Document ID: EPA-HQ-OPP-2005-0253-0084
Agency: epa
Document Type: Rule
Title: Tolerance Actions: Propylene oxide
Posted Date: 2012-05-15T04:00Z

[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Rules and Regulations]
[Pages 28493-28495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11632]

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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.

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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).

[[Page 28494]]

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

[[Page 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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.491 is amended by revising paragraphs (a)(1) and (a)(2) 
to read as follows:

Sec.  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.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              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.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              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