[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Notices]
[Pages 49983-49986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25338]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-761; FRL-5740-9]
Yoshitomi Fine Chemicals Ltd.; Pesticide Tolerance Petition
Filing
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 tolerances for residues of 4,5-
Dichloro-1,2-Dithiol-3-one (CASRN 1192-52-5) in or on paper and
paperboard.
DATES: Comments, identified by the docket control number PF-761, must
be received on or before October 24, 1997.
ADDRESSES: By mail submit written comments to: Information and Records
Integrity Branch, Public Information and Services Divison (7506C),
Office of Pesticides Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person bring comments to: Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by following
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. 1132 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: Portia Jenkins, Acting
Product Manager (34), Antimicrobials Division (7510C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 6C,
Crystal Plaza #1, 2800 Crystal Drive, Arlington, VA, (703) 308-6230; e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition ((PP)
7F4902) from Yoshitomi Fine Chemicals, Ltd., 6-9, Hiranomachi 2-chome,
Chuo-ku, Osaka, 541, Japan, 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 185 ``Tolerances for Pesticides in Food'' by establishing
Subpart D ``Tolerance Exemptions for Pesticides in Foods'' and
promulgating therein section 185.9000 establishing a tolerance
exemption for residues of the slimicide 4,5-Dichloro-1,2-Dithiol-3-one
(CASRN 1192-52-5) in or on paper and paperboard resulting from its
addition to pulp and paper mill process water to control slime forming
organisms. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.
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-761] (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''.
Electronic comments can be sent directly to EPA at:
[email protected]
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 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (PF-761) and appropriate petition
number. Electronic comments on this notice may be filed online at many
Federal Depository Libraries.
List of Subjects
Environmental protection, Administrative practice and procedure,
Paper and paperboard, Slimicides, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 16, 1997.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
Summary of Petition
Petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summary of the petition
was prepared by the petitioner and represent the views 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.
Yoshitomi Fine Chemicals, Ltd.
A. Residue Chemistry
This petition is not for residues in or on raw agricultural
commodities. It is for residues in or on food contact paper or
paperboard. Accordingly, the residue chemistry data submitted are
solely for the residues remaining in food contact paper and paperboard
when the subject slimicide (4,5-Dichloro-1,2-Dithiol-3-one, CASRN 1192-
52-5, hereafter referred to as RYH-86) is used in pulp and paper mill
process water to control slime forming organisms.
1. Residues in paper and paperboard. GC-MS-SIM analysis of
approximately 30 paper and paperboard samples manufactured in a
papermill which used RYH-86 amended slurry water revealed no RYH-86
detectable with a detection limit of 100 g/kilograms (Kg) of
paper (i.e., 100 parts per billion (ppb)). Extraction of such samples
with
[[Page 49984]]
food simulating solvents (FSL's), using standard FDA methods for
determining food additive extractives from food-contact materials which
allowed for the equilibration of RYH-86 between the paper and
paperboard samples and the FSL's for 10-days, revealed no RYH-86
migration into FSL's at detection limits of 10 g/Kg for
aqueous FSL's and 100 g/Kg for fatty FSL's (using the same GC-
MS-SIM method for analysis).
2. Analytical method. This is a tolerance exemption petition and,
accordingly, no enforcement analytical method is proposed.
B. Toxicological Profile
1. Acute toxicity. Technical RYH-86 (99.8% active ingredient) is
moderately toxic by the oral route, with acute oral LD50 of
350 milligrams/kilograms (mg/kg) in the male rat and 372 mg/kg in the
female rat (MRID 41562401). Technical RYH-86 is practically nontoxic by
dermal application (acute dermal LD50 > 5,000 mg/kg) but was
quite irritant to the skin (severe skin irritation and dermal necrosis
but no mortalities were observed) in an acute dermal toxicity and
irritation study (MRIDs 41531114 & 41562402). The acute inhalation
toxicity of RYH-86 was waived by EPA during review of the registration
for RYH-86 Slimicide (EPA Reg. No. 63898-1) due to its being applied
only by injection into process water and the resulting lack of
significant inhalation exposure potential. Guideline 81-4 and 81-5
primary eye and skin irritation studies for RYH-86 manufacturing use
product (about 50% RYH-86) showed it to produce severe ocular damage
and severe skin irritation (MRIDs 41531115 & 41531116). In these same
studies, technical RYH-86 was a severe eye irritant and a moderate skin
irritant. Tested at 1% solution (to minimize irritancy effects) RYH-86
was not a dermal sensitizer (MRID 41531117).
2. Subchronic toxicity. The evaluation of the subchronic toxicity
of RYH-86 has been carried out in 2 separate studies which, together
with a bridging analysis of both, constitute one 3-volume data set
which was previously reviewed by EPA during the registration review for
RYH-86 Slimicide (EPA Reg. No. 63898-1: MRIDs 41531118, 41531119, &
41531120). In these studies, one study used relatively high doses of
RYH-86 and the other used lower doses. The principal effect of note in
these studies was gastrointestinal irritation exhibiting as a
thickening of the gastric mucosa and, at sufficiently high dose,
ulceration. The No Observed Effects Level (NOEL) for these effects was
3.8 mg/Kg/day and the Lowest Observed Effects Level (LOEL) was 5.0 mg/
Kg/day. Other effects seen included: an increase in relative renal
weight in males only (LOEL 5.0 mg/Kg/day, NOEL 3.8 mg/Kg/day); an
increase in relative testicular weight and liver weight (LOEL 12 mg/Kg/
day, NOEL 5.0 mg/Kg/day); possible GI complications related mortality
(LOEL 45 mg/Kg/day, NOEL 15 mg/Kg/day); and miscellaneous effects on
clinical chemistry, ketonuria, body weight depression, and clinical
signs of distress (LOEL 45 mg/Kg/day, NOEL 15 mg/Kg/day).
3. Chronic toxicity. Chronic toxicity studies (2-year rat and 1-
year dog) have not been conducted with RYH-86 due to the fact that its
intended use pattern: (a) does not involve a potential for chronic
occupational exposure; (b) leads to only negligible dietary exposure
[see below]; and, (c) the only notable adverse effect observed in
subchronic gavage studies with the rat was GI irritation / ulceration
[see above]. Accordingly, Yoshitomi Fine Chemicals, Ltd. considers that
significant chronic exposure is not an issue for RYH-86 as it is to be
used and that the subchronic studies do not suggest that any unusual
toxicity (other than GI irritation which is likely to be dose-limiting)
will likely be seen in chronic toxicity studies. Indeed, the
registration of RYH-86 Slimicide (EPA Reg. No. 63898-1) was supported
by the Antimicrobials Data Call-in set of requirements and these
provide specifically that chronic toxicity and oncogenicity studies for
antimicrobial agents are required only if the results of subchronic
toxicity or of gene toxicity studies indicate a potential concern or if
there will, in fact, be significant chronic exposure.
4. Oncogenicity. Oncogenicity studies (2-year rat and 18-months
mouse) have not been conducted with RYH-86 due to the fact that its
intended use pattern: (a) does not involve a potential for chronic or
long term, frequent occupational exposure; (b) leads only to negligible
dietary exposure [see below]; (c) the only notable adverse effect
observed in subchronic gavage with the rat was GI irritation /
ulceration with no evidence for metaplasia, dysplasia, altered foci, or
peroxisome proliferation observed1; and, (d) RYH-86 is not
mutagenic or genotoxic (see No. 6, below). Accordingly, Yoshitomi Fine
Chemicals, Ltd. considers that significant chronic exposure is not an
issue for RYH-86 as it is to be used and that the subchronic studies do
not suggest that any unusual toxicity (other than GI irritation which
is likely to be dose-limiting) or oncogenicity is likely to be seen in
chronic toxicity / oncogenicity studies. Indeed, the registration of
RYH-86 Slimicide (EPA Reg. No. 63898-1) was supported by the
Antimicrobials Data Call-in set of requirements and these provide
specifically that chronic toxicity and oncogenicity studies for
antimicrobial agents are required only if the results of subchronic
toxicity or of gene toxicity studies indicate a potential concern or if
there will, in fact, be significant chronic exposure.
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1 Suggesting that the more typical forms of pre-neoplastic
lesions or lesions which have been associated with indirect
carcinogenesis, and which can often be observed already within 90-
day studies, are not present.
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5. Developmental toxicity. i. Rats - A standard Guideline 83-3
design teratology and developmental effects study (MRID 42680801) was
conducted in which maternal toxicity (as evidenced by decreases in body
weight, body weight gain, food consumption, and thickening of the
stomach mucosa) was observed at 45 mg/Kg/ day. At this dose (the
highest dose tested) no developmental or teratological effects were
observed. In this study, doses of 15 mg/Kg and lower were not toxic to
the dams and there were no developmental or teratological effects at
these lower doses. The dose selection for this study was based on the
observed GI effects in the rat 90-day gavage study.
ii. Rabbits or mice - Based on: (a) the lack of any suggestion of
teratological or developmental effects at doses which produced frank
maternal toxicity in the rat; (b) that the toxicity of RYH-86 in the
rat study appeared to be largely a function of its GI effects; and, (c)
the low exposure potential associated with RYH-86 in its intended uses,
Yoshitomi Fine Chemicals, Ltd. considers that conduct of a second
species developmental effect study is not needed to characterize the
toxicology of RYH-86. Indeed, the registration of RYH-86 Slimicide (EPA
Reg. No. 63898-1) was supported by the Antimicrobials Data Call-in set
of requirements and these provide specifically that second species
developmental toxicity studies for antimicrobial agents are required
only if the results of studies in the first species indicate a
potential concern or if there will, in fact, be significant exposure to
females of child bearing age. The conclusion that a second species
developmental toxicity study for RYH-86 is not needed has been reached
to date by the Swedish, Finnish, and Canadian regulatory authorities in
addition to EPA.
6. Genotoxicity. In the standard Ames test (5-strains), RYH-86 is
non-mutagenic with or without metabolic activation (MRID 42897501). In
the mouse, in vivo, bone marrow
[[Page 49985]]
micronucleus test RYH-86 did not induce chromosome aberrations (MRID
41531122). In the rat hepatocyte UDS (unscheduled DNA synthesis) test,
RYH-86 did not induce unscheduled DNA synthesis (MRID 41531123). On the
basis of this genotoxicity battery, Yoshitomi Fine Chemicals, Ltd.
concludes that RYH-86 is not mutagenic or genotoxic.
7. Metabolism. Specific mammalian metabolism studies with RYH-86
have not been conducted for the following reasons: (a) at the alkaline
pH of the small intestine, RYH-86 will hydrolyze rapidly with release
of chloride and active chlorine; and, (b) the toxicology profile for
RYH-86 indicates that the principle effect of RYH-86 is GI irritancy
and that metabolism does not appear to play a significant role in the
toxicology of RYH-86. Therefore, Yoshitomi Fine Chemicals, Ltd.
considers that mammalian metabolism studies in the rat with RYH-86 will
not provide additional useful information on the safety of RYH-86 and
such studies were not required by EPA to support the registration of
RYH-86 Slimicide (EPA Reg. No. 63898-1).
8. Reference Dose (RfD). EPA has not previously set a RfD for RYH-
86 since at the time of registration review for RYH-86 Slimicide (EPA
Reg. No. 63898-1) the regulation of RYH-86 residues in food contact
paper and paperboard was under the jurisdiction of the Food and Drug
Administration (FDA). Enactment of the Food Quality Protection Act
transferred jurisdiction over these residues to EPA. Based on the
subchronic NOEL of 3.8 mg/Kg/day (for gastro-intestinal (GI) irritation
effects) and an uncertainty factor (UF) of 100, Yoshitomi Fine
Chemicals, Ltd. proposes an RfD set at 0.038 mg/Kg/day for RYH-86. Such
an RfD leads to the following allowable daily intakes (ADI) for adult
males and females and for children: Adult male, 70 Kg, ADI = 2.7 mg/
day; Adult female, 60 Kg, ADI = 2.3 mg/day; Child, 20 Kg, ADI = 0.76
mg/day. Yoshitomi Fine Chemicals, Ltd. has considered the possible
special sensitivity to RYH-86 of infants and children and, also, of
sensitive individuals. The proposed RfD is based on a physico-chemical
effect of RYH-86: gastro-intestinal irritation. This, Yoshitomi Fine
Chemicals, Ltd. suggests is not an effect for which any wide
differences between infants / children and adults would be expected on
a reasonable scientific basis. The irritant effects of RYH-86 on the GI
tract are expected to be a function of the concentration of RYH-86 in
the GI tract and this will be a function of amount of RYH-86 per unit
of body weight. Thus, an RfD set at 0.038 mg/Kg/day will lead to
similar GI tract concentrations of RYH-86 in adults, children, and
infants. Also, since the effect of irritation is a physico-chemical
effect, the existence of metabolic differences among persons is not
reasonably expected to be a factor producing individuals with special
sensitivity to RYH-86. Also, since: (a) physico-chemical effects like
irritancy usually do not at all occur well below a threshold
concentration of irritant; and, (b) the RfD is based on gavage studies
in which RYH-86 is directly delivered to the gastric compartment
whereas daily dietary consumption of the RfD amount leads to a lower
peak GI tract level than would occur after gavage administration of the
RfD amount, it can be expected that even for persons with pre-existing
conditions such as ulcers, colitis, and similar pathologies that
dietary exposures to RYH-86 at levels up to the proposed RfD will not
exacerbate such conditions. Therefore, Yoshitomi Fine Chemicals, Ltd.
believs that the proposed RfD is suitable for adults, children,
infants, and persons with pre-existing GI tract disturbances.
C. Aggregate Exposure
1. Dietary exposure ---- i. Food. GC-MS-SIM analysis of
approximately 30 paper and paperboard samples manufactured in a
papermill which used RYH-86 amended slurry water revealed no detectable
RYH-86 with a detection limit of 100 g/Kg of paper (i.e., 100
ppb). Extraction of such samples with food simulating solvents (FSL's),
using standard FDA methods for determining food additive extractives
from food-contact materials which allowed for the equilibration of RYH-
86 between the paper and paperboard samples and the FSL's for 10-days,
revealed no RYH-86 migration into FSL's at detection limits of 10
g/Kg for aqueous FSL's and 100 g/Kg for fatty FSL's
(using the same GC-MS-SIM method for analysis). Using a standard
equation provided by U.S. FDA for estimating dietary exposure to
indirect food additives migrating from food packaging2, the
hypothetical worst case potential for dietary exposure to RYH-86 as a
result of migration into foods of RYH-86 residuals in food contact
paper and paperboard is:
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2 U.S. FDA (1985), ``Recommendations for Chemistry Data for
Indirect Food Additive Petitions'', Center for Food Safety and
Applied Nutrition, June 1995.
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= faqueous and acidic
(M10 percent ethanol) + f alcohol
(M50 percent ethanol) + ffatty
(Mfatty)
In which, for un-coated food contact paper and paperboard, the food
type distribution factors (ffood type) are:
faqueous and acidic 0.57 + 0.01 = 0.58
falcohol 0.01
ffatty 0.41
and is the concentration of residues in food when the solvent
to sample extraction ratio is 10 ml/sq. inch of sample surface (which
was the case for Yoshitomi Fine Chemicals, Ltd.'s residue migration
potential studies).
For the worst case, since no RYH-86 was detected in any of the
FSLs, Yoshitomi Fine Chemicals, Ltd. has taken the migration values (M)
which would result if RYH-86 were present in the FSLs at the limit of
detection for the relevant food simulating solvent type:
M10 percent ethanol 10 g/Kg
M50 percent ethanol 10 g/Kg
Mfatty 100 g/Kg
In which case the overall migrant load, is:
= (0.58 x 10 g/Kg) + (0.01 x 10 g/Kg)
+ (0.41 x 100 g/Kg) = 47 g/Kg
The above value of can then be used for derivation of the
estimated daily intake (EDI) for adults from the following FDA
formula:3
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3 Which considers that ``food'' consists of solid foods as well
as beverages consumed.
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EDI = 3.0 Kg food/day x x CF
where CF is the consumption factor for foods contacted by a given
type of material. In the case of paper and paperboard, CF = 0.1 for
uncoated paper (see footnote 2). Therefore, as a worst case, the
potential adult EDI for RYH-86 which derives from possible residuals in
food contact paper and paperboard is:
EDI = 3.0 Kg food/day x 47 g/Kg food x 0.1 = 14.1
g/day
For children, the daily diet is different in quantity. At 6 months
age, the daily caloric requirement is 110 cal/Kg body weight and the
mean body weight for 6 months infants is 8 Kg. This equates to an 880
Kg/day diet which at an average of 800 cal/Kg4 is a 1.1 Kg
total diet. In the age interval 4 years to 6 years of age (median body
weight 20 Kg), the daily calorie requirement is 1,600 cal/day which
equates to a 2 Kg total daily diet. The EDI's for infants and children
are based on these total diet amounts:
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4 The adult calorie requirement is 2,400 cal/day for males and
females averaged and this in a 3 Kg daily diet provides for calorie
density of 800 cal/Kg. For comparison, human breast milk has a
calorie density of 700 cal/Kg.
EDIINFANT = 1.1 Kg food/day x 47 g/Kg x
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0.1 = 5.2 g/day
EDICHILD = 2.0 Kg food/day x 47 g/Kg x
0.1 = 9.4 g/day
Thus, for a 6 month old infant, for a 20 Kg child (age 4-6), for a
60 Kg
[[Page 49986]]
woman, and for a 70 Kg man, the daily intakes associated with the above
EDI, expressed as g/Kg/day and as percent RfD utilization are:
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Percent RfD
Dietary Exposure Utilized
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Infant 0.65 g/Kg/ 1.71
day
Child 0.47 g/Kg/ 1.24
day
Woman 0.24 g/Kg/ 0.632
day
Man 0.20 g/Kg/ 0.526
day
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Yoshitomi Fine Chemicals, Ltd. notes that at 40 CFR 180.1(l) EPA
has defined that a ``negligible residue ... Ordinarily ... will add to
the diet an amount which will be less than 1/2,000th of the amount that
has been demonstrated to have no effect from feeding studies on the
most sensitive animal species tested.'' This, for a 100-fold
uncertainty factor based RfD, means an RfD utilization of 5% or less.
Yoshitomi considers, therefore, that under the hypothetical worst case
dietary exposure assessment RYH-86 residues are clearly negligible
residues.
i. Drinking water. The use of RYH-86 as a slimicide for pulp and
paper mills does not provide for entry of RYH-86 into drinking water
sources. Spent process water from such sites is treated as waste water,
typically on-site, prior to release into surface waters. In a Finnish
paper mill, with a use level of 1.5 ppm in the water (as an initial
load to the slurry water) no RYH-86 was detected in air or water at
sites by the paper making machine (detection limits were 4.5 ng/L in
water and 3 x 10-6 mg/dm3). Water samples which
were examined included samples from the waste water holding pond and
discharge from the on-site waste water treatment plant.
2. Non-dietary exposure. RYH-86 is an industrial-use slimicide
whose only other registered use (i.e., aside from slimicide use in pulp
and paper mills) is as a slime control agent in re-circulating cooling
water. All of the uses of RYH-86 involve only occupational exposures.
There are no registrations and no intended uses in residential
scenarios. There are, therefore, no Food Quality Protection Act covered
non-dietary exposures to RYH-86.
D. Cumulative Effects
There is no reliable information to indicate that RYH-86 has a
common mechanism of toxicity with any other chemical compound.
E. Safety Determination
1. U.S. population. Since the use of RYH-86 as a slimicide in pulp
and paper mills is, under hypothetical worst case conditions,
anticipated to lead to only negligible adult dietary exposures (i.e.,
not greater than 0.63% of the RfD for adults with ``negligible''
defined at 40 CFR 180.1(l) as ``ordinarily'' not greater than 5% of the
RfD) Yoshitomi Fine Chemicals, Ltd. concludes that there is a
reasonable certainty that no harm to the general adult population will
result from dietary exposure to RYH-86 residues which could occur in
food contact paper and paperboard produced in pulp and paper mills
utilizing RYH-86 for slime control in accordance with its FIFRA
labeling.
2. Infants and children. Since the use of RYH-86 as a slimicide in
pulp and paper mills is, under hypothetical worst case conditions,
anticipated to lead to only negligible dietary exposures (i.e., not
greater than 1.71% of the RfD for infants and not greater than 1.24% of
the RfD for children with ``negligible'' defined at 40 CFR 180.1(l) as
``ordinarily'' not greater than 5% of the RfD) Yoshitomi Fine
Chemicals, Ltd. concludes that there is a reasonable certainty that no
harm to infants and children will result from dietary exposure to RYH-
86 residues which could occur in food contact paper and paperboard
produced in pulp and paper mills utilizing RYH-86 for slime control in
accordance with its FIFRA labeling.
3. Sensitive individuals. The RfD for RYH-86 is based on gastro-
intestinal irritation as the effect which occurs at lowest dose in
animal gavage studies. Since the effect of irritation is a physico-
chemical effect, the existence of metabolic differences among persons
is not reasonably expected to be a factor producing individuals with
special sensitivity to RYH-86. Also, since: (a) physico-chemical
effects like irritancy usually do not at all occur well below a
threshold concentration of irritant; and, (b) the RfD is based on
gavage studies in which RYH-86 is directly delivered to the gastric
compartment whereas daily dietary consumption of the RfD amount leads
to a lower peak GI tract level than would occur after gavage
administration of the RfD amount, it can be expected that even for
persons with pre-existing conditions such as ulcers, colitis, and
similar pathologies that dietary exposures to RYH-86 at levels up to
the proposed RfD will not exacerbate such conditions. Therefore,
Yoshitomi Fine Chemicals, Ltd. concludes that there is a reasonable
certainty that no harm to persons with pre-existing GI-tract problems
will result from dietary exposure to RYH-86 residues which could occur
in food contact paper and paperboard produced in pulp and paper mills
utilizing RYH-86 for slime control in accordance with its FIFRA
labeling.
F. International Tolerances
There are no Codex maximum residue levels (MRLs) established for
residues of RYH-86 resulting from the use of RYH-86.
[FR Doc. 97-25338 Filed 9-23-97; 8:45 am]
BILLING CODE 6560-50-F