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salicylic acid Pesticide Petition Filing 9/98


[Federal Register: September 23, 1998 (Volume 63, Number 184)]
[Notices]               
[Page 50903-50906]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se98-69]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-833; FRL-6026-1]

 
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-833, must 
be received on or before October 23, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs,

[[Page 50904]]

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 Regulatory Action Leader listed in 
the table below:

------------------------------------------------------------------------
                                   Office location/
   Regulatory Action Leader        telephone number          Address
------------------------------------------------------------------------
Diana Horne...................  9th Floor, CM #2, 703-  1921 Jefferson
                                 308-8367, e-mail:       Davis Hwy,
                                 horne.diana@epamail.e   Arlington, VA
                                 pa.gov.
Sheila A. Moats...............  9th Floor, CM #2, 703-  Do.
                                 308-1259, e-mail:
                                 moats.sheila@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-833] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-833] 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: September 8, 1998.

Kathleen D. Knox,

Acting Director, Biopesticides and Pollution Prevention 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.


2. Stoller Enterprises, Inc.

PP 8F4960

    EPA has received a pesticide petition (PP 8F4960) from Stoller 
Enterprises, Inc., 8580 Katy Freeway, Suite 200, Houston, Texas 70024, 
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 the biochemical 
pesticide, salicylic acid, in or on all raw agricultural commodities.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Stoller Enterprises, Inc. has submitted the following summary of 
information, data and arguments in support of their pesticide petition. 
This summary was prepared by Stoller Enterprises, 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 extraneous 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

    Salicylic acid will be incorporated into the end-use product, 
Adjust I, as an active ingredient. Adjust I is proposed

[[Page 50906]]

for use on a variety of agricultural, horticultural, and floricultural 
applications to enhance plant defense against pathogens.
    Depending on the crop, the first application of Adjust I is made at 
the 3-5 leaf stage or other prescribed growth stage. Subsequent 
applications may be made at 12-day intervals. The rate is 2 quarts of 
formulated product/acre per treatment. This equates to the application 
of 20 grams/acre salicylic acid.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Salicylic 
acid is a phenolic acid found in insects and plants as free acid or 
bound. The biochemical is a white, practically odorless, free-flowing 
crystalline powder. It is slightly soluble in water, forming acidic 
solutions.
    2. Magnitude of the residue at time of harvest and method used to 
determine residue. An analytical method using High Performance Liquid 
Chromatography (HPLC), UV spectrophotometery, and Gas Chromatography 
for determining salicylic acid content in Adjust I is available.
    3. A statement of why an analytical method for detecting the levels 
and measuring of the pesticide residue is not needed. Because this 
phenolic acid is found naturally in plants, residue analysis would not 
yield meaningful results, i.e., the analysis would not discern whether 
the salicylic acid source was the plant or from treatment. 
Additionally, phenolic levels harmful to plants and animals are highly 
unlikely to occur when the product is applied according to label 
instructions.

C. Mammalian Toxicological Profile

    Salicylic acid is highly regulated in man and other organisms, the 
mechanisms of which are well understood. Salicylic acid has been 
administered to numerous species in long term dietary studies without 
adverse effects at a range of concentrations. The end-use product 
containing salicylic acid, Adjust I, has been evaluated for acute 
toxicity. Acute oral toxicity in rats is greater than 3,000 milligrams/
kilogram (mg/kg) (Toxicity Category III). Acute dermal toxicity in 
rabbits is greater than 5,050 mg/kg (Toxicity Category III). In an eye 
irritation study, there were no signs of irritation following 
administration of Adjust I (Toxicity Category IV). A rabbit dermal 
irritation study with Adjust I resulted in no signs of irritation 
(Toxicity Category IV). There was no indication of dermal sensitization 
in a guinea pig dermal sensitization study.
    Waivers have been requested for genotoxicity, reproductive and 
developmental toxicity, subchronic toxicity, chronic toxicity, and 
acute toxicity to nontarget species based on salicylic acid's ubiquity 
in nature, long history of medicinal uses, favorable toxicological 
profile in chronic toxicology studies, and inconsequential exposure 
resulting from label-directed use rates.

D. Aggregate Exposure

    1. Dietary exposure-- Food. Salicylic acid is ubiquitous in nature 
and is found in lower and higher plant species, insects, cosmetics, 
over-the-counter medications and natural and processed foods. Many 
items in the human daily diet contain appreciable quantities of free 
and bound salicylic acid. Dietary exposure due to topical applications 
of salicylic acid is difficult to estimate because of the phenolic 
acid's prevalence in skin care products and over-the-counter 
medications.
    Considering the low dose of salicylic acid required to achieve the 
desired effect, the levels of salicylic acid found naturally in the 
diet and the quantity consumed from processed foods, it can be 
concluded that incremental dietary exposure to salicylic acid resulting 
from Adjust I applications is negligible.
    2. Drinking water. The active ingredient, salicylic acid, 
decomposes readily in water and sunlight. The oxidation reactions of 
ultraviolet radiation/H<INF>2</INF>0<INF>2</INF>/O<INF>2</INF> with 
either phenol or salicylic acid successfully degrade those compounds, 
which are building blocks of aquatic humic substances. Many compounds, 
including salicylic acid, have been identified by means of spectroscopy 
and chromatography. The degradation pathway is thought to involve 
hydroxylation of the aromatic ring and abstraction of a hydrogen atom 
to form 1,2-benzoquinone, which is cleaved to form muconic acid. The 
muconic acid is converted to maleic acid, fumaric acid, and oxalic 
acid. Fumaric and maleic acids eventually become malic acid, and the 
oxalic acid is degraded to formic acid and then CO<INF>2</INF>. These 
reactions demonstrate how phenolics substances are converted to 
biodegradable ones.
    3. Non-dietary exposure. Adjust I is proposed for use on non-
residential turf and ornamentals. Exposure from turf grass applications 
is expected to be minimal because turf users will be protected by shoes 
and socks. Further, based on the limited frequency of use on turf 
grass, this non-food use is not likely to result in potential chronic 
exposure and thus should not be factored into a chronic exposure 
assessment. Exposures resulting from application to ornamentals is also 
anticipated to be negligible because consumers normally will not be in 
contact with treated plants.

E. Cumulative Exposure

    Salicylic acid is highly regulated in plants and mammals, the 
mechanisms of which are well understood. This phenolic acid is not 
intended for pesticidal use and does not share a common mechanism of 
toxicity with currently available pesticides, thus Adjust I anticipate 
no cumulative effects with other substances.

F. Safety Determination

    1. U.S. population. Because the use of salicylic acid will be 
delivered at label rates concentrations that are less than or equal to 
those found in plants, and because the active ingredient has a 
favorable toxicological profile, the use of the salicylic acid when 
delivered at label rates poses a negligible, or nonexistent, risk to 
the U.S. population.
    2. Infants and children. Salicylic acid and its conjugates, esters, 
and metabolites are ingested and excreted daily. The compound and its 
analogs are ubiquitous in the food chain. When used at label rates, the 
product poses no threat to infants and children. In fact as the product 
replaces existing fungicides with less favorable toxicological profiles 
the risk to infants and children will be reduced.

G. Effects on the Immune and Endocrine Systems

    There is no literature available to suggest the immune or endocrine 
systems will be compromised with the use of salicylic acid as an active 
ingredient at recommended rates.

H. Existing Tolerances

    There are no known existing tolerances for the use of salicylic 
acid for use as a pesticide.

I. International Tolerances

    There are no CODEX tolerances or international tolerance exemptions 
for salicylic acid at this time.
[FR Doc. 98-25315 Filed 9-22-98; 8:45 am]
BILLING CODE 6560-50-F
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