Docket Number: EPA-HQ-OPP-2009-0649 

www.regulations.gov 

 

Polybutene Resins 

Summary Document 

Registration Review: Initial Docket 

June 2010 

 

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TABLE OF CONTENTS 

I. PRELIMINARY WORK PLAN................................................................................. 4

II. FACT SHEET ............................................................................................................. 9

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency’s 

current position based on the following documents: 

1. Polybutene: Human Health Assessment Scoping Document in Support of Registration 

Review. April 23, 2010. 

2. Registration Review: Problem Formulation for Polybutene. May 19, 2010. 

3. Appendix A: Food/Feed & Non-Food/Non-Feed Uses Considered in Registration 

Review Work Planning Polybutene (011402) Case No. 4076. June 02, 2009. 

4. California Department of Pesticide Regulation (DPR) Usage Data for Polybutene. 

June 30, 2009. 

Additional supporting documents for polybutene may be found in docket EPA-HQ-OPP-2009-

0649, located on the internet at www.regulations.gov. 
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I. PRELIMINARY WORK PLAN 

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review 

program. All pesticides distributed or sold in the United States generally must be registered by 

the U.S. Environmental Protection Agency (EPA or the Agency), based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each 

registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard 

for registration. The Agency will consider benefits information and data as required by FIFRA. 

The public phase of registration review begins when the initial docket is opened for each case. 

The docket is the Agency’s opportunity to state what it knows about the pesticide and what 

additional risk analyses and data it believes are needed to make a registration review decision. 

After reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop and commit to a final work plan and schedule for the 

registration review of polybutene resins. 

There are two active ingredients in case #4076, polybutene (PC code 011402) and 

polyisobutylene (PC code 011403). The last polyisobutylene registration was cancelled in 1992. 

The only registered active ingredient is polybutene. Polybutene is a sticky polymer registered 

for use as a bird and small mammal repellant. It is formulated as a nondrying liquid or gel that 

remains sticky after being applied. It is registered for use to prevent pigeons, house sparrows, 

and starlings from roosting inside and outside of buildings, as well as to prevent beavers from 

attacking trees and shrubs. Animals that come in contact with surfaces treated with polybutene 

dislike the sticky sensation and usually do not return. Polybutene is registered for commercial 

and residential use. The Reregistration Eligibility Decision document (RED) for polybutene was 

signed in December 1994. 

Anticipated Risk Assessment and Data Needs:

Based on the current use patterns, the Agency does not anticipate conducting an 

ecological risk assessment for polybutene. The Agency anticipates conducting a qualitative 

endangered species risk assessment. The Agency anticipates conducting a polybutene dermal 

exposure human health risk assessment for residential and occupational handlers. Based on the 

current use patterns other human health risk assessments are not anticipated for polybutene. 

Below is a summary of the issues relevant to the registration review process of polybutene. 
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Ecological Risk: 

• An environmental fate and effects risk assessment for polybutene was completed in 

support of the 1994 Reregistration Eligibility Decision (RED). The risk assessment 

concluded that there is no significant risk to mammals and aquatic organisms. 

• Due to the application methods, the likelihood of exposure to non-target organisms is 

minimal. Therefore, the Agency does not anticipate conducting a new ecological risk 

assessment. 

• No additional ecological effects data are anticipated for the registration review of 

polybutene. 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether the use of polybutene has “no effect” or 

“may affect” federally listed threatened or endangered species (listed species) or their 

designated critical habitats. When an assessment concludes that a pesticide’s use “may 

affect” a listed species or its designated critical habitat, the Agency will consult with the 

U.S. Fish and Wildlife Service, as appropriate. 

• Please refer to Registration Review: Problem Formulation for Polybutene, dated May 19, 

2010, located in the polybutene docket, for further details. 

Human Health Risk: 

• A comprehensive human health risk assessment was conducted for the 1994 RED. 

• There is potential for residential and occupational handler dermal exposure. Therefore, 

the Agency anticipates conducting residential and occupational handler dermal exposure 

assessments during registration review. 

• All other residential and occupational routes of exposure are considered negligible due to 

the properties and use patterns of polybutene products. 

• Due to the application methods, dietary (food and water) exposure is not anticipated.

• The available toxicology data are considered adequate to assess the exposure from 

existing uses of polybutene.

• No additional human health data are anticipated to support the registration review of 

polybutene.
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• Please refer to Polybutene: Human Health Assessment Scoping Document in Support of 

Registration Review, dated April 23, 2010, located in the polybutene docket, for details. 

Endocrine Disruptor Screening Program (EDSP): 

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by 

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect. 

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the 

first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. This list of chemicals was selected based on the potential for human exposure 

through pathways such as food and water, residential activity, and certain post-application 

agricultural scenarios. This list should not be construed as a list of known or likely endocrine 

disruptors. 

Polybutene is not among the group of 58 pesticide active ingredients on the initial list to 

be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide 

chemicals. Accordingly, EPA anticipates issuing EDSP orders/data call-ins for all Registration 

Review cases, including those for which EPA has already opened a Registration Review docket 

for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list of 

67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.
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Timeline:

EPA has created the following estimated timeline for the completion of the polybutene 

registration review. 

Registration Review for Polybutene Resins – Projected Registration Review Timeline

Activities Estimated Date 

Opening the docket 

Open Docket and Public Comment Period 2010 – June 

Close Public Comment 2010 – August 

Case Development 

Final Work Plan 2010 – November 

Open Public Comment Period for Preliminary Risk Assessments 2012 – April – June 

Close Public Comment Period 2012 – July – Sept. 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

 2012 – Oct. - Dec. 

Close Public Comment Period 2013 – Jan. – March 

Final Registration Review Decision and Begin Post-Decision Follow-up 2013 

Total (years) 3 

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration review work plan 

and rationale. The Agency will carefully consider all comments as well as any additional 

information or data provided in a timely manner prior to issuing a final work plan for the 

polybutene resins case. 

Trade Irritants

Through the registration review process, the Agency intends to solicit information on 

trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. 

Growers and other stakeholders are asked to comment on any trade irritant issues resulting from 

lack of Maximum Residue Levels (MRLs) or disparities between U.S. tolerances and MRLs in 

key export markets, providing as much specificity as possible regarding the nature of the 

concern. 

Water Quality

Polybutene is not identified as a cause of impairment for any water bodies listed as 

impaired under section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for polybutene, 

based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. More information on impaired water bodies and 

TMDLs can be found at http://www.epa.gov/owow/tmdl/. The Agency invites submission of 

water quality data for this pesticide. To the extent possible, data should conform to the quality 
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standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 8 

Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm) in order to ensure they 

can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice

EPA seeks to achieve environmental justice, the fair treatment and meaningful 

involvement of all people, regardless of race, color, national origin, or income, in the 

development, implementation, and enforcement of environmental laws, regulations, and policies. 

To help address potential environmental justice issues, the Agency seeks information on any 

groups or segments of the population who, as a result of their location, cultural practices, or other 

factors, may have atypical, unusually high exposure to polybutene, compared to the general 

population. Please comment if you are aware of any sub-populations that may have atypical or 

unusually high exposure compared to the general population. 

Other Information

Stakeholders are also specifically asked to provide information and data that will assist 

the Agency in refining risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in the following information: 

1. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency. 

Next Steps:

After the 60-day public comment period closes, the Agency will review and respond to 

any comments received in a timely manner and then issue a Final Work Plan for polybutene 

resins. 
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II. FACT SHEET

 

Background Information:

• Polybutene Resins Registration Review Case Number: 4076 

• Polybutene PC Code: 011402; CAS#: 9003-29-6 

• There are no technical products. There are four Section 3 registrations. 

• Polybutene was first registered in 1960 for use as an insect control agent. 

• The Reregistration Eligibility Decision document (RED) for polybutene was signed in 

December 1994. 

• There is an exemption from the requirement of a tolerance (CFR 180.1037) for residues 

of polybutene in or on cotton seed and artichokes when used as a sticker agent for insect 

control products. 

• Pesticide Re-evaluation Division (PRD) Chemical Review Manager (CRM): José Gayoso 

(gayoso.jose@epa.gov) 

• Registration Division (RD) Contact: Dan Peacock (peacock.dan@epa.gov) 

Use & Usage Information: 

• Polybutene was first registered in 1960 for use as an insect control agent. However, after 

a 1976 Federal Register Notice (FRL 646-5) clarified the differences between pesticides 

and pest control devices, the Agency concluded that the insect use of polybutene products 

would be classified as devices because the mode of action was more to trap than repel. 

Therefore, FIFRA Section 3 registrations would no longer be required for insect use of 

polybutene products. All registrations with insect uses were cancelled by 1989. 

• Polybutene was registered in 1963 as a bird repellant and in 1967 as a tree squirrel 

repellent. Current labels do not include squirrel repellent uses. 

• Polybutene was registered in 2007 as a beaver repellent. 

• Polybutene is registered as a repellent used to discourage pigeons, starling, and house 

sparrows from roosting or perching in or on buildings, structure, or adjacent branches of 

vegetation. One product is registered for use to discourage beavers from damaging trees 

and shrubs. 

• Polybutene formulations include a gel, which is applied as a bead strip to surfaces with a 

ready-to-use tube or caulking gun, and a liquid concentrate, which is applied with a paint 

brush or sprayed on using a hand or pressure sprayer. 

• Use restrictions on label include a prohibition against applying products to surfaces 

where desirable bird species might become entangled in the repellent. 

• According to California Department of Pesticide Regulation data, about 172 lbs. of 

polybutene was applied in 2005, 1,406 lbs. in 2006, and 1,185 lbs. in 2007. No other 

usage data are currently available. 

Recent Actions:

• There are no recent actions or pending new uses proposed for this chemical. 
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Ecological Risk Assessment Status: 

Please refer to Registration Review: Problem Formulation for Polybutene, located in the 

polybutene resins docket at regulations.gov (EPA-HQ-OPP-2009-0649), for a discussion of the 

key findings of the most recent ecological risk assessment for polybutene. 

• An environmental fate and effects risk assessment for polybutene was completed in 

support of the 1994 RED. At the time, polybutene products were registered as bird and 

squirrel repellents. No endangered species assessment was conducted. 

• Since polybutene is a stable substance that is resistant to chemical change or off-site 

transport, the Agency did not require environmental fate data. 

• The hydrolysis data requirement was waived based on the limited environmental 

exposure that results from the use of polybutene products. 

• Polybutene is practically nontoxic to birds on an acute oral and subacute dietary basis. 

• Polybutene is practically nontoxic to small mammals on an acute basis. 

• Aquatic organism toxicity data requirements were waived due the insolubility of 

polybutene. 

• Because of its properties and use patterns, honey bees, small mammals, aquatic 

organisms, and other wildlife are not likely to ingest or otherwise be exposed to 

significant amounts of polybutene. 

• While small birds contacting treated surfaces may be temporarily trapped or rendered 

unable to fly, such potentially fatal incidents generally involve only one or several 

individuals. Furthermore, the liquid formulation of polybutene, which is sprayed to the 

point of runoff on vegetation and may pose risks to small non-target birds, is generally 

available to and applied by commercial applicators. 

• The environmental fate and effects risk assessment concluded that there was no 

significant risk to mammals and aquatic organisms. A warning statement clarifying the 

risk for potential harm to non-target birds, especially small birds covered by the Federal 

Migratory Bird Protection Treaty Act, was specified in the RED to appear on polybutene 

labels. 
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Human Health Risk Assessment Status:

Please refer to the document Polybutene: Human Health Assessment Scoping Document in 

Support of Registration Review, located in the polybutene resins docket at regulations.gov (EPAHQ-OPP-2009-0649), for a discussion of the key findings of the most recent human health risk 

assessment for polybutene. 

Hazard Characterization: 

• The toxicity of polybutene was reviewed for the 1994 RED. Based on the lack of effects 

observed in the available studies and the expectation of minimal exposure from registered 

uses, only acute toxicity and mutagenicity studies were required. No toxicity endpoints 

have been identified for polybutene. 

• Polybutene has a low acute toxicity by acute dermal and oral routes of exposure 

(Category III and IV, respectively). It is not a skin irritant (Category IV). Polybutene is 

irritating to the eyes (Category II). 

• Available data do not show evidence of mutagenicity. Based on the lack of concern for 

mutagenicity, additional data are not required. 

• Polybutene is also an ingredient in many cosmetic products, such as lipsticks, and such 

uses have been evaluated and characterized as safe by the Cosmetic Ingredient Review 

(CIR) Expert Panel. 

Dietary: 

• Dietary exposure to polybutene was not expected since no food-related uses were 

registered. Therefore, a dietary risk assessment has not been conducted. 

• Polybutene is approved by the Food and Drug Administration (FDA) as a food additive 

when used in packaging that may come in contact with food. 

Residential and Occupational: 

• The risk assessment concluded that risks to workers and homeowners from exposure to 

polybutene were negligible, due to low potential for exposure and low toxicity. 

Aggregate: 

• An aggregate exposure assessment for polybutene was not required because it was not 

expected that the use of polybutene would result in multiple routes of exposure. 

Incidents:

Ecological: 

• A preliminary review of the Agency’s Ecological Incident Information System (EIIS) 

contained the report of an incident involving 30-80 cedar waxwings (Bombycilla 

cedrorum). At least one was incapacitated and at least one was killed from the use of a 

polybutene product in a building. 
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Human: 

• The OPP Incident Database System (IDS) was searched for human incidents involving 

polybutene in the United States from 2002 to the present. IDS includes reports of 

incidents from various sources, including mandatory FIFRA Section 6(a)(2) reports from 

registrants, other federal and state health and environmental agencies, and individual 

customers. The IDS was found to contain no incidents involving polybutene reported 

between 2002 and the present. Based on this incident report, there does not appear to be 

a concern at this time that would warrant further investigation. The Agency will continue 

to monitor the incident information and if a concern is triggered, additional analysis will 

be included in the risk assessment (see incident report for further details EPA Docket 

Number EPA-HQ-OPP-2009-0649). 

Data Call-In Status:

• There are no outstanding data call-in requirements for polybutene. 

Tolerances: 

• Because polybutene has no registered food uses, no tolerances have been established for 

this pesticide. 

• There is an exemption from the requirement of a tolerance (CFR 180.1037) for residues 

of polybutene in or on cotton seed and artichokes when used as a sticker agent for insect 

control products. 

Labels: 

A list of registration numbers is included below and the labels can be obtained from the 

Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home. 

Registration # Product name Company name % Active 

Ingredient 

1621-17 Tanglefoot Bird 

Repellent Tanglefoot Co. 97 

8254-3 

4 The Birds 

Transparent Bird 

Repellent Liquid 

Bird Control International Corp. 49 

8254-5 4 The Birds Bird 

Repellent Bird Control International Corp. 93 

55943-1 Hot Foot Bird 

Repellent Hot Foot America L.P. 93.5