[Federal Register Volume 66, Number 229 (Wednesday, November 28, 2001)]
[Notices]
[Pages 59425-59427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29557]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-34240; FRL-6811-8]


Amendment to the Rodenticide Cluster and Zinc Phosphide 
Reregistration Eligibility Decision (RED) Documents

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The August 1998, Reregistration Eligibility Decision (RED) 
documents issued for the rodenticide cluster (brodifacoum, 
bromadiolone, bromethalin, chlorophacinone, diphacinone, and pival) and 
zinc phosphide outlined requirements to lessen the probability and 
severity of exposure to children. The RED established short-term risk 
mitigation including the incorporation of a bittering agent and an 
indicator dye in formulations to reduce accidental exposures to 
children and pets. In addition, the RED established the Rodenticide 
Stakeholder Workgroup (RSW) to develop long-term risk mitigation 
measures. On February 5, 2001, after extensive discussions, meetings, 
and recommendations from the RSW, the Agency came to a mutual agreement 
with the rodenticide registrants to rescind the bittering agent and 
indicator dye requirements from the RED. This decision, which amends 
the Rodenticide Cluster and Zinc Phosphide RED, is summarized below.

DATES: Comments, identified by docket control number OPP-34240, must be 
received on or before December 28, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative, that you identify docket control 
number OPP-34240 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: John Pates, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8195; fax number: 
(703) 308-7042; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to companies that formulate rodenticides for 
use by certified personnel and the general public. Since other entities 
may also be interested, the Agency has not attempted to describe all 
the specific entities that may be affected by this action. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

How Can I Get Additional Information, Including Copies of this Document 
and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet home page at http://www.epa.gov/. 
To access this document, on the home page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents. You can also go directly to the Federal Register listings at 
http://www.epa.gov/fedrgstr/. In addition, related information can be 
accessed at: http://www.epa.gov/pesticides.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-34240. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are

[[Page 59426]]

physically located in the docket, as well as, the documents that are 
referenced in those documents. The public version of the official 
record does not include any information claimed as CBI. The public 
version of the official record, which includes printed, paper versions 
of any electronic comments submitted during an applicable comment 
period, is available for inspection in the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2 1921 
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The PIRIB telephone number is 
(703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative, that 
you identify docket control number OPP-34240, in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-34240. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Action is the Agency Taking?

    In August 1998, EPA issued two reregistration eligibility decision 
(RED) documents on seven rodenticide active ingredients. The 
Rodenticide Cluster RED included brodifacoum, bromadiolone, 
bromethalin, chlorophacinone, diphacinone, and pival. One stand-alone 
RED covered the active ingredient zinc phosphide. As a group, the seven 
active ingredients are registered for rodent control in both 
agricultural and residential settings. In these decision documents, EPA 
found the seven rodenticides eligible for reregistration, provided 
certain modifications were made to the terms and conditions of 
registration and use. The REDs proposed registration modifications and 
risk mitigation measures aimed at minimizing the potential risk to 
wildlife, non-target animals and humans, particularly children. Some of 
these modifications related to the finding that the use of these 
compounds in the residential setting was responsible for a 
disproportionate number of exposures to children (<6 years old). Over a 
2-year period, the American Association of Poison Control Centers 
(AAPCC) collected data on over 18,000 exposures cases involving such 
young children.
    Initial concerns centered around exposure to children in the 
residential setting. The Agency, recognizing the important public 
health benefits of rodenticides, pursued ways of minimizing potential 
exposure to children. In order to mitigate the risk from the use of 
rodenticides and maintain the benefits, the Agency developed a two-
phased approach. Phase one centered on short-term risk mitigation 
measures, namely, the incorporation of a bittering agent and indicator 
dye in rodenticide formulations. Another requirement for registrants 
was to submit to the Agency annual reports on incidents of exposure. It 
was perceived that this information would enable the Agency to 
determine whether the imposed risk mitigation measures were reducing 
exposures to humans, particularly children. Phase two involved 
formation of a stakeholder group (the RSW) whose task was to find 
technologies or other measures to preclude such incidents from 
occurring in the future.
    The RSW was formed in 1999 as a subcommittee under the federally-
chartered advisory body, the Pesticide Program Dialogue Committee 
(PPDC), and met 5 times over an 8-month period in 1999. In forming the 
RSW, EPA's goal was to generate a stakeholder process that would 
explore creative ways of improving the management and/or regulation of 
rodenticides labeled for use in the home. The RSW was to consider 
evidence of the problem and develop potential measures to reduce 
exposures involving young children while being mindful of the following 
factors: Public health benefits of rodenticides; avoiding the creation 
or aggravation of other human health ``hazards'' equity among those who 
bear the cost and regulatory burden; and considering the overall 
economy and efficacy of the recommendations.
    The Rodenticide Cluster and Zinc Phosphide REDs concluded that the 
rodenticide bait would not be eligible

[[Page 59427]]

for reregistration without including an indicator dye and bittering 
agent into the formulations of all rodenticide baits. These indicator 
dyes were expected to show whether a child had come into contact with 
the bait by leaving a stain on a child's mouth or hands. By staining 
the hands, mouth, etc., of an exposed child, EPA believed that such an 
indicator dye would confirm whether a child ingested or handled any 
rodenticide bait. The recommendation of the RSW was to drop this 
requirement from the RED due to the lack of suitable dye. Other issues 
of concern included: (1) There are no data on indicator dyes as an 
adequate marker; (2) the dye's effect on the overall efficacy of the 
product; (3) potential cost of new efficacy testing; (4) distinguishing 
between stains on a child from food products and stains from indicator 
dyes; (5) finding a dye that was temporary; and (6) contending with 
inevitable property damage resulting from contacted surfaces. Some 
members of the RSW felt that if technology was available, indicator 
dyes might have merit in managing potential exposure cases. Additional 
research and development, however, is needed before implementing such a 
requirement.
    The REDs also concluded that a bittering agent be incorporated into 
the formulations of all rodenticide baits with the intention of 
minimizing the amount of bait accidentally ingested. In theory, a 
bittering agent would prevent a child from taking more than one 
mouthful, thereby possibly limiting the magnitude and severity of the 
exposure. The RSW recommended dropping the bittering agents as a 
mandatory requirement. Rodents have the ability to taste bittering 
agents raising the potential for bait acceptance problems. RSW members 
associated with urban rat control programs strongly believed that 
bittering agents adversely affect the efficacy of rodenticide baits. 
Another point of contention was EPA's reluctance to allow registrants 
of products containing bittering agents to make representations on the 
labeling about the bittering agent as a safety feature. Federal 
regulations prohibit making safety claims on pesticide labeling. (See 
40 CFR 156.10(a)(5)(ix)). Also, inclusion of the bittering agent does 
not make the bait less toxic nor does it provide absolute protection 
for children.
    While the RSW recommended dropping indicator dyes and bittering 
agents as mandatory requirements, members also recommended that EPA 
allow industry to retain the option of including such ingredients in 
rodenticide bait products on a voluntary basis.
    Therefore, based on the findings presented to the PPDC by the RSW, 
EPA has determined that the rodenticide bait products are eligible for 
reregistration without indicator dyes and bittering agents. Although 
indicator dyes and bittering agents may not be necessary in all cases, 
EPA supports voluntary incorporation of these ingredients in 
rodenticide formulations.

B. Next Steps

    EPA plans to move forward with a series of steps to implement the 
other recommendations of the RSW. These include modifying label 
language for rodenticide products, examining the potential value of 
reducing the amount of bait per placement to reduce a child's potential 
maximum exposure, considering the development of a website with 
educational and safety information for consumers, and improving the 
collection and quality of data on exposures. Additionally, as discussed 
in the 1998 Rodenticide Cluster RED, EPA is evaluating the comparative 
risk of secondary poisoning to birds and nontarget mammals associated 
with rodenticide products. Included in this comparative ecological risk 
assessment are three second-generation anticoagulants, three first-
generation anticoagulants, and three non-anticoagulants. Through the 
findings of this comparative risk analysis, EPA hopes to bring forth a 
better understanding of the major differences in the potential risks of 
these compounds and their overall implications to birds and non-target 
mammals as well as develop any necessary risk mitigation measures that 
may be warranted to address these risks.
    EPA has received comments and recommendations from stakeholders 
regarding label improvement. The Agency is in the process of reviewing 
these recommendations and expects to propose a strategy for label 
improvements within the next several months. EPA is also considering 
efficacy and other information to determine the feasibility of reducing 
the maximum quantity of bait per placement, and is also considering the 
content and presentation of consumer safety information that might be 
appropriate for a rodenticide website. The Agency has also obtained 
funds to purchase annual poisoning incident data directly from the 
American Association of Poison Control Centers (AAPCC). EPA will review 
these and other data, such as those submitted to the Agency under FIFRA 
section 6(a)(2), to explore the underlying causes of exposures, as well 
as, the adequacy of actions taken to reduce both the frequency and 
severity of incidents. The Agency will continue to monitor incident 
data in an effort to maintain awareness of reported exposures and to 
reduce the overall number of exposures to children.
    Finally, the Agency plans to amend the 1998 RED to address the 
findings of the comparative ecological risk assessment, which is now 
near completion. EPA plans to use a public participation process to 
ensure transparency and stakeholder involvement in the development of 
the risk assessment and risk management documents and decisions. This 
will parallel the process currently in use for tolerance reassessment 
and reregistration of other pesticides, and will involve an error-only 
review by the registrants and federal agencies, public comment on the 
risk assessment and risk characterization, and public comment on EPA's 
risk-reduction proposal prior to EPA's final risk management decision. 
This process is expected to be completed in FY-2002.
    Registrants are reminded that the date of publication of this 
Federal Register Notice will start the 8-month timetable for data 
submission as required per the Product Data Call-In (PDCI). Other time 
frames will also be imposed as required per the Generic Data Call-In as 
set forth in the Rodenticide Cluster RED; both of which had been 
temporarily put on hold, due to the RSW process.

C. What is the Agency's Authority for this Action?

    EPA's legal authority for the RED documents issued for the 
rodenticide cluster (brodifacoum, bromadiolone, bromethalin, 
chlorophacinone, diphacinone, and pival) and zinc phosphide comes from 
section 4(g)(2)(A) of FIFRA. Section 4(g)(2)(A) directs that, after 
submission of all data concerning a pesticide active ingredient, ``the 
Administrator shall determine whether pesticides containing such active 
ingredient are eligible for reregistration,'' before calling in 
product-specific data on individual end-use products, and either 
reregistering products or taking ``other appropriate regulatory 
action.''

List of Subjects

    Environmental protection.

    Dated: November 13, 2001.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 01-29557 Filed 11-27-01; 8:45 am]
BILLING CODE 6560-50-S