II

106TH CONGRESS

1ST SESSION S. 1905

To establish a program to provide for a reduction in the incidence and

prevalence of Lyme disease.

IN THE SENATE OF THE UNITED STATES

NOVEMBER 10, 1999

Mr. SANTORUM (for himself, Mr. DODD, Mr. TORRICELLI, Mr. LIEBERMAN,

Mr. SCHUMER, and Mr. LAUTENBERG) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To establish a program to provide for a reduction in the

incidence and prevalence of Lyme disease.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Lyme Disease Initia5 tive of 1999’’.

6 SEC. 2. FINDINGS.

7 Congress makes the following findings:

8 (1) The incidence of Lyme disease in the

9 United States is increasing rapidly. The Centers for
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1 Disease Control and Prevention (referred to in this

2 Act as the ‘‘CDC’’) has determined that, since 1982,

3 there has been a 32-fold increase in reported cases.

4 (2) In 1998, a total of 15,934 cases of Lyme

5 disease were reported to CDC by 50 States and the

6 District of Columbia (the overall incidence was 6.06

7 per 100,000), representing a 24 percent increase

8 from the 12,807 cases reported in 1997.

9 (3) There is no reliable standardized diagnostic

10 test for chronic Lyme disease, and the test for acute

11 Lyme disease should be improved. As a result, the

12 disease is underreported or misreported by as much

13 as 10 or 12 fold, according to some studies, because

14 the symptoms of Lyme disease mimic other health

15 conditions. Thus, precise figures on the incidence of

16 Lyme disease are difficult to develop.

17 (4) Lyme disease costs our Nation between

18 $1,000,000,000 and $2,000,000,000 in medical

19 costs annually, according to studies. Lost produc20 tivity annually per person from Lyme disease has

21 been estimated at 5 to 37 days.

22 (5) Many health care providers lack the nec23 essary knowledge and expertise—particularly in non24 endemic areas—to accurately diagnose and prevent

25 Lyme disease. As a result, patients often visit mul-
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1 tiple doctors before obtaining a diagnosis of the dis2 ease, resulting in prolonged pain and suffering, un3 necessary tests, and costly, delayed, or futile treat4 ments.

5 (6) Due to scientific uncertainties about the di6 agnosis of acute and chronic Lyme disease, and the

7 proper course and length of treatment, many pa8 tients have encountered difficulties in obtaining

9 needed insurance coverage for Lyme disease.

10 (7) Most Lyme disease infections are thought to

11 result from periresidential exposure to infected ticks

12 during property maintenance, recreation, and leisure

13 activities. Thus, individuals who live or work in resi14 dential areas surrounded by woods or overgrown

15 brush infested by vector ticks are at risk of Lyme

16 disease. In addition, persons who participate in rec17 reational activities away from home (such as hiking,

18 camping, fishing and hunting in tick habitat) and

19 persons who engage in outdoor occupations (such as

20 landscaping, brush clearing, forestry, military serv21 ice, and wildlife and parks management in endemic

22 areas) may also be at risk of Lyme disease. Some

23 estimates indicate outdoor workers have a 4-to-4

24 fold elevation in risk of Lyme disease.
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1 SEC. 3. PUBLIC HEALTH GOALS; 5-YEAR PLAN.

2 (a) IN GENERAL.—The Secretary of Health and

3 Human Services (acting as appropriate through the Direc4 tor of the Centers for Disease Control and Prevention, the

5 Director of the National Institutes of Health, and the

6 Commissioner of Food and Drugs), the Secretary of Agri7 culture, the Secretary of the Interior, and the Secretary

8 of Defense (in this Act referred to collectively as the ‘‘Sec9 retaries’’) shall collaborate to carry out the following:

10 (1) The Secretaries shall establish the goals de11 scribed in subsections (c) through (g) relating to ac12 tivities to provide for a reduction in the incidence

13 and prevalence of Lyme disease and related tick14 borne infectious diseases.

15 (2) The Secretaries shall carry out activities to16 ward achieving the goals, which may include activi17 ties carried out directly by the Secretaries and ac18 tivities carried out through awards of grants or con19 tracts to public or nonprofit private entities.

20 (3) In carrying out paragraph (2), the Secre21 taries shall give priority—

22 (A) first, to achieving the goal under sub23 section (c);

24 (B) second, to achieving the goal under

25 subsection (d);
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1 (C) third, to achieving the goal under sub2 section (e);

3 (D) fourth, to achieving the goal under

4 subsection (f); and

5 (E) fifth, to achieving the goal under sub6 section (g).

7 (b) FIVE-YEAR PLAN.—In carrying out subsection

8 (a), the Secretaries shall establish a plan that, for the 5

9 fiscal years following the date of the enactment of this

10 Act, provides for the activities to be carried out during

11 such fiscal years toward achieving the goals under sub12 sections (c) through (g). The plan shall, as appropriate

13 to such goals, provide for the coordination of programs

14 and activities regarding Lyme disease that are conducted

15 or supported by the Federal Government.

16 (c) FIRST GOAL: DETECTION TEST.—For purposes

17 of subsection (a), the goal described in this subsection is

18 the development of novel and more sensitive, specific, and

19 reproducible diagnostic tests and procedures (or the im20 provement or refinement of existing tests) that—

21 (1) can accurately determine whether an indi22 vidual has acute or chronic Lyme disease;

23 (2) can accurately determine the activity of

24 acute or chronic Lyme disease infection or both;
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1 (3) can accurately distinguish acute or chronic

2 Lyme disease or both from other related, tick-borne,

3 coinfectious diseases; and

4 (4) can accurately measure the responsiveness

5 of acute or chronic Lyme disease infection or both

6 to treatment.

7 (d) SECOND GOAL: IMPROVED SURVEILLANCE AND

8 REPORTING SYSTEM.—

9 (1) IN GENERAL.—For purposes of subsection

10 (a), the goal described in this subsection is to assess

11 the medical, social, and economic burden of Lyme

12 disease in the United States. This assessment shall

13 include a review of the system in the United States

14 for surveillance and reporting with respect to Lyme

15 disease and a determination of whether and in what

16 manner the system can be improved.

17 (2) CERTAIN ACTIVITIES.—In carrying out ac18 tivities toward the goal described in paragraph (1),

19 the Secretaries shall—

20 (A) consult with the States, the Conference

21 of State and Territorial Epidemiologists, units

22 of local government, physicians and health pro23 viders, patients with Lyme disease, and organi24 zations representing such patients;
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1 (B) consider whether uniform formats

2 should be developed for the reporting by physi3 cians and laboratories of cases of Lyme disease

4 to public health officials; and

5 (C) with respect to health conditions that

6 are reported by physicians as cases of Lyme

7 disease but do not meet the surveillance criteria

8 established by the Director of the Centers for

9 Disease Control and Prevention to be counted

10 as such cases, consider whether data on such

11 health conditions should be maintained and

12 analyzed to assist in understanding the cir13 cumstances in which Lyme disease is being di14 agnosed and the manner in which it is being

15 treated.

16 (e) THIRD GOAL: LYME DISEASE PREVENTION; DE17 VELOPMENT OF INDICATORS.—For purposes of subsection

18 (a), the goal described in this subsection is to reduce,

19 through the use of effective public health education, pre20 vention, and tick population reduction techniques, the inci21 dence of Lyme disease in the 10 highest endemic States

22 by 33 percent by the date that is 5 years after the date

23 of the enactment of this Act. In carrying out activities to24 ward such goal, the Secretaries shall carry out each of

25 the following:
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1 (1) Establish a baseline incidence rate of Lyme

2 disease in the 10 highest endemic States. The estab3 lishment of this baseline must take into consider4 ation the surveillance criteria review specified in sub5 section (d).

6 (2) Encourage the use of natural and nonpes7 ticidal methods to control and reduce tick popu8 lations, where appropriate.

9 (3) Reduce the risks of Lyme disease at all fed10 erally owned lands located in endemic States and re11 gions, as well as at locations known or suspected to

12 pose a risk of Lyme disease to patrons and employ13 ees, through the following:

14 (A) The development of standardized, peri15 odic (not less than 1 per year) Lyme disease

16 risk assessments that test and then categorize

17 the overall level of risk of Lyme disease at fed18 erally owned lands in endemic States and re19 gions. The Lyme disease risk assessments shall

20 be made available to the public in appropriate

21 forms, and may include such factors as—

22 (i) whether any human cases of Lyme

23 disease have been diagnosed and treated

24 on, or in areas adjacent to, the federally

25 owned lands;
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1 (ii) whether vectors capable of trans2 mitting Lyme disease to humans are

3 known to inhabit the federally owned land;

4 (iii) whether any such vectors present

5 on the federally owned land are known to

6 actually be infected with Lyme disease;

7 and

8 (iv) the geographic distribution of

9 Lyme disease risk within the federally

10 owned land.

11 (B) The development and coordination of

12 public awareness programs to educate patrons,

13 employees, and health professionals at federally

14 owned lands about the risks of Lyme disease,

15 all appropriate prevention methods that can be

16 used to reduce these risks, and information

17 about the symptoms and nature of the disease.

18 (C) The use of appropriate habitat man19 agement and integrated pest-control techniques

20 to reduce the number of tick-borne Lyme dis21 ease vectors in areas where humans work or

22 recreate.

23 (f) FOURTH GOAL: PREVENTION OF TICK-BORNE

24 DISEASES OTHER THAN LYME.—For purposes of sub25 section (a), the goal described in this subsection is to de-
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1 velop the capabilities at the Centers for Disease Control

2 and Prevention, within the Department of Defense, and

3 in State and local health departments to implement ade4 quate surveillance, improved diagnosis, and effective strat5 egies for the prevention and control of tick-borne diseases

6 other than Lyme disease. Such diseases may include

7 Lyme-like illness, ehrlichiosis, babesiosis, other bacterial,

8 viral and rickettsial diseases such as tularemia, tick-borne

9 encephalitis, and Rocky Mountain Spotted Fever, respec10 tively.

11 (g) FIFTH GOAL: IMPROVED PUBLIC AND PHYSICIAN

12 EDUCATION.—For purposes of subsection (a), the goal de13 scribed in this subsection is to improve the knowledge of

14 physicians, health care providers, and the public regarding

15 the best and most effective methods to prevent, diagnose,

16 and treat Lyme disease and related tick-borne diseases.

17 SEC. 4. LYME DISEASE TASKFORCE.

18 (a) IN GENERAL.—Not later than 120 days after the

19 date of enactment of this Act, there shall be established

20 in accordance with this section an advisory committee to

21 be known as the Lyme Disease Taskforce (in this section

22 referred to as the ‘‘Task Force’’).

23 (b) DUTIES.—The Task Force shall provide advice

24 to the Secretaries with respect to achieving the goals

25 under section 3, including advice on the plan under sub-
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1 section (b) of such section. Nothing in this section may

2 be construed as interfering with or undermining the peer

3 review process for research programs and grants, and the

4 Task Force shall take care that its activities complement

5 existing interagency relationships and interdepartmental

6 working groups to the maximum extent practicable.

7 (c) MEMBERSHIP.—

8 (1) EX OFFICIO MEMBERS.—The following offi9 cials (or their designees) shall serve as ex officio

10 members of the Task Force:

11 (A) The Director of the National Institute

12 of Allergy and Infectious Diseases.

13 (B) The Director of the National Institute

14 of Arthritis and Musculoskeletal and Skin Dis15 eases.

16 (C) The Director of the National Institute

17 of Neurological Disorders and Stroke.

18 (D) The Director of the National Center

19 for Infectious Diseases.

20 (E) The Director of the Epidemiology Pro21 gram Office.

22 (F) The Director of the Public Health

23 Practice Program Office.

24 (G) The Commander of the United States

25 Army Medical Command.
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1 (H) The Commander of the United States

2 Army Center for Health Promotion and Pre3 ventative Medicine.

4 (I) The Director of the Center for Bio5 logics Evaluation and Research.

6 (J) The Administrator of the Agricultural

7 Research Service.

8 (K) The Director of the National Park

9 Service.

10 (L) The Director of the Fish and Wildlife

11 Service.

12 (M) The Director of the Indian Health

13 Service.

14 (N) The Chief Biologist of the Biological

15 Resources Division, United States Geological

16 Survey.

17 (2) APPOINTED MEMBERS.—Appointments to

18 the Task Force shall be made in accordance with the

19 following:

20 (A) Two members shall be research sci21 entists with demonstrated achievements in re22 search related to Lyme disease and related tick23 borne diseases. The scientists shall be appointed

24 by the Secretary of Health and Human Services

25 (in this paragraph referred to as the ‘‘Sec-
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1 retary’’) in consultation with the National

2 Academy of Sciences.

3 (B) Four members shall be representatives

4 of organizations whose primary emphasis is on

5 research and public education into Lyme dis6 ease and related tick-borne diseases. One rep7 resentative from each of such organizations

8 shall be appointed by the Secretary in consulta9 tion with the National Academy of Sciences.

10 (C) Two members shall be clinicians with

11 extensive experience in the treatment of individ12 uals with chronic Lyme disease and related

13 tick-borne diseases. The clinicians shall be ap14 pointed by the Secretary in consultation with

15 the Institute of Medicine and the National

16 Academy of Sciences.

17 (D) Two members shall be individuals who

18 are the parents, spouse, or legal guardians of a

19 person or persons that have contracted Lyme

20 disease or a related tick-borne disease. The in21 dividuals shall be appointed by the Secretary in

22 consultation with the ex officio members under

23 paragraph (1) and the four organizations re24 ferred to in subparagraph (B).
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1 (E) One member shall be a representative

2 of the Council of State and Territorial Epi3 demiologists.

4 (F) One member shall be a representative

5 of the National Association of County and City

6 Health Officials.

7 (G) One member shall be an epidemiologist

8 of demonstrated achievements in the field of ep9 idemiology. The epidemiologist shall be ap10 pointed by the Secretary in consultation with

11 the National Academy of Sciences.

12 (d) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE;

13 OTHER PROVISIONS.—The following apply with respect to

14 the Task Force:

15 (1) The Task Force shall receive necessary and

16 appropriate administrative support from the Depart17 ment of Health and Human Services.

18 (2) Members of the Task Force shall be ap19 pointed for the duration of the Task Force.

20 (3) From among the members appointed under

21 subsection (c)(2), the Task Force shall designate an

22 individual to serve as the chairperson of the Task

23 Force.

24 (4) The Task Force shall meet no less than 2

25 times per year.
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1 (5) Members of the Task Force shall not re2 ceive additional compensation for their service. Such

3 members may receive reimbursement for appropriate

4 and additional expenses that are incurred through

5 service on the Task Force which would not have in6 curred had they not been a member of the Task

7 Force.

8 (6) Any vacancy in the membership of the Task

9 Force shall be filled in the manner in which the

10 original appointment was made and does not affect

11 the power of the remaining members to carry out

12 the duties of the Task Force.

13 SEC. 5. ANNUAL REPORTS.

14 The Secretaries shall submit to the Congress periodic

15 reports on the activities carried out under this Act and

16 the extent of progress being made toward the goals estab17 lished under section 3. The first such report shall be sub18 mitted not later than 18 months after the date of the en19 actment of this Act, and subsequent reports shall be sub20 mitted annually thereafter until the goals are met.

21 SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

22 (a) NATIONAL INSTITUTES OF HEALTH.—In addi23 tion to other authorizations of appropriations that are

24 available for carrying out the purposes described in this

25 Act and that are established for the National Institutes
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1 of Health, there are authorized to be appropriated to the

2 Director of such Institutes for such purposes $8,000,000

3 for each of the fiscal years 2000 through 2004.

4 (b) CENTERS FOR DISEASE CONTROL AND PREVEN5 TION.—In addition to other authorizations of appropria6 tions that are available for carrying out the purposes de7 scribed in this Act and that are established for the Centers

8 for Disease Control and Prevention, there are authorized

9 to be appropriated to the Director of such Centers for such

10 purposes $8,000,000 for each of the fiscal years 2000

11 through 2004.

12 (c) DEPARTMENT OF DEFENSE.—In addition to

13 other authorizations of appropriations that are available

14 for carrying out the purposes described in this Act and

15 that are established for the Department of Defense, there

16 are authorized to be appropriated to the Secretary of De17 fense for such purposes $6,000,000 for each of the fiscal

18 years 2000 through 2004.

19 (d) DEPARTMENT OF AGRICULTURE.—In addition to

20 other authorizations of appropriations that are available

21 for carrying out the purposes described in this Act and

22 that are established for the Department of Agriculture,

23 there are authorized to be appropriated to the Secretary

24 of Agriculture for such purposes $1,500,000 for each of

25 the fiscal years 2000 through 2004.
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1 (e) DEPARTMENT OF INTERIOR.—In addition to

2 other authorizations of appropriations that are available

3 for carrying out the purposes described in this Act and

4 that are established for the Department of Interior, there

5 are authorized to be appropriated to the Secretary of Inte6 rior for such purposes $1,500,000 million for each of the

7 fiscal years 2000 through 2004.

Æ