65 FR 188 pgs. 57966-57972 - Ethametsulfuron-methyl; Pesticide Tolerances for Emergency Exemptions
Type: RULEVolume: 65Number: 188Pages: 57966 - 57972
Docket number: [OPP-301048; FRL-6744-1]
FR document: [FR Doc. 00-24784 Filed 9-26-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301048; FRL-6744-1]
RIN 2070-AB78
Ethametsulfuron-methyl; Pesticide Tolerances for Emergency Exemptions
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes a time-limited tolerance forresidues of ethametsulfuron-methyl in or on canola. This action is in response to EPA'sgranting of emergency exemption under section 18 of the Federal Insecticide, Fungicide, andRodenticide Act authorizing use of the pesticide on canola. This regulation establishes amaximum permissible level for residues of ethametsulfuron-methyl in this food commodity.The tolerance will expire and is revoked on December 31, 2001.
DATES:
This regulation is effective September 27, 2000. Objections and requests for hearings, identified bydocket control number OPP-301048, must be received by EPA on or before November 27, 2000.
ADDRESSES:
Written objections and hearing requests may besubmitted by mail, in person, or by courier. Please follow the detailed instructions for eachmethod as provided in Unit VII. of the SUPPLEMENTARY INFORMATION section of the document. To ensure proper receipt by EPA, your objections andhearing requests must identify docket control number OPP-301048 in the subject lineon the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail:Dan Rosenblatt, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9375; and e-mail address:rosenblatt.dan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer,food manufacturer, or pesticide manufacturer. Potentially affected categories and entities mayinclude, but are not limited to:
| Categories | NAICS | Examples of Potentially Affected Entities |
|---|---|---|
| Industry | 111 | Crop production |
| 112 | Animal production | |
| 311 | Food manufacturing | |
| 32532 | Pesticide manufacturing |
This listing is not intended to be exhaustive, but rather provides a guide for readersregarding entities likely to be affected by this action. Other types of entities not listed in thetable 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 INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of This Document andOther Related Documents?
1. Electronically . You may obtain electronic copies of thisdocument, and certain other related documents that might be available electronically, from theEPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Pageselect "Laws and Regulations," "Regulations and ProposedRules," and then look up the entry for this document under the " Federal Register -Environmental Documents." You canalso go directly to the Federal Register listings athttp://www.epa.gov/fedrgstr/.
2. In person . The Agency has established an official recordfor this action under docket control number OPP-301048. The official recordconsists of the documents specifically referenced in this action, and other information related tothis action, including any information claimed as Confidential Business Information (CBI). Thisofficial record includes the documents that are physically located in the docket, as well as thedocuments that are referenced in those documents. The public version of the official record doesnot include any information claimed as CBI. The public version of the official record, whichincludes printed, paper versions of any electronic comments submitted during an applicablecomment period is available for inspection in the Public Information and Records IntegrityBranch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephonenumber is (703) 305-5805.
II. Background and Statutory Findings
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 a tolerance for residuesof the herbicide ethametsulfuron-methyl, in or on canola at 0.02 part per million (ppm).This tolerance will expire and is revoked on December 31, 2001. EPA will publish a documentin the Federal Register to remove the revoked tolerance from the Code ofFederal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited toleranceor exemption from the requirement for a tolerance for pesticide chemical residues in food thatwill result from the use of a pesticide under an emergency exemption granted by EPA undersection 18 of FIFRA. Such tolerances can be established without providing notice or period forpublic comment. EPA does not intend for its actions on section 18 related tolerances to setbinding 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 reasonable certainty that no harmwill result from aggregate exposure to the pesticide chemical residue, including all anticipateddietary exposures and all other exposures for which there is reliable information."This includes exposure through drinking water and in residential settings, but does not includeoccupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration toexposure of infants and children to the pesticide chemical residue in establishing a tolerance andto "ensure that there is a reasonable certainty that no harm will result to infants andchildren 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 suchexemption." This provision was not amended by the Food Quality Protection Act(FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part166.
III. Emergency Exemption for Ethametsulfuron-methyl on Canola and FFDCATolerances
EPA has authorized under FIFRA section 18 the use of ethametsulfuron-methylon canola for control of smartweeds in North Dakota and Minnesota. Products containingendothall had been available for use against smartweeds in the past. However, this use ofendothall is no longer being supported. Therefore, after considering the situation this year, EPAdetermined that emergency conditions existed for the growers and permitted the use.
As part of its assessment of this emergency exemption, EPA assessed the potentialrisks presented by residues of ethametsulfuron-methyl in or on canola. In doing so, EPAconsidered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessarytolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and withFIFRA section 18. Consistent with the need to move quickly on the emergency exemption inorder to address an urgent non-routine situation and to ensure that the resulting food is safe andlawful, EPA is issuing this tolerance without notice and opportunity for public comment asprovided in section 408(l)(6). Although this tolerance will expire and is revoked on December31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amountsspecified in the tolerance remaining in or on canola after that date will not be unlawful, providedthe pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceeda level that was authorized by this tolerance at the time of that application. EPA will take actionto revoke this tolerance earlier if any experience with, scientific data on, or other relevantinformation on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions, EPA has notmade any decisions about whether ethametsulfuron-methyl meets EPA's registrationrequirements for use on canola or whether a permanent tolerance for this use would beappropriate. Under these circumstances, EPA does not believe that this tolerance serves as abasis for registration of ethametsulfuron-methyl by a State for special local needs under FIFRAsection 24(c). Nor does this tolerance serve as the basis for any State other than North Dakota and Minnesota to use thispesticide on this crop under section 18 of FIFRA without following all provisions of EPA'sregulations implementing section 18 as identified in 40 CFR part 166. For additional informationregarding the emergency exemption for ethametsulfuron-methyl, contact the Agency'sRegistration Division at the address provided under FOR FURTHERINFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 Bifenthrin Pesticide 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 ethametsulfuron-methyl and to make a determination on aggregate exposure,consistent with section 408(b)(2), for a time-limited tolerance for ethametsulfuron-methyl in oron canola at 0.02 ppm. EPA's assessment of the dietary exposures and risks associated withestablishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no observed adverse effect level (NOAEL) are observed from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest observed adverse effect level (LOAEL) at which adverse effects of concern are identified 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 inherentin the extrapolation from laboratory animal data to humans and in the variations in sensitivityamong members of the human population as well as other unknowns. An UF of 100 is routinelyused, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculatean acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to theNOAEL divided by the appropriate UF (RfD=NOAEL/UF). Where an additionalsafety factor is retained due to concerns unique to the FQPA, this additional factor is applied tothe RfD by dividing the RfD by such additional factor. The acute or chronic Population AdjustedDose (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 determinethe level of concern (LOC). For example, when 100 is the appropriate UF (10X to account forinterspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, aratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) iscalculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currentlyused by the Agency to quantify carcinogenic risk. The Q* approach assumes that anyamount of exposure will lead to some degree of cancer risk. A Q* is calculated and usedto estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specificcircumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a "point of departure" is identified below whichcarcinogenic effects are not expected. The point of departure is typically a NOAEL based on anendpoint related to cancer effects though it may be a different value derived from the doseresponse curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.A summary of the toxicological endpoints for ethametsulfuron-methyl used for human risk assessment is shown in the following Table 1.
| Exposure scenario | Dose used in risk assessment, UF | FQPA SF * andlevel of concern for risk assessment | Study and toxicological effects |
|---|---|---|---|
| Acute dietary | NOAEL = none acute RfD = n/a | FQPA SF = 1x aPAD = n/a | A dose and endpoint were notselected since toxicologicaleffects attributable to a singledose (exposure) were notavailable from the oraltoxicological studies,including developmentaltoxicity studies in rats andrabbits. |
| Chronic dietary | NOAEL = 449 mg/kg/day UF = 100chronic RfD = 4.5 mg/kg/day | FQPA SF = 1 xcPAD = 4.5 (chronic NOAEL)/ 1 x(FQPA SF) = 4.5 mg/kg/day | Parental/systemic NOAEL= 449 mg/kg/day based onreduced body weight andbody weight gain in P andF1a males and females at theLOAEL of 1,817 mg/kg/dayin a 2-generationreproduction study. |
| Short-term,Intermediate-term, andLong-term dermal | Dermal (or oral)study NOAEL = n/a | LOC for MOE = n/a | A dose and endpoint were not identified since the dermal toxicity study in rats was waived based on lack of systemic toxicity in oraltoxicity studies. |
| Inhalation (anytime period) | Inhalation (or oral) studyNOAEL = n/a | LOC for MOE = n/a | No inhalation endpoints wereselected. |
| * The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA. | |||
B. Exposure Assessment
1. Dietary exposure from food and feed uses. This is the firstfood use tolerance that will be established for this herbicide. In support of this action, riskassessments were conducted by EPA to assess dietary exposures from ethametsulfuron-methylin food as follows:
i. Acute exposure. 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 one day or single exposure. For this action, no acute dietary risk assessment wasconducted. The rationale for this is that a dose and endpoint were not selected sincetoxicological effects attributable to a single dose (exposure) were not available from the oraltoxicology studies, including developmental toxicity studies in rats and rabbits.
ii. Chronic exposure . In conducting this chronic dietaryrisk assessment the dietary exposure evaluation model (DEEM) analysisevaluated the individual food consumption as reported by respondents in the USDA 1989-1992nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposureto the chemical for each commodity. The following assumptions were made for the chronicexposure assessments: A conservative Tier I analysis using tolerance level residues wasperformed. Besides the use connected with this action, there are no other food use orresidential registrations for ethametsulfuron-methyl. Percent crop-treated refinements andanticipated residues were not used.
iii. Cancer . EPA did not conduct a quantitative cancerrisk assessment for this action. The basis for this decision is that no evidence of chronictoxicity or carcinogenicity was seen in mice and rats; although, the dose levels tested inthese studies were determined to be inadequate. The cancer potential for othersulfonylurea herbicides is also germane to this decision. Other sulfonylurea herbicides donot show evidence of carcinogenicity or mutagenicity.
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete acomprehensive dietary exposure analysis and risk assessment for ethametsulfuron-methyl indrinking water. Because the Agency does not have comprehensive monitoring data, drinkingwater concentration estimates are made by reliance on simulation or modeling taking intoaccount data on the physical characteristics of ethametsulfuron-methyl.
The Agency uses the Generic Estimated Environmental Concentration (GENEEC)or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimatepesticide concentrations in surface water and Screening Concentration in Ground Water (SCI-GROW), which predicts pesticideconcentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before usingPRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. TheGENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoffscenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMSincorporate an index reservoir environment in place of the previous pond scenario. ThePRZM/EXAMS model includes a percent crop area factor as an adjustment to account for themaximum percent crop coverage within a watershed or drainage basin.
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 theremoval of pesticides from the source water. The primary use of these models by the Agency atthis stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikelythat drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessmentprocess, the Agency does not use estimated environmental concentrations (EECs) from thesemodels 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 ofcomparison against the model estimates of a pesticide's concentration in water. DWLOCs aretheoretical upper limits on a pesticide's concentration in drinking water in light of total aggregateexposure to a pesticide in food, and from residential uses. Since DWLOCs address totalaggregate exposure to ethametsulfuron-methyl they are further discussed in the aggregate risksections below.
Based on the PRZM/EXAMS and SCI-GROW models the estimatedEECs of ethametsulfuron-methyl in surface water and groundwater, respectively, for chronic exposures are estimated to be 0.3 parts per billion (ppb) forsurface water and 0.1 ppb for ground water.
3. From non-dietary exposure . The term"residential exposure" is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control,termiticides, and flea and tick control on pets).
Ethametsulfuron-methyl is not registered for use on any sites that would result inresidential exposure.
4. Cumulative exposure to substances with a common mechanism oftoxicity . 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 "othersubstances that have a common mechanism of toxicity."
EPA does not have, at this time, available data to determine whetherethametsulfuron-methyl has a common mechanism of toxicity with other substances or how toinclude this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPAhas followed a cumulative risk approach based on a common mechanism of toxicity,ethametsulfuron-methyl does not appear to produce a toxic metabolite produced by othersubstances. For the purposes of this tolerance action, therefore, EPA has not assumed thatethametsulfuron-methyl has a common mechanism of toxicity with other substances. Forinformation regarding EPA's efforts to determine which chemicals have a common mechanismof toxicity and to evaluate the cumulative effects of such chemicals, see the final rule forBifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. Safety factor for infants and children -i. In general . FFDCA section 408 provides that EPA shall apply an additionaltenfold margin of safety for infants and children in the case of threshold effects to account forprenatal and postnatal toxicity and the completeness of the data base on toxicity and exposureunless 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 amargin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating adose level that poses no appreciable risk to humans.
ii. Developmental toxicity studies . EPA has determined thatthere is adequate information about prenatal developmental toxicity to conclude thatethametsulfuron-methyl does not pose a risk of increased sensitivity due to in utero exposure.
iii. Reproductive toxicity study . There are adequate data forEPA to conclude that there is no indication of increased susceptibility of reproductivetoxicity.
iv. Prenatal and postnatal sensitivity. EPA considers thetoxicology data base to be complete and has concluded that there is no indication of prenataland postnatal sensitivity in rats and rabbits.
v. Conclusion . There is a complete toxicity data base forethametsulfuron-methyl and exposure data are complete or are estimated based on data thatreasonably accounts for potential exposures. Given that EPA considers that the toxicologydata base for ethametsulfuron-methyl is complete. There is no indication of increasedsusceptibility of rat or rabbit fetuses to in utero and or postnatal exposure in thedevelopmental and reproductive toxicity data. Unrefined dietary exposure estimates areprotective since they will exaggerate dietary exposure estimates; and there are currentlyno registered residential uses for ethametsulfuron-methyl, and therefore, non-dietaryexposure to infants and children is not expected. These factors led EPA to conclude thatthe special 10X safety factor for infants and children should be removed to 1X.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinking water, andresidential uses, the Agency calculates DWLOCs which are used as a point of comparisonagainst the model estimates of a pesticide's concentration in water (EECs). DWLOC values arenot regulatory standards for drinking water. DWLOCs are theoretical upper limits on apesticide's concentration in drinking water in light of total aggregate exposure to a pesticide infood and residential uses. In calculating a DWLOC, the Agency determines how much of theacceptable 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 drinkingwater is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking waterconsumption, and body weights. Default body weights and consumption values as used by theUS EPA Office of Water are used to calculate DWLOCs: 2 liters (L)/70 kilograms (kg) (adult male), 2L/60 kg (adultfemale), and 1L/10 kg (child). Default body weights and drinking water consumption valuesvary 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 havedifferent 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 calculatedDWLOCs, OPP concludes with reasonable certainty that exposures to ethametsulfuron-methylin drinking water (when considered along with other sources of exposure for which OPP hasreliable 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 associatedwith pesticide's uses, levels of comparison in drinking water may vary as those uses change. Ifnew uses are added in the future, OPP will reassess the potential impacts of ethametsulfuron-methyl on drinking water as a part of the aggregate risk assessment process.
1. Acute risk . An aggregate acute risk assessment was notconducted since a dose and endpoint were not selected because toxicological effectsattributable to a single dose (exposure) were not available from the oral toxicology studies,including developmental toxicity studies in rats and rabbits.
2. Chronic risk . Using the exposure assumptions described inthis unit for chronic exposure, EPA has concluded that exposure to ethametsulfuron-methylfrom food will utilize 0.0%% of the cPAD for the U.S. population and all other subpopulations. There are no residential uses for ethametsulfuron-methylthat result in chronic residential exposure to ethametsulfuron-methyl. In addition, despite thepotential for chronic dietary exposure to ethametsulfuron-methyl in drinking water, aftercalculating the DWLOCs and comparing them to conservative model estimated environmentalconcentrations of ethametsulfuron-methyl in surface and ground water, EPA does not expectthe aggregate exposure to exceed 100%% of the cPAD, as shown in the following Table 2.
| Population Subgroup | cPAD mg/kg/day | %%cPAD (Food) | Surface Water EEC (ppb) | Ground Water EEC (ppb) | Chronic DWLOC (microgram s/L) |
|---|---|---|---|---|---|
| U.S. Population | 4.5 mg/kg/day | 0.0 | 0.32 ppb | 0.11 ppb | 160,000 |
| Females 13+ | 4.5 mg/kg/day | 0.0 | 0.32 ppb | 0.11 ppb | 140,000 |
| Infant and Children | 4.5 mg/kg/day | 0.0 | 0.32 ppb | 0.11 ppb | 45,000 |
3. Short-term risk .Short-term aggregate exposure takes into account residential exposure plus chronicexposure to food and water (considered to be a background exposure level).
Ethametsulfuron-methyl is not registered for use on any sites that would result inresidential exposure. Therefore, the aggregate risk is the sum of the risk from food and water,which were previously addressed.
4. Intermediate-term risk .Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a backgroundexposure level).
Ethametsulfuron-methyl is not registered for use on any sites that would result inresidential exposure. Therefore, the aggregate risk is the sum of the risk from food and water,which were previously addressed.
5. Aggregate cancer risk for U.S. population . No evidence ofchronic toxicity or carcinogenicity was seen in mice and rats; however, the dose levelstested in these studies were determined to be inadequate. However, it is noted that othersulfonylurea herbicides do not show evidence of carcinogenicity or mutagenicity.Therefore a quantitative risk assessment is not warranted.
6. Determination of safety . Based on these risk assessments,EPA concludes that there is a reasonable certainty that no harm will result to the generalpopulation, and to infants and children from aggregate exposure to ethametsulfuron-methylresidues.
V. Other Considerations
A. Analytical Enforcement Methodology
The manufacturer of ethametsulfuron-methyl has submitted a proposedenforcement method to EPA (MRID # 42022113).
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue level's have been established for ethametsulfuron-methyl.
VI. Conclusion
Therefore, the tolerance is established for ethametsulfuron-methyl, in or on canola at 0.02 ppm.
VII. Objections and Hearing Requests
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 necessarymodifications can be made. The new section 408(g) provides essentially the same process forpersons to "object" to a regulation for an exemption from the requirementof a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCAsections 408 and 409. However, the period for filing objections is now 60 days, rather than 30days.
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 accordancewith the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt byEPA, you must identify docket control number OPP-301048 in the subject line onthe first page of your submission. All requests must be in writing, and must be mailed ordelivered to the Hearing Clerk on or before November 27, 2000.
1. Filing the request . Your objection must specify thespecific provisions in the regulation that you object to, and the grounds for the objections (40CFR 178.25). If a hearing is requested, the objections must include a statement of the factualissues(s) on which a hearing is requested, the requestor's contentions on such issues, and asummary of any evidence relied upon by the objector (40 CFR 178.27). Information submittedin connection with an objection or hearing request may be claimed confidential by marking anypart or all of that information as CBI. Information so marked will not be disclosed except inaccordance with procedures set forth in 40 CFR part 2. A copy of the information that does notcontain CBI must be submitted for inclusion in the public record. Information not markedconfidential 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 alsodeliver 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 theHearing Clerk is (202) 260-4865.
2. Tolerance fee payment . If you file an objection or requesta hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of thatfee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters AccountingOperations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251.Please identify the fee submission by labeling it "Tolerance Petition Fees."
EPA is authorized to waive any fee requirement "when in the judgementof the Administrator 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 maycontact James Tompkins by phone at (703) 305-5697, by e-mail attompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins atRegistration 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 mailyour request for such a waiver to: James Hollins, Information Resources and Services Division(7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460.
3. Copies for the Docket . In addition to filing an objection orhearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copyof your request to the PIRIB 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-301048, to: Public Informationand Records Integrity Branch, Information Resources and Services Division (7502C), Office ofPesticide Programs, 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:opp-docket@epa.gov. Please use an ASCII file format and avoid the use of specialcharacters and any form of encryption. Copies of electronic objections and hearing requests willalso be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do notinclude any CBI in your electronic copy. You may also submit an electronic copy of yourrequest at many Federal 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 thematerial submitted shows the following: There is a genuine and substantial issue of fact; there isa reasonable 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
This final rule establishes a time limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58FR 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 any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); 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 or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This actiondoes not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between thenational government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requiresEPA to develop an accountable process to ensure "meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." "Policies that have federalism implications" is defined in the Executive Order to include regulations that have "substantial directeffects on the States, on the relationship between the national government and the States, or onthe distribution of power and responsibilities among the various levels ofgovernment." This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCAsection 408(n)(4).
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , asadded 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 to the Comptroller General of the United States. EPA will submit a report containing this rule and other requiredinformation to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a "major rule" as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 12, 2000.
Susan B. Hazen,
Acting Director, 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. 321(q), (346a) and 371.
2. Section 180.563 is added to read as follows:
§ 180.563 Ethametsulfuron-methyl; tolerances for residues.
(a) General . [Reserved]
(b) Section 18 emergency exemptions . A time-limitedtolerance is established for ethametsulfuron-methyl (Methyl 2-(((((4-ethoxy-6-(methylamino)-1,3,5- triazin-2-yl)amino)carbonyl) amino)sulfonyl)benzoate) in or on canola in connection with the use of the pesticide under section 18 exemptions granted by EPA. The time-limited tolerance will expire on the date specified in the following table:
| Commodity | Parts per million | Expiration/Revocation Date |
|---|---|---|
| Canola | 0.02 | 12/31/01 |
(c) Tolerances with regional registrations . [Reserved]
(d) Indirect of inadvertent residues . [Reserved]
[FR Doc. 00-24784 Filed 9-26-00; 8:45 am]
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