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Memorandum Regarding the Relationship Between the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists

The following research memo is prepared by Duke Law student members of the Duke Law Lyme Disease Advocacy Project. The LDA has been working with this group for several years to help research difficult questions regarding Lyme disease policy.
 
Titles and affiliations are provided for identification purposes only. Any views, research, and conclusions expressed by the authors are theirs alone and do not reflect the views, research, and conclusions of Duke University or any of its constituent institutions.

    

Memorandum Prepared for the Lyme Disease Association Pro Bono Project[1]

Regarding the Relationship Between the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists[2]

 

Prepared by:

Sam Graber-Hahn, JD ‘24

 Lucas Lynn, JD ‘25

Sean Prestegord, JD ‘24

Sammy Sawyer, JD ‘25

Benjamin Spencer, JD/MA ‘24

May 7, 2024

 

QUESTIONS PRESENTED

  1. Where does the Council of State and Territorial Epidemiologists (CSTE) get its authority to create disease surveillance case definitions?
  2. Where does CSTE get its authority to create Lyme disease guidelines?
  3. Does the Centers for Disease Control and Prevention (CDC) accept CSTE guidelines for other diseases, including controversial diseases?

 

BRIEF ANSWERS

  1. The Council for State and Territorial Epidemiologists derives its authority to create disease surveillance criteria and guidelines from both federal and state law, as well as from regulations promulgated by the Department of Health and Human Services and from a longstanding partnership with the Centers for Disease Control and Prevention.
  2. CDC allocates most of its funds to outside organizations. CSTE was created to help CDC work with states on disease control, and the two organizations have a long history of working together on infectious disease. In 1997, CDC gave notice that CSTE definitions would be used for CDC-funded Lyme research.
  3. The CDC accepts CSTE disease surveillance criteria for controversial diseases in addition to Lyme disease, including amebiasis and Candida auris. Since 1990, the CDC has worked with the CSTE to develop case definitions. Currently, as part of its National Notifiable Disease Surveillance System, the CDC updates its case definitions annually in response to CSTE Position Statements.

 

BACKGROUND

Lyme disease is the most common vector-borne disease in the United States.[3] Transmitted by blacklegged ticks and caused by bacteria in the Borrelia family, initial symptoms of Lyme disease include fever, fatigue, and a rash.[4] If untreated, the infection can spread to the heart and nervous system, potentially resulting in significant damage and death.[5]

The Centers for Disease Control and Prevention (CDC) is a government agency responsible for detecting and responding to health threats throughout the United States.[6] To accomplish this goal, they maintain a system for reporting diseases that many health providers rely on when considering treatments.[7] Recently, the CDC has claimed that they are bound by the disease case definitions created by the Council for State and Territorial Epidemiologists.[8]

The Council for State and Territorial Epidemiologists (CSTE) is a non-government entity, formed at the request of then-CDC Epidemiology Director Alexander Langmuir in the 1950s.[9] In 1951, it published its first list of nationally notifiable diseases, and has continued to claim responsibility for managing and updating this list through the use of yearly position statements to the present day.[10]

The Council of State and Territorial Epidemiologists (CSTE) develops and adopts surveillance case definitions for these diseases. The Centers for Disease Control and Prevention (CDC) can provide input during the development process, although mechanisms are unknown.  Although our research has not discovered a formal adoption process on CDC’s part, the CDC seems to have adopted the CSTE’s surveillance case definitions for Lyme disease each time the CSTE has updated them since their inception in 1995.[11] The CDC has all iterations of these case definitions on its website. On many occasions, the CDC has stated that the CSTE is responsible for surveillance case definitions as per legislative process.[12]

Although CDC’s website stated for years that the surveillance case definition is not to be used for clinical diagnosis or treatment, many doctors continue to use it to justify not diagnosing patients with Lyme disease, especially when cases fall outside rigid geographic boundaries. Many insurers continue to use the Lyme disease surveillance case definition to deny payment for care if patients do not fit this restrictive definition.[13] Many clinicians and insurers have often referred to the Lyme surveillance criteria as “CDC criteria.”[14]

Due to the case definition’s emphasis on rashes, testing and the geographical restrictions, among other issues present in the CSTE surveillance case definition, many Lyme patients experience significant delays in diagnosis and treatment, which lead to worse clinical outcomes.[15]

A few years ago, the CDC developed its own set of clinical “guidelines” for Lyme disease.[16] No record could be found of these guidelines going through an accepted process for developing clinical practice guidelines and these guidelines appear similar to the IDSA treatment recommendations, without acknowledging these similarities. The CDC “guidelines” do not incorporate recommendations from other medical societies such as ILADS, according to the Lyme Disease Association President who was on a phone call about these guidelines with CDC after these were developed.

Determining what relationship between CSTE and CDC has been legislatively determined will enable stakeholders to examine what kinds of steps can be taken to improve the surveillance case definition. 

 

DISCUSSION

1. THE CSTE HAS THE AUTHORITY TO CREATE DISEASE SURVEILLANCE GUIDELINES IN CONJUNCTION WITH CDC.

The Council for State and Territorial Epidemiologists (CSTE) has the authority to create disease surveillance criteria and develop a list of notifiable diseases. This authority comes from a recognition of the CSTE’s expertise in developing guidelines by both federal and state statutes, regulations promulgated by the Department of Health and Human Services (DHHS), and a long-standing cooperative partnership between the CSTE and the Centers for Disease Control and Prevention (CDC).

The CSTE is rarely named in federal statutes due to the organization’s non-public character. When it is mentioned, it is cited as an authoritative source of guidance for disease surveillance criteria. The Frank R. Lautenberg Chemical Safety for the 21st Century Act is the most notable example, which instructs the Secretary of DHHS to work with the CSTE and state and local health departments to create guidelines for investigating potential cancer clusters.[17] This statute marks a Congressional recognition of the CSTE’s expertise in developing surveillance case definitions for notifiable diseases.

Several states cite to CSTE surveillance case definition as a source of authority for their local health departments. Indiana,[18] Mississippi,[19] Florida,[20] and Washington[21] all instruct their local health departments to consider guidelines from both the CDC and CSTE when developing their own lists of notifiable diseases. Nevada, however, only cited to the guidelines of the CSTE and neglected to mention the CDC when passing a blood-lead level control statute.[22] Similarly, Nebraska only defines a ‘confirmed case’ of a disease as one that “meets the case definitions specified and published by the [CSTE].”[23] While both the CDC and CSTE are persuasively authoritative at the state level, the balance tilts towards the greater authority of the CSTE.

However, it should be noted that many states do not follow the CSTE surveillance case definition for Lyme disease. Thus, there is not a universal recognition of CSTE’s authority.  For instance, New York and New Hampshire estimate Lyme disease cases, which the CSTE definition does not permit.[24] The CDC indicates it is not permitted by CSTE to use estimated numbers, so cases in New York and New Hampshire are vastly underreported.[25] In Wisconsin, reporting requirements are relaxed substantially, requiring providers to report a Lyme disease case only when there is Erythema Migrans rash.[26] Connecticut in 2003 changed reporting criteria in relation to Lyme which significantly dropped its reported case numbers[27] and Massachusetts in 2016 changed its approach to surveillance reporting which removed that state from one of the top in the country—2015 had 4,224 reported cases down to 7 in 2019[28]. In addition to statutory deference, regulations promulgated by the Department of Health and Human Services further define the authority of both the CDC and CSTE in directing the activity of the National Notifiable Disease Surveillance System (NNDSS), the government apparatus used to track disease outbreaks across the country. The CDC possesses the authority to “manage and operate the [NNDSS].”[29] The usage of the phrase ‘manage and operate,’ however, does not imply the authority to create the disease surveillance guidelines that are used by the NNDSS. That authority is instead explicitly given to the CSTE. As stated in a DHHS review conducted as part of the Paperwork Reduction Act: “Each year, the Council of State and Territorial Disease Epidemiologists (CSTE), supported by CDC, performs an assessment of conditions reported to state, territorial and local jurisdictions to determine which should be designated nationally notifiable conditions.”[30] Those disease surveillance guidelines are then found in the National Notifiable Conditions List (NNCL), which is maintained by the CSTE. While the CDC manages and operates the NNDSS, it is within the CSTE’s purview to create the disease [surveillance] criteria and guidelines of the NNCL, which the NNDSS uses.[31] The Council of State and Territorial Epidemiologists, an affiliate of the Association of State and Territorial Health Officials, has the authority in the United States to recommend which health conditions should be notifiable. After this list has been agreed upon, it is then up to each state to determine whether and how the conditions should be made reportable. Although most states report all those conditions considered to be nationally notifiable, a wide range of conditions are reportable in only a few states (3). States may exercise their authority through regulations, boards of health, or legislative procedures. The diversity of these methods is described more fully in Chapter XII. Each of these mechanisms entails the involvement of groups with an array of medical, administrative, public health, and policy interests.

The interaction between the NNDSS and the NNCL is the linchpin of the relationship between the CDC and CSTE.[32] A collaborative partnership has existed between the two organizations for decades, existing in its modern form since at least 1971, when a reporting system for water-based diseases was created.[33] The current organization of responsibility is stated by the CSTE Executive Committee in a guidance document.[34] In this guidance document, it is specifically stated that “CSTE shall establish a Nationally Notifiable Condition List… notifiable routinely to CDC.”[35] For a condition to be included on the list, the CDC must request that it be federally notifiable.[36] However, developing the case definitions remains in the hands of the CSTE. This arrangement is confirmed by the CDC, which “collaborate[s] with the [CSTE] to determine which conditions reported to local, state, and territorial public health departments are nationally notifiable. The [CSTE] brings together disease and surveillance experts at CDC and in the health departments to determine what types of data should be included in national notifications.”[37]

The actual procedures involved in updating surveillance case definition guidelines demonstrate the authority of the CSTE. The disease surveillance criteria are promulgated in position statements that undergo an extensive internal review process that includes a quorum vote at the annual CSTE conference, and are then sent out to both the CDC and state and territorial governments for responses, comment, and adoption.[38] According to the organization itself, CSTE is responsible for “defining and recommending which diseases and conditions are reportable within states and which of these diseases and conditions will be voluntarily reported to CDC.”[39]  This longstanding arrangement has been independently recognized by the United States Government Accountability Office through reliance on surveillance data and standardized reporting from the CSTE.[40] However, the CDC’s reliance on the CSTE appears more voluntary than obligatory. 

In conclusion, the CSTE has the authority to develop or not to develop disease surveillance criteria and guidelines. The CSTE’s expertise is recognized in both federal and state statutes. Additionally, the DHHS has explicitly bifurcated authority for nationally notifiable diseases, instructing CDC to manage and operate the NNDSS, and recognizing the CSTE’s responsibility for developing case guidelines for the NNCL. The collaborative, seemingly voluntary partnership between the CDC and CSTE has led to a precedent that places primary responsibility for case guidelines on the CSTE, however the CDC retains the right to not adopt the CSTE guidelines as it maintains final authority to disseminate public health surveillance information.[41]

2. THE CSTE HAS THE AUTHORITY TO CREATE LYME DISEASE GUIDELINES.

The CDC is a large federal agency that spends the vast majority of its budget on outside “grants, cooperative agreements, and contracts.”[42] CSTE is a smaller, independent organization of epidemiologists. The CSTE was created because the CDC wanted state input into decisions about how to address disease, and the two organizations have worked together as partners for decades.[43] Since its beginning in 1951, the CSTE has been responsible for “defining and recommending which diseases and conditions are reportable within states and which of these diseases and conditions will be voluntarily reported to CDC.”[44]  Unlike the CDC, the CSTE has a ten-member Executive Board that includes a chair representing chronic disease.[45] The CDC follows the CSTE definitions for influenza[46] and for COVID-19.[47]

The Public Health Service Act[48] authorizes the CDC to conduct a Lyme research program.[49] The CDC requires recipients of grants under this program to “[i]mplement, maintain, and evaluate an active Lyme disease surveillance system based on the 1990 (or subsequent) national case definition adopted by the Council of State and Territorial Epidemiologists (CSTE)” [emphasis added].[50] This follows the CDC’s general approach to defining infectious diseases.[51]

The CDC has promulgated guidelines recognizing the need to address questions about chronic Lyme disease.[52] The CDC’s general protocol for chronic disease guidelines is the Chronic Disease Indicators (CDI).[53] The CDIs are “developed by consensus among” the CDC, the CSTE, and the National Association of Chronic Disease Directors (NACDD).[54] “CDI is the only integrated source for comprehensive access to a wide range of indicators for the surveillance of chronic diseases, conditions, and risk factors at the state level.”[55]  The CDI was most recently updated in 2012-2013 when the CDC, CSTE, and NACDD “collaborated on a series of reviews that were informed by subject-matter expert opinion” to make recommendations on indicators and topic groups considered “essential for surveillance, prioritization, and evaluation of public health interventions.”[56] Lyme was not included in the CSTE’s 2013 position statement on the proposed revisions to the CDI.[57] No reason could be found for Lyme disease not being included. The CDC states that only that, beyond the selection of CIDs being chosen in conjunction with the CSTE and NACDD, that CIDs are identified in conjunction with state health departments to build a consensus set of “state-based health surveillance indicators.”[58] Because it was not included in the most recent 2012-2013 revision, the CDI does not currently address long-term implications of Lyme or provide data on it.[59]  

The Tick-Borne Disease Working Group (TBDWG) was established by the DHHS to review federal research and programs that address tick-borne disease.[60] The Babesiosis and Tick-Borne Pathogens Subcommittee Report to the TBDWG recommends that state health authorities follow CSTE case definitions and encourages the CSTE to continue developing case criteria for newly discovered diseases.[61] These subcommittee reports offer more detailed policy suggestions than the CSTE provides, and TBDWG’s collected reports to Congress reflect significant disagreement among experts on how to understand and treat Lyme.[62] These disagreements of individual members are expressed as minority responses, and reveal the extent of disagreement within and between different organizations. In light of this level of expert disagreement, the CDC incorporates Lyme information from organizations beyond the CSTE, such as[63] the Infectious Diseases Society of America (IDSA).[64] In fact, the CDC has used IDSA’s recommendations as the basis for their guidelines, despite not citing IDSA directly.[65] However, the CDC could also consider alternative treatment guidelines and diagnostic criteria from another medical society specifically dedicated to Lyme disease, such as the International Lyme and Associated Diseases Society (ILADS).[66]             

The CSTE’s most recent revisions to its Lyme Surveillance guidelines,[67] which the CDC has adopted,[68] include multiple types of chronic arthritis as signs and symptoms of Lyme, recognizing that “post-antibiotic Lyme arthritis is a well-studied, post-treatment, objective manifestation of Lyme disease.”[69] The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institute of Health (NIH) has drawn attention to the real suffering that the broad range of reported symptoms of what it  characterizes as “‘chronic Lyme disease syndrome” causes for patients and their caregivers, even if the cause and treatment of the symptoms is not understood by medical researchers.[70] Other organizations include more information that addresses other long-term effects of Lyme than the CSTE provides. For instance, the medical society ILADS “recommends longer durations of antibiotic therapy for Lyme disease prevention, erythema migrans treatment, and retreatment of patients with persistent symptoms. Some of these differences are due to differences in the interpretation and adoption of clinical trial results.”[71] Neither CSTE nor the government acknowledges ILADS guidelines. 

3. THE CDC USES CSTE GUIDELINES FOR OTHER CONTROVERSIAL DISEASES.

The CDC accepts CSTE guidelines for conditions in addition to Lyme disease, including several controversial conditions.

In 1990, the CDC collaborated with the CSTE to create the Morbidity and Mortality Weekly Report (MMWR), which published case definitions for infectious diseases.[72] A case definition is a set of standardized criteria used to define a condition.[73] This allows public health officials to identify and record cases consistently across different states.[74] About two decades later, the CSTE emphasized a need to create an official list of nationally notifiable conditions: both infectious and non-infectious.[75] In order to aid in this effort, the CSTE suggested the adoption of a standardized case definition for each condition on the official list.[76]

Under the recommendation of the CSTE, state health departments now report identified cases of specified conditions to the CDC’s National Notifiable Diseases Surveillance System (NNDSS).[77] The CDC provides corresponding case definitions on its official website.[78] These case definitions are accepted by the CDC and updated annually using the CSTE’s Position Statements.[79]

While these definitions are largely decided by the CSTE, each definition must comply with American Health Information Community standards.[80] In July 2008, the CSTE identified sixty-eight conditions warranting inclusion on the official list of notifiable diseases, and provided each of these conditions, including Lyme disease, with a case definition.[81]

The official list has since grown dramatically, now including over 120 identifiable conditions.[82] Admittedly, this list primarily consists of well-accepted and easily diagnosable diseases, such as chickenpox and strep throat.[83] There are, however, a number of controversial conditions—in addition to Lyme disease—for which the CDC accepts the CSTE case definitions.

Some diseases cause widespread, vague, and complex symptoms, resulting in difficulties with diagnosis, case definition, and classification.[84] Two such controversial examples are amebiasis (also known as amoebic dysentery) and various forms of Candida auris.[85]

First, Amebiasis is a parasitic infection of the colon from the amoeba Entamoeba histolytica.[86] The condition is controversial due in part to its rarity in the United States. Almost an entire century has passed since the last amebiasis outbreak, which occurred in Chicago at the 1933 World’s Fair.[87] Amebiasis is most common in tropical areas with poor sanitation conditions or untreated water.[88] As a result, cases are rare in the United States, and accordingly, many doctors may be unfamiliar with the condition.[89]

Additionally, similar to Lyme disease, amebiasis is controversial due in part to its mild and common symptoms. In fact, most people who contract amebiasis show no symptoms.[90] Those who do show symptoms tend to only suffer from nausea, cramping, or diarrhea.[91] These symptoms are mild and can be mistakenly attributed to a wide range of other conditions. Furthermore, intestinal parasites in general are controversial in the medical field. Specifically, gastroenterologists differ on which microbes are actually harmful and require antibiotics, and which are better left alone.[92]

Second, Candida auris is a type of fungus that normally lives in the body in places such as the mouth and stomach without causing any problems.[93] However, it can cause an infection if it enters the bloodstream or certain organs such as the heart.[94] Similar to Lyme disease, Candida auris is controversial due in part to disagreement regarding the best diagnosis criteria.[95] For example, Dr. William Crook, who provided the original description for the condition, created a list of 70 symptoms to guide diagnosis.[96] More recently, however, Dr. Jeffrey McCombs extended the list to 100,[97] while Dr. Amy Myers trimmed the list all the way down to 10.[98] Furthermore, the CDC itself admits that diagnosis is difficult, as Candida auris can be easily confused with other types of funguses.[99]

 

CONCLUSION

The Council of State and Territorial Epidemiologists derives its authority to create disease criteria and surveillance guidelines from federal and state law, regulations promulgated by the Department of Health and Human Services, and a longstanding partnership with the Centers for Disease Control and Prevention. Through the CDC’s long-standing reliance on CSTE surveillance criteria for Lyme disease, among other conditions and controversial diseases, the CDC has de facto delegated specific responsibility to the CSTE for developing Lyme disease surveillance guidelines. However, it does not appear that the CDC must adopt CSTE’s surveillance guidelines, as it maintains authority to regulate dissemination of public health information. Also, the CDC appears to be able to develop its own clinical treatment and diagnostic criteria.

 

REFERENCES:

[1] This paper and the findings by the Lyme Disease Advocacy Project do not represent the views or conclusions by Duke University or Duke University School of Law.

[2] The authors reached out to the CSTE and the CDC. The CSTE did not respond. The CDC responded that “the Council of State and Territorial Epidemiologists brings together disease and surveillance experts at CDC and in the health departments to determine what types of data should be included in national notifications.”

[3] Lyme Disease, Centers for Disease Control and Prevention (Jan. 19, 2022), https://www.cdc.gov/lyme/index.html.

[4] Id.

[5] Id.

[6] Mission, Role and Pledge, Centers for Disease Control and Prevention (Feb. 25, 2022), https://www.cdc.gov/about/organization/mission.htm.

[7] National Notifiable Diseases Surveillance System (NNDSS), Centers for Disease Control and Prevention (Sept. 29, 2021), https://www.cdc.gov/nndss/about/index.html.

[8] This was relayed based on information obtained from Pat Smith, President of the Lyme Disease Association, on a phone call with the CDC.

[9] CSTE History, Council of State and Territorial Epidemiologists (2022), https://www.cste.org/page/About_CSTE.

[10] Id.

[11] This can be seen in comparing all CSTE’s positional statements defining Lyme disease to the CDC’s definition of Lyme disease.

[12] CSTE History, Council of State and Territorial Epidemiologists (2022), https://www.cste.org/page/About_CSTE.

[13] Training, Education, Access to Care, and Reimbursement Subcommittee Report to the Tick-Borne Disease Working Group, U.S. Department of Health and Human Services, https://www.hhs.gov/ash/advisory-committees/tickbornedisease/reports/training-education-access-to-care-and-reimbursement-subcomm-2020/index.html.

[14] See, e.g., Information Quality Request for Correction, Disclaimers Needed for Lyme Disease Case Definition, U.S. Department of Health and Human Services, May 20, 2021 (stating “patients and doctors look to the Centers for Disease Control and prevention (CDC) for information on and guidance about Lyme disease, including diagnostic criteria”).

[15] Annemarie G. Hirsch, et al., Risk Factors and Outcomes of Treatment Delays in Lyme Disease: A Population-Based Retrospective Cohort Study, National Library of Medicine (Nov. 26, 2020).

[16] Guidance for Clinicians, Caring for Patients After a Tick Bite, Center for Disease Control (Dec. 21, 2021), https://www.cdc.gov/lyme/resources/FS-Guidance-for-Clinicians-Patients-after-TickBite-508.pdf.

[17] Frank R. Lautenberg Chemical Safety for the 21st Century Act, 42 USCS § 280g-17(c) (2016).

[18] Ind. Code Ann. § 16-41-2-1(c) (2022).

[19] 128 Miss. Gov’t Reg. 95 (March 2008).

[20] Fla. Stat. § 381.0031(4) (2022).

[21] 11 Wash. Reg. 28 (June 2, 2021).

[22] Nev. Rev. Stat. § 442.700(2) (2021).

[23] 173 Neb. Admin. Code Title § 1-002 (2022).

[24] New York Department of Health, Communicable Disease In New York State Cases Reported In 2020, https://www.health.ny.gov/statistics/diseases/communicable/2020/docs/cases.pdf; Amy Coveno, Despite Prevalence of Lyme disease, NH Provides Only Estimates of Cases, WMUR 9 ABC (Apr. 30, 2018), https://www.wmur.com/article/despite-prevalence-of-lyme-disease-nh-provides-only-estimate-of-cases/20107070#.

[25] See id.; This was confirmed via Pat Smith, the President of the Lyme Disease Association.

[26] https://www.health.ny.gov/statistics/diseases/communicable/2020/docs/cases.pdf

[27] Lyme Disease Association, Lyme Disease Reporting Criteria Changes, LDA Apps, https://lymediseaseassociation.org/LDA_Apps/content/Maps/criteriachanges.htm (citing Connecticut Epidemiologist Newsletter, Vol. 23, No. 1).

[28] Id. (citing the CDC for a change in Massachusetts reporting approach).

[29] Centers for Disease Control and Prevention: Statement of Organization, Functions, and Delegations of Authority, 59 Fed. Reg. 24451 (May 11, 1994).

[30] Agency Forms Undergoing Paperwork Reduction Act Review, 78 Fed. Reg. 69092 (Nov. 18, 2013).

[31] Steven M. Teutsch, Considerations in Planning a Surveillance System, in Principles and Practice of Public Health Surveillance 18, 28-29 (2010).

[32] U.S. Gov’t Accountability Off., GAO-10-645, Biosurveillance (2010).

[33] U.S. Gov’t Accountability Off., GAO-05-376 App. XIV, Environmental Information (2005).

[34] Jeffrey Engel, Council of State and Territorial Epidemiologists, CSTE Position Statement 08-EC-02, Criteria for Inclusion of Conditions on CSTE Nationally Notifiable Conditions List and for Categorization as Immediately or Routinely Notifiable 2 (2008).

[35] Id.

[36] Id. at 3.

[37] What is Case Surveillance?, Centers for Disease Control and Prevention (Sept. 29, 2021), https://www.cdc.gov/nndss/about/.

[38] Introduction to Position Statement Process, Council of State and Territorial Epidemiologists (2022),  https://www.cste.org/page/PSLanding#intro-process.

[39] CSTE History, Council of State and Territorial Epidemiologists (2022), https://www.cste.org/page/About_CSTE.

[40] U.S. Gov’t Accountability Off., GAO-01-973, Food Safety (2001).

[41] Centers for Disease Control and Prevention: Statement of Organization, Functions, and Delegations of Authority, 59 Fed. Reg. 24451 (May 11, 1994).

[42] Justification of Estimates for Appropriation Committees, Centers for Disease Control and Prevention 27 (2021), https://www.cdc.gov/budget/documents/fy2023/FY-2023-CDC-congressional-justification.pdf.

[43] CSTE History, Council of State and Territorial Epidemiologists (2022), https://www.cste.org/page/About_CSTE.

[44] Id.

[45] About CSTE, Council for State and Territorial Epidemiologists (2022), https://www.cste.org/page/about-cste.

[46] National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting. 76 Fed. Reg. 67742 (Nov. 2, 2011).

[47] Coronavirus Disease 2019 (COVID-19) 2021 Case Definition, Centers for Disease Control and Prevention (2021), https://ndc.services.cdc.gov/case-definitions/coronavirus-disease-2019-2021/.

[48] 42 U.S.C. 241 and 247b(k)(2).

[49] Cooperative Agreements to Conduct Research and Education Programs on Lyme Disease in the United States, 62 Fed. Reg. 26516  (May 14, 1997).

[50] Id. at 26517.

[51] David P. Fidler et. al., Emerging and Reemerging Infectious Diseases: Challenges for International, National, and State Law, 31 Int’l Law. 773, 781 (1997).

[52] 62 Fed. Reg. at 26517.

[53] Chronic Disease Indicators, Centers for Disease Control and Prevention (2021), https://www.cdc.gov/cdi/overview.html.

[54] Id.

[55] Id.

[56] Id.

[57]  Sara Huston, et. al, Council of State and Territorial Epidemiologists, CSTE Position Statement 13-CD-01, Revision to the National Chronic Disease Indicators (2013).

[58] See, Chronic Disease Indicators, Centers for Disease Control and Prevention (2021), https://www.cdc.gov/cdi/overview.htm.

[59] Id.

[60] Tick-Borne Disease Working Group Report to Congress, U.S. Department of Health and Human Services (2020), https://www.hhs.gov/sites/default/files/tbdwg-2020-report_to-ongress-final.pdf.

[61] Id.

[62] Id.

[63] Pitrak, D., Nguyen, C.T., Cifu, A.S.. Diagnosis of Lyme Disease. JAMA. (2022) 327(7):676–677. doi:10.1001/jama.2022.0081.

[64] 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease, Infectious Diseases Society of America (2020), https://www.idsociety.org/practice-guideline/lyme-disease/.

[65] This was relayed based on information obtained from Pat Smith, President of the Lyme Disease Association, on a phone call with the CDC.

[66] Evidence Assessments and Guidelines Recommendations in Lyme Disease, International Lyme and Associated Diseases Society (2023), https://www.ilads.org/patient-care/ilads-treatment-guidelines/.

[67] Catherine M. Brown, Council of State and Territorial Epidemiologists, CSTE Position Statement 21-ID-05, Modification of Lyme Disease Case Definitions (2021).

[68] Lyme Disease (Borrelia burgdorferi) 2022 Case Definition, Centers for Disease Control and Prevention (2021) https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/.

[69] Wong, K.H., Shapiro, E.D. & Soffer, G.K., A Review of Post-treatment Lyme Disease Syndrome and Chronic Lyme Disease for the Practicing Immunologist, Clinic Rev Allerg Immunol 62, 264–271 at 266 (2022), https://doi.org/10.1007/s12016-021-08906-w.

[70] Current Efforts in Lyme Disease Research, National Institute of Allergy and Infectious Diseases (2019), https://www.niaid.nih.gov/sites/default/files/NIAIDLymeRepot.pdf.

[71] Pitrak, D., Nguyen, C.T., Cifu, A.S. Prevention and Treatment of Lyme Disease, JAM (2022) 327(8):772–773, doi:10.1001/jama.2021.25302.

[72] Morbidity and Mortality Weekly Report, Vol. 39, No. RR-13 (October 19, 1990), https://www.cdc.gov/mmwr/PDF/rr/rr3913.pdf.

[73] Surveillance Case Definitions for Current and Historical Conditions, Centers for Disease Control and Prevention (Apr. 16, 2021), https://ndc.services.cdc.gov/.

[74] Id.

[75] Steven MacDonald, Council of State and Territorial Epidemiologists, CSTE Position Statement 07-EC-02, CSTE Official List of Nationally Notifiable Conditions (2007).

[76] Id.

[77] Surveillance Case Definitions for Current and Historical Conditions, Centers for Disease Control and Prevention (Apr. 16, 2021), https://ndc.services.cdc.gov/.

[78] Id.

[79] Id.

[80] Christine Hahn, et. al, Council of State and Territorial Epidemiologists, CSTE Position Statement 09-ID-11, National Surveillance for Severe Acute Respiratory Syndrome (SARS-CoV) (2009).

[81] Id.

[82] What is Case Surveillance?, Centers for Disease Control and Prevention (Sept. 29, 2021), https://www.cdc.gov/nndss/about/.

[83] Surveillance Case Definitions for Current and Historical Conditions, Centers for Disease Control and Prevention (Apr. 16, 2021), https://ndc.services.cdc.gov/.

[84] Edelberg, David, “Ten Controversial Medical Conditions: An Introduction,” WholeHealth Chicago, https://wholehealthchicago.com/blog/2018/04/30/ten-controversial-medical-conditions-an-introduction.

[85] Id.

[86] Amebiasis (amebic dysentery), New York State Department of Health (Oct. 2021), https://www.health.ny.gov/diseases/communicable/amebiasis/fact_sheet.htm.

[87] Bertha Spector, Amebiasis in Chicago – December, 1933, to June, 1936, American Journal of Public Health 24, no. 7, 756-758 (July 1, 1934).

[88] Amebiasis (amebic dysentery), New York State Department of Health (Oct. 2021), https://www.health.ny.gov/diseases/communicable/amebiasis/fact_sheet.htm.

[89] American Journal of Public Health, Amebic Dysentery in Chicago, AJPH 24, 7, 756-758.

[90] Amebiasis (amebic dysentery), New York State Department of Health (Oct. 2021), https://www.health.ny.gov/diseases/communicable/amebiasis/fact_sheet.htm.

[91] Id.

[92] Dhrati Patangia, et al., Impact of Antibiotics on the Human Microbiome and Consequences for Host Health, MicrobiologyOpen, Vol. 11, No. 1 (Jan. 13, 2022).

[93] General Information About Candida aurus, Centers for Disease Control and Prevention (Nov. 13, 2019),  https://www.cdc.gov/fungal/candida-auris/candida-auris-qanda.html.

[94] Id.

[95] Adekunle Sanyaolu, et al., Candida auris: An Overview of the Emerging Drug Resistant Fungal Infection, Infect Chemother, Vol. 54, No. 2 (Jun. 17, 2022).

[96] Crook, William G., M.D., The Yeast Connection Handbook (1st ed. 1995).

[97] McCombs, Jeffrey S., LifeForce: A Dynamic Plan for Health, Vitality and Weight Loss (1st ed. 2010).

[98] Myers, Amy, M.D., The Autoimmune Solution: Prevent and Reverse the Full Spectrum of Inflammatory Symptoms and Diseases (2d ed. 2017).

[99] Identification of Candida auris, Centers for Disease Control and Prevention (May 29, 2020), https://www.cdc.gov/fungal/candida-auris/identification.html.