Environmental Protection Agency (EPA).
This regulation establishes import tolerances for residues of fenazaquin, 4-tert-butylphenethyl quinazolin-4-yl ether, in or on apple at 0.2 parts per million (ppm); in or on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective August 8, 2007. Objections and requests for hearings must be received on or before October 9, 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-2006-0075. 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 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.Start Further Info Start Printed Page 44389
FOR FURTHER INFORMATION CONTACT:
Dan Peacock, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5407; 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 those engaged in the following activities:
- Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
- Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
- Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
- Pesticide manufacturing (NAICS code 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 to provide 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 EPA's tolerance regulations at 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, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2006-0075 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 as required by 40 CFR part 178 on or before October 9, 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 this copy, identified by docket ID number EPA-HQ-OPP-2006-0075, 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. Petition for Tolerance
In the Federal Register of April 12, 2006 (71 FR 18736) (FRL-7775-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of an import pesticide petition (PP 9E5059) by Gowan Company, 370 S. Main Street, Yuma, AZ 85364. The petition requested that 40 CFR part 180 be amended by establishing import tolerances for residues of the insecticide, fenazaquin, in or on apple at 0.2 ppm; in or on pear at 0.2 ppm, and in or on citrus fruits at 0.5 ppm. That notice referenced a summary of the petition prepared by Gowan Company, the registrant, which is available to the public in the docket, under docket identification (ID) number EPA-HQ-OPP-2006-0075-0002 at http://www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has modified Gowan Company's request for tolerances as follows. This regulation establishes import tolerances for residues of fenazaquin in or on apple at 0.2 ppm; in or on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. The reason for the addition of a tolerance for citrus oil at 10 ppm is explained in Unit V. (Conclusions).
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of 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. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for import tolerances for residues of Fenazaquin in or on apple at 0.2 ppm; in or on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.Start Printed Page 44390
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by Fenazaquin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov. The referenced document (Fenazaquin: PP# 9E5059. Tolerances on apples, pears and citrus fruits exported to the U.S. HED Risk Assessment) is available in the docket established by this action, which is described under ADDRESSES, and is identified as docket ID No. EPA-HQ-OPP-2006-0075-0004 in that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for Fenazaquin used for human risk assessment is shown in Table 1 below of this unit and in docket ID number EPA-HQ-OPP-2007-0075-0004 in an alternate format.
|Exposure/Scenario||Dose used in risk assessment, interspecies and intraspecies and any traditional FQPA, SF||Special FQPA SF and level of concern for risk assessment UF||Study and toxicological effects|
|Acute dietary (general population including infants and children)||NOAEL = 10 mg/kg/day SF = 100 Acute RfD = 0.1 mg/kg/day||Special FQPA SF = 1 x aPAD = acute RfD = 0.1 mg/kg/day||Rat developmental toxicity LOAEL = 40 mg/kg/day based on findings (as early as GD 6-9) of decreased body weight gain, food intake, and food efficiency.|
|Chronic dietary (all populations)||NOAEL= 5 mg/kg/day SF = 100 Chronic RfD = 0.05 mg/kg/day||Special FQPA SF = 1 x cPAD = chronic RfD = 0.05 mg/kg/day||Rat two-generation toxicity study LOAEL = 25 mg/kg/day based on excessive salivation and decreased body weight/weight gain and food intake.|
|Short-term, intermediate-term, and long-term incidential oral (1-30 days; 1-6 months) (Residential)||These exposure scenarios do not apply to this risk assessment because there are no proposed registered residential uses of fenazaquin.|
|Short-term, intermediate-term, and long-term dermal (1-30 days; 1-6 months) (Residential)||These exposure scenarios do not apply to this risk assessment because there are no proposed registered residential or occupational uses of fenazaquin.|
|Short-term, intermediate-term, long-term inhalation (1-30 days; 1-6 months) (Residential)||These exposure scenarios do not apply to this risk assessment because there are no proposed registered residential or occupational uses of fenazaquin.|
|Start Printed Page 44391|
|Cancer (oral, dermal, inhalation)||A quantitative exposure assessment for cancer risk was not performed because fenazaquin has been classified as “Not likely to be Carcinogenic to Humans” and is not expected to pose a cancer risk.|
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenazaquin, EPA considered exposure under the petitioned-for tolerances as well as a tolerance in or on citrus oil. EPA assessed dietary exposures from Fenazaquin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. Percent Crop Treated (PCT) and anticipated residues were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. Percent Crop Treated (PCT) and anticipated residues were not used.
iii. Cancer. A quantitative exposure assessment for cancer risk was not performed because fenazaquin has been classified as “Not likely to be Carcinogenic to Humans” and is not expected to pose a cancer risk.
iv. Anticipated residue and PCT information.PCT and anticipated residues were not used.
2. Dietary exposure from drinking water. Because the import tolerances in this Final Rule do not involve current or proposed registered uses of Fenazaquin in the United States, EPA does not anticipate dietary exposure from drinking water. Therefore, EPA has not assessed such exposure in this document.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Fenazaquin is not registered for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenazaquin and any other substances and fenazaquin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fenazaquin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (10X) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There are no qualitative or quantitative prenatal or postnatal susceptibility issues based on available data from two developmental toxicity studies and a two-generation reproduction toxicity study.
3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:
i. The toxicity database for fenazaquin is complete.
ii. There is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.
iii. There is no evidence that fenazaquin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues.
v. There is no potential for dietary drinking water exposure and there are no residential uses.Start Printed Page 44392
By using these screening-level assessments, acute and chronic exposures/risks will not be underestimated.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to fenazaquin will occupy 48% of the aPAD for the population group (children, 1-2 years old) receiving the greatest exposure. There is no acute dietary exposure from water.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fenazaquin from food will utilize 25% of the cPAD for the population group (children, 1-2 years old) receiving the greatest exposure. Because the tolerances being established in this Final Rule are for uses outside of the United States, there is no acute dietary exposure from water. There are no residential uses for Fenazaquin that result in chronic residential exposure to Fenazaquin.
3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Fenazaquin is not registered for use on any sites that would result in residential exposure. Also, because the tolerances being established in this Final Rule are for uses outside of the United States, there is no acute dietary exposure from water. Therefore, the aggregate risk is the sum of the risk from food, which does not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Fenazaquin is not registered for use on any sites that would result in residential exposure. Also, because the tolerances being established in this final rule are for uses outside of the United States, there is no chronic dietary exposure from water. Therefore, the aggregate risk is the sum of the risk from food, which does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Fenazaquin is not expected to pose a cancer risk based on negative cancer findings in two adequate rodent carcinogenicity studies.
6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fenazaquin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography) is available to enforce the tolerance expression, using the existing Food and Drug Administration (FDA) Multiresidue Methods in the Pesticide Analytical Manual (PAM), Vol I, available from http://www.cfsan.fda.gov/~lrd/pestadd.html.
B. International Residue Limits
There are no established or proposed Canadian, Mexican or Codex MRLs for residues of fenazaquin in plant commodities.
C. Response to Comments
The Agency did not receive any comments to this request for import tolerances for fenazaquin.
Therefore, the Agency is establishing import tolerances for residues of Fenazaquin in or on apple at 0.2 parts per million (ppm); in or on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. The original petition did not request the establishment of a tolerance in or on citrus oil at 10 ppm. However, the Agency added this tolerance for the following reason. Separate tolerances are not required for apple and orange juice as residues do not concentrate in these commodities. However, the citrus processing studies indicate that fenazaquin residues concentrate on average by 25x in citrus oil and thus residues in citrus oil could exceed the tolerance for citrus fruits. Based on the 25x processing factor and residue data on fenazaquin levels in or on oranges, a tolerance of 10 ppm would be appropriate for citrus oil.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the 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 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 Start Printed Page 44393Mandates 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).
VII. 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: July 26, 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 180.632 is added to read as follows:End Amendment Part
(a) General. Import tolerances are established for residues of the insecticide and miticide, fenazaquin, 4-tert-butylphenethyl quinazolin-4-yl ether, in or on raw agricultural commodities as follows:
|Commodity||Parts per million|
|Fruit, Citrus, Group 10, except Grapefruit||0.5|
(b) Section is emergency exempotions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]End Supplemental Information
[FR Doc. E7-15334 Filed 8-7-07; 8:45 am]
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