Environmental Protection Agency (EPA).
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.
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).
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 Start Printed Page 45650whose 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.Start Further Info
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: email@example.com.End Further Info End Preamble Start Supplemental 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 Start Printed Page 45651variability 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-Start Printed Page 45652occupational 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.
- 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, Start Printed Page 45653NJ (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).Start List of Subjects
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.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.1279 is added to subpart D to read as follows:End Amendment Part
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.End Supplemental Information
[FR Doc. E7-16057 Filed 8-14-07; 8:45 am]
BILLING CODE 6560-50-S