PMEP Home Page --> Pesticide Active Ingredient Information --> Herbicides, Growth Regulators and Desiccant --> 1-naphthaleneacetic acid to rimsulfuron --> N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) --> N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) Pesticide Petition Filing 12/97

N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) Pesticide Petition Filing 12/97


[Notices]             
[Page 1456-1464]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja98-67]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-786; FRL-5762-6]

 
Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).


[[Page 1457]]


ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-786, must 
be received on or before February 9, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under ``SUPPLEMENTARY 
INFORMATION.'' No confidential business information should be submitted 
through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). 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 Rm. 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: The product manager listed in the 
table below:

------------------------------------------------------------------------
                                   Office location/                     
        Product Manager            telephone number          Address    
------------------------------------------------------------------------
Joanne Miller (PM 23).........  Rm. 237, CM #2, 703-    1921 Jefferson  
                                 305-6224, e-mail:       Davis Hwy,     
                                 miller.joanne@epamail   Arlington, VA  
                                 .epa.gov.                              
Marion Johnson (PM 10)........  Rm. 217, CM #2, 703-    Do.             
                                 305-6788, e-mail:                      
                                 johnson.marion@epamai                  
                                 l.epa.gov.                             
Cynthia Giles-Parker (PM 22)..  Rm. 229, CM #2, 703-    Do.             
                                 305-7740, e-mail:                      
                                 giles-                                 
                                 parker.cynthia@epamai                  
                                 l.epa.gov.                             
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals 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 these petitions 
contain 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.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-786] (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 official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-786] and appropriate petition number. 
Electronic comments on this notice may be filed online at many Federal 
Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: December 17, 1997.

James Jones,

Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them 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.

2. GMJA Specialties

PP 7G4891

    EPA has received a pesticide petition (PP 7G4891) from GMJA 
Specialties, 1001 13th Avenue East, Bradenton, FL 34208, proposing 
pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act, 
21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance 
for residues of PT807-HCl in or on the raw agricultural commodity 
oranges at 0.01 ppm. The proposed analytical method is extracting 
PT807-HCl from whole oranges, juice, and dried pulp using organic 
solvents has been validated. Extracted PT807-HCl residues are analyzed 
using high performance liquid chromatography (HPLC) with a UV detector. 
The limit of quantitation (LOQ) of the method is 0.01 part per million 
(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

    Plant metabolism. The metabolism of PT807-HCl in plants and animals 
is understood. In plants (oranges), unchanged parent is the only 
residue identified in fruit. Valencia orange trees were treated with 
<SUP>14</SUP>C PT807-HCl at a nominal rate of 1,000 ppm (approximately 
60x the maximum recommended application rate). Fruit from the previous 
season's crop present on the tree at the time of application was 
harvested 50 days after treatment (DAT) and mature fruit (not present 
on the tree at application) was harvested 370 DAT. Total radioactive 
residue (TRR) levels were 0.538 ppm in 50 DAT orange samples and were 
0.051 ppm in 370 DAT orange samples. Most of the radioactivity was 
present on the peel (88.63% TRR or 0.475 ppm in the 50 DAT fruit, and 
64.19% TRR or 0.033 ppm in the 370 DAT fruit). Unchanged parent PT807-
HCl was detected in 50 DAT mature fruit using organic solvents has been 
validated. Extracted PT807-HCl residues are analyzed using HPLC with a 
UV detector. The LOQ of the method is 0.01 ppm.

B. Toxicological Profile

    1. Acute toxicity. A battery of acute toxicity studies has been 
conducted and the results indicate that PT807-HCl exhibits low acute 
oral, dermal, and inhalation toxicity. PT807-HCl also has low potential 
as a skin or eye irritant and is not a skin sensitizer.
    2. Genotoxicity. The genotoxic potential of PT807-HCl has been 
assessed in an Ames Salmonella assay, a CHO HGPRT gene mutation assay, 
a mouse micronucleus assay, and an in vitro CHO assay for chromosomal 
aberrations. The in vitro chromosomal aberration assay was positive 
with and without metabolic activation; however, all of the remaining 
assays were negative, indicating very low genotoxic potential of PT807 
weakened by the negative finding in an in vivo study (mouse 
micronucleus) measuring a similar endpoint.
    3. Reproductive and developmental toxicity. A 2-generation 
reproductive toxicity study of PT807-HCl is ongoing.
    4. Analytical method. An analytical method capable of extracting 
PT807-HCl from whole oranges, juice, and dried pulp using organic 
solvents has been validated. Extracted PT807-HCl residues are analyzed 
using high performance liquid chromatography (HPLC) with a UV detector. 
The limit of quantitation (LOQ) of the method is 0.01 ppm.
    5. Magnitude of residues. Seventeen field trials were conducted 
using various varieties of oranges in California (4 trials), Florida 
(12 trials), and Texas (1 trial). Two of the trials (1 in California 
and 1 in Florida) were decline studies with sampling intervals of 0, 7, 
14, 30, and 60 days after application. For all other trials, oranges 
were harvested at the earliest possible time for normal commercial 
harvest after a single application with PT807-HCl at the maximum 
recommended application rate (6 g a.i./A). At some of the test sites 
(depending on the variety of oranges), the previous season's crops was 
present on the tree at application for these trials, oranges were 
collected 0 to 68 days after treatment (DAT). In all other trials, 
fruit were not present on the trees at applications and mature oranges 
were collected at normal harvest (197 to 359 DAT). Samples were 
analyzed for residues of PT807-HCl by HPLC with UV detection. Residues 
of PT807-HCl were nondetectable (<0.01 ppm) in all treated and control 
samples.
    A processing study was conducted using oranges treated at 5x the 
maximum application rate in California. The harvested oranges were from 
the previous season's crop and were on the tree at the time of 
application. Therefore the application represents the maximum possible 
residues. No detectable residues were measured in whole oranges, juice, 
or oil. Residues of PT807-HCl were detectable in dried pulp at 0.015 
and 0.017 ppm (average 0.016 ppm). Correcting the measured residues for 
the exaggerated application rate, no detectable residues are likely in 
any processed product of oranges.
    Residues of PT807-HCl were determined to be stable in whole orange 
fruit, oil, juice, and dried pulp stored frozen up to 113 days.
    6. Subchronic toxicity. Subchronic toxicity studies have been 
conducted with PT807-HCl in mice, rats, and dogs. In dietary studies in 
rats and dogs, the most notable findings include decreased food 
consumption and a consequent decrease in bodyweight gain.(resulting 
primarily from poor palatability of the test material). Dogs also 
showed a trend toward anemia, and males showed arrested or delayed 
sexual maturation at the high dose (equivalent to approximately 222 mg/
kg/day). Marked weight loss and decreased weight gain was observed at 
this dose and this dose level is considered to have exceeded a MTD. 
Rats dosed by gavage showed signs of neurotoxic effects (tremors, 
incoordination, changes in activity) at doses 3-- mg/kg/day. In mice 
treatment-related decreased food consumption and body weight gain were 
seen in males at 7,000 (HDT). No treatment-related toxicity was evident 
at dietary doses up to 3,500 ppm (479 and 635 mg/kg/day for males and 
females, respectively).
    7. Chronic toxicity. Chronic toxicity studies of PT807-HCl in rats 
and doges are currently ongoing.
    8. Animal metabolism. <SUP>14</SUP>CPT807-HCl was extensively 
metabolized and readily eliminated in the urine and feces following 
oral administration to a lactating goat. The efficient elimination 
processes resulted in negligible to modest retention of radioactive 
residues in milk and tissues (<0.2 % of the administered dose). No 
residues of unchanged parent were identified in tissues or milk. The 
rapid elimination of the PT807-HCl and its metabolites

[[Page 1461]]

coupled with the highly exaggerated dose (approximately 3,600x the 
dietary burden) clearly indicates that no detectable residues of PT807-
HCl will accumulate in milk and tissues.
    9. Metabolite toxicology. The metabolism of PT807-HCl in oranges 
has been determined. The only significant metabolite is unchanged 
parent. No detectable residues of PT807-HCl are anticipated in oranges 
treated at the recommended application rate.

C. Aggregate Exposure

    1. Dietary exposure. There are no anticipated dietary exposures to 
PT807-HCl outside of those requested in this temporary tolerance 
petition. The chronic dietary exposure from the consumption of oranges 
and its processed products treated with PT807-HCl is very low. The 
exposure is only 5.0 % of the RfD (0.00063 mg/kg/day) for the most 
highly exposed sub-population, children 1 to 6 years old. The dietary 
exposure is only 1.7% of the RfD (0.00021 mg/kg/day) for the U.S. 
population.
    2. Food. The proposed temporary tolerance of 0.01 ppm was used for 
the residue level to calculate the dietary exposure from residues of 
PT807-HCl in or on oranges. Based on the processing study, there is no 
anticipated concentration of residues of PT807-HCl in processed 
products of oranges, therefore, the proposed temporary tolerance level 
for whole oranges was also used for the processed commodities. For the 
purpose of calculating a worst-case estimate, it was assumed that 100% 
of the oranges and their processed products were treated with PT807-
HCl.
    3. Drinking water. Based on the results of the GENEEC model, the 
56-day chronic EEC (calculated from the lowest K<INF>oc</INF> value 
measured for PT807-HCl) is 0.315 <greek-m>g/L. Using the standard 
drinking water consumption scenarios of 2 liters per day for a 70-kg 
adult and 1 liter per day for a 10 kg child, the calculated consumption 
of PT807-HCl in drinking is 0.009 <greek-m>g/kg/day for an adult and 
0.032 <greek-m>g/kg/day for a child. These consumption values 
correspond to 0.7% of the RfD for adults and 2.6% of the RfD for 
children. As discussed above, drinking water concentrations calculated 
by the GENEEC procedure represent very conservative screening level 
assessments of drinking water exposure. Finally, the above drinking 
water calculations use the water concentration calculated from the 
lowest K<INF>oc</INF> value measured for PT807-HCl. Three of four soils 
tested gave K<INF>oc</INF> values that are more than 10-fold higher, 
leading to correspondingly lower calculated water concentrations.
    4. Non-dietary exposure. There are currently no registered uses for 
PT807-HCl, and therefore, there is no anticipated non-occupational 
exposure to the chemical.

D. Cumulative Effects

    GMJA Specialities is not aware of any currently registered products 
that are structurally similar to PT-807-HCl or that would be likely to 
share a common mechanism of action. Therefore, no cumulative exposures 
are considered in the PT807-HCl dietary risk assessment.

E. Safety Determination

    1. U.S. population. The chronic dietary exposure from the 
consumption of oranges and its processed products treated with PT807-
HCl is very low. The exposure is only 5.0 % of the RfD (0.00063 mg/kg/
day) for the most highly exposed sub-population, children 1 to 6 years 
old. The dietary exposure is only 1.7% of the RfD (0.00021 mg/kg/day) 
for the U.S. population.
    2. Infants and children. The reference dose is conservatively 
calculated using a very high (10,000-fold ) safety factor for children. 
Based on currently available data, PT807-HCl does not present a unique 
hazard to infants or children and there is no evidence that children 
are likely to be more sensitive to the toxic effects of PT807-HCl. A 2-
generation reproductive toxicity study with PT807-HCl in rats is 
currently ongoing. PT807-HCl showed evidence of developmental effects 
in rats only at a severely maternally toxic dose level. No evidence of 
developmental toxicity was seen in rabbits.

F. International Tolerances

    There are no Codex Alimentarius Commission (Codex Maximum Residue 
Levels (MRLs) for PT807-HCl.    (PM 22)

[FR Doc. 98-557 Filed 1-8-98; 8:45 am]
BILLING CODE 6560-50-F