[Federal Register: August 6, 2003 (Volume 68, Number 151)]
[Notices]
[Page 46616-46619]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au03-81]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0240; FRL-7319-3]
Cyromazine; Notice of Filing of Pesticide Petitions 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 pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket ID number OPP-2003-0240, must be
received on or before September 5, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Industry (NAICS 111, 112, 311, 32532), e.g., Crop
production, Animal production, Food manufacturing, and 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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0240. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B. EPA intends to work towards
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and
[[Page 46617]]
without change, unless the comment contains copyrighted material, CBI,
or other information whose disclosure is restricted by statute. When
EPA identifies a comment containing copyrighted material, EPA will
provide a reference to that material in the version of the comment that
is placed in EPA's electronic public docket. The entire printed
comment, including the copyrighted material, will be available in the
public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0240. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0240. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0240.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0240. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed 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
ID 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2);
[[Page 46618]]
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 28, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petitions are printed below
as required by FFDCA section 408(d)(3). The summary of the petitions
were prepared by the petitioner and represents the view of the
petitioner. 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.
Interregional Research Project Number 4 (IR-4)
PP 2E6507 and PP 2E6510
EPA has received pesticide petitions (PP 2E6507 and PP 2E6510) from
IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390
proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to
amend 40 CFR 180.414 by establishing tolerances for residues of
cyromazine, (N-cyclopropyl-1,3,5-triazine-2,4,6-triamine) in or on the
following raw agricultural commodities: Leek; onion, green; onion,
potato; onion, tree; onion, welsh; and shallot, fresh leaves at 3.0
parts per million (ppm) (2E6507), garlic, bulb; garlic great-headed,
bulb; onion, dry bulb; rakkyo, bulb; and shallot, bulb at 0.2 ppm
(2E6507), vegetable brassica, leafy, group 5, except broccoli at 10 ppm
(2E6510), broccoli at 1.0 ppm, turnip, greens; cabbage, abyssinian;
cabbage, seakale; and hanover salad, leaves at 10 ppm, and kidney of
cattle, goats, hogs, horses, and sheep at 0.2 ppm, and meat byproducts
of cattle, goats, hogs, horses, and sheep at 0.05 ppm (2E6510). IR-4
also proposed that tolerances for residues of cyromazine in or on dry
bulb onion at 2.0 ppm and green onion at 0.1 ppm established under 40
CFR 180.414(a) and Chinese cabbage and Chinese mustard at 3.0 ppm
established under 40 CFR 180.414(c) be deleted when the proposed
tolerances are established. Chinese cabbage and Chinese mustard are
included in the Brassica leafy vegetable group. EPA has determined that
the petitions contain 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 petitions. Additional data may be
needed before EPA rules on the petitions. This summary has been
prepared by the Syngenta Crop Protection Incorporated.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyromazine in plants is
adequately understood for the purposes of these tolerances.
2. Analytical method. Methods AG-408 and AG-417 as listed in the
Food and Drug Administration's Pesticide Analytical Manual (PAM), Vol-
II are adequate to enforce the proposed tolerances.
3. Magnitude of residues. Residue field tests were conducted in
typical growing regions for Brassica and bulb vegetables and turnip
tops. The data collected support the proposed tolerances of 10.0 ppm
for Brassica leafy vegetables, 10.0 ppm for turnip tops and 3.0 ppm for
bulb vegetables.
B. Toxicological Profile
1. Acute. A rat acute oral toxicity study with a lethal dose
(LD)50 of approximately 3,387 milligrams/kilogram (mg/kg)
(toxicity category III; moderately toxic). A rat acute dermal toxicity
study with a LD50 greater than 3,100 mg/kg (toxicity
category III; moderately toxic). A rat acute inhalation study with a
lethal concentration (LC)50 greater than 2.9 mg/kg (toxicity
category IV; slightly toxic). A primary eye irritation study in the
rabbit that showed no eye irritation. A primary dermal irritation study
in the rabbit that showed mild irritation (toxicity category; IV). A
dermal sensitization study in the guinea pig that showed no
sensitization.
2. Genotoxicity. Studies on gene mutation and other genotoxic
effects showed no evidence of point mutation in an Ames test; no
indication of mutagenic effects in a dominant lethal test; and no
evidence of mutagenic effects in a nucleus anomaly test in Chinese
hamsters.
3. Reproductive and developmental toxicity. In a rat developmental
toxicity study, the maternal no observed adverse effect level (NOAEL)
was 100 mg/kg/day. The maternal lowest observed adverse effect level
(LOAEL) was 300 mg/kg based on decreased body weight gain and clinical
observations. The developmental NOAEL was 300 ppm. The developmental
LOAEL was 600 mg/kg based upon an increase of minor skeletal variation.
In a rabbit developmental toxicity study, the maternal NOAEL was 10
mg/kg. The maternal LOAEL was 30 mg/kg based upon decreased body weight
gain and food consumption. The developmental NOAEL/LOAEL was greater
than or equal to 60 mg/kg.
In a multi-generation study in rats, the systemic NOAEL was 30 ppm
(1.5 mg/kg). The systemic LOAEL was 1,000 ppm (50 mg/kg) based upon
decreased body weights associated with decreased food consumption. The
developmental/offspring systemic NOAEL was 1,000 ppm. The
developmental/offspring systemic LOAEL was 3,000 ppm (150 mg/kg) based
upon decreased body weight at birth through weaning. There were no
effects on reproductive parameters at the highest dose tested (HDT)
(3,000 ppm).
4. Subchronic toxicity. In a 6-month feeding study in dogs, the
NOAEL was 30 ppm (0.75 mg/kg). The LOAEL was 300 ppm (7.5 mg/kg) based
upon decreased hematocrit and decreased hemoglobin. Groups of male and
female beagle dogs (4/sex/dose) were fed diets containing cyromazine at
0, 30, 300, or 3,000 ppm (0, 0.75, 7.5, or 75 mg/kg/day, respectively)
for 6-months. No treatment-related effects were observed in survival,
clinical signs or body weight parameters. Pronounced effects on
hematologic parameters were manifested as decreases in hematocrit and
hemoglobin levels at 300 and 3,000 ppm.
5. Chronic toxicity. In a 24-month feeding study in rats the NOAEL
for the study was 30 ppm (1.5 mg/kg/day). The LOAEL was 300 ppm (15.0
mg/kg) based on decreased body weight. In a 24-month mouse chronic
feeding carcinogenicity study the NOAEL was 50 ppm (7.5 mg/kg/day). The
LOAEL was 1,000 ppm (150.0 mg/kg) based upon decreased body weight.
There was no evidence of carcinogenicity at 3,000 ppm (450 mg/kg). In a
24-month rat chronic feeding carcinogenicity study the NOAEL was
greater than 3,000 ppm (150 mg/kg) (HDT). There was no evidence of
carcinogenicity at 3,000 ppm.
Cancer Peer Review Committee determined that there is no evidence
of carcinogenicity in studies in either the mouse or rat. Based upon
this determination it can be concluded that cyromazine does not pose a
cancer risk.
[[Page 46619]]
6. Animal metabolism. The metabolism of cyromazine has been
adequately characterized in the rat, goat, and chicken.
7. Metabolite toxicology. EPA has removed melamine, a metabolite of
cyromazine, from the tolerance expression as a residue of toxicological
concern. For more information on melamine, see the Federal Register of
September 15, 1999 (64 FR 50043) (FRL-6098-7).
8. Endocrine disruption. Cyromazine does not belong to a class of
chemicals proven to have adverse effects on the endocrine system. There
is no evidence that cyromazine has any effect on endocrine function in
developmental or reproduction studies.
C. Aggregate Exposure
1. Dietary exposure--Food. For the purposes of assessing the
potential dietary exposure under the proposed tolerances, Syngenta Crop
Protection has estimated aggregate exposure from all crops for which
tolerances are established.
i. Acute. There were no toxicological effects attributed to a
single exposure (dose) observed in oral toxicity studies including the
developmental toxicity studies in rats and rabbits. Therefore, there is
a reasonable certainty of no harm from acute dietary exposure.
ii. Chronic. The cyromazine chronic dietary exposure assessment
utilized the Dietary Exposure Evaluation Model (DEEM[reg]), version
7.76 from Exponent. All consumption data from this assessment were
taken from the USDA's Continuing Survey of Food Intake by Individuals
(CSFII) with the 1994-96 consumption database and the Supplemental
CSFII children's survey (1998) consumption database.
The cyromazine Tier III chronic dietary exposure assessment was
based upon residue field trial results, and tolerance residues for
crops when no field trial data were available. Anticipated residue
estimates were used for milk, meat, fat, and meat by-products of
cattle, goats, hogs, horses, and sheep; and for all other commodities
tolerance level residues were assumed. The maximum percent crop treated
values for cyromazine were obtained from the Doane's Market Survey
Database (1999-2001) and used for lima beans (0.8%), cantaloupe (3.9%),
peppers (8.6%), tomatoes (2.9%), celery (68.9%), lettuce (9.7%),
spinach (19.5%), and onions (0.2%). For all other registered or
proposed crop uses, it was assumed that 100% of these crops were
treated.
2. Drinking water. EPA uses the FQPA Index Reservoir Screening Tool
(FIRST) to estimate pesticide concentrations in surface water and
screening concentration in ground water (SCI-GROW) to estimate
pesticide concentrations in ground water. FIRST incorporates an index
reservoir environment and includes a percent crop area factor as an
adjustment to account for the maximum percent crop coverage within a
watershed or drainage basin.
None of these models include consideration of the impact that
processing (mixing, dilution, or treatment) would have on the removal
of pesticides from the water source. The primary use of these models by
EPA is to provide a Tier I assessment to estimate the concentration of
pesticides in drinking water.
Estimated Environmental Concentrations (EECs) of cyromazine in
drinking water were determined for the highest use rate of cyromazine.
Based on the model outputs, the EECs of cyromazine are 1.8 parts per
billion (ppb) for chronic exposure to ground water and 10 ppb for
chronic exposure to surface water.
3. Non-dietary exposure. Cyromazine is currently registered for
commercial outdoor use on landscape ornamentals and commercial
interiorscapes. There are no lawn or indoor residential uses and
significant residential exposure is not expected.
D. Cumulative Effects
When considering whether to establish, modify, or revoke a
tolerance, section 408(b)(2)(D)(v) requires that the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residue and ``other substances that have a
common mechanism of toxicity.'' Neither Syngenta nor EPA has at this
time, data available to determine whether cyromazine has a common
mechanism of toxicity with other substances or the methodology to
include this pesticide in a cumulative risk assessment. Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, cyromazine does not appear to
produce a toxic metabolite produced by other substances.
E. Safety Determination.
1. Acute risk. There were no toxicological effects observed in oral
toxicity studies, including the developmental toxicity studies in rats
and rabbits, that could be attributed to a single exposure (dose).
Since there is a reasonable certainty of no harm from acute dietary
exposure, an acute aggregate risk assessment was not performed for
cyromazine.
2. Chronic risk. The chronic dietary exposure risk analysis (food
only) showed that exposure from all established and these proposed
tolerances would be 2.9% of the chronic reference dose (cRfD) for the
most exposed subpopulation, children 1 to 2 years old. EPA has
determined that reliable data support using the standard margin of
exposure and uncertainty factor (100 for combined interspecies and
intraspecies variability) for cyromazine and an additional safety
factor of 10X is not necessary to protect infants and children.
3. Drinking water. The chronic drinking water level of concern
(DWLOC) for the most exposed subpopulation (children 1-6 years) is 728
ppb. Based upon the SCI-GROW and FIRST model outputs, the EECs of
cyromazine in surface water and ground water are below the chronic
DWLOC; therefore, EPA should not have a concern regarding cyromazine in
drinking water.
4. Non-dietary exposure. Due to the nature of the non-dietary use,
the commercial use of cyromazine on landscape ornamentals will not
result in any significant residential exposure.
Syngenta has considered the potential aggregate exposure from food,
water, and non-occupational exposure routes and concluded that
aggregate exposure is not expected to exceed 100% of the cRfD.
Therefore, Syngenta has concluded that there is reasonable certainty
that no harm will result from aggregate exposure to cyromazine
residues.
F. International Tolerances.
The U.S. tolerances and Codex Maximum Residue Levels (MRLs) are
compatible for ruminant tissue, bell pepper, and tomato. Codex MRLs and
U.S. tolerances are incompatible for milk, celery, cucumber, lettuce,
melon, and mushroom.
[FR Doc. 03-20014 Filed 8-5-03; 8:45 am]
BILLING CODE 6560-50-S