Propanil, Phenmedipham, Triallate, and MCPA; Proposed Tolerance Actions, 56425-56433 [E6-15841]
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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Proposed Rules
subject to safety guidelines in industry
standards. These standards are typically
already required by state or local fire
codes, and this rule does not require
tribal governments to change their
regulations. Thus, Executive Order
13175 does not apply to this rule.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045: ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997) applies to any rule that:
(1) Is determined to be ‘‘economically
significant’’ as defined under Executive
Order 12866, and (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
the planned rule on children, and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
This proposed rule is not
economically significant as defined in
Executive Order 12866, and the Agency
does not have reason to believe the
environmental health or safety risks
addressed by this action present a
disproportionate risk to children. The
acceptability listings in this proposed
rule primarily apply to the workplace,
and thus, do not put children at risk
disproportionately. This rule is not
subject to Executive Order 13045
because it is not economically
significant as defined in Executive
Order 12866 and because the Agency
does not have reason to believe the
environmental health or safety risks
addressed by this action present a
disproportionate risk to children.
rwilkins on PROD1PC63 with PROPOSAL
H. Executive Order 13211 (Energy
Effects)
This rule is not a ‘‘significant energy
action’’ as defined in Executive Order
13211, ‘‘Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355 (May
22, 2001)) because it is not likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
The rule allows wider use of substitutes,
providing greater flexibility for industry
related to choices of alternative fire
suppression systems to support the
transition away from ozone-depleting
substances, but little if any impact
related to energy. Thus, we have
concluded that this rule is not likely to
have any adverse energy effects.
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I. National Technology Transfer and
Advancement Act
ENVIRONMENTAL PROTECTION
AGENCY
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law No.
104–113, Section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary
consensus standards in regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures, and
business practices) that are developed or
adopted by voluntary consensus
standards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
This rulemaking does not involve
technical standards. EPA is not
requiring that specific technical
standards be met in these regulations.
EPA defers to existing National Fire
Protection Association (NFPA)
voluntary consensus standards and
Occupational Safety and Health
Administration (OSHA) regulations that
relate to the safe use of halon substitutes
reviewed under SNAP. EPA refers users
to the latest edition of NFPA 2001
Standard on Clean Agent Fire
Extinguishing Systems which provides
for exposure guidelines and safe use of
halocarbon and inert gas agents used to
extinguish fires. EPA also refers to the
latest edition of NFPA 2010 Standard on
Aerosol Extinguishing Systems, 2005
edition, which provides for safe use of
aerosol extinguishing agents and
technologies. Copies of these standards
may be obtained by calling the NFPA’s
telephone number for ordering
publications at 1–800–344–3555. The
NFPA 2001 and 2010 standards meet
the objectives of the rule by setting
scientifically-based guidelines for safe
exposure to halocarbon and inert gas
agents and aerosol extinguishing agents,
respectively. In addition, EPA has
worked in consultation with OSHA to
encourage development of technical
standards to be adopted by voluntary
consensus standards bodies.
40 CFR Part 180
List of Subjects in 40 CFR Part 82
Environmental protection,
Administrative practice and procedure,
Air pollution control, Reporting and
recordkeeping requirements.
Dated: September 21, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. E6–15842 Filed 9–26–06; 8:45 am]
BILLING CODE 6560–50–P
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[EPA–HQ–OPP–2006–0586; FRL–8089–5]
Propanil, Phenmedipham, Triallate,
and MCPA; Proposed Tolerance
Actions
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing to revoke
certain tolerances for herbicides
propanil, triallate, and MCPA. Also,
EPA is proposing to modify certain
tolerances for the herbicides propanil,
phenmedipham, triallate, and MCPA. In
addition, EPA is proposing to establish
tolerances for the herbicides propanil,
phenmedipham, triallate, and MCPA.
DATES: Comments must be received on
or before November 27, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–0586, by
one of the following methods:
• Federal eRulemaking Portal: https://
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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’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 telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0586. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
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 Federal regulations.gov
website is an ‘‘anonymous access’’
system, which means EPA will not
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know your identity or contact
information unless you provide it in the
body of your comment. If you send an
e-mail 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. 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 https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
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
telephone number is (703) 3057–5805.
FOR FURTHER INFORMATION CONTACT: Jane
Smith, Special Review and
Reregistration Division (7805P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave, NW., Washington, DC 20460–0001;
telephone number: (703) 308–0048; email address: smith.jane-scott@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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).
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• 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 e-mail. 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.
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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.
C. What Can I do if I Wish the Agency
to Maintain a Tolerance that the Agency
Proposes to Revoke?
This proposed rule provides a
comment period of 60 days for any
person to state an interest in retaining
a tolerance proposed for revocation. If
EPA receives a comment within the 60–
day period to that effect, EPA will not
proceed to revoke the tolerance
immediately. However, EPA will take
steps to ensure the submission of any
needed supporting data and will issue
an order in the Federal Register under
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(f) if needed. The
order would specify data needed and
the time frames for its submission, and
would require that within 90 days some
person or persons notify EPA that they
will submit the data. If the data are not
submitted as required in the order, EPA
will take appropriate action under
FFDCA.
EPA issues a final rule after
considering comments that are
submitted in response to this proposed
rule. In addition to submitting
comments in response to this proposal,
you may also submit an objection at the
time of the final rule. If you fail to file
an objection to the final rule within the
time period specified, you will have
waived the right to raise any issues
resolved in the final rule. After the
specified time, issues resolved in the
final rule cannot be raised again in any
subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, remove,
modify, and establish specific tolerances
for residues of the herbicides propanil,
phenmedipham, triallate, and MCPA in
or on commodities listed in the
regulatory text.
EPA is proposing these tolerance
actions to implement the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes (including
follow-up on canceled or additional
uses of pesticides). As part of these
processes, EPA is required to determine
whether each of the amended tolerances
meets the safety standard of the Food
Quality Protection Act (FQPA). The
safety finding determination of
‘‘reasonable certainty of no harm’’ is
discussed in detail in each
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Reregistration Eligibility Decision (RED)
and Report of the FQPA Tolerance
Reassessment Progress and Risk
Management Decision (TRED) for the
active ingredients. REDs and TREDs
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
and TREDs may be obtained from EPA’s
National Service Center for
Environmental Publications (EPA/
NSCEP), P.O. Box 42419, Cincinnati,
OH 452427–2419, telephone 1–800–
490–9198; fax 1–513–489–8695; internet
at https://www.epa.gov/ncepihom and
from the National Technical Information
Service (NTIS), 5285 Port Royal Road,
Springfield, VA 22161, telephone 1–
800–553–6847 or (703) 605–6000;
internet at https://www.ntis.gov.
Electronic copies of REDs and TREDs
are available on propanil,
phenmedipham, triallate, and MCPA at
the internet at https://www.epa.gov/
pesticides/reregistration/status.htm and
in public dockets EPA–HQ–OPP–2003–
0348 and EPA–HQ–OPP–2002–0033
(propanil); EPA–HQ–OPP–2004–0384
(phenmedipham); and EPA–HQ–OPP–
2004–0156 and EPA–HQ–OPP–2004–
0239 (MCPA) at https://
www.regulations.gov.
The selection of an individual
tolerance level is based on crop field
residue studies designed to produce the
maximum residues under the existing or
proposed product label. Generally, the
level selected for a tolerance is a value
slightly above the maximum residue
found in such studies. The evaluation of
whether a tolerance is safe is a separate
inquiry. EPA recommends the raising of
a tolerance when data show that (1)
lawful use (sometimes through a label
change) may result in a higher residue
level on the commodity and (2) the
tolerance remains safe, notwithstanding
increased residue level allowed under
the tolerance. In REDs, Chapter IV on
Risk management, Reregistration, and
Tolerance Reassessment typically
describes the regulatory position, FQPA
assessment, cumulative safety
determination, determination of safety
for U.S. general population, and safety
for infants and children. In particular,
the human health risk assessment
document which supports the RED
describes risk exposure estimates and
whether the Agency has concerns. In
TREDs, the Agency discusses its
evaluation of the dietary risk associated
with the active ingredient and whether
it can determine that there is a
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reasonable certainty (with appropriate
mitigation) that no harm to any
population subgroup will result from
aggregate exposure.
Explanations for proposed
modifications in tolerances can be
found in the RED and TRED document
and in more detail in the Residue
Chemistry Chapter document which
supports the RED and TRED. Copies of
the Residue Chemistry Chapter
documents are found in the
Administrative Record and paper copies
are available in the public docket for
this proposed rule, while electronic
copies are available through EPA’s
electronic public docket and comment
system, regulations.gov at https://
www.regulations.gov. You may search
for docket ID number EPA–HQ–OPP–
006–0586, 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 or TRED which
lists the submitted studies that the
Agency found acceptable.
With respect to the tolerances that are
proposed in this document to be
modified, unless technical (e.g.,
commodity tolerance nomenclature
revision), EPA has found that these
tolerances are safe in accordance with
FFDCA section 408(b)(2)(A), and that
there is a reasonable certainty that no
harm will result to infants and children
from aggregate exposure to the pesticide
chemical residues, in accordance with
section 408(b)(2)(C). These findings are
discussed in detail in each RED. The
references are available for inspection as
described in this document under
SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to
revoke certain specific tolerances
because either they are no longer
needed or are associated with food uses
that are no longer registered under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The
registrations for these pesticide
chemicals were canceled because the
registrant failed to pay the required
maintenance fee and/or the registrant
voluntarily canceled one or more
registered uses of the pesticide. It is
EPA’s general practice to propose
revocation of those tolerances for
residues of pesticide active ingredients
on crop uses for which there are no
active registrations under FIFRA, unless
any person in comments on the
proposal indicates a need for the
tolerance to cover residues in or on
imported commodities or domestic
commodities legally treated.
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1. Propanil. Currently, in 40 CFR
180.274 (a)(1) and (2), tolerances are
established for the combined residues of
propanil and its metabolites (calculated
as propanil) in or on both raw
agricultural commodities (RACs) and
processed foods and feeds. EPA is
proposing to revise the tolerance
expression to specify the residues of
concern and combine the RACs and
processed foods and feed tolerances in
accordance with FFDCA 408 as
amended by FQPA (1996) in 40 CFR
180.274(a) to read as follows: Tolerances
are established for the combined
residues of the herbicide propanil (3′, 4′dichloropropionanilide) and its
metabolites convertible to 3, 4dichloroaniline (3, 4-DCA).
Tolerances currently exist for rice
milling fractions and rice polishings.
Rice milling fractions are no longer
considered a significant animal feed
item as delineated in ‘‘Table 1.—Raw
Agricultural and Processed
Commodities and Feedstuffs Derived
from Crops’’ which is found in Residue
Chemistry Test Guidelines OPPTS
860.1000 dated August 1996, available
at https://www.epa.gov/opptsfrs/
publications/OPPTS_Harmonized/
860_Residue_Chemistry_Test_
Guidelines/Series. Therefore, EPA is
proposing to remove the tolerances in
40 CFR 180.274(a) for the combined
residues of propanil in or on rice
milling fractions and rice, polishings at
10 parts per million (ppm).
The registered uses on barley, oat, and
wheat (small grains) have been
voluntarily cancelled (68 FR 68901,
December 10, 2003) (FRL–7332–5), (68
FR 38328, June 27, 2003) (FRL–7310–6).
In the absence of registered uses, the
tolerances associated with the small
grains should be revoked. Therefore,
EPA is proposing to revoke the
tolerances in 40 CFR 180.274(a) for the
combined propanil residues of concern
in or on barley, straw; oat, straw; and
wheat, straw at 0.75 ppm; barley, grain
at .2 ppm; oat, grain at .2 ppm; wheat,
grain at 0.2 ppm.
Two studies depicting the magnitude
of regulated propanil residues in or on
rice, grain exceeded the established
tolerance of 2 ppm in or on treated rice,
grain samples demonstrating residues
ranging from 0.03 ppm to 8.7 ppm.
Based on these data, EPA determined
the tolerance should be 10 ppm on rice,
grain. Therefore, EPA is proposing to
increase the tolerance in 40 CFR
180.274(a) for the combined propanil
residues of concern in or on rice, grain
from 2 ppm to 10 ppm. The Agency
determined that the increased tolerance
is safe; i.e. there is a reasonable
certainty that no harm will result from
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aggregate exposure to the pesticide
chemical residue.
A rice processing study showed no
concentration of residues in polished
rice and average concentration factors of
3.5x for rice, hulls and 4.6x for rice,
bran. The highest average field trial
(HAFT) propanil residues found in rice
were 8.7 ppm. Based on this HAFT and
the observed concentration factors, the
maximum expected residues are 30.45
ppm in or on rice, hulls (8.7 x 3.5) and
40.02 ppm in or on rice, bran (8.7 x 4.6).
These expected residues are higher in
the processed commodities than the
reassessed tolerance of 10 ppm for rice,
grain. Based on these data, EPA has
determined that the tolerances should
be 30 ppm on rice, hulls and 40 ppm on
rice, bran. Therefore, EPA is proposing
to increase tolerances in 40 CFR
180.274(a) for the combined propanil
residues of concern in or on rice, hulls
from 10 to 30 ppm and rice, bran from
10 to 40 ppm. The Agency determined
that the increased tolerances are safe;
i.e. there is a reasonable certainty that
no harm will result from aggregate
exposure to the pesticide chemical
residue.
The potential for secondary transfer of
propanil residues to animal
commodities exists because the
herbicide is registered for use on rice,
which may be used as animal feed.
Based on a maximum theoretical dietary
burden (x) and using the residues levels
found in dairy cattle and milk fed 15
ppm (0.75x) resulted in residues of:
0.035 ppm in milk, 0.31 ppm in liver,
0.77 ppm in kidney, < 0.05 ppm (nondetectable) in muscle, and 0.10 ppm in
fat. Based on these data, the Agency
determined the tolerances should be
0.05 ppm in cattle, meat; goat, meat;
hog, meat; horse, meat; and sheep, meat;
and 1.0 ppm in cattle, meat byproducts;
goat, meat byproducts; hog, meat
byproducts; horse, meat byproducts;
and sheep,meat byproducts. In addition,
the term ‘‘negligible residue’’ and its
designation, ‘‘(N)’’ associated with the
milk and animal tissue tolerances is
being removed to conform to current
Agency policy and practice. Therefore,
EPA is proposing in 40 CFR 180.274(a)
for the combined propanil residues of
concern to maintain and revise the
tolerances in or on milk from 0.05(N)
ppm to 0.05 ppm and cattle, fat; goat,
fat; hog, fat; horse, fat; and sheep, fat
from 0.1(N) ppm to 0.10 ppm; to
decrease and revise the tolerances in or
on cattle, meat; goat, meat; hog, meat;
horse, meat; and sheep, meat from
0.1(N) to 0.05 ppm; and to increase and
revise the tolerances in or on cattle,
meat byproducts; goat, meat byproducts;
hog, meat byproducts; horse, meat
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byproducts; and sheep,meat byproducts
from 0.1(N) to 1.0 ppm. The Agency
determined that the increased tolerances
are safe; i.e. there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue.
Maximum propanil residues were
0.212 ppm and 0.372 ppm, respectively,
in eggs from hens dosed with propanil
15 ppm (0.9x), and 50 ppm (3.1x).
Residues in liver from hens in the 15
ppm (0.9x), and 50 ppm (3.1x) dose
groups were 0.183–0.236, and 0.824–
1.755 ppm, respectively. Residues in
muscle were < 0.050–0.076 and 0.087–
0.161 ppm from the 0.9x and 3.1x dose
groups, respectively. In fat, propanil
residues of concern were < 0.05 ppm (<
non-detectable) up to 0.9x feeding
levels, and < 0.139–0.348 ppm at 3.1x.
Based on these data, the Agency has
determined that the propanil tolerances
should be 0.30 ppm for egg; 0.05 ppm
for poultry, fat; 0.50 ppm for poultry,
meat byproducts; and 0.10 ppm for
poultry, meat. In addition, the term
‘‘negligible residue’’ and its designation,
‘‘(N)’’ associated with the egg and
animal tissue tolerances is being
removed to conform to current Agency
policy and practice. Therefore, EPA is
proposing in 40 CFR 180.274(a) for the
combined propanil residues of concern
to increase and revise the tolerance for
egg from 0.05(N) to 0.30 ppm; to
decrease and revise the tolerance in or
on poultry, fat from 0.1(N) to 0.05 ppm;
to increase and revise the tolerance for
poultry, meat byproducts from 0.1(N) to
0.50 ppm; and maintain and revise the
tolerance in or on poultry, meat from
0.1(N) to 0.10 ppm. The Agency
determined that the increased tolerances
are safe; i.e. there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue.
Residues of propanil and its
metabolites, determined as basereleasable 3, 4 DCA and expressed as
propanil equivalents, were < 0.01–0.03
ppm in or on the edible portions of
crayfish (1x maximum season rate).
Based on these data, the Agency
determined the tolerance should be 0.05
ppm on crayfish. Therefore, EPA is
proposing to establish a tolerance in 40
CFR 180.274(a) for the combined
propanil residues of concern in or on
crayfish at 0.05 ppm.
In addition, the ‘‘N’’ (negligible
residues) designation correlated with
tolerances is being removed to conform
to current Agency practice. Therefore,
EPA is proposing to revise the tolerance
in 40 CFR 180.274(a) for the combined
propanil residues of concern in or on
rice, straw from 75(N) ppm to 75 ppm.
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2. Phenmedipham. The current
tolerance expression in 40 CFR 180.278
refers to phenmedipham as methyl mhydroxycarbanilate m-methylcarbanilate
which should be changed to the more
appropriate chemical name, 3methoxycarbonylaminophenyl-3methylcarbanilate. Therefore, EPA
proposes to change the chemical name
in 40 CFR 180.278(a) for residues of the
herbicide phenmedipham to 3methoxycarbonylaminophenyl-3methylcarbanilate.
Spinach field trial residue data
generated at the 1x seasonal application
rate and 14–22 day pre-harvest interval
(PHI) resulted in residues ranging from
2.1–3.6 ppm. Additional trials
conducted at similar rates and PHIs
yielded residues ranging from < 0.05 to
0.17 ppm. Based on the more recent
residue data and use pattern, EPA has
determined the tolerance on spinach
should be 4.0 ppm. Therefore, EPA is
proposing to increase the tolerance in 40
CFR 180.278(a) for residues of
phenmedipham in or on spinach from
0.5 ppm to 4.0 ppm. The Agency
determined that the increased tolerance
is safe; i.e. there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue.
Sugar beet processing studies indicate
that phenmedipham residues of concern
concentrated 3x in dried pulp, 1.3x in
molasses, and did not concentrate in
sugar. Because of the concentration
factors associated with dried pulp and
molasses, the current tolerance of 0.1
ppm for raw beet, sugar, roots and beet,
sugar, tops is not adequate to cover the
dried pulp and molasses from sugar
beets; therefore, the Agency has
determined that tolerances should be
established for beet, sugar, dried pulp at
0.5 ppm and beet, sugar, molasses at 0.2
ppm. EPA is proposing to establish
tolerances in 40 CFR 180.278(a) for
residues of phenmedipham in or on
beet, sugar, dried pulp at 0.5 ppm and
beet, sugar, molasses at 0.2 ppm.
In addition, the ‘‘N’’ (negligible
residues) designation that is correlated
with some of the tolerances is being
removed to conform to current Agency
practice. Therefore, EPA is proposing to
revise the tolerances in 40 CFR
180.278(a) for residues of
phenmedipham in or on beet, garden at
0.2(N) ppm to beet, garden, roots at 0.2
ppm; beet, sugar, roots at 0.1(N) ppm to
0.1 ppm; and beet, sugar, tops at 0.1(N)
ppm to 0.1 ppm.
3. Triallate. The available data,
reflecting the maximum registered use
patterns, indicate that the maximum
combined triallate residues of concern
were 0.26 ppm in or on barley, straw;
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0.12 ppm in or on the seed and pods of
succulent peas; 0.39 ppm in or on the
vines of succulent peas; 0.27 ppm in or
on the vines of dried peas; 0.73 ppm in
or on the straw (hay) of succulent peas;
0.36 ppm in or on the straw of dried
peas; and 0.94 ppm in or on wheat,
straw in the states of: Colorado, Idaho,
Kansas, Minnesota, Montana, Nebraska,
Nevada, North Dakota, Oregon, South
Dakota, Utah, Washington, and
Wyoming. In addition, the term
‘‘negligible residue’’ and its designation,
‘‘(N)’’ associated with the barley, grain
tolerance is being removed to conform
to current Agency policy and practice.
Based on these data, the Agency
determined the tolerances should be 0.3
ppm on barley, straw; 1.0 ppm on pea,
field, hay; 0.5 ppm on pea, field, vines;
0.2 ppm on pea, succulent; and 1.0 ppm
on wheat, straw and recodified under 40
CFR 180.314(c) as regional tolerances.
Therefore, EPA is proposing the
tolerances in 40 CFR 180.314(c) for the
combined residues of concern to be
increased in or on barley, straw from
0.05 to 0.3 ppm; pea, field, hay from
0.05 to 1.0 ppm; pea, field, vines from
0.05 to 0.5 ppm; pea, succulent from
0.05 to 0.2 ppm; wheat, straw from 0.05
to 1.0 ppm; and reclassified from 40
CFR 180.314(a) to 40 CFR 180.314(c) for
barley, grain at 0.05 ppm and wheat,
grain at 0.05 ppm. The Agency
determined that the increased tolerances
are safe; i.e., there is a reasonable
certainty that no harm will result from
aggregate exposure to the pesticide
chemical residue.
Lentil, hay is no longer considered
significant livestock feed item and has
been removed from Table 1 (OPPTS
GLN 860.1000) and lentil, seed is
covered by the established pea tolerance
in accordance with 40 CFR 180.1(h). As
a result, EPA proposes removing the
tolerances in 40 CFR 180.314(a) for the
combined triallate residues of concern
in or on lentil, hay at 0.05 ppm and
lentil, seed at 0.05 ppm.
Sugar beet processing studies were
conducted on sugar beets treated at 5x
the seasonal application rate resulting in
maximum residues of 0.14 ppm in root,
0.30 ppm in dried pulp, and < 0.03 ppm
in sugar and molasses. Therefore, EPA
is proposing to maintain the tolerances
and correct the terminology for sugar
beets to include roots in 40 CFR
180.314(c) for the combined triallate
residues of concern in or on beet, sugar,
dried pulp at 0.2 ppm; beet, sugar, roots
at 0.1 ppm; and beet, sugar, tops at 0.5
ppm.
The available data, reflecting the
maximum registered use patterns,
indicate that the maximum combined
triallate residues of concern were < 0.02
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ppm in or on the seed and pods of pea,
dry and 0.94 ppm on wheat, straw.
Because of similar cultural practices and
identical use rates, wheat, straw data is
used to support tolerances for barley,
hay and wheat, hay. Based on these
data, the Agency determined the
tolerances should be 0.2 ppm for pea,
dry and 1.0 ppm for barley, hay and
wheat, hay by translating the data from
wheat, straw. Therefore, EPA is
proposing to establish tolerances in 40
CFR 180.314(c) for the combined
triallate residues of concern in or on
barley, hay at 1.0 ppm; pea, dry at 0.2
ppm; and wheat, hay at 1.0 ppm. The
Agency determined that the
establishment of these tolerances is safe;
i.e., there is a reasonable certainty that
no harm will result from aggregate
exposure to the pesticide chemical
residue.
Although tolerances are established
on animal feed items, tolerances on the
edible tissues of animals are not
necessary because the available residue
data generated using exaggerated rates
indicate there is no reasonable
expectation of finite residues in meat,
milk, poultry, and eggs as a result of
ingestion of pesticide residues on raw
agricultural commodities in accordance
with 40 CFR 180.6(a)(3).
4. MCPA. The current tolerance
expression 40 CFR 180.339(a) regulates
residues of the herbicide 2-methyl-4chlorophenoxyacetic acid (MCPA) from
application of the herbicide in acid form
or in the form of its sodium,
ethanolamine, diethanolamine,
triethanolamine, isopropanolamine,
diisopropanolamine,
triisopropanolamine, or dimethylamine
salts or isooctyl or butoxyethyl esters
and 40 CFR 180.339(b) tolerances are
established for combined negligible
residues (N) of the herbicide 2-methyl4-chlorophenoxyacetic acid and its
metabolite 2-methyl-4-chlorophenol.
Based on toxicity data for 2-methyl-4chlorophenol, a currently regulated
livestock metabolite, EPA determined
that it is of significantly less concern
than the parent compound and therefore
can be excluded from the tolerance
expression. Although the chemical
name for MCPA has been presented as
‘‘(2-methyl-4-chlorophenoxy)acetic
acid’’, under current chemical naming
conventions the ‘‘(4-chloro-2methylphenoxy)acetic acid’’ designation
is preferred. EPA determined the
residues to be regulated in plant
commodities (40 CFR 180.339(a)) are
parent, free and conjugated MCPA.
When MCPA is applied in various forms
(e.g. ethanolamine and other salts and
esters), a single common moiety is
released that is the pesticidally active
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component and serves as the basis for
tolerance regulation. Therefore, EPA is
proposing to change the tolerance
expression in 40 CFR 180.339(a) to read
as follows: tolerances are established for
residues of the herbicide MCPA [(4chloro-2-methylphenoxy)acetic acid)],
both free and conjugated, resulting from
the direct application of MCPA or its
sodium or dimethylamine salts, or its 2ethylhexyl ester and in 40 CFR
180.339(b) to read as follows: tolerances
are established for residues of the
herbicide MCPA [(4-chloro-2methylphenoxy)acetic acid)] resulting
from the direct application of MCPA or
its sodium or dimethylamine salts, or its
2-ethylhexyl ester. 40 CFR 180.339 (a)
and (b) will be revised to read 40 CFR
180.339 (a)(1) and (2) for consistency.
Lastly, the term ‘‘negligible residue’’
and its designation, ‘‘(N)’’, associated
with some tolerances is being removed
to conform to current Agency policy and
practice.
Currently, tolerances exist reflecting
uses of MCPA on rice, sorghum, flax
(straw) and canarygrass. The uses on
rice, sorghum, and canarygrass are no
longer registered uses (69 FR 39467,
June 30, 2004) (FRL–7363–4) (71 FR
24687, April 26, 2006) (FRL–8059–2).
EPA policy no longer requires
tolerances to be established for flax,
straw. Therefore, EPA is proposing to
revoke tolerances in 40 CFR
180.339(a)(1) for the combined MCPA
residues of concern in or on flax, straw
at 2 ppm; grass, canary, annual, straw at
0.1 ppm; canary, annual, seed at 0.1
ppm; rice, grain at 0.1(N) ppm; rice,
straw at 2 ppm; sorghum, forage at 20
ppm; sorghum, grain at 0.1 ppm; and
sorghum, grain, stover at 20 ppm.
The crop field trial data indicate that
the maximum combined residues of
MCPA and its metabolites are < 0.29
ppm in or on alfalfa, forage and < 1.07
ppm in or on alfalfa, hay. Alfalfa, forage
and alfalfa, hay data will also be used
to satisfy crop field trial requirements
for the clover, forage; clover hay;
lespedeza, forage; lespedeza, hay;
trefoil, forage; trefoil, hay; vetch, forage;
and vetch, hay. Ordinarily, the Agency
would not translate data from alfalfa,
forage and alfalfa, hay to support uses
on clover, forage; clover hay; lespedeza,
forage; lespedeza, hay; trefoil, forage;
trefoil, hay; vetch, forage; and vetch,
hay; however, because the only
supported use of MCPA on these crops
is to the crops underseeded to small
grains it is reasonable to use alfalfa,
forage and alfalfa, hay data to support
these uses. Based on these data, EPA has
determined the tolerance should be 0.5
ppm in or on alfalfa, forage; clover,
forage; lespedeza, forage; trefoil, forage;
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and vetch, forage; and 2.0 ppm in or on
alfalfa, hay; clover hay; lespedeza, hay;
trefoil, hay; and vetch, hay. Therefore,
EPA is proposing to increase tolerances
and revise the terminology to include
forage consistently in 40 CFR 180.339
(a)(1) for residues of MCPA in or on
alfalfa, forage; clover, forage; lespedeza,
forage; trefoil, forage; and vetch, forage
from 0.1 to 0.5 ppm and alfalfa, hay;
clover hay; lespedeza, hay; trefoil, hay;
and vetch, hay from 0.1 to 2.0 ppm. The
Agency determined that the increased
tolerances are safe; i.e. there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue.
The crop field trial data indicate that
the maximum combined residues of
MCPA and its metabolites are 0.72 ppm
in or on wheat, grain and 21.4 ppm in
or on wheat, straw. Based on the HAFT
residue of 0.08 ppm for wheat, grain,
expected MCPA residues of concern in
or on wheat bran and germ will not
exceed the established tolerance of 0.1
ppm for wheat, grain and for wheat
processed commodities. Because of
similar cultural practices and identical
use rates, wheat residue field trial data
is used to support tolerances for barley,
oat, and rye. Based on these data, EPA
has determined the tolerance should be
1.0 ppm in or on barley, grain; oat,
grain; rye, grain; and wheat, grain and
25 ppm in or on barley, straw; oat,
straw; rye, straw; and wheat, straw.
Therefore, EPA is proposing to increase
the tolerances in 40 CFR 180.339(a)(1)
for residues of MCPA in or on barley,
grain; oat, grain; rye, grain; and wheat,
grain from 0.1 to 1.0 ppm and barley,
straw; oat, straw; rye, straw; and wheat,
straw from 2 to 25 ppm. The Agency
determined that these increased
tolerances are safe; i.e. there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue.
The crop field trial data indicate that
the maximum combined residues of
MCPA and its metabolites are 19.4 ppm
(7 day PHI) in or on wheat, forage, 39.5
ppm and 111 ppm (7 and14 day PHIs,
respectively) in or on wheat, hay. Also,
these data are translated to support
tolerances for barley, hay and oat, hay
and oat, forage and rye, forage. Based on
these data, EPA determined the
tolerances should be 20 ppm on oat,
forage; rye, forage; and wheat, forage
and 115 ppm on barley, hay; oat, hay;
and wheat, hay. EPA is proposing
tolerances be established in 40 CFR
180.339(a)(1) for residues of MCPA in or
on wheat, forage at 20 ppm; and barley,
hay; oat, hay; and wheat, hay at 115
ppm; and maintain tolerances for oat,
forage and rye, forage at 20 ppm. The
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Agency determined that these newly
established tolerances are safe; i.e. there
is a reasonable certainty that no harm
will result from aggregate exposure to
the pesticide chemicals residue.
In addition, EPA is proposing to
revise commodity terminology and
tolerances to conform to current Agency
practice at 40 CFR 180.339 as follows:
‘‘grass, pasture and grass, rangeland at
300 ppm to grass, forage at 300 ppm;’’
‘‘peavines at 0.1(N) ppm to pea, vines at
0.1 ppm;’’ ‘‘peavines, hay at 0.1(N) ppm
to pea, hay at 0.1 ppm;’’ ‘‘vegetables,
seed and pod at 0.1 ppm to pea, dry at
0.1 ppm and pea, succulent at 0.1 ppm;’’
‘‘cattle, fat; goat, fat; hog, fat; horse, fat;
and sheep, fat; cattle, meat byproducts;
goat, meat byproducts; hog, meat
byproducts; horse, meat byproducts;
and sheep, meat byproducts; and cattle,
meat; goat, meat; hog, meat; horse, meat;
and sheep, meat at 0.1(N) ppm to 0.1
ppm;’’ and ‘‘milk at 0.1(N) ppm to 0.1
ppm.’’
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 the 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 the 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.
EPA is proposing these tolerance
actions to implement the tolerance
recommendations made during the
reregistration and tolerance
reassessment processes (including
follow-up on canceled or additional
uses of pesticides). As part of these
processes, EPA is required to determine
whether each of the amended tolerances
meets the safety standard of the FQPA.
The safety finding determination is
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discussed in detail in each Post-FQPA
RED and TRED for the active ingredient.
REDs and TREDs 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 and
electronic copies of the REDs and
TREDs are available as provided in Unit
II.A.
EPA has issued post-FQPA REDs for
propanil, phenmedipham, triallate, and
MCPA, and a TRED for propanil. REDs
and TREDs contain the Agency’s
evaluation of the data base for these
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,
and in REDs state conditions under
which these uses and products will be
eligible for reregistration. The REDs and
TREDs recommended the establishment,
modification, and/or revocation of
specific tolerances. RED and TRED
recommendations such as establishing
or modifying tolerances, and in some
cases revoking tolerances, are the result
of assessment under the FQPA standard
of ‘‘reasonable certainty of no harm.’’
However, tolerance revocations
recommended in REDs and TREDs that
are proposed in this document do not
need such assessment when the
tolerances are no longer necessary.
EPA’s general practice is to propose
revocation of tolerances for residues of
pesticide active ingredients on crops for
which FIFRA registrations no longer
exist and on which the pesticide may
therefore no longer be used in the
United States. Nonetheless, EPA will
establish and maintain tolerances even
when corresponding domestic uses are
canceled if the tolerances, which EPA
refers to as ‘‘import tolerances,’’ are
necessary to allow importation into the
United States of food containing such
pesticide residues. However, where
there are no imported commodities that
require these import tolerances, the
Agency believes it is appropriate to
revoke tolerances for unregistered
pesticides in order to prevent potential
misuse.
Furthermore, as a general matter, the
Agency believes that retention of import
tolerances not needed to cover any
imported food may result in
unnecessary restriction on trade of
pesticides and foods. Under section 408
of the FFDCA, a tolerance may only be
established or maintained if EPA
determines that the tolerance is safe
based on a number of factors, including
an assessment of the aggregate exposure
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to the pesticide and an assessment of
the cumulative effects of such pesticide
and other substances that have a
common mechanism of toxicity. In
doing so, EPA must consider potential
contributions to such exposure from all
tolerances. If the cumulative risk is such
that the tolerances in aggregate are not
safe, then every one of these tolerances
is potentially vulnerable to revocation.
Furthermore, if unneeded tolerances are
included in the aggregate and
cumulative risk assessments, the
estimated exposure to the pesticide
would be inflated. Consequently, it may
be more difficult for others to obtain
needed tolerances or to register needed
new uses. To avoid potential trade
restrictions, the Agency is proposing to
revoke tolerances for residues on crops
uses for which FIFRA registrations no
longer exist, unless someone expresses
a need for such tolerances. Through this
proposed rule, the Agency is inviting
individuals who need these import
tolerances to identify themselves and
the tolerances that are needed to cover
imported commodities.
Parties interested in retention of the
tolerances should be aware that
additional data may be needed to
support retention. These parties should
be aware that, under FFDCA section
408(f), if the Agency determines that
additional information is reasonably
required to support the continuation of
a tolerance, EPA may require that
parties interested in maintaining the
tolerances provide the necessary
information. If the requisite information
is not submitted, EPA may issue an
order revoking the tolerance at issue.
When EPA establishes tolerances for
pesticide residues in or on raw
agricultural commodities, consideration
must be given to the possible residues
of those chemicals in meat, milk,
poultry, and/or eggs produced by
animals that are fed agricultural
products (for example, grain or hay)
containing pesticides residues (40 CFR
180.6). When considering this
possibility, EPA can conclude that:
1. Finite residues will exist in meat,
milk, poultry, and/or eggs.
2. There is a reasonable expectation
that finite residues will exist.
3. There is a reasonable expectation
that finite residues will not exist. If
there is no reasonable expectation of
finite pesticide residues in or on meat,
milk, poultry, or eggs, tolerances do not
need to be established for these
commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific
meat, milk, poultry, and egg tolerances
proposed for revocation in this
proposed rule and has concluded that
there is no reasonable expectation of
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finite pesticide residues of concern in or
on those commodities.
C. When do These Actions Become
Effective?
EPA is proposing that modifications,
establishment, commodity terminology
revisions, and revocation of these
tolerances become effective on the date
of publication of the final rule in the
Federal Register because their
associated uses have been canceled for
several years. The Agency believes that
treated commodities have had sufficient
time for passage through the channels of
trade. However, if EPA is presented
with information that existing stocks
would still be available and that
information is verified, the Agency will
consider extending the expiration date
of the tolerance. If you have comments
regarding existing stocks and whether
the effective date allows sufficient time
for treated commodities to clear the
channels of trade, 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 section, 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. Are the Proposed Actions
Consistent with International
Obligations?
The tolerance revocations in this
proposal are not discriminatory and are
designed to ensure that both
domestically-produced and imported
foods meet the food safety standard
established by the FFDCA. The same
food safety standards apply to
domestically produced and imported
foods.
The tolerance actions in this proposal
apply equally to domestically-produced
and imported foods. In making its
tolerance decisions, the Agency seeks to
harmonize with international standards
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56431
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, as required
by section 408(b)(4) of the FFDCA. 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
also considers MRLs established in
Canada and Mexico. EPA may establish
a tolerance that is different from a
Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain in a
Federal Register document the reasons
for departing from the Codex level.
Specific tolerance actions in this
proposed rule are discussed in Unit II.A.
EPA’s efforts to harmonize with MRLs is
summarized in the tolerance
reassessment section of individual REDs
and TREDs as mentioned in Unit II.A.
EPA has developed guidance
concerning submissions for import
tolerance support (65 FR 35069, June 1,
2000) (FRL–6559–3). This guidance will
be made available to interested persons.
Electronic copies are available on the
internet at https://www.epa.gov. On the
Home Page select ‘‘Laws, Regulations,
and Dockets,’’ then select Regulations
and Proposed Rules and then look up
the entry for this document under
‘‘Federal Register—Environmental
Documents.’’ You can also go directly to
the ‘‘Federal Register’’ listings at https://
www.epa.gov/fedrgstr.
IV. Statutory and Executive Order
Reviews
In this proposed rule, EPA is
proposing to establish tolerances under
FFDCA section 408(e), and also modify
and revoke specific tolerances
established under FFDCA section 408.
The Office of Management and Budget
(OMB) has exempted these types of
actions (e.g., establishment and
modification of a tolerance and
tolerance revocation for which
extraordinary circumstances do not
exist) 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,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This proposed rule does not
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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) (Public
Law 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, expansion of exemptions, or
revocations 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. These analyses
for tolerance establishments and
modifications, and for tolerance
revocations were published on May 4,
1981 (46 FR 24950) and on December
17, 1997 (62 FR 66020), respectively,
and were provided to the Chief Counsel
for Advocacy of the Small Business
Administration. Taking into account
this analysis, and available information
concerning the pesticides listed in this
proposed rule, the Agency hereby
certifies that this proposed action will
not have a significant negative economic
impact on a substantial number of small
entities. In a memorandum dated May
25, 2001, EPA determined that eight
conditions must all be satisfied in order
for an import tolerance or tolerance
exemption revocation to adversely affect
a significant number of small entity
importers, and that there is a negligible
joint probability of all eight conditions
holding simultaneously with respect to
any particular revocation (this Agency
document is available in the docket of
this proposed rule). Furthermore, for the
pesticide named in this proposed rule,
the Agency knows of no extraordinary
VerDate Aug<31>2005
16:43 Sep 26, 2006
Jkt 208001
circumstances that exist as to the
present proposal that would change
EPA’s previous analysis. Any comments
about the Agency’s determination
should be submitted to the EPA along
with comments on the proposal, and
will be addressed prior to issuing a final
rule. 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 the
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
6, 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
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
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: September 20, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR
part 180 be amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
would continue to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.274 is amended by
revising paragraph (a) to read as follows:
§ 180.274 Propanil; tolerances for
residues.
(a) General. Tolerances are
established for the combined residues of
the herbicide propanil (3′, 4′dichloropropionanilide) and its
metabolites convertible to 3, 4dichloroaniline (3, 4-DCA) in or on the
following food commodities:
Commodity
Cattle, fat ..................................
Cattle, meat byproducts ...........
Cattle, meat ..............................
Crayfish .....................................
Egg ...........................................
Goat, fat ....................................
Goat, meat byproducts .............
Goat, meat ................................
Hog, fat .....................................
Hog, meat byproducts ..............
Hog, meat .................................
Horse, fat ..................................
Horse, meat byproducts ...........
Horse, meat ..............................
Milk ...........................................
Poultry, fat ................................
Poultry, meat byproducts ..........
Poultry, meat ............................
Rice, bran .................................
Rice, grain ................................
Rice, hulls .................................
Rice, straw ................................
Sheep, fat .................................
Sheep, meat byproducts ..........
Sheep, meat .............................
Parts per
million
0.10
1.0
0.05
0.05
0.30
0.10
1.0
0.05
0.10
1.0
0.05
0.10
1.0
0.05
0.05
0.05
0.50
0.10
40
10
30
75
0.10
1.0
0.05
*
*
*
*
*
3. Section 180.278 is revised to read
as follows:
§ 180.278 Phenmedipham; tolerances for
residues.
(a) General. Tolerances are
established for the combined residues of
the herbicide phenmedipham (3-
E:\FR\FM\27SEP1.SGM
27SEP1
Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Proposed Rules
ethylhexyl ester in or on the following
food commodities:
methoxycarbonylaminophenyl-3methylcarbanilate) in or on the
following food commodities:
Commodity
Parts per
million
Beet, garden, roots ...................
Beet, sugar, dried pulp .............
Beet, sugar, molasses ..............
Beet, sugar, roots .....................
Beet, sugar, tops ......................
Spinach .....................................
0.2
0.5
0.2
0.1
0.1
4.0
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
4. Section 180.314 is revised to read
as follows:
§ 180.314 Triallate; tolerances for
residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. Tolerances are established
for residues of the herbicide (S-2, 3, 4trichloroallyl diisopropylthiocarbamate)
and its metabolite 2, 3, 3-trichloroprop2-enesulfonic acid (TCPSA) in or on the
following food commodities:
Commodity
Parts per
million
Barley, grain .............................
Barley, hay ................................
Barley, straw .............................
Beet, sugar, dried pulp .............
Beet, sugar, roots .....................
Beet, sugar, tops ......................
Pea, dry ....................................
Pea, field, hay ...........................
Pea, field, vines ........................
Pea, succulent ..........................
Wheat, grain .............................
Wheat, hay ...............................
Wheat, straw .............................
0.05
1.0
0.3
0.2
0.1
0.5
0.2
1.0
0.5
0.2
0.05
1.0
1.0
(d) Indirect or inadvertent residues.
[Reserved]
5. Section 180.339 is revised to read
as follows:
§ 180.339
MCPA; tolerances for residues.
rwilkins on PROD1PC63 with PROPOSAL
(a) General. (1) Tolerances are
established for residues of the herbicide
MCPA ((4-chloro-2methylphenoxy)acetic acid), both free
and conjugated, resulting from the
direct application of MCPA or its
sodium or dimethylamine salts, or its 2-
Parts per
million
Commodity
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E6–15841 Filed 9–26–06; 8:45 am]
Alfalfa, forage ...........................
Alfalfa, hay ................................
Barley, grain .............................
Barley, hay ................................
Barley, straw .............................
Clover, forage ...........................
Clover, hay ...............................
Flax, seed .................................
Grass, forage ............................
Grass, hay ................................
Lespedeza, forage ....................
Lespedeza, hay ........................
Oat, forage ................................
Oat, grain ..................................
Oat, hay ....................................
Oat, straw .................................
Pea, dry ....................................
Pea, hay ...................................
Pea, succulent ..........................
Pea, vines .................................
Rye, forage ...............................
Rye, grain .................................
Rye, straw .................................
Trefoil, forage ...........................
Trefoil, hay ................................
Vetch, forage ............................
Vetch, hay .................................
Wheat, forage ...........................
Wheat, grain .............................
Wheat, hay ...............................
Wheat, straw .............................
0.5
2.0
1.0
115
25
0.5
2.0
0.1
300
20
0.5
2.0
20
1.0
115
25
0.1
0.1
0.1
0.1
20
1.0
25
0.5
2.0
0.5
2.0
20
1.0
115
25
(2) Tolerances are established for
residues of the herbicide MCPA ((4chloro-2-methylphenoxy)acetic acid)
resulting from the direct application of
MCPA or its sodium or dimethylamine
salts, or its 2-ethylhexyl ester in or on
the following food commodities:
Parts per
million
Commodity
Cattle, fat ..................................
Cattle, meat byproducts ...........
Cattle, meat ..............................
Goat, fat ....................................
Goat, meat byproducts .............
Goat, meat ................................
Hog, fat .....................................
Hog, meat byproducts ..............
Hog, meat .................................
Horse, fat ..................................
Horse, meat byproducts ...........
Horse, meat ..............................
Milk ...........................................
Sheep, fat .................................
Sheep, meat byproducts ..........
Sheep, meat .............................
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
(b) Section 18 emergency exemptions.
[Reserved]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–2006–0755, EPA–HQ–
SFUND–2006–0758, EPA–HQ–SFUND–2006–
0759, EPA–HQ–SFUND–2006–0760, EPA–
HQ–SFUND–2006–0761, EPA–HQ–SFUND–
2006–0762; FRL–8223–2]
RIN 2050–AD75
National Priorities List, Proposed Rule
No. 45
Environmental Protection
Agency.
ACTION: Proposed rule.
AGENCY:
SUMMARY: The Comprehensive
Environmental Response,
Compensation, and Liability Act
(‘‘CERCLA’’ or ‘‘the Act’’), as amended,
requires that the National Oil and
Hazardous Substances Pollution
Contingency Plan (‘‘NCP’’) include a list
of national priorities among the known
releases or threatened releases of
hazardous substances, pollutants, or
contaminants throughout the United
States. The National Priorities List
(‘‘NPL’’) constitutes this list. The NPL is
intended primarily to guide the
Environmental Protection Agency
(‘‘EPA’’ or ‘‘the Agency’’) in determining
which sites warrant further
investigation. These further
investigations will allow EPA to assess
the nature and extent of public health
and environmental risks associated with
the site and to determine what CERCLAfinanced remedial action(s), if any, may
be appropriate. This rule proposes to
add six new sites to the NPL, all to the
General Superfund Section.
DATES: Comments regarding any of these
proposed listings must be submitted
(postmarked) on or before November 27,
2006.
ADDRESSES: Identify the appropriate
FDMS Docket Number from the table
below.
FDMS DOCKET IDENTIFICATION NUMBERS BY SITE
Site name
City/state
Elm Street Ground Water Contamination ...................
South Minneapolis Residential Soil Contamination ....
Terre Haute, IN .............................
Minneapolis, MN ...........................
VerDate Aug<31>2005
16:43 Sep 26, 2006
Jkt 208001
56433
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
FDMS docket ID No.
EPA–HQ–SFUND–2006–0755.
EPA–HQ–SFUND–2006–0759.
E:\FR\FM\27SEP1.SGM
27SEP1
Agencies
[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Proposed Rules]
[Pages 56425-56433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15841]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0586; FRL-8089-5]
Propanil, Phenmedipham, Triallate, and MCPA; Proposed Tolerance
Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke certain tolerances for herbicides
propanil, triallate, and MCPA. Also, EPA is proposing to modify certain
tolerances for the herbicides propanil, phenmedipham, triallate, and
MCPA. In addition, EPA is proposing to establish tolerances for the
herbicides propanil, phenmedipham, triallate, and MCPA.
DATES: Comments must be received on or before November 27, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0586, by one of the following methods:
Federal eRulemaking Portal: https://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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0586. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://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 e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not
[[Page 56426]]
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through regulations.gov, your e-mail 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.
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 https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
3057-5805.
FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and
Reregistration Division (7805P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail
address: smith.jane-scott@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. 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 e-mail. 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.
C. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f) if needed.
The order would specify data needed and the time frames for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What Action is the Agency Taking?
EPA is proposing to revoke, remove, modify, and establish specific
tolerances for residues of the herbicides propanil, phenmedipham,
triallate, and MCPA in or on commodities listed in the regulatory text.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of the Food Quality Protection Act (FQPA). The safety finding
determination of ``reasonable certainty of no harm'' is discussed in
detail in each
[[Page 56427]]
Reregistration Eligibility Decision (RED) and Report of the FQPA
Tolerance Reassessment Progress and Risk Management Decision (TRED) for
the active ingredients. REDs and TREDs 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 and TREDs may be obtained from EPA's National Service Center for
Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH
452427-2419, telephone 1-800-490-9198; fax 1-513-489-8695; internet at
https://www.epa.gov/ncepihom and from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
1-800-553-6847 or (703) 605-6000; internet at https://www.ntis.gov.
Electronic copies of REDs and TREDs are available on propanil,
phenmedipham, triallate, and MCPA at the internet at https://
www.epa.gov/pesticides/reregistration/status.htm and in public dockets
EPA-HQ-OPP-2003-0348 and EPA-HQ-OPP-2002-0033 (propanil); EPA-HQ-OPP-
2004-0384 (phenmedipham); and EPA-HQ-OPP-2004-0156 and EPA-HQ-OPP-2004-
0239 (MCPA) at https://www.regulations.gov.
The selection of an individual tolerance level is based on crop
field residue studies designed to produce the maximum residues under
the existing or proposed product label. Generally, the level selected
for a tolerance is a value slightly above the maximum residue found in
such studies. The evaluation of whether a tolerance is safe is a
separate inquiry. EPA recommends the raising of a tolerance when data
show that (1) lawful use (sometimes through a label change) may result
in a higher residue level on the commodity and (2) the tolerance
remains safe, notwithstanding increased residue level allowed under the
tolerance. In REDs, Chapter IV on Risk management, Reregistration, and
Tolerance Reassessment typically describes the regulatory position,
FQPA assessment, cumulative safety determination, determination of
safety for U.S. general population, and safety for infants and
children. In particular, the human health risk assessment document
which supports the RED describes risk exposure estimates and whether
the Agency has concerns. In TREDs, the Agency discusses its evaluation
of the dietary risk associated with the active ingredient and whether
it can determine that there is a reasonable certainty (with appropriate
mitigation) that no harm to any population subgroup will result from
aggregate exposure.
Explanations for proposed modifications in tolerances can be found
in the RED and TRED document and in more detail in the Residue
Chemistry Chapter document which supports the RED and TRED. Copies of
the Residue Chemistry Chapter documents are found in the Administrative
Record and paper copies are available in the public docket for this
proposed rule, while electronic copies are available through EPA's
electronic public docket and comment system, regulations.gov at https://
www.regulations.gov. You may search for docket ID number EPA-HQ-OPP-
006-0586, 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 or TRED which lists the submitted
studies that the Agency found acceptable.
With respect to the tolerances that are proposed in this document
to be modified, unless technical (e.g., commodity tolerance
nomenclature revision), EPA has found that these tolerances are safe in
accordance with FFDCA section 408(b)(2)(A), and that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residues, in
accordance with section 408(b)(2)(C). These findings are discussed in
detail in each RED. The references are available for inspection as
described in this document under SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances
because either they are no longer needed or are associated with food
uses that are no longer registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). The registrations for these
pesticide chemicals were canceled because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily canceled
one or more registered uses of the pesticide. It is EPA's general
practice to propose revocation of those tolerances for residues of
pesticide active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
1. Propanil. Currently, in 40 CFR 180.274 (a)(1) and (2),
tolerances are established for the combined residues of propanil and
its metabolites (calculated as propanil) in or on both raw agricultural
commodities (RACs) and processed foods and feeds. EPA is proposing to
revise the tolerance expression to specify the residues of concern and
combine the RACs and processed foods and feed tolerances in accordance
with FFDCA 408 as amended by FQPA (1996) in 40 CFR 180.274(a) to read
as follows: Tolerances are established for the combined residues of the
herbicide propanil (3', 4'-dichloropropionanilide) and its metabolites
convertible to 3, 4-dichloroaniline (3, 4-DCA).
Tolerances currently exist for rice milling fractions and rice
polishings. Rice milling fractions are no longer considered a
significant animal feed item as delineated in ``Table 1.--Raw
Agricultural and Processed Commodities and Feedstuffs Derived from
Crops'' which is found in Residue Chemistry Test Guidelines OPPTS
860.1000 dated August 1996, available at https://www.epa.gov/
opptsfrs/publications/OPPTS_Harmonized/860_
Residue_Chemistry_Test_Guidelines/Series. Therefore,
EPA is proposing to remove the tolerances in 40 CFR 180.274(a) for the
combined residues of propanil in or on rice milling fractions and rice,
polishings at 10 parts per million (ppm).
The registered uses on barley, oat, and wheat (small grains) have
been voluntarily cancelled (68 FR 68901, December 10, 2003) (FRL-7332-
5), (68 FR 38328, June 27, 2003) (FRL-7310-6). In the absence of
registered uses, the tolerances associated with the small grains should
be revoked. Therefore, EPA is proposing to revoke the tolerances in 40
CFR 180.274(a) for the combined propanil residues of concern in or on
barley, straw; oat, straw; and wheat, straw at 0.75 ppm; barley, grain
at .2 ppm; oat, grain at .2 ppm; wheat, grain at 0.2 ppm.
Two studies depicting the magnitude of regulated propanil residues
in or on rice, grain exceeded the established tolerance of 2 ppm in or
on treated rice, grain samples demonstrating residues ranging from 0.03
ppm to 8.7 ppm. Based on these data, EPA determined the tolerance
should be 10 ppm on rice, grain. Therefore, EPA is proposing to
increase the tolerance in 40 CFR 180.274(a) for the combined propanil
residues of concern in or on rice, grain from 2 ppm to 10 ppm. The
Agency determined that the increased tolerance is safe; i.e. there is a
reasonable certainty that no harm will result from
[[Page 56428]]
aggregate exposure to the pesticide chemical residue.
A rice processing study showed no concentration of residues in
polished rice and average concentration factors of 3.5x for rice, hulls
and 4.6x for rice, bran. The highest average field trial (HAFT)
propanil residues found in rice were 8.7 ppm. Based on this HAFT and
the observed concentration factors, the maximum expected residues are
30.45 ppm in or on rice, hulls (8.7 x 3.5) and 40.02 ppm in or on rice,
bran (8.7 x 4.6). These expected residues are higher in the processed
commodities than the reassessed tolerance of 10 ppm for rice, grain.
Based on these data, EPA has determined that the tolerances should be
30 ppm on rice, hulls and 40 ppm on rice, bran. Therefore, EPA is
proposing to increase tolerances in 40 CFR 180.274(a) for the combined
propanil residues of concern in or on rice, hulls from 10 to 30 ppm and
rice, bran from 10 to 40 ppm. The Agency determined that the increased
tolerances are safe; i.e. there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue.
The potential for secondary transfer of propanil residues to
animal commodities exists because the herbicide is registered for use
on rice, which may be used as animal feed. Based on a maximum
theoretical dietary burden (x) and using the residues levels found in
dairy cattle and milk fed 15 ppm (0.75x) resulted in residues of: 0.035
ppm in milk, 0.31 ppm in liver, 0.77 ppm in kidney, < 0.05 ppm (non-
detectable) in muscle, and 0.10 ppm in fat. Based on these data, the
Agency determined the tolerances should be 0.05 ppm in cattle, meat;
goat, meat; hog, meat; horse, meat; and sheep, meat; and 1.0 ppm in
cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts;
horse, meat byproducts; and sheep,meat byproducts. In addition, the
term ``negligible residue'' and its designation, ``(N)'' associated
with the milk and animal tissue tolerances is being removed to conform
to current Agency policy and practice. Therefore, EPA is proposing in
40 CFR 180.274(a) for the combined propanil residues of concern to
maintain and revise the tolerances in or on milk from 0.05(N) ppm to
0.05 ppm and cattle, fat; goat, fat; hog, fat; horse, fat; and sheep,
fat from 0.1(N) ppm to 0.10 ppm; to decrease and revise the tolerances
in or on cattle, meat; goat, meat; hog, meat; horse, meat; and sheep,
meat from 0.1(N) to 0.05 ppm; and to increase and revise the tolerances
in or on cattle, meat byproducts; goat, meat byproducts; hog, meat
byproducts; horse, meat byproducts; and sheep,meat byproducts from
0.1(N) to 1.0 ppm. The Agency determined that the increased tolerances
are safe; i.e. there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue.
Maximum propanil residues were 0.212 ppm and 0.372 ppm,
respectively, in eggs from hens dosed with propanil 15 ppm (0.9x), and
50 ppm (3.1x). Residues in liver from hens in the 15 ppm (0.9x), and 50
ppm (3.1x) dose groups were 0.183-0.236, and 0.824-1.755 ppm,
respectively. Residues in muscle were < 0.050-0.076 and 0.087-0.161 ppm
from the 0.9x and 3.1x dose groups, respectively. In fat, propanil
residues of concern were < 0.05 ppm (< non-detectable) up to 0.9x
feeding levels, and < 0.139-0.348 ppm at 3.1x. Based on these data, the
Agency has determined that the propanil tolerances should be 0.30 ppm
for egg; 0.05 ppm for poultry, fat; 0.50 ppm for poultry, meat
byproducts; and 0.10 ppm for poultry, meat. In addition, the term
``negligible residue'' and its designation, ``(N)'' associated with the
egg and animal tissue tolerances is being removed to conform to current
Agency policy and practice. Therefore, EPA is proposing in 40 CFR
180.274(a) for the combined propanil residues of concern to increase
and revise the tolerance for egg from 0.05(N) to 0.30 ppm; to decrease
and revise the tolerance in or on poultry, fat from 0.1(N) to 0.05 ppm;
to increase and revise the tolerance for poultry, meat byproducts from
0.1(N) to 0.50 ppm; and maintain and revise the tolerance in or on
poultry, meat from 0.1(N) to 0.10 ppm. The Agency determined that the
increased tolerances are safe; i.e. there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue.
Residues of propanil and its metabolites, determined as base-
releasable 3, 4 DCA and expressed as propanil equivalents, were < 0.01-
0.03 ppm in or on the edible portions of crayfish (1x maximum season
rate). Based on these data, the Agency determined the tolerance should
be 0.05 ppm on crayfish. Therefore, EPA is proposing to establish a
tolerance in 40 CFR 180.274(a) for the combined propanil residues of
concern in or on crayfish at 0.05 ppm.
In addition, the ``N'' (negligible residues) designation
correlated with tolerances is being removed to conform to current
Agency practice. Therefore, EPA is proposing to revise the tolerance in
40 CFR 180.274(a) for the combined propanil residues of concern in or
on rice, straw from 75(N) ppm to 75 ppm.
2. Phenmedipham. The current tolerance expression in 40 CFR 180.278
refers to phenmedipham as methyl m-hydroxycarbanilate m-
methylcarbanilate which should be changed to the more appropriate
chemical name, 3-methoxycarbonylaminophenyl-3-methylcarbanilate.
Therefore, EPA proposes to change the chemical name in 40 CFR
180.278(a) for residues of the herbicide phenmedipham to 3-
methoxycarbonylaminophenyl-3-methylcarbanilate.
Spinach field trial residue data generated at the 1x seasonal
application rate and 14-22 day pre-harvest interval (PHI) resulted in
residues ranging from 2.1-3.6 ppm. Additional trials conducted at
similar rates and PHIs yielded residues ranging from < 0.05 to 0.17
ppm. Based on the more recent residue data and use pattern, EPA has
determined the tolerance on spinach should be 4.0 ppm. Therefore, EPA
is proposing to increase the tolerance in 40 CFR 180.278(a) for
residues of phenmedipham in or on spinach from 0.5 ppm to 4.0 ppm. The
Agency determined that the increased tolerance is safe; i.e. there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Sugar beet processing studies indicate that phenmedipham residues
of concern concentrated 3x in dried pulp, 1.3x in molasses, and did not
concentrate in sugar. Because of the concentration factors associated
with dried pulp and molasses, the current tolerance of 0.1 ppm for raw
beet, sugar, roots and beet, sugar, tops is not adequate to cover the
dried pulp and molasses from sugar beets; therefore, the Agency has
determined that tolerances should be established for beet, sugar, dried
pulp at 0.5 ppm and beet, sugar, molasses at 0.2 ppm. EPA is proposing
to establish tolerances in 40 CFR 180.278(a) for residues of
phenmedipham in or on beet, sugar, dried pulp at 0.5 ppm and beet,
sugar, molasses at 0.2 ppm.
In addition, the ``N'' (negligible residues) designation that is
correlated with some of the tolerances is being removed to conform to
current Agency practice. Therefore, EPA is proposing to revise the
tolerances in 40 CFR 180.278(a) for residues of phenmedipham in or on
beet, garden at 0.2(N) ppm to beet, garden, roots at 0.2 ppm; beet,
sugar, roots at 0.1(N) ppm to 0.1 ppm; and beet, sugar, tops at 0.1(N)
ppm to 0.1 ppm.
3. Triallate. The available data, reflecting the maximum registered
use patterns, indicate that the maximum combined triallate residues of
concern were 0.26 ppm in or on barley, straw;
[[Page 56429]]
0.12 ppm in or on the seed and pods of succulent peas; 0.39 ppm in or
on the vines of succulent peas; 0.27 ppm in or on the vines of dried
peas; 0.73 ppm in or on the straw (hay) of succulent peas; 0.36 ppm in
or on the straw of dried peas; and 0.94 ppm in or on wheat, straw in
the states of: Colorado, Idaho, Kansas, Minnesota, Montana, Nebraska,
Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and
Wyoming. In addition, the term ``negligible residue'' and its
designation, ``(N)'' associated with the barley, grain tolerance is
being removed to conform to current Agency policy and practice. Based
on these data, the Agency determined the tolerances should be 0.3 ppm
on barley, straw; 1.0 ppm on pea, field, hay; 0.5 ppm on pea, field,
vines; 0.2 ppm on pea, succulent; and 1.0 ppm on wheat, straw and
recodified under 40 CFR 180.314(c) as regional tolerances. Therefore,
EPA is proposing the tolerances in 40 CFR 180.314(c) for the combined
residues of concern to be increased in or on barley, straw from 0.05 to
0.3 ppm; pea, field, hay from 0.05 to 1.0 ppm; pea, field, vines from
0.05 to 0.5 ppm; pea, succulent from 0.05 to 0.2 ppm; wheat, straw from
0.05 to 1.0 ppm; and reclassified from 40 CFR 180.314(a) to 40 CFR
180.314(c) for barley, grain at 0.05 ppm and wheat, grain at 0.05 ppm.
The Agency determined that the increased tolerances are safe; i.e.,
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue.
Lentil, hay is no longer considered significant livestock feed
item and has been removed from Table 1 (OPPTS GLN 860.1000) and lentil,
seed is covered by the established pea tolerance in accordance with 40
CFR 180.1(h). As a result, EPA proposes removing the tolerances in 40
CFR 180.314(a) for the combined triallate residues of concern in or on
lentil, hay at 0.05 ppm and lentil, seed at 0.05 ppm.
Sugar beet processing studies were conducted on sugar beets treated
at 5x the seasonal application rate resulting in maximum residues of
0.14 ppm in root, 0.30 ppm in dried pulp, and < 0.03 ppm in sugar and
molasses. Therefore, EPA is proposing to maintain the tolerances and
correct the terminology for sugar beets to include roots in 40 CFR
180.314(c) for the combined triallate residues of concern in or on
beet, sugar, dried pulp at 0.2 ppm; beet, sugar, roots at 0.1 ppm; and
beet, sugar, tops at 0.5 ppm.
The available data, reflecting the maximum registered use patterns,
indicate that the maximum combined triallate residues of concern were <
0.02 ppm in or on the seed and pods of pea, dry and 0.94 ppm on wheat,
straw. Because of similar cultural practices and identical use rates,
wheat, straw data is used to support tolerances for barley, hay and
wheat, hay. Based on these data, the Agency determined the tolerances
should be 0.2 ppm for pea, dry and 1.0 ppm for barley, hay and wheat,
hay by translating the data from wheat, straw. Therefore, EPA is
proposing to establish tolerances in 40 CFR 180.314(c) for the combined
triallate residues of concern in or on barley, hay at 1.0 ppm; pea, dry
at 0.2 ppm; and wheat, hay at 1.0 ppm. The Agency determined that the
establishment of these tolerances is safe; i.e., there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue.
Although tolerances are established on animal feed items,
tolerances on the edible tissues of animals are not necessary because
the available residue data generated using exaggerated rates indicate
there is no reasonable expectation of finite residues in meat, milk,
poultry, and eggs as a result of ingestion of pesticide residues on raw
agricultural commodities in accordance with 40 CFR 180.6(a)(3).
4. MCPA. The current tolerance expression 40 CFR 180.339(a)
regulates residues of the herbicide 2-methyl-4-chlorophenoxyacetic acid
(MCPA) from application of the herbicide in acid form or in the form of
its sodium, ethanolamine, diethanolamine, triethanolamine,
isopropanolamine, diisopropanolamine, triisopropanolamine, or
dimethylamine salts or isooctyl or butoxyethyl esters and 40 CFR
180.339(b) tolerances are established for combined negligible residues
(N) of the herbicide 2-methyl-4-chlorophenoxyacetic acid and its
metabolite 2-methyl-4-chlorophenol. Based on toxicity data for 2-
methyl-4-chlorophenol, a currently regulated livestock metabolite, EPA
determined that it is of significantly less concern than the parent
compound and therefore can be excluded from the tolerance expression.
Although the chemical name for MCPA has been presented as ``(2-methyl-
4-chlorophenoxy)acetic acid'', under current chemical naming
conventions the ``(4-chloro-2-methylphenoxy)acetic acid'' designation
is preferred. EPA determined the residues to be regulated in plant
commodities (40 CFR 180.339(a)) are parent, free and conjugated MCPA.
When MCPA is applied in various forms (e.g. ethanolamine and other
salts and esters), a single common moiety is released that is the
pesticidally active component and serves as the basis for tolerance
regulation. Therefore, EPA is proposing to change the tolerance
expression in 40 CFR 180.339(a) to read as follows: tolerances are
established for residues of the herbicide MCPA [(4-chloro-2-
methylphenoxy)acetic acid)], both free and conjugated, resulting from
the direct application of MCPA or its sodium or dimethylamine salts, or
its 2-ethylhexyl ester and in 40 CFR 180.339(b) to read as follows:
tolerances are established for residues of the herbicide MCPA [(4-
chloro-2-methylphenoxy)acetic acid)] resulting from the direct
application of MCPA or its sodium or dimethylamine salts, or its 2-
ethylhexyl ester. 40 CFR 180.339 (a) and (b) will be revised to read 40
CFR 180.339 (a)(1) and (2) for consistency. Lastly, the term
``negligible residue'' and its designation, ``(N)'', associated with
some tolerances is being removed to conform to current Agency policy
and practice.
Currently, tolerances exist reflecting uses of MCPA on rice,
sorghum, flax (straw) and canarygrass. The uses on rice, sorghum, and
canarygrass are no longer registered uses (69 FR 39467, June 30, 2004)
(FRL-7363-4) (71 FR 24687, April 26, 2006) (FRL-8059-2). EPA policy no
longer requires tolerances to be established for flax, straw.
Therefore, EPA is proposing to revoke tolerances in 40 CFR
180.339(a)(1) for the combined MCPA residues of concern in or on flax,
straw at 2 ppm; grass, canary, annual, straw at 0.1 ppm; canary,
annual, seed at 0.1 ppm; rice, grain at 0.1(N) ppm; rice, straw at 2
ppm; sorghum, forage at 20 ppm; sorghum, grain at 0.1 ppm; and sorghum,
grain, stover at 20 ppm.
The crop field trial data indicate that the maximum combined
residues of MCPA and its metabolites are < 0.29 ppm in or on alfalfa,
forage and < 1.07 ppm in or on alfalfa, hay. Alfalfa, forage and
alfalfa, hay data will also be used to satisfy crop field trial
requirements for the clover, forage; clover hay; lespedeza, forage;
lespedeza, hay; trefoil, forage; trefoil, hay; vetch, forage; and
vetch, hay. Ordinarily, the Agency would not translate data from
alfalfa, forage and alfalfa, hay to support uses on clover, forage;
clover hay; lespedeza, forage; lespedeza, hay; trefoil, forage;
trefoil, hay; vetch, forage; and vetch, hay; however, because the only
supported use of MCPA on these crops is to the crops underseeded to
small grains it is reasonable to use alfalfa, forage and alfalfa, hay
data to support these uses. Based on these data, EPA has determined the
tolerance should be 0.5 ppm in or on alfalfa, forage; clover, forage;
lespedeza, forage; trefoil, forage;
[[Page 56430]]
and vetch, forage; and 2.0 ppm in or on alfalfa, hay; clover hay;
lespedeza, hay; trefoil, hay; and vetch, hay. Therefore, EPA is
proposing to increase tolerances and revise the terminology to include
forage consistently in 40 CFR 180.339 (a)(1) for residues of MCPA in or
on alfalfa, forage; clover, forage; lespedeza, forage; trefoil, forage;
and vetch, forage from 0.1 to 0.5 ppm and alfalfa, hay; clover hay;
lespedeza, hay; trefoil, hay; and vetch, hay from 0.1 to 2.0 ppm. The
Agency determined that the increased tolerances are safe; i.e. there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
The crop field trial data indicate that the maximum combined
residues of MCPA and its metabolites are 0.72 ppm in or on wheat, grain
and 21.4 ppm in or on wheat, straw. Based on the HAFT residue of 0.08
ppm for wheat, grain, expected MCPA residues of concern in or on wheat
bran and germ will not exceed the established tolerance of 0.1 ppm for
wheat, grain and for wheat processed commodities. Because of similar
cultural practices and identical use rates, wheat residue field trial
data is used to support tolerances for barley, oat, and rye. Based on
these data, EPA has determined the tolerance should be 1.0 ppm in or on
barley, grain; oat, grain; rye, grain; and wheat, grain and 25 ppm in
or on barley, straw; oat, straw; rye, straw; and wheat, straw.
Therefore, EPA is proposing to increase the tolerances in 40 CFR
180.339(a)(1) for residues of MCPA in or on barley, grain; oat, grain;
rye, grain; and wheat, grain from 0.1 to 1.0 ppm and barley, straw;
oat, straw; rye, straw; and wheat, straw from 2 to 25 ppm. The Agency
determined that these increased tolerances are safe; i.e. there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
The crop field trial data indicate that the maximum combined
residues of MCPA and its metabolites are 19.4 ppm (7 day PHI) in or on
wheat, forage, 39.5 ppm and 111 ppm (7 and14 day PHIs, respectively) in
or on wheat, hay. Also, these data are translated to support tolerances
for barley, hay and oat, hay and oat, forage and rye, forage. Based on
these data, EPA determined the tolerances should be 20 ppm on oat,
forage; rye, forage; and wheat, forage and 115 ppm on barley, hay; oat,
hay; and wheat, hay. EPA is proposing tolerances be established in 40
CFR 180.339(a)(1) for residues of MCPA in or on wheat, forage at 20
ppm; and barley, hay; oat, hay; and wheat, hay at 115 ppm; and maintain
tolerances for oat, forage and rye, forage at 20 ppm. The Agency
determined that these newly established tolerances are safe; i.e. there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemicals residue.
In addition, EPA is proposing to revise commodity terminology and
tolerances to conform to current Agency practice at 40 CFR 180.339 as
follows: ``grass, pasture and grass, rangeland at 300 ppm to grass,
forage at 300 ppm;'' ``peavines at 0.1(N) ppm to pea, vines at 0.1
ppm;'' ``peavines, hay at 0.1(N) ppm to pea, hay at 0.1 ppm;''
``vegetables, seed and pod at 0.1 ppm to pea, dry at 0.1 ppm and pea,
succulent at 0.1 ppm;'' ``cattle, fat; goat, fat; hog, fat; horse, fat;
and sheep, fat; cattle, meat byproducts; goat, meat byproducts; hog,
meat byproducts; horse, meat byproducts; and sheep, meat byproducts;
and cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat
at 0.1(N) ppm to 0.1 ppm;'' and ``milk at 0.1(N) ppm to 0.1 ppm.''
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 the 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 the 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.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of the FQPA. The safety finding determination is discussed in
detail in each Post-FQPA RED and TRED for the active ingredient. REDs
and TREDs 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 and electronic copies of the REDs and TREDs are
available as provided in Unit II.A.
EPA has issued post-FQPA REDs for propanil, phenmedipham,
triallate, and MCPA, and a TRED for propanil. REDs and TREDs contain
the Agency's evaluation of the data base for these 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, and in REDs state conditions
under which these uses and products will be eligible for
reregistration. The REDs and TREDs recommended the establishment,
modification, and/or revocation of specific tolerances. RED and TRED
recommendations such as establishing or modifying tolerances, and in
some cases revoking tolerances, are the result of assessment under the
FQPA standard of ``reasonable certainty of no harm.'' However,
tolerance revocations recommended in REDs and TREDs that are proposed
in this document do not need such assessment when the tolerances are no
longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure
[[Page 56431]]
to the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, consideration must be given to the possible
residues of those chemicals in meat, milk, poultry, and/or eggs
produced by animals that are fed agricultural products (for example,
grain or hay) containing pesticides residues (40 CFR 180.6). When
considering this possibility, EPA can conclude that:
1. Finite residues will exist in meat, milk, poultry, and/or eggs.
2. There is a reasonable expectation that finite residues will
exist.
3. There is a reasonable expectation that finite residues will not
exist. If there is no reasonable expectation of finite pesticide
residues in or on meat, milk, poultry, or eggs, tolerances do not need
to be established for these commodities (40 CFR 180.6(b) and (c)).
EPA has evaluated certain specific meat, milk, poultry, and egg
tolerances proposed for revocation in this proposed rule and has
concluded that there is no reasonable expectation of finite pesticide
residues of concern in or on those commodities.
C. When do These Actions Become Effective?
EPA is proposing that modifications, establishment, commodity
terminology revisions, and revocation of these tolerances become
effective on the date of publication of the final rule in the Federal
Register because their associated uses have been canceled for several
years. The Agency believes that treated commodities have had sufficient
time for passage through the channels of trade. However, if EPA is
presented with information that existing stocks would still be
available and that information is verified, the Agency will consider
extending the expiration date of the tolerance. If you have comments
regarding existing stocks and whether the effective date allows
sufficient time for treated commodities to clear the channels of trade,
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 section, 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. Are the Proposed Actions Consistent with International
Obligations?
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
The tolerance actions in this proposal apply equally to
domestically-produced and imported foods. In making its tolerance
decisions, the Agency seeks to harmonize 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, as
required by section 408(b)(4) of the FFDCA. 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 also considers
MRLs established in Canada and Mexico. EPA may establish a tolerance
that is different from a Codex MRL; however, FFDCA section 408(b)(4)
requires that EPA explain in a Federal Register document the reasons
for departing from the Codex level. Specific tolerance actions in this
proposed rule are discussed in Unit II.A. EPA's efforts to harmonize
with MRLs is summarized in the tolerance reassessment section of
individual REDs and TREDs as mentioned in Unit II.A. EPA has developed
guidance concerning submissions for import tolerance support (65 FR
35069, June 1, 2000) (FRL-6559-3). This guidance will be made available
to interested persons. Electronic copies are available on the internet
at https://www.epa.gov. On the Home Page select ``Laws, Regulations, and
Dockets,'' then select Regulations and Proposed Rules and then look up
the entry for this document under ``Federal Register--Environmental
Documents.'' You can also go directly to the ``Federal Register''
listings at https://www.epa.gov/fedrgstr.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to establish tolerances
under FFDCA section 408(e), and also modify and revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted these types of actions (e.g.,
establishment and modification of a tolerance and tolerance revocation
for which extraordinary circumstances do not exist) 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, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not
[[Page 56432]]
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) (Public Law
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, expansion of exemptions, or revocations 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.
These analyses for tolerance establishments and modifications, and for
tolerance revocations were published on May 4, 1981 (46 FR 24950) and
on December 17, 1997 (62 FR 66020), respectively, and were provided to
the Chief Counsel for Advocacy of the Small Business Administration.
Taking into account this analysis, and available information concerning
the pesticides listed in this proposed rule, the Agency hereby
certifies that this proposed action will not have a significant
negative economic impact on a substantial number of small entities. In
a memorandum dated May 25, 2001, EPA determined that eight conditions
must all be satisfied in order for an import tolerance or tolerance
exemption revocation to adversely affect a significant number of small
entity importers, and that there is a negligible joint probability of
all eight conditions holding simultaneously with respect to any
particular revocation (this Agency document is available in the docket
of this proposed rule). Furthermore, for the pesticide named in this
proposed rule, the Agency knows of no extraordinary circumstances that
exist as to the present proposal that would change EPA's previous
analysis. Any comments about the Agency's determination should be
submitted to the EPA along with comments on the proposal, and will be
addressed prior to issuing a final rule. 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 the
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 6, 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: September 20, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.274 is amended by revising paragraph (a) to read as
follows:
Sec. 180.274 Propanil; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the herbicide propanil (3', 4'-dichloropropionanilide) and its
metabolites convertible to 3, 4-dichloroaniline (3, 4-DCA) in or on the
following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.10
Cattle, meat byproducts.................................... 1.0
Cattle, meat............................................... 0.05
Crayfish................................................... 0.05
Egg........................................................ 0.30
Goat, fat.................................................. 0.10
Goat, meat byproducts...................................... 1.0
Goat, meat................................................. 0.05
Hog, fat................................................... 0.10
Hog, meat byproducts....................................... 1.0
Hog, meat.................................................. 0.05
Horse, fat................................................. 0.10
Horse, meat byproducts..................................... 1.0
Horse, meat................................................ 0.05
Milk....................................................... 0.05
Poultry, fat............................................... 0.05
Poultry, meat byproducts................................... 0.50
Poultry, meat.............................................. 0.10
Rice, bran................................................. 40
Rice, grain................................................ 10
Rice, hulls................................................ 30
Rice, straw................................................ 75
Sheep, fat................................................. 0.10
Sheep, meat byproducts..................................... 1.0
Sheep, meat................................................ 0.05
------------------------------------------------------------------------
* * * * *
3. Section 180.278 is revised to read as follows:
Sec. 180.278 Phenmedipham; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the herbicide phenmedipham (3-
[[Page 56433]]
methoxycarbonylaminophenyl-3-methylcarbanilate) in or on the following
food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Beet, garden, roots........................................ 0.2
Beet, sugar, dried pulp.................................... 0.5
Beet, sugar, molasses...................................... 0.2
Beet, sugar, roots......................................... 0.1
Beet, sugar, tops.......................................... 0.1
Spinach.................................................... 4.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
4. Section 180.314 is revised to read as follows:
Sec. 180.314 Triallate; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. Tolerances are
established for residues of the herbicide (S-2, 3, 4-trichloroallyl
diisopropylthiocarbamate) and its metabolite 2, 3, 3-trichloroprop-2-
enesulfonic acid (TCPSA) in or on the following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain.............................................. 0.05
Barley, hay................................................ 1.0
Barley, straw.............................................. 0.3
Beet, sugar, dried pulp.................................... 0.2
Beet, sugar, roots......................................... 0.1
Beet, sugar, tops.......................................... 0.5
Pea, dry................................................... 0.2
Pea, field, hay............................................ 1.0
Pea, field, vines.......................................... 0.5
Pea, succulent............................................. 0.2
Wheat, grain............................................... 0.05
Wheat, hay................................................. 1.0
Wheat, straw............................................... 1.0
------------------------------------------------------------------------
(d) Indirect or inadvertent residues. [Reserved]
5. Section 180.339 is revised to read as follows:
Sec. 180.339 MCPA; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide MCPA ((4-chloro-2-methylphenoxy)acetic acid), both free and
conjugated, resulting from the direct application of MCPA or its sodium
or dimethylamine salts, or its 2-ethylhexyl ester in or on the
following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage............................................ 0.5
Alfalfa, hay............................................... 2.0
Barley, grain.............................................. 1.0
Barley, hay................................................ 115
Barley, straw.............................................. 25
Clover, forage............................................. 0.5
Clover, hay................................................ 2.0
Flax, seed................................................. 0.1
Grass, forage.............................................. 300
Grass, hay................................................. 20
Lespedeza, forage.......................................... 0.5
Lespedeza, hay............................................. 2.0
Oat, forage................................................ 20
Oat, grain................................................. 1.0
Oat, hay................................................... 115
Oat, straw................................................. 25
Pea, dry................................................... 0.1
Pea, hay................................................... 0.1
Pea, succulent............................................. 0.1
Pea, vines................................................. 0.1
Rye, forage................................................ 20
Rye, grain................................................. 1.0
Rye, straw................................................. 25
Trefoil, forage............................................ 0.5
Trefoil, hay............................................... 2.0
Vetch, forage.............................................. 0.5
Vetch, hay................................................. 2.0
Wheat, forage.............................................. 20
Wheat, grain............................................... 1.0
Wheat, hay................................................. 115
Wheat, straw............................................... 25
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide MCPA
((4-chloro-2-methylphenoxy)acetic acid) resulting from the direct
application of MCPA or its sodium or dimethylamine salts, or its 2-
ethylhexyl ester in or on the following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.1
Cattle, meat byproducts.................................... 0.1
Cattle, meat............................................... 0.1
Goat, fat.................................................. 0.1
Goat, meat byproducts...................................... 0.1
Goat, meat................................................. 0.1
Hog, fat................................................... 0.1
Hog, meat byproducts....................................... 0.1
Hog, meat.................................................. 0.1
Horse, fat................................................. 0.1
Horse, meat byproducts..................................... 0.1
Horse, meat................................................ 0.1
Milk....................................................... 0.1
Sheep, fat................................................. 0.1
Sheep, meat byproducts..................................... 0.1
Sheep, meat................................................ 0.1
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15841 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S