[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Notices]
[Page 42026-42030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-81]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0235; FRL-7317-4]
Gellan Gum; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2003-0235, must be received on or before August 15, 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: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; e-mail address: boyle.kathryn@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] Crop production (NAICS code 111)
[sbull] Animal production (NAICS code 112)
[sbull] Food manufacturing (NAICS code 311)
[sbull] Pesticide manufacturing (NAICS code 32532)
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 ID number OPP-2003-0235. 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 EPA's 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 without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is
[[Page 42027]]
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-2003-0235. 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-2003-0235. 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-2003-0235.
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-2003-0235. 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); however,
EPA has not fully evaluated the sufficiency of the submitted data at
[[Page 42028]]
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 7, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The summary may have been edited by EPA if the terminology used was
unclear, the summary contained extraneous material, or the summary
unintentionally made the reader conclude that the findings reflected
EPA's position and not the position 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.
CP Kelco
PP 3E6567
EPA has received a pesticide petition (PP 3E6567) from CP Kelco,
8355 Aero Drive, San Diego, CA 92123, proposing pursuant to section
408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for gellan
gum (CAS Reg. No. 71010-52-1) in or on all raw agricultural commodities
(RAC) when used as a sticker/thickener in seed treatment and pesticide
formulations. 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. As a polysaccharide polymer, gellan gum is
non-systemic and therefore no metabolism of gellan gum in raw
agricultural commodities or processed commodities is expected.
2. Analytical method. Analytical methods for determination of the
polysaccharide polymer, gellan gum are available. Gellan gum is
determined by the dissolution of gellan gum containing gels by heating
and cooling in the presence of a dilute sequestrant solution (e.g. 0.1%
w/v sodium hexametaphosphate). The gellan gum assay is based upon the
presence of the 6-deoxyhexose rhamnose which can be determined using
the cysteine-sulfuric acid procedure, originally developed by Dische
and Shettles and modified by Graham.
3. Magnitude of residues. Gellan gum is applied as a minor
component of pesticidal formulations. Gellan gum degrades into simple
non-toxic sugars and their salts.
B. Toxicological Profile
1. Acute toxicity. The acute toxicity of gellan gum was studied
using male and female rats via the oral and inhalation routes. In the
acute oral toxicity study, the lethal dose (LD)50 for both
males and females was established at >5,000 milligrams/kilogram body
weight (mg/kg bwt). For the acute inhalation toxicity study, the
LD50 for both males and females was established at >5.09
milligrams/Liter (mg/L). Gellan gum is practically non-toxic to rats
when administered as a single large dose (5 g/kg bwt) in diet or via
gavage.
2. Genotoxicity. Gellan gum was shown to be non-genotoxic in a
battery of standard short-term tests. The Ames test, involving S.
typhimurium at 10, 30, 100, 300, and 1,000 [mu]g/plate resulted in a
negative response. A deoxyribonucleic acid (DNA) repair test using the
rat hepatocyte as a test subject at 3, 5, 10, and 20 milligrams/liter
(mg/L) resulted in a negative response. For the V-79/hypoxanthine
guanine phophoribosyl transferase/(HGPRT) study, involving the Chinese
hamster lung fibroblasts, doses at 3, 5, 10, and 20 mg/mL resulted in a
negative response.
3. Reproductive and developmental toxicity. Groups of 26 male and
female CD (Sprague-Dawley) rats were administered gellan gum in their
diets at doses of 0, 2.5, 3.8, or 5.0%. Males were treated for 70 days
prior to mating and for 3 weeks after mating. Females were treated for
14 days prior to mating and throughout mating, gestation, and
lactation. Selection was made for the pups (F1) of this
mating and they were allowed to mature and were mated to form the
F2 generation. There was no treatment-related effect of
mating or fertility index, conception rate, length of gestation, length
or parturition, number of live pups, number of dead pups, post-
implantation loss index, survival index on day 4, 7, 14, or 21 or
lactation index for any of the generations.
For teratology studies, gellan gum was fed to groups of 25 pregnant
female Sprague-Dawley rats at dietary levels of 0, 2.5, 3.8, or 5.0%
during days 6-15 of gestation. Gellan gum has no fetotoxic or
teratogenic effects on rats when ingested in the diet at levels up to
5.0%. In the reproduction and teratogenic studies in rats in which
gellan gum was given at doses up to 50 g/kg in the diet, there was no
evidence of interference with the reproductive process, and no
embryotoxic or developmental effects were observed.
4. Subchronic toxicity. For short-term studies, male and female
Sprague-Dawley rats (20/sex/group) were fed dietary levels of gellan
gum ranging from 0-6% for 13 weeks. Although the animals on this study
experienced symptoms of a sialodacryoadenitis viral infection, all
animals survived treatment and there were no adverse effects associated
with the feeding of gellan gum at levels up to 60 gram/kilogram (g/kg).
Also, prepubertal rhesus monkeys (2/sex/group) were dosed by oral
gavage with gellan gum at levels of 0, 1, 2, or 3 g/kg/day for 28 days.
There were no overt signs of toxicity reported at levels up to 50 g/kg
in the diet.
5. Chronic toxicity. Groups of 50 male and female Swiss Crl mice
were fed gellan gum admixed in the diet at 0, 1.0, 2.0, and 3.0% for 96
and 98 weeks for males and females, respectively. All animals were
examined twice daily for mortality and morbidity. Physical examination
for the presence of palpable masses was initiated on a weekly basis
starting in week 26. Body weights and food consumption were measured
for 7-day periods on a weekly basis for the first 26 weeks of treatment
and every 2 weeks thereafter. At necropsy, a complete gross
pathological examination was performed on the animals from the control
and 3.0% groups. Only the liver, kidneys, ovaries, testes, adrenals,
pituitary, lungs, and heart were examined for animals of the 1.0 and
2.0% groups. There were no effects attributable to the feeding of
gellan gum on either body weight gain or food consumption. There were
no neoplastic or non-neoplastic changes which were associated with the
feeding of gellan gum.
For the rat, groups of 50 F1 generation Sprague-Dawley
rats of each sex were exposed to gellan gum in utero and continued on
gellan gum diets for approximately 104 weeks. The dietary levels of
gellan gum were 0, 2.5, 3.8, and 5.0%. The rats were observed daily for
[[Page 42029]]
the first 4 weeks of treatment and weekly thereafter for clinical signs
of toxicity. Individual bodyweights and food consumption were measured
on a weekly basis for the first 26 weeks of treatment and every 2 weeks
thereafter. Fundoscopic and biomicroscopic examinations were conducted
on the control and 5% groups during weeks 1, 13, 26, 52, 78, and 103.
Clinical chemistry and haematological samples were collected at weeks
13, 25, 39, and 51. After 104 weeks, ophthalmoscopic examinations,
haematology, clinical chemistries and organ weight data revealed no
changes which could be attributed to the feeding of gellan gum.
Survival of male treated rats was poor when compared to controls
whereas female treated rats exhibited better survival than their
concurrent controls. Male rats, fed gellan gum at the 3.8 and 5.0%
dietary levels, exhibited lower body weights after 76 weeks. The
initial bodyweights were 5.2 and 3.4% lower than the control values for
the 3.8 and 5.0% dietary levels, respectively. It was concluded that in
spite of the initial body weight deficit, the growth pattern for these
treated groups was identical to that of the control. In addition, this
effect was not seen in either the females or any other species tested.
There is no basis to suggest that the lower body weights, observed in
the male rats, are indicative of toxicity. Organs and tissues as those
listed in the mouse study were examined for histopathological changes
at study termination. There were no neoplastic or non-neoplastic
changes that could be associated with the feeding of gellan gum. The
authors concluded that gellan gum is non-carcinogenic to Sprague-Dawley
rats.
For chronic toxicity study on dogs, diets containing 0, 3, 4.5, and
6% gellan gum were fed to groups of 5 Beagle dogs per sex for a period
of 52 weeks. The dogs were observed daily for clinical signs of
toxicity and were measured for body weights and food consumption.
Ophthalmoscopic examinations were performed during pretreatment and
after 12, 24, 29, and 51 weeks. Hematology and clinical chemistry were
measured during pretreatment and after 6, 13, 25, 39, and 50 weeks.
After 52 weeks all animals were killed and grossly examined. All
animals survived treatment. Food intake was higher in the treated
groups compared to the controls. There were no adverse effects
associated with the feeding of gellan gum to beagle dogs for a period
1-year.
6. Animal metabolism. The adsorption, distribution, and excretion
of gellan gum was studied using a dually radiolabeled (\3\H and \14\C)
preparation. The use of dual labeling allowed simultaneous quantitation
of both polysaccharide and ``protein'' fractions of gellan gum.
One male and one female Sprague-Dawley rat were gavaged with single
doses of the \3\H/\14\C-gellan gum (ca. 960 mg/kg; ca. 4 [mu]Ci).
Expired air was collected 24 hours after dosing. Less than 0.55% of the
given radioactivity was detected as \14\C.
Four male and three female Sprague-Dawley rats were dosed with
single gavage dose of \3\H/\14\C-gellan gum (ca. 870 mg/kg; 2.9 - 4.1
[mu]Ci \14\C; 0.7 - 0.9 [mu]Ci \3\H). Urine and feces were collected
for 7 days, at which time the animals were sacrificed and their tissues
analyzed for residual radioactivity. Females excreted 86.8% and 1.9% of
the given \14\C in the feces and urine, respectively. Males excreted
86% of the dosed \14\C in the feces and 3.3% in the urine. Females
excreted 4.1% of the dosed \3\H in their urine and 100.1% in their
feces, while males excreted 3.6% of the total \3\H in their urine and
99.6% in their feces. In all animals, the activities of \3\H in tissues
(blood, brain, liver, kidney, lung, muscle, skin, heart, and carcass)
were too low to be quantitated accurately. Tissue and carcass
radioactivity for \14\C averaged 3.8% of dose for male rats and 3.0% of
dose for female rats. A male and four female Sprague-Dawley rats were
gavaged with about 1 g/kg of radiolabeled gellan gum and blood samples
collected from the tail vein at different time intervals over a 7-day
period. Data were reported as \14\C dmp/mL blood (\3\H dmp/mL blood was
not reported). The peak level of radioactivity, which amounted to about
0.4% of the administered radioactivity, occurred about 5 hours after
dosing.
Gellan gum was shown to be poorly absorbed and did not cause any
deaths in rats which received a single large dose (5 g/kg bwt) in the
diet or by gavage.
7. Metabolite toxicology. Gellan gum is a polysaccharide polymer
composed of D-mannopyranose with D-glucopyranose and 6-deoxy-L-
mannopyronose, calcium, potassium, and sodium salt. Gellan gum
metabolizes into simple non-toxic sugars and their salts.
8. Endocrine disruption. Gellan gum does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system. There is no evidence that gellan gum has any effect on
endocrine function in developmental or reproduction studies.
Furthermore, histological investigation of endocrine organs in chronic
dog, rat, and mouse studies did not indicate that the endocrine system
is targeted by gellan gum.
C. Aggregate Exposure
1. Dietary exposure. As a minor formulation component, there is no
reasonable expectation that gellan gum will appear in diet.
i. Food. Gellan gum is approved in the U.S. under 21 CFR 172.665 as
a food additive, stabilizer, and thickener in batters, breadings,
coatings, glazes, gravies, and sauces for meat and poultry products. As
a minor formulation component, there is no reasonable expectation that
gellan gum will appear in food from pesticide uses.
ii. Drinking water. As a minor formulation component, there is no
reasonable expectation that gellan gum will appear in water.
2. Non-dietary exposure. The only non-dietary exposure to gellan
gum will be exposure through treating and handling of treated seeds and
application of formulations containing gellan gum.
D. Cumulative Effects
The potential for cumulative effects of gellan gum and other
substances that have a common mechanism of toxicity has also been
considered. Gellan gum is a high-molecular-weight polysaccharide gum
produced by a pure-culture fermentation of a carbohydrate with
Sphingomonas elodea. There is no reliable information to indicate that
toxic effects produced by gellan gum would be cumulative with those of
any other chemical including another pesticide. Therefore, CP Kelco
believes it is appropriate to consider only the potential risks of
gellan gum in an aggregate risk assessment.
E. Safety Determination
1. U.S. population. The occupational exposure to gellan gum in
pesticide formulations during distribution and storage will be limited
to: Workers involved in the transportation of gellan gum to customers;
and those involved in the loading and off-loading of the product
containers from commercial carriers and during opening of drums
containing gellan gum. However, the potential for worker exposure is
expected to be well controlled and limited if worker-safety procedures
are routinely practiced. The potential opportunity for human exposure
to gellan gum is expected to be limited to clean-up activities during
routine maintenance, or following an accidental spill or release.
Exposures occurring during these activities would typically be
minimized by the accommodations made in equipment design and
[[Page 42030]]
employee work practices. As long as the recommended practices for
worker protection during use are respected, the risk of worker exposure
to gellan gum in an occupational setting is expected to be of minimal
significance.
2. Infants and children. The exposure to gellan gum in pesticide
formulations is limited to formulators and applicators. Dietary
exposure to infants and children does not differ from the general
population.
F. International Tolerances
Gellan gum is approved, registered, or filed as a food additive in
the countries of Argentina, Brazil, Canada, Chile, Columbia, Costa
Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama,
Paraguay, Peru, Uruguay, Venezuela, Egypt, Hungary, Israel, Jordan,
Morocco, Norway, Pakistan, Poland, South Africa, Switzerland, Tunisia,
Turkey, Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia,
Malta, New Zealand, Singapore, South Korea, Sri Lanka, Taiwan,
Thailand, the Philippines, and Vietnam. In the European community,
gellan gum has approval (E-418) as a food additive. Purity criteria are
established by JECFA (Joint Expert Committee on Food Additives).
[FR Doc. 03-17897 Filed 7-15-03; 8:45 am]
BILLING CODE 6560-50-S