[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:allen.edward@epa   Arlington, VA
                                 mail.epa.gov.
Bipin Gandhi..................  Rm. 707A, CM #2, 703-   Do.
                                 308-8380, 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-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:
    [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 (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