[Federal Register Volume 59, Number 61 (Wednesday, March 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7368]


[[Page Unknown]]

[Federal Register: March 30, 1994]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300314A; FRL-4761-9]
RIN 2070-AB78

 

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, 1994.

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, 
PA 15251.

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 health.
    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 
recordkeeping requirements.

    Dated: March 21, 1994.

Susan H. Wayland,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is 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 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]
BILLING CODE 6560-50-F