Cyhexatin; Tolerance Actions, 55268-55272 [05-18581]
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55268
Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations
Parts per
million
Commodity
Almond ......................................
Almond, hulls ............................
Apple .........................................
Apricot .......................................
Banana .....................................
Bean, lima .................................
Bean, snap, succulent ..............
Beet, garden, roots ...................
Beet, garden, tops ....................
Beet, sugar, roots .....................
Beet, sugar, tops ......................
Blackberry .................................
Blueberry ..................................
Carrot, roots ..............................
Cattle, fat ..................................
Celery .......................................
Cherry .......................................
Citrus ........................................
Corn, field, forage .....................
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Cranberry ..................................
Cucumber .................................
Endive .......................................
Fig .............................................
Filbert ........................................
Ginseng, roots ..........................
0.5
3.0
0.5
0.5
0.2
0.5
0.5
0.75
0.7
0.5
10.0
0.5
0.5
0.75
0.7
0.7
0.75
0.7
40.0
40.0
0.7
0.5
0.75
0.7
0.5
0.5
0.75
Parts per
million
Commodity
Grape ........................................
Hop, dried cones ......................
Kiwifruit .....................................
Lettuce ......................................
Loganberry ................................
Melon ........................................
Mushroom .................................
Nectarine ..................................
Olive ..........................................
Onion, dry bulb .........................
Onion, green .............................
Parsley, leaves .........................
Parsnip ......................................
Peach ........................................
Pear ..........................................
Pea, field, hay ...........................
Pea, field, vines ........................
Pea, succulent ..........................
Pepper ......................................
Pineapple ..................................
Plum, prune, fresh ....................
Potato .......................................
Potato, sweet ............................
Radicchio ..................................
Radish .......................................
Raspberry .................................
Rutabaga ..................................
Sheep, fat .................................
0.75
0.75
0.75
0.7
0.75
0.75
0.75
0.5
1. 0
0.75
0.75
0.75
0.5
0.7
0.5
10.0
25.0
0.5
0.5
0.5
0.5
0.1
0.1
0.7
0.5
0.5
0.75
0.7
Sheep, meat (fat basis) ............
Sheep, meat byproducts (fat
basis) .....................................
Spinach .....................................
Squash, summer ......................
Squash, winter ..........................
Strawberry ................................
Swiss chard ..............................
Tomato ......................................
Turnip, greens ..........................
Turnip, roots .............................
Vegetable, brassica, leafy,
group 5 ..................................
Walnut .......................................
Watercress ................................
*
*
*
*
§ 180.312 4-Aminopyridine; tolerances for
residues.
(a) General. Tolerances are
established for residues of the bird
repellent 4-aminopyridine in or on the
following food commodities:
§ 180.380 Vinclozolin; tolerances for
residues.
(a) General. Tolerances are
established for the combined residues of
the fungicide vinclozolin (3-(3,5dichlorophenyl)-5-ethenyl-5-methyl-2,4oxazolidinedione) and its metabolites
containing the 3,5-dichloroaniline
moiety in or on the food commodities in
the table below. There are no U.S.
registrations for grape (wine) as of July
30, 1997.
Parts per
million
Commodity
Bean, succulent
Canola, seed ....
Cattle, fat ..........
Cattle, meat ......
Cattle, meat byproducts ........
Egg ...................
VerDate Aug<31>2005
Expiration/
Revocation
Date
2.0
1.0
0.05
0.05
11/30/05
11/30/08
11/30/08
11/30/08
0.05
0.05
11/30/08
11/30/08
14:27 Sep 20, 2005
Jkt 205001
Goat, fat ............
Goat, meat ........
Goat, meat byproducts ........
Grape, wine ......
Hog, fat .............
Hog, meat .........
Hog, meat byproducts ........
Horse, fat ..........
Horse, meat ......
Horse, meat byproducts ........
Lettuce, head ....
Lettuce, leaf ......
Milk ...................
Poultry, fat ........
Poultry, meat ....
Poultry, meat
byproducts .....
Sheep, fat .........
Sheep, meat .....
Sheep, meat byproducts ........
PO 00000
Frm 00044
Expiration/
Revocation
Date
*
0.05
0.05
11/30/08
11/30/08
0.05
6. 0
0.05
0.05
11/30/08
None
11/30/08
11/30/08
0.05
0.05
0.05
11/30/08
11/30/08
11/30/08
0.05
10.0
10.0
0.05
0.1
0.1
11/30/08
11/30/05
11/30/05
11/30/08
11/30/08
11/30/08
0.1
0.05
0.05
11/30/08
11/30/08
11/30/08
0.05
11/30/08
Fmt 4700
Sfmt 4700
§§
*
Expiration/Revocation Date
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
*
*
1/15/06
1/15/06
1/15/06
1/15/06
1/15/06
1/15/06
1/15/06
1/15/06
1/15/06
I
Parts per
million
Commodity
0.7
0.5
0.7
3. Section 180.312 is amended by
revising paragraph (a) to read as follows:
Corn, field, forage ..................................................................................................................................................
Corn, field, grain ....................................................................................................................................................
Corn, field, stover ..................................................................................................................................................
Corn, pop, grain .....................................................................................................................................................
Corn, pop, stover ...................................................................................................................................................
Corn, sweet, forage ...............................................................................................................................................
Corn, sweet, kernel plus cob with husks removed ...............................................................................................
Corn, sweet, stover ................................................................................................................................................
Sunflower, seed .....................................................................................................................................................
*
*
*
*
4. Section 180.380 is amended by
revising paragraph (a) to read as follows:
0.7
0.7
0.5
0.75
0.5
0.7
0.75
0.75
0.5
*
Parts per
million
*
0.7
I
Commodity
I
Parts per
million
Commodity
*
180.528 and 180.529 [Removed]
5. Sections 180.528 and 180.529 are
removed.
6. Section 180.539 is amended by
revising paragraph (a)(1) to read as
follows:
I
§180.539 d-Limonene; tolerances for
residues.
(a) * * * (1) The insecticide dlimonene may be safely used in insectrepellent tablecloths and in insectrepellent strips used in food- or feedhandling establishments.
*
*
*
*
*
§§
180.1003 and 180.1008 [Removed]
7. Sections 180.1003 and 180.1008 are
removed.
I
[FR Doc. 05–18579 Filed 9–20–05; 8:45 am]
BILLING CODE 6560–50–S
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0160; FRL–7732–8]
Cyhexatin; Tolerance Actions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is revoking, under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(e)(1), all existing
tolerances for residues of the
insecticide/acaricide cyhexatin because
they do not meet requirements of
FFDCA section 408(b)(2). EPA canceled
food use registrations for cyhexatin in
1989. Currently, EPA determined that
acute dietary risks from use of cyhexatin
on commodities for which import
tolerances exist exceed the Agency’s
level of concern. However, EPA also
determined that if the only cyhexatin
tolerance is for orange juice, there is a
reasonable certainty that no harm to any
population subgroup will result from
exposure to cyhexatin treated oranges.
Because manufacturers support a
cyhexatin tolerance on orange juice for
purposes of importation and the Agency
has made a determination of safety for
such a tolerance, EPA is establishing,
concurrent with the revocation of the
citrus fruit group tolerance, an
individual time-limited tolerance on
orange juice. The regulatory actions in
this document contribute toward the
Agency’s tolerance reassessment
requirements of the FFDCA section
408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law,
EPA is required by August 2006 to
reassess the tolerances in existence on
August 2, 1996. The regulatory actions
in this document pertain to the
revocation of 41 tolerances which count
as tolerance reassessments toward the
August, 2006 review deadline.
DATES: This regulation is effective
September 21, 2005. Objections and
requests for hearings must be received
on or before November 21, 2005.
ADDRESSES: To submit a written
objection or hearing requestfollow the
detailed instructions as provided in
Unit IV. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under docket
identification (ID) number OPP–2005–
0160. All documents in the docket are
listed in the EDOCKET index at https://
www.epa.gov/edocket. Although listed
in the index, some information is not
publicly available, i.e., CBI or other
information whose disclosure is
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55269
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
electronically in EDOCKET or in hard
copy at the Public Information and
Records Integrity Branch (PIRIB), Rm.
119, Crystal Mall #2, 1801 S. Bell St.,
Arlington, VA. This docket facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (https://
www.epa.gov/edocket/), you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
FOR FURTHER INFORMATION CONTACT:
A. What Action is the Agency Taking?
In the Federal Register of July 27,
2005 (70 FR 43368) (FRL–7723–5), EPA
issued a proposed rule to revoke all
existing tolerances for residues of the
insecticide/acaricide cyhexatin and
establish a time-limited tolerance on
orange juice. Also, the proposal of July
27, 2005 provided a 30–day comment
period which invited public comment.
In response to the proposal published
in the Federal Register of July 27, 2005
(70 FR 43368), EPA received two
comments during the 30–day public
comment period, as follows:
Comments by private citizens. A
private citizen stated opposition to the
sale and use of cyhexatin, and stated
that cyhexatin tolerances should not be
extended for use on any food
commodity. Another private citizen
asked whether the final rule actions
would mean that any amount of
cyhexatin could be used on imported
foods.
Agency response. Recently, EPA
completed its Tolerance Reassessment
Eligibility Decision (TRED) for
cyhexatin. In the Federal Register of July
13, 2005 (70 FR 40341) (FRL–7720–3),
EPA published a decision notice for the
cyhexatin TRED. The TRED and
documents in support of the TRED are
available in Edocket ID number OPP–
2004–0295 at https://www.epa.gov/
edocket, and at https://www.epa.gov/
pesticides/reregistration/status.htm.
Because there are no active U.S.
registrations, human exposure to this
pesticide is strictly through the
consumption of treated imported foods.
Residential and occupational exposures
as well as dietary exposure through
drinking water are not expected because
there is no domestic use of cyhexatin.
Because there have been no active
U.S. registrations for cyhexatin since
1989, the comment on its sale and use
is not relevant to this rulemaking.
However, cyhexatin tolerances were
maintained for purposes of importation.
The commenters did not address EPA’s
determination that acute dietary
Joseph Nevola, Special Review and
Reregistration Division (7508C), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
8037; e-mail address:
nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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.
PO 00000
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II. Background
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exposure estimates for cyhexatin and
orange juice only are below the
Agency’s level of concern for all
population subgroups and that a timelimited import tolerance for orange juice
should be established. The commenters
did not refer to any scientific studies or
specific data that should be considered
by the Agency.
EPA determined that acute dietary
risks from use of cyhexatin on
commodities for which import
tolerances exist exceed the Agency’s
level of concern. Therefore,
manufacturers had indicated that they
would support only the import
tolerances for apple (fresh, juice, sauce,
and dried) and citrus (orange juice).
However, the estimated acute dietary
risks from use of cyhexatin on these
commodities exceed the Agency’s level
of concern. The assessment concluded
that for apples and oranges, the acute
dietary exposure estimate for children 12 years of age is at 223% of the acute
population-adjusted dose (aPAD) at the
99.9th percentile; for all infants < 1–year
of age at 187% of the aPAD, and for
children 3-5 years of age at 151% of the
aPAD. Apple juice and apple sauces
were the risk drivers.
Because of this acute dietary concern,
manufacturers have withdrawn support
for cyhexatin tolerances, except for
orange juice. EPA has evaluated the
dietary risks from the importation of
orange juice concentrate to be processed
into orange juice and has determined
that there is reasonable certainty that no
harm to any population subgroup will
result from exposure to cyhexatin
treated oranges. The acute dietary
exposure estimates for orange juice only
are below the Agency’s level of concern
for all population subgroups. The most
highly exposed sub-population was
children 1-2 years of age, at 35% of the
aPAD.
Therefore, EPA is revoking all existing
tolerances for residues of the
insecticide/acaricide cyhexatin under
FFDCA section 408(e)(1) because
existing tolerances do not meet
requirements of FFDCA section
408(b)(2).
Specifically, EPA is revoking the
tolerances in 40 CFR 180.144 for
combined residues of cyhexatin and its
organotin metabolites (calculated as
cyhexatin) in or on the following food
commodities: Almond; almond, hulls;
apple; cattle, fat; cattle, kidney; cattle,
liver; cattle, meat byproducts, except
kidney and liver; cattle, meat; citrus,
dried pulp; fruit, citrus; goat, fat; goat,
kidney; goat, liver; goat, meat
byproducts, except kidney and liver;
goat, meat; hog, fat; hog, kidney; hog,
liver; hog, meat byproducts, except
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kidney and liver; hog, meat; hop; hop,
dried cone; horse, fat; horse, kidney;
horse, liver; horse, meat byproducts,
except kidney and liver; horse, meat;
milk, fat (=N in whole milk); nectarine;
nut, macadamia; peach; pear; plum,
prune, dried; plum, prune, fresh; sheep,
fat; sheep, kidney; sheep, liver; sheep,
meat byproducts, except kidney and
liver; sheep, meat; strawberry; and
walnut.
However, concurrent with the
revocation of the crop group tolerance
on fruit, citrus in 40 CFR 180.144 at 2
parts per million (ppm), a tolerance on
orange juice should be established at 0.1
ppm. Available processing data indicate
that cyhexatin residues of concern in
orange juice concentrate were less than
the limit of quantitation; i.e., less than
0.1 ppm. Nevertheless, additional
generic data is needed for EPA to
confirm processing, analytical method,
and toxicological data. 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 tolerance provide the
necessary information. Therefore, EPA
is establishing an individual timelimited tolerance in 40 CFR 180.144 for
combined residues of cyhexatin and its
organotin metabolites (calculated as
cyhexatin) in orange, juice at 0.1 ppm
with an expiration/revocation date of
June 13, 2009; i.e., the time-limited
tolerance will be established for a
period of 4 years from the TRED
completion date of June 13, 2005 in
order to allow sufficient time for the
Agency to issue a data call-in request,
the manufacturers to submit the needed
data, and for the Agency to review it.
After reviewing the available data, EPA
will decide whether there is sufficient
data to support the orange juice
tolerance as a permanent one. If the
requisite information is not submitted,
EPA may issue an order revoking the
tolerance at issue or allow the timelimited tolerance to expire.
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)). 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.
A printed copy of the cyhexatin TRED
may be obtained from EPA’s National
Service Center for Environmental
Publications (EPA/NSCEP), P.O. Box
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
42419, Cincinnati, OH 45242–2419,
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/. An
electronic copy of the cyhexatin TRED
is available on the internet at https://
www.epa.gov/pesticides/reregistration/
status.htm.
B. What is the Agency’s Authority for
Taking this Action?
EPA’s general practice is to revoke
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.
EPA has historically been concerned
that retention of tolerances that are not
necessary to cover residues in or on
legally treated foods may encourage
misuse of pesticides within 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.
C. When Do These Actions Become
Effective?
EPA is revoking specific cyhexatin
tolerances and establishing a timelimited tolerance on orange juice
effective on the date of publication of
this final rule in the Federal Register.
Any commodities listed in the
regulatory text of this document that are
treated with the pesticides subject to
this final rule, and that are in the
channels of trade following the
tolerance revocations, shall be subject to
FFDCA section 408(1)(5), as established
by the 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 (FDA) 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
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or exemption from tolerance. Evidence
to show that food was lawfully treated
may include records that verify the
dates that the pesticide was applied to
such food.
D. What is the Contribution to Tolerance
Reassessment?
By law, EPA is required by August
2006 to reassess the tolerances in
existence on August 2, 1996. As of
September 6, 2005, EPA has reassessed
over 7,430 tolerances. This document
revokes a total of 41 tolerances which
are counted as tolerance reassessments
toward the August 2006 review deadline
of FFDCA section 408(q), as amended by
FQPA in 1996. For counting purposes,
the Agency counts the citrus fruit group
tolerance as one revocation (where a
time-limited tolerance on orange juice is
established in its place).
III. Are There Any International Trade
Issues Raised by this Final Action?
EPA is working to ensure that the U.S.
tolerance reassessment program under
FQPA does not disrupt international
trade. EPA considers Codex Maximum
Residue Limits (MRLs) in setting U.S.
tolerances and in reassessing them.
MRLs are established by the Codex
Committee on Pesticide Residues, a
committee within the Codex
Alimentarius Commission, an
international organization formed to
promote the coordination of
international food standards. When
possible, EPA seeks to harmonize U.S.
tolerances with Codex MRLs. 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. EPA’s effort to harmonize
with Codex MRLs is summarized in the
tolerance reassessment section of
individual REDs. EPA has developed
guidance concerning submissions for
import tolerance support of June 1, 2000
(65 FR 35069) (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 and Regulations,’’ 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. Objections and Hearing Requests
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
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Jkt 205001
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.
Although the procedures in those
regulations require some modification to
reflect the amendments made to FFDCA
by FQPA, EPA will continue to use
those procedures, with appropriate
adjustments, until the necessary
modifications can be made. The new
section 408(g) of FFDCA provides
essentially the same process for persons
to ’’object’’ to a regulation for an
exemption from the requirement of a
tolerance issued by EPA under new
section 408(d) of FFDCA, as was
provided in the old sections 408 and
409 of FFDCA. However, the period for
filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an
Objection or Request a Hearing?
You must file your objection or
request a hearing on this regulation in
accordance with the instructions
provided in this unit and in 40 CFR part
178. To ensure proper receipt by EPA,
you must identify docket ID number
OPP–2005–0160 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 November 21, 2005.
1. Filing the request. Your objection
must specify the specific provisions in
the regulation that you object to, and the
grounds for the objections (40 CFR
178.25). If a hearing is requested, the
objections must include a statement of
the factual issues(s) on which a hearing
is requested, the requestor’s contentions
on such issues, and a summary of any
evidence relied upon by the objector (40
CFR 178.27). Information submitted in
connection with an objection or hearing
request may be claimed confidential by
marking any part or all of that
information as CBI. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. A copy of the
information that does not contain CBI
must be submitted for inclusion in the
public record. Information not marked
confidential may be disclosed publicly
by EPA without prior notice.
Mail your written request to: Office of
the Hearing Clerk (1900L),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. You may also deliver
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of
the Hearing Clerk is open from 8 a.m.
to 4 p.m., Monday through Friday,
PO 00000
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55271
excluding legal holidays. The telephone
number for the Office of the Hearing
Clerk is (202) 564–6255.
2. Copies for the Docket. In addition
to filing an objection or hearing request
with the Hearing Clerk as described in
Unit IV.A.1., you should also send a
copy of your request to the PIRIB for its
inclusion in the official record that is
described in ADDRESSES. Mail your
copies, identified by docket ID number
OPP–2005–0160, to: Public Information
and Records Integrity Branch,
Information Resources and Services
Division (7502C), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. In person
or by courier, bring a copy to the
location of the PIRIB described in
ADDRESSES. You may also send an
electronic copy of your request via email to: opp-docket@epa.gov. Please use
an ASCII file format and avoid the use
of special characters and any form of
encryption. Copies of electronic
objections and hearing requests will also
be accepted on disks in WordPerfect
6.1/8.0 or ASCII file format. Do not
include any CBI in your electronic copy.
You may also submit an electronic copy
of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a
Request for a Hearing?
A request for a hearing will be granted
if the Administrator determines that the
material submitted shows the following:
There is a genuine and substantial issue
of fact; there is a reasonable possibility
that available evidence identified by the
requestor would, if established resolve
one or more of such issues in favor of
the requestor, taking into account
uncontested claims or facts to the
contrary; and resolution of the factual
issues(s) in the manner sought by the
requestor would be adequate to justify
the action requested (40 CFR 178.32).
V. Statutory and Executive Order
Reviews
In this final rule EPA revokes specific
tolerances established under FFDCA
section 408. The Office of Management
and Budget (OMB) has exempted this
type of action (i.e., a 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
rule has been exempted from review
under Executive Order 12866 due to its
lack of significance, this rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
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Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations
Distribution, or Use (66 FR 28355, May
22, 2001). 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., 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 104–13, 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 revocations
of tolerances 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. This analysis
was published on December 17, 1997
(62 FR 66020), and was 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 rule, the Agency hereby
certifies that this final rule will not have
a significant economic impact on a
substantial number of small entities.
Specifically, as per the 1997 notice, EPA
has reviewed its available data on
imports and foreign pesticide usage and
concludes that there is a reasonable
international supply of food not treated
with canceled pesticides. Furthermore,
for the pesticides named in this final
rule, the Agency knows of no
extraordinary circumstances that exist
as to the present revocations that would
change EPA’s previous analysis. 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
VerDate Aug<31>2005
14:27 Sep 20, 2005
Jkt 205001
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 final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this 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
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 rule.
VI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, 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
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
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: September 9, 2005.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.144 is amended by
revising the table under paragraph (a) to
read as follows:
I
§ 180.144 Cyhexatin; tolerances for
residues.
(a) General. *
*
*
Commodity
Parts per
million
Orange, juice
*
*
*
Expiration/
Revocation
Date
0.1
*
6/13/09
*
[FR Doc. 05–18581 Filed 9–20–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0221; FRL–7730–3]
Reynoutria Sachalinensis Extract;
Exemption from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the biochemical
pesticide Reynoutria sachalinensis
extract on all food commodities. The
Interregional Research Project Number 4
(IR-4), on behalf of KHH Bioscience,
Inc., submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA),
E:\FR\FM\21SER1.SGM
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Agencies
[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55268-55272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18581]
[[Page 55269]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0160; FRL-7732-8]
Cyhexatin; Tolerance Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic
Act (FFDCA) section 408(e)(1), all existing tolerances for residues of
the insecticide/acaricide cyhexatin because they do not meet
requirements of FFDCA section 408(b)(2). EPA canceled food use
registrations for cyhexatin in 1989. Currently, EPA determined that
acute dietary risks from use of cyhexatin on commodities for which
import tolerances exist exceed the Agency's level of concern. However,
EPA also determined that if the only cyhexatin tolerance is for orange
juice, there is a reasonable certainty that no harm to any population
subgroup will result from exposure to cyhexatin treated oranges.
Because manufacturers support a cyhexatin tolerance on orange juice for
purposes of importation and the Agency has made a determination of
safety for such a tolerance, EPA is establishing, concurrent with the
revocation of the citrus fruit group tolerance, an individual time-
limited tolerance on orange juice. The regulatory actions in this
document contribute toward the Agency's tolerance reassessment
requirements of the FFDCA section 408(q), as amended by the Food
Quality Protection Act (FQPA) of 1996. By law, EPA is required by
August 2006 to reassess the tolerances in existence on August 2, 1996.
The regulatory actions in this document pertain to the revocation of 41
tolerances which count as tolerance reassessments toward the August,
2006 review deadline.
DATES: This regulation is effective September 21, 2005. Objections and
requests for hearings must be received on or before November 21, 2005.
ADDRESSES: To submit a written objection or hearing requestfollow the
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under docket
identification (ID) number OPP-2005-0160. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
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 electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail
address: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
II. Background
A. What Action is the Agency Taking?
In the Federal Register of July 27, 2005 (70 FR 43368) (FRL-7723-
5), EPA issued a proposed rule to revoke all existing tolerances for
residues of the insecticide/acaricide cyhexatin and establish a time-
limited tolerance on orange juice. Also, the proposal of July 27, 2005
provided a 30-day comment period which invited public comment.
In response to the proposal published in the Federal Register of
July 27, 2005 (70 FR 43368), EPA received two comments during the 30-
day public comment period, as follows:
Comments by private citizens. A private citizen stated opposition
to the sale and use of cyhexatin, and stated that cyhexatin tolerances
should not be extended for use on any food commodity. Another private
citizen asked whether the final rule actions would mean that any amount
of cyhexatin could be used on imported foods.
Agency response. Recently, EPA completed its Tolerance Reassessment
Eligibility Decision (TRED) for cyhexatin. In the Federal Register of
July 13, 2005 (70 FR 40341) (FRL-7720-3), EPA published a decision
notice for the cyhexatin TRED. The TRED and documents in support of the
TRED are available in Edocket ID number OPP-2004-0295 at https://
www.epa.gov/edocket, and at https://www.epa.gov/pesticides/
reregistration/status.htm. Because there are no active U.S.
registrations, human exposure to this pesticide is strictly through the
consumption of treated imported foods. Residential and occupational
exposures as well as dietary exposure through drinking water are not
expected because there is no domestic use of cyhexatin.
Because there have been no active U.S. registrations for cyhexatin
since 1989, the comment on its sale and use is not relevant to this
rulemaking. However, cyhexatin tolerances were maintained for purposes
of importation. The commenters did not address EPA's determination that
acute dietary
[[Page 55270]]
exposure estimates for cyhexatin and orange juice only are below the
Agency's level of concern for all population subgroups and that a time-
limited import tolerance for orange juice should be established. The
commenters did not refer to any scientific studies or specific data
that should be considered by the Agency.
EPA determined that acute dietary risks from use of cyhexatin on
commodities for which import tolerances exist exceed the Agency's level
of concern. Therefore, manufacturers had indicated that they would
support only the import tolerances for apple (fresh, juice, sauce, and
dried) and citrus (orange juice). However, the estimated acute dietary
risks from use of cyhexatin on these commodities exceed the Agency's
level of concern. The assessment concluded that for apples and oranges,
the acute dietary exposure estimate for children 1-2 years of age is at
223% of the acute population-adjusted dose (aPAD) at the
99.9th percentile; for all infants < 1-year of age at 187%
of the aPAD, and for children 3-5 years of age at 151% of the aPAD.
Apple juice and apple sauces were the risk drivers.
Because of this acute dietary concern, manufacturers have withdrawn
support for cyhexatin tolerances, except for orange juice. EPA has
evaluated the dietary risks from the importation of orange juice
concentrate to be processed into orange juice and has determined that
there is reasonable certainty that no harm to any population subgroup
will result from exposure to cyhexatin treated oranges. The acute
dietary exposure estimates for orange juice only are below the Agency's
level of concern for all population subgroups. The most highly exposed
sub-population was children 1-2 years of age, at 35% of the aPAD.
Therefore, EPA is revoking all existing tolerances for residues of
the insecticide/acaricide cyhexatin under FFDCA section 408(e)(1)
because existing tolerances do not meet requirements of FFDCA section
408(b)(2).
Specifically, EPA is revoking the tolerances in 40 CFR 180.144 for
combined residues of cyhexatin and its organotin metabolites
(calculated as cyhexatin) in or on the following food commodities:
Almond; almond, hulls; apple; cattle, fat; cattle, kidney; cattle,
liver; cattle, meat byproducts, except kidney and liver; cattle, meat;
citrus, dried pulp; fruit, citrus; goat, fat; goat, kidney; goat,
liver; goat, meat byproducts, except kidney and liver; goat, meat; hog,
fat; hog, kidney; hog, liver; hog, meat byproducts, except kidney and
liver; hog, meat; hop; hop, dried cone; horse, fat; horse, kidney;
horse, liver; horse, meat byproducts, except kidney and liver; horse,
meat; milk, fat (=N in whole milk); nectarine; nut, macadamia; peach;
pear; plum, prune, dried; plum, prune, fresh; sheep, fat; sheep,
kidney; sheep, liver; sheep, meat byproducts, except kidney and liver;
sheep, meat; strawberry; and walnut.
However, concurrent with the revocation of the crop group tolerance
on fruit, citrus in 40 CFR 180.144 at 2 parts per million (ppm), a
tolerance on orange juice should be established at 0.1 ppm. Available
processing data indicate that cyhexatin residues of concern in orange
juice concentrate were less than the limit of quantitation; i.e., less
than 0.1 ppm. Nevertheless, additional generic data is needed for EPA
to confirm processing, analytical method, and toxicological data. 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
tolerance provide the necessary information. Therefore, EPA is
establishing an individual time-limited tolerance in 40 CFR 180.144 for
combined residues of cyhexatin and its organotin metabolites
(calculated as cyhexatin) in orange, juice at 0.1 ppm with an
expiration/revocation date of June 13, 2009; i.e., the time-limited
tolerance will be established for a period of 4 years from the TRED
completion date of June 13, 2005 in order to allow sufficient time for
the Agency to issue a data call-in request, the manufacturers to submit
the needed data, and for the Agency to review it. After reviewing the
available data, EPA will decide whether there is sufficient data to
support the orange juice tolerance as a permanent one. If the requisite
information is not submitted, EPA may issue an order revoking the
tolerance at issue or allow the time-limited tolerance to expire.
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)). 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.
A printed copy of the cyhexatin TRED may be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP),
P.O. Box 42419, Cincinnati, OH 45242-2419, 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/. An electronic copy of the
cyhexatin TRED is available on the internet at https://www.epa.gov/
pesticides/reregistration/status.htm.
B. What is the Agency's Authority for Taking this Action?
EPA's general practice is to revoke 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. EPA has historically been concerned that
retention of tolerances that are not necessary to cover residues in or
on legally treated foods may encourage misuse of pesticides within 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.
C. When Do These Actions Become Effective?
EPA is revoking specific cyhexatin tolerances and establishing a
time-limited tolerance on orange juice effective on the date of
publication of this final rule in the Federal Register.
Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocations, shall
be subject to FFDCA section 408(1)(5), as established by the 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 (FDA) 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
[[Page 55271]]
or exemption from tolerance. Evidence to show that food was lawfully
treated may include records that verify the dates that the pesticide
was applied to such food.
D. What is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996. As of September 6, 2005, EPA has
reassessed over 7,430 tolerances. This document revokes a total of 41
tolerances which are counted as tolerance reassessments toward the
August 2006 review deadline of FFDCA section 408(q), as amended by FQPA
in 1996. For counting purposes, the Agency counts the citrus fruit
group tolerance as one revocation (where a time-limited tolerance on
orange juice is established in its place).
III. Are There Any International Trade Issues Raised by this Final
Action?
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. When possible, EPA seeks
to harmonize U.S. tolerances with Codex MRLs. 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. EPA's effort to harmonize
with Codex MRLs is summarized in the tolerance reassessment section of
individual REDs. EPA has developed guidance concerning submissions for
import tolerance support of June 1, 2000 (65 FR 35069) (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 and Regulations,'' 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. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
''object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0160 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 November
21, 2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IV.A.1.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number OPP-2005-0160, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
V. Statutory and Executive Order Reviews
In this final rule EPA revokes specific tolerances established
under FFDCA section 408. The Office of Management and Budget (OMB) has
exempted this type of action (i.e., a 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 rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply,
[[Page 55272]]
Distribution, or Use (66 FR 28355, May 22, 2001). 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., 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 104-13, 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
revocations of tolerances 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. This analysis was published on December 17,
1997 (62 FR 66020), and was 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 rule, the Agency hereby certifies that this final rule will not
have a significant economic impact on a substantial number of small
entities. Specifically, as per the 1997 notice, EPA has reviewed its
available data on imports and foreign pesticide usage and concludes
that there is a reasonable international supply of food not treated
with canceled pesticides. Furthermore, for the pesticides named in this
final rule, the Agency knows of no extraordinary circumstances that
exist as to the present revocations that would change EPA's previous
analysis. 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 final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this 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 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 rule.
VI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: September 9, 2005.
James Jones,
Director, 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 180.144 is amended by revising the table under paragraph (a)
to read as follows:
Sec. 180.144 Cyhexatin; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Orange, juice 0.1 6/13/09
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-18581 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S