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### Table of Contents

I. Introduction ............................................................................................................... .................. 3 A. General Background ......................................................................................................... ..... 4

II. Scientific Assessments .................................................................................................... ........... 4
A. Human Health Assessment .................................................................................................... 5

Dietary Exposure Assessment ................................................................................................. 5

Food Tolerances ..................................................................................................................... 5

Hazard Characterization and Risk ......................................................................................... 5

Residential and Occupational Exposure ................................................................................. 5

B. Environmental Assessment ................................................................................................... . 5

Environmental Fate and Exposure ......................................................................................... 5

Ecological Risk Characterization ........................................................................................... 6
Threatened and Endangered Species ...................................................................................... 6
C. Endocrine Disruptor Screening Program ............................................................................... 6
III. Registration Review Decision ............................................................................................. ...... 63 I. Introduction

This document is the Environmental Prot ection Agency’s (EPA or the Agency) Registration Review Decision for polybutene resins and is be ing issued pursuant to 40 CFR Sections 155.57 and 155.58. A regist ration review decision is th e Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA). Among other things, the registration review decision states (1) the Ag ency’s proposed findings with respect to the FIFRA standard for registration and describes the basis for such pr oposed findings; (2) id entifies proposed risk mitigation measures or other remedies as needed and describes the basis for such proposed requirements; (3) states whether additional data ar e needed and, if so, describes what is needed; (4) specifies proposed labeling ch anges; and (5) identifies dead lines for completing any required
actions.

FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pest icides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on sc ientific data showing that they will not cause
unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

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In 2006, the Agency implemented the regist ration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it
continues to meet the FIFR A standard for registration.

Pursuant to 40 CFR Section 155.50, EPA forma lly initiated registration review for polybutene resins 1 (case 4076). The following highlights si gnificant events that have occurred during the registration revi ew of polybutene resins:

 June 23, 2010 – Publication of Polybutene Resins Summary Document for a 60-day public comment period. The Summary Document (PWP) included the preliminary work plan and was accompanied by the scoping document and problem formulation.

 November 16, 2010 - Final Work Plan (FWP) for polybutene resins was signed -- no public comments were received during the 60-day comment period for the Polybutene Resins Summary Document ; thus, the FWP did not modify the Summary Document

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o In the PWP, EPA specifically solicited comments on environmental justice, water quality concerns, and trade irritants.

1 Also referred to as polybutene.4 o The FWP noted that no additional data were expected to be needed for the polybutene resins registration review because sufficient information was available to conduct a qualitative risk assessment to support a proposed registration review decision, pursuant to 40 CFR section 155.53(b).

 March 12, 2013 – The preliminary risk assessments, Human Health Risk Assessment to Support Final Registration Review Decision 2 and Preliminary Environmental Fate and Ecological Risk Assessment in Support of Registration Review of Polybutene 3 for polybutene resins published for a 60-day comm ent period. No comments were received during the comment period.

 June 4, 2014 – The Polybutene Resins Proposed Re gistration Review Decision 4 published
in the Federal Register (79 FR 32284) (FRL-9911-16) fo r a 60-day comment period. One comment was received during the comment period from the Center for Biological Diversity, concurring with EPA’s “no eff ect” conclusion in the polybutene resins ecological risk assessment.

 September 2014 – The Agency is now publishing the Polybutene Resins Registration

Review Decision

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Additional information on polybutene resins ca n be found in EPA’s public docket, EPA-HQOPP-2009-0649, accessed at www.regulations.gov

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A. General Background

Polybutene (PC 011402) is a sticky polymer re gistered for use as a bird and small mammal repellent. It is formulated as a non-dryi ng liquid or gel that remains sticky after being applied. Polybutene's tacky quality is the source of the repellent action of pesticide products containing the active ingredient. Th e product therefore differs from t ypical pesticides in that it is not intended to be ingested by the pest species. It was first registered in 1960 for use as an insect control agent and is curr ently registered for use to prevent pigeons, house sparrows, and starlings from roosting inside and outside of buildings, as well as to prev ent beavers from damaging trees
and shrubs. Animals that come in contact with surfaces treated with polybutene dislike the sticky sensation and usually do not retu rn. Polybutene is registered for commercial and residential use. The Reregistration Eligibility Decision document (RED) for polybutene was issued in December,
1994. 5

II. Scientific Assessments

A summary of the Agency’s preliminary human health and environmental fate and ecological risk assessments published March 12, 2013 is presented below. For the detailed risk

2 Available at http://www.regulations.gov/#!document Detail;D=EPA-HQ-OP P-2009-0649-0011

. 3 Located at http://www.regulations.gov/#!document Detail;D=EPA-HQ-OP P-2009-0649-0010

. 4 Available at http://www.regulations.gov/#! documentDetail;D=EPA-H Q-OPP-2009-0649-0014

5 Available at http://www.epa.gov/oppsrrd1/REDs/4076.pdf

.5 assessments, see the polybutene public docket (EPA-HQ-OPP-2009-0649) accessed at www.regulations.gov

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A. Human Health Assessment

Dietary Exposure Assessment There are no registered food/feed uses and existing use patterns are not expected to contaminate surface or ground water; thus, a di etary exposure assessment was not conducted.

Food Tolerances
Polybutene is exempt from the requirement of a tolerance when used as a sticker agent in packaging of insect control products used on food crops.

Polybutene is approved by the US Food and Drug Administration (FDA) as an indirect food additive and is used as an ingredient in co smetic products that are applied directly to the skin such as sun block or moisturizer, and that ma y be incidentally ingest ed, such as lipstick (21 CFR 175.125). The use of polybutene in cosmetic products is considered safe, according to a review of available toxicity informat ion by the Cosmetic Ingredient Review 6 (CIR) Expert Panel
report 7

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Hazard Characterization and Risk
The toxicological database was considered adequate for characterizing hazard and assessing risk from polybutene. No additional st udies were required for registration review. No toxicological endpoints of con cern were identified for dermal or inhalation exposure to polybutene.

Residential and O ccupational Exposure
Although the registered end-use products of polybutene are intended for professional and commercial application, there are no restricti ons limiting their use by homeowners. Although exposure may occur during application of thes e products, quantitative exposure assessments were not performed for residential and occ upational handlers usi ng products containing polybutene because dermal or inhalation endpoin ts of concern were not identified.

B. Environmental Assessment

Environmental Fate and Exposure
Polybutene is a highly stable, viscous, and extremely insoluble material. Because of its extremely low solubility, and application methods that would produce litt le-to-no spray drift, polybutene is not expected to be transported to aquatic environm ents in significant amounts. Any leaching to ground water is also expected to be ne gligible. Since aquatic exposure is expected to

6 The Cosmetic Ingredient Review was established in 197 6 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Ca re Products Council), with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. Although funded by the Council, CIR and the review process are independent from the Council and the cosmetics industry. More information is available at http://www.cir-safety.org/about

. 7 Cosmetic Ingredient Review: Final Report on the Safety Assessment of Polybutene. J. Am. Coll. Toxicol

. 1(4):103-118, 1982.6 be negligible, no aquatic exposure or drinki ng water exposure assessment was conducted when evaluating the pesticidal uses of this chemical. Po lybutene is also expected to be immobile in the terrestrial habitats. Therefore, e xposure to terrestrial plants and an imals is expected to be limited
to the immediate treatment site.

Ecological Risk Characterization
Considering the low toxicity observed in bi rds and mammals, and the lack of any known toxic mode of action to aquatic species, any potential exposure to po lybutene through direct contact or ingestion is expected to have negligible toxicological effects. Furthermore, because of the very low solubility of polybutene, the amount of dissolved residues in aquatic environments is expected to be negligible, far below levels that might be toxic to aquatic organisms.

The use of polybutene is not expected to resu lt in any significant risk to terrestrial wildlife through any toxic mode of action, but may pose some lim ited hazard to small wildlife species that may become entangled or entrapped in the product. Furthermore, product labels limit application to times that are less attractive to i nvertebrates (such as prohi biting applications to woody plants while they are in bloom). Exposure to terrestrial plants is ex pected to be minimal, being limited to the plants that are directly tr eated with the product, or that lie immediately beneath treated plants. In addition, the use of pol ybutene is not believed to cause any significant damage to terrestrial plants even when directly exposed.

Threatened and Endangered Species
There is no reasonable expecta tion for any registered use of polybutene repellents to
cause direct or indirect adve rse effects to threatened and endangered species. No adverse modification of any designated critical habitat fo r such species is expected from the use of polybutene. This is because the trea ted area is very small relative to the range of species, most of the product use is expected to o ccur outside of areas inhabited by listed species, and the viscosity and very low solubility of polybutene makes it unlikely to runoff or leach from the target application site into non-target areas. Furthermore, since polybu tene is an effective physical repellent, listed animals are generally expected to avoid treated application sites. EPA has made a “no effect” determination under the Endangered Species Act (ESA) for all listed species and designated critical habitat for su ch species and has therefore conc luded that consu ltation with the
Fish and Wildlife Service and th e National Marine Fisheries Se rvice under ESA section 7(a)(2) is not required.

C. Endocrine Disruptor Screening Program Pursuant to FFDCA Section 408(p)(4), EPA has exempted polybutene from the requirements of the EDSP in an Administrative Order entitled Exemption of Polybutene from the Requirements of the Endocrine Disruptor Screening Program , April 11, 2014. The Order is available in the docket for this regi stration review at EPA-HQ-OPP-2009-0649. The
Administrative Order describes th e analysis and rationale that the Agency used to evaluate polybutene in order to determine th at it qualifies for the exemption.

III. Registration Review Decision

In accordance with 40 CFR Sections 155.57 and 155.58, the Agency is issuing this Registration Review Decision document. The EPA does not expect registered use of polybutene7 to result in adverse effects to human health. In addition, EPA does not exp ect polybutene to have
direct or indirect adve rse effects to non-listed and listed sp ecies or to adversely modify any designated critical habitat for su ch species and has made a “no effect” determination under the Endangered Species Act for all listed species a nd designated critical ha bitat for such species. Further, EPA has determined that due to the chem ical structure of polybuten e, it is exempt from the EDSP requirement. EPA’s Registration Review D ecision determination for polybutene is that the pesticide meets the standard for registration under FIFRA.