Document ID: EPA-HQ-OPP-2006-0329-0002
Agency: epa
Document Type: Rule
Title: Zucchini Yellow Mosaic Virus-Weak Strain; Exemption from the Requirement of a Tolerance
Posted Date: 2007-08-15T04:00Z

[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]                         

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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.

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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]

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