65 FR 86 pgs. 25647-25652 - Pyridate; Pesticide Tolerance
Type: RULEVolume: 65Number: 86Pages: 25647 - 25652
Docket number: [OPP-300989; FRL-6550-9]
FR document: [FR Doc. 00-10813 Filed 5-2-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300989; FRL-6550-9]
RIN 2070-AB78
Pyridate; Pesticide Tolerance
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes tolerances for combined residues of pyridate in or on peppermint tops, spearmint tops, Brassica, head and stem subgroup, and collards. The Interregional Research Project Number 4 and Novartis Crop Protection, Inc., requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES:
This regulation is effective May 3, 2000. Objections and requests for hearings, identified by docketcontrol number OPP-300989, must be received by EPA on or before July 3, 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 VI. of the SUPPLEMENTARY INFORMATION . To ensureproper receipt by EPA, your objections and hearing requests must identify docket control numberOPP-300989 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT:
By mail:Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-3194; and e-mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be affected by this action if you are an agricultural producer, foodmanufacturer, or pesticide manufacturer. Potentially affected categories and entities mayinclude, but are not limited to:
| Categories | NAICScodes | Examples of potentially affectedentities |
|---|---|---|
| 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 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 INFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of This Document and Other Related 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 " Federal Register -Environmental Documents." You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person . The Agency has established an official record for this action under docket control number OPP-300989. The official record consists of the documents 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
In the Federal Register of January 24, 2000 (65 FR 3682) (FRL-6399-6), and August 5, 1998 (63 FR 41835) (FRL-6017-1), EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (PP) 9E6025 and 6F4754 for tolerances by the Interregional Research Project Number 4, New Jersey Agricultural Experiment Station, Rutgers University, New Brunswick, NJ 08903, and Novartis Crop Protection Inc., 18300 Greensboro, NC 27419-8300, respectively. These notices included asummary of petitions prepared by Novartis Crop Protection Inc., the registrant. There were no comments received in response to the notice of filing.
These petitions requested that 40 CFR 180.462 be amended by establishingtolerances for combined residues of the herbicide pyridate, [ O -(6-chloro-3-phenyl-4-pyridazinyl)- S -octyl-carbonothioate and the metabolite CL-9673 (6-chloro-3-phenyl-pyradazine-4-ol), and conjugates of CL-9673], in or on peppermint tops and spearmint topsat 0.20, Brassica, head and stem subgroup, and collards at 0.03 parts per million (ppm).
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. * * *"
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).
III. Aggregate Risk Assessment and Determination of Safety
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, and to make a determination on aggregate exposure, consistent with section 408(b)(2),for tolerances for combined residues of pyridate on peppermint tops and spearmint tops at0.20 ppm, Brassica, head and stem subgroup, and collards at 0.03 ppm. EPA's assessment ofthe dietary exposures and risks associated with establishing the 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 pyridate are discussed in Unit II.A. of the Final Rule on PyridatePesticide Tolerance published in the Federal Register on October 7, 1998 (63 FR 53837) (FRL 6036-2).
B. Toxicological Endpoints
1. Acute toxicity . The acute dietary endpoint selected for the acutedietary risk assessment was 20 milligrams/kilogram/day (mg/kg/day) based on the subchronic (90-day) dog study with a no observed adverse effect level (NOAEL) of 20 mg/kg/day. Thelowest observed adverse effect level (LOAEL) was 60 mg/kg/day based on ataxia and emesisobserved within 1-3 hours of dosing beginning on the first day. An uncertainty factor of 100(10X for interspecies extrapolation and 10X for intraspecies variations) was used to determinethe acute Reference Dose (RfD) of 0.2 mg/kg/day. The acute Population Adjusted Dose(aPAD) is equal to the acute RfD divided by the FQPA Safety Factor. Since the FQPA SafetyFactor was reduced to 1X, the aPAD is equal to the acute RfD.
2. Chronic toxicity . EPA has established the chronic RfD forpyridate at 0.11 mg/kg/day. This RfD is based on a NOAEL of 10.8 mg/kg/day from the chronic/carcinogenicity study in rats where decreased body weight gain was reported at the LOAEL of 67.5 mg/kg/day. This dose was supported by the results of the 3-generation reproduction toxicity study. The NOAEL was 10.8 mg/kg/day based on the reported decrease in pup weights at 67.5 mg/kg/day on postnatal day 14 and 21 in both generations. An uncertainty factor of 100 (10X for interspecies extrapolation and 10X for intraspecies variation) was used to determine the chronic Reference Dose (cRfD) of 0.11 mg/kg/day. The chronic Population Adjusted Dose (cPAD) is equal to the chronic RfD divided by the FQPA Safety Factor. Since the FQPA Safety Factor was reduced to 1X, the cPAD is equal to the chronic RfD.
3. Carcinogenicity . Pyridate is not carcinogenic in either the rat or the mouse. Therefore, no carcinogenic endpoint was selected.
C. Exposures and Risks
1. From food and feed uses . Tolerances have been established (40 CFR 180.462) for the combined residues of pyridate, in or on a variety of raw agricultural commodities. Permanent tolerances are established for combined residues of pyridate, the metabolite CL-9673, and conjugates of CL-9673 in/on cabbage, corn, and peanut at 0.03 ppm. Risk assessments were conducted by EPA to assess dietary exposures from pyridate as follows:
i. Acute exposure and risk . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Tier 1 acute dietaryexposure analyses from food for pyridate were performed with the Dietary Exposure EvaluationModel (DEEM TM ) using published and proposed tolerance level residues and 100% croptreated (CT) for all commodities. Therefore, the acute risk was analyzed at the 95thpercentile. The acute dietary risk estimates from food are less than 1% of the aPAD for the generalU.S. population and all population subgroups. The results of the analyses indicate that theacute dietary risks from food associated with the existing and proposed uses of pyridate do not exceedEPA's level of concern for the U.S. population or any population subgroup.
ii. Chronic exposure and risk . Tier 1 chronic dietary exposureanalyses from food for pyridate were performed with the DEEM TM using published and proposed tolerance level residues and 100% CT for all commodities. The chronic dietary risk from food estimates are less than 1% of the cPAD for the general U.S. population and all population subgroups. The results of the analyses indicate that the chronic dietary risks from food associated with the existing and proposed uses of pyridate do not exceed EPA's level of concern for the U.S. population or any population subgroup
2. From drinking water . Although pyridate does not possess theenvironmental fate parameters associated with a compound that could leach to ground water, the fate parameters of its degradate CL-9673 seem to indicate that it has the potential to leach to ground water especially in soils of low organic matter. In unusual conditions such as flooding, where an aerobic conditions exist in the top soil layers for up to 60 days, CL-9673 could persist and possibly leach to ground water or run off to surface water. Pyridate is not listed in the EPA Pesticides in Ground Water Database, nor is there an EPA Maximum Contaminant Level or health advisory.
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 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end run off scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models includeconsideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking waterwould likely have on the removal of pesticides from the source water. The primary use ofthese models by the Agency at this stage is to provide a coarse screen for sorting outpesticides for which it is highly unlikely that drinking water concentrations would everexceed human health levels of concern.
Since the models used are considered to be screeningtools in the risk assessment process, the Agency does not use the estimatesenvironmental concentration (EECs) from these modelsto quantify drinking water exposure and risk as a %RfDor %PAD. Instead drinking water levels of comparisons (DWLOCs) are calculated andused as a point of comparison against the model estimates of a pesticide's concentration inwater. DWLOCs are theoretical upper limits on a pesticide's concentration in drinkingwater in light of total aggregate exposure to a pesticide in food, and fromresidential uses.Since DWLOCs address total aggregate exposure to pyridate, they are further discussed in the aggregate risk sections below.
EPA has calculated DWLOCs for both acute and chronic risks. To calculate theDWLOC for acute exposure relative to an acute toxicity endpoint, the acute dietaryfood exposure (from DEEM was subtracted from the aPAD to obtain the acceptableacute exposure to pyridate in drinking water. To calculate the DWLOC for chronic(non-cancer) exposure relative to a chronic toxicity endpoint, the chronic dietaryfood exposure (from DEEM) was subtracted from the cPAD to obtain the acceptablechronic (non-cancer) exposure to pyridate in drinking water. DWLOCs were thencalculated using default body weights and drinking water consumption figures.
i. Acute exposure . Based on the GENEEC and SCI-GROW models the EECs of pyridate in drinkingwater for acute exposures are estimated to be 97 parts per billion (ppb) for surface waterand 5 ppb for ground water.
ii. Chronic exposure . Based on the GENEEC and SCI-GROW models the EECs in drinking water for chronic exposures are estimated to be 25ppb for surface water and 5 pbb for ground water.
3. From non-dietary exposure . There are no residential or non-occupational uses for pyridate; therefore, residential exposures are not expected.
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 thecumulative effects of a particular pesticide's residues and "other substances that have a commonmechanism of toxicity."
EPA does not have, at this time, available data to determine whether pyridate hasa common 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, pyridate does not appear to produce atoxic metabolite produced by other substances. For the purposes of this tolerance action,therefore, EPA has not assumed that pyridate has a common mechanism of toxicity with othersubstances. For information regarding EPA's efforts to determine which chemicals have acommon mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see thefinal 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 . Ahigh-end exposure estimate from residues in food was calculated for the general U.S. population and all populationsubgroups. The acute dietary exposure from food for all populations subgroups (1% aPAD) is belowEPA's level of concern. The maximum EECs of pyridate in surface and ground water are lessthan EPA's DWLOCs for pyridate as a contribution to acute aggregate exposure (Table 1).
| Population Subgroups | % aPAD mg/kg/day | Food Exposure mg/kg/day | SCI-GROW (ppb) | GENEEC (ppb) | DWLOC (ppb) |
|---|---|---|---|---|---|
| U.S. population (48 contiguous states) | 1 | 0.000151 | 5 | 97 | 7,000 |
| Non-nursing infants | 1 | 0.000278 | 5 | 97 | 2,000 |
| Children 1-6 yrs. old | 1 | 0.000303 | 5 | 97 | 2,000 |
| Females 13+ yrs. old(nursing) (60 kg bodyweight assumed) | 1 | 0.000149 | 5 | 97 | 7,000 |
| Males 13-19 yrs. old | 1 | 0.000141 | 5 | 97 | 7,000 |
Therefore, EPA concludes with reasonable certainty that residues of pyridate in drinking waterdo not contribute significantly to the aggregate acute human health risk at the present time considering the present uses and uses proposed in this action. Acute risk estimates resulting from aggregate exposure to pyridate in food and water are below EPA's level of concern for all population subgroups.
2. Chronic risk . Using the Tier 1 exposure assumptionsdescribed in this unit, EPA has concluded that aggregate exposure to pyridate from food will utilize 1% of the cPADfor the U.S. population. The major identifiable subgroup with the highest aggregateexposure is infants or children. EPA generally has no concern for exposures below 100% ofthe cPAD because the cPAD represents the level at or below which daily aggregate dietaryexposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure topyridate in drinking water, EPA does not expect the aggregate exposure to exceed 100% of thecPAD, as indicated in Table 2.
| cPAD mg/kg/day | Food Exposure mg/kg/day | SCI-GROW(ppb) | GENEEC(ppb) | DWLOC(ppb) | |
|---|---|---|---|---|---|
| U.S. population (48 contiguousstates) | 1 | 0.000048 | 5 | 25 | 3,900 |
| Non-nursing infants | 1 | 0.000121 | 5 | 25 | 1,100 |
| Children 1-6 yrs | 1 | 0.000114 | 5 | 25 | 1,100 |
| Females 13+(nursing) | 1 | 0.000046 | 5 | 25 | 3,900 |
| Males 13-19 yrs. | 1 | 0.000057 | 5 | 25 | 3,900 |
EPA concludes that there is a reasonable certainty that no harm will result from aggregatechronic exposure to pyridate residues.
3. Short- and intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account chronicdietary food and water (considered to be a background exposure level) plus indoor and outdoorresidential exposure. Because there are no uses of pyridate that could result in residentialexposures, the short- and intermediate-term aggregate risk assessment for pyridate takes intoaccount exposure estimates only from dietary consumption of pyridate (food and drinking water).EPA concludes that there is a reasonable certainty that no harm will result from aggregate short-and intermediate-term exposure to pyridate residues.
4. Aggregate cancer risk for U.S. population . Pyridate is notcarcinogenic in either the rat or the mouse, and therefore is not expected to pose a cancer risk to humans.
5. Determination of safety . Based on these risk assessments, EPAconcludes that there is a reasonable certainty that no harm will result from aggregate exposure topyridate residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children -i. In general .In assessing the potential for additional sensitivity of infants and children to residues ofpyridate, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed toevaluate adverse effects on the developing organism resulting from maternal pesticide exposuregestation. Reproduction studies provide information relating to effects from exposure to thepesticide on the reproductive capability of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional tenfold margin ofsafety for infants and children in the case of threshold effects to account for prenatal andpostnatal toxicity and the completeness of the data base unless EPA determines that a differentmargin of safety will be safe for infants and children. Margins of safety are incorporated intoEPA risk assessments either directly through use of a margin of exposure (MOE) analysis orthrough using uncertainty (safety) factors in calculating a dose level that poses no appreciablerisk to humans. EPA believes that reliable data support using the standard uncertainty factor(usually 100 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 . The developmental toxicitystudy in Wistar HAN rats resulted in increased incidences of missing and ossifiedsternebrae and decreased fetal body weight. Maternal toxicity was characterized by adecrease in the mean body weight and food consumption and clinical signs which wereindicative of neurotoxicity (ventral body position, dyspnea, sedation and loss of reaction toexternal stimuli). Developmental and maternal NOAELs were 165 mg/kg/day. In thedevelopmental toxicity study in New Zealand White rabbits, no developmental effects werereported at the NOAEL of 600 mg/kg/day and maternal toxicity was characterized bydecreased body weight and body weight gain, decreased food consumption, increasedincidences of dried feces and increased incidences of abortion at the LOAEL of 600mg/kg/day. The maternal NOAEL was 300 mg/kg/day.
iii. Reproductive toxicity study . The 3-generationreproduction study in rats resulted in a decrease in maternal body weight gain and a decreasein pup weight gain at postnatal days 14 and 21. Both parental and offspring toxicity werereported at the high dose of 67.5 mg/kg/day.
iv. Prenatal and postnatal sensitivity . The data demonstrated no indication of increased sensitivity in utero and postnatal exposure to pyridate.
v. Conclusion . There is a complete toxicity data base for pyridate, and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency believes that reliable data support using the standard 100-foldsafety factor for assessing sensitivity to residues of pyridate and that an additional 10-fold marginof safety for infants and children is not warranted.
2. Acute risk . As presented in Table 1 above, EPA does not expect the aggregate exposure to exceed 100% of the aPAD.
3. Chronic risk . Using the exposure assumptions described in thisunit, EPA has concluded that aggregate exposure to pyridate from food will utilize 1% of thecPAD for infants and children. EPA generally has no concern for exposures below 100% of thecPAD, because the cPAD represents the level at or below which daily aggregate dietary exposureover a lifetime will not pose appreciable risks to human health. Despite the potential forexposure to pyridate in drinking water, EPA does not expect the aggregate exposure to exceed100% of the cPAD.
4. Short- or intermediate-term risk . Because there are no uses of pyridate that could result in residential exposures, the acute aggregate risk assessment for pyridate takes into account exposure estimates only from dietary consumption of pyridate (food and drinking water).
5. Determination of safety . Based on these risk assessments, EPAconcludes that there is a reasonable certainty that no harm will result to infants and children fromaggregate exposure to pyridate residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The nature of the residue in plants and ruminant animals is adequatelyunderstood. The residue of concern in plants consist of pyridate, the metabolite CL-9673, andconjugates of CL-9673, all expressed as pyridate.
B. Analytical Enforcement Methodology
The analytical method is a total residue procedure using ultraviolet-highpressure liquid chromotography. The method has undergone validation in EPA laboratoriesand is suitable to enforce tolerances.
The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of PesticidePrograms, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:furlow.calvin@epa.gov.
C. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican limits forresidues of pyridate in the subject crops. Therefore, a compatibility issue is not relevant to theproposed tolerances.
V. Conclusion
Therefore, the tolerance is established for combined residues of pyridate and itsmetabolite CL-9673 and conjugates of CL-9673, in or on peppermint tops and spearminttops at 0.20 ppm, Brassica, head and stem subgroup, and collards at 0.03 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objectionto any aspect of this regulation and may also request a hearing on those objections. The EPAprocedural regulations which govern the submission of objections and requests for hearingsappear 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 willcontinue to use those procedures, with appropriate adjustments, until the necessary modificationscan 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 EPAunder 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 withthe instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA,you must identify docket control number OPP-300989 in the subject line on the first page ofyour submission. All requests must be in writing, and must be mailed or delivered to the HearingClerk on or before July 3, 2000.
1. Filing the request . Your objection must specify the specific provisions in theregulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing isrequested, the objections must include a statement of the factual issues(s) on which a hearing isrequested, the requestor's contentions on such issues, and a summary of any evidence relied uponby the objector (40 CFR 178.27). Information submitted in connection with an objection orhearing request may be claimed confidential by marking any part or all of that information asCBI. Information so marked will not be disclosed except in accordance with procedures set forthin 40 CFR part 2. A copy of the information that does not contain CBI must be submitted forinclusion in the public record. Information not marked confidential may be disclosed publicly byEPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), EnvironmentalProtection Agency, Ariel Rios Bldg., 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 alsopay the 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 tompkins.jim@epa.gov, or by mailinga request for information to Mr. Tompkins at Registration Division (7505C), Office of PesticidePrograms, Environmental Protection Agency, Ariel Rios Bldg., 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, Ariel Rios Bldg.,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 VI.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 docket control number OPP-300989, to: Public Information and Records IntegrityBranch, Information Resources and Services Division (7502C), Office of Pesticide Programs,Environmental Protection Agency, Ariel Rios Bldg., 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 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).
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d) in response to thepetitions submitted to the Agency. The Office of Management and Budget (OMB) has exemptedthese types of actions from review under Executive Order 12866, entitled Regulatory Planningand Review (58 FR 51735, October 4, 1993). This final rule does not contain any informationcollections 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 underTitle II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor doesit require any prior consultation as specified by Executive Order 13084, entitled Consultationand Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); specialconsiderations as required by Executive Order 12898, entitled Federal Actions to AddressEnvironmental 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 action does not involve any technical standards that would require Agencyconsideration of voluntary consensus standards pursuant to section 12(d) of the NationalTechnology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis ofa petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require theissuance 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 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).
VIII. Submission to Congress and the Comptroller General
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agriculturalcommodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: April 17, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[Amended]
1. The authority citation for part 180 continues to read as follows:
Authority:
21 U.S.C. 321(q), (346a) and 371.
2. In § 180.462, by alphabetically adding the following commodities to the table in paragraph (a) to read as follows:
§ 180.462 Pyridate; tolerance for residues.
(a) * * *
| Commodity | Parts per million |
|---|---|
| Brassica, head and stemsubgroup | 0.03 |
| ***** | |
| Collards | 0.03 |
| ***** | |
| Peppermint tops | 0.20 |
| ***** | |
| Spearmint tops | 0.20 |
[FR Doc. 00-10813 Filed 5-2-00; 8:45 am]
BILLING CODE 6560-50-F