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H.R. 3411 (109th): Robin Danielson Act

The text of the bill below is as of Jul 22, 2005 (Introduced). The bill was not enacted into law.



1st Session

H. R. 3411


July 22, 2005

(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


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.


Short title

This Act may be cited as the Robin Danielson Act.


Research regarding risks posed by dioxin, synthetic fibers, and other additives in feminine hygiene products



The Congress finds as follows:


Tampons are used by approximately 73,000,000 women in the United States today, and the average woman may use as many as 16,800 tampons in her lifetime. A woman on estrogen replacement therapy may use as many as 24,360 tampons in her lifetime.


The Environmental Protection Agency and the International Agency for Research on Cancer, an arm of the World Health Organization, have concluded that dioxins are a probable human carcinogen (cancer causing agent).


Dioxin is a byproduct of chlorine-bleaching processes used in the manufacture of paper products, including tampons, sanitary pads, panty liners, and diapers.


While bleaching processes that do not produce dioxin in any amount are available, most pulp and paper manufacturers, which produce the raw materials used in tampons, currently use either elemental-chlorine or chlorine-dioxide bleaching processes. Both of these bleaching processes use chlorine and therefore produce dioxin.


The effects of dioxin from various sources are cumulative and can be measured 20 to 30 years after exposure. Women may be exposed to dioxin in tampons and other menstrual products for as long as 60 years over the course of their reproductive lives.


Internal documents of the Food and Drug Administration suggest the agency has not adequately investigated the danger of dioxin in tampons, according to a 1992 staff report of a subcommittee of the Committee on Government Operations of the House of Representatives.


The Food and Drug Administration has historically relied on data provided by manufacturers of feminine hygiene products in determining product safety.


Although the Food and Drug Administration currently requires tampon manufacturers to monitor dioxin levels in their finished products, the information is not readily available to the public.


Recent studies have produced conflicting information about the link between dioxin exposure and increased risks for endometriosis.


The Environmental Protection Agency has concluded that people with high levels of exposure to dioxins may be at risk for other noncancer effects that could suppress the immune system, increase the risk of pelvic inflammatory disease, reduce fertility, and interfere with fetal and childhood development.


An independent study in 1991 found that tampons commonly included one or more of the following additives: Chlorine compounds, absorbency enhancers (such as surfactants like polysorbate-20), natural and synthetic fibers (such as cotton, rayon, polyester, and polyacrylate), deodorant, and fragrance.


Toxic Shock Syndrome (TSS) has been linked to tampon use and the absorbency of the tampon. TSS is a rare bacterial illness that occurs mostly in menstruating women. During 1979 and 1980, the syndrome was responsible for at least 55 deaths and 1,066 nonfatal cases.


In response to a 1988 lawsuit, the Food and Drug Administration has required tampons to be labeled with reference to an absorbency standard (e.g., super tampons must absorb between 9 and 12 grams of liquid).


Independent research has shown that synthetic fiber additives in tampons amplify toxin production, which is associated with toxic shock syndrome.


National Institutes of Health; research on dioxin pursuant to Office of Research on Women’s Health

Part F of title IV of the Public Health Service Act (42 U.S.C. 287d et seq.) is amended by adding at the end the following section:


Certain projects regarding women’s health


Dioxin in feminine hygiene products


In general

The Director of NIH, in collaboration with the Director of the Office, shall provide for the conduct or support of research to determine the extent to which the presence of dioxin, synthetic fibers, and other additives in tampons and other feminine hygiene products—


poses any risks to the health of women who use the products, including risks relating to cervical cancer, endometriosis, infertility, ovarian cancer, breast cancer, immune system deficiencies, pelvic inflammatory disease, and toxic shock syndrome; and


poses any risks to the health of children of women who used such products during or before the pregnancies involved, including risks relating to fetal and childhood development.


Requirement regarding data from manufacturers

Research under paragraph (1) shall include research to confirm the data on tampons and other feminine hygiene products submitted to the Commissioner of Food and Drugs by manufacturers of such products.



For purposes of paragraph (1), the term feminine hygiene products means tampons, pads, liners, and similar products used by women with respect to menstruation or other genital-tract secretions.



Reports on the results of research under subsection (a) shall be periodically submitted to the Congress, the Commissioner of Food and Drugs, the Administrator of the Environmental Protection Agency, and the Chairman of the Consumer Product Safety Commission. Such reports shall be made available to the public through the data system and clearinghouse program established under section 486A, or through other appropriate means.



Collection and analysis of data on toxic shock syndrome



The Congress finds as follows:


Of the cases of toxic shock syndrome in the United States, approximately 50 percent are related to tampon use and approximately 50 percent occur in nonmenstruating women and in men and children.


The Centers for Disease Control and Prevention (CDC) believes that women are at increased risk for developing toxic shock syndrome due to a false sense of security that there is no longer any risk for developing the disease.


The CDC has estimated that each year such syndrome strikes more than 1,300 individuals. Among women in the age group 12 through 44 who use tampons or barrier contraceptives, between one and two of every 100,000 will develop the syndrome.


Epidemiological data on cases of toxic shock syndrome are not systematically collected in the United States, and information on cases seldom travels beyond the victim’s circle of family and friends.


The CDC and the States should cooperate to collect and analyze such data. Increasing the amount of information on toxic shock syndrome will lead to increased awareness about the disease in the medical community, and may also lead to an increased understanding of the causes of the syndrome.


Centers for Disease Control and Prevention; establishment of program for collection and analysis of data on toxic shock syndrome

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317S the following section:


Collection and analysis of data on toxic shock syndrome


In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to collect, analyze, and make available data on toxic shock syndrome, including data on the causes of such syndrome.


National incidence and prevalence

In carrying out the program under subsection (a), the Secretary shall to the extent practicable determine the national incidence and prevalence of toxic shock syndrome.


Cooperation with States

The Secretary may carry out the program under subsection (a) directly and through grants to States and local health departments.


Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.