Document ID: EPA-HQ-OPP-2005-0253-0081
Agency: epa
Document Type: Proposed Rule
Title: Tolerance Actions: Propylene Oxide
Posted Date: 2011-12-21T05:00Z

[Federal Register Volume 76, Number 245 (Wednesday, December 21, 2011)]
[Proposed Rules]
[Pages 79146-79149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32655]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0253; FRL-9329-8]

Propylene Oxide; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to establish 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 proposing minor revisions to tolerance 
expressions and specific tolerance nomenclatures for propylene oxide 
and propylene chlorohydrin.

DATES: Comments must be received on or before February 21, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2005-0253, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     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). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0253. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: 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., 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 either 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 hours of 
operation of this Docket Facility are 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).

[[Page 79147]]

     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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II.A. 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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    In this action, EPA is proposing to amend the propylene oxide 
tolerance regulation at 40 CFR 180.491 to add the crop group for tree 
nuts (nut, tree, group 14). In the Reregistration Eligibility Decision 
(RED) for propylene oxide, the Agency recommended that a tree nut crop 
group tolerance be established for two separate reasons:
    1. As a technical correction to conform the existing tolerance on 
``nutmeat, processed, except peanuts'' with current Agency commodity 
terms; and
    2. To address the lack of a tolerance for registered uses on raw 
nuts. U.S. EPA, RED for Propylene Oxide (August 2006). In the Federal 
Register of September 24, 2008 (73 FR 54954) (FRL-8382-2), EPA 
addressed the commodity conformity issue by replacing the ``nutmeat, 
processed, except peanuts'' with a tree nut crop group. However, a 
propylene oxide registrant objected to this action pointing out that 
this was not merely a technical correction to commodity terms but 
actually a substantive change to the tolerance because the tree nut 
crop group did not cover all nuts falling within the generic term 
``nutmeat, processed.'' Accordingly, EPA, on its initiative, corrected 
its error and replaced the tree nut crop group with the pre-existing 
tolerance for ``nutmeat, processed, except peanuts'' in the Federal 
Register of June 29, 2011 (76 FR 38036) (FRL-8877-7). Unfortunately, at 
the time of that action, EPA failed to recognize that the RED had found 
that a tree nut crop group was needed both as a technical, conforming 
change and to cover registered uses on raw nuts. Today, EPA is 
addressing the second reason by once again proposing to establish a 
tree nut group tolerance for propylene oxide in 40 CFR 180.491(a)(1) 
for residues of propylene oxide in or on nut, tree, group 14 at 300 ppm 
and in 40 CFR 180.491(a)(2) for residues of propylene chlorohydrin in 
or on nut, tree, group 14 at 10.0 ppm. However, because the current 
tree nut group tolerance does not cover all registered uses on nuts, 
EPA is also proposing to establish individual tolerances on these use 
sites (pistachios, pine nuts) in 40 CFR 180.491(a)(1) for residues of 
propylene oxide in or on pistachio at 300 ppm and nut, pine at 300 ppm, 
and in 40 CFR 180.491(a)(2) for residues of propylene chlorohydrin in 
or on pistachio at 10.0 ppm and nut, pine at 10.0 ppm. Establishment of 
tolerances for pistachios, pine nuts, and the nut, tree, group 14, 
would complete the actions recommended by the Agency in the RED.
    In order to conform to current Agency practice, EPA is proposing to 
revise the commodity terminology in 40 CFR 180.491(a)(1) from ``herbs 
and spices, group 19, dried'' to ``herbs and spices, group 19, dried 
leaves'' and in 40 CFR 180.491(a)(2) from ``herbs and spices, group 19, 
dried, except basil'' to ``herbs and spices, group 19, dried leaves, 
except basil.''
    Also, in accordance with current Agency practice to describe more 
clearly the measurement and scope or coverage of tolerances, including 
applicable metabolites and degradates, EPA is proposing minor revisions 
to tolerance expressions for propylene oxide and propylene 
chlorohydrins. The revisions will not substantively change the 
tolerance or, in any way, modify the permissible level of residues 
permitted by the tolerance.
    The Agency is proposing to revise the introductory text containing 
the tolerance expressions in 40 CFR 180.491(a)(1) and (a)(2).
    EPA is required to determine whether each of the amended tolerances 
meets the safety standard of FFDCA. The safety finding determination of 
``reasonable certainty of no harm'' is discussed in detail in each RED 
for the active ingredient. REDs recommend the implementation of certain 
tolerance actions, including modifications to reflect current use 
patterns, 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: (800) 490-9198; fax number: (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: (800) 553-6847 or (703) 605-6000; Internet 
at http://www.ntis.gov. An electronic copy of the propylene oxide RED 
and its addendums are available on the Internet in the docket for this 
proposed rule, ID

[[Page 79148]]

number EPA-HQ-OPP-2005-0253, at http://www.regulations.gov and at 
http://www.epa.gov/pesticides/reregistration/status.htm.
    Copies of the Residue Chemistry Chapter and other documents (such 
as the dietary exposure analysis of October 2011 for use of propylene 
oxide on pine nuts and comprehensive dietary exposure analysis of June 
2006) which support the propylene oxide RED are found in the 
Administrative Record. An electronic copy of the Residue Chemistry 
Chapter and addendum as well as other support documents for propylene 
oxide are available through EPA's electronic docket and comment system, 
regulations.gov at http://www.regulations.gov. You may search for 
docket ID number EPA-HQ-OPP-2005-0253, then click on that docket ID 
number to view its contents.
    EPA has determined that the aggregate exposures and risks are not 
of concern for the above mentioned pesticide active ingredients based 
upon the data identified in the RED which lists the submitted studies 
that the Agency found acceptable.

B. What is the agency's authority for taking this action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods. Without a tolerance or exemption, food containing 
pesticide residues is considered to be unsafe and therefore 
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such 
food may not be distributed in interstate commerce (21 U.S.C. 331(a)). 
For a food-use pesticide to be sold and distributed, the pesticide must 
not only have appropriate tolerances under the FFDCA, but also must be 
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not 
registered in the United States must have tolerances in order for 
commodities treated with those pesticides to be imported into the 
United States.
    The Agency's evaluation of the database for pesticides, including 
requirements for additional data on the active ingredients to confirm 
the potential human health and environmental risk assessments 
associated with current product uses, are contained in REDs, as are the 
Agency's conditions under which these uses and products will be 
eligible for reregistration. In REDs, the Agency recommends the 
establishment, modification, and/or revocation of specific tolerances. 
The Agency's tolerance recommendations, such as establishing or 
modifying tolerances, and in some cases revoking tolerances, are the 
result of assessment under the FFDCA standard of ``reasonable certainty 
of no harm.'' However, tolerance revocations recommended in REDs do not 
need such assessment when the tolerances are no longer necessary.

C. When do these actions become effective?

    EPA is proposing that the establishment of tolerances, and revision 
of tolerance expressions and nomenclatures become effective on the date 
of publication of the final rule in the Federal Register. If you have 
comments, please submit comments as described under SUPPLEMENTARY 
INFORMATION.
    Any commodities listed in this proposal treated with the pesticides 
subject to this proposal, and in the channels of trade following the 
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as 
established by FQPA. Under this unit, any residues of these pesticides 
in or on such food shall not render the food adulterated so long as it 
is shown to the satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA, 
and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates when the 
pesticide was applied to such food.

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 U.N. 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 proposed rule, EPA is proposing to establish tolerances 
under FFDCA section 408(e). The Office of Management and Budget (OMB) 
has exempted this type of action (e.g., establishment of a tolerance) 
from review under Executive Order 12866, entitled Regulatory Planning 
and Review (58 FR 51735, October 4, 1993). Because this proposed rule 
has been exempted from review under Executive Order 12866 due to its 
lack of significance, this proposed 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 proposed 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 104-113, section 12(d) 
(15 U.S.C. 272 note). Pursuant to 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

[[Page 79149]]

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 proposed rule, the Agency hereby certifies 
that this proposed rule will not have a significant negative 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 proposed 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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 14, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be 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:

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, dried bean.....................................        200
Cacao bean, cocoa powder...................................        200
Fig........................................................          3.0
Garlic, dried..............................................        300
Grape, raisin..............................................          1.0
Herbs and spices, group 19, dried leaves...................        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, dried bean.....................................         20.0
Cacao bean, cocoa powder...................................         20.0
Fig........................................................          3.0
Garlic, dried..............................................       6000
Grape, raisin..............................................          4.0
Herbs and spices, group 19, dried leaves, 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. 2011-32655 Filed 12-20-11; 8:45 am]
BILLING CODE 6560-50-P