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 Environmental Protection Agency [OPP-2004-0398; FRL-7689-1]
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Notice.
 SUMMARY: This  notice announces the initial filing of a pesticide petition proposing the establishment  of regulations for residues of    a    certain    pesticide   chemical   in   or   on   various    food commodities.
 DATES: Comments,  identified by docket identification(ID) number OPP-2004-0398, must  be  received  on or before January 7, 2005.
 ADDRESSES: Comments may be submitted electronically,  by mail,  or  through hand delivery/courier.  Follow the detailed instructions as   provided    in    Unit    I.    of    the 
                        **SUPPLEMENTARY INFORMATION**
                        .
 FOR FURTHER INFORMATION CONTACT: Joanne I. Miller,Registration Division (7505C), Office of Pesticide Programs,  Environmental Protection    Agency,    1200   Pennsylvania   Ave.,   NW.,Washington,   DC 20460-0001; telephone  number: (703) 305-6224;  e-mail address:
                        *miller.joanne@epamail.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 entities may include, but are not limited to: Crop production (NAICS 111)
                Animal production (NAICS 112)
                Food manufacturing (NAICS 311)
                Pesticide manufacturing (NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers  regarding  entities  likely  to  be  affected  by this action.  Other  types  of  entities  not  listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others  in  determining  whether  this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under 
                    **FOR FURTHER INFORMATION CONTACT**
                    . B.   How  Can  I  Get  Copies  of  this  Document  and  Other  Related Information? 1. 
                    *Docket.*
                     EPA  has established an official public docket  for  this action under docket ID number  OPP-2004-0398.The  official  public   docket   consists  of  the  documents  specifically referenced  in  this  action,  any  public  comments  received,  and  other information related to this action.   Although,  a  part  of  the  official docket,   the   public   docket  does  not  include  Confidential  Business Information (CBI) or other  information  whose  disclosure is restricted by statute.  The official public docket is the collection of materials that is available  for  public  viewing  at  the  Public  Information  and  Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall     #2,  1801  S.  Bell St., Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m.,Monday  through  Friday,  excluding  legal  holidays.  The docket telephone number is (703) 305-5805. 2. 
                    *Electronic access*. You may access this 
                    **Federal  Register**
                     document electronically through the EPA Internet under the “
                    **Federal Register**
                    ” listings at 
                    *http://www.epa.gov/​fedrgstr/​*. An electronic version of the public docket is available through EPA's electronic  public  docket  and comment system, EPA Dockets.  You may use EPA Dockets at 
                    *http://www.epa.gov/​edocket/​*
                     to  submit or view  public  comments,  access  the  index  listing of the contents of the official public docket, and to access those documents  in the public docket that are available electronically. Although, not all docket  materials  may be  available  electronically,  you  may  still  access any of the publicly available docket materials through the docket facility  identified  in Unit I.B.1.   Once  in the system, select “search,” then key in  the appropriate docket ID number. Certain  types  of  information  will  not  be placed in the EPA Dockets.  Information claimed as CBI and other information whose disclosure is  restricted  by  statute,  which is not included in the official  public docket, will not be available for public viewing in EPA's electronic public docket.  EPA's policy is that copyrighted  material  will  not be placed in EPA's electronic public docket but will be available only in printed, paper form  in  the  official  public  docket.  To the extent feasible,  publicly available  docket materials will be  made  available  in  EPA's  electronic public docket.   When  a  document  is  selected from the index list in EPA Dockets, the system will identify whether  the  document  is  available for viewing  in  EPA's  electronic  public  docket.  Although,  not  all docket materials may 
                    ( print page 71046)
                    be available electronically, you may still access any  of the publicly  available docket materials through the docket facility identified in Unit I.B.   EPA  intends  to work towards providing electronic access to all of the publicly available  docket  materials  through  EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public  docket  as EPA   receives  them  and  without  change,  unless  the  comment  contains copyrighted  material,  CBI,  or  other  information  whose  disclosure  is restricted   by   statute.    When  EPA  identifies  a  comment  containing copyrighted material, EPA will  provide a reference to that material in the version of the comment that is placed  in  EPA's  electronic public docket. The  entire printed comment, including the copyrighted  material,  will  be available in the public docket. Public  comments  submitted on computer disks that are mailed or delivered to the docket will be  transferred  to  EPA's  electronic  public docket.  Public comments that are mailed or delivered to the docket will be scanned  and  placed  in  EPA's electronic public docket.  Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket  along  with  a brief description written by the docket staff. C.  How and to Whom Do I Submit Comments? You may submit comments electronically,  by  mail,  or through hand delivery/courier.    To   ensure  proper  receipt  by  EPA,  identify   the appropriate docket ID number  in the subject line on the first page of your comment.   Please  ensure  that your  comments  are  submitted  within  the specified comment period.  Comments received after the close of the comment period will be marked “late.”   EPA is not required to consider these  late  comments. If you wish to submit CBI  or  information  that  is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA  Dockets or e-mail to submit CBI or information protected by statute. 1. 
                    *Electronically*.   If  you  submit  an  electronic comment as prescribed  in  this  unit, EPA recommends that you include your name, mailing address, and an e-mail  address  or other contact information in the body of your comment.  Also, include this contact information on the outside  of  any  disk  or  CD  ROM  you submit, and in  any  cover  letter accompanying the disk or CD ROM.  This  ensures  that you can be identified as the submitter of the comment and allows EPA to  contact  you in case EPA cannot  read  your  comment due to technical difficulties or needs  further information on the substance  of  your  comment.   EPA's policy is that EPA will  not  edit  your  comment, and any identifying or contact  information provided in the body of  a  comment will be included as part of the comment that is placed in the official  public  docket, and made available in EPA's electronic public docket.  If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification,  EPA may not be able to consider your comment. i. 
                    *EPA Dockets*.  Your use of EPA's electronic  public docket to submit  comments  to EPA electronically is EPA's preferred method for   receiving   comments.    Go   directly   to   EPA   Dockets   at 
                    *http://www.epa.gov/​edocket/​*,  and follow the online instructions for submitting comments.  Once in the system,  select “search,” and then key in docket ID number OPP-2004-0398.  The  system is an  “anonymous  access”  system, which means EPA will not  know your  identity, e-mail address, or other  contact  information  unless  you provide it in the body of your comment. ii. 
                    *E-mail*.   Comments  may  be  sent by e-mail to 
                    *opp-docket@epa.gov*,      Attention:     Docket     ID     number OPP-2004-0398.  In contrast  to EPA's electronic public docket, EPA's e-mail system is not an “anonymous  access”  system.   If you  send  an  e-mail  comment directly to the docket without going through EPA's electronic public  docket, EPA's e-mail system automatically captures your e-mail address.  E-mail  addresses  that are automatically captured by EPA's e-mail system are included as part of  the  comment that is placed in the official public docket, and made available in EPA's  electronic  public docket. iii. 
                    *Disk or CD ROM*.  You may submit comments on a  disk or  CD  ROM  that you mail to the mailing address identified in Unit I.C.2. These electronic  submissions will be accepted in WordPerfect or ASCII file format.   Avoid  the   use   of   special   characters   and  any  form  of encryption. 2. 
                    *By  mail*.   Send  your  comments  to:    Public Information  and  Records  Integrity  Branch  (PIRIB)  (7502C),  Office  of Pesticide   Programs   (OPP),   Environmental   Protection   Agency,   1200 Pennsylvania  Ave., NW., Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0398. 3. 
                    *By hand delivery or courier*.  Deliver your comments to:  Public Information  and  Records  Integrity  Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention:  Docket  ID number OPP-2004-0398.   Such  deliveries are only accepted during  the docket's normal hours of operation as identified in Unit I.B.1. D.  How Should I Submit CBI to the Agency? Do  not  submit  information  that   you   consider   to  be  CBI electronically  through  EPA's electronic public docket or by e-mail.   You may claim information that  you submit to EPA as CBI by marking any part or all of that information as CBI  (if  you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI  and  then identify electronically within  the  disk  or  CD  ROM  the  specific  information  that  is  CBI). Information  so  marked  will not be disclosed except  in  accordance  with procedures set forth in 40 CFR part 2. In addition to one  complete  version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the  information  claimed as CBI must be submitted  for  inclusion  in  the public docket and EPA's  electronic  public docket.  If you submit the copy that does not contain CBI on disk or CD  ROM,  mark the outside of the disk or CD ROM clearly that it does not contain CBI.   Information not marked as CBI  will  be  included  in the public docket and EPA's  electronic  public docket without prior notice.   If  you  have any questions about CBI or the procedures for claiming CBI, please consult  the  person  listed  under 
                    **FOR FURTHER INFORMATION CONTACT**
                    . E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1.   Explain your views as clearly as possible. 2.   Describe any assumptions that you used. 3.   Provide  copies  of  any technical information and/or data you used that support your views. 4.   If you estimate potential  burden or costs, explain how you arrived at the estimate that you provide. 5.   Provide specific examples to illustrate your concerns. 6.    Make  sure  to  submit  your comments  by  the  deadline  in  this notice. 7.   To ensure proper receipt by  EPA, be sure to identify the docket ID number assigned to this action in the  subject  line  on  the first page of your  response. 
                    ( print page 71047)
                    You may also provide the name, date, and 
                    **Federal Register**
                     citation. II. What Action is the Agency Taking? EPA  has  received  a  pesticide petition as follows proposing the establishment and/or amendment of  regulations  for  residues  of a certain pesticide chemical in or on various food commodities under section  408  of the  Federal  Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that  this  petition  contains data or information regarding the elements set forth in FFDCA section  408(d)(2);  however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data  support  granting of the petition.  Additional  data  may  be  needed before EPA rules on the petition. List of Subjects Environmental protection
Agricultural commodities
Feed additives
Food  additives
Pesticides   and   pests
Reporting  and  recordkeeping requirements
 Dated: November 24, 2004. Lois Rossi, Director,    Registration    Division,     Office    of    Pesticide Programs.
 Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary  of  the  petition  was prepared  by  Valent  U.S.A.  Corporation  and  represents  the view of the petitioner.   The   petition  summary  announces  the  availability  of   a description of the analytical  methods  available  to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. Valent U.S.A. Corportion PP 4F6829 EPA has received a pesticide petition (4F6829)  from Valent U.S.A. Corporation,  1600  Riviera  Ave.,  Suite  200,  Walnut  Creek,  CA  94596, proposing,  pursuant  to  section  408(d)  of the Federal Food,  Drug,  and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to  amend  40  CFR  part  180,  by establishing   a   tolerance   for   residues  of  the  herbicide  chemical flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in  or  on  the  following  raw agricultural commodities: Fruit, pome (Crop Group 11) at 0.02 parts per million  (ppm) and fruit, stone (Crop Group 12) at  0.02  ppm.   EPA has determined that  the  petition  contains  data  or information regarding  the  elements  set forth in section 408(d)(2) of the FFDCA;  however,  EPA  has  not  fully evaluated  the  sufficiency  of  the submitted data at this time or whether  the  data  support  granting of the petition.   Additional  data  may  be  needed  before  EPA  rules  on   the petition. A. Residue Chemistry 1. 
                    *Plant metabolism*. The metabolism of flumioxazin is adequately understood for the purpose of the proposed tolerances. 2. 
                    *Analytical  method*.   Practical analytical methods for detecting and measuring levels of flumioxazin  have  been developed and validated in or on all appropriate agricultural commodities  and respective processing  fractions.   The limit of quantitation (LOQ) of flumioxazin  in the methods is 0.02 ppm which  will  allow monitoring of food with residues at the levels proposed for the tolerances. 3. 
                    *Magnitude of residues*.   Residue  data  on apples, pears,  plums,  peaches,  and cherries (sweet and tart) have been submitted which adequately support the requested tolerances.  Processing studies were conducted with apples and plums.   No residues of flumioxazin were detected in  any  of  the  raw agricultural commodities  or  processing  commodities collected  from these  studies  even  when  orchards  were  treated  at  an exaggerated  (2x)  rate.   No  tolerances  are  proposed  for apple or plum processing commodities. B. Toxicological Profile The  toxicological  profile  for  flumioxazin which supports  this petition for tolerances was previously published  in  the 
                    **Federal Register**
                     of April 18, 2001 (66 FR 19870) (FRL-6778-5). C. Aggregate Exposure 1. 
                    *Dietary  exposure*.   Acute  and  chronic   dietary analyses  were  conducted  to  estimate  exposure  to potential flumioxazin residues  in  or  on the following crops:  Peanuts and  soybeans  (existing tolerances); cotton,  grapes,  almond, pistachio, and sugarcane, vegetable, tuberous and corm (Subgroup 1C),  onion,  dry  bulb  and  mint  (tolerances pending); nut, tree (Group 14), (tolerances to be proposed in the  future); and fruit, pome (Group 11) and fruit, stone (Group 12) (tolerances proposed in  the  current  petition).   The Cumulative and Aggregate Risk Evaluation System (CARES) Version 1.1 was used  to  conduct this assessment.  Proposed tolerances and conservative estimates for  percentages  of the percent crop treated  were  used  in  these assessments.  No adjustments were  made  for common washing, cooking, or  preparation  practices. Exposure estimates for water  were  made  based  upon  modeling  Generic   Expected  Environmental Concentration (GENEEC 1.2) i. 
                    *Food*
                    —a. 
                    *Acute.*
                     The acute dietary exposure   estimate  of  flumioxazin  residues  in  food  at   the   99.9th
                     percentile was calculated to be, at most, 26.3% of the acute reference dose (aRfD)  with  a  margin  of  exposure  (MOE)  of 3,797.  The population subgroup with the highest exposure was children 1-2  years old.   The aRfD was defined as the no observed adverse effect level (NOAEL) from an oral developmental study in rats and includes an uncertainty factor of 100 to  account  for  intraspecies  and  interspecies  variation  and an additional   10-fold   uncertainty   factor   for  FQPA  (NOAEL  =  3 milligrams/kilogram   body   weight   (mg/kg   bwt/day),   aRfD   =   0.003 mg/kg/day). b. 
                    *Chronic.*
                     The chronic dietary exposure estimate of flumioxazin  residues  in  food  at the 100th
                     percentile  was calculated to be, at most, 2.5% of the chronic reference dose (cRfD) with a MOE of 40,000.  The population subgroup  with  the highest exposure was the general U.S. population.  The cRfD was defined as  the  NOAEL  from  a  rat 2-year  chronic/oncogenicity study and includes an uncertainty factor of 100 to account  for  intraspecies  and  interspecies  variation  and  an additional 10-fold uncertainty factor for Food Quality Protection Act (FQPA) (NOAEL = 2 mg/kg bwt/day, cRfD = 0.002 mg/kg/day). ii. 
                    *Drinking  water*.    Since  flumioxazin is applied outdoors to growing agricultural crops, the potential exists for the parent or its metabolites to reach ground water or surface water  that may be used for  drinking water. Because of the physical properties of flumioxazin,  it is unlikely that flumioxazin or its metabolites can leach to potable ground water.   To  quantify potential exposure from drinking water, surface water concentrations for flumioxazin were estimated using GENEEC 1.2. Because KOC could not be measured  directly in adsorption-desorption studies because of chemical stability, GENEEC  values  representative of a range of KOC values were modeled. The simulation that was selected for these exposure estimates used  an average KOC of 385, indicating  high  mobility.  The  peak  GENEEC concentration  predicted  in  the  simulated  pond  water was 9.8 parts per billion  (ppb).   Using standard assumptions about body  weight  and  water consumption, the acute  exposure  from this drinking water would be 0.00028 and  0.00098  mg/kg/day  for 
                    ( print page 71048)
                     adults  and   children,   respectively.   The 56-day GENEEC concentration predicted in the simulated pond water was 0.34  ppb. Chronic exposure from this drinking water would be 0.0000097 and 0.000034  mg/kg/day  for  adults  and  children,  respectively; 1.7% of the chronic  population adjusted dose (cPAD) of 0.002 mg/kg/day  for  children. Based on this  worse  case  analysis, the contribution of drinking water to the dietary exposure is comparable to that from food, but the risk is still negligible. 2. 
                    *Non-dietary exposure*.  Flumioxazin is proposed only for agricultural uses and no   homeowner or turf uses. Thus, no non-dietary risk assessment is needed. D. Cumulative Effects Section 408(b)(2)(D)(v)  requires  that  the Agency must consider “available information” concerning the cumulative  effects of a particular  pesticide's  residues and “other substances that  have  a common mechanism of toxicity.”  Available information in this context include  not  only  toxicity,   chemistry,  and  exposure  data,  but  also scientific policies and methodologies  for  understanding common mechanisms of  toxicity  and  conducting cumulative risk assessments.   Although,  the Agency has some information in its files that may turn out to be helpful in eventually determining  whether  a  pesticide  shares a common mechanism of toxicity with any other substances, EPA does not  at  this  time  have  the methodologies  to  resolve  the complex scientific issues concerning common mechanism   of  toxicity  in  a  meaningful   way   for   most   registered pesticides. E. Safety Determination 1. 
                    *U.S. population*
                    —i. 
                    *Acute risk*
                    . The potential  acute  exposure from food to the U.S. population and various non-child/infant population  subgroups  will  utilize  at most 14.2% of the aRfD.   Addition  of the worse case, dietary exposure from  water  (0.00028 mg/kg/day) increases  this  exposure at the 99.9th
                     percentile to 23.7% of the aRfD.  The Agency  has  no cause for concern if total acute residue  contribution  is  less than 100% of  the  aRfD,  because  the  RfD represents the level at or below  which  daily  aggregate  exposure  over a lifetime will not pose appreciable risk to human health.  Therefore, it can be  concluded that there is a reasonable certainty that no harm will result to  the   overall   U.S.  population  from  aggregate,  acute  exposure  to flumioxazin residues. ii. 
                    *Chronic  risk*
                    .  The potential chronic exposure from food  to  the  U.S.  population  and  various  non-child/infant  population subgroups will utilize at most 2.5%  of  the  cRfD.   Addition of the worse case,  dietary  exposure  from water (0.0000097 mg/kg/day)  increases  this exposure at the 100th
                     percentile  to  3.0% of the cRfD.  The Agency  has no cause for concern if total chronic residue  contribution  is less than  100%  of  the  cRfD,  because the RfD represents the level at or below  which  daily  aggregate exposure  over  a  lifetime  will  not  pose appreciable risk to human  health.   Therefore,  it  can  be concluded that there  is  a reasonable certainty that no harm will result to  the  overall U.S.  population   from   aggregate,   chronic   exposure   to  flumioxazin residues. 2. 
                    *Infants  and  children*
                    —i. 
                    *Safety factor for infants and children*.  The FQPA safety factor  (as  required by the Food Quality Protection Act of August 3, 1996) has been retained  at 10x  in assessing the risk posed by flumioxazin.  The reasons for retaining the 10x safety factor are as follows. First, there is evidence of increased susceptibility  of  rat  fetuses  to 
                    *in  utero*
                     exposure to flumioxazin  by  the  oral  and  dermal route in the prenatal developmental toxicity studies in rats.  In addition,  there  is  evidence  of  increased susceptibility  of young animals exposed to flumioxazin in the 2-generation reproduction toxicity  study  in  rats.   Finally, there is concern for the severity of the effects observed in fetuses and young animals when compared to  those  observed  in  the  maternal  and parental  animals.   Since  the additional 10x safety factor has been retained  to account for the apparent increased   susceptibility   from  prenatal  or  postnatal   exposures   to flumioxazin, it would be appropriate  to  apply the extra 10x safety factor to   only   selected  subpopulations,  e.g.,  infants   and   children 
                    <
                    6 years old and females 
                    >
                    13 years old.  For these assessments,  however,  the 10x safety factor has been applied to all population subgroups for all exposure  durations  (acute and chronic), thus making these assessments additionally conservative. ii. 
                    *Acute risk.*
                     The potential  acute  exposure  from food to children  1-2 years old (the most highly exposed child/infant subgroup) will utilize  at  most  26.3% of the aRfD.  Addition of the worse case,  dietary  exposure  from  water (0.00098  mg/kg/day)  increases  this exposure  at  the 99.9th
                     percentile  to  59%  of  the  aRfD. Therefore, it can  be  concluded that, there is a reasonable certainty that no harm will result to infants  and children from aggregate, acute exposure to flumioxazin residues. iii. 
                    *Chronic risk.*
                     The  potential  chronic  exposure from  food  to  children  1-2  years  old  (the  most  highly exposed child/infant subgroup) will utilize at most 2.4% of the cRfD.   Addition of the worse case, dietary exposure from water (0.000034 mg/kg/day)  increases this  exposure  at the 100th
                     percentile to 4.2% of the  cRfD. Therefore, it can be concluded that there is a reasonable certainty that no harm will result  to  infants and children from aggregate, chronic exposure to flumioxazin residues. F. 
                    *International Tolerances.* Flumioxazin has not  been  evaluated  by  the joint meeting on pesticide residues (JMPR) and there are no codex Maximum  Residue  Limits  (MRL)  for flumioxazin.  MRL  values have been established to allow the following uses of flumioxazin in the following countries. Country
Crop
MRL (ppm)Argentina
Soybean 
                             Sunflower
0.015 
                             0.02Brazil
Soybean
0.05France
Grape
0.05Paraguay
Soybean
0.015South Africa
Soybean 
                             Groundnut
0.02 
                             0.02Spain
Soybean 
                             Peanut
0.05 
                             0.05


[FR Doc. 04-26819 Filed 12-7-04; 8:45 am] BILLING CODE 6560-50-S