Imidacloprid; Pesticide Tolerances for Emergency Exemptions
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 stone fruit (Crop Group 12). 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 stone fruit. This regulation establishes maximum permissible levels for residues of imidacloprid on these food commodities. The tolerances will expire and are revoked on December 31, 2001.
Table of Contents Back to Top
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- I. General Information
- A. Does this Action Apply to Me?
- B. How Can I Get Additional Information, Including Copies of This Document and OtherRelated Documents?
- II. Background and Statutory Findings
- III. Emergency Exemption for Imidacloprid on Stone Fruit and FFDCA Tolerances
- IV. Aggregate Risk Assessment and Determination of Safety
- A. Toxicological Profile
- B. Toxicological Endpoint
- C. Exposures and Risks
- D. Aggregate Risks and Determination of Safety for U.S. Population
- E. Aggregate Risks and Determination of Safety for Infants and Children
- V. Other Considerations
- A. Metabolism in Plants and Animals
- B. Analytical Enforcement Methodology
- C. Magnitude of Residues
- D. International Residue Limits
- E. Rotational Crop Restrictions
- VI. Conclusion
- VII. Objections and Hearing Requests
- A. What Do I Need to Do to File an Objection or Request a Hearing?
- B. When Will the Agency Grant a Request for a Hearing?
- VIII. Regulatory Assessment Requirements
- IX. Submission to Congress and the Comptroller General
- List of Subjects in 40 CFR Part 180
- PART 180—[AMENDED]
DATES: Back to Top
This regulation is effective June 8, 2000. Objections and requests for hearings, identified by docket control number OPP-301004, must be received by EPA on or before August 7, 2000.
ADDRESSES: Back to Top
Written objections and hearing requests may be submittedby mail, in person, or by courier. Please follow the detailed instructions for each method asprovided in Unit VII. of the “SUPPLEMENTARY INFORMATION.” To ensure proper receiptby EPA, your objections and hearing requests must identify docket control number OPP-301004 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: Back to Top
By mail: AndrewErtman, Registration Division (7505C), Office of Pesticide Programs, EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;telephone number: (703) 308-9367; e-mail address: firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: Back to Top
I. General Information Back to Top
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 categories and entities mayinclude, but are not limited to:
|Categories||NAICScodes||Examples of potentially affectedentities|
This listing is not intended to be exhaustive, but rather provides a guide forreaders regarding entities likely to be affected by this action. Other types of entities not listed inthe table could also be affected. The North American Industrial Classification System (NAICS)codes have been provided to assist you and others in determining whether or not this actionmight apply to certain entities. If you have questions regarding the applicability of this action toa particular entity, consult the person listed under “FOR FURTHER INFORMATIONCONTACT.”
B. How Can I Get Additional Information, Including Copies of This Document and OtherRelated Documents?
1. Electronically. You may obtain electronic copies of this document,and certain other related documents that might be available electronically, from the EPA InternetHome Page at http://www.epa.gov/. To access this document, on the Home Page select “Lawsand Regulations” and then look up the entry for this document under the “FederalRegister—Environmental Documents.” You can also go directly to the FederalRegister listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for thisaction under docket control number OPP-301004. The official record consists of thedocuments specifically referenced in this action, and other information related to this action,including any information claimed as Confidential Business Information (CBI). This officialrecord includes the documents that are physically located in the docket, as well as the documentsthat are referenced in those documents. The public version of the official record does not includeany information claimed as CBI. The public version of the official record, which includesprinted, paper versions of any electronic comments submitted during an applicable commentperiod is available for inspection in the Public Information and Records Integrity Branch(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m.to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is(703) 305-5805.
II. Background and Statutory Findings Back to Top
EPA, on its own initiative, in accordance with sections 408(l)(6) of the FederalFood, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for thecombined residues of the insecticide imidacloprid, in or on stone fruit at 1.0 part permillion (ppm) and the processed commodity prunes at 3.5 ppm. These tolerances will expireand are revoked on December 31, 2001. EPA will publish a document in the FederalRegister to remove the revoked tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-limitedtolerance or exemption from the requirement for a tolerance for pesticide chemical residues infood that will result from the use of a pesticide under an emergency exemption granted by EPAunder section 18 of FIFRA. Such tolerances can be established without providing notice orperiod for public comment. EPA does not intend for its actions on section 18-related tolerances toset binding precedents for the application of section 408 and the new safety standard to othertolerances and exemptions.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (thelegal limit for a pesticide chemical residue in or on a food) only if EPA determines that thetolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonablecertainty 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 reliableinformation.” This includes exposure through drinking water and in residential settings, but doesnot include occupational exposure. Section 408(b)(2)(C) requires EPA to give specialconsideration to exposure of infants and children to the pesticide chemical residue in establishinga tolerance and to “ensure that there is a reasonable certainty that no harm will result to infantsand children from aggregate exposure to the pesticide chemical residue. . . .”
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPAdetermines that “emergency conditions exist which require such exemption.” This provision wasnot amended by the Food Quality Protection Act (FQPA). EPA has established regulationsgoverning such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Imidacloprid on Stone Fruit and FFDCA Tolerances Back to Top
There are two situations that have arisen, resulting in the presentemergency condition. First, currently there are no reliable insecticides to control the greenpeach aphid (GPA) on peaches and nectarines because of insecticide resistance. Second,aphids are a vector for Plum Pox Virus (PPV), a disease that damages the fruits of sensitivecultivars of stone fruits. The mechanism by which aphids transmit PPV is called non-persistent transmission. Once an aphid probes into infected plant tissue and acquires thevirus, the virus can only remain infectious and be transmitted for a short period of time(minutes). Each aphid must feed directly on an infected plant, acquire sufficient virus, andthen fly immediately to the next plant in order to effect a transmission.
PPV was discovered for the first time in the United States in 18 stone fruit orchardsin Adams County, Pennsylvania in the fall of 1999. Indications are that PPV has been inPennsylvania for several years, and it is possible that undetected infections of PPV exist inpeach and nectarine orchards in New Jersey, New York, and West Virginia. EPA hasauthorized under FIFRA section 18 the use of imidacloprid on stone fruit for control of aphidsin New Jersey, New York, Pennsylvania and West Virginia. After having reviewed thesubmissions, EPA concurs that emergency conditions exist for these states.
As part of its assessment of these emergency exemptions, EPA assessed the potentialrisks presented by residues of imidacloprid in or on stone fruit. In doing so, EPA consideredthe safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerancesunder FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRAsection 18. Consistent with the need to move quickly on each emergency exemption in order toaddress 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 as providedin section 408(l)(6). Although these tolerances will expire and are revoked on December 31,2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amountsspecified in the tolerance remaining in or on stone fruit after that date will not be unlawful,provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues donot exceed a level that was authorized by these tolerances at the time of that application. EPAwill take action to revoke these tolerances earlier if any experience with, scientific data on, orother relevant information on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency conditions, EPAhas not made any decisions about whether imidacloprid meets EPA's registration requirementsfor use on stone fruit or whether permanent tolerances for this use would be appropriate. Underthese circumstances, EPA does not believe that these tolerances serve as a basis for registrationof imidacloprid by a State for special local needs under FIFRA section 24(c). Nor do thesetolerances serve as the basis for any State other than New Jersey, New York, Pennsylvania, andWest Virginia to use this pesticide on this crop under section 18 of FIFRA without following allprovisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. Foradditional information regarding the emergency exemption for imidacloprid, contact theAgency's Registration Division at the address provided under “FOR FURTHERINFORMATION CONTACT.”
IV. Aggregate Risk Assessment and Determination of Safety Back to Top
EPA performs a number of analyses to determine the risks from aggregateexposure to pesticide residues. For further discussion of the regulatory requirements of section408 and a complete description of the risk assessment process, see the final rule on BifenthrinPesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the available scientificdata and other relevant information in support of this action. EPA has sufficient data to assess thehazards of imidacloprid and to make a determination on aggregate exposure, consistent withsection 408(b)(2), for a time-limited tolerance for combined residues of imidacloprid and itsmetabolites containing the 6-chloropyridinyl moiety, all expressed as parent in or on stonefruit at 1.0 ppm and prunes 3.5 ppm. EPA's assessment of the dietary exposures and risksassociated with establishing these tolerances 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 humanrisk. EPA has also considered available information concerning the variability of the sensitivitiesof major identifiable subgroups of consumers, including infants and children. The nature of thetoxic effects caused by imidacloprid are discussed in this unit.
B. Toxicological Endpoint
Only acute and chronic dietary endpoints were defined. The 10x FQPA factor wasreduced to 3x for acute and chronic exposure, and applies to all population subgroups.
1. Acute toxicity. The acute reference dose (RfD) is 0.42 milligram/kilogram body weight/day (mg/kg bwt/day) based on a lowest observed adverse effect level (LOAEL) of 42mg/kg bwt/day based on decreased motor activity in female rats. An additional 3x FQPAfactor 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 reference dose (RfD/3) wascalculated 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- andintermediate-term risk assessments are not required for imidacloprid as dermal andinhalation exposure endpoints were not identified due to the demonstrated absence oftoxicity; however, because imidacloprid is registered for use on turf, home gardens andpets, EPA has identified potential short-term oral exposures to children for these uses.
A short-term oral endpoint was not identified for imidacloprid. According tocurrent EPA policy, if an oral endpoint is needed for short-term risk assessment (forincorporation of food, water, or oral hand-to-mouth type exposures into an aggregate riskassessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used toincorporate the oral component into aggregate risk.
3. Chronic toxicity. EPA has established the RfD for imidacloprid at0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on increased number ofthyroid 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 isthe 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 Echemical, no evidence of carcinogenicity for humans, thus, a cancer risk assessment is notrequired.
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 itsmetabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in or on avariety of raw agricultural and animal commodities at levels ranging from 0.02 ppm ineggs to 15 ppm in raisins, waste. Risk assessments were conducted by EPA to assess dietaryexposures and risks from imidacloprid as follows:
i. Acute exposure and risk. Acute dietary risk assessments are performed for a food-usepesticide if a toxicological study has indicated the possibility of an effect of concern occurring asa 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 assumestolerance level residues and 100% crop-treated (Tier 1). The analysis evaluates individualfood consumption as reported by respondents in the USDA Continuing Surveys of FoodIntake by Individuals conducted in 1989 through 1992. The model accumulates exposureto 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 rangedfrom 23% for the U.S. population to 45% 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 andpercent crop-treated (PCT) information for some of these crops.
The analysis evaluates individual foodconsumption as reported by respondents in the USDA Continuing Surveys of Food Intakeby Individuals conducted in 1989 through 1992. The percentages of cPAD consumed forthe general population and subgroups of interest ranged from 11% for nursing infants 1year old to 51% for children 1-6 years old.
Section 408(b)(2)(F) states that the Agency may use data on the actual percent of foodtreated for assessing chronic dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis to show what percentage ofthe food derived from such crop is likely to contain such pesticide residue.
Condition 2, that theexposure estimate does not underestimate exposure for any significant subpopulation group.
Condition 3, if data are available on pesticide use and food consumption in a particular area, theexposure estimate does not understate exposure for the population in such area. In addition, theAgency must provide for periodic evaluation of any estimates used. To provide for the periodicevaluation of the estimate of PCT as required by section 408(b)(2)(F), EPAmay require registrants to submit data on PCT.
The Agency used PCT information as follows.
The Agency believes that the three conditions listed above have been met. With respectto Condition 1, PCT estimates are derived from Federal and private market survey data, whichare reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietaryexposure estimates. This weighted average PCT figure is derived by averaging State-level datafor a period of up to 10 years, and weighting for the more robust and recent data. A weightedaverage of the PCT reasonably represents a person's dietary exposure over a lifetime and isunlikely to underestimate exposure to an individual because of the fact that pesticide use patterns(both regionally and nationally) tend to change continuously over time, such that an individual isunlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposureestimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from thisapproach reasonably represent the highest levels to which an individual could be exposed andare unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonablycertain that the percentage of the food treated is not likely to be an underestimated. As toConditions 2 and 3, regional consumption information and consumption information forsignificant subpopulation is taken into account through EPA's computer-based model forevaluating the exposure of significant subpopulations including several regional groups. Use ofthis consumption information in EPA's risk assessment process ensures that EPA's exposureestimate does not understate exposure for any significant subpopulation group and allows theAgency to be reasonably certain that no regional population is exposed to residue levels higherthan those estimated by the Agency. Other than the data available through national foodconsumption surveys, EPA does not have available information on the regional consumption offood to which imidacloprid may be applied in a particular area.
2. From drinking water. There is no established Maximum Contaminant Level forresidues of imidacloprid in drinking water. No health advisory levels for imidacloprid indrinking water have been established.
Imidacloprid is persistent, water soluble, and fairly mobile. Thus, residues ofimidacloprid may be transported to both surface and ground waters. As a condition ofregistration, the Agency is requiring the submission of the results of two prospectiveground water monitoring studies. Results from these studies are not yet available.
i. Acute exposure and risk. Estimated concentrations of imidacloprid in surface andground water used for the acute exposure analysis were 4.1 and 1.1 micrograms per liter (m g/L) (parts per billion (ppb)),respectively. These estimated concentrations of imidacloprid in surface and ground waterwere based upon an application rate of 0.5 lbs active ingredient/acre/year (ai/acre/year).
For purposes of risk assessment, the estimated maximum concentration forimidacloprid in surface and ground waters (which is 4.1 m g/L) should be used forcomparison to the back-calculated human health drinking water levels of concern(DWLOCs) for the acute endpoint. The DWLOCs ranged from 800 m g/L for children 1-6years old to 3,900 m g/L for the U.S. population. These figures are well above the drinkingwater estimate concentration (DWEC) of 4.1 m g/L.
ii. Chronic exposure and risk. Estimated concentrations of imidacloprid in surfaceand ground water for chronic exposure analysis were 0.1 and 1.1 m g/L (ppb), respectively.These estimated concentrations of imidacloprid in surface and ground water were basedupon an application rate of 0.5 lbs ai/acre/year.
For purposes of chronic risk assessment, the estimated maximum concentration forimidacloprid in ground waters (which is 1.1 m g/L) should be used for comparison to theback-calculated human health DWLOCs for the chronic (non-cancer) endpoint. TheDWLOCs ranged from 90 m g/L for children 1-6 years old to 490 m g/L for the U.S.population. These figures are well above the DWEC of 1.1 m g/L.
3. From non-dietary exposure. Imidacloprid is currently registered for use on thefollowing residential non-food sites: ornamentals (e.g., flowering and foliage plants, groundcovers, turf, lawns) tobacco, golf courses, walkways, recreational areas, household ordomestic 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 oralexposure are not expected for adult population subgroups. However, since imidacloprid isregistered for use on turf, home gardens and pets, EPA has identified potential short-termoral exposures to children for these uses. Thus, a residential short-term risk assessment viathe oral route is required. See Unit IV.E.4. for a full discussion of this exposure andrisk.
4. Cumulative exposure to substances with a common mechanism of toxicity. Section408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke atolerance, the Agency consider “available information” concerning the cumulative effects of aparticular 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 acommon mechanism of toxicity with other substances or how to include this pesticide in acumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulativerisk approach based on a common mechanism of toxicity, imidacloprid does not appear toproduce a toxic metabolite produced by other substances. For the purposes of this toleranceaction, therefore, EPA has not assumed that imidacloprid has a common mechanism of toxicitywith other substances. For more information regarding EPA's efforts to determine whichchemicals have a common mechanism of toxicity and to evaluate the cumulative effects of suchchemicals, 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 fromfood will utilize 23% of the aPAD (95th percentile) for the most highly exposed populationsubgroup (U.S. population—all seasons). Despite the potential for exposure to imidaclopridin drinking water, the Agency does not expect the aggregate exposure to exceed 100% ofthe aPAD. The DWLOC calculated for the U.S. population was 3,900 m g/L, which is wellabove the DWEC of 4.1 m g/L.
2. Chronic risk. In conducting the chronic dietary (food only) risk assessment, EPAused: Tolerance level residues for imidacloprid, and PCTinformation for some of these crops. The analysis evaluates individual food consumptionas reported by respondents in the USDA Continuing Surveys of Food Intake by Individualsconducted in 1989 through 1992. The percentage of cPAD consumed for the U.S.population was 24%. The major identifiable subgroup with the highest aggregate exposure isdiscussed below. EPA generally has no concern for exposures below 100% of the cPADbecause the cPAD represents the level at or below which daily aggregate dietary exposure over alifetime will not pose appreciable risks to human health. Despite the potential for exposure toimidacloprid in drinking water, the Agency does not expect the aggregate exposure toexceed 100% of the cPAD. The DWLOC calculated for the U.S. population was well abovethe DWEC of 1.1 m g/L.
3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposuretakes 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 notrequired for imidacloprid, as dermal and inhalation exposure endpoints were not identifieddue to the demonstrated absence of toxicity. Short- and intermediate-term oral exposureare not expected for adult population subgroups. A discussion of short- and intermediate-term oral exposure and risk for children 1-6 can be found in Unit IV.E.4.
4. Aggregate cancer risk for U.S. population. Imidacloprid has been classified as aGroup E chemical, no evidence of carcinogenicity for humans, thus, a cancer riskassessment is not required.
5. Determination of safety. Based on these risk assessments, EPA concludes that there isa 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 foradditional sensitivity of infants and children to residues of imidacloprid, EPA considered datafrom developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study inthe rat. The developmental toxicity studies are designed to evaluate adverse effects on thedeveloping organism resulting from maternal pesticide exposure during gestation. Reproductionstudies provide information relating to effects from exposure to the pesticide on the reproductivecapability of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safetyfor infants and children in the case of threshold effects to account for prenatal and postnataltoxicity, and the completeness of the data base unless EPA determines that a different margin ofsafety will be safe for infants and children. Margins of safety are incorporated into EPA riskassessments either directly through use of a margin of exposure (MOE) analysis or through usinguncertainty (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 (usually100 for combined interspecies and intraspecies variability) and not the additional tenfoldMOE/uncertainty factor when EPA has a complete data base under existing guidelines and whenthe severity of the effect in infants or children or the potency or unusual toxic properties of acompound 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 ofimidacloprid (94.2%) at 0, 10, 30, or 100 mg/kg bwt/day during gestation days 6 through16. Maternal toxicity was manifested as decreased body weight gain at all dose levels andreduced food consumption at 100 mg/kg bwt/day. No treatment-related effects were seen inany of the reproductive parameters (i.e., Cesarean section evaluation). At 100 mg/kgbwt/day, developmental toxicity manifested as wavy ribs (fetus = 7/149 in treated vs. 2/158in controls and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10 mg/kgbwt/day lowest dose tested (LDT) based on decreased body weight gain; a NOAEL was not established. Fordevelopmental toxicity, the NOAEL was 30 mg/kg bwt/day and the LOAEL was 100 mg/kgbwt/day based on increased wavy ribs.
In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant doeswere given oral doses of imidacloprid (94.2%) at 0, 8, 24 or 72 mg/kg bwt/day duringgestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/kg bwt/day andthe LOAEL was 72 mg/kg bwt/day based on mortality, decreased body weight gain,increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was24 mg/kg bwt/day and the LOAEL was 72 mg/kg bwt/day based on decreased fetal bodyweight, 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/kgbwt/day for females). For parental/systemic/reproductive toxicity, the NOAEL was 250 ppm(18.3 mg/kg bwt/day) and the LOAEL was 750 ppm (52 mg/kg bwt/day), based on decreasesin body weight in both sexes in both generations. Based on these factors, the Agencydetermined that the review be revised to indicate the parental/systemic/reproductive NOAELand LOAEL to be 250 and 700 ppm, respectively, based upon the body weight decrementsobserved in both sexes in both generations.
iv. Prenatal and postnatal sensitivity. The developmental toxicity data demonstratedno 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 increasedsensitivity of rats to in utero or postnatal exposure. Parental NOAELs were lower orequivalent to developmental or offspring NOAELs.
v. Conclusion. There is a need for a developmental neurotoxicity study forassessment of potential alterations of functional development. However, the Agency hasdetermined that this data gap does not preclude the establishment/continuance oftolerances. The 10x safety factor to account for enhanced sensitivity of infants andchildren (as required by FQPA) was reduced to 3x and the factor applies to all populationsubgroups.
2. Acute risk. Using the conservative TMRC exposure assumptions described above,and taking into account the completeness and reliability of the toxicity data, EPA hasestimated the acute exposure to imidacloprid from food for the most highly exposedpopulation subgroup (children 1-6 years old) will utilize 45% of the aPAD. It was determinedthat an acceptable acute dietary exposure (food plus water) of 100% or less of the aPAD isneeded to protect the safety of all population subgroups. Despite the potential for exposureto imidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed100% of the aPAD for children 1-6 years old. The maximum concentration of imidaclopridin surface and ground water for acute exposure is very small (4.1 m g/L) compared to theDWEC of 800 m g/L.
3. Chronic risk. Using the exposure assumptions described in this unit, EPA hasconcluded that aggregate exposure to imidacloprid from food will utilize 51% of the RfD forinfants and children. EPA generally has no concern for exposures below 100% of the RfDbecause the RfD represents the level at or below which daily aggregate dietary exposure over alifetime will not pose appreciable risks to human health. Despite the potential for exposure toimidacloprid in drinking water, EPA does not expect the aggregate exposure to exceed100% of the cPAD for children 1-6 years old. The maximum concentration of imidaclopridin surface and ground water for acute exposure is very small (1.1 m g/L) compared to theDWEC of 90 m g/L.
4. Short- and intermediate-term risk. As noted earlier in this document, dermal andinhalation short- and intermediate-term risk assessments are not required for imidaclopridas dermal and inhalation exposure endpoints were not identified due to the demonstratedabsence of toxicity. Short- and intermediate-term oral exposure are not expected for adultpopulation subgroups. However, since imidacloprid is registered for use on turf, homegardens and pets, EPA has identified potential short-term oral exposures to children forthese uses.
A short-term oral endpoint was not identified for imidacloprid. According tocurrent EPA policy, if an oral endpoint is needed for short-term risk assessment (forincorporation of food, water, or oral hand-to-mouth type exposures into an aggregate riskassessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used toincorporate the oral component into aggregate risk.
The margin of exposure for chronic dietary exposure (food only) and residentialexposure (hand-to-mouth from turf, garden, and pet uses) for children ages 1-6 wascalculated to be 300. The safe level for imidacloprid is 300.
Potential short-term exposure from drinking water is at a level below the Agency'slevel of concern with the DWLOC (2 m g/L) being greater than the DWEC of 1.1 m g/L.
The Agency, concludes the short-term aggregate risk to the highest exposedpopulation subgroup (children 1-6 years old) from home garden, turf, and pet uses ofimidacloprid does not exceed EPA's level of concern.
5. Determination of safety. Based on these risk assessments, EPA concludes that there is areasonable certainty that no harm will result to infants and children from aggregate exposure toimidacloprid residues.
V. Other Considerations Back to Top
A. Metabolism in Plants and Animals
The nature of imidacloprid residues in plants and in animals is adequatelyunderstood. 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 is available to enforce the tolerance expression. Themethod may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:email@example.com.
C. Magnitude of Residues
Crop field trials on peaches have been submitted, and the highest residues ofimidacloprid were found to be 0.77 ppm. For the purposes of this section 18, the Agencywill translate the peach residue data to all stone fruit and tolerances will be set at 1.0 ppm.
The only processed commodity associated with stone fruit is prunes, as plums can beprocessed into prunes. Since no processing study was submitted, a default factor of 3.4 wasused, and therefore, the tolerance on prunes will be set at 3.5 ppm.
D. International Residue Limits
There are no Codex, Canadian, or Mexican Maximum Residue Limits forimidacloprid on sweet corn. Thus, harmonization is not an issue for these time-limitedtolerances.
E. Rotational Crop Restrictions
The rotational crop restrictions follow the original section 3 labels. In addition, thereis little concern over rotational crops for this section 18 as stone fruit are rarely rotated toother crops.
VI. Conclusion Back to Top
Therefore, the tolerances are established for the combined residues of imidaclopridand its metabolites containing the 6-chloropyridinyl moiety, all expressed as parent, in oron stone fruit at 1.0 ppm and prunes at 3.5 ppm.
VII. Objections and Hearing Requests Back to Top
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file anobjection 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 forhearings appear in 40 CFR part 178. Although the procedures in those regulations require somemodification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301004 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 HearingClerk on or before August 7, 2000.
1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). 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.
Mail your written request to: Office of the Hearing Clerk (1900), EnvironmentalProtection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, WatersideMall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for theOffice of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a hearing, you must also paythe fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Officeof Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the feesubmission by labeling it “Tolerance Petition Fees.”
EPA is authorized to waive any fee requirement “when in the judgement of theAdministrator such a waiver or refund is equitable and not contrary to the purpose of thissubsection.” For additional information regarding the waiver of these fees, you may contactJames Tompkins by phone at (703) 305-5697, by e-mail at firstname.lastname@example.org, or by mailinga request for information to Mr. Tompkins at Registration Division (7505C), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail yourrequest for such a waiver to: James Hollins, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency,1200 Pennsylvania Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or hearing request with theHearing Clerk as described in Unit VII.A., you should also send a copy of your request to thePIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies,identified by the docket control number OPP-301004, to: Public Information and RecordsIntegrity Branch, Information Resources and Services Division (7502C), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIBdescribed in Unit I.B.2. You may also send an electronic copy of your request via e-mail to:email@example.com. Please use an ASCII file format and avoid the use of special charactersand any form of encryption. Copies of electronic objections and hearing requests will also beaccepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include anyCBI in your electronic copy. You may also submit an electronic copy of your request at manyFederal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the materialsubmitted shows the following: There is a genuine and substantial issue of fact; there is areasonable possibility that available evidence identified by the requestor would, if establishedresolve one or more of such issues in favor of the requestor, taking into account uncontestedclaims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by therequestor would be adequate to justify the action requested (40 CFR 178.32).
VIII. Regulatory Assessment Requirements Back to Top
This final rule establishes time-limited tolerances under FFDCA section 408. TheOffice of Management and Budget (OMB) has exempted these types of actions from reviewunder Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October4, 1993). This final rule does not contain any information collections subject to OMB approvalunder the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceableduty or contain any unfunded mandate as described under Title II of the Unfunded MandatesReform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation asspecified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by ExecutiveOrder 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 or anyAgency action under Executive Order 13045, entitled Protection of Children fromEnvironmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action doesnot involve any technical standards that would require Agency consideration of voluntaryconsensus standards pursuant to section 12(d) of the National Technology Transfer andAdvancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petitionunder FFDCA section 408, such as the tolerances in this final rule, do not require the issuanceof a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 etseq.) do not apply. In addition, the Agency has determined that this action will not have asubstantial direct effect on States, on the relationship between the national government and theStates, or on the distribution of power and responsibilities among the various levels ofgovernment, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure“meaningful and timely input by State and local officials in the development of regulatorypolicies that have federalism implications.” “Policies that have federalism implications” isdefined in the Executive Order to include regulations that have “substantial direct effects on theStates, on the relationship between the national government and the States, or on the distributionof power and responsibilities among the various levels of government.” This final rule directlyregulates growers, food processors, food handlers and food retailers, not States. This action doesnot alter the relationships or distribution of power and responsibilities established by Congress inthe preemption provisions of FFDCA section 408(n)(4).
IX. Submission to Congress and the Comptroller General Back to Top
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small BusinessRegulatory Enforcement Fairness Act of 1996, generally provides that before a rule may takeeffect, the agency promulgating the rule must submit a rule report, which includes a copy of therule, to each House of the Congress and to the Comptroller General of the United States. EPAwill submit a report containing this rule and other required information to the U.S. Senate, theU.S. House of Representatives, and the Comptroller General of the United States prior topublication of this final rule in the Federal Register. This final rule is not a “major rule” asdefined by 5 U.S.C. 804(2).
Dated: May 25, 2000.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180—[AMENDED] Back to Top
1. The authority citation for part 180 continues to read as follows:
2. In §180.472, by alphabetically adding the following commodities to the table in paragraph (b) to read as follows:
§ 180.472 Imidacloprid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions.***
|Commodity||Parts per million||Expiration/Revocation Date|
|Stone fruit, crop group 12||1.0||12/31/01|
* * * * *
[FR Doc. 00-14422 Filed 6-7-00; 8:45 am]
BILLING CODE 6560-50-F