[Federal Register Volume 65, Number 141 (Friday, July 21, 2000)]
[Notices]
[Pages 45375-45378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18519]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-953; FRL-6593-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical 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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-953, must be 
received on or before August 21, 2000.

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-953 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mary L. Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9354; e-mail address: [email protected].

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:

[[Page 45376]]



 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
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-953. 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-953 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, 1200 Pennsylvania Ave., NW., 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-953. 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 certain 
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 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: July 10, 2000.
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

[[Page 45377]]

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.

Novartis Crop Protection, Inc.

PP 9F5044

    EPA has received a pesticide petition PP 9F5044 from Novartis Crop 
Protection, Inc., 410 Swing Road, Greensboro, NC 27419 proposing, 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by establishing a tolerance for residues of mefenoxam or 
CGA329351, (R)-2-(2,6-dimethylphenyl)-methoxyacetylamino-propionic acid 
methyl ester in or on the raw agricultural commodity rape seed (canola) 
at 0.05 parts 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 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. Novartis believes the studies supporting this 
mefenoxam petition well characterize metabolism in plants and animals. 
The metabolism profile supports the use of an analytical enforcement 
method that accounts for combined residues of mefenoxam and its 
metabolites which contain the 2,6-dimethylaniline (DMA) moiety.
    2. Analytical method. Novartis has submitted a practical analytical 
method involving extraction, filtration, acid reflux, steam 
distillation, and solid phase cleanup with analysis by confirmatory gas 
chromatography using nitrogen/phosphorous (N/P) detection. A total 
residue method is used for determination of the combined residues of 
mefenoxam and its metabolites which contain the 2,6-dimethylaniline DMA 
moiety. The limit of quantitation (LOQ) for the method is 0.05 ppm.
    3. Magnitude of residues--i. Crops. This petition is supported by 
six field residue trials that were analyzed in concordance with the 
OPPTS guidelines based on expected reduced residues and environmental 
benefits of seed applications. The six trials accounting for 
approximately 84% of commercial U.S. canola production (agricultural 
statistics, 1991), were conducted in Georgia (2%), Minnesota (16%), 
North Dakota (53%), South Dakota (2%), Idaho (6%), and Washington (5%). 
No residues 0.05 ppm of mefenoxam were detected as 2,6-DMA in canola 
seed at either the 1x or 3x treatment rate.
    ii. Animals. As there were no detectable residues found with a 1x 
or 3x treatment regime, there is no expected impact on the dietary 
intake of livestock in association with this petition. Existing 
tolerances in 40 CFR part 180 are adequate to support the approval of 
this requested tolerance in the opinion of Novartis Crop Protection.

B. Toxicological Profile

    1. Acute toxicity. The toxicological endpoints for mefenoxam are 
discussed in B.4. of the Federal Register notice of July 25, 1997, (62 
FR 40084) (FRL-5726-4). The acute toxicity profile can be summarized as 
follows:
    Rat acute oral study with a LD50 value of 490 
milligrams/kilograms (mg/kg). Rat acute dermal study with a 
LD50 >2,000 mg/kg. Rat inhalation study with a 
LC50 >2.29 milligram/liter (mg/L) air. Primary eye 
irritation study in rabbit showing mefenoxam as severely irritating. 
Primary dermal irritation study in rabbit showing mefenoxam as slightly 
irritating. Skin sensitization studies in guinea pigs (Maximization and 
Buehler Test) showing mefenoxam is not a sensitizer.
    2. Genotoxicty. The toxicological endpoints for mefenoxam are 
discussed in Unit B.4. of the Federal Register notice of July 25, 1997 
(62 FR 40084). The genotoxicity profile can be summarized as follows:
    In vitro gene mutation test: Ames test-negative. In vitro 
chromosomal aberration test: Chinese hamster ovary (CHO)-negative. In 
vitro gene mutation tests: Ames tests (3 independent studies)-negative; 
gene mutation in mouse lymphoma cells-negative; reverse mutation in 
Saccharomyces cerevisiae-negative. In vitro chromosomal aberration 
tests: Chinese hamster bone marrow cytogenetic test-negative. DNA 
repair study in rat hepatocytes-negative.
    3. Reproductive and developmental toxicity. The toxicological 
endpoints for mefenoxam are discussed in B.4. of the Federal Register 
notice of July 25, 1997 (62 FR 40084). The reproductive and 
developmental toxicity profile can be summarized as follows:
    Teratology study in rats with a maternal no observed adverse effect 
level (NOAEL) of 10 mg/kg based on reduced body weight (bwt) gain. The 
fetuses remained entirely unaffected at the highest dose tested (HDT), 
250 mg/kg. Teratology study in rabbits with a maternal NOAEL of 150 mg/
kg based on bwt loss. The developmental NOAEL was greater than or equal 
to the HDT, 300 mg/kg. Three-generation reproduction study in rats with 
a NOAEL of 1,250 ppm, which was the HDT. The treatment had no effect on 
reproduction or fertility. Dominant lethal study in mouse-negative.
    4. Subchronic toxicity. The toxicological endpoints for mefenoxam 
are discussed in Unit IV.B. of the Federal Register notice of July 25, 
1997 (62 FR 40084). The subchronic toxicity profile can be summarized 
as follows:
    A 28-day cumulative toxicity study in rats with a NOAEL of 50 mg/kg 
based on liver changes. A 90-day subchronic dietary toxicity study in 
rats with a NOAEL of 250 ppm based on liver changes. A 90-day 
subchronic dietary toxicity study in dogs with a NOAEL of 250 ppm based 
on changes in blood biochemistry and hematology indicative of 
functional liver changes. A 21-day dermal toxicity study in rats with a 
NOAEL equal to or higher than the limit dose of 1,000 mg/kg. No local 
or systemic signs of toxicity were found. A 6-month dietary toxicity 
study in dogs with a NOAEL of 250 ppm based on changes in blood 
biochemistry indicative of hepatocellular damage.
    5. Chronic toxicity The toxicological endpoints for mefenoxam are 
discussed in B.4. of the Federal Register notice of July 25, 1997 (62 
FR 40084). The chronic toxicity profile can be summarized as follows:
    A 24-month combined chronic toxicity/carcinogenicity study 
conducted in rats with a NOAEL of 250 ppm based on liver changes. No 
evidence of oncogenicity was seen. A 24-month oncogenicity study 
conducted in mice with a NOAEL of 250 ppm based on liver changes. No 
evidence of oncogenicity was seen.
    6. Animal metabolism. The rat and goat rapidly metabolize and 
excrete via the same metabolic pathways as plants. Urinary metabolites 
are polar, primarily gucuronide and other conjugates. The parent 
compound is not retained in animal tissues nor secreted in milk.
    7. Metabolite toxicology. Metabolites are considered to be of equal 
or less toxicity than the parent material.
    8. Endocrine disruption. Mefenoxam does not belong to a class of 
chemicals known or suspected of having adverse effects on the endocrine 
system. Furthermore, supporting developmental toxicity studies in rats 
and rabbits, and a reproduction study in rats gave no indication of any 
effects on endocrine function related to development and reproduction. 
Subchronic and chronic

[[Page 45378]]

treatment did not induce any morphological changes in endocrine organs 
and tissues.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. For the purposes of assessing the 
potential dietary exposure under the proposed tolerance, Novartis Crop 
Protection has estimated aggregate exposure from all crops for which 
tolerances are established or proposed (i.e., rape seed).
    a. Chronic exposure. Under the conservative exposure assumption of 
residue levels being at tolerance level, less than 15% of the reference 
dose (RfD) will be utilized by the U.S. general population. EPA 
generally has no concern for exposures below 100% of the RfD. 
Therefore, based on the completeness and reliability of the toxicity 
data supporting this petition, Novartis Crop Protection believes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues arising from this requested use, including 
anticipated dietary exposure and all other types of non-occupational 
exposures. From toxicity studies supporting the registration of 
mefenoxam, the active ingredient is classified as a Group ``E'' 
compound (evidence of noncarcinogenicty for humans). There was no 
evidence of carcinogenicity in a 24-month feeding trial in mice nor in 
a 24-month feeding study in rats at the dosage levels tested. The doses 
tested were adequate for identifying a cancer risk.
    b. Acute exposure. The risk from acute dietary exposure to 
mefenoxam is considered to be very low. The NOAEL in a 28-day study was 
50 mg/kg, which is 6-fold higher than the chronic NOAEL. Since chronic 
exposure assessment did not result in any unacceptable exposure for 
even the most impacted population subgroup, it is anticipated that also 
the acute exposure will be in an acceptable range. Calculations show 
that with the most exposed group (non-nursing infants) only 26% of the 
acute RfD will be utilized; the requested tolerance for rape seed 
(i.e., canola does not add any measurable contribution to this exposure 
according to our analysis).
    ii. Drinking water. Novartis Crop Protection anticipates the 
potential exposure from residues of drinking water to be insignificant 
due to the proposed seed treatment use pattern associated with this 
petition.
    2. Non-dietary exposure. Given the seed treatment use pattern 
proposed in this petition, there are no anticipated non-dietary 
exposures resulting from this requested tolerance. Mefenoxam is 
registered for use as a product for use on turf and ornamentals for 
control of soil-borne diseases. However, the product is not used 
residentially by homeowners and the potential exposure to the general 
public from turf and ornamentals is thought to be negligible.

D. Cumulative Effects

    Novartis Crop Protection believes that consideration of a common 
mechanism of toxicity is not appropriate at this time since there is no 
information to indicate that toxic effects produced by mefenoxam would 
be cumulative with those of any other chemicals.

E. Safety Determination

    1. U.S. population--i. Acute risk. The risk from acute dietary 
exposure to mefenoxam is considered to be very low. The NOAEL in a 28-
day study was 50 mg/kg, which is 6-fold higher than the chronic NOAEL. 
Since chronic exposure assessment did not result in any unacceptable 
exposure for even the most impacted population subgroup, it is 
anticipated that also the acute exposure will be in an acceptable 
range. Again, the requested tolerance on rape seed (i.e., canola) was 
found not to contribute any measurable additional impact on acute 
exposure to mefenoxam so that for the general population less than 15% 
of the acute RfD is utilized.
    ii. Chronic risk. Under the conservative exposure assumptions of 
residue levels being at tolerance level, less than 10% of the RfD will 
be utilized by the U.S. general population. Use on canola does not 
measurably contribute to this exposure, particularly given that no 
detectable residues were found even when 3x the use rate was utilized. 
Therefore, based on the completeness and reliability of the toxicity 
data supporting this petition, Novartis Crop Protection believes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues of mefenoxam taking into account dietary and non-
occupational exposures.
    2. Infants and children. There is no indication that mefenoxam 
interferes with the prenatal or neonatal development, even when 
experimental animals were exposed to very high doses leading to 
maternal toxicity. Infants and children are not expected to show any 
particular sensitivity to mefenoxam.
    i. Acute risk. The risk from acute dietary exposure to mefenoxam is 
considered to be very low. The NOAEL in a 28-day study was 50 mg/kg, 
which is 6-fold higher than the chronic NOAEL. According to our 
analysis there is no measurable impact of the requested tolerance on 
the exposure to mefenoxam. The utilization of the acute RfD from the 
most exposed group is 26% (non-nursing infants).
    ii. Chronic risk. Calculated on the basis of the theoretical 
maximum residue contribution (TMRC) for mefenoxam, utilization of RfD 
from dietary exposure of children is estimated as: 4.3% for nursing 
infants, 14% for non-nursing infants, 21% for 1 to 6 years old, and 12% 
for children 7 to 12 years old.

F. International Tolerances

    There are no Codex maximum residue levels established for 
CGA329351.
[FR Doc. 00-18519 Filed 7-20-00; 8:45 am]
BILLING CODE 6560-50-F