Docket Number: EPA-HQ-OPP-2009-0649 www.regulations.gov



# Polybutene Resins Summary Document Registration Review: Initial Docket

June 20103 

### TABLE OF CONTENTS

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

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



### Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency’s current position based on the following documents:

1. Polybutene: Human Health Assessment Sc oping Document in Support of Registration Review. April 23, 2010.

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

3. Appendix A: Food/Feed & Non-Food/Non-F eed Uses Considered in Registration Review Work Planning Polybutene (011402) Case No. 4076. June 02, 2009.

4. California Department of Pesticide Regula tion (DPR) Usage Data for Polybutene.
June 30, 2009.

Additional supporting documents for polybuten e may be found in docket EPA-HQ-OPP-2009- 0649, located on the internet at www.regulations.gov.4 I. PRELIMINARY WORK PLAN

Introduction The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration 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 ri sks to human health or the environment when used as directed on product labeling. The regist ration 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 th e statutory standard of no unreas onable 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 marketpl ace can be used safely. Information on this program is provided at www.epa.gov/oppsrrd1/registration_review/

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The Agency is implementing the registration re view program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA), and will review each registered pesticide every 15 years to determine wh ether it continues to m eet the FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins wh en the initial docket is opened for each case. The docket is the Agency’s opportunity to stat e 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 po lyisobutylene registration was cancelled in 1992. The only registered active ingredie nt 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 we ll as to prevent beavers from attacking trees and shrubs. Animals that come in contact with surfaces treated with polybutene dislike the sticky sensation and us ually do not return. Polybutene is registered for commercial and residential use. The Reregistration Eligib ility 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. Th e Agency anticipates conducting a qualitative endangered species risk assessment. The Ag ency anticipates conduc ting a polybutene dermal exposure human health risk assessment for resi dential and occupational handlers. Based on the current use patterns other human health risk as sessments are not anticipated for polybutene. Below is a summary of the issues relevant to the registration review process of polybutene.5 Ecological Risk:

• An environmental fate and effects risk assessment for polybutene was completed in support of the 1994 Reregistration Eligibilit y Decision (RED). The risk assessment

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

• Due to the application methods, the likeli hood 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 asse ssment that supports a complete endangered species determination. The ecological risk a ssessment planned during registration review will allow the Agency to determine whethe r 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 assessm ent concludes that a pesticide’s use “may affect” a listed species or its designated critic al habitat, the Agency will consult with the

U.S. Fish and Wildlife Se rvice, 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 a ssessment was conducted for the 1994 RED.

• There is potential for residential and occupa tional handler dermal exposure. Therefore, the Agency anticipates conduc ting residential and occupati onal handler dermal exposure assessments during registration review.

• All other residential and occupational routes of exposure are considered negligible due to the properties and use patte rns of polybutene products.

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

• The available toxicology data are consider ed adequate to assess the exposure from existing uses of polybutene.

• No additional human health data are anticip ated to support the registration review of polybutene.6 • 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), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar 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 ap proach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine related eff ects caused by the substance, and establish a quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed 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 sele cted based on the potenti al for human exposure through pathways such as food and water, resi dential activity, and cer tain post-application agricultural scenarios. Th is list should not be construed as a list of known or likely endocrine disruptors.

Polybutene is not among the group of 58 pesticid e 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 issuin g EDSP orders/data call-ins for all Registration Review cases, including those for which EPA ha s already opened a Registration Review docket for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, plea se visit our website: http://www.epa.gov/endo/.7 Timeline: EPA has created the following estimated ti meline 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 a nd Begin Post-Decision Follow-up 2013 Total (years) 3

Guidance for Commenters: The public is invited to comme nt on EPA’s preliminary regi stration review work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manne r prior to issuing a fi nal work plan for the polybutene resins case.

Trade Irritants Through the registration review process, th e Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward fa cilitating irritant resolution.

Growers and other stakeholders are asked to comme nt 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 specifici ty 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 (T MDL) have been developed for polybutene, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?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 exte nt possible, data should conform to the quality8 standards in Appendix A of the OPP Standard Operating Procedur e: 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/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitati vely in pesticide risk assessments.

Environmental Justice EPA seeks to achieve environmental justi ce, 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 envir onmental justice issues, the Agency seeks information on any groups or segments of the population who, as a resu lt of their location, cultur al practices, or other factors, may have atypical, unus ually high exposure to polybuten e, compared to the general population. Please comment if you ar e 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 pr ovide information and da ta that will assist the Agency in refining risk assessments, incl uding 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 alr eady reported to the Agency.

Next Steps: After the 60-day public comment period clos es, the Agency will review and respond to any comments received in a timely manner a nd then issue a Final Work Plan for polybutene

resins.9 II. FACT SHEET

Background Information :

• Polybutene Resins Registrati on Review Case Number: 4076

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

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

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

• The Reregistration Eligibility Decision doc ument (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 Divi sion (PRD) Chemical Review Manager (CRM): José Gayoso ( gayoso.jose@epa.gov )

• Registration Division (RD) Contac t: 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) clar ified the differences between pesticides and pest control devices, the Agency conclude d 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 w ould no longer be required for insect use of polybutene products. All registrations w ith 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 us ed to discourage pige ons, starling, and house sparrows from roosting or perching in or on buildings, structure, or adjacent branches of vegetation. One product is registered for us e 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 ha nd or pressure sprayer.

• Use restrictions on label incl ude a prohibition against appl ying products to surfaces where desirable bird species might become entangled in the repellent.

• According to California Department of Pe sticide 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.10 Ecological Risk Assessment Status : Please refer to Registration Review: Problem Formulation for Polybutene , located in the polybutene resins docket at re gulations.gov (EPA-HQ-OPP-2009- 0649), for a discussion of the key findings of the most recent ecolo gical risk assessment for polybutene.

• An environmental fate and effects risk assessment for polybutene was completed in support of the 1994 RED. At the time, polybuten e products were registered as bird and squirrel repellents. No endangere d species assessment was conducted.

• Since polybutene is a stable substance that is resistant to chemical change or off-site transport, the Agency did not requ ire 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 requirement s were waived due the insolubility of polybutene.

• Because of its properties and use patte rns, 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 inci dents generally involve only one or several individuals. Furthermore, th e liquid formulation of polybuten e, which is sprayed to the point of runoff on vegetation and may pose risk s 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 orga nisms. A warning statement clarifying the risk for potential harm to non-target birds, es pecially small birds covered by the Federal Migratory Bird Protection Treaty Act, was sp ecified in the RED to appear on polybutene

labels.11 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 fi ndings 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 mini mal exposure from registered uses, only acute toxicity and mutagenicity stud ies 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 evid ence of mutagenicity. Base d on the lack of concern for mutagenicity, additional da ta are not required.

• Polybutene is also an ingredient in many co smetic 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 e xpected 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 polybut ene 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 Ecol ogical Incident Information System (EIIS) contained the report of an incide nt involving 30-80 cedar waxwings ( Bombycilla cedrorum) . At least one was incapac itated and at least one was killed from the use of a polybutene product in a building.12 Human:

• The OPP Incident Database System (IDS) wa s searched for human incidents involving polybutene in the United States from 2002 to the present. IDS includes reports of incidents from various sources, including ma ndatory FIFRA Section 6(a)(2) reports from registrants, other federal a nd state health and environmen tal agencies, and individual

customers. The IDS was found to contain no incidents involvi ng polybutene reported between 2002 and the present. Based on this in cident report, there do es not appear to be

a concern at this time that would warrant fu rther 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 in cident report for further details EPA Docket Number EPA-HQ- OPP-2009-0649).

Data Call-In Status:

• There are no outstanding data ca ll-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 be low and the labels can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

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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