pheromones Tolerance Exemption--Final Rule 3/94
40 CFR Part 180
Anthropod Pheromones; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA is establishing an exemption from the requirement
of a tolerance for residues of arthropod pheromones resulting
from the use of these substances in retrievably sized polymeric
matrix dispensers 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 (RAC). EPA is establishing
this regulation on its own initiative.
EFFECTIVE DATE: This regulation becomes effective March 30,
ADDRESSES: Written objections and hearing requests, identified
by the document control number, [OPP-300314A], 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 document 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 copy of objections and hearing requests to: Rm.
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Fees accompanying objections shall be labeled ``Tolerance Petition
Fees'' and forwarded to: EPA Headquarters Accounting Operations
Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Product
Manager (PM) 18, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 213, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202, (703)-305-7690.
SUPPLEMENTARY INFORMATION: In the Federal Register of December
8, 1993 (58 FR 64538), EPA issued a proposed rule to amend 40
CFR part 180 by establishing an exemption from the requirement
of a tolerance for all arthropod pheromones used in solid matrix
dispensers at rates less than or equal to 150 grams active ingredient
(AI)/acre/year. A pheromone is defined by EPA as a compound
produced by an arthropod that modifies the behavior of other
individuals of the same species (40 CFR 152.25(b)(1)). Solid
matrix dispensers as defined in the proposal include, but are
not limited to, the following: Rubber septa dispensers, trilaminate
sheets, tapes, tags, wafers, macrocapillary devices which are
placed by hand in the field and are of such size and construction
that they are readily recognized. Formulations not inlcuded
in this exemption are as follows: Liquid flowables, microcapsules,
microcapillary straws; granular powder, flakes, or confetti
formulations which are sprayed or broadcast over the crop area;
and cigaret filters or unprotected ropes which generally contain
the active ingredient on the outer surface of the unit. In the
proposal, EPA set forth its reasons for determining that a tolerance
for these pheromone products is not necessary to protect public
EPA is choosing to change the term ``solid matrix dispnesers''
to ``retrievably sized polymeric matrix dispensers'' for consistency
with 40 CFR 180.1122, which exempts from the requirement of
a tolerance the inert materials of these dispensers (58 FR 64493).
The Agency does not believe this change will change the intent
or scope of the original definition of a dispenser. EPA intendes
the term ``retrievably sized polymeric matrix dispensers ''
to include such dispensers as the following: Rubber septa dispensers;
trilaminate sheeps; tapes; tags, microcapillary devices such
as long tubes or fibers; twist ties; and protected ropes. Each
of these dispensers is placed by hand in the field and is of
such size and contstruction that it is readily recognized and
retrievable. Dispensers with similar characteristics would also
come within this term. In the preamble to the proposal, EPA
included ``wafers'' in the list of dispensers which would qualify
under this exemption. EPA now believes use of this example is
ambiguous because wafers could be of a size that could or could
not be retrieved. To emphasize that this exemption only applies
to retrievable dispensers, EPA has intentionally omitted wafers
from the examples given above of qualifying dispensers.
Three comments were received in response to the proposed
rule. All the responses were generally favorable to the generic
tolerance proposal, with two of the comments finding the proposal
too restrictive. These comments suggested the Agency should
further broaden the scope and the exemption to allow the tolerance
exemption to extend beyond polymeric, retrievably sized dispenser
formulations to include broadcast applications.
The Agency dose not have a toxicology data base for arthropod
pheromones that addresses the potential risk of repeated, direct
dietary exposure to the active ingredient possible with formulations
such as sprayables which can be incorporated into food. The
Agency believes that restricting the exemption to retrievably
sized dispensers will severely limit the possibility of direct
dietary exposure to the active ingredient and that such a limitation
is necessary to protect the public health. Producers of new
pheromone formulations not exempted by this proposal, including
smaller-sized granules, may request a tolerance exemption. Producers
of previously registered pheromone products wishing to utilize
formulations other than those mentioned in this rule may petition
for an amendment to the existing tolerance exemption for a registered
active ingredient, if they can demonstrate that the new formulation
does not increase the likely dietary exposure.
One of the commenters believed that the proposed rule was
too restrictive for lepidopteran pheromones. On the other hand,
the same commenter believed that the proposed rule was too lenient
for other types of pheromones. This commenter questioned how
the Agency could exempt all arthropod pheromones from a requirement
for a tolerance when several groups of arthropods are known
to produce pheromone compounds that are chemicals structurally
so diverse as to be of unknown toxicity. The Agency agrees that
the scope of the tolerance exemption is broad and does exempt
arthropod pheromones for which there is not an extensive data
base including pheromones with chemical structures unrelated
to the majority of pheromone active ingredients registered to
date. Nevertheless, the Agency believes the restrictions in
the proposed rule along with aspects of pheromone biology mitigate
concerns about the wider scope of this tolerance exemption.
First, the proposal incorporates features that would limit
the direct dietary exposure to the arthropod pheromones used
as pesticides by requiring the formulation to be restricted
to larger dispensers. This formulation restriction will limit
exposure to an active ingredient resulting from the small amount
that volatilizes from the dispenser and subsequently may deposit
on food crops. Due to its size, the dispenser itself, with or
without any remaining active ingredient, is not likely to become
incorporated into food. Second, the Agency believes that an
annual rate limitation of 150 grams AI/acre and a restriction
to retrievably sized dispensers are likely to limit the dietary
exposure to what is no greater than that found naturally in
food as a result of heavy infestations of the pest arthropods.
An arthropod species becomes a pest only if its populations
reach levels that impede economic returns. The Agency believes
there already has been dietary exposure to the arthropod pheromones
deposited after volatilization from natural heavy pest infestations
that could be shown to control such pest species. The dietary
exposure to these natural pheromones that results from registered
pheromones and those used in traps to date has not adversely
affected public health. No commenters found the annual 150 grams
AI/acre limit objectionable.
One commenter noted that it appeared that the Agency was
basing its tolerance exemption on wildlife exposure risks. The
primary reason for exempting arthropod phermones in these formulations
is based on human health considerations. The public health is
protected from unnecessary direct exposure to pheromone active
ingredients in food if these compunds are released from larger
retrievable dispensers. In addition, although not directly relevant
to this tolerance exemption, the Agency believes that wildlife
risks would be minimal with use of these dispensers.
A commenter claimed that the Agency was demonstrating a bias
against products developed from certain food crops such as grains
and row crops by the proposed tolerance exemption. EPA disagrees.
Larger dispenser formulations can be adapted to row crops by
incorporating pheromones dispensers into stakes or other supports.
The Agency believes that other pheromone formulations such as
sprayables and microencapsulated products should be developed
when the crop use demands these parameters and does not intend
to burden producers of these products unnecessarily. However,
the fate and subsequent dietary exposure of these smaller dispensers,
some perhaps still charged with the pheromone active ingredient,
must be addressed during a request for a tolerance exemption.
The same commenter requested that the Agency change the language
of the exmeption to indicate that many other organisms besides
arthropods produce pheromones but provided no information to
support expanding the exemption to other types of pheromones.
Without more information, EPA is unwilling to expand the exemption
in this manner at this time.
Based on the information considered, the Agency concludes
that tolerances for these pheromone products are not necessary
to protect the public health. Therefore, the tolerance exemptions
are established as set forth below.
Any person adversely affected by this regulation may, within
30 days after publication of this document in the Federal Register,
file written objections and/or request a hearing with the Hearing
Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing
Clerk should be submitted to the OPP docket for this rulemaking.
The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections
(40 CFR 178.25). Each objection must be accompanied by the fee
prescribed by 40 CFR 180.33(i). If a hearing is requested, the
objections must include a statement of the factual issue(s)
on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by
the objector (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is a genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one
or more of such issues in favor of the requestor, taking into
account uncontested claims or facts to the contrary; and resolution
of the factual issue(s) in the manner sought by the requestor
would be adequate to justify the action requested (40 CFR 178.32).
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993),
the Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management
and Budget (OMB) and the requirements of the Executive Order.
Under section 3(f), the order defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1)
Having an annual effect on the economy of $100 million or more,
or adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health
or safety, or State, local, or tribal governments or communities
(also referred to as ``economically significant''); (2) creating
serious inconsistency or otherwise interfering with an action
taken or planned by another agency; (3) materially altering
the budgetary impacts of entitlement, grants, user fees, or
loan programs or the rights and obligations or recipients thereof;
or (4) raising novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set
forth in this Executive Order.
Pursuant to the terms of the Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject
to OMB review.
Pursuant to the requirements of the Regulatory Flexibility
Act (Pub. L. 96-354, 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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: March 21, 1994.
Susan H. Wayland,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. By adding new sec 180.1124 to subpart D, to read as follows:
sec 180.1124 Arthropod pheromones; exemption from the requirement
of a tolerance.
Arthropod pheromones, as described in sec 152.25(b) of this
chapter, when used in retrievably sized polymeric matrix dispensers
are exempt from the requirement of a tolerance in or on all
raw agricultural commodities when applied to growing crops only
at a rate not to exceed 150 grams active ingredient/acre/year
in accordance with good agricultural practices.
[FR Doc. 94-7368 Filed 3-29-94; 8:45 am]