[Federal Register Volume 59, Number 153 (Wednesday, August 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19293]


[[Page Unknown]]

[Federal Register: August 10, 1994]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34058; FRL-4864-7]

 

Public Involvement in Significant Risk Reduction Decisions on 
Registered Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice describes the Agency's general policy to provide 
opportunities for public involvement before reaching final significant 
risk reduction decisions on registered pesticides. Through this notice, 
the Agency is soliciting comments and suggestions from interested 
parties concerning the mechanisms used for public involvement prior to 
the Agency reaching such decisions, particularly those reached through 
the Special Review process and negotiated settlement agreements.

DATES: Written comments, identified by the document control number 
``OPP-50787,'' must be received on or before October 11, 1994.

ADDRESSES: Comments should be 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. Hand delivered items should be delivered to: 
Public Response and Program Resources Branch, Field Operations 
Division, Office of Pesticide Programs, Environmental Protection 
Agency, Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA. Office hours are from 8 a.m. to 4:30p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph E. Bailey, Special 
Review and Reregistration Division (7508W), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Special Review Branch, Crystal Station #1, 3rd Floor, 
Room WF32G, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 
308-8173.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), EPA is given the responsibility of regulating the manufacture, 
sale, and use of pesticides to ensure that there are no unreasonable 
adverse effects to human health or the environment as a result of the 
use of a pesticide. Regulatory decisions that carry out this 
responsibility are reached by evaluating the risks and benefits 
associated with the pesticide's use, as well as with alternative 
pesticides and pest control methods. This process determines what 
degree of risk is reasonable while taking into consideration the 
economic and social benefits gained from the pesticide, ensuring that 
the risks do not outweigh the benefits. The Agency has several 
mechanisms in place to effect this balance if the results of the risk 
and benefit evaluations indicate that unreasonable adverse effects are 
likely from the pesticide's use and that regulatory action is 
warranted. Each of these mechanisms has advantages and disadvantages 
that range from the length of time required to reach the regulatory 
decision, the amount of Agency resources necessary, to the degree the 
public is involved.

II. Background

    When the Agency has reason to believe that the use of a currently 
registered pesticide may result in unreasonable adverse effects to 
human health or the environment, a structured review of the pesticide 
of concern may be carried out through the formal Special Review 
process. The risk criteria initiating this review process and the 
regulations governing it are set forth in 40 CFR part 154. The formal 
Special Review process as set forth in these regulations provides the 
opportunity for public input through the solicitation of comments at 
two distinct stages of the review: The formal announcement of 
initiation of the Special Review (Position Document 1) and the 
announcement of the Agency's preliminary decision (Position Document 2/
3). The Agency considers all significant comments before reaching a 
final decision.
    The formal Special Review process can prove to be resource 
intensive and time-consuming due in part to its discrete stages and the 
opportunities provided for public comment. The Government Accounting 
Office (GAO) issued reports in 1980 and 1986 concluding that the Office 
of Pesticide Programs (OPP) was not completing reviews of potentially 
hazardous pesticides in a timely manner. Similarly, in 1984, the House 
of Representatives Committee on Government Operations found that the 
Special Review process was not quickly reaching decisions on potential 
risks that were found to be associated with certain pesticide uses. 
Recently, the Agency's Office of Inspector General (OIG) conducted an 
audit of the Special Review process and presented its results in a 
final report dated July 22, 1993. This report, while critical of some 
aspects of the Special Review process and the time involved in 
completing the reviews, also raised concerns about using negotiated 
settlement agreements to achieve pesticide risk reduction rather than 
initiating new Special Reviews. The OIG concluded that negotiated 
settlement agreements do achieve risk reduction more quickly than the 
formal Special Review process, but was concerned that negotiated 
decisions were made between the Agency and pesticide registrants at the 
expense of public involvement. The report also reflected concern that 
the Agency does not notify the public of risk concerns while a decision 
is being made whether or not to formally initiate a Special Review; 
i.e., during the pre-Special Review (that period of time after a 
preliminary (Grassley-Allen) notification is sent to the registrants 
but before issuance of the public announcement (Position Document 1) 
initiating the Special Review).
    Other mechanisms are available to achieve pesticide risk reduction 
at a more accelerated pace than is afforded through a normal Special 
Review. They include the issuance of a Position Document 1/2/3 which 
combines the first two position documents issued in the formal Special 
Review process into one. This is used when enough information is 
available at the outset of a Special Review to fully assess the risks 
and benefits and reach a proposed decision. Additional mechanisms 
include issuing Notices of Intent to Cancel (NOIC), Suspension Orders, 
or Emergency Suspension Orders as provided under FIFRA section 6. These 
mechanisms can be used to remove pesticides from the market that pose 
significant risks or imminent hazards.
    Although the Agency has used all of these different means in the 
past to effect pesticide risk reduction, recently, negotiated 
settlement agreements have been used more and more frequently. Through 
the process of negotiation, the Agency and the registrant(s) reach a 
mutual agreement that legally commits the registrant(s) to specific 
measures that will reduce potential risks associated with a pesticide's 
use. Such measures typically include modifying the terms of 
registration by cancellation of uses, changing use patterns, changing 
application methods, or altering the manufacturing formula. The same 
scientific principles and weight-of-evidence information that govern 
the decisions made during a formal Special Review also apply to 
negotiated settlements; that is, carefully analyzing risks, benefits, 
and alternative pest control methods to ensure that the risk reduction 
measures desired will not result in risks that outweigh the benefits or 
that risks are reduced to the greatest extent practical while data are 
being generated to better understand the risks associated with the use 
of the pesticide. The agreements also make every effort to ensure that 
a pesticide use will not shift to an alternative pesticide or pest 
control method of equal or greater risk concern or result in the 
trading of one risk for another. By using the same analyses as those 
used in a formal Special Review, the public and the environment should 
be afforded the same level of protection in a more timely fashion. The 
main difference is that the Special Review process formally provides 
opportunities for public involvement before reaching risk reduction 
decisions.
    In all negotiated settlement agreements, the Agency reserves the 
right to take additional regulatory action if evidence arises that 
warrants it. Similarly, the Agency can remove restrictions if 
additional data are reviewed later that indicate risks are of less 
concern than previously thought. Negotiated settlement agreements, 
however, should not be viewed as an exclusive mechanism to achieve a 
final risk reduction decision. They may be used to reach an ultimate 
goal of the Agency such as use cancellation or use reduction, or they 
may be used as an interim measure to reduce risks while additional data 
are being generated, or during any stage of an ongoing Special Review 
prior to the Agency making its final decision. Although the Agency has 
been criticized for neglecting to include affected constituency groups 
(e.g., users and public interest groups) in risk reduction decisions 
made through negotiated settlement agreements and for not making the 
general public aware of risk concerns for pesticides being considered 
for the formal Special Review process, several steps already have been 
taken to open up the decision-making process to the public whenever 
possible. Specific examples of how the Agency has provided for public 
involvement in recent negotiated settlement agreements are provided 
below.
    1. Parathion. In September 1991, due to concerns of acute 
poisonings to workers exposed to parathion, the Agency reached a 
negotiated settlement agreement with the registrants whereby all but 
nine uses of parathion were voluntarily canceled. The Agency held 
public hearings in December 1992 to solicit public involvement and gain 
additional information on the risks and benefits of the remaining nine 
uses. These hearings were held in Amarillo, Texas; Lincoln, Nebraska; 
and Baltimore, Maryland and were announced in the Federal Register to 
encourage all interested parties to participate. The Agency also polled 
State and regional offices for advice and input.
    2. 2,4-D. In June 1992, in an effort to reduce the amount of 
exposure to persons applying 2,4-D and therefore reduce potential 
risks, the Agency met with the 2,4-D Task Force and requested that they 
include end-user input in the development of such measures. Also, 
through meetings and telephone conversations, the Agency actively 
included distributors and end-users to help develop effective and fair 
exposure reduction measures.
    3. Granular carbofuran. According to 40 CFR 154.35(c), the Agency 
must publish a notice in the Federal Register to modify an earlier 
determination in a way that might increase a risk that was the subject 
of a Special Review. During the final stages of the Special Review of 
granular carbofuran, the Agency negotiated a settlement agreement with 
the registrants to phase out most uses. In order to extend the 
registration for the use of carbofuran on rice, the Agency formally 
requested public comment as required under 40 CFR 154.35(c). The denial 
of extensions of registrations for two other uses, corn and sorghum, 
did not require such request for comment. The Agency, however, 
announced in the Federal Register its decision to deny extension of the 
registration for corn and sorghum uses and allowed the opportunity for 
comment from affected individuals or groups.
    4. Azinphos-methyl. Due to its concerns regarding the hazards 
azinphos-methyl posed to fish from use on sugarcane in Louisiana, the 
Agency reached an agreement with the registrants to amend their 
registrations in April 1993. The agreement, including prescription use, 
was the result of a cooperative effort between the Agency, Louisiana 
State officials, and the pesticide registrants. Through the use of 
public workshops held in Louisiana to collect additional information 
about azinphos-methyl use and alternative pesticides, the Agency 
advanced the use of negotiated settlement agreements by actively 
soliciting public input that contributed to the decision-making 
process. The workshops were announced in the Federal Register and 
participation of all interested parties was encouraged.
    Furthermore, in order to keep the public better informed of its 
risk concerns, the Agency has, as a matter of general policy, made 
available to the public those dockets established for pre-Special 
Review chemicals which have had private notifications issued for 6 
months but have not yet had a Special Review formally initiated. The 
Agency will continue this procedure. In addition, the Agency will 
announce those Special Review and pre-Special Review chemicals for 
which a public docket is available in the January edition of the 
quarterly Pesticide Reregistration Progress Report. Also, OPP's 
``Status of Pesticides in Reregistration and Special Review'' (Rainbow 
Report) provides a comprehensive status of all chemicals currently 
undergoing reregistration and Special Review. To receive copies of 
these reports or to be added to the mailing list, please write or fax 
the following address: U.S. EPA, NCEPI, P.O. Box 42419, Cincinnati, OH 
45242-0419, Telephone (513) 891-6561, Fax (513) 891-6685.
    Mechanisms that may provide opportunities for public input that the 
Agency has not frequently used but will consider in the future, include 
the following:
     Holding public hearings provided under FIFRA section 
6(b)(2). This section of FIFRA allows the Agency to issue a notice to 
hold hearings to determine whether or not a registration should be 
canceled or its classification changed and ``such notice shall be sent 
to the registrant and made public.''
     Requesting additional information and views from 
interested parties, particularly users, user associations and public 
interest groups, through solicitation of comments and notification of 
public hearings provided under FIFRA section 21(b).
     Publishing the Agency's risk concern and proposed 
regulatory action for a particular pesticide in the Federal Register, 
soliciting public comment. In fact, the Administrative Conference of 
the United States recently adopted Recommendation 93-5 concerning 
Procedures for Regulation of Pesticides. One of its final 
recommendations was that EPA provide public notification of pesticide 
risk concerns once negotiations begin, publicize the availability of a 
public docket, the proposed settlement and establish a ``compliance 
docket'' to address the effectiveness of the mitigated measures 
formally adopted. This recommendation was published in the Federal 
Register of February 1, 1994 (59 FR 4675).
    The Agency is committed to the responsibilities set forth in FIFRA 
and views pesticide risk reduction as an evolving process where 
flexibility is a key element for successfully reducing risk posed by 
pesticides. For this reason, the Agency feels that having the option of 
several mechanisms to achieve risk reduction provides for effective 
strategies that suit the varied situations that may present themselves. 
Each of the options lends itself to particular circumstances when other 
risk reduction mechanisms would prove less effective; therefore, the 
Agency will continue to consider all of the options available to 
promote safe and beneficial pesticide use.

III. General Policy to Provide for Public Involvement

    It is the Agency's responsibility to investigate all registered 
pesticides thought to cause unreasonable adverse effects to human 
health or the environment and to reduce those risks to levels that the 
Agency feels are reasonable while considering the benefits of use. It 
is the Agency's goal to reduce significant risks as quickly as 
possible, considering all aspects of the chemical and utilizing the 
most efficient and effective regulatory option(s) available. In cases 
where negotiated settlement agreements are appropriate, it will be the 
Agency's general policy to provide opportunity for public involvement, 
whenever possible. The Agency understands the importance of public 
input in reaching regulatory decisions, especially input from grower 
and user groups closely associated with a particular pesticide of 
concern who may provide useful risk and benefit information that the 
Agency would find helpful in reducing risks while not significantly 
reducing the efficacy of the pesticide. Other critical information that 
could be obtained through public input and that the Agency views as 
essential to making effective decisions includes human or environmental 
incident data held by end-user groups or other environmental 
organizations. The Agency will continue to consider those mechanisms 
used in the past to encourage public involvement and will maintain an 
openness for innovative approaches that will allow for greater public 
involvement in negotiated settlement agreements.

IV. Comments

    The Agency is requesting comments and suggestions on its existing 
or proposed means to acquire public input that can be used to enhance 
our risk/benefit analyses and the resulting regulatory decisions. The 
Agency is also seeking comment on the advantages and disadvantages of 
having affected or interested parties involved in negotiations.

    Dated: July 29, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 94-19293 Filed 8-9-94; 8:45 am]
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