For other versions of this document, see http://wikileaks.org/wiki/CRS-RL32619
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Prepared for Members and Committees of Congress
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In the 110th Congress, lawmakers reintroduced bipartisan, bicameral legislation to give the Food
and Drug Administration (FDA) broad new authority to regulate the manufacture, distribution,
advertising, promotion, sale, and use of cigarettes and smokeless tobacco products. The House
passed H.R. 1108 on July 30, 2008, by a vote of 326-102. The Senate version was order to be
reported out of committee but did not see floor action. The Family Smoking Prevention and
Tobacco Control Act was first introduced in the 108th Congress, the product of lengthy
negotiations in which lawmakers sought to balance the competing interests of public health
groups and Philip Morris, the nation's leading cigarette company.
In the mid-1990s, FDA claimed authority under the Federal Food, Drug, and Cosmetic Act
(FFDCA) to regulate cigarettes and smokeless tobacco products as delivery devices for nicotine,
an addictive drug. The agency's 1996 tobacco regulation was invalidated by the U.S. Supreme
Court in March 2000. The Court concluded that Congress had clearly intended to preclude FDA
from regulating tobacco products. It found that because the FFDCA prohibits the marketing of
products that have not been found to be safe and effective, the statute would have required FDA
to ban such manifestly harmful products as cigarettes and smokeless tobacco if the agency had
jurisdiction over them. Such a ban, argued the Court, would plainly contradict congressional
intent.
The Supreme Court's decision made it clear the Congress would have to enact legislation giving
FDA statutory authority over tobacco products in order for the agency to assert jurisdiction.
Lawmakers first drafted such language in the 105th Congress as part of legislation to implement
the 1997 proposed national tobacco settlement.
This report begins with an overview of the FDA's 1996 tobacco rule that includes a summary of
the agency's arguments for asserting jurisdiction over tobacco products. That is followed by an
analysis of the U.S. Supreme Court decision in FDA v. Brown & Williamson Tobacco
Corporation, which overturned the FDA tobacco rule. The report then reviews the 1997 proposed
national tobacco settlement, which would have codified the FDA rule and given the agency
explicit authority to regulate tobacco products as medical devices. It includes a discussion of the
FDA provisions in the McCain tobacco bill (see Table 1), which was introduced and debated in
the 105th Congress in an attempt to implement the proposed settlement. The final section of the
report summarizes the legislative history and provisions of H.R. 1108/S. 625 from the 110th
Congress (see Table 2),
For additional information on legal issues involving tobacco, seeCRS Report RL33719, Tobacco:
Selected Legal Issues, by Vanessa K. Burrows;CRS Report RS22944, Federal Trade Commission
Guidance Regarding Tar and Nicotine Yields in Cigarettes, by Vanessa K. Burrows; andCRS
Report RS22938, Rowe v. New Hampshire Motor Transport Association: Federal Preemption of
State Tobacco Shipment Laws, by Vanessa K. Burrows.
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Introduction ..................................................................................................................................... 1
FDA's 1996 Tobacco Regulation..................................................................................................... 2
FDA's Assertion of Jurisdiction over Tobacco Products ........................................................... 3
Court Challenge of the FDA Tobacco Rule..................................................................................... 5
U.S. District Court (Coyne Beahm, Inc. v. FDA) ...................................................................... 5
Federal Court of Appeals (Brown & Williamson Tobacco Corp. v. FDA)................................. 6
U.S. Supreme Court (FDA v. Brown & Williamson Tobacco Corp.)......................................... 6
1997 Proposed National Tobacco Settlement .................................................................................. 8
McCain Tobacco Bill (105th Congress) ..................................................................................... 9
FDA Tobacco Legislation from the 107th to the 110th Congresses ................................................ 12
107th Congress......................................................................................................................... 12
108th Congress......................................................................................................................... 13
109th Congress......................................................................................................................... 13
110th Congress ......................................................................................................................... 13
Table 1. Summary of McCain Tobacco Bill (105th Congress)....................................................... 15
Table 2. Family Smoking Prevention and Tobacco Control Act: Summary of S. 625 (as
reported) and Key Differences in H.R. 1108 (as reported)......................................................... 18
Author Contact Information .......................................................................................................... 25
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On February 15, 2007, Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) and
Senators Ted Kennedy (D-MA) and John Cornyn (R-TX) introduced the Family Smoking
Prevention and Tobacco Control Act (H.R. 1108, S. 625). On July 30, 2008, the House passed
H.R. 1108 by a vote of 326-102. The Senate Health, Education, Labor, and Pensions (HELP)
Committee approved S. 625 by a vote of 13-8 on August 1, 2007, but the bill did not see floor
action in the Senate. The two measures are broadly similar to each other, and to legislation
introduced in past Congresses. The legislation would create a new Chapter IX in the Federal
Food, Drug, and Cosmetic Act (FFDCA)1 giving the FDA broad new authority to regulate the
manufacture, distribution, advertising, promotion, sale, and use of cigarettes and smokeless
tobacco (i.e., snuff and chewing tobacco).
In its 1996 final rule, the Food and Drug Administration (FDA) had claimed jurisdiction over
tobacco products under the FFDCA, based on its conclusion that cigarettes and smokeless
tobacco products are delivery devices for nicotine, an addictive drug. However, in 2000, the U.S.
Supreme Court invalidated the FDA tobacco regulation. In a 5-4 decision, the Court ruled in FDA
v. Brown & Williamson that FDA does not have the authority under the FFDCA to regulate
cigarettes and smokeless tobacco products as drug-delivery devices.2 The Court based its ruling
on the finding that Congress has precluded the FDA from asserting jurisdiction over tobacco
products. According to the Court, such authority would be inconsistent with the congressional
intent clearly expressed in the FFDCA's overall regulatory scheme and in other tobacco-related
legislation. For example, the Court concluded that if the FDA asserted jurisdiction under the
FFDCA, it would have no choice but to prohibit the marketing of such harmful products. A ban
on tobacco products, argued the Court, would plainly contradict congressional policy, which
permits tobacco companies to market their products with limited oversight by the Federal Trade
Commission (FTC). In addition, the Court noted that Congress had, in enacting other tobacco-
specific legislation, repeatedly rejected proposals to grant the FDA authority over tobacco,
thereby demonstrating the intent to deny the agency such jurisdiction.
The Supreme Court's decision ended a four-year legal challenge by the tobacco industry to
overturn the FDA regulation. The ruling made it clear that Congress would have to enact
legislation giving FDA explicit statutory authority over tobacco products in order for the agency
to assert jurisdiction. Lawmakers first drafted such language in the 105th Congress and included it
in legislation that would have implemented the1997 proposed national tobacco settlement. That
legislation was debated and rejected by the Senate in 1998. Following the Supreme Court's
ruling, several lawmakers introduced FDA tobacco legislation in the 107th Congress without
subsequent legislative action.3
The Family Smoking Prevention and Tobacco Control Act was first introduced by
Representatives Davis and Waxman and Senators DeWine (R-OH) and Kennedy in the 108th
Congress (H.R. 4433, S. 2461). Its introduction followed months of negotiations in which
1
21 U.S.C. §§ 301 et seq.
2
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).
3
H.R. 1044 (Waxman); H.R. 1097 (Ganske); H.R. 2180 (Davis); S. 190 (Frist); S. 247 (Harkin); and S. 2626
(Kennedy).
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lawmakers sought to balance the competing interests of public health groups and the tobacco
industry.
This report examines the historical legislative debate over giving FDA the authority to regulate
tobacco products. It begins with an overview of the FDA's 1996 tobacco rule that includes a
summary of the agency's arguments for asserting jurisdiction over tobacco products. That is
followed by an analysis of the U.S. Supreme Court decision in FDA v. Brown & Williamson,
which overturned the FDA tobacco rule. The report then reviews the 1997 proposed national
tobacco settlement, which would have codified the FDA rule and given the agency explicit
authority to regulate tobacco products as medical devices. It includes a discussion of the FDA
provisions in the McCain tobacco bill (see Table 1), which was introduced and debated in the
105th Congress in an attempt to implement the proposed settlement. The report also includes a
summary comparing the key differences in the two tobacco bills from the 110th Congress (see
Table 2).
On August 28, 1996, the FDA issued a final rule aimed at reducing underage smoking and use of
smokeless tobacco products.4 The FDA rule included three sets of provisions: restrictions on the
sale and distribution of tobacco products to minors; limits on tobacco-product marketing and
advertising; and new labeling requirements for packaging and advertising (see box on next page).
The agency said that the purpose of the rule was to reduce the easy access to tobacco products by
minors. It also hoped to reduce the amount of positive advertising imagery used by manufacturers
to make their products appealing to minors. While the rule did not directly address adult tobacco
use, data from the National Survey on Drug Use and Health (NSDUH) suggest that over time it
would help reduce adult tobacco consumption. NSDUH data indicate that most smokers take up
the habit as teenagers. Thus, reducing the number of new teenage smokers, who are needed to
replace adult smokers that quit or die, is expected to lower overall tobacco consumption in the
future.
4
61 Fed. Reg. 44396-45318; 21 C.F.R. Parts 801, 803, 804, 807, 820, and 897.
and potentially even more dangerous products.
cigarettes would create an enormous black market, which might lead to the use of unregulated
addicts seeking assistance for withdrawal symptoms. Moreover, the agency argued, banning
option because the health care system would be overwhelmed by more than 40 million nicotine
term is generally understood, but concluded that banning tobacco products was not a realistic
addictive effects. In its rulemaking, the FDA conceded that tobacco products are "unsafe" as that
products, the agency would have no choice but to ban them because of their harmful and
used as intended. Critics of FDA's rule argued that in asserting regulatory authority over tobacco
poses a difficult challenge for regulating tobacco products, which are manifestly unsafe when
safe and effective in order to gain FDA marketing approval. The safety and effectiveness standard
Under the FFDCA, drug and device manufacturers must demonstrate that their products are both
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The FDA asserted jurisdiction over cigarettes and smokeless tobacco by concluding that nicotine
is a drug and that cigarettes and smokeless tobacco are drug-delivery devices under the FFDCA's
definitions. The statute defines a drug, in relevant part, as "... articles (other than food) intended
to affect the structure or any function of the body."5 In its rulemaking, the FDA drew on the
extensive scientific literature documenting nicotine's pharmacologic effects on the body,
including satisfaction of addiction, stimulation, and sedation. The agency also concluded that
cigarettes and smokeless tobacco are devices that deliver nicotine into the body. As with drugs,
the FFDCA's definition of medical devices includes articles that are intended by the manufacturer
to affect the structure and function of the body.6 Unlike a drug, however, a device is defined, in
part, as an article "which does not achieve its primary intended purpose through chemical
action."7
In the absence of direct claims by the manufacturers about the intended use of tobacco products,
the FDA relied on other lines of evidence in order to meet this key definitional criterion for drugs
and devices. For example, the agency considered evidence of foreseeability (i.e., a reasonable
manufacturer would foresee that consumers will use the product to satisfy nicotine addiction) and
actual consumer use (i.e., consumers use the product because they are addicted). FDA officials
combed through thousands of pages of internal tobacco company documents before concluding
that the manufacturers intended their products to be addictive.
Having made the determination that tobacco products fall under the statutory definitions of drugs
and devices, the FDA further concluded that these products are combination products since they
have components that are both a drug and a device. Under the FFDCA, the FDA is authorized to
regulate products that "constitute a combination of a drug, device, or biologic product."8 The
agency has interpreted this provision as giving it the discretion to regulate combination products
as drugs, as devices, or as biologic products.9 In its final rule, the FDA chose to regulate tobacco
products under the device provisions of the FFDCA because they offer the agency greater
regulatory flexibility than do the drug provisions of the act.10
The device authorities of the act present a range of regulatory controls that apply to all devices.
The FDA stated in its rule that these mandatory controls would apply to cigarettes and smokeless
tobacco products. They include, among others, adulteration and misbranding provisions, labeling
requirements, establishment registration, device listing and premarket notification, recordkeeping
and reporting requirements, and good manufacturing practices. The act also requires the agency to
classify each device based upon the degree of risk it poses to the user as well as other regulatory
concerns and unique qualities of the device. The FDA indicated in the final rule that it would
classify cigarettes and smokeless tobacco as either Class I, II, or III devices at some point in the
future. The agency further stated that when classification was determined, it would impose any
additional requirements that were appropriate.11
5
21 U.S.C. § 321(g)(1)(C); FFDCA § 201(g)(1)(C) (emphasis added).
6
21 U.S.C. § 321(h)(3); FFDCA § 201(h)(3).
7
21 U.S.C. § 321(h); FFDCA § 201(h).
8
21 U.S.C. § 353(g); FFDCA § 503(g).
9
61 Fed. Reg. 44396, 44400 (1996).
10
Id. at 44403.
11
Class I devices (e.g., elastic bandages, manual surgical instruments) present minimal harm to the user and are only
subject to general controls, such as manufacturer registration, and labeling. Class II devices (e.g., cardiac pressure
monitors, powered surgical instruments) are those for which general controls alone are insufficient to assure safety and
(continued...)
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In addition to mandatory controls, the FFDCA contains various discretionary provisions that
apply to devices under certain circumstances. The FDA predicated its authority to regulate
tobacco products on one such provision regarding restricted devices. The act's restricted device
provision states, in relevant part, that "[t]he Secretary may by regulation require that a device be
restricted to sale, distribution, or use . . . upon such other conditions as the Secretary may
prescribe in such regulation, if, because of its potentiality for harmful effect or the collateral
measures necessary for its use, the Secretary determines that there cannot otherwise be
reasonable assurance of its safety and effectiveness."12
In the final tobacco rule, the FDA relied on the FFDCA's restricted device provision when it
concluded that, because of the harmful effects of cigarettes and smokeless tobacco and in the
absence of a reasonable assurance of the safety and effectiveness of such products, it needed to
implement additional restrictions on tobacco access and advertising in order to prevent new users
from becoming addicted.13 As a result, the FDA used its restricted device authority to limit youth
access to tobacco products. Agency officials also concluded that the authority under the FFDCA's
restricted device provision was broad enough to permit the FDA to restrict tobacco-product
marketing and advertising. It reasoned that without advertising restrictions, the access restrictions
would be substantially diminished if manufacturers were "free to entice children and adolescents
to circumvent the access restrictions."14
The tobacco companies filed a lawsuit against the FDA and sought summary judgment on the
grounds that the FDA lacked the authority to regulate tobacco products when such products are
marketed and sold without explicit claims of therapeutic benefit. The lawsuit further charged that
the FDA exceeded its statutory authority because the FFDCA does not authorize the FDA to
regulate tobacco products as drugs or devices.15 Finally, the companies argued that the rule's
advertising restrictions, which limited advertisements to which children are exposed to a black-
on-white, text-only format, violated the First Amendment protection of commercial speech.
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On April 25, 1997, a North Carolina federal district court ruled in favor of the FDA, holding that
the agency had acted appropriately under the FFDCA when it classified nicotine as a drug and
tobacco products as drug-delivery devices.16 However, while the court upheld the rule's access
(...continued)
effectiveness. In addition to complying with general controls, Class II devices are also subject to special controls, such
as additional labeling requirements, mandatory performance standards, and postmarket surveillance. Class III devices
(e.g., replacement heart valves, breast implants) present the greatest potential for risk of illness or injury and are subject
to the most stringent regulatory control. They require premarket approval by FDA--a process that involves a
comprehensive agency review of their safety and effectiveness--unless they are substantially equivalent to a device
already on the market.
12
21 U.S.C. § 360j(e); FFDCA § 520(e) (emphasis added).
13
61 Fed. Reg. 44396, 44405.
14
61 Fed. Reg. 44406-07.
15
Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (M.D.N.C. 1997).
16
Id.
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restrictions and labeling requirements, it ruled that the FDA did not have the authority to restrict
tobacco advertising and promotion. The court permitted the two youth access provisions that had
taken effect prior to its ruling to remain in effect, but delayed implementation of the rule's other
provisions, pending further action by the court.17 Both sides appealed the district court's ruling.
On August 14, 1998, a three-judge panel of the U.S. Court of Appeals for the Fourth Circuit
overturned the lower court's decision and ruled that the FDA lacked the statutory authority to
regulate tobacco products.18 The court held that the decision to regulate cigarettes as a restricted
device rather than as a drug, in order to avoid having to ban them, was "... obvious sophistry,
[which] reinforces the conclusion that regulation of tobacco products under the Act was not
intended by Congress."19 The court's decision was stayed pending further appeal.
On November 10, 1998, in a 6-3 decision, the full appellate court rejected the Administration's
request to reconsider the ruling.20 The Justice Department filed a Petition for a Writ of Certiorari
with the U.S. Supreme Court on January 19, 1999, requesting that the court review the Fourth
Circuit ruling and find that the FDA has full statutory authority both to regulate tobacco products
and to issue all the provisions of the 1996 tobacco rule. The Supreme Court accepted the case and
ultimately upheld the Fourth Circuit's decision.
On March 21, 2000, the U.S. Supreme Court, in a 5-4 decision written by Justice Sandra Day
O'Connor, affirmed the ruling of the appeals court that the FDA does not have the authority to
regulate tobacco products as drug-delivery devices.21 Although the majority opinion
acknowledged the public health threat posed by tobacco use, the Court concluded that "Congress
has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such
authority is inconsistent with the intent that Congress has expressed in the [FFDCA's] overall
regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the
[FFDCA]."22
In reaching its decision, the Court examined the FDA tobacco rule in light of the precedents that
govern cases involving an agency's construction of a statute that it administers. As part of such a
review, the Court must determine whether an agency's interpretation of its statute is entitled to
deference and presents a reasonable or permissible construction of the law. Chevron U.S.A. v.
NRDC is the leading case on judicial review of agency interpretations of statutes.23 This case
17
The two youth access provisions were: (i) no sales to individuals under age 18; and (ii) photo ID required as a
condition of sale for all individuals under age 27.
18
Brown & Williamson Tobacco Corp. v. FDA, 153 F. 3d. 155 (4th Cir. 1998).
19
Id. at 165.
20
Brown & Williamson Tobacco Corp. v. FDA, 161 F.3d 764 (4th Cir. 1998).
21
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).
22
Id. at 126.
23
467 U.S. 837 (1984).
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involved EPA's rules regulating emissions under the Clean Air Act. In Chevron, the Court
enunciated a two-step test for judicial review of an agency's interpretation of its statute: (1) has
Congress spoken directly to the precise question at issue? and; (2) if Congress has not done so
and the statute is silent or ambiguous with respect to the specific issue, is the agency's answer
based on a permissible construction of the statute?24
Under Chevron step one, if Congress has spoken directly to the question at issue, then Chevron
deference is not due and the Court "must give effect to the unambiguously expressed intent of
Congress."25 In this case, the Court examined both the FFDCA and other tobacco-related statutes,
ultimately concluding that Congress had clearly intended to preclude the FDA from regulating
tobacco. As a result, the Court did not need to reach step two of Chevron. In reaching its decision,
the Court relied on a number of factors. First, the Court found that, because tobacco is a
dangerous product and because the FFDCA prohibits the marketing of products that have not
been found to be safe and effective, the statute would require the FDA to ban tobacco products if
the agency did indeed have jurisdiction over such products. Such a ban, argued the Court, would
plainly contradict the congressional intent reflected in the enactment of several pieces of
legislation that clearly contemplate the continued marketing of tobacco products.26 Thus, the
Court held that Congress had clearly "intended to exclude tobacco products from the FDA's
jurisdiction."27
In addition, the Court found that the FDA had repeatedly denied that it had jurisdiction over
tobacco and that Congress had repeatedly rejected bills that would have granted the agency such
authority.28 Instead, Congress had demonstrated its intent to create a distinct regulatory scheme
for tobacco by enacting other tobacco-related regulatory statutes, such as the Federal Cigarette
Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education
Act.29 The Court cited these tobacco-related statutes as additional evidence in support of its
conclusion that Congress had intended to preclude the FDA from regulating tobacco.30
Writing in dissent, Justice Stephen Breyer argued that cigarettes and other tobacco products
clearly fall within the plain meaning of the statutory definition of drugs and devices because such
products are intended to affect the structure and function of the body. In addition, the dissent
argued that the purpose of the FFDCA--to protect the public health--also supported the
24
Id. at 842-43.
25
Id. at 843.
26
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 134-43 (2000). Examples of such tobacco-related
legislation include the Federal Cigarette Labeling and Advertising Act (P.L. 89-92, 15 U.S.C. §§ 1331 et seq.); the
Public Health Cigarette Smoking Act of 1969 (P.L. 91-222, 15 U.S.C. §§ 1331 et seq.); the Comprehensive Smoking
Education Act (P.L. 98-474, 15 U.S.C. §§ 1331 et seq.); the Comprehensive Smokeless Tobacco Health Education Act
of 1986 (P.L. 99-252, 15 U.S.C. §§ 4401 et seq.); and the Alcohol, Drug Abuse, and Mental Health Administration
Reorganization Act (P.L. 102-321, § 202, 42 U.S.C. § 300x-26).
27
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 143 (2000).
28
According to the tobacco companies, beginning in 1906 and as recently as 1993, Congress rejected any legislation
designed to give the FDA jurisdiction over tobacco. Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (M.D.N.C. 1997)
(No. 2:95CV00591), at 6-11 (First Amended Complaint for Declaratory and Injunctive Relief).
29
These statutes, both of which are administered by the FTC, require health warnings on cigarette and smokeless
tobacco packages and advertising, respectively.
30
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, at 143-156.
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conclusion that the FDA was authorized to regulate tobacco products. For these reasons, the
dissent would have upheld the FDA's jurisdiction over such products.31
The Supreme Court's decision clarifies that the FDA cannot assert jurisdiction over cigarettes and
other tobacco products unless Congress enacts legislation to give the agency unambiguous
statutory authority over such products. Lawmakers first drafted such language during the 105th
Congress and included it in the comprehensive tobacco legislation that was introduced in an effort
to implement the 1997 proposed national tobacco settlement.
On June 20, 1997, a group of state attorneys general announced that they had reached an
agreement with the tobacco companies to settle the state tobacco lawsuits.32 Forty-one states and
Puerto Rico had sued the tobacco industry seeking to recover the costs, primarily Medicaid
expenditures, of treating smoking-related diseases. Under the proposed national settlement, the
industry agreed to pay $368.5 billion over the first 25 years, and $15 billion a year thereafter, to
reimburse states for their tobacco-related medical costs and pay for tobacco-control programs to
reduce tobacco use among teenagers. In addition to settling the state lawsuits, the proposed
settlement would have terminated all pending class-action lawsuits and nicotine addiction claims,
and provided the companies with immunity from such lawsuits in the future.
The proposed settlement incorporated all the provisions of the FDA tobacco rule and included
additional restrictions on marketing and advertising, as well as new warning labels. It also
proposed amending the FFDCA to classify tobacco products as Class II devices and give FDA the
authority to reduce or eliminate harmful compounds added to tobacco products or found in
smoke. A summary of the key provisions in the proposed national settlement is provided in the
box on the next page.
Public health officials criticized the restrictions the proposed settlement would have placed on
FDA's ability to regulate nicotine. For example, any proposal by the agency to reduce nicotine
yields or eliminate other harmful ingredients in cigarettes would have required formal rulemaking
with judicial review, instead of the informal, notice-and-comment rulemaking that is typically
used by federal agencies to promulgate regulations. Formal rulemaking, which is seldom used
today, involves trial-type hearings before an administrative judge, at which parties present
evidence and conduct cross-examinations. It is a rigorous and lengthy process that places a
considerable burden of proof on the agency.33 The FDA also would have been required to show
31
Id. at 161-64.
32
The full text of the June 1997 proposed national tobacco settlement is available online at http://www.stic.neu.edu/
settlement/6-20-settle.htm.
33
Most federal regulations are issued under the notice-and-comment procedure established by the Administrative
Procedure Act (5 U.S.C. §§ 551 et seq.). The agency publishes a notice of proposed rulemaking in the Federal
Register, solicits public comment, and incorporates in the final rule a concise statement about the rule's basis and
purpose. Courts review such rules under the "arbitrary, capricious, and abuse of discretion" standard, generally
upholding an agency's action if it is found to be rational, based on a consideration of the relevant factors, and within
the scope of the authority designated to the agency by Congress. Formal rulemaking, by contrast, is a more rigorous
and time-consuming process that tends to place a greater burden of proof on the agency promulgating the rule. Under
the proposed national settlement, the FDA would have had to show "substantial evidence" in support of its cigarette
performance standards, which is a more stringent standard than the arbitrary, capricious, and abuse of discretion
standard.
tobacco-control policy. Because the proposal included changes to the FFDCA and other federal
The proposed national settlement was presented to Congress as a blueprint for a comprehensive
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.noillib 5.863$ = sraey 52 tsrif revo
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a.tnemdnemA ranyS eht fo esoht no dednapxe snoisivorp ehT .sdnuf tnemelttes gnisol
ksir ro stcudorp occabot rof swal elas-fo-ega-muminim rieht ecrofne ot setats deriuqeR .swaL sseccA htuoY etatS
.tem ton era stegrat fi raey a noillib 2$ ot pu yrtsudni deniF .sraey 01 ni %06 ;sraey evif
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.esu fo snoitidnoc
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.stcudorp deifidomnu
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laiciduj htiw gnikam elur lamrof gnidulcni ,stcudorp occabot morf enitocin gnitanimile ro gnicuder rof stnemeriuqer
yrotaluger tcirts dehsilbatsE .gnigakcap dna gnisitrevda ni segami nootrac dna namuh fo esu eht gnitibihorp
dna ,gnisitrevda roodtuo dna senihcam gnidnev lla gninnab yb noitaluger s'ADF eht dednetxE .slebal gninraw
ticilpxe deriuqer ;stneve rehto dna gnitrops fo pihsrosnops eman-dnarb detibihorp ;strihs eet dna stah sa hcus smeti
occabot-non lanoitomorp fo noitubirtsid ro elas eht detibihorp ;tamrof ylno-txet ,etihw-no-kcalb ot desopxe era
nerdlihc hcihw ot gnisitrevda detimil ;ega yfirev ot DI otohp deriuqer ;81 ega rednu snosrep ot stcudorp occabot fo
elas detibihorp :)798 RFC 12( elur occabot 6991 s'ADF fo snoisivorp gniwollof eht detaroprocnI .noitalugeR ADF
)7991 ,02 enuJ( tnemeltteS occaboT lanoitaN desoporP fo yrammuS
seeking to eliminate its products.
FDA's authority by claiming that they represented reasonable constraints on an agency that was
eliminate nicotine from tobacco products. The tobacco companies defended those restrictions on
for unmodified products. Finally, the FDA would have to wait 12 years before proposing to
that the proposed modification significantly reduced health risks and did not create a black market
¢ ¢
http://www.naag.org/issues/issue-tobacco.php. NAAG is responsible for implementing and enforcing the MSA.
The full text of the MSA is available on the website of the National Association of Attorneys General (NAAG), at 34
.171-701 .L.P ".7991 fo tnemeergA tnemeltteS retsaM eht fo sesahp
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.72 ta ,7002 .raM ,lanruoJ .A.B.A ,ekomS ni pU ,nedirruC kraM b
.)B()2()d(b6931 § .C.S.U 24
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laredef eht wal yb ,stsoc lacidem s'etats hcae fo %05 tsael ta rof syap tnemnrevog laredef eht esuaceB .sdnuf
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a fI .1303 § tcA snoitairporppA latnemelppuS ycnegremE 9991YF .sdnuf diacideM fo stnemesrubmier yna
fo erahs sti tnemnrevog laredef eht tnarg naht rehtar ,seinapmoc occabot sa hcus ,seitrap driht morf eviecer
yeht stnemesrubmier peek ot setats eht swolla hcihw ,0002 ni 13-601 .L.P detcane ssergnoC ,yltneuqesbuS a
d.stcejorp rehto ot %8.7 detacolla dna ;%9.11 detacolla ton
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%6 ;sesoprup lareneg ot %1.7 ;sllaftrohs tegdub sdrawot %9.22 ;slatipsoh dna ,ecnarusni htlaeh ,diacideM gnidulcni
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,noitneverp edulcni ot stroffe sa senifed ti hcihw ,lortnoc occabot no ssel neve tneps evah setats taht etacidni serugif
eciffO ytilibatnuoccA tnemnrevoG b.lanruoJ noitaicossA raB naciremA eht yb elcitra 7002 hcraM a ot gnidrocca
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.)snoitcirtser
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7991 eht ot ecnalbmeser laicifrepus a erob ti hguohtlA .)8991/8/5 ,NM ;8991/61/1 ,XT ;7991/52/8 ,LF ;7991/3/7
,SM( sraey 52 revo noillib 04$ gnilatot stnemyap rof dellac taht yrtsudni eht htiw stnemelttes laudividni ,reilrae
dehcaer dah ASM eht ot ytrap ton erew taht setats ruof ehT .sraey 52 tsrif eht revo noillib 602$ yletamixorppa yap ot
seinapmoc eht deriuqer ASM ehT a.sesnepxe lacidem detaler-occabot tsap rof tnemesrubmier sa ytiuteprep ni setats
eht ot stnemyap launna ekam ot deerga seinapmoc ehT .)ynapmoC occaboT dralliroL dna ,.proC occaboT nosmailliW
& nworB ,ynapmoC occaboT sdlonyeR .J.R ,.cnI sirroM pilihP( seinapmoc etteragic rojam ruof eht htiw tnemeerga
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)ASM( tnemeergA tnemeltteS retsaM occaboT
over tobacco products (see box below).
Agreement, or MSA--to settle the state lawsuits.34 The MSA did not address FDA's authority
with the states and, in November 1998, signed a contractual agreement--the Master Settlement
debate. Following the demise of S. 1415, the major cigarette companies resumed negotiations
(S. 1415) was defeated on a pair of procedural votes on June 17, 1998, after an extended floor
by the 105th Congress to pass legislation to implement the settlement ended when the McCain bill
statutes, it would have required congressional legislative action in order to take effect. Attempts
¢ ¢
¢ ¢
Table 1 provides a summary of the major provisions of the McCain tobacco bill. Although the
measure was intended to implement the proposed national settlement, it was tougher on the
industry in several key respects. S. 1415 would have cost the companies $516 billion over the
first 25 years, an amount significantly higher than the figure agreed to in the proposed settlement
(i.e., $368.5 billion). It included stiffer financial penalties if the decline in underage tobacco use
did not meet the reduction targets, and it also provided the industry with fewer legal protections
than those negotiated in the June 1997 agreement.
The McCain bill also added a new Chapter IX to the FFDCA solely for the regulation of tobacco
products. That language, which was provided by Senator Frist, drew extensively on the act's
existing drug and device provisions in Chapter V, but with modifications.35 By establishing new
legal authority within the FFDCA for regulating tobacco products, the bill's sponsors sought to
address the unique challenges tobacco products present and avoid the safety and effectiveness
standard that applies to the regulation of drugs and devices. Under the new language, FDA would
be required to demonstrate that any proposed tobacco regulation was appropriate for the
protection of public health. Such a determination would involve a consideration of the risks and
benefits to the population as a whole.
The tobacco companies opposed S. 1415 and launched a $40 million advertising campaign that
helped defeat it. They portrayed the legislation as nothing more than a massive tax increase to pay
for new government spending. During the Senate floor debate, which stretched over four weeks
(May 18-June 17, 1998), lawmakers focused on where the bill's revenues should go, how to
compensate tobacco growers, and whether to limit the fees of private attorneys who were retained
by the states. Amendments were added to the bill to eliminate the so-called marriage income tax
penalty, boost funding for anti-drug programs, and cap attorneys' fees. There was no debate on
the bill's FDA provisions.
Public health officials supported many of the McCain bill's tobacco-control provisions, but were
critical of the measure's FDA provisions. They feared that the agency's attempts to implement the
new law would be blocked at every turn by lengthy legal challenges from the industry. Instead,
they sided with the FDA's arguments for asserting jurisdiction under existing law (i.e., FFDCA's
Chapter V device provisions). In its rulemaking the agency concluded that the device provisions,
which have been interpreted in case law, regulation, and agency practice for over two decades,
have established a comprehensive regulatory scheme that is appropriate for regulating tobacco
products.
Several other comprehensive tobacco bills were introduced in the 105th Congress, though none of
them saw any legislative activity.36 The bills, which were supported by the public health
community and opposed by the industry, would have given FDA explicit authority to regulate
tobacco products under the FFDCA's Chapter V drug and device provisions. In each case, the
legislation amended the act's definitions of drugs and devices to include nicotine and tobacco
products, respectively, and authorized the agency to regulate tobacco products using a standard of
35
The Frist language incorporated, with modifications, the following FFDCA drug and device provisions: adulterated
drugs and devices (§ 501); misbranded drugs and devices (§ 502); device manufacturer registration (§ 510);
performance standards (§ 514); premarket approval (§ 515); judicial review (§ 517); notification and recall (§ 518);
records and reports (§ 519); general provisions respecting control of devices intended for human use (§ 520);
preemption of state and local requirements (§ 521); and postmarket surveillance (§ 522).
36
S. 1492 (Kennedy); S. 1530 (Hatch); S. 1638 (Conrad); S. 1889 (Harkin); H.R. 3028 (DeLauro); H.R. 3474 (Fazio);
H.R. 3868 (Hansen).
¢ ¢
protecting the public health. By avoiding having to regulate tobacco products based on safety and
effectiveness, the agency would have been able to keep such unhealthful products on the market.
For more details, see CRS Report 98-6, Tobacco Legislation in the 105th Congress.
This section of the report includes a brief description of the tobacco legislation introduced in the
107th Congress (2001-2002) in the wake of the Supreme Court decision, followed by a summary
of tobacco legislation introduced in the 108th to the 110th Congresses.
Several FDA tobacco bills were introduced in the 107th Congress, none of which saw any
legislative action. Four bills (i.e., S. 190 (Frist), S. 2626 (Kennedy), S. 2764 (Miller), and H.R.
2180 (Tom Davis)) adopted the same approach as the McCain legislation. They would have
created a new FFDCA Chapter IX solely for the regulation of tobacco products. Senator
Kennedy's bill (S. 2626) was almost identical to the FDA provisions in the McCain bill. The three
other bills included many of the same provisions. However, they contained a few small but
significant changes that were intended to address industry concerns over the extent of FDA's
regulatory control. For example, all three measures specified that FDA could not compel the
industry to change the composition of its products in ways that would render them "unacceptable
for adult consumption." They also required the agency to show that any proposal to restrict the
sale, distribution, advertising, and promotion of tobacco products was based on a determination
that such regulation "would be appropriate for the prevention of, or decrease in, the use of
tobacco products by children...." Finally, all three measures reserved for Congress--not FDA--
the authority to eliminate nicotine or ban tobacco products.
In addition to giving FDA new regulatory authority over tobacco products, H.R. 2180 also
contained restrictions on youth access, advertising, and marketing that were broadly similar to
those included in the McCain bill. The provisions in H.R. 2180 were subsequently incorporated
into Representative McIntyre's bill (H.R. 3940) to eliminate tobacco quotas and the price support
loan program and compensate quota owners and active growers. S. 2764 also contained
substantially similar buyout provisions.
The three remaining FDA tobacco bills introduced in the 107th Congress (i.e., S. 247 (Harkin),
H.R. 1044 (Waxman), and H.R. 1097 (Ganske)), rather than creating new legal authority for
regulating tobacco products, would have given FDA the authority to regulate tobacco products as
drug-delivery devices under Chapter V of the FFDCA. This approach was favored by some public
health advocates, but strongly opposed by the industry. As with the earlier versions introduced
during the 105th Congress, each of these bills merely amended the definitions of drugs and
devices to include nicotine and tobacco products, respectively, and specified that tobacco
regulation would be based on a general standard of protecting the public health. Additionally, the
three measures would have made effective all the provisions of the 1996 FDA tobacco rule.
¢ ¢
At the beginning of the 108th Congress, Representatives McIntyre and Tom Davis reintroduced
their tobacco legislation (H.R. 140). The measure combined a buyout for quota owners and active
growers with FDA regulatory authority. H.R. 140 was supported by Philip Morris but opposed by
the public health community. In the Senate, negotiations among members of the Committee on
Health, Education, Labor, and Pension (HELP) to draft a compromise bill that had the support of
both sides came to a standstill in October 2003. Anti-smoking advocates and their congressional
supporters criticized the draft legislation for failing to give FDA sufficient authority to protect
public health.
Negotiations resumed in early 2004 and on May 20 Senators DeWine and Kennedy and
Representatives Tom Davis and Henry Waxman introduced the Family Smoking Prevention and
Tobacco Control Act (S. 2461, H.R. 4433). Both Philip Morris and the Campaign for Tobacco-
Free Kids announced their "enthusiastic" support for the legislation. On July 15, Senator DeWine
introduced the text of S. 2461 as an amendment to the American Jobs Creation Act of 2004 (H.R.
4520, P.L. 108-357), which was under consideration on the Senator floor. The amendment passed
by a vote of 78-15. However, during the conference on H.R. 4520, the House conferees on
October 6 rejected the DeWine amendment. Following its rejection by the conference committee,
Senators DeWine and Kennedy reintroduced the legislation with a new bill number (S. 2974) on
October 10. The measure was passed on the Senate floor that same day without amendment by
unanimous consent. No further action was taken by either chamber.
Senators DeWine and Kennedy and Representatives Davis and Waxman reintroduced the Family
Smoking Prevention and Tobacco Control Act on March 17, 2005. There was no legislative action
taken on the legislation during the 109th Congress.
Representatives Waxman and Davis and Senators Kennedy and Cornyn introduced H.R. 1108 and
S. 625, respectively, on February 15, 2007. As introduced the legislation was nearly identical to
H.R. 4433 and S. 2461 of the 108th Congress. While the two bills, as reported, remained broadly
similar, there were a number of significant differences between them. Table 2, beginning on page
19, summarizes the provisions in S. 625 and indicates key differences in H.R. 1108.
On August 1, 2007, the Senate HELP Committee adopted a handful of amendments to S. 625 and
approved the measure (as amended) by a vote of 13-8. On April 2, 2008, the House Energy and
Commerce Committee took up a manager's amendment to H.R. 1108, which included several
provisions intended to address the concerns of various stakeholder groups. The Committee then
adopted three additional amendments before approving the bill (as amended) by a vote of 38-12.
The House passed H.R. 1108 on July 30, 2008, by a vote of 326-102.
The Bush administration and the FDA Commissioner, Andrew von Eschenbach, had indicated
concerns regarding the legislation, specifically that the bill would be "creating a false impression
¢ ¢
that regulated tobacco products were safe,"37 and "that this will actually encourage individuals to
smoke more rather than less."38 Additionally, the Secretary of Health and Human Services had
stated in a July 21, 2008 letter that the Bush Administration "would strongly oppose this
legislation."
37
Stephanie Saul, Bill to Regulate Tobacco as a Drug Is Approved by a House Committee, N.Y. Times, Apr. 3, 2008,
at C3.
38
H.R. 1108, Family Smoking Prevention and Tobacco Control Act, Hearing Before the Subcomm. on Health of the H.
Comm. on Energy and Commerce, 110th Cong. (Oct. 3, 2007) (written statement of Andrew C. von Eschenbach,
Commissioner of Food and Drugs, FDA), http://www.fda.gov/ola/2007/tobacco100307.html.
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noitartsiger
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dna sronim ot elbissecca era taht seitilicaf ni gnisitrevda elas-fo-tniop rof tamrof etihw-no-kcalb seriuqeR .gnisitrevda elas-fo-tniop fo tnemecalp
dna ezis stimiL .stcudorp occabot rof seman dnarb ro edart occabot-non tnecer fo esu stibihorp ;stneve larutluc dna gnitrops fo pihsrosnops
eman-dnarb stibihorp ;seman dnarb gniraeb esidnahcrem occabot-non lanoitomorp stibihorp ;sronim ot laeppa taht aidem ni esu occabot
eziromalg ot gniyap stibihorp ;semag oediv ro ,VT ,seivom ni stcudorp occabot fo tnemecalp rof gniyap stibihorp ;sronim ot elbisseccani si etis snoitcirtser
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]101 noitceS[ .slortnoc htlaeh cilbup
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tekramtsop rof sedivorP .sdradnats ecnamrofrep ekover ro eussi ot snoitca yrotaluger fo weiver laiciduj rof sedivorP .stcudorp wen fo
lavorppa tekramerp seriuqeR .stnemeriuqer gnitroper yrtsudni fo tnemhsilbatse eht rof sedivorP .sksir htlaeh suoires esop taht stcefed yranidro
-eht-fo-tuo niatnoc taht stcudorp fo llacer eht sezirohtuA .stcudorp occabot nab ro enitocin etanimile ot lasoporp yna fo weiver lanoissergnoc
raey-owt seriuqeR .tceffe ekat sdradnats wen erofeb yaled raey-eno a seriuqeR .tekram kcalb a fo tnempoleved dna noitpmusnoc no dradnats
ecnamrofrep fo tcapmi fo noitaredisnoc gnidulcni ,gnikamelur tnemmoc dna eciton setadnam :htlaeh cilbup tcetorp ot redro ni tcudorp
eht fo noitisopmoc eht yfidom esiwrehto ro enitocin etanimile/ecuder ot sdradnats ecnamrofrep fo )noitacover dna( noitpoda sezirohtuA
.snoitadnemmocer s'eettimmoc yrosivda tcudorp occabot a ot tcejbus ,noitaluger ecitcarp gnirutcafunam doog rof sedivorP .htlaeh cilbup
tcetorp ot redro ni stcudorp occabot fo esu dna ,noitomorp ,gnisitrevda ,noitubirtsid ,elas eht fo noitaluger sezirohtuA .seitilicaf fo noitcepsni
lainneib dna srerutcafunam lla fo noitartsiger launna seriuqeR .stcudorp wen fo esaeler ro stcudorp deifidom fo noitacifiton seriuqeR .enitocin )ACDFF(
fo mrof dna ,dleiy ,tnetnoc eht fo noitpircsed a dna stneidergni dedda lla fo stnuoma eht fo tsil a yllaunna timbus ot srerutcafunam seriuqer tcA citemsoC dna ,gurD
,dnarb hcae roF .stcudorp occabot dednarbsim dna detaretluda senifeD .stcudorp occabot gnitaluger rof XI retpahC ACDFF wen setaerC ,dooF laredeF fo tnemdnemA
a)niaCcM( 5141 .S cipoT
)ssergnoC ht501( lliB occaboT niaCcM fo yrammuS . 1 elbaT
¢ ¢
]7011-1011 snoitceS[ .seirtnuoc ngierof yb occabot no snoitcirtser yrotanimircsidnon fo lavomer kees ot
ro stropxe occabot .S.U etomorp ot sdnuf laredef fo esu stibihorP .)ry/noillim 053$( stroffe lortnoc-occabot lanoitanretni rof gnidnuf sedivorP lortnoc occabot lanoitanretnI
snoitca
]5 noitceS[ .serusaem lortnoc tcudorp-occabot lanoitidda yna ecrofne dna tpoda ot stnemnrevog lacol dna etats swollA lacol dna etats fo noitpmeerP
]306-106 snoitceS[ .sreliater occabot labirt fo gnisnecil seriuqeR .tca eht fo stnemeriuqer eht morf sesu occabot lanoitidart dna suoigiler labirt
stpmexE .sdnal labirt no ylppa stcudorp occabot fo elas dna ,noitubirtsid ,erutcafunam eht ot gnitaler tca siht fo stnemeriuqer eht taht sedivorP snaciremA evitaN
]VX eltiT[ .stnanet etasnepmoc dna srenwo atouq tuo yub ot dnuf noillib 81$ na sehsilbatse ,margorp troppus ecirp occabot
laredef eht setanimreT )2( ]X eltiT[ .stimrep elbarefsnartnon htiw satouq deruc-eulf secalper ,margorp troppus ecirp occabot yelrub sniatniam
,seitinummoc rieht dna sremraf occabot ot ecnatsissa laicnanif edivorp ot dnuf noillib 5.82$ a sehsilbatsE )1( :seltit gnitepmoc owt setaroprocnI sremraf occaboT
]3041
,909-109 snoitceS[ .cilbup stnemucod degelivirp hcus gnikam revo setupsid elttes ot lenap seriuqeR .ycerces edart ro egelivirp tneilc-yenrotta
tressa yeht hcihw rof stnemucod lla fo lenap egduj-eerht a ot )gol deliated gniynapmocca htiw( noissimbus etarapes a ekam ot srerutcafunam
seriuqeR .tca eht ni deificeps stnemucod lla ADF ot timbus ot srerutcafunam seriuqeR .yrotisoped tnemucod occabot cilbup a sehsilbatsE stnemucod yrtsudnI
]2141-6041 snoitceS[ .esu occabot yb desuac era sesaesid niatrec dna evitcidda si enitocin taht noitpmuserp yraitnedive na hsilbatse ot ecnedive
fo elur seifidoM .noillib 8$ ta ytilibail launna latot spaC .smialc noitcidda stibihorp dna stiuswal noitca-ssalc 'srekoms seltteS .dnuF tsurT eht
morf stnemyap ogrof dna stiuswal rieht htiw eunitnoc ot tpo ro ,dnuF tsurT eht morf gnidnuf rof nruter ni stiuswal rieht elttes ot setats swollA ytinummi lageL
]3141 noitceS[ .rh/000,4$ ot seef stimiL .srerutcafunam
gnitapicitrap yb diap eb ot sdrawA .sesnepxe dna seef 'syenrotta ffitnialp drawa dna enimreted ot lenap noitartibra nosrep-eerht a sehsilbatsE seef 'syenrottA
]5041-2041 snoitceS[ .tca eht fo snoisivorp eht setaloiv taht ynapmoc yna )woleb ees( pac ytilibail launna morf
sedulcxE .)stnemyap launna ,snoitcirtser elas-fo-tniop dna gnisitrevda ,erusolcsid tnemucod ,ytirohtua yrotaluger ADF ,.g.e( tca eht fo snoisivorp
eht fo ynam ecrofne ot seerced tnesnoc gnidnib yllagel tub ,yratnulov otni retne ot tnemnrevog laredef eht dna ,setats ,srerutcafunam seriuqeR eerced tnesnoC
]554-154 snoitceS[ .sremraf occabot ot ecnatsissa laicnanif edivorp ot %61 dna ,hcraeser lacidemoib rof sdnuf tsurt fo noitacolla
%22 ,smargorp lortnoc-occabot rof %22 ,stsoc lacidem detaler-gnikoms rof setats esrubmier ot dnuF tsurT eht ni tnuoma eht fo %04 setacollA dna tnemesrubmier etatS
]604-104 snoitceS[ .)eciffO tegduB lanoissergnoC yb detamitse( noillib 615$
= sraey 52 tsrif revo eunever ten latoT .2002 ni gninnigeb tnemtsujda selas-fo-emulov a ot tcejbus dna ,raey htxis eht ni gninnigeb tnemtsujda dnuF tsurT occaboT lanoitaN
noitalfni ot tcejbus stnemyap launnA .dnuF tsurT otni stnemyap yrtsudni elbitcuded-xat setadnaM .dnuF tsurT occaboT lanoitaN sehsilbatsE ot stnemyap yrtsudnI
]705
-105 snoitceS[ .swal retcirts tcane ot stnemnrevog lacol dna etats swollA .nwo rieht fo wal tnegnirts erom ro ralimis a evah yeht fi tuo tpo yam
setatS .snosirp dna ,steltuo occabot ,srolrap ognib ,sonisac ,smoor tseug letoh ,sbulc etavirp ,srab ,)doof tsaf naht rehto( stnaruatser stpmexE
.saera gnikoms retne ot deriuqer eb ton yam seeyolpme taht seificepS .saera gnikoms detangised ,detalitnev yletarapes ,desolcne ot ,sgnidliub seitilicaf
desael ro denwo yllaredef gnidulcni ,)keew a yad eno tsael ta slaudividni erom ro 01 yb deretne esoht ,.e.i( seitilicaf cilbup ni gnikoms stcirtseR cilbup ni snoitcirtser gnikomS
]602-502 snoitceS[ .raey a noillib 5$ ta deppac seitlanep cificeps-rerutcafunam ;raey a noillib 2$ ta deppac seitlanep ediw
-yrtsudnI .tem ton era esu egarednu rof stegrat noitcuder fi )elbitcuded-xat ton( seitlanep cificeps-rerutcafunam dna ediw-yrtsudni setadnaM seitlanep yrtsudnI
a)niaCcM( 5141 .S cipoT
¢ ¢
.ylpmoc ot eruliaf rof sdnuf tnarg kcolb esuba ecnatsbus laredef
gnisol ksir setatS .wal eht htiw ecnailpmoc erusne ot steltuo liater fo snoitcepsni decnuonnanu ,modnar tcudnoc tsum setatS .81 ega rednu slaudividni ot stcudorp
occabot fo elas eht gnitibihorp swal rieht ecrofne ot setats seriuqer )031.69 .R.F.C 54 ;62-x003 .C.S.U 24( tcA ecivreS htlaeH cilbuP eht ot tnemdnemA ranyS ehT .d
.)1044 .C.S.U 51( tcA noitacudE htlaeH occaboT sselekomS evisneherpmoC )ii( ,)1331 .C.S.U 51( tcA gnisitrevdA dna gnilebaL etteragiC laredeF )i( .c
.pihsredaer latot eht fo %51 naht erom etutitsnoc 81 ega rednu sredaer taht ro ,81 ega rednu sredaer noillim 2 tsael ta gnivah sa denifed si pihsredaer htuoy tnacifingiS .b
.8991 ,71 enuJ--81 yaM :roolf etaneS eht no etabed gnirud dednema sa ,llib etutitsbus eettimmoc deifidoM .a
]1031 noitceS[ .erac htlaeh 'snaretev detaler-occabot rof dnuF tsurT eht morf sraey evif rof ry/noillim 006$ sedivorP snareteV
]0411-1311 snoitceS[ .stcudorp occabot lla edulcni ot tcA gnikciffarT etteragiC dnabartnoC sdnema
dna snehtgnertS .stnempihs tropxe tcudorp-occabot lla rof troper a timbus ot srotubirtsid dna srerutcafunam seriuqeR .segakcap no slebal
tropxe dna srebmun laires setadnaM .desnecil eb ot stcudorp occabot fo srelaselohw dna sretropxe ,sretropmi ,srerutcafunam lla seriuqeR gnilggumS
a)niaCcM( 5141 .S cipoT
¢ ¢
.tnemtcane
retfa sraey eerht nigeb tsum )evoba 3# ees(,dnarb yb ,stneutitsnoc lufmrah yllaitnetop lla fo stnuoma eht fo noissimbus eht taht seificeps 8011 .R.H
]409 .ceS
ACDFF[ .tsil eht gniunitnocsid ro gniyfidom rof snoitadnemmocer htiw ssergnoC ot hcraeser hcus fo stluser eht troper ot ,sraey evif retfa ,dna
cilbup eht ot gnidaelsim ton si tsil eht erusne ot hcraeser remusnoc cidoirep tcudnoc ot yraterceS eht seriuqeR .dnarb yb ,stneutitsnoc lufmrah
yllaitnetop fo stnuoma eht fo tsil a yalpsid ylcilbup dna )nosrep yal a ot elbadnatsrednu tamrof a ni( hsilbup ot yraterceS eht seriuqer ,retfaereht
yllaunna dna sraey eerht nihtiW .stnemucod hcraeser lla ro yna timbus ot retropmi ro rerutcafunam hcae seriuqer ,yraterceS eht fo tseuqer
eht tA .evitidda )gnitsixe na fo ytitnauq eht ni segnahc ro( wen a tuoba noitamrofni fo erusolcsid tpmorp seriuqer dna ,esaeler sti ot roirp
syad 09 tsael ta dettimbus eb ot tcudorp wen a tuoba noitamrofni seriuqeR .stcudorp erutuf ro tnerruc fo tcapmi htlaeh eht ot gnitaler tca siht
fo tnemtcane fo etad eht retfa depoleved stnemucod lla ,tnemtcane retfa shtnom 6 gninnigeb )4( dna ;dnarb yb ,stneutitsnoc ekoms lufmrah
yllaitnetop lla fo stnuoma eht fo tsil a )3( ;tcudorp hcae ni enitocin fo mrof dna ,dleiy ,tnetnoc eht fo noitpircsed a )2( ;dnarb yb ,stneidergni stnemucod hcraeser
dedda lla fo stnuoma eht fo tsil a ,tnemtcane fo shtnom 6 nihtiw )1( :timbus ot retropmi ro rerutcafunam tcudorp occabot hcae seriuqeR dna atad fo noissimbuS
]309 .ceS ACDFF[ .)woleb ees( stcudorp ksir deifidom rof tpecxe ,gnisitrevda tcudorp occabot fo tnetnoc eht fo lavorppa roirp eht
gniriuqer morf yraterceS eht stibihorP .slebal tcudorp occabot no edam stnemetats fo lavorppa roirp eht ,noitaluger yb ,eriuqer ot yraterceS
eht sezirohtuA .tcA eht rednu deriuqer sa ,ADF htiw retsiger ot rerutcafunam 'stcudorp eht fo eruliaf )4( dna ;tcA eht ot tnausrup deussi
snoitaluger tcudorp occabot fo noitaloiv ni elas dna noitubirtsid )3( ;tcudorp eht ni occabot nworg-ngierof dna citsemod fo egatnecrep eht
fo tnemetats a dna rerutcafunam eht fo ssenisub fo ecalp dna eman eht gnilebal egakcap eht ni edulcni ot eruliaf )2( ;ralucitrap yna ni gnidaelsim stcudorp
ro eslaf si taht gnisitrevda dna gnilebal tcudorp )1( :gnidulcni ,dednarbsim demeed era stcudorp occabot hcihw rednu snoitidnoc eht seificepS occabot dednarbsiM
]209 .ceS ACDFF[ .)woleb ees( stcudorp ksir deifidom
rof stnemeriuqer eht fo noitaloiv ni si tcudorp eht )5( ro ;)woleb ees( stnemeriuqer ecitcarp gnirutcafunam doog ot mrofnoc ot eruliaf
)4( ;)woleb ees( seef resu yap ot rerutcafunam a fo eruliaf )3( ;snoitidnoc yratinasnu rednu egarots ro ,gnigakcap ,noitaraperp )2( ;ecnatsbus stcudorp
suoireteled ro suonosiop yna yb noitanimatnoc )1( :gnidulcni ,detaretluda demeed era stcudorp occabot hcihw rednu snoitidnoc eht seificepS occabot detaretludA
.)seeyolpme 053 naht rewef gniyolpme seinapmoc( srerutcafunam tcudorp occabot llams
fo noitinifed a sedulcni noisrev esuoH eht ,526 .S ekilnu ,oslA .seicnega laredef etairporppa rehto htiw tlusnoc ot rovaedne llahs yraterceS eht gnikamelur
ot roirp taht dna ,5 retpahC .C.S.U 5 htiw ecnadrocca ni eb llahs retpahC siht rednu gnikamelur hcae taht stnemeriuqer lanoitidda eht sedulcni 8011 .R.H
]109
.ceS ACDFF[ .ACDFF eht htiw gniylpmoc ni srerutcafunam occabot llams tsissa ot eciffo na ADF nihtiw hsilbatse ot yraterceS eht seriuqeR .XI
retpahC tnemelpmi ot ADF ta stcudorP occaboT rof retneC a hsilbatse ot ,tnemtcane fo syad 09 nihtiw ,yraterceS eht seriuqeR .sesuoheraw
dna sreworg occabot )2( ro ;rerutcafunam a fo noissessop eht ni sselnu ,fael occabot )1( :revo ytirohtua yrotaluger yraterceS eht evig ton seoD
.)woleb dessucsid tcudorp ksir deifidom a si tcudorp eht sselnu( edam neeb sah mialc htlaeh a hcihw rof tcudorp a ro ,esaesid fo noitneverp stcudorp occabot
ro ,tnemtaert ,sisongaid eht rof dednetni tcudorp hcus yna gnidulcxe ,stcudorp occabot gnitaluger rof XI retpahC ACDFF wen a setaerC revo ytirohtua ADF
)XI retpahC ,tcA citemsoC dna ,gurD ,dooF laredeF(
ytirohtuA yrotalugeR occaboT ADF
)detroper sa( 8011 .R.H ni secnereffiD yeK dna )detroper sa( 526 .S fo yrammuS
:tcA lortnoC occaboT dna noitneverP gnikomS ylimaF . 2 elbaT
¢ ¢
.sronim tcetorp ot redro ni ,egnahcxe ecaf-ot-ecaf a ni reliater
a yb naht rehto detubirtsid ro dlos era taht stcudorp occabot fo gnitekram dna noitomorp eht gnidrager snoitaluger eussi ot ,sraey owt nihtiw ,yraterceS
eht seriuqer rehtruf tI .stcudorp hcus ot ssecca egarednu tneverp ot redro ni ,)selas redro-liam dna tenretnI ,.g.e (egnahcxe ecaf-ot-ecaf a ni reliater
a yb naht rehto stcudorp occabot fo noitubirtsid dna elas eht gnidrager snoitaluger eussi ot ,shtnom 81 nihtiw ,yraterceS eht seriuqer osla 8011 .R.H .tceffe
ekat yeht retfa sraey ruof litnu snoitaluger hcus htiw ylpmoc ot deriuqer ton era )llib eht ni denifed sa( srerutcafunam llams taht seificeps osla tI .seudiser
edicitsep rof occabot war fo gnitset eht rof edivorp yam hcihw ,snoitaluger PMG eussi ot yraterceS eht )sezirohtua ot desoppo sa( seriuqer 8011 .R.H
]609 .ceS ACDFF[ .stseuqer tcA noitamrofnI
fo modeerF morf ADF yb deniatbo sterces edart stcetorP .snoititep ot esnopser ni sPMG eht ot secnairav ro snoitpmexe tnenamrep
ro yraropmet tnarg ot ytirohtua eht sedivorP .)woleb ees( eettimmoC yrosivdA cifitneicS stcudorP occaboT eht fo snoitadnemmocer eht ot
tcejbus ,seudiser lacimehc edicitsep rof occabot war gnitset gnidulcni ,stnemeriuqer )PMG( ecitcarp gnirutcafunam doog hsilbatse ot ,noitaluger
yb ,yraterceS eht sezirohtuA .ega fo sraey 81 naht redlo snosrep ot elas fo ega muminim a gnihsilbatse stibihorp dna steltuo liater fo sepyt
cificeps ni snoitcasnart ecaf-ot-ecaf ni stcudorp occabot fo elas eht gnitcirtser stibihorP .renoititcarp lacidem a fo noitazirohtua laro ro nettirw
eht ot stcudorp occabot fo noitubirtsid dna elas eht gnitimil stibihorP .tnemmoc ot syad 06 tsael ta nevig eb nosrep detseretni taht dna ,cilbup
eht ot elbissecca edam eb tcA siht rednu detaerc seitirohtua ot tnausrup seciton dehsilbup rehto dna gnikamelur desoporp fo seciton taht
seriuqeR .stcudorp occabot fo sresunon dna sresu gnidulcni ,elohw a sa noitalupop eht ot stifeneb dna sksir eht fo noitaredisnoc a no desab stcudorp
eb noitanimreted a hcus taht seriuqeR .htlaeh cilbup eht tcetorp ot etairporppa si noitaluger hcus taht senimreted yraterceS eht fi ,stcudorp occabot no slortnoc
hcus ot ssecca dna ,stcudorp occabot fo noitomorp dna gnisitrevda ,noitubirtsid ,elas eht tcirtser ot ,noitaluger yb ,yraterceS eht sezirohtuA yrotaluger lareneG
]509 .ceS
ACDFF[ .stcudorp gnitsixeerp morf secnereffid ronim ylno evah taht stcudorp occabot niatrec stnemeriuqer eseht morf tpmexe ot ,shtnom
51 nihtiw seussi snoitaluger ot tnausrup ,yraterceS eht stimreP .7002 ,51 yraurbeF fo sa detekram yllaicremmoc tcudorp a ot ecnelaviuqe
laitnatsbus gnitnemucod troper rieht timbus ot )tnemtcane retfa shtnom 12 ,.e.i( etad taht litnu evah tnemtcane gniwollof shtnom 12
si taht etad eht ot roirp dna ,7002 ,51 yraurbeF retfa tcudorp a decudortni taht srerutcafunaM .tcA siht fo stnemeriuqer eht htiw ecnailpmoc
ni si tcudorp hcus taht dna ,etad taht fo sa ecremmoc etatsretni ni saw taht tcudorp occabot rehtona ot )woleb ,019 .ceS fo gninaem
eht nihtiw( tnelaviuqe yllaitnatsbus si tcudorp hcus taht noitanimreted sti )noitaluger yb debircserp rennam a ni( yraterceS eht ot edivorp
ot ,7002 ,51 yraurbeF fo sa detekram yllaicremmoc ton saw taht tcudorp a gnicudortni ot roirp syad 09 tsael ta rerutcafunam a seriuqeR
.retsiger ot setatS detinU eht otni stcudorp occabot tropmi ot gnikees stnemhsilbatse
rehto dna srerutcafunam ngierof seriuqeR .stnemhsilbatse deretsiger lla fo noitcepsni lainneib setadnaM .tsil tcudorp rieht ni segnahc
yna fo troper launnaib a elif ot stnartsiger seriuqeR .gnilebal tcudorp dna noitamrofni remusnoc fo seipoc gnidulcni ,tsil tcudorp deliated
a edivorp ot noitartsiger fo emit eht ta srerutcafunam seriuqeR .noitamrofni noitartsiger ot ssecca cilbup rof sedivorp dna )stcudorp occabot
fo gnissecorp dna ,gnidnuopmoc ,noitaraperp eht ni degagne srehto dna( srerutcafunam tcudorp occabot lla fo noitartsiger launna seriuqeR noitartsiger launnA
¢ ¢
]019 .ceS ACDFF[ .retpahC siht fo snoisivorp eht morf detpmexe eb ,noitaluger ni debircserp
snoitidnoc rednu ,yam stcudorp occabot lanoitagitsevnI .sresunon dna sresu gnidulcni ,elohw a sa noitalupop eht ot stifeneb dna sksir eht
noitaredisnoc otni gnikat ,htlaeh cilbup fo noitcetorp eht htiw tnetsisnocni si tcudorp occabot wen eht fo gnitekram eht gnittimrep taht gnidnif
a no desab eb llahs lained a taht seificepS .lavorppa hcus gnidnepsus yliraropmet ro gniwardhtiw rof dna ,lavorppa tekramerp rof noitacilppa na
gniyned rof serudecorp sehsilbatsE .)woleb ees( eettimmoC yrosivdA cifitneicS stcudorP occaboT eht ot noitacilppa eht refer ot ,tnacilppa na
fo tseuqer eht nopu ro evitaitini nwo sih no ,yraterceS eht seriuqeR .weiver tekramerp rof noitacilppa na ni dedulcni eb ot noitamrofni fo sepyt
eht seificeps dna ecnelaviuqe laitnatsbus senifeD .)noitanimreted ecnelaviuqe laitnatsbus a gniriuqer morf ti stpmexe hcihw( tcudorp gnitsixeerp
a morf snoitacifidom ronim ylno sah tcudorp wen eht fi deriuqer ton si weiver tekramerP .7002 ,51 yraurbeF fo sa tekram eht no tcudorp a
ot tnelaviuqe yllaitnatsbus eb ot ton dnuof si taht )stekram tset ni tcudorp a gnidulcni( tcudorp occabot wen yna fo weiver tekramerp seriuqeR weiver tekramerP
]909 .ceS ACDFF[ .retpahC siht fo noitaloiv a ydemer
ro ksir htlaeh a ecuder ot nekat noitca evitcerroc rehto ro tekram eht morf lavomer tcudorp yna troper ot sretropmi dna srerutcafunam
tcudorp occabot seriuqeR .tcudorp taht fo esu eht htiw detaicossa ecneirepxe esrevda detcepxenu suoires a ot detubirtnoc ro desuac
evah yam stcudorp sti fo eno taht stseggus ylbanosaer taht noitamrofni fo erawa semoceb taht rerutcafunam a morf troper a eriuqer yam ADF
,elpmaxe roF .htlaeh cilbup tcetorp esiwrehto ot dna dednarbsim ro detaretluda ton era stcudorp taht erussa ot eriuqer ylbanosaer noitaluger
yb yam ADF sa noitamrofni hcus edivorp dna sdrocer hcus niatniam dna hsilbatse ot sretropmi dna srerutcafunam tcudorp occabot seriuqeR stroper dna sdroceR
]809 .ceS ACDFF[ .sksir htlaeh suoires sesop taht tcefed yranidro-eht-fo-tuo na
sniatnoc taht tcudorp occabot a llacer ot ,gniraeh lamrofni na ot tcejbus ,dna noitubirtsid esaec ot snosrep etairporppa eht redro ot yraterceS
eht sezirohtuA .wal etats ro laredef rehto rednu ytilibail morf snosrep eveiler ton seod redro na hcus htiw ecnailpmoC .snosrep etairporppa
lla fo noitacifiton etauqeda erusne ot redro na eussi ot dezirohtua si yraterceS eht ,ksir hcus etanimile ot yrassecen si noitacifiton taht
dna htlaeh cilbup eht ot mrah laitnatsbus fo ksir elbanosaernu na stneserp tcudorp occabot a taht senimreted yraterceS eht taht tneve eht nI llacer dna noitacifitoN
.noitca hcus gnikat morf yraterceS eht stibihorp 8011 .R.H
,enitocin etanimile ro stcudorp occabot nab ot ytirohtua eht ssergnoC rof gnivreser fo daetsnI .retpahC siht fo stnemeriuqer eht teem ton od taht stcudorp
rof tekram kcalb a fo noitaerc eht no dradnats eht fo tcapmi eht )2( dna ;dradnats eht htiw ecnailpmoc fo ytilibisaef lacinhcet eht )1( :dradnats tcudorp
occabot desoporp a htiw noitcennoc ni dettimbus noitamrofni fo sepyt gniwollof eht redisnoc ot yraterceS eht seriuqer osla tI .sedicitsep devorppanu
gnisu nworg saw taht ro sdradnats .S.U deecxe taht slevel edicitsep htiw occabot nworg-ngierof gniniatnoc stcudorp occabot stibihorp 8011 .R.H
]709 .ceS ACDFF[ .snoitadnemmocer htiw troper ot deriuqer si eettimmoC yrosivdA eht ,larrefer eht fo syad 06 nihtiW .esuac doog
setartsnomed ohw nosrep detseretni na fo tseuqer eht nopu ro ,evitaitini nwo sih no desab larrefer a hcus ekam yam yraterceS ehT .)woleb
ees( eettimmoC yrosivdA cifitneicS stcudorP occaboT eht ot dradnats tcudorp a ekover ro ,dnema ,hsilbatse ot lasoporp a refer ot yraterceS
eht stimreP .sdradnats gnitsixe fo noitacover dna tnemdnema eht rof sedivorP .orez ot sdleiy enitocin ecuder ro stcudorp occabot nab
ot ytirohtua eht ssergnoC rof sevreseR .ksir htlaeh etanimile ro ecuder ton lliw lasoporp eht taht evorp tsum noitanimreted a hcus gnignellahc
ytrap a ,lufmrah eb ot tneutitsnoc tcudorp occabot a senimreted taht dradnats desoporp yna nI .htlaeh cilbup tcetorp ot yrassecen si etad
evitceffe reilrae na senimreted yraterceS eht sselnu tceffe ekat sdradnats wen erofeb yaled raey-eno a seriuqer dna ,syad 06 tsael ta fo doirep
tnemmoc a htiw ,gnikamelur tnemmoc dna eciton setadnaM .sdradnats hcus fo noitaulave cidoirep dna ,sdradnats tcudorp gnittes ni snosrep
demrofni dna seicnega laredef rehto fo tnemevlovni eht seriuqeR .stcudorp occabot fo sresunon dna sresu gnidulcni ,elohw a sa noitalupop
eht ot stifeneb dna sksir eht fo noitaredisnoc a no desab eb noitanimreted a hcus taht seriuqeR .htlaeh cilbup eht tcetorp ot etairporppa
si noitaluger hcus taht senimreted ti fi ,stcudorp occabot fo gnitset dna noitisopmoc eht yfidom esiwrehto ro ,stneutitsnoc lufmrah rehto
etanimile ro ecuder ,enitocin ecuder ot sdradnats tcudorp occabot etaglumorp ot yraterceS eht sezirohtuA .ecips ro breh na )2( ro ;lohtnem sdradnats
ro occabot naht rehto ,rovalf larutan ro laicifitra na )1( :gniniatnoc morf setteragic stibihorp ,gnikamelur yb noisiver tneuqesbus ot tcejbuS tcudorp occaboT
¢ ¢
.yticapac yrotarobal gnitset detimil
rof snoisnetxe gnidulcni ,snoitaluger gnitroper dna gnitset eht htiw ecnailpmoc rof emit lanoitidda edivorp taht )llib eht ni denifed sa( srerutcafunam llams
ot yllacificeps gnitaler snoisivorp lanoitidda sedulcni llib ehT .tnemtcane fo sraey eerht nihtiw snoitaluger wen eussi ot yraterceS eht seriuqer 8011 .R.H
]8011 .R.H ni 519 .ceS ACDFF ;619 .ceS ACDFF[ .stnemesitrevda dna slebal ,elpmaxe rof ,hguorht stluser gnitset fo erusolcsid eht eriuqer
yam snoitaluger hcuS .htlaeh cilbup eht tcetorp ot detset eb dluohs senimreted yraterceS eht taht ,dnarb-bus dna dnarb yb ,stneutitsnoc ekoms gnitset tneutitsnoc
dna stneidergni tcudorp occabot fo gnitroper dna gnitset eht gnitadnam snoitaluger wen eussi ot ,sraey owt nihtiw ,yraterceS eht seriuqeR ekoms dna tneidergnI
.noisivorp siht edulcni ton seod 8011 .R.H
]519 .ceS ACDFF[ .qes te 108 .C.S.U 5 ot tnausrup ,retpahC siht rednu detaglumorp elur yna fo weiver lanoissergnoc rof sedivorP weiver lanoissergnoC
]419
.ceS ACDFF[ .seitivitca yrotaluger occabot rieht etanidrooc ot namriahC CTF eht dna yraterceS eht seriuqeR .stcudorp occabot fo noitubirtsid noitcidsiruj noissimmoC
ro ,elas ,gnisitrevda eht etaluger ot CTF eht fo ytirohtua gnitsixe eht sehsinimid ro stimil )dedivorp ylsserpxe erehw tpecxe( tca siht ni gnihtoN edarT laredeF
]319 .ceS ACDFF[ .81 ega rednu slaudividni ot elbissecca steltuo liater ot elbacilppa snoitcirtser gnisitrevda steltuo
yna htiw ylpmoc ot stcudorp occabot gnilles si ssenisub tnanimoderp esohw steltuo liater gniriuqer snoitaluger eussi ot ADF seriuqeR liater fo tnemtaert lauqE
]219 .ceS ACDFF[ .wal htiw ecnadrocca ni ton esiwrehto ro ,noitercsid fo esuba na ,suoicirpac ,yrartibra eb ot dnuof snoisulcnoc ro ,sgnidnif
,noitca ycnega yna lufwalnu dloh lliw truoc gniweiver eht taht seificeps ,)A()2(607 .C.S.U 5 ot tnausruP .lavorppa tekramerp rof noitacilppa na
fo lained a )2( ro ;dradnats tcudorp occabot a gnikover ro ,gnidnema ,gnihsilbatse noitaluger a )1( :fo weiver laiciduj rof serudecorp sehsilbatsE weiver laiciduJ
]119 .ceS ACDFF[ .V retpahC ACDFF rednu secived/sgurd sa devorppa neeb evah yeht fi stcudorp ksir deifidom
ton era ,stcudorp noitassec gnidulcni ,ecnedneped occabot gnitaert rof stcudorP .secnatsbus niatrec ot erusopxe setanimile ro secuder ti taht
ro lufmrah ssel deredner si tcudorp eht taht gniveileb sremusnoc ni tluser ot detcepxe eb ylbanosaer dluow taht tcudorp occabot a no noitca
yna gnikat morf srotubirtsid stibihorP .stcudorp occabot ksir deifidom gnissessa rof deriuqer ecnedive cifitneics eht no ecnadiug ro snoitaluger
eussi ot ,strepxe rehto dna enicideM fo etutitsnI eht htiw noitatlusnoc ni dna sraey owt nihtiw ,ADF seriuqeR .dilav regnol on si mialc ksir
deifidom eht taht denimreted si ti fi ,gniraeh lamrofni na rof ytinutroppo na retfa ,lavorppa wardhtiw ot ADF stimreP .ecnallievrus tekramtsop
tcudnoc ot stcudorp ksir deifidom devorppa fo srerutcafunam seriuqeR .stnemeriuqer noitomorp dna gnisitrevda rehto htiw ylpmoc
stcudorp ksir deifidom devorppa fo srerutcafunam taht eriuqer ot ADF stimreP .sksir htlaeh detaler-occabot lla fo txetnoc eht ni ksir s'tcudorp
eht dneherpmoc ot cilbup eht elbane stcudorp hcus fo gnilebal dna gnisitrevda eht taht tnemeriuqer eht gnidulcni ,stcudorp ksir deifidom
fo lavorppa rof snoitidnoc rehto sehsilbatsE .lufmrah ssel eb ot detartsnomed neeb sah ti taht gniveileb otni sremusnoc daelsim ton lliw
tcudorp eht fo tekram dna gnilebal desoporp eht )3( dna ;sresu gnoma ksir ni noitcuder laitnatsbus a fo doohilekil elbanosaer a swohs ecnedive
cifitneics elbaliava eht )2( ;laitnatsbus si secnatsbus ro ecnatsbus lufmrah a ot erusopxe ni noitcuder eht )1( :taht setartsnomed rerutcafunam
eht fi )elbawener( doirep raey-evif a rof tcudorp a hcus evorppa ot ADF sezirohtua ,mialc erusopxe-decuder ticilpmi ro ticilpxe na ot detimil
si noitacilppa ksir deifidom eht hcihw rof tcudorp a fo esac eht nI .weiver rof )woleb ees( eettimmoC yrosivdA cifitneicS stcudorP occaboT eht
ot meht refer ot dna tnemmoc cilbup rof elbaliava snoitacilppa tcudorp ksir deifidom ekam ot ADF seriuqeR .stcudorp occabot fo sresunon
dna sresu gnidulcni ,elohw a sa noitalupop eht fo htlaeh eht tifeneb dna sresu occabot laudividni ot mrah ecuder yltnacifingis lliw ,sremusnoc yb
desu yllautca si ti sa ,tcudorp eht taht setartsnomed rerutcafunam eht fi mialc tcudorp ksir deifidom a evorppa ot ADF sezirohtuA .erusopxe
ro ksir secuder tcudorp eht taht eveileb ot detcepxe ylbanosaer eb dluow yeht taht hcus sremusnoc ta detcerid noitca rehto yna nekat
sah rerutcafunam eht hcihw rof tcudorp a )2( ro ;ecnatsbus a ot erusopxe secuder ro esaesid detaler-occabot fo ksir eht secuder tcudorp
eht taht ylticilpmi ro ylticilpxe smialc taht ro ,"wol" ro ",dlim" ",thgil" sa hcus srotpircsed sedulcni gnisitrevda/gnilebal esohw tcudorp a )1( :sa stcudorp
tcudorp occabot ksir deifidom a senifeD .stcudorp occabot ksir deifidom tekram ot redro ni lavorppa ADF niatbo ot srerutcafunam seriuqeR occabot ksir deifidoM
¢ ¢
.erahs tekram htuoy s'rerutcafunam a no trap ni ro elohw ni desab seef
resu gnitaluclac fo tcapmi dna ytilibisaef eht dna esu occabot egarednu no ssergnoC ot troper ot ,sraey eerht nihtiw ,OAG seriuqer ,noitidda ni ,8011 .R.H
]8011 .R.H
ni 919 .ceS ACDFF ;029 .ceS ACDFF[ .753-801 .L.P fo )h(-)e(526 snoitcesbus ot tnausrup erutlucirgA fo yraterceS eht yb denimreted sa ,tekram
citsemod eht fo erahs s'retropmi ro s'rerutcafunam taht no desab eb stcudorp occabot fo ssalc ralucitrap a fo retropmi ro rerutcafunam hcae
yb diap seef fo erahs egatnecrep eht taht seificepS .)753-801 .L.P( 4002 fo tcA mrofeR occaboT elbatiuqE dna riaF eht fo )c(526 noitcesbus
ni segatnecrep elbacilppa eht no desab ,tnemssessa latot eht fo egatnecrep a dessessa eb stcudorp occabot fo ssalc hcae taht seificepS
.raey lacsif tneuqesbus hcae ni dna 8102YF ni noillim 217$ ot gnisaercni ,8002YF ni noillim 58$ :noitaluger occabot
rof yraterceS eht ot elbaliava tnuoma rewol ylthgils a seificeps ti ,detcelloc seef eht fO .)stnemtsujda on htiw( raey lacsif tneuqesbus hcae ni dna 8102YF ni
noillim 7.457$ ot gnisaercni ,8002YF ni noillim 1.09$ ta tnemssessa eht fo tnuoma eht stes dna yrusaerT eht nihtiw dnuf a hsilbatse ton seod 8011 .R.H
.tcA siht fo tnemtcane morf gnitluser gnidneps dna eunever ni segnahc ot eud eunever lareneg ni ssol ten yna yarfed
ot ,yrusaerT eht fo dnuf lareneg eht ni detisoped eb ot sdnuf lanoitidda eseht htiw ,dessessa seef fo tnuoma latot eht ni tnemtsujda drawpu
launna na seriuqeR .stifeneb dna noitasnepmoc lennosrep ADF fo ,ETF rep ,tsoc eht ni egnahc launna egareva eht )3( ro ;CD notgnihsaW
ni srekrow laredef rof yap esab ni egnahc egatnecrep eht )2( ;xednI ecirP remusnoC eht ni egnahc egatnecrep eht )1( :fo retaerg eht tcelfer
ot raey lacsif tneuqesbus hcae ni detsujda ,0102YF ni noillim 054$ dna ,9002YF ni noillim 532$ ,8002YF ni noillim 58$ ta tnemssessa eht fo
tnuoma eht steS .retpahC siht rednu noitaluger occabot ADF fo tsoc eht rof yap ot ,dnuF eht ni detisoped eb ot ,sretropmi dna srerutcafunam
occabot no )ylretrauq elbayap( seef resu ssessa ot yraterceS eht stcurtsnI .dnuF eeF resU tcudorP occaboT a yrusaerT eht nihtiw sehsilbatsE seef resU
]8011 .R.H ni 819 .ceS ACDFF ;919 .ceS ACDFF[ .ecnedneped occabot
rof stnemtaert dna stcudorp evitavonni fo tnempoleved eht egaruocne dna ,etomorp ,etaluger ot tseb woh no troper a ssergnoC ot timbus
ot yraterceS eht seriuqer ,sraey eerht nihtiW .noitneverp espaler ro feiler gnivarc rof sa hcus ,stcudorp tnemecalper enitocin rof snoitacidni
lanoitidda rof ecnedive eht redisnoc )3( dna ;stcudorp tnemecalper enitocin fo esu dednetxe eht gnivorppa redisnoc )2( ;605 noitceS stcudorp
ACDFF rednu stcudorp kcart tsaf sa stcudorp tnemecalper enitocin etangised ,tnacilppa eht fo tseuqer eht ta )1( :ot yraterceS eht stcurtsnI tnemecalper enitociN
eettimmoC
]8011 .R.H ni 719 .ceS ACDFF ;819 .ceS ACDFF[ .noitasnepmoc dna ,seitud ,pihsrebmem s'eettimmoC yrosivdA cifitneicS
eht seificepS .eettimmoC yrosivdA cifitneicS stcudorP occaboT rebmem-21 na hsilbatse ot yraterceS eht seriuqer ,raey eno nihtiW stcudorP occaboT
]8011 .R.H ni 619 .ceS ACDFF ;719 .ceS ACDFF[ .stcudorp occabot fo noitomorp
dna ,gnisitrevda ,ot ssecca ,esu ,elas eht ot gnitaler stnemeriuqer lacol dna etats tpmeerp ton seoD .stcudorp ksir deifidom dna ;sPMG
;noitartsiger ;gnilebal ;gnidnarbsim ;noitaretluda ;lavorppa tekramerp ;sdradnats tcudorp occabot :retpahC siht ni snoisivorp gniwollof eht swal lacol
ot etaler taht stnemeriuqer lacol dna etats lla stpmeerp tub ,stcudorp occabot xat dna etaluger ot ytirohtua lacol dna etats sevreserp yllareneG dna etats fo noitpmeerP
¢ ¢
htlaeh emas eht eriuqer ot wal gnilebal occabot sselekoms gnitsixe eht sdnema rehtruF .stcudorp hcus etubirtsid ro lles ton od yeht dedivorp
,elbail ton era stnemeriuqer gnilebal eseht fo noitaloiv ni stcudorp occabot sselekoms htiw deilppus era taht sreliateR .stnemeriuqer gnilebal
egakcap eht morf stropxe occabot sselekoms stpmexE .slebal eht fo yhpargopyt dna tnemecalp eht seificepS d.segakcap occabot sselekoms slebaL gninraW htlaeH
no epyt dlob ni slebal gninraw htlaeh ticilpxe ,gnitator ,wen eriuqer ot cwal gnisitrevda dna gnilebal occabot sselekoms laredef eht sdnemA occaboT sselekomS
.esu occabot fo sksir eht fo gnidnatsrednu cilbup retaerg etomorp
ot redro ni ,ACDFF eht rednu deriuqer serusolcsid rehto yna fo ezis epyt dna ,tamrof ,txet eht tsujda dna ,scihparg roloc eriuqer ,stnemetats deriuqer
eht egnahc ot ,gnikamelur hguorht ,yraterceS eht rof stnemeriuqer deifidom ylthgils sah osla 8011 .R.H .slenap htob fo %03 pot eht tsael ta ypucco ot
slebal eht seriuqer 8011 .R.H ,egakcap etteragic a fo slenap raer dna tnorf eht fo %05 pot eht ypucco ot slebal gninraw eht seriuqer hcihw ,526 .S ekilnU
.noitomorp dna gnisitrevda etteragic fo ,tnetnoc eht ton tub ,rennam
dna ,ecalp ,emit eht etaluger ot setats stimreP .esu occabot fo sksir eht fo gnidnatsrednu cilbup retaerg a etomorp ot redro ni stnemeriuqer
lebal eht fo yna fo ezis epyt dna ,tamrof ,txet eht tsujda ,gnikamelur yb ,yam yraterceS eht ,retfaerehT .stnemeriuqer lebal eht ynapmocca
ot gnikoms fo secneuqesnoc htlaeh evitagen eht gnitciped scihparg roloc eriuqer ot ,gnikamelur hguorht dna ,sraey owt nihtiw ,yraterceS
eht stcurtsnI .tnemtcane retfa raey eno tceffe ekat lliw stnemeriuqer gnilebal wen eht taht seificepS .tcA siht htiw ecnadrocca ni delebal
ton si taht tnemesitrevda na yalpsid ylcilbup yeht fi elbail era sreliateR .stneutitsnoc rehto dna ,enitocin ,rat ot gnitaler stnemetats deriuqer
rehto fo ezis epyt dna ,tamrof ,txet eht ot ro stnemeriuqer gnilebal etteragic s'tcA eht fo ezis epyt dna tamrof eht ot stnemtsujda ekam
ot ,gnikamelur hguorht ,yraterceS eht sezirohtuA .sda retsop dna sserp ni )stneutitsnoc rehto dna ,enitocin ,rat ot gnitaler stnemetats deriuqer
rehto sa llew sa( sgninraw hcus fo yhpargopyt dna tnemecalp eht seificeps dna ,gnisitrevda etteragic ni sgninraw htlaeh emas eht eriuqer
ot wal gnilebal etteragic gnitsixe eht sdnema rehtruF .elbail ton era stnemeriuqer gnilebal eseht fo noitaloiv ni setteragic htiw deilppus era taht
sreliateR .stnemeriuqer gnilebal egakcap eht morf stropxe etteragic stpmexE .slebal eht fo yhpargopyt dna tnemecalp eht seificepS b.segakcap slebaL
etteragic no epyt dlob ni slebal gninraw htlaeh ticilpxe ,gnitator ,wen eriuqer ot awal gnisitrevda dna gnilebal etteragic laredef eht sdnemA gninraW htlaeH etteragiC
gnisitrevdA dna gnilebaL tcudorP occaboT
.)denifed sa( ytilicaf ylno-tluda deifilauq a ni selpmas eerf timrep ot )stcudorp occabot fo selpmas eerf no noitibihorp(
elur eht fo )d(61.798 noitcesbus sdnema osla llib ehT .tnemtcane retfa syad 081 naht renoos on elur lanif eht hsilbup ot yraterceS eht seriuqer 8011 .R.H
.tcA siht fo tnemtcane retfa raey eno naht
retal on evitceffe emoceb llahs elur ehT .elur lanif a sa )tcA siht ni desu snoitinifed eht ot tnausrup ,smret rehto dna "setteragic" fo snoitinifed
deifidom htiw dna ,C trapbuS ni snoisivorp gnilebal eht sunim( elur occabot ADF 6991 eht hsilbup ot syad 03 nihtiw yraterceS eht seriuqeR
)6991 ,82 tsuguA( eluR occaboT laniF ADF
.sebirt naidnI htiw edart gnidulcni ,edart etatsretni dna lanoitanretni sa edart redrob-ssorc senifed osla tI .stcudorp occabot ot elbacilppa
setar xat gnireffid )2( dna ;stcudorp occabot tiefretnuoc dna delggums )1( :fo stceffe htlaeh eht no atad edulcni ot yduts OAG eht seriuqer 8011 .R.H
]8011 .R.H ni
029 .ceS ACDFF ;129 .ceS ACDFF[ .yrtnuoc rehtona ot setatS detinU eht morf detubirtsid ro ,dettimsnart ,tsacdaorb si taht gnisitrevda occabot
dna )edart ticilli gnidulcni( stcudorp occabot fo edart redrob-ssorc no troper ,shtnom 81 nihtiw ,dna yduts ot OAG eht seriuqeR .lareneG
yenrottA eht yfiton yltpmorp ot snoitcasnart lagelli fo egdelwonk htiw srotubirtsid dna srerutcafunam tcudorp occabot seriuqeR .tcudorp
tiefretnuoc a si ro gnilggums ro edart ticilli na fo trap si tcudorp occabot a taht eveileb ot nosaer si ereht fi sdrocer lla ot ssecca yraterceS
eht stnarG .sesahcrup remotsuc laudividni fo sdrocer niatniam ot sreliater gniriuqer morf yraterceS eht stibihorP .stcudorp occabot stropmi
ro ,stropxe ,sdloh ,segakcap ,setubirtsid ,stropsnart ,sessecorp ,serutcafunam ohw nosrep yna yb sdrocer fo ecnanetniam dna tnemhsilbatse eht
gnidrager snoitaluger eussi ot yraterceS eht seriuqeR ".setatS detinU eht ni dewolla ylno elaS" :tnemetats eht raeb tsum noitpmusnoc citsemod
rof dednetni stcudorp rof sreniatnoc gnippihs dna ,gnigakcap ,slebal tcudorp occabot eht taht seriuqer ,tnemtcane retfa raey eno gninnigeB edart occabot ticillI
¢ ¢
.evitcidda si occabot sselekomS :GNINRAW )vi( dna ;setteragic ot evitanretla efas a ton si tcudorp
sihT :GNINRAW )iii( ;ssol htoot dna esaesid mug esuac nac tcudorp sihT :GNINRAW )ii( ;recnac htuom esuac nac tcudorp sihT :GNINRAW )i( :daer slebal wen ehT .d
.wal gnilebal occabot sselekoms eht secrofne dna sretsinimda CTF ehT .)1044 .C.S.U 51( tcA noitacudE htlaeH occaboT sselekomS evisneherpmoC .c
.htlaeh ruoy ot sksir suoires secuder yltaerg won
gnikoms gnittiuQ :GNINRAW )xi( dna ;srekomsnon ni esaesid gnul lataf sesuac ekoms occaboT :GNINRAW )iiiv( ;uoy llik nac gnikomS :GNINRAW )iiv( ;ybab ruoy
mrah nac ycnangerp gnirud gnikomS :GNINRAW )iv( ;esaesid traeh dna sekorts esuac setteragiC :GNINRAW )v( ;recnac esuac setteragiC :GNINRAW )vi( :esaesid
gnul lataf esuac setteragiC :GNINRAW )iii( ;nerdlihc ruoy mrah nac ekoms occaboT :GNINRAW )ii( ;evitcidda era setteragiC :GNINRAW )i( :daer slebal wen ehT .b
.wal eht secrofne
tnemtrapeD ecitsuJ eht ;wal gnilebal etteragic eht sretsinimda )CTF( noissimmoC edarT laredeF ehT .)1331 .C.S.U 51( tcA gnisitrevdA dna gnilebaL etteragiC laredeF .a
.sebirT naidnI ot tcepser htiw decrofne era ,tcudorp
occabot fo selas liater ot etaler taht esoht gnidulcni ,snoitaluger gnitnemelpmi sti dna tcA siht fo snoisivorp eht taht erusne ot yraterceS eht seriuqeR sebirT naidnI
noitartnecnoc
.sraey 01 nihtiw ,niaga ,dna sraey evif nihtiw ssergnoC ot troper dna yrtsudni occabot eht ni noitartnecnoc fo stceffe dna sesuac eht yduts ot CTF seriuqeR yrtsudni no tropeR
.stcudorp occabot rof ega esahcrup ega esahcrup
muminim eht gnisiar fo snoitacilpmi htlaeh cilbup eht no ssergnoC ot troper ,sraey evif nihtiw ,dna lenap trepxe na enevnoc ot yraterceS eht seriuqeR muminim no tropeR
)ylno 8011 .R.H( snoisivorP suoenallecsiM
.slebal gninraw htlaeh deriuqer eht tuohtiw stcudorp etubirtsid ro lles yeht fi elbail sreliater gnikam noisivorp eht edulcni ton seod 8011 .R.H
.tcA siht rednu deriuqer slebal gninraw htlaeh eht raeb ton od taht stcudorp occabot etubirtsid ro lles yeht fi elbail era sreliateR .tnemesitrevda
ro egakcap etteragic yna fo ecaf eht no deriuqer eb yam erusolcsid hcus on taht tpecxe ,esu occabot fo sksir htlaeh eht fo ssenerawa
esaercni esiwrehto ro htlaeh cilbup tifeneb dluow erusolcsid hcus fi ,)stneutitsnoc ekoms gnidulcni( stneutitsnoc tcudorp occabot rehto
fo level eht fo erusolcsid eriuqer yam ,gnikamelur yb ,yraterceS eht ,yllanoitiddA .wal gnitsixe rednu CTF yb dehsilbatse esoht dna yraterceS
eht yb dehsilbatse stnemeriuqer erusolcsid enitocin dna rat eht neewteb secnereffid yna )CTF( noissimmoC edarT laredeF eht htiw evloser ot erusolcsiD
,gnidnatsrednu fo mudnaromem a yb ,yraterceS eht seriuqeR .sdleiy enitocin dna rat esolcsid tsum gnisitrevda dna gnigakcap tcudorp occabot tneutitsnoC ekomS
rehto dna etteragic rehtehw enimreted ot ,gnikamelur yb ,yraterceS eht eriuqer ot awal gnisitrevda dna gnilebal etteragic laredef eht sdnemA rehtO dna ,enitociN ,raT
.stneutitsnoc rehto dna ,enitocin ,rat ot gnitaler stnemetats deriuqer rehto fo ezis epyt dna ,tamrof ,txet eht ot ro stnemeriuqer
gnilebal occabot sselekoms s'tcA eht fo ezis epyt dna tamrof eht ot stnemtsujda ekam ot ,gnikamelur hguorht ,yraterceS eht sezirohtua taht noisivorp
noitidda na sedulcni 8011 .R.H ,yllaniF .tcA siht htiw ecnadrocca ni delebal ton si taht tnemesitrevda na yalpsid ylcilbup yeht fi elbail era sreliater taht
seificeps osla tI .elbail ton era stnemeriuqer gnilebal eseht fo noitaloiv ni stcudorp occabot sselekoms htiw deilppus era taht sreliater taht setats 8011 .R.H
.esu occabot sselekoms fo sksir eht fo gnidnatsrednu cilbup retaerg a etomorp
ot redro ni ,ACDFF eht rednu deriuqer serusolcsid rehto yna fo ezis epyt dna ,tamrof ,txet eht tsujda dna ,slenap raer dna tnorf s'egakcap
a fo %05 ot %03 morf aera lebal deriuqer eht esaercni ,scihparg roloc eriuqer ,stnemeriuqer lebal eht fo yna fo ezis epyt dna ,tamrof ,txet
eht tsujda ot ,gnikamelur yb ,yraterceS eht sezirohtuA .tnemtcane retfa raey eno tceffe ekat lliw stnemeriuqer gnilebal wen eht taht seificepS
.noisivelet ro oidar no gnisitrevda occabot sselekoms stibihorP .sda retsop dna sserp ni )stneutitsnoc rehto dna ,enitocin ,rat ot gnitaler
stnemetats deriuqer rehto sa llew sa( sgninraw hcus fo yhpargopyt dna tnemecalp eht seificeps dna ,gnisitrevda occabot sselekoms ni sgninraw
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C. Stephen Redhead Vanessa K. Burrows
Specialist in Health Policy Legislative Attorney
credhead@crs.loc.gov, 7-2261 vburrows@crs.loc.gov, 7-0831
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