[Federal Register Volume 63, Number 224 (Friday, November 20, 1998)]
[Notices]
[Pages 64494-64497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31063]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-832; FRL-6027-6]
Notice of Filing of Pesticide Petitions
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
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-832, must
be received on or before December 21, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7502C), Information Resources and Services
Division, Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under ``SUPPLEMENTARY
INFORMATION.'' No confidential business information should be submitted
through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 119 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
Location, telephone number, and e-mail address: Rm. 707A, CM #2 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703-8380, e-mail:
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows
[[Page 64495]]
proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals 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 these petitions
contain 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.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-832] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [PF-832] and appropriate petition number.
Electronic comments on this notice may be filed online at many Federal
Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: October 22, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them 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.
1. EDM Corp
PP 8E4968
EPA has received a pesticide petition (8E4968) from EDM Corp 2278
So. Indiana Porterville, CA 93257 proposing pursuant to section 408(d)
of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend
40 CFR part 180 to establish an exemption from the requirement of a
tolerance for Yucca Extract in or on the raw agricultural commodity
when used in accordance with good agriculture practice as an inert
ingredient in pesticide formulations applied to growing crops, the 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. No plant metabolism studies have been
submitted in support of this tolerance exemption petition since yucca
extract, a sarsasaponin is present in most plant life.
2. Analytical method. Since the petitioner has requested a
tolerance exemption, a residue analytical method is not required.
3. Magnitude of residues. No yucca extract residue studies were
conducted since yucca extract is naturally found at significant levels
(> .68 ppm) in many different types of food. In addition, residue
trials are not practical since it is very difficult to distinguish
Sarsaponin residues naturally occurring versus sapsaponin residues from
yucca extract.
B. Toxicological Profile
1. Acute toxicity-- Study #6176-P320 acute oral toxicity. The acute
oral LD50 for a 70% solution of yucca extract is > 5,000
milligrams/kilogram (mg/kg). Accordingly, yucca extract relatively non-
toxic by the oral route.
The petitioner has requested that the Agency waive all sub-chronic,
chronic/oncogenicity, mutagenicity, developmental and reproductive
toxicity study requirements for yucca extract. There is an overwhelming
lack of evidence for any chronic effects induced by dietary ingestion
of yucca extract.
C. Aggregate Exposure
1. Food. The FDA title 21 under CFR 172.510, FEMA #3121, No
Limitations. Food. Sarsasaponin is naturally found in several types of
foods, such as fruits and vegetables,(asparagrus, legumes ect) at
various levels.
2. Drinking water. Degradation of sarsasaponin in water.
D. Cumulative Effects.
No cumulative adverse effects are expected from long-term exposure
to yucca extract.
E. Safety Determination
1. U.S. population. Yucca has been approved for uses in food and
beverages by the FDA title 21 CFR 172.510, FEMA number 3121, with no
limits. Approval of this petition will not increase dietary exposure to
yucca extract. Accordingly, there is reasonable certainty that no harm
will result from aggregate exposure of the U.S. population to yucca
extract.
2. Infants and children. Since yucca extract is also an additive in
soft drinks, root beer etc. the daily exposure to children is
anticipated to be trivial, no adverse effects on infants or children
are expected.
F. International Tolerances
There are no approved CODEX maximum residue levels (MRLS)
established for residues of yucca extract.
Previously submitted Yucca extract data:
1. THERM-70 Study #6176-P320 Acute Oral Toxicity.
2. Regarding the use of the inert ingredient Yucca extract:
A-350 tons raw materials are used for all usese in the United
States.
B- 300,000 lbs of raw material makes 4,630 gallons of THERMX-70 for
pesticidal uses.
C- CELLU-CON, INC. Received raw material in 1997 from Mexico (85%)
and U.S. 15%.
D- Yucca already approved for uses in food and beverages by the FDA
title 21 CFR 172.510, FEMA number 3,121, no limits.
E- We would like to waive Yucca (Schidigera) to be approved under
title 40 CFR in section 180.1001 as an Inert Ingredient.
3. This is to advise you regarding EDM's use of Yucca. We will not
be using more than 6% THERMX-70 as a wetting in our product MIRAGE.
[[Page 64496]]
Enclosed is a packet of information to assist you in studying this
material.
A- FDA 21 CFR 172.510
B- COMMERCIAL FEED LICENSE
C- THERMX-70 label
D- THERMX-70 MSDS sheet
E- Sarsaponin (Micro-Aid)
4. DESERT PRIDE label Yucca Herbal Food Tablets has been sold in
stores since 1974.
2. Hercules, Incorporated
PP 6E4782
EPA has received a pesticide petition (PP 6E4782) from Hercules,
Incorporated, 1313 North Market Street, Wilmington, Delaware, proposing
pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act,
21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption
from the requirement of a tolerance for polymers of -pinene
and/or B-pinene in or on raw agricultural commodities. 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. Toxicological Profile
1. Acute toxicity. An acute oral intubation test was conducted. Two
male and two female rats were administered four dose levels of
oligomeric copolymer ranging from 10.2 to 34.6 g/kg. No deaths
resulted. The oral LD50 in rats is therefore >34.6 g/kg. An
acute eye irritation study was conducted. Two rabbits were treated with
0.1 milliliter (ml) of undiluted oligomeric copolymer material
instilled in each eye. One eye of each animal was rinsed with running
water after one minute. The unwashed eye showed moderate irritation to
the iris and conjunctiva which persisted for 4 days after treatment.
Irritation in the washed eyes was mild and persisted for 3 days after
treatment.
2. Reproductive and developmental toxicity. Petitioner has not
identified a reproduction study in which the test substance was an
-pinene based polymer. In the interest of complete disclosure,
Petitioner is aware of a limited reproduction study dated 1960 that was
conducted at the LaWall & Harrisson Laboratories in connection with a
larger 2-year feeding study. The test substance was Hercules Piccolyte
S125 Polyterpene Resin, a B-pinene-based resin which is derived from
the polymerization of a terpene feedstock containing a minimum B-pinene
content of 80% and an -pinene content of between 5% and 9%.
Groups of six female Sprague-Dawley rats were fed the test substance at
0%, 3%, or 10% of the diet. After 4 months of exposure, the rats were
mated with similarly treated males. All females bore litters except one
from the untreated control group. All litters were normal in size and a
few stillborn pups were noted in each group. There were some deaths
among the pups, but survival to weaning was equal in all groups.
Indices of reproductive and developmental performance were not
calculated. The dietary level of 10% was considered the no-observed-
adverse-effect level (NOAEL) in this limited reproduction study.
3. Subchronic toxicity-- i. Study No. 1. In a study conducted in
1968, groups of 10 male and 10 female Charles River rats were fed diets
containing 0%, 1%, 3%, or 5% of an -pinene based resin for 3
months. Criteria of evaluation for possible toxic effects included
general appearance and behavior, growth, food consumption, survival,
clinical laboratory results, absolute and relative organ weights, and
gross and microscopic pathology. Effects seen at the 5% dietary
concentration include increases in relative liver weight in both sexes,
and absolute liver weight in females only. Increased relative thyroid
weight in males was noted at the 5% and 3% dosage levels. In the
absence of histopathological alterations, these changes are regarded as
adaptive and not of toxicological significance. The dietary level of
5%, equivalent to an overall average of 3,967 milligrams/kilogram/day
(mg/kg/day) is considered the NOAEL in this study.
ii. Study No. 2. Groups of ten male and ten female Sprague-Dawley
rats were fed diets containing 0%, 0% (i.e., two untreated controls),
0.01%, 0.05%, 0.2%, 1%, or 5% of Terpene AP for 90 days. Criteria of
evaluation included appearance and behavior, growth, survival,
hematology and urinalysis, organ weights and gross and microscopic
pathological evaluation. A paired feeding study was conducted in
conjunction with the main study to evaluate the significance of diet
rejection vs. compound-related toxicity in weight gain reduction
associated with high concentrations of Terpene AP. In the paired
feeding study, each rat fed 5% Terpene AP (Test Group) was matched with
a rat of the same sex and similar weight. Each of the Paired Feeding
Control Group received the same amount of diet in each 24-hour period
as the corresponding treated rat during the preceding reference 24-hour
period, but without the test material. Two deaths occurred during the
study. They were not dosage-related and were attributed to respiratory
infection and not to compound-related toxicity. Decreased body weight
gain and increased liver weight were consistent findings. Final body
weights were reduced 16% in males and 11% in females at the highest
dosage level. The paired-feeding study demonstrated that the effect was
due to food rejection based on poor palatability and not due to
systemic toxicity of the test material. Liver weight, as absolute
weight and liver/brain weight ratios, increased in a dosage-related
fashion. At the 5% dietary levels, 39% and 83% absolute weight
increases were noted in males and females, respectively. Lesser
increases were noted at the 1% and 0.2% dietary levels of the test
material. Liver weight/body weight ratios were increased artifactually
because of the growth depression. Since there were no adverse
histological findings associated with the liver weight increases, the
finding is attributed to generalized physiologic stress and not to
organ-specific toxicity. Thyroid hyperplasia noted in some rats at the
5% and 1% levels is a secondary effect of the liver weight increase.
The dietary concentration of 0.05% Polyterpene was a NOAEL in this 90-
day study. Because food consumption was not evaluated, an equivalent
mg/kg/day NOAEL could not be calculated in this study. Based on
analyses of food consumption data from similar studies, an approximate
dosage equivalent would be 37.5 mg/kg/day.
4. Chronic toxicity-- i. Study No. 3. A terpene resin was fed to
beagle dogs, three per sex per group, at dietary levels of 0%, 0.2%, 1%
and 5% for 2 years. Criteria of effect included appearance and
behavior, growth and survival, food consumption, hematology, clinical
chemistry, urinalysis, absolute and relative organ weights and gross
and microscopic pathology. Effects seen at the 5% dietary level
included moderate reduction in growth and increased absolute and
relative liver weight at 1 year and 2 years, and minimal hepatocellular
fatty changes at 1 year but not 2 years. Similar liver effects were
seen at the 1% dietary concentration. The dietary levels of 0.2%
terpene resin equivalent to an overall average of 51 mg/kg/day, a NOAEL
in this 2-year study.
ii. Study No. 4. Groups of 30 male and 30 female Sprague Dawley
rats were fed diets containing 0%, 0.2%, 1%, or 5% terpene resin for 2
years. The terpene resin was a copolymer of - and B-pinene. No
differences from controls were noted in any test groups with respect to
appearance and behavior,
[[Page 64497]]
food consumption, growth, survival, tumor incidence, hematology and
urinalysis. All means were within the range of normal variation.
Significant elevations of absolute and relative liver weight were noted
in females after 12 months on the 1% and 5% diets. In males, absolute
liver weight was elevated at the 5% level and relative liver weights
were elevated at both the 1% and 5% levels. After 24 months of
treatment, relative liver weights were elevated in males at 5% and in
females at 1% and 5%. Histological examinations after 2 years showed
only effects anticipated in untreated animals. Liver enlargement in the
absence of histopathological changes results from compensatory effects.
The highest dietary concentration of 5% terpene resin, equivalent to an
overall average of 3,100 mg/kg body weight per day, is regarded as the
NOAEL in this study.
5. Endocrine disruption. A comprehensive literature search has
revealed no reports associating pinene monomers or polymers with
endocrine effects. Petitioner has not undertaken any testing to explore
further the possibility that pinene polymers or monomers could cause
endocrine effects and understands that EPA will implement a screening
program for endocrine effects in the future.
C. Aggregate Exposure
1. Dietary exposure. Synthetic terpene resin, consisting of
polymers of -pinene, B-pinene, and/or dipentene, is currently
cleared by the Food and Drug Administration for use as an ingredient of
chewing gum base and for use in a variety of food-contact or food
packaging applications. The range of materials that are used in these
applications under the name ``synthetic terpene resin'' will vary in
composition and molecular weight. These existing food applications
result in some small amount of dietary exposure to pinene monomers,
oligomers, and polymers. This exposure can be expected to be quite
small given that only a small amount, if any, of the synthetic terpene
resin present in a food-contact article will migrate into food.
Similarly, the insoluble gum base portion of chewing gum is ordinarily
discarded after chewing, and like the other components of gum base,
synthetic terpene resin is not extracted to any significant degree by
saliva. Petitioner has presented calculations showing very roughly that
even if the total annual U.S. production volume of terpene resins were
incorporated directly into the diet, this would result in a per capita
consumption of -pinene and -pinene repeating units of
only 1.7 mg/kg body weight per day for a 60-kg adult. Actual intake
will be significantly less than this number, given that not all
synthetic terpene resin is used in food applications, and that very
little migration and ingestion can be attributed to the existing food-
contact and chewing gum applications.
2. Food. Petitioner does not manufacture sticker formulations and
therefore has not conducted studies to show the actual quantity of
pinene polymers that will remain on harvested food crops. Based on the
conservative assumption that all pinene polymer will remain on food
crops at the time of harvest, Petitioner has presented calculations
showing that the resulting dietary exposure will not exceed 0.43 mg/kg
body weight per day for a 60-kg adult. Actual intake will be less than
his number. Petitioner notes that this intake is a subset of the worst-
case aggregate exposure number, 1.7 mg/kg body weight per day.
3. Drinking water. Due to its relative insolubility, only trace
amounts of pinene polymer, if any, will be found in drinking water.
Some amount of pinene polymer will enter the soil in fields where it is
applied as part of a pesticide formulation. Any pinene polymer present
in the soil could potentially reach ground water, as is the case with
agricultural chemicals generally. In the case of pinene polymers,
Petitioner notes that they can be expected to adhere to the soil due to
their adhesive properties and that they may biodegrade before reaching
ground water. Petitioner further notes that any drinking water exposure
will be within the worst-case aggregate exposure estimate, 1.7 mg/kg
body weight per day.
4. Non-dietary exposure. Outside of food applications, pinene
polymers are used in various adhesive applications including
construction adhesives used, for example, to lay floor tile. Pinene
polymers present in adhesives are not volatile and will therefore not
be inhaled. The only human exposure will be that associated with
accidental skin contact. It would be difficult to assign a numerical
value to this non-occupational exposure for a typical person. Exposures
from all sources cannot exceed 1.7 mg/kg body weight per day for a
typical adult, given the total production volume of -pinene
polymers.
D. Cumulative Effects
No identified risks are associated with exposure to pinene
polymers. The mechanism or mode of action associated with pinene
polymers is simply that the substance is physically sticky.
E. Safety Determination
1. U.S. population. Petitioner estimates that exposure to
-pinene polymers and repeating units attributable to the
requested action will be less than 0.43 mg/kg body weight per day in a
60-kg adult. This number is based on a set of conservative assumptions,
and actual exposure is expected to be much less. In no event will
aggregate exposure, by all routes and from all sources, exceed 1.7 mg/
kg body weight, given the total production volume of -pinene
polymers. In several of the available animal feeding studies, the NOAEL
was found to be 5% or more of the diet (greater than 3,000 mg/kg body
weight per day). The lowest reported NOAEL of which the petitioner is
aware is 37.5 mg/kg body weight, which is somewhat of an outlying
value.
2. Infants and children. Infants and children will not experience
higher levels of exposure to pinene polymers than the rest of the
population as a result of the action requested in this petition.
Furthermore, no chronic or acute effects are associated with pinene
polymers, for which infants and children could be particularly
sensitive. Petitioner expects pesticide sticker formulations containing
pinene polymers to be used on a variety of food crops, which will lead
to low levels of residues distributed evenly throughout the food
supply. Considering this variety of uses, exposure should be spread
evenly over the entire population and not concentrated in any
particular sub-population. Dietary exposure in adults will not exceed
0.43 mg/kg body weight per day from the requested application, and
aggregate exposure from all sources and routes cannot exceed 1.7 mg/kg
body weight per day. These estimates correspond to an adult weighing 60
kg and consuming 1,500 grams of solid food per day. The numbers can be
adjusted to account for the weight of a child. For example a child
weighing 30 kg and consuming 1,000 g of solid food per day will be
exposed to no more than 0.56 mg/kg body weight per day from the
requested application and no more than an aggregate of 3.3 mg/kg body
weight per day from all routes and all sources. Exposure estimates thus
adjusted for children compare favorably with the NOAEL reported in the
animal feeding studies.
[FR Doc. 98-31063 Filed 11-19-98; 8:45 am]
BILLING CODE 6560-50-F
