
[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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.430 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]

BILLING CODE 6560-50-S
