[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Rules and Regulations]
[Page 12621-12625]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr09-22]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0095; FRL-8404-7]
Tristyrylphenol Ethoxylates (CAS Reg. No. 70559-25-0) and (CAS
Reg. No. 99734-09-5); Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-
[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxy- (CAS Reg. No. 70559-
25-0) and poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-
phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 99734-09-5), herein
referred to in this document as tristyrylphenol ethoxylates when used
as inert ingredients in post-harvest applications to citrus crops,
group 10, under 40 CFR 180.1288 at a maximum of 10.0% in pesticide
formulations with azoxystrobin and fludioxonil. Syngenta Crop
Protection, Inc. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of the
tristyrylphenol ethoxylates.
DATES: This regulation is effective March 25, 2009. Objections and
requests for hearings must be received on or before May 26, 2009, 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-2008-0095. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., 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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open 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: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8825; e-mail address: samek.karen@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. 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0095 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 May 26, 2009.
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-2008-0095, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (PP 7E7305) by Syngenta Crop Protection, Inc.,
P.O. Box 18300, Greensboro, NC 27409. The petition requested that 40
CFR 180.910 be amended by establishing an exemption
[[Page 12622]]
from the requirement of a tolerance for residues of the tristyrylphenol
ethoxylates when used as inert ingredients in post-harvest applications
at a maximum of 10.0% in pesticide formulations. That notice included a
summary of the petition prepared by the petitioner. This request is
specific for the post-harvest uses of these tristyrylphenol ethoxylates
and does not impact the existing pre-harvest tolerance exemptions under
40 CFR 180.920 granted by the Agency for these tristyrylphenol
ethoxylates with a limit of not more than 15% in pesticide
formulations. There were no comments received in response to the notice
of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene ploymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by the
tristyrylphenol ethoxylates are discussed in this unit.
In 2006, EPA reassessed the inert ingredient tolerance exemptions
under 40 CFR 180.920 for the tristyrylphenol ethoxylates when used as
inert ingredients at not more than 15% in pesticide formulations
applied to growing crops. This tolerance reassessment document can be
found at http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html. As
stated in that document, the tristyrylphenol ethoxylates have similar
use patterns, restrictions/limitations, and potential exposures. A
Structure Activity Relationship (SAR) assessment for the
tristyrylphenol ethoxylates was performed by the Agency's Office of
Pollution Prevention and Toxics (OPPT) Structure Activity Team (SAT).
In the 2006 document, the SAT determined that the data presented on the
analog compounds within the tristyrylphenol ethoxalates are adequate to
characterize the expected toxicity of subject chemicals (CAS Reg. Nos.
70559-25-0 and 99734-09-5) for the reasons set forth in Unit VII below.
The available toxicity database for the tristyrylphenol ethoxylates
consists of studies on some of the tristyrylphenol ethoxylate
chemicals, such as CAS Reg. No. 90093-37-1 and 119432-41-6, and
guideline studies on an analog chemical, CAS Reg. No. 105362-40-1. The
studies on the tristyrylphenol ethoxylate chemicals and analog
chemicals were considered appropriate to evaluate the toxicity of the
tristyrylphenol ethoxylates because these chemicals share a common
chemical structure and are members of the same chemical class. The
tristyrylphenol ethoxylates and analog chemicals share a close
structural similarity and same functional groups with the only
difference being in the associated counterions. Therefore, the toxicity
of these chemicals are expected to be similar.
An acute toxicity battery conducted on the tristyrylphenol
ethoxylates resulted in low acute oral toxicity, slight skin
irritation, and slight eye irritation. In subchronic toxicity studies,
the primary toxicity appears to be to the kidney and thyroid in rats
and the liver in dogs. The kidney effects in rats appear to be the most
sensitive endpoint. In this study, there were minimal effects observed
at 100 milligrams/kilogram/day (mg/kg/day) but these effects were not
considered adverse effects. Therefore, the no observed effect level
(NOEL) for the study was 30 mg/kg/day and the no observed adverse
effect level (NOAEL) was 100 mg/kg/day. No neurotoxicity studies are
available; however, no signs of neurotoxicity were observed in any of
the available studies.
Based on the results of submitted mutagenicity studies, the
tristyrylphenol ethoxylates are not likely to be mutagenic. There are
no carcinogenicity studies available on the tristyrylphenol
ethoxylates; however, the primary toxicity appears to be to the kidney
and thyroid in rats and liver in dogs. The kidney effects in rats
appear to be the most sensitive endpoint. The Agency has considerable
knowledge of the intratubular mineralization toxic effect to the
kidneys and has determined that by preventing the intratubular
mineralization in the kidney, tumor formation is unlikely to occur.
Since these kidney effects are the most sensitive endpoint, protective
measures for kidney toxicity will be protective of any other long term
effects. The thyroid toxicity in rats was observed at 1,500 mg/kg/day
and the NOAEL was 500 mg/kg/day. The Agency has determined the mode of
action of the compound causing thyroid toxicity and concluded that a
dose preventing thyroid toxicity would be protective of both cancer and
non cancer effects on the thyroid. In addition, the Agency also
recognizes that the rats are more sensitive to thyroid effects than
humans. The NOAEL used as the point of departure in calculating the
chronic reference dose (cRfD) selected for this risk assessment is
protective of any thyroid effects and is approximately 10 fold lower
than the NOAEL established for the thyroid effects. There is not a
concern for the liver toxicity seen in the dog study because the liver
effects at dosages of 500 mg/kg/day were marginal and seen in only one
dog out of six. The SAR models predicted low concern for the
[[Page 12623]]
carcinogenicity of the compounds. Considering the lack of mutagenicity,
the lack of target organ toxicity in subchronic studies and known mode
of action for the target organ toxicity seen, and the SAR prediction,
the Agency concluded that carcinogenicity concerns are unlikely for the
tristyrylphenol ethoxylates.
The developmental toxicity study in which rats were administered
CAS Reg. No. 119432-41-6, resulted in a NOAEL of 300 mg/kg/day for
maternal toxicity (based on reduced body weights and increase in liver
weights and loose feces seen at the lowest observed adverse effect
level (LOAEL) of 1,000 mg/kg/day) and a NOAEL of 300 mg/kg/day for
developmental toxicity based on increased skeletal variations
(increased incidence of all unossified proximal phalanges of the hind
limb seen at the LOAEL of 1,000 mg/kg/day).
The cRfD of 0.5 mg/kg/day was established based on the 90-day
subchronic toxicity study in dogs, with a NOAEL of 50 mg/kg/day and a
safety factor of 100 (10x for interspecies and 10x for intraspecies
variations). Since the Food Quality Protection Act (FQPA) safety factor
is reduced from 10x to 1x, the chronic population adjusted dose (cPAD)
is equal to the cRfD. In the dog study, the NOAEL of 50 mg/kg/day was
based on equivocal liver toxicity seen at the LOAEL of 500 mg/kg/day.
Therefore, in this dog study, the NOAEL would be between 50-500 mg/kg/
day. Since the NOAEL for the subchronic rat studies is 100 mg/kg/day
based on kidney and thyroid toxicity, choosing the NOAEL of 50 mg/kg/
day would be protective of both the liver effects seen in the dog and
the kidney and thyroid effects seen in the rat.
V. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
The primary route of exposure to these chemicals from their use as
inert ingredients in pesticide products would most likely be through
consumption of food to which pesticide products containing them have
been applied, and possibly through drinking water (from runoff). Dermal
and inhalation exposures are also possible from residential use of
pesticide products containing these inert ingredients. However, the
quantitative exposure assessment via inhalation and dermal routes of
exposure was not performed because negligible inhalation and dermal
absorption is expected based on the physicochemical properties of the
compounds.
There are no data available on tristyrylphenol ethoxylates
residues in food or on non-occupational exposures to tristyrylphenol
ethoxylates. In the absence of actual residue data for tristyrylphenol
ethoxylates, the Agency performed a dietary (food and drinking water)
exposure assessment for tristyrylphenol ethoxylates that included both
the existing pre-harvest uses and the proposed post-harvest use on
citrus crops in formulations of azoxystrobin and fludioxonil using
worst-case assumptions as detailed below. The dietary exposure was
calculated as a percentage of the cRfD. The chronic dietary estimate
for the U.S. Population was 12.2% (non-nursing infants were the most
highly exposed population with a chronic exposure estimate occupying
35.6% of the cPAD). In addition, this exposure assessment assumed that:
Tristyrylphenol ethoxylates would be used as an inert
ingredient in all food use pesticide formulations applied to all crops.
One hundred percent of all food crops would be treated
with pesticides containing tristyrylphenol ethoxylates.
Tristyrylphenol ethoxylates residues would be present in
all crops at levels equal to or exceeding the highest established
tolerance levels for any pesticide active ingredient for both the
existing preharvest uses and the proposed postharvest use, and
A conservative default value of 1,000 parts per billion
(ppb) for the concentration of an inert ingredient in all sources of
drinking water was used. This approach is highly conservative as it is
extremely unlikely that tristyrylphenol ethoxylates would have such use
as pesticide product inert ingredients and be present in food
commodities and drinking water at such high levels. In addition, this
highly conservative exposure assessment is protective of any possible
non-occupational exposures to tristyrylphenol ethoxylates as it results
in exposure estimates orders of magnitude greater than the high-end
exposure estimates for residential uses of pesticides routinely used by
the Office of Pesticide Programs.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Unlike other pesticide ingredients for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to tristyrylphenol ethoxylates and any other substances and
tristyrylphenol ethoxylates do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that tristyrylphenol ethoxylates
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/
cumulative/.
VII. Additional Safety Factor for the Protection of Infants and
Children
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants
[[Page 12624]]
and children. EPA concluded that the FQPA safety factor could be
removed for tristyrylphenol ethoxylates for the following reasons:
1. EPA has sufficient data to assess the toxicity of
tristyrylphenol ethoxylates. The data presented in the assessment on
the tristyrylphenol ethoxylates are adequate to characterize the
expected behavior of the subject chemicals. There are no
carcinogenicity studies available on the tristyrylphenol ethoxylates;
however, the primary toxicity appears to be to the kidney and thyroid
in rats and liver in dogs. The kidney effects in rats appear to be the
most sensitive endpoint. The Agency has considerable knowledge of the
intratubular mineralization toxic effect to the kidneys and has
determined that by preventing the intratubular mineralization in the
kidney, tumor formation is unlikely to occur. Since these kidney
effects are the most sensitive endpoint, protective measures for kidney
toxicity will be protective of any other long term effects. Further,
EPA concluded that there is no need for the additional FQPA safety
factor for use of subchronic toxicity for long term exposure
assessment. The critical effect seen in the subchronic study
(intratubular mineralization in the kidney) is believed to occur as a
result of precipitation of a chemical based on its physicochemical
properties. Precipitation of a chemical based on its physiochemical
properties is a function primarily of dose level rather than duration
of dosing. Thus, once the threshold for precipitation of the chemical
is established (as it was in the subchronic dog study), this threshold
level would be considered protective of any short or long term
exposure. Therefore, the additional safety factor for the lack of long
term studies is not warranted.
2. EPA concluded that there is no evidence of increased
susceptibility to infants and children. The developmental toxicity
study in which rats were administered (CAS Reg. No. 119432-41-6)
resulted in a NOAEL of 300 mg/kg/day for maternal toxicity (based on
reduced body weights and increase in liver weights and loose feces seen
at the LOAEL of 1,000 mg/kg/day) and a NOAEL of 300 mg/kg/day for
developmental toxicity based on increased skeletal variations
(increased incidence of all unossified proximal phalanges of the hind
limb seen at the LOAEL of 1,000 mg/kg/day). Fetal effects were seen
only at the limit dose and in the presence of maternal toxicity.
3. No rabbit developmental study or reproductive toxicity studies
are available for these chemicals, however, the developmental toxicity
study in rats indicates no robust developmental toxicity at the limit
dose and none of the reproductive parameters were affected in the rat
developmental study at the limit dose of 1,000 mg/kg/day. This endpoint
in the developmental study is considered conservative since the
incidence of skeletal variations seen at 1,000 mg/kg/day was marginal.
4. There is no indication in the database that the tristyrylphenol
ethoxylates are neurotoxic chemicals and there is no evidence of
increased susceptibility. Therefore, there is no need for a
developmental neurotoxicity study.
5. There are no residual uncertainties identified in the exposure
databases. In the absence of actual exposure data on tristyrylphenol
ethoxylates, a highly conservative dietary exposure assessment would
not underestimate the risk to infants and children. Based on overall
weight of evidence, the FQPA factor of 10X was reduced to 1X.
VIII. Determination of Safety for U.S. Population
Residues of concern are not anticipated for dietary exposure (food
and drinking water) or for residential exposure (inhalation and
dermal). EPA determines whether pesticide chemical exposures are safe
by comparing aggregate exposure estimates to the dose at which no
adverse effects were seen in the most sensitive animal studies. In the
case of tristyrylphenol ethoxylates, the estimated exposures are
compared to a dose level equal to the chronic RfD of 0.5 mg/kg/day
(based on the subchronic dog study). Utilizing a highly conservative
aggregate exposure assessment, the resulting chronic exposure estimates
do not exceed the Agency's level of concern (non-nursing infants were
the most highly exposed population with the chronic exposure estimates
occupying 35.6% of the cPAD). In addition, this highly conservative
exposure assessment is protective of any possible non-occupational
exposures to the tristyrylphenol ethoxylates as it results in exposure
estimates orders of magnitude greater than the high-end exposure
estimates for residential uses of pesticides routinely used by the
Office of Pesticides Programs.
Taking into consideration all available information on the
tristyrylphenol ethoxylates, it has been determined that there is a
reasonable certainty that no harm to any population subgroup, including
infants and children, will result from aggregate exposure to these
chemicals when used as inert ingredients in post-harvest applications
to citrus crops, group 10, at a maximum of 10.0% in pesticide
formulations with azoxystrobin and fludioxonil, when considering
dietary exposure and all other non-occupational sources of pesticide
exposure for which there is reliable information. Therefore, the
exemption from the requirement of a tolerance for residues of poly(oxy-
1,2-ethanediyl), [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-
hydroxy- (CAS Reg. No. 70559-25-0) and poly(oxy-1,2-ethanediyl),
[alpha]-[tris(1-phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No.
99734-09-5), when used as inert ingredients in post-harvest
applications to citrus crops, group 10, under 40 CFR 180.1288 at a
maximum of 10.0% in pesticide formulations with azoxystrobin and
fludioxonil can be considered safe under section 408 of the FFDCA.
IX. Other Considerations
A. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Existing Exemptions
The tristyrylphenol ethoxylates (CAS Reg. No. 70559-25-0 and CAS
Reg. No. 99734-09-5) are exempted from the requirement of a tolerance
under 40 CFR 180.920 when used as inert ingredients at not more than
15% in pesticide formulations applied to growing crops only.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
the tristyrylphenol ethoxylates nor have any CODEX Maximum Residue
Levels (MRLs) been established for any food crops at this time.
X. Conclusions
Accordingly, an exemption from the requirement for a tolerance is
established for poly(oxy-1,2-ethanediyl), [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxy- (CAS Reg. No. 70559-25-0) and
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5), when used as inert ingredients in
post-harvest applications to citrus crops, group 10, under 40 CFR
180.1288 at a maximum of 10.0% in pesticide formulations with
azoxystrobin and fludioxonil.
XI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the
[[Page 12625]]
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,
entitled 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 on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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).
XII. 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 4, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1288 is added to read as follows:
Sec. 180.1288 Tristyrylphenol ethoxylates; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of poly(oxy-1,2-ethanediyl), [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 70559-25-0) and
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5) on citrus crops, group 10, when
used as inert ingredients under the following conditions:
(a) They are applied post-harvest;
(b) They are used as inert ingredients in pesticide formulations
with azoxystrobin and fludioxonil; and
(c) They constitute no more than 10.0% of the formulated pesticide
product.
[FR Doc. E9-6259 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S