Environmental Protection Agency (EPA).
Final rule.
This regulation establishes time-limited tolerances for combined residues of coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate in or on honey and beeswax. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of the pesticide in beehives. This regulation establishes maximum permissible levels for residues of coumaphos in these food commodities. These tolerances will expire and are revoked on December 31, 2002.
This regulation is effective August 16, 2000. Objections and requests for hearings, identified by docket control number OPP–301039, must be received by EPA on or before October 16, 2000.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VII. of the
By mail: Barbara Madden, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305–6463; and e-mail address: madden.barbara@epa.gov.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the 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 action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
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EPA, on its own initiative, in accordance with sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the insecticide coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate, in or on honey at 0.1 part per million (ppm) and beeswax at 100 ppm. These tolerances will expire and are revoked on December 31, 2002. EPA will publish a document in the
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. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions.
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 the Federal Insecticide, Fungicide, and Rodenticide Act (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 the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
The varroa mite (
Fluvalinate is currently registered for the control of varroa mites however, populations of varroa mites have developed resistance to fluvalinate. Varroa mite resistance to fluvalinate has been well documented by the United States Department of Agriculture (USDA), Agricultural Research Service (ARS). According to USDA, ARS many hives treated with fluvalinate have resulted in wholesale colony losses. Due to the destructive nature of this pest coupled with the importance of honey bees (for honey production and pollination of numerous agricultural crops) to the U.S. economy, it is imperative that alternative means of controlling the varroa mite be developed. Currently, coumaphos is the only pesticide that has been identified as an effective alternative to fluvalinate. Extensive efficacy trials, performed in laboratories in the U.S.A. and abroad, have revealed that coumaphos will significantly reduce populations of varroa mites without causing any appreciable mortality to adult honey bees or their brood.
The small hive beetle (
The Agency has authorized the use of coumaphos under section 18 of FIFRA for the use of coumaphos impregnated in plastic strips to be hung in beehives to control varroa mites and small hive beetles to 45 States. To date based on studies conducted by USDA, ARS, no chemical other than coumaphos is available that provides reliable, effective control of both varroa mites and/or small hive beetles. To date, resistant strains of honey bees, biological control methods, and the use of other natural products are not completely functional management practices. The EPA did register formic acid during 1999. However it is only registered for suppression of varroa mites and is not labeled for control of small hive beetles. USDA, ARS has stressed that formic acid alone is not a viable replacement for fluvalinate.
The Agency has concluded that not only would beekeepers be adversely impacted if these emergency exemptions were not granted but that the impact on much of agriculture in the United States could be dire. That is, if coumaphos is not made available to control varroa mites and small hive beetles beekeepers and honey producers in at least 45 states will suffer significant economic losses. Additionally, much of agriculture in America will be adversely impacted. Few feral bee colonies remain in the United States due to disease and insect pressure (including that from varroa mites), increasing the American farmers dependency on managed bees for pollination. Over 150 crops have been identified that require bees for pollination. Based on figures published by the National Agricultural Statistics Service of USDA the estimated value of increased yield and quality achieved through pollination by honey bees is 14.6 billion dollars per year.
In 1999, based on limited residue data available in which honey and wax samples were collected from brood chambers, the Agency concluded that there would be no reasonable expectation of residues of coumaphos in commercial honey and processed beeswax used for food (taken from the honey supers) provided that the coumaphos strips were used in brood chambers when honey supers were not present (in accordance with the section 18 authorization letter). Therefore, the section 18 use was classified as a non-food use and no tolerances were established in either honey or beeswax. However, based on additional information submitted to the Agency in 2000 the non-food use classification is no longer supportable and establishing tolerances for honey and beeswax is necessary.
EPA has authorized under FIFRA section 18 the use of coumaphos in beehives for control of varroa mites and small hive beetles in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming. After having reviewed these submissions, EPA concurs that emergency conditions exist.
As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of coumaphos in or on honey and beeswax. 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 exemption 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 as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on honey and beeswax 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 levels that were 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 coumaphos meets EPA's registration requirements for use on honey and beeswax or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of coumaphos by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any other State to use this pesticide in beehives 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 coumaphos, contact the Agency's Registration Division at the address provided under
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 coumaphos and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for combined residues of coumaphos (O,O-diethyl O-3- chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate in or on honey at 0.1 ppm and beeswax at 100 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For coumaphos an extra UF of 3 (for a total UF of 300) was applied for acute dietary, short term inhalation, and intermediate term inhalation assessments to account for the lack of a NOAEL in the toxicology studies identified for use in these risk assessments.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE)=NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 × 10
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Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated 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 of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, 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 (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency used the following percent livestock treated (PLT) information: 5%% beef (and horse) including lean meat without removable fat, beef fat, beef liver, beef byproducts, kidney; 1%% hog including meat, hog fat, hog liver, hog byproducts, and hog kidney; 100%% veal including lean meat without removable fat, veal fat, veal liver, veal meat by-products, and veal kidney; and 4%% milk. Anticipated residue values (ARs) were calculated from field trial data for estimation of both acute and chronic dietary exposure for all livestock commodities, with the exception of milk. The residue values used for milk are from the USDA's PDP 1997 and 1998 monitoring data which show no detectable residues in milk out of 750 samples tested. Anticipated residues used for honey were based on monitoring data provided by Sioux Honey Association. These data represent raw honey samples which were likely to be treated under Section 18 exemptions in 1999 and 2000. Only those samples with detectable or quantifiable residues (limit of detection = 1 ppb) of coumaphos (parent) were included in the anticipated residue calculations. Some samples were analyzed more than once. In those cases the average value of the multiple analyses was used to calculate the residue level for chronic exposure, whereas the highest value was chosen for the acute analysis.
The Agency believes that the three conditions listed in Unit IV.B.1.iv. of this preamble have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely 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 is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and 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 coumaphos may be applied in a particular area.
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The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %%RfD or %%PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to coumaphos they are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of coumaphos in surface water and ground water, respectively, for acute exposures are estimated to be 1.9 parts per billion (ppb) for surface water and 0.17 ppb for ground water. The EECs for chronic exposures are estimated to be 0.41 ppb for surface water and 0.17 ppb for ground water. Note, in the Revised Risk Assessment for Coumaphos, released by the Agency as published in the
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In a developmental toxicity study pregnant rats received oral doses of coumaphos at 0, 1, 5 or 25 mg/kg/day during gestation days 6 through 15. For maternal toxicity, the NOAEL was 5 mg/kg/day and the LOAEL was 25 mg/kg/day based on clinical signs of cholinesterase inhibition. For developmentaltoxicity, the NOAEL was 25 mg/kg/day (HDT); a LOAEL was not established. There was no evidence of teratogenicity.
In a developmental toxicity study, pregnant rabbits were given single oral dose of coumaphos at 0, 0.25, 2, or 18 mg/kg/day during gestation days 7 through 19. For maternal toxicity, the NOAEL was 2 mg/kg/day and the LOAEL was 18 mg/kg/day based on mortality (2/17) and cholinergic signs. For developmental toxicity, the NOAEL was 18 mg/kg/day (HDT); a LOAEL was not established. There was no evidence of teratogenicity.
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The previous data gap for acute and subchronic neurotoxicity have been satisfied. There is no indication of increased susceptibility of rat or rabbits to coumaphos. In the developmental and reproduction toxicity studies, effects in the fetuses/offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity.
To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day)= cPAD—(average food+ chronic non-dietary, non-occupational exposure). This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to coumaphos in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of coumaphos on drinking water as a part of the aggregate risk assessment process.
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Comparing the risk estimates for the addition of honey and beeswax to those discussed in the risk assessment recently released for public comment under Phase 5 of the reregistration process for the registered uses on livestock, the Agency concludes that there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock. The slight changes reported in some cases (e.g., increase in acute exposure for children 7–12 years old) are likely to be within the noise or uncertainty of the analyses. The fact that the calculated exposure actually decreases in a few cases when honey is added to livestock is further indication of this.
Within the operating capability of the model, the Agency concludes that the above results show there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock.
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Comparing the risk estimates for the addition of honey and beeswax to those discussed in the risk assessment recently released for public comment under Phase 5 of the reregistration process for the registered uses on livestock, the Agency concludes that there is no incremental increase in dietary exposure or risk when the residues in honey are added to those from the registered uses on livestock. The slight changes reported in some cases are likely to be within the noise or uncertainty of the analyses. The fact that the calculated exposure actually decreases in a few cases when honey is added to livestock is further indication of this.
Within the operating capability of the model, the Agency concludes that the above results show there is no incremental increase in dietary exposure or risk when the residues in
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Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression. The method for honey is Bayer Method 150.803 and for beeswax is Bayer Method 150.804. Either method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305–5229; e-mail address: furlow.calvin@epa.gov.
There are no Codex tolerances for coumaphos, therefore there are no harmonization issues with this tolerance.
Therefore, the tolerances are established for combined residues of coumaphos, (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl) phosphate, in or on honey at 0.1 ppm and beeswax at 100 ppm.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification 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.
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–301039 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 16, 2000.
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Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260–4865.
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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 the waiver of these fees, you may contact James Tompkins by phone at (703) 305–5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, 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 your request 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.
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A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a 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(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
This final rule establishes time limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), (346a) and 371.
(b)