[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.94]

[Page 482-484]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
       Subpart C--Confidentiality and Public Access to Information
 
Sec. 725.94  Substantiation requirements.

    (a) Claims applicable to the period prior to commencement of 
manufacture or import for general commercial use--(1) MCAN, TME, Tier I 
certification, and Tier II exemption request requirements. Any person 
who submits a MCAN, TME, Tier I certification, or Tier II exemption 
request should strictly limit

[[Page 483]]

confidentiality claims to that information which is confidential and 
proprietary to the business.
    (i) If any information in the submission is claimed as confidential 
business information, the submitter must substantiate each claim by 
submitting written answers to the questions in paragraphs (c), (d), and 
(e) of this section at the time the person submits the information.
    (ii) If the submitter does not provide written substantiation as 
required in paragraph (a)(1)(i) of this section, the submission will be 
considered incomplete and the review period will not begin in accordance 
with Sec. 725.33.
    (2) TERA requirements. Any person who submits a TERA, should 
strictly limit confidentiality claims to that information which is 
confidential and proprietary to the business. If any information in such 
a submission is claimed as confidential business information, the 
submitter must have available for each of those claims, and agree to 
furnish to EPA upon request, written answers to the questions in 
paragraphs (d) and (e) of this section.
    (b) Claims applicable to the period after commencement of 
manufacture or import for general commercial use. (1) If a submitter 
claimed portions of the microorganism identity confidential in the MCAN 
and wants the identity to be listed on the confidential Inventory, the 
claim must be reasserted and substantiated at the time the Notice of 
Commencement (NOC) is submitted under Sec. 725.190. Otherwise, EPA will 
list the specific microorganism identity on the public Inventory.
    (2) The submitter must substantiate the claim for confidentiality of 
the microorganism identity by answering all of the questions in 
paragraphs (c), (d), and (e) in this section. In addition, the following 
questions must be answered:
    (i) What harmful effects to the company's or institution's 
competitive position, if any, would result if EPA publishes on the 
Inventory the identity of the microorganism? How could a competitor use 
such information given the fact that the identity of the microorganism 
otherwise would appear on the TSCA Inventory with no link between the 
microorganism and the company or institution? How substantial would the 
harmful effects of disclosure be? What is the causal relationship 
between the disclosure and the harmful effects?
    (ii) Has the identity of the microorganism been kept confidential to 
the extent that competitors do not know it is being manufactured or 
imported for general commercial use by anyone?
    (c) General questions. The following questions must be answered in 
detail for each confidentiality claim:
    (1) For what period of time is a claim of confidentiality being 
asserted? If the claim is to extend until a certain event or point in 
time, indicate that event or time period. Explain why the information 
should remain confidential until such point.
    (2) Briefly describe any physical or procedural restrictions within 
the company or institution relating to the use and storage of the 
information claimed as confidential. What other steps, if any, apply to 
use or further disclosure of the information?
    (3) Has the information claimed as confidential been disclosed to 
individuals outside of the company or institution? Will it be disclosed 
to such persons in the future? If so, what restrictions, if any, apply 
to use or further disclosure of the information?
    (4) Does the information claimed as confidential appear, or is it 
referred to, in any of the following questions? If the answer is yes to 
any of these questions, indicate where the information appears and 
explain why it should nonetheless be treated as confidential.
    (i) Advertising or promotional materials for the microorganism or 
the resulting end product?
    (ii) Material safety data sheets or other similar materials for the 
microorganism or the resulting end product?
    (iii) Professional or trade publications?
    (iv) Any other media available to the public or to competitors?
    (v) Patents?
    (vi) Local, State, or Federal agency public files?
    (5) Has EPA, another Federal agency, a Federal court, or a State 
made any confidentiality determination regarding the information claimed 
as confidential? If so, provide copies of such determinations.

[[Page 484]]

    (6) For each type of information claimed confidential, describe the 
harm to the company's or institution's competitive position that would 
result if this information were disclosed. Why would this harm be 
substantial? How could a competitor use such information? What is the 
causal connection between the disclosure and harm?
    (7) If EPA disclosed to the public the information claimed as 
confidential, how difficult would it be for the competitor to enter the 
market for the resulting product? Consider such constraints as capital 
and marketing cost, specialized technical expertise, or unusual 
processes.
    (d) Microorganism identity and production method. If confidentiality 
claims are asserted for the identity of the microorganism or information 
on how the microorganism is produced, the following questions must be 
answered:
    (1) Has the microorganism or method of production been patented in 
the U.S. or elsewhere? If so, why is confidentiality necessary?
    (2) Does the microorganism leave the site of production or testing 
in a form which is accessible to the public or to competitors? What is 
the cost to a competitor, in time and money, to develop appropriate use 
conditions? What factors facilitate or impede product analysis?
    (3) For each additional type of information claimed as confidential, 
explain what harm would result from disclosure of each type of 
information if the identity of the microorganism were to remain 
confidential.
    (e) Health and safety studies of microorganisms. If confidentiality 
claims are asserted for information in a health or safety study of a 
microorganism, the following questions must be answered:
    (1) Would the disclosure of the information claimed confidential 
reveal: confidential process information, or information unrelated to 
the effects of the microorganism on health and the environment. Describe 
the causal connection between the disclosure and harm.
    (2) Does the company or institution assert that disclosure of the 
microorganism identity is not necessary to interpret any health and 
safety studies which have been submitted? If so, explain how a less 
specific identity would be sufficient to interpret the studies.