[Federal Register Volume 63, Number 224 (Friday, November 20, 1998)]
[Notices]
[Pages 64478-64481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31068]
[[Page 64478]]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-843; FRL-6042-4]
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-843, must
be received on or before December 21, 1998.
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. 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: The product manager listed in the
table below:
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Office location/
Product Manager telephone number Address
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Edward Allen.................. Rm. 902W16, CM #2, 703- 1921 Jefferson
308-8699, e- Davis Hwy,
mail:[email protected] Arlington, VA
mail.epa.gov.
Bipin Gandhi.................. Rm. 707A, CM #2, 703- Do.
308-8380, e-mail:
gandhi.bipin@epamail..
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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-843] (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 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (insert docket number) 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: November 12, 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. Agrium US Inc.
PP 8F5035
EPA has received a pesticide petition (PP 8F5035) from Agrium US
Inc., 4582 S. St., Suite 1400, Denver, CO 80237, 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 Pseudomonas chlororaphis Strain 63-28 in
or on the raw agricultural commodity greenhouse vegetable crops.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Agrium US Inc. has submitted the following summary of information, data
and arguments in support of their pesticide petition. This summary was
prepared by Agrium US Inc. and EPA has not fully evaluated the merits
of the petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneuos
material, or the summary was not clear that it reflected the conclusion
of the petitioner and not necessarily EPA.
A. Product Name and Proposed Use Practices
Pseudomonas chloroaphis Strain 63-28 will be incorporated into the
end-use product, AtEze, as an active ingredient. AtEze is proposed for
use on greenhouse vegetable crops for the suppression of two important
soil-borne diseases Rhizoctonia solani and Pythium spp.
The product is applied as a soil drench treatment at a dilution
rate of 1:500 using potable water. In addition,
[[Page 64479]]
the product may also be applied with drip irrigation systems in
production greenhouses.
B. Product Identity/Chemistry
Identity of the pesticide and corresponding residues. Pseudomonas
chloroaphis Strain 63-28 is a liquid suspension containing living cells
at a concentration of 109 colony forming units (cfu)/mL of fermentation
product. Pseudomonas chloroaphis Strain 63-28 is a plant-beneficial
rhizobacterium that is a non-pathogenic, non-toxic, free-living
organism which is naturally occuring in soils and water worldwide.
The association of Pseudomonas chlororaphis Strain 63-28 with
plants is adequately understood for purposes of the tolerance
exemption. This rhizosphere bacterium is one of the most commonly-
occurring microorganisms in soils and on roots of many plants during
growing seasons. Inocula of P. chlororaphis Strain 63-28 applied into
natural soils do not persist for a long period of time, nor do they
change soil microbial processes significantly, according to published
literature. Several strains of P. chlororaphis Strain 63-28, when
introduced at a concentration of approximately 106 cfu/g of root, fall
below detection levels after 8-12 weeks. There is no indication that
the bacterium can be translocated in great numbers within plants. An
analytical method for residues is not applicable, since the petitioner
has requested an exemption from the requirement of a tolerance.
C. Toxicological Profile
Acute toxicity. AtEze, the end-use formula containing 1.15%
Pseudomonas chlororaphis Strain 63-28, has been studied for acute
toxicity. The results of these studies indicate a Toxicity Category III
or IV and poses no significant human health risks. The acute oral
toxicity of Pseudomonas chlororaphis Strain 63-28 in rats is greater
than 5,000 milligrams/kilogram (mg/k)g (5.50 x 1010 cfu-
Toxicity Category IV). Acute dermal toxicity in rabbits is greater than
2,000 mg/kg (6.82 x 1010 cfu-Toxicity Category III). In an
eye irritation study, each rabbit received a dose of 1.06 x
109 cfu viable bacteria. The highest primary irritation
score observed during the study was 0.8 (out of a maximum score of
110), which was observed in a 24-hour scoring interval. No signs of
ocular irritation were observed in any rabbit at the 48-hour scoring
interval (Toxicity Category III). Agrium has not observed any incidents
of hypersensitivity from personnel working with the product strain or
the product in laboratory, fermentation facilities, greenhouses, or
field studies. Their is no report in the literature to suggest that
members of the species Pseudomonas chlororaphis, or closely related
Pseudomonads cause any hypersensitive reaction in humans or animals.
Waivers have been requested for acute oral toxicity/pathogenicity,
and acute pulmonary toxicity/pathogenicity toxicity, genotoxicity,
reproductive and developmental toxicity, subchronic toxicity, chronic
toxicity, and acute toxicity to nontarget species based on AtEze's
ubiquity in nature, favorable toxicological profile in that Pseudomonas
chlororaphis Strain 63-28 has never been reported as a pathogen of
humans or any type of animals, other published research and toxicology
studies, and inconsequential exposure resulting from label-directed
uses.
D. Aggregate Exposure
1. Dietary exposure--Food. The estimate of aggregate exposure to P.
chlororaphis Strain 63-28 contained in AtEze through food intake is
based on potential dispersal of the bacterial to edible portions of
greenhouse vegetables and on a theoretical maximum residue contribution
(TMRC) to diet. The TMRC considers a maximum level of residue consumed
daily if each greenhouse vegetable crop is treated with the product.
According to the research data on greenhouse tomato, residual
populations of the product bacterium on fruits will be less than 10 cfu
/g. It is likely that residue levels on greenhouse cucumber or pepper
will be similar with the same product use pattern. A very liberal
estimation of daily consumption of all greenhouse vegetables is used
for calculation of the TMRC. With 2 kg/day, the TMRC value would be no
more than 400 cfu/kg body weight for a person weighing 50 kg. Suppose
the person had the same daily intake for a life time (80 years), the
accumulative amount would still be only 1.2 x 107 cfu/kg body weight,
which is less than 1% of the amount used in the oral toxicity test.
With the large overestimate of human dietary exposure through food, the
total amount is still well below levels used, and demonstrated safe in
the acute oral toxicity study. The chronic toxicity information has not
been established. However, a potential residue level is so low on food
crops that natural populations of the bacterium may surpass it.
Therefore, a chronic toxic impact is not expected.
2. Dietary exposure--Drinking water. There is no maximum
contaminant level established for Pseudomonas chlororaphis Strain 63-28
in drinking water, nor it is listed for drinking water monitoring under
the Safe Drinking Water Act. The risk of contaminating well water by
applied bacteria is very low because the product is used in greenhouses
and the recommended amount of drench application severely limits
leaching. It is expected that human exposure through drinking water is
negligible. This bacterium exists in abundance in natural surface water
such as ponds, lakes or streams.
3. Non-dietary exposure. AtEze is labeled for uses on commercial
greenhouse crops only. Based on the study of persistence on several
greenhouse crops, residue populations of the bacterium on the roots and
in the growth medium will be negligibly low by the time of crop sales.
Since the product is not found in or on fruits, and the general public
has limited exposure to production greenhouses or plant growth media,
the estimated non-occupational exposure to the general population is
minuscule. Occupational exposure will be mitigated by the use of proper
personal protective equipment and clothing.
E. Cumulative Exposure
The product strain belongs to the bacterial genus of Pseudomonas.
Although other registered pseudomonads may have similar modes of action
in suppressing plant diseases, there is no information available to
suggest that these organisms exhibit a similar toxicity profile in the
mammalian system that would be cumulative with P. chlororaphis Strain
63-28. Thus, consideration of a common mechanism of toxicity is not
appropriate at this time. Agrium is considering only the potential
risks of P. chlororaphis 63-28 in its aggregate exposure assessment.
F. Safety Determination
1. U.S. population. Based on the physical and chemical
characteristics, low use rates, no evidence of any acute toxicity, lack
of other toxicological concerns and a liberal estimation of exposure,
Agrium believes that there is a reasonable certainty of no harm to the
U.S. population in general from aggregate exposure to AtEze residue
from all anticipated dietary and non-dietary exposures.
2. Infants and children. A developmental toxicity study was not
conducted. Based on the observation that no adverse effect was found in
acute toxicological studies, very low residue if any, limited exposure,
and on the lack of reported concerns in the literature, Agrium believes
that the product is of minimal risk.
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G. Effects on the Immune and Endocrine Systems
Endocrine disruptors. Agruim has no information to suggest that
P. chlororaphis Strain 63-28 will have an effect on the immune and
endocrine systems. Furthermore, EPA is not requiring information on
endocrine effects of this microbial pesticide at this time; Congress is
allowing 3 years after August 3, 1996, to implement a screening program
with respect to endocrine effects.
H. International Tolerances
There are no CODEX tolerances or international tolerance exemptions
issued for P. chlororaphis Strain 63-28 at this time. (Edward Allen)
2. Rohm and Haas Company
PP 8E4952
EPA has received a pesticide petition (PP 8E4952) from Rohm and
Haas Company, 100 Independence Mall West, Philadelphia, PA 19106-2399,
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 Alkyl (C12-C20)
Methacrylate copolymer when used in accordance with good agricultural
practices as inert ingredient in pesticide formulations applied to
growing crops in or on the raw agricultural commodity after harvest or
to animals at parts per million (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 (Low-Risk Criteria for Polymers)
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. Alkyl (C12-C20)
Methacrylate copolymers 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. Alkyl (C12-C20) Methacrylate copolymer is not a cationic
polymer, nor is it capable of becoming a cationic polymer in the
natural aquatic environment.
2. Alkyl (C12-C20) Methacrylate copolymer contains as an integral
part of its composition the atomic elements carbon, hydrogen, oxygen
and less than 0.10% sulfur.
3. Alkyl (C12-C20) Methacrylate copolymer does not contain as an
integral part of its composition, except as impurities, any element
other than those listed in 40 CFR 723.250 (d)(2)(iii).
4. Alkyl (C12-C20) Methacrylate copolymer is not designed, nor is
it reasonably anticipated to substantially degrade, decompose or
depolymerize.
5. Alkyl (C12-C20) Methacrylate copolymer is 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. Alkyl (C12-C20) Methacrylate copolymer is 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 Alkyl (C12-C20)
Methacrylate copolymer is 50,000 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
generally are not absorbed through the intact gastrointestinal (GI)
tract. Chemicals not absorbed through the skin or GI tract generally
are incapable of eliciting a toxic response.
8. Alkyl (C12-C20) Methacrylate copolymer has a minimum number
average molecular weight of 50,000 and contains less than 2% oligomeric
material below molecular weight 500 and less than 5% oligomeric
material below 1,000 molecular weight.
9. Alkyl (C12-C20) Methacrylate copolymer does contain aliphatic
ester groups as reactive functional groups. However, these reactive
groups are not intended or reasonably anticipated to undergo further
reactions under usual environmental conditions.
10. There are no evidence that Alkyl (C12-C20) Methacrylate
copolymer is an endocrine disrupter, where as substances with molecular
weights greater than 400 generally are not absorbed through the intact
skin, and substances with molecular weights greater than 1,000
generally are not absorbed through the intact gastrointestinal (GI)
tract. Chemicals not absorbed through the skin or GI tract generally
are incapable of eliciting a toxic response.
B. Aggregate Exposure
1. Dietary. Alkyl (C12-C20) Methacrylate copolymer is not absorbed
through the intact gastrointestinal tract and is considered incapable
of eliciting a toxic response.
2. Water. Based upon the aqueous insolubility of Alkyl (C12-C20)
Methacrylate copolymer, there is no reason to expect human exposure to
residues in drinking water.
3. Non-dietary. Typical use of Alkyl (C12-C20) Methacrylate
copolymer is in the oil industry as a wax and viscosity modifier at
very low use rates. In these uses the primary exposure rate would be
dermal, however, Alkyl (C12-C20) Methacrylate copolymer with a
molecular weight significantly greater that 400 is not absorbed through
the intact skin.
C. Cumulative Risk
There is data to support cumulative risk from Alkyl (C12-C20)
Methacrylate copolymer, since polymers with molecular weights greater
than 400 generally are not absorbed through the intact skin, and
substances with molecular weights greater than 1,000 generally are not
absorbed through the intact gastrointestinal (GI) tract. Chemicals not
absorbed through the skin or GI tract generally are incapable of
eliciting a toxic response. Therefore, there is no reasonable
expectations of increased risk due to cumulative exposure.
D. Safety Determination
1. U.S. population. Alkyl (C12-C20) Methacrylate copolymer causes
no safety concerns because it conforms to the definition of a low risk
polymer given in 40 CFR 723.250 (b) and as such is 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. Alkyl (C12-C20) Methacrylate copolymer
causes no additional concern to infants and children because it
conforms to the definition of a low risk polymer given in 40 CFR
723.250 (b) and as such is considered incapable of eliciting a toxic
response. Also there are no additional pathways of exposure (non-
occupational, drinking water, etc.)
[[Page 64481]]
where infants and children would be at additional risk.
E. International Tolerances
Rohm and Haas is petitioning that Alkyl (C12-C20) Methacrylate
copolymer be exempt from the requirement of a tolerance based upon the
low risk polymer as per 40 CFR 723.250. Therefore, an analytical method
to determine residues of Alkyl (C12-C20) Methacrylate copolymer in raw
agricultural commodities has not been proposed.
We are not aware of any country requiring a tolerance for Alkyl
(C12-C20) Methacrylate copolymer. Nor have there been any CODEX Maximum
Residue Levels (MRL's) established for any food crops at this time.
(Bipin Gandhi)
[FR Doc. 98-31068 Filed 11-19-98; 8:45 am]
BILLING CODE 6560-50-F
