dimethomorph (Acrobat) Pesticide Petition Filing 4/00
[Federal Register: April 12, 2000 (Volume 65, Number 71)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
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
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@example.com.
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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.,
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
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: ``firstname.lastname@example.org,'' 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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
Dated: April 5, 2000.
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
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
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
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
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
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
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
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