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pheromones Tolerance Exemption--Final Rule 3/94

40 CFR Part 180

[OPP-300314A; FRL-4761-9]

RIN 2070-AB78

Anthropod Pheromones; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.
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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]