[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3070 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 3070

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 improved public health and food safety through enhanced enforcement, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 13, 1997

Mr. Pallone (for himself, Mr. Brown of Ohio, Mr. Stupak, Ms. Eshoo, and 
 Ms. DeLauro) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 improved public health and food safety through enhanced enforcement, 
                        and for other purposes.

    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 ``Food Safety Enforcement Enhancement 
Act of 1997''.

SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) In General.--The Federal, Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by adding after section 413 the 
following new sections:

``SEC. 414. NOTIFICATION AND RECALL.

    ``(a) Notice to Secretary of Adulteration or Misbranding.--Any 
person (other than a household consumer or other individual who is the 
intended consumer of an article of food) that has a reasonable basis 
for believing that any article of food introduced into or in interstate 
commerce, or held for sale (whether or not the first sale) after 
shipment in interstate commerce, may be adulterated or misbranded shall 
immediately notify the Secretary, in such manner and by such means as 
the Secretary may by regulation prescribe, of the identity and location 
of such article.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary procedures.--If the Secretary finds, upon 
        such notification or otherwise, that any article of food is 
        adulterated or misbranded when introduced into or while in 
        interstate commerce or while held for sale (whether or not the 
        first sale) after shipment in interstate commerce and there is 
        a reasonable probability that such article, if consumed, would 
        present a threat to public health, as determined by the 
        Secretary, the Secretary shall provide the appropriate persons 
        (including the manufacturers, importers, distributors, or 
        retailers) with an opportunity to--
                    ``(A) cease distribution of such article,
                    ``(B) notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such article, or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold,
                to immediately cease distribution of such article,
                    ``(C) recall such article,
                    ``(D) provide, in consultation with the Secretary, 
                notice to consumers to whom such article was, or may 
                have been, distributed, or
                    ``(E) take any combination of the above measures, 
                as appropriate in the circumstances.
            ``(2) Pre-hearing order to cease distribution and give 
        notice.--If such person refuses to or does not voluntarily 
        cease distribution, make notification, recall such article, or 
        provide notice to consumers, as applicable, within the time and 
        in the manner prescribed by the Secretary, the Secretary shall, 
        by order, require, as the Secretary deems necessary, such 
        person to--
                    ``(A) immediately cease distribution of such 
                article,
                    ``(B) immediately notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such article, or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold,
                to immediately cease distribution of such article, or
                    ``(C) immediately take the actions specified in 
                both subparagraphs (A) and (B).
            ``(3) Notification of consumers by secretary.--The 
        Secretary shall, as the Secretary deems necessary, provide 
        notice to consumers to whom such article was, or may have been, 
        distributed.
    ``(c) Hearing on Order.--The Secretary shall provide any person 
subject to an order under subsection (b) with an opportunity for a 
hearing, to be held as soon as possible but not later than 2 days after 
the issuance of the order, on the actions required by the order and on 
why the article that is the subject of the order should not be 
recalled.
    ``(d) Post-Hearing Recall Order.--
            ``(1) Amendment of order.--If, after providing opportunity 
        for a hearing under subsection (c), the Secretary determines 
        that there is a reasonable probability that the article that is 
        the subject of an order under subsection (b), if consumed, 
        presents a threat to public health, the Secretary, as the 
        Secretary deems necessary, may--
                    ``(A) amend the order to require recall of such 
                article or other appropriate action,
                    ``(B) specify a timetable in which the recall shall 
                occur,
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall, and
                    ``(D) provide notice to consumers to whom such 
                article was, or may have been, distributed.
            ``(2) Vacation of order.--If, after such a hearing, the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.

``SEC. 418. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Acts subject to penalty; penalty amount.--Any person 
        that commits an act prohibited by section 301 with respect to 
        food may be assessed a civil penalty by the Secretary of not 
        more than $100,000 for each such act. Each such act and each 
        day during which such act continues shall be a separate 
        offense.
            ``(2) Notice and hearing.--No penalty shall be assessed by 
        the Secretary under this section unless such person is given 
        notice and opportunity for a hearing on the record before the 
        Secretary in accordance with sections 554 and 556 of title 5, 
        United States Code.
            ``(3) Other requirements.--The amount of such civil penalty 
        shall be assessed by the Secretary by written order, taking 
        into account the gravity of the violation, degree of 
        culpability, size and type of business, and any history of 
        prior offenses; and may be reviewed only as provided in 
        subsection (b).
    ``(b) Judicial Review.--An order assessing a civil penalty under 
subsection (a) shall be final and conclusive unless the person files, 
within 30 days from the effective date of the order, an application for 
judicial review in the Court of Appeals of the United States for the 
circuit in which such person resides or has its principal place of 
business or in the United States Court of Appeals for the District of 
Columbia Circuit by filing a notice of appeal in such court and by 
simultaneously sending a copy of such notice by certified mail to the 
Secretary. The Secretary shall promptly file in such court a certified 
copy of the record upon which such penalty was assessed. The findings 
of the Secretary shall be set aside only if found to be unsupported by 
substantial evidence on the record as a whole.
    ``(c) Collection Actions.--If any person 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, the Secretary shall refer the matter to the 
Attorney General, who shall institute a civil action to recover the 
amount assessed in an appropriate district court of the United States. 
In such collection action, the validity and appropriateness of the 
Secretary's order imposing the civil penalty shall not be subject to 
review.
    ``(d) Penalties Paid Into Treasury.--All penalties collected under 
authority of this section shall be paid into the Treasury of the United 
States.
    ``(e) Secretary's Discretion To Prosecute.--Nothing in this Act 
shall be construed as requiring the Secretary to report for 
prosecution, or for the institution of libel or injunction proceedings, 
violations of this Act whenever the Secretary believes that the public 
interest will be adequately served by assessment of civil penalties.
    ``(f) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.''.
    (b) Conforming Amendment; 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 new subsection:
    ``(x) The failure or refusal to comply with an order issued under 
section 414(b)(2) or 414(d).''.

SEC. 3. WHISTLEBLOWER PROTECTION.

    (a) In General.--No employee or other person may be harassed, 
prosecuted, held liable, or discriminated against in any way because 
that person--
            (1) has commenced, caused to be commenced, or is about to 
        commence a proceeding, testified or is about to testify at a 
        proceeding, or assisted or participated or is about to assist 
        or participate in any manner in such a proceeding or in any 
        other action to carry out the purposes, functions, or 
        responsibilities of the Federal Food, Drug, and Cosmetic Act, 
        or of the Department of Agriculture; or
            (2) is refusing to violate or assist in violation of law, 
        rule, or regulation.
    (b) Procedures and Penalties.--The process and procedures with 
respect to prohibited discrimination under subsection (a) shall be 
governed by the applicable provisions of section 31105 of title 49, 
United States Code, unless the party bringing an action under this 
subsection chooses alternative dispute resolution procedures such as 
mediation or arbitration.
    (c) Burdens of Proof.--The legal burdens of proof with respect to 
prohibited discrimination under subsection (a) shall be governed by the 
applicable provisions of sections 1214 and 1221 of title 5, United 
States Code.
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