Document ID: EPA-HQ-OPP-2010-0423-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-07-28T04:00Z

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

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)