[Federal Register Volume 65, Number 71 (Wednesday, April 12, 2000)]
[Notices]
[Pages 19756-19759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8959]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[PF-934; FRL-6551-8]


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.

-----------------------------------------------------------------------

SUMMARY: This notice announces the amendment 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-934, must be 
received on or before May 12, 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-934 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mary Waller, fungicide 
Branch, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 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:

 
------------------------------------------------------------------------
                                                          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-934. 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.,

[[Page 19757]]

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-934 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, Ariel Rios Bldg., 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-934. 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: April 5, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the amendment to a 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.

American Cyanamid Company

PP 7F4816

    EPA has received an amendment to pesticide petition (7F4816) from 
American Cyanamid Company, Global Agricultural Products Research 
Division, P.O. Box 400, Princeton, NJ 08543-0400 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 tolerances for 
residues of dimethomorph (E,Z)4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]-morpholine in or on the raw 
agricultural commodity (RAC) imported grapes at 3.5 parts per million 
(ppm) and in or on imported grape, raisin, at 6 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. Radiolabeled dimethomorph was applied to grape 
vines at 0.8 lb. active ingredient per acre (ai/acre) for 4 consecutive 
weeks, giving a total application rate of 3.2 lb. ai/acre. The amount 
of total radioactive residue (TRR) in or on grapes harvested 35 days 
following the last of these applications was 14.6 ppm. Parent 
dimethomorph accounted for 87.3% of the TRR (12.7 ppm). No metabolites 
were identified that require regulation.
    2. Analytical method. FAMS 002-04 is a reliable high performance 
liquid chromatography (HPLC) method for the determination of 
dimethomorph residues in grape and raisin.
    3. Magnitude of residues. The residue data were collected from 
studies having multiple applications (3-11) of dimethomorph with a 
maximum seasonal rate of up to 2.94 lb. ai/acre. The resulting 
dimethomorph residues in the RAC grape ranged from  0.01 ppm (the limit 
of quantitation (LOQ) of the

[[Page 19758]]

method) to 2.55 ppm. Residues of dimethomorph upon processing of grape 
to raisin were concentrated by a factor of 1.8x. Residues of 
dimethomorph did not concentrate upon processing of grape to juice or 
wine. Therefore, tolerances of 3.5 ppm in/on imported grape and 6.0 ppm 
in/on imported raisins are proposed.

B. Toxicological Profile

    The toxicity of dimethomorph has been studied extensively and there 
is a complete data base to address the acute and chronic effects, 
effects on genetic material, the potential for carcinogenicity, or 
teratogenicity, and effects on reproductive performance or growth of 
offspring. EPA has previously evaluated the available toxicological 
data and considered its validity, completeness, and reliability as well 
as the relationship of the results of the studies to human risk. EPA 
has also, considered available information concerning the variability 
of the sensitivities of major identifiable subgroups of consumers, 
including infants and children. The toxicological profile for 
dimethomorph which supports this petition for tolerances of 
dimethomorph in or on imported grapes and imported raisins was 
previously published in the Federal Register final rule of October 13, 
1998 (63 FR 545587) (FRL-6036-7).

C. Aggregate Exposure

    1. Dietary exposure. To assess the potential chronic dietary 
exposure to dimethomorph residues for all tolerances in effect early in 
1999, EPA used the dietary exposure evaluation model (DEEM 89) to 
conduct a chronic dietary (food only) exposure analysis. In conducting 
this analysis, EPA made very conservative assumptions: that all 
commodities having dimethomorph tolerances contain residues of 
dimethomorph and those residues are at the level of the tolerance. 
These assumptions result in an overestimate of human dietary exposure. 
All section 18 tolerances (cantaloupes, watermelons, cucumbers, squash, 
and tomatoes) were included in this assessment along with tolerances 
for cereal grains crops, and potatoes. The results of the analysis were 
theoretical maximum residue contributions (TMRC) that were equivalent 
to the following percentages of the population adjusted dose (PAD) 
(equivalent to the reference dose (RfD), as EPA removed the extra 10x 
safety factor): U.S. population (total), 2%; nursing infants, 0.6%; 
non-nursing infants, 2.4%; children 1-6 years, 4.3%; and children 7-12 
years, 3%. In a similar analysis utilizing data derived by TAS, Inc., 
the chronic dietary exposure to dimethomorph was evaluated for 
tolerances pending at that time for imported commodities of hops, 
tomato, and grape (at 2 ppm with no tolerance for raisin proposed). The 
assumptions made in this assessment were likewise very conservative: 
all of these commodities (domestically- produced and imported) contain 
residues of dimethomorph and residues at the level of the tolerance. 
The results of the analyses were TMRC values that were equivalent to 
the following percentages of the PAD: U.S. population (total), 1.58%; 
all infants, 2.38%; non-nursing infants, 2.6%; children 1-6 years, 
4.39%; and children 7-12 years, 1.81%. From these two analyses, 
American Cyanamid had previously concluded that the chronic dietary 
exposure to dimethomorph from all established and pending tolerances 
was less than 10% of the PAD for the U.S. population and for population 
subgroups (e.g., for children 1-6 years, 4.3% plus 4.39%). This 
conclusion was supported by conservative assumptions and the expiration 
of the section 18 tolerances for tomato commodities. Given these 
factors, an increase of the proposed tolerance for imported grape from 
2 ppm to 3.5 ppm and the addition of a 6 ppm tolerance for raisin is 
not expected to exceed the allowed chronic dietary exposures.
    i. Food--acute dietary exposure. An acute dietary risk assessment 
is not required because no acute toxicological endpoints were 
identified by EPA for dimethomorph.
    ii. Drinking water. The tolerances proposed in this petition are 
for imported commodities, thus there is no direct impact of 
establishment of these tolerances on domestic drinking water. 
Currently, the only federally-registered food/feed use of dimethomorph 
in the United States is on potato crops. For this use, the drinking 
water level of concern (DWLC) from chronic exposure to dimethomorph was 
estimated by EPA to be 3,400 parts per billion (ppb) for the U.S. 
population and for males 13 years and older; 2,900 ppb for females 13 
years and older; and 960 ppb for children (1-6 years of age). These 
levels are all much greater than that calculated from the generic 
estimated environmental concentration (GENEEC; 24 ppb for 56 days) 
which simulates the residues in surface water. Dimethomorph residues in 
ground water were also estimated using the screening concentration in 
ground water model, SCI-GRO, but these estimates were significantly 
lower than those obtained from the GENEEC model. Given the low levels 
of dimethomorph residues as estimated by the GENEEC model and the large 
margin of exposure (40x-142x), the registered food use of dimethomorph 
does not meet or exceed a level of concern for residues in drinking 
water.
    2. Non-dietary exposure. Currently, there are no registered 
residential uses for dimethomorph in the United States. Thus, an 
assessment of non-dietary exposure is not relevant to this petition.

D. Cumulative Effects

    There is no information to indicate that any toxic effects produced 
by dimethomorph would be cumulative with those of any other chemical. 
The fungicidal mode of action of dimethomorph is unique; dimethomorph 
inhibits cell wall formation only in Oomycete fungi. The result is 
lysis of the cell wall which kills growing cells and inhibits spore 
formation in mature hyphae. This unique mode of action and limited pest 
spectrum suggest that there is little or no potential for cumulative 
toxic effects in mammals. In addition, the toxicity studies submitted 
to support this petition do not indicate that dimethomorph is a 
particularly toxic compound. No toxic end-points of potential concern 
were identified.

E. Safety Determination

    1. U.S. population. The PAD is 0.1 milligram/kilogram bodyweight 
per day (mg/kg bwt/day), based on a no observed adverse effect level 
(NOAEL) of approximately 10 mg/kg bwt/day (200 ppm) from a 2-year 
dietary toxicity study in rats that demonstrated decreased body weight 
and liver foci in females at 750 ppm. The PAD is calculated using an 
uncertainty factor of 100. The combined TMRC for all current and 
pending dimethomorph tolerances will utilize less than 100% of the PAD 
for the general U.S. population. Since EPA generally has no concern for 
exposures below 100% of the PAD, EPA should conclude that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to dimethomorph residues as result of establishment of the requested 
tolerances.
    2. Infants and children. The results of the studies submitted to 
support this package provide no evidence that dimethomorph caused 
reproductive, developmental or fetotoxic effects. No such effects were 
noted at dose levels which were not maternally toxic. There is no 
evidence to indicate that children or infants would be more sensitive 
than adults to toxic effects caused by exposure to dimethomorph. The 
NOAELs observed in the developmental

[[Page 19759]]

and reproductive studies were 6 to 65 times higher than the NOAEL used 
to establish the PAD. Further, the combined TMRC values for all current 
and pending dimethomorph tolerances will utilize less than 100% of the 
PAD for each of these subgroups. Therefore, the registrant believes 
that the results of the toxicology and metabolism studies support both 
the safety of dimethomorph to humans based on the intended use as a 
fungicide on imported grapes and raisins and the granting of the 
requested tolerances

F. International Tolerances

    There are no Codex tolerances established for dimethomorph.
[FR Doc. 00-8959 Filed 4-11-00; 8:45 am]
BILLING CODE 6560-50-F