1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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## T ABLE 

## O F 

## C ONTENTS



### I. PRELIMINARY WORK PLAN ........................................................................................... 4 A. Overview ..................................................................................................................... 4 B. Statutory and Regulatory Authority ............................................................................. 4 C. Background and Regulatory Information ..................................................................... 5 D. Anticipated Data Needs and Risk Assessments ............................................................. 9 E. Risk to Threatened and Endangered Species .............................................................. 12 F. Endocrine Effects ....................................................................................................... 14 G. Incidents .................................................................................................................... 14 I. Guidance for Commenters ......................................................................................... 15 J. Next Steps .................................................................................................................. 17

II. BIBLIOGRAPHY .............................................................................................................. 18 A. Studies Supporting Registration Review of 1-MCP ..................................................... 18 B. U.S. Environmental Protection Agency Regu latory Documents and Risk Assessment Memoranda ............................................................................................................... 371-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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## ACRONYMS AND ABBREVIATIONS

AI or a.i. Active Ingredient BPPD The EPA’s Biopesticides and Pollution Prevention Division C.F.R. 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. PWP Preliminary Work Plan TGAI Technical grade of the active ingredient TMDL Total Maximum Daily Load US United States1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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### I. PRELIMINARY WORK PLAN

A. Overview

The docket (EPA-HQ-OPP-2014-0670) for 1-methylcycl opropene (1-MCP) is now open, initiating the first public comment period for this registrati on review case (case numbe r 6075). Sixteen products containing 1-MCP are currently registered for ou tdoor, commercial, ornamental and food use to counteract the effects of ethylene (r ipening). This Preliminary Work Pl an (PWP) explains what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) knows about 1-MCP, highlights its anticipated data and assessment needs, identifies types of information that would be especially useful in conducting the review, and provides an anticipated timeline for completing the registration review process for 1-MCP.

The registration review process was designed to include a public participation component and, by sharing this information in the docket, EPA intends to inform the public of what it knows about 1-MCP and what types of new data or other information w ould be helpful to receive as it moves toward a decision on 1-MCP. 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 1-MCP, which includes a desc ription of its mode of action, the currently registered pesticide products, ap plication rates and me thods, 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 fo r the registration review of 1-MCP.

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 product 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 st atutory standard of no unreasonable ad verse effects to human health or the environment. Changes in science, public policy , and pesticide use practices will occur over time. Through the registration review progra m, the EPA periodically reevaluates pesticides to make sure that,1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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### as change occurs, products in the marketplace 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 pest icide 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 when 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 1-MCP.

C. Background and Regulatory Information

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

Products containing 1-methylcycloprope ne (1-MCP) are registered for use as a post-harvest tool for counteracting the undesirable effects of ethylene on harvested fruits, vegetables, and ornamental (such as cut flowers) during transport and storage, and for pre-harvest use on growing crops and ornamentals. Under normal environmental conditions, 1-MCP is a gas. End-use products (EPs) containing 1-MCP are solid (tablets or powder) or liquid formulations. In these products, 1-MCP is encapsulated in the formulation to enable delivery. When the formulations are applied, 1-MCP is released to the target crop.

End-use products (EPs) containing 1-MCP are used in enclosed containers, su ch as coolers, truck trailers, greenhouses, storag e facilities, and shipping containers or in the field applied via ground spray tanks or aerial application.

The following table provides a summary of the chemical facts for 1-MCP:

Table 1. Chemical Facts for 1-Methylcyclopropene (1-MCP) PC code 224459 Case Number 6075 CAS Number 3100-04-7 Year first registered 1999 Pesticide Type Plant growth regulator Chemical class Biochemical Reregistration Eligibility Decision (RED) Not applicable. Because it was regi stered after November 1984, 1- Methylcyclopropene was not subject to reregistration. Tolerance Reassessment Eligibility Decision (TRED) Not applicable. 1-Methylcyclopropene is exempt from the requirement for a tolerance. See 40 CFR § 180.1220. Cumulative group Not applicable. 1-Methylcycloprop ene has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

1 See http://www2.epa.gov/pes ticide-reevaluation

.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

6 Table 1. Chemical Facts for 1-Methylcyclopropene (1-MCP) 40 CFR Citation § 180.1220: 1-Methylcyclopropene; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of the 1-Methylcyclopropene in or on fruits and vegetables when: (a) Used as a post-harvest plant growth regulator, i.e. , for the purpose of inhibiting the effects of ethylene. (b) Applied or used outdoors for pre-harvest treatments. Non-pesticidal uses N/A


### The following table summarizes the use and usage information for 1-MCP:

Table 2. 1-Methylcyclopropene (1-MCP) Use and Usage Information

Summary of Use 1-MCP is registered for use to prolong the life of ornamental plants and cut flowers, as a post-harvest tool for co unteracting the undesirable effects of ethylene on harvested fruits and vegetables during transport and storage, and for pre-harvest use on growing crops and ornamentals.

Use Sites Ornamental plants, cut flowers, and harvested fruits and vegetables in enclosed indoor sites, such as coolers, truck trailers, greenhouses, storage facilities, and shipping containers. Summary of Usage EPA has no available usage data for 1-MCP.

Formulation Types 1-MCP is a gas at room temperature, however, end-use product formulations are powders, tablets and liquids. 1-MCP is released from these formulations with the addition of water or proprietar y buffer at the time of application.

Application Method Powders or tablets are mixed with water or a buffer to release 1-MCP gas in the presence of stored or growing commodities (ground application); liquid formulations are mixed with water and applied within 30 minutes to the commodity (ground or aerial application). Technical Registrant AgroFresh, Inc., a subsidiary of Rohm and Haas Company.

No. of Registrations 16

Restricted Use No



### The following table lists the currently registered products containing 1-MC P as their active ingredient.

Table 3. Information Ab out the Currently Registered 1-Methylcyclopropene (1-MC P) Pesticide Products
EPA Registration

Number Product Name (% Active Ingredient;

Formulation Type) Date Registered Application Rates Application Methods Use Sites

71297-1 ETHYLBLOC (0.14%; powder) April 22, 1999 1.5 g Ethylbloc + 1/1.5 oz Mixing solution per 100/200 ft 3 Apply solution directly onto plants and flowers Fresh cut flowers and potted flowering, bedding, nursery and foliage plants

71297-2 SMARTFRESH TECHNOLOGY (3.3%; powder) July 17, 2002 Depending on crop, 0.017- 0.067

oz/1000ft 3 Apply with use of proprietary generator; place appropriate Post-harvest fruits (apples, melons, tomatoes, pears, avocadoes,
mangos, papayas, kiwifruit, plums,1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

7 Table 3. Information Ab out the Currently Registered 1-Methylcyclopropene (1-MC P) Pesticide Products
EPA Registration

Number Product Name (% Active Ingredient;

Formulation Type) Date Registered Application Rates Application Methods Use Sites

size Smartfresh pouch into

water within generator apricots and persimmons)

71297-3 SMARTFRESH SMARTTABS (0.63%; tablets) March 11, 2004 Depending on size of enclosed area, add 1-14 tablets to Activator solution Place appropriate number of tablets into container containing Activator solution Food commodities derived from: apples, melons, tomatoes, pears, avocadoes,
mangos, papayas, kiwifruit, plums,

apricots and persimmons

71297-4 MANUFACTURINGUSE PRODUCT-SF (4.5%; powder) January 30, 2004 N/A N/A For formulation into plant growth regulators (PGRs) that can be applied to apples, melons, tomatoes, pears, avocados, mangos, papayas, kiwifruit, peaches, nectarines,

plums, apricots,

persimmons, flowers and ornamental plants

71297-5 ETHYLBLOC SACHET (0.014%; sachet) February 3, 2006 Number of sachets depends on box volume (2-10) Dip sachets into clean water, place into box containing flowers and close lid Fresh cut flowers and potted flowering and foliage plants

71297-6 AFXRD-038 (3.8%; pouch) April 21, 2008 Depending on crop, 9.4 oz/acre to 112.7 oz/acre Apply through spray tank; adjuvant must be used Apples, pears, kiwifruit, walnut, tomatoes, peppers, corn, cotton, rice, soybean, sunflower, wheat

71297-7 AF-600 (1%; liquid) April 8, 2009 Depending on crop, 36-428 fl oz/acre Apply through spray tank; aerial application also possible Apples, pears, kiwifruit, walnut

71297-8 A17492F (1%; liquid) March 11, 2010 5.7 -11.4 fl oz/acre Apply through spray tank; aerial application also possible Tomatoes, peppers, corn, cotton, rice, soybean, sunflower, wheat

71297-10 SMARTFRESH PROTABS (2%; tablets) March 5, 2012 Depending on crop and size of space, x number of tablets used (1 tablet treats

1350ft 3 -5300ft 3 ) Place appropriate number of tablets into ProPack pouch Apples, avocadoes, bananas, broccoli, kiwifruit, melons,

persimmons, tomatoes, pears, peaches, nectarines,1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

8 Table 3. Information Ab out the Currently Registered 1-Methylcyclopropene (1-MC P) Pesticide Products
EPA Registration

Number Product Name (% Active Ingredient;

Formulation Type) Date Registered Application Rates Application Methods Use Sites

plums, plumcots, apricots

71297-11 AF-2005 (0.8%; liquid) May 16, 2012 90-470 fl oz/acre Apply through spray tank; aerial application also possible Apples and pears

71297-12 MANUFACTURINGUSE PRODUCT – EB – 0.14 (0.14%; powder) January 30, 2013 N/A N/A For formulation into PGRs that can

be applied to cut flowers, potted flowers, nursery plants and foliage plants

71297-13 MANUFACTURINGUSE PRODUCT –SF – 3.3 (3.3%; powder) January 30, 2013 N/A N/A For formulation into PGRs that can be applied to apples, melons, tomatoes, pears, avocados, mangos, papayas, kiwifruit, peaches, nectarines,

plums, apricots, plumcots, Asian pears, bananas, broccoli, persimmons, flowers and ornamental plants

71297-14 MANUFACTURINGUSE PRODUCT – EB -0.014 (0.014%; powder) January 30, 2013 N/A N/A For formulation into PGRs that can

be applied to cut flowers, potted flowers, nursery plants, bedding plants and foliage plants

71297-15 MANUFACTURINGUSE PRODUCT – ST -0.63 (0.63%; powder) January 30, 2013 N/A N/A For formulation into PGRs that can be applied to apples, bananas, broccoli, melons, tomatoes, pears,

Asian pears, avocados, kiwifruit, peaches, nectarines,

plums, plumcots, apricots, persimmons, cut flowers, potted1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

9 Table 3. Information Ab out the Currently Registered 1-Methylcyclopropene (1-MC P) Pesticide Products
EPA Registration

Number Product Name (% Active Ingredient;

Formulation Type) Date Registered Application Rates Application Methods Use Sites

flowers, and bedding, nursery and potted plants

71297-16 MANUFACTURINGUSE PRODUCT – PT – 2.0 (2.0%; powder) January 30, 2013 N/A

N/A For formulation into PGRs that can be applied to apples, avocados, bananas, broccoli, kiwifruit, melons,

persimmons, tomatoes, pears,

Asian pears, peaches, nectarines,

plums, plumcots, and apricots

71297-17 AF-701 (1.3%; liquid) April 10, 2014 Depending on crop, 12-242 fl oz/acre Ground application through injector nurse tank; aerial application also possible Apples, pears, kiwifruit



### ii. Tolerance Actions

1-MCP is exempt from the requireme nt of a tolerance as follows:

40 C.F.R. § 180.1220 1-Methylcyclopropene; exempti on from the requirement of tolerance:

An exemption from the requirement of a tole rance is established for residues of the 1- Methylcyclopropene in or on fruits and vegetables when: (a) Used as a post-harvest plant growth regulator, i.e. , for the purpose of inhibiting the effects of ethylene. (b) Applied or used outdoors for pre-harvest treatments.

Federal Register Citation – Final Rule 73 FR 19150, April 9, 2008.

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 C.F.R. § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health assessment, and nontarget organisms) 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 1-MCP have been identified. The most recent comprehensive risk assessment for 1-MCP was completed February 21, 2001, in support of a request to establish an exemption from the requirement of a tolerance for residues of 1-MCP on all food commod ities (U.S. EPA, 2001). Be cause there are no data gaps for 1-MCP or anticipated data needs, and no additional information has been received on this1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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### biochemical since this most recent risk assessment, the Agency does not anticipate the need to conduct a new risk assessment during registration review.

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

Table 4. Summary of Product Analysis Data for 1-Methylcyclopropene (1-MCP)

Harmonized

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

880.1100 Product Identity and Composition Yes – Study 44517001

880.1200 Description of Staring Materials, Production, and Formulation Process Yes – Study 44464701

880.1400 Discussion of Formation of Impurities Yes – Study 44517002 830.1700 Preliminary Analysis Yes – Study 44464702 830.1750 Certified Limits Yes – Study 44517003 830.1800 Enforcement Analytical Method Yes – Study 44464703

Table 5. Summary of Physical and Chemical Characteristics for 1-Methylcyclopropene (1-MCP)
Harmonized

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

830.6302 Color Yes – Study 44567601

830.6303 Physical State Yes – Study 44567601
830.6304 Odor Yes – Study 44567601

830.6313 Stability to Normal and Elevated Temperatures, Metals and Metal Ions Yes – Study U.S. EPA, 2008

830.7000 pH Yes – Study U.S. EPA, 2008
830.7050 UV/Visible Light Absorption Yes – Study 47088604
830.7200 Melting Point/Melting Range Not required 2 830.7220 Boiling Point/Boiling Range Not required 3

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) Yes – Study U.S. EPA, 2008

830.7520 Particle Size, Fiber Length, and Diameter Distribution Not required – substance is a gas.

830.7550 830.7560 830.7570 Partition Coefficient (n-Oct anol Water) Not required 4

2 Per 40 § CFR 158.2030 Test Note 13: Required when the technical ch emical is a solid at room temp erature. The technical grade ac tive ingredient (TGAI) 1-MCP is a gas.
3 Per 40 § CFR 158.2030 Test Note 14: Required when the technica l chemical is a liquid at room temperature. 1-MCP is a gas.
4 Per 40 § CFR 158.2030 Test Note 16: Required for organic chemi cals unless they dissociate in wate r or are partially or complet ely soluble in water. 1-MCP is partially soluble in water.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

11 Table 5. Summary of Physical and Chemical Characteristics for 1-Methylcyclopropene (1-MCP)
Harmonized

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

830.7840 Water Solubility Yes – Study 47088615

830.7950 Vapor Pressure Yes – Study 45458603 47088614



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

1-MCP exhibits low acute toxicity fo r all routes of exposure. It is a Toxicity Category IV for acute oral toxicity, acute inhalation toxicity, and primary dermal irritation, and Toxicity Category III for acute dermal toxicity and primary eye irritation (U.S. EPA, 2001) . 1-MCP is not a skin sensitizer, and no hypersensitivity incidents were observed following e xposure to 1-MCP. Data and information submitted to the Agency support the conclusions that 1-MCP is not mutagenic, not subchroni cally toxic, and is not a developmental toxicant.

Table 6. Summary of Human Health Assessment Data for 1-Methylcyclopropene
Harmonized

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

870.1100 Acute Oral Toxicity - Rat Yes – Study 44464704
870.1200 Acute Dermal Toxicity Yes – Study 44464705
870.1300 Acute Inhalation Toxicity – Rat Yes – Study 44464706 870.2400 Primary Eye Irritation Yes – Study 44464707 870.2500 Primary Dermal Irritation Yes – Study 44464708 870.2600 Dermal Sensitization Yes – Study 44517005

None Hypersensitivity Incidents None have been reported 5
870.3100 90-Day Oral (one species) Yes – Rationale 6 U.S. EPA, 2001 870.3250 90-Day Dermal – Rat Not required 7 870.3465 90-Day Inhalation – Rat Yes – Study U.S. EPA, 2008
870.3700 Prenatal Developmental – Rat Preferably Yes – Study U.S. EPA, 2008 870.5100 Bacterial Reverse Mutation Assay Yes – Study 49265008 870.5300 870.5375 In vitro Mammalian Cell Assay Yes – Study 49265009 49265010

5 Any occurrence must be reported as an adverse incident (FIFRA § 6(a)(2)).
6 The applicant submitted a scientifically creditable rationale in lieu of conducting a guideline study. The rationale is acceptable to fulfill the EP A data requirement.

7 Per 40 C.F.R. § 158.2050(e), a 90-Day Dermal study is only requ ired to support uses involving purposeful application to the hu man skin or those which would results in co mparable prolonged human exposure.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

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### iii. Nontarget Organisms and Environmental Fate ( 40 C.F.R. § 158.2060 )

Table 7. Summary of Nontarget Organism Data for 1-Methylcyclopropene (1-MCP)

Harmonized Guideline Number Data Requirement Has Data Requirement Been Addressed? How? MRID

850.2100 Avian Acute Oral Toxicity Yes - Study 47024917 850.2200 Avian Dietary Toxicity Yes – Study 47024918 850.1075 Fish Acute Toxicity, Freshwater Yes - Study 47024915

850.1010 Aquatic Invertebrate Acute Toxicity, Freshwater Yes - Study 47024914

850.4100 Terrestrial Plant Toxicity, Seedling Emergence Yes - Rationale 8 47024921

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor Yes - Rationale 9 47024922

880.4350 Nontarget Insect Testing Yes - Study 47024920



### E. Risk to Threatened and Endangered Species

Exposure of nontarget species to 1- MCP is highly unlikely for uses i nvolving enclosed containers (such as coolers, truck trailers, greenhouses , storage facilities, and shipping cont ainers). Exposure to terrestrial organism from outdoor uses (ground or aerial spray to apples, pears, kiwifruit, walnut, tomatoes, peppers, corn, cotton, rice, soybean, sunflower, or wheat) are expected to be minimal because 1-MCP degrades quickly: when applied at the maximum use ra te of 10 gram AI per hect are, residue levels were 0.040 mg ai/kg on the day of application and declined approximately 5-fold by 14-days post application (U.S. EPA, 2010). Exposure to aquatic organisms is unlikely because there are no products registered for aquatic use and all labels for outdoor use cont ain environmental hazard language to mitigate aquatic
exposure.
Risks to nontarget species from the pesticidal us e of 1-MCP are expected to be minimal. Studies submitted in support of the registration and exemption for the requirement of a tolerance for residues of 1-MCP demonstrated that this biochemical has very low mammalian toxicity (Toxicity Category IV for acute oral toxicity, acute inhalati on toxicity, and primary dermal irr itation; Toxicity Category III for acute dermal toxicity and primary eye irritation; not a dermal sensit izer; non-mutagenic; no subchronic or developmental toxicity (U.S. EPA, 2001 )) . Avian and non-target insect te sting at high doses indicate that 1-MCP is practically non-toxic to these species. Aquatic organism laboratory studies tested only one dose level of 1-MCP and saw no mortality. The dose chosen was selected because calculations based upon Henry’s law constant and atmospheric pressure indicate a 1000 ppm headsp ace concentration of 1- MCP to be equal to approximately 0.825 mg ai/L (t he actual concentrations achieved in the test

8 The applicant submitted a scientifically creditable rationale in lieu of conducting a guideline study. The rationale is acceptable to fulfill the EPA data requirement.
9 The applicant submitted a scientifically creditable rationale in lieu of conducting a guideline study. The rationale is acceptable to fulfill the EPA data requirement.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

13 

### environment were 0.766 mg ai/L for aquatic inve rtebrates and 0.966 mg ai/L for fish (MRIDs 47024914 and 47024915)).These were highly conserva tive tests, as the concentration of 1-MCP is not expected to exceed 1 ppm in air during actual us e conditions (U.S. EPA, 2001) and, as noted above, when applied at the maximum use rate, 1-MCP residues were only 0.040 mg ai/kg (equivalent to approximately 0.040mg ai/L) on the day of application.

Based upon the results of toxicity te sts and the low potential for exposure, the risks to nontarget species, including endangered/threatened spec ies and their designated critical ha bitats, from 1-MCP as an active ingredient in pesticide pr oducts are expected to be negligible. Th erefore, EPA has reached a “No Effect” determination for endangered/threatened sp ecies and designated cr itical habitat.

EPA anticipates conducting no further analysis of pot ential risks to endangered or threatened species, unless data or information are obtai ned during the Registration Review pr ocess that would indicate such an assessment would be needed to inform the Agency’s final decision concerning th is case, or if future registrations for products containing 1-MCP as the AI are formulated in a manner that would increase toxicity and/or exposures above those currently registered.

Table 8. Summary of Nontarget Organism Data Results for 1-Methylcyclopropene (1-MCP)

Harmonized Guideline Number Data Requirement Results MRID

850.2100 Avian Acute Oral Toxicity (Bobwhite Quail) LD50 > 2250 mg/kg practically non-toxic 47024917

850.2200 Avian Dietary Toxicity (Bobwhite Quail) LC50 > 5620ppm practically non-toxic 47024918

850.1075 Fish Acute Toxicity, Freshwater (Rainbow Trout) 96-hour LC50 > 0.966 mg ai/L no mortality seen at highest dose tested (1000 times greater than

actually use concentrations) 47024915

850.1010 Aquatic Invertebrate Acute Toxicity, Freshwater (Daphnia) 48-hour EC50 > 0.776 mg ai/L no mortality seen at highest dose tested (1000 times greater than

actually use concentrations) 47024914

850.4100 Terrestrial Plant Toxicity, Seedling Emergence Soil column data indicating that negligible amounts of 1-MCP will be deposited to soil under realistic use conditions and, if deposited to soil, 1-

MCP will be tightly bound to soil particles and thus not available to germinating seeds. 47024921

850.4150 Terrestrial Plant Toxicity, Vegetative Vigor Summary of data indicating that field trials with 1-MCP up to four times the maximum label rate showed no phytotoxic effects on crops including corn, soybean, cotton, sunflower and others. 47024922

880.4350 Nontarget Insect Testing 48-hour LD50 > 10 ppm in air practically non-toxic – actual use concentrations not expected to exceed 1 ppm 470249201-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

14 

### 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.”
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, 10 

### and includes some pesticides scheduled for registra tion review and chemicals found in water. 1-MCP is not among the group of pesticide active ingr edients on the lists to be screened under the EDSP.
The EPA, as part of this Preliminary Work Plan, believes that 1-MCP 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 1-MCP 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 April 22, 1999 (the first date of 1-MCP pes ticide registration), through September 2, 2014, OPP’s Incident Data System (IDS) contai ns six reported human incidents c onsisting of headache, dizziness and nausea by applicators while using pe sticide products containing 1-MCP as the active ingredient; in two of the incidences, the situation was confounded by work conditions consisting of heat stress, dehydration and fatigue. In all incidences, the sy mptoms dissipated within one day.

A search of OPP’s Environmental Incident Info rmation System (EIIS) conducted on September 3, 2014, revealed no incidents associated w ith 1-MCP; this database contains information dating back to the 1970s. The EPA will consider any incident data or co mments submitted in response to this Preliminary Work Plan.

H. Timeline
Below is the projected timeline for Re gistration Review case 0670: 1-MCP:

10 See http://www.regulations. gov/#!documentDetail;D=E PA-HQ-OPPT-2009-0477-0074 for the second list of chemicals.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

15 

### Activities Estimated Month/Year Opening the Docket Open Docket and 60-Day Public Comment Period for March 2015 Close Public Comment Period May 2015

Case Development Issue Final Work Plan September 2015

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 December 2015

Close Public Comment Period February 2016

Final Decision June 2016 *Estimated Total (years) 1 year and 3 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 will set forth a new timeline and, if applicable, any new data requirements will be included in the amended document and a Data Call-In Notice will be issued.



### I. Guidance for Commenters

The public is invited to comment on the EPA’s PWP for 1-MCP and rationale. The areas below highlight topics of special interest to the EPA where comments , information 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 provid ed in a timely manner, 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 1-MCP, 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.

ii. Water Quality1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

16 

### 1-MCP is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 11 

### In addition, no Total Maximum Daily Loads (TMDLs) have been developed for 1-MCP. 12 

### More information on impaired water bodies and TMDLs can be found on EPA’s website. 13 

### 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: Incl usion of Impaired Water Body and Other Water Quality Data in Registration Review Risk A ssessment and Management Process 14 

### to ensure they can be used quantitatively or qualitatively 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.
There are no known MRLs for 1-MCP. Therefore, th e EPA does not anticipate th at current uses of 1- MCP 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 interested in obtaining the following information regarding 1- MCP:

 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

 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)

11 Based on information provided at http://water.epa.gov/lawsregs/la wsguidance/cwa/tmdl/index.cfm

. 12 Based on information provided at http://iaspub.epa.gov/apex/wate rs/f?p=ASKWATERS:DOC_SEARCH:0 :::::
13 See http://water.epa.gov/lawsregs/l awsguidance/cwa/tmdl/index.cfm

. 14 This document can be found at http://www.epa.gov/pesticides/registra tion-review2/water_quality_sop.htm

.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

17 

###  State or local use restrictions

 Monitoring data  Foreign technical registrants not listed above who supply techni cal 1-MCP to the US market

J. Next Steps

After the 60-day comment period closes, the EPA will review and respond to any comments received in a timely manner, then issue a Final Work Plan for 1-MCP.1-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

18 

### II. BIBLIOGRAPHY

A. Studies Supporting Registration Review of 1-MCP

MRID Citation Receipt Date

44464700 Biotechnologies for Horticulture, Inc. (1997) Submission of Toxicity and Product Chemistry Data in Support of the Application for Registration of MCP. Transmittal of 11 Studies. 11-Dec1997

44464701 Kourelis, B. (1997) Manufacturing Process for Methylcyclopropene (MCP). Unpublished study prepared by BioTechnologies for Horticulture, Inc. 20 p. 11-Dec1997

44464702 Kourelis, B. (1997) Preliminary Analysis of Methylcyclopropene (MCP). Unpublished study prepared by BioTechnologies for Horticulture, Inc. 15 p. 11-Dec1997

44464703 Daly, J. (1997) Analytical Method for Cer tified Limits of Methylcyclopropene (MCP). Unpublished study prepared by BioTechnologies for Horticulture, Inc. 14 p. 11-Dec1997

44464704 Pfeifer, R. (1996) Acute Oral Toxicity Study (in Rats): Methylcyclopropene (MCP): Final Report: Lab Project Number: 96G-2085. Unpublished study prepared by Toxikon Corp. 30 p. 11-Dec1997

44464705 Pfeifer, R. (1997) Acute Dermal Toxicity Study (Single Exposure) (in Rabbits): Methylcyclopropene (MCP): Final Report: Lab Project Number: 96G-2086: JRM/VIVO/002- 96/000. Unpublished study prepared by Toxikon Corp. 34 p. 11-Dec1997

44464706 Bennick, J. (1997) Acute Inhalation Toxicity Stud y in Rats: EthylBloc (MCP): Final Report: Lab Project Number: 3333-97: S9-FF81-3. Unpublished study prepared by Stillmeadow, Inc. 16 p. 11-Dec1997

44464707 Prezioso, J. (1996) Primary Eye Irritation Study (in Rabbits): MCP: Final Report: Lab Project Number: 96G-2089: JRC/VIVO/005-96/000. Unpublished study prepared by Toxikon Corp. 39 p. 11-Dec1997

44464708 Pfeifer, R. (1996) Primary Dermal Irritation--FIF RA (in Rabbits): MCP: Final Report: Lab Project Number: 96G-2088: JRM/VIVO/004-96/000. Unpublished study prepared by Toxikon Corp. 33 p. 11-Dec1997

44464709 Prezioso, J. (1996) Salmonella Typhimurium Reverse Mutation Assay--FIFRA: MCP: Final Report: Lab Project Number: 96G-2139: JRM/VITRO/001-96/000. Unpublished study prepared by Toxikon Corp. 36 p. 11-Dec1997

44464710 Cifone, M. (1997) Mutagenicity Test on MCP in the L5178Y TK +/-Mouse Lymphoma Forward Mutation Assay: Final Report: Lab Project Number: 18384-0-431: COVANCE 18384-0-431. Unpublished study prepared by Covance Labs., Inc. 29 p. 11-Dec1997

44464711 Ivett, J. (1997) Mutagenicity Test on MCP in an in vivo Mouse Micronucleus Assay: Final Report: Lab Project Number: 18384-0-455: COVANCE 18384-0-455. Unpublished study prepared by Covance Labs., Inc. 42 p. 11-Dec1997

44517000 Biotechnologies for Horticulture, Inc. (1997) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of EthylBloc. Transmittal of 6 Studies. 18-Mar1997

44517001 Daly, J. (1997) Product Identity and Disclosure of Ingredients for 1-Methylcyclopropene (MCP). Unpublished study prepared by Biotechnologies for Horticulture, Inc. 59 p. 18-Mar1997

44517002 Daly, J. (1997) Discussion of the Formation of Unintentional Ingredients in Ethylbloc: Methylcyclopropene (MCP). Unpublished study prepared by Biotechnologies for Horticulture, Inc. 17 p. 18-Mar19971-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

19 44517003 Daly, J. (1997) Certification of Ingredient Limits for EthylBloc. Unpublished study prepared by Biotechnologies for Horticulture, Inc. 4 p. 18-Mar1997

44517004 Bennick, J. (1997) Product Chemistry for Non- Combustible End-Use Solids: EthylBloc (MCP): Lab Project Number: 3454-97: JRM/VIVO/001-96/000: S9-FD63/EUS. Unpublished study prepared by Stillmeadow, Inc. 30 p. 18-Mar1997

44517005 Pfeifer, R. (1996) Buehler Sensitization Test (in Guinea Pigs): Final Repo rt: (MCP): Lab Project Number: 96G-2087: JRM/VIVO/003-96/000. Unpublished study prepared by Toxikon Corp. 42 p. 18-Mar1997

44517006 Daly, J. (1997) Hypersensitivity Incidents Repo rt for Methylcyclopropene (MCP). Unpublished study prepared by Biotechnologies for Horticulture, Inc. 4 p. 18-Mar1997

44567600 Biotechnologies for Horticulture Inc. (1998) Submission of Product Chemistry Data in Support of the Application for Registration of EthylBloc. Transmittal of 1 Study. 28-May1998

44567601 Roberts, A. (1998) Physical and Chemical Properties of EthylBloc-Part II. Unpublished study prepared by Biotechnologies for Horticulture, In c. 4 p. {830.6302, 830.6 303, 830.6304, 830.7200, 83063.14, 830.6316, 830.6320} 28-May1998

44735400 Biotechnologies for Horticulture (1999) Submission of Product Chemistry Data in Support of the Application for Registration of EthylBloc. Transmittal of 1 Study. 19-Jan1999

44735401 Roberts, A. (1999) Manufacturing Process and Cer tified Limits for EthylBloc--Supplemental Data. Unpublished study prepared by Biotechnologies for Horticulture, Inc. 10 p. {OPPTS 885.1200, 885.1500} 19-Jan1999

44991400 Biotechnologies for Horticulture, Inc. (1999) Submission of Product Chemistry Data in Support of the Registration of Ethylbloc. Transmittal of 1 Study. 10-Dec1999

44991401 Roberts, A. (1999) Supplemental Product Chemistry for EthylBloc. Unpublished study prepared by Biotechnologies for Horticulture, Inc. 30 p. {OPPTS 830.1700, 830.1800} 10-Dec1999

45089600 BioTechnologies for Horticulture (2000) Submission of Product Chemistry, Toxicity, Residue Chemistry, and Risk and Exposure Assessment Data in Support of the Registration of EthylBloc Technology, and the Petition For Tolerance of 1-Methylcyclopropene in/on Food Commodities. Transmittal of 1 Study. 12-Apr2000

45089601 Longacre, S. (2000) An Assessment of the Risk Cr iteria Established in the Food Quality Protection Act (FQPA) Supporting an Exemption from the Requirement of Tolerances for BioTechnologies for Horticulture, Inc. Pesticide Petition Unassigne d (1-Methylcyclopropene on Post-Harvest Fruits and Vegetables): Lab Project Number: AGREG-00-01. Unpublished study prepared by Biotechnologies for Horticulture, Inc. 10 p. 12-Apr2000

45317100 Rohm and Haas Company (2001) Submission of Exposure Data in Support of the Registration of 1- Methylcyclopropene. Transmittal of 1 Study. 01-Feb2001

45317101 Shade, W. (2001) 1-Methylcyclopropene (1-MCP): Industrial Source Complex (ISCST3) Dispersion Modeling of Air Emissions from Controlled Atmosphere Facilities: Lab Project Number: 00R-1066. Unpublished study prepared by Rohm and Haas Company. 10 p. 01-Feb2001

45380300 Rohm and Haas Company (2001) Submission of Toxicity, Residue Chemistry and Risk Assessment and Exposure Data in Support of the Registration of EthylBloc Technology and the Petition for Tolerance of EthylBloc Technology on Harvested Fruit and Vegetables. Transmittal of 9 Studies. 12-Apr2001

45380301 Ferguson, J.; Craig, L.; Bernacki, H. (2001) 1-Methylcyclopropene: Acute Inhalation Toxicity Study in Rats: Lab Project Number: 00P-180: 00R-180. Unpublished study prepared by Rohm and Haas Company. 26 p. {OPPTS 870.1300} 12-Apr20011-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

20 45380302 O'Neill, P.; Frederick, C. (2001) 1-Me thylcyclopropene Vapor Released from 1- Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% a.i.): Salmonella typhimurium Gene Mutation Assay: Lab Project Number: 00R-193A. Unpublished study prepared by Rohm and Haas Company. 93 p. 12-Apr2001

45380303 Cifone, M. (2001) 1-Methylcyclopropene Vapor Released from 1-Methylcyclopropene AlphaCyclodextrin Complex (3.3% a.i.): CHO HGPRT Forward Mutation Assay with a Confirmatory Assay and Duplicate Cultures: Final Report: Lab Project Number: 21917-0-435 OECD: 00P-195: 00RC-195. Unpublished study prepared by Covance Laboratories, Inc. 60 p. 12-Apr2001

45380304 Murli, H. (2001) 1-Methylcyclopropene Vapor Released from 1-Methylcyclopropene AlphaCyclodextrin Complex (3.3% a.i.): Chromosomal Abberations in Cultured Human Peripheral Blood Lymphocytes: Final Report: Lab Project Number: 21917-0-449OECD: 00P-194: 00RC-194. Unpublished study prepared by Covance Laboratories Inc. 66 p. 12-Apr2001

45380305 Sames, J.; Frederick, C. (2001) 1-Methylcyclopropene: Micronucleus Assay in CD-1 Mouse Bone Marrow Cells: Lab Project Number: 00R-232. Unpublished study prepared by Rohm and Haas Company. 43 p. 12-Apr2001

45380306 Ferguson, J.; Craig, L. (2001) 1-Methylcyclopropene: Two-Week Inhalation Range-Finding Study in Female Rats: Lab Project Number: 00P-183A: 00R-183A. Unpublished study prepared by Rohm and Haas Company. 34 p. 12-Apr2001

45380307 Longacre, S.; Hazelton, G. (2 001) 1-Methylcyclopropene (1-MCP ): Dietary and Worker Risk Assessments: Lab Project Number: AGREG-01-01. Unpublished study prepared by Rohm and Haas Company and AgroFr esh, Inc. 14 p. 12-Apr2001

45380308 Parno, J.; Craig, L.; Eberly, S. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% a.i.): Acute Oral Toxicity Study in Male and Female Rats: Lab Project Number: 00P-199: 00R-199. Unpublished study prepared by Rohm and Haas Company. 26 p. {OPPTS 870.1100} 12-Apr2001

45380309 Verona, D. (2001) (Carbon-14)-1-Methylcyclopropene (1-MCP): Preliminary Result of (Carbon14)-Residues in Apples: Lab Projec1 Number: TR34-01-30. Unpublished study prepared by Rohm and Haas Company. 22 p. 12-Apr2001

45458600 Rohm and Haas Company (2001) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of AgroFresh Technology. Transmittal of 8 Studies. 03-Jul2001

45458601 Crawford, J. (2001) Product Chemistry Series Group A: Product Identity, Composition, and Analysis of 1-MCP Formulation: Lab Project Number: APR-01-068: APR-01-068: 29P-00-078. Unpublished study prepared by Rohm and Haas Company. 296 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1670, 830.1700, 830.1750, 830.1800} 03-Jul2001

45458602 Hu, W. (2001) GLP Validation of Test Method TM-2000-245-01: Lab Project Number: 29P-00- 080: APR-01-017: TM-2000-245-01. Unpublished study prepared by Rohm and Haas Company. 43 p. {OPPTS 830.1800} 03-Jul2001

45458603 Crawford, J. (2001) Product Chemistry Series 83 0 Group B: Physical and Chemical Characteristics of 1-MCP Formulation: Lab Project Number: APR-01-069: 794046: APR-01-019. Unpublished study prepared by RCC, Ltd. and Rohm and Haas Company. 370 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6314, 830.6315, 830.6316, 830.631 7, 830.6319, 830.6320, 830.6321, 830.7000, 830.7050, 830.7100, 830.7200, 830.7220, 83 0.7200, 830.7250, 830.7570, 830.7950} 03-Jul2001

45458604 Parno, J.; Craig, L.; Eberly, S. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3%a.i.) Acute Dermal Toxicity Study in Male and Female Rats: Lab Project Number: 00P-200: 00R200. Unpublished study prepared by Rohm and Haas Company. 19 p. {OPPTS 870.1200} 03-Jul20011-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

21 45458605 Parno, J.; Craig, L.; Eberly, S. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% a.i.) Skin Irritation Study in Rabbits: Lab Project Number: 00P-201: 00R-201. Unpublished study prepared by Rohm and Haas Company. 17 p. {OPPTS 870.2500} 03-Jul2001

45458606 Parno, J.; Craig, L.; Eberly, S. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% a.i.) Eye Irritation Study in Rabbits: Lab Project Number: 00P-202: 00R-202. Unpublished study prepared by Rohm and Haas Company. 18 p. {OPPTS 870.2400} 03-Jul2001

45458607 Parno, J.; Anderson, D.; Danberry, T. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% a.i.): Dermal Sensitization Study in Guin ea Pigs Maximization Test: Lab Project Number: 00P-203: 00R-203. Unpublished study prepared by Rohm and Haas Company. 62 p. {OPPTS 870.2600} 03-Jul2001

45458608 Wood, S.; Craig, L.; Bernacki, H. et al. (2001) 1-Methylcyclopropene: Inhalation (Whole-Body) Developmental Toxicity Study in Rats: Lab Project Number: 00P-181: 00R-181. Unpublished study prepared by Rohm and Haas Company. 248 p. {OPPTS 870.3700} 03-Jul2001

45609000 AgroFresh, Inc. (2001) Submission of Toxicity, Residue, Risk and Exposure Data in Support of the Amended Registration of EthylBloc Technology, the Application for Registration of SmartFresh and the Petition for Exemption from Tolerance for 1-MCP on All Food Commodities. Transmittal of 4 Studies. 14-Dec2001

45609001 Ferguson, J.; Anderson, D.; Bernacki, H. (2001) 1-Methylcyclopropene: Three-Month Inhalation (Whole-Body) Toxicity Study in Rats: Lab Project Number: 00P-183: 00R-183: Unpublished study prepared by Rohm and Haas Company. 729 p. {OPPTS 870.3465} 14-Dec2001

45609002 Verona, D. (2001) (Carbon 14)-1-Methylcyclopropene (1-MCP) Apple Residue Study: Lab Project Number: 34P-01-04: AF-01-141: 1507.03. Unpublished study prepared by AgroFresh, Inc. 351 p. {OPPTS 860.1000, 860.1500} 14-Dec2001

45609003 Snyder, B. (2001) Determination of 3-Chloro-2-Methylpropene Concentration in Chamber Treated with 1-Methylcyclopropene: Lab Project Number: AF-P-01-01: AF-01-143: AF-P-01-01B. Unpublished study prepared by Rohm and Haas Company. 112 p. 14-Dec2001

45609004 Hazelton, G. (2001) 1-Methylcyclopropene (1-MCP ): Assessment of Worker and Consumer Risk: Lab Project Number: 01R-1071. Unpublished study prepared by Rohm and Haas Company. 16 p. 14-Dec2001

45843900 AgroFresh, Inc. (2003) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of SmartFresh SmartTabs. Transmittal of 2 Studies. 21-Jan2003

45843901 Jacobson, R. (2002) Product Chemistry Series 830 Group A: Product Identity, Composition and Analysis of SmartFresh Tablet Formulation: Lab Project Number: AGROFRESH-02-054: AF-02- 054: APR-01-017. Unpublished study prepared by AgroFresh Inc.; a Rohm and Haas Company. 51 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1650, 830.1700, 830.1750, 830.1800} 21-Jan2003

45843902 Cerven, D. (2002) Acute Oral Toxicity/LD 50 in Rats: SmartFresh Tablets: Lab Project Number: MB 02-10029.01: 1000R: 02P-010. Unpublished study prepared by MB Research Laboratories. 13 p. {OPPTS 870.1100} 21-Jan2003

45884100 AgroFresh Inc. (2003) Submission of Product Chemistry Data in Support of the Application for Registration of SmartFresh SmartTabs. Transmittal of 2 Studies. 17-Jan2003

45884101 Jacobson, R.; Verona, D. (2002) Product Chemistr y Series 830 Group B: Physical and Chemical Characteristics of SmartFresh Tablet Formula tion: Lab Project Number: AGROFRESH-02-059: 842968: AF-02-041. Unpublished study prepared by RCC Ltd. and AgroFresh Inc. 235 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6314, 830.6316, 830.6317, 830.6320, 830.7000, 830.7300} 17-Jan20031-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

22 45884102 Jacobson, R. (2002) Description and Composition of the SmartFresh SmartTabs Formulation and Activator Kit: Lab Project Number: AGROFRESH 02 -089: 02-089. Unpublished study prepared by AgroFresh Inc. 13 p. 17-Jan2003

47024900 Agro Fresh Inc. (2006) Submission of Product Chemistry, Residue, Exposure and Risk, Toxicity and Environmental Fate Data in Support of the Application for Registration of AFxRD-038. Transmittal of 28 Studies. 26-Dec2006

47024907 Tognucci, A. (2002) Determination of the UV/VIS Absorption Spectra of 1-MCP. Project Number: 823645, AF/01/186. Unpublished study prepared by RCC Umweltchemie Ag. 44 p. 26-Dec2006

47024912 Schaefer, E.; Siddiqui, A. (2001) 1 Methylcyclopropene (1-MCP): An Evaluation of Ready Biodegradability Using the Die-Away Test Method. Project Number: 129E/103, 01RC/0006. Unpublished study prepared by Wildlife International Ltd. 60 p. 26-Dec2006

47024914 Drottar, K.; Kendall, T.; Krueger, H. (2001) 1-Methylcyclopropene: A 48 Hour Static Acute Immobilization Test with the Cladoceran (Daphnia Magna). Project Number: 129A/184A, 01RC/0002. Unpublished study prepared by Rohm and Haas Co. 65 p. 26-Dec2006

47024915 Drottar, K.; Kendall, T.; Krueger, H. (2001) 1-Methylcycloprope ne: A-96 House Static-Renewal Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Project Number: 129A/183, 01RC/0001. Unpublished study prepared by Rohm and Haas Co. 69 p. 26-Dec2006

47024917 Gallagher, S.; Beavers, J. (2006) AFxRD-038: An Acute Oral Toxicity Study with the Northern Bobwhite. Project Number: 129/185, 05RC/071. Unpublished study prepared by Rohm and Haas Co. 51 p. 26-Dec2006

47024918 Gallagher, S.; Beavers, J. (2006) AFxRD-038: A Dietary LC50 Study with the Northern Bobwhite. Project Number: 129/184, 05RC/072. Unpublished study prepared by Rohm and Haas Co. 87 p. 26-Dec2006

47024919 Gallagher, S.; Martin, K.; Beavers, J. (2006) AFxRD-038: A Dietary LC50 Study with the Mallard. Project Number: 129/188, 06RC/130. Unpublished study prepared by Rohm and Haas Co. 87 p. 26-Dec2006

47024920 Porch, J.; Krueger, H. (2001) 1-Methylcyclopropene Alpha-Cyclodextrin Complex (3.3% A.I.): An Acute Toxicity Study with the Honey Bee. Project Number: 129/178, 01RC/0097. Unpublished study prepared by Wildlife International, Ltd. 50 p. 26-Dec2006

47024921 Carbone, J. (2006) 1-Methylcyclopropene: Rationale for Waiver of OPPTS 850.4225 Seedling Emergence. Project Number: 06R/1052. Unpublished study prepared by Rohm and Haas Co. 7 p. 26-Dec2006

47024922 Carbone, J. (2006) 1-Methylcyclopropene: Rationale for Waiver of OPPTS 850.4250 Vegetative Vigor. Project Number: 06R/1053. Unpublished study prepared by Rohm and Haas Co. 6 p. 26-Dec2006

47024923 Krueger, H.; Desjardins, D.; Kendall, T. (2006) Final Report: AFxRD-038: A 96 Hour Toxicity Test with the Freshwater Alga (Pseudokirchne riella subcapitata). Pr oject Number: 12A/197B, 05RC/070. Unpublished study prepared by Wildlife International, Ltd. 74 p. 26-Dec2006

47024924 Drottar, K.; Kendall, T.; Krueger, H. (2001) 1-Methylcyclopropene: A 96 Hour Toxicity Test with the Freshwater Alga (Selenastrus capricorn utum). Project Number: 129A/185, 01RC/0003. Unpublished study prepared by Wild life International, Ltd. 78 p. 26-Dec2006

47024928 Moore, G. (2007) AFxRD 038: Acute Oral Toxicity Up and Down Procedure in Rats. Project Number: 18521, 05RC/064, P320/UDP/R/AND/H. Unpublished study prepared by Product Safety Laboratories. 16 p. 26-Dec2006

47024929 Moore, G. (2006) AFxRD 038: Acute Dermal Toxic ity Study in Rats - Limit Test. Project Number: 18522, 05RC/065, P322/R/AND/H. Unpublished study prepared by Product Safety Laboratories. 16 p. 26-Dec20061-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

23 47024930 Moore, G. (2006) AFxRD 038: Primary Eye Irritation Study in Rabbits. Project Number: 18523, 05RC/067, 051020/1R. Unpublished study prepared by Product Safety Laboratories. 15 p. 26-Dec2006

47024931 Moore, G. (2006) AFxRD 038: Primary Skin Irritation Study in Rabbits. Project Number: 18524, 05RC/066, P326/R/AND/H. Unpublished study prepared by Product Safety Laboratories. 16 p. 26-Dec2006

47024932 Nave, V. (2006) Dermal Sensitization Potential of AFxRD 038: Rationale to Use Surrogate Toxicology Data. Project Number: 06R/1048. Unpublished study prepared by Rohm and Haas Co. 7 p. 26-Dec2006

47024933 Nave, V. (2006) Acute Inhalation Potential of AFxR-038: Rationale to Use Surrogate Toxicology Data: 1 Methycyclpropene. Project Number: 06R/1011. Unpublished study prepared by Rohm and Haas Co. 7 p. 26-Dec2006

47024934 Ferguson, J. (2001) 1-Methylcyclopropene: Two-Week Inhalation Range-Finding Study in Male Rats. Project Number: 00R/183B, 00P/183B. Unpublished study prepared by Rohm and Haas Co. 30 p. 26-Dec2006

47024938 Tognucci, A. (2002) Hydrolysis Determination of 1-MCP at Different pH Values. Project Number: 830790, AF/01/188. Unpublished study prepared by RCC Ltd. 39 p. 26-Dec2006

47024941 Nienstedt, K. (2002) Final Report: 1-Methylcyclopr opene: Toxicity Test with the Parasitic Wasp, Aphidius rhopalosiphi (Hymenoptera: Braconidae). Project Number: 1007/078/270, 1RC/0283. Unpublished study prepared by Rohm and Haas Co. and Springborn Laboratories (Europe) Ag. 70
p. 26-Dec2006

47024942 Tognucci, A. (2006) Determination of the Flammability of 1-MCP Formulation. Project Number: 823713, AF/01/153. Unpublished study prepared by RCC Ltd. 27 p. 26-Dec2006

47024944 Nienstedt, K.; Milligan, D. (2002) Final Report: 1-Methylcyclopropene: A 14-Day Acute Toxicity Test with the Earthworm Eisenia fetida. Project Number: 01RC/0284, 1007/078/630. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 89 p. 26-Dec2006

47024946 Nienstedt, K. (2006) Amended Final Report: AFxRD-038: Laboratory Acute Toxicity Test with the Parasitic Wasp Aphidius Phopalosiphi (Hyme noptera: Braconidae). Proj ect Number: 06RC/193, 1007/080/270. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 40 p. 26-Dec2006

47024947 Nienstedt, K. (2006) Amended Final Report: AFxRD-038: Laboratory Acute Toxicity Test with Poecilus cupreus L. (Coleoptera: Carabidae). Project Number: 06RC/195, 1007/080/267. Unpublished study prepared by Springborn Laboratories (Europe) Ag. 41 p. 26-Dec2006

47024949 Carbone, J. (2006) Pre-Harvest of 1-Methylcycpropene on Agriculture Crops: Environmental Risk Assessment. Project Number: 06R/1056. Unpublished study prepared by Rohm and Haas Co. 46 p. 26-Dec2006

47024950 Nave, V. (2006) 1-Methylcyclopropene: Rationale for Waiver of OPPTS 880.3550 Immunotoxicity. Project Number: 06R/1050. Unpublished study prepared by Rohm and Haas Co. 7
p. 26-Dec2006

47024954 Hazelton, G.; Nave, V.; Shade, W. (2006) Pr e-Harvest Use of 1-Methylcyclopropene on Agricultural Crops: Toxicology Summary and Assessment of Worker, Bystander and Consumer Risks. Project Number: 06R/1055. Unpublished study prepared by Rohm and Haas Co. 133 p. 26-Dec2006

47088600 AgroFresh Inc. (2007) Submission of Product Ch emistry, Residue, Fate and Toxicity Data in Support of the Application for Registration of AFxRD-038 and the Petition for Tolerance of 1- Methylcyclopropene (1-MCP). Transmittal of 20 Studies. 26-Mar2007

47088601 Weissenfeld, M. (2006) Determination of Colour, Physical State and Odour of AFxRD-038. Project Number: A39701, AF/05/032. Unpublished study prepared by RCC Umweltchemie Ag. 23 p. 26-Mar20071-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

24 47088602 Kurilla, K. (2006) Accelerated Storage Stability of 1-Methyl cyclopropene Formulation AFxRD038. Project Number: AF/06/077, AF/P/06/010. Unpublished study prepared by Agro Fresh Inc. and Rohm and Haas Co. 15 p. 26-Mar2007

47088603 Weissenfeld, M. (2006) pH-Determination of an Aqueous Solution of AFxRD-038. Project Number: A39712, AF/05/033. Unpublished study prepared by RCC Umweltchemie Ag. 24 p. 26-Mar2007

47088604 Weissenfeld, M. (2006) Determination of the UV/Vis Absorption Spectrum of AFxRD-038. Project Number: A39723, AF/05/034. Unpublished study prepared by RCC Umweltchemie Ag. 33 p. 26-Mar2007

47088605 Weissenfeld, M. (2006) Determination of the Me lting Point / Melting Range and the Boiling Point / Boiling Range of AFxRD-038. Project Number: A39745, AF/05/036. Unpublished study prepared by RCC Umweltchemie Ag. 37 p. 26-Mar2007

47088606 Weissenfeld, M. (2006) Determination of the Bulk Density of AFxRD-038. Project Number: A39734, AF/05/035. Unpublished study pr epared by RCC Umweltchemie Ag. 24 p. 26-Mar2007

47088607 Weissenfeld, M. (2006) Determination of the Particle Size Distribution of AFxRD-038. Project Number: A39756, AF/05/037. Unpublished study prepared by RCC Umweltchemie Ag. 29 p. 26-Mar2007

47088608 Weissenfeld, M. (2006) Determination of the Water Solubility of AFxRD-038. Project Number: A71763, AF/06/031. Unpublished study pr epared by RCC Umweltchemie Ag. 27 p. 26-Mar2007

47088609 Sutherland, C.; Kendall, T.; Kruege r, H. (2006) A 48-Hour Static Acute Immobilization Test with the Cladoceran (Daphnia magna): AFxRD-038. Project Number: 129A/195A, 05RC/069. Unpublished study prepared by Rohm and Haas Co. and Wildlife International, Ltd. 62 p. 26-Mar2007

47088610 Sutherland, C.; Krueger, H.; Kend all, T. (2006) A 96-Hour Static- Renewal Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): AFxRD-038. Project Number: 129A/196, 05RC/068. Unpublished study prepared by Rohm and Haas Co. and Wildlife International, Ltd. 63
p. 26-Mar2007

47088611 Mamouni, A. (2006) [14-Carbon]-1-Methylcyclopropene: Residues in Maize. Project Number: A73225, AF/06/079. Unpublished study pr epared by RCC Umweltchemie Ag. 90 p. 26-Mar2007

47088612 Rosenwald, J. (2006) [14-Carbon]-1-Methylcyclopropene: Residue in Apple. Project Number: A98515, AF/06/080. Unpublished study pr epared by RCC Umweltchemie Ag. 71 p. 26-Mar2007

47088613 Weissenfeld, M. (2006) Calculation of the Vapour Pressure of AFxRD-038. Project Number: A39778, AF/06/001. Unpublished study pr epared by RCC Umweltchemie Ag. 13 p. 26-Mar2007

47088614 Tognucci, A. (2002) Determination of the Vapour Pressure of 1-MCP. Project Number: 823601, AF/01/190. Unpublished study prepared by RCC Umweltchemie Ag. 33 p. 26-Mar2007

47088615 Tognucci, A. (2002) Determination of the Water Solubility of 1-MCP. Project Number: 830801, AF/01/191. Unpublished study prepared by RCC Umweltchemie Ag. 34 p. 26-Mar2007

47088616 Hazelton, G.; Swenson, R. (2007) [14-Carbon]-1-Methylcyclopropene: Toxicokinetic Study in Rats: Amended Final Report. Project Number: 01R/004E. Unpublished study prepared by Rohm and Haas Co. 151 p. 26-Mar2007

47088617 Lampe, K.; Neinstedt, K. (200 2) 1-Methylcyclopropene: Labora tory Toxicity Test with the Predatory Mite, Typhlodromus pyri Scheuten (Acari: Phytoseiidae): Final Report. Project Number: 01RC/0282, 1007/078/268. Unpublished study prepared by Rohm and Haas Co. and Springborn Laboratories (Europe) Ag. 86 p. 26-Mar2007

47088618 Esdaile, D. (2005) 1-Methylcycl opropene: Structure-Ac tivity Hazard Identification Screen Using Derek: Final Report. Project Number: 05RC/1008. Unpublished study prepared by LAB International Research Centre Hungary Ltd. 19 p. 26-Mar20071-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

25 47088619 Porch, J.; Krueger, H.; Martin, K. (2007) AFxRD-038: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 129/191, 06RC/212. Unpublished study prepared by Wildlife International, Ltd.. 165 p. 26-Mar2007

47088620 Porch, J.; Krueger, H.; Martin, K. (2007) AFxRD-038: A Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants: Final Report. Project Number: 129/190, 06RC/213. Unpublished study prepared by Wildlife International, Ltd. 138 p. 26-Mar2007

47108200 Agrofresh Inc. (2007) Submission of Product Chemistry and Environmental Fate Data in Support of the Application for Registration of AFxRD-038. Transmittal of 8 studies. 16-Apr2007

47108202 Mallipudi, M. (2006) GLP Characterization of Five Representative Lots of AFxRD-038 Formulation. Project Number: AF/P/06/09, AF/06/083. Unpublished study prepared by Agrofresh, Inc. 16 p. 16-Apr2007

47108203 Verona, D. (2007) Environmental Fate of 1-MC P when Applied Pre-Harvest to Tomato Plants: Final Report. Project Number: AF/06/084. Unpublished study prepared by Agrofresh, Inc. 128 p. 16-Apr2007

47108204 Mamouni, A. (2006) (carbon -14)-1-Methylcyclopropene: Leachin g in Four Soils. Project Number: A79053, AF/06/081. Unpublished study pr epared by RCC Umweltchemie Ag. 88 p. 16-Apr2007

47108205 Kostansek, E. (2007) Product Chemistry AFxRD-038 Formulation. Project Number: AF/06/10. Unpublished study prepared by Agrofresh, Inc. 37 p. 16-Apr2007

47108206 Rodriguez, J. (2001) Atmospheric Fate of 1-Methylcyclopropene. Unpublished Study Prepared by Division of Marine and Atmospheric Science, Univ. of Miami, Project Number: 01RC/1017. 26 p. 16-Apr2007

47108207 Hynes, A. (2001) A Laser Photolysis-Laser Induced Fluorecence Determination of the Rate Coefficient for the Reaction of the Hydroxyl Radi cal with 1- Methylcycl opropene. Prepared by Division of Marine and Atmospheric Chemistr y at the Univ. of Mi ami. Project Number: 01RC/1016. 27 p. 16-Apr2007

47108208 Verona, D.; Mallipudi, M; Kurilla, K (2007) GL P Validation of the GC /FID Method for the Determination of 1 MCP in Smart Fresh and AFxRD-038 Formulations using cis-2-Butene as a Calibration/Internal Standard. Project Number: AF/06/078, AF/P/06/13. Unpublished study prepared by Agrofresh, Inc. 56 p. 16-Apr2007

47286100 AgroFresh, Inc. (2007) Submission of Product Chemistry Data in Support of the Application for Registration of AFXRD-038. Transmittal of 2 Studies. 20-Nov2007

47286101 Espino, P. (2000) Process Safety Test Result and Interpretation for Methylcyclopropene. Project Number: RO2685AR. Unpublished study prepared by Chilworth Technology, Inc. 37 p. 20-Nov2007

47286102 Weisel, L. (2003) Physical & Chemical Characterization of 3. 3% 1-Methylcycloprene (1-MCP) Formulation: Storage Stability and Corrosion Char acteristics after 18 Months & 24 Months at Room Temperature. Project Number: 713P/00/12, 03/013. Unpublished study prepared by Rohm and Haas Co. 127 p. 20-Nov2007

47465300 AgroFresh, Inc. (2008) Submission of Product Chemistry Data in Support of the Registration of AFxRD-038. Transmittal of 1 Study. 02-Jul2008

47465301 Kurilla, K.; Verona, D. (2008) Interim Repor t: A 24 Month Study of Storage Stability and Corrosion Characteristics of an AFxRD-038 Formul ation at 25 Degrees Ce lsius. Project Number: AF/P/07/01, AF/08/074, CIS/CTR/01. Unpublished study prepared by Agrofresh, Inc. 23 p. 02-Jul2008

47515000 AgroFresh, Inc. (2008) Submission of Residue Data in Support of the Amended Registration of AFxRD-038. Transmittal of 3 Studies. 13-Aug20081-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

26 47515001 Rosenwald, J. (2008) (Carbon 14)-1-Methylcyclopr opene: Characterization of Residues in Maize Grown Under Field Conditions in Switzerland. Project Number: B25784, AF/07/064. Unpublished study prepared by RCC, Ltd. 73 p. 13-Aug2008

47515002 Mallipudi, N. (2007) Residues and Characterization of [Carbon 14] 1-Methylcycloprene-Derived Residues in Soybean under Field Conditions. Project Number: AF/P/07/03. Unpublished study prepared by Xenobiotic, Inc., A ccess Research and Consulting, Inc. and Research for Hire. 173 p. 13-Aug2008

47515003 Verona, D. (2008) [Carbon 14]-1-Methylcyclopropene (1-MCP) Residue in Cotton under Field Conditions: Determination of TRR and Characterization of 1-MCP Residues in Cotton. Project Number: AF/P/07/05, AF/08/064. Unpublished study prepared by AgroFresh, Inc., Xenobiotic, Inc. and Access Research and Consulting, Inc. 132 p. 13-Aug2008

47554100 AgroFresh, Inc. (2008) Submission of Product Chemistry, Toxicity and Exposure and Risk Data in Support of the Application for Registration of AF-600. Transmittal of 20 Studies. 29-Sep2008

47554101 Smith, S.; Kurilla, K. (2008) GLP Characterizati on of Five Representative Batches of AF-600 Formulation. Project Number: AF/P/08/12, AF/08/079, AF/08/078. Unpublished study prepared by Agrofresh, Inc. 29 p. 29-Sep2008

47554102 Weissenfeld, M. (2008) AF-600: Determination of Color, Physical State and Odor: Final Report. Project Number: B84014, AF/08/024. Unpublished study prepared by RCC, Ltd. 31 p. 29-Sep2008

47554103 Kurilla, K. (2008) Accelerated Storage Stability of 1-Methylcy clopropene Formulation AF-600. Project Number: AF/08/085, AF/P/08/13. Unpublished study prepared by Agrofresh, Inc. 18 p. 29-Sep2008

47554104 Weissenfeld, M. (2008) AF-600: pH-Determination: Final Report. Project Number: B83992, AF/08/23. Unpublished study prepared by RCC, Ltd. 33 p. 29-Sep2008

47554105 Cerven, D. (2008) Acute Oral Toxicity - Up an d Down Procedure (UDP): AF-600: (Rat). Project Number: 08P/044, 08RC/044, MB/08/16870/01. Unpublished study prepared by MB Research Laboratories. 14 p. 29-Sep2008

47554106 Cerven, D. (2008) Acute Dermal Toxicity /LD50 in Rats: AF-600. Project Number: MB/08/16870/02, 2100S/02, 08P/045. Unpublished study prepared by MB Research Laboratories. 16 p. 29-Sep2008

47554107 DiDonato, L. (2008) Primary Dermal Irritation/Co rrosion in Rabbits: AF-600. Project Number: MB/08/16870/03, 4130R/H/02, 08P/046. Unpublished study prepared by MB Research Laboratories. 17 p. 29-Sep2008

47554108 Nave, V. (2008) Acute Inhalation Potential of AF-600: Rationale to Use Ingredient Data. Project Number: 08R/1013. Unpublished study prepared by Rohm and Haas Co. 10 p. 29-Sep2008

47554109 Hall, D. (2008) Acute Eye Irritation in Rabb its: AF-600. Project Number: MB/08/16870/04, 1200R/02, 08P/047. Unpublished study prepared by MB Research Laboratories. 19 p. 29-Sep2008

47554110 Hall, D. (2008) Guinea Pig Maximization Test (Magnusson-Kligman). Project Number: MB/08/16870/06, 2160R/02, 08P/048. Unpublished study prepared by MB Research Laboratories. 58 p. 29-Sep2008

47554111 Weissenfeld, M. (2008) AF-600: Determination of the Viscosity: Final Report. Project Number: B84060, AF/08/027. Unpublished study prepared by RCC, Ltd. 43 p. 29-Sep2008

47554112 Weissenfeld, M. (2008) AF-600: Determination of the Auto-Ignition Temperature: Final Report. Project Number: B84058, AF/08/026. Unpublished study prepared by: RCC, Ltd. 37 p. 29-Sep2008

47554113 Weissenfeld, M. (2008) AF-600: Determination of the Flash Point: Final Report. Project Number: B84047, AF/08/025. Unpublished study prepared by RCC, Ltd. 33 p. 29-Sep20081-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

27 47554114 Weissenfeld, M. (2008) AF-600: Determination of the Relative Density: Final Report. Project Number: B84071, AF/08/028. Unpublished st udy prepared by RCC, Ltd. 36 p. 29-Sep2008

47554115 Kurilla, K.; Verona, D. (2008) GLP Validation of the GC/FID Method for the Determination of 1- MCP in AF-600 Formulations Using Cis-2-Butene as a Calibration/Internal Standard. Project Number: AF/08/051, AF/P/08/04. Unpublished study prepared by Agrofresh, Inc. 34 p. 29-Sep2008

47554116 Nave, V. (2008) AF-600: Rationale for Waiver of Acute Oral Toxicity Study with the Northern Bobwhite Quail. Project Number: 08R/1043. Unpublished study prepared by Rohm and Haas Co. 8
p. 29-Sep2008

47554117 Nave, V. (2008) AF-600: Rationale for Waiver of Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Project Number: 08R/1044. Unpublished study prepared by Rohm and Haas Co. 8 p. 29-Sep2008

47554118 Nave, V. (2008) AF-600: Rationale for Waiver of Acute Toxicity Immobilization Test with the Cladoceran (Daphnia magna). Project Number: 08R/1045. Unpublished study prepared by Rohm and Haas Co. 8 p. 29-Sep2008

47554119 Kostansek, E. (2008) Product Chemistry: AF-600. Project Number: AGROFRESH/08/093, AF/08/051, AF/P/08/04. Unpublished study prepared by Agrofresh, Inc. 165 p. 29-Sep2008

47554120 Driver, J.; Hewitt, A.; Ross, J. (2008) Evaluation of Potential Handler and Bystander Exposures and Health Risks Associated w ith Pre-Harvest Aerial Applica tion of 1-MCP. Project Number: IS/C/02/001/08, 08RC/1004. Unpublished study prepared by Rohm and Haas Co. 48 p. 29-Sep2008

47611800 AgroFresh (2008) Submission of Product Chemistry Data in Support of the Amended Registration of EthylBloc Sachet. Transmittal of 1 Study. 28-Nov2008

47611801 Ranly, P. (2008) EthylBloc Sachet: Alternate Manu facturing Process. Proj ect Number: AF/08/106. Unpublished study prepared by Agrofresh, Inc. 26 p. 28-Nov2008

47690300 AgroFresh, Inc. (2009) Submission of Product Chemistry Data in Support of the Application for Registration of AF-600. Transmittal of 1 Study. 02-Mar2009

47690301 Kostansek, E. (2009) Additional Product Chemis try Information for AF-600. Project Number: AGROFRESH/08/093B, B84036, B84025. Unpublished study prepared by Agrofresh, Inc. 47 p. 02-Mar2009

47876400 Agro Fresh, Inc. (2009) Submission of Product Chemistry, Toxicity, Fate and Residue Data in Support of the Application for Registration of A17492F. Transmittal of 16 Studies. 01-Oct2009

47876401 Verona, D. (2009) A17492F Formulation: Product Chemistry Group A. Project Number: AF/09/070, T001982/09, TK0001951. Unpublished study prepared by Syngenta Crop Protection. 116 p. 01-Oct2009

47876402 Verona, D. (2009) A17492F Formulation: Product Chemistry Group B. Project Number: AF/09/073, TK0001953, HT09/226. Unpublished study prepared by Syngenta Crop Protection, Inc. 32 p. 01-Oct2009

47876403 Mallipudi, N. (2009) Comparative Residue Study of the 1-Methylcyclopropene (1-MCP) Formulations AFxRD-038 and A17492F: Residue and Characterization of [Carbon 14], 1-MCP Residues in Soybean under Field Conditions: Interim Report. Project Number: 27893, AF/09/067, 09049. Unpublished study prepared by Eurofins/Product Safety Laboratories and Xenobiotic, Inc. 64 p. 01-Oct2009

47876404 Kumar, S. (2009) 1-Methylcyclopropene XX: Acute Oral Toxicity Study (Up-and-Down Procedure) In Rats: Amended Final Report. Project Number: G6801, G6801/AOR. Unpublished study prepared by Advinus Therapeutics Private, Limited. 49 p. 01-Oct20091-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

28 47876405 Kumar, S. (2009) 1-Methylcyclopropene XX: Acute Dermal Toxicity Study in Rats: Amended Final Report. Project Number: G6802, G6802/ADR. Unpublished study prepared by Advinus Therapeutics Private, Limited. 48 p. 01-Oct2009

47876406 Kumar, S. (2009) 1-Methylcyclopropene XX: Acute Eye Irritation Study in Rabbits: Amended Final Report. Project Number: G6803, G6803/EYE. Unpublished study prepared by Advinus Therapeutics Private, Limited. 53 p. 01-Oct2009

47876407 Kumar, M. (2009) 1-Methylcyclopropene XX: Acute Dermal Irritation Study in Rabbits: Amended Final Report. Project Number: G6804, G6804/SKIN. Unpublished study prepared by Advinus Therapeutics Private, Limited. 47 p. 01-Oct2009

47876408 Nave, V. (2009) Acute Inhalation Potential of Formulation A17492F (1-Methylcyclopropene XX): Rationale to Use Surrogate Toxicology Data. Project Number: 09R/1029. Unpublished study prepared by Agrofresh, Inc. 10 p. 01-Oct2009

47876409 Nave, V. (2009) Dermal Sensitization Potential of Formulation A17492F (1-Methylcyclopropene XX): Rationale to Use Surrogate Toxicology Data. Project Number: 09R/1030. Unpublished study prepared by Agrofresh, Inc. 10 p. 01-Oct2009

47876410 Nave, V. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of OPPTS 880.3550 Immunotoxicity. Project Number: 09R/1031. Unpublished study prepared by Agrofresh, Inc. 12 p. 01-Oct2009

47876411 Carbone, J. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Acute Oral Toxicity Study with the Northern Bobwhite Quail. Project Number: 09R/1033. Unpublished study prepared by Agrofresh, Inc. 9 p. 01-Oct2009

47876412 Carbone, J. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Dietary Toxicity Study with the Northern Bobwhite Quail. Project Number: 09R/1034. Unpublished study prepared by Agrofresh, Inc. 9 p. 01-Oct2009

47876413 Carbone, J. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Project Number: 09R/1035. Unpublished study prepared by Agrofresh, Inc. 11 p. 01-Oct2009

47876414 Carbone, J. (2009) A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Acute Toxicity Immobilization Test with the Cladoceran (D aphnia magna). Project Number: 09R/1036. Unpublished study prepared by Agrofresh, Inc. 11 p. 01-Oct2009

47876415 Carbone, J. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Seedling Emergence Test. Project Number: 09R/1037. Unpublished study prepared by Agrofresh, Inc. 9 p. 01-Oct2009

47876416 Carbone, J. (2009) Formulation A17492F (1-Methylcyclopropene XX): Rationale for Waiver of Vegetative Vigor Test. Project Number: 09R/1038. Unpublished study prepared by Agrofresh, Inc. 9 p. 01-Oct2009

47913700 AgroFresh, Inc. (2009) Submission of Product Chemistry, Toxicity and Fate Data in Support of the Application for Registration of AF-625. Transmittal of 15 Studies. 16-Nov2009

47913701 Kostansek, E.; Verona, D. (2009) AF-625 Formulation: Product Chemistry Group A. Project Number: AGROFRESH/09/068, 5945. Unpublished study prepared by Agrofresh, Inc. 159 p. 16-Nov2009

47913702 Verona, D. (2009) AF-625 Formulation: Product Chemistry Group B. Project Number: AGROFRESH/09/076, AF/09/064, AF/P/09/08. Unpublished study prepared by Agrofresh, Inc. and Harlan Laboratories, Ltd. 203 p. 16-Nov20091-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

29 47913703 Ravi, G. (2009) AF-625: Acute Oral Toxicity Study (Up-and-Down Procedure) in Rats: Final Report. Project Number: G6851, G6851/AOR. Unpublished study prepared by Advinus Therapeutics Private Limited. 48 p. 16-Nov2009

47913704 Ravi, G. (2009) AF-625: Acute Dermal Toxicity Study in Rats: Final Report. Project Number: G6852/ADR, G6852, SP/G6852. Unpublished study prepared by Advinus Therapeutics Private Limited. 48 p. 16-Nov2009

47913705 Kumar, S. (2009) AF-625: Acute Eye Irritation Study in Rabbits: Final Report. Project Number: G6853, G6853/EYE, SP/G6853. Unpublished study prepared by Advinus Therapeutics Private Limited. 50 p. 16-Nov2009

47913706 Kumar, M. (2009) AF-625: Acute Dermal Irritation Study in Rabbits: Final Report. Project Number: G6854, G6854/SKIN, SP/G6854. Unpublished study prepared by Advinus Therapeutics Private Limited. 47 p. 16-Nov2009

47913707 Nave, V. (2009) Acute Inhalation Potential of Fo rmulation AF-625: Rationale to Use Surrogate Toxicology Data. Project Number: 09R/1042. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913708 Nave, V. (2009) Dermal Sensitization Potential of Formulation AF-625: Rationale to Use Surrogate Toxicology Data. Project Number: 09R/1043. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913709 Nave, V. (2009) Formulation AF-625: Rationale for Waiver of OPPTS 880.3550 Immunotoxicity. Project Number: 09R/1044. Unpublished study prepared by Agrofresh, Inc. 12 p. 16-Nov2009

47913710 Carbone, J. (2009) AF-625: Rationale for Waiver of Acute Oral Toxicity Study with the Northern Bobwhite Quail: Final Report. Project Number : 09R/1045. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913711 Carbone, J. (2009) AF-625: Rationale for Waiver of Dietary Toxicity Study with the Northern Bobwhite Quail: Final Report. Project Number : 09R/1046. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913712 Carbone, J. (2009) AF-625: Rationale for Waiver of Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: 09R/1047. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913713 Carbone, J. (2009) AF-625: Rationale for Waiver of Acute Toxicity Immobilization Test with the Cladoceran (Daphnia magna): Final Report. Project Number: 09R/1048. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913714 Carbone, J. (2009) AF-625: Rationale for Waiver of Seedling Energence Test: Final Report. Project Number: 09R/1049. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

47913715 Carbone, J. (2009) AF-625: Rationale for Waiver of Vegetative Vigor Test: Final Report. Project Number: 09R/1050; 09/1050. Unpublished study prepared by Agrofresh, Inc. 10 p. 16-Nov2009

48087000 Agro Fresh, Inc. (2010) Submission of Toxicity Da ta in Support of the Application for Registration of AF-625. Transmittal of 2 Studies. 07-May2010

48087001 Nave, V. (2009) Acute Inhalation Potential of Fo rmulation AF-625: Rationale to Use Surrogate Toxicology Data. Project Number: 09R/1042. Unpublished study prepared by Agro Fresh, Inc. 10
p. 07-May2010

48087002 Carbone, J. (2010) AF-625: Rationale for Waiver of Non-Target Insect Toxicity Test. Project Number: 10R/1017. Unpublished study prepared by Agro Fresh, Inc. 9 p. 07-May2010

48567300 AgroFresh, Inc. (2011) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of SmartFresh ProTabs. Transmittal of 12 Studies. 09-Aug20111-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

30 48567301 Durando, J. (2011) AF-777 Powder: 1-Methylcyclopropene: Acute Oral Toxicity Up and Down Procedure in Rats. Unpublished study prepared by Eurofins/Product Safety Laboratories. 28p. 09-Aug2011

48567302 Durando, J. (2011) AF-777 Powder: 1-Methylcyclopropene: Acute Dermal Toxicity Study in Rats. Project Number: 31418 100293 P322/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 26p. 09-Aug2011

48567303 Durando, J. (2011) AF-777 Powder: 1-Methylcyclopropene: Acute Inhalation Toxicity Study in Rats. Project Number: 31419 100315 P330/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 37p. 09-Aug2011

48567304 Durando, J. (2011) AF-777 Powder: 1-Methylcyclopropene: Primary Eye Irritation Study in Rabbits. Project Number: 31420 100295 P324/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 29p. 09-Aug2011

48567305 Durando, J. (2011) AF-777: 1-Methylcycloprope ne: Primary Skin Irritation Study in Rabbits. Project Number: 31421 100294 P326/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 29p. 09-Aug2011

48567306 Durando, J. (2011) AF-777 Powder: 1-Methylcyclopropene: Local Lymph Node Assay (LLNA) in Mice. Project Number: 31422 100296 P327/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 40p. 09-Aug2011

48567307 Carbone, J. (2011) AF-777: Rationale for Waiver of Acute Oral Toxicity Study with the Northern Bobwhite Quail. Project Number: NS000037. Unpublished study prepared by The Dow Chemical Co. 10p. 09-Aug2011

48567308 Carbone, J. (2011) AF-777: Rationale for Waiver of Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss). Project Number: NS000039. Unpublished study prepared by The Dow Chemical Co. 10p. 09-Aug2011

48567309 Carbone, J. (2011) AF-777: Rationale for Waiver of Acute Toxicity Immobilization Test with the Cladoceran (Daphnia magna). Project Number: NS000040. Unpublished study prepared by The Dow Chemical Co. 10p. 09-Aug2011

48567310 Carbone, J. (2011) AF-777: Rationale for Waiver of Dietary Toxicity Study with the Northern Bobwhite Quail. Project Number: NS000041. Unpublished study prepared by The Dow Chemical Co. 10p. 09-Aug2011

48567311 Jacobson, R.; Verona, D. (2011) AF-777 1-Methylcyclopropene Formulation: Product Chemistry Group A. Project Number: AGROFRESH/11/097, AF/11/097. Unpublished study prepared by Agrofresh, Inc., and Wildlife International, Ltd. 252p. 09-Aug2011

48567312 Verona, D. (2011) Product Chemistry Series 830 Group B: Physical and Chemical Characteristics of AF-777 1-Methylcyclopropene Formulation. Project Number: AGROFRESH/11/098, D15766. Unpublished study prepared by Agrofresh, Inc., and Harlan Laboratories, Ltd. 232p. 09-Aug2011

48628300 Agri Fresh, Inc. (2011) Submission of Product Chemistry, Toxicity and Residue Data in Support of the Application for Registration of AF-2005. Transmittal of 19 Studies. 11-Oct2011

48628301 Jacobson, R.; Kurilla, K. (2011) AF-2005 1-Methylcyclopropene Formulation Product Chemistry Group A. Project Number: AGROFRESH/11/112. Unpublished study prepared by Agrofresh, Inc. 222p. 11-Oct2011

48628302 Kurilla, K. (2011) Product Chemistry Series 830 Group B: Physical and Chemical Characteristics of AF-2005 1-Methylcyclopropene Formulation. Project Number: AGROFRESH/11/117. Unpublished study prepared by Harlan Laboratories, Ltd. and Agrofresh, Inc. 64p. 11-Oct20111-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

31 48628303 Minderhout, T.; Martin, K.; Gallagher, S.; et al. (2011) AF-2005: Formulation of 1- Methylcyclopropene (1-MCP): A 48-Hour Static Acute Immobilization Test with the Cladoceran (Daphnia magna): Final Report. Project Number: 103A/165, 110057, 100297. Unpublished study prepared by Wildlife International, Ltd. 64p. 11-Oct2011

48628304 Minderhout, T.; Kendall, T.; Gallagher, S.; et al. (2011) AF-2005: Formulation of 1- Methylcyclopropene (1-MCP): A 96-Hour Static-Renewal Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: 103A/166, 110058. Unpublished study prepared by Wildlife International, Ltd. 68p. 11-Oct2011

48628305 Hubbard, P.; Beavers, J. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1-MCP): An Acute Oral Toxicity Study with the Northern Bobwhite. Project Number: 103/448, 110053. Unpublished study prepared by Wildlife International, Ltd. 59p. 11-Oct2011

48628306 Hubbard, P.; Martin, K.; Beavers, J. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1- MCP): A Dietary LC50 Study with the Northern Bobwhite. Project Number: 103/446, 110054. Unpublished study prepared by Wildlife International, Ltd. 69p. 11-Oct2011

48628307 Sindermann, A.; Porch, J.; Krueger, H. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1- MCP): An Acute Contact Toxicity Study with the Honey Bee: Final Re port. Project Number: 103/445, 100317. Unpublished study prepared by Wildlife International, Ltd. 32p. 11-Oct2011

48628308 Carbone, J. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1-MCP): Rationale for Waiver of Seedling Emergence Test. Project Number: NS000047. Unpublished study prepared by Dow Chemical Company. 10p. 11-Oct2011

48628309 Carbone, J. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1-MCP): Rationale for Waiver of Vegetative Vigor Test. Project Number: NS000048. Unpublished study prepared by Dow Chemical Company. 10p. 11-Oct2011

48628310 Kurilla, K.; Faubion, D.; Jacobson, A.; et al. (2011) Magnitude of Residues of 1- Methylcyclopropene (1-MCP) on Apples following Application of AF-2005. Project Number: AF/P/11/04, AF/11/124. Unpublished study prepared by Agrofresh, Inc. and ExperiCo. 107 p. 11-Oct2011

48628311 Kumar, S. (2011) AF-2005: Acute Oral Toxicity Study (Up-and-Down Procedure) in Rats: Final Report. Project Number: G7768, G7768/AOR. Unpublished study prepared by Advinus Therapeutics Private Limited. 50p. 11-Oct2011

48628312 Kumar, S. (2009) 1-MCP: Manufacturing Use Product: Acute Oral Toxicity Study (Up-and-Down Procedure) in Rats: Amended Final Report. Project Number: G6799, G6799/AOR. Unpublished study prepared by Advinus Therapeutics Private Limited. 49p. 11-Oct2011

48628313 Kumar, S. (2011) AF-2005: Acute Dermal Toxicity Study in Rats: Final Report. Project Number: G7769, G7769/ADR. Unpublished study prepared by Advinus Therapeutics Private Limited. 49p. 11-Oct2011

48628314 Durando, J. (2010) Manufacturing Use Product - HAIP (1-Methylcyclopropene): Acute Inhalation Toxicity Study in Rats. Project Number: 30311, 100137, P330/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 37p. 11-Oct2011

48628315 Krieger, S.; Mahoney, K. (2011) AF-2005: Acute Liquid Aerosol Inhalation Toxicity Study in Crl:CD(SD) Rats. Project Number: 111102. Unpublished study prepared by The Dow Chemical Co. 71p. 11-Oct2011

48628316 Prakash, P. (2011) AF-2005: Acute Eye Irritation Study in Rabbits: Final Report. Project Number: G7919, G7919/EYE. Unpublished study prepared by Advinus Therapeutics Private Limited. 50p. 11-Oct2011

48628317 Prakash, P. (2011) AF-2005: Acute Dermal Irritation Study in Rabbits: Final Report. Project Number: G7770, G7770/SKIN. Unpublished study prepared by Advinus Therapeutics Private Limited. 50p. 11-Oct20111-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

32 48628318 Sulaiman, S. (2011) AF-2005: Local Lymph Node Assay (LLNA) in CBA/Ca Mice: Final Report. Project Number: G7772, G7772/LLNA. Unpublished study prepared by Advinus Therapeutics Private Limited. 71p. 11-Oct2011

48628319 Durando, J. (2011) AF-2005 without 1-MCP: Local Lymph Node Assay (LLNA) in Mice. Project Number: 32615, 110115, P327/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 41p. 11-Oct2011

48786100 Agro Fresh, Inc. (2012) Submission of Fate Data in Support of the Application for Registration of AF-2005. Transmittal of 2 Studies. 30-Mar2012

48786101 Sindermann, A.; Martin, K.; Porch, J. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1- MCP): A Toxicity Test to Determ ine the Effects of the Test Subs tance on Seedling Emergence of Ten Species of Plants: Final Report. Project Number: 103/449, 110061. Unpublished study prepared by Wildlife International, Ltd. 83p. 30-Mar2012

48786102 Sindermann, A.; Porch, J.; Martin, K. (2011) AF-2005: Formulation of 1-Methylcyclopropene (1- MCP): A Toxicity Test to Determ ine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number: 103/450, 110060. Unpublished study prepared by Wildlife International, Ltd. 103p. 30-Mar2012

49061100 Agro Fresh, Inc. (2013) Submission of Product Chemistry Data in Support of the Registration of Smartfresh Protabs. Transmittal of 1 Study. 19-Feb2013

49061101 Kurilla, K. (2013) Storage Stability and Corrosion Characteristics of AF-777 1- Methylcyclopropene (Yellow) Formulation (Vector Yellow VEC298-2011 Lot 1): Final Report. Project Number: AF/P/11/32, AF/13/005. Unpublished study prepared by Agrofresh, Inc. 25p. 19-Feb2013

49183700 AgroFresh, Inc. (2013) Submission of Product Chemistry Data in Support of the Registration of AF-2005. Transmittal of 1 Study. 25-Jul2013

49183701 Kurilla, K. (2013) Storage Stability of 0.8% 1- Methylcyclopropene Formulation AF-2005 for 12 months at 25 Degrees Celsius. Project Numb er: AF/P/11/30, AF/13/001. Unpublished study prepared by Agro Fresh, Inc. 28p. 25-Jul2013

49201900 AgroFresh, Inc. (2013) Submission of Toxicity and Product Chemistry Data in Support of the Application of Registration of AF-701. Transmittal of 15 Studies. 26-Aug2013

49201901 Jacobson, A. (2013) Formulation AF-701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver Acute Toxicity Immobilization Test with the Cladoceran (Daphnia magna): Final Report. Project Number: AF/13/072. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201902 Jacobson, A. (2013) Formulation AF/701 (Active Ingredient 1-Methycyclopropene): Rationale for Waiver of Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: AF/13/071. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201903 Jacobson, A. (2013) Formulation AF/701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver of Acute Oral Toxicity Study with the Northern Bobwhite Quail: Final Report. Project Number: AF/13/070. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201904 Jacobson, A. (2013) Formulation AD-701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver of Dietary Toxicity Study with the Northern Bobwhite Quail: Final Report. Project Number: AF/13/076. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201905 Jacobson, A. (2013) Formulation AF-701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver of Honey Bee (Apis mellif era) Acute Contact Toxicity Tes t: Final Report. Project Number: AF/13/075. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug20131-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

33 49201906 Jacobson, A. (2013) Formulation AF-701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver of Seedling Emergence Test: Final Report. Project Number: AF/13/073. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201907 Jacobson, A. (2013) Formulation AF-701 (Active Ingredient 1-Methylcyclopropene): Rationale for Waiver of Vegetative Vigor Test: Final Report. Project Number: AF/13/073. Unpublished study prepared by Agrofresh, Inc. 10p. 26-Aug2013

49201908 Durando, J. (2010) 1-Methylcyclopropene Formulation AF-701: Acute Oral Toxicity Up and Down Procedure in Rats. Project Number: 28867, 090592, P320/UDP/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 30p. 26-Aug2013

49201909 Durando, J. (2010) 1-Methylcyclopropene Formulation AF-701: Acute Dermal Toxicity Study in Rats. Project Number: 28868, 090593, P322/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 29p. 26-Aug2013

49201910 Merolla, L. (2013) Formulation AF-701 (active ingredient 1-Methycyclopropene): Rationale for Waiver of Acute Inhalation Study. Project Number: AF/13/082. Unpublished study prepared by Agrofresh, Inc. 9p. 26-Aug2013

49201911 Durando, J. (2010) 1-Methylcyclopropene Formulation AF-701: Primary Eye Irritation Study in Rabbits. Project Number: 28869, 090595, P324/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 32p. 26-Aug2013

49201912 Durando, J. (2010) 1-Methylcyclopropene Formulation AF-701: Primary Skin Irritation Study in Rabbits. Project Number: 28870, 090594, P326/DOW. Unpublished study prepared by Eurofins/Product Safety Laboratories. 31p. 26-Aug2013

49201913 Boverhof, D.; Sosinski, L. (2010) 1-Methylcyclopropene Formulation AF-701: Local Lymph Node Assay In CBA/ J Mice. Project Number: 091147. Unpublished study prepared by Dow Chemical, USA. 25p. 26-Aug2013

49201914 Guo, I.; Jacobson, A.; Lieberman, E. et al. (2013) AF-701: A 1--Methycyclopropene (1-MCP) Formulation Product Chemistry Group A. Project Number: AF/13/068. Unpublished study prepared by Agrofresh, Inc. 112p. 26-Aug2013

49201915 Guo, I. (2010) 1-Methycyclopropene (1-MCP) AF-701 Formulation Product Chemistry Group B. Project Number: AGROFRESH/10/013. Unpublished study prepared by Agrofresh, Inc. 161p. 26-Aug2013

49265000 Janssen PMP (2014) Submission of Product Chemistry, Toxicity, Fate, Residue and Efficacy Data in Support of the Application for Registration of Fysium. Transmittal of 55 Studies. 11-Mar2014

49265001 Goodwine, W. (2014) Product Chemistry Group A: Product Identity & Composition, and Analysis: Fysium (1-MCP). Project Number: PPD/60. Unpublished study prepared by Janssen Pharmaceutica. 94p. 11-Mar2014

49265002 Comb, A. (2014) 1-MCP Five Batch Analysis (using five batches of LAg 2011 009 and one generator): Final Report. Project Number: AGR/4954, IMB0059, CT003597PCP01. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 53p. 11-Mar2014

49265003 Comb, A. (2014) 1-MCP Method Validation: Final Report. Project Number: AGR/4958, IMB0063, 295469. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 95p. 11-Mar2014

49265004 Comb, A. (2014) 1-MCP: Assessment of Yield of Gas Generator at Different Loadings. Project Number: AGR/4957, IMB0062, 295469. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30p. 11-Mar20141-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

34 49265005 Comb, A. (2014) 1-MCP: Physico-Chemical Pr operties (Interim Repor t). Project Number: AGR/4959, IMB0064, 295469. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 46p. 11-Mar2014

49265006 Younis, S. (2013) Regulatory Testing on a Sample of 1-Methycyclopropene: Final Report. Project Number: AGR/4944, GLP109415R1V1/2013, GLP/109415. Unpublished study prepared by Chilworth Technology. 18p. 11-Mar2014

49265007 Robinson, M. (2013) 1-Methylcyclopropene: Single Dose Toxicity Study by Inhalation Administration to Rats: Final Report. Project Number: AGR/4802, IMB0042. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 49p. 11-Mar2014

49265008 May, K. (2013) 1-MCP: Bacterial Reverse Mutation Test (Gas Phase): Final Report. Project Number: AGR/4803, IMB0043. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 61p. 11-Mar2014

49265009 Woods, I. (2013) 1-MCP: In Vitro HPRT Mutati on Test Using Chinese Hamster Ovary Cells (Gas Phase): Final Report. Project Number: AGR/4805, IMB0045. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 55p. 11-Mar2014

49265010 Woods, I. (2013) 1-MCP: In Vitro Mammalian Chromosome Aberration Test in Human Lymphocytes (Gas Phase): Final Report. Pr oject Number: AGR/4804 , IMB0044. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 52p. 11-Mar2014

49265011 Goodwine, W. (2014) Product Chemistry Group A: Product Identity, Composition, Analysis - Component B (LAG 2011 009). Project Number: PPD/60. Unpublished study prepared by Janssen Pharmaceutica. 64p. 11-Mar2014

49265012 Comb, A. (2014) LAg 2011 009: Five Batch Analysis: Final Report. Project Number: AGR/4947, IMB0055. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 30p. 11-Mar2014

49265013 Comb, A. (2014) LAg 0211 009: Method Validation: Final Report. Project Number: AGR/4948, IMB0056. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 34p. 11-Mar2014

49265014 Wo, C. (2013) Physical and Chemical Charact eristics: Color, Physical State, Odor, Oxidation/Reduction, Flashpoint, pH, Viscosity and Density/Relative Density: LAG 2011 009. Project Number: AGR/4815, PSL/35789, P804/TGAI. Unpublished study prepared by Product Safety Laboratories. 18p. 11-Mar2014

49265015 Comb, A. (2014) LAg 2011 009: Physico-Chemical Properties: Final Report. Project Number: AGR/4905, IMB0052. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 62p. 11-Mar2014

49265016 Comb, A. (2014) LAg 2011 009: Accelerated Storage Stability: Final Report. Project Number: AGR/5033, IMB0083. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 27p. 11-Mar2014

49265017 Comb, A. (2014) LAg 2011 009: Low Temperature Stability: Final Report. Project Number: AGR/5032, IMB0082. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 12p. 11-Mar2014

49265018 Lowe, C. (2013) Acute Oral Toxicity Up and Down Procedure in Rats: LAG 2011 009. Project Number: AGR/4809, PSL/35766, P320/UDP. Unpublished study prepared by Product Safety Laboratories. 15p. 11-Mar2014

49265019 Lowe, C. (2013) Acute Dermal Toxicity Study in Rats: LAG 2011 009. Project Number: AGR/4810, PSL/35767, P322/RAT. Unpublished study prepared by Product Safety Laboratories. 15p. 11-Mar2014

49265020 Lowe, C. (2013) Acute Inhalation Toxicity Study in Rats: LAG 2011 009. Project Number: AGR/4811, PSL/35768, P330. Unpublished study prepared by Product Safety Laboratories. 23p. 11-Mar20141-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

35 49265021 Lowe, C. (2013) Primary Eye Irritation Study in Rabbits: LAG 2011 009. Project Number: AGR/4812, PSL/35769, P324. Unpublished study prepared by Product Safety Laboratories. 15p. 11-Mar2014

49265022 Lowe, C. (2013) Primary Skin Irritation Study in Rabbits: LAG 2011 009. Project Number: AGR/4813, PSL/35770, P326. Unpublished study prepared by Product Safety Laboratories. 15p. 11-Mar2014

49265023 Lowe, C. (2013) Local Lymph Node Assay (LLNA) in Mice: LAG 2011 009. Project Number: AGR/4814, PSL/35771, P327. Unpublished study prepared by Product Safety Laboratories. 24p. 11-Mar2014

49265024 May, K. (2013) Lag 2011 009: Bacterial Reverse Mutation Test: Final Report. Project Number: AGR/4800, IMB0040. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 49p. 11-Mar2014

49265025 Woods, I. (2013) Lag 2011 009: In Vitro Mammalian Chromosome Aberration Test in Human Lymphocytes: Final Report. Project Number: AGR/4801, IMB0041. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 50p. 11-Mar2014

49265026 Goodwine, W. (2014) Product Chemistry Group A: Product Identity, Composition and Analysis: Component A (LAG 2011 009). Project Number: PPD/62. Unpublished study prepared by Janssen Pharmaceutica. 53p. 11-Mar2014

49265027 Comb, A. (2014) LAg 2011 008: Five-Batch Analysis: Final Report. Project Number: AGR/5052, IMB0084, 2723/140613. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 21p. 11-Mar2014

49265028 Comb, A. (2014) LAg 2011 008: Method Validation: Final Report. Project Number: AGR/5044, IMB0077. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 22p. 11-Mar2014

49265029 Wo, C. (2013) Physical & Chemical Charact eristics: Color, Physical State, Odor, Oxidation/Reduction, Flammability, pH, Viscosity, Density/Relative Density - Janssen Code# LAG 2011 008. Project Number: AGR/4992, PSL/36385, P801. Unpublished study prepared by Product Safety Laboratories. 16p. 11-Mar2014

49265030 Comb, A. (2014) LAg 2011 008: Physico-Chemical Properties: Final Report. Project Number: AGR/5034, IMB0076. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 23p. 11-Mar2014

49265031 Comb, A. (2014) LAg 2011 008: Accelerated Storage Stability: Final Report. Project Number: AGR/5042, IMB0079. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 24p. 11-Mar2014

49265032 Comb, A. (2014) LAg 2011 008: Low Temperature Storage Stability: Final Report. Project Number: AGR/5041, IMB0078. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 12p. 11-Mar2014

49265033 Wo, C. (2013) Janssen Code# LAg 2011 008: Physical and Chemical Characteristics: Boiling Point. Project Number: AGR/5065, PSL/36810, P801. Unpublished study prepared by Product Safety Laboratories. 11p. 11-Mar2014

49265034 Lowe, C. (2013) Acute Oral Toxicity Up and Down Procedure in Rats: Janssen Code# LAg 2011 008. Project Number: AGR/4995, PSL/36386, P320/UDP. Unpublished study prepared by Product Safety Laboratories. 15p. 11-Mar2014

49265035 Lowe, C. (2013) Acute Dermal Toxicity Study in Rats: Janssen Code# LAg 2011 008. Project Number: AGR/4996, PSL/36387, P322/RAT. Unpublished study prepared by Product Safety Laboratories. 20p. 11-Mar2014

49265036 Lowe, C. (2013) Acute Dermal Toxicity Study in Rats - Limit Test: Janssen Code# LA g 2011 008. Project Number: AGR/5107, PSL/37090, P322/RAT. Unpublished study prepared by Product Safety Laboratories. 23p. 11-Mar2014

49265037 Lowe, C. (2013) Janssen Code # LAg 2011 008: Acute Inhalation Toxicity Study in Rats - Limit Test. Project Number: AGR/4997, PSL/36388, P330. Unpublished study prepared by Product Safety Laboratories. 22p. 11-Mar20141-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

36 49265038 Lowe, C. (2013) Janssen Code #LAg 2011 008: Primary Skin Irritation Study in Rabbits. Project Number: AGR/4999, PSL/36390, P326. Unpublished study prepared by Product Safety Laboratories. 14p. 11-Mar2014

49265039 Lowe, C. (2013) Janssen Code# LAg 2011 008: Local Lymph Node Assay (LLNA) in Mice. Project Number: AGR/5000, PSL/36391, P327. Unpublished study prepared by Product Safety Laboratories. 23p. 11-Mar2014

49265040 Neumans, E. (2013) 1-methylcyclopropene: Physical & Chemical Characteristics: Vapor Pressure. Project Number: AGR/51 30. Unpublished study prepared by Janssen Pharmaceutica. 7p. 11-Mar2014

49265041 Douahiher, M. (2013) Physical & Chemical Characteristics: Determination of the Melting Point/Melting Range of 1-Methycycloprene. Project Number: AGR/5131. Unpublished study prepared by Jansse n Pharmaceutica. 8p. 11-Mar2014

49265042 Warkentien, K. (2014) 1-MCP Physical-Chemical Properties Data Waivers. Project Number: FYSIUM/PC/1013. Unpublished study prepared by Lewis & Harrison, LLC. 20p. 11-Mar2014

49265043 Warkentien, K. (2014) 1-MCP: Health E ffects: Data Waivers. Project Number: FYSIUM/TOX/0913. Unpublished study prepared by Lewis & Harrison, LLC. 20p. 11-Mar2014

49265044 Warkentien, K. (2014) 1-MCP Ecological Ef fects Data Waivers. Project Number: FYSIUM/ECO/0913. Unpublished study prepared by Lewis & Harrison, LLC. 17p. 11-Mar2014

49265045 Lauwers, D. (2013) Storage Stability Test on Component B (Lag 2011 009) for 14 days 54 (Degrees Celcius). Project Numb er: 13024. Unpublished study pr epared by Janssen Pharmaceutica. 31p. 11-Mar2014

49265046 Warkentien, K (2014) 1-MCP: Precursor Physi cal-Chemical Properties Data Waivers. Project Number: FYSIUM/PRE/PC/1013. Unpublished study prepared by Lewis and Harrision, LLC. 18p. 11-Mar2014

49265047 Warkentien, K. (2014) 1-MCP Precursor Health Effects Data Waiver s. Project Number: FYSIUM/PRE/TOX/0913. Unpublished study prepared by Lewis & Harrison, LLC. 22p. 11-Mar2014

49265048 Warkentien, K. (2014) 1-MCP: Precursor Ecological Effects. Project Number: FYSIUM/PRE/ECO/0913. Unpublished study prepared by Lewis & Harrison, LLC. 22p. 11-Mar2014

49265049 Cotterhill, J. (2013) In Silico Assessment of Ma mmalian Toxicity and Ecotoxicity of Lag 2011 009. Project Number: AGR/5113, W5ZZ3001/2. Unpublished study prepared by Food and Environmental Research Agency (Fera). 61p. 11-Mar2014

49265050 Warkentien, K. (2014) 1-MCP Activator Physical -Chemical Properties Data Waivers. Project Number: FYSIUM/PC/1013. Unpublished study prepared by Lewis & Harrison, LLC. 21p. 11-Mar2014

49265051 Warkentien, K. (2014) 1-MCP Activator Health Effects. Project Number: FYSIUM/ACT/TOX/0913. Unpublished study prepared by Lewis & Harrison, LLC. 26p. 11-Mar2014

49265052 Warkentien, K. (2014) 1-MCP Activator Ecological Effects. Project Number: FYSIUM/ACT/ECO/0913. Unpublished study prepared by Lewis & Harrison, LLC. 22p. 11-Mar2014

49265053 Cotterhill, J. (2013) In Silico Assessment of Ma mmalian Toxicity and Ecotoxicity of Lag 2011 008: Final Report. Project Number: AGR/5112, W5ZZ3001/1. Unpublished study prepared by Food and Environmental Res earch Agency (Fera). 39p. 11-Mar2014

49265054 Bosselaers, J. (2014) Physical & Chemical Characteristics: Boiling Point: 1-Methylcyclopropene. Project Number: AGR/51 40. Unpublished study prepared by Janssen Pharmaceutica. 9p. 11-Mar2014

49265055 Neumans, E. (2014) Physical & Chemical Characteristics: Henry''s Law Constant: 1- methylcyclopropene. Project Number: AGR/5141. Unpublished study prepared by Janssen Pharmaceutica. 8p. 11-Mar20141-Methylcyclopropene EPA-HQ-OPP-2014-0670 (1-MCP) www.regulations.gov

37 49340500 AgroFresh, Inc. (2014) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of AF-701. Transmittal of 3 Studies. 13-Mar2014

49340501 Kurilla, K. (2011) Storage Stability of 1-Methyl cyclopropene Formulation AF-701 for 12 Months at 25(Degree)C. Project Number: AF/P/10/02, AF/11/007, GLP1002. Unpublished study prepared by Agrofresh, Inc. 25p. 13-Mar2014

49340502 Minderhout, T.; Siddiqui, A.; Martin, K.; et al. (2014) AF-701: Formulation of 1- Methylcyclopropene (1-MCP): A 48-Hour Static Acute Immobilization Test with Cladoceran (Daphnia magna): Final Report. Project Number: 103A/175, AF/13/091, 103/102113/DAP/48H1/SUB103. Unpublished study prepared by Wildlife International, Ltd. 64p. 13-Mar2014

49340503 Minderhout, T.; Siddiqui, A.; Martin, K.; et al. (2014) AF-701: Formulation of 1- Methylcyclopropene (1-MCP): A 96-Hour Static Renewal Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report. Project Number: 103A/176, AF/13/093, 103/102113/RBT/96H3/SUB103. Unpublished study prepared by Wildlife International, Ltd. 68p. 13-Mar2014



### B. U.S. Environmental Protection Agency Regu latory Documents and Risk Assessment Memoranda

U.S, EPA, 2001. Science Review in Support of a Pe tition (Petition No. 0F06144) from the Requirements of a Tolerance on All Food Commodities and Label Amendment for EthylBloc TM 

### (EPA Reg. No. 071297-1) Containing 0.14% 1-Me thylcyclopropene (Chemical No. 224459). From Russell S. Jones, Ph.D, through Freshteh Toghrol, P h.D., to Driss Benmhend. February 21, 2001.

U.S, EPA, 2010. Science Review in Support of the Registration of A17492F, Containing 1.0% 1 Methylcyclopropene (1-MCP) As Its Active Ingr edient. From Russell S. Jones, Ph.D, to Menyon Adams. February 9, 2010.

U.S. EPA, 2008. Biopesticide Regist ration Action Document (BRAD) 1- Methylcyclopropene (PC Code 224459). U.S. Environmental Protection Agen cy (U.S. EPA), May 30, 2008. Available at: http://www.epa.gov/opp00001/chem_search/reg _actions/registra tion/decision_PC-224459_30- May-08.pdf