United States Environmental Protection Agency, Washington, D.C. 20460

DATA CALL-IN RESPONSE

OMB Approval 2070-0174

INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form. Use additional sheet(s) if necessary.

1. Company Name and Address 2. Case # and Name

250 Mevinphos

 Active Ingredient # and name

 015801 Mevinphos

3. Date and Type of DCI and Number

GENERIC FFDCA DCI

Item 9, enter the appropriate numerical response for each guideline study that you intend to support: 1 = Developing Data, 2 = Submitting an Existing Study, 3 = Upgrading a Study, 4 = 

Citing an Existing Study. (For 860.1500 or 860.1520, concerning a specific commodity, you may enter 5 = Will not support).

4. Guideline

Requirement

Number

5. Study title Footnotes to 

Data

Requirements

6a. Protocol 6b. Progress Reports 7. Test 

Substance

8. Time 

Frame

(Months)

9. Recipient 

Response 1 2 3

860.1200 Directions for Use No ---- 12

860.1500 Crop Field Trial - Broccoli Yes TEP 24

860.1500 Crop Field Trial - Cabbage Yes TEP 24

860.1500 Crop Field Trial - Cauliflower Yes TEP 24

860.1500 Crop Field Trial - Celery Yes TEP 24

860.1500 Crop Field Trial - Grapes Yes TEP 24

860.1500 Crop Field Trial - Lettuce Yes TEP 24

860.1500 Crop Field Trial - Peas Yes TEP 24

860.1500 Crop Field Trial - Peppers Yes TEP 24

860.1500 Crop Field Trial - Spinach Yes TEP 24

860.1500 Crop Field Trial - Squash, summer Yes TEP 24

860.1500 Crop Field Trial - Strawberries Yes TEP 24

860.1500 Crop Field Trial - Tomatoes Yes TEP 24

860.1520 Processing Study - Tomatoes Yes TEP 24

870.6300 Comparative Cholinesterase Assay Yes TGAI 12

870.7800 Immunotoxicity No TGAI 12

10. Certification: I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 

knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.

Signature of Individual or Signature and Title of Company’s Authorized Representative _____________________________________________

11. Date

12. Name of Company or Individual Contact (Include e-mail address) 13. Phone Number
Failure to Submit the 90-Day Response:

If a submission of a response to U.S. EPA to comply with the Data Call-In requirements of the final order is not submitted within 90 days after publication of the 

final order in the Federal Register, EPA may revoke the appropriate tolerance or tolerances associated with the active ingredient named in Item 2. 

90-Day Response Instructions:

Item 1, enter your company or individual name and address.

Item 6a identifies any study protocol report timeframe, if required by the Agency.

Item 6b identifies study progress report timeframes, if required by the Agency.

Item 7 identifies the code associated with the substance that must be used for testing: 

PAI = pure active ingredient, TGAI = technical grade active ingredient, EUP = end-use product, MP = manufacturing-use product, MET = metabolites, TEP = 

typical end-use product, PAI/M = pure active ingredient and metabolites, TEP/MET = typical end-use product and metabolites, DEGR = degradates, IMP = 

impurities, PAIRA = pure active ingredient radiolabeled, PAIRA/M = pure active ingredient radiolabeled and metabolites, PAIRA/PM = pure active ingredient 

radiolabeled and plant metabolites, TGAI/TEP = technical grade active ingredient or typical end-use product, PAI/PAIRA = pure active ingredient or pure active 

ingredient radiolabeled, MP/TGAI = manufacturing-use product and technical grade active ingredient, TGAI/PAIRA = technical active ingredient or pure active 

ingredient radiolabeled, TGAI/PAI = technical grade active ingredient or pure active ingredient, TEP/PAI/M = typical end-use product or pure active ingredient 

and metabolites.

Item 8 identifies timeframes for EPA’s receipt of data. Timeframes begin on the date of publication in the Federal Register of the final order for the Data Call-In.

Item 9, enter the appropriate numerical response for each guideline study that you intend to support: 1 = Developing Data, 2 = Submitting an Existing Study (that 

has not been submitted previously to EPA by anyone), 3 = Upgrading a Study (classified by EPA as partially acceptable and upgradeable), 4 = Citing an Existing 

Study (that EPA has classified as acceptable or an existing study that has been submitted but not reviewed by the Agency). Note, for guidelines 860.1500 or 

860.1520, concerning a specific commodity, you may enter 5 = Will not support.

Item 10, sign the certification statement – it must be signed by an authorized representative of your company and the person signing must include his/her title.

Item 11, enter the date of signature.

Item 12, enter the name of the person EPA should contact with questions regarding your response (Include e-mail address).

Item 13, enter the telephone number of your company contact.

Failure to Comply with Response Commitment and/or Data Requirements:

Events that may be the basis for revocation of tolerances associated with the active ingredient named in Item 2 include, but are not limited to the following:

No person submits on the required schedule: (1) an acceptable proposed or final protocol when such is required to be submitted to the Agency for review, (2) an 

adequate progress report on a study as required by the final order, (3) acceptable data as required by the final order, (4) supportable certifications as to the 

conditions of submitted data, where required by the final order and where no other cited or submitted study meets the data requirements the study was intended to 

fulfill.
United States Environmental Protection Agency, Washington, D.C. 20460

FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS

Case # and Name 250 Mevinphos, GENERIC FFDCA DCI

OMB Approval 2070-0174

Footnotes:

860.1200 Directions for use

(No footnotes for this study)

860.1500 Crop field trials

1. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.

2. A residue method, storage stability data, and crop field trials are required for the nonfood crop tobacco (green, freshly harvested). Depending on the level of residues found on the green tobacco, 

additional data may be required on cured/dried tobacco and pyrolysis products.

3. Required for indoor uses which are direct postharvest treatments of raw agricultural commodities (e.g., fungicidal axes or stored grain fumigants).

4. Crop field trials are required to establish tolerances on rotational crops when quantifiable residues of concern are observed in the field rotational crops study.

5. Not required for an exemption from a tolerance provided that dietary exposure estimates are not needed due to low toxicity or that theoretical estimates of exposure are adequate to assess dietary 

risk.

860.1520 Processed food or feed

1. Required if indoor use could result in pesticide residues in or on food or feed.

2. Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher 

than that of the raw agricultural commodity.

3. Not required for an exemption from a tolerance provided that dietary exposure estimates are not needed due to low toxicity or that theoretical estimates of exposure are adequate to assess dietary 

risk.

870.6300 Developmental neurotoxicity

1. An information-based approach to testing is preferred, which utilizes the best available knowledge on the chemical (hazard, pharmacokinetic, or mechanistic data) to determine whether a standard 

guideline study, an enhanced guideline study, or an alternative study should be conducted to assess potential hazard to the developing animal, or in some cases to support a waiver for such 

testing. Registrants should submit any alternative proposed testing protocols and supporting scientific rationale to the Agency prior to study initiation.

2. Study required using a weight-of-evidence approach considering:

(i) The pesticide causes treatment-related neurological effects in adult animal studies (i.e., clinical signs of neurotoxicity, neuropathology, functional or behavioral effects).

(ii) The pesticide causes treatment-related neurological effects in developing animals, following pre- and postnatal exposure ( i.e. , nervous system malformations or neuropathy, brain weight changes 

in offspring, functional or behavioral changes in the offspring).

(iii) The pesticide elicits a causative association between exposures and adverse neurological effects in human epidemiological studies.

(iv) The pesticide evokes a mechanism that is associated with adverse effects on the development of the nervous system (e.g., SAR relationship to known neurotoxicants, altered neuroreceptor or 

neurotransmitter responses).

3. The use of a combined study that utilizes the 2–generation reproduction study in rodents as a basic protocol for the addition of other endpoints or functional assessments in the immature animal is 

encouraged.

870.7800 Immunotoxicity

(No footnotes for this study)