I 112th CONGRESS 2d Session H. R. 6601 IN THE HOUSE OF REPRESENTATIVES November 16, 2012 Mr. Deutch (for himself and Mrs. Myrick) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 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 programs in the executive branch to permit the labeling of certain products that do not contain any carcinogens as Carcinogen-Free, and for other purposes.

1.

Short title

This Act may be cited as the Carcinogen-Free Label Act of 2012.

2.

Findings and purpose

(a)

Findings

Congress finds the following: (1)Approximately 1.5 million Americans, including children, are diagnosed with cancer annually. (2)Over 500,000 Americans die from cancer every year. (3)Less than 5 percent of all cancers are caused by genetic factors. (4)Cancer is the top cause of disease-related death for American children and adolescents. (5)Children are more vulnerable to environmental carcinogens than adults. (6)Reducing exposure to carcinogens reduces risk of cancer. (7)The average consumer currently lacks the ability to easily identify products that do not contain carcinogens. (8)Consumers benefit from additional information about the potential health impact of products they use. (9)When comparing products to purchase for their families, many consumers use potential health impact as a determining factor. (10)The 2008–2009 Annual Report of the President’s Cancer Panel urges action to prevent environmental and occupational exposure to carcinogens. (b)

Purpose

The purpose of this Act is to enable consumers to reduce their exposure to carcinogens by allowing manufacturers to affix a Carcinogen-Free label to products that do not contain known or probable carcinogens through a voluntary process that does not require public disclosure of trade secrets.

3.

Carcinogen-Free labels

(a)

In general

The head of each Federal department or agency that regulates a covered product shall establish in that department or agency a program to permit the labeling of covered products that do not contain any carcinogens as Carcinogen-Free. (b)

Development of label

The heads of each Federal department or agency that regulates a covered product shall coordinate to develop an easily recognizable label to be affixed to a covered product to signify that the product has been approved for labeling as Carcinogen-Free. Such label shall include the following notice: This product does not contain known or likely carcinogens that increase your risk of cancer.. (c)

Premarket approval of label

(1)

In general

It shall be unlawful to introduce or offer for introduction into interstate commerce a covered product affixed with a Carcinogen-Free label described under subsection (b)— (A)if the head of each Federal department or agency that regulates the product has not approved an application submitted under paragraph (2) for the labeling of the product as Carcinogen-Free; or (B)if the product contains any substance that is not listed in such application. (2)

Application

Any person may submit an application for the labeling of a covered product as Carcinogen-Free. Such application shall include a list of all the substances contained within the product, and shall be accompanied by a sample of the product. (3)

Criteria for approval

The head of each Federal department or agency to which an application is submitted under paragraph (2) shall approve the application if such head determines that— (A)the application accurately lists all substances contained in the product; (B)the product does not contain any carcinogens; (C)the product does not contain any substances that display carcinogenicity upon degradation, upon interactions with other substances contained within the product or exposed to the product, during storage or transportation, or during intended use of the product, as determined by such head based on previous findings made by such department or agency; and (D)the applicant has demonstrated a plan to comply with guidance issued under subsection (e) relating to manufacture, storage, and transportation. (4)

Confidentiality of information

Any information provided to the head of a Federal department or agency under paragraph (2)— (A)shall be kept confidential by such department or agency, and shall be treated as trade secrets or confidential information for purposes of section 552(b)(4) of title 5, United States Code, and section 1905 of title 18, United States Code; (B)may not be used for any purpose other than approval of an application under this subsection; and (C)may not be made public except with the prior written consent of the applicant. Submission of an application under paragraph (2) does not constitute disclosure of trade secrets by the applicant or public disclosure for the determination of patentability, and any information contained in an application may not be used as prior art to a claimed invention.(5)

Label integrity

The head of each agency to which applications are submitted under paragraph (2) shall— (A)conduct random testing of covered products for which applications are submitted for approval under such paragraph to ensure that the applications accurately list all the substances contained in such products; (B)conduct random audits of facilities in which such covered products are manufactured; and (C)take reasonable measures to ensure compliance with agency guidance issued under subsection (e) relating to manufacture, storage, and transportation of such covered products. (6)

Fees

The head of each Federal department or agency may charge a reasonable fee for the submission and approval of an application under paragraph (2). The amount of such fee shall be the amount necessary to result in an estimated total revenue from all such fees received by the department or agency that is equal to the estimated total cost of the program established by the department or agency under subparagraph (a). (d)

Penalty for violations

In addition to any other penalty authorized by law, any person who knowingly violates subparagraph (A) or (B) of subsection (c)(1) shall be subject to a civil penalty of not more than $100,000. (e)

Guidance To prevent indirect introduction of carcinogens

The head of each Federal department or agency that regulates a covered product shall issue guidance to prevent the introduction of carcinogens into such covered product during the manufacture, storage, and transportation of such covered product. (f)

National list

The head of each Federal department or agency that regulates a covered product shall each post on the public website of that department or agency a list of all covered products regulated by that department or agency that have been approved for labeling as Carcinogen-Free. (g)

Definitions

In this section: (1)

Carcinogen

The term carcinogen means any of the following: (A)A substance listed in the National Toxicology Program Report on Carcinogens as known to be a human carcinogen or reasonably anticipated to be a human carcinogen. (B)A substance described in the Environmental Protection Agency Integrated Risk Information System as carcinogenic to humans or likely to be carcinogenic to humans. (2)

Covered product

The term covered product means any product offered for sale that— (A)is regulated by the Food and Drug Administration, the Environmental Protection Agency, the Department of Agriculture, or the Consumer Product Safety Commission; and (B)is intended for individual or residential use.