Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 28493 

EPA-APPROVED REGULATIONS, TECHNICAL MEMORANDA, AND STATUTES IN THE MARYLAND SIP—Continued 

Code of Maryland administrative 

regulations (COMAR) citation Title/Subject State effective date EPA approval date Additional explanation/ citation at 40 CFR 52.1100 

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[FR Doc. 2012–11626 Filed 5–14–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0253; FRL–9346–8] 

RIN 2070–ZA16 

Propylene Oxide; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is establishing the tree 

nut crop group tolerance and separate 

tolerances on pistachio and pine nuts 

for both the fumigant propylene oxide 

and the reaction product from the use of 

propylene oxide, known as propylene 

chlorohydrin, to cover all registered 

uses on raw and processed nuts. Also, 

in accordance with current Agency 

practice, EPA is making minor revisions 

to tolerance expressions for propylene 

oxide and propylene chlorohydrin. 

DATES: This regulation is effective May 

15, 2012. Objections and requests for 

hearings must be received on or before 

July 16, 2012, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2005–0253. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; email address: 

nevola.joseph@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://ecfr.

gpoaccess.gov/cgi/t/text/text-idx?&c=

ecfr&tpl=/ecfrbrowse/Title40/40tab_

02.tpl. 

C. How can I file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (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–2005–0253 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 16, 2012. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2005–0253, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 


wreier-aviles on DSK7SPTVN1PROD with RULES
28494 Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background 

A. What action is the agency taking? 

In the Federal Register of December 

21, 2011 (76 FR 79146) (FRL–9329–8), 

EPA issued a proposed rule to establish 

specific tolerances, and make minor 

revisions to tolerance expressions and 

specific tolerance nomenclatures for the 

fumigant propylene oxide and the 

reaction product from the use of 

propylene oxide, known as propylene 

chlorohydrin. Also, the proposed rule of 

December 21, 2011 provided a 60-day 

comment period which invited public 

comment for consideration. 

In this final rule, in order to cover all 

registered uses on raw and processed 

nuts, EPA is establishing in 40 CFR 

180.491(a)(1) tolerances for propylene 

oxide at 300 ppm on nut, pine; nut, tree, 

group 14; and pistachio; and in 40 CFR 

180.491(a)(2) tolerances for propylene 

chlorohydrin at 10.0 ppm on nut, pine; 

nut, tree, group 14; and pistachio. Also, 

in accordance with current Agency 

practice, EPA is making minor revisions 

to tolerance expressions for propylene 

oxide and propylene chlorohydrin. 

However, the proposed tolerance 

terminology changes in 40 CFR 

180.491(a)(1) and (a)(2) for crop group 

19 (each from dried to dried leaves) 

would have excluded a variety of herbs 

and spices in crop group 19 that are not 

leaves, such as pepper or poppy. 

Therefore, EPA has decided not to 

amend the current tolerance 

terminologies in 40 CFR 180.491(a)(1) 

for ‘‘herbs and spices, group 19, dried’’ 

and in 40 CFR 180.491(a)(2) for ‘‘herbs 

and spices, group 19, dried, except 

basil.’’ 

EPA is finalizing these tolerance 

actions in order to implement the 

tolerance recommendations made in the 

Reregistration Eligibility Decision (RED) 

for propylene oxide to establish a tree 

nut crop group to address the lack of a 

tolerance for registered uses on raw nuts 

and conform the existing tolerance on 

‘‘nutmeat, processed, except peanuts’’ 

with current Agency commodity terms. 

As part of the RED and tolerance 

reassessment processes, EPA is required 

to determine whether each of the 

amended tolerances meets the safety 

standard of the Federal Food, Drug, and 

Cosmetic Act (FFDCA). The safety 

finding determination of ‘‘reasonable 

certainty of no harm’’ is discussed in 

detail in each RED. REDs recommend 

the implementation of certain tolerance 

actions, including modifications, to 

reflect current use patterns, to meet 

safety findings and change commodity 

names and groupings in accordance 

with new EPA policy. Printed copies of 

many REDs may be obtained from EPA’s 

National Service Center for 

Environmental Publications (EPA/ 

NSCEP), P.O. Box 42419, Cincinnati, 

OH 45242–2419; telephone number: 1– 

800–490–9198; fax number: 1–513–489– 

8695; Internet at http://www.epa.gov/ 

ncepihom and from the National 

Technical Information Service (NTIS), 

5285 Port Royal Rd., Springfield, VA 

22161; telephone number: 1–800–553– 

6847 or 703–605–6000; Internet at 

http://www.ntis.gov. Electronic copies of 

REDs are available on the Internet at 

http://www.regulations.gov and http:// 

www.epa.gov/pesticides/reregistration/ 

status.htm. 

In response to the proposed rule 

published in the Federal Register of 

December 21, 2011 (76 FR 79146), EPA 

received one comment during the 60- 

day public comment period, as follows: 

Comment by private citizen. The 

commenter expressed concerns about 

pesticides on food and that only zero 

tolerance levels should be acceptable. 

Agency response. The commenter did 

not take issue with the Agency’s specific 

conclusions to establish certain 

tolerances for propylene oxide and 

propylene chlorohydrin. Also, the 

commenter did not refer to any specific 

studies which pertain to those 

conclusions. The Agency has not 

changed its previous determination that 

the tolerances in question are safe and 

is therefore not making any changes in 

response to this comment. 

B. What is the agency’s authority for 

taking this action? 

EPA may issue a regulation 

establishing, modifying, or revoking a 

tolerance under FFDCA section 408(e). 

In this final rule, EPA is establishing 

tolerances to implement the tolerance 

recommendations made in the RED for 

propylene oxide. 

C. When do these actions become 

effective? 

As stated in the DATES section, this 

regulation is effective on the date of 

publication in the Federal Register. In 

this final rule, EPA is establishing 

specific tolerances and making minor 

revisions to tolerance expressions for 

propylene oxide and propylene 

chlorohydrin. 

III. 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 propylene oxide or propylene 

chlorohydrin. 

IV. Statutory and Executive Order 

Reviews 

In this final rule, EPA establishes 

tolerances under FFDCA section 408(e). 

The Office of Management and Budget 

(OMB) has exempted this type of action 

(i.e., establishment of a tolerance) from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993). 

Because this rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this 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). 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., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). Nor does it require any special 

considerations as required by Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any other 

Agency action under Executive Order 

13045, entitled Protection of Children 

from Environmental Health Risks and 

Safety Risks (62 FR 19885, April 23, 

1997). This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–13, section 

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


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Federal Register / Vol. 77, No. 94 / Tuesday, May 15, 2012 / Rules and Regulations 28495 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency 

previously assessed whether 

establishment of tolerances, exemptions 

from tolerances, raising of tolerance 

levels, or expansion of exemptions 

might significantly impact a substantial 

number of small entities and concluded 

that, as a general matter, these actions 

do not impose a significant economic 

impact on a substantial number of small 

entities. This analysis for tolerance 

establishments and modifications was 

published on May 4, 1981 (46 FR 

24950), and was provided to the Chief 

Counsel for Advocacy of the Small 

Business Administration. Taking into 

account this analysis and available 

information concerning the pesticide 

involved in this final rule, the Agency 

hereby certifies that this final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. 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). 

For these same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 9, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

V. 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: April 27, 2012. 

Steven Bradbury, 

Director, 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 180.491 is amended by 

revising paragraphs (a)(1) and (a)(2) to 

read as follows: 

§ 180.491 Propylene oxide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fumigant 

propylene oxide, including its 

metabolites and degradates, in or on the 

commodities in the table in this 

paragraph. Compliance with the 

tolerance levels specified in this 

paragraph is to be determined by 

measuring only propylene oxide, when 

used as a postharvest fumigant, in or on 

the commodity. 

Commodity Parts per 

million 

Cacao bean, cocoa powder ......... 200 

Cacao bean, dried bean ............... 200 

Fig ................................................. 3.0 

Garlic, dried .................................. 300 

Grape, raisin ................................. 1.0 

Herbs and spices, group 19, dried 300 

Nut, pine ....................................... 300 

Nut, tree, group 14 ....................... 300 

Nutmeat, processed, except peanuts ........................................... 300 

Onion, dried .................................. 300 

Pistachio ....................................... 300 

Plum, prune, dried ........................ 2.0 

(2) Tolerances are established for 

residues of the reaction product, 

propylene chlorohydrin, including its 

metabolites and degradates, in or on the 

commodities in the table in this 

paragraph. Compliance with the 

tolerance levels specified in this 

paragraph is to be determined by 

measuring only the sum of propylene 

chlorohydrin (1-chloro-2-propanol), and 

its isomer 2-chloro-1-propanol, 

calculated as the stoichiometric 

equivalent of propylene chlorohydrin 

(1-chloro-2-propanol), that results from 

the use of propylene oxide as a 

postharvest fumigant, in or on the 

commodity. 

Commodity Parts per 

million 

Basil, dried leaves ........................ 6000 

Cacao bean, cocoa powder ......... 20.0 

Cacao bean, dried bean ............... 20.0 

Fig ................................................. 3.0 

Garlic, dried .................................. 6000 

Grape, raisin ................................. 4.0 

Herbs and spices, group 19, 

dried, except basil ..................... 1500 

Nut, pine ....................................... 10.0 

Nut, tree, group 14 ....................... 10.0 

Nutmeat, processed, except peanuts ........................................... 10.0 

Onion, dried .................................. 6000 

Pistachio ....................................... 10.0 

Plum, prune, dried ........................ 2.0 

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[FR Doc. 2012–11632 Filed 5–14–12; 8:45 am] 

BILLING CODE 6560–50–P 


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