PRN 94-7: Label Improvement Program for the Revision of Use Directions for Commensal Rodenticides and Statement of the Agency's Policies on the Use of Rodenticide Bait Stations
September 16, 1994
Notice To: Manufactures, Formulators Registrants and Users of Pesticides
Attention: Persons Responsible for Federal Registration of Pesticides
Subject: Label Improvement Program for the Revision of Use Directions for Commensal Rodenticides and Statement of the Agency's Policies on the Use of Rodenticide Bait Stations
This Notice requires registrants of certain pesticide products claimed to control commensal rodents and registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to revise the labeling of such products to bear certain statements concerning "tamper-resistant bait stations."
This Notice also informs rodenticide registrants, applicants, and other interested persons of EPA's continued concern for the safe use of rodenticides. This Notice outlines EPA's current policies regarding the isolation of commensal rodenticides from children, dogs, other pets, domestic animals, and nontarget wildlife. For purposes of this Notice, product labels, and EPA's policies, the term "commensal rodents" includes the following species: Norway rats (Rattus norvegicus), roof rats (R. rattus), and/or house mice (Mus musculus).
To comply with this Notice, you must submit an application for amended registration if you are a registrant of any of the following types of products claimed to control commensal rodents:
- ready-to-use solid bait formulations (e.g., pelleted, meal, paraffinized block, etc.);
- liquid baits;
- concentrates with labels bearing directions for preparing and applying solid or liquid baits; and
- tracking powders for which current labeling permits use in "tamper-proof bait boxes," other protective structures, or other locations accessible to children or nontarget animals. Amended registration applications for such products must include proposed amended labeling revised as indicated in this Notice. Amendment applications are not required for products for which current accepted labeling already includes the language prescribed by this Notice.
Within 90 days of receipt of this Notice, all registrants of products affected by this Notice must submit five (5) copies of revised labeling for each affected product. The new labeling requirements for baits and concentrates from which users prepare baits are listed under the heading "Required Label Statements" on pages 9 and 10 of this Notice. The types of label statements that must be deleted from labels for tracking powders are discussed on page 10 of this Notice. Any registrant who wishes to modify the labeling statements prescribed by this Notice must include with the application for an amended registration a statement of each specific modification sought and the reasons why each modification is believed to be justified. Alternative text will not be accepted if EPA determines that it is not consistent with the intent of this Notice. All affected products released for shipment after March 16, 1996, must bear labeling in compliance with this Notice.
- Rodenticide-Caused Accidents And Illnesses
- Practices And Problems With Use of Bait Stations
- Criteria, Labeling, And Terminology
- Standards And Protocols For Testing Bait Stations
- Required Label Statements For Commensal Rodenticide Baits
- Labeling For Tracking Powders
- Implementation Of Policy
- Compliance Procedures
- Required Labeling - Timetable For Compliance
- Consequences Of Failure To Comply
- Where To Submit Labeling
- Further Information
In PR Notice 83-5, EPA summarized its historical policy regarding the use of bait stations to isolate rodenticide baits from nontarget animals. Part of this policy has been to require that baits registered to control commensal rats and mice bear on their labels a statement such as:
"Treated baits should be placed in locations not accessible to children, pets, wildlife and domestic animals, or in tamper-proof bait boxes."
PR Notice 83-5 listed the reasons for requiring this type of label language and the eight "Proposed Criteria" which the Agency had developed for "tamper-proof bait boxes". PR Notice 83-5 also listed five commercially marketed bait stations that were believed at that time to provide adequate protection for applications made in environmentally sensitive areas.
PR Notice 83-5 was issued because EPA had become aware that bait protection practices directed by labels usually were not being followed. Persons using rodent baits in areas where nontarget exposures might occur typically were protecting baits inadequately or not at all.
In PR Notice 83-5, the Agency also announced its plans to hold public hearings. In a Federal Register Notice (48 FR, 48711), EPA stated that the purpose of the hearings would be to obtain information in four areas:
- Practices and problems with the use of bait stations.
- Attitudes regarding EPA's "Proposed Criteria" for tamper-proof bait boxes, including any suggested changes in the criteria, terminology, and/or rodenticide label language pertaining to bait stations.
- Ideas for developing standards and test protocols through existing standards-setting institutions.
- Accidents, illnesses, deaths, or nontarget exposures resulting from the use of commensal rodenticides."
Two sessions of public hearings were held: the first on November 4, 1983, in Arlington, VA; and the second on March 5, 1984, in Sacramento, CA. Participants represented commercial pest control interests, rodenticide manufacturers, bait station manufacturers, research institutions, and various government agencies.
Since circulation of PR Notice 83-5, EPA has received and answered more than 300 letters pertaining to the Notice and the use of bait stations. EPA also has sought additional information on these topics. Relevant information received by the Agency through these letters, the public hearings, and other sources, is summarized in the report "Rodenticide Bait Stations" by William W. Jacobs. This report is available upon request. The Agency's major findings are summarized by topic below.
Historically, more than 1000 incidents of human exposure to rodent poisons have been reported annually in the U.S. Numbers of human incidents reported have increased greatly in recent years with the advent of a new reporting network. In 1988, more than 10,000 rodenticide incidents were reported in the American Association of Poison Control Center's National Data Collection System. Nearly 90% of these cases involved children under six years of age. Nearly all of such exposures are classed as accidents. The human exposure incidents that are reported may represent less than half of those which occur. Well over 80% of reported human rodenticide exposures involve anticoagulant compounds.
Young children thought to have been exposed to rodenticides are often given some medical attention, although symptoms of poisoning usually are not observed, especially in cases involving anticoagulants which act very slowly. Although young children have been killed by rodenticides, most rodenticide-related deaths of humans result from intentional ingestions by persons much older than five years of age.
Dog incidents account for more than 80% of the reported exposures of nontarget animals to commensal rodenticides. Most dog exposures are believed to be accidental. The annual number of incidents of animals being exposed to rodenticides is not known, but over 4,000 rodenticide-related inquiries were made to the Illinois Animal Poison information Center in each of the years from 1986 to 1988, with a high of 6,272 inquiries having been made in 1987.
Symptoms of rodenticide poisoning are detected more frequently in reported animal cases than in child cases. A larger percentage of asymptomatic exposures of animals may go undetected as pets and livestock generally are not watched as closely as children. Dogs may die as a result of rodenticide exposures, especially if acute poisons are involved. Extended Vitamin K1 therapy may be needed for dogs that have been exposed to certain anticoagulants, such as brodifacoum or diphacinone, which are retained in the body for a relatively long time. For animal exposures reported in 1987 (and probably in other years as well), the animal's owner typically was the source of the rodenticide. Most of these exposures were accidental and occurred in or around human residences.
While reports summarizing incidents typically do not indicate exactly how exposures have occurred, it is likely that most accidents are related to improper use rather than to improper storage. Accidents of both types are preventable. EPA believes that the large numbers of exposure incidents provide evidence that current policies for promoting bait protection have not been sufficient and, therefore, that tougher, more explicit policies are needed. EPA has not been persuaded by contentions that the relatively low incidences of serious human illnesses caused by accidental exposures to compounds such as warfarin justify selective relaxations of requirements for bait protection. Warfarin has been implicated in many human and animal exposure incidents and was one of the rodenticides considered when the "tamper-proof bait boxes" statement originally was developed.
The Reregistration Eligibility Document (RED) issued for warfarin on June 6, 1991, requires that the bait protection text prescribed in this Notice be added to the labels for warfarin ready-to-use baits and concentrates with labels which include bait mixing and application directions, and that labels for warfarin tracking powders be amended as prescribed in this Notice.
The major problem identified in this area was generally inadequate protection of baits applied in areas accessible to children or nontarget animals. According to available information, pest control operators traditionally used stations of the sorts which PR Notice 83-5 described as "inadequate." These include weak stations made of cardboard or thin plastic, and sturdier stations which do not inhibit spillage or reach-in access to baits.
Nonprofessional users (i.e., the "general public") often apply baits in open containers or in ready-to-use, non-protective, packaging. Bait stations typically are not offered for sale at the outlets where nonprofessional users buy rodenticides. Attempts to market ready-to-use (bait-filled) protective rodenticide bait stations to the general public have not been reported as commercially successful ventures. Ready-to-use bait stations that have been tested generally have been found not to be completely "tamper-resistant". Improvements to such units probably would add to their retail prices and put them at further competitive disadvantages relative to baits sold "loose," in cardboard boxes, or in plastic placepacks.
The rodenticide brand names mentioned in the incidents reported prior to 1983 (summarized by the National Clearinghouse for Poison Control Centers) and the "source" information from reports of animal incidents suggest that private users have accounted for most of the nontarget exposure incidents involving rodenticides. Available data do not indicate whether this trend reflects an effect other than a greater likelihood for nonprofessional users to apply rodenticide baits in areas where incidents are most likely to occur and to be reported.
Bait protection requirements are the same for similar products, whether they are marketed to professional users or to the general public. However, professional applicators are more easily reached by EPA's policy statements than are nonprofessional users. Many pest control firms have contacted EPA directly. Many more have been reached through professional publications and associations. Some firms have improved their bait protection practices in response to PR Notice 83-5. If the numbers of rodenticide exposure incidents occurring are to be minimized, however, all users of rodenticides must protect baits adequately.
Several hearing participants suggested approaches for insuring better bait protection by nonprofessional users. Many of these involved reclassification of products and/or special packaging requirements. EPA might pursue these options for some rodenticide compounds. As such actions could not be taken rapidly, there is need for more immediate action. This Notice requires label changes designed to draw attention to bait protection statements and to clarify users' responsibilities.
This Notice directs that the term "tamper-proof" be replaced on rodenticide labels by "tamper-resistant". This change was requested by most who contacted the Agency on matters relating to bait stations. The most persuasive argument on this issue was that "tamper-proof" implies absolute bait protection, performance beyond that which could be guaranteed even if units meeting all of EPA's "proposed criteria" were used. "Tamper-proof" also was thought to put applicators on very tenuous legal grounds in instances in which nontarget exposures might occur, due to unusual and unpredictable events beyond the applicator's control, despite use of the best practical efforts to protect baits. EPA recognizes that this change results in substitution of a broader term for the virtually self-defining "tamper-proof." Accordingly, EPA has expanded the required label text pertaining to bait protection and the criteria for "tamper-resistant" bait stations.
In response to concerns of hearing participants, the expression "not accessible" (or "inaccessible") has been replaced by wording which informs the user of the degree of bait protection needed.
For complete text of new bait station label language, see "Required Label Statements for Commensal Rodenticide Baits" on pages 9 and 10 of this Notice.
EPA concurs with those who stated that the Agency's eight criteria for "tamper-proof" bait stations would not guarantee that the units would be absolutely impervious to all forms of tampering imaginable. EPA agrees that these criteria are better suited to describing "tamper-resistant" stations.
EPA also concurs with those who stated that the criterion that stations be capable of being secured should be waived for designs which prevent the shaking of bait from a station after it has been moved. The criterion that bait stations be "resistant to weather" should be applied only when baits are used in areas where weather could be a factor (e.g., when water from rain or run-off could enter the unit).
The revised criteria for tamper-resistant bait stations are as follows:
- resistant to destruction or weakening by elements of typical non-catastrophic weather (e.g., snow, rain, extremes of temperature and humidity, direct sunshine, etc.);
- strong enough to prohibit entry or destruction by dogs and by children under six years of age using their hands, their feet, or objects commonly found in the use environment (e.g., sticks, stones, broken glass, etc. -- stations stronger than "tamper-resistant" are needed in areas frequented by hoofed livestock, raccoons, bears, other potentially destructive animals, or in areas prone to vandalism);
- capable of being locked or sealed so that children and nontarget animals cannot gain access through the opening or procedures used to fill the bait compartment(s);
- equipped with rodent entrances which a) readily allow target animals access to baits, b) deny such access to other animals larger than adults of the target species, and c) discourage entry by birds. Means for achieving these ends might include use of baffles, mazes, or small entrances;
- capable of being anchored securely to resist efforts to move the station or to displace its contents, or equipped with a mechanism which virtually prevents bait from being shaken out of the station after it has been moved;
- equipped with internal structures for containing baits and minimizing spillage and tracking of bait outside of the station or into readily accessible parts of the station;
- made of a design and color that is not especially attractive to children; and
- capable of displaying precautionary statements in a prominent location. These criteria for "tamper-resistant" bait stations identify the performance features required of bait stations by labeling when commensal rodenticide baits are applied in areas accessible to children and nontarget animals. Note that label requirements for using tamper-resistant bait stations apply to those who place bait, not to bait station manufacturers. EPA has no direct regulatory authority over the production and sale of bait stations unless they are sold with rodenticide baits.
EPA has received relatively little information regarding the elements to be included in protocols for testing bait stations or on performance standards for bait stations. Several bait station manufacturers have consulted with EPA staff regarding tests for evaluating protective qualities of bait stations. These tests have dealt primarily with young children and dogs, the nontarget organisms for which the largest numbers of rodenticide exposure incidents have been reported. In tests done to date, children or dogs have been given incentives to enter bait stations sealed and secured as they should be in rodent control operations. With children, Child-resistant Packaging (CRP) test protocols may be modified for use in screening bait stations. Several manufacturers have had their stations evaluated according to adapted CRP testing procedures.
EPA has concluded that its staff should draft standards and protocols for bait stations, but that testing according to these methods should be performed in the private sector at the expense of bait station manufacturers. Through cooperation with these manufacturers and other interested parties, EPA believes that the protocols can be refined and that agreements on appropriate adjustments to test procedures and performance standards for "tamper-resistant bait stations" can be reached.
EPA concurs with those who testified at the hearings that all stations, including those identified as "adequate" in PR Notice 83-5, ultimately should be tested according to the same set of standards. Under such standards, stations could be rated according to their performances in various aspects of bait protection. Station users then would be able to select units appropriate for specific applications.
Until protocols and standards are developed, EPA will continue to provide lists of "adequately protective" bait stations. These units are considered to provide adequate bait protection when use is consistent with directions for the bait and the station, common sense, EPA's criteria for "tamper-resistant bait stations", principles of safe and effective rodent control, and any stipulations noted on the lists.
Since PR Notice 83-5 was issued, the number of adequately protective bait station designs available commercially has increased. A current list is appended to this notice. Lists of "adequate" units are current as of the dates noted on them and are "historical" in that stations are listed even if they no longer are commercially available. In the future, lists will be updated as new units are added but will not be circulated each time that a change is made. Updated lists may be obtained by contacting William W. Jacobs (see information on page 12 of this notice).
The list refers to the specific designs evaluated by EPA. If manufacturers modify stations after EPA has examined them, their protective qualities might be compromised in the process. The stations are considered to be "adequately protective" only when they are used properly. 'In most cases, "proper use" means that units must be immobilized and locked.
Units are listed to provide guidance to rodenticide users concerning the degree of protection that must be provided when rodenticide baits are used in areas accessible to children, pets, domestic animals, and nontarget wildlife. Other adequate stations may be available now or may become available in the future. Users may build stations consistent with the criteria listed in this notice instead of purchasing commercial units. EPA does not endorse bait stations. While they may note whether their specific models are on the Agency's list of adequately protective bait stations, advertisers may not imply that their units are endorsed by the U.S. Government, the U.S. Environmental Protection Agency, or any employee thereof.
The statements below must be added to labels which bear directions for applying solid or liquid baits to control commensal rodents: Norway rats, roof rats, or house mice. Statements now on labels which address use of "tamper-proof bait boxes" must be deleted. On many labels, such text is found in the second paragraph under "USE RESTRICTIONS".
The following language must appear on the label directly below the heading "DIRECTIONS FOR USE".
"It is a violation of Federal law to use this product in a manner inconsistent with its labeling.
READ THIS LABEL: Read this entire label and follow all use directions and use precautions.
IMPORTANT: Do not expose children, pets, or other nontarget animals to rodenticides. To help to prevent accidents:
- Store product not in use in a location out of reach of children and pets.
- Apply bait in locations out of reach of children, pets, domestic animals and nontarget wildlife, or in tamper-resistant bait stations. These stations must be resistant to destruction by dogs and by children under six years of age, and must be used in a manner that prevents such children from reaching into bait compartments and obtaining bait. If bait can be shaken from stations when they are lifted, units must be secured or otherwise immobilized. Even stronger bait stations are needed in areas open to hoofed livestock, raccoons, bears, other potentially destructive animals, or in areas prone to vandalism.
- Dispose of product container, and unused,spoiled, and unconsumed bait as specified on this label." The captions "READ THIS LABEL" and "IMPORTANT" must be printed in conspicuous type, preferably in a color which contrasts with the remainder of the text in this section and with the background. A sample format label for anticoagulant commensal rodenticide solid baits is appended to this notice to provide an example of how new labels should appear. If you have any questions concerning the labeling, please contact William W. Jacobs (see information on page 12 of this notice).
EPA will consider modifying this language appropriately for products sold in structures that meet the criteria for tamper resistant bait stations.
Statements implying that tracking powders registered to control Norway rats, roof rats, and/or house mice may be used in bait stations or in other locations to which children or nontarget animals might have access must be deleted from product labels. The parts of bait stations to which tracking powders would be applied are the areas through which target rodents travel. Such areas generally are accessible to children and to certain species of nontarget animals.
The policies set forth in this notice are effective immediately. Deadlines for bringing labels into compliance are indicated below and on page 11.
Bait Products and Concentrates with End-Use Directions Within 90 days of receipt of this Notice, you must submit applications for amended registrations for any commensal rodenticide products which are solid baits, liquid baits, or concentrate products with labels which bear directions for preparing and applying baits. At the beginning of the "DIRECTIONS FOR USE" section, amended labels should include the text identified on pages 9 and 10 of this Notice. The attached format label for "dry" anticoagulant baits indicates appropriate placement for the new text. Five (5) copies of proposed amended labels must be submitted along with the Application for Pesticide: Registration Amendment (EPA Form 8570-1).
Registrants need not submit revised labels for products with accepted labels which already bear the language required by this Notice.
Registrants who wish to modify the labeling statements contained in this Notice must submit an Application for Amended Registration (EPA Form 8570-1), five (5) copies of revised draft labeling, and a document which notes each specific modification and states why each modification is believed to be justified.
Compliance Procedures for Tracking Powders
Within 90 days of receipt of this Notice, registrants of tracking powder products must submit an Application for Amended Registration (EPA Form 8570-1) and five (5) copies of revised draft labeling, if current labeling language permits use of tracking powders in bait stations or other locations accessible to children, pets or other nontarget animals. The new labeling must delete all references to use of tracking powders in bait stations or other places accessible to children or nontarget animals.
No product subject to the labeling requirements of this Notice may be released for shipment by the registrant after March 16, 1996, unless the product bears amended labeling that complies with the requirements of this notice.
No product subject to the labeling requirements of this Notice may be distributed, sold, offered for sale, held for sale, shipped, delivered for shipment, or received and (having been so received) delivered or offered to be delivered by any person after September 16, 1996 unless the product bears amended labeling which complies with the requirements of this Notice.
Products affected by this Notice that are not labeled appropriately on or before the above compliance dates will be deemed "misbranded" under FIFRA section 2(q)(1).
Failure to revise the product labeling to include the requirements of this notice may also result in initiation of cancellation proceedings under FIFRA section 6(b).
All labeling submissions in response to this notice should be sent to the following address:
Document Processing Desk (BBOX-14)
Office of Pesticide Programs (7504C)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460-0001
Persons interested in specific details regarding the content of this notice should contact:
Dr. William W. Jacobs
Registration Division (7505C)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, D.C. 20460
Stephen L. Johnson, Director
Registration Division (7505C)