I 

109TH CONGRESS 

1ST SESSION H. R. 3411 

To amend the Public Health Service Act to establish a program of research 

regarding the risks posed by the presence of dioxin, synthetic fibers, 

and other additives in feminine hygiene products, and to establish a 

program for the collection and analysis of data on toxic shock syndrome. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 22, 2005 

Mrs. MALONEY (for herself, Mr. GUTIERREZ, Mr. WAXMAN, Mr. MCNULTY, 

Mr. SANDERS, Mrs. CHRISTENSEN, Ms. JACKSON-LEE of Texas, Mr. 

ABERCROMBIE, and Ms. WOOLSEY) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to establish a program of research regarding the risks posed by the presence of dioxin, synthetic fibers, and other additives in 

feminine hygiene products, and to establish a program 

for the collection and analysis of data on toxic shock 

syndrome. 

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 ‘‘Robin Danielson Act’’. 
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1 TITLE I—RESEARCH REGARDING 

2 RISKS POSED BY DIOXIN, SYN3 THETIC FIBERS, AND OTHER 

4 ADDITIVES IN FEMININE HY5 GIENE PRODUCTS 

6 SEC. 101. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Tampons are used by approximately 

9 73,000,000 women in the United States today, and 

10 the average woman may use as many as 16,800 

11 tampons in her lifetime. A woman on estrogen re12 placement therapy may use as many as 24,360 tam13 pons in her lifetime. 

14 (2) The Environmental Protection Agency and 

15 the International Agency for Research on Cancer, an 

16 arm of the World Health Organization, have con17 cluded that dioxins are a probable human carcinogen 

18 (cancer causing agent). 

19 (3) Dioxin is a byproduct of chlorine-bleaching 

20 processes used in the manufacture of paper prod21 ucts, including tampons, sanitary pads, panty liners, 

22 and diapers. 

23 (4) While bleaching processes that do not 

24 produce dioxin in any amount are available, most 

25 pulp and paper manufacturers, which produce the 
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1 raw materials used in tampons, currently use either 

2 elemental-chlorine or chlorine-dioxide bleaching proc3 esses. Both of these bleaching processes use chlorine 

4 and therefore produce dioxin. 

5 (5) The effects of dioxin from various sources 

6 are cumulative and can be measured 20 to 30 years 

7 after exposure. Women may be exposed to dioxin in 

8 tampons and other menstrual products for as long 

9 as 60 years over the course of their reproductive 

10 lives. 

11 (6) Internal documents of the Food and Drug 

12 Administration suggest the agency has not ade13 quately investigated the danger of dioxin in tam14 pons, according to a 1992 staff report of a sub15 committee of the Committee on Government Oper16 ations of the House of Representatives. 

17 (7) The Food and Drug Administration has his18 torically relied on data provided by manufacturers of 

19 feminine hygiene products in determining product 

20 safety. 

21 (8) Although the Food and Drug Administra22 tion currently requires tampon manufacturers to 

23 monitor dioxin levels in their finished products, the 

24 information is not readily available to the public. 
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1 (9) Recent studies have produced conflicting in2 formation about the link between dioxin exposure 

3 and increased risks for endometriosis. 

4 (10) The Environmental Protection Agency has 

5 concluded that people with high levels of exposure to 

6 dioxins may be at risk for other noncancer effects 

7 that could suppress the immune system, increase the 

8 risk of pelvic inflammatory disease, reduce fertility, 

9 and interfere with fetal and childhood development. 

10 (11) An independent study in 1991 found that 

11 tampons commonly included one or more of the fol12 lowing additives: Chlorine compounds, absorbency 

13 enhancers (such as surfactants like polysorbate-20), 

14 natural and synthetic fibers (such as cotton, rayon, 

15 polyester, and polyacrylate), deodorant, and fra16 grance. 

17 (12) Toxic Shock Syndrome (TSS) has been 

18 linked to tampon use and the absorbency of the tam19 pon. TSS is a rare bacterial illness that occurs most20 ly in menstruating women. During 1979 and 1980, 

21 the syndrome was responsible for at least 55 deaths 

22 and 1,066 nonfatal cases. 

23 (13) In response to a 1988 lawsuit, the Food 

24 and Drug Administration has required tampons to 

25 be labeled with reference to an absorbency standard 
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1 (e.g., super tampons must absorb between 9 and 12 

2 grams of liquid). 

3 (14) Independent research has shown that syn4 thetic fiber additives in tampons amplify toxin pro5 duction, which is associated with toxic shock syn6 drome. 

7 SEC. 102. NATIONAL INSTITUTES OF HEALTH; RESEARCH 

8 ON DIOXIN PURSUANT TO OFFICE OF RE9 SEARCH ON WOMEN’S HEALTH. 

10 Part F of title IV of the Public Health Service Act 

11 (42 U.S.C. 287d et seq.) is amended by adding at the end 

12 the following section: 

13 ‘‘SEC. 486C. CERTAIN PROJECTS REGARDING WOMEN’S 

14 HEALTH. 

15 ‘‘(a) DIOXIN IN FEMININE HYGIENE PRODUCTS.— 

16 ‘‘(1) IN GENERAL.—The Director of NIH, in 

17 collaboration with the Director of the Office, shall 

18 provide for the conduct or support of research to de19 termine the extent to which the presence of dioxin, 

20 synthetic fibers, and other additives in tampons and 

21 other feminine hygiene products— 

22 ‘‘(A) poses any risks to the health of 

23 women who use the products, including risks re24 lating to cervical cancer, endometriosis, infer25 tility, ovarian cancer, breast cancer, immune 
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1 system deficiencies, pelvic inflammatory disease, 

2 and toxic shock syndrome; and 

3 ‘‘(B) poses any risks to the health of chil4 dren of women who used such products during 

5 or before the pregnancies involved, including 

6 risks relating to fetal and childhood develop7 ment. 

8 ‘‘(2) REQUIREMENT REGARDING DATA FROM

9 MANUFACTURERS.—Research under paragraph (1) 

10 shall include research to confirm the data on tam11 pons and other feminine hygiene products submitted 

12 to the Commissioner of Food and Drugs by manu13 facturers of such products. 

14 ‘‘(3) DEFINITION.—For purposes of paragraph 

15 (1), the term ‘feminine hygiene products’ means 

16 tampons, pads, liners, and similar products used by 

17 women with respect to menstruation or other gen18 ital-tract secretions. 

19 ‘‘(b) REPORTS.—Reports on the results of research 

20 under subsection (a) shall be periodically submitted to the 

21 Congress, the Commissioner of Food and Drugs, the Ad22 ministrator of the Environmental Protection Agency, and 

23 the Chairman of the Consumer Product Safety Commis24 sion. Such reports shall be made available to the public 

25 through the data system and clearinghouse program es-
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1 tablished under section 486A, or through other appro2 priate means.’’. 

3 TITLE II—COLLECTION AND 

4 ANALYSIS OF DATA ON TOXIC 

5 SHOCK SYNDROME 

6 SEC. 201. FINDINGS. 

7 The Congress finds as follows: 

8 (1) Of the cases of toxic shock syndrome in the 

9 United States, approximately 50 percent are related 

10 to tampon use and approximately 50 percent occur 

11 in nonmenstruating women and in men and children. 

12 (2) The Centers for Disease Control and Pre13 vention (CDC) believes that women are at increased 

14 risk for developing toxic shock syndrome due to a 

15 false sense of security that there is no longer any 

16 risk for developing the disease. 

17 (3) The CDC has estimated that each year such 

18 syndrome strikes more than 1,300 individuals. 

19 Among women in the age group 12 through 44 who 

20 use tampons or barrier contraceptives, between one 

21 and two of every 100,000 will develop the syndrome. 

22 (4) Epidemiological data on cases of toxic shock 

23 syndrome are not systematically collected in the 

24 United States, and information on cases seldom 
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1 travels beyond the victim’s circle of family and 

2 friends. 

3 (5) The CDC and the States should cooperate 

4 to collect and analyze such data. Increasing the 

5 amount of information on toxic shock syndrome will 

6 lead to increased awareness about the disease in the 

7 medical community, and may also lead to an in8 creased understanding of the causes of the syn9 drome. 

10 SEC. 202. CENTERS FOR DISEASE CONTROL AND PREVEN11 TION; ESTABLISHMENT OF PROGRAM FOR 

12 COLLECTION AND ANALYSIS OF DATA ON 

13 TOXIC SHOCK SYNDROME. 

14 Part B of title III of the Public Health Service Act 

15 (42 U.S.C. 243 et seq.) is amended by inserting after sec16 tion 317S the following section: 

17 ‘‘SEC. 317T. COLLECTION AND ANALYSIS OF DATA ON TOXIC 

18 SHOCK SYNDROME. 

19 ‘‘(a) IN GENERAL.—The Secretary, acting through 

20 the Director of the Centers for Disease Control and Pre21 vention, shall carry out a program to collect, analyze, and 

22 make available data on toxic shock syndrome, including 

23 data on the causes of such syndrome. 

24 ‘‘(b) NATIONAL INCIDENCE AND PREVALENCE.—In 

25 carrying out the program under subsection (a), the Sec-
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1 retary shall to the extent practicable determine the na2 tional incidence and prevalence of toxic shock syndrome. 

3 ‘‘(c) COOPERATION WITH STATES.—The Secretary 

4 may carry out the program under subsection (a) directly 

5 and through grants to States and local health depart6 ments. 

7 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 

8 purpose of carrying out this section, there are authorized 

9 to be appropriated such sums as may be necessary for 

10 each of the fiscal years 2006 through 2010.’’. 

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