I

107TH CONGRESS

1ST SESSION H. R. 1254

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

prevalence of Lyme disease.

IN THE HOUSE OF REPRESENTATIVES

MARCH 27, 2001

Mr. SMITH of New Jersey (for himself, Mr. PITTS, Mr. MALONEY of Connecticut, Mr. GILMAN, Mrs. MORELLA, Mr. HINCHEY, Mr. DELAHUNT,

Mr. TRAFICANT, Mr. WOLF, Mr. TOWNS, and Mr. SAXTON) introduced

the following bill; which was referred to the Committee on Energy and

Commerce, and in addition to the Committees on Armed Services, Resources, and Agriculture, for a period to be subsequently determined by

the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

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,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Lyme Disease Initia3 tive of 2001’’.

4 SEC. 2. FINDINGS.

5 The Congress finds as follows:

6 (1) The incidence of Lyme disease in the

7 United States is increasing rapidly. The Centers for

8 Disease Control and Prevention (‘‘CDC’’) has deter9 mined that, since 1982, there has been a 25-fold in10 crease in reported cases.

11 (2) In 1999, a total of 16,273 cases of Lyme

12 disease were reported to CDC by 50 States and the

13 District of Columbia (the overall incidence was 4.67

14 per 100,000), representing a 27 percent increase

15 from the 12,807 cases reported in 1997.

16 (3) There is no reliable standardized diagnostic

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

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

19 disease is underreported or misreported by as much

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

21 the symptoms of Lyme disease mimic other health

22 conditions. Thus, precise figures on the incidence of

23 Lyme disease are difficult to develop.

24 (4) Lyme disease costs our Nation between

25 $1,000,000,000 and $2,000,000,000 in medical

26 costs annually, according to studies. Lost produc-
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1 tivity annually per person from Lyme disease has

2 been estimated at 5 to 37 days.

3 (5) Many health care providers lack the nec4 essary knowledge and expertise—particularly in non5 endemic areas—to accurately diagnose and prevent

6 Lyme disease. As a result, patients often visit mul7 tiple doctors before obtaining a diagnosis of the dis8 ease, resulting in prolonged pain and suffering, un9 necessary tests, and costly, delayed, or futile treat10 ments.

11 (6) Due to scientific uncertainties about the di12 agnosis of acute and chronic Lyme disease, and the

13 proper course and length of treatment, many pa14 tients have encountered difficulties in obtaining

15 needed insurance coverage for Lyme disease.

16 (7) Most Lyme disease infections are thought to

17 result from periresidential exposure to infected ticks

18 during property maintenance, recreation, and leisure

19 activities. Thus, individuals who live or work in resi20 dential areas surrounded by woods or overgrown

21 brush infested by vector ticks are at risk of Lyme

22 disease. In addition, persons who participate in rec23 reational activities away from home (such as hiking,

24 camping, fishing and hunting in tick habitat) and

25 persons who engage in outdoor occupations (such as
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1 landscaping, brush clearing, forestry, military serv2 ice, and wildlife and parks management in endemic

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

4 estimates indicate outdoor workers have a four-to-six

5 fold elevation in risk of Lyme disease.

6 SEC. 3. PUBLIC HEALTH GOALS; FIVE-YEAR PLAN.

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

8 Human Services (acting as appropriate through the Direc9 tor of the Centers for Disease Control and Prevention, the

10 Director of the National Institutes of Health, and the

11 Commissioner of Food and Drugs), the Secretary of Agri12 culture, the Secretary of the Interior, and the Secretary

13 of Defense (in this Act referred to collectively as the ‘‘Sec14 retaries’’) shall collaborate to carry out the following:

15 (1) The Secretaries shall establish the goals de16 scribed in subsections (c) through (g) relating to ac17 tivities to provide for a reduction in the incidence

18 and prevalence of Lyme disease and related tick19 borne infectious diseases.

20 (2) The Secretaries shall carry out activities to21 ward achieving the goals, which may include activi22 ties carried out directly by the Secretaries and ac23 tivities carried out through awards of grants or con24 tracts to public or nonprofit private entities.
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1 (3) In carrying out paragraph (2), the Secre2 taries shall give priority—

3 (A) first, to achieving the goal under sub4 section (c);

5 (B) second, to achieving the goal under

6 subsection (d);

7 (C) third, to achieving the goal under sub8 section (e);

9 (D) fourth, to achieving the goal under

10 subsection (f); and

11 (E) fifth, to achieving the goal under sub12 section (g).

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

14 (a), the Secretaries shall establish a plan that, for the five

15 fiscal years following the date of the enactment of this

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

17 such fiscal years toward achieving the goals under sub18 sections (c) through (g). The plan shall, as appropriate

19 to such goals, provide for the coordination of programs

20 and activities regarding Lyme disease that are conducted

21 or supported by the Federal Government.

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

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

24 the development of novel and more sensitive, specific, and
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1 reproducible diagnostic tests and procedures (or the im2 provement or refinement of existing tests) that—

3 (1) can accurately determine whether an indi4 vidual has acute or chronic Lyme disease;

5 (2) can accurately determine the activity of

6 acute or chronic Lyme disease infection or both;

7 (3) can accurately distinguish acute or chronic

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

9 coinfectious diseases; and

10 (4) can accurately measure the responsiveness

11 of acute or chronic Lyme disease infection or both

12 to treatment.

13 (d) SECOND GOAL: IMPROVED SURVEILLANCE AND

14 REPORTING SYSTEM.—

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

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

17 the medical, social, and economic burden of Lyme

18 disease in the United States. This assessment shall

19 include a review of the system in the United States

20 for surveillance and reporting with respect to Lyme

21 disease and a determination of whether and in what

22 manner the system can be improved.

23 (2) CERTAIN ACTIVITIES.—In carrying out ac24 tivities toward the goal described in paragraph (1),

25 the Secretaries shall—
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1 (A) consult with the States, the Conference

2 of State and Territorial Epidemiologists, units

3 of local government, physicians and health pro4 viders, patients with Lyme disease, and organi5 zations representing such patients;

6 (B) consider whether uniform formats

7 should be developed for the reporting by physi8 cians and laboratories of cases of Lyme disease

9 to public health officials; and

10 (C) with respect to health conditions that

11 are reported by physicians as cases of Lyme

12 disease but do not meet the surveillance criteria

13 established by the Director of the Centers for

14 Disease Control and Prevention to be counted

15 as such cases, consider whether data on such

16 health conditions should be maintained and

17 analyzed to assist in understanding the cir18 cumstances in which Lyme disease is being di19 agnosed and the manner in which it is being

20 treated.

21 (e) THIRD GOAL: LYME DISEASE PREVENTION; DE22 VELOPMENT OF INDICATORS.—For purposes of subsection

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

24 through the use of effective public health education, pre25 vention, and tick population reduction techniques, the inci-
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1 dence of Lyme disease in the 10 highest endemic States

2 by 33 percent by the date that is five years after the date

3 of the enactment of this Act. In carrying out activities to4 ward such goal, the Secretaries shall carry out each of

5 the following:

6 (1) Establish a baseline incidence rate of Lyme

7 disease in the 10 highest endemic States. The estab8 lishment of this baseline must take into consider9 ation the surveillance criteria review specified in sub10 section (d).

11 (2) Encourage the use of natural and nonpes12 ticidal methods to control and reduce tick popu13 lations, where appropriate.

14 (3) Reduce the risks of Lyme disease at all fed15 erally owned lands located in endemic States and re16 gions, as well as at locations known or suspected to

17 pose a risk of Lyme disease to patrons and employ18 ees, through the following:

19 (A) The development of standardized, peri20 odic (not less than one per year) Lyme disease

21 risk assessments that test and then categorize

22 the overall level of risk of Lyme disease at fed23 erally owned lands in endemic States and re24 gions. The Lyme disease risk assessments shall
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1 be made available to the public in appropriate

2 forms, and may include such factors as—

3 (i) whether any human cases of Lyme

4 disease have been diagnosed and treated

5 on, or in areas adjacent to, the federally

6 owned lands;

7 (ii) whether vectors capable of trans8 mitting Lyme disease to humans are

9 known to inhabit the federally owned land;

10 (iii) whether any such vectors present

11 on the federally owned land are known to

12 actually be infected with Lyme disease;

13 and

14 (iv) the geographic distribution of

15 Lyme disease risk within the federally

16 owned land;

17 (B) The development and coordination of

18 public awareness programs to educate patrons,

19 employees, and health professionals at federally

20 owned lands about: the risks of Lyme disease,

21 all appropriate prevention methods that can be

22 used to reduce these risks, and information

23 about the symptoms and nature of the disease.

24 (C) The use of appropriate habitat man25 agement and integrated pest-control techniques
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1 to reduce the number of tick-borne Lyme dis2 ease vectors in areas where humans work or

3 recreate.

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

5 DISEASES OTHER THAN LYME.—For purposes of sub6 section (a), the goal described in this subsection is to de7 velop the capabilities at the Centers for Disease Control

8 and Prevention, within the Department of Defense, and

9 in State and local health departments to implement ade10 quate surveillance, improved diagnosis, and effective strat11 egies for the prevention and control of tick-borne diseases

12 other than Lyme disease. Such diseases may include

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

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

15 encephalitis, and Rocky Mountain Spotted Fever, respec16 tively.

17 (g) FIFTH GOAL: IMPROVED PUBLIC AND PHYSICIAN

18 EDUCATION.—For purposes of subsection (a), the goal de19 scribed in this subsection is to improve the knowledge of

20 physicians, health care providers, and the public regarding

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

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

23 SEC. 4. LYME DISEASE TASKFORCE.

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

25 date of enactment of this Act, there shall be established
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1 in accordance with this section an advisory committee to

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

3 referred to as the ‘‘Task Force’’).

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

5 to the Secretaries with respect to achieving the goals

6 under section 3, including advice on the plan under sub7 section (b) of such section. Nothing in this section may

8 be construed as interfering with or undermining the peer

9 review process for research programs and grants, and the

10 Task Force shall take care that its activities complement

11 existing interagency relationships and interdepartmental

12 working groups to the maximum extent practicable.

13 (c) MEMBERSHIP.—

14 (1) EX OFFICIO MEMBERS.—The following offi15 cials (or their designees) shall serve as ex officio

16 members of the Task Force:

17 (A) The Director of the National Institute

18 of Allergy and Infectious Diseases.

19 (B) The Director of the National Institute

20 of Arthritis and Musculoskeletal and Skin Dis21 eases.

22 (C) The Director of the National Institute

23 of Neurological Disorders and Stroke.

24 (D) The Director of the National Center

25 for Infectious Diseases.
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1 (E) The Director of the Epidemiology Pro2 gram Office.

3 (F) The Director of the Public Health

4 Practice Program Office.

5 (G) The Commander of the United States

6 Army Medical Command.

7 (H) The Commander of the United States

8 Army Center for Health Promotion and Pre9 ventative Medicine.

10 (I) The Director of the Center for Bio11 logics Evaluation and Research.

12 (J) The Administrator of the Agricultural

13 Research Service.

14 (K) The Director of the National Park

15 Service.

16 (L) The Director of the Fish and Wildlife

17 Service.

18 (M) The Director of the Indian Health

19 Service.

20 (N) The Chief Biologist of the Biological

21 Resources Division, United States Geological

22 Survey.

23 (2) APPOINTED MEMBERS.—Appointments to

24 the Task Force shall be made in accordance with the

25 following:
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1 (A) Two members shall be research sci2 entists with demonstrated achievements in re3 search related to Lyme disease and related tick4 borne diseases. The scientists shall be appointed

5 by the Secretary of Health and Human Services

6 (in this paragraph referred to as the ‘‘Sec7 retary’’) in consultation with the National

8 Academy of Sciences.

9 (B) Four members shall be representatives

10 of organizations whose primary emphasis is on

11 research and public education into Lyme dis12 ease and related tick-borne diseases. One rep13 resentative from each of such organizations

14 shall be appointed by the Secretary in consulta15 tion with the National Academy of Sciences.

16 (C) Two members shall be clinicians with

17 extensive experience in the treatment of individ18 uals with chronic Lyme disease and related

19 tick-borne diseases. The clinicians shall be ap20 pointed by the Secretary in consultation with

21 the Institute of Medicine and the National

22 Academy of Sciences.

23 (D) Two members shall be individuals who

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

25 person or persons that have contracted Lyme
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1 disease or a related tick-borne disease. The in2 dividuals shall be appointed by the Secretary in

3 consultation with the ex officio members under

4 paragraph (1) and the four organizations re5 ferred to in subparagraph (B).

6 (E) One member shall be a representative

7 of the Council of State and Territorial Epi8 demiologists.

9 (F) One member shall be a representative

10 of the National Association of County and City

11 Health Officials.

12 (G) One member shall be an epidemiologist

13 of demonstrated achievements in the field of ep14 idemiology. The epidemiologist shall be ap15 pointed by the Secretary in consultation with

16 the National Academy of Sciences.

17 (d) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE;

18 OTHER PROVISIONS.—The following apply with respect to

19 the Task Force:

20 (1) The Task Force shall receive necessary and

21 appropriate administrative support from the Depart22 ment of Health and Human Services.

23 (2) Members of the Task Force shall be ap24 pointed for the duration of the Task Force.
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1 (3) From among the members appointed under

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

3 individual to serve as the chair of the Task Force.

4 (4) The Task Force shall meet no less than two

5 times per year.

6 (5) Members of the Task Force shall not re7 ceive additional compensation for their service. Such

8 members may receive reimbursement for appropriate

9 and additional expenses that are incurred through

10 service on the Task Force which would not have in11 curred had they not been a member of the Task

12 Force.

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

14 Force shall be filled in the manner in which the

15 original appointment was made and does not affect

16 the power of the remaining members to carry out

17 the duties of the Task Force.

18 SEC. 5. ANNUAL REPORTS.

19 The Secretaries shall submit to the Congress periodic

20 reports on the activities carried out under this Act and

21 the extent of progress being made toward the goals estab22 lished under section 3. The first such report shall be sub23 mitted not later than 18 months after the date of the en24 actment of this Act, and subsequent reports shall be sub25 mitted annually thereafter until the goals are met.
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1 SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

2 (a) NATIONAL INSTITUTES OF HEALTH.—In addi3 tion to other authorizations of appropriations that are

4 available for carrying out the purposes described in this

5 Act and that are established for the National Institutes

6 of Health, there are authorized to be appropriated to the

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

8 for each of the fiscal years 2002 through 2006.

9 (b) CENTERS FOR DISEASE CONTROL AND PREVEN10 TION.—In addition to other authorizations of appropria11 tions that are available for carrying out the purposes de12 scribed in this Act and that are established for the Centers

13 for Disease Control and Prevention, there are authorized

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

15 purposes $8,000,000 for each of the fiscal years 2002

16 through 2006.

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

18 other authorizations of appropriations that are available

19 for carrying out the purposes described in this Act and

20 that are established for the Department of Defense, there

21 are authorized to be appropriated to the Secretary of De22 fense for such purposes $6,000,000 for each of the fiscal

23 years 2002 through 2006.

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

25 other authorizations of appropriations that are available

26 for carrying out the purposes described in this Act and
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1 that are established for the Department of Agriculture,

2 there are authorized to be appropriated to the Secretary

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

4 the fiscal years 2002 through 2006.

5 (e) DEPARTMENT OF INTERIOR.—In addition to

6 other authorizations of appropriations that are available

7 for carrying out the purposes described in this Act and

8 that are established for the Department of the Interior,

9 there are authorized to be appropriated to the Secretary

10 of the Interior for such purposes $1,500,000 million for

11 each of the fiscal years 2002 through 2006.

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