[Congressional Record Volume 148, Number 66 (Tuesday, May 21, 2002)]
[House]
[Pages H2685-H2732]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ENCOURAGING WORK AND SUPPORTING MARRIAGE ACT OF 2002
Mr. WELLER. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 4626) to amend the Internal Revenue Code of 1986 to
accelerate the marriage penalty relief in the standard deduction and to
modify the work opportunity credit and the welfare-to-work credit, as
amended.
The Clerk read as follows:
H.R. 4626
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Encouraging Work and
Supporting Marriage Act of 2002''.
TITLE I--ACCELERATION OF MARRIAGE PENALTY RELIEF
SEC. 101. ACCELERATION OF INCREASE IN STANDARD DEDUCTION FOR
JOINT RETURNS.
(a) In General.--Paragraph (7) of section 63(c) of the
Internal Revenue Code of 1986, as amended by section 301 of
the Economic Growth and Tax Relief Reconciliation Act of
2001, is amended to read as follows:
``(7) Applicable percentage.--For purposes of paragraph
(2), the applicable percentage shall be determined in
accordance with the following table:
``For taxable years beginning in calendarThe applicable percentage is--
2003 or 2004.................................................170
2005.........................................................174
2006.........................................................184
2007.........................................................187
2008.........................................................190
2009 and thereafter.......................................200.''.
(b) Conforming Amendment.--Subsection (d) of section 301 of
the Economic Growth and Tax Relief Reconciliation Act of 2001
is amended by striking ``December 31, 2004'' and inserting
``December 31, 2002''.
(c) Effective Date.--The amendments made by this section
shall apply to taxable years beginning after December 31,
2002.
TITLE II--MODIFICATIONS TO WORK OPPORTUNITY CREDIT AND WELFARE-TO-WORK
CREDIT
SEC. 201. MODIFICATIONS TO WORK OPPORTUNITY CREDIT AND
WELFARE-TO-WORK CREDIT.
(a) Eligibility of Ex-Felons Determined Without Regard to
Family Income.--Paragraph (4) of section 51(d) of the
Internal Revenue Code of 1986 is amended by adding ``and'' at
the end of subparagraph (A), by striking ``, and'' at the end
of subparagraph (B) and inserting a period, and by striking
all that follows subparagraph (B).
(b) Increase in Maximum Age for Eligibility of Food Stamp
Recipients.--Clause (i) of section 51(d)(8)(A) of such Code
is amended by striking ``25'' and inserting ``30''.
(c) Clarification of Treatment of Individuals Under
Individual Work Plans.--Subparagraph (B) of section 51(d)(6)
of such Code (relating to vocational rehabilitation referral)
is amended by striking ``or'' at the end of clause (i), by
striking the period at the end of clause (ii) and inserting
``, or'', and by adding at the end the following new clause:
``(iii) an individual work plan developed and implemented
by an employment network pursuant to subsection (g) of
section 1148 of the Social Security Act with respect to which
the requirements of such subsection are met.''
(d) Effective Date.--The amendments made by this section
shall apply to individuals who begin work for the employer
after December 31, 2002.
SEC. 202. CONSOLIDATION OF WORK OPPORTUNITY CREDIT WITH
WELFARE-TO-WORK CREDIT.
(a) In General.--Paragraph (1) of section 51(d) of the
Internal Revenue Code of 1986 is amended by striking ``or''
at the end of subparagraph (G), by striking the period at the
end of subparagraph (H) and inserting ``, or'', and by adding
at the end the following new subparagraph:
``(I) a long-term family assistance recipient.''
(b) Long-Term Family Assistance Recipient.--Subsection (d)
of section 51 of such Code is amended by redesignating
paragraphs (10) through (12) as paragraphs (11) through (13),
respectively, and by inserting after paragraph (9) the
following new paragraph:
``(10) Long-term family assistance recipient.--The term
`long-term family assistance recipient' means any individual
who is certified by the designated local agency--
``(A) as being a member of a family receiving assistance
under a IV-A program (as defined in paragraph (2)(B)) for at
least the 18-month period ending on the hiring date,
``(B)(i) as being a member of a family receiving such
assistance for 18 months beginning after August 5, 1997, and
``(ii) as having a hiring date which is not more than 2
years after the end of the earliest such 18-month period, or
``(C)(i) as being a member of a family which ceased to be
eligible for such assistance by reason of any limitation
imposed by Federal or State law on the maximum period such
assistance is payable to a family, and
``(ii) as having a hiring date which is not more than 2
years after the date of such cessation.''
(c) Increased Credit for Employment of Long-Term Family
Assistance Recipients.--Section 51 of such Code is amended by
inserting after subsection (d) the following new subsection:
``(e) Credit for Second-Year Wages for Employment of Long-
Term Family Assistance Recipients.--
``(1) In general.--With respect to the employment of a
long-term family assistance recipient--
``(A) the amount of the work opportunity credit determined
under this section for the taxable year shall include 40
percent of the qualified second-year wages for such year, and
``(B) in lieu of applying subsection (b)(3), the amount of
the qualified first-year wages, and the amount of qualified
second-year wages, which may be taken into account with
respect to such a recipient shall not exceed $10,000 per
year.
``(2) Qualified second-year wages.--For purposes of this
subsection, the term `qualified second-year wages' means
qualified wages--
[[Page H2686]]
``(A) which are paid to a long-term family assistance
recipient, and
``(B) which are attributable to service rendered during the
1-year period beginning on the day after the last day of the
1-year period with respect to such recipient determined under
subsection (b)(2).
``(3) Special rules for agricultural and railway labor.--If
such recipient is an employee to whom subparagraph (A) or (B)
of subsection (h)(1) applies, rules similar to the rules of
such subparagraphs shall apply except that--
``(A) such subparagraph (A) shall be applied by
substituting `$10,000' for `$6,000', and
``(B) such subparagraph (B) shall be applied by
substituting `$833.33' for `$500'.''
(d) Repeal of Separate Welfare-to-Work Credit.--
(1) In general.--Section 51A of such Code is hereby
repealed.
(2) Clerical amendment.--The table of sections for subpart
F of part IV of subchapter A of chapter 1 of such Code is
amended by striking the item relating to section 51A.
(e) Effective Date.--The amendments made by this section
shall apply to individuals who begin work for the employer
after December 31, 2002.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Illinois (Mr. Weller) and the gentleman from Massachusetts (Mr. Neal)
each will control 20 minutes.
The Chair recognizes the gentleman from Illinois (Mr. Weller).
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I bring H.R. 4626, legislation sponsored by my friend,
the gentleman from New York (Mr. Houghton) and myself, legislation
called the Encouraging Work and Supporting Marriage Act of 2002 to the
floor today.
This is important legislation because it helps American families in
two ways. First, it makes marriage penalty relief more quickly
available to 21 million low and moderate income married working
couples. Second, it facilitates the transition from welfare to work by
simplifying the work opportunity and welfare-to-work tax credits and
making them easier for employers as well as employees to use.
This past year, in what we know as the Bush tax cut, last year's tax
law, which President Bush signed into law June of 2001, it phased out
the marriage tax penalty for 43 million married working couples. It
included a phaseout of marriage penalty relief particularly targeted to
low and moderate income married couples which we include in today's
legislation which resulted from the doubling of the standard deduction
which was to begin in the year 2005.
This legislation before us today accelerates this relief for low and
moderate income married working couples by increasing the standard
deduction for joint filers to twice that for singles and reducing the
marriage penalty by many low and middle income Americans beginning next
year in 2003. It is estimated that 9 million American married couples
currently use the standard deduction. With this legislation they will
begin to see marriage tax relief next year instead of in 2005 as
originally planned.
H.R. 4626 will also help simplify the tax code. With an earlier
phaseout of the marriage tax penalty, 300,000 married working couples
who now use the standard deduction instead of itemizing their taxes
next year will be able to use the standard deduction and no longer need
to itemize. Again, 300,000 married working couples will see their taxes
simplified as a result of this marriage tax penalty relief in this
legislation.
Besides affecting the marriage taxes penalty, H.R. 4626 will also
help simplify the work opportunity and welfare-to-work tax credits, two
very successful programs which have given hundreds of thousands of low
income Americans the opportunity to go back to work. As we have often
said in this House Chamber, the best solution to welfare is a job.
And I would also note that President Bush recently traveled to
Chicago, to my home State, and visited a United Parcel Services
facility to highlight the success of this program which has given tens
of thousands of Chicago area residents the opportunity to have a job,
to have a chance to go to work and get off welfare. Current law
provides a work opportunity tax credit to employers who hire
individuals from 8 target groups that are considered hard to hire.
Employers who hire long term TANF recipients can claim a separate
welfare-to-work tax credit. The proposal would simplify the tax code to
combine the 2 tax credits and conform most of their rules, making the
credits easier for employers to use.
Additionally, this bill eliminates the family income tax for ex-
felons under work opportunity tax credit. Under current law, employers
can claim the work opportunity tax credit for hiring ex-felons only if
he or she meets a complicated family income test which requires a State
to document the income of all members in the ex-felon's household.
H.R. 4626 eliminates the family income tax for this group, thus
simplifying the work opportunity tax credit and helping ex-felons
transition into the workplace.
Finally, H.R. 4626 increases eligibility age limit for food stamp
recipients. Under current law, employers can claim the work opportunity
tax credit for hiring certain food stamp recipients between the ages of
18 to 25.
{time} 1215
This proposal would increase the age to 3 and give more low-income
individuals the opportunity to go to work.
Mr. Speaker, H.R. 4626 is a good bill. It has bipartisan support, and
I would note that this legislation passed the House Committee on Ways
and Means on a unanimous voice vote.
This legislation encourages the values we hold most dear: marriage,
family, and hard work. I encourage my colleagues to vote for this bill
to eliminate the marriage tax penalty more quickly for low-income and
moderate-income married working couples and also help facilitate an
easier transition from welfare to work.
Mr. Speaker, I reserve the balance of my time.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I
may consume.
I want to agree with what the gentleman from Illinois (Mr. Weller)
said a couple of moments ago, that this measure did indeed pass through
the Committee on Ways and Means on a unanimous vote. So for the purpose
of this moment, I think that we are really discussing the benefits of
this legislation for the American citizenry.
What we should be debating, as opposed to just discussing here, is
how we are going to pay for this tax relief. I am a supporter of the
measure that is in front of us, and indeed the Committee on Ways and
Means voted for it as well. But what we are not voting on here today,
Mr. Speaker, and what we should be voting on here today, and what we
have been prohibited from voting on for the last few weeks is a way to
ensure that while providing for this tax relief that we do not steal
from the Social Security and Medicare trust funds. That is what this
House has to have a debate about, not simply a discussion.
Last week, the Republican leadership in the House withdrew
consideration of this very important legislation, in my judgment, to
protect a certain group that has been characterized as being financial
traitors. We wanted to pay for this legislation, because we agree with
the merit of what has been offered by the gentleman from Illinois (Mr.
Weller), by implementing provisions of H.R. 3884, the Corporate Patriot
Enforcement Act, a bill authored by myself and the gentleman from
Connecticut (Mr. Maloney).
Knowing that this House would vote overwhelmingly to stop the exodus
of American corporations to tax havens, the leadership of this House
opted to impose procedural barriers to preclude our amendment.
Mr. Speaker, once again the New York Times highlighted yesterday
morning on its front page what precisely is happening. The leadership
in this institution continues to procrastinate. Our constituents around
the country want Congress to act now to stop these corporations from
shelving their patriotism to save a few bucks. And as we discovered
yesterday, not only to save what they have claimed to be money for the
shareholders, but we have now discovered what will happen to the
salaries of the executives once they leave. It is unconscionable to
have this occur at the same time when we could be taking a vigorous and
measured response to end it.
The Neal-Maloney Corporate Patriot Enforcement Act would immediately
and permanently shut down the exodus of American corporations to tax
havens, and end benefits for those who set
[[Page H2687]]
up shell headquarters in island countries to avoid U.S. corporate
income taxes.
Again, the gentleman from Illinois (Mr. Weller) is right. Hardworking
American families are entitled to tax relief, but I am sure these
families do not want to burden their children by placing our Social
Security and Medicare trust funds and our budget at risk.
Let us pay up front for the Marriage Penalty Relief Act. Let us stop
the procedural games and pass the Neal-Maloney bill to stop the
corporate expatriates.
Mr. Speaker, I reserve the balance of my time.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
Briefly, in response to my friend from Massachusetts, I would note
today's legislation before us is about giving welfare recipients the
opportunity to go to work and providing greater marriage tax relief.
The issue of inversions that the gentleman from Massachusetts (Mr.
Neal) has brought up is an issue of bipartisan concern. I particularly
want to commend my colleague, the gentlewoman from Connecticut (Mrs.
Johnson), for her leadership on this issue and sponsorship of H.R.
4756.
I would note the flaws in the gentleman from Massachusetts' (Mr.
Neal) proposal, some suggest may even promote foreign takeover of U.S.
companies under the proposal that he has offered, and that is why out
of fairness a hearing has been scheduled by the House Committee on Ways
and Means on June 13. Also, as part of that hearing, we will be looking
at a Treasury review and study which was released this past Friday.
Mr. Speaker, I yield 3 minutes to the gentleman from New York (Mr.
Houghton), one of the leaders of the welfare-to-work initiative.
Mr. HOUGHTON. Mr. Speaker, I would like to rise in support of H.R.
4626, and I would like to thank the gentleman from Illinois (Mr.
Weller) for all the great work he has done and also thank the gentleman
from California (Mr. Thomas) for his support and the whole broad
parameter of encouraging work and supporting marriage.
This is a very simple and a straightforward piece of legislation. It
improves the Work and Opportunity Act. It reduces the marriage penalty
for lower-middle income people, and this is it. There are lots of
things I would have gone over, but the gentleman from Illinois (Mr.
Weller) has described those very eloquently, and I will not try to
duplicate his words. However, I would just like to mention several
facts.
First of all, this bill combines the work and opportunity and the
welfare-to-work credit, and while it increases the welfare-to-work
credit from 35 to 40 percent, for the first year, very, very important
feature here, it would also extend this 40 percent credit into the
second year for employers who retain the workers. Also, it would expand
incentives for vocational rehabilitation.
This is important. It would eliminate family income tests for ex-
felons, which the gentleman from Illinois (Mr. Weller) mentioned, and
the test is a really significant impediment to hiring ex-felons.
Finally, the legislation would increase the age limitation for food
stamps recipients from 25 to 30; and what this is going to do, it is
going to assist many people, many men who should be taking advantage of
the work opportunity tax credit, but where the current age limit
prevents their eligibility.
So, Mr. Speaker, let me say this legislation is a good piece of work.
It will increase the opportunity for those who want to work and the
need to save and leave welfare for steady, long-term employment.
I appreciate my colleagues' understanding of this, and I appreciate
the gentleman from Illinois' (Mr. Weller) leadership.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield 3 minutes to the
gentleman from Michigan (Mr. Levin), who has been a leader on this
issue and question as well.
(Mr. LEVIN asked and was given permission to revise and extend his
remarks.)
Mr. LEVIN. Mr. Speaker, I want to congratulate the gentleman from
Massachusetts (Mr. Neal) for bringing up this issue of how we pay for
this legislation and urging that we use the Neal-Maloney bill to pay
for it.
Once again, the Republican majority has come forth with an idea, in
this case a good one, without paying for it except to divert Social
Security and Medicare moneys. That is how they are paying for
everything. As we dip more and more into debt, we use more and more
moneys that are payroll taxes for Social Security and Medicare.
So what the gentleman from Massachusetts (Mr. Neal) has suggested is
let us pay for it with a good idea, and that is the Neal-Maloney bill;
but my colleagues abuse our House rules by not letting us bring it up.
Once again, what they are saying is we will bring it up on suspension
so there is no way to propose a good pay-for for a good idea. So they
have a bad pay-for for a good idea. Why? They do not want up and down
votes on these issues. They are going to do the same apparently or try
to do the same on debt relief.
Look, we do not really need hearings. My colleagues have not held
many hearings on many of these issues in the Committee on Ways and
Means, and now the dodge for not taking up Neal-Maloney is let us hold
a hearing. What I suggest is let us have some action.
The gentleman from Connecticut (Mr. Maloney) has been out on the
streets working this issue, right? The gentleman from Massachusetts
(Mr. Neal) has been talking about this issue for how long? A long time.
It is time for action.
These are paper reincorporations, purely filing some paper to duck
paying taxes to the United States of America. So if my colleagues
really care about the American taxpayer, as they claim, they will let
us bring up this proposal and it will pass; but instead, to kind of
help out some people who are escaping taxes, they delay action on this,
and it hurts the American taxpayer, the people that we represent.
So I want to salute the gentleman from Massachusetts (Mr. Neal) and
the gentleman from Connecticut (Mr. Maloney) for pressing this issue.
Ultimately, we will prevail.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
I would remind my colleagues that today we are focusing on
eliminating the marriage tax penalty and giving welfare recipients the
opportunity to go back to work.
I would also note this legislation is paid for through the budget
which the House has adopted which allows for an additional $28 billion
in tax provisions. It is estimated this provision will cost $1 billion
or less. So it fits well within those parameters and does not need to
be paid for under the House-adopted budget.
Mr. Speaker, I yield 4 minutes to the gentleman from Arizona (Mr.
Hayworth), one of our leaders on the Committee on Ways and Means, a
distinguished gentleman who has been a real leader on bringing tax
fairness to those married working couples, as well as giving
opportunity to those who need to work.
Mr. HAYWORTH. Mr. Speaker, I thank the gentleman from Illinois (Mr.
Weller) for the recognition.
Listening with interest to the debate; and indeed those who may join
us, either in the gallery, Mr. Speaker, or electronically across the
country, and indeed, around the world, may view with curiosity the
debate thus far.
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (Mr. Linder). The gentleman will suspend. The
gentleman will refrain from referencing the gallery or the TV audience.
Mr. HAYWORTH. Mr. Speaker, I apologize. Those who listen to our
debate, and I thank the gentleman. It was not intentional to violate
House rules. I thank the Speaker for his attention to discourse, and I
will return to it right now.
Perhaps as the Speaker listens to the debate and as our colleagues in
the Chamber listen to the debate, they might be mystified that what we
have done is transform a debate on expanding opportunities for welfare
to work and to lift the burden of the marriage tax penalty on those who
need that help and thereby help bolster the institution of marriage to
be caught up in the debate on other bills and other issues that we
indeed will address in the days ahead. It is an interesting concept to
focus on process in the House rather than content of the legislation.
[[Page H2688]]
The legislation before us today helps us simplify the Tax Code. It
increases the standard deduction for married couples, 300,000 married
couples, would allow them to claim the standard deduction on their tax
return rather than itemize. That, in itself, is a major simplification.
It seems to me, Mr. Speaker, that we should work to emphasize
policies that are family friendly, policies that would support marriage
when we offer this economic incentive. It allows us to accelerate the
lifting of the burdensome marriage tax penalty. It accelerates relief
for 21 million married couples, and that is vitally important to offer
them access to the American dream.
My friend from New York was here just moments ago in this Chamber,
Mr. Speaker, addressing the entire concept of welfare to work, indeed
to complement the legislation passed last week, to build upon a major
success over the last half decade. We need to offer opportunities for
people to get to work.
My colleague from Illinois said it best. The best social program, the
best opportunity to lift the burden of poverty is to offer people jobs,
to get them into the workforce, and enhancing the welfare-to-work tax
credit increases an employer's incentive to hire long-term recipients
of the temporary assistance to needy families.
{time} 1230
This allows us to put people back to work.
Mr. Speaker, I would be remiss if I did not address something that
has been repeated here time and again. It is important to clear up any
misconception that may have been offered on the floor by my friends on
the other side of the aisle. I appreciate their newfound adherence to
what they believe to be sound fiscal policy, but the fact is this
reasonable, rational, bipartisan reduction in taxes is allowed for in
our House-passed budget resolution. Indeed, the budget resolution
allows for a $28 billion reduction in taxation. We are not taking a
penny, nor a dollar, nor a quarter nor a nickel, we are not going into
Social Security and Medicare revenues to pay for this.
Indeed, as disturbing as it is, if that indeed is the charge, would
our friends on the other side vote ``no'' to expand this tax relief, an
opportunity for those who look to seize it? I hope that would not be
the case.
I would hope, Mr. Speaker, that at the end of the day, they will rise
and join us in support of this legislation.
Mr. NEAL of Massachusetts. Mr. Speaker, the previous speaker is quite
correct. He did use the word welfare. It occurred to me that you will
not catch that bunch that are currently moving to Bermuda sleeping on
the grates when they get there. You can bet on that. The point that we
raised earlier is this is merely a discussion of the issue, but we
want, as Democrats, to have a substantive debate about these companies
that are moving to Bermuda to avoid taxes, and who better to speak
about it than the distinguished gentleman from Washington (Mr.
McDermott) to whom I yield 3 minutes.
Mr. McDERMOTT. Mr. Speaker, I was glad to come out here and join in
the preparing the press-release-of-the-week event. The Republicans say,
well, every week we have got to have something to put out in the press
to confuse the public, so let us go vote another tax cut. It reminds me
of that old saying, ``Tonight we drink, tomorrow we'll fix the truck.''
What are you drinking from? You are drinking from the tax cut cup.
You are putting another billion dollars in the hole. And for anybody to
get up at that other side of the well and say that that does not come
out of Social Security means he has paid no attention to the fact that
we are going to end this year $300 billion in debt.
Why add one more? Well, we have to have the press release, right?
Even more, though, let me tell you what is going on here. The reason
this is out here on the suspension calendar, with no hearings in the
committee, just out on the suspension calendar, is because they did not
want to bring it to the committee. They did not want to give the
gentleman from Massachusetts (Mr. Neal) the opportunity to raise the
question of the runaway companies and paying for this particular
option. There is no payment in here. This is just taken out of the
Social Security. So the leadership on the Committee on Ways and Means
said, I know how we can get around this uncomfortable situation that
the gentleman from Massachusetts is going to put us in, forcing us to
vote about whether we want people running away, creating paper
companies and taking tremendous profits because they are no longer an
American company. Why, one of them even in Connecticut, just recently,
makes hand tools. They decided they would go to Bermuda, create a paper
company. As luck would have it, there might be a member on the
Committee on Ways and Means who would be embarrassed by having to vote
on that issue. So the chairman said, ``Don't worry, we'll never let it
come up in the committee. We will send this directly to the floor.''
At some point, somebody has got to talk seriously out here. You
cannot blame the fact that a tool company goes to Bermuda on 9/11 or on
the war on terrorism. Why would they be moving from Connecticut to
Bermuda? Is it to get away from the terror in this country? They went
there for tax purposes and everybody knows it. I could give you a list
as long as my arm of companies doing it all the time to avoid paying
taxes in this country. They want the protection of the United States,
they want the military, they want us patrolling the oceans so that they
can send their exports everywhere, but they do not want to pay for it.
I wish that I would hear the President of the United States say, ``We
all have to make a sacrifice, we all have to pay taxes,'' and that he
would say it to his friends in Bermuda, ``Come on home. Pay your
share.''
This is a terrible bill.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
Responding briefly to my colleague from Washington State, a friend of
mine on my committee, being a member of the House Committee on Ways and
Means, I would note that today's debate is whether or not we more
quickly phase out the marriage tax penalty, and do we make it easier
for those on welfare to go to work. I realize that with a hearing
coming up on June 13 that the gentleman from Massachusetts (Mr. Neal)
requested and agreed to and, of course, on an issue that the
gentlewoman from Connecticut (Mrs. Johnson) has been a leader on, that
we are planning to have plenty of debate and discussion of the issue
that they are raising. The bottom line is today we want to eliminate
the marriage tax penalty, and today we want to help those who are on
welfare go to work.
Mr. Speaker, I reserve the balance of my time.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield 2 minutes to the
gentleman from Massachusetts (Mr. Lynch), a worthy successor to
McCormick and O'Neill, newly elected here from South Boston.
Mr. LYNCH. Mr. Speaker, in response to my esteemed colleague from
Arizona, I think this is a perfect time to talk about correct tax
policy in this country. I think you will find widespread agreement that
there is support for reducing the marriage penalty. It is a sensible
adjustment to our tax code. However, I think you will also find
widespread agreement here that stopping American companies from
avoiding their fair share of taxes by incorporating into offshore tax
havens is also a sensible adjustment to our tax code.
Mr. Speaker, I rise in support of the gentleman from Massachusetts
(Mr. Neal) and the gentleman from Connecticut (Mr. Maloney) and their
recommendation entitled the Corporate Patriot Enforcement Act.
Unfortunately, the Republican leadership is not allowing us to debate
that bill today. We quite frankly are in a time of great challenge in
this country. It is a time when we should set aside our partisan
squabbling and pull together and do what is necessary, do what is right
for this country.
There are some Americans, however, Mr. Speaker, who seem to feel that
the burden of defending our country should fall rather lightly on them.
In the last few years, we have seen a growing epidemic of companies
voting to, quote, unquote, reincorporate themselves in Bermuda, in
Barbados, in offshore tax havens, asking us to believe that buying a
post office box in Bermuda or
[[Page H2689]]
Barbados is a legitimate way to avoid paying to support our efforts
against terrorism, paying to support our troops overseas. Profits and
jobs are shipped abroad by this process. Those profits are not
reinvested in the United States. And it leaves their share, these
runaway corporations, it leaves their share of the tax burden to fall
unfairly on those companies and individuals who are too honest and are
too patriotic to engage in these kinds of schemes.
Mr. Speaker, the executives of these companies have practically dared
Congress to shut down their offshore tax schemes. I believe we should
take them up on that challenge.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
To briefly respond to my friend and colleague from Massachusetts,
again today's debate is about do we more quickly eliminate the marriage
tax penalty, and do we give thousands, if not millions, more of those
who are on welfare the opportunity to go to work? I would note that the
issue that has been raised, of course, has been an issue that has been
led on by the gentlewoman from Connecticut (Mrs. Johnson), and as the
gentleman from Massachusetts (Mr. Neal) and the gentlewoman from
Connecticut (Mrs. Johnson) have both requested, the committee will be
addressing this on June 13.
Mr. Speaker, I reserve the balance of my time.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I
may consume.
They won't give us a vote in this institution on this measure, the
Corporate Patriot Enforcement Act. This is the way we have to do it. I
will assure the folks on the other side of the aisle this is the way we
are going to continue to do it until we get an up-or-down vote on this
question.
Mr. Speaker, I yield 3 minutes to the gentleman from Connecticut (Mr.
Maloney) who has been a leader on this issue. He knows it firsthand and
indeed has been a passionate critic of what these corporations are
doing in an effort to scheme to avoid taxes.
Mr. MALONEY of Connecticut. Mr. Speaker, I rise in support of H.R.
4626, the legislation before us today. It is a good measure, but it
could be substantially better. This debate is about our tax policy. Tax
policy very much is in question. Last month while citizens of this
country were paying their income taxes, some of America's largest
corporations decided they no longer wanted to pay their fair share of
U.S. taxes. Instead, they sought out a loophole and are trying to
exploit it for their own gain. For little more than the cost of a post
office box in an offshore tax haven like Bermuda, U.S. companies are
trying to avoid millions of dollars in Federal taxes. The tax dodgers
may set up paper headquarters in Bermuda, but they continue to operate
in the United States. They still receive Federal, State and local
services such as police, fire and schools and, of course, they still
rely on the protection of our courageous armed services here at home
and around the world. The only difference is they now get it all for
free while U.S. citizens and loyal U.S. companies continue to pay the
bill. This is unpatriotic, especially in light of our current economic
situation. We are now seeing a major growing budget deficit, expected
to be as much as $100 billion this year. The huge Federal surplus we
had only a year ago has been entirely wiped out, mostly because of
erroneous, irresponsible tax policy. So critical programs like Social
Security and Medicare are in serious jeopardy just as the largest
generation in the history of this country is getting ready to retire.
Stanley Works in Connecticut, which has been alluded to previously,
stamps ``USA'' on its products while at the same time ships its jobs
overseas, ships its corporate entity to Bermuda, and will end up
evading virtually all of its U.S. taxes. But that is not the end of the
outrage that we face. I had previously noted that the U.S. Treasury and
small shareholders will have to bear the brunt of this unfair tax
scheme. In fact, if this tax dodge goes through, individual Stanley
shareholders will have to pay an estimated $150 million in additional
capital gains taxes. But yesterday's New York Times reported on the
real scope of this outrage, and I quote:
``Even if their shares rose 11.5 percent, they, the shareholders,
will barely break even after taxes. At Stanley Works, the CEO stands to
pocket an amount equal to 58 cents of each dollar the company would
save in corporate income taxes in the first year.''
That is $17.4 million of an estimated $30 million in savings out of
the Treasury into the CEO's individual pocket. Additionally, the CEO,
if he receives all of the options he is eligible for under the current
plan, would gain $385 million by exercising those options. The CEO is
raiding the U.S. Treasury at a time of war at the expense of the
taxpayers of this country and the shareholders that the CEO is supposed
to represent. The gentleman from Massachusetts (Mr. Neal) and I have
offered legislation on this issue. We call on the majority to allow it
to be brought forward for a vote.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
I would briefly like to remind the gentleman from Connecticut that
the Committee on Ways and Means will be conducting a hearing on this
subject which he raises. I also note that the gentlewoman from his home
State Connecticut (Mrs. Johnson) has been a leader on this issue with
the legislation that she has offered, H.R. 4756. That legislation, as
well as the gentleman from Massachusetts' legislation, will be the
subject of the Committee on Ways and Means hearing on June 13.
Mr. Speaker, I reserve the balance of my time.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I
may consume.
We have a request for $48 billion more for national defense which the
President is going to largely get, $38 billion more for homeland
security, and these corporations are moving to Bermuda rather than
joining in with the rest of the American family and paying their share.
Mr. Speaker, I yield 3 minutes to the gentleman from Texas (Mr.
Doggett).
Mr. DOGGETT. Mr. Speaker, the tragedy of September 11 really brought
out the best of the American spirit, with so many people across this
country asking, ``What can I do to help my country? What can I do to
help my neighbors?'' But unfortunately that spirit did not extend to
some of the larger multinationals in this country. Recognizing that
there would be additional costs for national security, for homeland
security, their first concern seems to have been, ``What can I do to
dodge my fair share of the cost of additional security, which, as a
multinational operating around the globe, I particularly need?
{time} 1245
So we have seen a series of companies decide that their sacrifice for
America would be buying a mailbox in Bermuda or some other country and
would shift the responsibility of paying for our enhanced national
security needs on to ordinary taxpaying families.
Stanley Tool Company, which the gentleman from Connecticut (Mr.
Maloney) and the gentleman from Massachusetts (Mr. Neal) have taken the
lead in focusing attention on the problem and demanding action now. Our
Republican colleagues prefer studying the problem until so many
corporations have departed.
Stanley Tool Company has hammered the American taxpayer. Who do you
think is going to pick up the cost of this additional national
security? It will not be Stanley Tool. They renounced their American
citizenship like these other companies and decided they would go
abroad, or at least send their mailbox abroad.
For our Republican colleagues, who never seem to have met an abusive
tax shelter that they did not like, this is only one of many types of
corporate tax shelters that are abusive and they have avoided taking
any action on, but instead tell us that what we need is a study. Well,
I have here the study that the Treasury Department just completed on
Friday, and if you look in the fine print of that study, you will find
one very significant conclusion. The conclusion of the Treasury
Department is that we ought to keep multinational corporations from
having to send their mailbox abroad by awarding further corporate tax
breaks. Treasury's answer is, cut Stanley Tool Company's taxes here so
they do not have to pay for a mailbox abroad.
[[Page H2690]]
That is not sharing the sacrifice. ``Study'' has been an excuse for
inaction, and the call for study this morning invites more inaction. If
we keep studying, as they recommend, the only appropriate legislation
for this Congress to enact would call to erect a big sign that says:
``Let the last multinational flip off the lights in America.''
I would say that the gentleman from Illinois (Mr. Weller) is
absolutely right about saying that today this debate is about the
marriage penalty. It is about the marriage penalty that all of America
suffers when the House Republican leadership and this Administration
are married to special interests, even to the extent that they let them
totally dodge their tax responsibility and instead turn to the Social
Security and Medicare trust funds to pick up the tab. That is wrong.
That is the kind of a marriage penalty we need to be addressing today
by adopting the Neal-Maloney legislation.
Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, briefly responding to the dialogue of my colleague and
member of the Committee on Ways and Means, I would note again that he
is absolutely right. Today's debate is about eliminating the marriage
tax penalty, simplifying the Tax Code for low- and moderate-income
working married couplings.
This debate is also about whether or not we give hundreds of
thousands, if not millions, of welfare recipients the opportunity to
have a job, to have a chance. That is what this debate is about.
I realize there are some who came here to practice campaign rhetoric;
it is a campaign season. And the Committee on Ways and Means is
conducting a hearing on the issue that the gentlemen and women on the
other side have raised this morning.
Mr. Speaker, I reserve the balance of my time.
Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself the balance of
my time to close.
The SPEAKER pro tempore (Mr. Linder). The gentleman from
Massachusetts is recognized for 1\1/2\ minutes.
Mr. NEAL of Massachusetts. Mr. Speaker, an editorial from the
Hartford Courant on May 14 said: ``Guess who will wind up picking up
the tab as a result of Stanley's tax avoidance? Other American
taxpayers, of course.''
The New York Times on May 13 wrote: ``Even in the best of times, it
is outrageous for companies to engage in offshore shenanigans to avoid
paying their fair share of taxes. Doing so after the Enron scandal, in
dire fiscal times and when the Nation is at war is unconscionable.''
How about the Houston Chronicle on May 9 which stated: ``American
companies that have no headquarters, no employees or operations in
foreign tax havens should not be able to lower their taxes by acquiring
an island post office box. Basic fairness to American companies that
remain incorporated in America is at stake.''
How about the Springfield Union News editorial on May 7: ``When a
U.S.-based corporation decides to reincorporate, basing its operations
in, say, the Cayman Islands when the company has little more than a
mailbox there, it can legally avoid millions of dollars in taxes, there
will come no better moment than this one as an opportunity to right a
wrong. We look forward to a floor vote on this matter.''
How about Paul Krugman writing in the New York Times: ``Flying the
flag of convenience and seeking rewards.''
Or columnist Jeff Brown in the Philadelphia Inquirer: ``Yet Stanley
won't have to pay its fair share for the good life and safe business
climate that we have created for all of them. It shouldn't be allowed
to get away with this.''
And one might ask, will it play in Peoria? Let us try the editorial
from the Peoria Journal Star as well: ``Tax policy of this sort is
outrageously offensive, if not masochistic. It penalizes businesses
that have ethically and responsibly done their part and rewards those
that do not.''
Mr. Speaker, we would like a vote on our side on the question of
these companies moving to Bermuda in this time of war. We want an
opportunity to voice to the American people the concerns that they have
expressed to us through a vote in this Chamber to stop corporate
expatriation.
Mr. WELLER. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I rise in support of the Encouraging Work and Supporting
Marriage Act of 2002, legislation that accomplishes two goals, that is,
a quicker phase-out of the marriage tax penalty for low- and moderate-
income workers, and increasing the opportunity for those who are on
welfare to have a chance to have a job. That is what this debate is all
about.
I know there are other issues that have been raised by some that are
in the ``excuse caucus'' of the Democratic Party, who believe there is
always an excuse not to do these things. But today we wanted to
eliminate the marriage tax penalty. Today we want to increase the
opportunity to help those who are on welfare go to work.
Let me give you an example of a couple from the district that I
represent who suffer the marriage tax penalty, a result of the
complicated Tax Code that we have had and, until President Bush became
President, was in place, and thanks to President Bush and the
Republican leadership as well as Republican majority in this House of
Representatives, we eliminated the marriage tax penalty. Unfortunately,
it had to be phased out, we could not do it all at once; but we passed
legislation to accomplish that.
Jose and Magdalena Castillo are two laborers from Joliet, Illinois.
They are both in the workforce. Because they are married, they file
their taxes jointly, it pushes them into a higher tax bracket, they pay
the marriage tax penalty, about $1,150 in higher taxes just because
they are married. But thanks to the Bush tax cut, which resulted from a
Republican majority in this House, Jose and Magdalena Castillo no
longer pay the marriage tax penalty.
Today we want to help millions of couples such as Jose and Magdalena
Castillo by phasing out the marriage tax penalty more quickly. For
those who are low- and moderate-income taxpayers, those who do not
itemize, in the phase-in they were not going to receive the full impact
of the elimination of the marriage tax penalty to them until 2005.
What we have before us today is legislation that eliminates the
marriage tax penalty for low- and moderate-income taxpayers in 2003,
next year. As a result of that, 9 million married couples will receive
immediate relief, and I will note that 300,000 low- and moderate-income
married working couples will no longer have to itemize their taxes as a
result of this legislation. That is progress, and I am proud to say
this is good legislation.
I would also note that this legislation helps hundreds of thousands
of other hard-working, low-income families. This legislation simplifies
the Work Opportunity and Welfare-to-Work tax credits. President Bush
was in my home area of Chicago just this past week. President Bush went
to a facility, it was a UPS, United Parcel Service, facility. They are
one of the leading companies in helping those on welfare with an
opportunity to go to work. The President highlighted the Work
Opportunity Tax Credit, how it has been a successful tool in our effort
to give those on welfare a chance, a chance for a job.
Well, the President drew attention to a very successful program that
we need to continue to improve. Today's legislation simplifies the Work
Opportunity and Welfare-to-Work tax credits. In fact, it combines the
two so there is only one, to make it much more simple for those that
use, the private business that hires and gives opportunities for
welfare recipients.
But also I would note that this legislation gives more low-income
welfare recipients the opportunity to participate. If they have a
criminal past and they are trying to make right, if they have been an
ex-felon, we give greater opportunity because they want to do the right
thing and go to work. If they are on food stamps, we raise the
eligibility age limit for those on food stamps to participate in the
Work Opportunity Tax Credit. We also expand incentives for vocational
rehabilitation referrals, again giving more opportunity for low-income
individuals to have a chance to go to work and get off of welfare.
This is good legislation, and regardless of some of the rhetoric we
have heard today, it is about two things:
[[Page H2691]]
eliminating the marriage tax penalty and giving those on welfare an
opportunity to go to work. Those are two very noble goals, and I am
proud to say that this legislation passed the Committee on Ways and
Means unanimously. Regardless of the rhetoric we have heard from the
other side from the ``excuses caucus,'' it passed unanimously. They
voted for it. My hope is they will vote for it again, because this
legislation to eliminate the marriage tax penalty, to give those on
welfare a chance, an opportunity to go to work, deserves bipartisan
support.
Mr. Speaker, I ask for bipartisan support for this legislation.
Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Illinois (Mr. Weller) that the House suspend the rules
and pass the bill, H.R. 4626, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. WELLER. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
Conference Report (H. Rept. 107-481)
The committee of conference on the disagreeing votes of the
two Houses on the amendment of the Senate to the bill (H.R.
3448), to improve the ability of the United States to
prevent, prepare for, and respond to bioterrorism and other
public health emergencies, having met, after full and free
conference, have agreed to recommend and do recommend to
their respective Houses as follows:
That the House recede from its disagreement to the
amendment of the Senate and agree to the same with an
amendment as follows:
In lieu of the matter proposed to be inserted by the Senate
amendment, insert the following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Public
Health Security and Bioterrorism Preparedness and Response
Act of 2002''.
(b) Table of Contents.--The table of contents of the Act is
as follows:
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness;
National Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and
Prevention.
Sec. 104. Advisory committees and communications; study regarding
communications abilities of public health agencies.
Sec. 105. Education of health care personnel; training regarding
pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for advance registration of health
professions volunteers.
Sec. 108. Working group.
Sec. 109. Antimicrobial resistance.
Sec. 110. Supplies and services in lieu of award funds.
Sec. 111. Additional amendments.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Sec. 121. Strategic national stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Issuance of rule on animal trials.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding
bioterrorist attack and other public health emergencies.
Sec. 127. Potassium iodide.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Sec. 131. Grants to improve State, local, and hospital preparedness for
and response to bioterrorism and other public health
emergencies.
Subtitle D--Emergency Authorities; Additional Provisions
Sec. 141. Reporting deadlines.
Sec. 142. Streamlining and clarifying communicable disease quarantine
provisions.
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP
requirements.
Sec. 144. Provision for expiration of public health emergencies.
Subtitle E--Additional Provisions
Sec. 151. Designated State public emergency announcement plan.
Sec. 152. Expanded research by Secretary of Energy.
Sec. 153. Expanded research on worker health and safety.
Sec. 154. Enhancement of emergency preparedness of Department of
Veterans Affairs.
Sec. 155. Reauthorization of existing program.
Sec. 156. Sense of Congress.
Sec. 157. General Accounting Office report.
Sec. 158. Certain awards.
Sec. 159. Public access defibrillation programs and public access
defibrillation demonstration projects.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Sec. 201. Regulation of certain biological agents and toxins.
Sec. 202. Implementation by Department of Health and Human Services.
Sec. 203. Effective dates.
Sec. 204. Conforming amendment.
Subtitle B--Department of Agriculture
Sec. 211. Short title.
Sec. 212. Regulation of certain biological agents and toxins.
Sec. 213. Implementation by Department of Agriculture.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins
Sec. 221. Interagency coordination.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Sec. 231. Criminal penalties.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
Sec. 301. Food safety and security strategy.
Sec. 302. Protection against adulteration of food.
Sec. 303. Administrative detention.
Sec. 304. Debarment for repeated or serious food import violations.
Sec. 305. Registration of food facilities.
Sec. 306. Maintenance and inspection of records for foods.
Sec. 307. Prior notice of imported food shipments.
Sec. 308. Authority to mark articles refused admission into United
States.
Sec. 309. Prohibition against port shopping.
Sec. 310. Notices to States regarding imported food.
Sec. 311. Grants to States for inspections.
Sec. 312. Surveillance and information grants and authorities.
Sec. 313. Surveillance of zoonotic diseases.
Sec. 314. Authority to commission other Federal officials to conduct
inspections.
Sec. 315. Rule of construction.
Subtitle B--Protection of Drug Supply
Sec. 321. Annual registration of foreign manufacturers; shipping
information; drug and device listing.
Sec. 322. Requirement of additional information regarding import
components intended for use in export products.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
Sec. 331. Expansion of Animal and Plant Health Inspection Service
activities.
Sec. 332. Expansion of Food Safety Inspection Service activities.
Sec. 333. Biosecurity upgrades at the Department of Agriculture.
Sec. 334. Agricultural biosecurity.
Sec. 335. Agricultural bioterrorism research and development.
Sec. 336. Animal enterprise terrorism penalties.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
Sec. 401. Terrorist and other intentional acts.
Sec. 402. Other Safe Drinking Water Act amendments.
Sec. 403. Miscellaneous and technical amendments.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
Sec. 501. Short title.
Sec. 502. Findings.
[[Page H2692]]
Sec. 503. Definitions.
Sec. 504. Authority to assess and use drug fees.
Sec. 505. Accountability and reports.
Sec. 506. Reports of postmarketing studies.
Sec. 507. Savings clause.
Sec. 508. Effective date.
Sec. 509. Sunset clause.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
Sec. 521. Office of Drug Safety.
Sec. 522. Division of Drug Marketing, Advertising, and Communications.
Sec. 523. Office of Generic Drugs.
Subtitle C--Additional Provisions
Sec. 531. Transition to digital television.
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans;
change in Medicare+Choice reporting deadlines and annual,
coordinated election period for 2003, 2004, and 2005.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.
(a) In General.--The Public Health Service Act (42 U.S.C.
201 et seq.) is amended by adding at the end the following
title:
``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
``Subtitle A--National Preparedness and Response Planning,
Coordinating, and Reporting
``SEC. 2801. NATIONAL PREPAREDNESS PLAN.
``(a) In General.--
``(1) Preparedness and response regarding public health
emergencies.--The Secretary shall further develop and
implement a coordinated strategy, building upon the core
public health capabilities established pursuant to section
319A, for carrying out health-related activities to prepare
for and respond effectively to bioterrorism and other public
health emergencies, including the preparation of a plan under
this section. The Secretary shall periodically thereafter
review and, as appropriate, revise the plan.
``(2) National approach.--In carrying out paragraph (1),
the Secretary shall collaborate with the States toward the
goal of ensuring that the activities of the Secretary
regarding bioterrorism and other public health emergencies
are coordinated with activities of the States, including
local governments.
``(3) Evaluation of progress.--The plan under paragraph (1)
shall provide for specific benchmarks and outcome measures
for evaluating the progress of the Secretary and the States,
including local governments, with respect to the plan under
paragraph (1), including progress toward achieving the goals
specified in subsection (b).
``(b) Preparedness Goals.--The plan under subsection (a)
should include provisions in furtherance of the following:
``(1) Providing effective assistance to State and local
governments in the event of bioterrorism or other public
health emergency.
``(2) Ensuring that State and local governments have
appropriate capacity to detect and respond effectively to
such emergencies, including capacities for the following:
``(A) Effective public health surveillance and reporting
mechanisms at the State and local levels.
``(B) Appropriate laboratory readiness.
``(C) Properly trained and equipped emergency response,
public health, and medical personnel.
``(D) Health and safety protection of workers responding to
such an emergency.
``(E) Public health agencies that are prepared to
coordinate health services (including mental health services)
during and after such emergencies.
``(F) Participation in communications networks that can
effectively disseminate relevant information in a timely and
secure manner to appropriate public and private entities and
to the public.
``(3) Developing and maintaining medical countermeasures
(such as drugs, vaccines and other biological products,
medical devices, and other supplies) against biological
agents and toxins that may be involved in such emergencies.
``(4) Ensuring coordination and minimizing duplication of
Federal, State, and local planning, preparedness, and
response activities, including during the investigation of a
suspicious disease outbreak or other potential public health
emergency.
``(5) Enhancing the readiness of hospitals and other health
care facilities to respond effectively to such emergencies.
``(c) Reports to Congress.--
``(1) In general.--Not later than one year after the date
of the enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, and
biennially thereafter, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report concerning
progress with respect to the plan under subsection (a),
including progress toward achieving the goals specified in
subsection (b).
``(2) Additional authority.--Reports submitted under
paragraph (1) by the Secretary (other than the first report)
shall make recommendations concerning--
``(A) any additional legislative authority that the
Secretary determines is necessary for fully implementing the
plan under subsection (a), including meeting the goals under
subsection (b); and
``(B) any additional legislative authority that the
Secretary determines is necessary under section 319 to
protect the public health in the event of an emergency
described in section 319(a).
``(d) Rule of Construction.--This section may not be
construed as expanding or limiting any of the authorities of
the Secretary that, on the day before the date of the
enactment of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, were in effect with
respect to preparing for and responding effectively to
bioterrorism and other public health emergencies.''.
(b) Other Reports.--
(1) In general.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the
``Secretary'') shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a
report concerning--
(A) the recommendations and findings of the National
Advisory Committee on Children and Terrorism under section
319F(c)(2) of the Public Health Service Act;
(B) the recommendations and findings of the EPIC Advisory
Committee under section 319F(c)(3) of such Act;
(C) the characteristics that may render a rural community
uniquely vulnerable to a biological attack, including
distance, lack of emergency transport, hospital or laboratory
capacity, lack of integration of Federal or State public
health networks, workforce deficits, or other relevant
characteristics;
(D) the characteristics that may render areas or
populations designated as medically underserved populations
(as defined in section 330 of such Act) uniquely vulnerable
to a biological attack, including significant numbers of low-
income or uninsured individuals, lack of affordable and
accessible health care services, insufficient public and
primary health care resources, lack of integration of Federal
or State public health networks, workforce deficits, or other
relevant characteristics;
(E) the recommendations of the Secretary with respect to
additional legislative authority that the Secretary
determines is necessary to effectively strengthen rural
communities, or medically underserved populations (as defined
in section 330 of such Act); and
(F) the need for and benefits of a National Disaster
Response Medical Volunteer Service that would be a private-
sector, community-based rapid response corps of medical
volunteers.
(2) Study regarding local emergency response methods.--The
Secretary shall conduct a study of effective methods for the
provision of emergency response services through local
governments (including through private response contractors
and volunteers of such governments) in a consistent manner in
response to acts of bioterrorism or other public health
emergencies. Not later than 180 days after the date of the
enactment of this Act, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report describing the
findings of the study.
SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY
PREPAREDNESS; NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Title XXVIII of the Public Health Service
Act, as added by section 101 of this Act, is amended by
adding at the end the following subtitle:
``Subtitle B--Emergency Preparedness and Response
``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES.
``(a) Assistant Secretary for Public Health Emergency
Preparedness.--
``(1) In general.--There is established within the
Department of Health and Human Services the position of
Assistant Secretary for Public Health Emergency Preparedness.
The President shall appoint an individual to serve in such
position. Such Assistant Secretary shall report to the
Secretary.
``(2) Duties.--Subject to the authority of the Secretary,
the Assistant Secretary for Public Health Emergency
Preparedness shall carry out the following duties with
respect to bioterrorism and other public health emergencies:
``(A) Coordinate on behalf of the Secretary--
``(i) interagency interfaces between the Department of
Health and Human Services (referred to in this paragraph as
the `Department') and other departments, agencies, and
offices of the United States; and
``(ii) interfaces between the Department and State and
local entities with responsibility for emergency
preparedness.
``(B) Coordinate the operations of the National Disaster
Medical System and any other emergency response activities
within the Department of Health and Human Services that are
related to bioterrorism and other public health emergencies.
``(C) Coordinate the efforts of the Department to bolster
State and local emergency preparedness for a bioterrorist
attack or other public health emergency, and evaluate the
progress of such entities in meeting the benchmarks and other
outcome measures contained in the national plan and in
meeting the core public health capabilities established
pursuant to 319A.
``(D) Any other duties determined appropriate by the
Secretary.
``(b) National Disaster Medical System.--
``(1) In general.--The Secretary shall provide for the
operation in accordance with this section of a system to be
known as the National Disaster Medical System. The Secretary
shall designate the Assistant Secretary for Public Health
[[Page H2693]]
Emergency Preparedness as the head of the National Disaster
Medical System, subject to the authority of the Secretary.
``(2) Federal and state collaborative system.--
``(A) In general.--The National Disaster Medical System
shall be a coordinated effort by the Federal agencies
specified in subparagraph (B), working in collaboration with
the States and other appropriate public or private entities,
to carry out the purposes described in paragraph (3).
``(B) Participating federal agencies.--The Federal agencies
referred to in subparagraph (A) are the Department of Health
and Human Services, the Federal Emergency Management Agency,
the Department of Defense, and the Department of Veterans
Affairs.
``(3) Purpose of system.--
``(A) In general.--The Secretary may activate the National
Disaster Medical System to--
``(i) provide health services, health-related social
services, other appropriate human services, and appropriate
auxiliary services to respond to the needs of victims of a
public health emergency (whether or not determined to be a
public health emergency under section 319); or
``(ii) be present at locations, and for limited periods of
time, specified by the Secretary on the basis that the
Secretary has determined that a location is at risk of a
public health emergency during the time specified.
``(B) Ongoing activities.--The National Disaster Medical
System shall carry out such ongoing activities as may be
necessary to prepare for the provision of services described
in subparagraph (A) in the event that the Secretary activates
the National Disaster Medical System for such purposes.
``(C) Test for mobilization of system.--During the one-year
period beginning on the date of the enactment of the Public
Health Security and Bioterrorism Preparedness and Response
Act of 2002, the Secretary shall conduct an exercise to test
the capability and timeliness of the National Disaster
Medical System to mobilize and otherwise respond effectively
to a bioterrorist attack or other public health emergency
that affects two or more geographic locations concurrently.
Thereafter, the Secretary may periodically conduct such
exercises regarding the National Disaster Medical System as
the Secretary determines to be appropriate.
``(c) Criteria.--
``(1) In general.--The Secretary shall establish criteria
for the operation of the National Disaster Medical System.
``(2) Participation agreements for non-federal entities.--
In carrying out paragraph (1), the Secretary shall establish
criteria regarding the participation of States and private
entities in the National Disaster Medical System, including
criteria regarding agreements for such participation. The
criteria shall include the following:
``(A) Provisions relating to the custody and use of Federal
personal property by such entities, which may in the
discretion of the Secretary include authorizing the custody
and use of such property to respond to emergency situations
for which the National Disaster Medical System has not been
activated by the Secretary pursuant to subsection (b)(3)(A).
Any such custody and use of Federal personal property shall
be on a reimbursable basis.
``(B) Provisions relating to circumstances in which an
individual or entity has agreements with both the National
Disaster Medical System and another entity regarding the
provision of emergency services by the individual. Such
provisions shall address the issue of priorities among the
agreements involved.
``(d) Intermittent Disaster-Response Personnel.--
``(1) In general.--For the purpose of assisting the
National Disaster Medical System in carrying out duties under
this section, the Secretary may appoint individuals to serve
as intermittent personnel of such System in accordance with
applicable civil service laws and regulations.
``(2) Liability.--For purposes of section 224(a) and the
remedies described in such section, an individual appointed
under paragraph (1) shall, while acting within the scope of
such appointment, be considered to be an employee of the
Public Health Service performing medical, surgical, dental,
or related functions. With respect to the participation of
individuals appointed under paragraph (1) in training
programs authorized by the Assistant Secretary for Public
Health Emergency Preparedness or a comparable official of any
Federal agency specified in subsection (b)(2)(B), acts of
individuals so appointed that are within the scope of such
participation shall be considered within the scope of the
appointment under paragraph (1) (regardless of whether the
individuals receive compensation for such participation).
``(e) Certain Employment Issues Regarding Intermittent
Appointments.--
``(1) Intermittent disaster-response appointee.--For
purposes of this subsection, the term `intermittent disaster-
response appointee' means an individual appointed by the
Secretary under subsection (d).
``(2) Compensation for work injuries.--An intermittent
disaster-response appointee shall, while acting in the scope
of such appointment, be considered to be an employee of the
Public Health Service performing medical, surgical, dental,
or related functions, and an injury sustained by such an
individual shall be deemed `in the performance of duty', for
purposes of chapter 81 of title 5, United States Code,
pertaining to compensation for work injuries. With respect to
the participation of individuals appointed under subsection
(d) in training programs authorized by the Assistant
Secretary for Public Health Emergency Preparedness or a
comparable official of any Federal agency specified in
subsection (b)(2)(B), injuries sustained by such an
individual, while acting within the scope of such
participation, also shall be deemed `in the performance of
duty' for purposes of chapter 81 of title 5, United States
Code (regardless of whether the individuals receive
compensation for such participation). In the event of an
injury to such an intermittent disaster-response appointee,
the Secretary of Labor shall be responsible for making
determinations as to whether the claimant is entitled to
compensation or other benefits in accordance with chapter 81
of title 5, United States Code.
``(3) Employment and reemployment rights.--
``(A) In general.--Service as an intermittent disaster-
response appointee when the Secretary activates the National
Disaster Medical System or when the individual participates
in a training program authorized by the Assistant Secretary
for Public Health Emergency Preparedness or a comparable
official of any Federal agency specified in subsection
(b)(2)(B) shall be deemed `service in the uniformed services'
for purposes of chapter 43 of title 38, United States Code,
pertaining to employment and reemployment rights of
individuals who have performed service in the uniformed
services (regardless of whether the individual receives
compensation for such participation). All rights and
obligations of such persons and procedures for assistance,
enforcement, and investigation shall be as provided for in
chapter 43 of title 38, United States Code.
``(B) Notice of absence from position of employment.--
Preclusion of giving notice of service by necessity of
Service as an intermittent disaster-response appointee when
the Secretary activates the National Disaster Medical System
shall be deemed preclusion by `military necessity' for
purposes of section 4312(b) of title 38, United States Code,
pertaining to giving notice of absence from a position of
employment. A determination of such necessity shall be made
by the Secretary, in consultation with the Secretary of
Defense, and shall not be subject to judicial review.
``(4) Limitation.--An intermittent disaster-response
appointee shall not be deemed an employee of the Department
of Health and Human Services for purposes other than those
specifically set forth in this section.
``(f) Rule of Construction Regarding Use of Commissioned
Corps.--If the Secretary assigns commissioned officers of the
Regular or Reserve Corps to serve with the National Disaster
Medical System, such assignments do not affect the terms
and conditions of their appointments as commissioned
officers of the Regular or Reserve Corps, respectively
(including with respect to pay and allowances, retirement,
benefits, rights, privileges, and immunities).
``(g) Definition.--For purposes of this section, the term
`auxiliary services' includes mortuary services, veterinary
services, and other services that are determined by the
Secretary to be appropriate with respect to the needs
referred to in subsection (b)(3)(A).
``(h) Authorization of Appropriations.--For the purpose of
providing for the Assistant Secretary for Public Health
Emergency Preparedness and the operations of the National
Disaster Medical System, other than purposes for which
amounts in the Public Health Emergency Fund under section 319
are available, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2002
through 2006.''.
(b) Sense of Congress Regarding Resources of National
Disaster Medical System.--It is the sense of the Congress
that the Secretary of Health and Human Services should
provide sufficient resources to entities tasked to carry out
the duties of the National Disaster Medical System for
reimbursement of expenses, operations, purchase and
maintenance of equipment, training, and other funds expended
in furtherance of the National Disaster Medical System.
SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL
AND PREVENTION.
Section 319D of the Public Health Service Act (42 U.S.C.
247d-4) is amended to read as follows:
``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``(a) Facilities; Capacities.--
``(1) Findings.--Congress finds that the Centers for
Disease Control and Prevention has an essential role in
defending against and combatting public health threats and
requires secure and modern facilities, and expanded and
improved capabilities related to bioterrorism and other
public health emergencies, sufficient to enable such Centers
to conduct this important mission.
``(2) Facilities.--
``(A) In general.--The Director of the Centers for Disease
Control and Prevention may design, construct, and equip new
facilities, renovate existing facilities (including
laboratories, laboratory support buildings, scientific
communication facilities, transshipment complexes, secured
and isolated parking structures, office buildings, and other
facilities and infrastructure), and upgrade security of such
facilities, in order to better conduct the capacities
described in section 319A, and for supporting public health
activities.
``(B) Multiyear contracting authority.--For any project of
designing, constructing, equipping, or renovating any
facility under subparagraph (A), the Director of the Centers
for Disease Control and Prevention may enter into a single
contract or related contracts that collectively include the
full scope of the project, and the solicitation and contract
shall contain the clause `availability of funds' found at
section 52.232-18 of title 48, Code of Federal Regulations.
``(3) Improving the capacities of the centers for disease
control and prevention.--The Secretary, taking into account
evaluations under section 319B(a), shall expand, enhance,
[[Page H2694]]
and improve the capabilities of the Centers for Disease
Control and Prevention relating to preparedness for and
responding effectively to bioterrorism and other public
health emergencies. Activities that may be carried out under
the preceding sentence include--
``(A) expanding or enhancing the training of personnel;
``(B) improving communications facilities and networks,
including delivery of necessary information to rural areas;
``(C) improving capabilities for public health surveillance
and reporting activities, taking into account the integrated
system or systems of public health alert communications and
surveillance networks under subsection (b); and
``(D) improving laboratory facilities related to
bioterrorism and other public health emergencies, including
increasing the security of such facilities.
``(b) National Communications and Surveillance Networks.--
``(1) In general.--The Secretary, directly or through
awards of grants, contracts, or cooperative agreements, shall
provide for the establishment of an integrated system or
systems of public health alert communications and
surveillance networks between and among--
``(A) Federal, State, and local public health officials;
``(B) public and private health-related laboratories,
hospitals, and other health care facilities; and
``(C) any other entities determined appropriate by the
Secretary.
``(2) Requirements.--The Secretary shall ensure that
networks under paragraph (1) allow for the timely sharing and
discussion, in a secure manner, of essential information
concerning bioterrorism or another public health emergency,
or recommended methods for responding to such an attack or
emergency.
``(3) Standards.--Not later than one year after the date of
the enactment of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, the Secretary, in
cooperation with health care providers and State and local
public health officials, shall establish any additional
technical and reporting standards (including standards for
interoperability) for networks under paragraph (1).
``(c) Authorization of Appropriations.--
``(1) Facilities; capacities.--
``(A) Facilities.--For the purpose of carrying out
subsection (a)(2), there are authorized to be appropriated
$300,000,000 for each of the fiscal years 2002 and 2003, and
such sums as may be necessary for each of the fiscal years
2004 through 2006.
``(B) Mission; Improving capacities.--For the purposes of
achieving the mission of the Centers for Disease Control and
Prevention described in subsection (a)(1), for carrying out
subsection (a)(3), for better conducting the capacities
described in section 319A, and for supporting public health
activities, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2002 through
2006.
``(2) National communications and surveillance networks.--
For the purpose of carrying out subsection (b), there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2002 through 2006.''.
SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY
REGARDING COMMUNICATIONS ABILITIES OF PUBLIC
HEALTH AGENCIES.
(a) In General.--Section 319F of the Public Health Service
Act (42 U.S.C. 247d-6) is amended--
(1) by striking subsections (b) and (i);
(2) by redesignating subsections (c) through (h) as
subsections (e) through (j), respectively; and
(3) by inserting after subsection (a) the following
subsections:
``(b) Advice to the Federal Government.--
``(1) Required advisory committees.--In coordination with
the working group under subsection (a), the Secretary shall
establish advisory committees in accordance with paragraphs
(2) and (3) to provide expert recommendations to assist such
working groups in carrying out their respective
responsibilities under subsections (a) and (b).
``(2) National advisory committee on children and
terrorism.--
``(A) In general.--For purposes of paragraph (1), the
Secretary shall establish an advisory committee to be known
as the National Advisory Committee on Children and Terrorism
(referred to in this paragraph as the `Advisory Committee').
``(B) Duties.--The Advisory Committee shall provide
recommendations regarding--
``(i) the preparedness of the health care (including mental
health care) system to respond to bioterrorism as it relates
to children;
``(ii) needed changes to the health care and emergency
medical service systems and emergency medical services
protocols to meet the special needs of children; and
``(iii) changes, if necessary, to the national stockpile
under section 121 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 to meet
the emergency health security of children.
``(C) Composition.--The Advisory Committee shall be
composed of such Federal officials as may be appropriate to
address the special needs of the diverse population groups of
children, and child health experts on infectious disease,
environmental health, toxicology, and other relevant
professional disciplines.
``(D) Termination.--The Advisory Committee terminates one
year after the date of the enactment of the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002.
``(3) Emergency public information and communications
advisory committee.--
``(A) In general.--For purposes of paragraph (1), the
Secretary shall establish an advisory committee to be known
as the Emergency Public Information and Communications
Advisory Committee (referred to in this paragraph as the
`EPIC Advisory Committee').
``(B) Duties.--The EPIC Advisory Committee shall make
recommendations to the Secretary and the working group under
subsection (a) and report on appropriate ways to communicate
public health information regarding bioterrorism and other
public health emergencies to the public.
``(C) Composition.--The EPIC Advisory Committee shall be
composed of individuals representing a diverse group of
experts in public health, medicine, communications,
behavioral psychology, and other areas determined appropriate
by the Secretary.
``(D) Dissemination.--The Secretary shall review the
recommendations of the EPIC Advisory Committee and ensure
that appropriate information is disseminated to the public.
``(E) Termination.--The EPIC Advisory Committee terminates
one year after the date of the enactment of Public Health
Security and Bioterrorism Preparedness and Response Act of
2002.
``(c) Strategy for Communication of Information Regarding
Bioterrorism and Other Public Health Emergencies.--In
coordination with working group under subsection (a), the
Secretary shall develop a strategy for effectively
communicating information regarding bioterrorism and other
public health emergencies, and shall develop means by which
to communicate such information. The Secretary may carry out
the preceding sentence directly or through grants, contracts,
or cooperative agreements.
``(d) Recommendation of Congress Regarding Official Federal
Internet Site on Bioterrorism.--It is the recommendation of
Congress that there should be established an official Federal
Internet site on bioterrorism, either directly or through
provision of a grant to an entity that has expertise in
bioterrorism and the development of websites, that should
include information relevant to diverse populations
(including messages directed at the general public and such
relevant groups as medical personnel, public safety workers,
and agricultural workers) and links to appropriate State and
local government sites.''.
(b) Study Regarding Communications Abilities of Public
Health Agencies.--The Secretary of Health and Human Services,
in consultation with the Federal Communications Commission,
the National Telecommunications and Information
Administration, and other appropriate Federal agencies, shall
conduct a study to determine whether local public health
entities have the ability to maintain communications in the
event of a bioterrorist attack or other public health
emergency. The study shall examine whether redundancies are
required in the telecommunications system, particularly with
respect to mobile communications, for public health entities
to maintain systems operability and connectivity during such
emergencies. The study shall also include recommendations to
industry and public health entities about how to implement
such redundancies if necessary.
SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING
REGARDING PEDIATRIC ISSUES.
Section 319F(g) of the Public Health Service Act, as
redesignated by section 104(a)(2) of this Act, is amended to
read as follows:
``(g) Education; Training Regarding Pediatric Issues.--
``(1) Materials; core curriculum.--The Secretary, in
collaboration with members of the working group described in
subsection (b), and professional organizations and societies,
shall--
``(A) develop materials for teaching the elements of a core
curriculum for the recognition and identification of
potential bioweapons and other agents that may create a
public health emergency, and for the care of victims of such
emergencies, recognizing the special needs of children and
other vulnerable populations, to public health officials,
medical professionals, emergency physicians and other
emergency department staff, laboratory personnel, and other
personnel working in health care facilities (including poison
control centers);
``(B) develop a core curriculum and materials for
community-wide planning by State and local governments,
hospitals and other health care facilities, emergency
response units, and appropriate public and private sector
entities to respond to a bioterrorist attack or other public
health emergency;
``(C) develop materials for proficiency testing of
laboratory and other public health personnel for the
recognition and identification of potential bioweapons and
other agents that may create a public health emergency; and
``(D) provide for dissemination and teaching of the
materials described in subparagraphs (A) through (C) by
appropriate means, which may include telemedicine, long-
distance learning, or other such means.
``(2) Certain entities.--The entities through which
education and training activities described in paragraph (1)
may be carried out include Public Health Preparedness
Centers, the Public Health Service's Noble Training Center,
the Emerging Infections Program, the Epidemic Intelligence
Service, the Public Health Leadership Institute, multi-State,
multi-institutional consortia, other appropriate educational
entities, professional organizations and societies, private
accrediting organizations, and other nonprofit institutions
or entities meeting criteria established by the Secretary.
``(3) Grants and contracts.--In carrying out paragraph (1),
the Secretary may carry out activities directly and through
the award of grants and contracts, and may enter into
interagency cooperative agreements with other Federal
agencies.
[[Page H2695]]
``(4) Health-related assistance for emergency response
personnel training.--The Secretary, in consultation with the
Attorney General and the Director of the Federal Emergency
Management Agency, may provide technical assistance with
respect to health-related aspects of emergency response
personnel training carried out by the Department of Justice
and the Federal Emergency Management Agency.''.
SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH
PROFESSIONALS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section
319G the following section:
``SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF
CERTAIN HEALTH PROFESSIONALS.
``(a) In General.--The Secretary may make awards of grants
and cooperative agreements to appropriate public and
nonprofit private health or educational entities, including
health professions schools and programs as defined in section
799B, for the purpose of providing low-interest loans,
partial scholarships, partial fellowships, revolving loan
funds, or other cost-sharing forms of assistance for the
education and training of individuals in any category of
health professions for which there is a shortage that the
Secretary determines should be alleviated in order to prepare
for or respond effectively to bioterrorism and other public
health emergencies.
``(b) Authority Regarding Non-Federal Contributions.--The
Secretary may require as a condition of an award under
subsection (a) that a grantee under such subsection provide
non-Federal contributions toward the purpose described in
such subsection.
``(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.''.
SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH
PROFESSIONS VOLUNTEERS.
Part B of title III of the Public Health Service Act, as
amended by section 106 of this Act, is amended by inserting
after section 319H the following section:
``SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF
HEALTH PROFESSIONS VOLUNTEERS.
``(a) In General.--The Secretary shall, directly or through
an award of a grant, contract, or cooperative agreement,
establish and maintain a system for the advance registration
of health professionals for the purpose of verifying the
credentials, licenses, accreditations, and hospital
privileges of such professionals when, during public health
emergencies, the professionals volunteer to provide health
services (referred to in this section as the `verification
system'). In carrying out the preceding sentence, the
Secretary shall provide for an electronic database for the
verification system.
``(b) Certain Criteria.--The Secretary shall establish
provisions regarding the promptness and efficiency of the
system in collecting, storing, updating, and disseminating
information on the credentials, licenses, accreditations, and
hospital privileges of volunteers described in subsection
(a).
``(c) Other Assistance.--The Secretary may make grants and
provide technical assistance to States and other public or
nonprofit private entities for activities relating to the
verification system developed under subsection (a).
``(d) Coordination Among States.--The Secretary may
encourage each State to provide legal authority during a
public health emergency for health professionals authorized
in another State to provide certain health services to
provide such health services in the State.
``(e) Rule of Construction.--This section may not be
construed as authorizing the Secretary to issue requirements
regarding the provision by the States of credentials,
licenses, accreditations, or hospital privileges.
``(f) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,000,000 for fiscal year 2002, and such sums
as may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 108. WORKING GROUP.
Section 319F of the Public Health Service Act, as amended
by section 104(a), is amended by striking subsection (a) and
inserting the following:
``(a) Working Group on Bioterrorism and Other Public Health
Emergencies.--
``(1) In general.--The Secretary, in coordination with the
Secretary of Agriculture, the Attorney General, the Director
of Central Intelligence, the Secretary of Defense, the
Secretary of Energy, the Administrator of the Environmental
Protection Agency, the Director of the Federal Emergency
Management Agency, the Secretary of Labor, the Secretary of
Veterans Affairs, and with other similar Federal officials as
determined appropriate, shall establish a working group on
the prevention, preparedness, and response to bioterrorism
and other public health emergencies. Such joint working
group, or subcommittees thereof, shall meet periodically for
the purpose of consultation on, assisting in, and making
recommendations on--
``(A) responding to a bioterrorist attack, including the
provision of appropriate safety and health training and
protective measures for medical, emergency service, and other
personnel responding to such attacks;
``(B) prioritizing countermeasures required to treat,
prevent, or identify exposure to a biological agent or toxin
pursuant to section 351A;
``(C) facilitation of the awarding of grants, contracts, or
cooperative agreements for the development, manufacture,
distribution, supply-chain management, and purchase of
priority countermeasures;
``(D) research on pathogens likely to be used in a
biological threat or attack on the civilian population;
``(E) development of shared standards for equipment to
detect and to protect against biological agents and toxins;
``(F) assessment of the priorities for and enhancement of
the preparedness of public health institutions, providers of
medical care, and other emergency service personnel
(including firefighters) to detect, diagnose, and respond
(including mental health response) to a biological threat or
attack;
``(G) in the recognition that medical and public health
professionals are likely to provide much of the first
response to such an attack, development and enhancement of
the quality of joint planning and training programs that
address the public health and medical consequences of a
biological threat or attack on the civilian population
between--
``(i) local firefighters, ambulance personnel, police and
public security officers, or other emergency response
personnel; and
``(ii) hospitals, primary care facilities, and public
health agencies;
``(H) development of strategies for Federal, State, and
local agencies to communicate information to the public
regarding biological threats or attacks;
``(I) ensuring that the activities under this subsection
address the health security needs of children and other
vulnerable populations;
``(J) strategies for decontaminating facilities
contaminated as a result of a biological attack, including
appropriate protections for the safety of workers conducting
such activities;
``(K) subject to compliance with other provisions of
Federal law, clarifying the responsibilities among Federal
officials for the investigation of suspicious outbreaks of
disease and other potential public health emergencies, and
for related revisions of the interagency plan known as the
Federal response plan; and
``(L) in consultation with the National Highway Traffic
Safety Administration and the U.S. Fire Administration, ways
to enhance coordination among Federal agencies involved with
State, local, and community based emergency medical services,
including issuing a report that--
``(i) identifies needs of community-based emergency medical
services; and
``(ii) identifies ways to streamline and enhance the
process through which Federal agencies support community-
based emergency medical services.
``(2) Consultation with experts.--In carrying out
subparagraphs (B) and (C) of paragraph (1), the working group
under such paragraph shall consult with the pharmaceutical,
biotechnology, and medical device industries, and other
appropriate experts.
``(3) Use of subcommittees regarding consultation
requirements.--With respect to a requirement under law that
the working group under paragraph (1) be consulted on a
matter, the working group may designate an appropriate
subcommittee of the working group to engage in the
consultation.
``(4) Discretion in exercise of duties.--Determinations
made by the working group under paragraph (1) with respect to
carrying out duties under such paragraph are matters
committed to agency discretion for purposes of section 701(a)
of title 5, Unites States Code.
``(5) Rule of construction.--This subsection may not be
construed as establishing new regulatory authority for any of
the officials specified in paragraph (1), or as having any
legal effect on any other provision of law, including the
responsibilities and authorities of the Environmental
Protection Agency.''.
SEC. 109. ANTIMICROBIAL RESISTANCE.
Section 319E of the Public Health Service Act (42 U.S.C.
247d-5) is amended--
(1) in subsection (b)--
(A) by striking ``shall conduct and support'' and inserting
``shall directly or through awards of grants or cooperative
agreements to public or private entities provide for the
conduct of''; and
(B) by amending paragraph (4) to read as follows:
``(4) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as
determined by the Director of the National Institutes of
Health in consultation with the task force established under
subsection (a)), in collaboration and coordination with the
activities of the Department of Defense and the Joint Genome
Institute of the Department of Energy; and'';
(2) in subsection (e)(2), by inserting after ``societies,''
the following: ``schools or programs that train medical
laboratory personnel,''; and
(3) in subsection (g), by striking ``and such sums'' and
all that follows and inserting the following: ``$25,000,000
for each of the fiscal years 2002 and 2003, and such sums as
may be necessary for each of the fiscal years 2004 through
2006.''.
SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
Part B of title III of the Public Health Service Act, as
amended by section 107 of this Act, is amended by inserting
after section 319I the following section:
``SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS
``(a) In General.--Upon the request of a recipient of an
award under any of sections 319 through 319I or section 319K,
the Secretary may, subject to subsection (b), provide
supplies, equipment, and services for the purpose of aiding
the recipient in carrying out the purposes for which the
award is made and, for such purposes, may detail to the
recipient any officer or employee of the Department of Health
and Human Services.
``(b) Corresponding Reduction in Payments.--With respect to
a request described in
[[Page H2696]]
subsection (a), the Secretary shall reduce the amount of
payments under the award involved by an amount equal to the
costs of detailing personnel and the fair market value of any
supplies, equipment, or services provided by the Secretary.
The Secretary shall, for the payment of expenses incurred in
complying with such request, expend the amounts withheld.''.
SEC. 111. ADDITIONAL AMENDMENTS.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq) is amended--
(1) in section 319A(a)(1), by striking ``10 years'' and
inserting ``five years'';
(2) in section 319B(a), in the first sentence, by striking
``10 years'' and inserting ``five years''; and
(3) in section 391F(e)(2), as redesignated by section
104(a)(2) of this Act--
(A) by striking ``or'' after ``clinic,''; and
(B) by inserting before the period following: ``,
professional organization or society, school or program that
trains medical laboratory personnel, private accrediting
organization, or other nonprofit private institution or
entity meeting criteria established by the Secretary''.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
SEC. 121. STRATEGIC NATIONAL STOCKPILE.
(a) Strategic National Stockpile.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), in
coordination with the Secretary of Veterans Affairs, shall
maintain a stockpile or stockpiles of drugs, vaccines and
other biological products, medical devices, and other
supplies in such numbers, types, and amounts as are
determined by the Secretary to be appropriate and
practicable, taking into account other available sources, to
provide for the emergency health security of the United
States, including the emergency health security of children
and other vulnerable populations, in the event of a
bioterrorist attack or other public health emergency.
(2) Procedures.--The Secretary, in managing the stockpile
under paragraph (1), shall--
(A) consult with the working group under section 319F(a) of
the Public Health Service Act;
(B) ensure that adequate procedures are followed with
respect to such stockpile for inventory management and
accounting, and for the physical security of the stockpile;
(C) in consultation with Federal, State, and local
officials, take into consideration the timing and location of
special events;
(D) review and revise, as appropriate, the contents of the
stockpile on a regular basis to ensure that emerging threats,
advanced technologies, and new countermeasures are adequately
considered;
(E) devise plans for the effective and timely supply-chain
management of the stockpile, in consultation with appropriate
Federal, State and local agencies, and the public and private
health care infrastructure; and
(F) ensure the adequate physical security of the stockpile.
(b) Smallpox Vaccine Development.--
(1) In general.--The Secretary shall award contracts, enter
into cooperative agreements, or carry out such other
activities as may reasonably be required in order to ensure
that the stockpile under subsection (a) includes an amount of
vaccine against smallpox as determined by the Secretary to be
sufficient to meet the health security needs of the United
States.
(2) Rule of construction.--Nothing in this section shall be
construed to limit the private distribution, purchase, or
sale of vaccines from sources other than the stockpile
described in subsection (a).
(c) Disclosures.--No Federal agency shall disclose under
section 552, United States Code, any information identifying
the location at which materials in the stockpile under
subsection (a) are stored.
(d) Definition.--For purposes of subsection (a), the term
``stockpile'' includes--
(1) a physical accumulation (at one or more locations) of
the supplies described in subsection (a); or
(2) a contractual agreement between the Secretary and a
vendor or vendors under which such vendor or vendors agree to
provide to the Secretary supplies described in subsection
(a).
(e) Authorization of Appropriations.--
(1) Strategic national stockpile.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated $640,000,000 for fiscal year 2002, and such sums
as may be necessary for each of fiscal years 2003 through
2006.
(2) Smallpox vaccine development.--For the purpose of
carrying out subsection (b), there are authorized to be
appropriated $509,000,000 for fiscal year 2002, and such sums
as may be necessary for each of fiscal years 2003 through
2006.
SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.
(a) In General.--The Secretary of Health and Human Services
may designate a priority countermeasure as a fast-track
product pursuant to section 506 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356) or as a device granted
review priority pursuant to section 515(d)(5) of such Act (21
U.S.C. 360e(d)(5)). Such a designation may be made prior to
the submission of--
(1) a request for designation by the sponsor or applicant;
or
(2) an application for the investigation of the drug under
section 505(i) of such Act or section 351(a)(3) of the Public
Health Service Act.
Nothing in this subsection shall be construed to prohibit a
sponsor or applicant from declining such a designation.
(b) Use of Animal Trials.--A drug for which approval is
sought under section 505(b) of the Federal Food, Drug, and
Cosmetic Act or section 351 of the Public Health Service Act
on the basis of evidence of effectiveness that is derived
from animal studies pursuant to section 123 may be designated
as a fast track product for purposes of this section.
(c) Priority Review of Drugs and Biological Products.--A
priority countermeasure that is a drug or biological product
shall be considered a priority drug or biological product for
purposes of performance goals for priority drugs or
biological products agreed to by the Commissioner of Food and
Drugs.
(d) Definitions.--For purposes of this title:
(1) The term ``priority countermeasure'' has the meaning
given such term in section 319F(h)(4) of the Public Health
Service Act.
(2) The term ``priority drugs or biological products''
means a drug or biological product that is the subject of a
drug or biologics application referred to in section 101(4)
of the Food and Drug Administration Modernization Act of
1997.
SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.
Not later than 90 days after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
complete the process of rulemaking that was commenced under
authority of section 505 of the Federal Food, Drug, and
Cosmetic Act and section 351 of the Public Health Service Act
with the issuance of the proposed rule entitled ``New Drug
and Biological Drug Products; Evidence Needed to Demonstrate
Efficacy of New Drugs for Use Against Lethal or Permanently
Disabling Toxic Substances When Efficacy Studies in Humans
Ethically Cannot be Conducted'' published in the Federal
Register on October 5, 1999 (64 Fed. Reg. 53960), and shall
promulgate a final rule.
SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
Part B of title III of the Public Health Service Act, as
amended by section 110 of this Act, is amended by inserting
after section 319J the following section:
``SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND
PRODUCTION.
``(a) In General.--The Secretary, in consultation with the
Attorney General and the Secretary of Defense, may provide
technical or other assistance to provide security to persons
or facilities that conduct development, production,
distribution, or storage of priority countermeasures (as
defined in section 319F(h)(4)).
``(b) Guidelines.--The Secretary may develop guidelines to
enable entities eligible to receive assistance under
subsection (a) to secure their facilities against potential
terrorist attack.''.
SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND
DEVELOPMENT.
Section 319F(h) of the Public Health Service Act, as
redesignated by section 104(a)(2) of this Act, is amended to
read as follows:
``(h) Accelerated Research and Development on Priority
Pathogens and Countermeasures.--
``(1) In general.--With respect to pathogens of potential
use in a bioterrorist attack, and other agents that may cause
a public health emergency, the Secretary, taking into
consideration any recommendations of the working group under
subsection (a), shall conduct, and award grants, contracts,
or cooperative agreements for, research, investigations,
experiments, demonstrations, and studies in the health
sciences relating to--
``(A) the epidemiology and pathogenesis of such pathogens;
``(B) the sequencing of the genomes, or other DNA analysis,
or other comparative analysis, of priority pathogens (as
determined by the Director of the National Institutes of
Health in consultation with the working group established in
subsection (a)), in collaboration and coordination with the
activities of the Department of Defense and the Joint Genome
Institute of the Department of Energy;
``(C) the development of priority countermeasures; and
``(D) other relevant areas of research;
with consideration given to the needs of children and other
vulnerable populations.
``(2) Priority.--The Secretary shall give priority under
this section to the funding of research and other studies
related to priority countermeasures.
``(3) Role of department of veterans affairs.--In carrying
out paragraph (1), the Secretary shall consider using the
biomedical research and development capabilities of the
Department of Veterans Affairs, in conjunction with that
Department's affiliations with health-professions
universities. When advantageous to the Government in
furtherance of the purposes of such paragraph, the Secretary
may enter into cooperative agreements with the Secretary of
Veterans Affairs to achieve such purposes.
``(4) Priority countermeasures.--For purposes of this
section, the term `priority countermeasure' means a drug,
biological product, device, vaccine, vaccine adjuvant,
antiviral, or diagnostic test that the Secretary determines
to be--
``(A) a priority to treat, identify, or prevent infection
by a biological agent or toxin listed pursuant to section
351A(a)(1), or harm from any other agent that may cause a
public health emergency; or
``(B) a priority to diagnose conditions that may result in
adverse health consequences or death and may be caused by the
administering of a drug, biological product, device, vaccine,
vaccine adjuvant, antiviral, or diagnostic test that is a
priority under subparagraph (A).''.
SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES
REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC
HEALTH EMERGENCIES.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
promptly carry out a program to periodically evaluate new and
emerging technologies that, in the determination of the
Secretary, are designed to improve or enhance the ability of
public health or safety officials to conduct public health
surveillance activities relating to a bioterrorist attack or
other public health emergency.
[[Page H2697]]
(b) Certain Activities.--In carrying out this subsection,
the Secretary shall, to the extent practicable--
(1) survey existing technology programs funded by the
Federal Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information
from non-Federal public and private entities for ongoing
activities in this area; and
(3) evaluate technologies identified under paragraphs (1)
and (2) pursuant to subsection (c).
(c) Consultation and Evaluation.--In carrying out
subsection (b)(3), the Secretary shall consult with the
working group under section 319F(a) of the Public Health
Service Act, as well as other appropriate public, nonprofit,
and private entities, to develop criteria for the evaluation
of such technologies and to conduct such evaluations.
(d) Report.--Not later than 180 days after the date of the
enactment of this Act, and periodically thereafter, the
Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a
report on the activities under this section.
SEC. 127. POTASSIUM IODIDE.
(a) In General.--Through the national stockpile under
section 121, the President, subject to subsections (b) and
(c), shall make available to State and local governments
potassium iodide tablets for stockpiling and for distribution
as appropriate to public facilities, such as schools and
hospitals, in quantities sufficient to provide adequate
protection for the population within 20 miles of a nuclear
power plant.
(b) State and Local Plans.--
(1) In general.--Subsection (a) applies with respect to a
State or local government, subject to paragraph (2), if the
government involved meets the following conditions:
(A) Such government submits to the President a plan for the
stockpiling of potassium iodide tablets, and for the
distribution and utilization of potassium iodide tablets in
the event of a nuclear incident.
(B) The plan is accompanied by certifications by such
government that the government has not already received
sufficient quantities of potassium iodide tablets from the
Federal Government.
(2) Local governments.--Subsection (a) applies with respect
to a local government only if, in addition to the conditions
described in paragraph (1), the following conditions are met:
(A) The State in which the locality involved is located--
(i) does not have a plan described in paragraph (1)(A); or
(ii) has a plan described in such paragraph, but the plan
does not address populations at a distance greater than 10
miles from the nuclear power plant involved.
(B) The local government has petitioned the State to modify
the State plan to address such populations, not exceeding 20
miles from such plant, and 60 days have elapsed without the
State modifying the State plan to address populations at the
full distance sought by the local government through the
petition.
(C) The local government has submitted its local plan under
paragraph (1)(A) to the State, and the State has approved the
plan and certified that the plan is not inconsistent with the
State emergency plan.
(c) Guidelines.--Not later than one year after the date of
the enactment of this Act, the President, in consultation
with individuals representing appropriate Federal, State, and
local agencies, shall establish guidelines for the
stockpiling of potassium iodide tablets, and for the
distribution and utilization of potassium iodide tablets in
the event of a nuclear incident. Such tablets may not be made
available under subsection (a) until such guidelines have
been established.
(d) Information.--The President shall carry out activities
to inform State and local governments of the program under
this section.
(e) Reports.--
(1) President.--Not later than six months after the date on
which the guidelines under subsection (c) are issued, the
President shall submit to the Congress a report--
(A) on whether potassium iodide tablets have been made
available under subsection (a) or other Federal, State, or
local programs, and the extent to which State and local
governments have established stockpiles of such tablets; and
(B) the measures taken by the President to implement this
section.
(2) National academy of sciences.--
(A) In general.--The President shall request the National
Academy of Sciences to enter into an agreement with the
President under which the Academy conducts a study to
determine what is the most effective and safe way to
distribute and administer potassium iodide tablets on a mass
scale. If the Academy declines to conduct the study, the
President shall enter into an agreement with another
appropriate public or nonprofit private entity to conduct the
study.
(B) Report.--The President shall ensure that, not later
than six months after the date of the enactment of this Act,
the study required in subparagraph (A) is completed and a
report describing the findings made in the study is submitted
to the Congress.
(f) Applicability.--Subsections (a) and (d) cease to apply
as requirements if the President determines that there is an
alternative and more effective prophylaxis or preventive
measures for adverse thyroid conditions that may result from
the release of radionuclides from nuclear power plants.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL
PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
(a) In General.--Part B of title III of the Public Health
Service Act (42 U.S.C. 243 et seq.) is amended by inserting
after section 319C the following sections:
``SEC. 319C-1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL
PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM
AND OTHER PUBLIC HEALTH EMERGENCIES.
``(a) In General.--To enhance the security of the United
States with respect to bioterrorism and other public health
emergencies, the Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such
entities to conduct the activities described in subsection
(d).
``(b) Eligible Entities.--
``(1) In general.--To be eligible to receive an award under
subsection (a), an entity shall--
``(A)(i) be a State; and
``(ii) prepare and submit to the Secretary an application
at such time, and in such manner, and containing such
information as the Secretary may require, including an
assurance that the State--
``(I) has completed an evaluation under section 319B(a), or
an evaluation that is substantially equivalent to an
evaluation described in such section (as determined by the
Secretary);
``(II) has prepared, or will (within 60 days of receiving
an award under this section) prepare, a Bioterrorism and
Other Public Health Emergency Preparedness and Response Plan
in accordance with subsection (c);
``(III) has established a means by which to obtain public
comment and input on the plan prepared under subclause (II),
and on the implementation of such plan, that shall include an
advisory committee or other similar mechanism for obtaining
comment from the public at large as well as from other State
and local stakeholders;
``(IV) will use amounts received under the award in
accordance with the plan prepared under subclause (II),
including making expenditures to carry out the strategy
contained in the plan; and
``(V) with respect to the plan prepared under subclause
(II), will establish reasonable criteria to evaluate the
effective performance of entities that receive funds under
the award and include relevant benchmarks in the plan; or
``(B)(i) be a political subdivision of a State or a
consortium of 2 or more such subdivisions; and
``(ii) prepare and submit to the Secretary an application
at such time, and in such manner, and containing such
information as the Secretary may require.
``(2) Coordination with statewide plans.--An award under
subsection (a) to an eligible entity described in paragraph
(1)(B) may not be made unless the application of such entity
is in coordination with, and consistent with, applicable
Statewide plans described in subsection (d)(1).
``(c) Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan.--Not later than 60 days after
receiving amounts under an award under subsection (a), an
eligible entity described in subsection (b)(1)(A) shall
prepare and submit to the Secretary a Bioterrorism and Other
Public Health Emergency Preparedness and Response Plan.
Recognizing the assessment of public health needs conducted
under section 319B, such plan shall include a description of
activities to be carried out by the entity to address the
needs identified in such assessment (or an equivalent
assessment).
``(d) Use of Funds.--An award under subsection (a) may be
expended for activities that may include the following and
similar activities:
``(1) To develop Statewide plans (including the development
of the Bioterrorism and Other Public Health Emergency
Preparedness and Response Plan required under subsection
(c)), and community-wide plans for responding to bioterrorism
and other public health emergencies that are coordinated with
the capacities of applicable national, State, and local
health agencies and health care providers, including poison
control centers.
``(2) To address deficiencies identified in the assessment
conducted under section 319B.
``(3) To purchase or upgrade equipment (including
stationary or mobile communications equipment), supplies,
pharmaceuticals or other priority countermeasures to enhance
preparedness for and response to bioterrorism or other public
health emergencies, consistent with the plan described in
subsection (c).
``(4) To conduct exercises to test the capability and
timeliness of public health emergency response activities.
``(5) To develop and implement the trauma care and burn
center care components of the State plans for the provision
of emergency medical services.
``(6) To improve training or workforce development to
enhance public health laboratories.
``(7) To train public health and health care personnel to
enhance the ability of such personnel--
``(A) to detect, provide accurate identification of, and
recognize the symptoms and epidemiological characteristics of
exposure to a biological agent that may cause a public health
emergency; and
``(B) to provide treatment to individuals who are exposed
to such an agent.
``(8) To develop, enhance, coordinate, or improve
participation in systems by which disease detection and
information about biological attacks and other public health
emergencies can be rapidly communicated among national,
State, and local health agencies, emergency response
[[Page H2698]]
personnel, and health care providers and facilities to detect
and respond to a bioterrorist attack or other public health
emergency, including activities to improve information
technology and communications equipment available to health
care and public health officials for use in responding to a
biological threat or attack or other public health emergency.
``(9) To enhance communication to the public of information
on bioterrorism and other public health emergencies,
including through the use of 2-1-1 call centers.
``(10) To address the health security needs of children and
other vulnerable populations with respect to bioterrorism and
other public health emergencies.
``(11) To provide training and develop, enhance,
coordinate, or improve methods to enhance the safety of
workers and workplaces in the event of bioterrorism.
``(12) To prepare and plan for contamination prevention
efforts related to public health that may be implemented in
the event of a bioterrorist attack, including training and
planning to protect the health and safety of workers
conducting the activities described in this paragraph.
``(13) To prepare a plan for triage and transport
management in the event of bioterrorism or other public
health emergencies.
``(14) To enhance the training of health care professionals
to recognize and treat the mental health consequences of
bioterrorism or other public health emergencies.
``(15) To enhance the training of health care professionals
to assist in providing appropriate health care for large
numbers of individuals exposed to a bioweapon.
``(16) To enhance training and planning to protect the
health and safety of personnel, including health care
professionals, involved in responding to a biological attack.
``(17) To improve surveillance, detection, and response
activities to prepare for emergency response activities
including biological threats or attacks, including training
personnel in these and other necessary functions and
including early warning and surveillance networks that use
advanced information technology to provide early detection of
biological threats or attacks.
``(18) To develop, enhance, and coordinate or improve the
ability of existing telemedicine programs to provide health
care information and advice as part of the emergency public
health response to bioterrorism or other public health
emergencies.
Nothing in this subsection may be construed as establishing
new regulatory authority or as modifying any existing
regulatory authority.
``(e) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in subparagraph (B),
the Secretary shall, in carrying out the activities described
in this section, address the following hazards in the
following priority:
``(i) Bioterrorism or acute outbreaks of infectious
diseases.
``(ii) Other public health threats and emergencies.
``(B) Determination of the secretary.--In the case of the
hazard involved, the degree of priority that would apply to
the hazard based on the categories specified in clauses (i)
and (ii) of subparagraph (A) may be modified by the Secretary
if the following conditions are met:
``(i) The Secretary determines that the modification is
appropriate on the basis of the following factors:
``(I) The extent to which eligible entities are adequately
prepared for responding to hazards within the category
specified in clause (i) of subparagraph (A).
``(II) There has been a significant change in the
assessment of risks to the public health posed by hazards
within the category specified in clause (ii) of such
subparagraph.
``(ii) Prior to modifying the priority, the Secretary
notifies the appropriate committees of the Congress of the
determination of the Secretary under clause (i) of this
subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of
hazards specified in clause (i) of paragraph (1)(A), and
shall determine areas of emphasis within the category of
hazards specified in clause (ii) of such paragraph, based on
an assessment of the risk and likely consequences of such
hazards and on an evaluation of Federal, State, and local
needs, and may also take into account the extent to which
receiving an award under subsection (a) will develop
capacities that can be used for public health emergencies of
varying types.
``(f) Certain Activities.--In administering activities
under section 319C(c)(4) or similar activities, the Secretary
shall, where appropriate, give priority to activities that
include State or local government financial commitments, that
seek to incorporate multiple public health and safety
services or diagnostic databases into an integrated public
health entity, and that cover geographic areas lacking
advanced diagnostic and laboratory capabilities.
``(g) Coordination with Local Medical Response System.--An
eligible entity and local Metropolitan Medical Response
Systems shall, to the extent practicable, ensure that
activities carried out under an award under subsection (a)
are coordinated with activities that are carried out by local
Metropolitan Medical Response Systems.
``(h) Coordination of Federal Activities.--In making awards
under subsection (a), the Secretary shall--
``(1) annually notify the Director of the Federal Emergency
Management Agency, the Director of the Office of Justice
Programs, and the Director of the National Domestic
Preparedness Office, as to the amount, activities covered
under, and status of such awards; and
``(2) coordinate such awards with other activities
conducted or supported by the Secretary to enhance
preparedness for bioterrorism and other public health
emergencies.
``(i) Definition.--For purposes of this section, the term
`eligible entity' means an entity that meets the conditions
described in subparagraph (A) or (B) of subsection (b)(1).
``(j) Funding.--
``(1) Authorizations of appropriations.--
``(A) Fiscal year 2003.--
``(i) Authorizations.--For the purpose of carrying out this
section, there is authorized to be appropriated
$1,600,000,000 for fiscal year 2003, of which--
``(I) $1,080,000,000 is authorized to be appropriated for
awards pursuant to paragraph (3) (subject to the authority of
the Secretary to make awards pursuant to paragraphs (4) and
(5)); and
``(II) $520,000,000 is authorized to be appropriated--
``(aa) for awards under subsection (a) to States,
notwitstanding the eligibility conditions under subsection
(b), for the purpose of enhancing the preparedness of
hospitals (including children's hospitals), clinics, health
centers, and primary care facilities for bioterrorism and
other public health emergencies; and
``(bb) for Federal, State, and local planning and
administrative activities related to such purpose.
``(ii) Contingent additional authorization.--If a
significant change in circumstances warrants an increase in
the amount authorized to be appropriated under clause (i) for
fiscal year 2003, there are authorized to be appropriated
such sums as may be necessary for such year for carrying out
this section, in addition to the amount authorized in clause
(i).
``(B) Other fiscal years.--For the purpose of carrying out
this section, there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years 2004
through 2006.
``(2) Supplement not supplant.--Amounts appropriated under
paragraph (1) shall be used to supplement and not supplant
other State and local public funds provided for activities
under this section.
``(3) State bioterrorism and other public health emergency
preparedness and response block grant for fiscal year 2003.--
``(A) In general.--For fiscal year 2003, the Secretary
shall, in an amount determined in accordance with
subparagraphs (B) through (D), make an award under subsection
(a) to each State, notwithstanding the eligibility conditions
described in subsection (b), that submits to the Secretary an
application for the award that meets the criteria of the
Secretary for the receipt of such an award and that meets
other implementation conditions established by the Secretary
for such awards. No other awards may be made under subsection
(a) for such fiscal year, except as provided in paragraph
(1)(A)(i)(II) and paragraphs (4) and (5).
``(B) Base amount.--In determining the amount of an award
pursuant to subparagraph (A) for a State, the Secretary shall
first determine an amount the Secretary considers appropriate
for the State (referred to in this paragraph as the `base
amount'), except that such amount may not be greater than the
minimum amount determined under subparagraph (D).
``(C) Increase on basis of population.--After determining
the base amount for a State under subparagraph (B), the
Secretary shall increase the base amount by an amount equal
to the product of--
``(i) the amount appropriated under paragraph (1)(A)(i)(I)
for the fiscal year, less an amount equal to the sum of all
base amounts determined for the States under subparagraph
(B), and less the amount, if any, reserved by the Secretary
under paragraphs (4) and (5); and
``(ii) subject to paragraph (4)(C), the percentage
constituted by the ratio of an amount equal to the population
of the State over an amount equal to the total population of
the States (as indicated by the most recent data collected by
the Bureau of the Census).
``(D) Minimum amount.--Subject to the amount appropriated
under paragraph (1)(A)(i)(I), an award pursuant to
subparagraph (A) for a State shall be the greater of the base
amount as increased under subparagraph (C), or the minimum
amount under this subparagraph. The minimum amount under this
subparagraph is--
``(i) in the case of each of the several States, the
District of Columbia, and the Commonwealth of Puerto Rico, an
amount equal to the lesser of--
``(I) $5,000,000; or
``(II) if the amount appropriated under paragraph
(1)(A)(i)(I) is less than $667,000,000, an amount equal to
0.75 percent of the amount appropriated under such paragraph,
less the amount, if any, reserved by the Secretary under
paragraphs (4) and (5); or
``(ii) in the case of each of American Samoa, Guam, the
Commonwealth of the Northern Mariana Islands, and the Virgin
Islands, an amount determined by the Secretary to be
appropriate, except that such amount may not exceed the
amount determined under clause (i).
``(4) Certain political subdivisions.--
``(A) In general.--For fiscal year 2003, the Secretary may,
before making awards pursuant to paragraph (3) for such year,
reserve from the amount appropriated under paragraph
(1)(A)(i)(I) for the year an amount determined necessary by
the Secretary to make awards under subsection (a) to
political subdivisions that have a substantial number of
residents, have a substantial local infrastructure for
responding to public health emergencies, and face a high
degree of risk from bioterrorist attacks or other public
health emergencies. Not more than three political
subdivisions may receive awards pursuant to this
subparagraph.
[[Page H2699]]
``(B) Coordination with statewide plans.--An award pursuant
to subparagraph (A) may not be made unless the application of
the political subdivision involved is in coordination with,
and consistent with, applicable Statewide plans described in
subsection (c)(1).
``(C) Relationship to formula grants.--In the case of a
State that will receive an award pursuant to paragraph (3),
and in which there is located a political subdivision that
will receive an award pursuant to subparagraph (A), the
Secretary shall, in determining the amount under paragraph
(3)(B) for the State, subtract from the population of the
State an amount equal to the population of such political
subdivision.
``(D) Continuity of funding.--In determining whether to
make an award pursuant to subparagraph (A) to a political
subdivision, the Secretary may consider, as a factor
indicating that the award should be made, that the political
subdivision received public health funding from the Secretary
for fiscal year 2002.
``(5) Significant unmet needs; degree of risk.--
``(A) In general.--For fiscal year 2003, the Secretary may,
before making awards pursuant to paragraph (3) for such year,
reserve from the amount appropriated under paragraph
(1)(A)(i)(I) for the year an amount determined necessary by
the Secretary to make awards under subsection (a) to eligible
entities that--
``(i) have a significant need for funds to build capacity
to identify, detect, monitor, and respond to a bioterrorist
or other threat to the public health, which need will not be
met by awards pursuant to paragraph (3); and
``(ii) face a particularly high degree of risk of such a
threat.
``(B) Recipients of grants.--Awards pursuant to
subparagraph (A) may be supplemental awards to States that
receive awards pursuant to paragraph (3), or may be awards to
eligible entities described in subsection (b)(1)(B) within
such States.
``(C) Finding with respect to district of columbia.--The
Secretary shall consider the District of Columbia to have a
significant unmet need for purposes of subparagraph (A), and
to face a particularly high degree of risk for such purposes,
on the basis of the concentration of entities of national
significance located within the District.
``(6) Funding of local entities.--For fiscal year 2003, the
Secretary shall in making awards under this section ensure
that appropriate portions of such awards are made available
to political subdivisions, local departments of public
health, hospitals (including children's hospitals), clinics,
health centers, or primary care facilities, or consortia of
such entities.
``SEC. 319C-2. PARTNERSHIPS FOR COMMUNITY AND HOSPITAL
PREPAREDNESS.
``(a) Grants.--The Secretary shall make awards of grants or
cooperative agreements to eligible entities to enable such
entities to improve community and hospital preparedness for
bioterrorism and other public health emergencies.
``(b) Eligibility.--To be eligible for an award under
subsection (a), an entity shall--
``(1) be a partnership consisting of--
``(A) one or more hospitals (including children's
hospitals), clinics, health centers, or primary care
facilities; and
``(B)(i) one or more political subdivisions of States;
``(ii) one or more States; or
``(iii) one or more States and one or more political
subdivisions of States; and
``(2) prepare, in consultation with the Chief Executive
Officer of the State, District, or territory in which the
hospital, clinic, health center, or primary care facility
described in paragraph (1)(A) is located, and submit to the
Secretary, an application at such time, in such manner, and
containing such information as the Secretary may require.
``(c) Regional Coordination.--In making awards under
subsection (a), the Secretary shall give preference to
eligible entities that submit applications that, in the
determination of the Secretary, will--
``(1) enhance coordination--
``(A) among the entities described in subsection (b)(1)(A);
and
``(B) between such entities and the entities described in
subsection (b)(1)(B); and
``(2) serve the needs of a defined geographic area.
``(d) Consistency of Planned Activities.--An entity
described in subsection (b)(1) shall utilize amounts received
under an award under subsection (a) in a manner that is
coordinated and consistent, as determined by the Secretary,
with an applicable State Bioterrorism and Other Public Health
Emergency Preparedness and Response Plan.
``(e) Use of Funds.--An award under subsection (a) may be
expended for activities that may include the following and
similar activities--
``(1) planning and administration for such award;
``(2) preparing a plan for triage and transport management
in the event of bioterrorism or other public health
emergencies;
``(3) enhancing the training of health care professionals
to improve the ability of such professionals to recognize the
symptoms of exposure to a potential bioweapon, to make
appropriate diagnosis, and to provide treatment to those
individuals so exposed;
``(4) enhancing the training of health care professionals
to recognize and treat the mental health consequences of
bioterrorism or other public health emergencies;
``(5) enhancing the training of health care professionals
to assist in providing appropriate health care for large
numbers of individuals exposed to a bioweapon;
``(6) enhancing training and planning to protect the health
and safety of personnel involved in responding to a
biological attack;
``(7) developing and implementing the trauma care and burn
center care components of the State plans for the provision
of emergency medical services; or
``(8) conducting such activities as are described in
section 319C-1(d) that are appropriate for hospitals
(including children's hospitals), clinics, health centers, or
primary care facilities.
``(f) Limitation on Awards.--A political subdivision of a
State shall not participate in more than one partnership
described in subsection (b)(1).
``(g) Priorities in Use of Grants.--
``(1) In general.--
``(A) Priorities.--Except as provided in subparagraph (B),
the Secretary shall, in carrying out the activities described
in this section, address the following hazards in the
following priority:
``(i) Bioterrorism or acute outbreaks of infectious
diseases.
``(ii) Other public health threats and emergencies.
``(B) Determination of the secretary.--In the case of the
hazard involved, the degree of priority that would apply to
the hazard based on the categories specified in clauses (i)
and (ii) of subparagraph (A) may be modified by the Secretary
if the following conditions are met:
``(i) The Secretary determines that the modification is
appropriate on the basis of the following factors:
``(I) The extent to which eligible entities are adequately
prepared for responding to hazards within the category
specified in clause (i) of subparagraph (A).
``(II) There has been a significant change in the
assessment of risks to the public health posed by hazards
within the category specified in clause (ii) of such
subparagraph.
``(ii) Prior to modifying the priority, the Secretary
notifies the appropriate committees of the Congress of the
determination of the Secretary under clause (i) of this
subparagraph.
``(2) Areas of emphasis within categories.--The Secretary
shall determine areas of emphasis within the category of
hazards specified in clause (i) of paragraph (1)(A), and
shall determine areas of emphasis within the category of
hazards specified in clause (ii) of such paragraph, based on
an assessment of the risk and likely consequences of such
hazards and on an evaluation of Federal, State, and local
needs, and may also take into account the extent to which
receiving an award under subsection (a) will develop
capacities that can be used for public health emergencies of
varying types.
``(h) Coordination with Local Medical Response System.--An
eligible entity and local Metropolitan Medical Response
Systems shall, to the extent practicable, ensure that
activities carried out under an award under subsection (a)
are coordinated with activities that are carried out by local
Metropolitan Medical Response Systems.
``(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of fiscal
years 2004 through 2006.''.
(b) Certain Grants.--Section 319C of the Public Health
Service Act (42 U.S.C. 247d-3) is amended by striking
subsection (f).
Subtitle D--Emergency Authorities; Additional Provisions
SEC. 141. REPORTING DEADLINES.
Section 319 of the Public Health Service Act (42 U.S.C.
247d) is amended by adding at the end the following:
``(d) Data Submittal and Reporting Deadlines.--In any case
in which the Secretary determines that, wholly or partially
as a result of a public health emergency that has been
determined pursuant to subsection (a), individuals or public
or private entities are unable to comply with deadlines for
the submission to the Secretary of data or reports required
under any law administered by the Secretary, the Secretary
may, notwithstanding any other provision of law, grant such
extensions of such deadlines as the circumstances reasonably
require, and may waive, wholly or partially, any sanctions
otherwise applicable to such failure to comply. Before or
promptly after granting such an extension or waiver, the
Secretary shall notify the Congress of such action and
publish in the Federal Register a notice of the extension or
waiver.''.
SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE
QUARANTINE PROVISIONS.
(a) Elimination of Prerequisite for National Advisory
Health Council Recommendation Before Issuing Quarantine
Rules.--
(1) Executive orders specifying diseases subject to
individual detentions.--Section 361(b) of the Public Health
Act (42 U.S.C. 264(b)) is amended by striking ``Executive
orders of the President upon the recommendation of the
National Advisory Health Council and the Surgeon General''
and inserting ``Executive orders of the President upon the
recommendation of the Secretary, in consultation with the
Surgeon General,''.
(2) Regulations providing for apprehension of
individuals.--Section 361(d) of the Public Health Act (42
U.S.C. 264(d)) is amended by striking ``On recommendation of
the National Advisory Health Council, regulations'' and
inserting ``Regulations''.
(3) Regulations providing for apprehension of individuals
in wartime.--Section 363 of the Public Health Act (42 U.S.C.
266) is amended by striking ``the Surgeon General, on
recommendation of the National Advisory Health Council,'' and
inserting ``the Secretary, in consultation with the Surgeon
General,''.
(b) Apprehension Authority To Apply in Cases of Exposure to
Disease.--
[[Page H2700]]
(1) Regulations providing for apprehension of
individuals.--Section 361(d) of the Public Health Act (42
U.S.C. 264(d)), as amended by subsection (a)(2), is further
amended--
(A) by striking ``(1)'' and ``(2)'' and inserting ``(A)''
and ``(B)'', respectively;
(B) by striking ``(d)'' and inserting ``(d)(1)'';
(C) in paragraph (1) (as designated by subparagraph (B) of
this paragraph), in the first sentence, by striking ``in a
communicable stage'' each place such term appears and
inserting ``in a qualifying stage''; and
(D) by adding at the end the following paragraph:
``(2) For purposes of this subsection, the term `qualifying
stage', with respect to a communicable disease, means that
such disease--
``(A) is in a communicable stage; or
``(B) is in a precommunicable stage, if the disease would
be likely to cause a public health emergency if transmitted
to other individuals.''.
(2) Regulations providing for apprehension of individuals
in wartime.--Section 363 of the Public Health Act (42 U.S.C.
266), as amended by subsection (a)(3), is further amended by
striking ``in a communicable stage''
(c) State Authority.--Section 361 of the Public Health Act
(42 U.S.C. 264) is amended by adding at the end the
following:
``(e) Nothing in this section or section 363, or the
regulations promulgated under such sections, may be construed
as superseding any provision under State law (including
regulations and including provisions established by political
subdivisions of States), except to the extent that such a
provision conflicts with an exercise of Federal authority
under this section or section 363.''.
SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP
REQUIREMENTS.
(a) Waiver Authority.--Title XI of the Social Security Act
(42 U.S.C. 1301 et seq.) is amended by inserting after
section 1134 the following new section:
``authority to waive requirements during national emergencies
``Sec. 1135. (a) Purpose.--The purpose of this section is
to enable the Secretary to ensure to the maximum extent
feasible, in any emergency area and during an emergency
period (as defined in subsection (g)(1))--
``(1) that sufficient health care items and services are
available to meet the needs of individuals in such area
enrolled in the programs under titles XVIII, XIX, and XXI;
and
``(2) that health care providers (as defined in subsection
(g)(2)) that furnish such items and services in good faith,
but that are unable to comply with one or more requirements
described in subsection (b), may be reimbursed for such items
and services and exempted from sanctions for such
noncompliance, absent any determination of fraud or abuse.
``(b) Secretarial Authority.--To the extent necessary to
accomplish the purpose specified in subsection (a), the
Secretary is authorized, subject to the provisions of this
section, to temporarily waive or modify the application of,
with respect to health care items and services furnished by a
health care provider (or classes of health care providers) in
any emergency area (or portion of such an area) during any
portion of an emergency period, the requirements of titles
XVIII, XIX, or XXI, or any regulation thereunder (and the
requirements of this title other than this section, and
regulations thereunder, insofar as they relate to such
titles), pertaining to--
``(1)(A) conditions of participation or other certification
requirements for an individual health care provider or types
of providers,
``(B) program participation and similar requirements for an
individual health care provider or types of providers, and
``(C) pre-approval requirements;
``(2) requirements that physicians and other health care
professionals be licensed in the State in which they provide
such services, if they have equivalent licensing in another
State and are not affirmatively excluded from practice in
that State or in any State a part of which is included in the
emergency area;
``(3) sanctions under section 1867 (relating to examination
and treatment for emergency medical conditions and women in
labor) for a transfer of an individual who has not been
stabilized in violation of subsection (c) of such section if
the transfer arises out of the circumstances of the
emergency;
``(4) sanctions under section 1877(g) (relating to
limitations on physician referral);
``(5) deadlines and timetables for performance of required
activities, except that such deadlines and timetables may
only be modified, not waived; and
``(6) limitations on payments under section 1851(i) for
health care items and services furnished to individuals
enrolled in a Medicare+Choice plan by health care
professionals or facilities not included under such plan.
Insofar as the Secretary exercises authority under paragraph
(6) with respect to individuals enrolled in a Medicare+Choice
plan, to the extent possible given the circumstances, the
Secretary shall reconcile payments made on behalf of such
enrollees to ensure that the enrollees do not pay more than
would be required had they received services from providers
within the network of the plan and may reconcile payments to
the organization offering the plan to ensure that such
organization pays for services for which payment is included
in the capitation payment it receives under part C of title
XVIII.
``(c) Authority for Retroactive Waiver.--A waiver or
modification of requirements pursuant to this section may, at
the Secretary's discretion, be made retroactive to the
beginning of the emergency period or any subsequent date in
such period specified by the Secretary.
``(d) Certification to Congress.--The Secretary shall
provide a certification and advance written notice to the
Congress at least two days before exercising the authority
under this section with respect to an emergency area. Such a
certification and notice shall include--
``(1) a description of--
``(A) the specific provisions that will be waived or
modified;
``(B) the health care providers to whom the waiver or
modification will apply;
``(C) the geographic area in which the waiver or
modification will apply; and
``(D) the period of time for which the waiver or
modification will be in effect; and
``(2) a certification that the waiver or modification is
necessary to carry out the purpose specified in subsection
(a).
``(e) Duration of Waiver.--
``(1) In general.--A waiver or modification of requirements
pursuant to this section terminates upon--
``(A) the termination of the applicable declaration of
emergency or disaster described in subsection (g)(1)(A);
``(B) the termination of the applicable declaration of
public health emergency described in subsection (g)(1)(B); or
``(C) subject to paragraph (2), the termination of a period
of 60 days from the date the waiver or modification is first
published (or, if applicable, the date of extension of the
waiver or modification under paragraph (2)).
``(2) Extension of 60-day periods.--The Secretary may, by
notice, provide for an extension of a 60-day period described
in paragraph (1)(C) (or an additional period provided under
this paragraph) for additional period or periods (not to
exceed, except as subsequently provided under this paragraph,
60 days each), but any such extension shall not affect or
prevent the termination of a waiver or modification under
subparagraph (A) or (B) of paragraph (1).
``(f) Report to Congress.--Within one year after the end of
the emergency period in an emergency area in which the
Secretary exercised the authority provided under this
section, the Secretary shall report to the Congress regarding
the approaches used to accomplish the purposes described in
subsection (a), including an evaluation of such approaches
and recommendations for improved approaches should the need
for such emergency authority arise in the future.
``(g) Definitions.--For purposes of this section:
``(1) Emergency area; emergency period.--An `emergency
area' is a geographical area in which, and an `emergency
period' is the period during which, there exists--
``(A) an emergency or disaster declared by the President
pursuant to the National Emergencies Act or the Robert T.
Stafford Disaster Relief and Emergency Assistance Act; and
``(B) a public health emergency declared by the Secretary
pursuant to section 319 of the Public Health Service Act.
``(2) Health care provider.--The term `health care
provider' means any entity that furnishes health care items
or services, and includes a hospital or other provider of
services, a physician or other health care practitioner or
professional, a health care facility, or a supplier of health
care items or services.''.
(b) Effective Date.--The amendment made by subsection (a)
shall be effective on and after September 11, 2001.
SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH
EMERGENCIES.
(a) In General.--Section 319(a) of the Public Health
Service Act (42 U.S.C. 247d(a)), is amended by adding at the
end the following new sentence: ``Any such determination of a
public health emergency terminates upon the Secretary
declaring that the emergency no longer exists, or upon the
expiration of the 90-day period beginning on the date on
which the determination is made by the Secretary, whichever
occurs first. Determinations that terminate under the
preceding sentence may be renewed by the Secretary (on the
basis of the same or additional facts), and the preceding
sentence applies to each such renewal. Not later than 48
hours after making a determination under this subsection of a
public health emergency (including a renewal), the Secretary
shall submit to the Congress written notification of the
determination.''.
(b) Applicability.--The amendment made by subsection (a)
applies to any public health emergency under section 319(a)
of the Public Health Service Act, including any such
emergency that was in effect as of the day before the date of
the enactment of this Act. In the case of such an emergency
that was in effect as of such day, the 90-day period
described in such section with respect to the termination of
the emergency is deemed to begin on such date of enactment.
Subtitle E--Additional Provisions
SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT
PLAN.
Section 613(b) of the Robert T. Stafford Disaster Relief
and Emergency Assistance Act (42 U.S.C. 5196b(b)) is
amended--
(1) in paragraph (5), by striking ``and'' at the end;
(2) in paragraph (6), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(7) include a plan for providing information to the
public in a coordinated manner.''.
SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.
(a) Detection and Identification Research.--
(1) In general.--In conjunction with the working group
under section 319F(a) of the Public Health Service Act, the
Secretary of Energy and the Administrator of the National
Nuclear Security Administration shall expand, enhance, and
intensify research relevant to the rapid detection and
identification of pathogens likely to be used in a
bioterrorism attack or other agents that may cause a public
health emergency.
[[Page H2701]]
(2) Authorized activities.--Activities carried out under
paragraph (1) may include--
(A) the improvement of methods for detecting biological
agents or toxins of potential use in a biological attack and
the testing of such methods under variable conditions;
(B) the improvement or pursuit of methods for testing,
verifying, and calibrating new detection and surveillance
tools and techniques; and
(C) carrying out other research activities in relevant
areas.
(3) Report.--Not later than 180 days after the date of the
enactment of this Act, the Administrator of the National
Nuclear Security Administration shall submit to the Committee
on Energy and Natural Resources and the Committee on Armed
Services of the Senate, and the Committee on Energy and
Commerce and the Committee on Armed Services of the House of
Representatives, a report setting forth the programs and
projects that will be funded prior to the obligation of funds
appropriated under subsection (b).
(b) Authorization.--For the purpose of carrying out this
section, there are authorized to be appropriated such sums as
may be necessary in each of fiscal years 2002 through 2006.
SEC. 153. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.
The Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), acting through the
Director of the National Institute of Occupational Safety and
Health, shall enhance and expand research as deemed
appropriate on the health and safety of workers who are at
risk for bioterrorist threats or attacks in the workplace,
including research on the health effects of measures taken to
treat or protect such workers for diseases or disorders
resulting from a bioterrorist threat or attack. Nothing in
this section may be construed as establishing new regulatory
authority for the Secretary or the Director to issue or
modify any occupational safety and health rule or regulation.
SEC. 154. ENHANCEMENT OF EMERGENCY PREPAREDNESS OF DEPARTMENT
OF VETERANS AFFAIRS.
(a) Readiness of Department Medical Center.--(1) The
Secretary of Veterans Affairs shall take appropriate actions
to enhance the readiness of Department of Veterans Affairs
medical centers to protect the patients and staff of such
centers from chemical or biological attack or otherwise to
respond to such an attack and so as to enable such centers to
fulfil their obligations as part of the Federal response to
public health emegencies.
(2) Actions under paragraph (1) shall include--
(A) the provision of decontamination equipment and personal
protection equipment at Department medical centers; and
(B) the provision of training in the use of such equipment
to staff of such centers.
(b) Security at Department Medical and Research
Facilities.--(1) Not later than 180 days after the date of
the enactment of this Act, the Secretary shall carry out an
evaluation of the security needs at Department medical
centers and research facilities. The evaluation shall address
the following needs:
(A) Needs for the protection of patients and medical staff
during emergencies, including a chemical or biological attack
or other terrorist attack.
(B) Needs, if any, for screening personnel engaged in
research relating to biological pathogens or agents,
including work associated with such research.
(C) Needs for securing laboratories or other facilities
engaged in research relating to biological pathogens or
agents.
(D) Any other needs the Secretary considers appropriate.
(2) The Secretary shall take appropriate actions to enhance
the security of Department medical centers and research
facilities, including staff and patients at such centers and
facilities. In taking such actions, the Secretary shall take
into account the results of the evaluation required by
paragraph (1).
(c) Tracking of Pharmaceuticals and Medical Supplies and
Equipment.--The Secretary shall develop and maintain a
centralized system for tracking the current location and
availability of pharmaceuticals, medical supplies, and
medical equipment throughout the Department health care
system in order to permit the ready identification and
utilization of such pharmaceuticals, supplies, and equipment
for a variety of purposes, including response to a chemical
or biological attack or other terrorist attack.
(d) Training.--The Secretary shall ensure that the
Department medical centers, in consultation with the
accredited medical school affiliates of such medical centers,
develop and implement curricula to train resident physicians
and health care personnel in medical matters relating to
biological, chemical, or radiological attacks.
(e) Participation in National Disaster Medical System.--(1)
The Secretary shall, in consultation with the Secretary of
Defense, the Secretary of Health and Human Services, and the
Director of the Federal Emergency Management Agency,
establish and maintain a training program to facilitate the
participation of the staff of Department medical centers, and
of the community partners of such centers, in the National
Disaster Medical System.
(2) The Secretary shall establish and maintain the training
program under paragraph (1) in accordance with the
recommendations of the working group under section 319F(a) of
the Public Health Service Act.
(f) Mental Health Counseling.--(1) With respect to
activities conducted by personnel serving at Department
medical centers, the Secretary shall, in consultation with
the Secretary of Health and Human Services, the American Red
Cross, and the working group under section 319F(a) of the
Public Health Service Act, develop and maintain various
strategies for providing mental health counseling and
assistance, including counseling and assistance for post-
traumatic stress disorder, to local and community emergency
response providers, veterans, active duty military personnel,
and individuals seeking care at Department medical centers
following a bioterrorist attack or other public health
emergency.
(2) The strategies under paragraph (1) shall include the
following:
(A) Training and certification of providers of mental
health counseling and assistance.
(B) Mechanisms for coordinating the provision of mental
health counseling and assistance to emergency response
providers referred to in that paragraph.
(g) Authorization of Appropriations.--There is hereby
authorized to be appropriated for the Department of Veterans
Affairs amounts as follows:
(1) To carry out activities required by subsection (a)--
(A) $100,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each of fiscal years
2003 through 2006.
(2) To carry out activities required by subsections (b)
through (f)--
(A) $33,000,000 for fiscal year 2002; and
(B) such sums as may be necessary for each of fiscal years
2003 through 2006.
SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.
Section 582(f) of the Public Health Service Act (42 U.S.C.
290hh-1(f)) is amended by striking ``2002 and 2003'' and
inserting ``2003 through 2006''.
SEC. 156. SENSE OF CONGRESS.
It is the sense of the Congress that--
(1) many excellent university-based programs are already
functioning and developing important biodefense products and
solutions throughout the United States;
(2) accelerating the crucial work done at university
centers and laboratories will contribute significantly to the
United States capacity to defend against any biological
threat or attack;
(3) maximizing the effectiveness of, and extending the
mission of, established university programs would be one
appropriate use of the additional resources provided for in
this Act and the amendments made by this Act; and
(4) the Secretary of Health and Human Services should, as
appropriate, recognize the importance of existing public and
private university-based research, training, public
awareness, and safety related biological defense programs
when the Secretary makes awards of grants and contracts in
accordance with this Act and the amendments made by this Act.
SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.
(a) In General.--The Comptroller General shall submit to
the Committee on Health, Education, Labor, and Pensions and
the Committee on Appropriations of the Senate, and to the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives, a report that
describes--
(1) Federal activities primarily related to research on,
preparedness for, and the management of the public health and
medical consequences of a bioterrorist attack against the
civilian population;
(2) the coordination of the activities described in
paragraph (1);
(3) the effectiveness of such efforts in preparing
national, State, and local authorities to address the public
health and medical consequences of a potential bioterrorist
attack against the civilian population;
(4) the activities and costs of the Civil Support Teams of
the National Guard in responding to biological threats or
attacks against the civilian population;
(5) the activities of the working group under subsection
(a) and the efforts made by such group to carry out the
activities described in such subsection; and
(6) the ability of private sector contractors to enhance
governmental responses to biological threats or attacks.
SEC. 158. CERTAIN AWARDS.
Section 319(a) of the Public Health Service Act (42 U.S.C.
247d(a)) is amended in the matter after and below paragraph
(2) by striking ``grants and'' and inserting ``grants,
providing awards for expenses, and''
SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC
ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
(a) Short Title.--This section may be cited as the
``Community Access to Emergency Defibrillation Act of 2002''.
(b) Findings.--Congress makes the following findings:
(1) Over 220,000 Americans die each year from cardiac
arrest. Every 2 minutes, an individual goes into cardiac
arrest in the United States.
(2) The chance of successfully returning to a normal heart
rhythm diminishes by 10 percent each minute following sudden
cardiac arrest.
(3) Eighty percent of cardiac arrests are caused by
ventricular fibrillation, for which defibrillation is the
only effective treatment.
(4) Sixty percent of all cardiac arrests occur outside the
hospital. The average national survival rate for out-of-
hospital cardiac arrest is only 5 percent.
(5) Communities that have established and implemented
public access defibrillation programs have achieved average
survival rates for out-of-hospital cardiac arrest as high as
50 percent.
(6) According to the American Heart Association, wide use
of defibrillators could save as many as 50,000 lives
nationally each year.
(7) Successful public access defibrillation programs ensure
that cardiac arrest victims have access to early 911
notification, early
[[Page H2702]]
cardiopulmonary resuscitation, early defibrillation, and
early advanced care.
(c) Public Access Defibrillation Programs and Projects.--
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.), as amended by Public Law 106-310, is
amended by adding after section 311 the following:
``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
``(a) In General.--The Secretary shall award grants to
States, political subdivisions of States, Indian tribes, and
tribal organizations to develop and implement public access
defibrillation programs--
``(1) by training and equipping local emergency medical
services personnel, including firefighters, police officers,
paramedics, emergency medical technicians, and other first
responders, to administer immediate care, including
cardiopulmonary resuscitation and automated external
defibrillation, to cardiac arrest victims;
``(2) by purchasing automated external defibrillators,
placing the defibrillators in public places where cardiac
arrests are likely to occur, and training personnel in such
places to administer cardiopulmonary resuscitation and
automated external defibrillation to cardiac arrest victims;
``(3) by setting procedures for proper maintenance and
testing of such devices, according to the guidelines of the
manufacturers of the devices;
``(4) by providing training to members of the public in
cardiopulmonary resuscitation and automated external
defibrillation;
``(5) by integrating the emergency medical services system
with the public access defibrillation programs so that
emergency medical services personnel, including dispatchers,
are informed about the location of automated external
defibrillators in their community; and
``(6) by encouraging private companies, including small
businesses, to purchase automated external defibrillators and
provide training for their employees to administer
cardiopulmonary resuscitation and external automated
defibrillation to cardiac arrest victims in their community.
``(b) Preference.--In awarding grants under subsection (a),
the Secretary shall give a preference to a State, political
subdivision of a State, Indian tribe, or tribal organization
that--
``(1) has a particularly low local survival rate for
cardiac arrests, or a particularly low local response rate
for cardiac arrest victims; or
``(2) demonstrates in its application the greatest
commitment to establishing and maintaining a public access
defibrillation program.
``(c) Use of Funds.--A State, political subdivision of a
State, Indian tribe, or tribal organization that receives a
grant under subsection (a) may use funds received through
such grant to--
``(1) purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration;
``(2) provide automated external defibrillation and basic
life support training in automated external defibrillator
usage through nationally recognized courses;
``(3) provide information to community members about the
public access defibrillation program to be funded with the
grant;
``(4) provide information to the local emergency medical
services system regarding the placement of automated external
defibrillators in public places;
``(5) produce materials to encourage private companies,
including small businesses, to purchase automated external
defibrillators; and
``(6) further develop strategies to improve access to
automated external defibrillators in public places.
``(d) Application.--
``(1) In general.--To be eligible to receive a grant under
subsection (a), a State, political subdivision of a State,
Indian tribe, or tribal organization shall prepare and submit
an application to the Secretary at such time, in such manner,
and containing such information as the Secretary may
reasonably require.
``(2) Contents.--An application submitted under paragraph
(1) shall--
``(A) describe the comprehensive public access
defibrillation program to be funded with the grant and
demonstrate how such program would make automated external
defibrillation accessible and available to cardiac arrest
victims in the community;
``(B) contain procedures for implementing appropriate
nationally recognized training courses in performing
cardiopulmonary resuscitation and the use of automated
external defibrillators;
``(C) contain procedures for ensuring direct involvement of
a licensed medical professional and coordination with the
local emergency medical services system in the oversight of
training and notification of incidents of the use of the
automated external defibrillators;
``(D) contain procedures for proper maintenance and testing
of the automated external defibrillators, according to the
labeling of the manufacturer;
``(E) contain procedures for ensuring notification of local
emergency medical services system personnel, including
dispatchers, of the location and type of devices used in the
public access defibrillation program; and
``(F) provide for the collection of data regarding the
effectiveness of the public access defibrillation program to
be funded with the grant in affecting the out-of-hospital
cardiac arrest survival rate.
``(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $25,000,000 for fiscal year 2003, and such sums
as may be necessary for each of the fiscal years 2004 through
2006. Not more than 10 percent of amounts received under a
grant awarded under this section may be used for
administrative expenses.
``SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION
PROJECTS.
``(a) In General.--The Secretary shall award grants to
political subdivisions of States, Indian tribes, and tribal
organizations to develop and implement innovative,
comprehensive, community-based public access defibrillation
demonstration projects that--
``(1) provide cardiopulmonary resuscitation and automated
external defibrillation to cardiac arrest victims in unique
settings;
``(2) provide training to community members in
cardiopulmonary resuscitation and automated external
defibrillation; and
``(3) maximize community access to automated external
defibrillators.
``(b) Use of Funds.--A recipient of a grant under
subsection (a) shall use the funds provided through the grant
to--
``(1) purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration;
``(2) provide basic life training in automated external
defibrillator usage through nationally recognized courses;
``(3) provide information to community members about the
public access defibrillation demonstration project to be
funded with the grant;
``(4) provide information to the local emergency medical
services system regarding the placement of automated external
defibrillators in the unique settings; and
``(5) further develop strategies to improve access to
automated external defibrillators in public places.
``(c) Application.--
``(1) In general.--To be eligible to receive a grant under
subsection (a), a political subdivision of a State, Indian
tribe, or tribal organization shall prepare and submit an
application to the Secretary at such time, in such manner,
and containing such information as the Secretary may
reasonably require.
``(2) Contents.--An application submitted under paragraph
(1) may--
``(A) describe the innovative, comprehensive, community-
based public access defibrillation demonstration project to
be funded with the grant;
``(B) explain how such public access defibrillation
demonstration project represents innovation in providing
public access to automated external defibrillation; and
``(C) provide for the collection of data regarding the
effectiveness of the demonstration project to be funded with
the grant in--
``(i) providing emergency cardiopulmonary resuscitation and
automated external defibrillation to cardiac arrest victims
in the setting served by the demonstration project; and
``(ii) affecting the cardiac arrest survival rate in the
setting served by the demonstration project.
``(d) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2002 through 2006. Not more than 10
percent of amounts received under a grant awarded under this
section may be used for administrative expenses.''.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and
Effective Death Penalty Act of 1996; Codification in the
Public Health Service Act, With Amendments.--Subpart 1 of
part F of title III of the Public Health Service Act (42
U.S.C. 262 et seq.) is amended by inserting after section 351
the following:
``SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS
AND TOXINS.
``(a) Regulatory Control of Certain Biological Agents and
Toxins.--
``(1) List of biological agents and toxins.--
``(A) In general.--The Secretary shall by regulation
establish and maintain a list of each biological agent and
each toxin that has the potential to pose a severe threat to
public health and safety.
``(B) Criteria.--In determining whether to include an agent
or toxin on the list under subparagraph (A), the Secretary
shall--
``(i) consider--
``(I) the effect on human health of exposure to the agent
or toxin;
``(II) the degree of contagiousness of the agent or toxin
and the methods by which the agent or toxin is transferred to
humans;
``(III) the availability and effectiveness of
pharmacotherapies and immunizations to treat and prevent any
illness resulting from infection by the agent or toxin; and
``(IV) any other criteria, including the needs of children
and other vulnerable populations, that the Secretary
considers appropriate; and
``(ii) consult with appropriate Federal departments and
agencies and with scientific experts representing appropriate
professional groups, including groups with pediatric
expertise.
``(2) Biennial review.--The Secretary shall review and
republish the list under paragraph (1) biennially, or more
often as needed, and shall by regulation revise the list as
necessary in accordance with such paragraph.
``(b) Regulation of Transfers of Listed Agents and
Toxins.--The Secretary shall by regulation provide for--
``(1) the establishment and enforcement of safety
procedures for the transfer of listed agents and toxins,
including measures to ensure--
``(A) proper training and appropriate skills to handle such
agents and toxins; and
[[Page H2703]]
``(B) proper laboratory facilities to contain and dispose
of such agents and toxins;
``(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any
other criminal purpose;
``(3) the establishment of procedures to protect the public
safety in the event of a transfer or potential transfer of
such an agent or toxin in violation of the safety procedures
established under paragraph (1) or the safeguard and security
measures established under paragraph (2); and
``(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate
purposes.
``(c) Possession and Use of Listed Agents and Toxins.--The
Secretary shall by regulation provide for the establishment
and enforcement of standards and procedures governing the
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect the public health and
safety.
``(d) Registration; Identification; Database.--
``(1) Registration.--Regulations under subsections (b) and
(c) shall require registration with the Secretary of the
possession, use, and transfer of listed agents and toxins,
and shall include provisions to ensure that persons seeking
to register under such regulations have a lawful purpose to
possess, use, or transfer such agents and toxins, including
provisions in accordance with subsection (e)(6).
``(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration
include (if available to the person registering) information
regarding the characterization of listed agents and toxins to
facilitate their identification, including their source. The
Secretary shall maintain a national database that includes
the names and locations of registered persons, the listed
agents and toxins such persons are possessing, using, or
transferring, and information regarding the characterization
of such agents and toxins.
``(e) Safeguard and Security Requirements for Registered
Persons.--
``(1) In general.--Regulations under subsections (b) and
(c) shall include appropriate safeguard and security
requirements for persons possessing, using, or transferring a
listed agent or toxin commensurate with the risk such agent
or toxin poses to public health and safety (including the
risk of use in domestic or international terrorism). The
Secretary shall establish such requirements in consultation
with the Attorney General, and shall ensure compliance with
such requirements as part of the registration system under
such regulations.
``(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include provisions to
ensure that registered persons--
``(A) provide access to listed agents and toxins to only
those individuals whom the registered person involved
determines have a legitimate need to handle or use such
agents and toxins;
``(B) submit the names and other identifying information
for such individuals to the Secretary and the Attorney
General, promptly after first determining that the
individuals need access under subparagraph (A), and
periodically thereafter while the individuals have such
access, not less frequently than once every five years;
``(C) deny access to such agents and toxins by individuals
whom the Attorney General has identified as restricted
persons; and
``(D) limit or deny access to such agents and toxins by
individuals whom the Attorney General has identified as
within any category under paragraph (3)(B)(ii), if limiting
or denying such access by the individuals involved is
determined appropriate by the Secretary, in consultation with
the Attorney General.
``(3) Submitted names; use of databases by attorney
general.--
``(A) In general.--Upon the receipt of names and other
identifying information under paragraph (2)(B), the Attorney
General shall, for the sole purpose of identifying whether
the individuals involved are within any of the categories
specified in subparagraph (B), promptly use criminal,
immigration, national security, and other electronic
databases that are available to the Federal Government and
are appropriate for such purpose.
``(B) Certain individuals.--For purposes of subparagraph
(A), the categories specified in this subparagraph regarding
an individual are that--
``(i) the individual is a restricted person; or
``(ii) the individual is reasonably suspected by any
Federal law enforcement or intelligence agency of--
``(I) committing a crime set forth in section 2332b(g)(5)
of title 18, United States Code;
``(II) knowing involvement with an organization that
engages in domestic or international terrorism (as defined in
section 2331 of such title 18) or with any other organization
that engages in intentional crimes of violence; or
``(III) being an agent of a foreign power (as defined in
section 1801 of title 50, United States Code).
``(C) Notification by attorney general regarding submitted
names.--After the receipt of a name and other identifying
information under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the individual is
within any of the categories specified in subparagraph (B).
``(4) Notifications by secretary.--The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of
whether the individual is granted or denied access under
paragraph (2). If the individual is denied such access, the
Secretary shall promptly notify the individual of the denial.
``(5) Expedited review.--Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon
request to the Secretary by a registered person who submits
names and other identifying information under paragraph
(2)(B) and who demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
``(A) request the Attorney General to expedite the process
of identification under paragraph (3)(A) and notification of
the Secretary under paragraph (3)(C); and
``(B) expedite the notification of the registered person by
the Secretary under paragraph (4).
``(6) Process regarding persons seeking to register.--
``(A) Individuals.--Regulations under subsections (b) and
(c) shall provide that an individual who seeks to register
under either of such subsections is subject to the same
processes described in paragraphs (2) through (4) as apply to
names and other identifying information submitted to the
Attorney General under paragraph (2)(B). Paragraph (5) does
not apply for purposes of this subparagraph.
``(B) Other persons.--Regulations under subsections (b) and
(c) shall provide that, in determining whether to deny or
revoke registration by a person other than an individual, the
Secretary shall submit the name of such person to the
Attorney General, who shall use criminal, immigration,
national security, and other electronic databases available
to the Federal Government, as appropriate for the purpose of
promptly notifying the Secretary whether the person, or,
where relevant, the individual who owns or controls such
person, is a restricted person or is reasonably suspected by
any Federal law enforcement or intelligence agency of being
within any category specified in paragraph (3)(B)(ii) (as
applied to persons, including individuals). Such regulations
shall provide that a person who seeks to register under
either of such subsections is subject to the same processes
described in paragraphs (2) and (4) as apply to names and
other identifying information submitted to the Attorney
General under paragraph (2)(B). Paragraph (5) does not apply
for purposes of this subparagraph. The Secretary may exempt
Federal, State, or local governmental agencies from the
requirements of this subparagraph.
``(7) Review.--
``(A) Administrative review.--
``(i) In general.--Regulations under subsections (b) and
(c) shall provide for an opportunity for a review by the
Secretary--
``(I) when requested by the individual involved, of a
determination under paragraph (2) to deny the individual
access to listed agents and toxins; and
``(II) when requested by the person involved, of a
determination under paragraph (6) to deny or revoke
registration for such person.
``(ii) Ex parte review.--During a review under clause (i),
the Secretary may consider information relevant to the review
ex parte to the extent that disclosure of the information
could compromise national security or an investigation by any
law enforcement agency.
``(iii) Final agency action.--The decision of the Secretary
in a review under clause (i) constitutes final agency action
for purposes of section 702 of title 5, United States Code.
``(B) Certain procedures.--
``(i) Submission of ex parte materials in judicial
proceedings.--When reviewing a decision of the Secretary
under subparagraph (A), and upon request made ex parte and in
writing by the United States, a court, upon a sufficient
showing, may review and consider ex parte documents
containing information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency. If the court determines that portions of
the documents considered ex parte should be disclosed to the
person involved to allow a response, the court shall
authorize the United States to delete from such documents
specified items of information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency, or to substitute a summary of the
information to which the person may respond. Any order by the
court authorizing the disclosure of information that the
United States believes could compromise national security or
an investigation by any law enforcement agency shall be
subject to the processes set forth in subparagraphs (A) and
(B)(i) of section 2339B(f)(5) of title 18, United States Code
(relating to interlocutory appeal and expedited
consideration).
``(ii) Disclosure of information.--In a review under
subparagraph (A), and in any judical proceeding conducted
pursuant to such review, neither the Secretary nor the
Attorney General may be required to disclose to the public
any information that under subsection (h) shall not be
disclosed under section 552 of title 5, United States Code.
``(8) Notifications regarding theft or loss of agents.--
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal,
State, and local law enforcement agencies, of the theft or
loss of listed agents and toxins.
``(9) Technical assistance for registered persons.--The
Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
``(f) Inspections.--The Secretary shall have the authority
to inspect persons subject to regulations under subsection
(b) or (c) to ensure their compliance with such regulations,
including prohibitions on restricted persons and other
provisions of subsection (e).
``(g) Exemptions.--
``(1) Clinical or diagnostic laboratories.--Regulations
under subsections (b) and (c) shall exempt clinical or
diagnostic laboratories and other persons who possess, use,
or transfer listed
[[Page H2704]]
agents or toxins that are contained in specimens presented
for diagnosis, verification, or proficiency testing, provided
that--
``(A) the identification of such agents or toxins is
reported to the Secretary, and when required under Federal,
State, or local law, to other appropriate authorities; and
``(B) such agents or toxins are transferred or destroyed in
a manner set forth by the Secretary by regulation.
``(2) Products.--
``(A) In general.--Regulations under subsections (b) and
(c) shall exempt products that are, bear, or contain listed
agents or toxins and are cleared, approved, licensed, or
registered under any of the Acts specified in subparagraph
(B), unless the Secretary by order determines that applying
additional regulation under subsection (b) or (c) to a
specific product is necessary to protect public health and
safety.
``(B) Relevant laws.--For purposes of subparagraph (A), the
Acts specified in this subparagraph are the following:
``(i) The Federal Food, Drug, and Cosmetic Act.
``(ii) Section 351 of this Act.
``(iii) The Act commonly known as the Virus-Serum-Toxin Act
(the eighth paragraph under the heading `Bureau of Animal
Industry' in the Act of March 4, 1913; 21 U.S.C. 151-159).
``(iv) The Federal Insecticide, Fungicide, and Rodenticide
Act.
``(C) Investigational use.--
``(i) In general.--The Secretary may exempt an
investigational product that is, bears, or contains a listed
agent or toxin from the applicability of provisions of
regulations under subsection (b) or (c) when such product is
being used in an investigation authorized under any Federal
Act and the Secretary determines that applying additional
regulation under subsection (b) or (c) to such product is not
necessary to protect public health and safety.
``(ii) Certain processes.--Regulations under subsections
(b) and (c) shall set forth the procedures for applying for
an exemption under clause (i). In the case of investigational
products authorized under any of the Acts specified in
subparagraph (B), the Secretary shall make a determination
regarding a request for an exemption not later than 14 days
after the first date on which both of the following
conditions have been met by the person requesting the
exemption:
``(I) The person has submitted to the Secretary an
application for the exemption meeting the requirements
established by the Secretary.
``(II) The person has notified the Secretary that the
investigation has been authorized under such an Act.
``(3) Public health emergencies.--The Secretary may
temporarily exempt a person from the applicability of the
requirements of this section, in whole or in part, if the
Secretary determines that such exemption is necessary to
provide for the timely participation of the person in a
response to a domestic or foreign public health emergency
(whether determined under section 319(a) or otherwise) that
involves a listed agent or toxin. With respect to the
emergency involved, such exemption for a person may not
exceed 30 days, except that the Secretary, after review of
whether such exemption remains necessary, may provide one
extension of an additional 30 days.
``(4) Agricultural emergencies.--Upon request of the
Secretary of Agriculture, after the granting by such
Secretary of an exemption under section 212(g)(1)(D) of the
Agricultural Bioterrorism Protection Act of 2002 pursuant to
a finding that there is an agricultural emergency, the
Secretary of Health and Human Services may temporarily exempt
a person from the applicability of the requirements of this
section, in whole or in part, to provide for the timely
participation of the person in a response to the agricultural
emergency. With respect to the emergency involved, the
exemption under this paragraph for a person may not exceed 30
days, except that upon request of the Secretary of
Agriculture, the Secretary of Health and Human Services may,
after review of whether such exemption remains necessary,
provide one extension of an additional 30 days.
``(h) Disclosure of Information.--
``(1) Nondisclosure of certain information.--No Federal
agency specified in paragraph (2) shall disclose under
section 552 of title 5, United States Code, any of the
following:
``(A) Any registration or transfer documentation submitted
under subsections (b) and (c) for the possession, use, or
transfer of a listed agent or toxin; or information derived
therefrom to the extent that it identifies the listed agent
or toxin possessed, used, or transferred by a specific
registered person or discloses the identity or location of a
specific registered person.
``(B) The national database developed pursuant to
subsection (d), or any other compilation of the registration
or transfer information submitted under subsections (b) and
(c) to the extent that such compilation discloses site-
specific registration or transfer information.
``(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security measures
used by a registered person to prevent unauthorized access to
listed agents and toxins.
``(D) Any notification of a release of a listed agent or
toxin submitted under subsections (b) and (c), or any
notification of theft or loss submitted under such
subsections.
``(E) Any portion of an evaluation or report of an
inspection of a specific registered person conducted under
subsection (f) that identifies the listed agent or toxin
possessed by a specific registered person or that discloses
the identity or location of a specific registered person if
the agency determines that public disclosure of the
information would endanger public health or safety.
``(2) Covered agencies.--For purposes of paragraph (1)
only, the Federal agencies specified in this paragraph are
the following:
``(A) The Department of Health and Human Services, the
Department of Justice, the Department of Agriculture, and the
Department of Transportation.
``(B) Any Federal agency to which information specified in
paragraph (1) is transferred by any agency specified in
subparagraph (A) of this paragraph.
``(C) Any Federal agency that is a registered person, or
has a sub-agency component that is a registered person.
``(D) Any Federal agency that awards grants or enters into
contracts or cooperative agreements involving listed agents
and toxins to or with a registered person, and to which
information specified in paragraph (1) is transferred by any
such registered person.
``(3) Other exemptions.--This subsection may not be
construed as altering the application of any exemptions to
public disclosure under section 552 of title 5, United States
Code, except as to subsection 552(b)(3) of such title, to any
of the information specified in paragraph (1).
``(4) Rule of construction.--Except as specifically
provided in paragraph (1), this subsection may not be
construed as altering the authority of any Federal agency to
withhold under section 552 of title 5, United States Code, or
the obligation of any Federal agency to disclose under
section 552 of title 5, United States Code, any information,
including information relating to--
``(A) listed agents and toxins, or individuals seeking
access to such agents and toxins;
``(B) registered persons, or persons seeking to register
their possession, use, or transfer of such agents and toxins;
``(C) general safeguard and security policies and
requirements under regulations under subsections (b) and (c);
or
``(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection
evaluations and reports, or individuals seeking access to
such agents and toxins.
``(5) Disclosures to congress; other disclosures.--This
subsection may not be construed as providing any authority--
``(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
``(B) to withhold information from any person under any
other Federal law or treaty.
``(i) Civil Money Penalty.--
``(1) In general.--In addition to any other penalties that
may apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000
in the case of any other person.
``(2) Applicability of certain provisions.--The provisions
of section 1128A of the Social Security Act (other than
subsections (a), (b), (h), and (i), the first sentence of
subsection (c), and paragraphs (1) and (2) of subsection (f))
shall apply to a civil money penalty under paragraph (1) in
the same manner as such provisions apply to a penalty or
proceeding under section 1128A(a) of such Act. The Secretary
may delegate authority under this subsection in the same
manner as provided in section 1128A(j)(2) of the Social
Security Act, and such authority shall include all powers as
contained in section 6 of the Inspector General Act of 1978
(5 U.S.C. App.).
``(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification
of the Secretary by a registered person whenever a release,
meeting criteria established by the Secretary, of a listed
agent or toxin has occurred outside of the biocontainment
area of a facility of the registered person. Upon receipt of
such notification and a finding by the Secretary that the
release poses a threat to public health or safety, the
Secretary shall take appropriate action to notify relevant
State and local public health authorities, other relevant
Federal authorities, and, if necessary, other appropriate
persons (including the public). If the released listed agent
or toxin is an overlap agent or toxin (as defined in
subsection (l)), the Secretary shall promptly notify the
Secretary of Agriculture upon notification by the registered
person.
``(k) Reports.--The Secretary shall report to the Congress
annually on the number and nature of notifications received
under subsection (e)(8) (relating to theft or loss) and
subsection (j) (relating to releases).
``(l) Definitions.--For purposes of this section:
``(1) The terms `biological agent' and `toxin' have the
meanings given such terms in section 178 of title 18, United
States Code.
``(2) The term `listed agents and toxins' means biological
agents and toxins listed pursuant to subsection (a)(1).
``(3) The term `listed agents or toxins' means biological
agents or toxins listed pursuant to subsection (a)(1).
``(4) The term `overlap agents and toxins' means biological
agents and toxins that--
``(A) are listed pursuant to subsection (a)(1); and
``(B) are listed pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002.
``(5) The term `overlap agent or toxin' means a biological
agent or toxin that--
``(A) is listed pursuant to subsection (a)(1); and
``(B) is listed pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002.
``(6) The term `person' includes Federal, State, and local
governmental entities.
``(7) The term `registered person' means a person
registered under regulations under subsection (b) or (c).
[[Page H2705]]
``(8) The term `restricted person' has the meaning given
such term in section 175b of title 18, United States Code.
``(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007.''.
(b) Report to Congress.--Not later than one year after the
date of the enactment of this Act, the Secretary of Health
and Human Services, after consultation with other appropriate
Federal agencies, shall submit to the Congress a report
that--
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable
regulations under section 351A of the Public Health Service
Act (as added by subsection (a) of this section), including
the extent of compliance before the date of the enactment of
this Act, and including the extent of compliance with
regulations promulgated after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and
toxins under such section 351A;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under
such section 351A and for taking appropriate enforcement
actions;
(4) evaluates the impact of such section 351A on research
on biological agents and toxins listed pursuant to such
section; and
(5) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such
section 351A.
SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN
SERVICES.
(a) Date Certain for Notice of Possession.--Not later than
90 days after the date of the enactment of this Act, all
persons (unless exempt under subsection (g) of section 351A
of the Public Health Service Act, as added by section 201 of
this Act) in possession of biological agents or toxins listed
under such section 351A of the Public Health Service Act
shall notify the Secretary of Health and Human Services of
such possession. Not later than 30 days after such date of
enactment, the Secretary shall provide written guidance on
how such notice is to be provided to the Secretary.
(b) Date Certain for Promulgation; Effective Date Regarding
Criminal and Civil Penalties.--Not later than 180 days after
the date of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate an interim final
rule for carrying out section 351A of the Public Health
Service Act, subject to subsection (c). Such interim final
rule shall take effect 60 days after the date on which such
rule is promulgated, including for purposes of--
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section
231(a)(5) of this Act; and
(2) section 351A(i) of the Public Health Service Act
(relating to civil penalties).
(c) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (b) shall
include time frames for the applicability of the rule that
minimize disruption of research or educational projects that
involve biological agents and toxins listed pursuant to
section 351A(a)(1) of the Public Health Service Act and that
were underway as of the effective date of such rule.
SEC. 203. EFFECTIVE DATES.
(a) In General.--Regulations promulgated by the Secretary
of Health and Human Services under section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 are
deemed to have been promulgated under section 351A of the
Public Health Service Act, as added by section 201 of this
Act. Such regulations, including the list under subsection
(d)(1) of such section 511, that were in effect on the day
before the date of the enactment of this Act remain in effect
until modified by the Secretary in accordance with such
section 351A and with section 202 of this Act.
(b) Effective Date Regarding Disclosure of Information.--
Subsection (h) of section 351A of the Public Health Service
Act, as added by section 201 of this Act, is deemed to have
taken effect on the effective date of the Antiterrorism and
Effective Death Penalty Act of 1996.
SEC. 204. CONFORMING AMENDMENT.
Subsections (d), (e), (f), and (g) of section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 (42
U.S.C. 262 note) are repealed.
Subtitle B--Department of Agriculture
SEC. 211. SHORT TITLE.
This subtitle may be cited as the ``Agricultural
Bioterrorism Protection Act of 2002''.
SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Regulatory Control of Certain Biological Agents and
Toxins.--
(1) List of biological agents and toxins.--
(A) In general.--The Secretary of Agriculture shall by
regulation establish and maintain a list of each biological
agent and each toxin that the Secretary determines has the
potential to pose a severe threat to animal or plant health,
or to animal or plant products.
(B) Criteria.--In determining whether to include an agent
or toxin on the list under subparagraph (A), the Secretary
shall--
(i) consider--
(I) the effect of exposure to the agent or toxin on animal
or plant health, and on the production and marketability of
animal or plant products;
(II) the pathogenicity of the agent or the toxicity of the
toxin and the methods by which the agent or toxin is
transferred to animals or plants;
(III) the availability and effectiveness of
pharmacotherapies and prophylaxis to treat and prevent any
illness caused by the agent or toxin; and
(IV) any other criteria that the Secretary considers
appropriate to protect animal or plant health, or animal or
plant products; and
(ii) consult with appropriate Federal departments and
agencies and with scientific experts representing appropriate
professional groups.
(2) Biennial review.--The Secretary shall review and
republish the list under paragraph (1) biennially, or more
often as needed, and shall by regulation revise the list as
necessary in accordance with such paragraph.
(b) Regulation of Transfers of Listed Agents and Toxins.--
The Secretary shall by regulation provide for--
(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, including
measures to ensure--
(A) proper training and appropriate skills to handle such
agents and toxins; and
(B) proper laboratory facilities to contain and dispose of
such agents and toxins;
(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any
other criminal purpose;
(3) the establishment of procedures to protect animal and
plant health, and animal and plant products, in the event of
a transfer or potential transfer of such an agent or toxin in
violation of the safety procedures established under
paragraph (1) or the safeguard and security measures
established under paragraph (2); and
(4) appropriate availability of biological agents and
toxins for research, education, and other legitimate
purposes.
(c) Possession and Use of Listed Agents and Toxins.--The
Secretary shall by regulation provide for the establishment
and enforcement of standards and procedures governing the
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect animal and plant health,
and animal and plant products.
(d) Registration; Identification; Database.--
(1) Registration.--Regulations under subsections (b) and
(c) shall require registration with the Secretary of the
possession, use, and transfer of listed agents and toxins,
and shall include provisions to ensure that persons seeking
to register under such regulations have a lawful purpose to
possess, use, or transfer such agents and toxins, including
provisions in accordance with subsection (e)(6).
(2) Identification; database.--Regulations under
subsections (b) and (c) shall require that registration
include (if available to the person registering) information
regarding the characterization of listed agents and toxins to
facilitate their identification, including their source. The
Secretary shall maintain a national database that includes
the names and locations of registered persons, the listed
agents and toxins such persons are possessing, using, or
transferring, and information regarding the characterization
of such agents and toxins.
(e) Safeguard and Security Requirements for Registered
Persons.--
(1) In general.--Regulations under subsections (b) and (c)
shall include appropriate safeguard and security requirements
for persons possessing, using, or transferring a listed agent
or toxin commensurate with the risk such agent or toxin poses
to animal and plant health, and animal and plant products
(including the risk of use in domestic or international
terrorism). The Secretary shall establish such requirements
in consultation with the Attorney General, and shall ensure
compliance with such requirements as part of the registration
system under such regulations.
(2) Limiting access to listed agents and toxins.--
Requirements under paragraph (1) shall include provisions to
ensure that registered persons--
(A) provide access to listed agents and toxins to only
those individuals whom the registered person involved
determines have a legitimate need to handle or use such
agents and toxins;
(B) submit the names and other identifying information for
such individuals to the Secretary and the Attorney General,
promptly after first determining that the individuals need
access under subparagraph (A), and periodically thereafter
while the individuals have such access, not less frequently
than once every five years; and
(C)(i) in the case of listed agents and toxins that are not
overlap agents and toxins (as defined in subsection
(g)(1)(A)(ii)), limit or deny access to such agents and
toxins by individuals whom the Attorney General has
identified as within any category under paragraph (3)(B), if
limiting or denying such access by the individuals involved
is determined appropriate by the Secretary, in consultation
with the Attorney General; and
(ii) in the case of listed agents and toxins that are
overlap agents--
(I) deny access to such agents and toxins by individuals
whom the Attorney General has identified as within any
category referred to in paragraph (3)(B)(i); and
(II) limit or deny access to such agents and toxins by
individuals whom the Attorney General has identified as
within any category under paragraph (3)(B)(ii), if limiting
or denying such access by the individuals involved is
determined appropriate by the Secretary, in consultation with
the Attorney General.
(3) Submitted names; use of databases by attorney
general.--
(A) In general.--Upon the receipt of names and other
identifying information under paragraph (2)(B), the Attorney
General shall, for the sole purpose of identifying whether
the individuals involved are within any of the categories
[[Page H2706]]
specified in subparagraph (B), promptly use criminal,
immigration, national security, and other electronic
databases that are available to the Federal Government and
are appropriate for such purpose.
(B) Certain individuals.--For purposes of subparagraph (A),
the categories specified in this subparagraph regarding an
individual are that--
(i) the individual is within any of the categories
described in section 175b(d)(1) of title 18, United States
Code (relating to restricted persons); or
(ii) the individual is reasonably suspected by any Federal
law enforcement or intelligence agency of--
(I) committing a crime set forth in section 2332b(g)(5) of
title 18, United States Code;
(II) knowing involvement with an organization that engages
in domestic or international terrorism (as defined in section
2331 of such title 18) or with any other organization that
engages in intentional crimes of violence; or
(III) being an agent of a foreign power (as defined in
section 1801 of title 50, United States Code).
(C) Notification by attorney general regarding submitted
names.--After the receipt of a name and other identifying
information under paragraph (2)(B), the Attorney General
shall promptly notify the Secretary whether the individual is
within any of the categories specified in subparagraph (B).
(4) Notifications by secretary.--The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of
whether the individual is granted or denied access under
paragraph (2). If the individual is denied such access, the
Secretary shall promptly notify the individual of the denial.
(5) Expedited review.--Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon
request to the Secretary by a registered person who submits
names and other identifying information under paragraph
(2)(B) and who demonstrates good cause, the Secretary may, as
determined appropriate by the Secretary--
(A) request the Attorney General to expedite the process of
identification under paragraph (3)(A) and notification of the
Secretary under paragraph (3)(C); and
(B) expedite the notification of the registered person by
the Secretary under paragraph (4).
(6) Process regarding persons seeking to register.--
(A) Individuals.--Regulations under subsections (b) and (c)
shall provide that an individual who seeks to register under
either of such subsections is subject to the same processes
described in paragraphs (2) through (4) as apply to names and
other identifying information submitted to the Attorney
General under paragraph (2)(B). Paragraph (5) does not apply
for purposes of this subparagraph.
(B) Other persons.--Regulations under subsections (b) and
(c) shall provide that, in determining whether to deny or
revoke registration by a person other than an individual, the
Secretary shall submit the name of such person to the
Attorney General, who shall use criminal, immigration,
national security, and other electronic databases available
to the Federal Government, as appropriate for the purpose of
promptly notifying the Secretary whether the person, or,
where relevant, the individual who owns or controls such
person, is within any of the categories described in section
175b(d)(1) of title 18, United States Code (relating to
restricted persons), or is reasonably suspected by any
Federal law enforcement or intelligence agency of being
within any category specified in paragraph (3)(B)(ii) (as
applied to persons, including individuals). Such regulations
shall provide that a person who seeks to register under
either of such subsections is subject to the same processes
described in paragraphs (2) and (4) as apply to names and
other identifying information submitted to the Attorney
General under paragraph (2)(B). Paragraph (5) does not apply
for purposes of this subparagraph. The Secretary may exempt
Federal, State, or local governmental agencies from the
requirements of this subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under subsections (b) and (c)
shall provide for an opportunity for a review by the
Secretary--
(I) when requested by the individual involved, of a
determination under paragraph (2) to deny the individual
access to listed agents and toxins; and
(II) when requested by the person involved, of a
determination under under paragraph (6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a review under clause (i),
the Secretary may consider information relevant to the review
ex parte to the extent that disclosure of the information
could compromise national security or an investigation by any
law enforcement agency.
(iii) Final agency action.--The decision of the Secretary
in a review under clause (i) constitutes final agency action
for purposes of section 702 of title 5, United States Code.
(B) Certain procedures.--
(i) Submission of ex parte materials in judicial
proceedings.--When reviewing a decision of the Secretary
under subparagraph (A), and upon request made ex parte and in
writing by the United States, a court, upon a sufficient
showing, may review and consider ex parte documents
containing information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency. If the court determines that portions of
the documents considered ex parte should be disclosed to the
person involved to allow a response, the court shall
authorize the United States to delete from such documents
specified items of information the disclosure of which could
compromise national security or an investigation by any law
enforcement agency, or to substitute a summary of the
information to which the person may respond. Any order by the
court authorizing the disclosure of information that the
United States believes could compromise national security or
an investigation by any law enforcement agency shall be
subject to the processes set forth in subparagraphs (A) and
(B)(i) of section 2339B(f)(5) of title 18, United States Code
(relating to interlocutory appeal and expedited
consideration).
(ii) Disclosure of information.--In a review under
subparagraph (A), and in any judical proceeding conducted
pursuant to such review, neither the Secretary nor the
Attorney General may be required to disclose to the public
any information that under subsection (h) shall not be
disclosed under section 552 of title 5, United States Code.
(8) Notifications regarding theft or loss of agents.--
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal,
State, and local law enforcement agencies, of the theft or
loss of listed agents and toxins.
(9) Technical assistance for registered persons.--The
Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
(f) Inspections.--The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b)
or (c) to ensure their compliance with such regulations,
including prohibitions on restricted persons and other
provisions of subsection (e).
(g) Exemptions.--
(1) Overlap agents and toxins.--
(A) In general.--
(i) Limitation.--In the case of overlap agents and toxins,
exemptions from the applicability of provisions of
regulations under subsection (b) or (c) may be granted only
to the extent provided in this paragraph.
(ii) Definitions.--For purposes of this section:
(I) The term ``overlap agents and toxins'' means biological
agents and toxins that--
(aa) are listed pursuant to subsection (a)(1); and
(bb) are listed pursuant to section 315A(a)(1) of the
Public Health Service Act.
(II) The term ``overlap agent or toxin'' means a biological
agent or toxin that--
(aa) is listed pursuant to subsection (a)(1); and
(bb) is listed pursuant to section 315A(a)(1) of the Public
Health Service Act.
(B) Clinical or diagnostic laboratories.--Regulations under
subsections (b) and (c) shall exempt clinical or diagnostic
laboratories and other persons who possess, use, or transfer
overlap agents or toxins that are contained in specimens
presented for diagnosis, verification, or proficiency
testing, provided that--
(i) the identification of such agents or toxins is reported
to the Secretary, and when required under Federal, State, or
local law, to other appropriate authorities; and
(ii) such agents or toxins are transferred or destroyed in
a manner set forth by the Secretary by regulation.
(C) Products.--
(i) In general.--Regulations under subsections (b) and (c)
shall exempt products that are, bear, or contain overlap
agents or toxins and are cleared, approved, licensed, or
registered under any of the Acts specified in clause (ii),
unless the Secretary by order determines that applying
additional regulation under subsection (b) or (c) to a
specific product is necessary to protect animal or plant
health, or animal or plant products.
(ii) Relevant laws.--For purposes of clause (i), the Acts
specified in this clause are the following:
(I) The Federal Food, Drug, and Cosmetic Act.
(II) Section 351 of the Public Health Service Act.
(III) The Act commonly known as the Virus-Serum-Toxin Act
(the eighth paragraph under the heading `Bureau of Animal
Industry' in the Act of March 4, 1913; 21 U.S.C. 151-159).
(IV) The Federal Insecticide, Fungicide, and Rodenticide
Act.
(iii) Investigational use.--
(I) In general.--The Secretary may exempt an
investigational product that is, bears, or contains an
overlap agent or toxin from the applicability of provisions
of regulations under subsection (b) or (c) when such product
is being used in an investigation authorized under any
Federal Act and the Secretary determines that applying
additional regulation under subsection (b) or (c) to such
product is not necessary to protect animal and plant health,
and animal and plant products.
(II) Certain processes.--Regulations under subsections (b)
and (c) shall set forth the procedures for applying for an
exemption under subclause (I). In the case of investigational
products authorized under any of the Acts specified in clause
(ii), the Secretary shall make a determination regarding a
request for an exemption not later than 14 days after the
first date on which both of the following conditions have
been met by the person requesting the exemption:
(aa) The person has submitted to the Secretary an
application for the exemption meeting the requirements
established by the Secretary.
(bb) The person has notified the Secretary that the
investigation has been authorized under such an Act.
(D) Agricultural emergencies.-- The Secretary may
temporarily exempt a person from the applicability of the
requirements of this section with respect to an overlap agent
or toxin, in whole or in part, if the Secretary determines
that such exemption is necessary to provide for the timely
participation of the person in a response to a domestic or
foreign agricultural
[[Page H2707]]
emergency that involves such an agent or toxin. With respect
to the emergency involved, the exemption under this
subparagraph for a person may not exceed 30 days, except that
the Secretary, after review of whether such exemption remains
necessary, may provide one extension of an additional 30
days.
(E) Public health emergencies.--Upon request of the
Secretary of Health and Human Services, after the granting by
such Secretary of an exemption under 351A(g)(3) of the Public
Health Service Act pursuant to a finding that there is a
public health emergency, the Secretary of Agriculture may
temporarily exempt a person from the applicability of the
requirements of this section with respect to an overlap agent
or toxin, in whole or in part, to provide for the timely
participation of the person in a response to the public
health emergency. With respect to the emergency involved,
such exemption for a person may not exceed 30 days, except
that upon request of the Secretary of Health and Human
Services, the Secretary of Agriculture may, after review of
whether such exemption remains necessary, provide one
extension of an additional 30 days.
(2) General authority for exemptions not involving overlap
agents or toxins.--In the case of listed agents or toxins
that are not overlap agents or toxins, the Secretary may
grant exemptions from the applicability of provisions of
regulations under subsection (b) or (c) if the Secretary
determines that such exemptions are consistent with
protecting animal and plant health, and animal and plant
products.
(h) Disclosure of Information.--
(1) Nondisclosure of certain information.--No Federal
agency specified in paragraph (2) shall disclose under
section 552 of title 5, United States Code, any of the
following:
(A) Any registration or transfer documentation submitted
under subsections (b) and (c), or permits issued prior to the
date of the enactment of this Act, for the possession, use or
transfer of a listed agent or toxin; or information derived
therefrom to the extent that it identifies the listed agent
or toxin possessed, used or transferred by a specific person
or discloses the identity or location of a specific person.
(B) The national database developed pursuant to subsection
(d), or any other compilation of the registration or transfer
information submitted under subsections (b) and (c) to the
extent that such compilation discloses site-specific
registration or transfer information.
(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security measures
used by a registered person to prevent unauthorized access to
listed agents and toxins.
(D) Any notification of a release of a listed agent or
toxin submitted under subsections (b) and (c), or any
notification of theft or loss submitted under such
subsections.
(E) Any portion of an evaluation or report of an inspection
of a specific registered person conducted under subsection
(f) that identifies the listed agent or toxin possessed by a
specific registered person or that discloses the identity or
location of a specific registered person if the agency
determines that public disclosure of the information would
endanger animal or plant health, or animal or plant products.
(2) Covered agencies.--For purposes of paragraph (1) only,
the Federal agencies specified in this paragraph are the
following:
(A) The Department of Health and Human Services, the
Department of Justice, the Department of Agriculture, and the
Department of Transportation.
(B) Any Federal agency to which information specified in
paragraph (1) is transferred by any agency specified in
subparagraph (A) of this paragraph.
(C) Any Federal agency that is a registered person, or has
a sub-agency component that is a registered person.
(D) Any Federal agency that awards grants or enters into
contracts or cooperative agreements involving listed agents
and toxins to or with a registered person, and to which
information specified in paragraph (1) is transferred by any
such registered person.
(3) Other exemptions.--This subsection may not be construed
as altering the application of any exemptions to public
disclosure under section 552 of title 5, United States Code,
except as to subsection 552(b)(3) of such title, to any of
the information specified in paragraph (1).
(4) Rule of construction.--Except as specifically provided
in paragraph (1), this subsection may not be construed as
altering the authority of any Federal agency to withhold
under section 552 of title 5, United States Code, or the
obligation of any Federal agency to disclose under section
552 of title 5, United States Code, any information,
including information relating to--
(A) listed agents and toxins, or individuals seeking access
to such agents and toxins;
(B) registered persons, or persons seeking to register
their possession, use, or transfer of such agents and toxins;
(C) general safeguard and security policies and
requirements under regulations under subsections (b) and (c);
or
(D) summary or statistical information concerning
registrations, registrants, denials or revocations of
registrations, listed agents and toxins, inspection
evaluations and reports, or individuals seeking access to
such agents and toxins.
(5) Disclosures to congress; other disclosures.--This
subsection may not be construed as providing any authority--
(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
(B) to withhold information from any person under any other
Federal law or treaty.
(i) Civil Money Penalty.--
(1) In general.--In addition to any other penalties that
may apply under law, any person who violates any provision of
regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount not
exceeding $250,000 in the case of an individual and $500,000
in the case of any other person.
(2) Applicability of certain provisions.--The provisions of
sections 423 and 425(2) of the Plant Protection Act (7 U.S.C.
7733 and 7735(2) shall apply to a civil money penalty or
activity under paragraph (1) in the same manner as such
provisions apply to a penalty or activity under the Plant
Protection Act.
(j) Notification in Event of Release.--Regulations under
subsections (b) and (c) shall require the prompt notification
of the Secretary by a registered person whenever a release,
meeting criteria established by the Secretary, of a listed
agent or toxin has occurred outside of the biocontainment
area of a facility of the registered person. Upon receipt of
such notification and a finding by the Secretary that the
release poses a threat to animal or plant health, or animal
or plant products, the Secretary shall take appropriate
action to notify relevant Federal, State, and local
authorities, and, if necessary, other appropriate persons
(including the public). If the released listed agent or toxin
is an overlap agent or toxin, the Secretary shall promptly
notify the Secretary of Health and Human Services upon
notification by the registered person.
(k) Reports.--The Secretary shall report to the Congress
annually on the number and nature of notifications received
under subsection (e)(8) (relating to theft or loss) and
subsection (j) (relating to releases).
(l) Definitions.--For purposes of this section:
(1) The terms ``biological agent'' and ``toxin'' have the
meanings given such terms in section 178 of title 18, United
States Code.
(2) The term ``listed agents and toxins'' means biological
agents and toxins listed pursuant to subsection (a)(1).
(3) The term ``listed agents or toxins'' means biological
agents or toxins listed pursuant to subsection (a)(1).
(4) The terms ``overlap agents and toxins'' and ``overlap
agent or toxin'' have the meaning given such terms in
subsection (g)(1)(A)(ii).
(5) The term ``person'' includes Federal, State, and local
governmental entities.
(6) The term ``registered person'' means a person
registered under regulations under subsection (b) or (c).
(7) The term ```Secretary'' means the Secretary of
Agriculture.
(m) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2007, in addition to other funds
that may be available.
SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.
(a) Date Certain for Promulgation of List.--Not later than
60 days after the date of the enactment of this Act, the
Secretary of Agriculture (referred to in this section as the
``Secretary'') shall promulgate an interim final rule that
establishes the initial list under section 212(a)(1). In
promulgating such rule, the Secretary shall provide written
guidance on the manner in which the notice required in
subsection (b) is to be provided to the Secretary.
(b) Date Certain for Notice of Possession.--Not later than
60 days after the date on which the Secretary promulgates the
interim final rule under subsection (a), all persons (unless
exempt under section 212(g)) in possession of biological
agents or toxins included on the list referred to in
subsection (a) shall notify the Secretary of such possession.
(c) Date Certain for Promulgation; Effective Date Regarding
Criminal and Civil Penalties.--Not later than 180 days after
the date of the enactment of this Act, the Secretary shall
promulgate an interim final rule for carrying out section
212, other than for the list referred to in subsection (a) of
this section (but such rule may incorporate by reference
provisions promulgated pursuant to subsection (a)). Such
interim final rule shall take effect 60 days after the date
on which such rule is promulgated, including for purposes
of--
(1) section 175b(c) of title 18, United States Code
(relating to criminal penalties), as added by section
231(a)(5) of this Act; and
(2) section 212(i) of this Act (relating to civil
penalties).
(d) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (c) shall
include time frames for the applicability of the rule that
minimize disruption of research or educational projects that
involve biological agents and toxins listed pursuant to
section 212(a)(1) and that were underway as of the effective
date of such rule.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins
SEC. 221. INTERAGENCY COORDINATION.
(a) In General.--
(1) Coordination.--The Secretary of Agriculture and the
Secretary of Health and Human Services shall in accordance
with this section coordinate activities regarding overlap
agents and toxins.
(2) Overlap agents and toxins; other terms.--For purposes
of this section:
(A) The term ``overlap agent or toxin'' means a biological
agent or toxin that--
(i) is listed pursuant to section 315A(a)(1) of the Public
Health Service Act, as added by section 201 of this Act; and
(ii) is listed pursuant to section 212(a)(1) of this Act.
(B) The term ``section 351A program'' means the program
under section 351A of the Public Health Service Act.
(C) The term ``section 212 program'' means the program
under section 212 of this Act.
(b) Certain Matters.--In carrying out the section 351A
program and the section 212 program, the Secretary of Health
and Human Services and the Secretary of Agriculture shall, to
[[Page H2708]]
the greatest extent practicable, coordinate activities to
achieve the following purposes:
(1) To minimize any conflicts between the regulations
issued under, and activities carried out under, such
programs.
(2) To minimize the administrative burden on persons
subject to regulation under both of such programs.
(3) To ensure the appropriate availability of biological
agents and toxins for legitimate biomedical, agricultural or
veterinary research, education, or other such purposes.
(4) To ensure that registration information for overlap
agents and toxins under the section 351A and section 212
programs is contained in both the national database under the
section 351A program and the national database under the
section 212 program.
(c) Memorandum of Understanding.--
(1) In general.--Promptly after the date of the enactment
of this Act, the Secretary of Agriculture and the Secretary
of Health and Human Services shall enter into a memorandum of
understanding regarding overlap agents and toxins that is in
accordance with paragraphs (2) through (4) and contains such
additional provisions as the Secretary of Agriculture and the
Secretary of Health and Human Services determine to be
appropriate.
(2) Single registration system regarding registered
persons.--The memorandum of understanding under paragraph (1)
shall provide for the development and implementation of a
single system of registration for persons who possess, use,
or transfer overlap agents or toxins and are required to
register under both the section 351A program and the section
212 program. For purposes of such system, the memorandum
shall provide for the development and implementation of the
following:
(A) A single registration form through which the person
submitting the form provides all information that is required
for registration under the section 351A program and all
information that is required for registration under the
section 212 program.
(B) A procedure through which a person may choose to submit
the single registration form to the agency administering the
section 351A program (in the manner provided under such
program), or to the agency administering the section 212
program (in the manner provided under such program).
(C) A procedure through which a copy of a single
registration form received pursuant to subparagraph (B) by
the agency administering one of such programs is promptly
provided to the agency administering the other program.
(D) A procedure through which the agency receiving the
single registration form under one of such programs obtains
the concurrence of the agency administering the other program
that the requirements for registration under the other
program have been met.
(E) A procedure through which--
(i) the agency receiving the single registration form under
one of such programs informs the agency administering the
other program whether the receiving agency has denied the
registration; and
(ii) each of such agencies ensures that registrations are
entered into the national database of registered persons that
is maintained by each such agency.
(3) Process of identification.--With respect to the process
of identification under the section 351A program and the
section 212 program for names and other identifying
information submitted to the Attorney General (relating to
certain categories of individuals and entities), the
memorandum of understanding under paragraph (1) shall provide
for the development and implementation of the following:
(A) A procedure through which a person who is required to
submit information pursuant to such process makes (in
addition to the submission to the Attorney General) a
submission, at the option of the person, to either the agency
administering the section 351A program or the agency
administering the section 212 program, but not both, which
submission satisfies the requirement of submission for both
of such programs.
(B) A procedure for the sharing by both of such agencies of
information received from the Attorney General by one of such
agencies pursuant to the submission under subparagraph (A).
(C) A procedure through which the agencies administering
such programs concur in determinations that access to overlap
agents and toxins will be granted.
(4) Coordination of inspections and enforcement.--The
memorandum of understanding under paragraph (1) shall provide
for the development and implementation of procedures under
which Federal personnel under the section 351A program and
the section 212 program may share responsibilities for
inspections and enforcement activities under such programs
regarding overlap agents and toxins. Activities carried out
under such procedures by one of such programs on behalf of
the other may be carried out with or without reimbursement by
the agency that administers the other program.
(5) Date certain for implementation.--The memorandum of
understanding under paragraph (1) shall be implemented not
later than 180 days after the date of the enactment of this
Act. Until the single system of registration under paragraph
(2) is implemented, persons who possess, use, or transfer
overlap agents or toxins shall register under both the
section 351A program and the section 212 program.
(d) Joint Regulations.--Not later than 18 months after the
date on which the single system of registration under
subsection (c)(2) is implemented, the Secretary of Health and
Human Services and the Secretary of Agriculture shall jointly
issue regulations for the possession, use, and transfer of
overlap agents and toxins that meet the requirements of both
the section 351A program and the section 212 program.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
SEC. 231. CRIMINAL PENALTIES.
(a) In General.--Section 175b of title 18, United States
Code, as added by section 817 of Public Law 107-56, is
amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by transferring subsection (c) from the current
placement of the subsection and inserting the subsection
before subsection (b);
(3) by striking ``(c)'' and inserting ``(2);
(4) by redesignating subsection (b) as subsection (d); and
(5) by inserting before subsection (d) (as so redesignated)
the following subsections:
``(b) Transfer to Unregistered Person.--
``(1) Select agents.--Whoever transfers a select agent to a
person who the transferor knows or has reasonable cause to
believe is not registered as required by regulations under
subsection (b) or (c) of section 351A of the Public Health
Service Act shall be fined under this title, or imprisoned
for not more than 5 years, or both.
``(2) Certain other biological agents and toxins.--Whoever
transfers a biological agent or toxin listed pursuant to
section 212(a)(1) of the Agricultural Bioterrorism Protection
Act of 2002 to a person who the transferor knows or has
reasonable cause to believe is not registered as required by
regulations under subsection (b) or (c) of section 212 of
such Act shall be fined under this title, or imprisoned for
not more than 5 years, or both.
``(c) Unregistered for Possession.--
``(1) Select agents.--Whoever knowingly possesses a
biological agent or toxin where such agent or toxin is a
select agent for which such person has not obtained a
registration required by regulations under section 351A(c) of
the Public Health Service Act shall be fined under this
title, or imprisoned for not more than 5 years, or both.
``(2) Certain other biological agents and toxins.--Whoever
knowingly possesses a biological agent or toxin where such
agent or toxin is a biological agent or toxin listed pursuant
to section 212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002 for which such person has not obtained
a registration required by regulations under section 212(c)
of such Act shall be fined under this title, or imprisoned
for not more than 5 years, or both.''.
(b) Conforming Amendments.--Chapter 10 of title 18, United
States Code, is amended--
(1) in section 175b (as added by section 817 of Public Law
107-56 and amended by subsection (a) of this section)--
(A) in subsection (d)(1), by striking ``The term'' and all
that follows through ``does not include'' and inserting the
following: ``The term `select agent' means a biological agent
or toxin to which subsection (a) applies. Such term
(including for purposes of subsection (a)) does not
include''; and
(B) in the heading for the section, by striking
``Possession by restricted persons'' and inserting ``Select
agents; certain other agents''; and
(2) in the chapter analysis, in the item relating to
section 175b, by striking ``Possession by restricted
persons.'' and inserting ``Select agents; certain other
agents.''.
(c) Technical Corrections.--Chapter 10 of title 18, United
States Code, as amended by section 817 of Public Law 107-56
and subsections (a) and (b) of this section, is amended--
(1) in section 175(c), by striking ``protective'' and all
that follows and inserting ``protective, bona fide research,
or other peaceful purposes.'';
(2) in section 175b--
(A) in subsection (a)(1), by striking ``described in
subsection (b)'' and all that follows and inserting the
following: ``shall ship or transport in or affecting
interstate or foreign commerce, or possess in or affecting
interstate or foreign commerce, any biological agent or
toxin, or receive any biological agent or toxin that has been
shipped or transported in interstate or foreign commerce, if
the biological agent or toxin is listed as a select agent in
Appendix A of part 72 of title 42, Code of Federal
Regulations, pursuant to section 351A of the Public Health
Service Act, and is not exempted under subsection (h) of
section 72.6, or Appendix A of part 72, of title 42, Code of
Federal Regulations.''; and
(B) in subsection (d)(3), by striking ``section
1010(a)(3)'' and inserting ``section 101(a)(3)'';
(3) in section 176(a)(1)(A), by striking ``exists by reason
of'' and inserting ``pertains to''; and
(4) in section 178--
(A) in paragraph (1), by striking ``means any micro-
organism'' and all that follows through ``product, capable
of'' and inserting the following: ``means any microorganism
(including, but not limited to, bacteria, viruses, fungi,
rickettsiae or protozoa), or infectious substance, or any
naturally occurring, bioengineered or synthesized component
of any such microorganism or infectious substance, capable
of'';
(B) in paragraph (2), by striking ``means the toxic'' and
all that follows through ``including--'' and inserting the
following: ``means the toxic material or product of plants,
animals, microorganisms (including, but not limited to,
bacteria, viruses, fungi, rickettsiae or protozoa), or
infectious substances, or a recombinant or synthesized
molecule, whatever their origin and method of production, and
includes--''; and
(C) in paragraph (4), by striking ``recombinant molecule,''
and all that follows through ``biotechnology,'' and inserting
``recombinant or synthesized molecule,''.
(d) Additional Technical Correction.--Section 2332a of
title 18, United States Code, is amended--
(1) in subsection (a), in the matter preceding paragraph
(1), by striking ``section 229F)'' and all that follows
through ``section 178)--'' and inserting ``section 229F)--'';
and
(2) in subsection (c)(2)(C), by striking ``a disease
organism'' and inserting ``a biological
[[Page H2709]]
agent, toxin, or vector (as those terms are defined in
section 178 of this title)''.
TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
Subtitle A--Protection of Food Supply
SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.
(a) In General.--The President's Council on Food Safety (as
established by Executive Order 13100) shall, in consultation
with the Secretary of Transportation, the Secretary of the
Treasury, other relevant Federal agencies, the food industry,
consumer and producer groups, scientific organizations, and
the States, develop a crisis communications and education
strategy with respect to bioterrorist threats to the food
supply. Such strategy shall address threat assessments;
technologies and procedures for securing food processing and
manufacturing facilities and modes of transportation;
response and notification procedures; and risk communications
to the public.
(b) Authorization of Appropriations.--For the purpose of
implementing the strategy developed under subsection (a),
there are authorized to be appropriated $750,000 for fiscal
year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.
(a) Increasing Inspections for Detection of Adulteration of
Food.--Section 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381) is amended by adding at the end the
following subsection:
``(h)(1) The Secretary shall give high priority to
increasing the number of inspections under this section for
the purpose of enabling the Secretary to inspect food offered
for import at ports of entry into the United States, with the
greatest priority given to inspections to detect the
intentional adulteration of food.''.
(b) Improvements to Information Management Systems.--
Section 801(h) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a) of this section, is amended by
adding at the end the following paragraph:
``(2) The Secretary shall give high priority to making
necessary improvements to the information management systems
of the Food and Drug Administration that contain information
related to foods imported or offered for import into the
United States for purposes of improving the ability of the
Secretary to allocate resources, detect the intentional
adulteration of food, and facilitate the importation of food
that is in compliance with this Act.''.
(c) Linkages With Appropriate Public Entities.--Section
801(h) of the Federal Food, Drug, and Cosmetic Act, as
amended by subsection (b) of this section, is amended by
adding at the end the following paragraph:
``(3) The Secretary shall improve linkages with other
regulatory agencies of the Federal Government that share
responsibility for food safety, and shall with respect to
such safety improve linkages with the States and Indian
tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C.
450b(e))).''.
(d) Testing for Rapid Detection of Adulteration of Food.--
Section 801 of the Federal Food, Drug, and Cosmetic Act, as
amended by subsection (a) of this section, is amended by
adding at the end the following:
``(i)(1) For use in inspections of food under this section,
the Secretary shall provide for research on the development
of tests and sampling methodologies--
``(A) whose purpose is to test food in order to rapidly
detect the adulteration of the food, with the greatest
priority given to detect the intentional adulteration of
food; and
``(B) whose results offer significant improvements over the
available technology in terms of accuracy, timing, or costs.
``(2) In providing for research under paragraph (1), the
Secretary shall give priority to conducting research on the
development of tests that are suitable for inspections of
food at ports of entry into the United States.
``(3) In providing for research under paragraph (1), the
Secretary shall as appropriate coordinate with the Director
of the Centers for Disease Control and Prevention, the
Director of the National Institutes of Health, the
Administrator of the Environmental Protection Agency, and the
Secretary of Agriculture.
``(4) The Secretary shall annually submit to the Committee
on Energy and Commerce of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions of
the Senate, a report describing the progress made in research
under paragraph (1), including progress regarding paragraph
(2).''.
(e) Assessment of Threat of Intentional Adulteration of
Food.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall ensure
that, not later than six months after the date of the
enactment of this Act--
(1) the assessment that (as of such date of enactment) is
being conducted on the threat of the intentional adulteration
of food is completed; and
(2) a report describing the findings of the assessment is
submitted to the Committee on Energy and Commerce of the
House of Representatives and to the Committee on Health,
Education, Labor, and Pensions of the Senate.
(f) Authorization of Appropriations.--For the purpose of
carrying out this section and the amendments made by this
section, there are authorized to be appropriated $100,000,000
for fiscal year 2002, and such sums as may be necessary for
each of the fiscal years 2003 through 2006, in addition to
other authorizations of appropriations that are available for
such purpose.
SEC. 303. ADMINISTRATIVE DETENTION.
(a) Expanded Authority.--Section 304 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding
at the end the following subsection:
``(h) Administrative Detention of Foods.--
``(1) Detention authority.--
``(A) In general.--An officer or qualified employee of the
Food and Drug Administration may order the detention, in
accordance with this subsection, of any article of food that
is found during an inspection, examination, or investigation
under this Act conducted by such officer or qualified
employee, if the officer or qualified employee has credible
evidence or information indicating that such article presents
a threat of serious adverse health consequences or death to
humans or animals.
``(B) Secretary's approval.--An article of food may be
ordered detained under subparagraph (A) only if the Secretary
or an official designated by the Secretary approves the
order. An official may not be so designated unless the
official is the director of the district under this Act in
which the article involved is located, or is an official
senior to such director.
``(2) Period of detention.--An article of food may be
detained under paragraph (1) for a reasonable period, not to
exceed 20 days, unless a greater period, not to exceed 30
days, is necessary, to enable the Secretary to institute an
action under subsection (a) or section 302. The Secretary
shall by regulation provide for procedures for instituting
such action on an expedited basis with respect to perishable
foods.
``(3) Security of detained article.--An order under
paragraph (1) with respect to an article of food may require
that such article be labeled or marked as detained, and shall
require that the article be removed to a secure facility, as
appropriate. An article subject to such an order shall not be
transferred by any person from the place at which the article
is ordered detained, or from the place to which the article
is so removed, as the case may be, until released by the
Secretary or until the expiration of the detention period
applicable under such order, whichever occurs first. This
subsection may not be construed as authorizing the delivery
of the article pursuant to the execution of a bond while the
article is subject to the order, and section 801(b) does not
authorize the delivery of the article pursuant to the
execution of a bond while the article is subject to the
order.
``(4) Appeal of detention order.--
``(A) In general.--With respect to an article of food
ordered detained under paragraph (1), any person who would be
entitled to be a claimant for such article if the article
were seized under subsection (a) may appeal the order to the
Secretary. Within five days after such an appeal is filed,
the Secretary, after providing opportunity for an informal
hearing, shall confirm or terminate the order involved, and
such confirmation by the Secretary shall be considered a
final agency action for purposes of section 702 of title 5,
United States Code. If during such five-day period the
Secretary fails to provide such an opportunity, or to confirm
or terminate such order, the order is deemed to be
terminated.
``(B) Effect of instituting court action.--The process
under subparagraph (A) for the appeal of an order under
paragraph (1) terminates if the Secretary institutes an
action under subsection (a) or section 302 regarding the
article of food involved.''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the
end the following:
``(bb) The transfer of an article of food in violation of
an order under section 304(h), or the removal or alteration
of any mark or label required by the order to identify the
article as detained.''.
(c) Temporary Holds at Ports of Entry.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
302(d)of this Act, is amended by adding at the end the
following:
``(j)(1) If an officer or qualified employee of the Food
and Drug Administration has credible evidence or information
indicating that an article of food presents a threat of
serious adverse health consequences or death to humans or
animals, and such officer or qualified employee is unable to
inspect, examine, or investigate such article upon the
article being offered for import at a port of entry into the
United States, the officer or qualified employee shall
request the Secretary of Treasury to hold the food at the
port of entry for a reasonable period of time, not to exceed
24 hours, for the purpose of enabling the Secretary to
inspect, examine, or investigate the article as appropriate.
``(2) The Secretary shall request the Secretary of Treasury
to remove an article held pursuant to paragraph (1) to a
secure facility, as appropriate. During the period of time
that such article is so held, the article shall not be
transferred by any person from the port of entry into the
United States for the article, or from the secure facility to
which the article has been removed, as the case may be.
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held.
``(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if
the Secretary or an official designated by the Secretary
approves the request. An official may not be so designated
unless the official is the director of the district under
this Act in which the article involved is located, or is an
official senior to such director.
``(4) With respect to an article of food for which a
request under paragraph (1) is made, the Secretary, promptly
after the request is made, shall notify the State in which
the port of entry involved is located that the request has
been made, and as applicable, that such article is being held
under this subsection.''.
[[Page H2710]]
SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT
VIOLATIONS.
(a) Debarment Authority.--
(1) Permissive debarment.--Section 306(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is
amended--
(A) in subparagraph (A), by striking ``or'' after the comma
at the end;
(B) in subparagraph (B), by striking the period at the end
and inserting ``, or''; and
(C) by adding at the end the following subparagraph:
``(C) a person from importing an article of food or
offering such an article for import into the United
States.'';
(2) Amendment regarding debarment grounds.--Section 306(b))
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
335a(b)) is amended--
(A) in paragraph (2), in the matter preceding subparagraph
(A), by inserting ``subparagraph (A) or (B) of'' before
``paragraph (1)'';
(B) by redesignating paragraph (3) as paragraph (4); and
(C) by inserting after paragraph (2) the following
paragraph:
``(3) Persons subject to permissive debarment; food
importation.--A person is subject to debarment under
paragraph (1)(C) if--
``(A) the person has been convicted of a felony for conduct
relating to the importation into the United States of any
food; or
``(B) the person has engaged in a pattern of importing or
offering for import adulterated food that presents a threat
of serious adverse health consequences or death to humans or
animals.''.
(b) Conforming Amendments.--Section 306 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--
(1) in subsection (a), in the heading for the subsection,
by striking ``Mandatory Debarment.--'' and inserting
``Mandatory Debarment; Certain Drug Applications.--'';
(2) in subsection (b)--
(A) in the heading for the subsection, by striking
``Permissive Debarment.--'' and inserting ``Permissive
Debarment; Certain Drug Applications; Food Imports.--''; and
(B) in paragraph (2), in the heading for the paragraph, by
striking ``permissive debarment.--'' and inserting
``permissive debarment; certain drug applications.--'';
(3) in subsection (c)(2)(A)(iii), by striking ``subsection
(b)(2)'' and inserting ``paragraph (2) or (3) of subsection
(b)'';
(4) in subsection (d)(3)--
(A) in subparagraph (A)(i), by striking ``or (b)(2)(A)''
and inserting `` or paragraph (2)(A) or (3) of subsection
(b)'';
(B) in subparagraph (A)(ii)(II), by inserting ``in
applicable cases,'' before ``sufficient audits'';
(C) in subparagraph (B), in each of clauses (i) and (ii),
by inserting ``or subsection (b)(3)'' after ``subsection
(b)(2)(B)''; and
(D) in subparagraph (B)(ii), by inserting before the period
the following: ``or the food importation process, as the case
may be''.
(c) Effective Dates.--Section 306(l)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is
amended--
(1) in the first sentence--
(A) by striking ``and'' after ``subsection (b)(2),''; and
(B) by inserting ``, and subsection (b)(3)(A)'' after
``subsection (b)(2)(B)''; and
(2) in the second sentence, by inserting ``, subsection
(b)(3)(B),'' after ``subsection (b)(2)(B)''.
(d) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 303(b) of this Act,
is amended by adding at the end the following:
``(cc) The importing or offering for import into the United
States of an article of food by, with the assistance of, or
at the direction of, a person debarred under section
306(b)(3).''.
(e) Importation by Debarred Persons.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
303(c) of this Act, is amended by adding at the end the
following subsection:
``(k)(1) If an article of food is being imported or offered
for import into the United States, and the importer, owner,
or consignee of the article is a person who has been debarred
under section 306(b)(3), such article shall be held at the
port of entry for the article, and may not be delivered to
such person. Subsection (b) does not authorize the delivery
of the article pursuant to the execution of a bond while the
article is so held. The article shall be removed to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by
any person from the port of entry into the United States for
the article, or from the secure facility to which the article
has been removed, as the case may be.
``(2) An article of food held under paragraph (1) may be
delivered to a person who is not a debarred person under
section 306(b)(3) if such person affirmatively establishes,
at the expense of the person, that the article complies with
the requirements of this Act, as determined by the
Secretary.''.
SEC. 305. REGISTRATION OF FOOD FACILITIES.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:
``SEC. 415. REGISTRATION OF FOOD FACILITIES.
``(a) Registration.--
``(1) In general.--The Secretary shall by regulation
require that any facility engaged in manufacturing,
processing, packing, or holding food for consumption in the
United States be registered with the Secretary. To be
registered--
``(A) for a domestic facility, the owner, operator, or
agent in charge of the facility shall submit a registration
to the Secretary; and
``(B) for a foreign facility, the owner, operator, or agent
in charge of the facility shall submit a registration to the
Secretary and shall include with the registration the name of
the United States agent for the facility.
``(2) Registration.--An entity (referred to in this section
as the `registrant') shall submit a registration under
paragraph (1) to the Secretary containing information
necessary to notify the Secretary of the name and address of
each facility at which, and all trade names under which, the
registrant conducts business and, when determined necessary
by the Secretary through guidance, the general food category
(as identified under section 170.3 of title 21, Code of
Federal Regulations) of any food manufactured, processed,
packed, or held at such facility. The registrant shall notify
the Secretary in a timely manner of changes to such
information.
``(3) Procedure.--Upon receipt of a completed registration
described in paragraph (1), the Secretary shall notify the
registrant of the receipt of such registration and assign a
registration number to each registered facility.
``(4) List.--The Secretary shall compile and maintain an
up-to-date list of facilities that are registered under this
section. Such list and any registration documents submitted
pursuant to this subsection shall not be subject to
disclosure under section 552 of title 5, United States Code.
Information derived from such list or registration documents
shall not be subject to disclosure under section 552 of title
5, United States Code, to the extent that it discloses the
identity or location of a specific registered person.
``(b) Facility.--For purposes of this section:
``(1) The term `facility' includes any factory, warehouse,
or establishment (including a factory, warehouse, or
establishment of an importer) that manufactures, processes,
packs, or holds food. Such term does not include farms;
restaurants; other retail food establishments; nonprofit food
establishments in which food is prepared for or served
directly to the consumer; or fishing vessels (except such
vessels engaged in processing as defined in section 123.3(k)
of title 21, Code of Federal Regulations).
``(2) The term `domestic facility' means a facility located
in any of the States or Territories.
``(3)(A) The term `foreign facility' means a facility that
manufacturers, processes, packs, or holds food, but only if
food from such facility is exported to the United States
without further processing or packaging outside the United
States.
``(B) A food may not be considered to have undergone
further processing or packaging for purposes of subparagraph
(A) solely on the basis that labeling was added or that any
similar activity of a de minimis nature was carried out with
respect to the food.
``(c) Rule of Construction.--Nothing in this section shall
be construed to authorize the Secretary to require an
application, review, or licensing process.''.
(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section
304(d) of this Act, is amended by adding at the end the
following:
``(dd) The failure to register in accordance with section
415.''.
(c) Importation; Failure to Register.--Section 801 of the
Federal Food, Drug, and Cosmetic Act, as amended by section
304(e) of this Act, is amended by adding at the end the
following subsection:
``(l)(1) If an article of food is being imported or offered
for import into the United States, and such article is from a
foreign facility for which a registration has not been
submitted to the Secretary under section 415, such article
shall be held at the port of entry for the article, and may
not be delivered to the importer, owner, or consignee of the
article, until the foreign facility is so registered.
Subsection (b) does not authorize the delivery of the article
pursuant to the execution of a bond while the article is so
held. The article shall be removed to a secure facility, as
appropriate. During the period of time that such article is
so held, the article shall not be transferred by any person
from the port of entry into the United States for the
article, or from the secure facility to which the article has
been removed, as the case may be.''.
(d) Electronic Filing.--For the purpose of reducing
paperwork and reporting burdens, the Secretary of Health and
Human Services may provide for, and encourage the use of,
electronic methods of submitting to the Secretary
registrations required pursuant to this section. In providing
for the electronic submission of such registrations, the
Secretary shall ensure adequate authentication protocols are
used to enable identification of the registrant and
validation of the data as appropriate.
(e) Rulemaking; Effective Date.--Not later than 18 months
after the date of the enactment of this Act, the Secretary of
Health and Human Services shall promulgate proposed and final
regulations for the requirement of registration under section
415 of the Federal Food, Drug, and Cosmetic Act (as added by
subsection (a) of this section). Such requirement of
registration takes effect--
(1) upon the effective date of such final regulations; or
(2) upon the expiration of such 18-month period if the
final regulations have not been made effective as of the
expiration of such period, subject to compliance with the
final regulations when the final regulations are made
effective.
SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.
(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305 of this Act, is
amended by inserting before section 415 the following
section:
``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.
``(a) Records Inspection.--If the Secretary has a
reasonable belief that an article of food is adulterated and
presents a threat of serious adverse health consequences or
death to humans
[[Page H2711]]
or animals, each person (excluding farms and restaurants) who
manufactures, processes, packs, distributes, receives, holds,
or imports such article shall, at the request of an officer
or employee duly designated by the Secretary, permit such
officer or employee, upon presentation of appropriate
credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article that are needed to assist the
Secretary in determining whether the food is adulterated and
presents a threat of serious adverse health consequences or
death to humans or animals. The requirement under the
preceding sentence applies to all records relating to the
manufacture, processing, packing, distribution, receipt,
holding, or importation of such article maintained by or on
behalf of such person in any format (including paper and
electronic formats) and at any location.
``(b) Regulations Concerning Recordkeeping.--The Secretary,
in consultation and coordination, as appropriate, with other
Federal departments and agencies with responsibilities for
regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for
not longer than two years, of records by persons (excluding
farms and restaurants) who manufacture, process, pack,
transport, distribute, receive, hold, or import food, which
records are needed by the Secretary for inspection to allow
the Secretary to identify the immediate previous sources and
the immediate subsequent recipients of food, including its
packaging, in order to address credible threats of serious
adverse health consequences or death to humans or animals.
The Secretary shall take into account the size of a business
in promulgating regulations under this section.
``(c) Protection of Sensitive Information.--The Secretary
shall take appropriate measures to ensure that there are in
effect effective procedures to prevent the unauthorized
disclosure of any trade secret or confidential information
that is obtained by the Secretary pursuant to this section.
``(d) Limitations.--This section shall not be construed--
``(1) to limit the authority of the Secretary to inspect
records or to require establishment and maintenance of
records under any other provision of this Act;
``(2) to authorize the Secretary to impose any requirements
with respect to a food to the extent that it is within the
exclusive jurisdiction of the Secretary of Agriculture
pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et
seq);
``(3) to have any legal effect on section 552 of title 5,
United States Code, or section 1905 of title 18, United
States Code; or
``(4) to extend to recipes for food, financial data,
pricing data, personnel data, research data, or sales data
(other than shipment data regarding sales).''.
(b) Factory Inspection.--Section 704(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--
(1) in paragraph (1), by inserting after the first sentence
the following new sentence: ``In the case of any person
(excluding farms and restaurants) who manufactures,
processes, packs, transports, distributes, holds, or imports
foods, the inspection shall extend to all records and other
information described in section 414 when the Secretary has a
reasonable belief that an article of food is adulterated and
presents a threat of serious adverse health consequences or
death to humans or animals, subject to the limitations
established in section 414(d).''; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``second sentence'' and inserting ``third
sentence''.
(c) Prohibited Act.--Section 301 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 331) is amended--
(1) in paragraph (e)--
(A) by striking ``by section 412, 504, or 703'' and
inserting ``by section 412, 414, 504, 703, or 704(a)''; and
(B) by striking ``under section 412'' and inserting ``under
section 412, 414(b)''; and
(2) in paragraph (j), by inserting ``414,'' after ``412,''.
(d) Expedited Rulemaking.--Not later than 18 months after
the date of the enactment of this Act, the Secretary shall
promulgate proposed and final regulations establishing
recordkeeping requirements under subsection 414(b) of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a)).
SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 305(c) of this Act, is
amended by adding at the end the following subsection:
``(m)(1) In the case of an article of food that is being
imported or offered for import into the United States, the
Secretary, after consultation with the Secretary of the
Treasury, shall by regulation require, for the purpose of
enabling such article to be inspected at ports of entry into
the United States, the submission to the Secretary of a
notice providing the identity of each of the following: The
article; the manufacturer and shipper of the article; if
known within the specified period of time that notice is
required to be provided, the grower of the article; the
country from which the article originates; the country from
which the article is shipped; and the anticipated port of
entry for the article. An article of food imported or offered
for import without submission of such notice in accordance
with the requirements under this paragraph shall be refused
admission into the United States. Nothing in this section may
be construed as a limitation on the port of entry for an
article of food.
``(2)(A) Regulations under paragraph (1) shall require that
a notice under such paragraph be provided by a specified
period of time in advance of the time of the importation of
the article of food involved or the offering of the food for
import, which period shall be no less than the minimum amount
of time necessary for the Secretary to receive, review, and
appropriately respond to such notification, but may not
exceed five days. In determining the specified period of time
required under this subparagraph, the Secretary may consider,
but is not limited to consideration of, the effect on
commerce of such period of time, the locations of the various
ports of entry into the United States, the various modes of
transportation, the types of food imported into the United
States, and any other such consideration. Nothing in the
preceding sentence may be construed as a limitation on the
obligation of the Secretary to receive, review, and
appropriately respond to any notice under paragraph (1).
``(B)(i) If an article of food is being imported or offered
for import into the United States and a notice under
paragraph (1) is not provided in advance in accordance with
the requirements under paragraph (1), such article shall be
held at the port of entry for the article, and may not be
delivered to the importer, owner, or consignee of the
article, until such notice is submitted to the Secretary, and
the Secretary examines the notice and determines that the
notice is in accordance with the requirements under paragraph
(1). Subsection (b) does not authorize the delivery of the
article pursuant to the execution of a bond while the article
is so held. The article shall be removed to a secure
facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by
any person from the port of entry into the United States for
the article, or from the secure facility to which the article
has been removed, as the case may be.
``(ii) In carrying out clause (i) with respect to an
article of food, the Secretary shall determine whether there
is in the possession of the Secretary any credible evidence
or information indicating that such article presents a threat
of serious adverse health consequences or death to humans or
animals.
``(3)(A) This subsection may not be construed as limiting
the authority of the Secretary to obtain information under
any other provision of this Act.
``(B) This subsection may not be construed as authorizing
the Secretary to impose any requirements with respect to a
food to the extent that it is within the exclusive
jurisdiction of the Secretary of Agriculture pursuant to the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or
the Egg Products Inspection Act (21 U.S.C. 1031 et seq).''.
(b) Prohibited Act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 305(b) of this Act,
is amended by adding at the end the following:
``(ee) The importing or offering for import into the United
States of an article of food in violation of the requirements
under section 801(m).''.
(c) Rulemaking; Effective Date.--
(1) In general.--Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate proposed and final regulations for
the requirement of providing notice in accordance with
section 801(m) of the Federal Food, Drug, and Cosmetic Act
(as added by subsection (a) of this section). Such
requirement of notification takes effect--
(A) upon the effective date of such final regulations; or
(B) upon the expiration of such 18-month period if the
final regulations have not been made effective as of the
expiration of such period, subject to compliance with the
final regulations when the final regulations are made
effective.
(2) Default; minimum period of advance notice.--If under
paragraph (1) the requirement for providing notice in
accordance with section 801(m) of the Federal Food, Drug, and
Cosmetic Act takes effect without final regulations having
been made effective, then for purposes of such requirement,
the specified period of time that the notice is required to
be made in advance of the time of the importation of the
article of food involved or the offering of the food for
import shall be not fewer than eight hours and not more than
five days, which shall remain in effect until the final
regulations are made effective.
SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO
UNITED STATES.
(a) In General.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a)
of this Act, is amended by adding at the end the following:
``(n)(1) If a food has been refused admission under
subsection (a), other than such a food that is required to be
destroyed, the Secretary may require the owner or consignee
of the food to affix to the container of the food a label
that clearly and conspicuously bears the statement: `UNITED
STATES: REFUSED ENTRY'.
``(2) All expenses in connection with affixing a label
under paragraph (1) shall be paid by the owner or consignee
of the food involved, and in default of such payment, shall
constitute a lien against future importations made by such
owner or consignee.
``(3) A requirement under paragraph (1) remains in effect
until the Secretary determines that the food involved has
been brought into compliance with this Act.''.
(b) Misbranded Foods.--Section 403 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding
at the end the following:
``(v) If--
``(1) it fails to bear a label required by the Secretary
under section 801(n)(1) (relating to food refused admission
into the United States);
[[Page H2712]]
``(2) the Secretary finds that the food presents a threat
of serious adverse health consequences or death to humans or
animals; and
``(3) upon or after notifying the owner or consignee
involved that the label is required under section 801, the
Secretary informs the owner or consignee that the food
presents such a threat.''.
(c) Rule of Construction.--With respect to articles of food
that are imported or offered for import into the United
States, nothing in this section shall be construed to limit
the authority of the Secretary of Health and Human Services
or the Secretary of the Treasury to require the marking of
refused articles of food under any other provision of law.
SEC. 309. PROHIBITION AGAINST PORT SHOPPING.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342) is amended by adding at the end the following:
``(h) If it is an article of food imported or offered for
import into the United States and the article of food has
previously been refused admission under section 801(a),
unless the person reoffering the article affirmatively
establishes, at the expense of the owner or consignee of the
article, that the article complies with the applicable
requirements of this Act, as determined by the Secretary.''.
SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following section:
``SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.
``(a) In General.--If the Secretary has credible evidence
or information indicating that a shipment of imported food or
portion thereof presents a threat of serious adverse health
consequences or death to humans or animals, the Secretary
shall provide notice regarding such threat to the States in
which the food is held or will be held, and to the States in
which the manufacturer, packer, or distributor of the food is
located, to the extent that the Secretary has knowledge of
which States are so involved. In providing notice to a State,
the Secretary shall request the State to take such action as
the State considers appropriate, if any, to protect the
public health regarding the food involved.
``(b) Rule of Construction.--Subsection (a) may not be
construed as limiting the authority of the Secretary with
respect to food under any other provision of this Act.''.
SEC. 311. GRANTS TO STATES FOR INSPECTIONS.
Chapter IX of the Federal Food, Drug and Cosmetic Act, as
amended by section 310 of this Act, is amended by adding at
the end the following section:
``SEC. 909. GRANTS TO STATES FOR INSPECTIONS.
``(a) In General.--The Secretary is authorized to make
grants to States, territories, and Indian tribes (as defined
in section 4(e) of the Indian Self-Determination and
Education Assistance Act (25 U.S.C. 450b(e))) that undertake
examinations, inspections, and investigations, and related
activities under section 702. The funds provided under such
grants shall only be available for the costs of conducting
such examinations, inspections, investigations, and related
activities.
``(b) Notices Regarding Adulterated Imported Food.--The
Secretary may make grants to the States for the purpose of
assisting the States with the costs of taking appropriate
action to protect the public health in response to
notification under section 908, including planning and
otherwise preparing to take such action.
``(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $10,000,000 for fiscal year 2002, and such sums
as may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND
AUTHORITIES.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by inserting after section
317P the following:
``SEC. 317R. FOOD SAFETY GRANTS.
``(a) In General.--The Secretary may award grants to States
and Indian tribes (as defined in section 4(e) of the Indian
Self-Determination and Education Assistance Act (25 U.S.C.
450b(e))) to expand participation in networks to enhance
Federal, State, and local food safety efforts, including
meeting the costs of establishing and maintaining the food
safety surveillance, technical, and laboratory capacity
needed for such participation.
``(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $19,500,000 for fiscal year 2002, and such sums
as may be necessary for each of the fiscal years 2003 through
2006.''.
SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.
The Secretary of Health and Human Services, through the
Commissioner of Food and Drugs and the Director of the
Centers for Disease Control and Prevention, and the Secretary
of Agriculture shall coordinate the surveillance of zoonotic
diseases.
SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO
CONDUCT INSPECTIONS.
Section 702(a) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 372(a)) is amended--
(1) by striking ``(a)'' and inserting ``(a)(1)'';
(2) by striking ``In the case of food packed'' and
inserting the following:
``(3) In the case of food packed'';
(3) by striking ``For the purposes of this subsection'' and
inserting the following:
``(4) For the purposes of this subsection,''; and
(4) by inserting after paragraph (1) (as designated by
paragraph (1) of this section) the following paragraph:
``(2)(A) In addition to the authority established in
paragraph (1), the Secretary, pursuant to a memorandum of
understanding between the Secretary and the head of another
Federal department or agency, is authorized to conduct
examinations and investigations for the purposes of this Act
through the officers and employees of such other department
or agency, subject to subparagraph (B). Such a memorandum
shall include provisions to ensure adequate training of such
officers and employees to conduct the examinations and
investigations. The memorandum of understanding shall contain
provisions regarding reimbursement. Such provisions may, at
the sole discretion of the head of the other department or
agency, require reimbursement, in whole or in part, from the
Secretary for the examinations or investigations performed
under this section by the officers or employees of the other
department or agency.
``(B) A memorandum of understanding under subparagraph (A)
between the Secretary and another Federal department or
agency is effective only in the case of examinations or
inspections at facilities or other locations that are jointly
regulated by the Secretary and such department or agency.
``(C) For any fiscal year in which the Secretary and the
head of another Federal department or agency carries out one
or more examinations or inspections under a memorandum of
understanding under subparagraph (A), the Secretary and the
head of such department or agency shall with respect to their
respective departments or agencies submit to the committees
of jurisdiction (authorizing and appropriating) in the House
of Representatives and the Senate a report that provides, for
such year--
``(i) the number of officers or employees that carried out
one or more programs, projects, or activities under such
memorandum;
``(ii) the number of additional articles that were
inspected or examined as a result of such memorandum; and
``(iii) the number of additional examinations or
investigations that were carried out pursuant to such
memorandum.''.
SEC. 315. RULE OF CONSTRUCTION.
Nothing in this title, or an amendment made by this title,
shall be construed to alter the jurisdiction between the
Secretaries of Agriculture and of Health and Human Services,
under applicable statutes and regulations.
Subtitle B--Protection of Drug Supply
SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS;
SHIPPING INFORMATION; DRUG AND DEVICE LISTING.
(a) Annual Registration; Listing.--Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is
amended--
(1) in subsection (i)(1)--
(A) by striking ``Any establishment'' and inserting ``On or
before December 31 of each year, any establishment''; and
(B) by striking ``shall register'' and all that follows and
inserting the following: ``shall, through electronic means in
accordance with the criteria of the Secretary, register with
the Secretary the name and place of business of the
establishment, the name of the United States agent for the
establishment, the name of each importer of such drug or
device in the United States that is known to the
establishment, and the name of each person who imports or
offers for import such drug or device to the United States
for purposes of importation.''; and
(2) in subsection (j)(1), in the first sentence, by
striking ``or (d)'' and inserting ``(d), or (i)''.
(b) Importation; Statement Regarding Registration of
Manufacturer.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 308(a) of this Act, is
amended by adding at the end the following subsection:
``(o) If an article that is a drug or device is being
imported or offered for import into the United States, and
the importer, owner, or consignee of such article does not,
at the time of offering the article for import, submit to the
Secretary a statement that identifies the registration under
section 510(i) of each establishment that with respect to
such article is required under such section to register with
the Secretary, the article may be refused admission. If the
article is refused admission for failure to submit such a
statement, the article shall be held at the port of entry for
the article, and may not be delivered to the importer, owner,
or consignee of the article, until such a statement is
submitted to the Secretary. Subsection (b) does not authorize
the delivery of the article pursuant to the execution of a
bond while the article is so held. The article shall be
removed to a secure facility, as appropriate. During the
period of time that such article is so held, the article
shall not be transferred by any person from the port of entry
into the United States for the article, or from the secure
facility to which the article has been removed, as the case
may be.''.
(2) Prohibited act.--Section 301 of the Federal Food, Drug,
and Cosmetic Act, as amended by section 307(b) of this Act,
is amended by adding at the end the following:
``(ff) The importing or offering for import into the United
States of a drug or device with respect to which there is a
failure to comply with a request of the Secretary to submit
to the Secretary a statement under section 801(o).''.
(c) Effective Date.--The amendments made by this section
take effect upon the expiration of the 180-day period
beginning on the date of the enactment of this Act.
SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING
IMPORT COMPONENTS INTENDED FOR USE IN EXPORT
PRODUCTS.
(a) In General.--Section 801(d)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to
read as follows:
[[Page H2713]]
``(3)(A) Subject to subparagraph (B), no component of a
drug, no component part or accessory of a device, or other
article of device requiring further processing, which is
ready or suitable for use for health-related purposes, and no
article of a food additive, color additive, or dietary
supplement, including a product in bulk form, shall be
excluded from importation into the United States under
subsection (a) if each of the following conditions is met:
``(i) The importer of such article of a drug or device or
importer of such article of a food additive, color additive,
or dietary supplement submits to the Secretary, at the time
of initial importation, a statement in accordance with the
following:
``(I) Such statement provides that such article is intended
to be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug,
biological product, device, food, food additive, color
additive, or dietary supplement that will be exported by the
initial owner or consignee from the United States in
accordance with subsection (e) or section 802, or with
section 351(h) of the Public Health Service Act.
``(II) The statement identifies the manufacturer of such
article and each processor, packer, distributor, or other
entity that had possession of the article in the chain of
possession of the article from the manufacturer to such
importer of the article.
``(III) The statement is accompanied by such certificates
of analysis as are necessary to identify such article, unless
the article is a device or is an article described in
paragraph (4).
``(ii) At the time of initial importation and before the
delivery of such article to the importer or the initial owner
or consignee, such owner or consignee executes a good and
sufficient bond providing for the payment of such liquidated
damages in the event of default as may be required pursuant
to regulations of the Secretary of the Treasury.
``(iii) Such article is used and exported by the initial
owner or consignee in accordance with the intent described
under clause (i)(I), except for any portions of the article
that are destroyed.
``(iv) The initial owner or consignee maintains records on
the use or destruction of such article or portions thereof,
as the case may be, and submits to the Secretary any such
records requested by the Secretary.
``(v) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions
thereof, and the manner in which such owner or consignee
complied with the requirements of this subparagraph.
``(B) Notwithstanding subparagraph (A), the Secretary may
refuse admission to an article that otherwise would be
imported into the United States under such subparagraph if
the Secretary determines that there is credible evidence or
information indicating that such article is not intended to
be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug,
biological product, device, food, food additive, color
additive, or dietary supplement that will be exported by the
initial owner or consignee from the United States in
accordance with subsection (e) or section 802, or with
section 351(h) of the Public Health Service Act.
``(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles
imported into the United States under authority of
subparagraph (A) meet each of the conditions established in
such subparagraph for importation.''.
(b) Prohibited Act.--Section 301(w) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(w)) is amended to read
as follows:
``(w) The making of a knowingly false statement in any
statement, certificate of analysis, record, or report
required or requested under section 801(d)(3); the failure to
submit a certificate of analysis as required under such
section; the failure to maintain records or to submit records
or reports as required by such section; the release into
interstate commerce of any article or portion thereof
imported into the United States under such section or any
finished product made from such article or portion, except
for export in accordance with section 801(e) or 802, or with
section 351(h) of the Public Health Service Act; or the
failure to so export or to destroy such an article or
portions thereof, or such a finished product.''.
(c) Effective Date.--The amendments made by this section
take effect upon the expiration of the 90-day period
beginning on the date of the enactment of this Act.
Subtitle C--General Provisions Relating to Upgrade of Agricultural
Security
SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION
SERVICE ACTIVITIES.
(a) In General.--The Secretary of Agriculture (referred to
in this section as the ``Secretary'') may utilize existing
authorities to give high priority to enhancing and expanding
the capacity of the Animal and Plant Health Inspection
Service to conduct activities to--
(1) increase the inspection capacity of the Service at
international points of origin;
(2) improve surveillance at ports of entry and customs;
(3) enhance methods of protecting against the introduction
of plant and animal disease organisms by terrorists;
(4) develop new and improve existing strategies and
technologies for dealing with intentional outbreaks of plant
and animal disease arising from acts of terrorism or from
unintentional introduction, including--
(A) establishing cooperative agreements among Veterinary
Services of the Animal and Plant Health Inspection Service,
State animal health commissions and regulatory agencies for
livestock and poultry health, and private veterinary
practitioners to enhance the preparedness and ability of
Veterinary Services and the commissions and agencies to
respond to outbreaks of such animal diseases; and
(B) strengthening planning and coordination with State and
local agencies, including--
(i) State animal health commissions and regulatory agencies
for livestock and poultry health; and
(ii) State agriculture departments; and
(5) otherwise improve the capacity of the Service to
protect against the threat of bioterrorism.
(b) Automated Recordkeeping System.--The Administrator of
the Animal and Plant Health Inspection Service may implement
a central automated recordkeeping system to provide for the
reliable tracking of the status of animal and plant
shipments, including those shipments on hold at ports of
entry and customs. The Secretary shall ensure that such a
system shall be fully accessible to or fully integrated
with the Food Safety Inspection Service.
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $30,000,000 for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE
ACTIVITIES.
(a) In General.--The Secretary of Agriculture may utilize
existing authorities to give high priority to enhancing and
expanding the capacity of the Food Safety Inspection Service
to conduct activities to--
(1) enhance the ability of the Service to inspect and
ensure the safety and wholesomeness of meat and poultry
products;
(2) improve the capacity of the Service to inspect
international meat and meat products, poultry and poultry
products, and egg products at points of origin and at ports
of entry;
(3) strengthen the ability of the Service to collaborate
with relevant agencies within the Department of Agriculture
and with other entities in the Federal Government, the
States, and Indian tribes (as defined in section 4(e) of the
Indian Self-Determination and Education Assistance Act (25
U.S.C. 450b(e))) through the sharing of information and
technology; and
(4) otherwise expand the capacity of the Service to protect
against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $15,000,000 for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
SEC. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF
AGRICULTURE.
There is authorized to be appropriated for fiscal year
2002, $180,000,000 for the purpose of enabling the
Agricultural Research Service to conduct building upgrades to
modernize existing facilities, of which (1) $100,000,000
shall be allocated for renovation, updating, and expansion of
the Biosafety Level 3 laboratory and animal research
facilities at the Plum Island Animal Disease Center
(Greenport, New York), and of which (2) $80,000,000 shall be
allocated for the Agricultural Research Service/Animal and
Plant Health Inspection Service facility in Ames, Iowa. There
are authorized to be appropriated such sums as may be
necessary for fiscal years 2003 through 2006 for the purpose
described in the preceding sentence, for the planning and
design of an Agricultural Research Service biocontainment
laboratory for poultry research in Athens, Georgia, and for
the planning, updating, and renovation of the Arthropod-Borne
Animal Disease Laboratory in Laramie, Wyoming.
SEC. 334. AGRICULTURAL BIOSECURITY.
(a) Security at Colleges and Universities.--
(1) Grants.--The Secretary of Agriculture (referred to in
this section as the ``Secretary'') may award grants to
covered entities to review security standards and practices
at their facilities in order to protect against bioterrorist
attacks.
(2) Covered entities.--Covered entities under this
subsection are colleges or universities that--
(A) are colleges or universities as defined in section 1404
of the National Agricultural Research, Extension, and
Teaching Policy Act of 1977 (7 U.S.C. 3103); and
(B) have programs in food and agricultural sciences, as
defined in such section.
(3) Limitation.--Each individual covered entity may be
awarded one grant under paragraph (1), the amount of which
shall not exceed $50,000.
(4) Contract authority.--Colleges and universities
receiving grants under paragraph (1) may use such grants to
enter into contracts with independent private organizations
with established and demonstrated security expertise to
conduct the security reviews specified in such paragraph.
(b) Guidelines for Agricultural Biosecurity.--
(1) In general.--The Secretary may award grants to
associations of food producers or consortia of such
associations for the development and implementation of
educational programs to improve biosecurity on farms in order
to ensure the security of farm facilities against potential
bioterrorist attacks.
(2) Limitation.--Each individual association eligible under
paragraph (1) may be awarded one grant under such paragraph,
the amount of which shall not exceed $100,000. Each
consortium eligible under paragraph (1) may be awarded one
grant under such paragraph, the amount of which shall not
exceed $100,000 per association participating in the
consortium.
(3) Contract authority.--Associations of food producers
receiving grants under paragraph (1) may use such grants to
enter into contracts with independent private organizations
with established and demonstrated expertise in biosecurity to
assist in the development and implementation of educational
programs to improve biosecurity specified in such paragraph.
[[Page H2714]]
(c) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each fiscal year.
SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.
(a) In General.--The Secretary of Agriculture (referred to
in this section as the ``Secretary'') may utilize existing
research authorities and research programs to protect the
food supply of the United States by conducting and supporting
research activities to--
(1) enhance the capability of the Secretary to respond in a
timely manner to emerging or existing bioterrorist threats to
the food and agricultural system of the United States;
(2) develop new and continue partnerships with institutions
of higher education and other institutions to help form
stable, long-term programs to enhance the biosecurity and
food safety of the United States, including the coordination
of the development, implementation, and enhancement of
diverse capabilities for addressing threats to the nation's
agricultural economy and food supply, with special emphasis
on planning, training, outreach, and research activities
related to vulnerability analyses, incident response,
detection, and prevention technologies;
(3) strengthen coordination with the intelligence community
to better identify research needs and evaluate materials or
information acquired by the intelligence community relating
to potential threats to United States agriculture;
(4) expand the involvement of the Secretary with
international organizations dealing with plant and animal
disease control;
(5) continue research to develop rapid detection field test
kits to detect biological threats to plants and animals and
to provide such test kits to State and local agencies
preparing for or responding to bioterrorism;
(6) develop an agricultural bioterrorism early warning
surveillance system through enhancing the capacity of and
coordination between State veterinary diagnostic
laboratories, Federal and State agricultural research
facilities, and public health agencies; and
(7) otherwise improve the capacity of the Secretary to
protect against the threat of bioterrorism.
(b) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $190,000,000
for fiscal year 2002, and such sums as may be necessary for
each subsequent fiscal year.
SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.
(a) In General.--Section 43(a) of title 18, United States
Code, is amended to read as follows:
``(a) Offense.--Whoever--
``(1) travels in interstate or foreign commerce, or uses or
causes to be used the mail or any facility in interstate or
foreign commerce for the purpose of causing physical
disruption to the functioning of an animal enterprise; and
``(2) intentionally damages or causes the loss of any
property (including animals or records) used by the animal
enterprise, or conspires to do so,
shall be punished as provided for in subsection (b).''.
(b) Penalties.--Section 43(b) of title 18, United States
Code, is amended to read as follows:
``(b) Penalties.--
``(1) Economic damage.--Any person who, in the course of a
violation of subsection (a), causes economic damage not
exceeding $10,000 to an animal enterprise shall be fined
under this title or imprisoned not more than 6 months, or
both.
``(2) Major economic damage.--Any person who, in the course
of a violation of subsection (a), causes economic damage
exceeding $10,000 to an animal enterprise shall be fined
under this title or imprisoned not more than 3 years, or
both.
``(3) Serious bodily injury.--Any person who, in the course
of a violation of subsection (a), causes serious bodily
injury to another individual shall be fined under this title
or imprisoned not more than 20 years, or both.
``(4) Death.--Any person who, in the course of a violation
of subsection (a), causes the death of an individual shall be
fined under this title and imprisoned for life or for any
term of years.''.
(c) Restitution.--Section 43(c) of title 18, United States
Code, is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(3) for any other economic damage resulting from the
offense.''.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended by inserting the following new
section after section 1432:
``SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.
``(a) Vulnerability Assessments.--(1) Each community water
system serving a population of greater than 3,300 persons
shall conduct an assessment of the vulnerability of its
system to a terrorist attack or other intentional acts
intended to substantially disrupt the ability of the system
to provide a safe and reliable supply of drinking water. The
vulnerability assessment shall include, but not be limited
to, a review of pipes and constructed conveyances, physical
barriers, water collection, pretreatment, treatment, storage
and distribution facilities, electronic, computer or other
automated systems which are utilized by the public water
system, the use, storage, or handling of various chemicals,
and the operation and maintenance of such system. The
Administrator, not later than August 1, 2002, after
consultation with appropriate departments and agencies of the
Federal Government and with State and local governments,
shall provide baseline information to community water systems
required to conduct vulnerability assessments regarding which
kinds of terrorist attacks or other intentional acts are the
probable threats to--
``(A) substantially disrupt the ability of the system to
provide a safe and reliable supply of drinking water; or
``(B) otherwise present significant public health concerns.
``(2) Each community water system referred to in paragraph
(1) shall certify to the Administrator that the system has
conducted an assessment complying with paragraph (1) and
shall submit to the Administrator a written copy of the
assessment. Such certification and submission shall be made
prior to:
``(A) March 31, 2003, in the case of systems serving a
population of 100,000 or more.
``(B) December 31, 2003, in the case of systems serving a
population of 50,000 or more but less than 100,000.
``(C) June 30, 2004, in the case of systems serving a
population greater than 3,300 but less than 50,000.
``(3) Except for information contained in a certification
under this subsection identifying the system submitting the
certification and the date of the certification, all
information provided to the Administrator under this
subsection and all information derived therefrom shall be
exempt from disclosure under section 552 of title 5 of the
United States Code.
``(4) No community water system shall be required under
State or local law to provide an assessment described in this
section to any State, regional, or local governmental entity
solely by reason of the requirement set forth in paragraph
(2) that the system submit such assessment to the
Administrator.
``(5) Not later than November 30, 2002, the Administrator,
in consultation with appropriate Federal law enforcement and
intelligence officials, shall develop such protocols as may
be necessary to protect the copies of the assessments
required to be submitted under this subsection (and the
information contained therein) from unauthorized disclosure.
Such protocols shall ensure that--
``(A) each copy of such assessment, and all information
contained in or derived from the assessment, is kept in a
secure location;
``(B) only individuals designated by the Administrator may
have access to the copies of the assessments; and
``(C) no copy of an assessment, or part of an assessment,
or information contained in or derived from an assessment
shall be available to anyone other than an individual
designated by the Administrator.
At the earliest possible time prior to November 30, 2002, the
Administrator shall complete the development of such
protocols for the purpose of having them in place prior to
receiving any vulnerability assessments from community water
systems under this subsection.
``(6)(A) Except as provided in subparagraph (B), any
individual referred to in paragraph (5)(B) who acquires the
assessment submitted under paragraph (2), or any reproduction
of such assessment, or any information derived from such
assessment, and who knowingly or recklessly reveals such
assessment, reproduction, or information other than--
``(i) to an individual designated by the Administrator
under paragraph (5),
``(ii) for purposes of section 1445 or for actions under
section 1431, or
``(iii) for use in any administrative or judicial
proceeding to impose a penalty for failure to comply with
this section,
shall upon conviction be imprisoned for not more than one
year or fined in accordance with the provisions of chapter
227 of title 18, United States Code, applicable to class A
misdemeanors, or both, and shall be removed from Federal
office or employment.
``(B) Notwithstanding subparagraph (A), an individual
referred to in paragraph (5)(B) who is an officer or employee
of the United States may discuss the contents of a
vulnerability assessment submitted under this section with a
State or local official.
``(7) Nothing in this section authorizes any person to
withhold any information from Congress or from any committee
or subcommittee of Congress.
``(b) Emergency Response Plan.--Each community water system
serving a population greater than 3,300 shall prepare or
revise, where necessary, an emergency response plan that
incorporates the results of vulnerability assessments that
have been completed. Each such community water system shall
certify to the Administrator, as soon as reasonably possible
after the enactment of this section, but not later than 6
months after the completion of the vulnerability assessment
under subsection (a), that the system has completed such
plan. The emergency response plan shall include, but not be
limited to, plans, procedures, and identification of
equipment that can be implemented or utilized in the event of
a terrorist or other intentional attack on the public water
system. The emergency response plan shall also include
actions, procedures, and identification of equipment which
can obviate or significantly lessen the impact of terrorist
attacks or other intentional actions on the public health and
the safety and supply of drinking water provided to
communities and individuals. Community water systems shall,
to the extent possible, coordinate with existing Local
Emergency Planning Committees established under the Emergency
Planning and Community Right-to-Know Act (42 U.S.C. 11001, et
seq.) when preparing or revising an emergency response plan
under this subsection.
[[Page H2715]]
``(c) Record Maintenance.--Each community water system
shall maintain a copy of the emergency response plan
completed pursuant to subsection (b) for 5 years after such
plan has been certified to the Administrator under this
section.
``(d) Guidance to Small Public Water Systems.--The
Administrator shall provide guidance to community water
systems serving a population of less than 3,300 persons on
how to conduct vulnerability assessments, prepare emergency
response plans, and address threats from terrorist attacks or
other intentional actions designed to disrupt the provision
of safe drinking water or significantly affect the public
health or significantly affect the safety or supply of
drinking water provided to communities and individuals.
``(e) Funding.--(1) There are authorized to be appropriated
to carry out this section not more than $160,000,000 for the
fiscal year 2002 and such sums as may be necessary for the
fiscal years 2003 through 2005.
``(2) The Administrator, in coordination with State and
local governments, may use funds made available under
paragraph (1) to provide financial assistance to community
water systems for purposes of compliance with the
requirements of subsections (a) and (b) and to community
water systems for expenses and contracts designed to address
basic security enhancements of critical importance and
significant threats to public health and the supply of
drinking water as determined by a vulnerability assessment
conducted under subsection (a). Such basic security
enhancements may include, but shall not be limited to the
following:
``(A) the purchase and installation of equipment for
detection of intruders;
``(B) the purchase and installation of fencing, gating,
lighting, or security cameras;
``(C) the tamper-proofing of manhole covers, fire hydrants,
and valve boxes;
``(D) the rekeying of doors and locks;
``(E) improvements to electronic, computer, or other
automated systems and remote security systems;
``(F) participation in training programs, and the purchase
of training manuals and guidance materials, relating to
security against terrorist attacks;
``(G) improvements in the use, storage, or handling of
various chemicals; and
``(H) security screening of employees or contractor support
services.
Funding under this subsection for basic security enhancements
shall not include expenditures for personnel costs, or
monitoring, operation, or maintenance of facilities,
equipment, or systems.
``(3) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make
grants to community water systems to assist in responding to
and alleviating any vulnerability to a terrorist attack or
other intentional acts intended to substantially disrupt the
ability of the system to provide a safe and reliable supply
of drinking water (including sources of water for such
systems) which the Administrator determines to present an
immediate and urgent security need.
``(4) The Administrator may use not more than $5,000,000
from the funds made available under paragraph (1) to make
grants to community water systems serving a population of
less than 3,300 persons for activities and projects
undertaken in accordance with the guidance provided to such
systems under subsection (d).
SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.
The Safe Drinking Water Act (title XIV of the Public Health
Service Act) is amended by inserting the following new
sections after section 1433 (as added by section 401 of this
Act):
``SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.
``(a) In General.--The Administrator, in consultation with
the Centers for Disease Control and, after consultation with
appropriate departments and agencies of the Federal
Government and with State and local governments, shall review
(or enter into contracts or cooperative agreements to provide
for a review of) current and future methods to prevent,
detect and respond to the intentional introduction of
chemical, biological or radiological contaminants into
community water systems and source water for community water
systems, including each of the following:
``(1) Methods, means and equipment, including real time
monitoring systems, designed to monitor and detect various
levels of chemical, biological, and radiological contaminants
or indicators of contaminants and reduce the likelihood that
such contaminants can be successfully introduced into public
water systems and source water intended to be used for
drinking water.
``(2) Methods and means to provide sufficient notice to
operators of public water systems, and individuals served by
such systems, of the introduction of chemical, biological or
radiological contaminants and the possible effect of such
introduction on public health and the safety and supply of
drinking water.
``(3) Methods and means for developing educational and
awareness programs for community water systems.
``(4) Procedures and equipment necessary to prevent the
flow of contaminated drinking water to individuals served by
public water systems.
``(5) Methods, means, and equipment which could negate or
mitigate deleterious effects on public health and the safety
and supply caused by the introduction of contaminants into
water intended to be used for drinking water, including an
examination of the effectiveness of various drinking water
technologies in removing, inactivating, or neutralizing
biological, chemical, and radiological contaminants.
``(6) Biomedical research into the short-term and long-term
impact on public health of various chemical, biological and
radiological contaminants that may be introduced into public
water systems through terrorist or other intentional acts.
``(b) Funding.--For the authorization of appropriations to
carry out this section, see section 1435(e).
``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND
RESPONSE.
``(a) Disruption of Supply or Safety.--The Administrator,
in coordination with the appropriate departments and agencies
of the Federal Government, shall review (or enter into
contracts or cooperative agreements to provide for a review
of) methods and means by which terrorists or other
individuals or groups could disrupt the supply of safe
drinking water or take other actions against water
collection, pretreatment, treatment, storage and distribution
facilities which could render such water significantly less
safe for human consumption, including each of the following:
``(1) Methods and means by which pipes and other
constructed conveyances utilized in public water systems
could be destroyed or otherwise prevented from providing
adequate supplies of drinking water meeting applicable public
health standards.
``(2) Methods and means by which collection, pretreatment,
treatment, storage and distribution facilities utilized or
used in connection with public water systems and collection
and pretreatment storage facilities used in connection with
public water systems could be destroyed or otherwise
prevented from providing adequate supplies of drinking water
meeting applicable public health standards.
``(3) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with
public water systems could be altered or affected so as to be
subject to cross-contamination of drinking water supplies.
``(4) Methods and means by which pipes, constructed
conveyances, collection, pretreatment, treatment, storage and
distribution systems that are utilized in connection with
public water systems could be reasonably protected from
terrorist attacks or other acts intended to disrupt the
supply or affect the safety of drinking water.
``(5) Methods and means by which information systems,
including process controls and supervisory control and data
acquisition and cyber systems at community water systems
could be disrupted by terrorists or other groups.
``(b) Alternative Sources.--The review under this section
shall also include a review of the methods and means by which
alternative supplies of drinking water could be provided in
the event of the destruction, impairment or contamination of
public water systems.
``(c) Requirements and Considerations.--In carrying out
this section and section 1434--
``(1) the Administrator shall ensure that reviews carried
out under this section reflect the needs of community water
systems of various sizes and various geographic areas of the
United States; and
``(2) the Administrator may consider the vulnerability of,
or potential for forced interruption of service for, a region
or service area, including community water systems that
provide service to the National Capital area.
``(d) Information Sharing.--As soon as practicable after
reviews carried out under this section or section 1434 have
been evaluated, the Administrator shall disseminate, as
appropriate as determined by the Administrator, to community
water systems information on the results of the project
through the Information Sharing and Analysis Center, or other
appropriate means.
``(e) Funding.--There are authorized to be appropriated to
carry out this section and section 1434 not more than
$15,000,000 for the fiscal year 2002 and such sums as may be
necessary for the fiscal years 2003 through 2005.''.
SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.
The Safe Drinking Water Act is amended as follows:
(1) Section 1414(i)(1) is amended by inserting ``1433''
after ``1417''.
(2) Section 1431 is amended by inserting in the first
sentence after ``drinking water'' the following: ``, or that
there is a threatened or potential terrorist attack (or other
intentional act designed to disrupt the provision of safe
drinking water or to impact adversely the safety of drinking
water supplied to communities and individuals), which''.
(3) Section 1432 is amended as follows:
(A) By striking ``5 years'' in subsection (a) and inserting
``20 years''.
(B) By striking ``3 years'' in subsection (b) and inserting
``10 years''.
(C) By striking ``$50,000'' in subsection (c) and inserting
``$1,000,000''.
(D) By striking ``$20,000'' in subsection (c) and inserting
``$100,000''.
(4) Section 1442 is amended as follows:
(A) By striking ``this subparagraph'' in subsection (b) and
inserting ``this subsection''.
(B) By amending subsection (d) to read as follows:
``(d) There are authorized to be appropriated to carry out
subsection (b) not more than $35,000,000 for the fiscal year
2002 and such sums as may be necessary for each fiscal year
thereafter.''.
TITLE V--ADDITIONAL PROVISIONS
Subtitle A--Prescription Drug User Fees
SEC. 501. SHORT TITLE.
This subtitle may be cited as the ``Prescription Drug User
Fee Amendments of 2002''.
SEC. 502. FINDINGS.
The Congress finds that--
(1) prompt approval of safe and effective new drugs and
other therapies is critical to the improvement of the public
health so that patients
[[Page H2716]]
may enjoy the benefits provided by these therapies to treat
and prevent illness and disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources
of the Food and Drug Administration that are devoted to the
process for the review of human drug applications and the
assurance of drug safety;
(3) the provisions added by the Prescription Drug User Fee
Act of 1992, as amended by the Food and Drug Administration
Modernization Act of 1997, have been successful in
substantially reducing review times for human drug
applications and should be--
(A) reauthorized for an additional 5 years, with certain
technical improvements; and
(B) carried out by the Food and Drug Administration with
new commitments to implement more ambitious and comprehensive
improvements in regulatory processes of the Food and Drug
Administration, including--
(i) strengthening and improving the review and monitoring
of drug safety;
(ii) considering greater interaction between the agency and
sponsors during the review of drugs and biologics intended to
treat serious diseases and life-threatening diseases; and
(iii) developing principles for improving first-cycle
reviews; and
(4) the fees authorized by amendments made in this subtitle
will be dedicated towards expediting the drug development
process and the process for the review of human drug
applications as set forth in the goals identified for
purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the
Secretary of Health and Human Services to the chairman of the
Committee on Energy and Commerce of the House of
Representatives and the chairman of the Committee on Health,
Education, Labor and Pensions of the Senate, as set forth in
the Congressional Record.
SEC. 503. DEFINITIONS.
Section 735 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g) is amended--
(1) in paragraph (1), in the matter after and below
subparagraph (C), by striking ``licensure, as described in
subparagraph (D)'' and inserting ``licensure, as described in
subparagraph (C)'';
(2) in paragraph (3)--
(A) in subparagraph (A), by striking ``and'' at the end;
(B) in subparagraph (B), by striking the period and
inserting ``, and'';
(C) by inserting after subparagraph (B) the following
subparagraph:
``(C) which is on the list of products described in section
505(j)(7)(A) or is on a list created and maintained by the
Secretary of products approved under human drug applications
under section 351 of the Public Health Service Act.''; and
(D) in the matter after and below subparagraph (C) (as
added by subparagraph (C) of this paragraph), by striking
``Service Act,'' and all that follows through ``biological
product'' and inserting the following: ``Service Act. Such
term does not include a biological product'';
(3) in paragraph (6), by adding at the end the following
subparagraph:
``(F) In the case of drugs approved after October 1, 2002,
under human drug applications or supplements: collecting,
developing, and reviewing safety information on the drugs,
including adverse event reports, during a period of time
after approval of such applications or supplements, not to
exceed three years.''; and
(4) in paragraph (8)--
(A) by striking the matter after and below subparagraph
(B);
(B) by striking subparagraph (B);
(C) by striking ``is the lower of'' and all that follows
through ``Consumer Price Index'' and inserting ``is the
Consumer Price Index''; and
(D) by striking ``1997, or'' and inserting ``1997.''.
SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 1998'' and inserting ``fiscal year 2003'';
(2) in paragraph (1)(A)--
(A) in each of clauses (i) and (ii), by striking ``in
subsection (b)'' and inserting ``under subsection (c)(4)'';
and
(B) in clause (ii), by adding at the end the following
sentence: ``Such fee shall be half of the amount of the fee
established under clause (i).'';
(3) in paragraph (2)(A), in the matter after and below
clause (ii)--
(A) by striking ``in subsection (b)'' and inserting ``under
subsection (c)(4)''; and
(B) by striking ``payable on or before January 31'' and
inserting ``payable on or before October 1''; and
(4) in paragraph (3)--
(A) by amending subparagraph (A) to read as follows:
``(A) In general.--Except as provided in subparagraph (B),
each person who is named as the applicant in a human drug
application, and who, after September 1, 1992, had pending
before the Secretary a human drug application or supplement,
shall pay for each such prescription drug product the annual
fee established under subsection (c)(4). Such fee shall be
payable on or before October 1 of each year. Such fee shall
be paid only once for each product for a fiscal year in which
the fee is payable.''; and
(B) in subparagraph (B), by striking ``The listing'' and
all that follows through ``filed under section 505(b)(2)''
and inserting the following: ``A prescription drug product
shall not be assessed a fee under subparagraph (A) if such
product is identified on the list compiled under section
505(j)(7)(A) with a potency described in terms of per 100 mL,
or if such product is the same product as another product
approved under an application filed under section 505(b)''.
(b) Fee Amounts.--Section 736(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as
follows:
``(b) Fee Revenue Amounts.--Except as provided in
subsections (c), (d), (f), and (g), fees under subsection (a)
shall be established to generate the following revenue
amounts:
----------------------------------------------------------------------------------------------------------------
Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
``Type of Fee Revenue 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
Application/Supplement.......... $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000
Establishment................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Product......................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Total Fee Revenue............... $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000
----------------------------------------------------------------------------------------------------------------
If, after the date of the enactment of the Prescription Drug
User Fee Amendments of 2002, legislation is enacted requiring
the Secretary to fund additional costs of the retirement of
Federal personnel, fee revenue amounts shall be increased in
each year by the amount necessary to fully fund the portion
of such additional costs that are attributable to the process
for the review of human drug applications.''.
(c) Adjustments.--Section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by striking
``fees and total fee revenues'' and inserting ``revenues'';
(B) in subparagraph (A)--
(i) by striking ``during the preceding fiscal year''; and
(ii) by striking ``, or'' and inserting the following:
``for the 12 month period ending June 30 preceding the fiscal
year for which fees are being established, or'';
(C) in subparagraph (B), by striking ``for such fiscal
year'' and inserting ``for the previous fiscal year''; and
(D) in the matter after and below subparagraph (B), by
striking ``fiscal year 1997''; and inserting ``fiscal year
2003'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively;
(3) by inserting after paragraph (1) the following
paragraphs:
``(2) Workload adjustment.--Beginning with fiscal year
2004, after the fee revenues established in subsection (b)
are adjusted for a fiscal year for inflation in accordance
with paragraph (1), the fee revenues shall be adjusted
further for such fiscal year to reflect changes in the
workload of the Secretary for the process for the review of
human drug applications. With respect to such adjustment:
``(A) The adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of human drug applications, commercial investigational new
drug applications, efficacy supplements, and manufacturing
supplements submitted to the Secretary. The Secretary shall
publish in the Federal Register the fee revenues and fees
resulting from the adjustment and the supporting
methodologies.
``(B) Under no circumstances shall the adjustment result in
fee revenues for a fiscal year that are less than the fee
revenues for the fiscal year established in subsection (b),
as adjusted for inflation under paragraph (1).
``(3) Final year adjustment.--For fiscal year 2007, the
Secretary may, in addition to adjustments under paragraphs
(1) and (2), further increase the fee revenues and fees
established in subsection (b) if such an adjustment is
necessary to provide for not more than three months of
operating reserves of carryover user fees for the process for
the review of human drug applications for the first three
months of fiscal year 2008. If such an adjustment is
necessary, the rationale for the amount of the increase shall
be contained in the annual notice establishing fee revenues
and fees for fiscal year 2007. If the Secretary has carryover
balances for such process in excess of three months of such
operating reserves, the adjustment under this paragraph shall
not be made.''; and
(4) in paragraph (4) (as redesignated by paragraph (2) of
this subsection), by amending such paragraph to read as
follows:
``(4) Annual fee setting.--The Secretary shall, 60 days
before the start of each fiscal year that begins after
September 30, 2002, establish, for the next fiscal year,
application, product, and establishment fees under subsection
(a), based on the revenue amounts established under
subsection (b) and the adjustments provided under this
subsection.''.
(d) Fee Waiver or Reduction.--Section 736(d)) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by inserting ``or'' after the
comma at the end;
(B) by striking subparagraph (D); and
[[Page H2717]]
(C) by redesignating subparagraph (E) as subparagraph (D);
and
(2) in paragraph (3), in each of subparagraphs (A) and (B),
by striking ``paragraph (1)(E)'' each place such term appears
and inserting ``paragraph (1)(D)''.
(e) Assessment of Fees.--Section 736(f) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended--
(1) in the heading for the subsection, by striking
``Assessment of Fees.--'' and inserting ``Limitations.--'';
and
(2) in paragraph (1), by striking the heading for the
paragraph and all that follows through ``fiscal year
beginning'' and inserting the following: ``In general.--Fees
under subsection (a) shall be refunded for a fiscal year
beginning''.
(f) Crediting and Availability of Fees.--
(1) In general.--Section 736(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by
striking ``Fees collected for a fiscal year'' and all that
follows through ``fiscal year limitation.'' and inserting the
following: ``Fees authorized under subsection (a) shall be
collected and available for obligation only to the extent and
in the amount provided in advance in appropriations Acts.
Such fees are authorized to remain available until
expended.''.
(2) Collections and appropriation acts.--Section 736(g)(2)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(g)(2)) is amended--
(A) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively;
(B) by striking ``(2) Collections'' and all that follows
through ``the amount specified'' in clause (i) (as so
redesignated) and inserting the following:
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) shall be retained in each fiscal year in an amount
not to exceed the amount specified'';
(C) by moving clause (ii) (as so redesignated) two ems to
the right; and
(D) by adding at the end the following subparagraph:
``(B) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (A)(ii) in any
fiscal year if the costs funded by appropriations and
allocated for the process for the review of human drug
applications--
``(i) are not more than 3 percent below the level specified
in subparagraph (A)(ii); or
``(ii)(I) are more than 3 percent below the level specified
in subparagraph (A)(ii), and fees assessed for the fiscal
year following the subsequent fiscal year are decreased by
the amount in excess of 3 percent by which such costs fell
below the level specified in such subparagraph; and
``(II) such costs are not more than 5 percent below the
level specified in such subparagraph.''.
(3) Authorization of appropriations.--Section 736(g)(3) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(g)(3)) is amended by striking subparagraphs (A) through
(E) and inserting the following:
``(A) $222,900,000 for fiscal year 2003;
``(B) $231,000,000 for fiscal year 2004;
``(C) $252,000,000 for fiscal year 2005;
``(D) $259,300,000 for fiscal year 2006; and
``(E) $259,300,000 for fiscal year 2007;''.
SEC. 505. ACCOUNTABILITY AND REPORTS.
(a) Public Accountability.--
(1) Consultation.--In developing recommendations to the
Congress for the goals and plans for meeting the goals for
the process for the review of human drug applications for the
fiscal years after fiscal year 2007, and for the
reauthorization of sections 735 and 736 of the Federal Food,
Drug, and Cosmetic Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall consult with the Committee on Energy and Commerce of
the House of Representatives, the Committee on Health,
Education, Labor, and Pensions of the Senate, appropriate
scientific and academic experts, health care professionals,
representatives of patient and consumer advocacy groups, and
the regulated industry.
(2) Recommendations.--The Secretary shall publish in the
Federal Register recommendations under paragraph (1), after
negotiations with the regulated industry; shall present such
recommendations to the congressional committees specified in
such paragraph; shall hold a meeting at which the public may
present its views on such recommendations; and shall provide
for a period of 30 days for the public to provide written
comments on such recommendations.
(b) Performance Report.--Beginning with fiscal year 2003,
not later than 60 days after the end of each fiscal year
during which fees are collected under part 2 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g et seq.), the Secretary of Health and Human
Services shall prepare and submit to the President, the
Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education,
Labor, and Pensions of the Senate a report concerning the
progress of the Food and Drug Administration in achieving the
goals identified in the letters described in section 502(4)
during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals.
(c) Fiscal Report.--Beginning with fiscal year 2003, not
later than 120 days after the end of each fiscal year during
which fees are collected under the part described in
subsection (b), the Secretary of Health and Human Services
shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives, and the Committee
on Health, Education, Labor, and Pensions of the Senate, a
report on the implementation of the authority for such fees
during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected during such fiscal year
for which the report is made.
SEC. 506. REPORTS OF POSTMARKETING STUDIES.
Section 506B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356b) is amended by adding at the end the
following subsections:
``(d) Disclosure.--If a sponsor fails to complete an agreed
upon study required by this section by its original or
otherwise negotiated deadline, the Secretary shall publish a
statement on the Internet site of the Food and Drug
Administration stating that the study was not completed and,
if the reasons for such failure to complete the study were
not satisfactory to the Secretary, a statement that such
reasons were not satisfactory to the Secretary.
``(e) Notification.--With respect to studies of the type
required under section 506(b)(2)(A) or under section 314.510
or 601.41 of title 21, Code of Federal Regulations, as each
of such sections was in effect on the day before the
effective date of this subsection, the Secretary may require
that a sponsor who, for reasons not satisfactory to the
Secretary, fails to complete by its deadline a study under
any of such sections of such type for a drug or biological
product (including such a study conducted after such
effective date) notify practitioners who prescribe such drug
or biological product of the failure to complete such study
and the questions of clinical benefit, and, where
appropriate, questions of safety, that remain unanswered as a
result of the failure to complete such study. Nothing in this
subsection shall be construed as altering the requirements of
the types of studies required under section 506(b)(2)(A) or
under section 314.510 or 601.41 of title 21, Code of Federal
Regulations, as so in effect, or as prohibiting the Secretary
from modifying such sections of title 21 of such Code to
provide for studies in addition to those of such type.''.
SEC. 507. SAVINGS CLAUSE.
Notwithstanding section 107 of the Food and Drug
Administration Modernization Act of 1997, and notwithstanding
the amendments made by this subtitle, part 2 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act,
as in effect on the day before the date of the enactment of
this Act, continues to be in effect with respect to human
drug applications and supplements (as defined in such part as
of such day) that, on or after October 1, 1997, but before
October 1, 2002, were accepted by the Food and Drug
Administration for filing.
SEC. 508. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect
October 1, 2002.
SEC. 509. SUNSET CLAUSE.
The amendments made by sections 503 and 504 cease to be
effective October 1, 2007, and section 505 ceases to be
effective 120 days after such date.
Subtitle B--Funding Provisions Regarding Food and Drug Administration
SEC. 521. OFFICE OF DRUG SAFETY.
Of the amounts appropriated for the Food and Drug
Administration for a fiscal year, the Secretary of Health and
Human Services shall reserve for the Office of Drug Safety
(within such Administration), the following amounts:
(1) For fiscal year 2003, an amount equal to the sum of
$5,000,000 and the amount made available under appropriations
Acts for such Office for fiscal year 2002.
(2) For fiscal year 2004, an amount equal to the sum of
$10,000,000 and the amount made available under
appropriations Acts for such Office for fiscal year 2002.
(3) For each subsequent fiscal year, an amount equal to the
sum of the amount made available under appropriations Acts
for such Office for fiscal year 2004 and an amount sufficient
to offset the effects of inflation occurring after the
beginning of fiscal year 2004.
SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND
COMMUNICATIONS.
For the Division of Drug Marketing, Advertising, and
Communications (within the Office of Medical Policy, Food and
Drug Administration), there are authorized to be appropriated
the following amounts, stated as increases above the amount
made available under appropriations Acts for such Division
for fiscal year 2002:
(1) For fiscal year 2003, an increase of $2,500,000.
(2) For fiscal year 2004, an increase of $4,000,000.
(3) For fiscal year 2005, an increase of $5,500,000.
(4) For fiscal year 2006, an increase of $7,500,000.
(5) For fiscal year 2007, an increase of $7,500,000.
SEC. 523. OFFICE OF GENERIC DRUGS.
For the Office of Generic Drugs (within the Food and Drug
Administration), there are authorized to be appropriated the
following amounts, stated as increases above the amount made
available under appropriations Acts for such Office for
fiscal year 2002:
(1) For fiscal year 2003, an increase of $3,000,000.
(2) For fiscal year 2004, an increase of $6,000,000.
(3) For fiscal year 2005, an increase of $9,000,000.
(4) For fiscal year 2006, an increase of $12,000,000.
(5) For fiscal year 2007, an increase of $15,000,000.
Subtitle C--Additional Provisions
SEC. 531. TRANSITION TO DIGITAL TELEVISION.
(a) Pair Assignment Required.--In order to further promote
the orderly transition to digital
[[Page H2718]]
television, and to promote the equitable allocation and use
of digital channels by television broadcast permittees and
licensees, the Federal Communications Commission, at the
request of an eligible licensee or permittee, shall, within
90 days after the date of enactment of this Act, allot, if
necessary, and assign a paired digital television channel to
that licensee or permittee, provided that--
(1) such channel can be allotted and assigned without
further modification of the tables of allotments as set forth
in sections 73.606 and 73.622 of the Commission's regulations
(47 CFR 73.606, 73.622); and
(2) such allotment and assignment is otherwise consistent
with the Commission's rules (47 CFR part 73).
(b) Eligible Transition Licensee or Permittee.--For
purposes of subsection (a), the term ``eligible licensee or
permittee'' means only a full power television broadcast
licensee or permittee (or its successor in interest) that--
(1) had an application pending for an analog television
station construction permit as of October 24, 1991, which
application was granted after April 3, 1997; and
(2) as of the date of enactment of this Act, is the
permittee or licensee of that station.
(c) Requirements on Licensee or Permittee.--
(1) Construction deadline.--Any licensee or permittee
receiving a paired digital channel pursuant to this section--
(A) shall be required to construct the digital television
broadcast facility within 18 months of the date on which the
Federal Communications Commission issues a construction
permit therefore, and
(B) shall be prohibited from obtaining or receiving an
extension of time from the Commission beyond the construction
deadline established by paragraph (1).
(2) Prohibition of analog operation using digital pair.--
Any licensee or permittee receiving a paired digital channel
pursuant to this section shall be prohibited from giving up
its current paired analog assignment and becoming a single-
channel broadcaster and operating in analog on such paired
digital channel.
(d) Relief Restricted.--Any paired digital allotment and
assignment made under this section shall not be available to
any other applicant unless such applicant is an eligible
licensee or permittee within the meaning of subsection (b).
SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR
MEDICARE+CHOICE PLANS; CHANGE IN CERTAIN
MEDICARE+CHOICE DEADLINES AND ANNUAL,
COORDINATED ELECTION PERIOD FOR 2003, 2004, AND
2005.
(a) Lock-In Delay.--Section 1851(e) of the Social Security
Act (42 U.S.C. 1395w-21(e)) is amended--
(1) in paragraph (2)(A), by striking ``through 2001'' and
``during 1998, 1999, 2000, and 2001'' and inserting ``through
2004'' and ``during the period beginning January 1, 1998, and
ending on December 31, 2004'', respectively;
(2) in the heading to paragraph (2)(B), by striking
``during 2002'' and inserting ``during 2005'';
(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking
``2002'' and inserting ``2005'' each place it appears;
(4) in paragraph (2)(D), by striking ``2001'' and inserting
``2004''; and
(5) in paragraph (4), by striking ``2002'' and inserting
``2005'' each place it appears.
(b) Change in Reporting Deadline.--
(1) In general.--Section 1854(a)(1) of such Act (42 U.S.C.
1395w-24(a)(1)) is amended by striking ``Not later than July
1 of each year'' and inserting ``Not later than the second
Monday in September of 2002, 2003, and 2004 (or July 1 of
each other year)''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to information submitted for years beginning with
2003.
(c) Delay in Annual, Coordinated Election Period.--
(1) In general.--Section 1851(e) of such Act (42 U.S.C.
1395w-21(e)) is amended--
(A) in paragraph (3)(B), by striking ``means'' and all that
follows and inserting the following: ``means, with respect to
a year before 2003 and after 2005, the month of November
before such year and with respect to 2003, 2004, and 2005,
the period beginning on November 15 and ending on December 31
of the year before such year.''; and
(B) in paragraph (6)(A), by striking ``each subsequent year
(as provided in paragraph (3))'' and inserting ``during the
annual, coordinated election period under paragraph (3) for
each subsequent year''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to the annual, coordinated election period for
years beginning with 2003.
(d) Change to Annual Announcement of Payment Rates.--
(1) In general.--Section 1853(b)(1) of such Act (42 U.S.C.
1395w-23(b)(1)) is amended by striking ``not later than March
1 before the calendar year concerned'' and inserting ``for
years before 2004 and after 2005 not later than March 1
before the calendar year concerned and for 2004 and 2005 not
later than the second Monday in May before the respective
calendar year''.
(2) Effective date.--The amendment made by paragraph (1)
shall first apply to announcements for years after 2003.
And the Senate agree to the same.
From the Committee on Energy and Commerce, for consideration
of the House bill and the Senate amendment, and modifications
committed to conference:
Billy Tauzin,
Michael Bilirakis,
Paul E. Gillmor,
Richard Burr,
John Shimkus,
John D. Dingell,
Henry A. Waxman,
Sherrod Brown,
Provided that Mr. Pallone is appointed in lieu of Mr. Brown
of Ohio for consideration of title IV of the House bill, and
modifications committed to conference:
Frank Pallone, Jr.,
From the Committee on Agriculture, for consideration of title
II of the House bill and sec. 216 and title V of the Senate
amendment, and modifications committed to conference:
Larry Combest,
Frank D. Lucas,
Saxby Chambliss,
Charles Stenholm,
Tim Holden,
From the Committee on the Judiciary, for consideration of
title II of the House bill and secs. 216 and 401 of the
Senate amendment, and modifications committed to conference:
F. James Sensenbrenner, Jr.,
Lamar Smith,
John Conyers, Jr.,
Managers on the Part of the House.
Edward Kennedy,
Chris Dodd,
Tom Harkin,
Barbara A. Mikulski,
Jim Jeffords,
Judd Gregg,
Bill Frist,
Mike Enzi,
Tim Hutchinson,
Managers on the Part of the Senate.
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE
The managers on the part of the House and the Senate at the
conference on the disagreeing votes of the two Houses on the
amendment of the Senate to the bill (H.R. 3448), to improve
the ability of the United States to prevent, prepare for, and
respond to bioterrorism and other public health emergencies,
submit the following joint statement to the House and the
Senate in explanation of the effect of the action agreed upon
by the managers and recommended in the accompanying
conference report:
The Senate amendment struck all of the House bill after the
enacting clause and inserted a substitute text.
The House recedes from its disagreement to the amendment of
the Senate with an amendment that is a substitute for the
House bill and the Senate amendment. The differences between
the House bill, the Senate amendment, and the substitute
agreed to in conference are noted below, except for clerical
corrections, conforming changes made necessary by agreements
reached by the conferees, and minor drafting and clerical
changes.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH
EMERGENCIES
As approved by the conference Managers, Title I addresses
core public health concerns associated with preparedness for
and effective response to bioterrorism and other public
health emergencies in a number of different ways. First Title
I improves communications between and among all levels of
government, public health officials, first responders, and
health care providers and facilities during emergencies. The
Managers have authorized substantial sums in FY 2002 and
beyond in grants to States, local governments, and other
public and private health care facilities and other entities
to improve planning and preparedness activities, and educate
and train health care personnel. Under Title I, the
Department of Health and Human Services (HHS) will have a new
focus, and improved coordination and accountability, through
a new Assistant Secretary for Public Health emergency
preparedness. The legislation also authorizes the National
Disaster medical system, new planning and reporting
provisions, training exercises, and improved communications
strategies and networks. The Managers also believe that the
provisions of Title I will ensure that the nation has
sufficient drugs, vaccines, and other supplies for our
emergency health security. The Managers intend for activities
under Title I to enhance the Nation's public health
infrastructure at the national, state, and local levels. The
Managers believe that an effective public health system is
essential to responding effectively to bioterrorism and other
public health emergencies.
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
Section 101. National Preparedness and Response
House provision: The House provision requires the Secretary
of HHS to continue the process of developing and implementing
a coordinated strategy, including the preparation of a
national plan for carrying out health-related activities to
prepare for and respond effectively to bioterrorism and other
public health emergencies. The plan would be in consultation
with other Federal agencies and other appropriate public and
private entities. The plan also would be coordinated with
activities of State and local governments to meet
preparedness goals set out under the Act. National
preparedness goals include providing effective assistance to
State and local governments to ensure that they and their
health care facilities have
[[Page H2719]]
adequate capacity and properly trained response personnel; a
coordinated plan, effective communications networks, and
laboratory readiness, training and surveillance; developing
and maintaining medical countermeasures against biological
agents; and effective coordination at all levels of
government. There would be evaluations and reports of
progress.
Senate amendment: The Senate amendment contains similar
provisions.
Conference substitute: The Conference adopts the House
provisions with certain modifications to clarify the
provision does not expand regulatory or other authority, and
to incorporate various advisory committee and study
provisions. A study to emergency response services and their
use during public health emergencies, formerly located in
section 114 of the House bill, is now located in this
section.
Section 102. Assistant Secretary for Public Health Emergency
Preparedness; National Disaster Medical System
House provision: The House provision establishes the new
position of Assistant Secretary for Emergency Preparedness to
coordinate HHS activities under the new Act. The provision
also would authorize the National Disaster Medical System,
under the new Assistant Secretary to provide for further
National capacity during public health emergencies.
Senate amendment: The Senate amendment contains a similar
provision in section 211 of the Senate amendment.
Conference substitute: The Conference substitute uses the
House language with modification. The managers believe that
there is a need to increase coordination of the Department of
Health and Human Services' efforts in responding to
bioterrorism and other public health emergencies, and thus
has provided for the creation of an Assistant Secretary for
Public Health Emergency Preparedness. The substitute also
formally establishes the National Disaster Medical System
(NDMS), recognizing the important role already played by the
NDMS in the Federal government's response to all types of
emergencies and disasters. The substitute also addresses a
number of critical personnel issues within the NDMS,
including liability protections, employment rights, and
compensation for work injuries. In addition, the Secretary
shall take into account the role and expertise of the Agency
for Toxic Substances and Disease Registry.
Section 103. Improving Ability of Centers for Disease Control
and Prevention
House provision: The House bill provides authorization and
multi-year contracting authority for the renovation,
development and security at facilities for the Centers for
Disease Control and Prevention (CDC). The House bill also
enhances training and nationwide laboratory capacity, and the
establishment of integrated, national public health
communications and surveillance networks.
Senate amendment: The Senate amendment, in section 202,
also contains provisions for upgrading CDC's activities and
facilities.
Conference substitute: The Conference substitute adopts the
House provision with modifications. The substitute recognizes
the critical role played by CDC in the nation's efforts to
defend against bioterrorism and other public health
emergencies. The Managers are concerned by extreme disrepair
at many CDC laboratories and believe that repair and
modernization funds are desperately needed. To that end, the
substitute has provided multi-year contracting authority for
CDC and has authorized an accelerated program of facilities
funding. The substitute also recognizes the central role
played by CDC in maintaining robust public health alert
communications and surveillance networks, and has provided
for grants, contracts, and cooperative agreements to further
strengthen a national network that includes public health
laboratories and other health care facilities. Provisions
concerning priorities for public health lab enhancements have
been moved to the general grants section, section 131, of the
Conference substitute.
Section 104. Advisory Committees and Communications; Study
Regarding Communications Abilities of Public Health
Agencies
House provision: Section 104 of the House bill establishes
an advisory committee on children and terrorism and also one
on emergency public information and communications. The
provision also requires a coordinated strategy on public
health communications during a bioterrorism attack. Section
111 also contains a provision for a study regarding the
communications ability of public health agencies and to
improve telecommunications infrastructure and connectivity
during public health emergencies.
Senate amendment: Section 213 of the Senate amendment
contains similar provisions. Section 214 of the Senate
amendment also contains a provision establishing the official
Federal Internet Site on Bioterrorism.
Conference substitute: The Conference substitute adopts,
with minor modification, the provisions from the House and
Senate establishing an advisory committee on children and
terrorism; an advisory committee on emergency public
information and communications; a coordinated strategy on
public health communications during a bioterrorism attack;
and the official Federal Internet Site on Bioterrorism.
Section 105. Education of Health Care Personnel; Training
Regarding Pediatric Issues
House provision: The House bill requires the establishment
of core curriculum materials for public health emergencies,
for the purpose of education and training of health care
personnel.
Senate amendment: Section 105 of the Senate amendment
contains a similar provision.
Conference substitute: The Conference substitute adopts the
House provision with minor modification. The Managers intend
that the eligible entity phrase ``other appropriate
educational entities'' includes medical schools that have
established departments of medical education.
Section 106. Grants Regarding Shortages of Certain Health
Professionals
House provision: The House bill provides grants for
training and education to certain categories of health care
professionals for which there exist shortages impacting the
ability to respond to bioterrorism and other public health
emergencies.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference adopts the House
provision without modification.
Section 107. Emergency System for Advance Registration of
Health Professions Volunteers
House provision: The House bill establishes a national
system to help verify the licenses, credentials and hospital
privileges of health professionals who volunteer to respond
during public health emergencies.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference adopts the House
provision with modifications to make clear that use of the
verification database is entirely voluntary, and that nothing
in the section changes the roles of States in licensing or
hospitals in establishing privileging requirements.
Section 108. Working Groups
House provision: House section 108 makes modifications to
the existing working groups in section 319 of the Public
Health Service Act (PHSA).
Senate amendment: The Senate amendment also makes
modifications and additions to the working group provisions.
The Senate amendment also consolidates the two existing
working groups in sections 319F of the Public Health Service
Act.
Conference substitute: The Conference substitute adopts a
single working group, but allows for subcommittees to
represent the working group with respect to particular
matters. The authority of the working group is limited
through various savings clauses. The primary purposes of the
working group are consultation, assisting in coordination,
and making recommendations on a variety of topics related to
preparedness for and response to bioterrorism and other
public health emergencies. The Managers expect the working
group to take into account the role and expertise of the
Agency for Toxic Substances and Disease Registry.
Additionally, the Managers encourage the working group to
recognize the role of private ambulance services, especially
when they may be the only ambulance services in the area.
Section 109. Antimicrobial Resistance
House provision: The House bill authorizes further research
and DNA analysis of priority pathogens that may be used by
bioterrorists, and contains other provisions concerning
antimicrobial resistance.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision on antimicrobial resistance. The provision
concerning priority pathogens has been moved to section 125
of the Conference substitute.
Section 110. Supplies and Services in Lieu of Award Funds
House provision: The House bill provides flexibility to
allow the Secretary of HHS to supply actual supplies,
equipment, or services instead of, or in conjunction with,
grants.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision.
Section 111. Additional Amendments
House provision: The House bill makes revisions to time
frames to accelerate preparedness planning.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision.
Subtitle B--Strategic National Stockpile; Development of Priority
Countermeasures
Section 121. Strategic National Stockpile
House provision: The House bill authorizes a national
stockpile or stockpiles of drugs, vaccines, biologic
products, medical devices and supplies to meet the health
security needs of the United States. It requires enhanced
procedures for coordination, maintenance, delivery, and
distribution. House authorization language in section 151 of
the House bill specifies specific sums for smallpox vaccines.
Senate amendment: Section 201 of the Senate amendment also
authorizes a national stockpile, and separately has a
provision under section 402 for authorizing smallpox vaccines
for the stockpile.
Conferece substitute: The Conference substitute adopts the
House provision with modifications and inclusion of a
specific provision on smallpox vaccines. The Managers believe
that antiviral products may be appropriate for the strategic
national stockpile
[[Page H2720]]
and may include antiviral products reviewed by the Food and
Drug Administration (FDA) or National Institutes of Health
(NIH).
Section 122. Accelerated Approval of Priority Countermeasures
House provision: The House bill clarifies certain fast-
track authority for drug priority countermeasures under the
Federal Food, Drug, and Cosmetic Act.
Senate amendment: Section 405 of the Senate amendment
contains a similar provision.
Conference substitute: The Conference substitute adopts the
Senate provision with modification.
Section 123. Issuance of Rule on Animal Trials
House provision: The House bill requires the FDA to issue a
final rule within six months allowing reliance on animal
trials for certain priority countermeasures for public health
emergencies.
Senate amendment: The Senate amendment contains a similar
requirement with a 30-day time frame.
Conference substitute: The Conference substitute adopts the
House provision with modifications to provide the rule within
90 days of the date of enactment.
Section 124. Security for Countermeasure Development and
Production
House provision: The House bill authorizes the Secretary,
in consultation with the Attorney General and Secretary of
Defense, to provide technical or other assistance to enhance
security at facilities that conduct development, production,
distribution, or storage of priority countermeasures.
Senate amendment: Section 402 of the Senate amendment
contains a similar provision and also provides for best
practices guidelines.
Conference substitute: The Conference substitute adopts the
House provisions without a requirement for best practices
guidelines.
Section 125. Accelerated Countermeasure Research and
Development
House provision: The House bill directs the Secretary to
conduct an accelerated countermeasure development program,
and to award grants for biomedical research, development of
vaccines, and diagnostic tests for priority countermeasures.
Senate amendment: Section 404 of the Senate amendment
contains similar provisions.
Conference substitute: The Conference substitute adopts the
Senate provisions with modifications. The House provision
concerning priority pathogens is included. The Managers
encourage the Secretary to consider novel methods for
detecting and identifying viral and bacterial pathogens, and
developing and manufacturing effective therapeutic responses,
including both vaccines and antibiotics. The Managers also
encourage the Secretary to consider the use of emerging
biophysical and biomanufacturing technologies that hold the
promise of producing rapid detection/response programs that
can achieve accelerated responses to bioterrist attacks or
threats. In addition, the Managers encourage the Secretary,
in coordination with the Administrator of the Environmental
Protection Agency, to develop protocols for and enhance
facilities for testing technologies used to decontaminate
facilities contaminated as a result of bioterrorism.
Section 126. Evaluation of New and Emerging Technologies
Regarding Bioterrist Attack and Other Public Health
Emergencies
House provision: The House bill requires the Secretary to
evaluate new and emerging technologies to help detect,
identify, diagnose, or conduct public health surveillance
activities for public health emergencies, and prioritize
development and deployment where warranted.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with limiting modifications.
Section 127. Potassium Iodide
House provision: The House bill requires the Secretary to
make potassium iodide available to States and local
governments that submit a plan for local stockpile and
distribution for the population within 20 miles of a nuclear
power plant.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with modifications that include authority
provided to the President; additional restrictions on the
eligibility of local governments; and a different schedule
for effective dates, and other modifications.
Subtitle C--Improving State, Local, and Hospital Preparedness for and
Response to Bioterrorism and Other Public Health Emergencies
Section 131. Grants to Improve State, Local, and Hospital
Preparedness for and Response to Bioterrorism and Other
Public Health Emergencies
House provision: The House bill modifies current
authorities under section 319 of the PHSA and otherwise
authorized grant funding to improve State, local, and
hospital preparedness for and response to bioterrorism and
other public health emergencies through the existing
mechanisms of the PHSA. Authorization was provided from FY
2002-2006.
Senate amendment: The Senate amendment contains a provision
for State block grants for fiscal years 2002-2003 for
bioterrorism activities only, and the authorization would not
continue past FY 2003. It also provides an authorization for
bioterrorism medical centers with authorization from FY 2002-
2006, limited to bioterrorism activities. Finally, the Senate
amendment maintains and authorizes a portion of funding under
section 319 for a broader list of purposes and eligible
entities.
Conference substitute: The Conference substitute reflects a
compromise between House and Senate approaches. For FY 2003,
there is a modified State block grant provision. Beyond FY
2003, greater flexibility is provided to the Secretary to
either continue the same approach or modify the approach
without the restrictions of the FY 2003 formulas. The
substitute also provides authorization for the purpose of
enhancing the preparedness of hospitals (including children's
hospitals), clinics, health centers, and primary care
facilities, and for planning and administrative purposes
relating to such authorizations. For FY 2004-2006, there is a
new section 319 C-2.
The Managers want to ensure that section 131 does not delay
or disrupt the current grants and cooperative agreements that
the Administration has been using in FY 2002, including those
programs administered by CDC and the Health Resources and
Services Administration (HRSA). It is the Managers' intent to
allow the Administration to continue this approach. The
Managers expect the Administration to evaluate the
effectiveness of the program and make revisions where
necessary to improve effectiveness and accountability.
The Managers intend that a permissible use of funds under
this section includes grants to one or more centers of
excellence to develop appropriate innovative technology
projects--for example, the development of a web-based
computerized planning application that incorporates
standardized language and utilizes wireless mobile
technology. The Managers intend that training programs
pursuant to this section could include the use of virtual
reality training methods, human patient simulators, computer-
assisted training modalities, and internet-based training and
modeling capabilities. One or more centers of excellence
could be established to develop, deploy, and evaluate virtual
and augmented reality-based, internet-ready training
capabilities.
Subtitle D--Emergency Authorities; Additional Provisions
Section 141. Reporting Deadlines
House provision: The House bill provides extensions for
certain reporting deadlines during a public health emergency,
and for transfer authority for funds during a public health
emergency.
Senate amendment: The Senate amendment contains an
analogous provision on reporting deadlines and no new
transfer authority.
Conference substitute: The Conference substitute adopts the
Senate provision on reporting deadlines with minor
modifications.
Section 142. Streamlining and Clarifying Communicable Disease
Quarantine Provisions
House provision: The House bill changes existing law to
expand the authority of the Secretary, in consultation with
the Surgeon General, and under certain conditions, to specify
diseases that are subject to individual detention orders.
Senate amendment: The senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with modifications to the standards required
before the Secretary may exercise this authority.
Section 143. Emergency Waiver of Medicare, Medicaid, and
SCHIP Requirements
House provision: Section 143 allows the Secretary of Health
and Human Services to waive certain requirements (and related
regulations) in of titles XVIII, XIX, and XXI of the Social
Security Act (as well as requirements and regulations
under title XI of the Social Security Act, only as
necessary to effectuate the waiver of the enumerated
requirements of titles XVIII, XIX, and XXI to meet the
purposes of this section) in the event of an emergency or
disaster in order to: (1) facilitate the provision of
health services in the emergency or disaster area, and (2)
ensure that health care providers who furnish care in good
faith to individuals enrolled in these programs during an
emergency or disaster may be reimbursed without penalty.
The Secretary can waive requirements pertaining to:
conditions of participation for providers; provider
licensing requirements; sanctions for physician self-
referral; sanctions relating to transferring patients in
an emergency; and deadlines for filing reports for periods
of up to 90 days.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with modifications. The Managers agree that
the Secretary shall provide written notice to Congress,
including a certification that a waiver is necessary. This
notice shall be issued before the waiver authority is
exercised. Additionally, the Secretary must report to
Congress within a year evaluating the effectiveness of the
approaches used during the operation of the waiver. The time
frame for such waivers shall be 60 days.
Section 144. Provision for Expiration of Public Health
Emergencies
House provision: The House bill provides that public health
emergencies expire by announcement of the Secretary, or after
90 days. The Secretary may renew emergency declarations at
his or her discretion.
[[Page H2721]]
Senate amendment: Section 212 of the Senate Amendment
contains a similar provision, but with a 180-day expiration
period.
Conference substitute: The Conference substitute adopts the
House provision with amendments, including clarifying the
status of any existing declaration of public health
emergencies.
Subtitle--Additional Provisions
Section 151. Designated State Public Emergency Announcement
Plan
House provision: Section 135 of the House bill amends the
Stafford Act to provide for coordinated communications
response.
Senate amendment: Section 312 of the Senate amendment
contains an identical provision.
Conference substitute: The Conference substitute adopts the
identical House and Senate provisions.
Section 152. Expanded Research by Secretary of Energy
House provision: The House bill expands current research at
the Department of Energy (DOE) and the National Nuclear
Security Administration (NNSA) on rapid detection of
pathogens likely to be used in bioterrorist attacks or other
agents that may cause a public health emergency.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision.
Section 153. Expanded Research on Worker Health and Safety
House provision: The House bill authorizes the National
Institutes of Occupational Safety and Health (NIOSH) to
expand research on health and safety of workers who are at
risk for bioterrorist threats or attacks in the workplace.
Senate amendment: The Senate amendment contains an
analogous provision.
Conference substitute: The Conference substitute adopts the
Senate Amendment with minor modification.
Section 154. Enhancement of Emergency Preparedness of
Department of Veterans Affairs
House provision: The House bill has no analogous provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute instructs
the Secretary of Veterans Affairs to take appropriate actions
to enhance the readiness of the Department's medical centers
and research facilities for a chemical or biological attack,
based on the results of an evaluation to be conducted by the
Secretary on the security needs at these facilities.
Section 155. Reauthorization of Existing Program
House provision: The House bill has no analogous provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute amends
section 582(f) of the Public Health Service Act by
reauthorizing a grant program through 2006 that provides
awards to public and private entities, as well as Indian
tribes and tribal organizations, that develop programs
focusing on the behavioral and biological aspects of
psychological trauma response and research that will help
treat psychiatric disorders of children and youth resulting
from witnessing or experiencing a traumatic event.
Section 156. Sense of Congress
House provision: The House bill has no analogous provision.
Senate amendment: The Senate amendment states that Congress
recognizes that many university-based programs are already
functioning and developing important biodefense products and
solutions. Congress should recognize the importance of
supporting work done at university centers and laboratories.
In addition, Congress should recognize the importance of
existing public and private university-based research,
training, public awareness, and safety-related biological
defense programs in the awarding of grants and contracts made
in accordance with this Act.
Conference substitute: The Conference substitute contains
one modification to the Senate amendment, which clarifies
that the Secretary of Health and Human Services may recognize
the importance of existing public and private university-
based efforts in grants and cooperative agreements.
Section 157. General Accounting Office Report
House provision: The House bill has no analogous provision.
Senate amendment: The Senate amendment requires a General
Accounting Office (GAO) report to Congress on Federal
bioterrorism-related activities.
Conference substitute: The Conference substitute amends
section 319F of the Public Health Service Act to require GAO
to report on Federal bioterrorism-related activities,
including research, preparedness, and response, to the
following committees: Senate Health, Education, Labor, and
Pensions; Senate Appropriations; House Energy and Commerce;
and House Appropriations.
Section 158. Certain Awards
House provision: The House bill has no analogous provision.
Senate amendment: The Senate amendment has no analogous
provision.
Conference substitute: The Conference substitute amends
section 319(a) of the Public Health Service Act by inserting
after ``grants,'' ``providing awards for expenses, and.''
Section 159. Public Access Defibrillation Programs and Public
Access Defibrillation Demonstration Projects
House provision: The House bill contains no such analogous
provision.
Senate amendment: The Senate amendment contains no such
analogous provision.
Conference substitute: The Conference substitute amends
section 243 of title 42, United States Code, to enact the
``Community Access to Emergency Defibrillation Act of 2002.''
The Conference substitute directs the Secretary to establish
a new grant program for States, political subdivisions of
States, Indian tribes, and tribal organizations to develop
and implement public access defibrillation programs. These
grants may be used to purchase automated external
defibrillators (AEDs), to provide automated external
defibrillation and basic life support training in AED usage,
to provide information to community members about the public
access defibrillation program, to provide information to the
local emergency medical system regarding the placement of
AEDs, and to produce materials to encourage private companies
to purchase AEDs. For this new grant program, the Conference
substitute authorizes the appropriation of $25 million in
fiscal year 2002, and such sums as may be necessary for each
of the fiscal years 2004 through 2006. The Conference
substitute also establishes a new grant program for political
divisions of States, Indian tribes, and tribal organizations
to develop and implement innovative, comprehensive,
community-based public access defibrillation demonstration
projects. These grants may be used to purchase AEDs, to
provide basic life training in automated external
defibrillator usage, to provide information to community
members about the public access defibrillation demonstration
project, and to provide information to the local emergency
medical services system regarding the placement of AEDs. For
these demonstration projects, the Conference substitute
authorizes the appropriation of $5 million for fiscal years
2003 through 2006. The Managers intend that the ``Good
Samaritan'' protections regarding emergency use of AEDs
outlined in section 238(q) of title 42, United States Code
will apply to this section. It is the intent of the Managers
that this new program coordinates its activities with the
Rural AED program and avoid duplication of effort.
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Section 201. Regulation of Certain Biological Agents and
Toxins
House provision: The House bill requires all persons who
possess, use or transfer ``select agents''--the 36 biological
agents or toxins currently determined by the Secretary of the
Department of Health and Human Services (HHS) to pose ``a
severe threat to public health and safety''--to register with
the Secretary and be subject to reasonable safety and
security requirements and inspections. Current law requires
registration only of those entities transferring such agents.
The House bill also directs that the Secretary maintain a
national database of all such agents, with sufficient
information to facilitate their identification and
traceability. The Secretary, in consultation with the
Attorney General, must establish specific security
requirements for registered facilities and a personnel
screening protocol to ensure that access to such agents is
not permitted by individuals who are ``restricted persons''
under the USA PATRIOT Act (18 U.S.C. 175b), are named in a
warrant for violent criminal or terrorist activity, are under
investigation for involvement in domestic or international
terrorist or criminal organizations, or suspected of spying
for the military or intelligence operations of a foreign
nation. The Secretary is granted authority to assist public
and nonprofit private entities in meeting such security
requirements. The House bill also imposes civil penalties for
those who violate the regulations, up to $500,000.
The House bill grants the Secretary discretion to make
exemptions to the registration requirements only where those
exemptions are consistent with protecting the public health
and safety--for example, with respect to inactivated or
attenuated strains of select agents used in vaccines or other
products for legitimate medical research or use--or when the
agent is presented for diagnosis, verification or proficiency
testing purposes at a clinical laboratory and is promptly
destroyed or transferred to a registered facility after such
identification. The House bill also exempts from mandatory
disclosure under the Freedom of Information Act (FOIA) site-
specific or identifying information submitted under these
regulations concerning registered persons, select agents, and
security mechanisms.
Senate amendment: The Senate amendment is substantially
similar to the House bill but differs in a few respects.
First, in developing the list of select agents, the Secretary
is directed to consider the needs of children and other
vulnerable populations. Second, individuals who seek access
to select agents are screened only to identify if they are
``restricted persons'' under the USA PATRIOT Act, or are
named in a warrant for participation in a domestic or
international act of terrorism. Third, the Secretary is
permitted
[[Page H2722]]
to exempt certain attenuated or inactive biological agents or
toxins and certain approved medical products from the list of
select agents.
Conference substitute: The Conference substitute adopts
provisions of both bills, with significant modifications. The
primary goals of this subtitle are to ensure the prompt
reporting to the Federal government of possession of select
agents (including by those who were in possession prior to
April 15, 1997, the effective date for reporting transfers of
select agents), to increase the security over such agents
(including access controls and screening of personnel), and
to establish a comprehensive and detailed national database
of the location and characterization of such agents and the
identities of those in possession of them. To effectuate
these goals, the substitute requires that, at a minimum, all
possession of select agents (unless exempt under the
provisions of this subtitle) must be registered with the
Secretary. The Managers expect that most ``persons'' who
register under this subtitle will be public and private
entities, rather than individuals. But these provisions also
will cover individuals possessing, using or transferring
select agents who have not been granted authority to do so by
registered persons. If an individual has not been granted
such authority, then that individual would be a person
required to register under this subtitle. If an individual
has been granted such authority without proper authorization
from the Secretary, as required by this subtitle, then the
registered person is subject to any penalties provided for
violation of such regulations. The Managers emphasize that
the primary responsibility for registration and the screening
of employees working with select agents is with the entity or
employer, not the individual employee. The Secretary also is
required to promulgate regulations establishing safety
requirements for the possession, use, and transfer of select
agents. These regulations must include procedures to protect
the public safety in the event the safety requirements for
possession, use or transfer are violated.
The Managers recognize that some select agents may pose a
greater threat to the public health and safety than others.
Accordingly, the Conference substitute amends the security
requirements of both bills by adding the phrase
``commensurate with the risk such agent or toxin poses to
public health and safety (including the risk of use in
domestic or international terrorism).'' The Secretary will
have flexibility to impose different levels of security
requirements on different select agents based on his or her
evaluation of the level of threat to the public, as is
currently done with respect to laboratory biosafety levels.
Because an agent must pose a severe threat to human health to
be placed on the select agent list, the Secretary may not
decide that security requirements or registration of
possession are unnecessary for a particular select agent.
The substitute also modifies the existing statutory
requirements for the transfer regulations by adding ``and
security measures'' after ``safeguards'' in the term
``safeguards to prevent access . . . for use in domestic or
international terrorism or for any other criminal purposes''
to clarify that such regulations include the imposition of
security requirements. The substitute also requires that
registered persons promptly notify the Secretary whenever a
select agent is lost, stolen, or released outside of a
biocontainment area of a facility. Current HHS regulations do
not mandate such notifications.
The Conference substitute adds new provisions regarding the
screening of entities and individuals seeking to register
their possession, use or transfer of select agents. While
both the House and Senate bills mandate screening of
individuals seeking access to agents through a registered
person, neither bill required screening of the registered
persons themselves. The substitute provides for such
screening in a similar manner to that performed for
individuals working at the facilities of registered persons.
Further with respect to screening, the substitute drops the
provision in both bills relating to outstanding warrants, as
duplicative of the fugitive provision in the restricted
person categories of the USA PATRIOT Act, and adds a
screening category that was in neither bill--those reasonably
suspected of committing Federal crimes of terrorism. The
substitute includes but makes revisions to the two additional
screening categories contained in the House bill to ensure an
objective basis for governmental suspicion of involvement
with terrorist or criminal organizations, or with foreign
powers. In the case of restricted persons, the substitute
mandates that access to select agents be denied, because of
the criminal prohibition on possession by such persons. In
the case of persons falling within the other three specified
categories, the substitute grants the Secretary and
Attorney General discretion in determining how to proceed,
given the law enforcement sensitivity of such situations.
By making this distinction between the handling of
restricted persons and other screening categories, the
Managers do not intend that potential terrorists or
foreign agents should be subject to a less strict
screening standard than restricted persons. The substitute
also clarifies that the screening performed by the
Attorney General is for the sole purpose of identifying--
through the use of official, electronic databases
available to the Federal government--whether an individual
or entity falls within any of the specified categories,
and for notifying the HHS Secretary of such
identification. It is the Managers' intent that the term
``electronic databases'' is not meant to preclude the use
of other databases or files by the Attorney General to
clarify or confirm information obtained during the
electronic database search.
To address concerns within the academic and research
communities about the timeliness and accuracy of the
background screening process, the Conference substitute
amends both bills by requiring ``prompt'' action by the
Attorney General and the Secretary with respect to screening
of and notification to affected individuals, and by providing
for an expedited review process where good cause has been
demonstrated by the registered person. The substitute also
provides for a review of denials by the Secretary based on
the screening process, and subsequent judicial review--with
provisions to ensure that classified or sensitive law
enforcement information is not compromised during such
reviews. Specifically, the substitute allows for ex parte
review by the Secretary in administrative proceedings, and
the court during judicial review, whenever a denial is
challenged. In providing the right for ex parte review, the
Managers intend to protect classified and law enforcement
sensitive information, including through the use of in camera
proceedings. Moreover, the Managers intend that a reviewing
court should not order the disclosure of any information that
the United States believes may compromise national security
or an ongoing law enforcement investigation without affording
the United States an opportunity for further review in
accordance with this subtitle. It is the Managers' overall
expectation that the screening process be conducted in a
timely and fair manner, and that the Secretary and the
Attorney General will work closely together to effectuate
such intent.
With respect to the national database of select agents that
the Secretary must develop pursuant to this section, the
Conference substitute slightly alters the language used in
both bills with respect to the database's purpose. The object
of the registration and database requirements is to provide
information about all persons possessing, using or
transferring select agents, and to collect sufficiently
detailed characterization information on the registered
select agents so that the database can differentiate between
and within strains of a given agent or toxin. Such
information should be in a format that public health and law
enforcement officials can use to identify the origin or
source of an agent or toxin that is used to cause harm to the
public. Because of concerns over the potential for
misconstruction, the term ``traceability''--which could imply
a chain of custody or tracking requirement--was eliminated,
and was replaced with the concept of ``source.''
Significant modifications were made to both bills with
respect to exemptions from the statutory and regulatory
requirements governing select agents. The Conference
substitute establishes several exemptions from the regulatory
regime for select agents, most of which are consistent with
the Secretary's current regulations and practices. First, the
Conference substitute adopts, with modifications, the Senate
amendment's language with respect to product exemptions. The
substitute directs the Secretary to exempt from such
regulations products that are, bear or contain a select agent
and are licensed or approved under several specified Federal
laws, unless the Secretary determines that additional
regulation is necessary for a specific product to ensure
protection of public health and safety. The Managers intend
that the Secretary will exempt by regulation categories of
products, consistent with current regulations, and will act
to regulate a specific product, or a particular application
of a specific product, only when existing regulation under
other Federal laws is inadequate. For example, HHS currently
exempts the FDA-approved medical product Botox, which is the
select agent botulinum toxin, when it is used by licensed
physicians in the treatment of patients. However, when it is
used in purely research settings or as part of early-stage
clinical trials, HHS has chosen not to exempt Botox from
current regulations. The Managers do not intend to alter this
flexibility.
Second, the Conference substitute adds a provision granting
the Secretary discretionary authority to exempt, on a case-
by-case basis, investigational products when they are being
used in investigational or clinical trials authorized under
other Federal laws, such as the Federal Food, Drug, and
Cosmetic Act. Given the time sensitivity of such trials, the
substitute also includes a provision mandating a prompt
determination by the Secretary of such an exemption request--
within 14 days after the applicant has submitted a
complete exemption request and has notified the Secretary
that the investigation may proceed as authorized under
Federal law.
Third, with respect to clinical or diagnostic laboratories
that may come into possession of select agents when
conducting specimen diagnosis, verification or proficiency
testing, the substitute adopts with minor changes the
comparable provisions in the House and Senate bills. The
Secretary shall exempt such laboratories from registration
requirements, but only if they report the identification of
select agents to the Secretary and either promptly transfer
the agent to a registered person or destroy the agent on
site, in accordance with regulations established by the
Secretary. While HHS currently exempts such laboratories,
existing
[[Page H2723]]
regulations permit them to transfer, destroy, or store the
agent on site for reference purposes. The Conference
substitute expressly rejects that regulatory approach, as it
is inconsistent with the fundamental premise of this title--
that all those who maintain possession of a select agent must
register and be subject to appropriate security and safety
requirements. The Secretary may not exempt laboratories that
possess select agents for reference purposes, or any other
clinical or diagnostic laboratories that do not qualify for
an exemption under the terms of this title. In addition, the
Conference substitute creates two temporary exemption
authorities to deal with public health emergencies and
agricultural emergencies, whether domestic or foreign.
With respect to funding, the Conference substitute
authorizes such sums as may be necessary to carry out these
new and expanded functions. The Managers note that,
historically, HHS has had insufficient resources to properly
run the existing select agent transfer program. While current
regulations permit inspections, only 20 percent of all
registered facilities have been inspected since the inception
of the program in 1997, and virtually none of these
inspections were conducted prior to registration. The
Managers also note that HHS received a large increase in
funding for this program in the Fiscal Year 2002 supplemental
appropriations bill. Given the broader, but uncertain scope
of the new regulatory regime, it is unclear whether
additional funds beyond current appropriations will be
necessary for Fiscal Year 2003. Once all persons possessing
select agents notify the Secretary of such possession 90 days
after enactment of this title, the appropriations level may
need to be re-evaluated.
Section 202. Implementation by Department of Health and Human
Services
House provision: The House bill requires notification to
the Secretary by all persons possessing select agents within
60 days of enactment, and an interim final rule establishing
a regulatory structure to be issued within 120 days of
enactment.
Senate amendment: The Senate amendment requires the
Secretary to issue an interim final rule within 180 days of
enactment, and requires all persons possessing select agents
to register within 60 days of issuance of the rule.
Conference substitute: The Conference substitute adopts the
House bill with modifications. The substitute requires
notification to the Secretary by all persons possessing
select agents within 90 days of enactment, based on guidance
issued by the Secretary within 30 days of enactment, and the
issuance of an interim final rule within 180 days of
enactment. The substitute also provides that the interim
final rule shall include time frames for applicability of the
rule that minimize disruption of research or educational
projects that involves select agents and that were underway
as of the effective date of such rule. The Managers note that
the interim final rule and effective date provisions will
result in these new regulations going into effect at
approximately the same time as the National Institutes of
Health (NIH) begins to award Fiscal Year 2003 grants for
research, some of which will be in the select agent area. The
Managers expect that the Secretary will encourage those
seeking such grants to begin the registration and screening
process under this title concurrently with the NIH grant
process, and that the Secretary will ensure the timely
registration and screening of such grantees, so as not to
delay this important research.
Section 203. Effective dates
House provision and Senate amendment: both the House bill
and the Senate amendment provide that regulations promulgated
by the Secretary under section 511 of the Antiterrorism and
Effective Death Penalty Act of 1996 are deemed to have been
promulgated under section 351A of the Public Health Service
Act, as added by this Act. They both also provide that the
FOIA exemptions apply retroactively to the effective date
of the Antiterrorism and Effective Death Penalty Act of
1996.
Conference substitute: The Conference substitute adopts the
same provisions.
Section 204. Conforming Amendment
House provision and Senate amendment: Both the House bill
and the Senate amendment repeal those provisions of the
Antiterrorism and Effective Death Penalty Act of 1996 that
have been codified in section 351A of the Public Health
Service Act by this Act.
Conference substitute: The Conference substitute adopts the
same provisions.
Subtitle B--Department of Agriculture
Section 211. Short Title
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous
provision.
Conference substitute: The Conference substitute includes a
new subtitle, with its own short title--the Agricultural
Bioterrorism Protection Act of 2002.
Section 212. Regulation of Certain Biological Agents and
Toxins
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous
provision.
Conference substitute: The Conference substitute adopts
provisions that would grant comparable regulatory authorities
to the U.S. Department of Agriculture (USDA) as those granted
to HHS under subtitle A of this title for the regulation of
possession, use or transfer of listed biological agents and
toxins that present a severe threat to plant or animal
health, or animal or plant products. In an effort to minimize
regulatory duplication and burden, the substitute seeks to
ensure, to the greatest extent practicable, uniformity in the
statutory authority that the two departments will administer.
Exceptions exist in the criteria to be used by the Secretary
of Agriculture in developing a list of agriculturally
significant biological agents and toxins; considerations to
be made in granting exemptions from regulation under the
statute; procedures related to civil monetary penalties; and
the time frames for promulgation of a biological agents and
toxins list and the accompanying requirement that individuals
who possess these agents notify the Secretary of such
possession. In addition, with respect to the screening of
persons registering or accessing listed agents, the
substitute uses the same screening categories as are in
subtitle A, but does not mandate any denials of access, given
that possession of USDA-listed agents by restricted persons
is not a Federal crime. Instead, the Secretary and Attorney
General are granted discretion as to how to proceed in such
situations.
The Managers recognize that, under provisions of current
law, biologics manufacturers have had to register, maintain
associated paperwork, and be subject to inspections and
requirements from both USDA and HHS. Likewise, the Managers
are aware that the inadequacy of the penalty provisions of
the Virus-Serum-Toxin Act--enacted in 1913 and under which
USDA currently regulates these dangerous agents--as well as
the lack of authority for the Secretary of Agriculture to
regulate possession of biological agents and toxins that pose
a severe threat to plant or animal health may expose the
Unite States to potential acts of bioterrorism that could
have a devastating impact on animal and plant health, or the
domestic agricultural economy.
The Managers intend that, in developing the list of agents
and toxins to be regulated under this subtitle, the USDA
Secretary shall consult with other appropriate Federal
agencies. With regard to zoonotic agents, which pose a threat
to both animals and humans, the Managers expect that the USDA
Secretary will consult with the HHS Secretary in developing
such a list. The Managers also intend that the USDA Secretary
will develop the list of regulated agents and toxins based
solely on the risk to animals or plants, or to animal or
plant products, including consideration of the effect of
exposure on the production and marketability of such
products. The Managers do not intend that the USDA Secretary
will include an agent or toxin on the USDA list because of
the effect of that agent or toxin on human health, which is
governed by the statutory provisions of section 351A of the
Public Health Service Act, as amended by this title.
The Managers expect that most ``persons'' who register
under this subtitle will be public and private entities,
rather than individuals. But these provisions also will cover
individuals possessing, using or transferring listed agents
who have not been granted authority to do so by registered
persons. If an individual has not been granted such
authority, then that individual would be a person required to
register under this subtitle. If an individual has been
granted such authority without proper authorization from the
Secretary, as required by this subtitle, then the registered
person is subject to any penalties provided for violation of
such regulations. The Managers emphasize that the primary
responsibility for registration and the screening of
employees working with listed agents is with the entity or
employer, not the individual employee.
Procedures for the registration of persons, review of
individuals, and inspection of facilities have been described
in the statutory language in some detail. Of equal importance
to the Managers are the regulations, to be established by the
Secretary, which, to ensure compliance with this substitute,
shall include provisions for the revocation and suspension of
registrations for failure to maintain safe and secure
facilities.
Section 213. Implementation by the Department of Agriculture
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analagous
provision.
Conference substitute: The Conference substitute provides
that, within 60 days of enactment, the Secretary of
Agriculture shall promulgate an interim final rule that
establishes an initial list of agents and toxins meeting the
statutory criteria for enhanced regulation. Within 60 days of
the publishing of the interim final rule, all persons (unless
exempt) must notify the Secretary of such possession. Within
180 days of enactment, the Secretary shall promulgate an
interim final rule for carrying out the remainder of section
212, which such rule shall include time frames that minimize
disruption of ongoing research and education with listed
agents and toxins.
Subtitle C--Interagency Coordination Regarding Overlap Agents and
Toxins
Section 221. Interagency Coordination
It is the Managers' intent that the two Secretaries will
coordinate closely with respect to exemptions from these new
regulatory regimes for overlap agents, so as to create a
uniform and consistent approach. The Managers also intend
that, under the Memorandum of Understanding, a regulated
party will interact with one agency with respect to all
matters--including registration,
[[Page H2724]]
screening, and inspections--so as to avoid confusion and
forum shopping. The Managers also expect that the two
Departments will coordinate and consult with respect to
overlap agent registration, screening, and exemptions in a
timely manner, particularly in situations of public health or
agricultural emergencies.
Within 18 months of the implementation of a Memorandum of
Understanding between USDA and HHS, the Managers intend that
a formal, joint regulatory system shall be implemented by the
two Departments for agents and toxins that appear on both the
USDA and HHS lists. Once implemented, the Managers intend
that these joint regulations shall supercede the Memorandum
of Understanding with respect to matters covered by such
regulations.
Subtitle D--Criminal Penalties Regarding Certain Biological Agents and
Toxins
Section 231. Criminal Penalties
House provision: The House bill authorizes amendments to
current law to require all persons who possess, use of
transfer biological agents or toxins that have been listed as
select agents by the HHS Secretary to register with the
Secretary. To enforce these new regulatory provisions,
subsection (a) of section 231 of the House bill provides that
any person who knowingly transfers a select agent to any
person without first verifying such registration with the
Secretary could be fined or imprisoned up to five years, or
both. The subsection also provides that any person who
knowingly possesses a biological agent or toxin, where such
agent or toxin is a select agent for which such person has
not obtained a registration required by the Secretary, could
be fined or imprisoned for up to five years, or both.
The House bill makes technical changes to 18 U.S.C. 175b to
renumber current subsection (a) as (a)(1), and to redesignate
subsection (c) as (a)(2). This change will result in the
description of the possible penalties being placed
immediately following the description of the unlawful
conduct. The House bill also redesignates subsection (b) as
subsection (d). The two new criminal provisions added under
this bill are designated subsections (b) and (c) of section
175b. The House bill also makes conforming amendments to
clarify the definition of the term ``select agent.'' The
House bill also changes the title of section 175b from
``Possession by restricted persons'' to ``Select Agents.''
Senate amendment: The Senate amendment includes the same
criminal provision relating to those who possess select
agents without being registered, but differs with respect to
the criminal penalty for unauthorized transfers. The Senate
amendment criminalizes transfers to unregistered persons when
the transferor has reason to believe that the recipient is
not registered. The Senate amendment also differs by
including the unlawful conduct in 18 U.S.C. 175, rather than
175b. The Senate amendment makes conforming changes to 18
U.S.C. 175 to make the sections technically correct and to
eliminate a definition that is already provided in another
section. The Senate amendment provides that current 18 U.S.C.
175(b) and (c) are redesignated as (c) and (d). New
subsection (b) creates the criminal penalties referenced
above. New subsection (d), which contains the definitions,
amends current law to provide new definitions for the
following terms: ``biological agent,'' ``for use as a
weapon,'' and ``select agent.''
Conference substitute: The Conference substitute adopts the
House language with regard to technical changes to 18 U.S.C.
175b, but adopts the Senate language with respect to new
criminal penalties with modifications. The Conference
substitute adopts the common language dealing with unlawful
possession. However, the Conference substitute amends the
Senate language regarding transfers to provide that any
person who transfers a select agent to any person one knows
or has reasonable cause to believe has not registered with
the HHS Secretary could be fined or imprisoned up to five
years, or both.
The Conference substitute also amends both bills by adding
language that requires all persons who possess, use or
transfer biological agents that have been listed as agents
that pose a threat to agriculture by the Secretary of
Agriculture to register with such Secretary. The Conference
substitute provides that knowing possession of a biological
agent or toxin, where such agent or toxin is listed by the
Secretary of Agriculture under this Act and for which a
required registration has not been obtained, is punishable by
a fine or up to five years imprisonment, or both.
Similarly, transfer of a biological agent or toxin listed
by the Secretary of Agriculture to a person one knows or
has reasonable cause to believe has not registered with
the Secretary is punishable by a fine or up to five years
imprisonment, or both.
The Conference substitute also makes additional conforming
and technical amendments to title 18, including providing a
comma in 18 U.S.C. 175(c); specifically describing what
activities restricted persons are prohibited from engaging in
under this section; referring to the correct code section for
the definition of ``alien''; replacing legislative language
in 176(a)(1)(A); modifying the definitions in 18 U.S.C. 178
for ``biological agent'', ``toxin'', and ``vector'' to make
each more accurate; and modifying 18 U.S.C. 2332a regarding
use of weapons of mass destruction to make it clear it refers
to use of biological agents or toxins.
The Managers expect that most ``persons'' who register
under this title will be public and private entities, rather
than individuals. When an entity fails to register as
required, the new criminal possession statutes will apply to
that entity. These provisions also will cover individuals
possessing select or listed agents who are unregistered and
who have not been granted access to such agents by registered
persons. If an individual has not been granted access by a
registered person, then that individual would be a person
required to register under this title for purposes of these
criminal possession provisions. If an individual is granted
access to a select or listed agent by a registered person
without proper authorization from the Secretary, as required
by this title, then the registered person is subject to any
penalties provided for violation of such regulations. The
Managers emphasize that the primary responsibility for
registration and the screening of employees working with
select or listed agents is with the entity or employer, not
the individual employee. This same analysis applies to the
criminal transfer provisions set forth in this section.
TITLE III--PROTECTING THE SAFETY AND SECURITY OF THE FOOD AND DRUG
SUPPLY
Subtitle A--Protection of Food Supply
For purposes of this Title, the term ``Secretary'' refers
to the Secretary of Health and Human Services, unless
otherwise indicated.
Section 301. Food Safety and Security Strategy
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment expands the
responsibilities of the President's Council on Food and
Safety (established by Executive Order 13100) by directing
the Council, with the Secretary of Commerce and the Secretary
of Treasury to develop a crisis communications and education
strategy with respect to bioterrorist threats to the flood
supply. The Senate amendment authorizes to be appropriated
$500,000 to develop such a strategy.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
expands the scope of consultation between the President's
Council on Food Safety and other entities to include any
other relevant Federal agencies, including law enforcement
and intelligence related agencies, and scientific
organizations. The Conference substitute also expands the
scope of the food safety and security strategy to address
technologies, threat assessments, risk communication, and
procedures for securing food processing and manufacturing
facilities and modes of transportation. The Conference
substitute increases the amount of funds that are authorized
to be appropriated for fiscal year 2002 to $750,000 to
develop such a strategy.
Section 302. Protection Against Adulteration of Food
House provision: The House bill authorizes to be
appropriated $100,000,000 for fiscal year 2002, and such sums
as may be necessary for each year from fiscal year 2003
thorugh fiscal year 2006, for the Secretary to carry out
increased activities to ensure the safety of the food supply.
Specifically, the House bill amends section 801 of the
Federal Food Drug and Cosmetic act (FFDCA) directing the
Secretary to give high priority to increasing the number of
food safety inspections at ports of entry, with highest
priority on inspections to detect intentional adulteration of
food. The House bill also directs the Secretary to give a
high priority to improving the information management
systems that support food safety inspection programs for
the purpose of improving the ability of the Secretary to
detect intentional adulteration of food and to facilitate
the importation of food that is in compliance with the
Act. Further, the House bill directs the Secretary to give
high priority to researching and developing improved tests
and sampling methods for the purpose of rapidly detecting
adulterated foods, with highest priority on detection of
intentional adulteration. Finally, the House bill directs
the Secretary to complete an assessment of potential
threats to the food supply posed by efforts to
intentionally adulterate food, and to report the findings
on such assessment to Congress within six months.
Senate amendment: The Senate amendment authorizes to be
appropriated $59,000,000 for fiscal year 2002 and such sums
as may be necessary for each year thereafter to expand the
capacity of the Food and Drug Administration (FDA) to
increase inspections to ensure the safety of the food supply
and to improve linkages between the FDA and other Federal
regulatory agencies, the States, and Indian tribes.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
directs the Secretary to improve linkages with other Federal
regulatory agencies that share responsibility for food
safety, and directs the Secretary to improve linkages with
the States and Indian tribes with respect to food safety. The
Managers intend that the Secretary in making improvements to
the information management systems that support food safety
inspection programs, including the OASIS system, may include
improvements that assist food importers and filers in
providing accurate and timely information on entries filed on
food import shipments. The Managers also intend that in
conducting research to develop improved tests and sampling
methods for the purpose of rapidly detecting adulterated
foods, the Secretary may
[[Page H2725]]
involve institutions of higher education, including such
institutions that receive Federal funding to operate
consortiums within the food industries, for the purpose of
conducting research and development in food safety and food
security. Finally, it is the understanding of the Managers
that FDA already has underway (under agreement with Battelle
Laboratories) an assessment of potential threats to the food
supply posed by efforts to intentionally adulterate food. For
purposes of this section, the requirement to conduct an
assessment of potential threats to the food supply posed by
efforts to intentionally adulterate food refers to such
threat assessment that is already underway or very recently
completed.
Section 303. Administrative Detention
House provision: The House bill amends section 304 of the
FFDCA by authorizing the Secretary to administratively detain
an article of food that is found during an inspection,
examination or investigation under this Act if the Secretary
has credible evidence or information indicating that the
article presents a threat of serious adverse health
consequences or death to humans or animals. Such food may be
detained for a reasonable period of up to 20 days, and where
needed up to 30 days, for the purpose of enabling the
Secretary to institute a seizure action under section 304(a)
or injunctive relief under section 302, as warranted. The
House bill authorizes the Secretary to move detained food
from the place at which it has been detained to a secured
facility, as appropriate, for the period of detention or
until released by the Secretary. The House bill also
authorizes a claimant of an article of food that has been
detained under this section to appeal the detention of the
article. In addition, where the Secretary already has
credible evidence or information indicating that an imported
article of food presents a threat of serious adverse health
consequences or death to humans or animals, this section also
requires the Secretary to request the Secretary of Treasury
to temporarily hold imported food at a port of entry for up
to 24 hours to enable the Secretary to inspect, examine or
investigate the food. For an article of food temporarily held
under this section, the Secretary is also required to notify
the State in which the port of entry is located about such
request or that such food is being temporarily held.
Senate amendment: The Senate amendment provides authority
to administratively detain food that is similar to the House
bill. The Senate amendment allows the Secretary to detain
food that violates the FFDCA and that presents a threat of
serious adverse health consequences or death, and requires
that the Secretary provide an opportunity for a hearing (and
to confirm or to revoke) a detention order within 15 days of
the filing of an appeal by a claimant. Unlike the House bill,
the Senate amendment does not include additional authority to
temporarily hold food, nor does it require the Secretary to
notify a State regarding the port of entry within such
State at which food is being temporarily held.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
clarifies that food that is detained under this section may
not be delivered pursuant to an execution of a bond in
accordance with section 801 of the FFDCA (if the detained
food is imported) or otherwise (if the detained food is
domestically produced), while the food is subject to the
detention order, unless released by the Secretary. The
Conference substitute requires the Secretary in response to
an appeal filed by a claimant challenging the detention of an
article of food to conduct an informal hearing and confirm or
terminate a detention order within five days after an appeal
is filed, at which time the Secretary's determination is
subject to judicial review in accordance with section 702 of
title 5, United States Code. The Conference substitute amends
section 304 of the FFDCA by authorizing the Secretary to
detain an article of food for the purpose of enabling the
Secretary to institute a seizure action under section 304(a)
or to seek injunctive relief under section 302 of the Act.
This section provides a claimant of the food the right to
appeal a detention order, but that right of appeal terminates
if the Secretary institutes either a seizure action under
section 304(a) or injunctive relief under section 302 of the
Act. The Managers do not intend to terminate the claimant's
right to appeal a detention order under paragraph 4(B) of
such subsection, unless the basis for the seizure action
instituted under section 304(a) or the injunctive relief
sought under section 302 is related to the original basis for
detention under this section.
The Conference substitute provides that an article of food
subject to detention shall be held in a secure facility, as
appropriate. Under this title, in instances where the
Secretary moves food that has been refused admission to a
secure facility, the Secretary should ensure that such food
will be held under appropriate conditions of cleanliness,
temperature, humidity and other such considerations that are
necessary so as not to erode the safety and wholesomeness of
the detained article.
The Managers recognize that perishable foods may be
detained under this section. As a result, the Secretary is
required to promulgate a rule to establish expedited
procedures for instituting an action under section 304(a) or
section 302 of the FFDCA for perishable foods, such as fresh
produce, fresh fish and fresh seafood products. The Secretary
should promptly complete such rule making.
The Conference substitute requires the Secretary to
temporarily hold food for not longer than 24 hours, where the
Secretary has credible evidence or information indicating
that such article of food presents a threat of serious
adverse health consequences or death to humans or animals.
The period of temporary hold is intended to allow the
Secretary time to dispatch an inspector to the port of entry
in order to conduct the needed inspection, examination or
investigation.
Section 304. Debarment For Repeated or Serious Food Import
Violations
House provision: The House bill provides authority to the
Secretary to debar from importing articles of food, any
person that is convicted of a felony relating to food
importation or any person that repeatedly imports food and
who knew, or should have known, that such food was
adulterated. The House bill treats the importation or offer
for importation of an article of food by a debarred person as
a prohibited act under section 301 of the FFDCA.
Senate amendment. The Senate amendment includes permissive
debarment authority for food importers that is similar to the
permissive debarment authority of the House bill, but
replaces the standard in the House bill, allowing debarment
for repeatedly importing unsafe food, with a different
standard allowing debarment of food importers for engaging in
a pattern of importing unsafe food. Unlike the House bill,
the Senate amendment treats food that is imported by a
debarred person as adulterated.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. Unlike the Senate
amendment, the Conference substitute does not treat food that
is imported by a debarred person as adulterated solely on the
basis of its importation by a debarred person. Rather the
Conference substitute treats the importation or offering for
importation into the United States of an article of food by,
and with the assistance of, or at the direction of, a
debarred person as a prohibited act under section 301 of the
FFDCA. In addition, the Conference substitute requires food
imported by a debarred person to be refused admission and
held in a secure facility as appropriate, unless a person,
other than a debarred person, affirmatively establishes
that such food complies with the requirements of the
FFDCA. The Conference substitute also clarifies that
imported food that is refused admission may not be
delivered pursuant to the execution of a bond under
subsection (b) of section 801 of the FFDCA. For purposes
of this section, the person other than the debarred person
who may established that food, which has been refused
admission under this section, is in compliance with this
Act is intended to be an innocent purchaser of food, not a
person that is engaged in the improper importation of food
with a debarred person. In addition, the classification as
a prohibited act (under section 301 of the FFDCA) of the
importation or offer for importation of food ``with the
assistance of'' a debarred person is not intended to
include an innocent purchaser who did not have knowledge,
actual or constructive, of the importer's debarred status.
Finally, the Conference substitute clarifies that the
Secretary has the authority to terminate the debarment of
corporations or persons under this subsection.
Section 305. Registration of Food Facilities
House provision: The House bill requires facilities
(excluding farms) that manufacture, process, pack or hold
food for consumption in the United States to file with the
Secretary, and keep up to date, a registration that contains
the identity and address of the facility and, when the
Secretary determines appropriate the general category of food
manufactured, processed, packed or held at the facility. The
House bill also authorizes the Secretary to exempt certain
retail establishments only if the Secretary determines that
the registration of such facilities is not needed for
effective enforcement. Enforcement of this section is delayed
one hundred and eighty days from the date of enactment, and
this section requires the Secretary to notify and issue
guidance within sixty days identifying facilities that are
required to register under this section.
Senate amendment: The Senate amendment includes a
requirement for certain food facilities to register with the
Secretary that is similar to the registration requirement for
food facilities that is contained in the House bill. The
Senate amendment exempts types of farms or retail
establishments but, unlike the House bill, farms can be
exempted only if the Secretary determines that the
registration of such facilities is not needed for effective
enforcement of the FFDCA. The Senate amendment also lacks the
requirements of the House bill relating to notice to those
who must register and relating to electronic registration.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
requires the Secretary to establish registration requirements
for specified food facilities by regulation not later than
eighteen months after the date of enactment of this Act. If
such regulations are not effective prior to the conclusion of
such eighteen-month period, the requirements of this section
are self-executing and enter into effect
[[Page H2726]]
at such time and remain in effect unless superseded by such
final regulations. The Managers strongly encourage the
Secretary to complete this rule making in a timely manner in
order to enable the efficient operation of these registration
requirements.
The Conference substitute treats the failure of a specified
facility to register under this section as a prohibited act
under section 301 of the FFDCA. The Conference substitute
requires the Secretary to refuse admission to food imported
from foreign facilities that have failed to register in
accordance with this section until such facility is
registered, and requires the Secretary to remove such food to
a secure facility, as appropriate. The Conference substitute
clarifies that imported food that is refused admission under
this section shall not be delivered pursuant to the execution
of a bond under subsection (b) of section 801 of the FFDCA.
The Conference substitute exempts from the requirements of
registration farms, restaurants, other retail food
establishments, non-profit food establishments in which food
is prepared for, or served directly to, the consumer, and
fishing vessels not engaged in processing, as defined in
section 123.3(k) of title 21, Code of Federal Regulations.
The Managers intend that, for purposes of this section, the
term ``retail food establishments'' includes establishments
that store, prepare, package, serve or otherwise provide
articles of food directly to the retail consumer for human
consumption, such as grocery stores, convenience stores,
cafeterias, lunch rooms, food stands, saloons, taverns, bars,
lounges, catering or vending facilities, or other similar
establishments that provide food directly to a retail
consumer. The term does not include a warehouse that does not
provide articles of food directly to a retail consumer as its
primary function. The Managers intend that, for purposes of
this section, the term ``non-profit food establishments''
includes not-for-profit establishments in which food is
prepared for, or served directly to the consumer, such as
food banks, soup kitchens, homebound food delivery
services, or other similar charitable organizations that
provide food or meals for human consumption. In addition,
the Managers intend that, for purposes of this section,
``facility'' does not include trucks or other motor
carriers, by reason of their receipt, carriage, holding,
or delivery of food in the usual course of business as
carriers. In addition, nothing in this section shall be
construed to alter or amend the treatment of carriers
under section 703 of the FFDCA.
Finally, the Conference substitute calls for one-time
registration of covered facilities, rather than annual
registration of such facilities. Once a facility is
registered it should amend its original registration in a
timely manner to reflect any changes. The Conference
substitute encourages electronic registration to help reduce
paperwork and reporting burden, but registration is also
promitted using a paper form.
Section 306. Maintenance and Inspectionse informa of Records
for Foods
House provision: The House bill provides the Secretary with
authority to inspect and copy all records relating to an
article of food if the Secretary has credible evidence or
information indicating that an article of food presents a
threat of serious health consequences or death to humans or
animals. The House bill contains certain limitations on the
Secretary's authority, including limitations to ensure the
protection of trade secrets and confidential information. The
House bill provides the Secretary with the discretion to
issue a regulation requiring maintenance of additional
records that are needed to identify the source and chain of
distribution of food, in order to address credible threats of
serious adverse health consequences or death to humans or
animals. The House bill excludes restaurants and farms, and
the Secretary is provided the authority to take into account
the size of the business when imposing any record keeping
requirements.
Senate amendment: The Senate amendment includes records
access authority that is similar to the records access
authority granted to the Secretary in the House bill. The
Senate amendment authorizes the Secretary to inspect and copy
records relating to the violation when he has a reason to
believe that an article of food is adulterated or misbranded
and presents a threat of serious adverse health consequences
or death. The Senate amendment also includes record keeping
authority that is similar to the record keeping authority in
the House bill. The Senate amendment requires the Secretary
to issue a regulation to require the maintenance and
retention of records to trace the chain and distribution of
food within 18 months of enactment of the Act. In addition,
the Senate amendment allows the Secretary to require
maintenance and retention of records necessary to determine
if a food may be adulterated or misbranded to the extent that
it presents a threat of serious adverse health consequences
or death. The Senate amendment limits the Secretary's
authority to require the retention of either type of records
for not longer than two years. The Senate amendment also
criminalizes the release of trade secret information obtained
by inspection of records under this section.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
replaces the standard for records acccess in the House bill
with a different standard that grants the Secretary records
access if the Secretary has a reasonable belief that an
article of food is adulterated and presents a threat of
serious adverse health consequences or death to humans or
animals. The Conference substitute limits access to those
records relaitng to such artricle of food that are needed to
assist the Secretary in determining whether food is
adulterated and presents a threat of serious adverse health
consequences or death to humans or animals.
The Conference substitute amends the scope of record
keeping authority contained in the House bill by clarifying
that the authority under this section applies to both the
establishment and maintenance of records that meet the
standard under this section and by limiting the record
retention requirement to a period of not longer than 2 years.
The Conference substitute also adopts the requirement of the
Senate amendment to criminalize the disclosure of trade
secrets obtained under this section.
The Conference substitute authorizes the issuance of
regulations to require establishment and maintenance of chain
of distribution records. This authority should not be used to
require a business to maintain records regarding transactions
or activities to which it was not a party. The Managers
intend that those records that document the person from whom
food was directly received, and to whom food was
directly delivered, are adequate to enable identification
of the source and distribution of food. As a result, for
purposes of this section, the terms ``immediate previous
sources'' and ``immediate subsequent recipients'' refer to
the person from whom the food was received and the person
to whom the food was delivered, respectively.
The Managers did not adopt a Senate proposal to authorize
the Secretary to require the maintenance and retention of
other records for inspection relating to food safety, because
the Secretary has authority under section 701(a) of the FFDCA
to issue regulations for the ``efficient enforcement of this
Act'' and this authority, in combination with other
provisions (such as section 402), gives the Secretary the
authority to require appropriate record keeping in food
safety regulations.
Section 307. Prior Notice of Imported Food Shipments
House provision: The House bill directs the Secretary by
regulation to require importers of articles of food to
provide up to seventy-two hours, but not less than twenty-
four hours, prior notice that food will be imported or
offered for import into the United States. The House bill
requires that the notice contain the following information: a
description of food to be imported; the identity of the
manufacturer and shipper; and, if known within the specified
period of time that notice is required to be provided, the
identity of the grower; the country of origin of the article;
the country from which the food is being shipped; and the
anticipated port of entry into the United States. In the
event notice is not provided in advance of importation in
accordance with the Secretary's regulation, the food shall be
held at the port of entry until notice is properly provided
and the Secretary determines whether there is credible
evidence or information in his possession indicating that the
article presents a threat of serious adverse health
consequences or death to humans or animals.
Senate amendment: The Senate amendment, like the House
bill, includes a requirement that food importers provide
prior notice to the Secretary of incoming food imports. The
Senate amendment differs from the requirement in the House
bill, because the prior notice requirement in the Senate
amendment is self-effectuating upon enactment of the Act and
requires at least four hours minimum prior notice and no
limitation on the maximum notice allowable. The Senate
amendment requires that the notification contain the identity
of the food, the food's country of origin, the quantity
imported, and other information that the Secretary may
require by regulation. Finally, if an importer fails to
provide the required prior notice, under the Senate amendment
the Secretary is provided with discretion to refuse admission
into the United States of the food.
Conference substitute: The Conference substitute adopts the
House amendment with modification. The Conference substitute
requires the Secretary to establish by regulation the period
of time for prior notice, that must be no less than the
minimum amount of time necessary for the Secretary to
receive, review, and appropriately respond to the notice, but
that may not exceed five days. In determining the specified
period of time for prior notice, by regulation, the
Conference substitute identified several factors the
Secretary may take into account, including the effect on
commerce, the locations of various ports of entry, the
various modes of transportation, the types of food imported
into the United States, and other such considerations.
Nothing in the preceding sentence may be construed as a
limitation on the obligation of the Secretary to receive,
review, and appropriately respond to any notice under this
section.
The Conference substitute treats the failure to provide
adequate prior notice under this section as a prohibited act
under section 301 of the FFDCA. The Conference substitute
requires the Secretary to refuse admission to food imported
without properly providing prior notice in accordance with
this section until such prior notice is properly provided. In
addition, the Conference substitute requires the Secretary to
remove such food to
[[Page H2727]]
a secure facility, as appropriate and clarifies that imported
food that is refused admission under this section shall not
be delivered pursuant to the execution of a bond under
subsection (b) of section 801 of the FFDCA.
The Conference substitute directs the Secretary to
establish prior notice requirements for imported foods by
regulation not later than eighteen months after the date of
enactment of this Act. If such regulations are not effective
prior to the conclusion of such eighteen-month period, the
requirements of this section are self-executing and enter
into effect at such time and remain in effect unless
superseded by such final regulations. In addition, at the
conclusion of the eighteen-month period, if such final
regulations are not effective, the Conference substitute
establishes a default period of time for prior notice of not
less than 8 hours and not more than 5 days that remains in
effect unless superseded by such final regulations. The
Managers strongly encourage the Secretary to complete this
rule making in a timely manner in order to enable the
efficient operation of these requirements.
The Managers intend that the requirements of this section
should not be construed to apply to packaging materials if,
at the time of importation, such materials will not be used
for, or in contact with, food as defined under section 201 of
the FFDCA. Nothing in this section shall be construed to
alter or amend the regulatory treatment of food packaging
materials or food contact substances under the FFDCA. Also,
the Conference substitute requires the importer of an article
of food to provide information about the grower of the
article of food, but this provision only requires the
importer to provide the identity of the grower of the article
of food if known during the period of time in which prior
notice is required to be provided. Finally, the Secretary
shall consult and coordinate with the Secretary of Treasury
in developing the prior notice regulation. This section of
the Conference substitute contains prior notice requirements
for imported food and is not intended as a limitation on the
port of entry for an article of food.
Section 308. Authority to Mark Articles Refused Admission
into United States
House provision: The House bill requires that food that has
been refused admission to the United States, but has not been
ordered destroyed, may have a label affixed to its container
at the expense of the owner or consignee indicating that it
has been refused admission.
Senate amendment: The Senate amendment, similar to the
House bill, includes authority regarding the marking of food
that has been refused admission into the United States.
Unlike the House bill, the Senate amendment provides the
Secretary with a broader authority than the House bill to
mark foods as refused admission, including foods that have
not been determined to present a threat of serious adverse
health consequences or death to humans or animals. The Senate
contains an enforcement provision under which food that has
been refused admission but that has not been properly marked
as refused admission is treated as misbranded if it is
determined that it presents a threat of serious adverse
health consequences or death to humans or animals.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
provides the Secretary with discretionary authority to
require that items that have been refused admission to the
United States under section 801 of the FFDCA shall be so
marked. The Conference substitute clarifies that the marking
of such items may be applied to the container of the food.
The Conference substitute also requires the Secretary to
notify the owner or consignee of an article of food that has
been refused admission and that has been required to be so
marked under this section, if at some time subsequent to
requirement to mark the food, the Secretary determines that
the food is misbranded and presents a threat of serious
adverse health consequences or death to humans or animals.
Nothing in this section shall be construed to alter or
amend the authority of the Secretary to authorize the
admission of an article of food that has been relabeled,
reconditioned or otherwise brought into compliance with the
Act in accordance with subsection (b) of section 801 of the
Act.
Section 309. Prohibition Against Port Shopping
House provision: The House bill requires any person
attempting to re-offer for admission an article of food at a
port of entry into the United States, after it has been
previous refused admission at another port of entry into the
United States, to affirmatively establish that the food is
not adulterated.
Senate amendment: The Senate amendment contains a
prohibition against port shopping that is comparable to the
prohibition contained in the House bill. The Senate amendment
prohibits a person from port shopping with respect to food
that has been refused admission, by requiring that the person
show that food that has been refused admission previously,
has been brought into compliance with the applicable
requirements of the FFDCA.
Conference substitute: The Conference substitute adopts the
Senate amendment without modification.
Section 310. Notice to States Regarding Imported Food
House provision: The House bill requires that where the
Secretary has credible evidence or information indicating
that an article of food presents a threat of serious adverse
health consequences or death to humans or animals, the
Secretary shall provide notice regarding the threat posed by
such food to those States in which the food is held or will
be held and shall request that such States take appropriate
remedial action.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
clarifies the scope of the rule of construction included in
subsection (b) of this section.
Section 311. Grants to States for Inspections
House provision: The House bill authorizes the Secretary to
make grants for increased food safety inspections,
examinations, investigations and related activities and to
assist States in taking appropriate actions to respond to any
Federal notice received pursuant to section 309 (governing
notice to States) of the House bill. The House bill
authorizes to be appropriated such sums as may be necessary
for fiscal year 2002 through fiscal year 2006 to establish
and carry out the grants under the section.
Senate amendment: The Senate amendment authorizes the
Secretary to make grants to States, territories, and
Federally recognized tribes to cover the cost of food safety
examinations, inspections, investigations, and related
activities under section 702 of the FFDCA, and it authorizes
to be appropriated $10 million in fiscal year 2002 and such
sums as may be necessary for each year thereafter for such
purpose.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
extends the grants made available under this section to
Indian tribes to the extent they undertake inspections,
investigations or examinations under section 702 of the
FFDCA. The Conference substitute authorizes to be
appropriated $10 million in fiscal year 2002 and such sums as
may be necessary for each fiscal year 2003-2006 for such
purpose.
Section 312. Surveillance and Information Grants and
Authorities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment authorizes the
Secretary to award grants to States to increase participation
in Pulsenet, the Foodborne Diseases Active Surveillance
Network, and other such networks, and authorizes to be
appropriated $19.5 million in fiscal year 2002, and such sums
as may be necessary each year for such purpose from fiscal
year 2003 through fiscal year 2006.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Managers intend that
funds awarded under this section shall be used by States and
Indian tribes to assist in meeting the costs of establishing
and maintaining the food safety surveillance, technical and
laboratory capacity needed to participate in programs,
including Pulsenet, Foodborne Diseases Active Surveillance
Network, and other networks to enhance Federal, State, and
local food safety efforts.
Section 313. Surveillance of Zoonotic Disease
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Health and Human Services and the Secretary of
Agriculture to develop and implement a plan for the
surveillance of zoonotic and human disease.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
directs the Secretary, through the Commissioner of FDA and
the Director of the Centers for Disease Control and
Prevention (CDC), and the Secretary of Agriculture to
coordinate the surveillance of zoonotic diseases.
Section 314. Authority to Commission Other Federal Officials
to Conduct Inspections
House provision: The House bill does contain no analogous
provision.
Senate amendment: The Senate amendment includes authority
that is not included in the House bill that allows the
Secretary to commission officers and qualified employees of
other Federal Departments or Federal agencies to conduct
examinations and inspections for the Secretary under section
702 of the FFDCA.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
clarifies that the authority of the Secretary to commission
other Federal officials to conduct inspections, examinations
and investigations under section 702 of the FFDCA shall be
carried out pursuant to a memorandum of understanding between
the Secretary and the head of the Department or agency of
such other Federal employees.
Section 315. Rule of Construction
House provision: The House bill does contain no analogous
provision.
Senate amendment: The Senate amendment includes a rule of
construction that applies to the amendments made in Title V
of the Senate amendment that provides that such amendments do
not provide the FDA with additional authority over meat,
poultry, and egg products, nor do such amendments limit the
authority of the Department of Agriculture over such
products.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
[[Page H2728]]
clarifies that nothing in this Title, or an amendment made by
this Title, shall be construed to alter the jurisdiction
between the Secretary and the Secretary of Agriculture, under
applicable statutes and regulations.
Subtitle B--Protection of Drug Supply
Section 321. Annual Registration of Foreign Manufacturers;
Shipping Information; Drug and Device Listing
House provision: The House bill mandates annual
registration of foreign manufacturers engaged in the import
of drug and device products into United States. The House
bill also requires that the annual registration include
information on each importer or carrier transporting the
foreign manufacturer's drug or device products. The House
bill also directs that the registration and listing numbers
be included in the declaration for the products when offered
for import.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House bill with modification. The conference substitute
requires registration through electronic means. The
Conference substitute deletes carrier in the annual
registration and replaces with ``person who imports or offers
for import.'' The Conference substitute makes non-
registration a prohibited act rather than deeming it
misbranded. Non-registration is a failure to comply with the
Secretary's request to submit registration information. The
Conference substitute provides for a non-registered drug or
device to be removed to a secure facility until non-
registration is cured. For purposes of this section, the
Managers intend ``person who imports or offers for import''
to capture import brokers and other persons who file import-
related paperwork with the U.S. Customs Service or the FDA.
Section 322. Requirement of Additional Information Regarding
Import Components Intended for Use in Export Products
House provision: The House bill mandates a chain of
possession identification and a customs bond for those firms
that seek to import components of drugs, devices, food
additives, color additives, or dietary supplements for
further processing and export. The House bill requires
certificates of analysis for components containing any
chemical substance or biological substance intended for
export.
Senate provision: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House bill with modification. The Conference substitute
deletes reference to carriers in chain of possession
identification. The Conference substitute exempts devices and
products covered by section 801(d)(4) of the FFDCA from the
certificate of analysis requirement. The Conference
substitute clarifies that the provisions permitting import-
for-export do not apply to articles for which the Secretary
of Health and Human Services determines that there is
credible evidence or information indicating the article is
not intended to be imported for export.
The Managers understand this section does not change any
definitions of regulated articles or the scope of regulation
of those articles as set forth in the FFDCA and its
implementing regulations.
The Managers intend that this section shall not be
construed to restrict or facilitate the entry of articles
imported for research and development or quality assurance
purposes under subsection 801(d)(3) of the FFDCA beyond the
existing authority.
For the purposes of articles subject to subsection
801(d)(4) of the FFDCA, the Managers understand that the
collection agency would be considered the first manufacturer
under subsection 801(d)(3)(A)(i)(II) of the FFDCA, relating
to the chain-of-possession.
The Managers agree that certificates of analysis are not
required if the only chemical or biological component of the
article imported under subsection 801(d)(3) of the FFDCA is
de minimis, incidental and poses no danger to human or animal
health. Further, the Managers expect that the Secretary will
understand that ``certificate of analysis'' is a widely
understood and utilized document to assure the identity of
the substance and its components in the chemical and drug
industries. However, the Secretary in consultation with other
affected industries may accept documents that convey
equivalent assurance as to the identity of the article and
its components or substances. For example, the Secretary may
determine that for an article of food additive or color
additive, a document indicating specification of purity
serves as the functional equivalent of a certificate of
analysis and meets the requirement of a certificate analysis
for purposes of this section. This section exempts devices
and blood and blood products covered under subsection
801(d)(4) of the FFDCA from the certificate of analysis
requirement.
The Managers do not intend the Secretary of the Treasury to
engage in a new rulemaking to specify the requirement for the
bonding of goods imported under subsection 801(d)(3) of
FFDCA. Existing requirements for the bonding of goods
imported for further processing and export should be applied.
The Managers agree that articles imported for export under
this section 322 which otherwise meet the requirements of
this section should be permitted entry unless the Secretary
determines there is credible evidence or information that an
article offered for import is not intended to be imported for
export. In this regard, the Managers believe that refusal of
entry should not involve shipments between known shippers and
known recipients unless the Secretary has received credible
evidence or information that suggests such shipments may not
be legitimate. The Managers intend to permit the Secretary to
refuse admission of articles if the Secretary determines
there is credible evidence or information that the articles
may be used as instruments of terror. Such evidence might
include highly toxic or otherwise exceptionally dangerous
products going to recipients unknown to the Secretary or to
recipients believed to lack the capacity to further process
such dangerous articles, for example, nitroglycerin imported
under this section for delivery to a business other than a
pharmaceutical manufacturer. Such standard may also include,
for example, presentation for entry of articles not
consistent with the accompanying documentation.
Subtitle C--General Provisions Relating to Upgrading of Agricultural
Security
Section 331. Expansion of Animal and Plant Health Inspection
Service Activities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to enhance and expand the capacity
of the Animal and Plant Health Inspection Service (APHIS) to
protect against the threat of bioterrorism, including
through increased inspection capacity internationally,
improved surveillance at ports of entry, and enhanced
protections against terrorist use of plant and animal
disease organisms. The Senate amendment also requires the
Secretary of Agriculture to implement and then expand a
high-tech agriculture early warning and emergency response
system, as well as an automated record keeping system to
track animal and plant shipments. The Senate amendment
authorizes the appropriation of $30 million in fiscal year
2002 and such sums in each year thereafter, as may be
necessary for such purposes.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
clarifies that this section provides additional authorization
of appropriations to the Secretary of Agriculture to utilize
existing authorities to give high priority to enhancing and
expanding the capacity of APHIS to conduct the specified
activities and to otherwise improve the capacity of APHIS to
protect against the threat of bioterrorism. The Conference
substitute authorizes to be appropriated $30 million for
fiscal year 2002, and such sums as may be necessary for each
subsequent fiscal year.
Section 332. Expansion of Food Safety Inspection Service
Activities
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to enhance and expand the capacity
of the Food Safety Inspection Service (FSIS) to protect
against the threat of bioterrorism, including through
enhanced ability to inspect meat and poultry products and
increased inspections of meat and meat products, poultry and
poultry products, and egg products at ports of entry. The
Senate amendment authorizes the appropriation of $15 million
in fiscal year 2002 and such sums in each year thereafter, as
may be necessary for such purposes.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
authorizes to be appropriated $15 million in fiscal year 2002
and such sums in each year thereafter, as may be necessary
for the the purpose of providing additional authorization to
the Secretary of Agriculture to utilize existing authorities
to give high priority to enhancing and expanding the capacity
of FSIS to conduct the specified activities and to otherwise
improve the capacity of FSIS to protect against the threat of
bioterrorism.
Section 333. Biosecurity Upgrades at the Department of
Agriculture
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment authorizes to be
appropriated $180 million in fiscal year 2002 to update,
renovate, and expand the Department of Agriculture laboratory
and research facilities at Plum Island Animal Disease Center
and the Agricultural Research Service and Animal and Plant
Health Inspection Service facility in Ames, Iowa, and also
authorizes such sums as may be necessary in each year from
fiscal year 2003 through fiscal year 2006, for those
facilities, and for similar improvements at two other
Department of Agriculture facilities, one in Athens, Georgia,
and the other in Laramie, Wyoming.
Conference substitute: The Conference substitute adopts the
Senate amendment without modification. In addition to the
biosecurity upgrades at the Department of Agriculture
authorized in this section, the Managers intend that the
Secretary of Health and Human Services shall also continue to
take such actions as may be necessary to secure existing
facilities of the Department of Health and Human Services
where potential animal and plant pathogens are housed and
researched.
Section 334. Agricultural Biosecurity
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture to establish minimum security
standards and
[[Page H2729]]
award grants of up to $50,000 to land grant universities
to assess security needs and plan upgrades of both
security of facilities where hazardous biological agents
or toxins are stored or used, and communication networks
about such agents or toxins, as well as to develop a
national inventory of such agents and toxins. The Senate
amendment also requires the Secretary of Agriculture to
provide for screening of personnel who require access at
agricultural research facilities, and to develop and
implement educational programs directed at biosecurity at
agricultural facilities, including farms, livestock
confinement operations, and crop producers, handlers,
processors, and transporters, as well as educational
programs related to animal quarantine and testing. The
Senate amendment authorizes to be appropriated $20 million
in fiscal year 2002 and such sums in each year thereafter,
as may be necessary for such purposes.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
authorizes to be appropriated such sums as may be necessary
for the Secretary of Agriculture to award grants of up to
$50,000 each, to colleges and universities that have food and
agricultural science programs to review security standards
and practices at their facilities in order to protect against
bioterrorist threats. The Conference substitute also
authorizes the Secretary of Agriculture to award grants, of
up to $100,000 per association, to associations of food
producers or consortia of such associations for the
development and implementation of educational programs to
improve bio-security on farms against bioterrorist attacks.
Section 335. Agricultural Bioterrorism Research and
Development
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment requires the
Secretary of Agriculture, to the maximum extent practicable,
to expand research and development programs of the
Agricultural Research Service and the Cooperative State
Research Education and Extension Service to protect the
nation's food supply from bioterrorism, including by
enhancing their capability to respond to the needs of other
food and agricultural regulatory agencies, continuing
existing partnerships with institutions of higher education
with programs related to agricultural biosecurity, and by
strengthening linkages with the intelligence community. The
Senate amendment authorizes the appropriation of $190 million
in fiscal year 2002 and such sums in each year thereafter, as
may be necessary for such purposes.
Conference substitute: The Conference substitute adopts the
Senate amendment with modification. The Conference substitute
authorizes to be appropriated $190 million in fiscal year
2002 and such sums in each year thereafter, as may be
necessary for the Secretary of Agriculture to utilize
existing research authorities and programs to protect the
food supply of the United States by conducting various
research activities, including developing new and continuing
partnerships with institutions of higher education and other
institutions to establish and enhance bio-security and food
safety programs, with special emphasis on vulnerability
analyses, incident response, detection and prevention
technologies. The Conference substitute also authorizes the
Secretary of Agriculture to continue research to develop
improved rapid detection field test kits to detect biological
threats to plants and animals for use in responding to
bioterrorism, and to develop an agriculture bioterrorism
early warning surveillance system by enhancing the capacity
of and coordination between State veterinary diagnostic
laboratories, Federal and State agricultural research
facilities, and public health agencies.
Section 336. Animal Enterprise Terrorism Penalties
House provision: The House bill contains no analogous
provision.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute amends
section 43(a) of title 18, United States Code, establishing a
Federal criminal offense against a person traveling in
interstate or foreign commerce for intentionally damaging or
causing the loss of any property used by the animal
enterprise, or conspiring to do such activities. The
Conference substitute establishes penalties for such criminal
offense and authorizes restitution for economic damage
resulting from the loss.
TITLE IV--DRINKING WATER SECURITY AND SAFETY
The conference agreement builds upon title IV of the House
bill to ensure that drinking water systems across the country
assess their vulnerability to terrorist attack and develop
emergency plans to prepare for and respond to such attacks.
Americans deserve to know that the water they drink everyday
is safe. The legislation will lay the groundwork for
developing the necessary information, and emergency planning
and response efforts that are needed to address potential
terrorist attacks at drinking water systems.
Section 401. Terrorist and Other Intentional Acts
House provision: The House bill requires community water
systems serving over 3,300 persons to conduct vulnerability
assessments. These requirements are phased-in, depending on
the size of the community water system. Community water
systems serving over 100,000 persons must complete a
vulnerability assessment by December 31, 2002; community
water systems serving over 50,000 persons must complete a
vulnerability assessment by June 30, 2003; community water
systems serving over 3,300 persons must complete a
vulnerability assessment by December 31, 2003. Each community
water system must certify to the Administrator of the
Environmental Protection Agency (EPA) that they have
conducted a vulnerability assessment. The Administrator of
EPA is also required to provide baseline information by June
1, 2002 regarding which kinds of terrorist attacks or other
intentional acts are probable threats.
The House bill also requires community water systems to
prepare or revise emergency response plans that incorporate
the results of the vulnerability assessments. Community water
systems must certify to the Administrator of the
Environmental Protection Agency within 6 months of the
completion of a vulnerability assessment that they have
completed an emergency response plan. To the extent possible,
community water systems are to coordinate with Local
Emergency Planning Committees when preparing or revising an
emergency response plan. The House bill additionally requires
EPA to provide guidance to community water systems serving
under 3,300 persons on how to conduct vulnerability
assessments and prepare emergency response plans.
In order to carry out the provisions of the section, the
House bill authorized $120 million in Fiscal Year 2002 and
such sums as necessary in Fiscal Years 2003 and 2004. The
funds are made available for purposes of complying with
vulnerability assessment and emergency response plan
requirements and to address basic security enhancements of
critical importance and significant threats to public health
as determined by a vulnerability assessment.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with modifications. The Conference substitute
extends dates for certifying that systems have completed a
vulnerability assessment by three months for systems serving
over 100,000 persons and by six months for all other systems.
The substitute also extends the time for EPA baseline
information to August 1, 2002 to reflect the passage of time
between House action and conference agreement.
The Conference substitute also adds the requirement that
community water systems provide a copy of their vulnerability
assessment to the Administrator of the EPA. Under the
conference substitute, however, information that is provided
by a community water system to EPA and information that is
derived thereof is exempt from disclosure under the Freedom
of Information Act except for information that identifies the
community water system and the date on which a community
water system certifies to EPA that it has completed a
vulnerability assessment. In addition, no community water
system shall be required under State or local law to provide
an assessment to any State, regional or local governmental
authority solely by reason of the requirements to submit such
assessment to the Administrator of EPA.
The Administrator of the EPA is also required, by November
30, 2002 to develop protocols to protect the assessments from
unauthorized disclosure. These protocols shall ensure that
all assessments and information are kept in a secure
location, only individuals designated by the Administrator
have access and that assessment in whole or in part or
information contained or derived from such assessments shall
not be available to anyone other than individuals designated
by the Administrator.
The Conference substitute also provides that any individual
designated by the Administrator who acquires assessments or
information derived from assessments and who knowingly or
recklessly reveals such information other than to an
individual designated by the Administrator shall be subject
to up to 1 year imprisonment, or a fine in accordance with 16
U.S.C. 227 and shall be removed from Federal office or
employment unless the information is revealed for purposes of
section 1445 of the Act, or actions taken under section 1431
of the Act, or for use in any administrative or judicial
proceeding to impose a penalty to failure to comply with
section 1433 of the bill. The substitute further provides
that an individual designated by the Administrator who is an
employee or officer of the United States may discuss the
content of a vulnerability assessment submitted under this
section with a State or local official. The Conference
substitute provides that nothing authorizes any person to
withhold any information from Congress.
The Conference substitute adds the requirement that each
community water system maintain a copy of the emergency
response plan it has completed for 5 years after it certifies
to the Administrator of the EPA that it has completed such
plan. The Conference agreement also increases authorized
funding for Fiscal Year 2002 to $160 million and adds
additional specification of basic security enhancements. The
Conference Agreement also extends authorizations in this
section through Fiscal year 2005. Finally, the Conference
agreement provides that not more than $5,000,000 of the funds
made available under the section may be used by the
[[Page H2730]]
Administrator of EPA for immediate and urgent security needs
and for grants for community water systems under 3,300 in
accordance with the guidance provided by EPA under the
section.
Section 402. Other Safe Drinking Water Act Amendments
House provision: The House bill provides for a review of
current and future methods to prevent, detect and respond to
the intentional introduction of chemical, biological and
radiological contaminants into community water systems and
source water for community water systems. The review is to
encompass methods and means to detect contaminants, to
provide sufficient notice of contaminated drinking water, to
negate or mitigate deleterious effects on public health and
to conduct biomedical research.
The House bill also provides for a review of methods and
means by which terrorists or other individuals or groups
could disrupt the supply of safe drinking water or render a
public water system significantly less safe for human
consumption. The House bill required a review of the methods
and means by which pipes, constructed conveyances,
collection, pretreatment, storage or distribution facilities
would be destroyed or otherwise prevented from providing
adequate supplies of drinking water and methods and means by
which they could be protected. The House bill also required a
review of methods and means by which such items could be
subjected to cross-contamination and a review of methods and
means by which alternative supplies of water could be
provided in the event of destruction, impairment or
contamination of public water systems. The House bill
authorized $15,000,000 in Fiscal Year 2002 to carry out
sections 1434 and 1435 and such sums as may be necessary for
Fiscal Years 2003 and 2004.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The Conference substitute adopts the
House provision with modifications. The Conference substitute
includes further specification in section 1434 as to the
detection of various levels of contaminants and indicators of
contaminants using methods, means and equipment that include
real time monitoring systems. The Conference substitute
additionally requires methods and means for developing
education and awareness programs for community water systems.
The conference substitute also adds additional
specification to the reviews undertaken under section 1435 to
include methods and means by which information systems,
including process controls, supervisory control and data
acquisition and syber systems could be disrupted by
terrorists or other groups. The Conference substitute also
includes additional requirements and considerations that are
applicable in the implementation of sections 1434 and 1435.
These requirements and considerations include the assurance
that reviews reflect the needs of various community water
system sizes and geographical locations, the vulnerability of
regions or service areas, including the National Capitol
area, and that the Administrator of EPA disseminate certain
information through the Information Sharing and Analysis
Center. The Conference substitute also provides such sums as
may be necessary in Fiscal Year 2005.
Section 403. Miscellaneous and Technical Amendments
House provision: The House bill provides that section 1433
be included as a cross-reference in section 1414(i)(1) on the
Safe Drinking Water Act (SDWA), that section 1431 of the SDWA
be amended, that existing penalties for tampering with
drinking water systems under section 1432 be increased and
that section 1442 of the SDWA be amended to provide
authorization for $35 million in Fiscal Year 2002 and such
sums as may be necessary in fiscal years thereafter.
Senate amendment: The Senate amendment contains no
analogous provision.
Conference substitute: The conference substitute adopts the
House provisions. The conferees encourage the committees of
jurisdiction in the House and Senate to develop comparable
legislation covering publicly owned treatment works in this
legislative session. The conferees encourage EPA to work
closely with organizations representing small and rural water
systems to implement the provisions of this Title.
TITLE V--ADDITIONAL PROVISIONS
The Managers agree to the following provisions.
Subtitle A--Prescription Drug User Fees
Section 501. Short Title
Designates the name of this title as the ``Prescription
Drug User Fee Amendments of 2002.''
Section 502. Findings
Declares the findings of Congress related to the
reauthorization of prescription drug user fees.
Section 503. Definitions
The following terms in section 735 of the Federal Food,
Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 379g) are
modified by this section: human drug application,
prescription drug product, process for the review of human
drug applications, and adjustment factor. These modifications
are necessary to give effect to the changes instituted by the
reauthorization of the Prescription Drug User Fee Act
(PDUFA).
The term ``human drug application'' is modified to make a
technical correction.
The term ``prescription drug product'' is modified to allow
the Secretary to use the Prescription Drug Product List (the
active portion) in the ``Approved Drug Products with
Therapeutic Equivalence Evaluations,'' (the Orange Book) as
the basis for identifying which products should be considered
to be prescription drug products for fee assessment purposes.
The Managers expect that these proposed changes will lead to
a more efficient, less burdensome, billing procedure. Under
current law, any prescription drug product eligible for drug
listing is subject to product fees. Determining eligibility
for listing is administratively complex and sometimes
resource intensive. In addition, listing is often controlled
by a re-packer or distributor rather than by the sponsor, but
the sponsor must nonetheless pay the product fee. The
Managers expect that the use of the Orange Book, which is
found on FDA's Internet site, as the basis to identify
products for user fee assessment purposes will not be
construed to affect the legal status of the book or the
products in the book. The purpose of using this method is
merely a tool for the Secretary to provide a public,
efficient billing process. It also provides sponsors an
easier way to remove products from the list that is the basis
for billing.
Also, the addition of the reference to the list of products
approved under human drug applications under section 351 of
the Public Health Service Act created and maintained by the
Secretary refers to the current FDA method of identifying
biological products considered to be prescription drug
products for fee assessment determinations. The Managers do
not intend this to be a change in practice; rather it
documents FDA's current practice. The list is to be provided
on FDA's Internet site.
A further change to the term ``prescription drug product''
deletes the clause ``does not include a large volume
parenteral drug product approved before September 1, 1992.''
As a result, any large volume parenteral (LVP) product is
treated as a prescription drug product and is subject to a
fee. However, when coupled with a corresponding change
proposed to section 736(a)(3)(B), all LVP's would be
exempt from product fees in this reauthorization,
including products approved after September 1, 1992. The
Managers intend this change to decrease FDA's
administrative burden in determining which products should
be billed.
The term ``process for the review of human drug
applications'' is modified to allow the use of funds, for a
period of up to three years after approval, to cover risk
management activities for products approved after October 1,
2002. This change is highly important to the Managers, as
improving drug and biological product safety is a goal shared
by all.
The term ``adjustment factor'' is modified to eliminate
obsolete provisions.
Section 504. Authority to Assess and Use Drug Fees
Subsection (a) of this section allows fees authorized by
the Act to be assessed beginning on October 1, 2002. With
respect to prescription drug establishment fees and
prescription drug product fees, the subsection advances the
date by which fees are payable to October 1 of each year.
Under the second Prescription Drug User Fee Act (PDUFA),
prescription drug establishment and product fees, which
represent two-thirds of PDUFA fees were due January 31, four
months into the fiscal year. This necessitated carrying
forward funds from a previous year to sustain operations for
the first four months of each new fiscal year. By advancing
the date for annual fees to be paid to FDA, the necessity of
carrying forward these large cash surpluses from year to year
is eliminated. Also, by making this change effective for FY
2003, FDA will have access to revenue as early in FY 2003 as
invoices can be issued and fees collected rather than having
to wait until January 31 to collect funds. This is especially
important for FDA operations in FY 2003 because the agency
does not expect to have any appreciable carryover funds at
the end of FY 2002.
Making the fee due and payable on October 1 necessitates
other changes to the FFD&C Act that are executed in
subsection (e) and (f) of this section.
This section sets forth a table containing the application,
establishment, and product fee revenues, and total fee
revenue, for fiscal years 2003 through 2007. The subsection
further authorizes an increase in fee revenue amounts to
fully fund the portion of additional costs attributable to
the cost of the retirement of Federal personnel. This
provision would go into effect, if, after the enactment of
the Prescription Drug User Fee Amendments of 2002,
legislation is enacted requiring the Secretary to fund
additional costs of the retirement of Federal personnel.
This section also authorizes inflation adjustments,
workload adjustments, and a final year adjustment. Under
present law, annual inflation adjustments were based on the
higher of the federal pay raise applicable for employees in
the fiscal year for which the fees were set or the CPI for
the previous year. In order to collect fees on October 1, FDA
will have to set fees and issue invoices in August of each
year well before the pay-raise determination for the next
fiscal year is made. For this reason the inflation adjustment
factors have been changed to the Federal pay raise for
employees in the Washington, D.C., area for the previous
fiscal year or the change in the CPI for the 12 month period
ending June 30, whichever is higher. Both of these figures
will be available in August when fees must be set. As has
been the
[[Page H2731]]
case in the past, these inflationary changes will continue to
be cumulative and compounded.
Under the workload adjustment, annual revenue adjustments
are made that reflect changes in review workload, after
inflation adjustments. the workload adjustment is to be
determined by the Secretary based on a weighted average of
the changes in the total number of (1) human drug
applications, (2) commercial investigational new drug
applications, (3) efficacy supplements, and (4) manufacturing
supplements. The subsection provides that the Secretary shall
publish in the Federal Register the fees resulting from this
adjustment and the supporting methodologies. Each of the 4
components used to develop the workload adjustment is a
defined category of applications that FDA currently counts.
Each component will be given a weighting factor that
corresponds to its percent of FDA review workload.
The workload adjustment envisioned for each component has
as its base the average number of applications of each
particular type that FDA received over the five-year period
of current law. It requires that a rolling average of
submissions also be calculated each year for the latest five-
year period that ends on June 30 before the end of each
fiscal year beginning on or after October 1, 2002. The
percent change in the latest five-year average, compared to
the base year is then multiplied by the weighting factor for
that component. Then all four components of the workload
adjuster are added together and the total percent that
results is the workload adjuster that will be used to further
adjust the inflation-adjusted statutory revenue levels each
year after FY 2003. Use of five year rolling averages in
this process dampens the impact of revenue fluctuations--
both up and down.
Under this section, the revenue adjuster will never result
in lower revenues than the inflation-adjusted statutory
revenue levels. Nonetheless, in years when fee-paying
applications fall below projections, FDA will automatically
experience a shortfall in revenues due to the shortfall in
fee-paying applications. Further downward adjustment of the
revenues would over-compensate for such a decline in workload
and is not authorized under the subsection. This is a lesson
learned from experience during 1998 through 2002. If such a
model had been in place for the past five years, revenues
during PDUFA II would have been much more predictable year to
year rather than exhibiting the volatility FDA experienced.
Also under this section, FDA is allowed to make a one-time
increase in fees in FY 2007, if necessary, to assure that the
agency will have no less than three months of operating
reserves on hand at the end of FY 2007, when this legislation
will expire. This final year adjustment will allow the agency
sufficient fees to operate for up to 3 months in FY 2008 if
there is any delay in the reauthorization of PDUFA at the end
of FY 2007. Further, delaying this payment from industry
until FY 2007 minimizes the need for FDA to carry large
balances over from year to year, reducing industry outlays
until they are necessary to support operations.
Finally, this section provides that application, product,
and establishment fees are to be established 60 days before
the start of the fiscal year based on the revenue amounts
previously established in this section.
Under subsection (d), the waiver or fee reduction for
supplements filed under section 505(b)(1) of the FFD&C Act is
eliminated.
In this section the word ``assessed'' in section 736(f) of
the FFD&C Act has been changed to ``retained.'' This change
is part of a series of changes made to permit FDA to issue
invoices and collect fees before an appropriation is actually
made for the fiscal year. The change maintains the original
intent of this and related provisions, however, by providing
that the conditions originally specified in these sections
must be fulfilled once all appropriations for the fiscal
year, including any supplemental appropriations, are enacted.
If the conditions are not fulfilled, FDA may not retain the
fees it collects. Further, under this section, the word
``collected'' in section 736(g)(2)(A) of the FFD&C Act is
changed to ``retained.'' Once again, this change is part of a
series of changes made to permit FDA to issue invoices and
collect fees before an appropriation is actually made for the
fiscal year. The change maintains the original intent of this
and related provisions by asserting that the conditions
originally specified in these sections must be fulfilled once
all appropriations for the fiscal year, including any
supplemental appropriations, are enacted.
This section also responds to the problems associated with
FDA's inability under the FFD&C Act to collect and spend fees
in any year that FDA fails to spend from appropriations as
much as it spend in FY 1997, adjusted for inflation. Failing
to meet this obligation by as little as one dollar causes FDA
to lose the authority to collect application, product and
establishment fees for a given fiscal year. The consequence
of failing to meet this ``trigger'' would be catastrophic.
Since the trigger is based on the amount FDA spends, the
agency can never identify exactly how much it has actually
spend until after the end of the fiscal year. As a result,
FDA consistently overspends by a substantial amount to be
certain that FDA expenditures do not fall below the trigger
amount and thereby cause the agency to lose the authority to
collect fees.
Modifications to section 736(g)(2)(B) are proposed to
provide FDA a margin of error in its effort to meet this
requirement of the law. This section is being modified so
that if FDA's spending is within five percent of the amount
required by this section of the Act, the requirement of this
section is considered to be satisfied. If FDA under-spends by
three percent or less, there are no consequences. If FDA
under-spends by more than three percent but not more than
five percent, FDA will be required to reduce collections in
the fiscal year following the subsequent fiscal year by the
amount in excess of three percent by which FDA under-spent
from appropriations. The intent is to relieve FDA of the need
to overspend from appropriations each year, as it has done
consistently since 1993 to assure that this trigger is met.
Spending from appropriations on the drug review process each
year is still expected to be at or very close to the amount
specified by this trigger, and may never be more than five
percent below the trigger amount.
This section also authorizes appropriations for fiscal
years 2003 through 2007 in amounts consistent with the total
fee revenue amounts set forth in subsection (b).
Section 505. Accountability and Annual Reports
This section for the first time requires the agency to meet
with interested public and private stakeholders when
considering the reauthorization of this program before its
expiration. The Managers believe that the agency will be in
the best position to recognize what best serves the public
health by meeting with representatives of consumer and
patient advocacy groups, industry, the Congress, health care
professionals, and academic experts prior to the next
reauthorization of PDUFA. Further, the Managers believe that
it is very important for the agency to make any
recommendations to the Congress public, so this section
requires that the FDA both publish the recommendations, as
well as hold a public hearing at which time the agency can
receive public feedback.
This section also requires an annual Performance Report and
a Financial Report.
Section 506. Reports of Postmarketing Studies
Under this section, the Managers intend that in instances
wherein a study subject to the reporting requirements of
Section 130 is not completed by the original or otherwise
negotiated deadline agreed upon by the sponsor and if the
reasons for such failure to complete the study were not
satisfactory to the Secretary, the Secretary shall so note on
the agency website. The Managers intend that the Secretary
would not find the delay or termination of a study
unsatisfactory if the Secretary determined that the delay or
termination occurred through no fault of the sponsor (such as
ethical concerns, or the study is no longer needed).
This section also empowers the Secretary to require a
sponsor of a study required under section 505(b)(2)(A) or
sections 314.510 or 601.41 of Title 21, Code of Federal
Regulations, to notify health care practitioners who
prescribe such drugs or biological products of the sponsor's
failure to complete the study, and the questions of clinical
benefit and, where appropriate, questions of safety, that
remain unanswered as a result of such failure. The Managers
intend that this authority not be utilized in cases where,
through no fault of the sponsor (such as ethical concerns, or
the study is no longer needed), the study has been delayed or
terminated.
Section 507. Savings Clause
This section authorizes user fees to be assessed and
collected after October 1, 2002 for human drug applications
and supplements accepted for filing prior to October 1, 2002.
For example, in the event that application fees are owed but
have not been collected prior to the expiration date for
PDUFA II established by section 107 of the Food and Drug
Administration Modernization Act (FDAMA), the section will
allow these fees to be collected after October 1, 2002. The
section further authorizes assessment and collection of
product and establishment fees after October 1, 2002 that are
owed but have not been collected.
Section 508. Effective Date
Section 508 provides that the Prescription Drug User Fee
Amendments of 2002 shall take effect October 1, 2002.
Section 509. Sunset Clause
Section 509 provides that the amendments made by sections
503 (relating to definitions) and 504 (relating to the
authority to assess and use drug fees) shall cease to be
effective on October 1, 2007.
The section further provides that the amendments made by
section 505 (relating to annual reports) shall cease to be
effective 120 days after October 1, 2007. The additional 120
days will allow the prescription drug user fee reports for
fiscal year 2007 to be prepared and submitted.
Subtitle B--Additional Authorizations of Appropriations Regarding Food
and Drug Administration
Section 521. Office of Drug Safety
This section will help the FDA fulfill its vitally
important role of ensuring drug safety. The Managers are
highly supportive of the postmarket surveillance activities
conducted by the Office of Drug Safety (ODS), and to that end
other provisions in this legislation ensure for the first
time that user fee monies will be available for postmarket
purposes. This section complements those efforts by ensuring
that not only will new user fee monies be available for
this very important purpose, but so will new appropriated
monies.
[[Page H2732]]
Section 522. Division of Drug Marketing, Advertising, and
Communications
This section provides an increased authorization for the
Division of Drug Marketing, Advertising, and Communications
(DDMAC) within the Office of Medical Policy, Center for Drug
Evaluation and Research at the FDA. DDMAC plays a vital role
in ensuring that promotional drug material is not false or
misleading, and they do so on a limited budget. The
authorized amounts will better ensure that DDMAC can perform
its mission.
Section 523. Office of Generic Drugs
This section provides an increased authorization for the
Office of Generic Drugs (OGD) within the Center for Drug
Evaluation and Research at the FDA. OGD is vitally important
to ensuring that Americans have access to safe, effective
generic drugs. This Office needs increased funding, however,
due to the fact that it presently takes OGD nearly 18 months
to review the typical ANDA. This section will lead to
increased funding, so that these review times can be
decreased without compromising health and safety.
Subtitle C--Additional Provisions
Section 531. Transition to Digital Television
In an effort to further promote the orderly transition to
digital television, and to promote the equitable allocation
and use of digital channels by television broadcast
permittees and licensees, the Managers direct the Federal
Communications Commission, at the request of an eligible
licensee or permittee, to, within 90 days after the date of
enactment of this Act, allot, if necessary, and assign a
requested and identified paired digital television channel to
that licensee or permittee. In order to avoid any undue
burden to the Commission, which is required to allot and
assign the paired digital television channel within a short
timeframe, the Managers expect all eligible applicants to
file their applications as soon as practicable after the date
of enactment. The FCC shall only do this if such channel can
be allotted and assigned without further modification of the
tables of allotments as set forth in sections 73.606 and
73.622 of the Commission's regulations (47 CFR 73.606,
73.622) and such allotment and assignment is consistent with
the Commission's technical rules (47 CFR part 73). The only
licensees or permittees eligible for this digital allotment
are those that are full power television broadcast licensee
or permittees (or their successors in interest) that had an
application pending for an analog television station
construction permit as of October 24, 1991, which application
was granted after April 3, 1997; and as of the date of
enactment of this Act, is the permittee or licensee of that
station. This provision enables such licensees or permittees
an opportunity to realize their expectations created by prior
FCC action to foster a digital audience during the transition
period to digital television without having to terminate
abruptly analog service now enjoyed by their viewers. Without
this change, those broadcast licensees or permittees would be
denied the flexibility to operate an analog and a digital
facility simultaneously in the near term, especially in a
major market. This is contrary to the Congressional goals of
increasing competition and accelerating the digital
television transition. The Managers are ensuring that
eligible licensees or permittees will meet the intended
objectives by doing two important things. First, the Managers
impose an unequivocally hard 18-month deadline for the
construction of the digital facility from the time of the
FCC's issuance of the construction permit for the new digital
channel. In this regard, eligible licensees are absolutely
prohibited from obtaining or receiving an extension of time
from the Commission pursuant to 47 C.F.R. 73.624(d)(3).
Second, the Managers safeguard against eligible licensees
from using the newly granted ``in-core'' digital channel
allotment and assignment to provide analog service.
Section 532. 3-Year Delay in Lock in Procedures for
Medicare+Choice Plans; Change in Medicare+Choice
Reporting Deadlines and Annual, Coordinated Election
Period for 2003, 2004, and 2005
This section changes the deadline for Medicare+Choice plans
to submit information to the Secretary on Medicare benefits,
premiums, cost sharing, supplemental benefits, and actuarial
values of such coverage from July 1 to the second Monday in
September for the years 2002, 2003, and 2004. It would
also delay the annual election period for Medicare
enrollees to select a M+C plan to the period of time
beginning on November 15 and ending on December 31 in
2002, 2003, and 2004. This section also delays the phase
in of the limitation on Medicare beneficiaries changing
health plans more than once a year (the ``lock-in''). This
requirement, enacted in the Balanced Budget Act of 1997,
was scheduled to phase in incrementally beginning in 2002.
The substitute would postpone the lock-in requirements
until 2005.
From the Committee on Energy and Commerce, for consideration
of the House bill and the Senate amendment, and modifications
committed to conference:
Billy Tauzin,
Michael Bilirakis,
Paul E. Gillmor,
Richard Burr,
John Shimkus,
John D. Dingell,
Henry A. Waxman,
Provided that Mr. Pallone is appointed in lieu of Mr. Brown
of Ohio for consideration of title IV of the House bill, and
modifications committed to conference:
Sherrod Brown,
Frank Pallone, Jr.,
From the Committee on Agriculture, for consideration of title
II of the House bill and sec. 216 and title V of the Senate
amendment, and modifications committed to conference:
Larry Combest,
Frank D. Lucas,
Saxby Chambliss,
Charles Stenholm,
Tim Holden,
From the Committee on the Judiciary, for consideration of
title II of the House bill and secs. 216 and 401 of the
Senate amendment, and modifications committed to conference:
F. James Sensenbrenner, Jr.,
Lamar Smith,
John Conyers, Jr.,
Managers on the Part of the House.
Edward Kennedy,
Chris Dodd,
Tom Harkin,
Barbara A. Mikulski,
Jim Jeffords,
Judd Gregg,
Bill Frist,
Mike Enzi,
Tim Hutchinson,
Managers on the Part of the Senate.
____________________