduced 

in the 250 mg/kg/day treated doses 

shortly after treatment initiation (over 

gestation days 6 to 9 and 9 to 12). This 

reduction in food consumption was 

likely treatment-related. Corollary 

reductions in mean body weight gain 

were observed in the 250 mg/kg/day 

treated group over gestation days 6 to 9. 

Alterations in uterus weight were not 

observed, nor were changes seen in 

maternal body weight or body weight 

gain when corrected for uterus weight. 

As such, the changes seen early on in 

gestational body weight gain were 

considered to be solely associated with 

maternal toxicity. Therefore, the lowest 

observed adverse effect level (LOAEL) 

for maternal toxicity of 1,4-DMN in rats 

is 250 mg/kg/day based on reduced food 

consumption and reduced body weight 

gain. The no observed adverse effect 

level (NOAEL) for maternal toxicity is 

80 mg/kg/day based on no effects 

observed at this dose. 

For developmental toxicity, no 

treatment-related differences in litter 

viability were detected at any dose level 

tested. The number of male, female, and 

total fetuses (sexes combined) were 

similar across the treatment and control 

groups and average fetal weights were 

unaffected. No structural alterations, 

including gross external, visceral, 

skeletal, and cephalic, were evident 

from the fetal examinations; as such, 

1,4-DMN did not produce any frank 

malformations and was not teratogenic. 

Based on no effects observed for 

developmental toxicity at any doses 

tested, the NOAEL for developmental 

toxicity is greater than 250 mg/kg/day 

(highest dose tested). The LOAEL was 

not identified for developmental 

toxicity, suggesting that the test animals 

could have tolerated a higher dose. 

Based on the developmental toxicity 

data submitted for this expansion to the 

tolerance exemption, which showed no 

adverse effects at the highest dose 

tested, 250 mg/kg/day, there are 

sufficient data and information to 

confirm that 1,4-DMN is not a 

developmental toxicant. Therefore, the 

consumption of food commodities that 

have been treated with 1,4-DMN when 

used as a pesticide is safe and will not 

result in any harm to human health, 

specifically women of child-bearing age, 

from dietary exposure. 

B. Additional Toxicity Data 

Additional toxicity data for 1,4-DMN 

that were not required by EPA to 

support this expansion of the tolerance 

exemption were submitted by the 

petitioner. The additional data include 

the following: Unscheduled DNA 

synthesis (mutagenicity), in vitro skin 

absorption, dermal sensitization, onegeneration reproductive toxicity, and a 

combined chronic toxicity/ 

carcinogenicity study (OCSPP Guideline 

Nos. 870.5550, 870.7600, 870.2600, 

870.3800, and 870.4300, respectively). 

Although the developmental data 

submitted were sufficient to support 

this expansion of the tolerance 

exemption, EPA has used this data, 

along with the required data submitted 

to support the previous tolerance 

exemption (60 FR 7456), to confirm that 

the consumption of food commodities 

that have been treated with 1,4-DMN 

when used as a pesticide is safe and will 

not result in any harm to human health 

from dietary exposure. 

1. An in vivo unscheduled DNA 

synthesis in rats (MRID 48590902) 

showed no genotoxicity activity in rat 

livers when given a single dose of 1,4- 

DMN up to the limit dose of 1,000 mg/ 

kg (Ref. 1). These results, combined 

with the lack of mutagenic and 

genotoxic effects observed in the 

bacterial reverse mutation (Ames) test, 

in vitro unscheduled DNA synthesis in 

mammalian cells, and in vivo 

mammalian erythrocyte micronucleus 

test submitted to support the previous 

tolerance exemption (60 FR 7456), 

confirm that 1,4-DMN is not a mutagen. 

2. An in vitro precutaneous 

absorption test (MRID 48590903) in 

humans showed that the mean total 

dermal absorption of 1,4-DMN was 

2.5% of the dose applied (Ref. 1). Based 

on the relatively low absorption of 1,4- 

DMN and the data submitted to support 

the previous tolerance exemption (60 FR 

7456), which included an acute dermal 

toxicity study that showed a low acute 

dermal toxicity (median lethal dose 

(LD)50 > 2,000 mg/kg), 1,4-DMN is not 

considered a dermal toxicant. 

3. A dermal sensitization test (MRID 

48590904) utilizing the Local Lymph 

Node Assay (LLNA) method showed 

that 1,4-DMN is not a dermal sensitizer 

(Ref. 1). The dermal sensitization test 

utilizing the Buehler method submitted 

to support the previous tolerance 

exemption (60 FR 7456) also showed 

that 1,4-DMN is not a dermal sensitizer. 

4. A one-generation reproductive 

toxicity study (MRID 48590906) was 

conducted on rats to assess systemic, 

developmental, and reproductive 

toxicity. 1,4-DMN was administered in 

the diet at the dose concentrations of 0, 

500, 2,000, and 7,500 ppm with each 

dose group consisting of 24 males and 

24 female rats. The results of the study 

showed that the NOAEL for systemic 

toxicity was 2,000 ppm (equivalent to 

121 to 207 mg/kg/day in parental male 

and female rats and 184 to 213 mg/kg/ 

day in F1 males and females, 

respectively) and the LOAEL was 7,500 

ppm based on a single histological 

change in the kidney of one, 7,500 ppm 

treated rat (Ref. 1). The NOAEL and 

LOAEL for developmental toxicity were 

also 2,000 ppm and 7,500 ppm, 

respectively, based on delayed vaginal 


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patency and preputial separation in the 

7,500 ppm group; although, the delay in 

development was considered secondary 

to body weight effects that were 

attributed to reduced food consumption. 

The NOAEL for reproductive toxicity 

was 7,500 ppm (equivalent to 441 to 591 

mg/kg/day in parental male and female 

rats and 776 to 839 mg/kg/day in F1

males and females, respectively) based 

on the lack of change in reproductive 

endpoints such as mating performance, 

fertility, fecundity, litter survival, sperm 

morphology/vaginal cytology as well as 

the lack of histological change in the 

reproductive organs. The LOAEL was 

not identified for reproductive toxicity, 

suggesting that the test animals could 

have tolerated a higher dose. 

Based on the reproductive toxicity 

data submitted for this expansion to the 

tolerance exemption, which showed no 

adverse reproductive effects at the 

highest dose tested, 7,500 ppm 

(equivalent to 441 to 591 mg/kg/day in 

parental male and female rats and 776 

to 839 mg/kg/day in F1 males and 

females, respectively), there are 

sufficient data and information to 

confirm that 1,4-DMN is not a 

reproductive toxicant, and that 

consumption of food commodities that 

have been treated with this substance 

when used as a pesticide is safe and will 

not result in any harm to human health 

from dietary exposure. 

5. A combined chronic toxicity and 

carcinogenicity study (MRID 48590907) 

was conducted on rats (65 rats/sex/ 

group for carcinogenicity and 20 rats/ 

sex/group for chronic toxicity) to assess 

the chronic toxicity and carcinogenicity 

potential for 1,4-DMN. 1,4-DMN was 

administered in the diet of rats 7 days/ 

week for a minimum of 52 weeks 

(chronic toxicity phase) or 104 weeks 

(carcinogenicity phase), at the dose 

concentrations of 0, 150, 500, and 3,750 

ppm, equivalent to the dose 

concentrations of 0, 10, 33, and 250 mg/ 

kg/day. For the chronic study, decreased 

food consumption with concurrent 

decreases in body weight and body 

weight gain were noted in the 250 mg/ 

kg/day dose group. Minimal to moderate 

histologic test material-related effects in 

the kidney (proteinosis, papillary 

necrosis and karyomegaly) were noted 

in male rats at 250 mg/kg/day, while 

minimal to mild karyomegaly was noted 

in the kidney of female rats 

administered 1,4-DMN at dosages of 33 

or 250 mg/kg/day. Based on the results 

of the chronic toxicity study, the 

NOAEL for chronic toxicity was 33 mg/ 

kg/day for males and 10 mg/kg/day for 

females. For the carcinogenicity study, 

no incidences of carcinogenicity were 

noted in rats in any of the dose 

concentrations after the 97 weeks and 

104 weeks of treatment for female and 

male rats, respectively. 

Based on the results of the 

carcinogenicity data submitted for this 

expansion to the tolerance exemption, 

which showed that there was no 

evidence of carcinogenicity at the 

highest dose tested, 3,750 ppm 

(equivalent to 250 mg/kg/day), there are 

sufficient data and information to 

confirm that 1,4-DMN is not a 

carcinogen, and that consumption of 

food commodities that have been treated 

with this substance when used as a 

pesticide is safe and will not result in 

any harm to human health from dietary 

exposure. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Dietary risks to humans are 

considered negligible based on the lack 

of significant dietary toxicological 

endpoints for 1,4-DMN, its non-toxic 

mode of action, and the fact that it is 

applied to postharvest root, tuber, and 

bulb crops at the relatively low 

application rate of 20 ppm up to four 

applications during the storage season. 

No significant acute, subchronic, 

mutagenic, developmental, chronic, or 

carcinogenicity dietary toxicity hazards 

were identified in the studies submitted 

to support this expansion of the 

tolerance exemption or the previous 

tolerance exemption (60 FR 7456). The 

submitted data and information for this 

expansion of the tolerance exemption 

show that any residues of 1,4-DMN 

found in or on the sprouting root, tuber, 

and bulb crops are far below any 

toxicological endpoints identified in 

this expansion of the tolerance 

exemption or in the previous tolerance 

exemption (60 FR 7456) and confirm 

1,4-DMN’s lack of dietary toxicity 

hazards for mammals (Ref. 2). 

1. Food. The petitioner submitted a 

scientific literature summary of the 

natural occurrence of 1,4-DMN in food 

crops (MRID 48653101) to support the 

expansion of the tolerance exemption 

from postharvest use on potatoes only, 

which are found in EPA Crop Group 01, 

to include all other sprouting root and 

tuber vegetables in the same EPA Crop 

Group 01 and all bulb vegetables (EPA 

Crop Group 03). Bulb vegetables include 

garlic, leek, onion, rakkyo, and shallot. 

As stated in the summary, 1,4-DMN has 

been detected in various crops 

including cocoa, coffee, apples, corn, 

raisins, tomatoes, apricots, peaches, 

pear juice, eggplants, green peppers, star 

fruit, tea, radishes (EPA Crop Group 01), 

oranges, cinnamon, poppies, and red 

beans (Ref. 1). It is likely that 1,4-DMN 

occurs naturally in other crops not 

listed in the literature summary, 

including crops in EPA Crop Group 01 

(besides the already listed potatoes and 

radishes), and bulb crops in EPA Crop 

Group 03. The literature summary also 

indicated that the isomers of 

dimethylnaphthalene were shown to be 

present in various crops; however, the 

research indicates that it is extremely 

difficult to measure the amounts of the 

natural occurrence due to the volatility 

of the dimethylnaphthalene isomers, 

and any amounts reported are most 

likely an underestimation of the actual 

amount naturally present in the crop. As 

stated in Unit III of this final rule, the 

previous tolerance exemption (60 FR 

7456) indicated that 1,4-DMN is found 

naturally occurring in potatoes. When 

conditions are right for sprouting, the 

potato metabolizes 1,4-DMN to a low 

enough level so that sprouting can 

occur. 1,4-DMN is applied to 

postharvest potatoes at a level, generally 

20 ppm up to four applications during 

a storage season, to maintain 1,4-DMN 

at a sufficient concentration in the 

potato to continue to inhibit sprouting. 

Based on the submitted data and 

information for this expansion of the 

tolerance exemption, any residues of 

1,4-DMN found in or on the sprouting 

root, tuber, and bulb crops are far below 

any toxicological endpoints identified 

in this expansion of the tolerance 

exemption or in the previous tolerance 

exemption (60 FR 7456). These 

toxicological endpoints identified in 

Unit III of this final rule include: 

Maternal toxicity NOAEL of 80 mg/kg/ 

day, developmental toxicity NOAEL 

greater than 250 mg/kg/day, 

reproductive toxicity NOAEL of 7,500 

ppm (equivalent to 441 to 591 mg/kg/ 

day in parental male and female rats 

and 776 to 839 mg/kg/day in F1 males 

and females, respectively), and chronic 

toxicity NOAEL of 33 mg/kg/day (500 

ppm) for males and 10 mg/kg/day (150 

ppm) for females. The previous 

tolerance exemption showed an acute 

oral toxicity LD50 of 2,730 mg/kg/day. In 

addition, under the conditions of the 

respective studies, there were no signs 

of mutagenicity or carcinogenicity for 

1,4-DMN. In summary, the toxicity data 


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68696 Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 

submitted for 1,4-DMN, the natural 

occurrence of the substance in the 

various crops listed in this section, the 

nontoxic mode of action, the volatility 

of the isomers of dimethylnaphthalene, 

and the fact that it is applied to 

postharvest root, tuber, and bulb crops 

at the relatively low application rate of 

20 ppm up to four applications during 

the storage season, demonstrate a lack of 

aggregate dietary risk that is sufficient to 

support this expansion of the tolerance 

exemption. 

2. Drinking water exposure. No new 

drinking water exposure is expected to 

result from the new food uses of 1,4- 

DMN. Exposure of humans to 1,4-DMN 

in drinking water is highly unlikely 

since the products are labeled for 

postharvest application to sprouting 

root, tuber, and bulb crops stored in 

indoor facilities and are not applied 

directly to crops in the field. The data 

and information demonstrate a lack of 

aggregate dietary risk via drinking water 

and is sufficient to support this 

expansion of the tolerance exemption. 

B. Other Non-Occupational Exposure 

No new non-occupational exposure is 

expected to result from the new food 

uses of 1,4-DMN. No health risks are 

expected from any non-occupational 

exposure to 1,4-DMN based on the data 

submitted for the previous tolerance 

exemption (60 FR 7456) and for this 

expansion of the tolerance exemption. 

1. Dermal exposure. No new nonoccupational dermal exposure is 

expected to result from the new food 

uses of 1,4-DMN resulting from this 

expansion of the tolerance exemption. 

Any new dermal exposure associated 

with this expansion of the tolerance 

exemption is expected to be 

occupational in nature. 

2. Inhalation exposure. No new nonoccupational inhalation exposure is 

expected to result from the new food 

uses of 1,4-DMN resulting from this 

expansion of the tolerance exemption. 

Any new inhalation exposure associated 

with this expansion of the tolerance 

exemption is expected to be 

occupational in nature. 

V. 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 1,4-DMN to share 

a common mechanism of toxicity with 

any other substances, and 1,4-DMN does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 1,4- 

DMN 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. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides 

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall 

apply an additional tenfold 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 unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. Margins of exposure (safety), 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

Relevant data and information 

submitted for the previous tolerance 

exemption (60 FR 7456) and for this 

expansion of the tolerance exemption 

indicate that 1,4-DMN has negligible 

acute, subchronic, mutagenic, 

developmental, chronic, or 

carcinogenicity toxicity hazards. 

Moreover, 1,4-DMN has a nontoxic 

mode of action and naturally occurs in 

various crops as listed in Unit IV.A.1. 

Therefore, the Agency 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 the residues of 

1,4-DMN. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. EPA has arrived at this 

conclusion because the data and 

information available on 1,4-DMN do 

not demonstrate significant toxic 

potential to mammals. Thus, there are 

no threshold effects of concern and, as 

a result, an additional margin of safety 

is not necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated above, and because EPA 

is establishing an exemption from the 

requirement of a tolerance without any 

numerical limitation. 

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 1,4-DMN. 

VIII. Conclusions 

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 1,4-DMN. 

Therefore, the existing exemption from 

the requirement of a tolerance for 

residues of the plant growth regulator, 

1,4-DMN, when applied postharvest to 

potatoes is amended by establishing the 

exemption from the requirement of a 

tolerance for residues of the plant 

growth regulator, 1,4-DMN, when 

applied postharvest to sprouting root, 

tuber, and bulb crops in accordance 

with good agricultural practices. 

IX. References 

The following references used in this 

document and the previous Final Rule 

published in the Federal Register on 

February 8, 1995, (60 FR 7456) (FRL– 

4932–4) are in the OPP docket listed 

under docket ID EPA–HQ–OPP–2011– 

1029 and may be seen by accessing the 

www.regulations.gov Web site. 

1. U.S. EPA. 2012. Memorandum from 

Gina M. Burnett to Colin Walsh. Science 

Review of Tolerance Petition 1F7920, 


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Federal Register / Vol. 77, No. 222 / Friday, November 16, 2012 / Rules and Regulations 68697 

Intended to Expand the Use of 1,4- 

Dimethylnaphthalene to Include Use on 

All Root and Tuber Vegetables (Crop 

Group 01) and Bulb Vegetables (Crop 

Group 03); Label Amendments for 

67727–1, –3 and –4 Upon Tolerance 

Amendment Approval. U.S. 

Environmental Protection Agency, 

Office of Pesticide Programs. March 16, 

2012. 

2. U.S. EPA. 2012. Memorandum from 

Russell S. Jones, Ph.D., to Colin Walsh. 

Science Review of Registrant’s Response 

to Deficiencies in Tolerance Petition 

1F7920, Intended to Expand the Use of 

1,4-Dimethylnaphthalene to Include Use 

on All Root and Tuber Vegetables (Crop 

Group 01) and Bulb Vegetables (Crop 

Group 03); Label Amendments for 

67727–1, –3 and –4 Upon Tolerance 

Amendment Approval. U.S. 

Environmental Protection Agency, 

Office of Pesticide Programs. June 21, 

2012. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance 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 exemption 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) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 26, 2012. 

Keith A. Mathews, 

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. Revise § 180.1142 to read as 

follows: 

§ 180.1142 1,4-Dimethylnaphthalene; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of the plant growth regulator, 

1,4-dimethylnaphthalene (1,4-DMN), 

when applied postharvest to all 

sprouting root, tuber, and bulb crops in 

accordance with good agricultural 

practices. 

[FR Doc. 2012–27809 Filed 11–15–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2012–0003; Internal 

Agency Docket No. FEMA–8255] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at http:// 

www.fema.gov/fema/csb.shtm. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 

listed in the third column of the 

following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact David Stearrett, 

Federal Insurance and Mitigation 


emcdonald on DSK7TPTVN1PROD with RULES