Statement from WTC Program Administrator John Howard, M.D. Regarding the Notice of Proposed Rulemaking to Add Two Health Conditions to the List of WTC-Related Health Conditions

September 11, 2015

We know that our members of the WTC Health Program continue to face health challenges that stem from their exposures on 9/11. Today's proposal posted in the Federal Register would add new-onset chronic obstructive pulmonary disease (COPD) and acute traumatic injury to the List of WTC-Related Health Conditions. This proposal for adding these conditions is available for public review and comment for 45 days beginning on September 11, 2015, and we welcome all comments on the proposal. The World Trade Center Health Program is committed to an open and transparent decision-making process.

Federal Register display of the Notice of Proposed Rulemaking:

https://federalregister.gov/a/2015-22599

What is being proposed with this Notice of Proposed Rulemaking (NPRM)?

The Administrator of the WTC Health Program is proposing to add two health conditions to the List of WTC-Related Health Conditions. The conditions proposed for addition are: 1) new-onset chronic obstructive pulmonary disease (COPD); and 2) acute traumatic injury.

Why is the WTC Health Program moving to add these two conditions now?

The Administrator of the WTC Health Program received a request from the directors of the WTC Health Program's Clinical Centers of Excellence (CCEs) and Data Centers (DCs) to consider adding new-onset COPD and significant traumatic injuries like head trauma, burns, fractures, tendon tears and serious complex sprains." After a review of the relevant medical and scientific literature on these health conditions and 9/11 survivors and responders, it was determined that there was enough evidence to support the addition of these two health conditions.

Is this a final determination?

No, this is a proposal and is not a final determination. The notice of proposed rulemaking is subject to public review and a 45-day comment period. Once public comment is received, the Administrator will consider and address those comments as appropriate before issuing a final rule regarding the request. If a final rule is published, the WTC Health Program will certify these health conditions on or after the effective date of that final rule.

How long do I have to submit comments on this notice of proposed rulemaking?

The rule will be available for public comment until October 26, 2015.

How do I submit comments?

You can submit written comments through the following channels:

• Federal eRulemaking Portal: https://www.regulations.gov . Search for CDC-2015-0063 and follow the instructions for submitting comments;
• Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, OH 45226-1998.

Can you define what "new on-set Chronic Obstructive Pulmonary Disease" is and how it differs from what the Program currently covers?

Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term that encompasses those pulmonary conditions exhibiting chronic inflammation of the airways, lung tissue, and pulmonary blood vessels and persistent airflow limitation; a combination of large and small airways disease (obstructive chronic bronchitis and obstructive bronchiolitis, respectively) and parenchymal destruction (emphysema).

Currently, the WTC Health Program regulations identify "WTC-exacerbated chronic obstructive pulmonary disease (COPD)" as a covered health condition. This means that an individual's COPD must have been present prior to September 11, 2001. The proposed addition of "new-onset COPD" would allow for the certification and treatment of COPD that did not present until after September 11, 2001.

What is the Program's definition of "acute traumatic injury"?

The WTC Health Program is defining "acute traumatic injury" as a type of injury characterized by physical damage to a person's body, including but not limited to eye injuries, severe burns, head trauma, fractures, tendon tears, complex sprains, and similar injuries. The injury must have been caused by exposure to hazards or adverse conditions resulting from the terrorist attacks. Examples include but are not limited to: being hit by falling debris; a fall from a height or a trip suffered during evacuation, rescue, or recovery activities; and burns or other injuries caused by the ignition of combustible materials, chemical reactions, and explosions. The notice of proposed rulemaking notes that the Administrator proposes to limit the availability of certification of this health condition to those responders and survivors who received initial medical care for the injury no later than September 11, 2003.

Conditions most likely to receive treatment within the WTC Health Program will be those medically associated conditions which are the long-term consequences of the certified WTC-related acute traumatic injuries. Health conditions medically associated with WTC-related health conditions are determined on a case-by-case basis in accordance with WTC Health Program regulations and policy.¹ Examples of such health conditions medically associated with an acute traumatic injury may include chronic back pain caused by vertebrae fractures, chronic peripheral neuropathy due to severe burns, and problems with executive brain function due to closed head injuries.

Why is there a limit on the time for certification of an "acute traumatic injury"?

The WTC Health Program believes this date offers a reasonable amount of time in which to expect that an injured responder or survivor received treatment for an acute traumatic injury. The September 11, 2003 date is also the same date that was originally used to identify traumatic injuries determined to be eligible for treatment by the WTC Medical Monitoring and Treatment Program that pre-dated the WTC Health Program, and the date used to identify musculoskeletal disorders eligible for certification in responders.

What is the process for adding new conditions to the current List of WTC-Related Health Conditions?

Consideration of an addition to the List of WTC-Related Health Conditions may be initiated at the Administrator's discretion ² or following receipt of a petition by an interested party. ³ Pursuant to § 3312(a)(6)(D) of Title XXXIII of the PHS Act and 42 C.F.R. § 88.17, the Administrator is required to publish a notice of proposed rulemaking and allow interested parties to comment on the proposed rule. The Administrator has also established a methodology for evaluating whether to add non-cancer health conditions to the List of WTC-Related Health Conditions; this methodology is published online in the Policies and Procedures section of the WTC Health Program website. ⁴

1 Howard J [2014]. Health conditions medically associated with World Trade Center-related health conditions.
2 PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.17(b).
3 PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.17(a).
4 Howard J, Administrator of the WTC Health Program. Policy and procedures for adding non-cancer conditions to the List of WTC-Related Health Conditions. October 21, 2014.