97-2466. American Cyanamid Company; Pesticide Tolerance Petition Filing  

  • [Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
    [Notices]
    [Pages 5399-5403]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-2466]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    [PF-697; FRL-5584-4]
    
    
    American Cyanamid Company; Pesticide Tolerance Petition Filing
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Notice of filing.
    
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    SUMMARY: This notice announces the filing of a pesticide petition 
    proposing regulations establishing tolerances for residues of 4-bromo-
    2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1-pyrrole-3-
    carbonitrile, (chlorfenapyr) in or on cottonseed. This notice includes 
    a summary of the petition that was prepared by the petitioner, American 
    Cyanamid Company.
    
    DATES: Comments, identified by the docket control number [PF-697], must 
    be received on or before March 7, 1997.
    
    ADDRESSES: By mail, submit written comments to: Public Response and 
    Program Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. In person, bring comments to: Crystal Mall #2, 
    Room 1132, 1921 Jefferson Davis Highway, Arlington, VA.
        Comments and data may also be submitted electronically by sending 
    electronic mail (e-mail) to: opp-docket@epamail.epa.gov or by 
    submitting disks. Electronic comments must be submitted either in ASCII 
    format (avoiding the use of special characters and any form of 
    encryption) or in WordPerfect in 5.1 file format. All comments and data 
    in electronic form must be identified by the docket control number [PF-
    697]. Electronic comments on this notice may be filed online at many 
    Federal Depository Libraries. The official record for this notice, as 
    well as the public version described above, will be kept in paper form. 
    Accordingly, EPA will transfer all comments received electronically 
    into printed, paper form as they are received and will place the paper 
    copies in the official record, which will also include all comments 
    submitted directly in writing.
        Information submitted as comments concerning this notice may be 
    claimed confidential by marking any part or all of that information as 
    ``Confidential Business Information'' (CBI). The CBI should not be 
    submitted through e-mail. Information marked as CBI will not be 
    disclosed except in accordance with procedures set forth in 40 CFR part 
    2. A copy of the comment that does not contain CBI must be submitted 
    for inclusion in the public record. Information not marked confidential 
    may be disclosed publicly by EPA without prior notice. All written 
    comments will be available for public inspection in Room 1132 at the 
    address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
    excluding legal holidays.
    
    FOR FURTHER INFORMATION CONTACT: Dennis Edwards (PM 19), Registration 
    Division (7505C), Office of Pesticide Programs, Environmental 
    Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
    location, telephone number, and e-mail address: Crystal Mall #2, Room 
    207, 1921 Jefferson Davis Highway, Arlington, VA, 703-305-6386,
    
    [[Page 5400]]
    
    e-mail: edwards.dennis@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition from 
    American Cyanamid Company. The petition proposes, pursuant to section 
    408 of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, 
    to amend 40 CFR part 180 to establish tolerances for the insecticide, 
    4-bromo-2-(4-chlorophenyl)-1(ethoxymethyl)-5-(trifluoromethyl)-1-
    pyrrole-3-carbonitrile, (chlorfenapyr), in or on the raw agricultural 
    commodity cottonseed.
        The proposed analytical method is capillary gas chromatography 
    using an electron capture detector.
        As required by section 408(d) of the FFDCA, as recently amended by 
    the Food Quality Protection Act (FQPA) Pub. L. 104-170, American 
    Cyanamid Company included in the petition a summary of the petition and 
    authorization for the summary to be published in the Federal Register 
    in a notice of receipt of the petition. The summary represents the 
    views of American Cyanamid; EPA is in the process of evaluating the 
    petition. As required by section 408(d)(3) of the FFDCA, EPA is 
    including the summary as a part of this notice of filing. EPA may have 
    made minor edits to the summary for the purpose of clarity.
    
    I. Petition Summary
    
        The American Cyanamid Company has petitioned EPA, under pesticide 
    petition number PP-5F4456, for a permanent tolerance of 0.5 parts per 
    million (ppm) for the residues of chlorfenapyr in or on cottonseed. As 
    cottonseed processed commodities fed to food animals may be transferred 
    to milk and edible tissues, tolerances are also proposed for the 
    following ruminant food items:
        Milk: 0.01 ppm
        Milk fat: 0.15 ppm
        Meat: 0.01 ppm
        Meat by-products (including fat): 0.10 ppm
        Section 408(b)(2)(A) of the amended FFDCA allows EPA to establish a 
    tolerance if it determines that the tolerance is ``safe, '' i.e., 
    ``there is a reasonable certainty that no harm will result from 
    aggregate exposure to the pesticide chemical residue, including all 
    anticipated dietary exposure, and all other exposures for which there 
    is reliable information.''
        All of the studies required for the proposed use pattern have been 
    completed according to EPA requirements. American Cyanamid believes 
    that the available information indicates there is a reasonable 
    certainty that no harm will result from various types of exposure.
        The following is a summary of the information on chlorfenapyr 
    submitted to the EPA which supports the establishment, under section 
    408(b)(2)(D) of the amended FFDCA, of the proposed tolerances in or on 
    cottonseed and in food items derived from ruminants exposed to 
    processed cottonseed commodities.
    
    A. Residue Chemistry
    
        1. Plant metabolism. American Cyanamid believes that the nature of 
    the residues of chlorfenapyr in plants is adequately understood and 
    that the residue of concern in cotton consists of the parent molecule. 
    Expressed on a whole seed basis, the parent compound accounted for 59-
    68% of the total radioactive residue (TRR).
        2. Analytical method. Section 408(b)(3) of the amended FFDCA 
    requires EPA to determine that there is a practical method for 
    detecting and measuring levels of the pesticide chemical residue in or 
    on food and that the tolerance be set at a level at or above the limit 
    of detection of the designated method. The gas chromatographic (GC) 
    analytical method, M2216.01, which is proposed as the enforcement 
    method for the residues of chlorfenapyr in cottonseed, has been 
    validated at the EPA laboratories in Beltsville, MD and has a limit of 
    detection (LOD) of 0.05 ppm and a limit of quantitation (LOQ) of 0.5 
    ppm.
        3. Magnitude of residue. Extensive cotton field trials were 
    conducted over multiple growing seasons in all major cotton growing 
    regions of the U.S. Residues of chlorfenapyr were 0.32 ppm 
    and 0.31 ppm in/on cottonseed samples harvested 21 and 28 
    days, respectively following the last of 5 foliar broadcast 
    applications for a total of approximately 2x the proposed current 
    maximum seasonal application rate of 1.05 lbs active ingredient/acre/
    season (ai/acre/season). These field trial data are adequate to support 
    the proposed tolerance of 0.5 ppm in/on cottonseed harvested 21 days 
    following the last application. Processing studies have also 
    demonstrated that there is no concentration of chlorfenapyr residues 
    apparent in crude or refined oils or in the meal and hull and no 
    tolerances are needed for these commodities.
    
    B. Toxicological Profile
    
        American Cyanamid has conducted a full battery of acute and chronic 
    toxicology studies to characterize any potential toxic effects of 
    chlorfenapyr. The data base is complete, valid, and reliable and all 
    meet EPA requirements. The following are important conclusions from 
    these studies:
        1. Acute toxicity. Based on the EPA's toxicity category criteria, 
    the acute toxicity category for chlorfenapyr technical and the 3SC 
    formulation is Category II or moderately toxic (signal word WARNING) 
    and the acute toxicity category for the 2SC formulation is Category III 
    or slightly toxic (signal word CAUTION). Males appear to be more 
    sensitive to the effects of chlorfenapyr than females. The acute 
    toxicity profile indicates that absorption by the oral route appears to 
    be greater than by the dermal route. The following are the results from 
    the acute toxicity tests conducted on the technical material:
    
                                                                            
                                                                            
                                                                            
                                                                            
    Rat oral LD50...................  441/1152 milligram/ Tox. Category II  
                                       kilogram of body                     
                                       weight (mg/kg                        
                                       b.w.)(M/F).                          
    Rabbit dermal LD50..............  >2000 mg/kg b.w.(M/ Tox. Category III 
                                       F).                                  
    Acute inhaltion LC50............  0.83/>2.7 mg/L (M/  Tox. Category III 
                                       F).                                  
    Eye irritation..................  Moderately          Tox. Category III 
                                       irritating.                          
    Dermal irritation...............  Non-irritating....  Tox. Category IV  
    Dermal sensitization............  Non-sensitizer....  Non-sensitizer    
    Acute neurotoxicity.............  NOEL 45 mg/kg b.w.  Not an acute      
                                                           neurotoxicant    
                                                                            
    
        2. Genotoxicity. Chlorfenapyr technical (94.5% active ingredient 
    (ai)) was examined in a battery of in vitro and in vivo tests to assess 
    its genotoxicity and its potential for carcinogenicity.
    
    [[Page 5401]]
    
        These tests are summarized below:
    
                                                                            
                                                                            
                                                                            
                                                                            
    Microbial/Microsome Mutagenicity Assay....  Non-mutagenic               
    Mammalian Cell CHO/HGPRT Mutagenicity       Non-mutagenic               
     Assay.                                                                 
    In Vivo Micronucleus Assay................  Non-genotoxic               
    In Vitro Chromosome Aberration Assay in     Non-clastogenic             
     CHO.                                                                   
    In Vitro Chromosome Aberration Assay in     Non-clastogenic             
     CHLC.                                                                  
    Unscheduled DNA Synthesis (UDS) Assay.....  Non-genotoxic               
                                                                            
    
        3. Reproductive and developmental toxicity. Chlorfenapyr is neither 
    a reproductive or developmental toxicant and is not a teratogenic agent 
    in the Sprague-Dawley rat or the New Zealand white rabbit. This is 
    demonstrated by the results of the following studies:
    
                                                                            
                                                                            
                                                                            
    Rat oral teratology..................  NOEL for maternal toxicity 25 mg/
                                            kg b.w./day                     
                                           NOEL for fetal/developmental     
                                            toxicity 225 mg/kgb.w./day      
                                                                            
    Rabbit oral teratology...............  NOEL for maternal toxicity 5 mg/ 
                                            kg b.w./day                     
                                           NOEL for fetal/developmental     
                                            toxicity 30 mg/kg b.w./day      
    Rat two-generation reproduction......  NOEL for parental toxicity/growth
                                            and offspring development 60 ppm
                                            (5mg/kg b.w./day)               
                                           NOEL for reproductive performance
                                            600 ppm (44 mg/kg b.w./day)     
                                                                            
    
        4. Subchronic toxicity. The following are the results of the 
    subchronic toxicity tests that have been conducted with chlorfenapyr:
    
                                                                            
                                                                            
                                                                            
                                                                            
    28-Day rabbit dermal.................  NOEL 100 mg/kg b.w./day          
    28-Day rat feeding...................  NOEL <600 ppm=""><71.6 mg/kg="" b.w./="" day)="" 28-day="" mouse="" feeding.................="" noel=""><160 ppm=""><32 mg/kg="" b.w./="" day)="" 13-week="" rat="" dietary..................="" no="" observed="" adverse="" effects="" level="" (noael)="" 150="" ppm="" (11.7="" mg/kg="" b.w./="" day)="" 13-week="" mouse="" dietary................="" noel="" 40="" ppm="" (8.2="" mg/kg="" b.w./day)="" 13-week="" dog="" dietary..................="" noael="" 120="" ppm="" (4.2="" mg/kg="" b.w./="" day)="" 5.="" chronic="" toxicity.="" chlorfenapyr="" is="" not="" oncogenic="" in="" either="" sprague-dawley="" rats="" or="" cd-1="" mice="" and="" is="" not="" likely="" to="" be="" carcinogenic="" in="" humans.="" the="" following="" are="" the="" results="" of="" the="" chronic="" toxicity="" tests="" that="" have="" been="" conducted="" with="" chlorfenapyr:="" 1-year="" neurotoxicity="" in="" rats.........="" noel="" 60="" ppm="" (2.6/3.4="" mg/kg="" b.w./="" day="" m/f)="" 1-year="" dog="" dietary...................="" noel="" 120="" ppm="" (4.0/4.5="" mg/kg="" b.w./="" day="" m/f)="" 24-month="" rat="" dietary.................="" noel="" for="" chronic="" effects="" 60="" ppm="" (2.9/3.6="" mg/kg="" b.w./day="" m/f)="" noel="" for="" oncogenic="" effects="" 600="" ppm="" (31/37="" mg/kg="" b.w./day="" m/f)="" 18-month="" mouse="" dietary...............="" noel="" for="" chronic="" effects="" 20="" ppm="" (2.8/3.7="" mg/kg="" b.w./day="" m/f)="" noel="" for="" oncogenic="" effects="" 240="" ppm="" (34.5/44.5="" mg/kg="" b.w./day="" m/="" f)="" 6.="" endocrine="" effects.="" collective="" organ="" weights="" and="" histopathological="" findings="" from="" the="" two-generation="" rat="" reproduction="" study,="" as="" well="" as="" from="" the="" subchronic="" and="" chronic="" toxicity="" studies="" in="" two="" or="" more="" animal="" species,="" demonstrate="" no="" apparent="" estrogenic="" effects="" or="" effects="" on="" the="" endocrine="" system.="" there="" is="" no="" information="" available="" which="" suggests="" that="" chlorfenapyr="" would="" be="" associated="" with="" endocrine="" effects.="" 7.="" animal="" metabolism.="" a="" metabolism="" study="" was="" conducted="" in="" sprague-="" dawley="" rats="" at="" approximately="" 20="" and="" 200="" mg/kg="" b.w.="" using="" radiolabeled="" chlorfenapyr.="" approximately="" 65%="" of="" the="" administered="" dose="" was="" eliminated="" during="" the="" first="" 24="" hours="" (62%="" in="" feces="" and="" 3%="" in="" urine)="" and="" by="" 48="" hours="" following="" dosing,="" approximately="" 85%="" of="" the="" dose="" had="" been="" excreted="" (80%="" in="" feces="" and="" 5%="" in="" urine).="" the="" absorbed="" chlorfenapyr-related="" residues="" were="" distributed="" throughout="" the="" body="" and="" detected="" in="" tissues="" and="" organs="" of="" all="" treatment="" groups.="" the="" principal="" route="" of="" elimination="" was="" via="" feces,="" mainly="" as="" unchanged="" parent="" plus="" minor="" n-dealkylated,="" debrominated,="" and="" hydroxylated="" oxidation="" products.="" the="" metabolic="" pathway="" of="" chlorfenapyr="" in="" the="" laying="" hen="" and="" the="" lactating="" goat="" was="" also="" similar="" to="" that="" in="" laboratory="" rats.="" 8.="" metabolite="" toxicology.="" the="" parent="" molecule="" is="" the="" only="" moiety="" of="" toxicological="" significance="" which="" needs="" [[page="" 5402]]="" regulation="" in="" plant="" and="" animal="" commodities.="" c.="" aggregate="" exposure="" 1.="" dietary="" exposure--i.="" food.="" the="" potential="" dietary="" exposure="" has="" been="" calculated="" from="" the="" tolerance="" of="" chlorfenapyr="" in/on="" cottonseed="" at="" 0.5="" ppm.="" this="" exposure="" assessment="" is="" based="" on="" very="" conservative="" assumptions,="" namely="" 100%="" of="" all="" cotton="" is="" treated="" with="" chlorfenapyr="" and="" that="" the="" residues="" of="" chlorfenapyr="" in="" cottonseed="" are="" at="" the="" tolerance="" level.="" as="" there="" are="" no="" other="" established="" u.s.="" permanent="" tolerances="" for="" chlorfenapyr,="" the="" only="" dietary="" exposure="" to="" residues="" of="" chlorfenapyr="" in="" or="" on="" food="" will="" be="" limited="" to="" residues="" in="" cottonseed="" meal="" and="" food="" and="" feed="" items="" derived="" from="" cottonseed.="" as="" cottonseed="" meal="" is="" a="" dairy="" and="" beef="" cattle="" feed="" item,="" a="" cold="" feeding="" study="" with="" dairy="" cattle="" was="" conducted.="" since="" this="" study="" demonstrated="" that="" measurable="" residues="" of="" chlorfenapyr="" may="" occur="" in="" milk,="" meat,="" and="" meat="" by="" products,="" appropriate="" residue="" tolerances="" for="" these="" items="" are="" proposed.="" the="" contribution="" of="" all="" these="" tolerances="" to="" the="" daily="" consumption="" uses="" less="" than="" 1%="" (actual="" 0.62%)="" of="" the="" reference="" dose="" (rfd)="" for="" the="" overall="" u.s.="" population="" and="" less="" than="" 2%="" (actual="" 1.8%)="" and="" less="" than="" 1%="" (actual="" 0.81%)="" of="" the="" rfds="" for="" children="" aged="" 1-6="" and="" for="" non-nursing="" infants,="" respectively.="" ii.="" drinking="" water.="" there="" is="" no="" available="" information="" about="" chlorfenapyr="" exposures="" via="" levels="" in="" drinking="" water.="" there="" is="" no="" concern="" for="" exposure="" to="" residues="" of="" chlorfenapyr="" in="" drinking="" water="" because="" of="" its="" extremely="" low-water="" solubility="" (120="" parts="" per="" billion="" (ppb)="" at="" 25="" deg.="" c).="" chlorfenapyr="" is="" also="" immobile="" in="" soil="" and="" does="" not="" leach="" because="" it="" is="" strongly="" absorbed="" in="" all="" common="" soil="" types.="" in="" addition,="" the="" label="" explicitly="" prohibits="" applications="" near="" aquatic="" areas.="" american="" cyanamid="" believes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" dietary="" exposure="" to="" chlorfenapyr,="" because="" dietary="" exposure="" to="" residues="" on="" food="" will="" use="" only="" a="" small="" fraction="" of="" the="" rfd="" (including="" exposure="" of="" sensitive="" subpopulations),="" and="" exposure="" through="" drinking="" water="" is="" expected="" to="" be="" insignificant.="" 2.="" non-dietary="" exposure.="" there="" is="" no="" available="" information="" quantifying="" non-dietary="" exposure="" to="" chlorfenapyr.="" however,="" based="" on="" the="" physico-chemical="" characteristics="" of="" the="" compound,="" the="" proposed="" use="" pattern="" and="" available="" information="" concerning="" its="" environmental="" fate,="" non-dietary="" exposure="" is="" expected="" to="" be="" negligible.="" the="" vapor="" pressure="" of="" chlorfenapyr="" is="" less="" than="" 1="" x="">-7millimeters (mm) of mercury 
    (Hg); therefore, the potential for non-occupational exposure by 
    inhalation is insignificant. Moreover, the current proposed 
    registration is for outdoor, terrestrial uses which severely limit the 
    potential for non-occupational exposure.
    
    D. Cumulative Effects
    
        The pyrrole insecticides represent a new class of chemistry with a 
    unique mechanism of action. The parent molecule, AC303,630 is a pro-
    insecticide which is converted to the active form, CL303,268, via rapid 
    metabolism by mixed function oxidases (MFOs). The active form uncouples 
    oxidative phosphorylation in the insect mitochondria by disrupting the 
    proton gradient across the mitochondrial membrane. The production of 
    adenosine triphosphate (ATP) is inhibited resulting in the cessation of 
    all cellular functions. Because of this unique mechanism of action, 
    American Cyanamid believes that it is highly unlikely that toxic 
    effects produced by chlorfenapyr would be cumulative with those of any 
    other pesticide chemical.
        In mammals, there is a lower titer of MFOs, and chlorfenapyr is 
    metabolized by different pathways (including dehalogenation, oxidation, 
    and ring hydroxylation) to other polar metabolites without any 
    significant accumulation of the potent uncoupler, CL303,268. In the 
    rat, approximately 85% of the administered dose is excreted in the 
    feces within 48 hours, thereby reducing the levels of AC303,630 and 
    CL303,268 that are capable of reaching the mitochondria. This 
    differential metabolism of AC303,630 to CL303,268 in insects, versus to 
    other polar metabolites in mammals, is responsible for the selective 
    insect toxicity of the pyrroles.
    
    E. Safety Determination
    
        1. U. S. population. The RfD of 0.03 mg/kg b.w./day for the 
    residues of chlorfenapyr in cotton is calculated by applying a 100-fold 
    safety factor to the overall no observed effect level (NOEL) of 3 mg/kg 
    b.w./day. This NOEL is based on the results of the chronic feeding 
    studies in the rat and mouse and the two-generation reproduction study 
    in the rat (see Unit I.E.2. of this document). Therefore, the combined 
    exposure for the proposed chlorfenapyr tolerances in cottonseed, milk, 
    and meat (0.0001866 mg/kg b.w./day) will utilize approximately 0.62% of 
    the RfD for the general U.S. population.
        2. Infants and children. The theoretical maximum residue 
    contribution (TMRC) in milk consumed by a non-nursing infant (<1 year="" of="" age)="" is="" 0.0002435="" mg/kg="" b.w./day.="" this="" will="" use="" less="" than="" 1%="" (actual="" 0.81%)="" of="" the="" rfd="" for="" non-nursing="" infants.="" the="" tmrc="" in="" milk="" consumed="" by="" a="" child="" (1-6="" years="" of="" age)="" is="" 0.0003886="" mg/kg="" b.w./day.="" the="" combined="" tmrc="" for="" the="" proposed="" chlorfenapyr="" tolerances="" in="" meat="" and="" milk="" consumed="" by="" a="" child="" 1-6="" years="" of="" age="" is="" 0.0005415="" mg/kg="" b.w./day,="" which="" is="" less="" than="" 2%="" (actual="" 1.8%)="" of="" the="" rfd.="" therefore,="" american="" cyanamid="" believes="" that="" the="" results="" of="" the="" toxicology="" and="" metabolism="" studies="" support="" both="" the="" safety="" of="" chlorfenapyr="" to="" humans="" based="" on="" the="" intended="" use="" as="" an="" insecticide-miticide="" on="" cotton="" and="" the="" granting="" of="" the="" requested="" tolerances="" in="" cottonseed,="" milk,="" milk="" fat="" solids,="" meat,="" and="" meat="" by-="" products.="" based="" on="" the="" conservative="" assumptions="" used="" in="" proposing="" the="" above="" tolerances="" and="" the="" absence="" of="" other="" non-dietary="" routes="" of="" exposure="" to="" chlorfenapyr,="" and="" since="" the="" calculated="" exposures="" are="" well="" below="" 100%="" of="" the="" rfd,="" american="" cyanamid="" believes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" residues="" of="" chlorfenapyr,="" including="" all="" anticipated="" dietary="" exposure="" and="" all="" other="" non-occupational="" exposures.="" american="" cyanamid="" believes="" that="" the="" use="" of="" a="" 100-fold="" safety="" factor="" ensures="" an="" acceptable="" margin="" of="" safety="" for="" both="" the="" overall="" u.="" s.="" population="" as="" well="" as="" infants="" and="" children.="" american="" cyanamid="" concludes="" that="" the="" toxicology="" data="" base="" (reproduction/developmental="" and="" teratology="" studies)="" is="" complete,="" valid,="" and="" reliable,="" and="" therefore="" no="" additional="" safety="" factor="" is="" needed.="" the="" 100-fold="" margin="" of="" safety="" is="" adequate="" to="" assure="" a="" reasonable="" certainty="" of="" no="" harm="" to="" infants="" and="" children="" from="" the="" proposed="" use.="" as="" stated="" earlier,="" the="" noel="" is="" based="" on="" the="" effects="" observed="" in="" the="" rat="" and="" mouse="" chronic="" oncogenicity="" studies,="" (reduced="" body="" weight="" gains,="" increased="" globulin="" and="" cholesterol="" values,="" and="" increased="" liver="" weights="" in="" the="" rat="" and="" reduced="" body="" weight="" gains="" and="" vacuolation="" of="" white="" matter="" of="" the="" mouse="" brain),="" the="" 1-year="" neurotoxicity="" study="" in="" the="" rat,="" (reduced="" body="" weight="" gains="" and="" vacuolar="" myelinopathy="" of="" the="" brain="" and="" spinal="" cord="" that="" is="" completely="" reversible="" following="" termination="" of="" treatment="" and="" is="" not="" associated="" with="" any="" damage="" to="" neuronal="" cell="" bodies="" or="" axons;="" vacuolation="" of="" the="" white="" matter="" is="" a="" consequence="" of="" edema="" (water)="" formation="" between="" the="" myelin="" layers="" which="" result="" from="" the="" unrestricted="" movement="" of="" ions="" across="" the="" cell="" membranes)="" and="" the="" two-="" generation="" rat="" reproduction="" study,="" (reduced="" body="" weight="" gains="" for="" parental="" animals="" and="" reduced="" pup="" body="" weights="" for="" the="">1 and 
    F2 litters; however no
    
    [[Page 5403]]
    
    behavioral changes were observed in either F1 or F2 
    offsprings in the two-generation reproduction study). Moreover, as the 
    NOELs for fetal/developmental toxicity are significantly higher than 
    those for maternal toxicity, the results indicate that chlorfenapyr is 
    neither a developmental toxicant nor a teratogenic agent in either the 
    Sprague-Dawley rat or New Zealand white rabbit. Thus, there is no 
    reliable information to indicate that there would be a variability in 
    the sensitivities of infants and children and adults to the effects of 
    exposure to chlorfenapyr.
        Therefore, a chronic dietary exposure analysis for the residues of 
    chlorfenapyr in cotton, meat, and milk, using the ``worst case'' 
    proposed tolerance-level residues, demonstrates that these levels are 
    well below the RfD of 0.03 mg/kg b.w./day and thus the proposed use of 
    chlorfenapyr is toxicologically supported.
    
    F. International Tolerances
    
        Section 408(b)(4) of the amended FFDCA requires EPA to determine 
    whether a maximum residue level has been established for the pesticide 
    chemical by the Codex Alimentarius Commission.
        There is neither a Codex proposal, nor Canadian or Mexican 
    tolerances/limits for residues of chlorfenapyr in/on cottonseed. 
    Therefore, a compatibility issue is not relevant to the proposed 
    tolerance.
    
    II. Public Record
    
        EPA invites interested persons to submit comments on this notice of 
    filing. Comments must bear a notification indicating the docket control 
    number [PF-697]. All written comments filed in response to this 
    petition will be available, in the Public Response and Program 
    Resources Branch, at the address given above from 8:30 a.m. to 4 p.m., 
    Monday through Friday, except legal holidays.
        A record has been established for this notice under docket control 
    numbers [PF-697] (including comments and data submitted electronically 
    as described below). A public version of this record, including 
    printed, paper versions of electronic comments, which does not include 
    any information claimed as CBI, is available for inspection from 8:30 
    a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
    public record is located in Room 1132 of the Public Response and 
    Program Resources Branch, Field Operations Division (7506C), Office of 
    Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
    1921 Jefferson Davis Highway, Arlington, VA.
        Electronic comments can be sent directly to EPA at:
        opp-docket@epamail.epa.gov
    
        Electronic comments must be submitted as ASCII file avoiding the 
    use of special characters and any form of encryption. The official 
    record for this notice, as well as the public version, as described 
    above will be kept in paper form. Accordingly, EPA will transfer all 
    comments received electronically into printed, paper form as they are 
    received and will place the paper copies in the official record which 
    will also include all comments submitted directly in writing.
        The official record is the paper record maintained at the address 
    in ``ADDRESSES'' at the beginning of this notice.
    
    List of Subjects
    
        Environmental protection, Agricultural commodities, Pesticides and 
    pests, Reporting and recordkeeping.
    
        Dated: January 24, 1997.
    
    Stephen L. Johnson,
    Director, Registration Division, Office of Pesticide Programs.
    
    [FR Doc. 97-2466 Filed 2-4-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
02/05/1997
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice of filing.
Document Number:
97-2466
Dates:
Comments, identified by the docket control number [PF-697], must be received on or before March 7, 1997.
Pages:
5399-5403 (5 pages)
Docket Numbers:
PF-697, FRL-5584-4
PDF File:
97-2466.pdf