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Lepidopteran Pheromones: Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: August 30, 1995 (Volume 60, Number 168)]
[Rules and Regulations]
[Page 45060-45062]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au95-14]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300396; FRL-4971-8]
40 CFR Part 180
Lepidopteran Pheromones: Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement of
a food tolerance for residues of certain Lepidopteran pheromones
resulting from the use of these substances independent of formulation,
mode of application or physical form or shape with an annual
application limitation of 150 grams active ingredient per acre (gm AI/
acre) for pest control in or on all raw agricultural commodities. This
exemption pertains only to the pheromone active ingredient. Any
encapsulating material needs to be a cleared inert for pesticidal uses
on food crops. EPA is establishing this regulation on its own initiative.
EFFECTIVE DATE: This regulation becomes effective August 30, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, OPP-300396, may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. A copy of any objections and hearing requests
filed with the Hearing Clerk should be identified by the docket control
number and submitted to: Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to: Public
Docket, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
``OPP-300396.'' No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in Unit IV. of this document.
[[Page 45061]]
FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Product Manager
(PM-90), Biopesticides and Pollution Prevention Division (7501W),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: 5th Floor, Crystal Station 1, 2805 Crystal Drive,
Arlington, VA, (703) 308-8260, e-mail: hutton.phil@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 29, 1995
(60 FR 16128), EPA issued a notice of filings and invited comments on a
pesticide petition to propose amending 40 CFR part 180 by establishing
an exemption from the requirement of a food tolerance for certain
Lepidopteran pheromones regardless of mode of application when used at
rates less than or equal to 150 grams ai/acre/year. The Agency received
no comments in response to its notice. In this document, EPA sets forth
its reasons for determining that a tolerance for these pheromone
products is not necessary to protect public health.
For the purposes of this exemption, a Lepidopteran pheromone is
defined as a naturally occurring compound, or identical or
substantially similar synthetic compound, designated by the unbranched
aliphatics (with a chain between 9 and 18 carbons) ending in an
alcohol, aldehyde or acetate functional group and containing up to 3
double bonds in the aliphatic backbone. This definition encompasses the
majority of Lepidopteran pheromones. While other types of chemical
compounds have been demonstrated to be Lepidopteran pheromones and
other arthropod pheromones have been recommended for tolerance
exemptions, there is limitied toxicity data and exposure information
available. The Agency believes the type described here represents not
only the majority of Lepidopteran pheromones but also those with the
most complete toxicological data base. Synthetically produced compounds
that are identical to a known aliphatic Lepidopteran pheromone as
described above, and those that differ only in that their molecular
structures are stereochemical isomers (or ratios of such isomers) are
also included in this tolerance exemption. Other Lepidopteran
pheromones and other pheromones not included within the described scope
will still require mammalian toxicity testing (40 CFR 158.690) if used
on food crops and are not otherwise exempt from the requirement of a
tolerance.
I. Background
A pheromone (including an identical synthetic compound) is defined
by EPA as a compound produced by an arthropod (insect, arachnid, or
crustacean) that modifies the behavior of other individuals of the same
species (40 CFR 152.25(b)). Lepidopteran pheromones are those produced
by a member of the order Lepidoptera, which includes butterflies and
moths. One physical-chemical feature common to all these compounds is
their volatility which is the basis for the signalling and homing
mechanism. The Agency has registered 17 arthropod pheromones active
ingredients, 11 of which are Lepidopteran pheromones.
The Agency has assumed that pheromones and other similar
semiochemicals are different from conventional synthetic pesticides,
and has attempted to facilitate their registration with reduced data
requirements and regulatory relief efforts. Most recently the Agency
has recognized that a special category of pheromone products dispensed
from larger sized polymeric matrices with low annual use rates
represent minimal risk for dietary and environmental exposure and has
greatly eased the burden to register these items. Broadcast methods of
application were not included because the Agency did not have
sufficient information on the levels of exposure from pheromones
applied in this manner. The Agency has since received data in this
area. In addition to submitted data, the Agency utilized in its
decision an internal document of the toxicology of certain Lepidopteran
pheromones related by their chemical structure.
For pheromone products, especially those directly applied to food,
one problem has been a lack of subchronic toxicity studies and an
estimate of the actual pheromone residues occurring with use. Some
pheromone uses in solid matrix dispensers have been registered based on
the low probability of exposure justifying the waiver of the subchronic
toxicity studies, namely the 90-day feeding, the developmental toxicity
and immunotoxicity studies. However, the Agency has held that sprayable
formulations or other modes of application that may increase the
likelihood of human exposure would still require the subchronic
toxicology studies.
II. Human Health
Data has been submitted on subchronic toxicology studies done to
date on compounds similar in structure to the Lepidopteran pheromones
and published in the peer reviewed, public literature. The information
submitted covered compounds that were from six to sixteen carbon
unbranched alcohols, acetates and aldehydes. Since the Agency is basing
this tolerance exemption on chemical structure, it is relevant to
consider the available subchronic toxicology data for this group. The
results given in these literature reports indicate that there is no
significant acute toxicity associated with the primary alcohols,
acetates or aldehydes mentioned (C8 to C16 unbranched
aliphatics). In addition, the subchronic toxicity of an isomeric
mixture of tridecenyl acetate indicated no significant signs of
toxicity other than those expected with longer term exposure to high
doses of a hydrocarbon. The findings of the published studies indicate
that there were no significant health effects from subchronic exposures
to this group of chemicals.
Studies examining the volatilization of a pheromone from a
microcapsule indicates that about 70 percent of the pheromone remains
after 30 days. These results indicate the pheromone is released at a
slower rate than anticipated. The studies show that only a small
proportion of the microcapsules actually release any pheromone or only
a portion of the total pheromone loaded into the capsule is capable of
ever being released. These laboratory studies indicate a potential for
pheromone residues to occur in the absence of any biological or
environmental factors.
In a submitted field study, however, residue analyses from field
treated plants indicate no significant amounts of pheromone can be
detected on the resulting fruit. The detectable residues on unwashed
fruit of tomato pinworm pheromone ranged from 21-72 ppb on the day of
application, decreased to 0.9-6.8 ppb on day 15, and was recorded at
0.29-1.2 ppb on day 30. Washing the tomatoes brought all the residues
below the level of detection. This study demonstrates that the expected
pheromone residue levels found in tomato fruit are several orders of
magnitude lower than previously calculated estimates. The process of
application, weathering, and other environmental degradation leads to a
reduction in the active ingredient that approaches the system limit of
detection in the expected 3-week lifetime of the raw agricultural product.
III. Conclusion
The Agency believes that the potential for pheromone residues is
not a dietary hazard. This conclusion is based on: (1) The low acute
toxicity seen in the data
[[Page 45062]]
review of the Lepidopteran pheromones registered to date; (2) the known
metabolism of long-chain fatty acids that predicts these compounds
would be metabolized either by -oxidation yielding a series of
paired carbon losses or by complexing with glucuronide and excretion by
the kidneys; and (3) low exposure subsequent to application from
product aging, volatilization, and the results of the field residue
studies.
EPA has determined that, when used in accordance with good
agricultural practices, a food tolerance for the defined subset of
Lepidopteran pheromones is not necessary to protect the public health.
A generic exemption for this low-risk, low-exposure group of substances
will facilitate the use of semiochemicals as alternatives to
conventional synthetic pesticides. Therefore, EPA is establishing an
exemption from the requirement of a tolerance as set forth below for
the defined group of compounds with from 9 to 18 carbon atoms,
regardless of formulation or mode of application, at use rates of less
than 150 grams active ingredient/acre/year. It is important to note
that any encapsulating material needs to be a cleared inert for
pesticidal uses on food crops. To the extent that other straight
chained, or non-straight chained chemicals within this group may be
naturally occurring and sufficiently similar to these Lepidopteran
compounds in use, they may also meet the exemption from the requirement
for a food tolerance upon review by the Agency.
Any person adversely affected by this regulation may, within 30
days, file written objections and/or request a hearing with the Hearing
Clerk and a copy submitted to the OPP docket for this rulemaking at the
addresses given above.
IV. Rulemaking Record
A record has been established for this rulemaking under docket
number ``OPP-300396'' (including objections and hearing requests
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 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number ``OPP-300396'', may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-docket@epamail.epa.gov
A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all objections and hearing requests submitted directly in
writing. The official rulemaking record is the paper record maintained
at the address in ``ADDRESSES'' at the beginning of this document.
V. Regulatory Assessments
The Office of Management and Budget has exempted this notice from
the requirement of section 3 of Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has
determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
Dated: August 18, 1995.
Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division Office
of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding Sec. 180.1153 to subpart D to read as follows:
Sec. 180.1153 Lepidopteran pheromones; exemption from the requirement
of a tolerance.
Lepidopteran pheromones that are naturally occurring compounds, or
identical or substantially similar synthetic compounds, designated by
an unbranched aliphatic chain (between 9 and 18 carbons) ending in an
alcohol, aldehyde or acetate functional group and containing up to 3
double bonds in the aliphatic backbone, are exempt from the requirement
of a tolerance in or on all raw agricultural commodities. This
exemption pertains to only those situations when the pheromone is
applied to growing crops at a rate not to exceed 150 grams active
ingredient/acre/year in accordance with good agricultural practices.
[FR Doc. 95-21037 Filed 8-29-95; 8:45 am]
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