Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Rules and Regulations 73661 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0099; FRL–9936–50] 

Aureobasidium Pullulans Strains DSM 

14940 and DSM 14941; Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

existing exemption from the 

requirement of a tolerance for residues 

of Aureobasidium pullulans strains 

DSM 14940 and DSM 14941 to include 

residues of Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 in 

or on all food commodities when used 

in accordance with label directions and 

good agricultural practices. Bio-ferm 

GmbH submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

amendment of the exemption from the 

requirement of a tolerance that includes 

food commodities that are treated postharvest. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 under FFDCA. 

DATES: This regulation is effective 

November 25, 2015. Objections and 

requests for hearings must be received 

on or before January 25, 2016, 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–2010–0099, 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), West William 

Jefferson Clinton 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: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@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. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2010–0099 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 January 25, 2016. 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– 

2010–0099, 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. Background 

An exemption from the requirement 

of a tolerance for residues of the 

Aureobasidium pullulans strains DSM 

14940 and DSM 14941 in or on all food 

commodities when applied pre-harvest 

and used in accordance with good 

agricultural practices was established 

and published in the Federal Register of 

February 15, 2012 (77 FR 8731) (FRL– 

9337–3). In the Federal Register of July 

17, 2015 (80 FR 42462) (FRL–9929–13), 

EPA issued a document pursuant to 

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

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

pesticide tolerance petition (PP 4F8342) 

by bio-ferm GmbH, Technologiezentrum 

Tulln, Technopark 1, Tulln, 3430, 

Austria. The petition requested that 40 

CFR 180.1312 be amended by 

expanding the current exemption to also 

include food commodities that are 

treated post-harvest. Therefore an 

exemption from the requirement of a 

tolerance for residues of Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941 in or on all food commodities 

was proposed. The Notice of Filing 

referenced a summary of the petition 

prepared by the petitioner bio-ferm 

GmbH, which is available in the docket 

via http://www.regulations.gov. There 

were no comments received in response 

to the notice of filing. 

III. Final Rule 

A. EPA’s Safety Determination 

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 


jstallworth on DSK7TPTVN1PROD with RULES
73662 Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Rules and Regulations 

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 or tolerance exemption, 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 EPA 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues’’ and 

‘‘other substances that have a common 

mechanism of toxicity.’’ 

EPA evaluated the available toxicity 

and exposure data on Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941 and considered its validity, 

completeness, and reliability, as well as 

the relationship of this information to 

human risk. A full explanation of the 

data upon which EPA relied and its risk 

assessment based on that data can be 

found within the October 15, 2015, 

document entitled ‘‘Federal Food, Drug, 

and Cosmetic Act (FFDCA) 

considerations for Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941’’. This document, as well as other 

relevant information, is available in the 

docket for this action as described under 

ADDRESSES. Based upon its evaluation, 

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 Aureobasidium pullulans 

strains DSM 14940 and DSM 14941. 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of Aureobasidium pullulans 

strains DSM 14940 and DSM 14941 in 

or on all food commodities when used 

in accordance with label directions and 

good agricultural practices. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons contained in the October 15, 

2015, document entitled ‘‘Federal Food, 

Drug, and Cosmetic Act (FFDCA) 

considerations for Aureobasidium 

pullulans strains DSM 14940 and DSM 

14941’’ and because EPA is establishing 

an exemption from the requirement of a 

tolerance without any numerical 

limitation. 

IV. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

EPA. 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action, 

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 action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes. As a result, 

this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

EPA 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, EPA 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

EPA’s consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

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 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: November 5, 2015. 

Robert McNally, 

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 § 180.1312 to read as 

follows: 

§ 180.1312 Aureobasidium pullulans 

strains DSM 14940 and DSM 14941; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of Aureobasidium pullulans strains 

DSM 14940 and DSM 14941 in or on all 

food commodities when used in 

accordance with label directions and 

good agricultural practices. 

[FR Doc. 2015–29888 Filed 11–24–15; 8:45 am] 

BILLING CODE 6560–50–P 


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