FAQs: Special Exposure Cohort (SEC)

The rule describes the process for individuals and/or organizations to file a petition to add a class of employees to the SEC.

HHS created the SEC procedures rule to ensure that:

• Petitions are submitted by authorized parties
• Petitions are justified
• Petitions are given uniform, fair, and scientific consideration
• Petitioners are given the opportunity to be involved with the petition process

The Final Rule for the Procedures for Designating Classes of Employees as Members of the SEC is located on The Act page of this website.

You can also request a copy of the rule via email at dcas@cdc.gov or by calling NIOSH directly at 513-533-6800.

The following topics are discussed in the SEC Final Rule:

• How HHS will determine whether or not it is feasible to estimate the radiation dose that the class received and if there is a reasonable likelihood that the radiation dose may have endangered the health of members of the class

• The procedures that are necessary to add a class of employees to the SEC
• Individuals and organizations that are qualified to submit an SEC petition on behalf of a class
• Minimum requirements that must be met for an SEC petition to qualify for consideration
• Procedures to involve and notify petitioners in the petition process and to allow petitioners to seek administrative reviews of proposed decisions

The following is required before a class of employees can be added to the SEC:

1. The class must petition to be added to the SEC;
2. HHS must obtain the advice of the Advisory Board on Radiation and Worker Health;
3. HHS must determine that:

   • it is not feasible to estimate the radiation dose that the class received with sufficient accuracy (in accordance with 42 CFR 83); and

   • there is a reasonable likelihood that the radiation dose may have endangered the health of members of the class; and
4. A recommended decision by HHS to add a class to the SEC must be submitted to Congress. Unless Congress takes action, the recommendation will take effect 30 days after it has been sent to Congress.

NIOSH’s role is to:

• Collect SEC petitions
• Determine whether or not the petitions meet the minimum requirements for review and evaluation
• Notify the petitioners, the Advisory Board, and the public as to whether or not the petitions meet the minimum requirements for review and evaluation
• Provide the Advisory Board and the petitioners with information on the steps of the petition evaluation and other required procedures
• Evaluate the petition
• Provide a report on the SEC petition evaluation to the Advisory Board

The Advisory Board’s role is to:

• Consider the petition and the NIOSH evaluation report
• Obtain and consider additional information not addressed in the petition or the initial NIOSH evaluation report, if necessary
• Develop and send the Secretary of HHS a report containing the Advisory Board’s recommendation upon the completion of NIOSH evaluations and Advisory Board deliberations

No, the Advisory Board only provides a recommendation to the Secretary of the Department of Health and Human Services (HHS).

The role of the Secretary of HHS is to:

• Make the final recommended decision as to whether to add or deny adding a class to the SEC after considering recommendations provided by NIOSH, the Board, and from the HHS administrative review, if applicable
• Develop and send a report of the final recommended decision to the petitioners, including a description of the relevant criteria and a summary of the information and findings that the decision is based upon
• Provide Congress with a report giving the final recommended decision, the definition of the class of employees covered by the decision, and the criteria and findings upon which the decision was based for classes to be added to the SEC

Congress reviews the Secretary of HHS’ final decision. Congress can reverse or expedite the decision to add a class to the SEC. If Congress takes no action that effects the decision, it will take effect 30 calendar days after Congress receives the Secretary’s final decision.

DOL’s role is to determine the eligibility of claims to be paid under the SEC. DOL will determine if the energy employee worked during the defined period established by the class, meets the 250 days of employment requirement, and has one of the 22 “specified cancers” or an eligible secondary cancer.

If NIOSH determined that the dose reconstruction cannot be completed, then the petition must provide:

• Identifying and contact information; and
• The justification that the dose reconstruction cannot be completed due to insufficient records and information, as indicated in the written notification from NIOSH.

All other petitioners must provide:

• Identifying and contact information; and
• A proposed class definition; and

• A description of why the proposed class should be added to the SEC (e.g., records and information available are inadequate to estimate the radiation doses acquired by members of the proposed class of employees with sufficient accuracy; identification of any exposure incident that was unmonitored, unrecorded, or inadequately monitored or recorded if the petition is based on an exposure incident, etc.).

  Please Note: Petitioners may be required to provide evidence that the incident occurred if NIOSH is unable to obtain records or confirmation of the incident form sources independent of the petitioners. This evidence is not required at the time the petition is submitted. The petitioners will be directly informed of the need for the supplemental information.

The proposed class definition should include:

1. The DOE/AWE facility where the proposed class worked;
2. The location(s) within the facility where the covered class worked;
3. The job titles/duties of the class members; and
4. The years the proposed class worked.

The basis must include one of the following:

• Documentation or worker statements provided by affidavit that indicate the radiation exposures and doses of the members were not monitored, either through personal or area monitoring;
• Documentation or worker statements provided by affidavit that indicate that radiation monitoring records for members have been lost, falsified, or destroyed.
• A report from a Health Physicist or other individual with expertise in dose reconstruction that documents the limitations of existing DOE/AWE records on radiation exposure at the facility; or
• A scientific or technical report published or issues by a government agency of the Executive Branch of Government, the Government Accounting Office, the Nuclear Regulatory Commission, the Defense Nuclear Facilities Safety Board, or published in a peer-reviewed journal that identifies dosimetry and related information that are unavailable due to either a lack of monitoring or the destruction or loss of records for estimating radiation doses of employees covered by the petition.

• If relevant, inclusion of information indicating an exposure incident that was unmonitored, unrecorded, or inadequately monitored or recorded.

  Please Note: Petitioners may be required to provide evidence that the incident occurred if NIOSH is unable to obtain records or confirmation of the incident from sources independent of the petitioners. This evidence is not required at the time the petition is submitted. The petitioners will be directly informed of the need for the supplemental information.

Petitioners may be required to provide evidence that the incident occurred if NIOSH is unable to obtain records or confirmation of the incident from sources independent of the petitioner’s source. This evidence is not required at the time the petition is submitted. The petitioners will be directly informed of the need for the supplemental information.

The following may qualify as evidence:

• Medical evidence that one or more members of the class may have been exposed to high dose of radiation from the incident

If the above is not available, then

• Notarized affidavits from one or more employees who witnessed the incident may qualify

  Please Note: The affidavits alone, however, may not be sufficient to confirm the occurrence of an incident. As with all evidence provided, NIOSH will consider the adequacy and credibility of the evidence provided in the affidavits.

Notarized affidavits from one or more individuals who did not witness the incident may be substituted if the individual was directly informed by one or more employees who witnessed the incident. The affidavits alone, however, may not be sufficient to confirm the occurrence of an incident. As with all evidence provided, NIOSH will consider the adequacy and credibility of the evidence provided in the affidavits.

The steps in the petition process are listed below:

1. A petition is submitted to NIOSH.
2. The petition then goes through a qualification stage to ensure that the petition meets all of the minimum requirements for review and evaluation.
3. Once the petition meets the minimum requirements for review and evaluation, NIOSH publishes a notice in the Federal Register to notify the public of its decision to evaluate the petition.
4. NIOSH evaluates the petition and writes a report detailing the findings.
5. NIOSH sends the report to the Advisory Board and to the petitioner(s).
6. NIOSH presents the evaluation of the petition to the Advisory Board in a public meeting where petitioners and other interested parties can attend. During the meeting, petitioner(s) have the opportunity to speak to the Board.
7. The Advisory Board provides a recommendation to the Secretary of Health and Human Services (HHS).
8. The Secretary of HHS reviews all of the information and makes a final decision.
9. The Secretary of HHS submits the final decision to Congress.
10. Congress reviews the Secretary of HHS’ final decision. Congress can reverse or expedite the decision to add a class to the SEC. If Congress takes no action that effects the decision, it will take effect 30 calendar days after Congress receives the Secretary’s final decision.
11. The Secretary of HHS sends DOL a report providing the final decision on the petition after the Congressional review period.

NIOSH provides guidance to SEC petitioners throughout the petition process. Both an Ombudsman to NIOSH and an SEC Petition Counselor are available to help petitioners understand the requirements and information needed to file an SEC petition. They will discuss the petition with the petitioner, clarify the information submitted, and discuss deficiencies in the petition, if any. Additional information on the Ombudsman to NIOSH and the SEC Petition Counselor can be found on the Who to Contact for Help with SEC Petitions page of our website.

SEC general information, petition forms, requirements, detailed steps in the petition process, and other pertinent SEC information can also be found on the Frequently Asked Questions (FAQs) Special Exposure Cohort (SEC) page and a general fact sheet on the SEC is located on the Print Materials page of our website.

If you have questions about the SEC petition process, please contact:

Josh Kinman, NIOSH SEC Petition Counselor

Phone: 513-533-6831

Email: jkinman@cdc.gov

– or –

Denise Brock, NIOSH Ombudsman

Email: CKO7@cdc.gov

If an SEC petition does not meet the minimum requirements set forth in the SEC petition procedures, NIOSH may determine that the petition does not meet the minimum requirements for review and evaluation and may deny the SEC petition.

If the SEC petition does not meet the minimum requirements for review and evaluation, NIOSH will notify petitioners of any requirements that the petition failed to meet and provide guidance to the petitioners in developing the relevant information.

Petitioners have 30 calendar days from the date of notification to revise the petition. If, after 30 days, the petition remains unqualified, NIOSH will issue a decision that the petition does not qualify for evaluation. Petitioners then have 30 calendar days to request a review of that decision. If a review has been requested, NIOSH will make the final decision as to whether to accept or deny the petition based on results of the review. If at the end of the 30 calendar days the petition does not meet the minimum requirements or is not reviewed, NIOSH’s proposed finding will become a final decision.

After the 30 calendar days from the date of the initial notification, NIOSH will let the petitioners know that the petition still does not meet the minimum requirements for review and evaluation. The petitioners will have 30 calendar days to request a review of that decision.

If after 61 days from the original notification, the petition still does not meet the minimum requirements for review and evaluation, and a review has not been requested, NIOSH will inform the petitioners of the decision to deny the petition and provide the basis for the finding.

Yes, if the petition is denied because it does not meet the minimum requirements for review and evaluation, the petitioner can request a review of that decision. The petitioners have 30 calendar days after notification that the petition remains unqualified to request the review, in writing, and must specify why the finding should be reversed.

The request may not include any new information or documentation that was not included in the original completed petition. If petitioners obtain new information within the allotted 30 day period, petitioners should provide the new information to NIOSH. NIOSH will consider this new information as a revision to the petition.

Three HHS personnel, appointed by the Director of NIOSH, who were not involved in developing the proposed finding will complete the reviews within 30 work days of the request for review.

The Director of NIOSH makes the final decision as to whether or not the petition meets the minimum requirements for review and evaluation after the review.

If the petitioner obtains new information within the allotted 30 day period, the petitioner should provide it to NIOSH. NIOSH will consider this new information as a revision of the petition.

The decision to accept or deny a petition will become final in 31 calendar days if there is not a request by the petitioner to review the decision.

NIOSH may, at its discretion, reconsider a decision to deny a petition that does not meet the minimum requirements for review and evaluation if new information on the petition becomes available.

When the Director of NIOSH determines that the SEC petition meets the minimum requirements for review and evaluation, the petitioners, the Board, and the public will be notified. NIOSH will proceed with an evaluation of the petition and provide the petitioners and the Board with information on the steps of the evaluation and other required procedures.

An evaluation report will be given to the petitioners and the Board for review. The Board will review and discuss the evaluation report and submit a recommendation to add or deny adding the class to the SEC to the Secretary of HHS. The petitioners will be notified of the Board’s recommended decision.

The Secretary of HHS, after considering information and recommendations provided by NIOSH, the Board, and from the administrative review, if applicable, will submit the final recommended decision to add or deny adding the class to the SEC to Congress. If Congress takes no action that effects the Secretary of HHS’s final decision, it will take effect in 30 calendar days after the date the Secretary of HHS’s report is submitted to Congress. The Secretary of HHS will provide a report to DOL and the petitioners containing the definition of the class and either the addition of the class to the SEC and/or the result of any action by Congress that effects the decision. A notice will also be published in the Federal Register notifying the public of all decisions.

No, if the SEC petition meets the minimum requirements for review and evaluation, the class does not automatically get added to the SEC. Meeting the minimum requirements for review and evaluation just means that the petition will continue in the SEC petition process. The petition will receive a full evaluation by NIOSH, the Board, and HHS.

NIOSH will present the petitions to the Board with a plan for each that includes:

1. An initial proposed definition of the class being evaluated; and
2. A list of activities for evaluating the radiation exposure and adequacy of existing information needed to conduct a dose reconstruction for all class members.

Yes, NIOSH can combine separate petitions and evaluate them as a single petition if at any point in the evaluation process NIOSH finds that the petitions represent the same class of employees.

Yes, NIOSH may begin the evaluation immediately.

Yes, petitioners will be invited to present views and information on the petition and the NIOSH evaluation report at the Board meeting.

The date and time of the meeting will be posted in the Federal Register and on the Advisory Board page of our website. Josh Kinman, NIOSH SEC Petition Counselor, also notifies petitioners of Board meetings where the petition will be discussed.

Yes, NIOSH will provide the Advisory Board and all petitioners with a copy of the evaluation report.

Yes.

Yes, upon the Advisory Board’s request, NIOSH may further evaluate a petition. If NIOSH conducts additional evaluation, the new findings will be reported to the Board and petitioner(s).

The Advisory Board’s report includes:

• the identification and inclusion of the relevant petition(s)
• the definition of the class of employees covered by the recommendation
• a recommendation as to whether or not the Secretary should designate the class as an addition the SEC

• the relevant criteria under 42 CFR 83.13(c) and findings and information upon which the recommendation is based, including NIOSH evaluation reports, information provided by the petitioner(s), any other information considered by the Advisory Board, and the deliberations of the Advisory Board.

After the Secretary makes a recommended decision, the report containing the recommended decision is sent to the petitioners. This report includes a description of the relevant criteria and summary of the information and findings that the recommended decision is based upon.

The reports are posted on our website on the Special Exposure Cohort (SEC) and specific work site pages. The reports are also published in the Federal Register.

Congress has 30 calendar days after the date the Secretary of HHS’ report is submitted to Congress to review the Secretary’s decision.

If Congress takes no action that effects the Secretary’s decision, the decision will take effect 30 calendar days after the date the Secretary’s report is submitted to Congress.

The Secretary of HHS will provide DOL and the affected petitioners a report with the definition of the class and one of the following outcomes:

1. The addition of or the decision not to add the class to the SEC; and, if appropriate
2. The result of any action by Congress to reverse or expedite the decision to add a class to the SEC.

When a decision is made to add a class, the Secretary provides Congress with a report of the final decision, the definition of the class of employees covered by the decision, and the criteria and findings upon which the decision was based for classes to be added to the SEC. If Congress takes no action that effects the Secretary’s decision, the Secretary’s decision to add the class of employees will take effect 30 calendar days after the date the Secretary of HHS’ report is submitted to Congress.

The SEC rule requires that NIOSH evaluate all petitions that meet the minimum requirements to add a class of employees to the SEC. The evaluation is intended to provide a fair, science-based determination of whether it is feasible to estimate with sufficient accuracy the radiation doses of the class of employees through NIOSH dose reconstructions. NIOSH documents its findings in an SEC Petition Evaluation Report.

An SEC Petition Evaluation Report typically contains the following:

• Petitioner Requested Class
• Class Evaluated by NIOSH
• NIOSH Proposed Class to be Added to the SEC
• Feasibility of Dose Reconstruction
• Health Endangerment Determination
• Data Sources Reviewed by NIOSH to Evaluate the Class
• Radiological Operations Relevant to the Class
• Available Monitoring Data for the Class
• Class Conclusion
• References

Once completed, the SEC Petition Evaluation Report is provided to the petitioner(s) and to the Advisory Board on Radiation and Worker Health. The evaluation will then be discussed by the Advisory Board, which provides advice to the Secretary of Health and Human Services on whether to add a class of employees to the SEC.

Yes, SC&A’s pre-decisional reports are provided to the petitioners, the public, and all pertinent Advisory Board Work Groups. The reports are posted on our website on the Advisory Board: Reports from the Technical Support Contractor page, and the work site page to which they apply, under the Advisory Board and NIOSH Discussions section. Copies of the report can also be obtained by contacting NIOSH directly at 513-533-6800 or by e-mail at dcas@cdc.gov or ocas@cdc.gov.

No, the Advisory Board does not always task its technical contractor, SC&A, to review the report. The Advisory Board decides when to task its technical contractor to perform a review of an SEC Petition Evaluation Report, and on what areas the review will focus.

The petitioner has 30 calendars days from the date of the original NIOSH notification that the petition did not meet the minimum requirements for review and evaluation to revise the petition.

If the petition is not revised within 30 days, NIOSH will issue a decision that the petition does not meet the minimum requirements for review and evaluation.

The petitioner has 30 days to request a review of NIOSH’s decision. If a review has been requested, NOSH will make the final decision as to whether to accept or deny the petition based on results of the review.

Petitioners can contest the Secretary’s final decision and request an administrative review, in writing, within 30 calendar days of the final decision.

The decision to accept or deny a petition because it does not meet the minimum requirements for review and evaluation becomes a final decision in 31 days if there is not a request by the petitioner to review the decision.

NIOSH has 180 days to provide a recommendation to the Advisory Board regarding qualified SEC petitions.

The 180 day time frame begins when NIOSH receives a petition and ends when NIOSH sends the SEC Petition Evaluation Report of that petition to the Advisory Board. This time does not include days when the petitioner is working on a response to a deficiency in the petition that affects the qualification of the petition or on clarification of information for qualifying the petition.

NIOSH makes every effort to meet the 180-day deadline to provide an SEC Petition Evaluation Report to the petitioner and to the Advisory Board. However, there are circumstances where NIOSH is unable to meet the 180-day time frame. This is most often due to data capture problems, either where a facility is having difficulty locating or assembling the records requested, or where DOE does not have the resources available to process the data.

The evaluation of a qualified petition includes in-depth research on the available monitoring records and worker data to determine if NIOSH has the information needed to reconstruct radiation doses with sufficient accuracy, and if it does not, whether the radiation doses may have endangered the health of the class of workers defined in the petition. This in-depth research may take longer than 180 days.

When a petition covers a very broad time frame, it also can take additional time to evaluate the petition.

In addition, NIOSH’s evaluation often goes well beyond the issues the petitioner identified in the petition. A petition might have identified a small number of issues to qualify, but NIOSH will review past Evaluation Reports, issues that are under review by the Advisory Board and its technical contractor, and any issues that might have arisen during NIOSH’s site research and add those issues to the list to be researched during the evaluation process. This ensures that NIOSH has made a thorough investigation of potential reasons that it might not be able to complete dose reconstructions with sufficient accuracy and if the radiation doses may have endangered the health of the class of workers.

The Secretary of HHS has 30 days from the receipt of the Advisory Board’s recommendation to submit a final recommended decision on a petition to Congress.

The Secretary of HHS has 30 days from receipt of the Advisory Board’s recommendation to submit his decision to Congress. If this 30-day deadline is not met and the Advisory Board has recommended adding the class, the class will be added to the SEC automatically, even if the Secretary’s decision would have been to deny adding the class.

If Congress takes no action that effects the Secretary’s final recommended decision, the decision will take effect 30 calendar days after the date the Secretary’s report is submitted to Congress.

No formal timeframes have been placed on the Advisory Board to submit a recommendation to the Secretary of HHS at this time. The Board, however, has informally agreed to submit its recommendation to the Secretary within 21 days after the determination by the Advisory Board of their recommendation.

Not always. After an SEC Petition Evaluation Report is presented to the Advisory Board, the Board may form a Work Group to review the report or task the technical contractor assisting the board (Sanford Cohen & Associates-SC&A) to perform a review of the report before making a recommendation. If the Advisory Board tasks SC&A to conduct an independent review of the report, the Board’s Work Group will review SC&A’s findings and discuss any technical issues that have been identified. The Advisory Board will make a recommendation on the SEC petition after all identified issues have been evaluated.

Congress has 30 days after the date the Secretary’s report is submitted to Congress.

If Congress takes no action that effects the Secretary’s final decision, the decision will take effect 30 calendar days after the date the Secretary’s report is submitted to Congress.

If the SEC petition does not meet the minimum requirements for review and evaluation, NIOSH will notify petitioners of any requirements that the petition failed to meet and provide guidance to the petitioners in developing the relevant information.

Petitioners have 30 calendar days from the date of notification to revise the petition. If, after 30 days, the petition remains unqualified, NIOSH will issue a decision that the petition does not qualify for evaluation. Petitioners then have 30 calendar days to request a review of that decision. If a review has been requested, NIOSH will make the final decision as to whether to accept or deny the petition based on results of the review. If at the end of the 30 calendar days the petition does not meet the minimum requirements or is not reviewed, NIOSH’s proposed finding will become a final decision.