[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-32655 Filed 12-20-11; 8:45 am]
BILLING CODE 6560-50-P