Introduction of New Food Safety Legislation


                                            Release No. 0298.97
REMARKS

                               of
                     Secretary Dan Glickman
          Introduction of New Food Safety Legislation
              USDA Headquarters -- August 29, 1997

     Thank you all for joining me. One week ago, I made a promise to the
American people that when Congress returned from the August recess, I would
have ready for them legislation to enhance USDA's authority to improve the
safety of America's meat and poultry. 

     I have the bill right here. It basically does 3 things. It gives USDA
the authority to:

     order mandatory recalls of suspect meat and poultry;

     impose civil fines against plants and processors that violate USDA's
     food safety laws;

     and expedite our existing authority to withdraw inspectors and shut
     plants down where there is a  willful' violation -- where people knew
     what was right, and still did what was wrong -- or repeat violations.
     We need to be able to move decisively in these cases.

     We've asked for these authorities before, but I think the dynamics of
the debate have changed a bit in light of recent events. My sense is that
the vast majority of people had no idea that industry -- and not federal
food safety experts -- ultimately decide whether food is recalled when the
public safety is compromised. That's something that I just don't sits real
well with folks out in the country.

     These enforcement tools are critical for 3 reasons: 1) They're a
persuasive incentive to do things safely from the start ... to be extra
careful to avoid the high-risk practices that trigger these actions. 2) We
have tough new safety standards coming down the pike. Industry's going to be
responsible for meeting the new, higher standards, and these tools that we
are asking for will allow us to hold industry accountable for doing that.
And 3) These penalties come into play when we know the public's health has
been put at risk. Once we know there is a problem, let me tell you: The
clock starts ticking. 

     Under this new law, we will still give industry the opportunity to
make the recall voluntarily. The difference is: In those circumstances where
they refuse, we can order the recall and that is critical. We don't have
much time for a protracted debate over how much product should be recalled.
We don't have time for a snail's-pace procedure to stop a plant's production
until they clean up their act. Once the experts make the determination that
these steps are necessary, we need to move quickly. Every minute we wait is
another minute a person could become ill or worse. That's something that
weighs very heavily on our minds every time we deal with an outbreak. These
new tools will ensure a rapid response throughout the commercial food chain
-- plants, processors, retailers, restaurants.

     I should also add that it's my understanding that the Food and Drug
Administration will soon introduce sister legislation -- through their
committees -- seeking similar authorities for food.

     I am also today sending to Congress a request that they fully fund
President Clinton's Food Safety Initiative. This is clearly an area where we
need and the American people want more money invested. Overall, USDA's food
safety budget has fared quite well in Congress. But 2 critical areas remain
underfunded: Consumer education and research into new food safety
technologies. Advances in these areas could dramatically reduce food-borne
illnesses. I ask that Congress fully fund these efforts at the levels laid
out in the President's budget.

     I'd also like to emphasize that these actions we're taking today are
not the last step on food safety; they're simply the next step. There's a
whole lot more we can and will do.

     When it comes to food safety, this Administration's philosophy from
day one has been: We are never done ... Whether we just revolutionized meat
and poultry inspections or launched the President's food safety initiative,
the first question is always: What next?
 
     We have learned a lot from the events of the last 2 weeks. This
     legislation is not, however, about any specific company. It's about
     our basic enforcement tools to help ensure that America's food is
     safe. Without question, we're going to learn more and do more once we
     can move forward responsibly with all the facts in hand. For example,
     rework -- the practice of carrying over beef from one shift's
     production to the next -- is one area that might very well be ripe for
     stricter standards. 

     We're also doing research into on-farm practices to improve food
     safety. This is an area that's getting more and more attention and
     concern, and we're going to have to find a way to address it
     responsibly.

     We're also going to be taking a hard look at the role of our
     inspectors. Their work will be even more critical under HACCP-- the
     new meat and poultry inspection system. HACCP asks each plant to come
     up with its own safety plan that identifies where contamination might
     occur and prescribes specific steps to close those safety gaps.
     Inspectors must ensure that the plans are put into practice and that
     they work, so they will do a whole lot more than just eyeballing the
     carcasses.  

     I'm also going to ask industry leaders into my office for a post-mortem on the whole recall issue of the last couple weeks, so we can
     seek ways to learn from this experience. I'll ask them and all plants
     to find ways to accelerate their adoption of HACCP. I think we'll see
     a very positive response, and not because I asked for it, but because
     today's consumers demand it. After all, consumers are the marketplace.
     In an era of heightened public awareness of food safety issues, I
     think we're going to see consumer and industry interests coalesce --
     move into much closer alignment for a simple reason: Safe food sells.
     That's why we see some companies way out front in terms of their food
     safety standards. It's responsible business, and it pays off.

     Most folks don't know this but meat and poultry together comprise more
than half of the gross sales of American agriculture. Consumer confidence is
critical to their success. So every responsible step we take on food safety
protects the American people and protects this industry.

     Between the advances of science and stepped-up government vigilance,
food safety has really come a long way. It was not too long ago that the
government's basic message was: Cook your food well. Now, we're doing much
more. We're erecting barrier after barrier to contamination, working from
farm to table to keep food safe.

     I think the fairly minimal impact that the Hudson recall has had on
people's appetites is a reflection of just how far we have come. People have
confidence in their food. By and large, they do trust that government --
working with consumer groups, with industry, and with Congress -- is looking
out for them. 

     These actions, and the many more to follow, are designed to
consistently earn Americans' confidence that their food is the safest in the
world. 

     Given that confidence, I'd like to encourage all Americans to go out
and enjoy their Labor Day picnics. I'd like to remind consumers that fully
cooked is the way to go. I hope well-done are the burgers of choice at your
barbeque. I'll bet this year, they'll be the most popular pick. That's a
good thing. Consumers are much more aware and able to enjoy good, safe food
-- and that's something we can all celebrate. 

Thank you, and I'd be glad to take your questions.




                  SECTION-BY-SECTION-ANALYSIS
        FOOD SAFETY ENFORCEMENT ENHANCEMENT ACT OF 1997

     Section 1.  Section 1 would provide that the Act may be cited as "The
Food Safety Enforcement Enhancement Act of 1997".

     Section 2.  Section 2 would amend the Federal Meat Inspection Act
(FMIA) by redesignating the current section 411 as section 414 and adding
three new enforcement provisions related to notification and recall of
products, the refusal and withdrawal of inspection, and the assessment of
civil penalties.

     Section 411, Notification and Recall, would require persons, firms, or
corporations to notify the Secretary of the identity and location of
adulterated and misbranded products.  Further, section 411 would provide the
Secretary with authority to issue orders to cease distribution of and to
recall adulterated and misbranded products if there is a reasonable
probability of a threat to public health.  Section 411 would provide a
mechanism to prevent such articles from reaching consumers.

     Section 411(a) would require any person, firm, or corporation which
has a reasonable basis for believing that any carcasses, parts of carcasses,
meat, or meat food products are adulterated or misbranded to immediately
notify the Secretary of the identity and location of such articles.  The
immediate notification of the identity and location of articles believed to
be adulterated or misbranded is necessary to provide the Secretary with the
opportunity to limit the distribution of such articles, and possibly avoid
human illness.  The Secretary would prescribe by regulation the means and
manner that notification is to be provided.

     Section 411(b) would provide that if the Secretary finds, through
notification or otherwise, that (1) any carcasses, parts of carcasses, meat,
or meat food products are adulterated or misbranded and (2) there is a
reasonable probability that human consumption of such articles presents a
threat to public health, the Secretary would provide the persons, firms, or
corporations with an opportunity to (1) voluntarily cease distribution of
such articles; (2) notify all persons, firms, and corporations transporting,
storing, or distributing such articles or to which such articles were
transported or sold, to immediately cease distribution of such articles; (3)
to recall the articles; and (4) to provide, in consultation with the
Secretary, notice to consumers to whom such articles were, or may have been,
distributed.  
     
     If the person, firm, or corporation refuses to or does not voluntarily
cease distribution, make notification, recall the articles, and notify the
public, within the time and in the manner prescribed by the Secretary, the
Secretary would have the  authority to issue an order requiring such person,
firm, or corporation immediately (1) to cease distribution of the articles
and (2) to notify all persons, firms, and corporations transporting or
distributing the articles, or to which the articles were transported or
sold, to immediately cease distribution.  The Secretary shall, as he deems
necessary, provide for notice to consumers to whom such articles were, or
may have been, distributed.

     Section 411(c)  would provide for an opportunity for an informal
hearing, to be held as soon as possible but not later than two days after
the issuance of the order, to allow the affected person, firm, or
corporation the opportunity to contest the order.  Further, the informal
hearing would allow the affected person, firm or corporation an opportunity
to present evidence as to why the articles should not be recalled. 

     Section 411(d) would give the Secretary authority to require recall of
the articles if, after opportunity for a hearing under subsection (c), the
Secretary continues to find that there is a reasonable probability of a
threat to public health.  Upon this determination, the Secretary would, as
he deems necessary, amend the order to require a recall.  The order would
specify a timetable for the recall, require periodic reports describing the
progress of the recall, and provide for notice to consumers, to whom such
articles were or may have been distributed.  If, after such hearing, the
Secretary determines that adequate grounds do not exist to continue the
actions required by the order, the Secretary would be required to vacate the
order.

     Section 411(e) would provide that the remedies provided in section 411
are in addition to all other available remedies.

     Section 411 would enable the Secretary to better protect the public
from receiving products that present a reasonable probability that human
consumption of the product presents a threat to public health. Authorized
representatives of the Secretary currently have authority to detain products
for 20 days that are found outside an official establishment and not in
compliance with the FMIA (see section 402 of the FMIA).  Under present
authority, FSIS must institute an action in the appropriate U.S. District
Court in order to get a judicial seizure and condemnation order.  The
present authority is resource intensive and lengthy.  FSIS frequently relies
on voluntary recalls by official establishments.  This new authority to
require recall of certain adulterated or misbranded articles would allow
FSIS to protect consumers more effectively and efficiently. 

     Section 412, Refusal or Withdrawal of Inspection, would provide the
Secretary with additional grounds upon which to refuse or withdraw
inspection.  Section 401 of the FMIA currently authorizes the Secretary,
after opportunity for a hearing, to refuse to provide or to withdraw
inspection based upon a determination that the applicant or recipient of
inspection is unfit to engage in any business requiring inspection under the
FMIA because the applicant, recipient, or anyone responsibly connected with
the applicant or recipient, has been convicted in Federal or State court of
certain violations of law. 

     Section 412(a) would provide that the Secretary may refuse to provide
or withdraw inspection from an applicant or recipient when it has been
determined, after an opportunity for hearing, that the applicant or
recipient or any person responsibly connected with the applicant or
recipient (as defined in section 401) has committed any willful violation of
the requirements of the Act or the regulations promulgated under the Act
(one willful violation may result in this section being applied) or repeated
violations of the requirements of the Act or the regulations promulgated
under the Act.  This provision does not require a determination of
unfitness, nor is a prior criminal conviction or civil or administrative
order or determination required.

     Section 412(b) would authorize the Secretary to deny or suspend
inspection, pending an opportunity for an expedited hearing, with respect to
an action under section 412(a) to refuse to provide or withdraw inspection,
if the Secretary deems such denial or suspension in the public interest in
order to protect the health or welfare of consumers or to assure the safe
and effective performance of official duties under the Act. The Secretary
would have the authority to take immediate action against a violator if such
action is deemed in the public health or to assure the safe and effective
performance of official duties under the Act.  The denial or suspension
would be effective upon service of the complaint or other such notice.  

     Section 412(c) would provide that the determination and order of the
Secretary is final and conclusive unless the affected person, firm, or
corporation files for judicial review within thirty days after the effective
date of the order. Unless the Secretary directs otherwise, inspection would
be refused or withdrawn as of the effective date of the order, pending
judicial review of the order. The United States Court of Appeals for the
circuit in which the applicant for, or recipient of, inspection  resides or
has its principal place of business and the United States Court of Appeals
for the District of Columbia Circuit would have jurisdiction.  Judicial
review would be on the record upon which the determination and order are
based.

     Section 412(d) would provide that the remedies provided in section 412
are in addition to all other available remedies.

     Section 413, Civil Penalties, would authorize the Secretary to assess
civil monetary penalties for violations of any provision of the Act, the
regulations promulgated under the Act, or any order issued under new section
411 of the Act.
     
     Section 413(a) would authorize the Secretary to impose civil penalties
of not more than $100,000 for each violation against any person, firm or
corporation which violates any provision of the Act, the regulations under
the Act, or any order issued under the Act.  Each violation and each day
would be a separate offense subject to civil penalties.  These penalties
would be assessed after the person, firm, or corporation has received notice
and an opportunity for a hearing on the record in accordance with 5 U.S.C.
554 and 556.  The sanction would be based upon the gravity of the violation,
degree of culpability, size and type of business, and any history of prior
offenses.  
     
     Criminal sanctions are vital in ensuring the enforcement of the FMIA,
but are not enough.  Criminal prosecution can be a lengthy and cumbersome
process in an overburdened judicial system.  Civil monetary penalties, on
the other hand, can be imposed administratively, ensuring a timely and
effective resolution.  Moreover, a monetary penalty is more tangible than a
distant and lengthy legal process that may or may not be instituted and may
or may not lead to a conviction.  The proposed civil penalty amount is
reasonable and will deter potential violators.  Civil penalties would
therefore be an effective enforcement tool.  

     Section 413(b) would provide that orders of the Secretary assessing a
civil penalty may be reviewed in the U.S. Court of Appeals for the circuit
in which the party resides or has its principal place of business or in the
U.S. Court of Appeals for the District of Columbia Circuit by filing a
notice of appeal within thirty days from the date of such order and by
simultaneously sending a copy of such notice by certified mail to the
Secretary.  The findings of the Secretary would be set aside only if found
to be unsupported by substantial evidence on the record as a whole.  

     Section 413(c) would provide that failure to pay the civil penalty
after the order assessing the penalty has become final and unappealable or
after the appropriate Court of Appeals has entered final judgement in favor
of the Secretary shall result in the Secretary referring the matter to the
Attorney General who shall institute a civil action to recover the assessed
penalty. The validity of the Secretary's order would not be reviewable in
such a collection action.  

     Section 413(d) would require that the civil penalties collected under
section 413 be paid into the U.S. Treasury. 

     Section 413(e) would provide that the Secretary may refuse to provide
inspection to, or suspend inspection from any person, firm, or corporation
that fails to pay an assessment of a civil penalty after it has become a
final and unappealable order, or after the appropriate Court of Appeals has
entered final judgment in favor of the Secretary.

     Section 413(f) would provide that nothing in the Act shall require the
Secretary to report for criminal prosecution or for the institution of libel
or injunction proceedings violations of the Act when the Secretary believes
that the public interest will be adequately served by the assessment of
civil penalties.  

     Section 413(g) would provide that the remedies provided in section 413
are in addition to all other available remedies.

     Section 3.  Section 3 would amend section 5(c) the Poultry Products
Inspection Act (PPIA) by substituting sections 12-22, and 31-33 of this Act
for the reference to sections 12-22.  Section 5(c) of the PPIA requires that
the Secretary designate any State whose poultry products inspection
requirements with respect to transactions wholly within such State are not
at least equal to those of sections 1-4, 6-10, and 12-22 of the PPIA.  This
section would provide that sections 1-4, 6-10, 12-22, and 31-33 would apply
to such intrastate transactions and no poultry or poultry products could be
sold unless inspected for wholesomeness and passed by inspectors of the Food
Safety and Inspection Service (FSIS). 

     Section 3 of the bill would add at the end of the PPIA three new
enforcement provisions related to notification and recall of products, the
refusal and withdrawal of inspection, and the assessment of civil penalties.

     Section 31, Notification and Recall, would require persons (as defined
in Section 4(j)) to notify the Secretary of the identity and location of
adulterated and misbranded products.  Further, section 31 would provide the
Secretary with authority to issue orders to cease distribution of and orders
to recall adulterated and misbranded products if there is a reasonable
probability of a threat to public health.  Section 31 would provide a
mechanism to prevent such articles from reaching consumers.

     Section 31(a) would require any person which has a reasonable basis
for believing that any adulterated or misbranded, immediately to notify the
Secretary of the identity and location of such articles.  The immediate
notification of the identity and location of articles believed to be
adulterated or misbranded is necessary to provide the Secretary with the
opportunity to limit the distribution of such articles, and possibly avoid
human illness.  The Secretary would prescribe by regulation the means and
manner that notification is to be provided.  

     Section 31(b) would provide that if the Secretary finds, through
notification or otherwise, that (1) any poultry or poultry products are
adulterated or misbranded, and (2) there is a reasonable probability that
human consumption of such poultry or poultry products presents a threat to
public health, the Secretary would provide the appropriate person with an
opportunity to (1) voluntarily cease distribution of such poultry or poultry
products; (2) notify all persons transporting, storing, or distributing such
poultry or poultry products or to which such poultry or poultry products
were transported or sold to immediately cease distribution of such articles;
(3) to recall the poultry or poultry products; and (4) to provide, in
consultation with the Secretary notice, to consumers to whom such articles
were, or may have been, distributed.  
    
     If the person refuses to or does not voluntarily cease distribution,
make notification, recall the articles, and notify the public, within the
time and in the manner prescribed by the Secretary, the Secretary would have
the authority to issue an order requiring the person immediately (1) to
cease distribution of the poultry or poultry products and (2) to notify all
persons transporting or distributing the poultry or poultry products, or to
which the poultry or poultry products were transported or sold, to
immediately cease distribution.  The Secretary shall, as he deems necessary,
provide for notice to consumers to whom such articles were, or may have
been, distributed.

     Section 31(c) would provide for opportunity for an informal hearing,
to be held as soon as possible but not later than two days after the
issuance of the order, to allow the affected person the opportunity to
contest the order.  Further, the informal hearing would allow the affected
person an opportunity to present evidence as to why the articles should not
be recalled.

     Section 31(d) would give the Secretary authority to require recall of
the articles if, after opportunity for a hearing under subsection (c), the
Secretary continues to find that there is a reasonable probability of a
threat to public health.  Upon this determination, the Secretary would, as
he deems necessary, amend the order to require a recall.  The order would
specify a timetable for the recall, require periodic reports describing the
progress of the recall, and provide for notice to consumers, to whom such
articles were or may have been distributed.  If, after such hearing, the
Secretary determines that adequate grounds do not exist to continue the
actions required by the order, the Secretary would be required to vacate the
order.

     Section 31(e) would provide that the remedies provided in section 31
are in addition to all other available remedies.

     Section 31 would enable the Secretary to better protect the public
from receiving products that present a reasonable probability that human
consumption of the products presents a threat to public health.  Authorized
representatives of the Secretary currently have authority to detain products
for 20 days that are found outside an official establishment and not in
compliance with the PPIA (see section 19 of the PPIA).  Under present
authority, FSIS must institute an action in the appropriate U.S. District
Court in order to get a judicial seizure and condemnation order.  The
present authority is resource intensive and lengthy.  FSIS frequently relies
on voluntary recalls by official establishments.  This new authority to
require recall of certain adulterated or misbranded articles would allow
FSIS to protect consumers more effectively and efficiently. 
     
     Section 32, Refusal or Withdrawal of Inspection, would provide the
Secretary with additional grounds upon which to refuse or withdraw
inspection.  Section 18 of the PPIA currently authorizes the Secretary,
among other things, to refuse to provide or to withdraw inspection, after
opportunity for a hearing, based upon a determination that the applicant or
recipient of inspection is unfit to engage in any business requiring
inspection under the PPIA because the applicant or recipient (or anyone
responsibly connected with the applicant or recipient) has been convicted in
a Federal or State court of certain violations of law. 

    Section 32(a) would provide that the Secretary may refuse to provide
or withdraw inspection from an applicant or recipient when it has been
determined, after an opportunity for hearing, that the applicant or
recipient or any person responsibly connected with the applicant or
recipient (as defined in section 18(a)) has had committed any willful
violation of the requirements of Act or the regulations promulgated under
the Act (one willful violation may result in this section being applied) or
repeated violations of the requirements the Act or the regulations
promulgated under the Act.  This provision does not require a determination
of unfitness, nor is a prior criminal conviction or civil or administrative
order or determination required.

     Section 32(b) would authorize the Secretary to deny or suspend
inspection, pending an opportunity for an expedited hearing, with respect to
an action under section 32(a) to refuse to provide or withdraw inspection,
if the Secretary deems such denial or suspension in the public interest in
order to protect the health or welfare of consumers or to assure the safe
and effective performance of official duties under the Act. The Secretary
would have the authority to take immediate action against a violator if such
action is deemed necessary to protect the public health or to assure the
safe and effective performance of official duties under the Act.  The denial
or suspension would be effective upon service of the complaint or other such
notice.
  
     Section 32(c) would provide that the determination and order of the
Secretary is final and conclusive unless the affected person files for
judicial review within thirty days after the effective date of the order.
Unless the Secretary directs otherwise, inspection would be refused or
withdrawn as of the effective date of the order, pending judicial review of
the order. The United States Court of Appeals for the circuit in which the
applicant for, or recipient of, inspection resides or has its principal
place of business and the United States Court of Appeals for the District of
Columbia Circuit would have jurisdiction.  Judicial review would be on the
record upon which the determination and order are based.

     Section 32(d) would provide that the remedies provided in section 31
are in addition to all other available remedies.

     Section 33 Civil Penalties, would authorize the Secretary to assess
civil monetary penalties for violations of any provision of the Act, the
regulations promulgated under the Act, or any order issued under new section
31 of the Act.

     Section 33(a) would authorize the Secretary to impose civil penalties
of not more than $100,000 for each violation against any person who violates
any provision of the Act, regulations under the Act, or any order issued
under the Act.  Each violation and each day would be a separate offense
subject to civil penalties.  These penalties shall be assessed after the
person has received notice and an opportunity for a hearing on the record in
accordance with 5 U.S.C. 554 and 556.  The sanction would be based upon the
gravity of the violation, degree of culpability, size and type of business
of the person, and any history of prior offenses.  

     Criminal sanctions are vital in ensuring the enforcement of the PPIA,
but are not enough. Criminal prosecution can be a lengthy and cumbersome
process in an overburdened judicial system.  Civil monetary penalties, on
the other hand, can be imposed administratively, ensuring a timely and
effective resolution.  Moreover, a monetary penalty is more tangible than a
distant and lengthy legal process that may or may not be instituted and may
or may not lead to a conviction.  The proposed civil penalty amount is
reasonable and will deter potential violators.  Civil penalties could
therefore be an effective enforcement tool.  

     Section 33(b) would provide that orders of the Secretary assessing a
civil penalty may be reviewed in the U.S. Court of Appeals for the circuit
in which the person resides or has its principal place of business or in the
U.S. Court of Appeals for the District of Columbia Circuit by filing a
notice of appeal within thirty days from the date of such order and by
simultaneously sending a copy of such notice by certified mail to the
Secretary.  The findings of the Secretary would be set aside only if found
to be unsupported by substantial evidence on the record as a whole.  

     Section 33(c) would provide that failure to pay the civil penalty
after the order assessing the penalty has become final and unappealable or
after the appropriate Court of Appeals has entered final judgement in favor
of the Secretary shall result in the Secretary referring the matter to the
Attorney General who shall institute a civil action to recover the assessed
penalty. The validity of the Secretary's order would not be reviewable in
such a collection action.  
  
     Section 33(d) would require that the civil penalties collected under
section 33 shall be paid into the U.S. Treasury. 

     Section 33(e) would provide that the Secretary may refuse to provide
inspection to, or suspend inspection from any person that fails to pay an
assessment of a civil penalty after it has become a final and unappealable
order, or after the appropriate Court of Appeals has entered final judgment
in favor of the Secretary.

     Section 33(f) would provide that nothing in the Act shall require the
Secretary to report for criminal prosecution or for the institution of libel
or injunction proceedings violations of the Act when the Secretary believes
that the public interest will be adequately served by the assessment of
civil penalties.  

     Section 33(g) would provide that the remedies provided in section 33
are in addition to all other available remedies.

                                #

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