Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

3 

### ACRONYMS AND ABBREVIATIONS

BPPD The EPA’s Biopesticides and Pollution Prevention Division CFR Code of Federal Regulations
DCI Data Call-In EDSP Endocrine Disruptor Screening Program EPA U.S. Environmental Protection Agency FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register FWP Final Work Plan IDS Incident Data System MRID No. Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the Office of Pesticide Programs.
MRL Maximum Residue Limit OPP The EPA’s Office of Pesticide Programs PC Code Pesticide chemical code: a six-digit numb er assigned by OPP to identify pesticide chemicals. PMRA Health Canada’s Pest Management Regulatory Agency PWP Preliminary Work Plan TGAI Technical grade of the active ingredient TMDL Total Maximum Daily Load US United StatesSucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

4 I. PRELIMINARY WORK PLAN

A. Overview

The docket for Sucrose (Case 5117) is now open, in itiating the first public comment period for this Registration Review case (docket number EPA-HQ-OPP-2013-0751). Sucros e is currently registered in one product for use as an insect bait in a trap for c ontrolling flies in an outdoor setting. This Preliminary Work Plan (PWP) explains what the U.S. Environm ental Protection Agency’s (EPA) Office of Pesticide Programs knows about sucrose, highli ghts its anticipated data and assess ment needs, identifies types of information that would be especially useful in conducting the review, and provides an anticipated timeline for completing the Registrati on Review process for sucrose.

The Registration Review process was designed to include a public particip ation component and by sharing this information in the docket, EPA intends to inform the public of what it knows about sucrose and what types of new data or other information w ould be helpful to receive as it moves toward a decision on sucrose. The EPA encourages all interested stakeholders to review the PWP and to provide comments and additional information that will he lp the EPA’s decision-making process for this biochemical pesticide. Interested stakeholders could incl ude the following: environmental nonprofit or interest groups; pesticide manuf acturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large. In addition to general areas on which persons may wish to comment, there are so me areas identified in the PWP about which the EPA specifically seeks comments and information.

The PWP begins by describing the statutory and regul atory authorities for Registration Review. Next, it provides background on sucrose, which includes a de scription of its mode of action, the currently registered pesticide product, application rates and methods, use sites, and tolerance exemption information. Then, it lists the antic ipated data needs, risk assessm ents, and a projected Registration Review timeline for this case. Finally, the PWP pr ovides guidance for commenters, explains the next steps EPA will be taking, summarizes background information, and lists supporting studies, risk assessments, and other documents available for the Registration Review of sucrose.

Further information about this case, including background and supporting documents, is available at http://www.regulations.gov (under “SEARCH for: Rules, Comm ents, Adjudications or Supporting Documents,” enter the docket identification number, which is indicated above).
B. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review program. All pesticides distributed or sold in the United States (U S) must generally be registered by the EPA, based on scientific data showing that they will not cau se unreasonable risks to human health or the environment when used as directed on the pr oduct 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 statutor y 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 EPA periodically reevaluates pesticides to makeSucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

5 sure that, as change occurs, products in the marketpl ace can continue to be used safely. Information on this program is provided on the EPA’s website. 1

The EPA is implementing the Registration Review progr am pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will re view each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing Registration Review begin at 40 C.F.R. § 155.40. The EPA 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 EPA’s opportunity to state what it knows about the pesticide and what additional risk analyses a nd data or information it believes are needed to make a Registration Review decision. After reviewing and responding to comments a nd data received in the docket during this initial comment period, the EPA will develop a Final Work Plan (FWP) and the anticipated schedule for the Registration Review of Sucrose.
C. Background and Regulatory Information

i. Summary of the Active Ingredient, Usage and the Associated Pesticide Product

Sucrose, also known as common table s ugar, is registered as a biochemical pesticide for use as an insect bait. EPA has no available usage data for sucrose, likely due to its non-agri cultural use pattern.

On June 2, 2009, the EPA registered Bull Run Fly Attrac tant as a fly trap for outdoor use. Bull Run Fly Attractant is the only curr ently registered pesticide product containing sucrose as an active ingredient. Through use of the currently register ed product containing sucrose as an active ingredient, it is intended that flies be attracted into a bag filled with the sucr ose solution where they eventually die as a result of drowning. The bag is made of plastic and designed to allow flies to enter th rough a small opening at the top. The product is intended to be hung in outdoor areas where flies congregate. Further information regarding this product appear s in Table 2, below.

Table 1 provides a summary of the chemical facts for Sucrose.

Table 1. Chemical Facts for Sucrose

PC code 000023 Case Number 5117 CAS Number 57-50-1 Year first registered 2009 Pesticide Type Bait Chemical class Biochemical Reregistration Eligibility Decision (RED) Not applicable. Because it was registered after November 1984, sucrose was not subject to reregistration. Tolerance Reassessment Eligibility Decision (TRED) Not applicable.

Cumulative group Not applicable. Sucrose has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation This chemical falls under the exemption from a requirement of a tolerance established at 40 CFR § 180.950, Tolerance exemption for minimal risk active and inert ingredients. Non-pesticidal uses Commonly consumed food ingredient.

1 See http://www.epa.gov/oppsrr d1/registration_review/

.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

6 TABLE 2. Information About the Currently Registered Sucrose Pesticide Product

EPA Registration

Number Product Name (% Active Ingredient;

Formulation Type) Date Registered Application Rates Application Methods Use Sites

84565-2 Bull Run Fly Attractant (42.1% Sucrose; dry formulation, user adds water) June 2, 2009 1 trap per infested area (area not specified) - trap will catch up to 20,000 flies Hanging trap Outdoor lawn/garden/farm use (compost piles, garbage area, stables, etc)

ii. Tolerance Actions

Currently, there are no registered pro ducts for food use that contain sucr ose. However, sucrose is exempt from the requirement of a tolerance as follows:

40 C.F.R. § 180.950 Tolerance exemptions for mi nimal risk active and inert ingredients

Unless specifically excluded, residu es resulting from the use of the fo llowing substances as either an inert or an active ingredient in a pesticide chem ical formulation, including antimicrobial pesticide chemicals, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices.

(a) Commonly consumed food commodities. Commonly consumed food commodities means foods that are commonly consumed for their nutrient properties. The term commonly consumed food commodities shall only apply to food commoditie s (whether a raw agricultural commodity or a processed commodity) in the form the commodity is so ld or distributed to th e public for consumption.

(1) Included within the term commo nly consumed food commodities are:

(i) Sugars such as sucrose, lactose, dextro se and fructose, and i nvert sugar and syrup.

(ii) Spices such as cinn amon, cloves, and red pepper.

(iii) Herbs such as basil, anise, or fenugreek.

(2) Excluded from the term commo nly consumed food commodities are:

(i) Any food commodity that is adulterated under 21 U.S.C. 342.

(ii) Both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

7 (iii) Alcoholic beverages.

(iv) Dietary supplements.

(b) Animal feed items. Animal feed items means meat meal and all items derived from field crops that are fed to livestock excluding both the raw and processed forms of pe anuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat. Meat meal is an animal feed composed of dried animal fat and protein that has been sterilize d. Other than meat meal, the term animal feed item does not extend to any item designed to be fed to animals that contai ns, to any extent, components of animals. Included within the term animal feed items are:

(1) The hulls and shells of the commodities specif ied in paragraph (a)(2)(ii) of this section, and cocoa bean.

(2) Bird feed such as canary seed.

(3) Any feed component of a me dicated feed meeting the definition of an animal feed item.

(c) Edible fats and oils. Edible fats and oils means all edible (food or feed) fats and oils, derived from either plants or animals, whether or not commonly consumed, includi ng products derived from hydrogenating (food or feed) oils, or liquefying (food or feed) fats.

(1) Included within the term edible fats and oils ar e oils (such as soybean o il) that are derived from the commodities specified in paragraph (a)(2)(ii) of th is section when such oils are highly refined via a solvent extraction procedure.

(2) Excluded from the term edible fats and oils are plant oils used in the pesticide chemical formulation specifically to impart their ch aracteristic fragranc e and/or flavoring.

(d) [Reserved]

(e) Specific chemical substances. Residues resulting from the use of the following substances [ See 40 CFR § 180.950 for table ] as either an inert or an active ingredient in a pesticide chemical formulation, including antimicrobi al pesticide chemicals, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices.

Federal Register Citation – Final Rule ( 67 FR 36534, May 24, 2002 )

D. Anticipated Data Needs and Risk Assessments

Provided below are tables of the current data requirem ents for biochemical pestic ides as set forth in 40 CFR § 158, subpart U. They are arraye d by scientific discipline (i.e., product chemistry, human health assessment, and nontarget organisms and environmenta l fate) and descriptions are included regarding how the data requirements have been fulfilled or where data have been waived. At this time, no data gaps (anticipated data needs) for sucrose have be en identified. The most recent comprehensive risk assessment for sucrose was completed September 20, 2008, in support of the first biochemicalSucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

8 registration of sucrose, which occurred on June 2, 2009 (U.S. EPA, 2008). Because there are no data gaps for sucrose and no additional in formation has been received on th is biochemical since it was first registered, the Agency does not anticipate the need to conduct a new risk assessment during registration review.

i. Product Analysis ( 40 C.F.R. § 158.2030 )

TABLE 2. Summary of Product Analysis Data for Sucrose
Harmonized

Guideline Number Data Requirement Has Data Requirement Been Addressed? How? Source MRID No.

880.1100 Product Identity and Composition Yes – Study U.S. EPA (2008) 473969-22

880.1200 Description of Staring Materials, Production, and Formulation Process Yes – Study U.S. EPA (2008) 473969-22

880.1400 Discussion of Formation of Impurities Yes – Study U.S. EPA (2008) 473969-22 830.1700 Preliminary Analysis Yes – Study U.S. EPA (2008) 473969-22 830.1750 Certified Limits Yes – Study U.S. EPA (2008) 473969-22 830.1800 Enforcement Analytical Method Yes – Study U.S. EPA (2008) 473969-22

TABLE 3. Summary of Physical and Chemical Characteristics for Sucrose
Harmonized

Guideline Number Data Requirement Has Data Requirement Been Addressed? How? Source MRID No.

830.6302 Color Yes – Study U.S. EPA (2008) 473969-23

830.6303 Physical State Yes – Study U.S. EPA (2008) 473969-23
830.6304 Odor Yes – Study U.S. EPA (2008) 473969-23

830.6313 Stability to Normal and Elevated Temperatures, Metals and Metal Ions Yes – Study U.S. EPA (2008) 473969-23

830.6315 Flammability Not applicable; data are not re quired for technical grade active ingredients.
830.6317 Storage Stability Not applicable; data are not re quired for technical grade active ingredients. 830.6319 Miscibility Not applicable; data are not required for technical grade active ingredients. 830.6320 Corrosion Characteristics Not applicable; data are not required for technical grade active ingredients. 830.7000 pH Yes – Study U.S. EPA (2008) 473969-24
830.7050 UV/Visible Light Absorption Not applicable to the TGAI test substance. 1

830.7100 Viscosity Not applicable; data are not re quired for technical grade active ingredients. 830.7200 Melting Point/Melting Range Yes – Study U.S. EPA (2008) 473969-23 830.7220 Boiling Point/Boiling Range Not applicable to the TGAI test substance. 2

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) Yes – Study U.S. EPA (2008) 473969-23Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

9 TABLE 3. Summary of Physical and Chemical Characteristics for Sucrose
Harmonized

Guideline Number Data Requirement Has Data Requirement Been Addressed? How? Source MRID No.

830.7520 Particle Size, Fiber Length, and Diameter Distribution Not applicable to the TGAI test substance. 3

830.7550 830.7560 830.7570 Partition Coefficient (n-Octanol Water) Yes – Study U.S. EPA (2008) 473969-23

830.7840 Water Solubility Yes – Study U.S. EPA (2008) 473969-23
830.7950 Vapor Pressure Yes – Study U.S. EPA (2008) 473969-23

1 UV/Visible Light Absorption data are not applicable because sucr ose is white and sucrose solutions are colorless; therefore, s ucrose does not absorb visible light.
2 Boiling point data are not app licable because sucrose is a so lid at room temperature.
3 Particle size, fiber length, and diameter distribution data is not app licable because sucrose is no t water insoluble or fibrou s (with diameter ≥ 0.1 μm).

ii. Human Health Assessment ( 40 C.F.R. § 158.2050 )

TABLE 4. Summary of Human Heal th Assessment Data for Sucrose
Harmonized

Guideline Number Data Requirement Has Data Requirement Been Addressed? How? Source MRID No. or Other Reference

870.1100 Acute Oral Toxicity - Rat Yes – Data Waiver U.S EPA (2008) 473969-27

870.1200 Acute Dermal Toxicity Yes – Data Waiver U.S EPA (2008) 473969-27

870.1300 Acute Inhalation Toxicity – Rat Yes – Data Waiver U.S EPA (2008) 473969-27

870.2400 Primary Eye Irritation Yes – Data Waiver U.S EPA (2008) 473969-27

870.2500 Primary Dermal Irritation Yes – Data Waiver U.S EPA (2008) 473969-27

870.2600 Dermal Sensitization Yes – Data Waiver U.S EPA (2008) 473969-27
870.3100 90-Day Oral (one species) Yes – Data Waiver U.S EPA (2008) 473969-27
870.3250 90-Day Dermal – Rat Yes – Data Waiver U.S EPA (2008) 473969-27
870.3465 90-Day Inhalation – Rat Yes – Data Waiver U.S EPA (2008) 473969-27
870.3700 Prenatal Developmental – Rat Preferably Yes – Data Waiver U.S EPA (2008) 473969-27

870.5100 Bacterial Reverse Mutation Assay Yes – Data Waiver U.S EPA (2008) 473969-27

870.5300 870.5375 In vitro Mammalian Cell Assay Yes – Data Waiver U.S EPA (2008) 473969-27Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

10 iii. Nontarget Organisms and Environment Fate ( 40 C.F.R. § 158.2060 )

TABLE 5. Summary of Nontarget Organism Data for Sucrose
Harmonized

Guideline Number Data Requirement Has Data Requirement Been Addressed? How? Source MRID No.

850.2100 Avian Acute Oral Toxicity Yes – Data Waiver U.S EPA (2008) 473969-26

850.2200 Avian Dietary Toxicity Yes – Data Waiver U.S EPA (2008) 473969-26

850.1075 Fish Acute Toxicity, Freshwater Yes – Data Waiver U.S EPA (2008) 473969-26

850.1010 Aquatic Invertebrate Acute Toxicity, Freshwater Yes – Data Waiver U.S EPA (2008) 473969-26

850.4100 Terrestrial Plant Toxicity, Seedling Emergence Yes – Data Waiver U.S EPA (2008) 473969-26

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor Yes – Data Waiver U.S EPA (2008) 473969-26

880.4350 Nontarget Insect Testing Yes – Data Waiver U.S EPA (2008) 473969-26

E. Risk to Threatened and Endangered Species

Sucrose is a commonly consumed food commodity. Acut e and subchronic human health toxicity studies have been waived, based upon the long history of safe use of sucrose (U.S. EPA, 2008). Nontarget organism studies were waived, based upon the natura l occurrence of sucrose (e.g., sugar cane and sugar beets), and the packaging of sucrose in a trap for the currently register ed product, which is not expected to result in exposure to n ontarget organisms. Consequently, advers e effects to terrestrial and aquatic organisms are expected to be negligible; therefore, the effects determination for endangered/threatened species and designated critical habi tat is a “No Effect.” EPA anticipat es conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the Registration Review process that would indicate such an assessment would be needed to inform the Agency’s decision.

F. Endocrine Effects

As required by the Administrator under the Fede ral Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the EPA has developed the Endocrine Disruptor Screening Pr ogram (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pestic ide active and other ingredients) ma y have an effect in humans or wildlife similar to an effect produc ed by a “naturally occu rring estrogen, or other such endocrine effects as the Administrator may designate.”Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

11 FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurr ing estrogenic substance.
Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingr edients and 9 inert ingredients. A second list of chemicals identified for EDSP scr eening was published on June 14, 2013, 2 and includes some pesticides scheduled for registration review and chemicals found in water. Sucrose is not among the group of pesticide active ingredients on the lis ts to be screened under the EDSP.
The EPA, as part of this Preliminary Work Plan, believes that sucrose is a substance that would not likely produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. As such, pursuant to Section 408(p)(4), th e EPA will determine in the future whether it can exempt sucrose from the requirements of the Secti on 408(p) EDSP. In the event the EPA does determine to exempt this substance from the EDSP, an order will be issued.
For further information on the status of the EDSP, th e policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, pleas e visit our website at http://www.epa.gov/endo/

.

G. Incidents

From January 1, 1991 through November 15, 2013, the Offi ce of Pesticide Programs’ Incident Data System (IDS) and Ecological Incident Information System indicates that there have been no reports of adverse human, domestic animal, or environmenta l incidents for the pesticide product containing sucrose as its active ingredient. The EPA will consid er any incident data or comments submitted in response to this Preliminary Work Plan.

2 See http://www.regulations. gov/#!documentDetail;D=E PA-HQ-OPPT-2009-0477-0074 for the second list of chemicals.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

12 H. Timeline

Below is the projected timeline for Re gistration Review case 5117: Sucrose.

Activities Estimated Month/Year
Opening the Docket Open Docket and 60-Day Public Comment Period for Sucrose December 2013 Close Public Comment Period February 2014

Case Development
Issue Final Work Plan June 2014
Issue Data Call-in N/A
Data Submission N/A Open 30-Day Public Comment Period for Draft Risk Assessments N/A
Close Public Comment Period N/A

Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review Decision November 2014

Close Public Comment Period January 2015 Final Decision February 2015 *Estimated Total (years) 1 year and 2 months
* This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time. That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline.

I. Guidance for Commenters

The public is invited to comment on the EPA’s Prel iminary Work Plan and rationale. The areas below highlight topics of special intere st to the EPA where comments, info rmation and data, or reference to sources of additional information could be of particular use. The EPA will consider all comments, as well as any additional information or data provided in a timely manne r, prior to issuing a Final Work Plan for this case.

i. Environmental Justice

The EPA seeks to achieve environmental justice, the fair treatment and meani ngful 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 EPA seeks information on any groups or segments of the population who, as a result of their location, cultu ral practices, or other factor s, may have unusually high exposure to the pesticidal use of sucrose, compared to the general population. Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

13 ii. Water Quality

Sucrose is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 3 In addition, no Total Maximum Daily Loads (TMDLs) have been developed for sucrose. 4 More information on impaired water bodies and TMDLs can be found at the EPA’s website. 5 The EPA invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the Office of Pesticide Program’s (OPP) Standard Operating Procedure: In clusion of Impaired Wate r Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process 6 to ensure they can be used quantitatively or qualitati vely in pesticide risk assessments.

iii. Trade Irritants

Through the Registration Review process, the EPA inte nds to solicit information on trade irritants and, to the extent feasible, take steps toward facilitati ng irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs) and, if necessary, may modify tolerance levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of 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.

Pesticidal food-use of sucrose is covered under an existing exemption from the requirement of a tolerance. Moreover, there are no kno wn MRLs for sucrose. Therefore, the EPA does not anticipate that current uses of sucrose will pose concerns as trade irritants.

iv. Additional Information

Stakeholders are also specifically asked to provide information and da ta that will assist the EPA in refining the risk assessments. The EPA is interest ed in obtaining the followi ng information regarding Sucrose:

 Any data, information, and/or scientific ratio nale that could be used to fill data gaps

 Confirmation on the following label information:

- Sites of application - Formulations - Application methods and equipment - Maximum application rates - Frequency of application, app lication intervals, and maxi mum number of applications - Geographic limitations on use

 Use or potential use distribu tion (e.g., acreage and geographical distribution of relevant use sites)

 Median and 90 th percentile reported use rates (lbs active ingredien t/1,000 square feet) from usage data – national, state, and county

3 Based on information provided at http://www.epa.gov/owow/tmdl/

. 4 Based on information provided at http://iaspub.epa.gov/tmdl_waters 10/text_search.tmdl_search_form

. 5 See http://www.epa.gov/owow/tmdl/

. 6 This document can be found at http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm

.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

14  Application timing (date of first application and applicat ion intervals) – national, state, and county

 Usage/use information for nonagricultural uses

 Typical applicati on interval (days)

 State or local use restrictions

 Monitoring data

J. Next Steps

After the 60-day comment period closes, the EPA will review and respond to any comments received in a timely manner and then issue a Final Work Plan for case 5117: Sucrose.Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

15 II. BIBLIOGRAPHY

A. Studies Supporting Registration Review of Sucrose

MRID Number Citation Agency Receipt

Date

45141400 Triangle Laboratories Inc. (200 0) Submission of Efficacy Data in Support of the Application for Registration of RS21. Transmittal of 1 Study. 19-Apr2000

45141401 Roper, C. (2000) Report of the Efficacy of RS21. Unpublishe d study prepared by Triangle Laboratories Inc. 35 p. 19-Apr2000

45141500 Triangle Laboratories Inc. (2000) Submission of Product Chemistry Data in Support of the Application for Registration of RS21. Transmittal of 1 Study. 06-Jun2000

45141501 Roper, C. (2000) 830 Series Tests of RS21. Unp ublished study prepared by Triangle Laboratories Inc. 26 p. {OPPTS 830.1600, 830.1620, 830.1650, 830.1700, 830.1750, 830.1800, 830.1900, 830.6302, 830.6303, 830.6304, 830.6307, 830.631 6, 830.6317, 830.6320, 830.7200, 830.7220, 830.7370, 830.7840, 830.7950} 06-Jun2000

47396900 Bull Run Scientific, VBT. (2008) Submission of Pr oduct Chemistry, Toxicity and Efficacy Data in Support of the Application for Registration of Bull Run Fly Attractant. Transmittal of 37 Studies. 08-Apr2008

47396903 Smith, C. (2008) Bull Run Fly A ttractant: Field Bioassays to Eval uate Efficacy, Effects on NonTarget Organisms, and Storage Stability. Unpub lished study prepared by Bull Run Scientific, VBT. 11 p. 08-Apr2008

47396906 Smith, C. (2008) Bull Run Fly Attractant: Product Identity, Composition, and Analysis. Unpublished study prepared by Bull Run Scientific, VBT. 91 p. 08-Apr2008

47396907 Smith, C. (2008) Bull Run Fly Attractant: Physi cal State, pH and Bulk Density. Unpublished study prepared by Bull Run Scientific, VBT. 17 p. 08-Apr2008

47396908 Smith, C. (2008) Bull Run Fly Attractant: Corrosio n Characteristics. Unp ublished study prepared by Bull Run Scientific, VBT. 7 p. 08-Apr2008

47396909 Smith, C. (2008) Bull Run Attractant: Effects on Non-Target Organisms. Unpublished study prepared by Bull Run Scientific, VBT. 7 p. 08-Apr2008

47396911 Smith, C. (2008) Bull Run Fly Attractant: Tier I Mammalian Toxicology. Unpublished study prepared by Bull Run Scientific, VBT. 8 p. 08-Apr2008

47396922 Smith, C. (2008) Sucrose: Product Identity, Composition and Analysis. Unpublished study prepared by Bull Run Scientific, VBT. 29 p. 08-Apr2008

47396923 Smith, C. (2008) Sucrose: Physical-Chemical Characteristics. Unpublished study prepared by Bull Run Scientific, VBT. 20 p. 08-Apr2008

47396924 Smith, C. (2008) Sucrose: pH. Unpublished study prepared by Bull Run Scientific, VBT. 13 p. 08-Apr2008

47396925 Smith, C. (2008) Sucrose: UV/Visible Light Absorption. Unpublished study prepared by Bull Run Scientific, VBT. 5 p. 08-Apr2008

47396926 Smith, C. (2008) Sucrose: Effects on Non-Target Organisms. Unpublished study prepared by Bull Run Scientific, VBT. 7 p. 08-Apr2008Sucrose EPA-HQ-OPP-2013-0751 www.regulations.gov

16 47396927 Smith, C. (2008) Sucrose: Tier I Mammalian Toxicology. Unpublished study prepared by Bull Run Scientific, VBT. 10 p. 08-Apr2008

47406000 Bull Run Scientific, VBT (2008) Submission of Toxi city Data in Support of the Application for Registration of Bull Run Fly Attractant. Transmittal of 1 Study. 18-Apr2008

47406001 Noonan, R. (2008) NFTD Disposable Fly Trap Pouch Ingredients: Sample Code: S1-352-A (Including Report Supplement). Project Number: X0I198G, 16D/05. Unpublished study prepared by Northwest Pacific Laboratories, Inc. 25 p. 18-Apr2008

B. U.S. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2008. Science Review in Support of th e Registration of a new product, Bull Run Fly Attractant, containing 3 new ac tive ingredients, sucrose, tr imethylamine (99.94% w/w), and yeast, and 2 active ingredients in previously registered products from unregistered sources, putrescent whole egg solid and indole (99.92% w/w). Memorandum from C. Fuentes to J. Fournier, dated September 30, 2008.

U.S. EPA. 2009. Science Review of registrant response to deficien cies in support of new product registration. The proposed new end-use product, Bull Run Fly Attractant, will be inside traps of various sizes, and it contains 2 new active ingredients, sucros e, trimethylamine (99.94% w/w), and 3 active ingredient in previously registered products fr om unregistered sources, putrescent whole egg solid, yeast and indole (99.92% w/w). Memorandum from C. Fuentes to J. Fournier, dated February 26, 2009.