I 

112TH CONGRESS 

1ST SESSION H. R. 2332 

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 

JUNE 23, 2011 

Mrs. MALONEY (for herself, Mr. FARR, and Mr. CONYERS) 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’’. 


emcdonald on DSK2BSOYB1PROD with BILLS
2 

•HR 2332 IH

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) According to the Food and Drug Adminis20 tration, dioxins are formed as a result of combustion 

21 processes such as commercial and municipal waste 

22 incineration and from burning fuels (like wood, coal, 

23 or oil). Dioxins are a byproduct of chlorine bleaching 

24 of pulp and paper. 


emcdonald on DSK2BSOYB1PROD with BILLS
3 

•HR 2332 IH

1 (4) Tampons currently sold in the United 

2 States are composed of cotton, rayon, or of a com3 bination of cotton and rayon. Rayon is produced 

4 from cellulose fibers derived from bleached wood 

5 pulp. 

6 (5) While bleaching processes that do not 

7 produce dioxin in any amount are available, most 

8 wood pulp manufacturers currently use elemental9 chlorine free bleaching processes. This process uses 

10 chlorine dioxide as a bleaching agent and still pro11 duces dioxins. 

12 (6) The Food and Drug Administration has not 

13 explicitly forbidden the use of chlorine in tampon 

14 manufacturing. 

15 (7) Trace amounts of dioxins can also be found 

16 in tampons that use a chlorine-free bleaching proc17 ess as well as 100 percent cotton tampons as the 

18 Environmental Protection Agency states that due to 

19 decades of pollution, dioxin can be found in the air, 

20 water, and ground and thus can be found in both 

21 cotton and wood pulp raw materials used in tampon 

22 production. 

23 (8) The effects of dioxin from various sources 

24 are cumulative. Women may be exposed to dioxin in 

25 tampons and other menstrual products for as long 


emcdonald on DSK2BSOYB1PROD with BILLS
4 

•HR 2332 IH

1 as 60 years over the course of their reproductive 

2 lives. 

3 (9) The Food and Drug Administration has his4 torically relied on data provided by manufacturers of 

5 feminine hygiene products in determining product 

6 safety. 

7 (10) Although the Food and Drug Administra8 tion currently requires tampon manufacturers to 

9 monitor dioxin levels in their finished products, they 

10 do not generally collect this information and it is not 

11 readily available to the public. 

12 (11) Recent studies have produced conflicting 

13 information about the link between dioxin exposure 

14 and increased risks for endometriosis. 

15 (12) The Environmental Protection Agency has 

16 concluded that people with high levels of exposure to 

17 dioxins may be at risk for other noncancer effects 

18 that could suppress the immune system, increase the 

19 risk of pelvic inflammatory disease, reduce fertility, 

20 and interfere with fetal and childhood development. 

21 (13) Toxic Shock Syndrome (TSS) has been 

22 linked to tampon use especially those tampons con23 taining synthetic fibers and the absorbency of the 

24 tampon. TSS is a rare bacterial illness that occurs 

25 mostly in menstruating women. During 1979 and 


emcdonald on DSK2BSOYB1PROD with BILLS
5 

•HR 2332 IH

1 1980, the syndrome was responsible for at least 55 

2 deaths and 1,066 nonfatal cases. 

3 (14) In response to a 1988 lawsuit, the Food 

4 and Drug Administration has required tampons to 

5 be labeled with reference to an absorbency standard 

6 (e.g., super tampons must absorb between 9 and 12 

7 grams of liquid). 

8 (15) As a result of independent research that 

9 showed that synthetic fiber additives in tampons am10 plify toxin production, which is associated with toxic 

11 shock syndrome, manufacturers have ceased to in12 clude three of the four synthetic ingredients once 

13 often used to increase tampon absorbency. Highly 

14 absorbent viscose rayon is still used in tampon pro15 duction. According to some TSS researchers inci16 dence of menstrually related TSS is creeping up and 

17 strains of Staphylococcus aureus causing it are be18 coming more antibiotic resistant and more virulent. 

19 SEC. 102. NATIONAL INSTITUTES OF HEALTH; RESEARCH 

20 ON DIOXIN PURSUANT TO OFFICE OF RE21 SEARCH ON WOMEN’S HEALTH. 

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

23 (42 U.S.C. 287d et seq.) is amended by adding at the end 

24 the following section: 


emcdonald on DSK2BSOYB1PROD with BILLS
6 

•HR 2332 IH

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

2 HEALTH. 

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

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

5 collaboration with the Director of the Office, shall 

6 provide for the conduct or support of research to de7 termine the extent to which the presence of dioxin, 

8 synthetic fibers, and other additives in tampons and 

9 other feminine hygiene products— 

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

11 women who use the products, including risks re12 lating to cervical cancer, endometriosis, infer13 tility, ovarian cancer, breast cancer, immune 

14 system deficiencies, pelvic inflammatory disease, 

15 and toxic shock syndrome; and 

16 ‘‘(B) poses any risks to the health of chil17 dren of women who used such products during 

18 or before the pregnancies involved, including 

19 risks relating to fetal and childhood develop20 ment. 

21 ‘‘(2) REQUIREMENT REGARDING DATA FROM

22 MANUFACTURERS.—Research under paragraph (1) 

23 shall include research to confirm the data on tam24 pons and other feminine hygiene products submitted 

25 to the Commissioner of Food and Drugs by manu26 facturers of such products. 


emcdonald on DSK2BSOYB1PROD with BILLS
7 

•HR 2332 IH

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

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

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

4 women with respect to menstruation or other gen5 ital-tract secretions. 

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

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

8 Congress, the Commissioner of Food and Drugs, the Ad9 ministrator of the Environmental Protection Agency, and 

10 the Chairman of the Consumer Product Safety Commis11 sion. Such reports shall be made available to the public 

12 through the data system and clearinghouse program es13 tablished under section 486A, or through other appro14 priate means.’’. 

15 TITLE II—COLLECTION AND 

16 ANALYSIS OF DATA ON TOXIC 

17 SHOCK SYNDROME 

18 SEC. 201. FINDINGS. 

19 The Congress finds as follows: 

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

21 United States, approximately 50 percent are related 

22 to tampon use and approximately 50 percent occur 

23 in nonmenstruating women and in men and children. 

24 (2) The Centers for Disease Prevention and 

25 Control has estimated that between one and two of 


emcdonald on DSK2BSOYB1PROD with BILLS
8 

•HR 2332 IH

1 every 100,000 women 15 to 44 years of age will de2 velop the syndrome. 

3 (3) Epidemiological data on cases of toxic shock 

4 syndrome are not systematically collected in the 

5 United States, and information on cases seldom 

6 travels beyond the victim’s circle of family and 

7 friends. Toxic Shock Syndrome is a nationally 

8 notifiable disease that States report to the Centers 

9 for Disease Prevention and Control, but the report10 ing by the States is voluntary. 

11 (4) According to the Council of State and Ter12 ritorial Epidemiologists, as of 2006, only 39 States 

13 required reporting of streptococcal and non-strepto14 coccal toxic shock syndrome to State health officials. 

15 (5) The last active surveillance of toxic shock 

16 syndrome occurred in 1987 only in four States and 

17 surveying 12 million people. National surveillance is 

18 conducted through the National Electronic Tele19 communications Systems. 

20 (6) The Centers for Disease Prevention and 

21 Control and the States should cooperate to collect 

22 and analyze such data. Increasing the amount of in23 formation on toxic shock syndrome will lead to in24 creased awareness about the disease in the medical 


emcdonald on DSK2BSOYB1PROD with BILLS
9 

•HR 2332 IH

1 community, and may also lead to an increased un2 derstanding of the causes of the syndrome. 

3 SEC. 202. CENTERS FOR DISEASE CONTROL AND PREVEN4 TION; ESTABLISHMENT OF PROGRAM FOR 

5 COLLECTION AND ANALYSIS OF DATA ON 

6 TOXIC SHOCK SYNDROME. 

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

8 (42 U.S.C. 243 et seq.) is amended by inserting after sec9 tion 317T the following section: 

10 ‘‘SEC. 317U. COLLECTION AND ANALYSIS OF DATA ON 

11 TOXIC SHOCK SYNDROME. 

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

13 the Director of the Centers for Disease Control and Pre14 vention, shall carry out a program to collect, analyze, and 

15 make available data on toxic shock syndrome, including 

16 data on the causes of such syndrome. 

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

18 carrying out the program under subsection (a), the Sec19 retary shall to the extent practicable determine the na20 tional incidence and prevalence of toxic shock syndrome. 

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

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

23 and through grants to States and local health depart24 ments. 


emcdonald on DSK2BSOYB1PROD with BILLS
10 

•HR 2332 IH

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

2 purpose of carrying out this section, there are authorized 

3 to be appropriated such sums as may be necessary for 

4 each of the fiscal years 2012 through 2016.’’. 

Æ 


emcdonald on DSK2BSOYB1PROD with BILLS