		I
		111th CONGRESS
		2d Session
		H. R. 5578
		IN THE HOUSE OF REPRESENTATIVES

			June 23, 2010
			Mr. Kucinich (for
			 himself, Mr. DeFazio,
			 Mr. Frank of Massachusetts,
			 Mr. Grijalva,
			 Mr. Stark, and
			 Ms. Woolsey) introduced the following
			 bill; which was referred to the Committee
			 on Agriculture, and in addition to the Committee on
			 Energy and Commerce, 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 prohibit the open-air cultivation of genetically
		  engineered pharmaceutical and industrial crops, to prohibit the use of common
		  human food or animal feed as the host plant for a genetically engineered
		  pharmaceutical or industrial chemical, to establish a tracking system to
		  regulate the growing, handling, transportation, and disposal of pharmaceutical
		  and industrial crops and their byproducts to prevent human, animal, and general
		  environmental exposure to genetically engineered pharmaceutical and industrial
		  crops and their byproducts, to amend the Federal Food, Drug, and Cosmetic Act
		  with respect to the safety of genetically engineered foods, and for other
		  purposes.

		1.Short title; table of
			 contents
			(a)Short
			 titleThis Act may be cited as the Genetically Engineered Safety
			 Act.
			(b)Table of
			 contentsThe table of contents for this Act is as follows:

					Sec. 1. Short title; table of contents.
					Title I—Genetically engineered pharmaceutical and industrial crop
				safety
					Sec. 101. Short title.
					Sec. 102. Findings.
					Sec. 103. Definitions.
					Sec. 104. Regulation of production of pharmaceutical crops and
				industrial crops.
					Sec. 105. Civil penalties for violation.
					Sec. 106. Report to Congress on alternative methods to produce
				pharmaceutical and industrial crops.
					Title II—Genetically engineered food safety
					Sec. 201. Short title.
					Sec. 202. Findings.
					Sec. 203. Federal determination of safety of genetically
				engineered food; regulation as food additive.
					Sec. 204. User fees regarding determination of safety of
				genetic food additives.
					Sec. 205. Embargo authority.
					Sec. 206. Rulemaking; effective date; previously unregulated
				marketed additives.

			IGenetically
			 engineered pharmaceutical and industrial crop safety
			101.Short
			 titleThis title may be cited
			 as the Genetically Engineered Pharmaceutical and Industrial Crop Safety
			 Act of 2010.
			102.FindingsCongress finds the following:
				(1)A
			 pharmaceutical crop or industrial crop is a plant that has been genetically
			 engineered to produce a medical or industrial product, including a human or
			 veterinary drug, biologic, industrial, or research chemical, or enzyme.
				(2)The Department of
			 Agriculture has issued split approval permits to allow the
			 cultivation of 10 food crops genetically engineered to produce
			 biopharmaceuticals or chemicals that are not approved for human consumption. As
			 of January 1, 2003, more than 300 field trials have been conducted in the
			 United States. In nearly 70 percent of these tests, corn has been the crop
			 used, but other crops tested include soybean, tobacco, rice, alfalfa, barley,
			 rapeseed (canola), wheat, tomato, safflower, and sugercane.
				(3)Many of the novel
			 substances produced in pharmaceutical crops and industrial crops exhibit high
			 levels of biological activity and are intended to be used for particular
			 medical or industrial purposes, under very controlled circumstances. None of
			 these substances is intended to be incorporated in food or to be spread into
			 the environment.
				(4)The magnitude of
			 the risks posed by pharmaceutical crops and industrial crops depends on many
			 factors, including the chemicals involved, the organisms or environments
			 exposed, and the level and duration of the exposure. Humans, animals, and the
			 environment at large could be at risk from contamination, a major concern of
			 which is that bioactive nonfood substances, which have not been tested, will
			 contaminate or otherwise adversely affect the food supply. Substances intended
			 for use as human drugs are especially problematic because they are intended to
			 be biologically active in people.
				(5)Pharmaceutical
			 crops and industrial crops also pose substantial liability and other economic
			 risks to farmers, grain handlers, food companies, and other persons in the food
			 and feed supply chain. These risks include liability for contamination
			 episodes, costly food recalls, losses in export markets, reduced prices for a
			 contaminated food or feed crop, and loss of confidence in the safety of the
			 American food supply among foreign importers and consumers of American
			 agricultural commodities.
				(6)These risks
			 necessitate a zero tolerance standard for the presence of pharmaceutical crops
			 and industrial crops and their byproducts in crops used to produce human food
			 or animal feed.
				(7)While there
			 presently exists a pro forma zero tolerance standard, the Department of
			 Agriculture and experts in the field acknowledge that contamination of human
			 food and animal feed is inevitable due to the inherent imprecision of
			 biological and agricultural systems, as well as the laxity of the regulatory
			 regime. This is illustrated, for example, in the Department of Agriculture’s
			 regulations, which aim not for prevention (recognized as unattainable), but
			 rather mitigation of the gene flow that results in contamination of food/feed
			 crops with these substances. Some experts in the field are calling for
			 establishment of tolerances, despite the potential risks involved.
				(8)Therefore,
			 appropriate regulatory controls, as established by this title, are urgently
			 needed to ensure that pharmaceutical crops and industrial crops and their
			 byproducts do not enter human food or animal feed crops at any level.
				103.DefinitionsIn this title:
				(1)The term
			 genetically engineered plant means a plant that contains a
			 genetically engineered material or was produced from a genetically engineered
			 seed. A plant shall be considered to contain a genetically engineered material
			 if the plant has been injected or otherwise treated with a genetically
			 engineered material (except that the use of manure as a fertilizer for the
			 plant may not be construed to mean that the plant is produced with a
			 genetically engineered material).
				(2)The term
			 genetically engineered material means material that has been
			 altered at the molecular or cellular level by means that are not possible under
			 natural conditions or processes (including recombinant DNA and RNA techniques,
			 cell fusion, microencapsulation, macroencapsulation, gene deletion and
			 doubling, introducing a foreign gene, and changing the positions of genes),
			 other than a means consisting exclusively of breeding, conjugation,
			 fermentation, hybridization, in vitro fertilization, tissue culture, or
			 mutagenesis.
				(3)The term
			 genetically engineered seed means a seed that contains a
			 genetically engineered material or was produced with a genetically engineered
			 material. A seed shall be considered to contain a genetically engineered
			 material or to have been produced with a genetically engineered material if the
			 seed (or the plant from which the seed is derived) has been injected or
			 otherwise treated with a genetically engineered material (except that the use
			 of manure as a fertilizer for the plant may not be construed to mean that any
			 resulting seeds are produced with a genetically engineered material).
				(4)The term
			 pharmaceutical crop means a genetically engineered plant that is
			 designed to produce medical products, including human and veterinary drugs and
			 biologics. The term includes a crop intentionally treated with genetically
			 engineered material that, in turn, produces a medical substance.
				(5)The term
			 industrial crop means a genetically engineered plant that is
			 designed to produce industrial products, including industrial and research
			 chemicals and enzymes. The term includes a crop intentionally treated with
			 genetically engineered material that, in turn, produces an industrial
			 substance.
				104.Regulation of
			 production of pharmaceutical crops and industrial crops
				(a)Temporary
			 moratorium pending regulationsNo pharmaceutical crop or
			 industrial crop may be grown, raised, or otherwise cultivated until the final
			 regulations and tracking system required by this section are in effect.
				(b)Prohibition on
			 open-Air cultivationNo person may grow, raise or otherwise
			 cultivate a pharmaceutical crop or industrial crop in an open air
			 environment.
				(c)Prohibition on
			 use of common human foods or animal feedsNo person may grow,
			 raise, or otherwise cultivate a pharmaceutical crop or industrial crop in a
			 food commonly used for human food or domestic animal feed.
				(d)Biotech tracking
			 systemThe United States Department of Agriculture shall
			 establish a tracking system to regulate the growing, handling, transportation,
			 and disposal of all pharmaceutical and industrial crops and their byproducts to
			 prevent contamination.
				(e)RegulationsThe
			 Secretary of Agriculture shall issue regulations—
					(1)to enforce the
			 prohibitions imposed by subsections (b) and (c);
					(2)to designate the
			 common foods whose use as a source of a pharmaceutical crop or industrial crop
			 is prohibited by subsection (c); and
					(3)to establish the
			 tracking system required by subsection (d).
					105.Civil penalties
			 for violation
				(a)Authority To
			 access penaltiesThe Secretary of Agriculture may assess, by
			 written order, a civil penalty against a person that violates a provision of
			 section 105, including a regulation promulgated or order issued under such
			 section. Each violation, and each day during which a violation continues, shall
			 be a separate offense.
				(b)Amount and
			 factors in accessing penaltiesThe maximum amount that may be
			 accessed under this section for a violation may not exceed $1,000,000. In
			 determining the amount of the civil penalty, the Secretary shall take into
			 account—
					(1)the gravity of the
			 violation;
					(2)the degree of
			 culpability;
					(3)the size and type
			 of the business; and
					(4)any history of
			 prior offenses under such section or other laws administered by the
			 Secretary.
					(c)Notice and
			 opportunity for hearingThe Secretary shall not assess a civil
			 penalty under this section against a person unless the company is given notice
			 and opportunity for a hearing on the record before the Secretary in accordance
			 with sections 554 and 556 of title 5, United States Code.
				(d)Judicial
			 review(1)An
			 order assessing a civil penalty against a person under subsection (a) may be
			 reviewed only in accordance with this subsection. The order shall be final and
			 conclusive unless the person—
						(A)not later than 30 days after the
			 effective date of the order, files a petition for judicial review in the United
			 States court of appeals for the circuit in which the person resides or has its
			 principal place of business or in the United States Court of Appeals for the
			 District of Columbia; and
						(B)simultaneously sends a copy of the
			 petition by certified mail to the Secretary.
						(2)The Secretary shall promptly file in
			 the court a certified copy of the record on which the violation was found and
			 the civil penalty assessed.
					(e)Collection
			 action for failure To pay assessmentIf a person fails to pay a
			 civil penalty after the order assessing the civil penalty has become final and
			 unappealable, the Secretary shall refer the matter to the Attorney General, who
			 shall bring a civil action to recover the amount of the civil penalty in United
			 States district court. In the collection action, the validity and
			 appropriateness of the order of the Secretary imposing the civil penalty shall
			 not be subject to review.
				106.Report to
			 Congress on alternative methods to produce pharmaceutical and industrial
			 cropsThe National Academy of
			 Sciences shall submit to Congress a report that explores alternative methods to
			 produce pharmaceuticals or industrial chemicals that have the advantage of
			 being conducted in controlled production facilities and do not present the risk
			 of contamination.
			IIGenetically
			 engineered food safety
			201.Short
			 titleThis title may be cited
			 as the Genetically Engineered Food Safety Act.
			202.FindingsThe Congress finds as follows:
				(1)Genetic
			 engineering is an artificial gene transfer process wholly different from
			 traditional breeding.
				(2)Genetic
			 engineering can be used to produce new versions of virtually all plant and
			 animal foods. Thus, within a short time, the food supply could consist almost
			 entirely of genetically engineered products.
				(3)This conversion
			 from a food supply based on traditionally bred organisms to one based on
			 organisms produced through genetic engineering could be one of the most
			 important changes in our food supply in this century.
				(4)Genetically
			 engineered foods present new issues of safety that have not been adequately
			 studied.
				(5)The Congress has
			 previously required that food additives be analyzed for their safety prior to
			 their placement on the market.
				(6)Adding new genes
			 into a food should be considered adding a food additive, thus requiring an
			 analysis of safety factors.
				(7)Federal agencies
			 have failed to uphold congressional intent of the Food Additives Amendment of
			 1958 by allowing genetically engineered foods to be marketed, sold and
			 otherwise used without requiring pre-market safety testing addressing their
			 unique characteristics.
				(8)The food additive
			 process gives the Food and Drug Administration discretion in applying the
			 safety factors that are generally recognized as appropriate to evaluate the
			 safety of food and food ingredients.
				(9)Given the
			 consensus among the scientific community that genetic engineering can
			 potentially introduce hazards, such as allergens or toxins, genetically
			 engineered foods need to be evaluated on a case-by-case basis and cannot be
			 presumed to be generally recognized as safe.
				203.Federal
			 determination of safety of genetically engineered food; regulation as food
			 additive
				(a)Inclusion in
			 definition of food additiveSection 201 of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 321) is amended—
					(1)in paragraph (s),
			 by adding after and below subparagraph (6) the following sentence:

							Such term
				includes the different genetic constructs, proteins of such constructs,
				vectors, promoters, marker systems, and other appropriate terms that are used
				or created as a result of the creation of a genetically engineered food (as
				defined in paragraph (ss)), other than a genetic construct, protein, vector,
				promoter, or marker system or other appropriate term for which an application
				under section 505 or 512 has been filed. For purposes of this Act, the term
				genetic food additive means a genetic construct, protein, vector,
				promoter, or marker system or other appropriate term that is so
				included.;
				and
					(2)by adding at the
			 end the following:

							(ss)(1)The term
				genetically engineered food means food that contains or was
				produced with a genetically engineered material.
								(2)The term genetically engineered
				material means material derived from any part of a genetically
				engineered organism, without regard to whether the altered molecular or
				cellular characteristics of the organism are detectable in the material.
								(3)The term genetically engineered
				organism means—
									(A)an organism that has been altered at
				the molecular or cellular level by means that are not possible under natural
				conditions or processes (including but not limited to recombinant DNA and RNA
				techniques, cell fusion, microencapsulation, macroencapsulation, gene deletion
				and doubling, introducing a foreign gene, and changing the positions of genes),
				other than a means consisting exclusively of breeding, conjugation,
				fermentation, hybridization, in vitro fertilization, tissue culture, or
				mutagenesis; and
									(B)an organism made through sexual or
				asexual reproduction (or both) involving an organism described in clause (A),
				if possessing any of the altered molecular or cellular characteristics of the
				organism so described.
									(4)For purposes of subparagraph (1), a
				food shall be considered to have been produced with a genetically engineered
				material if the organism from which the food is derived has been injected or
				otherwise treated with a genetically engineered material (except that the use
				of manure as a fertilizer for raw agricultural commodities may not be construed
				to mean that such commodities are produced with a genetically engineered
				material).
								.
					(b)Petition To
			 establish safety
					(1)Data in
			 petitionSection 409(b)(2) of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 348(b)(2)) is amended by adding after and below subparagraph (E) the
			 following sentence:

							In the
				case of a genetic food additive, such reports shall include all data that was
				collected or developed pursuant to the investigations, including data that does
				not support the claim of safety for
				use..
					(2)Notices; public
			 availability of informationSection 409(b)(5) of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 348(b)(5)) is amended—
						(A)by striking
			 (5) and inserting (5)(A); and
						(B)by adding at the
			 end the following subparagraphs:

								(B)In the case of a genetic food
				additive:
									(i)Promptly after providing the notice
				under subparagraph (A), the Secretary shall make available to the public all
				reports and data described in paragraph (2)(E) that are contained in the
				petition involved, and all other information in the petition to the extent that
				the information is relevant to a determination of the safety for use of the
				additive.
									(ii)Such notice shall state whether any
				information in the petition is not being made available to the public because
				the Secretary has made a determination that the information does not relate to
				the safety for use of the additive. Any person may petition the Secretary for a
				reconsideration of such a determination.
									(C)In the case of genetic food
				additives:
									(i)The Secretary shall maintain and make
				available to the public through telecommunications a list of petitions that are
				pending under this subsection and a list of petitions for which regulations
				under subsection (c)(1)(A) have been established. Such list shall include
				information on the additives involved, including the source of the additives,
				and including any information received by the Secretary pursuant to clause
				(ii).
									(ii)If a regulation is in effect under
				subsection (c)(1)(A) for a genetic food additive, any person who manufactures
				such additive for commercial use shall submit to the Secretary a notification
				of any knowledge of data that relate to the adverse health effects of the
				additive, when knowledge is acquired by the person after the date on which the
				regulation took effect. If the manufacturer is in possession of the data, the
				notification shall include the data. The Secretary shall by regulation
				establish the scope of the responsibilities of manufacturers under this clause,
				including such limits on the responsibilities as the Secretary determines to be
				appropriate.
									.
						(3)Effective date
			 of regulation regarding safe use; opportunity for public
			 commentSection 409(c)(2) of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 348(c)(2)) is amended—
						(A)by striking
			 (2) and inserting (2)(A); and
						(B)by adding at the
			 end the following subparagraph:

								(B)(i)In the case of a genetic
				food additive, an order under paragraph (1)(A) may not be issued regarding the
				petition involved before the expiration of the applicable period under clause
				(ii). During such period, and continuing until an order under paragraph (1) is
				issued, the Secretary shall provide interested persons an opportunity to submit
				to the Secretary comments on the petition. In publishing such notice, the
				Secretary shall inform the public of such opportunity.
									(ii)For purposes of clause (i), the
				applicable period under this clause regarding a petition is the 30-day period
				beginning on the date on which the Secretary has under subparagraph (B)(i) of
				subsection (b)(5) made information available to the public regarding the
				petition, except that, if under subparagraph (B)(ii) of such subsection the
				Secretary finds in favor of a person who files for reconsideration (relating to
				a determination by the Secretary that information does not relate to safety),
				such 30-day period is extended by an additional period of 30 days. For purposes
				of the preceding sentence, a discrete 30-day extension applies to each such
				reconsideration for which the Secretary finds in favor of the person filing for
				reconsideration.
									.
						(4)Consideration of
			 certain factorsSection 409(c) of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 348(c)) is amended by adding at the end the following
			 paragraph:

							(6)In the case of a genetic food
				additive, the factors considered by the Secretary regarding safety for use
				shall include (but not be limited to) the results of the following
				analyses:
								(A)Allergenicity effects resulting from
				the added proteins, including proteins not found in the food supply.
								(B)Pleiotropic effects. The Secretary
				shall require tests to determine the potential for such effects (using
				molecular characterization, biochemical characterization, mRNA profiling, or
				other techniques, or as appropriate, combinations of such techniques).
								(C)Appearance of new toxins or increased
				levels of existing toxins.
								(D)Changes in the functional
				characteristics of food.
								(E)Changes in the levels of important
				nutrients.
								(F)Changes in the levels of
				anti-nutrients.
								.
					(5)Certain
			 testsSection 409(c) of the Federal Food, Drug, and Cosmetic Act, as
			 amended by paragraph (4), is amended by adding at the end the following
			 paragraph:

							(7)In the case of genetic food
				additives:
								(A)If a genetic food additive is a
				protein from a commonly or severely allergenic food, the Secretary may not
				establish a regulation under paragraph (1)(A) if the petition under subsection
				(b)(1) fails to include full reports of investigations that used serum or skin
				tests (or other advanced techniques) on a sensitive population to determine
				whether such additive is commonly or severely allergenic.
								(B)(i)If a genetic food
				additive is a protein that has not undergone the investigations described in
				subparagraph (A), the Secretary may not establish a regulation under paragraph
				(1)(A) if the petition under subsection (b)(1) fails to include full reports of
				investigations that used the best available biochemical and physiological
				protocols to evaluate whether it is likely that the protein involved is an
				allergen.
									(ii)For purposes of clause (i), the
				Secretary shall by regulation determine the best available biochemical and
				physiological protocols. In carrying out rulemaking under the preceding
				sentence, the Secretary shall consult with the Director of the National
				Institutes of
				Health.
									.
					(6)Prohibited
			 additivesSection 409(c) of the Federal Food, Drug, and Cosmetic Act, as
			 amended by paragraph (5), is amended by adding at the end the following
			 paragraph:

							(8)In the case of a genetic food
				additive, the Secretary may not establish a regulation under paragraph (1)(A)
				if—
								(A)the additive is a protein and a report
				of an investigation finds that the additive is likely to be commonly or
				severely allergenic;
								(B)the additive is a protein and a report
				of an investigation that uses a protocol described in paragraph (7)(B) fails to
				find with reasonable certainty that the additive is unlikely to be an allergen;
				or
								(C)effective June 1, 2006, a selective
				marker is used with respect to the additive, the selective marker will remain
				in the food involved when the food is marketed, and the selective marker
				inhibits the function of one or more
				antibiotics.
								.
					(7)Additional
			 provisionsSection 409(c) of the Federal Food, Drug, and Cosmetic Act, as
			 amended by paragraph (6), is amended by adding at the end the following
			 paragraph:

							(9)(A)In determining the
				safety for use of genetic food additives, the Secretary may (directly or
				through contract) conduct investigations of such additives for purposes of
				supplementing the information provided to the Secretary pursuant to petitions
				under subsection (b)(1).
								(B)To provide the Congress with a
				periodic independent, external review of the Secretary’s formulation of the
				approval process under paragraph (1)(A) that relates to genetic food additives,
				the Secretary shall enter into an agreement with the Institute of Medicine.
				Such agreement shall provide that, if the Institute of Medicine has any
				concerns regarding the approval process, the Institute of Medicine will submit
				to the Congress a report describing such
				concerns.
								.
					(c)Regulation
			 issued on secretary’s initiativeSection 409(d) of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 348(d)) is amended—
					(1)by striking
			 (d) The Secretary and inserting (d)(1) Subject to
			 paragraph (2), the Secretary; and
					(2)by adding at the
			 end the following paragraph:

							(2)The provisions of subsections (b) and
				(c) that expressly reference genetic food additives apply with respect to a
				regulation proposed by the Secretary under paragraph (1) to the same extent and
				in the same manner as such provisions apply with respect to a petition filed
				under subsection
				(b)(1).
							.
					(d)Civil
			 penaltiesSection 303 of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 333) is amended by adding at the end the following subsection:

						(h)(1)With respect to a
				violation of section 301(a), 301(b), or 301(c) involving the adulteration of
				food by reason of failure to comply with the provisions of section 409 that
				relate to genetic food additives, any person engaging in such a violation shall
				be liable to the United States for a civil penalty in an amount not to exceed
				$100,000 for each such violation.
							(2)Paragraphs (5) through (7) of
				subsection (f) apply with respect to a civil penalty under paragraph (1) of
				this subsection to the same extent and in the same manner as such paragraphs
				(5) through (7) apply with respect to a civil penalty under paragraph (1), (2),
				(3), (4), or (9) of subsection
				(f).
							.
				(e)Citizen
			 suitsChapter III of the Federal
			 Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by
			 adding at the end the following section:

						311.Citizen suits
				regarding genetic food additives
							(a)In
				generalExcept as provided in subsection (c), any person may on
				his or her behalf commence a civil action in an appropriate district court of
				the United States against—
								(1)a person who is
				alleged to have engaged in a violation of section 301(a), 301(b), or 301(c)
				involving the adulteration of food by reason of failing to comply with the
				provisions of section 409 that relate to genetic food additives; or
								(2)the Secretary
				where there is alleged a failure of the Secretary to perform any act or duty
				under section 409 that relates to such additives and is not
				discretionary.
								(b)ReliefIn
				a civil action under subsection (a), the district court involved may, as the
				case may be—
								(1)enforce the
				compliance of a person with the applicable provisions referred to paragraph (1)
				of such subsection; or
								(2)order the
				Secretary to perform an act or duty referred to in paragraph (2) of such
				subsection.
								(c)Limitations
								(1)Notice to
				SecretaryA civil action may not be commenced under subsection
				(a)(1) prior to 60 days after the plaintiff has provided to the Secretary
				notice of the violation involved.
								(2)Relation to
				actions of SecretaryA civil action may not be commenced under
				subsection (a)(2) if the Secretary has commenced and is diligently prosecuting
				a civil or criminal action in a district court of the United States to enforce
				compliance with the applicable provisions referred to in subsection
				(a)(1).
								(d)Right of
				Secretary To interveneIn any civil action under subsection (a),
				the Secretary, if not a party, may intervene as a matter of right.
							(e)Award of costs;
				filing of bondIn a civil action under subsection (a), the
				district court involved may award costs of litigation (including reasonable
				attorney and expert witness fees) to any party whenever the court determines
				such an award is appropriate. The court may, if a temporary restraining order
				or preliminary injunction is sought, require the filing of a bond or equivalent
				security in accordance with the Federal Rules of Civil Procedure.
							(f)Savings
				provisionThis section does not restrict any right that a person
				(or class of persons) may have under any statute or common law to seek
				enforcement of the provisions referred to subsection (a)(1), or to seek any
				other relief (including relief against the
				Secretary).
							.
				(f)Rule of
			 constructionWith respect to section 409 of the
			 Federal Food, Drug, and Cosmetic Act
			 as amended by this section, compliance with the provisions of such section 409
			 that relate to genetic food additives does not constitute an affirmative
			 defense in any cause of action under Federal or State law for personal injury
			 resulting in whole or in part from a genetic food additive.
				204.User fees
			 regarding determination of safety of genetic food additivesChapter IV of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 341 et seq.) is amended by inserting after section 409 the following
			 section:

					409A.User fees
				regarding safety of genetic food additives
						(a)In
				generalIn the case of
				genetic food additives, the Secretary shall in accordance with this section
				assess and collect a fee on each petition that is filed under section
				409(b)(1). The fee shall be collected from the person who submits the petition,
				is due upon submission of the petition, and shall be assessed in an amount
				determined under subsection (c). This section applies as of the first fiscal
				year that begins after the date of promulgation of the final rule required in
				section 206 of the Genetically Engineered Food Safety Act (referred to in this
				section as the first applicable fiscal year).
						(b)Purpose of
				fees
							(1)In
				generalThe purposes of fees under subsection (a) are as
				follows:
								(A)To defray
				increases in the costs of the resources allocated for carrying out section 409
				for the first applicable fiscal year over the costs of carrying out such
				section for the preceding fiscal year, other than increases that are not
				attributable to the responsibilities of the Secretary with respect to genetic
				food additives.
								(B)To provide for a
				program of basic and applied research on the safety of genetic food additives
				(to be carried out by the Commissioner). The program shall address fundamental
				questions and problems that arise repeatedly during the process of reviewing
				petitions under section 409(b)(1) with respect to genetic food additives, and
				shall not directly support the development of new genetically engineered
				foods.
								(2)Allocations by
				SecretaryOf the total fee revenues collected under subsection
				(a) for a fiscal year, the Secretary shall reserve and expend—
								(A)95 percent for the
				purpose described in paragraph (1)(A); and
								(B)5 percent for the
				purpose described in paragraph (1)(B).
								(3)Certain
				provisions regarding increased administrative costsWith respect
				to fees under subsection (a):
								(A)Increases referred
				to in paragraph (1)(A) include the costs of the Secretary in providing for
				investigations under section 409(c)(9)(A).
								(B)Increases referred
				to in paragraph (1)(A) include increases in costs for an additional number of
				full-time equivalent positions in the Department of Health and Human Services
				to be engaged in carrying out section 409 with respect to genetic food
				additives.
								(c)Total fee
				revenues; individual fee amountsThe total fee revenues collected
				under subsection (a) for a fiscal year shall be the amounts appropriated under
				subsection (f)(2) for such fiscal year. Individual fees shall be assessed by
				the Secretary on the basis of an estimate by the Secretary of the amount
				necessary to ensure that the sum of the fees collected for such fiscal year
				equals the amount so appropriated. In assessing the individual fees, the
				Secretary shall by regulation provide for the assessment of reduced fee amounts
				for entities that are small businesses, or nonprofit private entities, as
				defined by the Secretary for purposes of this section.
						(d)Fee waiver or
				reductionThe Secretary shall grant a waiver from or a reduction
				of a fee assessed under subsection (a) if the Secretary finds that the fee to
				be paid will exceed the anticipated present and future costs incurred by the
				Secretary in carrying out the purposes described in subsection (b) (which
				finding may be made by the Secretary using standard costs).
						(e)Assessment of
				fees
							(1)LimitationFees
				may not be assessed under subsection (a) for a fiscal year beginning after the
				first applicable fiscal year unless the amount appropriated for salaries and
				expenses of the Food and Drug Administration for such fiscal year is equal to
				or greater than the amount appropriated for salaries and expenses of the Food
				and Drug Administration for the first applicable fiscal year multiplied by the
				adjustment factor applicable to the fiscal year involved, except that in making
				determinations under this paragraph for the fiscal years involved there shall
				be excluded—
								(A)the amounts
				appropriated under subsection (f)(2) for the fiscal years involved; and
								(B)the amounts
				appropriated under sections 736(g), 738(h), 740(g), and 741(g) for such fiscal
				years.
								(2)AuthorityIf
				under paragraph (1) the Secretary does not have authority to assess fees under
				subsection (a) during a portion of a fiscal year, but does at a later date in
				such fiscal year have such authority, the Secretary, notwithstanding the due
				date under such subsection for fees, may assess and collect such fees at any
				time in such fiscal year, without any modification in the rate of the
				fees.
							(f)Crediting and
				availability of fees
							(1)In
				generalFees collected for a fiscal year pursuant to subsection
				(a) shall be credited to the appropriation account for salaries and expenses of
				the Food and Drug Administration and shall be available in accordance with
				appropriation Acts until expended without fiscal year limitation. Such sums as
				may be necessary may be transferred from the Food and Drug Administration
				salaries and expenses appropriation account without fiscal year limitation to
				such appropriation account for salaries and expenses with such fiscal year
				limitation. The sums transferred shall be available solely for the purposes
				described in paragraph (1) of subsection (b), and the sums are subject to
				allocations under paragraph (2) of such subsection.
							(2)Authorization of
				appropriations
								(A)First fiscal
				yearFor the first applicable fiscal year—
									(i)there is
				authorized to be appropriated for fees under subsection (a) an amount equal to
				the amount of increase determined under subsection (b)(1)(A) by the Secretary
				(which amount shall be published in the Federal Register); and
									(ii)in addition,
				there is authorized to be appropriated for fees under subsection (a) an amount
				determined by the Secretary to be necessary to carry out the purpose described
				in subsection (b)(1)(B) (which amount shall be so published).
									(B)Subsequent
				fiscal yearsFor each of the four fiscal years following the
				first applicable fiscal year—
									(i)there is
				authorized to be appropriated for fees under subsection (a) an amount equal to
				the amount that applied under subparagraph (A)(i) for the first applicable
				fiscal year, except that such amount shall be adjusted under paragraph (3)(A)
				for the fiscal year involved; and
									(ii)in addition,
				there is authorized to be appropriated for fees under subsection (a) an amount
				equal to the amount that applied under subparagraph (A)(ii) for the first
				applicable fiscal year, except that such amount shall be adjusted under
				paragraph (3)(B) for the fiscal year involved.
									(3)Adjustments
								(A)Agency cost of
				resourcesFor each fiscal year other than the first applicable
				fiscal year, the amount that applied under paragraph (2)(A)(i) for the first
				applicable fiscal year shall be multiplied by the adjustment factor (as defined
				in subsection (i)).
								(B)Research
				programFor each fiscal year other than the first applicable
				fiscal year, the amount that applied under paragraph (2)(A)(ii) for the first
				applicable fiscal year shall be adjusted by the Secretary (and as adjusted
				shall be published in the Federal Register) to reflect the greater of—
									(i)the total
				percentage change that occurred during the preceding fiscal year in the
				Consumer Price Index for all urban consumers (all items; U.S. city average);
				or
									(ii)the total
				percentage change for such fiscal year in basic pay under the General Schedule
				in accordance with section 5332 of title 5, United States Code, as adjusted by
				any locality-based comparability payment pursuant to section 5304 of such title
				for Federal employees stationed in the District of Columbia.
									(4)OffsetAny
				amount of fees collected for a fiscal year under subsection (a) that exceeds
				the amount of fees specified in appropriation Acts for such fiscal year shall
				be credited to the appropriation account of the Food and Drug Administration as
				provided in paragraph (1), and shall be subtracted from the amount of fees that
				would otherwise be authorized to be collected under this section pursuant to
				appropriation Acts for a subsequent fiscal year.
							(g)Collection of
				unpaid feesIn any case where the Secretary does not receive
				payment of a fee assessed under subsection (a) within 30 days after it is due,
				such fee shall be treated as a claim of the United States Government subject to
				subchapter II of chapter 37 of title 31, United States Code.
						(h)ConstructionThis
				section may not be construed as requiring that the number of full-time
				equivalent positions in the Department of Health and Human Services, for
				officers, employers, and advisory committees not engaged in carrying out
				section 409 with respect to genetic food additives be reduced to offset the
				number of officers, employees, and advisory committees so engaged.
						(i)Definition of
				adjustment factorFor purposes of this section, the term
				adjustment factor applicable to a fiscal year is the lower
				of—
							(1)the Consumer Price
				Index for all urban consumers (all items; United States city average) for April
				of the preceding fiscal year divided by such Index for April of the first
				applicable fiscal year; or
							(2)the total of
				discretionary budget authority provided for programs in categories other than
				the defense category for the immediately preceding fiscal year (as reported in
				the Office of Management and Budget sequestration preview report, if available,
				required under section 254(c) of the Balanced Budget and Emergency Deficit
				Control Act of 1985) divided by such budget authority for the first applicable
				fiscal year (as reported in the Office of Management and Budget final
				sequestration report submitted for such year).
							For
				purposes of this subsection, the terms budget authority and
				category have the meaning given such terms in the Balanced Budget
				and Emergency Deficit Control Act of
				1985..
			205.Embargo
			 authority
				(a)Embargo
					(1)Temporary
			 detentionSection 304(g)(1) of the
			 Federal Food, Drug, and Cosmetic Act
			 (21 U.S.C. 334(g)(1)) is amended—
						(A)in the first
			 sentence—
							(i)by
			 striking If during and all that follows through order the
			 device or tobacco product detained and inserting the following:
			 If, during an inspection conducted under section 704, an officer or
			 employee of the Department has reason to believe that a food, device, or
			 tobacco product is in violation of this Act, such officer or employee may order
			 the food, device, or tobacco product detained; and
							(ii)by
			 striking he may authorize and inserting the Secretary may
			 authorize;
							(B)in the second and
			 third sentences, by striking device or tobacco product each
			 place it appears and inserting food, device, or tobacco
			 product;
						(C)by striking the
			 fourth and fifth sentences; and
						(D)by adding at the
			 end the following sentence: A detention order under this paragraph shall
			 be considered final agency action..
						(2)Conforming
			 amendmentsChapter III of the Federal Food, Drug, and Cosmetic Act (21
			 U.S.C. 331 et seq.) is amended—
						(A)in section
			 301(r)—
							(i)by
			 striking device or tobacco product the first place such term
			 appears and inserting food, device, or tobacco product;
			 and
							(ii)by
			 striking the device or tobacco product and inserting such
			 food, device, or tobacco product; and
							(B)in section
			 304(g)(2)—
							(i)in
			 subparagraph (A), by striking device or tobacco product and
			 inserting food, device, or tobacco product; and
							(ii)in
			 subparagraph (B), by striking device each place it appears and
			 inserting food or device.
							(b)Date certain for
			 proposed and final rulesWithin six months of the date of the
			 enactment of this title, the Secretary of Health and Human Services shall
			 propose a revision to the regulations in effect on such date under section
			 304(g) of the Federal Food, Drug, and Cosmetic
			 Act to include food. Within three months of the date such proposed
			 revision is published in the Federal Register, the Secretary shall issue a
			 final revision of such regulations.
				(c)ConfidentialityFor
			 any food embargoed, seized, or recalled under the
			 Federal Food, Drug, and Cosmetic
			 Act, the Food and Drug Administration shall disclose all necessary
			 information without regard to business confidentiality, if such disclosure is
			 necessary to fully embargo, seize, or recall any adulterated food.
				(d)Food retailer
			 registrationAll food retailers shall register with the Food and
			 Drug Administration for the purpose of expediting recalls, embargoes, and
			 seizures under the Federal Food, Drug, and
			 Cosmetic Act.
				206.Rulemaking;
			 effective date; previously unregulated marketed additives
				(a)Rulemaking;
			 effective dateNot later than one year after the date of the
			 enactment of this title, the Secretary of Health and Human Services shall by
			 regulation establish criteria for carrying out section 409 of the
			 Federal Food, Drug, and Cosmetic Act
			 in accordance with the amendments made by section 203, and criteria for
			 carrying out section 409A of such Act (as added by section 204). Such
			 amendments take effect upon the expiration of the 30-day period beginning on
			 the date on which the Secretary promulgates the final rule under the preceding
			 sentence, subject to subsection (b).
				(b)Previously
			 unregulated marketed additives
					(1)In
			 generalIn the case of a genetic food additive (as defined
			 pursuant to the amendments made by section 203) that in the United States was
			 in commercial use in food as of the day before the date on which the final rule
			 under subsection (a) is promulgated, the amendments made by this title apply to
			 the additive upon the expiration of the two-year period beginning on the date
			 on which the final rule is promulgated, subject to paragraph (2).
					(2)User
			 feesWith respect to a genetic food additive described in
			 paragraph (1), such paragraph does not waive the applicability of section 409A
			 of the Federal Food, Drug, and Cosmetic
			 Act to a petition under section 409(b)(1) of such Act that is filed
			 before the expiration of the two-year period described in such
			 paragraph.


116 HR 1367 IH: Children and Media Research Advancement Act
U.S. House of Representatives
2019-02-26
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I
116th CONGRESS1st Session
H. R. 1367
IN THE HOUSE OF REPRESENTATIVES

February 26, 2019
Mr. Raskin (for himself and Mr. Budd) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL
To amend the Public Health Service Act to authorize a program on children and the media within the National Institutes of Health to study the health and developmental effects of technology on infants, children, and adolescents.

1.Short titleThis Act may be cited as the Children and Media Research Advancement Act  or the CAMRA Act.  2.Research on the health and development effects of media on infants, children, and adolescentsSubpart 7 of part C of title IV of the Public Health Service Act (42 U.S.C. 285g et seq.) is amended by adding at the end the following:

452H.Research on the health and development effects of media on infants, children, and adolescents
(a)In generalThe Director of the National Institutes of Health, in coordination with or acting through the Director of the Institute, shall conduct and support research and related activities concerning the health and developmental effects of media on infants, children, and adolescents, which may include the positive and negative effects of exposure to and use of media, such as social media, applications, websites, television, motion pictures, artificial intelligence, mobile devices, computers, video games, virtual and augmented reality, and other media formats as they become available. Such research shall attempt to better understand the relationships between media and technology use and individual differences and characteristics of children and shall include longitudinally designed studies to assess the impact of media on youth over time. Such research shall include consideration of core areas of child and adolescent health and development including the following: (1)CognitiveThe role and impact of media use and exposure in the development of children and adolescents within such cognitive areas as language development, executive functioning, attention, creative problem solving skills, visual and spatial skills, literacy, critical thinking, and other learning abilities, and the impact of early technology use on developmental trajectories.
(2)PhysicalThe role and impact of media use and exposure on children's and adolescent's physical development and health behaviors, including diet, exercise, sleeping and eating routines, and other areas of physical development.  (3)Socio-emotionalThe role and impact of media use and exposure on children’s and adolescents’ social-emotional competencies, including self-awareness, self-regulation, social awareness, relationship skills, empathy, distress tolerance, perception of social cues, awareness of one’s relationship with the media, and decision making, as well as outcomes such as privacy, violence, bullying, depression, anxiety, addiction, obsessive behavior, and suicidal ideation.
(b)Developing research agendaThe Director of the National Institutes of Health, in coordination with the Director of the Institute, other appropriate national research institutes, academies, and centers, the Trans-NIH Pediatric Research Consortium, and non-Federal experts as needed, shall develop a research agenda on the health and developmental effects of media on infants, children, and adolescents to inform research activities under subsection (a). In developing such research agenda, the Director may use whatever means necessary (such as scientific workshops and literature reviews) to assess current knowledge and research gaps in this area.  (c)Research programIn coordination with the Institute and other national research institutes and centers, and utilizing the National Institutes of Health’s process of scientific peer review, the Director of the National Institutes of Health shall fund an expanded research program on the health and developmental effects of media on infants, children, and adolescents.
(d)Report to CongressNot later than 1 year after the date of enactment of this Act, the Director of the National Institutes of Health shall submit a report to Congress on the progress made in gathering data and expanding research on the health and developmental effects of media on infants, children, and adolescents in accordance with this section. Such report shall summarize the grants and research funded, by year, under this section.  (e)Authorization of appropriationsThere are authorized to be appropriated to carry out this section—
(1)$15,000,000 for each of fiscal years 2020 through 2022; and  (2)$25,000,000 for each of fiscal years 2023 and 2024..


115 SRES 451 IS: Recognizing the significance of endometriosis as an unmet chronic disease for women and designating March 2018 as “Endometriosis Awareness Month”.
U.S. Senate
2018-03-22
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		III
		115th CONGRESS
		2d Session
		S. RES. 451
		IN THE SENATE OF THE UNITED STATES

			March 22, 2018
			Ms. Duckworth (for herself and Ms. Warren) submitted the following resolution; which was referred to the Committee on the Judiciary

		RESOLUTION
		Recognizing the significance of endometriosis as an unmet chronic disease for women and designating
			 March 2018 as Endometriosis Awareness Month.

 Whereas 6,500,000 women in the United States are living with endometriosis; Whereas endometriosis is a chronic disease affecting 176,000,000 women throughout the world and an estimated 1 in 10 women in the United States ages 18 through 49;
 Whereas medical societies and patient groups including the Endometriosis Association, the American College of Obstetricians and Gynecologists, the National Association of Nurse Practitioners in Women's Health, the American Society for Reproductive Medicine, and the American Social Health Association all have expressed the need for greater public attention and updated resources targeted to public education about this unmet health need for women;
 Whereas endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside the uterus;
 Whereas, while endometriosis is one of the most common gynecological disorders in the United States, there is a lack of awareness and prioritization of endometriosis as an important health issue for women;
 Whereas women can suffer up to 6 to 10 years before properly diagnosed; Whereas approximately 1/3 to 1/2 of all women with endometriosis will have difficulty getting pregnant;
 Whereas endometriosis is a painful and debilitating disorder; Whereas endometriosis is associated with increased health care costs and poses a substantial burden to patients in the health care system;
 Whereas the total annual direct health care cost of symptoms associated with endometriosis is $56,000,000,000, or nearly $11,000 per patient;
 Whereas 51 percent of endometriosis patients report that the disease detrimentally affects their performance of their job;
 Whereas the Centers for Disease Control and Prevention found that the average number of bed days for patients with endometriosis was 18 days per year; Whereas women with endometriosis can lose 11 hours per work week through lost productivity;
 Whereas, in 2010, endometriosis patients were hospitalized over 100,000 days because of this disease;
 Whereas there is a need for more research and updated guidelines to treat endometriosis; Whereas the research dollars from the National Institutes of Health dedicated to endometriosis has dropped from $16,000,000 in 2010 to $7,000,000 in 2018;
 Whereas there is an ongoing need for additional clinical research and treatment options to manage this debilitating disease; and
 Whereas there is no known cure for endometriosis: Now, therefore, be it   That the Senate—
 (1)designates March 2018 as Endometriosis Awareness Month; (2)recognizes the importance of endometriosis as a health issue for women that requires far greater attention, public awareness, and education about the disease;
 (3)encourages the Secretary of Health and Human Services— (A)to provide information to women, patients, and health care providers with respect to endometriosis, including available screening tools and treatment options, with a goal of improving the quality of life and health outcomes of women affected by endometriosis;
 (B)to conduct additional research on endometriosis and possible clinical options; and (C)to update information, tools, and studies currently available with respect to helping women live with endometriosis; and
 (4)respectfully requests that the Secretary of the Senate transmit a copy of this resolution to the Secretary of Health and Human Services.


114 HR 5858 IH: Research to Accelerate Cures and Equity for Children Act
U.S. House of Representatives
2016-07-14
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I114th CONGRESS2d SessionH. R. 5858IN THE HOUSE OF REPRESENTATIVESJuly 14, 2016Mr. McCaul (for himself, Mr. Butterfield, Mr. Duffy, and Mr. Van Hollen) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend the Federal Food, Drug, and Cosmetic Act to establish a program to provide additional
			 incentives for the development of new drugs to treat pediatric cancers,
			 and for other purposes.

 1.Short titleThis Act may be cited as the Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act. 2.Required pediatric assessments (a)Molecular targets regarding cancer drugsSection 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended—
 (1)in subsection (a)(1)— (A)in subparagraph (A), by striking or at the end;
 (B)in subparagraph (B), by inserting or after administration,; and (C)by inserting after subparagraph (B) the following:

 (C)under section 505 of this Act or section 351 of the Public Health Service Act, as described in subparagraph (A) or (B), that is directed at a molecular target present in one or more cancers in one or more pediatric populations,; and
 (2)in subsection (b)(1)— (A)by amending subparagraph (A)(i) to read as follows:

							(A)
 (i)the drug or biological product is used for a substantial number of pediatric patients— (I)for the labeled indications; or
 (II)with respect to one or more specific molecular targets present in cancers in pediatric populations; and;
 (B)by amending subparagraph (B) to read as follows:  (B)there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients—
 (i)for one or more of the claimed indications; or (ii)with respect to one or more specific molecular targets present in cancers in pediatric populations; or; and
 (C)by amending paragraph (2) of subsection (c) to read as follows:  (2)the drug or biological product is in a class of products, is for an indication, or is directed at a specific molecular target present in cancers in pediatric populations, for which there is need for additional options..
					(b)Early meeting on pediatric study plan
 (1)In generalClause (i) of section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to read as follows:

 (i)shall meet with the applicant— (I)if requested by the applicant with respect to a drug that is directed at a molecular target that is present in one or more cancers in one or more pediatric populations, as described in subsection (a)(1)(C), to discuss, not later than the end-of-Phase1 meeting (as such term is used in section 312.82(b) of title 21, Code of Federal Regulations, or successor regulations), preparation of the initial pediatric study plan;
 (II)to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and
 (III)to discuss any scientific or operational challenges that may be the basis of a deferral under subsection (a)(3) or a full or partial waiver under subsection (a)(4);.
 (2)Conforming changesSection 505B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended— (A)in the heading of paragraph (2), by striking meeting and inserting meetings;
 (B)in the heading of paragraph (2)(C), by striking Meeting and inserting Meetings; (C)in clauses (ii) and (iii) of paragraph (2)(C), by striking no meeting each place it appears and inserting no meeting under clause (i)(II); and
 (D)in paragraph (3) by striking meeting under paragraph (2)(C)(i) and inserting meeting under paragraph (2)(C)(i)(II). (c)Orphan drugsSection 505B(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(k)) is amended by inserting except in the case of a drug or biological product that is the subject of an application described in subsection (a)(1)(C), after regulation,.
 (d)GuidanceNot later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance on the implementation of this section (including the amendments made by this section), including study designs and molecular targets likely to be present in one or more cancers in pediatric populations that are appropriate for assessment under the amendments made by this Act.
 (e)ApplicabilityThis Act and the amendments made by this Act apply with respect to applications for a drug submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) on or after the date that is 18 months after the date of enactment of this Act.
 (f)Report to CongressNot later than July 12, 2021, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit to Congress a report on the implementation of the amendments made by this section, together with any recommendations of the Secretary regarding such amendments.
 (g)Rule of constructionNothing in this Act, including the amendments made by this Act, shall limit the authority of the Secretary of Health and Human Services to issue written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a).


115 S392 RS: 400 Years of African-American History Commission Act
U.S. Senate
2017-02-15
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IICalendar No. 81115th CONGRESS1st SessionS. 392[Report No. 115–63]IN THE SENATE OF THE UNITED STATESFebruary 15, 2017Mr. Kaine (for himself, Mr. Warner, Mr. Booker, and Mr. Blunt) introduced the following bill; which was read twice and referred to the Committee on Energy and Natural ResourcesMay 16, 2017Reported by Ms. Murkowski, without amendmentA BILLTo establish the 400 Years of African-American History Commission, and for other purposes.

 1.Short titleThis Act may be cited as the 400 Years of African-American History Commission Act.
 2.DefinitionsIn this Act: (1)CommemorationThe term commemoration means the commemoration of the 400th anniversary of the arrival of Africans in the English colonies, at Point Comfort, Virginia, in 1619.
 (2)CommissionThe term Commission means the 400 Years of African-American History Commission established by section 3(a).
 (3)SecretaryThe term Secretary means the Secretary of the Interior.
			3.Establishment
			(a)In
 generalThere is established a commission, to be known as the 400 Years of African-American History Commission.
			(b)Membership
 (1)CompositionThe Commission shall be composed of 15 members, of whom— (A)3 members shall be appointed by the Secretary, after considering the recommendations of Governors of States, including the Governor of Virginia;
 (B)6 members shall be appointed by the Secretary, after considering the recommendations of civil rights organizations and historical organizations;
 (C)1 member shall be an employee of the National Park Service having experience relating to the historical and cultural resources related to the commemoration, to be appointed by the Secretary;
 (D)2 members shall be appointed by the Secretary, after considering the recommendations of the Secretary of the Smithsonian Institution; and
 (E)3 members shall be individuals who have an interest in, support for, and expertise appropriate to the commemoration, to be appointed by the Secretary, after considering the recommendations of Members of Congress.
					(2)Time of
 appointmentEach appointment of an initial member of the Commission shall be made before the expiration of the 120-day period beginning on the date of enactment of this Act.
				(3)Term;
		vacancies
 (A)TermA member of the Commission shall be appointed for the life of the Commission.
					(B)Vacancies
						(i)In
 generalA vacancy on the Commission shall be filled in the same manner in which the original appointment was made.
						(ii)Partial
 termA member appointed to fill a vacancy on the Commission shall serve for the remainder of the term for which the predecessor of the member was appointed.
						(C)Continuation of
 membershipIf a member of the Commission was appointed to the Commission as an employee of the National Park Service, and ceases to be an employee of the National Park Service, that member may continue to serve on the Commission for not longer than the 30-day period beginning on the date on which that member ceases to be an employee of the National Park Service.
 (c)DutiesThe Commission shall—
 (1)plan, develop, and carry out programs and activities throughout the United States—
 (A)appropriate for the commemoration; (B)to recognize and highlight the resilience and contributions of African-Americans since 1619;
 (C)to acknowledge the impact that slavery and laws that enforced racial discrimination had on the United States; and
 (D)to educate the public about— (i)the arrival of Africans in the United States; and
 (ii)the contributions of African-Americans to the United States; (2)encourage civic, patriotic, historical, educational, artistic, religious, economic, and other organizations throughout the United States to organize and participate in anniversary activities to expand understanding and appreciation of—
 (A)the significance of the arrival of Africans in the United States; and
 (B)the contributions of African-Americans to the United States; (3)provide technical assistance to States, localities, and nonprofit organizations to further the commemoration;
 (4)coordinate and facilitate for the public scholarly research on, publication about, and interpretation of—
 (A)the arrival of Africans in the United States; and (B)the contributions of African-Americans to the United States;
 (5)ensure that the commemoration provides a lasting legacy and long-term public benefit by assisting in the development of appropriate programs; and
 (6)help ensure that the observances of the commemoration are inclusive and appropriately recognize the experiences and heritage of all individuals present at the arrival of Africans in the United States.
				4.Commission
		meetings
			(a)Initial
 meetingNot later than 30 days after the date on which all members of the Commission have been appointed, the Commission shall hold the initial meeting of the Commission.
 (b)MeetingsThe Commission shall meet—
 (1)at least 3 times each year; or
 (2)at the call of the Chairperson or the majority of the members of the Commission.
 (c)QuorumA majority of the voting members shall constitute a quorum, but a lesser number may hold meetings.
			(d)Chairperson and
		vice chairperson
 (1)ElectionThe Commission shall elect the Chairperson and the Vice Chairperson of the Commission on an annual basis.
				(2)Absence of the
 chairpersonThe Vice Chairperson shall serve as the Chairperson in the absence of the Chairperson.
 (e)VotingThe Commission shall act only on an affirmative vote of a majority of the members of the Commission.
			5.Commission
		powers
 (a)GiftsThe Commission may solicit, accept, use, and dispose of gifts, bequests, or devises of money or other property for aiding or facilitating the work of the Commission.
			(b)Appointment of
 advisory committeesThe Commission may appoint such advisory committees as the Commission determines to be necessary to carry out this Act.
			(c)Authorization
 of actionThe Commission may authorize any member or employee of the Commission to take any action that the Commission is authorized to take under this Act.
			(d)Procurement
				(1)In
 generalThe Commission may procure supplies, services, and property, and make or enter into contracts, leases, or other legal agreements, to carry out this Act (except that a contract, lease, or other legal agreement made or entered into by the Commission shall not extend beyond the date of termination of the Commission).
 (2)LimitationThe Commission may not purchase real property.
				(e)Postal
 servicesThe Commission may use the United States mails in the same manner and under the same conditions as other agencies of the Federal Government.
			(f)Grants and
 technical assistanceThe Commission may— (1)provide grants in amounts not to exceed $20,000 per grant to communities and nonprofit organizations for use in developing programs to assist in the commemoration;
 (2)provide grants to research and scholarly organizations to research, publish, or distribute information relating to the arrival of Africans in the United States; and
 (3)provide technical assistance to States, localities, and nonprofit organizations to further the commemoration.
				6.Commission
		personnel matters
			(a)Compensation of
		members
				(1)In
 generalExcept as provided in paragraph (2), a member of the Commission shall serve without compensation.
				(2)Federal
 employeesA member of the Commission who is an officer or employee of the Federal Government shall serve without compensation other than the compensation received for the services of the member as an officer or employee of the Federal Government.
				(b)Travel
 expensesA member of the Commission shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for an employee of an agency under subchapter I of chapter 57 of title 5, United States Code, while away from the home or regular place of business of the member in the performance of the duties of the Commission.
			(c)Director and
		staff
				(1)In
 generalThe Chairperson of the Commission may, without regard to the civil service laws (including regulations), nominate an executive director to enable the Commission to perform the duties of the Commission.
				(2)Confirmation of
 executive directorThe employment of an executive director shall be subject to confirmation by the Commission.
				(d)Compensation
				(1)In
 generalExcept as provided in paragraph (2), the Commission may fix the compensation of the executive director and other personnel without regard to the provisions of chapter 51 and subchapter III of chapter 53 of title 5, United States Code, relating to classification of positions and General Schedule pay rates.
				(2)Maximum rate of
 payThe rate of pay for the executive director and other personnel shall not exceed the rate payable for level V of the Executive Schedule under section 5316 of title 5, United States Code.
				(e)Detail of
		government employees
				(1)Federal
		employees
 (A)DetailAt the request of the Commission, the head of any Federal agency may detail, on a reimbursable or nonreimbursable basis, any of the personnel of the agency to the Commission to assist the Commission in carrying out the duties of the Commission under this Act.
					(B)Civil service
 statusThe detail of an employee under subparagraph (A) shall be without interruption or loss of civil service status or privilege.
					(2)State
 employeesThe Commission may— (A)accept the services of personnel detailed from the State; and
 (B)reimburse the State for services of detailed personnel.
					(f)Procurement of
 temporary and intermittent servicesThe Chairperson of the Commission may procure temporary and intermittent services in accordance with section 3109(b) of title 5, United States Code, at rates for individuals that do not exceed the daily equivalent of the annual rate of basic pay prescribed for level V of the Executive Schedule under section 5316 of such title.
			(g)Volunteer and
 uncompensated servicesNotwithstanding section 1342 of title 31, United States Code, the Commission may accept and use such voluntary and uncompensated services as the Commission determines to be necessary.
			(h)Support
		services
				(1)In
 generalThe Secretary shall provide to the Commission, on a reimbursable basis, such administrative support services as the Commission may request.
 (2)ReimbursementAny reimbursement under this paragraph shall be credited to the appropriation, fund, or account used for paying the amounts reimbursed.
				(i)No effect on
 authorityNothing in this section supersedes the authority of the National Park Service with respect to the commemoration.
			7.Plans;
		reports
			(a)Strategic
 planThe Commission shall prepare a strategic plan for the activities of the Commission carried out under this Act.
			(b)Final
 reportNot later than July 1, 2020, the Commission shall complete and submit to Congress a final report that contains—
 (1)a summary of the activities of the Commission;
 (2)a final accounting of funds received and expended by the Commission; and
 (3)the findings and recommendations of the Commission.
				8.Authorization of
		appropriations
			(a)In
 generalThere are authorized to be appropriated to the Commission such sums as are necessary to carry out this Act.
 (b)AvailabilityAmounts made available under subsection (a) shall remain available until July 1, 2020.
			9.Termination of
		Commission
			(a)Date of
 terminationThe Commission shall terminate on July 1, 2020.
			(b)Transfer of
 documents and materialsBefore the date of termination specified in subsection (a), the Commission shall transfer all documents and materials of the Commission to the National Archives or another appropriate Federal entity.May 16, 2017Reported without amendment


		IIB
		111th CONGRESS
		2d Session
		H. R. 5458
		IN THE SENATE OF THE UNITED
		  STATES

			September 29, 2010
			Received; read twice and referred to the
			 Committee on Health, Education, Labor,
			 and Pensions

		AN ACT
		To amend the Truth in Lending Act and the
		  Higher Education Act of 1965 to require additional disclosures and protections
		  for students and cosigners with respect to student loans, and for other
		  purposes.

		1.Short title;
			 findings
			(a)Short
			 titleThis Act may be cited
			 as the Christopher Bryski Student Loan
			 Protection Act and Christopher’s Law.
			(b)FindingsThe
			 Congress finds the following:
				(1)There is no
			 requirement for Federal or private educational lenders to provide information
			 with respect to creating a durable power of attorney for financial
			 decisionmaking in accordance with State law to be used in the event of the
			 death, incapacitation, or disability of the borrower or such cosigner (if
			 any).
				(2)No requirement
			 exists for private educational lenders’ master promissory notes to include a
			 clear and conspicuous description of the responsibilities of a borrower and
			 cosigner in the event the borrower or cosigner becomes disabled, incapacitated,
			 or dies.
				(3)Of the 1,400,000
			 people who sustain a traumatic brain injury each year in the United States,
			 50,000 die; 235,000 are hospitalized; and 1,100,000 are treated and released
			 from an emergency department.
				(4)It is estimated that the annual incidence
			 of spinal cord injury, not including those who die at the scene of an accident,
			 is approximately 40 cases per 1,000,000 people in the United States or
			 approximately 12,000 new cases each year. Since there have not been any overall
			 incidence studies of spinal cord injuries in the United States since the 1970s,
			 it is not known if incidence has changed in recent years.
				(5)In the 2007–2008 academic year, 13 percent
			 of students attending a 4-year public school, and 26.2 percent of students
			 attending a 4-year private school, borrowed monies from private educational
			 lenders.
				(6)According to Sallie Mae, in 2009, the
			 number of cosigned private education loans increased from 66 percent to 84
			 percent of all private education loans.
				2.Additional
			 student loan protections
			(a)In
			 generalSection 140 of the
			 Truth in Lending Act (15 U.S.C. 1650) is amended by
			 adding at the end the following new subsection:

					(f)Additional
				protections relating to death or disability of borrower or cosigner of a
				private education loan
						(1)Obligation to
				discuss durable power of attorneysIn conjunction with—
							(A)any student loan counseling, if any,
				provided by a covered educational institution to any new borrower and cosigner
				(if any) at the time of any loan application, loan origination, or loan
				consolidation, or at the time the cosigner assumes responsibility for
				repayment, the institution shall provide information with respect to creating a
				durable power of attorney for financial decisionmaking, in accordance with
				State law; and
							(B)any application for a private education
				loan, the private educational lender involved in such loan shall provide
				information to the borrower, and cosigner (if any), concerning the creation of
				a durable power of attorney for financial decisionmaking, in accordance with
				State law, with respect to such loan.
							(2)Clear and
				conspicuous description of cosigner’s obligationIn the case of any private educational
				lender who extends a private education loan for which any cosigner is jointly
				liable, the lender shall clearly and conspicuously describe, in writing, the
				cosigner’s obligations with respect to the loan, including the effect the
				death, disability, or inability to engage in any substantial gainful activity
				of the borrower or cosigner (if any) would have on any such obligation, in
				language that the Board determines would give a reasonable person a reasonable
				understanding of the obligation being assumed by becoming a cosigner for the
				loan.
						(3)Model
				formsThe Board shall publish model forms under section 105
				for—
							(A)the information required under paragraph
				(1) with respect to a durable power of attorney for financial decisionmaking,
				for each State (and such model forms under this subparagraph shall be uniform
				for all States to the greatest extent possible); and
							(B)describing a
				cosigner’s obligation for purposes of paragraph (2).
							(4)Definition of
				death, disability, or inability to engage in any substantial gainful
				activityFor the purposes of
				this subsection with respect to a borrower or cosigner, the term death,
				disability, or inability to engage in any substantial gainful
				activity—
							(A)means any
				condition described in section 437(a) of the Higher Education Act of 1965
				(20 U.S.C.
				1087(a)); and
							(B)shall be
				interpreted by the Board in such a manner as to conform with the regulations
				prescribed by such Secretary of Education under section 437(a) of the Higher
				Education Act of 1965 (20 U.S.C. 1087(a)) to the fullest
				extent practicable, including safeguards to prevent fraud and
				abuse.
							.
			(b)DefinitionsSubsection (a) of section 140 of the Truth
			 in Lending Act (15
			 U.S.C. 1650(a)) is amended by adding at the end the following
			 new paragraphs:

					(9)Durable power of
				attorneyThe term durable power of attorney—
						(A)means a written
				instruction recognized under State law (whether statutory or as recognized by
				the courts of the State), relating to financial decisionmaking in cases when
				the individual lacks the capacity to make such decisions; or
						(B)has the meaning
				given to such term in the Uniform Durable Power of Attorney Act of 2006 and
				sections 5-501 through 5-505 of the Uniform Probate Code, as in effect in any
				State.
						(10)CosignerThe term cosigner—
						(A)means any
				individual who is liable for the obligation of another without compensation,
				regardless of how designated in the contract or instrument;
						(B)includes any
				person whose signature is requested as condition to grant credit or to forebear
				on collection; and
						(C)does not include a
				spouse of an individual referred to in subparagraph (A) whose signature is
				needed to perfect the security interest in the
				loan.
						.
			3.Federal student
			 loansSection 485(l)(2) of the
			 Higher Education Act of 1965 (20 U.S.C. 1092(l)(2)) is amended by
			 adding at the end the following:

				(L)Information on the conditions required to
				discharge the loan due to the death, disability, or inability to engage in any
				substantial gainful activity of the borrower in accordance with section 437(a),
				and an explanation that, in the case of a private education loan made through a
				private educational lender, the borrower, the borrower’s estate, and any
				consigner of a such a private education loan may be obligated to repay the full
				amount of the loan, regardless of the death or disability of the borrower or
				any other condition described in section 437(a).
				(M)The model form for the State in which the
				institution is located with respect to durable power of attorneys published by
				the Board of Governors of the Federal Reserve System in accordance with
				subsection (f)(3)(A) of section 140 of the Truth in Lending Act (15 U.S.C. 1650)
				and, in the case of a borrower who is not a resident of the State in which the
				institution is located, information on how to access such model form for the
				State in which the borrower is a
				resident.
				.

			Passed the House of
			 Representatives September 28, 2010.
			Lorraine C. Miller,
			Clerk.


117 S321 ES: ‘Six Triple Eight’ Congressional Gold Medal Act of 2021
U.S. Senate

text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

117th CONGRESS1st SessionS. 321IN THE SENATE OF THE UNITED STATESAN ACTTo award a Congressional Gold Medal to the members of the Women’s Army Corps who were assigned to the 6888th Central Postal Directory Battalion, known as the Six Triple Eight.1.Short titleThis Act may be cited as the ‘Six Triple Eight’ Congressional Gold Medal Act of 2021.2.FindingsCongress finds the following:(1)On July 1, 1943, President Franklin D. Roosevelt signed into law legislation that established the Women’s Army Corps (referred to in this section as the WAC) as a component in the Army. The WAC was converted from the Women’s Army Auxiliary Corps (referred to in this section as the WAAC), which had been created in 1942 without official military status. First Lady Eleanor Roosevelt and Mary McLeod Bethune, the founder of the National Council of Negro Women, advocated for the admittance of African-American women into the newly formed WAC to serve as officers and enlisted personnel.(2)Dubbed 10 percenters, the recruitment of African-American women to the WAAC was limited to 10 percent of the population of the WAAC to match the proportion of African-Americans in the national population. Despite an Executive order issued by President Franklin D. Roosevelt in 1941 banning racial discrimination in civilian defense industries, the Armed Forces remained segregated. Enlisted women served in segregated units, participated in segregated training, lived in separate quarters, ate at separate tables in mess halls, and used segregated recreational facilities. Officers received their officer candidate training in integrated units but lived under segregated conditions. Specialist and technical training schools were integrated in 1943. During World War II, a total of 6,520 African-American women served in the WAAC and the WAC.(3)After several units of White women were sent to serve in the European Theater of Operations (referred to in this section as the ETO) during World War II, African-American organizations advocated for the War Department to extend the opportunity to serve overseas to African-American WAC units.(4)In November 1944, the War Department approved sending African-American women to serve in Europe. A battalion of all African-American women drawn from the WAC, the Army Service Forces, and the Army Air Forces was created and designated as the 6888th Central Postal Directory Battalion (referred to in this section as the 6888th), which was nicknamed the Six Triple Eight.(5)Army officials reported a shortage of qualified postal officers within the ETO, which resulted in a backlog of undelivered mail. As Allied forces drove across Europe, the ever-changing locations of servicemembers hampered the delivery of mail to those servicemembers. Because 7,000,000 civilians and military personnel from the United States served in the ETO, many of those individuals had identical names. For example, 7,500 such individuals were named Robert Smith. One general predicted that the backlog in Birmingham, England, would take 6 months to process and the lack of reliable mail service was hurting morale.(6)In February 1945, the 6888th arrived in Birmingham. Upon their arrival, the 6888th found warehouses filled with millions of pieces of mail intended for members of the Armed Forces, United States Government personnel, and Red Cross workers serving in the ETO.(7)The 6888th created effective processes and filing systems to track individual servicemembers, organize undeliverable mail, determine the intended recipient for insufficiently addressed mail, and handle mail addressed to servicemembers who had died. Adhering to their motto of No mail, low morale, the women processed an average of 65,000 pieces of mail per shift and cleared the 6-month backlog of mail within 3 months.(8)The 6888th traveled to Rouen, France, in May 1945 and worked through a separate backlog of undelivered mail dating back as far as 3 years.(9)At the completion of their mission, the unit returned to the United States. The 6888th was discontinued on March 9, 1946, at Camp Kilmer, New Jersey.(10)The accomplishments of the 6888th in Europe encouraged the General Board, United States Forces, European Theater of Operations to adopt the following premise in their study of the WAC issued in December 1945: [T]he national security program is the joint responsibility of all Americans irrespective of color or sex and the continued use of colored, along with white, female military personnel is required in such strength as is proportionately appropriate to the relative population distribution between colored and white races.(11)With the exception of smaller units of African-American nurses who served in Africa, Australia, and England, the 6888th was the only African-American Women's Army Corps unit to serve overseas during World War II.(12)The members of the Six Triple Eight received the European African Middle Eastern Campaign Medal, the Women’s Army Corps Service Medal, and the World War II Victory Medal for their service.(13)In 2019, the Army awarded the 6888th the Meritorious Unit Commendation.3.Congressional Gold Medal(a)Award authorizedThe Speaker of the House of Representatives and the President pro tempore of the Senate shall make appropriate arrangements for the award, on behalf of Congress, of a single gold medal of appropriate design in honor of the women of the 6888th Central Postal Directory Battalion (commonly known as the Six Triple Eight) in recognition of—(1)the pioneering military service of those women;(2)the devotion to duty of those women; and(3)the contributions made by those women to increase the morale of all United States personnel stationed in the European Theater of Operations during World War II.(b)Design and strikingFor the purposes of the award described in subsection (a), the Secretary of the Treasury (referred to in this Act as the Secretary) shall strike the gold medal with suitable emblems, devices, and inscriptions, to be determined by the Secretary.(c)Smithsonian Institution(1)In generalAfter the award of the gold medal under subsection (a), the medal shall be given to the Smithsonian Institution, where the medal shall be available for display, as appropriate, and made available for research.(2)Sense of CongressIt is the sense of Congress that the Smithsonian Institution should make the gold medal received under paragraph (1) available elsewhere, particularly at—(A)appropriate locations associated with the 6888th Central Postal Directory Battalion;(B)the Women in Military Service for America Memorial;(C)the United States Army Women’s Museum;(D)the National World War II Museum and Memorial;(E)the National Museum of the United States Army; and(F)any other location determined appropriate by the Smithsonian Institution.4.Duplicate medalsUnder such regulations as the Secretary may prescribe, the Secretary may strike and sell duplicates in bronze of the gold medal struck under section 3 at a price sufficient to cover the costs of the medals, including labor, materials, dies, use of machinery, and overhead expenses.5.National medals(a)National medalsMedals struck under this Act are national medals for purposes of chapter 51 of title 31, United States Code.(b)Numismatic itemsFor purposes of section 5134 of title 31, United States Code, all medals struck under this Act shall be considered to be numismatic items.6.Authority to use fund amounts; proceeds of sale(a)Authority To use fund amountsThere is authorized to be charged against the United States Mint Public Enterprise Fund such amounts as may be necessary to pay for the costs of the medals struck under this Act.(b)Proceeds of saleAmounts received from the sale of duplicate bronze medals authorized under section 4 shall be deposited into the United States Mint Public Enterprise Fund.Passed the Senate April 29, 2021.Secretary


		II
		111th CONGRESS
		1st Session
		S. 1627
		IN THE SENATE OF THE UNITED STATES

			August 6, 2009
			Mr. Harkin introduced
			 the following bill; which was read twice and referred to the
			 Committee on Commerce, Science, and
			 Transportation

		A BILL
		To improve choices for consumers for vehicles and fuel,
		  and for other purposes.

		1.Short titleThis Act may be cited as the
			 Consumer Fuels and Vehicle Choice Act
			 of 2009.
		2.Ensuring the
			 availability of dual fueled automobiles and light duty trucks
			(a)In
			 generalChapter 329 of title 49, United States Code, is amended
			 by inserting after section 32902 the following:

					32902A.Requirement
				to manufacture dual fueled automobiles and light duty trucks
						(a)In
				generalFor each model year
				listed in the following table, each manufacturer shall ensure that the
				percentage of automobiles and light duty trucks manufactured by the
				manufacturer for sale in the United States that are dual fueled automobiles and
				light duty trucks is not less than the percentage set forth for that model year
				in the following table:

										Model YearPercentage

										Model years 2011 and 201250 percent

										Model year 2013 and each subsequent model year90 percent.

						(b)ExceptionSubsection
				(a) shall not apply to automobiles or light duty trucks that operate only on
				electricity.
						.
			(b)Clerical
			 amendmentThe table of sections for chapter 329 of title 49,
			 United States Code, is amended by inserting after the item relating to section
			 32902 the following:

						32902A. Requirement to manufacture dual fueled automobiles and
				light duty
				trucks.

					.
			(c)RulemakingNot
			 later than 1 year after the date of the enactment of this Act, the Secretary of
			 Transportation shall prescribe regulations to carry out the amendments made by
			 this Act.
			3.Blender pump
			 promotion
			(a)Blender Pump
			 grant program
				(1)DefinitionsIn
			 this subsection:
					(A)Blender
			 pumpThe term blender pump means an automotive fuel
			 dispensing pump capable of dispensing at least 3 different blends of gasoline
			 and ethanol, as selected by the pump operator, including blends ranging from 0
			 percent ethanol to 85 percent denatured ethanol, as determined by the
			 Secretary.
					(B)E–85
			 fuelThe term E–85 fuel means a blend of gasoline
			 approximately 85 percent of the content of which is ethanol.
					(C)Ethanol fuel
			 blendThe term ethanol fuel blend means a blend of
			 gasoline and ethanol, with a minimum of 0 percent and maximum of 85 percent of
			 the content of which is denatured ethanol.
					(D)SecretaryThe
			 term Secretary means the Secretary of Energy.
					(2)GrantsThe
			 Secretary shall make grants under this subsection to eligible facilities (as
			 determined by the Secretary) to pay the Federal share of—
					(A)installing
			 blender pump fuel infrastructure, including infrastructure necessary—
						(i)for
			 the direct retail sale of ethanol fuel blends (including E–85 fuel), including
			 blender pumps and storage tanks; and
						(ii)to
			 directly market ethanol fuel blends (including E–85 fuel) to gas retailers,
			 including inline blending equipment, pumps, storage tanks, and loadout
			 equipment; and
						(B)providing
			 subgrants to direct retailers of ethanol fuel blends (including E–85 fuel) for
			 the purpose of installing fuel infrastructure for the direct retail sale of
			 ethanol fuel blends (including E–85 fuel), including blender pumps and storage
			 tanks.
					(3)Federal
			 shareThe Federal share of the cost of a project carried out
			 under this subsection shall be 50 percent of the total cost of the
			 project.
				(4)Authorization
			 of appropriationsThere are authorized to be appropriated to the
			 Secretary to carry out this subsection, to remain available until
			 expended—
					(A)$50,000,000 for
			 fiscal year 2010;
					(B)$100,000,000 for
			 fiscal year 2011;
					(C)$200,000,000 for
			 fiscal year 2012;
					(D)$300,000,000 for
			 fiscal year 2013; and
					(E)$350,000,000 for
			 fiscal year 2014.
					(b)Installation of
			 blender pumps by major fuel distributors at owned stations and branded
			 stationsSection 211(o) of
			 the Clean Air Act (42 U.S.C. 7545(o)) is amended by adding at the end the
			 following:

					(13)Installation
				of blender pumps by major fuel distributors at owned stations and branded
				stations
						(A)DefinitionsIn
				this paragraph:
							(i)E–85
				fuelThe term E–85 fuel means a blend of gasoline
				approximately 85 percent of the content of which is ethanol.
							(ii)Ethanol fuel
				blendThe term ethanol fuel blend means a blend of
				gasoline and ethanol, with a minimum of 0 percent and maximum of 85 percent of
				the content of which is denatured ethanol.
							(iii)Major fuel
				distributor
								(I)In
				generalThe term major fuel distributor means any
				person that owns a refinery and directly markets the output of a
				refinery.
								(II)ExclusionThe
				term major fuel distributor does not include any person that owns
				less than 50 retail fueling stations.
								(iv)SecretaryThe
				term Secretary means the Secretary of Energy, acting in
				consultation with the Administrator of the Environmental Protection Agency and
				the Secretary of Agriculture.
							(B)RegulationsThe
				Secretary shall promulgate regulations to ensure that each major fuel
				distributor that sells or introduces gasoline into commerce in the United
				States through majority-owned stations or branded stations installs or
				otherwise makes available 1 or more blender pumps that dispense E–85 fuel and
				ethanol fuel blends (including any other equipment necessary, such as tanks, to
				ensure that the pumps function properly) for a period of not less than 5 years
				at not less than the applicable percentage of the majority-owned stations and
				the branded stations of the major fuel distributor specified in subparagraph
				(C).
						(C)Applicable
				percentageFor the purpose of subparagraph (B), the applicable
				percentage of the majority-owned stations and the branded stations shall be
				determined in accordance with the following table:

										Applicable percentage of majority-owned
						stations and branded stations

										Calendar year:Percent:

										201110

										201320

										201535

										2017 and each calendar year thereafter50.

						(D)Geographic
				distribution
							(i)In
				generalSubject to clause (ii), in promulgating regulations under
				subparagraph (B), the Secretary shall ensure that each major fuel distributor
				described in that subparagraph installs or otherwise makes available 1 or more
				blender pumps that dispense E–85 fuel and ethanol fuel blends at not less than
				a minimum percentage (specified in the regulations) of the majority-owned
				stations and the branded stations of the major fuel distributors in each
				State.
							(ii)RequirementIn
				specifying the minimum percentage under clause (i), the Secretary shall ensure
				that each major fuel distributor installs or otherwise makes available 1 or
				more blender pumps described in that clause in each State in which the major
				fuel distributor operates.
							(E)Financial
				responsibilityIn promulgating regulations under subparagraph
				(B), the Secretary shall ensure that each major fuel distributor described in
				that subparagraph assumes full financial responsibility for the costs of
				installing or otherwise making available the blender pumps described in that
				subparagraph and any other equipment necessary (including tanks) to ensure that
				the pumps function properly.
						(F)Production
				credits for exceeding blender pumps installation requirement
							(i)Earning and
				period for applying creditsIf the percentage of the
				majority-owned stations and the branded stations of a major fuel distributor at
				which the major fuel distributor installs blender pumps in a particular
				calendar year exceeds the percentage required under subparagraph (C), the major
				fuel distributor shall earn credits under this paragraph, which may be applied
				to any of the 3 consecutive calendar years immediately after the calendar year
				for which the credits are earned.
							(ii)Trading
				creditsSubject to clause (iii), a major fuel distributor that
				has earned credits under clause (i) may sell the credits to another major fuel
				distributor to enable the purchaser to meet the requirement under subparagraph
				(C).
							(iii)ExceptionA
				major fuel distributor may not use credits purchased under clause (ii) to
				fulfill the geographic distribution requirement in subparagraph
				(D).
							.