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Notice of Filing of Pesticide Petitions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 26, 1999 (Volume 64, Number 101)]
[Notices]
[Page 28480-28485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my99-79]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-874; FRL-6081-3]
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-874, must
be received on or before June 25, 1999.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), 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: opp-
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: The product manager listed in the
table below:
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Office location/
Product Manager telephone number Address
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JoAnne Miller................. Rm. 237, CM #2, 703- 1921 Jefferson
305-6224, e- Davis Hwy,
mail:miller.joanne@ep Arlington, VA
amail.epa.gov.
Bipin C. Gandhi............... Rm. 707A, CM #2, 703- Do.
305-7740, e-mail:
gandhi.bipin@epamail.
epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows 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-874] (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. Comments 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
[[Page 28481]]
the docket control number [PF-874] and appropriate petition number.
Electronic comments this on 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: May 13, 1999.
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. Novartis Crop Protection, Inc.
PP 7F4897
EPA has received an amended pesticide petition (7F4897) from
Novartis Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR part 180.368 by establishing and amending current
tolerances for residues of metolachlor (2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide and its metabolites,
determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound, in or on the raw
agricultural commodities sunflower seed at 0.5 parts per million (ppm);
sunflower meal at 1.0 ppm; sugar beet tops at 15.0 ppm; sugar beet
roots at 0.5 ppm; sugar beet dried pulp at 1.0 ppm; sugar beet molasses
at 3.0 ppm; cotton gin trash at 5.0 ppm; liver (of goats, hogs, horses,
sheep, cattle) at 0.1 ppm and kidney (of goats, hogs, horses, sheep,
cattle) at 0.5 ppm. EPA has determined that the petition contains data
or information regarding the elements set forth in section 408(d)(2) of
the FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The qualitative nature of the metabolism of
metolachlor in plants is well understood. Metabolism in plants involves
conjugation of the chloroacetyl side chain with glutathione, with
subsequent conversion to the cysteine and thiolactic acid conjugates.
Oxidation to the corresponding sulfoxide derivatives occurs and
cleavage of the side chain ether group, followed by conjugation with
glucose.
2. Analytical method. Novartis has submitted a practical analytical
method involving extraction by acid reflux, filtration, partition and
cleanup with analysis by gas chromatography using Nitrogen/Phosphorous
(N/P) detection. The methodology converts residues of metolachlor into
a mixture of CGA-37913 and CGA-49751. The limit of quantitation (LOQ)
for the method is 0.03 ppm for CGA-37913 and 0.05 ppm for CGA-49751.
3. Magnitude of residues--i. Sunflower. A total of 15 residue
trials were conducted in major sunflower growing areas of the United
States. Applications were made at 1- and 2x the maximum labeled rate of
3.0 lbs. ai/A (metolachlor). Processing was also conducted with seeds
processed into meal, hulls, crude oil, refined oil and soapstock. Based
on these studies, tolerances are proposed in sunflower seed at 0.5 ppm
and in sunflower meal at 1.0 ppm.
ii. Sugarbeets. Eleven sugar beet trials were conducted using six
different treatment scenarios. The maximum 1x use rate was 4.0 lbs.
active ingredient (ai)/A of S-metolachlor applied preplant surface or
preplant incorporated (1.33 lbs. ai/A) plus a post foliar spray (2.66
lbs. ai/A). 3x and 5x treatments were also conducted. Maximum residues
at the 1x rate were 14 ppm in sugar beet tops and 0.32 ppm in sugar
beet roots. Using theoretical animal diets, Novartis determined that
current tolerances for metolachlor in kidney and liver may not be
adequate to cover residues resulting from the feeding of sugar beet
tops in combination with peanut hay and sorghum grain. In the
processing study, it was determined that tolerances would be required
in dried pulp and molasses, but not in refined sugar.
iii. Cotton. Results of data submitted September 1998, to address
an EPA request for residue data to determine residues of metolachlor in
cotton gin trash indicated a tolerance of 5.0 ppm needed to be
established for metolachlor in this raw agricultural commodity (RAC).
B. Toxicological Profile
1. Acute toxicity. Metolachlor has a low order of acute toxicity.
The combined rat oral LD<INF>50</INF> is 2,877 milligrams/kilograms
(mg/kg). The acute rabbit dermal LD<INF>50</INF> is > 2,000 mg/kg and
the rat inhalations LC<INF>50</INF> is > 4.33 milligrams per liter (mg/
L). Metolachlor is not irritating to the skin and eye. It was shown to
be positive in guinea pigs for skin sensitization. End use formulations
of metolachlor also have a low order of acute toxicity and cause slight
skin and eye irritation.
2. Genotoxicity. Assays for genotoxicity were comprised of tests
evaluating metolachlor's potential to induce point mutations
(Salmonella assay and an L5178/TK+/- mouse lymphoma assay), chromosome
aberrations (mouse micronucleus and a dominant lethal assay) and the
ability to induce either unscheduled or scheduled DNA synthesis in rat
hepatocytes or DNA damage or repair in human fibroblasts. The results
indicate that metolachlor is not mutagenic or clastogenic and does not
provoke unscheduled DNA synthesis.
3. Reproductive and developmental toxicity. The developmental and
teratogenic potential of metolachlor was investigated in rats and
rabbits. The results indicate that metolachlor is not embryotoxic or
teratogenic in either species at maternally toxic doses. The no-
observed adverse effect level (NOAEL) for developmental toxicity for
metolachlor was 360 mg/kg/day for both the rat and rabbit, while the
NOAEL for maternal toxicity was established at 120 mg/kg/day in the
rabbit and 360 mg/kg/day in the rat. A 2-generation reproduction study
was conducted with metolachlor in rats at feeding levels of 0, 30, 300
and 1,000 ppm. The reproductive NOAEL of 300 ppm (equivalent to 23.5 to
26 mg/kg/day) was based upon reduced pup weights in the F1a and F2a
litters at the 1,000 ppm dose level (equivalent to 75.8 to 85.7 mg/kg/
day). The NOAEL for parental toxicity was equal to or greater than the
1,000 ppm dose level.
4. Subchronic toxicity. Metolachlor was evaluated in a 21-day
dermal toxicity study in the rabbit and a 6-month dietary study in
dogs; NOAELs of 100 mg/kg/day and 7.5 mg/kg/day were established in the
rabbit and dog, respectively. The liver was identified as the main
target organ. Metolachlor was also recently evaluated in a new 90-day
subchronic feeding study in rats. The
[[Page 28482]]
NOAEL was defined as 300 ppm, corresponding to average daily intakes of
20.2 mg/kg body weight (bwt) in males and 23.4 mg/kg bwt in females.
5. Chronic toxicity. A 1 year dog study was conducted at dose
levels of 0, 3.3, 9.7, or 32.7 mg/kg/day. The reference dose (RfD) for
metolachlor is based on the 1 year dog study with a NOAEL of 9.7 mg/kg/
day. The RfD for metolachlor is established at 0.1 mg/kg/day using a
100-fold uncertainty factor. A combined chronic toxicity/oncogenicity
study was also conducted in rats at dose levels of 0. 1.5, 15 or 150
mg/kg/day. The NOAEL for systemic toxicity was 15 mg/kg/day.
6. Animal metabolism. In animals, metolachlor is rapidly
metabolized and almost totally eliminated in the excreta of rats,
goats, and poultry. Metabolism in animals proceeds through common Phase
1 intermediates and glutathione conjugation.
7. Metabolite toxicology. The metabolism of metolachlor has been
well characterized in standard Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) rat metabolism studies. The metabolites found
are considered to be toxicologically similar to parent. Metolachlor
does not readily undergo dealkylation to form an aniline or quinone
imine as has been reported for other members of the chloroacetanilide
class of chemicals. Therefore, it is not appropriate to include
metolachlor with the group of chloroacetanilides that readily undergo
dealkylation, producing a common toxic metabolite (quinone imine).
8. Endocrine disruption. Metolachlor does not belong to a class of
chemicals known or suspected of having adverse effects on the endocrine
system. There is no evidence that metolachlor has any effect on
endocrine function in developmental or reproduction studies.
Furthermore, histological investigation of endocrine organs in the
chronic dog, rat and mouse studies conducted with metolachlor did not
indicate that the endocrine system is targeted by metolachlor, even at
maximally tolerated doses administered for a lifetime. Although
residues of metolachlor have been found in RAC, there is no evidence
that metolachlor bioaccumulates in the environment.
C. Aggregate Exposure
1. Dietary exposure. For purposes of assessing the potential
dietary exposure to metolachlor, aggregate exposure has been estimated
based on the theoretical maxium residue contribution (TMRC) from the
use of metolachlor in or on RAC for which tolerances have been
previously established (40 FR 180.368). The incremental effect on
dietary risk resulting from the addition of the uses on sunflowers and
sugarbeets was also included by conservatively assuming that exposure
would occur at the proposed tolerance levels with 100% of the crop
treated.
i. Food. The TMRC is obtained by multiplying the tolerance level
residue for all these RAC by the consumption data which estimates the
amount of these products consumed by various population subgroups. Some
of these RAC (e.g. corn forage and fodder, peanut hay, sunflower meal,
sugarbeet tops) are fed to animals; thus exposure of humans to residues
in these fed commodities might result if such residues are transferred
to meat, milk, poultry, or eggs. Therefore, tolerances of 0.02 ppm for
milk, meat and eggs and 0.2 ppm for kidney and 0.05 ppm for liver have
been previously established for metolachlor. Based upon theoretical
diets constructed from the sugar beet residue data, Novartis is
proposing raising the tolerances in kidney (0.5 ppm) and liver (0.1
ppm) to cover any transfer of residues to animals that may occur from
the feeding of treated sugar beet tops. In conducting this exposure
assessment, it has been conservatively assumed that 100% of all RAC for
which tolerances have been established or proposed in this petition for
metolachlor will contain metolachlor residues and those residues would
be at the level of the tolerance, which results in an over estimation
of human exposure.
ii. Drinking water. Another potential source of exposure of the
general population to residues of pesticides are residues in drinking
water. Environmental fate studies show that metolachlor appears to be
moderately persistent and ranges from being mobile to highly mobile in
different soils. Based on experience with metolachlor, it is believed
metolachlor will be infrequently found in drinking water sources, and
when found, will be in the low parts per billion (ppb) range.
Metolachlor is not yet regulated under the Safe Drinking Water Act;
therefore, no maximum contaminant level (MCL) has been established for
it. A 1-10 day Health Advisory Level has been established at 2,000 ppb
and a Lifetime Health Advisory Level has been established at 100 ppb.
It is not likely that maximum or average concentrations of metolachlor
will exceed the 1-10 day HA levels or that annual average metolachlor
concentrations will exceed the lifetime HA of 100 ppb. In addition,
through the reregistration process, Novartis has amended its labels to
include further protections to minimize ground and surface water
contamination.
2. Non-dietary exposure. Although metolachlor may be used on turf
and ornamentals in a residential setting, that use represents less than
0.1% of the total herbicide market for residential turf and landscape
uses. No indoor uses of metolachlor are registered. Currently, there
are no acceptable, reliable exposure data available to assess any
potential risks. However, given the small amount of material that is
used, it is concluded that the potential for non-occupational exposure
to the general population is unlikely. EPA has identified a toxicity
endpoint for intermediate-term residential risks. Based on the high
level of this endpoint (NOAEL of 100 mg/kg/day and lowest-observed
adverse effect level (LOAEL) of 1,000 mg/kg/day from the 21-day dermal
toxicity study in rabbits), EPA has said it does not expect the
intermediate-term aggregate risk to exceed the level of concern.
D. Cumulative Effects
The potential for cumulative effects of metolachlor and other
substances that have a common mechanism of toxicity has also been
considered. It is concluded that consideration of a common mechanism of
toxicity with other registered pesticides in this chemical class
(chloroacetamides) is not appropriate. Since EPA itself has stated that
the carcinogenic potential of metolachlor is not the same as other
registered chloroacetamide herbicides, based on differences in rodent
metabolism (EPA Peer Review of metolachlor, 1994), it is believed that
metolachlor should only be considered in an aggregate exposure
assessment and not a cumulative assessment.
E. Safety Determination
1. U.S. population. Using the conservative exposure assumptions
described above, based on the the completeness and reliability of the
toxicity data, it is concluded that aggregate exposure to metolachlor
(including the proposed uses) in food will utilize 2.06% of the RfD for
the U.S. population. EPA generally has no concern for exposures below
100% of the RfD because the RfD represents the level at or below which
daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. Despite the potential for exposure
to metolachlor in drinking water and from non-dietary, non-occupational
exposures, it is not expected that aggregate exposure from all sources
will exceed 100% of the RfD. Therefore, one can conclude there is a
reasonable certainty that no harm will result from aggregate exposure
to metolachlor.
[[Page 28483]]
2. Infants and children. In assessing the potential for additional
sensitivity of infants and children to residues of metolachlor, data
from developmental toxicity studies in the rat and rabbit and a 2-
generation reproduction study in the rat have been considered. The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from chemical exposure during
prenatal development to one or both parents. Reproduction studies
provide information relating to effects from exposure to a chemical on
the reproductive capability of mating animals and data on systemic
toxicity.
Developmental toxicity (reduced mean fetal bwt, reduced number of
implantations/dam with resulting decreased litter size, and a slight
increase in resorptions/dam with a resulting increase in post-
implantation loss) was observed in studies conducted with metolachlor
in rats and rabbits. The NOAEL's for developmental effects in both rats
and rabbits were established at 360 mg/kg/day. The developmental effect
observed in the metolachlor rat study is believed to be a secondary
effect resulting from maternal stress (lacrimation, salivation,
decreased bwt gain and food consumption and death) observed at the
limit dose of 1,000 mg/kg/day.
A 2-generation reproduction study was conducted with metolachlor at
feeding levels of 0, 30, 300 and 1,000 ppm. The reproductive NOAEL of
300 ppm (equivalent to 23.5 to 26 mg/kg/day) was based upon reduced pup
weights in the F1a and F2a litters at the 1,000 ppm dose level
(equivalent to 75.8 to 85.7 mg/kg/day). The NOAEL for parental toxicity
was equal to or greater than the 1,000 ppm dose level.
FFDCA section 408 provides that EPA may apply an additional safety
factor for infants and children in the case of threshold effects to
account for pre- and postnatal toxicity and the completeness of the
data base. Based on the current toxicological data requirements, the
data base relative to pre- and postnatal effects for children is
complete. Further, for the chemical metolachlor, the NOAEL of 9.7 mg/
kg/day from the metolachlor chronic dog study, which was used to
calculate the RfD (discussed above), is already lower than the
developmental NOAELs of 360 mg/kg/day from the metolachlor
teratogenicity studies in rats and rabbits. With regard to the
metolachlor reproduction study, the lack of severity of the pup effects
observed (decreased bwt) in the reproduction study at the systemic
LOAEL (equivalent to 75.8 to 85.7 mg/kg/day) and the fact that the
effects were observed at a dose that is nearly 10 times greater than
the NOAEL in the chronic dog study (9.7 mg/kg/day), suggest there is no
additional sensitivity for infants and children. Therefore, it is
concluded that an additional uncertainty factor is not warranted to
protect the health of infants and children and that the RfD at 0.1 mg/
kg/day based on the chronic dog study is appropriate for assessing
aggregate risk to infants and children from use of metolachlor.
Using the conservative exposure assumptions described above, the
percent of the RfD that will be utilized by aggregate exposure to
residues of metolachlor is 1.27% for nursing infants less than 1 year
old, 4.13% for non-nursing infants, 4.42% for children 1-6 years old
and 3.26% for children 7-12 years old. EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to metolachlor in drinking water and from non-dietary, non-
occuptional exposure, it is not expected that aggregate exposure from
all sources will exceed 100% of the RfD. Therefore, based on the
completeness and reliability of the toxicity data and the conservative
exposure assessment, it is concluded there is a reasonable certainty
that no harm will result to infants and children from aggregate
exposure to metolachlor residues.
F. International Tolerances
There are no Codex Alimentarius Commission (CODEX) maximum residue
levels (MRL's) established for residues of metolachlor in or on RAC.
2. Omnichem S.A., Industrial Research Park, 1348 Louvain-La-Neuve,
Belgium
PP 8E4950
EPA has received a pesticide petition (8E4950) from Omnichem S.A.,
Industrial Research Park, 1348 Louvain-La-Neuve, Belgium proposing,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an
exemption from the requirement of a tolerance for a range of <greek-a>-
alkyl (C<INF>12</INF> - C<INF>18 </INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers
(where the poly(oxypropylene) content is 3-60 moles and the
poly(oxyethylene) content is 5-80 moles) when used in accordance with
good agricultural practices as an inert ingredient in pesticide
formulations applied to growing agricultural crops in or on the RAC
after harvest or to animals at ppm. EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.
A. Toxicological Profile
In the case of certain chemical substances that are defined as
``polymers,'' the Agency has established a set of criteria which
identify categories of polymers that present low risk. These criteria
(described in 40 CFR 723.250) identify polymers that are relatively
unreactive and stable compounds compared to other chemical substances
as well as polymers that typically are not readily absorbed. These
properties generally limit a polymer's ability to cause adverse
effects. In addition, these criteria exclude polymers about which
little is known. The Agency believes that polymers meeting the criteria
noted above will present minimal or no risk. Alpha-alkyl
(C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles)
conform to the definition of a polymer given in 40 CFR 723.250(b) and
meet the following criteria that are used to identify low risk
polymers.
1. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) are not cationic polymers, nor are they capable
of becoming a cationic polymer in the natural aquatic environment.
2. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) contains as an integral part of their
composition the atomic elements carbon, hydrogen, and oxygen.
3. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) do not contain as an integral part of their
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(iii).
[[Page 28484]]
4. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) are not designed, nor are they reasonably
anticipated to substantially degrade, decompose or depolymerize.
5. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) are not manufactured or imported from monomers
and/or other reactants that are not already included on the TSCA
Chemical Substance Inventory or manufactured under an applicable TSCA
section 5 exemption.
6. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) are not a water absorbing polymer with a number
average molecular weight greater than or equal to 10,000 daltons.
7. The minimum number-average molecular weight of <greek-a>-alkyl
(C<INF>12</INF>- C <INF>18</INF>)-<greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles)
is 1,517 daltons. Substances with molecular weights greater than 400
generally are not absorbed through the intact skin, and substances with
molecular weights greater than 1,000 normally are not absorbed through
the intact gastrointestinal (GI) tract. Chemicals not absorbed through
the skin or GI tract usually are incapable of eliciting a toxic
response.
8. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) has a range of molecular weights from a minimum
of 1,517 to a maximum or 4,540 and contains less than 2% oligomeric
material below molecular weight 500 and less than 5% oligomeric
material below 1,000 molecular weight.
9. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene)content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) does not contain reactive functional groups.
10. There is no evidence that <greek-a>-alkyl (C<INF>12</INF> -
C<INF>18</INF>)- <greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles)
are endocrine disrupters, whereas substances with molecular weights
greater than 400 generally are not absorbed through the intact skin,
and substances with molecular weights greater than 1,000 normally are
not absorbed through the intact gastrointestinal tract (GI). Chemicals
not absorbed through the skin or GI tract usually are incapable of
eliciting a toxic response.
B. Aggregate Exposure
1. Dietary exposure. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-
<greek-oh>- hydroxypoly(oxypropylene) poly(oxyethylene)
copolymers (where the poly(oxypropylene) content is 3-60 moles and the
poly(oxyethylene) content is 5-80 moles) are not absorbed through the
intact GI tract and are considered incapable of eliciting a toxic
response.
i. Food. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles) are not absorbed through the intact GI tract and
are considered incapable of eliciting a toxic response.
ii. Drinking water. Even though some members of this family of
polymers are water soluble, the high binding capacity to clay particles
renders them immobile. Based upon the high binding to clay of
<greek-a>-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles,) there is no reason to expect human exposure to
residues in drinking water. The copolymers are biodegraded in the
environment over time into small molecular units that are easily
mineralized into the soil matrix or utilized by the microbial
populations. These small molecular units are considered to be
toxicologically safe.
2. Non-dietary exposure. Typical use of this type of polymer is in
the detergent formulations.
C. Cumulative Effects
There are data that support cumulative risk from <greek-a>-alkyl
(C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles),
since polymers with molecular weights greater than 400 are not readily
absorbed through the intact skin and substances with molecular weights
greater than 1,000 are not normally absorbed through the intact GI
tract. Chemicals not absorbed through the skin or GI tract generally
are incapable of eliciting a toxic response. Therefore, there are no
reasonable expectations of increased risk due to cumulative exposure.
D. Safety Determination
1. U.S. population. Alpha-alkyl (C<INF>12</INF> - C<INF>18</INF>)-
<greek-oh>- hydroxypoly(oxypropylene) poly(oxyethylene)
copolymers (where the poly(oxypropylene) content is 3-60 moles and the
poly(oxyethylene) content is 5-80 moles) cause no safety concerns
because they conform to the definition of a low risk polymer given in
40 CFR 723.250(b) and as such are considered incapable of eliciting a
toxic response. Also, there are no additional pathways of exposure
(non-occupational, drinking water, etc.) where there would be
additional risk.
2. Infants and children. Alpha-alkyl (C<INF>12</INF> -
C<INF>18</INF>)-<greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles)
cause no aditional concern to infants and children because the polymers
conform to the definition of a low risk polymer given in 40 FR
723.250(b) and as such are considered incapable of eliciting a toxic
response. Also, there are no additional pathways of exposure (non-
occupational, drinking water, etc.) where infants and children would be
additional risk.
E. International Tolerances
We are not aware of any country requiring a tolerance for
<greek-a>-alkyl (C<INF>12</INF> - C<INF>18</INF>)-<greek-oh>-
hydroxypoly(oxypropylene) poly(oxyethylene) copolymers (where
the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene)
content is 5-80 moles). Nor have there been any CODEX Maximum Residue
Levels (MRLs) established for any food crops at this time.
Omnichem SA is petitioning that <greek-a>-alkyl (C<INF>12</INF> -
C<INF>18</INF>)-<greek-oh>- hydroxypoly(oxypropylene)
poly(oxyethylene) copolymers (where the Poly(oxypropylene)
content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles)
be exempt from the requirement of a tolerance based upon the low risk
polymer definition as per 40 CFR 723.250. Therefore, an analytical
method to determine residues of <greek-a>-alkyl (C<INF>12</INF> -
C<INF>18</INF>)-<greek-oh>- hydroxypoly (oxypropylene)
[[Page 28485]]
poly(oxyethylene) copolymers in RAC has not been proposed.
[FR Doc. 99-13035 Filed 5-25-99; 8:45 am]
BILLING CODE 6560-50-F