[Federal Register Volume 64, Number 226 (Wednesday, November 24, 1999)]
[Notices]
[Pages 66181-66185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30615]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-904; FRL-6396-4]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-904, must be 
received on or before December 27, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION:. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-904 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Cynthia Giles-Parker, 
Fungicide Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 305-7740; e-mail address: giles-
[email protected].


[[Page 66182]]


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, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
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Industry                          111                 Crop production
 
                                  112                 Animal production
 
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``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 Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
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 PF-904. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-904 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-904. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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 
control number assigned to this action in the subject line on the first 
page of your response. 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 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports 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

[[Page 66183]]

and pests, Reporting and recordkeeping requirements.

    Dated: November 18, 1999.
James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. 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.

BASF Corporation

PP1F3955 and PP1H5610

Summary of Petition
    EPA has received pesticide petitions (PP1F3955 and PP1H5610) from 
BASF Corporation, P.O. Box 13528, RTP, NC 27709-3528 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 mepiquat chloride, N,N-dimethylpiperidinium 
chloride in or on the raw agricultural commodity grapes at 1.0 parts 
per million (ppm) and raisins at 5.0 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 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of mepiquat chloride in plants 
and animals is well understood. Based on a nature of the residue study 
in grapes and supported by similar studies in cotton, the residue of 
concern from mepiquat chloride use in grapes consists only of the 
parent compound.
    2. Analytical method. An adequate analytical method for enforcement 
of the tolerances exists. The analytical method used for quantitative 
determinations was designed to measure mepiquat chloride residues 
present as the parent compound.
    3. Magnitude of residues. Twenty-eight field trials were conducted 
in grape vineyards with treatments made at the maximum proposed label 
rate. Trials were established in eight states over a 2-year period. Ten 
varieties of grapes were studied in these trials. Sixty-four treated 
samples were obtained and analyzed. The number and geographical 
distribution of the grape residue studies exceeds the current 
requirements for grape tolerances on all grape varieties.
    Grape samples from eight field trials were processed to either 
raisins and raisin waste or grape juice, wet pomace, and dry pomace. 
The processed fractions were analyzed for residues of mepiquat chloride 
to determine the effects of processing on residue levels. Drying the 
grapes to raisins concentrated the residues a maximum of 6 fold. 
Residues did not concentrate in grape juice.

B. Toxicological Profile

    1. Acute toxicity. Based on the acute toxicity data, mepiquat 
chloride does not pose any acute toxicity risks. The acute toxicology 
studies place mepiquat chloride in toxicity category II for acute oral 
toxicity, category III for acute dermal, and toxicity category IV for 
acute inhalation toxicity, eye irritation and dermal irritation. 
Mepiquat chloride is not a skin sensitizer.
    2. Genotoxicty. The carcinogenic potential of mepiquat chloride was 
evaluated by the OPP's Reference Dose (RfD)/Peer Review Committee on 
May 2, 1996. The Committee classified mepiquat chloride into Group E 
(evidence of noncarcinogenicity for humans), based on a lack of 
carcinogenicity in acceptable studies with two animal species, rat and 
mouse.
    3. Reproductive and developmental toxicity. In a 2-generation 
reproductive toxicity study, Wistar rats were fed mepiquat chloride in 
their diets at concentrations of 0, 500, 1,500, or 5,000 ppm for 10 
weeks (F0) or 14 weeks (F1) before mating, and 
during mating, gestation, and lactation. The F0 parents were 
mated a second time 2 weeks after weaning the first litter. The doses 
corresponding to the dietary concentrations are 51.2 and 48.6, 153.1 
and 146.6, and 499.3 and 574.5 milligrams/kilograms/day (mg/kg/day), 
respectively for F0 and F1 males and 54.0 and 
53.3, 163.6 and 162.0, and 530.0 and 626.5 mg/kg/day, respectively for 
F0 and F1 females.
    The lowest observed adverse effect level (LOAEL) for systemic 
toxicity is 5,000 ppm (499 mg/kg/day) for male and female rats based on 
neurological impairment, decreased body weight and body weight gain in 
the adults, and retarded growth of F0 and F1 
pups. The corresponding no observed adverse effect level (NOAEL) is 
1,500 ppm (147 mg/kg/day). OPP's Reference Dose (RfD)/Peer Review 
Committee concluded on May 2, 1996, that, because of the retarded 
growth of the pups in the 5,000 ppm (499 mg/kg/day) group, the systemic 
NOAEL of 1,500 ppm (147 mg/kg/day) would also be regarded as the 
reproductive NOAEL.
    4. Subchronic toxicity. The NOAEL is 58.4 mg/kg/day and the LOAEL 
is 95.3 mg/kg/day based on the combined results for two 1 year feeding 
studies and one 90-day feeding study in dogs. This endpoint is the same 
as that used for acute dietary and chronic RfD.
    5. Chronic toxicity. On May 2, 1996, the OPP's Reference Dose 
(RfD)/Peer Review Committee recommended that the RfD for mepiquat 
chloride be established at 0.6 mg/kg/day. This value was based on the 
systemic NOAEL of 1,800 ppm (58.4 mg/kg/day) from the 1 year dog 
feeding study and the uncertainty factor (UF) of 100.
    i. Chronic feeding--Nonrodent. In a chronic toxicity study, 
mepiquat chloride (99.5%) was administered to beagle dogs in the diet 
at dose levels of 0, 200, 600, or 1,800 ppm (0, 6.3, 19.9 or 58.4 mg/
kg/day, respectively) for 12 months. There were no significant 
treatment-related effects. In order to establish a LOAEL, a second 
chronic toxicity study was conducted at dose levels of 0 or 6,000 ppm 
(170 mg/kg/day) for 12 months. Based on the results of the two chronic 
dog studies, the NOAEL is 1,800 ppm (58.4 mg/kg/day) and the LOAEL is 
6,000 ppm (170 mg/kg/day).
    ii. Chronic feeding--Rats. In a chronic feeding study, mepiquat 
chloride (58%) was administered for 24 months in the diet to Wistar 
rats at concentrations of 0, 290, 2,316, or 5,790 ppm (active 
ingredient), equivalent to doses of 0, 13, 106, 268 mg/kg/day for males 
and 0, 18, 146, or 371 mg/kg/day for females, respectively. The NOAEL 
is 2,316 ppm (105 mg/kg/day). The LOAEL is 5790 ppm (268 mg/kg/day).
    6. Animal metabolism. In a metabolism study, mepiquat chloride, 
labeled with 14C (radiochemical purity: 98%), was administered to young 
adult Sprague-Dawley rats either intravenously or orally. Mepiquat 
chloride was absorbed rapidly from the stomach, distributed evenly in 
the intra-and extracellular compartments of the blood, demonstrated 
high bioavailability via the oral route, was excreted mostly in urine, 
and did not accumulate in tissues. Urine, feces, and bile samples from 
various treatments were used for studies of the metabolic fate of 
mepiquat chloride. In all cases, only the unchanged compound could be

[[Page 66184]]

detected. Therefore, there was no biotransformation of mepiquat 
chloride in vivo. The potential metabolites, such as 1-methylpiperidine 
or piperidine, were not detected.
    7. Endocrine disruption. No specific tests have been conducted with 
mepiquat chloride to determine whether the chemical may have an 
endocrine like effect in humans. However, there were no significant 
findings in other relevant tests (developmental and reproductive 
toxicity tests) which would suggest that mepiquat chloride produces 
endocrine like effects.

C. Aggregate Exposure

    1. Dietary exposure. The mepiquat chloride Registration Eligibility 
Decision (RED) indicates that EPA has found no dietary risks of concern 
for mepiquat chloride for the general U.S. population nor any subgroup. 
Pursuant to the requirements under the Food Quality Protection Act of 
1996, the Agency has determined that the use of mepiquat chloride will 
not pose dietary risks to infants and children due primarily to the 
chemical's low toxicity and its low usage rate.
    i. Food--a. Chronic dietary exposure. A Dietary Risk Evaluation 
System (DRES) chronic exposure analysis was conducted by EPA for the 
RED. The analysis was performed using tolerance level residues 
(including those that have been revoked and the three expired grape and 
raisin temporary tolerances previously established for an Experimental 
Use Permit) and an assumption of 100 percent crop treated to estimate 
the Theoretical Maximum Residue Contribution (TMRC) for the general 
population and 22 subgroups. No Anticipated Residue (AR) information 
was used in this analysis. Existing tolerances result in a Theoretical 
Maximum Residue Contribution (TMRC) which represents less than 1% of 
the RfD for the U.S. general population and each of the 22 subgroups, 
including non-nursing infants (<1 year old).
    The TMRC calculation results in a significant overestimate of human 
dietary exposure. The chronic analysis for mepiquat chloride is a worst 
case estimate of dietary exposure with all residues at tolerance level 
and 100% of the commodities assumed to be treated with mepiquat 
chloride. This analysis does not take into account that this use of 
mepiquat chloride on grapes is restricted to use on Concord and Niagara 
grapes only. Concord and Niagara grapes represent less than 10% of the 
total U.S. grape acreage (74,000 versus 763,850). Based on the risk 
estimates calculated in this analysis, it has been concluded that 
dietary exposure to mepiquat chloride does not pose any risk concerns.
    b. Acute dietary exposure. The Margin of Exposure (MOE) is a ratio 
of the NOAEL to the exposure. Generally, the Agency concludes that 
there is no dietary concern when the acute dietary margins of exposure 
are greater than 100. The results of the acute analysis conducted for 
the RED indicate that mepiquat chloride in the diet represents no 
serious risk concern for acute exposure. All MOEs were well above the 
Agency's level of concern for acute dietary risk (ranging from a low of 
3,893 for infants to a high of 29,200 for females 13+ years old).
    ii. Drinking water. Neither a Maximum Contaminant Level (MCL) nor a 
Hazard Advisory (HA) has been established for mepiquat chloride. 
According to the EPA's Pesticides in Ground Water Database, there have 
been no mepiquat chloride detections reported in monitoring wells. 
Based on its low application rate, relatively rapid degradation rate, 
and soil binding ability, the Agency does not expect mepiquat chloride 
to contaminate ground water or surface water. Consequently neither a 
chronic or acute drinking water assessment was not performed.
    2. Non-dietary exposure. Mepiquat chloride has no residential or 
other non-occupational uses that might result in exposures to humans.

D. Cumulative Effects

    EPA has addressed the issue of the potential risk from the 
cumulative effects of mepiquat chloride and other pesticides with a 
common mechanism of toxicity in the RED document. In assessing the 
potential risks, the Agency first considered structural similarities 
and common effects that exist between mepiquat chloride and other 
related compounds such as paraquat, diquat, and difenzoquat. The Agency 
then considered other compounds which could potentially result in 
neurotoxic effects similar to mepiquat chloride.
    With one substance, difenzoquat, there appears to be similar 
neurotoxic effects. The Agency has concluded that the cumulative 
effects from the combined dietary exposure to mepiquat and difenzoquat 
would be virtually nil because the chronic dietary exposure for all 
population subgroups is less than 1% of the RfD for both difenzoquat 
and mepiquat chloride. The acute dietary MOE range for difenzoquat is 
50,000 to 16,000 while the acute dietary MOE range for mepiquat 
chloride is 3,900 to 29,000.
    In evaluating other chemicals with neurotoxic effects similar to 
mepiquat chloride, the Agency determined that it is unlikely that these 
other chemicals share a common mode/mechanism of toxicity with mepiquat 
chloride, or that cumulative risk assessment would be required. 
Although the mode/mechanism of toxicity of mepiquat chloride has not 
been well defined, the effects noted on the nervous system appear to be 
secondary to general systemic toxicity that occurs at high dose levels. 
Based on available data and structure-activity relationship analyses, 
mepiquat chloride would be considered to have minimal neurotoxic 
activity.

E. Safety Determination

    1. U.S. population. In the mepiquat RED, EPA has determined that 
the established tolerances for mepiquat chloride meet the safety 
standards under the FQPA amendments to section 408(b)(2)(D) for the 
general population. In reaching this determination, EPA has considered 
the available information on the aggregate exposures (both acute and 
chronic) from the feed use on cotton, as well as the possibility of 
cumulative effects from mepiquat chloride and other chemicals with a 
similar mode/mechanism of toxicity. BASF does not believe that the 
limited use of mepiquat chloride on Concord and Niagara grapes alters 
these conclusions
    Since there are no residential or lawn uses of mepiquat chloride, 
no dermal or inhalation exposure is expected in and around the home. No 
acute toxicity endpoints of concern have been identified for mepiquat 
chloride.
    In assessing chronic dietary risk, EPA estimates that mepiquat 
chloride residues in food account for <1% of the RfD and residues in 
drinking water are not expected. Thus, the aggregate exposures from all 
sources of mepiquat chloride (in this case, only dietary is relevant) 
account for <1% of the RfD for the general population. Therefore, the 
Agency concludes that aggregate risks for the general population 
resulting from mepiquat chloride uses are not of concern.
    In evaluating the potential for cumulative effects, EPA compared 
structural similarities and toxic effects seen in mepiquat chloride 
studies with other related compounds. With one substance, difenzoquat, 
there appears to be similar neurotoxic effects. However, the Agency has 
concluded that the cumulative effects from the combined dietary 
exposure to mepiquat chloride and difenzoquat would be virtually nil 
because the chronic dietary exposure for all population subgroups is 
less than

[[Page 66185]]

1% of the RfD for both difenzoquat and mepiquat chloride.
    2. Infants and children. In the RED EPA has determined that the 
established tolerances for mepiquat chloride (including the previously 
established temporary tolerances for grapes) meet the safety standard 
under the FQPA amendment to section 408(b)(2)(C) for infants and 
children. The safety determination for infants and children considers 
the factors noted above for the general population, but also takes into 
account the possibility of increased dietary exposure due to the 
specific consumption patterns of infants and children, as well as the 
possibility of increased susceptibility to the toxic effects of 
mepiquat chloride residues in this population subgroup.
    In the developmental studies, effects were seen in the fetuses only 
at the same or higher dose levels than effects on the mothers. In the 
reproduction study, no effects on reproductive performance were seen. 
Also, because the NOAELs from the developmental and reproduction 
studies were equal to or greater than the NOAEL used for establishing 
the reference dose, EPA concludes that it is unlikely that there is 
additional risk concern for immature or developing organisms. Finally, 
the Agency has no epidemiological information suggesting special 
sensitivity of infants and children to mepiquat chloride. Therefore, 
EPA finds that the uncertainty factor (100x) routinely used in RfD 
calculations is adequately protective of infants and children, and an 
additional uncertainty factor is not warranted for mepiquat chloride.
    EPA estimates that mepiquat chloride residues in the diet of 
infants and children account for less than 1% of the RfD and residues 
in drinking water are not expected. Thus, the chronic aggregate 
exposure from all sources of mepiquat chloride account for less than 1% 
for infants and children. The acute dietary MOE for infants and 
children exposed to mepiquat chloride is 3,893. Therefore, the Agency 
concludes that aggregate risks for infants and children resulting from 
mepiquat chloride uses are not of concern.

F. International Tolerances

    There are no Codex, Canadian, or Mexican tolerances established for 
mepiquat chloride on grapes. Thus, international harmonization is not 
an issue for these tolerances.
[FR Doc. 99-30615 Filed 11-23-99; 8:45 am]
BILLING CODE 6560-50-F