![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Imidacloprid; Pesticide Tolerances for Emergency Exemptions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
----------------------------------------------------------------------- [Federal Register: July 21, 1999 (Volume 64, Number 139)] [Rules and Regulations] [Page 39041-39049] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr21jy99-22] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-300884; FRL-6088-3] RIN 2070-AB78 Imidacloprid; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes time-limited tolerances for the combined residues of imidacloprid and its metabolites containing the 6- chloropyridinyl moiety, all expressed as parent in or on blueberries and cranberries. This action is in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide on blueberries and cranberries. This regulation establishes maximum permissible levels for residues of imidacloprid in these food commodities pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. The tolerances will expire and are revoked on June 1, 2001. DATES: This regulation is effective July 21, 1999. Objections and requests for hearings must be received by EPA on or before September 20, 1999. ADDRESSES: Written objections and hearing requests, identified by the docket control number [OPP-300884], must be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees [[Page 39042]] accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing requests filed with the Hearing Clerk identified by the docket control number, [OPP-300884], must also be submitted to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring a copy of objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of objections and hearing requests filed with the Hearing Clerk may also be submitted electronically by sending electronic mail (e-mail) to: opp-docket@epa.gov. Copies of electronic objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of electronic objections and hearing requests must be identified by the docket control number [OPP-300884]. No Confidential Business Information (CBI) should be submitted through e-mail. Copies of electronic objections and hearing requests on this rule may be filed online at many Federal Depository Libraries. FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 280, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, ertman.andrew@epa.gov. SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the insecticide imidacloprid and its metabolites containing the 6- chloropyridinyl moiety, all expressed as parent, in or on blueberries at 1.0 part per million (ppm) and cranberries at 0.5 ppm. This tolerance will expire and is revoked on June 1, 2001. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations. I. Background and Statutory Findings The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) was signed into law August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among other things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting activities under a new section 408 with a new safety standard and new procedures. These activities are described in this preamble and discussed in greater detail in the final rule establishing the time- limited tolerance associated with the emergency exemption for use of propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9). New 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) 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) 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. . . .'' Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' This provision was not amended by FQPA. EPA has established regulations governing such emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA requires EPA to establish a time- limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. Because decisions on section 18-related tolerances must proceed before EPA reaches closure on several policy issues relating to interpretation and implementation of the FQPA, EPA does not intend for its actions on such tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. II. Emergency Exemption for Imidacloprid on Blueberries and Cranberries and FFDCA Tolerances Cranberries. The applicant states that the cranberry rootworm is becoming a serious pest of cranberries in New Jersey. The infestations of this insect are spreading from few acres in 1995 to several hundreds of acres in 1998. Prior to 1995, cranberry rootworm was considered a minor pest rarely requiring insecticide interventions. However, in 1997 and in 1998, severe infestations were seen in approximately 500 acres around Chatsworth, Burlington County. Most of the cranberry rootworm grubs are found in the top 6-8 inches from the ground surface area available for absorption of water and nutrients. The affected vines become weak, often produce fewer berries, and are easily rolled back as a mat. Severe infestations of cranberry rootworm can kill the vines and reduce fruit yield. The effect of cranberry rootworm feeding on roots is more severe under moisture stress during summer months as vines are unable to uptake the limited moisture available with reduced root systems. Replanting is often necessary to fill dead patches as a result of rootworm injury. Newly planted vines may take as long as 5 years to reach full yield potential. Adults also skeletonize the foliage and affect the process of photosynthesis. Currently there are no soil insecticides registered for managing cranberry rootworm in New Jersey. Lack of effective materials for use against the grub stage has resulted in the present emergency condition which left unchecked will cause significant crop losses to growers. Blueberries (Oriental Beetle). The applicant states that the Oriental beetle has recently become a serious pest of commercial highbush blueberries. In surveys undertaken during 1995 and 1996, the Oriental beetle was found to be the predominant grub species found in a majority of locations surveyed in Atlantic and Burlington Counties. The damage to blueberries is caused by grub stages feeding on fine fibrous root hairs. Bushes that have sustained damage to the root system by grubs show reduced vigor, are twiggy, have smaller leaves, and support fewer berries than [[Page 39043]] uninfested bushes of the same age. Infested bushes can be easily pulled off and growers often replace them with newer, younger bushes. In contrast to the grubs feeding on the root system, adults do not feed and therefore are not vulnerable to insecticide applications made above the ground. In blueberry fields in New Jersey, larvae become active and begin feeding by late March. The majority of these grubs are found in the top 8 inches of soil. Pupation occurs during the last week of May to early June with adults first appearing in the second week of June. The most effective strategy in managing the Oriental beetle is to apply insecticides targeting early instar grubs which are closer to the soil surface. However, there are currently no soil insecticides registered for use against any insect pest in blueberries. Out of desperation, some growers have attempted the use of organophosphate and carbamate insecticides targeting the adult stage. This strategy is generally effective in killing the adults only if the adults come in direct contact with the insecticide. Applications of insecticides targeting adults have proven to be very ineffective and resulted in unwarranted applications of organophosphate and carbamate insecticides. Lack of effective materials for use against the grub stage has resulted in the present emergency situation. Availability of effective insecticides targeting the early instar grubs will alleviate this problem and improve the management of Oriental beetle populations in blueberries. Blueberries (Blueberry Aphid). According to the applicant, blueberry aphids, Fimbriaphis fimbriata and Illinoia pepperi are the most important pests of highbush blueberries in New Jersey. The green peach aphid Myzus persicae also occurs on blueberries on a regular basis, but is of less significance. All of these species feed on plant sap and reduce the vigor of the bushes. But more importantly, these three species of aphids have recently been shown to be the vectors of the Blueberry Scorch virus (BBScV), the most important viral disease of blueberries in New Jersey. This virus is transmitted in a non- persistent fashion, and in greenhouse experiments, the applicant has shown that as little as 5 minutes of feeding any of the above three species is sufficient to transmit the BBScV from an infected plant to a non-infected plant. The Blueberry Scorch disease (also known as Sheep Pen Hill disease) was first detected in the early eighties. For several years this disease was restricted to a few areas in Burlington County, but during the past 3-4 years, there have been numerous fields that have become 100% infected with BBScV and showing visible symptoms of the disease. This disease is now firmly established in all major blueberry producing areas in Atlantic and Burlington counties. Primary symptoms of Blueberry Scorch disease are blighting of both flowers and new vegetative growth at full bloom and appearance of necrotic line patter just prior to leaf drop in autumn. The blighted blossoms are often retained throughout the summer but fail to develop into fruit and infected plants are less vigorous than healthy plants. The major problem in containing this disease is the inability to aggressively rogue out infected bushes because disease symptoms may not manifest for several years after the transmission of the causal agent (BBScV). This allows for the rapid spread of the disease if infected plants (symptom free) and aphids are present in a given location. Growers have no option but to completely destroy or kill the bushes and replant with new, clean bushes. Accurate estimates of total losses due to this disease in New Jersey are yet to be determined. Effective management of the aphid vectors is the only viable strategy to contain the spread of the Blueberry Scorch disease; there are no other methods available at the present time. Inadequate control of aphids with the existing insecticides has resulted in the present emergency situation which could cause severe crop loss to blueberry growers if left unchecked. EPA has authorized under FIFRA section 18 the use of imidacloprid on blueberries for control of blueberry aphids and the oriental beetle and cranberries for control of the cranberry rootworm in New Jersey. After having reviewed the submission, EPA concurs that emergency conditions exist for this State. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of imidacloprid in or on blueberries and cranberries. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment under section 408(e), as provided in section 408(l)(6). Although these tolerances will expire and are revoked on June 1, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on blueberries and cranberries after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether imidacloprid meets EPA's registration requirements for use on blueberries and cranberries or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of imidacloprid by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than New Jersey to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for imidacloprid, contact the Agency's Registration Division at the address provided under the ``ADDRESSES'' section. III. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7). Consistent with 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 imidacloprid and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of imidacloprid and its metabolites containing the 6- chloropyridinyl moiety, all expressed as parent on blueberries at 1.0 ppm and cranberries at 0.5 ppm. EPA's assessment of the dietary exposures and [[Page 39044]] risks associated with establishing the tolerance follows. 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. The nature of the toxic effects caused by imidacloprid are discussed in this unit. B. Toxicological Endpoint Only acute and chronic dietary endpoints were defined. The 10X FQPA factor was reduced to 3X for acute and chronic exposure, and applies to all population subgroup. 1. Acute toxicity. The acute Reference Dose (RfD) is 0.42 mg/kg bwt/day based on a lowest observed adverse effect level (LOAEL) of 42 mg/kg body weight/day (bwt/day) based on decreased motor activity in female rats. An additional 3X FQPA factor was incorporated for all population subgroups to account for neurotoxicity, structure-activity concerns, and lack of a no observed adverse effect level (NOAEL). The acute Population Adjusted Dose (aPAD), which is the RfD/3 was calculated to be 0.14 mg/kg bwt/day. Acceptable acute dietary exposure (food plus water) of 100% or less of the aPAD is required for all population subgroups. 2. Short- and intermediate-term toxicity. Dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity. However, because imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses. A short-term oral endpoint was not identified for imidacloprid. According to current OPP policy, if an oral endpoint is needed for short-term risk assessment (for incorporation of food, water, or oral hand-to-mouth type exposures into an aggregate risk assessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used to incorporate the oral component into aggregate risk. 3. Chronic toxicity. EPA has established the RfD for imidacloprid at 0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on increased number of thyroid lesions at the LOAEL of 16.9/24.9 mg/kg bwt/day (males and females, respectively). An additional 3X FQPA factor was used for all population subgroups. The chronic Population Adjusted Dose (cPAD), which is the RfD/3 was calculated to be 0.019 mg/kg bwt/ day. Acceptable chronic dietary exposure (food plus water) of 100% or less of the cPAD is required for all population subgroups. 4. Carcinogenicity. Imidacloprid has been classified by the Agency as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required. C. Exposures and Risks 1. From food and feed uses. Tolerances, some time-limited, are currently established (40 CFR 180.472) for the combined residues of the insecticide imidacloprid and its metabolites containing the 6- chloropyridinyl moiety, all expressed as parent, in or on a variety of raw agricultural and animal commodities at levels ranging from 0.02 ppm in eggs to 15 ppm in raisins, waste. Risk assessments were conducted by EPA to assess dietary exposures and risks from imidacloprid as follows: i. Acute exposure and risk. Acute dietary 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 1-day or single exposure. In conducting the acute dietary (food) risk assessment, EPA used the Theoretical Maximum Residue Contribution (TMRC) which assumes tolerance level residues and 100% crop-treated (Tier 1). The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The model accumulates exposure to the chemical for each commodity and expresses risk as a function of dietary exposure. Resulting exposure values (at the 95th percentile) and percentage of aPAD utilized ranged from 22% for the U.S. population to 44% for children 1-6 years old. ii. Chronic exposure and risk. In conducting the chronic dietary (food only) risk assessment, EPA used tolerance level residues for imidacloprid and percent crop-treated (%CT) information for some of these crops. The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The percentages of cPAD consumed for the general population and subgroups of interest ranged from 9.2% for nursing infants <1 year old to 48.5% for children 1-6 years old. Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) states that the Agency may use data on the actual percent of crop treated (PCT) for assessing chronic dietary risk only if the Agency can make the following findings: That the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; that the exposure estimate does not underestimate exposure for any significant subpopulation group; and if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated as required by the section 408(b)(2)(F), EPA may require registrants to submit data on PCT. As noted above, the Agency used an analysis that evaluated individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The Agency believes that the three conditions, discussed in section 408 (b)(2)(F) concerning the Agency's responsibilities in assessing chronic dietary risk findings, have been met. The PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. Typically, a range of estimates are supplied and the upper end of this range is assumed for the exposure assessment. By using this upper end estimate of the PCT, the Agency is reasonably certain that that the percentage of the food treated is not likely to be underestimated. The regional consumption information and [[Page 39045]] consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which imidacloprid may be applied in a particular area. 2. From drinking water. There is no established Maximum Contaminant Level for residues of imidacloprid in drinking water. No health advisory levels for imidacloprid in drinking water have been established. Imidacloprid is persistent, water soluble, and fairly mobile. Thus, residues of imidacloprid may be transported to both surface and ground waters. As a condition of registration, the Agency is requiring the submission of the results of two prospective ground water monitoring studies. Results from these studies are not yet available. i. Acute exposure and risk. Estimated concentrations of imidacloprid in surface and ground water used for the acute exposure analysis were 4.1 and 1.1 <greek-m>g/L (ppb), respectively. These estimated concentrations of imidacloprid in surface and ground water were based upon an application rate of 0.5 lbs ai/A/year. For purposes of risk assessment, the estimated maximum concentration for imidacloprid in surface and ground waters (which is 4.1 <greek-m>g/L) should be used for comparison to the back-calculated human health drinking water levels of concern (DWLOCs) for the acute endpoint. The DWLOCs ranged from 780 <greek-m>g/L for children 1-6 years old to 3,900 <greek-m>g/L for the U.S. population. These figures are well above the drinking water estimate concentration (DWEC) of 4.1 <greek-m>g/L. ii. Chronic exposure and risk. Estimated concentrations of imidacloprid in surface and ground water for chronic exposure analysis were 0.1 and 1.1 <greek-m>g/L (ppb), respectively. These estimated concentrations of imidacloprid in surface and ground water were based upon an application rate of 0.5 lbs ai/A/year. For purposes of chronic risk assessment, the estimated maximum concentration for imidacloprid in ground waters (which is 1.1 <greek-m>g/L) should be used for comparison to the back-calculated human health DWLOCs for the chronic (non-cancer) endpoint. The DWLOCs ranged from 98 <greek-m>g/L for children 1-6 years old to 490 <greek-m>g/L for Non-hispanic males (other than black or white). These figures are well above the DWEC of 1.1 <greek-m>g/L. 3. From non-dietary exposure. Imidacloprid is currently registered for use on the following residential non-food sites: ornamentals (e.g., flowering and foliage plants, ground covers, turf, and lawns), tobacco, golf courses, walkways, recreational areas, household or domestic dwellings (indoor/outdoor), and cats/dogs. i. Acute exposure and risk. Occupational/residential exposure risk assessments (namely, short-term dermal, intermediate-term dermal, long- term dermal, and inhalation) are not required owing to the demonstrated absence of dermal and inhalation toxicity. ii. Chronic exposure and risk. Occupational/residential exposure risk assessments (namely, short-term dermal, intermediate-term dermal, long-term dermal, and inhalation) are not required owing to the demonstrated absence of dermal and inhalation toxicity. iii. Short- and intermediate-term exposure and risk. Short- and intermediate-term oral exposure are not expected for adult population subgroups. However, since imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses. Thus, a residential short-term risk assessment via the oral route is required. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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.'' EPA does not have, at this time, available data to determine whether imidacloprid has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, imidacloprid 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 imidacloprid has a common mechanism of toxicity with other substances. For more 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 the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997). D. Aggregate Risks and Determination of Safety for U.S. Population 1. Acute risk. EPA has determined that the acute exposure to imidacloprid from food will utilize 22% of the aPAD (95th percentile) for the most highly exposed population subgroup (U.S. population - all seasons). Despite the potential for exposure to imidacloprid in drinking water, the Agency does not expect the aggregate exposure to exceed 100% of the aPAD. The DWLOC calculated for the U.S. population was 3,900 <greek-m>g/L, which is well above the DWEC of 4.1 <greek-m>g/ L. 2. Chronic risk. In conducting the chronic dietary (food only) risk assessment, EPA used tolerance level residues for imidacloprid and percent crop-treated (%CT) information for some of these crops. The analysis evaluates individual food consumption as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 through 1992. The percentage of cPAD consumed for the U.S. population was 22%. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to imidacloprid in drinking water, the Agency does not expect the aggregate exposure to exceed 100% of the cPAD. The DWLOC calculated for the U.S. population was well above the DWEC of 1.1 <greek-m>g/L. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account chronic dietary food and water (considered to be a background exposure level) plus indoor and outdoor residential exposure. Dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity. Short- and intermediate-term oral exposure are not expected for adult population subgroups. 4. Aggregate cancer risk for U.S. population. Imidacloprid has been [[Page 39046]] classified as a Group E chemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is not required. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues. E. Aggregate Risks and Determination of Safety for Infants and Children 1. Safety factor for infants and children-- i. In general. In assessing the potential for additional sensitivity of infants and children to residues of imidacloprid, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre- and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard MOE and uncertainty factor (usually 100 for combined inter- and intra-species variability) and not the additional tenfold MOE/uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor. ii. Developmental toxicity studies. In a developmental toxicity study with Sprague-Dawley rats, groups of pregnant animals (25/group) received oral administration of imidacloprid (94.2%) at 0, 10, 30, or 100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity was manifested as decreased body weight gain at all dose levels and reduced food consumption at 100 mg/kg bwt/day. No treatment-related effects were seen in any of the reproductive parameters (i.e., Cesarean section evaluation). At 100 mg/kg bwt/day, developmental toxicity manifested as wavy ribs (fetus =7/149 in treated vs. 2/158 in controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10 mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL was not established. For developmental toxicity, the NOAEL was 30 mg/kg bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy ribs. In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0, 8, 24, or 72 mg/kg bwt/day during gestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOEL was 72 mg/kg bwt/day based on mortality, decreased body weight gain, increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was 24 mg/kg bwt/day and the LOEL was 72 mg/kg bwt/day based on decreased fetal body weight, increased resorptions, and increased skeletal abnormalities. iii. Reproductive toxicity study. In a 2-generation reproductive toxicity study, imidacloprid (95.3%) was administered to Wistar/Han rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or 52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day for females). For parental/systemic/reproductive toxicity, the NOAEL was 250 ppm (18.3 mg/kg bwt/day) and the LOEL was 750 ppm (52 mg/kg bwt/day), based on decreases in body weight in both sexes in both generations. Based on these factors, the Agency determined that the review be revised to indicate the parental/systemic/reproductive NOAEL and LOEL to be 250 and 700 ppm, respectively, based upon the body weight decrements observed in both sexes in both generations. iv. Pre- and postnatal sensitivity. The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to imidacloprid. In addition, the multi-generation reproductive toxicity study data did not identify any increased sensitivity of rats to in utero or postnatal exposure. Parental NOAELs were lower or equivalent to developmental or offspring NOAELs. v. Conclusion. There is a need for a developmental neurotoxicity study for assessment of potential alterations of functional development. However, the Agency has determined that this data gap does not preclude the establishment/continuance of tolerances. The 10X safety factor to account for enhanced sensitivity of infants and children (as required by FQPA) was reduced to 3X and the factor applies to all population subgroups. 2. Acute risk. Using the conservative TMRC exposure assumptions described above, and taking into account the completeness and reliability of the toxicity data, EPA has estimated the acute exposure to imidacloprid from food for the most highly exposed population subgroup (Children 1 - 6 yrs) will utilize 44% of the aPAD. It was determined that an acceptable acute dietary exposure (food plus water) of 100% or less of the aPAD is needed to protect the safety of all population subgroups. Despite the potential for exposure to imidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD for children 1-6 years old. The maximum concentration of imidacloprid in surface and ground water for acute exposure is very small (4.1 <greek-m>g/L) compared to the DWEC of 780 <greek-m>g/L. 3. Chronic risk. Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to imidacloprid from food will utilize 48% of the cPAD for infants and children. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to imidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD for children 1-6 years old. The maximum concentration of imidacloprid in surface and ground water for acute exposure is very small (1.1 <greek-m>g/L) compared to the DWEC of 98 <greek-m>g/L. 4. Short- or intermediate-term risk. As noted earlier in this document, dermal and inhalation short- and intermediate-term risk assessments are not required for imidacloprid as dermal and inhalation exposure endpoints were not identified due to the demonstrated absence of toxicity. Short- and intermediate-term oral exposure are not expected for adult population subgroups. However, since imidacloprid is registered for use on turf, home gardens and pets, EPA has identified potential short-term oral exposures to children for these uses. A short-term oral endpoint was not identified for imidacloprid. According to current OPP policy, if an oral endpoint is needed for short-term risk assessment (for incorporation of food, water, or oral hand-to-mouth type exposures into an aggregate risk assessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be [[Page 39047]] used to incorporate the oral component into aggregate risk. The margin of exposure for chronic dietary exposure (food only) and residential exposure (hand-to-mouth from turf, garden, and pet uses) for children age 1-6 was calculated to be 302. The safe level for imidacloprid is 300. Potential short-term exposure from drinking water is at a level below the Agency's level of concern with the DWLOC (10 <greek-m>g/L) being greater than the DWEC of 1.1 <greek-m>g/L. The Agency concludes the short-term aggregate risk to the highest exposed population subgroup (children, 1 to 6 years old) from home garden, turf, and pet uses of imidacloprid does not exceed EPA's level of concern. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to imidacloprid residues. IV. Other Considerations A. Metabolism in Plants and Animals The nature of imidacloprid residues in plants and in animals is adequately understood. The residue of concern is imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, as specified in 40 CFR 180.472. B. Analytical Enforcement Methodology Adequate enforcement methodology (example - gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229. C. Magnitude of Residues Based on data submitted by the Applicant, the Agency is establishing time-limited tolerances for residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent in or on blueberries at 1.0 ppm and cranberries at 0.5 ppm. D. International Residue Limits There are no CODEX, Canadian, or Mexican Maximum Residue Limits (MRL) for imidacloprid on cranberry and blueberries. Thus, harmonization is not an issue for these time-limited tolerances. E. Rotational Crop Restrictions The rotational crop restrictions follow the original section 3 labels. For the use of Provado 1.6 Flowable and Admire 2 Flowable, most vegetables can be immediately plantedback while all other crops have a 12-month plantback interval. V. Conclusion Therefore, the tolerance is established for the combined residues of imidacloprid and its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on blueberries at 1.0 ppm and cranberries at 0.5 ppm. VI. Objections and Hearing Requests The new FFDCA section 408(g) provides essentially the same process for persons to ``object'' to a tolerance regulation issued by EPA under new section 408(l)(6) as was provided in the old section 408 and in section 409. However, the period for filing objections is 60 days, rather than 30 days. EPA currently has procedural regulations which govern the submission of objections and hearing requests. These regulations will require some modification to reflect the new law. However, until those modifications can be made, EPA will continue to use those procedural regulations with appropriate adjustments to reflect the new law. Any person may, by September 20, 1999, file written objections to any aspect of this regulation and may also request a hearing on those objections. Objections and hearing requests must be filed with the Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding tolerance objection fee waivers, contact James Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance objection fees should be sent to James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. If a hearing is requested, the objections must include a statement of the factual issues on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the requestor (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. VII. Public Record and Electronic Submissions EPA has established a record for this regulation under docket control number [OPP-300884] (including any comments and data submitted electronically). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The public record is located in Room 119 of the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. Objections and hearing requests may be sent by e-mail directly to EPA at: opp-docket@epa.gov E-mailed objections and hearing requests must be submitted as an ASCII [[Page 39048]] file avoiding the use of special characters and any form of encryption. The official record for this regulation, as well as the public version, as described in this unit will be kept in paper form. Accordingly, EPA will transfer any copies of objections and hearing requests received electronically into printed, paper form as they are received and will place the paper copies in the official record which will also include all comments submitted directly in writing. The official record is the paper record maintained at the Virginia address in ``ADDRESSES'' at the beginning of this document. VIII. Regulatory Assessment Requirements A. Certain Acts and Executive Orders This final rule establishes tolerances under section 408 of the FFDCA. 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), or require OMB review in accordance with Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). In addition, since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(l)(6), such as the tolerances 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. Nevertheless, the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels or expanding exemptions might adversely impact small entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. B. Executive Order 12875 Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to OMB a description of the extent of EPA's prior consultation with representatives of affected State, local, and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local, and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.'' Today's rule does not create an unfunded Federal mandate on State, local, or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule. C. Executive Order 13084 Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.'' Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule. IX. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and 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 the rule in the Federal Register. This 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: July 1, 1999. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180-[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a, 321q and 371. 2. In Sec. 180.472, in paragraph (b), by aphabetically inserting the following commodities to the table. Sec. 180.472 Imidacloprid; tolerance for residues. * * * * * (b)* * * ------------------------------------------------------------------------ Parts Expiration/ Commodity per revocation million date ------------------------------------------------------------------------ Blueberries....................................... 1.0 6/1/01 * * * * * Cranberries....................................... 0.5 6/1/01 [[Page 39049]] * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 99-18190 Filed 7-20-99; 8:45 am] BILLING CODE 6560-50-FRelated Material