2



### Table of Contents

I. Introduction

................................ ................................ ................................ ................................ . 3 A. General Background

................................ ................................ ................................ .............. 4

II. Scie ntific Assessments

................................ ................................ ................................ ............... 4

A. Human Health Assessment

................................ ................................ ................................ .... 4

Dietary Exposure Assessment

................................ ................................ ................................ . 4

Food Tolerances

................................ ................................ ................................ ..................... 5

Hazard Charact erization and Risk

................................ ................................ ......................... 5

Residential and Occupational Exposure

................................ ................................ ................. 5

B. Environmental Assessment

................................ ................................ ................................ .... 5

Environmental Fate and Exposure

................................ ................................ ......................... 5

Ecological Risk Characterization

................................ ................................ ........................... 5

Threatened and Endangered Species

................................ ................................ ...................... 6

C. Endocrine Disruptor Screening Program

................................ ................................ ............... 6

III. Proposed Interim Registration Review Decision

................................ ................................ ...... 6 IV. Next Steps and Timeline

................................ ................................ ................................ ........... 73

I. Introduction

This document is the Environmental Protection Agency’s (EPA or the Agency) Proposed Registration Review Decision for polybutene resins and is being issued pursuant to 40 CFR

S ection s 155.57 and 155.58

. A registration review decision is the Agency's determi nation whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Among other things, the proposed registration review decision states (1) the Agency’s proposed findings wi th respect to the FIFRA standard for registration and describes the basis for such proposed findings ; (2) identifies proposed risk mitigation measures or other remedies as needed and describes the basis for such proposed requirements ; (3) states whether ad ditional data are needed and

, if so

, describes what is

needed ; (4) specifies proposed labeling changes ; and (5) identifies deadlines for completing any required actions.

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause

unreasonable risks to human health or to the environment whe n 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 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 these changes occur, products in the marketplace can continu e to be used safely. Information on this program is provided as www.epa.gov/oppsrrd1/registration_review/

.

In 2006, the Agency implemented the registration 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 FIFRA standard for registration.

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for polybutene resins 1 (case 4076 )

. The following highlights significant events that have occurred during the registration review of polybutene resins :

 June 23, 2010

– Publication of Polybutene Resins S ummary Document for a 60

- day public comment period . The Summary Document (PWP) included the preliminary w ork

p lan and was accompanied by the scoping document and problem formulation

.

 November 16, 2010

- Final Work Plan (FWP) for polybutene resins was signed

-- n o public comments were received during the 60

- day comment period for th e Polybutene

Resins Summary Document ; thus

, the FWP did not modify the S ummary D ocument

.

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 we re 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, 2 013

– The p reliminary risk a ssessments

, 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 comment period

. N o comments were received during the comment period

.

Additional information on p olybutene r esins can be found in EPA’s public docket

, EPA

- HQ

OPP

- 200 9

- 0 649

, accessed at www.r egulations.gov

.

A. General Background

Polybutene is a sticky polymer registered for use as a bird and small mammal repellent. It

is formulated as a non

- drying 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. The product therefore differs from typical pesticides in that it is not intended to be ingested by the pest species. It was first registered in 196 0 for use as an insect control agent and is currently registered for use to prevent pigeons, house sparrows, and starlings from roosting inside and outside of buildings, as well as to prevent beavers from damaging trees and shrubs.

Animals that come in con tact 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 issued in December,

19 94. 4

II. Scientific Assessments

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

. For the detailed risk

assessment s , see the p olybutene public docket ( EPA

- HQ

- OPP

- 200 9

- 0649 ) accessed at www.regulations.gov

.

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 dietary exposure assessment was not co nducted

.

2 Located at http://www.regulations.gov/#!docume ntDetail;D=EPA

- HQ

- OPP

- 2009

- 0649

- 0011

. 3 Located at http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2009

- 0649

- 0010

. 4 Located at http://www.epa.gov/oppsrrd1/REDs/4076.pdf

.5 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 cosmetic products that are applied d irectly to the

skin such as sun block or moisturizer, and that may be incidentally ingested, such as lipstick. The use of polybutene in cosmetic p roducts is considered safe

, according to a review of available toxicity information by the Cosmetic Ingredient Review 5 (CIR) Expert Panel report 6

.

Hazard Characterization and Ris k
The toxicological database wa s considered adequate for characterizing hazard and assessing risk from polybutene. No additional studies were requ ired for registration review. N o toxicological endpoints of concern were identified for dermal or inhalation e xposure to polybutene.

Residential and Occupational Exposure
Although the registered end

- use products of polybutene are intended for professional and

commercial application, there are no restrictions limiting their use by homeowner s . Therefore,

both residential and occupational applicator and post

- application exposures were considered in

the assessment. Although exposure may occur during application of these products, quantitative

exposure assessments wer e not performed for polybutene because d ermal o r inhalation endpoints

of concern were not identified.

B. Environmental Assessment

Environmental Fate and Exposure
Polybutene is a highly stable , viscous, and extremely insoluble inorganic material.

B ecause of its extremely low solubility, and application methods that would produce little

- to

- no spray drift, polybutene is not expected to be transported to aquatic environments in significant amounts. Any leaching to ground water is also expected to be negligible. Since aquatic exposure is expected to be negligible, no aquatic exposure or drinking water exposure assessment was conducted when evaluating the pesticidal uses of this chemical. Polybutene is also expected to be immobile in the terrestrial habitats. Therefore, exposure to terrestrial plan ts and animals is expected to be limited to the immediate treatment site.

Ecological Risk Characterization
Considering the low toxicity observed in birds and mammals, and the lack of any known toxic mode of action to aquatic species, any potential exposu re to polybutene through direct contact or ingestion is expected to have negligible toxicological effects. Furthermore, because of

5 The Cosmetic Ingredient Review was established in 1976 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care 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 availa ble at http://www.cir

- safety.org/about

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

. 1(4):103

- 118, 1982.6

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 result in any significant risk to terrestrial wildlife through any toxic mode of action, but may pose some limited 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 invertebrates (such as prohibiting applications to woody plants while they are in bloom). Exposure to terrestrial plants is expected to be minimal

, being limited to the plants that are directly treated with the product, or that lie immediately beneath treated plants. In addition, the use of polybutene is not believed to cause any significant damage to terrestrial plants even w hen directly exposed.

Threatened and E ndangered Species

T here is no reasonable expectation for any registered use of polybutene repellents to

cause direct or indirect adverse effects to threatened and endangered species

. No adverse

modification of any de signated critical habitat for such species is expected from the use of polybutene. This is because the treated area is very small relative to the range of species, most of the product use is expected to occur outside of are as 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 polybutene 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 such species and has therefore concluded that consultation with the

Fish and Wildlif

e Service and the National Marine Fisheries Service under ESA s ection 7(a)(2) is not required.

C. Endocrine Disruptor Screening Program
Pursuant to FFDCA Section 408(p)(4), EPA has exempted p olybutene 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 registration review at EPA

- HQ

- OPP

- 20 09

- 0649 . The

Administrative O r der describes the an alysis and rationale that the Agency used to evaluate

p olybutene in order to determine that it qualifies for the exemption.

III. Proposed Registration Review Decision

In accordance with 40 CFR Section s 155.57 and 155.58 , the Agency is issuing this

P roposed Registration Review D ecision document. T he Agency has made the following proposed decision : (1) no additional data are required at this time ; and (2) no changes to the affected registrations or their labeling are needed at this time. In addition, E PA does not expect polybutene to have direct or indirect adverse effects to non

- listed and listed species or to adversely modify any designated critical habitat for such species and has made a “no effect” determination under the Endangered Species Act for all listed species and designated critical habitat for such species. Further, EPA has determined that due to the chemical structure of polybutene

, it is exempt from the EDSP requirement. EPA’s P roposed Registration Review

Decision determination for polybutene is that the pesticide meets the standard for registration

under FIFRA

.7

IV. Next Steps and Timeline

A Federal Register N otice will announce the availability of this P roposed R egistration

R eview D ecision for polybutene and allow a 60

- day comment period

. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA will issue its R egistration R eview D ecision for polybutene (c ase 4076).