[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Notices]
[Pages 12244-12248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5632]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-918; FRL-6491-4]


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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-918, must be 
received on or before April 7, 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-918 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mary Waller, Product Manager 
(21), 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            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-918. 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-918 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

[[Page 12245]]

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-918. 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 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 and pests, Reporting and recordkeeping 
requirements.

    Dated: February 21, 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 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

8F4946

    EPA has received a pesticide petition (8F4946) from American 
Cyanamid Company, 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 a 
tolerance for residues of dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-
(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on the imported 
raw agricultural commodities (RAC) of dried hops cones at 45 parts per 
million (ppm); and on the RAC of tomato fruit at 0.50 ppm and in or on 
the processed commodities of tomato puree at 0.50 ppm and tomato paste 
at 1.50 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. American Cyanamid believes that the nature of 
the residues in hops and tomatoes is considered to be understood. This 
belief is based upon the results of the metabolism studies conducted on 
potato, grape, and lettuce. The results of the potato metabolism study 
show only negligible residues in tubers, 0.01-0.02 ppm total 
radioactive residues (TRR). This is in contrast to the aerial portions 
of the plant which were found to have up to 23.5 ppm TRR, thus 
demonstrating that translocation of dimethomorph within the plant was 
not significant. Almost all of the radioactive residue (97.8%) was 
extractable from the plant at harvest. In the aerial portion of the 
plant, approximately 70% of the TRR was identified as dimethomorph. No 
metabolites were identified that require regulation.
    The results of the grape metabolism study showed that the TRR in/on 
grapes harvested 35 days following the last of four applications 0.8 lb 
active ingredient per acre (ai/acre) per application for four 
consecutive weeks for a total rate of 3.2 lb ai/acre (3x the proposed 
maximum seasonal rate) was 14.6 ppm. Unmetabolized dimethomorph 
accounted for 87.3% of the TRR (12.7 ppm). No metabolites were 
identified that require regulation.
    The results of the lettuce metabolism study showed that the TRR in/
on lettuce leaves harvested 4 days following the last of four 
applications approximately 1.0 lb ai/acre per application with a 9 to 
11-day spray interval, for a total rate of 4.1 lb ai/acre, was 102 ppm. 
Of this total residue, 98.5% was extractable and unmetabolized 
dimethomorph accounted for greater than 93% of the extractable TRR. No 
metabolites were identified that require regulation.
    2. Analytical method. A reliable method for the determination of 
dimethomorph residues in hops and

[[Page 12246]]

tomatoes exists; this method is the FDA Multi-Residue Method, Protocol 
D, as published in the Pesticide Analytical Manual I.
    3. Magnitude of residues. The residue data for hops submitted to 
support this tolerance petition were taken from studies conducted in 
Germany. Dimethomorph residues observed in dried hops cones collected 
from these field studies ranged from 4.3 ppm to 42.0 ppm. These trials 
were conducted using four applications of dimethomorph with a maximum 
seasonal rate of 1.82 lb ai/acre. Therefore, a tolerance of 45.0 ppm is 
appropriate.
    The residue data for tomatoes submitted to support this tolerance 
petition were collected from 16 studies conducted in tomato-producing 
regions of the United States. Trials were conducted using multiple 
applications (6-7) of dimethomorph with a maximum seasonal rate of up 
to 1.4 lb ai/acre (1.4x the proposed label rate). Dimethomorph residues 
observed in these field trials ranged from  0.05 ppm to 0.55 ppm 
immediately after harvest. In a study on the magnitude of residue in 
tomato processed commodities, residues of dimethomorph did not 
concentrate in any fraction except in paste (3x). Therefore, tolerances 
of 0.50 ppm in/on tomato fruit, 0.50 ppm in/on tomato puree, and 1.50 
ppm in/on tomato paste are proposed.

B. Toxicological Profile

    1. Acute toxicity--i. An acute oral toxicity study in the Sprague-
Dawley rat for dimethomorph technical with a LD50 of 4,300 
milligrams/kilograms body weight (mg/kg bwt) for males and 3,500 mg/kg 
bwt for females. Based upon EPA toxicity criteria, the acute oral 
toxicity category for dimethomorph technical is Category III or 
slightly toxic.
    ii. Oral LD50 studies were conducted on the two isomers 
(E and Z) alone:
    a. An acute oral toxicity study in the Wistar rat for the E-isomer 
with a LD50 greater than 5,000 mg/kg bwt for males and 
approximately 5,000 mg/kg bwt for females.
    b. An acute oral toxicity study in the Wistar rat for the Z-isomer 
with a LD50 greater than 5,000 mg/kg bwt for both males and 
females.
    iii. An acute dermal toxicity study in the Wistar rat for 
dimethomorph technical with dermal LD50 greater than 5,000 
mg/kg bwt for both males and females. Based on the EPA toxicity 
category criteria, the acute dermal toxicity category for dimethomorph 
is Category IV or relatively non-toxic.
    iv. A 4-hour inhalation study in Wistar rats for dimethomorph 
technical with a LC50 greater than 4.2 milligrams/liter (mg/
L) for both males and females. Based on the EPA toxicity category 
criteria, the acute inhalation toxicity category for dimethomorph 
technical is Category IV or relatively non-toxic.
    2. Genotoxicity--i. Salmonella reverse gene mutation assays (2 
studies) were negative up to a limit dose of 5,000 g/plate. 
Chinese hamster (CH) lung V79 cells were negative up to toxic doses in 
two studies.
    ii. Two CH lung structural chromosomal studies were reportedly 
positive for chromosomal aberrations at the highest dose tested (HDT) 
(160 (g/mL)-S9; 170 g/mL/+S9). Dimethomorph induced 
only a weak response in increasing chromosome aberrations in this test 
system. These results were not confirmed in two micronucleus tests 
under in vivo conditions.
    iii. Structural chromosomal aberration studies were weakly positive 
in human lymphocytic cultures, but only in S9 activated cultures 
treated at 422 g/mL HDT, which was strongly cytotoxic. No 
increase in chromosomal aberrations was observed in the absence of S9 
activation at all doses. Furthermore, the positive clastogenic response 
observed under the in vitro conditions was not confirmed in two in vivo 
micronucleus assays.
    iv. Micronucleus assay (two studies) indicated that dimethomorph 
was negative for inducing micronuclei in bone marrow cells of mice 
following i.p. administration of doses up to 200 mg/kg or oral doses up 
to the limit dose of 5,000 mg/kg. Thus, dimethomorph was found to be 
negative in these studies for causing cytogenic damage in vivo.
    v. Dimethomorph was negative for inducing unscheduled DNA synthesis 
(UDS), in cultured rat liver cells, at doses up to 250 g/mL, a 
weakly cytotoxic level.
    vi. Dimethomorph was negative for transformation in Syrian hamster 
embryo cells treated, in the presence and absence of activation, up to 
cytotoxic concentrations (265 g/ml/+S9; 50 g/ml/-S9).
    3. Reproductive and developmental toxicity--i. A rat developmental 
toxicity study with a lowest observed adverse effect level (LOAEL) for 
maternal toxicity of 160 mg/kg/day and a no observed adverse effect 
level (NOAEL) for maternal toxicity of 60 mg/kg/day. The NOAEL for 
developmental toxicity is 60 mg/kg/day. Dimethomorph is not teratogenic 
in the Sprague-Dawley rat.
    ii. A rabbit developmental toxicity study with a LOAEL for maternal 
toxicity of 650 mg/kg/day and a NOAEL for maternal toxicity of 300 mg/
kg/day. The NOAEL for developmental toxicity is 650 mg/kg/day HDT. 
Dimethomorph is not teratogenic in the New Zealand white rabbit.
    iii. A 2-generation rat reproduction study with a LOAEL for 
parental systemic toxicity of 1,000 ppm (80 mg/kg/day) and a NOAEL for 
parental systemic toxicity of 300 ppm (24 mg/kg/day). The NOAEL for 
fertility and reproductive function was 1,000 ppm (80 mg/kg bwt/day) 
HDT.
    4. Subchronic toxicity--i. A 90-day dietary study in Sprague-Dawley 
rats with a NOAEL of greater than or equal to 1,000 ppm HDT (73 mg/kg/
day) for males and 82 mg/kg/day for females.
    ii. A 90-day dog dietary study with a NOAEL 450 ppm (15 mg/kg/day) 
and a LOAEL 1,350 ppm (43 mg/kg/day).
    5. Chronic toxicity--i. A 2-year chronic toxicity study in Sprague-
Dawley rats with a NOAEL of 200 ppm (9 mg/kg/day for males and 12 mg/
kg/day for females). The LOAEL for systemic toxicity is 750 ppm (36 mg/
kg/day for males and 58 mg/kg/day for females).
    ii. A 1 year chronic toxicity study in dogs with a NOAEL of 450 ppm 
(14.7 mg/kg/day) and a LOAEL of 1,350 ppm (44.6 mg/kg/day).
    iii. A 2-year oncogenicity study in Sprague-Dawley rats with a 
NOAEL for systemic toxicity of 200 ppm (9 mg/kg/day for males and 11 
mg/kg/day for females). The LOAEL for systemic toxicity was 750 ppm (34 
mg/kg/day for males and 46 mg/kg/day for females). There was no 
evidence of increased incidence of neoplastic lesions in treated 
animals. The NOAEL for oncogenicity is 2,000 ppm (95 mg/kg/day for 
males and 132 mg/kg/day for females) HDT.
    iv. A 2-year oncogenicity study in mice with a NOAEL for systemic 
toxicity of 100 mg/kg/day and a LOAEL of 1,000 mg/kg/day. There was no 
evidence of increased incidence of neoplastic lesions in treated 
animals. The NOAEL for oncogenicity is 1,000 mg/kg/day HDT.
    6. Animal metabolism. Results from the livestock and rat metabolism 
studies show that orally administered dimethomorph was rapidly excreted 
by the animals. The principal route of elimination is the feces.
    7. Metabolite toxicology. There were no metabolites identified in 
plant or animal commodities which require regulation.
    8. Endocrine disruption. Collective organ weights and 
histopathological findings from the 2-generation reproduction study in 
rats, as well as

[[Page 12247]]

from the subchronic and chronic toxicity studies in two or more animal 
species, demonstrate no apparent estrogenic effects or effects on the 
endocrine system. There is no information available which suggests that 
dimethomorph technical would be associated with endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. For purposes of assessing the 
potential dietary exposure, a Theoretical Maximum Residue Contribution 
(TMRC) has been calculated from the tolerance of dimethomorph technical 
in or on hops at 45 ppm, whole tomatoes at 0.50 ppm, tomato puree at 
0.50 ppm, and tomato paste (including tomato juice and catsup) at 1.50 
ppm. This exposure assessment is based on very conservative 
assumptions, namely, 100% of all hops and tomato commodities consumed 
is treated with dimethomorph technical and that the residues of 
dimethomorph technical in hops and tomato commodities are equal to the 
tolerance. Although there are no other established United States 
permanent tolerances for dimethomorph technical, petitions for a 
permanent tolerance of 0.05 ppm in or on potatoes and for a time-
limited tolerance of 2.0 ppm in or on imported grapes are pending at 
the Agency. Therefore, the dietary exposures to residues of 
dimethomorph technical in or on food will be limited to residues in 
hops, tomatoes, potatoes and grapes. For the overall population, the 
contribution of the tolerances for hops and tomato commodities to daily 
consumption uses only 0.05% and 0.58%, respectively, of the Reference 
Dose (RfD). The combined contributions of the hops, tomato and pending 
potato and grapes tolerances to the daily consumption uses only 1.58% 
of the RfD for the overall U.S. population, less than 5% for infants 
and non-nursing infants (2.38% and 2.60%, respectively) and less than 
5% for children ages 1-6 and 7-12 (4.39% and 1.81%, respectively). 
Therefore, American Cyanamid concludes that the chronic dietary 
exposure to dimethomorph from all current and pending tolerances is 
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%).
    ii. 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 from chronic exposure was 
estimated by the 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). 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, the large 
margin of exposure (40x-142x), and the similarity in use pattern on 
potato and tomato, the additional use of dimethomorph on tomatoes is 
not expected to reach a level of concern for residues in drinking 
water. Potential exposure in drinking water in the U.S. for the 
proposed tolerance on imported hops is not relevant to this petition.
    2. Non-dietary exposure. The proposed tolerances are for imported 
hops and, there are no residential uses for dimethomorph in the United 
States; therefore, non-dietary exposure in the United States 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 proposed RfD is 0.1 mg/kg bwt/day, based on 
a 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. Because American Cyanamid Company 
believes that dimethomorph technical is not genotoxic, carcinogenic, or 
teratogenic and is not a reproductive toxicant, the proposed RfD is 
calculated using an uncertainty factor of 100. The TMRC for imported 
hops is estimated at 0.0000515 mg/kg bwt/day for the general 
population. This represents a dietary exposure to the general U.S. 
population which is 0.05% of the RfD. Similarly, the TMRC for all 
tomato commodities is estimated at 0.0005818 mg/kg bwt/day for the 
general U.S. population. This represents a dietary exposure to the 
general U.S. population which is 0.58% of the RfD. No population 
subgroup is more highly exposed to hops than the general population. 
Children ages 1-6 and 7-12 are more highly exposed to tomato 
commodities than the general population. The TMRC values for tomato 
commodities are estimated at 0.0011050 and 0.0008449 mg/kg bwt/day for 
children ages 1-6 and 7-12, respectively. The dietary exposure to 
children ages 1-6 is 1.10% of the RfD, and the dietary exposure to 
children ages 7-12 is 0.84% of the RfD. The combined TMRC for all 
current and proposed dimethomorph tolerances in hop, tomatoes, cereal 
grain commodities, cantaloupe, cucumber, squash, watermelon, potatoes, 
and grapes will utilize less than 10% of the RfD for the general U.S. 
population. Since EPA generally has no concern for exposures below 100% 
of the RfD, EPA should conclude that there is a reasonable certainty 
that no harm will result from aggregate exposure to dimethomorph 
residues in or on commodities of the cited crops.
    2. Infants and children. The TMRC for hops consumed by infants, 
non-nursing infants, children ages 1-6 and children ages 7-12 is 
minimal. For all population subgroups, consumption of residues of 
dimethomorph in or on hops will use 0.00% of the RfD. The TMRC for 
tomato commodities consumed by infants, non-nursing infants, children 
ages 1-6 and children ages 7-12 is also minimal. The consumption of 
residues of dimethomorph on tomato commodities will use 0.17%, 0.25%, 
1.10%, and 0.84% of the RfD for infants, non-nursing infants, children 
ages 1-6 and children ages 7-12, respectively. The combined TMRC values 
for the proposed dimethomorph tolerances in/on hops, tomatoes, potatoes 
and grapes in infants and non-nursing infants are 0.0023770 mg/kg bwt/
day and 0.0026026 mg/kg bwt/day, respectively. The combined tolerances 
will use less than 5% of the RfD for infants and non-nursing infants 
(2.38% and 2.60%, respectively). The combined TMRC values for the 
proposed dimethomorph tolerances in/on hops, tomatoes, potatoes and 
grapes consumed by a child 1-6 years of age is 0.0043911 mg/kg bwt/day, 
which is less than 5% (actual 4.39%) of the RfD. The

[[Page 12248]]

combined TMRC values for the proposed dimethomorph tolerances in/on 
hops, tomatoes, potatoes and grapes consumed by a child 7-12 years of 
age is 0.0018062 mg/kg bwt/day, which is also less than 5% (actual 
1.81%) of the RfD. Moreover, the combined TMRC values for all current 
and proposed dimethomorph tolerances will utilize less than 10% of the 
RfD for each of these subgroups. American Cyanamid Company believes 
that 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. The NOAELs observed in the 
developmental and reproductive studies were 6 to 65 times higher than 
the NOAEL used to establish the proposed RfD (10 mg/kg bwt/day). There 
is no evidence to indicate that children or infants would be more 
sensitive than adults to toxic effects caused by exposure to 
dimethomorph. Therefore, American Cyanamid believes that the results of 
the toxicology and metabolism studies support both the safety of 
dimethomorph technical to humans based on the intended use as a 
fungicide on hops, tomatoes, potatoes and grapes and the granting of 
the requested tolerances for hops, tomato, potato and grape 
commodities.

F. International Issues

    No Codex maximum residue levels have been established for 
dimethomorph to date.
[FR Doc. 00-5632 Filed 3-7-00; 8:45 am]
BILLING CODE 6560-50-F