[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]
[Page 45649-45653]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-15]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0329; FRL-8137-9]
Zucchini Yellow Mosaic Virus-Weak Strain; Exemption from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the zucchini yellow mosaic virus-weak
strain (ZYMV-WK) on cucurbits, including, cucumbers, cantaloupes,
watermelons, muskmelons, winter and summer squash, pumpkins, zucchini
and other cucurbits when applied/used as a viruscide to protect
curcurbit crop plants against severe strains of zucchini yellow mosaic
virus. Bio-Oz Biotechnologies Limited 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), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of ZYMV-WK
strain.
DATES: This regulation is effective August 15, 2007. Objections and
requests for hearings must be received on or before October 15, 2007,
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-2006-0329. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information
[[Page 45650]]
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: Gail Tomimatsu, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8543; e-mail address: tomimatsu.gail@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 an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0329 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 October 15, 2007.
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-2006-0329, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 14, 2006 (71 FR 34338) (FRL-8059-
8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6E7050) by Bio-Oz Biotechnologies Ltd., Kibbutz Yad
Mordechai, DN Hof Ashkelon 79145, Israel. The petition requested that
40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of ZYMV-WK strain. This notice
included a summary of the petition prepared by the petitioner Bio-Oz
Biotechnologies Ltd. There were no comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of the 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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the 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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require 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. . . . ''
Additionally, section 408(b)(2)(D) of the FFDCA requires that 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.''
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. Toxicological Profile
Consistent with section 408(b)(2)(D) of the 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
[[Page 45651]]
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children.
ZYMV-WK is a potyvirus, a type of plant virus, and potyviruses have
no known toxicity or pathogenicity to any organism other than plants.
They are unable to infect animals because they lack binding site
receptors on cell surfaces common to animal viruses. Potyviruses enter
plant cells only through open wounds (i.e., wounds produced by feeding
insects, such as aphids, or by mechanical methods) or through cell-to-
cell transfer (Frankel-Conrat, et.al., 1988). Nearly all living things
are routinely exposed to plant viruses, including potyviruses, through
plants and plant products (e.g., foods). Naturally occurring strains of
ZYMV are known to infect about 18 plant species, within seven different
families (Plant Viruses Online). The intended microbial pesticide,
ZYMV-WK is reported as a naturally-occurring, weakened strain of ZYMV,
and was first recovered from infected zucchini plants in France (LeCoq
et al., 1991). Consequently humans are likely already exposed to ZYMV-
WK through the diet. Throughout the available literature, there are no
reports of adverse effects in animals resulting from ingestion of, or
exposure to these viruses. Although severe viral strains of the ZYMV
may replicate in aphids ZYMV-WK, does not replicate in aphids and is
transmitted poorly by these insects (LeCoq et al., 1991).
ZYMV-WK strain is a natural plant virus isolate and replicates only
in susceptible plant hosts, such as the cucurbitaceae, e.g., zucchini
and cantaloupe. This weak strain of ZYMV cucurbitaceae does not cause
overt plant disease and appears to stimulate plant defenses against
severe strains of ZYMV. In addition, there are no reports of adverse
effects in humans that handle and administer the viruses, or of the
laboratory animals exposed to this virus developing any nasal, eye,
skin, or pulmonary allergic reactions, or any other adverse reactions.
In support of this tolerance exemption, mammalian toxicology
requirements were satisfied by publicly available information submitted
by Bio-Oz Biotechnologies, Ltd., summarized in the preceding paragraph.
Specifically, the information provided supports the lack of toxicity of
potyviruses to mammals and humans, plus the fact that only certain
plants (and no animals) are susceptible to ZYMV-WK.
1. Acute oral toxicity/pathogenicity (OPPTS 885.3050). To satisfy
this requirement, the registrant submitted supporting public literature
in lieu of a laboratory animal study, which documents that plant
viruses, including ZYMV-WK, are found in food ingested by humans and
animals. According to the submitted published literature, no known
adverse effects or deaths have occurred in any species as a result of
dietary exposure. Furthermore, there are ``no reports of ill-health,
sensitization, pathogenicity or allergenicity'' from these plant
viruses, to humans or other vertebrates even after use of ZYMV-WK as a
pesticide in the EU and Israel. Plant viruses are not known to infect
mammalian cells, nor replicate in mammals.
2. Acute dermal toxicity/pathogenicity (OPPTS 885.3100) and primary
dermal irritation (OPPTS harmonized guideline 152-34). The registrant
submitted supporting public literature in lieu of a laboratory animal
study to fulfill this requirement, documenting that plant viruses,
including ZYMV-WK are ubiquitous in susceptible host plants, and are
not known to cause acute dermal toxicity or pathogenicity to mammals.
Furthermore, there are ``no reports of ill-health, sensitization or
allergenicity'' from these plant viruses, to humans or other
vertebrates even after use of ZYMV-WK as a pesticide in the EU and
Israel.
3. Primary eye irritation (OPPTS harmonized guideline 152-35). The
registrant submitted supporting public literature rather than a study
to fulfill this requirement, showing that plant viruses are ubiquitous
in plants, and they are not known to cause acute eye irritation or
pathogenicity to mammals. Furthermore, routine exposures to ZYMV-WK
have not led to any known adverse effects; there are ``no reports of
ill-health, sensitization or allergenicity'' from these plant viruses,
to humans or other vertebrates even after use of ZYMV-WK as a pesticide
in the EU and Israel.
4. Acute pulmonary toxicity/pathogenicity (OPPTS 885.3150). To
fulfill this requirement, the registrant submitted supporting public
literature in lieu of a laboratory animal study, showing that plant
viruses, including ZYMV-WK, are ubiquitous in susceptible host plants,
and they are not known to cause acute pulmonary toxicity or
pathogenicity to mammals. There are ``no reports of ill-health,
sensitization or allergenicity'' from these plant viruses, to humans or
other vertebrates even after use of ZYMV-WK as a pesticide in the EU
and Israel.
5. Acute injection toxicity/pathogenicity (OPPTS 885.3200). To
fulfill this requirement, the registrant submitted supporting public
literature in lieu of a laboratory animal study, documenting the
following:
i. ZYMV-WK, like all potyviruses may evoke immune responses and
produce antibodies if properly injected into laboratory animals such as
rabbits, mice, chickens, and guinea pigs without causing adverse
effects to the animals, and;
ii. There are no reports of humans that handle and administer ZYMV-
WK, or laboratory animals developing adverse reactions to the virus.
There are ``no reports of ill-health, sensitization or allergenicity''
from these plant viruses, to humans or other vertebrates even after use
of ZYMV-WK as a pesticide in the EU and Israel.
6. Hypersensitivity incidents (OPPTS 885.3400). Workers handling
ZYMV-WK on a daily basis since 1986 have not had a single incidence of
hypersensitivity. There are no reports of hypersensitivity in humans or
other animals due to potyviruses, in the literature.
7. Cell culture (OPPTS 885.3500). To satisfy this requirement, the
registrant submitted the following information, supported by public
literature. Potyviruses such as ZYMV-WK are unable to infect animal
cells since the cell surface plays an important role in viral infection
of animal cells. During infection, animal viruses interact specifically
with receptors on the animal cell surface. Potyviruses lack recognition
for animal infectivity receptors and only enter plant cells through
open wounds or via cell-to-cell transfer through intercellular
connections.
8. Immune response (OPPTS harmonized guideline 152-38). To fulfill
this requirement, the registrant submitted supporting public literature
in lieu of a laboratory animal study, documenting the following: No
health effects were noticed when infectious plant viruses, including
ZYMV, were repeatedly injected into rabbits over several weeks for
polyclonal antibody production.
In summary, ZYMV-WK is ubiquitous in susceptible host plants and
is not known to cause toxicity or pathogenicity to mammals. Based on
the published literature, in accordance with Tier I toxicology data
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III
toxicology data requirements were not triggered in connection with this
action.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-
[[Page 45652]]
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).
A. Dietary Exposure
1. Food. Virus-infected food plants have always been a part of the
human and domestic animal food supply (Dewan and Pearson, 1995;
McKinney, 1929; Provvidenti and Gonsalves, 1984; Palukaitis, 1991;
Jones et al., 1934; Beemster and de Bokx, 1987). Most plants may be
infected by at least one virus, and components of plant viruses are
often found in the produce of crop plants. Even plants that show no
disease symptoms are often found to be infected with viruses (Jones et
al., 1934; Fulton, 1986). In addition, a common agricultural practice
used since the 1920s for protection against viral disease involves
intentionally inoculating healthy plants with a mild form of a virus in
order to prevent infection by a more virulent form (Fulton, 1986). A
great deal of information supports the ubiquitous appearance of plant
viruses in foods, and to date there have been no reports of adverse
human or animal health effects associated with consumption of plant
viruses in food. Furthermore, the proposed section 3 registration and
ensuing commercial use is not expected to result in increased exposures
of ZYMV-WK to the general population: The intended use of ZYMV-WK is
within semi-contained environments and consequently exposures to humans
are limited. Even if there were increased exposures to residues of
ZYMV-WK as a result of other pesticidal uses, there is a reasonable
certainty that no harm will result to human health because of the lack
of toxicity or pathogenicity of ZYMV-WK to humans.
2. Drinking water exposure. ZYMV-WK is not intended for use in
drinking water. However, in the event that ZYMV-WK would reach water
consumed by humans, for the reasons enumerated above, the Agency
concludes that there is reasonable certainty that no harm will result
to humans from such exposures through water because of the lack of
toxicity or pathogenicity of ZYMV-WK to humans.
B. Other Non-Occupational Exposure
EPA concludes that dermal or inhalation exposure to the general
population as a result of this section 3 registration is not likely to
occur, based on the proposed uses in semi-contained environments and
limited exposure to young cucurbit crop plants. Moreover, the general
population, including infants and children, are exposed to plant
viruses daily in food with no known adverse effects ever being
reported. Therefore, the Agency concludes that in the unlikely event
that there is non-occupational, non-dietary exposure to ZYMV-WK, such
exposure would pose no risks to the general population, including
infants and children.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that EPA consider
available information on the cumulative effects of a particular
pesticide's residues and other substances that have a common mechanism
of toxicity when establishing, modifying, or revoking a tolerance.
These considerations include the possible cumulative effects on infants
and children of such residues and other substances with a common mode
of toxicity. Because ZYMV-WK does not have any toxic or pathogenic
effects, it cannot share a common mechanism of toxicity with other
substances. Therefore, section 408(b)(2)(D)(v) does not apply.
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. For all of the reasons discussed above, there
is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
residues of ZYMV-WK. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information.
2. Infants and children. FFDCA section 408(b)(2)(C) provides that
EPA shall apply an additional tenfold margin of exposure (MOE) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the data base
on toxicity and exposure, unless EPA determines that a different MOE
will be safe for infants and children. MOEs, which are often referred
to as uncertainty (safety) factors, are incorporated into EPA risk
assessments either directly, or through the use of a MOE analysis or by
using uncertainty factors in calculating a dose level that poses no
appreciable risk. As previously indicated in the toxicological profile,
humans, including infants and children, have been exposed to plant
viruses through food, where they are commonly found, with no known or
reported adverse effects. As discussed above, the Agency has concluded
that ZYMV-WK is non-toxic to mammals, including infants and children.
Because there are no threshold levels of concern to infants, children,
and adults when ZYMV-WK is used as labeled, the Agency concludes that
the additional MOE is not necessary to protect infants and children.
VII. Other Considerations
A. Endocrine Disruptors
At this time, the Agency is not requiring information on the
endocrine effects of this active ingredient, ZYMV-WK. The Agency has
considered, among other relevant factors, available information
concerning whether the weak plant virus may have an effect in humans
similar to an effect produced by a naturally occurring estrogen or
other endocrine effects. Plant viruses cannot infect mammals, and there
is no known metabolite that acts as an ``endocrine disruptor'' produced
by this virus. Therefore, there is no impact via endocrine-related
effects on the Agency's safety findings in this final rule.
B. Analytical Method(s)
Through this action, the Agency is proposing to establish an
exemption from the requirement of a tolerance for residues of ZYMV-WK
on cucurbit crops for the purposes of a FIFRA section 3 registration.
The Agency reached this decision based on the reasons discussed above,
including lack of toxicity to mammals, and therefore, concludes that an
analytical method for detecting ZYMV-WK is not required for enforcement
purposes.
C. Codex Maximum Residue Level
No Codex maximum residue levels exist for the virus ZYMV-WK.
VIII. REFERENCES
Beemster ABR, de Bokx JA. Survey of properties and
symptoms. In: De Bokx JA, van der Want JPH. Viruses of Potatoes and
Seed Potato Production. Wageningen: Pudoc, 1987:84-93.
Braverman, M. Acute Oral, Dermal, Pulmonary and Injection
Toxicity/Pathogenicity Cell Culture, Acute Toxicology Tier 2,
Subchronic Toxicity/Pathogenicity, Reproductive and Fertility Effects.
2005. OPP/EPA MRID No. 467854-19
Dewan, C, Pearson MN. Natural field infection of garlic by
garlic yellow streak virus in the Pukekohe area of New Zealand and
associated problems with the introduction of new garlic cultivars. New
Zealand Journal of Crop and Horticultural Science 1995; 23:97-102.
Fraenkel-Conrat, H., Kimball, P.C., and Levy, J.A. 1988.
Virology, 2nd edition. Prentice Hall, Englewood Cliffs,
[[Page 45653]]
NJ (virus cellular receptors and cell membrane changes, p. 299-300).
Fulton R. Practices and precautions in the use of cross
protection for plant virus disease control. Annual Review of
Phytopathology 1986; 24:67-81.
Jones L, Anderson E, Burnett G. The latent virus of
potatoes. Journal of Phytopathology 1934; 7:93-115.
McKinney HH. Mosaic diseases in the Canary Islands, West
Africa, and Gibraltar. Journal of Agricultural Research 1929; 39:557-
78.
Palukaitis P. Virus-mediated genetic transfer in plants.
In: Levin M, Strauss H. Risk Assessment in Genetic Engineering. New
York: McGraw-Hill, 1991:140-62.
Provvidenti R, Gonsalves D. Occurrence of ZYMV in
cucurbits from Connecticut, New York, Florida, and California. Plant
Disease 1984; 68:443-6. Palukaitis P. Virus-mediated genetic transfer
in plants. In: Levin M, Strauss H. Risk Assessment in Genetic
Engineering. New York: McGraw-Hill, 1991:140-62.
Plant viruses Online, 2007. http://image.fs.uidaho.edu/vide/descr909.htm
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866, this rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the exemption from
the requirement of a 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 6,
2000) do not apply to this rule. In addition, This 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).
X. 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: August 1, 2007.
Debra Edwards,
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 180.1279 is added to subpart D to read as follows:
Sec. 180.1279 Zucchini yellow mosaic virus - weak strain; exemption
from the requirement of a tolerance.
An exemption from the requirement of a tolerance for residues of
the ZYMV-WK strain in or on all raw cucurbits when applied/used in
accordance with label directions.
[FR Doc. E7-16057 Filed 8-14-07; 8:45 am]
BILLING CODE 6560-50-S