Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 35143 

TABLE 2—(33 CFR 165.171)—Continued 

43°47′44′′ N 070°07′27′′ W. 

43°47′57′′ N 070°07′27′′ W. 

Eliot Festival Day Fireworks ..................................................................... • Event Type: Fireworks Display. 

• Sponsor: Eliot Festival Day Committee. 

• Date: September 27, 2013. 

• Rain date: September 29, 2013. 

• Time: 8 p.m. to 10:30 p.m. 

• Location: In the vicinity of Eliot Town Boat Launch, Eliot, Maine in 

approximate position: 

43°08′56′′ N, 070°49′52′′ W. (NAD 83). 

For events where the date is different 

from the dates previously published for 

that event, new Temporary Rules may 

be issued to enforce limited access areas 

for the marine event. The Coast Guard 

may patrol each event area under the 

direction of a designated Coast Guard 

Patrol Commander. The Patrol 

Commander may be contacted on 

Channel 16 VHF–FM (156.8 MHz) by 

the call sign ‘‘PATCOM.’’ Official patrol 

vessels may consist of any Coast Guard, 

Coast Guard Auxiliary, state, or local 

law enforcement vessels assigned or 

approved by the Captain of the Port, 

Sector Northern New England. For 

information about regulations and 

restrictions for waterway use during the 

effective periods of these events, please 

refer to 33 CFR 100.120 and 33 CFR 

165.171. 

This notice is issued under authority 

of 33 CFR 100.120, 33 CFR 165.171, and 

5 U.S.C. 552 (a). In addition to this 

notice in the Federal Register, the Coast 

Guard will provide the maritime 

community with advance notification of 

this enforcement period via the Local 

Notice to Mariners and marine 

information broadcasts. If the COTP 

determines that the regulated area need 

not be enforced for the full duration 

stated in this notice, he or she may use 

a Broadcast Notice to Mariners to grant 

general permission to enter the 

regulated area. 

Dated: May 24, 2013. 

B.S. Gilda, 

Captain, U. S. Coast Guard, Captain of the 

Port Sector Northern New England. 

[FR Doc. 2013–13907 Filed 6–11–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0921; FRL–9386–8] 

1,3-Propanediol; Exemptions From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of 1,3-propanediol 

(CAS Reg. No. 504–63–2) when used as 

an inert ingredient solvent, co-solvent, 

diluent, or freeze-point depressant in 

pesticide formulations applied to 

growing crops and to raw agricultural 

crops after harvest and in antimicrobial 

pesticide formulations applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils. 

DuPont Tate & Lyle BioProducts 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of 

exemptions from the requirement of a 

tolerance. These regulations eliminate 

the need to establish a maximum 

permissible level for residues of 1,3- 

propanediol. 

DATES: This regulation is effective June 

12, 2013. Objections and requests for 

hearings must be received on or before 

August 12, 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–2012–0921, 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: 

David Lieu, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0079; email address: 

lieu.david@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:// 

www.ecfr.gov/cgi-bin/textidx?&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–2012–0921 in the subject line on 


ehiers on DSK2VPTVN1PROD with RULES
35144 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 

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 August 12, 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 Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0921, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of January 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

2E8091) by DuPont Tate & Lyle 

BioProducts, LLC, 198 Blair Bend Dr., 

Loudon, TN 37774. The petition 

requested two exemptions from the 

requirement of a tolerance be 

established for residues of 1,3- 

propanediol (CAS Reg. No. 504–63–2) 

when used as an inert ingredient under 

40 CFR 180.910 for its use as a solvent, 

co-solvent, diluent, or freeze-point 

depressant in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest 

and under 40 CFR 180.940(a) for its use 

in antimicrobial pesticide formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils. That document 

referenced a summary of the petition 

prepared by DuPont Tate & Lyle 

BioProducts, the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply non-toxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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 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. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 1,3-propanediol 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with 1,3-propanediol follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by 1,3-propanediol as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

The acute oral toxicity of 1,3- 

propanediol in rodents, expressed as an 

LD50 ranges from 10,500 to 15,789 

milligram/kilogram body weight (mg/kg 

bw). No acute dermal toxicity studies 

for 1,3-propanediol were available in 

the toxicity database. The acute 

inhalation toxicity of 1,3-propanediol in 

rats produced a LC50 was > 5.0 mg/liter 

(L). It is minimally irritating to the eyes 

of rabbits. It is mildly irritating to the 

skin of rabbits. Dermal sensitization 

studies on guinea pigs showed that 1,3- 

propanediol is not a sensitizer. 

In a 14-day inhalation toxicity study, 

three groups of 10 male Crl:CD (SD) IGS 

BR rats each were exposed by inhalation 

to either vapor only or a vapor/aerosol 

mixture of 1,3-propanediol in air at 

concentrations targeted to 60, 600, or 

1,800 mg/meter cubed (m3) (0.06, 0.60, 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 35145 

or 1.80 mg/L) for 6 hours/day, 4 or 5 

days/week for a total of 9 exposures. A 

procedural control group of 10 male rats 

were exposed simultaneously to air 

only. There were no clinical signs of 

toxicity, body weight effects, clinical 

chemistry parameters, hematology 

measurements, and histopathological 

findings. The NOAEL for repeated 

inhalation exposure to 1,3-propanediol 

in male rats was considered to be 1,800 

mg/m3 or 1.8 mg/L (the highest dose 

tested) and no LOAEL was identified. 

In a 90-day oral toxicity study, 1,3- 

propanediol was administered to 10 

Crl:CD®(SD)BR rats/sex/dose by gavage 

at dosages of 0, 100, 300, or 1,000 mg/ 

kg/day. No treatment-related effects 

were observed on clinical signs, 

mortality, body weights and body 

weight gain, food consumption, 

ophthalmoscopic examination, sperm 

abnormalities, organ weights and 

macroscopic, and microscopic 

examinations at doses up to and 

including 1,000 mg/kg/day. The NOAEL 

for systemic toxicity of 1,3-propanediol 

administered orally via gavage to male 

and female rats for 91 or 92 consecutive 

days was 1,000 mg/kg/day (the highest 

dose tested) and no LOAEL was 

identified. 

The mutagenic potential of 1,3- 

propanediol was evaluated in a bacterial 

reverse mutation test, an in vitro 

mammalian cell gene mutation test, an 

in vitro chromosome aberration assay, 

an in vitro mammalian cell chromosome 

aberration assay, and an in vivo 

mammalian erythrocyte micronucleus 

test. Although the in vitro mammalian 

cell chromosome aberration assay in the 

V79 Chinese hamster cell line indicated 

some chromosomal aberrations, the 

remainders of the studies including the 

in vivo mouse micronucleus assay were 

negative; therefore, there are no 

concerns for clastogenicity. Based on 

the results of these studies, 1,3- 

propanediol is not considered to be 

mutagenic. 

No carcinogenicity studies on 1,3- 

propanediol were available in the 

toxicity database, however based on the 

lack of mutagenicity concerns, lack of 

any systemic toxicity at the limit dose, 

and lack of any structural alerts for 

carcinogenicity in the Derek analysis, 

there are no concerns for 

carcinogenicity for 1,3-propanediol. 

In a developmental toxicity study, 

1,3-propanediol was administered to 20 

pregnant female Sprague-Dawley 

(Hag:SD) rats/dose by gavage in 0.8% 

aqueous hydroxypropyl-methylcellulose 

gel (with constant dose volume of 10 

milliliter (mL)/kg bw) at dose levels of 

0, 250, or 1,000 mg/kg bw/day on 

gestation days (GDs) 6 through 15. Dams 

were sacrificed and necropsied on 

gestation day (GD) 20. There were no 

treatment-related effects on maternal 

survival, clinical signs, body weight, 

food consumption, or gross pathology. 

The maternal LOAEL is not identified, 

and the maternal NOAEL is greater than 

or equal to 1,000 mg/kg bw/day (the 

highest dose tested). There were no 

treatment-related effects on live litter 

size, fetal deaths, fetal weights, early or 

late resorptions, or the fetal sex ratio. 

The developmental LOAEL is not 

identified, and the developmental 

NOAEL is greater than or equal to 1,000 

mg/kg bw/day (the highest dose tested). 

There were no immunotoxicity or 

neurotoxicity studies on 1,3- 

propanediol available in the toxicity 

database. However, there was no 

evidence of clinical signs of 

neurotoxicity or immunotoxicity 

triggers in the available database up to 

the limit dose. 

The proposed metabolic pathway for 

1,3-propanediol follows that for other 

simple alcohols, where alcohol and 

aldehyde dehydrogenase enzymes 

sequentially break down this substance 

to aldehydes and acids used in 

intermediary metabolism. 1,3- 

propanediol is metabolized to 3- 

hydroxypropionaldehyde, 

malondialdehyde, or 3- 

hydroxypropionic acid, malonic semialdehyde, malonic acid, and ultimately, 

carbon dioxide and water. 

B. Toxicological Points of Departure/ 

Levels of Concern 

There was no hazard identified in 

repeat dose toxicity and developmental 

studies with 1,3-propanediol at the limit 

dose of 1,000 mg/kg/day to either 

parental animals or their offspring. 

Based on the available mutagenicity 

studies, EPA concluded that 1,3- 

propanediol is not likely to be 

genotoxic. In addition, there were no 

structural alerts for carcinogenicity in 

the Derek analysis. Thus, due to its low 

potential hazard and lack of hazard 

endpoint, the Agency has determined 

that a quantitative risk assessment using 

safety factors applied to a point of 

departure protective of an identified 

hazard endpoint is not appropriate for 

1,3-propanediol. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to 1,3-propanediol, EPA 

considered exposure under the 

proposed exemptions from the 

requirement of a tolerance. Dietary 

exposure to 1,3-propanediol can occur 

eating food treated with pesticide 

formulation containing this inert 

ingredient. In addition, dietary exposure 

to 1,3-propanediol could occur via 

residues from treated food contact 

surfaces. Since an endpoint for risk 

assessment was not identified, a 

quantitative dietary exposure 

assessment for 1,3-propanediol was not 

conducted. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to 1,3-propanediol can occur by 

drinking water that has been 

contaminated by run-off from a 

pesticide treated area and from 

antimicrobial formulations used in foodcontact surface sanitizing solutions. 

Since an endpoint for risk assessment 

was not identified, a quantitative dietary 

exposure assessment from drinking 

water for 1,3-propanediol was not 

conducted. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, and 

tables). 

Residential (oral, dermal, and 

inhalation) exposure from food-contact 

surface sanitizing solutions for public 

eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils are possible. In 

addition, residential exposure through 

other potential agricultural uses is also 

possible. Since an endpoint for risk 

assessment was not identified, a 

quantitative residential exposure 

assessment for 1,3-propanediol was not 

conducted. 

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 1,3-propanediol to 

share a common mechanism of toxicity 

with any other substances, and 1,3- 

propanediol does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that 1,3-propanediol 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 


ehiers on DSK2VPTVN1PROD with RULES
35146 Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. The toxicity 

database for 1,3-propanediol contains 

several acute and subchronic studies, 

mutagenic studies, and a developmental 

toxicity study. No hazard was identified 

based on those studies. The toxicity 

database does not contain a 

carcinogenicity study and an 

immunotoxicity study, but for the 

reasons stated in Unit IV.A., the Agency 

has concluded that there are no 

concerns for carcinogenicity or 

immunotoxicity for this chemical. No 

acute or subchronic neurotoxicity 

studies are available, but there were no 

clinical signs of neurotoxicity or any 

systemic toxicity observed with 1,3- 

propanediol in the available database at 

doses up to 1,000 mg/kg/day. No 

developmental or reproductive effects 

were seen in the available studies at 

doses of 1,3-propanediol up to and 

including 1,000 mg/kg/day. Thus, there 

is no residual uncertainty regarding 

prenatal and/or postnatal toxicity of 1,3- 

propanediol. 

Based on this information, there is no 

concern at this time for increased 

sensitivity to infants and children to 

1,3-propanediol when used as an inert 

ingredient in pesticide formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and for food-contact surface sanitizing 

applications. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on 1,3-propanediol, EPA 

has determined that there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

aggregate exposure to 1,3-propanediol 

under reasonable foreseeable 

circumstances. Therefore, the 

establishment of exemptions from 

tolerance under 40 CFR 180.910 for 

residues of 1,3-propanediol when used 

as an inert ingredient in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest and under 40 CFR 180.940(a) for 

residues of 1,3-propanediol when used 

as an inert ingredient in food-contact 

surface sanitizing solutions for public 

eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils is safe under 

FFDCA section 408. 

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, 1,3-propanediol is 

not expected to pose an acute risk. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

chronic exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a chronic oral exposure was identified, 

and no chronic dietary endpoint was 

selected. Therefore, 1,3-propanediol is 

not expected to pose a chronic risk. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short-term 

adverse effect was identified, 1,3- 

propanediol is not expected to pose a 

short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, 1,3-propanediol is 

not expected to pose a intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit IV.A., 

1,3-propanediol 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 1,3- 

propanediol residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing exemptions 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 Nation 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 1,3-propanediol. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance are 

established for residues of 1,3- 

propanediol (CAS Reg. No. 504–63–2) 

under 40 CFR 180.910 when used as an 

inert ingredient (solvent, co-solvent, 

diluent, or freeze point depressant) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest and under 40 

CFR 180.940(a) when used as an inert 

ingredient in food-contact surface 

sanitizing solutions for public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes exemptions 

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 


ehiers on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Rules and Regulations 35147 

the exemptions 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). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 3, 2013. 

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. In § 180.910, add to the table, after 

the entry ‘‘Propane,’’ the following inert 

ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

1,3-Propanediol (CAS Reg. No. 504–63–2) ................................... ................ Solvent, co-solvent, diluent, or freeze-point depressant. 

* * * * * * * 

■ 3. In § 180.940, add to the table in 

paragraph (a), after the entry ‘‘potassium 

iodide,’’ the following inert ingredient 

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 

* * * * * * * 

1,3-Propanediol ............................................................................................................ 504–63–2 None. 

* * * * * * * 

* * * * * 

[FR Doc. 2013–13823 Filed 6–11–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0264; FRL–9389–2] 

Bacillus pumilus Strain BU F–33; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Bacillus 

pumilus strain BU F–33 in or on all food 

commodities when applied to elicit 

induced systemic resistance in plants 

and used in accordance with label 

directions and good agricultural 

practices. Becker Underwood, Inc., 

submitted a petition to the EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) requesting an exemption 

from the requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus pumilus strain 

BU F–33 under the FFDCA. 

DATES: This regulation is effective June 

12, 2013. Objections and requests for 

hearings must be received on or before 

August 12, 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–2012–0264, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 


ehiers on DSK2VPTVN1PROD with RULES