Guidelines to Restrict the Dissemination of Confidential Pesticide Data

Guidelines to Restrict the Dissemination by Researchers of Confidential Pesticide Registry and Pesticide Application Information
May 2007

  1. Background

    Public Health Law ("PHL") § 2411(1)(d) requires the Health Research Science Board ("Board") to review requests by researchers engaged in human health related research projects for access to Pesticide Registry information maintained by the New York State Department of Environmental Conservation pursuant to Environmental Conservation Law ("ECL") § 33-1203(1)(b) and pesticide application information maintained by private applicators of pesticides pursuant to ECL § 33-1205(2)(c). Pesticide Registry and pesticide application information sought by researchers may include the names, addresses and other information that would identify commercial or private applicators of pesticides and/or persons who receive the services of commercial applicators. PHL § 2411(1)(d) provides that the Board "shall establish guidelines to restrict the dissemination by researchers of the name, address or other information that would otherwise identify a commercial applicator or private applicator or any person who receives the services of a commercial applicator." These guidelines have been established to fulfill this statutory mandate. Nothing set forth in these guidelines prevents the Board or its staff from varying from the guidelines as specific circumstances may dictate, provided that their actions comply with applicable statutory and regulatory requirements. Because these guidelines are not fixed rules, their use by any party does not create any enforceable right.

  2. Guidelines
    1. Definitions
      1. "Board" means the Health Research Science Board.
      2. "Confidentiality agreement" means an agreement between a researcher, or a designated person, and the Board to maintain the confidentiality of confidential information.
      3. "Confidential information" means information which contains the name, address or other information that would identify a commercial or private applicator of pesticides or any person who receives the services of a commercial applicator.
      4. "Pesticide application information" means pesticide application information, including confidential information, maintained by a private applicator of pesticides pursuant to Environmental Conservation Law ("ECL") § 33-1205(2)(b).
      5. "Pesticide Registry information" means pesticide application and sales information, including confidential information, maintained by the New York State Department of Environmental Conservation pursuant to ECL Title 12.
      6. "Researcher" means a person who informs the Board that he or she is engaged in human health related research and requests access to Pesticide Registry information or pesticide application information.
      7. "Designated person" means an individual designated by a researcher in the researcher's Request for Pesticide Registry Information or Pesticide Application Information Form whose access to confidential information is required by the researcher to carry out the research study for which such information is sought.
      8. "Institution," for the purpose of access to Pesticide Registry Information or Pesticide Application Information, means any public or private entity or agency (including federal, state, and other agencies).
    2. Requests for Pesticide Registry Information or Pesticide Application Information
      1. A researcher who seeks access to Pesticide Registry information or pesticide application information shall obtain from the Board a Request for Pesticide Registry Information or Pesticide Application Information Form. A copy of this form is annexed to these guidelines as Appendix A.
      2. To obtain access to Pesticide Registry information or pesticide application information, the researcher must provide the Board with a completed Request for Pesticide Registry Information or Pesticide Application Information Form and:
        1. if the research is to be conducted under the auspices of an institution, copies of (1) the research proposal or research protocol approved by the institution; (2) the institution's Institutional Review Board (IRB) approval of such proposal or protocol, or such approval by a review board that the applicant demonstrates is the equivalent of an IRB, or if such approval has not been obtained, documentation from such IRB or equivalent review board as to why such approval is not required; and (3) for a research proposal or protocol approved by an IRB, documentation that the IRB has been approved by the New York State Department of Health and/or the federal government; or
        2. if the research is to be conducted outside the auspices of an institution, copies of (1) the research proposal; (2) IRB approval of such proposal, or such approval by a review board that the applicant demonstrates is the equivalent of an IRB, or if such approval has not been obtained, documentation from such IRB or equivalent review board as to why such approval is not required; (3) for a research proposal or protocol approved by an IRB, documentation that the IRB has been approved by the New York State Department of Health and/or the federal government; and (4) at least one, but no more than three, articles authored by the researcher and published in peer-reviewed scientific journals.
      3. Upon receipt of (1) a completed Request for Pesticide Registry Information or Pesticide Application Information Form from a researcher; and (2) all other documentation to be provided by the researcher to the Board pursuant to Paragraph (B)(2), the Board will determine whether to approve, approve in part, or deny the researcher's request for Pesticide Registry information or pesticide application information. In making this determination, the Board will consider, among other things:
        1. whether the researcher is engaged in human health related research;
        2. whether an IRB or equivalent review board has approved the research proposal or protocol or, if such approval has not been obtained, documentation from such IRB or equivalent review board as to why such approval is not required;
        3. with respect to research conducted outside the auspices of an institution:
          1. whether the researcher is qualified to conduct the proposed research, as indicated by the researcher's authorship of one or more articles published in a peer-reviewed scientific journal or other information on professional qualifications made available to the Board; and
          2. whether the research proposal follows accepted scientific practice for the design of a research project.

          If, with respect to research conducted outside the auspices of an institution, the Board determines that the research proposal does not follow accepted scientific practice for the design of a research project, the Board will deny access to site-specific and nine-digit zip code Pesticide Registry information and pesticide application information.

      4. Upon a determination by the Board approving all or part of a researcher's request for Pesticide Registry information or pesticide application information, the Board shall inform the researcher of the determination, and provide the researcher with a confidentiality agreement to be executed by the researcher and the Board and to be notarized. The Board shall also provide confidentiality agreements to designated persons identified by the researcher to be executed by such persons and the Board and to be notarized. The Board shall not give the researcher access to any Pesticide Registry information or permission to seek access to any pesticide application information until the researcher and the Board have executed a notarized confidentiality agreement. The researcher shall not give any such designated person access to confidential information unless the designated person and the Board have executed a notarized confidentiality agreement.
      5. A researcher shall not obtain pesticide application information from the custodian of such information unless the researcher has provided, to the custodian, a copy of an executed and notarized confidentiality agreement between the researcher and the Board regarding such information.
      6. Executed and notarized confidentiality agreements shall include, at a minimum, the following provisions:
        1. The researcher or designated person shall maintain the confidentiality of confidential information provided to the researcher by the Board.
        2. The researcher or designated person shall use confidential information solely for the purpose described by the researcher in the researcher's Request for Pesticide Registry Information or Pesticide Application Information Form. Changes to the use of confidential information as described in the Researcher's Request for Pesticide Registry Information or Pesticide Application Information Form shall be submitted in a letter to the Board for consideration.
        3. The researcher or designated person shall not publish, or disclose to any person or entity, other than designated persons who have executed notarized confidentiality agreements that also have been executed by the Board, any confidential information. If there are any circumstances whereby publication of data or information by zip code, county and/or other geographic unit would directly identify an individual, or a particular parcel of real property, the researcher or designated person shall not knowingly publish, or knowingly disclose to any person or entity other than a designated person who has executed a notarized confidentiality agreement that also has been executed by the Board Pesticide Registry information or pesticide application information in a manner which would directly identify such an individual or parcel of real property.
        4. The researcher or designated person shall maintain the confidential information so as to ensure that it is accessible only to the researcher and designated persons who have executed confidentiality agreements as required by the Board and as provided in the confidentiality plan referenced below, as approved by the Board. At all times, confidential information and the equipment upon which it resides shall be subject to electronic and physical security. The specific written plan to be submitted by the researcher and designated persons to maintain the confidentiality of the confidential pesticide registry information or pesticide application information as specified in Part II.I of the "Request for Pesticide Registry or Pesticide Application Information" shall address work area access, PC security, server/network security, and internet exposure. The researcher or designated person shall never leave confidential information unattended, unless such information is in locked storage, to which only the researcher and designated persons have keys, or in secure electronic files. In addition, for electronic files, the researcher shall keep all confidential information on a computer that operates under a secure operating system and shall implement procedures regarding security settings and password protection for data access, as required by the approved plan. Similarly, provisions shall be made, using current computer security knowledge and technology, to secure and limit access to confidential information stored on network computers or computers with an internet connection. Network administrators must be informed of the confidential nature and location of data stored on network resources, and aware that they shall only grant access to these networks under authority of the researcher.
        5. Upon determining, based on information from any source other than the Board, that confidential information provided to the researcher has been disclosed, may have been disclosed and/or is at risk of disclosure to any person or entity other than designated persons who have executed notarized confidentiality agreements that also have been executed by the Board, the researcher shall, within two business days, send to the Board, by overnight mail, a description of any information the researcher has regarding such disclosure, possible disclosure and/or risk of disclosure of confidential information.
        6. Following receipt of an allegation that confidential information provided to the researcher has been disclosed, or is at risk of disclosure, to any person or entity other than designated persons who have executed notarized confidentiality agreements that also have been executed by the Board, and a written determination by the Board (to be made expeditiously following receipt of such an allegation) sustaining such an allegation which sets forth the reasons for that determination, the Board shall promptly direct the researcher to return such confidential information, and any copies of that information in the custody of the researcher, to the Board. The researcher agrees to return such confidential information, and any copies of such information in the custody of the researcher, to the Board within two business days of receipt of such a directive from the Board. The researcher may request that the Board reconsider its determination, upon a claim that the Board has overlooked or misunderstood the researcher's position regarding the disclosure, or risk of disclosure, of confidential information to a person or entity other than a designated person who has executed a notarized confidentiality agreement that also has been executed by the Board.
        7. The Researcher shall destroy all confidential information within two years of __(date)__, which is the anticipated conclusion of the research for which the confidential information was obtained, unless the Researcher demonstrates to the Board, and the Board finds, that there is a compelling reason for maintaining such information for a specified additional period of time. If confidential information has been stored on network resources, the researcher should work with the network administrator to assure that all backup copies or archives of confidential information are also destroyed.
        8. If the researcher concludes that it is necessary to the conduct of his or her research to provide confidential information to a person not identified as a designated person in the researcher's Request for Pesticide Registry Information or Pesticide Application Information Form (e.g., a person hired by the researcher subsequent to the submission to the Board of the researcher's Request for Pesticide Registry Information or Pesticide Application Information Form), confidential information may be provided to that person only after (1) the researcher submits to the Board a supplemental Request for Pesticide Registry Information or Pesticide Application Information Form identifying that person as a designated person; and (2) the Board and that person execute a notarized confidentiality agreement.
        9. By executing this agreement, the researcher or designated person acknowledges that he or she understands (1) the restrictions set forth above regarding the publication and disclosure of confidential information, (2) that he or she may be subject to legal action, including, but not limited to, legal action by persons with an interest in maintaining the confidentiality of confidential information, and, under certain circumstances, criminal prosecution in the event that confidential information provided to the researcher is published or disclosed to any person or entity, other than designated persons who have executed notarized confidentiality agreements that also have been executed by the Board, and (3) in such event, that the Board may recommend, to the New York State Department of Health and/or other state agencies, that such agencies restrict the researcher's or designated person's access to information maintained in confidence by such agencies, consistent with applicable law.
      7. Upon a determination to approve, or approve in part, a researcher's request for access to Pesticide Registry information or pesticide application information, the Board shall, within ten business days of its determination, provide to the Environmental Notice Bulletin, for publication as soon thereafter as feasible, a statement consisting of: (a) the Board's determination; and (b) an abstract of the research project for which access to Pesticide Registry information and/or pesticide application information was sought by the researcher (the abstract will have been provided by the researcher to the Board in the researcher's Request for Pesticide Registry Information or Pesticide Application Information Form).

A copy of a model confidentiality agreement is annexed to these guidelines and is entitled "Agreement to Maintain Confidentiality."