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Cyanazine; Notice of Final Determination to Terminate Special Review of Cyanazine; Notice of Voluntary Cancellation and Cancellation Order of Cyanazine Product Registrations
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 25, 1996 (Volume 61, Number 144)]
[Notices]
[Page 39023-39029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy96-130]
[[Page 39024]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000/60B; FRL-5385-7]
Cyanazine; Notice of Final Determination to Terminate Special
Review of Cyanazine; Notice of Voluntary Cancellation and Cancellation
Order of Cyanazine Product Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Final Determination to Terminate Special Review;
Notice of Voluntary Cancellation.
-----------------------------------------------------------------------
SUMMARY: This Notice announces the conclusion of the Special Review of
cyanazine and EPA's acceptance of requests for the voluntary
cancellation of cyanazine registrations. EPA is concluding the Special
Review because the registrants have agreed to voluntarily modify the
terms and conditions of the cyanazine registrations so that use of the
pesticide will not cause unreasonable adverse effects on the
environment. The registrants have agreed to voluntarily amend their
registrations and phase out cyanazine use by gradually reducing
application rates, implementing additional protective use restrictions
during the phaseout, and voluntarily cancelling cyanazine registrations
effective December 31, 1999. EPA is accepting these voluntary
cancellations of technical and end use pesticide products containing
cyanazine pursuant to agreements by the registrants.
FOR FURTHER INFORMATION CONTACT: By mail: Joseph E. Bailey, Review
Manager, Special Review and Reregistration Division (7508W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., S.W.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Special Review Branch, 3rd Floor, Crystal Station, 2800
Jefferson Davis Highway, Arlington, VA 22202, Telephone: 703-308-8173,
e-mail: bailey.joseph@epamail.epa.gov. For a copy of documents in the
public docket, to request information concerning the Special Review, or
to request indices to the Special Review public docket, contact the
Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460, Telephone: 703-305-5805.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Regulatory Background
This Notice of Final Determination concludes the Special Review of
cyanazine which began in November 1994 when EPA issued the Notice of
Initiation of Special Review of atrazine, simazine, and cyanazine (58
FR 60412, November 23, 1994) (FRL-4919-5). The Agency initiated the
Special Review based upon concerns that cyanazine may pose a risk of
inducing cancer in humans from dietary, occupational, and residential
exposure.
When EPA initiated this Special Review, E.I. duPont de Nemours and
Company (``DuPont'') and Ciba Geigy Corporation (``Ciba'') were the
only registrants of cyanazine products. On August 2, 1995, DuPont
voluntarily proposed to amend its cyanazine registrations to
incrementally reduce cyanazine maximum application rates in 1997, 1998,
and 1999, and to terminate the production of cyanazine for use in the
United States by the end of 1999. DuPont proposed that after December
31, 1999, the registrant would not release for shipment any cyanazine
formulated end use products for use in the United States. EPA would
authorize distribution and sale through September 30, 2002, of any
existing stocks of cyanazine formulated end use products that were
released for shipment on or before December 31, 1999. It also would
authorize use of these products in accordance with the product labels
through December 31, 2002. DuPont would modify the labels of cyanazine
formulated end use products released for shipment by the registrant
after July 25, 1996, to specify the maximum application rates during
the phaseout and to inform the public of the existing stocks
provisions. It also would modify cyanazine labels to require use of
application equipment with enclosed cabs for applicators beginning in
1998. Cyanazine technical products released for shipment by DuPont
after July 25, 1996, would bear labels subjecting any end use products
made from those technical products to the terms and conditions
described in this paragraph. Finally, DuPont requested that EPA accept
the voluntary cancellation of all registered DuPont cyanazine products
effective on December 31, 1999. DuPont also waived any right to
challenge EPA's final action on the Special Review or the terms and
conditions upon EPA's final acceptance of the proposed amendments. On
August 2, 1995, EPA accepted DuPont's proposal to amend the cyanazine
registrations.
On November 8, 1995, EPA announced receipt of a request from Ciba
to voluntarily cancel its only product containing cyanazine (60 FR
56333) (4984-1). The cancellation order for Ciba's sole product
containing cyanazine was effective February 6, 1996.
After EPA initiated Special Review, Griffin Corporation
(``Griffin'') filed an application to register certain cyanazine
pesticide products and subsequently agreed to the same terms and
conditions of registration that were proposed by DuPont. EPA granted
Griffin's applications and issued conditional registrations subject to
those same terms and conditions.
On March 1, 1996, EPA issued a Notice of Preliminary Determination
to Terminate Special Review and a Notice of Receipt of Requests for
Voluntary Cancellation of cyanazine registrations (61 FR 8186) (5352-
6). In this Notice, EPA explained that it was proposing to terminate
the Special Review of cyanazine because, based upon the modified terms
and conditions of the cyanazine registrations, the use of cyanazine
will not cause any unreasonable adverse effects on the environment. The
complete terms and conditions to amend cyanazine registrations that
were agreed to by the registrants were provided in the Notice.
In the same Notice, EPA announced receipt of requests from DuPont
and Griffin to voluntarily cancel their registrations pursuant to
section 6(f) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. section 136d(f)). The requested voluntary
cancellations would take effect on December 31, 1999.
The cyanazine product registrations that are subject to the
modified terms and conditions of registrations as agreed to by DuPont
and Griffin, including voluntary cancellation effective on December 31,
1999, are listed below by registration number and product name.
------------------------------------------------------------------------
Registration No. Product Name
------------------------------------------------------------------------
352-470 DuPont Bladex (R)4L Herbicide
352-475 DuPont Cyanazine Technical
352-495 DuPont Bladex (R)90 DF
Herbicide
352-500 DuPont Extrazine (R)II 4L
Herbicide
352-577 DuPont Extrazine (R)II DF
Herbicide
1812-364 Griffin Cyanazine Technical
[[Page 39025]]
1812-365 Griffin Cynex DF
1812-366 Griffin Cynex 4L Herbicide
Liquid
1812-367 Griffin Cynex Extra 4L
1812-368 Griffin Cynex Extra DF
------------------------------------------------------------------------
B. Legal Background
1. Summary of Special Review Process. Special Review is a decision-
making process designed to help EPA determine whether the Agency should
initiate formal procedures, such as involuntary cancellation or
suspension of a pesticide registration or the imposition of modified
terms and conditions of registration because use of the pesticide may
cause unreasonable adverse effects on the environment (40 CFR
154.1(a)).
EPA announces its decision to initiate the process by publishing a
Notice of Special Review. EPA may initiate a Special Review if a
pesticide use under the existing terms and conditions of registration
meets or exceeds the risk criteria specified in the regulations at 40
CFR 154.7. In the initial Notice, EPA solicits comments concerning the
risks and benefits of the uses that are subject to Special Review (40
CFR 154.25).
In response to the Notice of Special Review, the public may submit
comments pertinent to whether the use of a pesticide product as
currently registered meets or exceeds the risk criteria as currently
registered; whether any additional restrictions on the use of the
product, in accordance with a pending application or amendment, would
cause it to meet or exceed the risk criteria; whether the risks caused
by use of the product are unreasonable; and what regulatory action EPA
should take (40 CFR 154.26).
The regulations governing Special Review contemplate that EPA may
terminate the process if the pesticides' registrants are willing and
able to voluntarily eliminate any unreasonable adverse effects without
formal proceedings by voluntarily modifying the terms and conditions of
registration or voluntarily cancelling registrations. Section 154.1(a)
of the regulations states that the issuance of a Notice of Special
Review means that the Agency expects to initiate a formal proceeding
unless ``the Agency's initial determination was erroneous, . . . the
risks can be reduced to acceptable levels without the need for formal
proceedings, or . . . the benefits of the pesticide's use outweigh the
risks.''
If EPA determines that the risks can be reduced to acceptable
levels because the registrants are able and willing to modify the terms
and conditions of registration, then it will issue a Notice of
Preliminary Decision to Terminate Special Review. This Notice explains
EPA's basis for concluding that the measures agreed to by the
registrants will reduce risks to an acceptable level and responds to
significant comments received in response to the initial Notice of
Special Review. It also solicits public comments on EPA's position to
terminate Special Review and its proposed resolution of risk concerns
(59 FR 12188; March 27, 1985).
One of the risk reduction measures that a registrant may agree to
is a voluntary cancellation under FIFRA section 6(f). This provision
authorizes EPA to cancel a registration based upon the request of the
registrant without regard for whether the pesticide poses an
unreasonable risk of adverse effects. Other possible risk reduction
measures that a registrant may agree to are modifications of the use of
the pesticide that will reduce risk to an acceptable level, such as
requiring the use of respirators or reducing the amount of pesticide
that may be used. Registrants generally agree to incorporate such
voluntary risk reduction measures into the terms and conditions of
their registration to insure future compliance.
Sometimes registrants are unable or unwilling to voluntarily amend
the existing terms and conditions of registration so that the products
in question do not cause unreasonable adverse effects. If this occurs,
the regulations contemplate that the Agency will issue a Notice of
Preliminary Determination to Terminate Special Review and, among other
things, will describe the regulatory measures that the Agency intends
to initiate following termination of the process (40 CFR 154.31).
After the close of the comment period for a Notice of Preliminary
Determination, EPA issues a Notice of Final Determination. This Notice
includes the Agency's final determination and a discussion of the
reasons for that determination, any comments submitted by the Secretary
of Agriculture or the Scientific Advisory Panel, any significant public
comments submitted in response to the Notice of Preliminary
Determination, and instructions to registrants, applicants for
registration, and other interested persons with respect to procedures
that will be used to implement the final determination (40 CFR 154.33).
Following termination of Special Review, the Agency may either
return the pesticide to the regular registration process or initiate
formal proceedings. These formal proceedings include cancellation under
FIFRA section 6(b), suspension under FIFRA section 6(c), denial of a
registration application under FIFRA section 3(c)(6), or change of
classification under FIFRA section 3(d)(2). A more detailed description
of the Special Review Process may be found at 40 CFR part 154 and 61 FR
8187-8.
2. Voluntary Cancellation Process. FIFRA section 6(f)(1)(D)
authorizes the Administrator to approve or deny a request for voluntary
cancellation (7 U.S.C. section 136d(f)(10(D)). Unlike an involuntary
cancellation under FIFRA section 6(b), FIFRA does not require the
Administrator to make a finding that use of the pesticide may generally
cause unreasonable adverse effects on the environment to approve a
voluntary cancellation request. If a registrant wishes to voluntarily
cancel its registration, it may do so at any time under section 6(f),
by submitting a request to EPA (7 U.S.C. section 136d(f)(1)(A)). The
statute also contains provisions governing the publication of a notice
of such a request which ensures that users and others will have
adequate notice of the voluntary cancellation and time to submit their
own applications to assume the registrations (7 U.S.C. section
136d(f)(1)). FIFRA does not require EPA to conduct a hearing on whether
a voluntary cancellation request should be granted.
II. Summary of Notice of Preliminary Determination
In the Preliminary Determination, EPA reviewed the risks and
benefits of phasing out and eventually cancelling cyanazine
registrations pursuant to the terms and conditions of registration
agreed to by DuPont and Griffin. It concluded that the phaseout and
cancellation will eventually reduce risk to zero when the product may
no longer be used. Prior to cancellation, EPA noted that progressive
restrictions on the maximum amount of cyanazine that may be applied per
acre, combined with closed cab requirements and depletion of existing
stocks will progressively reduce risk (61 FR at 8200).
EPA also discussed the benefits of cyanazine use under the terms
and conditions of the phaseout and cancellation. It determined that the
gradual phaseout will lessen the economic impact to growers who have
used cyanazine when compared to an immediate cancellation. The phaseout
should allow growers sufficient time to find suitable alternative weed
control strategies to replace cyanazine, causing
[[Page 39026]]
little disruption to agricultural production. The phaseout also makes
it unnecessary to recall and dispose of unused product because it
provides advance notice of the ultimate cancellation and prohibition of
use to distributors and growers.
Based upon the assessment of risks and benefits in light of the
terms and conditions agreed to by DuPont and Griffin, EPA concluded
that the use of cyanazine during the phaseout would not pose any
unreasonable adverse effects.
III. Response to Public Comments
A. Analysis Required by Special Review Regulations
Griffin, citing 40 CFR 154.1(a), asserts that after EPA initiates
Special Review it is prohibited from taking further steps to ``cancel
or alter a product registration if the record establishes that `the
Agency's initial determination was erroneous . . . or that the benefits
of the pesticide's use outweigh the risks.'''
The Agency disagrees with Griffin's characterization of this
Special Review regulation. The regulation, cited in part by the
commenter, reads:
The purpose of the Special Review process is to help the Agency
determine whether to initiate procedures to cancel, deny, or
reclassify registration of a pesticide product because uses of that
product may cause unreasonable adverse effects on the environment in
accordance with section 3(c)(6) and 6 of [FIFRA]. The process is
intended to ensure that the Agency assesses risks that may be posed
by pesticides and the benefits of use of those pesticides in an open
and responsive manner. The issuance of a Notice of Special Review
means that the Agency has determined that one or more uses of a
pesticide may pose significant risks and that, following completion
of the Special Review process, the Agency expects to initiate formal
proceedings seeking to cancel, deny, reclassify, or require
modifications to the registration of the product(s) in question
unless it has been shown during the Special Review that the Agency's
initial determination was erroneous, that the risks can be reduced
to acceptable levels without the need for formal proceedings, or
that the benefits of the pesticide's use outweigh the risks (40 CFR
154.1(a)).
This provision describes the actions that EPA believes may be
necessary after termination of Special Review depending upon the
circumstances. It does not establish mandatory procedures that restrict
the Agency's options once Special Review is initiated as the commenter
seems to suggest. Rather it describes possible steps that the Agency
may consider taking after it terminates Special Review.
The regulation describes the steps that EPA expects to initiate
after termination of Special Review as ``formal proceedings'' to
``cancel, deny, reclassify, or require modifications'' to product
registrations. The regulation contemplates that ``formal proceedings''
likely would not be appropriate if the Agency determines that one of
the following occurs: (1) The decision to initiate Special Review is
erroneous, (2) the risks cannot be reduced to acceptable levels without
a formal proceeding, or (3) the benefits outweigh the risks. Based upon
this language, it is clear that the term ``formal proceedings'' means
involuntary, EPA-initiated proceedings such as the issuance of a Notice
of Intent to Cancel under FIFRA section 6(b) or the required
modification of the terms and conditions of a registration and does not
include other measures that the registrants agree to such as voluntary
cancellations under FIFRA section 6(f) or voluntary modifications to
product registrations. If any one of the three circumstances specified
in the rule exists, then formal involuntary proceeding would be
unnecessary because the risk/benefit balance would not justify such an
action.
Griffin's assertion that the regulation prohibits EPA from taking
steps to cancel or alter a registration if the Agency's initial risk
determination is erroneous or if the benefits outweigh the risks would
produce an absurd result. Both the statute and the regulations
contemplate that registrants may address unreasonable risks by amending
their registrations to reduce risk or even by requesting voluntary
cancellation of their registrations. Griffin's interpretation would
effectively prevent EPA from accepting such risk reduction measures
once it has initiated Special Review and force it to initiate
unnecessary measures such as a FIFRA section 6(b) cancellation. Such an
interpretation of 154.1(a) is inconsistent with the meaning of the
regulation and with congressional intent underlying FIFRA's voluntary
cancellation provision.
EPA has determined that the risks posed by cyanazine can be reduced
to acceptable levels without formal proceedings because of the
voluntary cancellation and phaseout agreed to by both DuPont and
Griffin. As a result, it does not need to initiate formal cancellation
or other involuntary proceedings upon completion of the Special Review.
Instead, EPA will return the cyanazine registrations to the regular
registration process.
B. Applicability of Rulemaking Provisions of the Administrative
Procedure Act (APA)
Griffin claims that the Special Review process constitutes
rulemaking under the APA and that EPA must comply with the APA's notice
and comment requirements when it conducts a Special Review. It also
alleges that EPA violated APA rulemaking requirements in a number of
instances by failing to provide background information that was not
cited in any Special Review Notice and by failing to respond to
comments on various aspects of the Agency's risk assessment and on
alternative methods of addressing risks posed by cyanazine usage.
EPA has always taken the position that Special Review does not
constitute APA rulemaking but instead is an informal information
gathering mechanism for assessing whether the use of specific
pesticides causes unreasonable adverse effects on the environment based
upon the terms and conditions of registration. As noted in the
regulations, Special Review is designed to help EPA decide whether to
initiate a formal proceeding to cancel or reclassify an existing
registration or deny an application for a registration (40 CFR 154.1(a)).
The APA imposes notice-and-comment requirements only upon
``legislative'' rules. See generally Community Nutrition Institute v.
Young, 818 F.2d 943 (D.C. Cir. 1987). Legislative rules generally
``create law,'' Gibson Wine Co. v. Synder, 194 F.2d 329, 331 (D.C. Cir.
1952) and ``grant rights, impose obligations, or produce other
significant effects on private interests.'' Batterton v. Marshall, 648
F.2d 694, 701-02 (D.C. Cir.1980); see also American Hospital Ass'n v.
Bowen, 834 F.2d 1037, 1045 (D.C. Cir. 1987). Courts also give some
deference to an agency's characterization of its statement although
that characterization is not determinative. Community Nutrition, 818
F.2d at 946.
Based upon these standards, it is clear that the Special Review
process is not legislative rulemaking. Termination of Special Review
does not itself grant a new right or create a new legal obligation.
Following the termination of Special Review, EPA may affect private
rights but only by taking further steps to initiate an involuntary
adjudicative process or by implementing voluntary risk reduction
measures. Accordingly, the Special Review process does not create a new
law and thus, is not a legislative rule requiring notice and comment.
[[Page 39027]]
The Ninth Circuit rejected an argument similar to that proposed by
Griffin in a challenge to EPA's consideration of permit applications
for storm water discharges under the Clean Water Act. Natural Resources
Defense Council, Inc. v. EPA, 966 F.2d 1292, 1309 (9th Cir. 1992). NRDC
argued that EPA's decision to approve or disapprove a group application
was a rule of ``general applicability'' and thus subject to APA's
notice and comment requirements. Id. The court rejected this argument.
It first observed that ``rulemaking ordinarily involves `broad
judgments, legislative in nature rather than the resolution of a
particular dispute of facts.''' Id. (citation omitted). The court held
that EPA's decision on the permit application was ``essentially a
factual determination,'' not rulemaking, because it focused on a
specific factual question regarding whether the application adequately
identified a second group that would be subject to more extensive data
requirements. Id. The court also explicitly noted that EPA was not
engaged in rulemaking even though the decision on the permit
applications might affect a large number of applicants.
The principal case that Griffin relies upon, Waste Management, Inc.
v. EPA, 669 F. Supp. 536 (D.D.C. 1987), does not support the conclusion
that Special Review constitutes rulemaking. In Waste Management, EPA
was engaged in issuing a regulation governing ocean incineration. EPA
decided to temporarily freeze all applications for ocean incineration
permits until the final regulation was promulgated but it did not make
any specific factual determinations regarding specific permit
applications. The court held that this temporary freeze constituted APA
rulemaking.
In contrast to the circumstances in Waste Management, EPA is
utilizing the cyanazine Special Review to analyze the risks and
benefits of cyanazine under the terms and conditions of registration.
This analysis is preparatory either to initiating proceedings to
address any unreasonable risk or implementing voluntary risk reduction
measures and does not itself impose any limitations upon existing
registrations. See, 40 CFR 154.1(a). Such preliminary factual
determinations are not rulemaking under the APA.
C. Risk/Benefit Comments Beyond Scope of Agency Determination
1. Scope of Agency determination. A number of comments address
matters beyond those at issue in the Agency's Final Determination. The
regulations governing Special Review do not require the Agency to
consider such immaterial comments.
As EPA stated in the Notice of Preliminary Determination, the issue
is whether the modified terms and conditions agreed to by the
registrants ``will eliminate any unreasonable adverse effects posed by
cyanazine registrations'' (61 FR at 8200). Where the registrants agree
to modify the terms and conditions of registration, the controlling
issue is whether the use of cyanazine pursuant to the modifications
poses any unreasonable adverse effects. If EPA determines that use
pursuant to the modified registrations continues to cause unreasonable
adverse effects despite the modifications, then it terminates Special
Review and initiates other involuntary mechanisms to address the risk.
On the other hand, if EPA determines that the use pursuant to the
modified registrations eliminates any unreasonable adverse effects,
then additional involuntary proceedings are unnecessary and the Agency
would terminate Special Review and return the registrations to the
registration process.
The regulations specifically require EPA to respond in the Notice
of Final Determination to ``significant public comments submitted on
the Notice of Preliminary Determination'' (40 CFR 154.33(a)(3)).
Significant comments concern a matter that is at issue in the
proceeding or that is probative of a matter at issue; in other words,
those that raise matters material to EPA's Preliminary Determination.
At this point, the only issue is whether the modified terms and
conditions agreed to by the registrants will eliminate any unreasonable
adverse effects caused by the use of the products and the Agency will
respond only to comments that address that issue.
This interpretation of Sec. 154.33(a)(3), which governs responses
to significant comments, is consistent with other Special Review
regulations. As discussed in Unit III.A. of this document, the
regulations contemplate that EPA will likely terminate Special Review
and not impose any involuntary actions upon a pesticide registration if
the registrant agrees to modify the terms and conditions of
registration to reduce risk to an acceptable level.
Some of the comments indicate a fundamental misunderstanding of the
nature of Special Review. EPA review focuses on the risks and benefits
of a pesticide that result from the use of the pesticide under the
terms and conditions of the existing registrations. At this point, the
registrants have agreed to amend the terms and conditions that control
the use of the pesticide and EPA has accepted those amendments. Terms
and conditions of registration that governed the use of cyanazine
before EPA accepted the amendments no longer exist and therefore have
no effect upon the risks and benefits associated with the use of
cyanazine. Similarly, hypothetical alternative terms and conditions of
registration suggested by commenters do not address the issue of the
risks and benefits associated with the use of cyanazine under the
modified terms and conditions agreed to by the registrants. Thus
comments pertaining to previous terms and conditions of registration or
to hypothetical alternative arrangements, and the risks or benefits
associated with such terms and conditions, are immaterial to the
Agency's decision to terminate the cyanazine Special Review.
2. Specific comments. Some commenters focus on issues that EPA
raised in the initial Notice of Special Review and that concern the
risks or benefits of cyanazine usage under the old terms and conditions
of registrations that existed at the time Special Review was initiated.
These issues do not address whether cyanazine usage poses any
unreasonable adverse effects under the new terms and conditions agreed
to by the registrants in 1995. For example, Griffin comments that EPA
erroneously decided to initiate Special Review based upon a flawed risk
assessment and provides a lengthy critique of that initial risk
assessment. While such comments were material to the Agency's initial
Notice of Special Review, they do not concern the issue now before the
Agency - whether cyanazine poses any unreasonable adverse effects under
the new terms and conditions of registration.
Griffin and other commenters claim that the benefits of cyanazine
use may be higher than EPA first estimated in the Notice of Special
Review, asserting that the Agency did not calculate the relative costs
of cyanazine and alternative pesticides correctly and did not recognize
that cyanazine is ``significantly superior'' to alternatives. These
claims are immaterial to the Agency's decision to terminate Special
Review. EPA has decided to terminate the process because the benefits
of continued use under the new terms and conditions of registration
outweigh the risks. At this point it is inconsequential whether the
benefits outweigh the risks by a greater margin than EPA earlier
calculated because greater benefits would only provide more support for
the decision to terminate Special Review without initiating formal
proceedings.
[[Page 39028]]
Some additional commenters discuss alternative terms and conditions
of registrations that might yield an acceptable risk/benefit balance.
At this point, however, such alternatives are immaterial because the
agreed upon modifications already insure that cyanazine usage does not
pose any unreasonable adverse effects. Given the registrants' agreement
to these modifications, it is unnecessary for EPA to address these issues.
The comments directed towards the old terms and conditions of
cyanazine registration appear to be directed at the decision of the
registrants to voluntarily amend their cyanazine registrations rather
than the Agency's decision to terminate Special Review. The termination
of Special Review will not prevent interested persons from applying for
registrations with terms and conditions different from those currently
in effect. Such an application may be filed at any time, even after the
current registrations are cancelled. If the application otherwise
fulfills the prerequisites for registration, the Agency would consider
the risks and benefits of use under the proposed terms and conditions
and pursuant to FIFRA and the regulation including 40 CFR 154.35. An
applicant may contest the decision to deny an application as specified
in FIFRA section 3(c)(6).
D. Response to Material Risk/Benefit Comments
Griffin also addresses the economic impact of the phaseout and
voluntary cancellations and concludes that ``EPA's conclusions
concerning the economic impact of the phase-out and registration
cancellations likely are correct.'' In reaching this conclusion, the
commenter relied in part upon the data that EPA used to determine
cyanazine application rates as summarized in Table 5 of the Preliminary
Determination. It also utilized additional application rate data that
it obtained independently.
Based upon the information underlying Table 5, EPA agrees that its
conclusions with respect to the economic impact of the modified terms
and conditions of registration are correct. The Agency has not analyzed
the additional data utilized by Griffin because the comment states that
it supports rather than contradicts the Agency's preliminary economic
determination.
E. Secretary of Agriculture and Scientific Advisory Panel
The Special Review regulations require the Agency to respond to any
comments submitted by the Secretary of Agriculture or the Scientific
Advisory Panel (40 CFR 154.33(a)(2)) but neither submitted comments.
The regulations require EPA to refer proposals to initiate involuntary
proceedings such as a FIFRA section 6(b) cancellation to those bodies.
The regulations, however, do not impose such a requirement where, as
here, the registrants have accepted voluntary modifications of the
terms and conditions of their registrations followed by voluntary
cancellations.
IV. Decision Regarding Special Review
EPA has decided to terminate the cyanazine Special Review. This
decision is based upon EPA's determination that the use of cyanazine on
cotton, field and sweet corn, and sorghum in accordance with the
voluntary cancellation and phaseout agreed to by the cyanazine
registrants does not cause any unreasonable adverse effects.
The new terms and conditions of registration will gradually lower
and then eliminate the risks caused by cyanazine. Maximum application
rates will be reduced in 1997, 1998, and 1999, and applicators will be
required to use closed cab equipment beginning in 1998. Risks will
eventually be reduced to zero when the use prohibition takes effect in
2002. The requirement that cyanazine applicators use closed cabs to
apply the pesticide beginning in 1998 also will reduce occupational
exposure to the substance. While there will be some exposure to
cyanazine during the phaseout, exposure and thus, risks will decline as
application rates drop and existing stocks are depleted.
The phaseout of cyanazine will lessen the economic impact to
growers who have used cyanazine to control weeds. The phaseout should
allow growers sufficient time to replace cyanazine with alternative
weed control practices so that there will be little disruption to
agricultural production. Another likely benefit of the incremental
phaseout is depletion of existing stocks of cyanazine so there will be
little unused product to recall and dispose of after the cancellations
take effect. Furthermore, the costs, time and uncertainties associated
with an involuntary cancellation proceeding are avoided.
For all these reasons, EPA has decided that the implementation of
the terms and conditions of the cyanazine voluntary cancellation and
phaseout will prevent any unreasonable adverse effects which might
otherwise be caused by the use of cyanazine on corn, cotton, and sorghum.
V. Decision Regarding Voluntary Cancellation and Use of Existing Stocks
A. Voluntary Cancellation/Cancellation Order
EPA accepts the voluntary cancellation of all cyanazine products as
requested by the cyanazine registrants in accordance with FIFRA section
6(f). Both of the cyanazine registrants, DuPont and Griffin, have
requested voluntary cancellations as terms and conditions of their
registrations. EPA has not received any applications to assume the
existing registrations of cyanazine under the new terms and conditions
of registration. Consequently, EPA accepts the voluntary cancellations
effective December 31, 1999 and orders the cancellations to take effect
on January 1, 2000. Those products for which EPA accepts the voluntary
cancellation are listed by product registration number and product name
in Unit I.A. of this Notice. When the voluntary cancellations take
effect on December 31, 1999, the Agency will issue an order confirming
the cancellations.
B. Existing Stocks
For any cyanazine formulated end use products that are released for
shipment by a registrant on or before December 31, 1999, EPA authorizes
the continued sale and distribution of such products in the channels of
trade in accordance with their labels through September 30, 2002. EPA
authorizes the continued use of such existing stocks in accordance with
their labels through December 31, 2002. EPA prohibits the use of
cyanazine products after December 31, 2002. EPA is not establishing any
existing stocks provisions for technical cyanazine products (DuPont
Registration Number 352-475 and Griffin Registration Number 1812-364);
however, any technical or formulated end use cyanazine product may be
exported pursuant to FIFRA sections 3 and 17.
VI. Availability of Public Docket
EPA established a public docket, OPP-30000/60, for the cyanazine
Special Review. This public docket includes this Notice and any other
Notices associated with the cyanazine Special Review and EPA's decision
to terminate the cyanazine Special Review. This docket also contains
documents not considered Confidential Business Information that are
pertinent to the cyanazine Special Review and copies of written
comments or other material submitted to EPA by any person outside the
government in response to the cyanazine Special Review. The docket is
available for inspection from 8 a.m. to
[[Page 39029]]
4:30 p.m., Monday through Friday, excluding legal holidays. The public
docket is located in Rm. 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 22202.
List of Subjects
Environmental protection.
Dated: July 17, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pollution and Toxic Substances.
[FR Doc. 96-18921 Filed 7-24-96; 8:45 am]
BILLING CODE 6560-50-F