Fenoxaprop-ethyl; Pesticide Tolerances for Emergency Exemptions
PDF Version (5 pp, 125K, About PDF)
[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]
[Page 33714-33718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn08-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-1107; FRL-8366-6]
Fenoxaprop-ethyl; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of fenoxaprop-ethyl and its metabolites in or on
grass hay and forage. This action is in response to EPA's granting of
an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on grasses grown for seed. This regulation establishes a maximum
permissible level for residues of fenoxaprop-ethyl and its metabolites
in these feed commodities. The time-limited tolerances expire and are
revoked on December 31, 2010.
DATES: This regulation is effective June 13, 2008. Objections and
requests for hearings must be received on or before August 12, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1107. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9356; e-mail address: conrath.andrea@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
[[Page 33715]]
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at
http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
any person may file an objection to any aspect of this regulation and
may also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-1107 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before August 12, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-1107, by one of the following methods:
• Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for combined residues of the herbicide
fenoxaprop-ethyl, [()-ethyl 2-[4-[(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoate], and its metabolites (2-[4-[(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one) in or on grass forage and hay at 0.05 parts
per million (ppm). These time-limited tolerances expire and are revoked
on December 31, 2010. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related time-limited tolerances to set binding precedents
for the application of section 408 of FFDCA to other tolerances and
exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance
or an exemption from the requirement of a tolerance on its own initiative,
i.e., without having received any petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Fenoxaprop-ethyl on Grasses Grown for Seed
and FFDCA Tolerances
The Oregon Department of Agriculture (ODA) states that an emergency
situation has arisen from weed problems that were once controlled with
an older product, under Special Local Needs (SLN) registrations that
were in effect from 1987 to 2002. Since 2002, the growers have been
lacking a method to effectively control the problem weeds and the
problem has continued to worsen since the SLNs were cancelled. The ODA
states that none of the herbicides currently registered for use on
grasses grown for seed are effective for controlling the weed species
addressed by their request, or do not provide adequate control, due to
timing of application, or spectrum of control. Cultural controls are
not viable alternatives due to the soil type, steep terrain, density of
grass stand; or adaptability of the weed species to various grass seed
production systems, such as varying planting date, row spacing, or
grass variety planted. In grass seed production, the presence of
noxious weed seeds like wild oat, results in significant discounts to
the sale prices, and certain states and countries completely prohibit
sale of grass seed containing noxious weed species; thus, growers
suffer losses of significant sales. Certain weed species can also cause
yield losses of up to 50%
[[Page 33716]]
under moderate to high infestation levels. Therefore, ODA states that
an urgent and non-routine situation has arisen, with significant
economic losses expected. After having reviewed the submission, EPA
determined that emergency conditions exist for this State, and that the
criteria for an emergency exemption are met. EPA has authorized under
FIFRA section 18 the use of fenoxaprop-ethyl on grasses grown for seed
for control of grassy weeds in Oregon.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of fenoxaprop-
ethyl in or on grass forage and hay. In doing so, EPA considered the
safety standard in section 408(b)(2) of FFDCA, and EPA decided that the
necessary tolerance under section 408(l)(6) of FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6) of FFDCA. Although these time-limited tolerances
expire and are revoked on December 31, 2010, under section 408(l)(5) of
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerance remaining in or on grass forage and hay after that
date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
fenoxaprop-ethyl meets FIFRA's registration requirements for use on
grasses grown for seed or whether permanent tolerances for this use
would be appropriate. Under these circumstances, EPA does not believe
that this time-limited tolerance decision serves as a basis for
registration of fenoxaprop-ethyl by a State for special local needs
under FIFRA section 24(c). Nor do these tolerances serve as the basis
for persons in any State other than Oregon to use this pesticide on
these crops under FIFRA section 18 absent the issuance of an emergency
exemption applicable within that State. For additional information
regarding the emergency exemption for fenoxaprop-ethyl, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue. . . .''
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for combined residues of fenoxaprop-ethyl
on grass forage and hay at 0.05 ppm. EPA's assessment of exposures and
risks associated with establishing time-limited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fenoxaprop-ethyl used
for human risk assessment is discussed in Unit II. of the final rule
published in the Federal Register of April 22, 1998 (63 FR 19829)
(FRL-5782-1).
B. Exposure Assessment
EPA believes that no changes need to be made as a result of this
section 18 emergency exemption use on grasses grown for seed, to the
conclusions of the risk assessment discussed in the final rule
published on April 22, 1998 in the Federal Register (63 FR 19829)
(FRL-5782-1) which established tolerances in barley commodities. EPA has
used barley data to estimate residues which could occur on the hay and
forage from grasses grown for seed, and this section 18 use is not
expected to change the aggregate exposure estimates from the 1998
barley assessment. This conclusion is based upon the position that this
section 18 use will not contribute to human dietary exposure for the
following reasons:
1. This section 18 use does not involve use on human foods; and
2. This section 18 use is unlikely to alter the dietary burden for
livestock (and corresponding residues in livestock tissues) because the
resulting feed commodities do not comprise a significant part of
livestock diet.
[[Page 33717]]
Therefore, because EPA has reasonable certainty of no harm from
dietary exposure from the existing uses, and, that this use on grasses
grown for seed pursuant to the emergency exemption would not increase
dietary exposure, EPA is establishing these time-limited tolerances for
grass hay and forage.
Since the time of the 1998 risk assessment, there has been a shift
to (+) fenoxaprop-ethyl (the r-isomer enriched (95%) formulation of
fenoxaprop-ethyl) as the primary active ingredient (also referred to as
fenoxaprop-P-ethyl to denote the direction in which it rotates
polarized light), rather than a 50:50 mix of ()fenoxaprop-
ethyl (the racemic mixture of the r- and s- isomers) both referred to
in this document as the parent, fenoxaprop-ethyl. The current tolerance
action is for fenoxaprop-ethyl, which covers both the ``+'' and ``-''
isomers. The analytical method used to determine residues of
fenoxaprop-ethyl and its metabolites, expressed as the parent, is
unable to distinguish between stereochemical isomers. Further, adequate
data was provided (for barley) to indicate that comparable residue
results are obtained from application of either the 50:50 mixture, or
the so-called ``enriched'' mixture. At the time of the change in
formulation, EPA determined that the established tolerances would
protect human health and that the existing toxicology data supported
the continued registration with the enriched formulation. EPA
determined that there was a reasonable certainty of no harm from the
continued registrations of the enriched formulation. EPA has determined
that, for the purposes of this section 18 use only, the residue data
for barley may be relied on for grass hay and forage, since the use
patterns are nearly identical. For these reasons, as well as those
given in Unit IV.B.1. and 2., the agency believes that the existing
data are adequate to support these tolerances.
EPA concludes that establishing the tolerances for grass hay and
forage, as set forth in this document, will not change the estimated
aggregate risks, as discussed in the April 22, 1998 Federal Register.
Refer to the April 22, 1998 Federal Register document for a detailed
discussion of the aggregate risk assessments and determination of
safety. EPA relies upon those risk assessments and the findings made in
the Federal Register document in support of this action.
Based on the risk assessments discussed in the final rule published
in the Federal Register of April 22, 1998, EPA concludes that there is
a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
fenoxaprop-ethyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (electron capture gas
chromatography) is available to enforce the tolerance expression. The
method is available in the Pesticide Analytical Manual (PAM) II, and
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established Codex tolerances for fenoxaprop-ethyl and
its metabolites in or on grass forage or hay.
VI. Conclusion
Therefore, time-limited tolerances are established for combined
residues of fenoxaprop-ethyl [()-ethyl 2-[4-[(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoic acid], and its metabolites (2-[4-
[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one), in or on grass hay and grass forage, both at
0.05 ppm. These tolerances expire and are revoked on December 31, 2010.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA in response to a petition submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this final
rule has been exempted from review under Executive Order 12866, this
final 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) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
[[Page 33718]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 4, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
• Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.430 is amended by adding text to paragraph (b) to read
as follows:
Sec. 180.430 Fenoxaprop-ethyl; tolerances for residues.
(a) * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide fenoxaprop-ethyl,
[(±)-ethyl 2-[4-[(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoic acid], and its metabolites (2-[4-
[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one), each expressed as fenoxaprop-ethyl, in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA, in or on the food commodities in the
following table. The tolerances expire and are revoked on the dates
specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Grass, forage..................... 0.05 12/31/10
Grass, hay........................ 0.05 12/31/10
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-13372 Filed 6-12-08; 8:45 am]
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