Docket Number: EPA-HQ-OPP-2010-0384 www.regulations.gov



## Amended Bifenthrin Final Work Plan for Registration Review

June 20113 AMENDED FINAL WORK PLAN FOR BIFENTHRIN

Introduction :

This is the Environmental Protection Agency’s (EPA or the Agency) Amended Final Work Plan for the registration review of bifenthrin. This document amends the December 2010 Bifenthrin Final Work

Plan (FWP) to include additional human health effects toxicological data requirements and to remove several other data requirements previ ously included in the data gaps ta ble. Unless otherwise stated in this amendment, all other elements of the Agency’s 2010 Bifenthrin Final Work Plan remain unchanged.

Changes to the Human Health Effects Data Needs :

The Bifenthrin Human Health Assessment Scoping Document in Support of Registration Review was completed on May 25, 2010 (D371583). The data needs as listed in the scoping document were subsequently amended by the memo Toxicology Data Needs Update: Bifenthrin Human Health Assessment Scoping Document in Support of Registration Review, dated May 17, 2011 (D389066). The May 2010 scoping document listed specif ic toxicological data needs. However, upon further evaluation of the bifenthrin database, the Agency has determined that two additional toxicology studies (GLNs 870.1300, acute inhalation and 870.3250, 90-day dermal) are also needed for use in conducting a complete risk assessment for bifenthrin during registration review. The 90-day dermal study will be used to evaluate dermal exposure of an intermediate duration. The acute inhalation study will be used to define the acute toxicity category for this exposure route and to determine the appropria te warning signal wo rd on product labels.

To summarize, the following data require ments are being added for bifenthrin:

• 870.1300 Acute Inhalation Study

• 870.3250 90-day Dermal Study

All other toxicological and resi due chemistry data requirements remain as listed in the May 2010 Bifenthrin Scoping Document and December 2010 FWP.

Changes to the Ecological Data Needs:

Acute sediment toxicity tests (GLNs 850.1735 a nd 850.1740) were erroneously listed as data requirements in the “Summary of Data Gaps – Bifent hrin” table in the Decembe r 2010 Bifenthrin FWP. The “Summary of Comments and Agency Responses ” section of the FWP explained that these two acute studies are no longer required because of the persistent half-life of bifenthrin. Although this change was explained in the text of the FWP, the data gaps summary table was not similarly updated. The requirements for chronic sediment toxicity tests for bifenthrin we re included as data gaps in the December 2010 FWP and are still required, but the acute sediment toxicity studies are not required. The table listing the data gaps for bife nthrin has been corrected below.

To summarize, the following ecological data requ irements are being removed from the list of data requirements for bifenthrin:

• 850.1735 Whole sediment: acute freshwater invertebrates

• 850.1740 Whole sediment: acute marine invertebrates4 All other environmental fate and ecological effects data requirements remain as listed in the

December 2010 Bifenthrin FWP.

Changes to Other Data Needs:

Recently, the Agency decided to no longer re quire GLN 830.7050, UV/Visible light absorption during registration review. This data was helpful during product reregistrati on, as it pertains to the structural analysis of the ac tive ingredient. However, it is not necessary for the registration review process because it does not concern human health or environmental effects.

Note on the European Review of Bifenthrin

In May 2011, the European Food Safety Authority (EFSA) published the document “Conclusion on the peer review of the pesticide risk a ssessment of the active substance bifenthrin” in the

EFSA Journal 1 . Although the findings in the peer revi ew document do not change the planned ecological or human health risk assessments, data requirements, or schedule for EPA’s registration review of bifenthr in, there are a number of studi es referenced in the EFSA assessment that EPA has not had the opportunity to review. For example, there are some studies

referenced in the EFSA document for which EP A has no data (i.e., honeybee tunnel and field studies) or studies that appear to indicate e ndpoints more sensitive than those relied on by EPA (i.e., chronic mouse study).

EPA requests that any data generated for the Eu ropean review process, which have not been previously submitted to EPA, be submitted to the Agency for review and consideration, as appropriate, during the registration re view of bifenthrin. Further, if the data includes information on adverse effects of their products, these data ar e required to be submitted to EPA in accordance with Section 6(a)(2) of the Fe deral Insecticide, Fungicide, and Rodenticide Act (FIFRA).

1 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance bifenthrin. EFSA Journal 2011;9(5):2159. [101 pp.]. doi:10.2903/j.efsa.2011.2159. Available online: www.efsa.europa.eu/efsajournal.htm5 Amended Summary of Data Gaps for Bifenthrin :

The table below summarizes all regist ration review data needs for bifenthrin. For more information on these data needs please refer to the following documents: Bifenthrin Final Work Plan, December 2010; Bifenthrin Human Health Assessment Scoping Document in Support of Registration Review , May 25, 2010 (D371583); Toxicology Data Needs Update: Bifent hrin Human Health Assessment Scoping Document in Support of Registration Review , May 17, 2011 (D389066); Revised EFED Registration Review Problem Formulation for Bifenthrin , December 22, 2010 (D384352). These documents are located in the bifenthrin docket (EPA-HQ-OPP-2010-0384).

Guideline

Number Data Requirement Test

Material Estimated

Timeframe

835.1230 Mobility Adsorption/Desorption TGAI 12

835.2120 Hydrolysis TGAI 12

835.2240 Photodegradation in Water TGAI 12

835.4100 Aerobic Soil Metabolism TGAI 24

835.4200 Anaerobic Soil Metabolism TGAI 24

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 24

835.6100 (7) 2 Environmental Chemistry Met hods (ECM) and Independent Laboratory Validation (ILV)– soil TGAI 24

835.6200 (7) 2 ECM and ILV – water and sediment TGAI 24

850.1010 Acute Toxicity Freshwater Invertebrates ( Hyalella azteca ) TGAI 12

850.1035 Acute Toxicity Estuarine/Marine Organisms – Mysid TEP 12

850.1350 Aquatic Invertebrate Life Cycle (saltwater) TGAI 12

850.1400 Fish Early Life Stage (estuarine / marine) TGAI 12

850.1500 Fish Life Cycle 3 TGAI 24

850.2100 Avian Oral Toxicity (passerine species) TGAI 12

850.4100 Seedling Emergence (Tier II 4 ) TEP 12

850.4150 Vegetative Vigor (Tier II 4 ) TEP 12

850.4400 Aquatic Plant Growth (aquatic plant toxicity) (Tier II 4 ) TGAI 12

850.5400 Aquatic Plant Growth (algal toxicity) (Tier II 4 ) TGAI 12

2 40 CFR Part 158 Guideline Study 835.6100 and 835.6200 Footnote 7 states “Environmental chemistry methods

used to generate data associated with this study must in clude results of a successful co nfirmatory method trial by an independent laboratory. Test standards and procedures for independent laboratory validation are available as addenda to the guideline for this test requirement.”

3 If the registrant chooses to conduct this study on an estu arine / marine fish, then the additional requirement for the

fish early life stage study (Guideline 850.1400) could be satisfied with this one study.

4 A Tier II study is required. A Tier I plant study may be conducted in lieu of a Tier II study with the understanding

that any adverse effects observed by th e Tier I study would necessitate conduct and submission of a Tier II study as

well.6 Guideline

Number Data Requirement Test

Material Estimated

Timeframe

Non-GDLN Whole sediment: chronic invertebrates, freshwater and

marine 5 TGAI 12

Non-GDLN POTW Treatability Study TGAI 12

Non-GDLN Leachability from Treated Wood 6 TEP 24

860.1340 Residue Analytical Method (revised version of method P2763) TGAI 24

860.1500 Magnitude of Residue in Crop Plants [herb subgroup 19A, artichoke, caneberry subgroup 13-07A, hops, cotton gin byproducts, and grapes]. TGAI 24

870.1300 Acute Inhalation Study TGAI 8

870.3250 90-Day Dermal Study TGAI 24

870.3465 90-Day Inhalation Study TGAI 24

870.7800 Immunotoxicity Study TGAI 12

5 Tests on Hyalella azteca, Chironomus dilutus , and Leptocheirus plumulosus are expected to be required.

6 Data are currently in Agency review. When available, EPA will provide the registrant with a Data Evaluation

Record documenting its review and classification of the data. Should the Agency determine these data to be unacceptable, the leachability from treated wood data requ irement will remain outstand ing, and new data will be required.