[Congressional Record Volume 142, Number 127 (Monday, September 16, 1996)]
[Senate]
[Pages S10609-S10614]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          AMENDMENTS SUBMITTED

                                 ______
                                 

THE DEPARTMENT OF THE INTERIOR AND RELATED AGENCIES APPROPRIATIONS ACT, 
                                  1997

                                 ______
                                 

                        GRAMS AMENDMENT NO. 5350

  (Ordered to lie on the table.)
  Mr. GRAMS submitted an amendment intended to be proposed by him to 
the bill (H.R. 3662) making appropriations for the Department of the 
Interior and related agencies for the fiscal year ending September 30, 
1997, and for other purposes; as follows:


[[Page S10610]]


       At the appropriate place in title I, insert the following:

     SEC. 1  . VOYAGEURS NATIONAL PARK.

       The Secretary of the Interior, acting through the Director 
     of the National Park Service, shall, during fiscal year 1997, 
     in cooperation with State, local, and tribal governments, 
     other public entities, and private organizations, as 
     appropriate, begin substantial implementation of section 
     401(b) of the Act entitled ``An Act to authorize the 
     establishment of the Voyageurs National Park in the State of 
     Minnesota, and for other purposes'', approved January 8, 1971 
     (16 U.S.C. 160k(b)).
                                 ______
                                 

                      PRESSLER AMENDMENT NO. 5351

  Mr. PRESSLER proposed an amendment to the bill, H.R. 3662, supra; as 
follows:

       At the end of the bill, add the following:
                     TITLE ____--LIVESTOCK INDUSTRY
                       Subtitle A--Captive Supply

     SEC. ____01. CAPTIVE SUPPLY.

       (a) Definition of Captive Supply.--Section 2(a) of the 
     Packers and Stockyards Act, 1921 (7 U.S.C. 182(a)), is 
     amended by adding at the end the following:
       ``(12) Captive supply.--The term `captive supply' means 
     livestock acquired for slaughter by a packer (including 
     livestock delivered 7 days or more before slaughter) under a 
     standing purchase arrangement, forward contract, or packer 
     ownership, feeding, or financing arrangement, as determined 
     by the Secretary.''.
       (b) Annual Report on Livestock Marketed or Slaughtered.--
     Section 407 of the Packers and Stockyards Act, 1921 (7 U.S.C. 
     228), is amended by adding at the end the following:
       ``(f) Annual Report on Livestock Marketed or Slaughtered.--
       ``(1) In general.--The Secretary shall make available to 
     the public an annual statistical report on the number and 
     volume of livestock marketed or slaughtered in the United 
     States, including--
       ``(A) information collected on the date of enactment of 
     this Act; and
       ``(B) information on transactions involving livestock in 
     regional and local markets.
       ``(2) Administration.--In carrying out paragraph (1), the 
     Secretary shall ensure that--
       ``(A) a significant share of regional and local livestock 
     transactions are reported; and
       ``(B) the confidentiality of individual livestock 
     transactions is maintained.''.
       (c) Information on Captive Supply Transactions.--Section 
     407 of the Packers and Stockyards Act, 1921 (7 U.S.C. 228), 
     as amended by subsection (b), is amended by adding at the end 
     the following:
       ``(g) Information on Captive Supply Transactions.--
       ``(1) In general.--Not later than 24 hours after a 
     transaction involving captive supply is recorded, the 
     Secretary shall make information concerning the transaction 
     (including the specific standing arrangement) available to 
     the public using electronic and other means that will ensure 
     wide availability of the information.
       ``(2) Ongoing livestock transactions.--Any information 
     collected on captive supply under paragraph (1) shall be 
     reported in conjunction with ongoing livestock 
     transactions.''.
                   Subtitle B--Livestock Dealer Trust

     SEC. ____11. LIVESTOCK DEALER TRUST.

       Title III of the Packers and Stockyards Act, 1921 (7 U.S.C. 
     201 et seq.), is amended by adding at the end the following:

     ``SEC. 318. LIVESTOCK DEALER TRUST.

       ``(a) Findings.--Congress finds that--
       ``(1) a burden on and obstruction to commerce in livestock 
     is caused by financing arrangements under which dealers and 
     market agencies purchasing livestock on commission encumber, 
     give lenders security interests in, or have liens placed on 
     livestock purchased by the dealers and market agencies in 
     cash sales, or on receivables from or proceeds of the sales, 
     when payment is not made for the livestock; and
       ``(2) the carrying out of the arrangements is contrary to 
     the public interest.
       ``(b) Purpose.--The purpose of this section is to remedy 
     the burden on and obstruction to commerce in livestock 
     described in paragraph (1) and protect the public interest.
       ``(c) Definitions.--In this section:
       ``(1) Cash sale.--The term `cash sale' means a sale in 
     which the seller does not expressly extend credit to the 
     buyer.
       ``(2) Trust.--The term `trust' means 1 or more assets of a 
     buyer that (subsequent to a cash sale of livestock) 
     constitutes the corpus of a trust held for the benefit of an 
     unpaid cash seller and consists of--
       ``(A) account receivables and proceeds earned from the cash 
     sale of livestock by a dealer or market agency buying on a 
     commission basis;
       ``(B) account receivables and proceeds of a marketing 
     agency earned on commission from the cash sale of livestock;
       ``(C) the inventory of the dealer or marketing agency; or
       ``(D) livestock involved in the cash sale, if the seller 
     has not received payment in full for the livestock and a bona 
     fide third-party purchaser has not purchased the livestock 
     from the dealer or marketing agency.
       ``(d) Holding in Trust.--
       ``(1) In general.--The account receivables and proceeds 
     generated in a cash sale made by a dealer or a market agency 
     on commission and the inventory of the dealer or market 
     agency shall be held by the dealer or market agency in trust 
     for the benefit of an unpaid cash seller of the livestock 
     until the seller receives payment in full for the livestock.
       ``(2) Exemption.--Paragraph (1) does not apply in the case 
     of a cash sale made by a dealer or market agency if the total 
     amount of cash sales made by the dealer or market agency 
     during the preceding 12 months does not exceed $250,000.
       ``(3) Dishonor of instrument of payment.--A payment in a 
     sale described in paragraph (1) shall not be considered to be 
     made if the instrument by which payment is made is 
     dishonored.
       ``(4) Loss of benefit of trust.--If an instrument by which 
     payment is made in a sale described in paragraph (1) is 
     dishonored, the seller shall lose the benefit of the trust 
     under paragraph (1) on the earlier of--
       ``(A) the date that is 15 business days after date on which 
     the seller receives notice of the dishonor; or
       ``(B) the date that is 30 days after the final date for 
     making payment under section 409,

     unless the seller gives written notice to the dealer or 
     market agency of the seller's intention to preserve the trust 
     and submits a copy of the notice to the Secretary.
       ``(5) Rights of third-party purchaser.--The trust 
     established under paragraph (1) shall have no effect on the 
     rights of a bona fide third-party purchaser of the livestock, 
     without regard to whether the livestock are delivered to the 
     bona fide purchaser.
       ``(e) Jurisdiction.--The district courts of the United 
     States shall have jurisdiction in a civil action--
       ``(1) by the beneficiary of a trust described in subsection 
     (c)(1), to enforce payment of the amount held in trust; and
       ``(2) by the Secretary, to prevent and restrain dissipation 
     of a trust described in subsection (c)(1).''.
                   Subtitle C--Cooperative Bargaining

     SEC. ____21. COOPERATIVE BARGAINING.

       Section 4 of the Agricultural Fair Practices Act of 1967 (7 
     U.S.C. 2303) is amended by adding at the end the following:
       ``(g) To fail to engage in good-faith negotiations with 
     producer cooperatives (including new cooperatives), or to 
     unfairly discriminate among producer cooperatives (including 
     new cooperatives), with respect to the purchase, acquisition, 
     or other handling of agricultural products.''.
                       Subtitle D--Meat Labeling

     SEC. ____31. LABELING OF MEAT AND MEAT FOOD PRODUCTS.

       Section 7(b) of the Federal Meat Inspection Act (21 U.S.C. 
     607(b)) is amended by striking ``require,'' and all that 
     follows through the period at the end and inserting 
     ``require--
       ``(1) the information required under section 1(n); and
       ``(2) if it was imported (or was produced from an animal 
     that was located in another country for at least 120 days) 
     and is graded, a grading labeling that bears the words 
     `imported', `may have been imported', `this product contains 
     imported meat', `this product may contain imported meat', 
     `this container contains imported meat', or `this container 
     may contain imported meat', as the case may be, or words to 
     indicate its country of origin.''.
      Subtitle E--Interstate Shipment of Meat and Poultry Products

     SEC. ____41. FEDERAL AND STATE COOPERATION WITH RESPECT TO 
                   MEAT INSPECTION.

       (a) Waiver of Intrastate Distribution Limitation Under the 
     Federal Meat Inspection Act.--Section 301(a) of the Federal 
     Meat Inspection Act (21 U.S.C. 661(a)) is amended by adding 
     at the end the following:
       ``(5) Waiver of Intrastate Distribution Limitation.--
       ``(A) In general.--On application of an appropriate State 
     agency with which the Secretary may cooperate under this Act, 
     the Secretary shall reevaluate the applicant State's meat 
     inspection program to verify that its mandatory requirements 
     are at least equal to the Federal inspection, reinspection, 
     and sanitation requirements under title I.
       ``(B) Waivers.--If the Secretary verifies that the 
     mandatory inspection requirements of the applicant State are 
     at least equal to Federal inspection requirements, the 
     limitation in paragraph (1) that restricts meat inspected by 
     the applicant State to intrastate distribution shall be 
     waived by the Secretary.
       ``(C) Inspections.--Following any waiver under subparagraph 
     (B), the Secretary may perform random inspections of State-
     inspected plants within the applicant State to ensure that 
     the mandatory State inspection requirements employed in the 
     State are at least equal to the substantive Federal 
     inspection requirements under title I.
       ``(D) Personnel.--The Secretary may use Federal personnel, 
     or may cooperate with the appropriate State agency under this 
     Act to train and use State personnel, to perform any random 
     inspections authorized by this paragraph.
       ``(E) Noncompliance.--If a random inspection performed 
     under this paragraph discloses that a State-inspected plant 
     is not employing mandatory inspection requirements that are 
     at least equal to the substantive Federal inspection 
     requirements under title I, the Secretary shall reimpose

[[Page S10611]]

     the restriction against the interstate distribution of meat 
     and meat products produced at the plant until a subsequent 
     inspection verifies that the plant has reestablished 
     mandatory inspection requirements that are at least equal to 
     the substantive Federal inspection requirements under title 
     I.''.
       (b) Waiver of Intrastate Distribution Limitation Under the 
     Poultry Products Inspection Act.--Section 5(a) of the Poultry 
     Products Inspection Act (21 U.S.C. 454(a)) is amended by 
     adding at the end the following:
       ``(5) Waiver of Intrastate Distribution Limitation.--
       ``(A) In general.--On application of an appropriate State 
     agency with which the Secretary may cooperate under this Act, 
     the Secretary shall reevaluate the applicant State's poultry 
     inspection program to verify that its mandatory requirements 
     are at least equal to the Federal inspection, reinspection, 
     and sanitation requirements of this Act.
       ``(B) Waivers.--If the Secretary verifies that the 
     mandatory inspection requirements of the applicant State are 
     at least equal to Federal inspection requirements, the 
     limitation in paragraph (1) that restricts poultry or poultry 
     products inspected by the applicant State to intrastate 
     distribution shall be waived by the Secretary.
       ``(C) Inspections.--Following any waiver under subparagraph 
     (B), the Secretary may perform random inspections of State-
     inspected plants within the applicant State to ensure that 
     the mandatory State inspection requirements employed in the 
     State are at least equal to the substantive Federal 
     inspection requirements under this Act.
       ``(D) Personnel.--The Secretary may use Federal personnel, 
     or may cooperate with the appropriate State agency under this 
     Act to train and use State personnel, to perform any random 
     inspections authorized by this paragraph.
       ``(E) Noncompliance.--If a random inspection performed 
     under this paragraph discloses that a State-inspected plant 
     is not employing mandatory inspection requirements that are 
     at least equal to the substantive Federal inspection 
     requirements of this Act, the Secretary shall reimpose the 
     restriction against the interstate distribution of poultry 
     and poultry products produced at the plant until a subsequent 
     inspection verifies that the plant has reestablished 
     mandatory inspection requirements that are at least equal to 
     the substantive inspection Federal requirements of this 
     Act.''.
                    Subtitle F--Agricultural Credit

     SEC. ____51. REVIEW OF FEDERAL AGRICULTURE CREDIT POLICIES.

       The Secretary of Agriculture, in consultation with the 
     Secretary of the Treasury, the Chairman of the Board of 
     Governors of the Federal Reserve System, and the Chairman of 
     the Board of the Farm Credit Administration, shall establish 
     an interagency working group to study--
       (1) the extent to which Federal lending practices and 
     policies have contributed, or are contributing, to market 
     concentration in the livestock and dairy sectors of the 
     national economy; and
       (2) whether Federal policies regarding the financial system 
     of the United States adequately take account of the weather 
     and price volatility risks inherent in livestock and dairy 
     enterprises.
                     Subtitle G--Agricultural Trade

     SEC. ____61. INTERNATIONAL BARRIERS TO TRADE.

       It is the sense of the Senate that--
       (1) the Secretary of Agriculture should continue to 
     identify and seek to eliminate unfair trade barriers and 
     subsidies affecting United States beef markets;
       (2) the United States and Canadian Governments should 
     expeditiously negotiate the elimination of animal health 
     barriers that are not based on sound science; and
       (3) the import ban on beef from cattle treated with 
     approved growth hormones imposed by the European Union should 
     be terminated.

     SEC. ____62. USE OF GSM PROGRAMS TO PROMOTE AGRICULTURAL 
                   EXPORTS TO AFRICA.

       It is the sense of the Senate that the Secretary of 
     Agriculture shall use the Export Credit Guarantee Program 
     (GSM-102) and the Intermediate Export Credit Guarantee 
     Program (GSM-103) established under section 202 of the 
     Agricultural Trade Act of 1978 (7 U.S.C. 5622) to promote the 
     export of United States agricultural commodities to countries 
     of Africa.
                  Subtitle H--Animal Drug Availability

     SEC.   71. SHORT TITLE; REFERENCE.

       (a) Short Title.--This Act may be cited as the ``Animal 
     Drug Availability Act of 1996''.
       (b) Reference.--Whenever in this Act an amendment or repeal 
     is expressed in terms of an amendment to, or repeal of, a 
     section or other provision, the reference shall be considered 
     to be made to a section or other provision of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).

     SEC.   72. EVIDENCE OF EFFECTIVENESS.

       (a) Original Applications.--Section 512(d) (21 U.S.C. 
     360b(d)) is amended by striking paragraph (3) and by adding 
     at the end the following:
       ``(4) As used in this section, the term `substantial 
     evidence' means evidence consisting of one or more adequate 
     and well controlled investigations, such as a study in a 
     target species, a study in laboratory animals, any field 
     investigation that may be required under this section and 
     that meets the requirements of subsection (b)(3) if a 
     presubmission conference is requested by the applicant, a 
     bioequivalence study, or an in vitro study, by experts 
     qualified by scientific training and experience to evaluate 
     the effectiveness of the drug involved, on the basis of which 
     it could fairly and reasonably be concluded by such experts 
     that the drug will have the effect it purports or is 
     represented to have under the conditions of use prescribed, 
     recommended, or suggested in the labeling or proposed 
     labeling thereof.''
       (b) Conforming Amendments.--
       (1) Section 512(c)(2)(F) (ii) and (iii) (21 U.S.C. 
     360b(c)(2)(F) (ii) and (iii)) is amended--
       (i) by striking ``reports of new clinical or field 
     investigations (other than bioequivalence or residue studies) 
     and,'' and inserting ``substantial evidence of the 
     effectiveness of the drug involved, any studies of animal 
     safety, or,''; and
       (ii) by striking ``essential to'' and inserting ``, 
     required for''.
       (2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is 
     amended--
       (i) by striking ``(B)(iv)'' each place it appears and 
     inserting ``(F)(iv)'' in lieu thereof;
       (ii) by striking ``reports of clinical or field 
     investigations'' and inserting ``substantial evidence of the 
     effectiveness of the drug involved, any studies of animal 
     safety,''; and
       (iii) by striking ``essential to'' and inserting ``required 
     for''.
       (c) Combination Drugs.--Section 512(d) (21 U.S.C. 360b(d)) 
     is amended by inserting before paragraph (4) (as added by 
     subsection (a)) the following new paragraph:
       ``(3) In a case in which an animal drug contains more than 
     one active ingredient, or the labeling of the drug 
     prescribes, recommends, or suggests use of the drug in 
     combination with one or more other animal drugs, and the 
     active ingredients or drugs intended for use in the 
     combination have previously been separately approved for 
     particular uses and conditions of use for which they are 
     intended for use in the combination--
       ``(A) the Secretary shall not issue an order under 
     paragraph (1) (A), (B), or (D) refusing to approve the 
     application for such combination on human food safety grounds 
     unless the Secretary finds that the application fails to 
     establish that:
       ``(i) none of the active ingredients or drugs intended for 
     use in the combination, respectively, at the longest 
     withdrawal time of any of the active ingredients or drugs in 
     the combination, respectively, exceeds its established 
     tolerance; or
       ``(ii) none of the active ingredients or drugs in the 
     combination interferes with the methods of analysis for 
     another of the active ingredients or drugs in the 
     combination, respectively;
       ``(B) the Secretary shall not issue an order under 
     paragraphs (1) (A), (B), or (D) refusing to approve the 
     application for such combination on target animal safety 
     grounds unless the Secretary finds that--
       ``(i)(I) there is a substantiated scientific issue, 
     specific to one or more of the active ingredients or animal 
     drugs in the combination, that cannot adequately be evaluated 
     based on information contained in the application for the 
     combination (including any investigations, studies, or tests 
     for which the applicant has a right of reference or use from 
     the person by or for whom the investigations, studies, or 
     tests were conducted); or
       ``(II) there is a scientific issue raised by target animal 
     observations contained in studies submitted to the Secretary 
     as part of the application; and
       ``(ii) based on the Secretary's evaluation of the 
     information contained in the application with respect to the 
     issues identified in clauses (i) (I) and (II), paragraphs (1) 
     (A), (B), or (D) apply;
       ``(C) except in the case of a combination that contains a 
     nontropical antibacterial ingredient or animal drug, the 
     Secretary shall not issue an order under paragraph (1)(E) 
     refusing to approve an application for a combination animal 
     drug intended for use other than in animal feed or drinking 
     water unless the Secretary finds that the application fails 
     to demonstrate that:
       ``(i) there is substantial evidence that any active 
     ingredient or animal drug intended only for the same use as 
     another active ingredient or animal drug in the combination 
     makes a contribution to labeled effectiveness; or
       ``(ii) each active ingredient or animal drug intended for 
     at least one use that is different from all other active 
     ingredients or animal drugs used in the combination provides 
     appropriate concurrent use for the intended target 
     population; or
       ``(iii) where based on scientific information the Secretary 
     has reason to believe the active ingredients or animal drugs 
     may be physically incompatible or have disparate dosing 
     regimens, such active ingredients or animal drugs are 
     physically compatible or do not have disparate dosing 
     regimens; and
       ``(D) the Secretary shall not issue an order under 
     paragraph (1)(E) refusing to approve an application for a 
     combination animal drug intended for use in animal feed or 
     drinking water unless the Secretary finds that the 
     application fails to demonstrate that:
       ``(i) there is substantial evidence that any active 
     ingredient or animal drug intended only for the same use as 
     another active ingredient or animal drug in the combination 
     makes a contribution to the labeled effectiveness; or
       ``(ii) each of the active ingredients or animal drugs 
     intended for at least one use that is different from other 
     active ingredients or

[[Page S10612]]

     animal drugs used in combination provides appropriate 
     concurrent use for the intended target population; or
       ``(iii) where a combination contains more than one 
     nontopical antibacterial ingredient or animal drug, there is 
     substantial evidence that each of the nontopical 
     antibacterial ingredients or animal drugs makes a 
     contribution to the labeled effectiveness; or
       ``(iv) where based on scientific information the Secretary 
     has reason to believe the active ingredients or animal drugs 
     intended for use in drinking water may be physically 
     incompatible, such active ingredients or animal drugs 
     intended for use in drinking water are physically 
     compatible.''
       (d) Presubmission Conference.--Section 512(b) (21 U.S.C. 
     360b(b)) is amended by adding at the end the following:
       ``(3) Any person intending to file an application under 
     subparagraph (1) or a request for an investigational 
     exemption under subsection (j) shall be entitled to one or 
     more conferences prior to such submission to reach agreement 
     acceptable to the Secretary establishing a submission or an 
     investigational requirement, which may include a requirement 
     for a field investigation. A decision establishing a 
     submission or an investigational requirement shall bind the 
     Secretary and the applicant or requester unless (a) the 
     Secretary and the applicant or requestor mutually agree to 
     modify the requirement, or (b) the Secretary by written order 
     determines that a substantiated scientific requirement 
     essential to the determination of safety or effectiveness of 
     the animal drug involved has appeared after the conference. 
     No later than 25 calendar days after each such conference, 
     the Secretary shall provide a written order setting forth 
     scientific justification specific to the animal drug and 
     intended uses under consideration if such decision requires 
     more than one field investigation as being essential to 
     provide substantial evidence of effectiveness for the 
     intended uses of the drug. Nothing in this subparagraph 
     shall be construed as compelling the Secretary to require 
     field investigation.''
       (e) Implementation.--
       (1) In general.--Not later than 6 months after the date of 
     enactment of this Act the Secretary shall issue proposed 
     regulations implementing the amendments made by this Act as 
     described in paragraph (2)(A) of this subsection, and not 
     later than 18 months after the date of enactment of this Act 
     the Secretary shall issue final regulations implementing such 
     amendments. Not later than 12 months after the date of 
     enactment of this Act the Secretary shall issue proposed 
     regulations implementing the other amendments made by this 
     Act as described in paragraphs (2)(B) and (2)(C) of this 
     subsection, and not later than 24 months after the date of 
     enactment of this Act the Secretary shall issue final 
     regulations implementing such amendments.
       (2) Contents.--In issuing regulations implementing the 
     amendments made by this Act, and in taking an action to 
     review an application for approval of a new animal drug under 
     section 512 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360b), or a request for an investigational exemption 
     for a new animal drug under subsection (j) of such section, 
     that is pending or has been submitted prior to the effective 
     date of the regulations, the Secretary shall--
       (A) further define the term ``adequate and well 
     controlled,'' as used in subsection (d)(4) of section 512, to 
     require that field investigations be designed and conducted 
     in a scientifically sound manner, taking into account 
     practical conditions in the field and differences between 
     field conditions and laboratory conditions; Provided, That 
     until the regulations required by this subparagraph are 
     issued, nothing in 21 C.F.R. 514.111(a)(5) (April 1, 1996) 
     shall be construed to compel the Secretary to require field 
     investigation under section 512(d)(1)(E), or to apply any of 
     its provisions in a manner inconsistent with the 
     considerations for scientifically sound field investigations 
     set forth in this subparagraph;
       (B) further define the term ``substantial evidence'', as 
     defined in subsection (d)(4) of such section, in a manner 
     that encourages the submission of applications and 
     supplemental applications; and
       (C) take into account the proposals contained in the 
     citizen petition (FDA Docket No. 91P-0434-CP) jointly 
     submitted by the American Veterinary Medical Association and 
     the Animal Health Institute, dated October 21, 1991.
       (f) Minor Species and Uses.--The Secretary shall consider 
     legislative and regulatory options for facilitating the 
     approval of animal drugs intended for minor species and for 
     minor uses and, within 18 months after the date of enactment 
     of this Act, announce proposals for legislative or regulatory 
     change to the approval process for animal drugs intended for 
     use in minor species for minor uses.

     SEC.   . 73. LIMITATION ON RESIDUES.

       Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended 
     to read as follows:
       ``(F) upon the basis of information submitted to the 
     Secretary as part of the application or any other information 
     before the Secretary with respect to such drug, any use 
     prescribed, recommended, or suggested in labeling proposed 
     for such drug will result in a residue of such drug in excess 
     of a tolerance found by the Secretary to be safe for such 
     drug;''.

     SEC.  74. IMPORT TOLERANCES.

       Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the 
     following new paragraph at the end:
       ``(6) For purposes of section 402(a)(2)(D), a use or 
     intended use of a new animal drug shall not be deemed unsafe 
     under section 512 if the Secretary establishes a tolerance 
     for such drug and any edible portion of any animal imported 
     into the United States does not contain residues exceeding 
     such tolerance. In establishing such tolerance, the Secretary 
     shall rely on data sufficient to demonstrate that a proposed 
     tolerance is safe based on similar food safety criteria used 
     by the Secretary to establish tolerances for applications for 
     new animal drugs filed under subsection (b)(1). The Secretary 
     may consider and rely on data submitted by the drug 
     manufacturer, including data submitted to appropriate 
     regulatory authorities in any country where the new animal 
     drug is lawfully used, or data available from a relevant 
     international organization, to the extent such data are not 
     inconsistent with the criteria used by the Secretary to 
     establish a tolerance for applications for new animal drugs 
     filed under subsection (b)(1). For purposes of this 
     paragraph, relevant organization means the Codex Alimenterius 
     Commission or other international organization deemed 
     appropriate by the Secretary. The Secretary may, under 
     procedures specified by regulation, revoke a tolerance 
     established under this paragraph if information demonstrates 
     that the use of the new drug under actual use conditions 
     results in food being imported into the United States with 
     residues exceeding the tolerance.''

     SEC.  75. VETERINARY FEED DIRECTIVES.

       (a) Section 503(f)(1)(A) (21 U.S.C. 353(f)(1)(A)) is 
     amended by inserting after ``other than man'' the following: 
     ``, other than a veterinary feed directive drug intended for 
     use in animal feed or an animal feed bearing or containing a 
     veterinary feed directive drug,''.
       (b) New Section 504 (21 U.S.C. 354) is added, to read as 
     follows:

     ``SEC. 504. VETERINARY FEED DIRECTIVE DRUGS.

       ``(a)(1) A drug intended for use in or on animal feed which 
     is limited by an approved application filed pursuant to 
     Section 512(b) to use under the professional supervision of a 
     licensed veterinarian is a veterinary feed directive drug. 
     Any animal feed bearing or containing a veterinary feed 
     directive drug shall be fed to animals only by or upon a 
     lawful veterinary feed directive issued by a licensed 
     veterinarian in the course of the veterinarian's professional 
     practice. When labeled, distributed, held, and used in 
     accordance with this section, a veterinary feed directive 
     drug and any animal feed bearing or containing a 
     veterinary feed directive drug shall be exempt from 
     Section 502(f).
       ``(2) A veterinary feed directive is lawful if it:
       ``(A) Contains such information as the Secretary may by 
     general regulation or by order require; and
       ``(B) Is in compliance with the conditions and indications 
     for use of the drug set forth in the notice published 
     pursuant to Section 512(i).
       ``(3)(A) Any persons involved in the distribution or use of 
     animal feed bearing or containing a veterinary feed directive 
     drug and the licensed veterinarian issuing the veterinary 
     feed directive shall maintain a copy of the veterinary feed 
     directive applicable to each such feed, except in the case of 
     a person distributing such feed to another person for further 
     distribution, such person distributing the feed shall 
     maintain a written acknowledgment for the person to whom the 
     feed is shipped stating that that person shall not ship or 
     move such feed to an animal production facility without a 
     veterinary feed directive or ship such feed to another person 
     for further distribution unless that person has provided the 
     same written acknowledgment to its immediate supplier.
       ``(B) Every person required under the previous subparagraph 
     to maintain records, and every person in charge or custody 
     thereof, shall, upon request of an officer or employee 
     designated by the Secretary, permit such officer or employee 
     at all reasonable times to have access to and copy and verify 
     such records.
       ``(C) Any person who distributes animal feed bearing or 
     containing a veterinary feed directive drug shall upon first 
     engaging such distribution notify the Secretary of that 
     person's name and place of business. The failure to provide 
     such notification shall be deemed to be an act which results 
     in the drug being misbranded.
       ``(b) a veterinary feed directive drug and any feed bearing 
     or containing a veterinary feed directive drug shall be 
     deemed to be misbranded if their labeling fails to bear such 
     cautionary statement and such other information as the 
     Secretary may be general regulation or by order prescribe, or 
     their advertising fails to conform to the conditions and 
     indications for use published pursuant to Section 512(i) or 
     fails to contain the general cautionary statement prescribed 
     by the Secretary.
       ``(c) Neither a drug subject to this section, nor animal 
     feed bearing or containing such a drug, shall be deemed to be 
     a prescription article under any federal or state law.''
       (c) Section 512 (21 U.S.C. 360b) is amended as follows:
       (1) In subsection (i) by inserting after the words 
     ``including special labeling requirements'' the following: 
     ``and any requirement that an animal feed bearing or 
     containing the new animal drug be limited to use under

[[Page S10613]]

     the professional supervision of a licensed veterinarian''.
       (2) In subparagraph (a)(2)(C) by inserting after ``its 
     labeling,'' the following: ``its distribution, its 
     holding,''.
       (3) In subparagraph (m)(4)(B)(i) by inserting after 
     ``paragraph (5)(A)'' the following: ``or under section 
     504(a)(3)(A)''; and by inserting after ``subparagraph (B) of 
     such paragraph'' the following: ``or section 504(a)(3)(B)''.
       (d) Section 301(e) (21 U.S.C. 331(e)) is amended by 
     inserting after ``by section 412'' the following: ``, 504,''; 
     and by inserting after ``under Section 412,'' the following: 
     ``504,''.

     SEC.  76. FEED MILL LICENSES.

       (a) Section 512(a)(1) and (2) (21 U.S.C. 360b(a)(1) and 
     (2)) is amended to read as follows:
       ``(a) (1) A new animal drug shall, with respect to any 
     particular use or intended use of such drug, be deemed unsafe 
     for the purposes of section 501(a)(5) and section 
     402(a)(2)(D) unless--
       ``(A) there is in effect an approval of an application 
     filed pursuant to subsection (b) of this section with respect 
     to such use or intended use of such drug, and
       ``(B) such drug, its labeling, and such use conform to such 
     approved application.

     A new animal drug shall also be deemed unsafe for such 
     purposes in the event of removal from the establishment of a 
     manufacturer, packer, or distributor of such drug for use in 
     the manufacture of animal feed in any State unless at the 
     time of such removal such manufacturer, packer, or 
     distributor has an unrevoked written statement from the 
     consignee of such drug, or notice from the Secretary, to the 
     effect that, with respect to the use of such drug in animal 
     feed, such consignee--
       ``(i) holds a license issued under subsection (m) of this 
     section and has in its possession current approved labeling 
     for such drug in animal feed; or
       ``(ii) will, if the consignee is not a user of the drug, 
     ship such drug only to a holder of a license issued under 
     subsection (m) of this section.
       ``(2) An animal feed bearing or containing a new animal 
     drug shall, with respect to any particular use or intended 
     use of such animal feed, be deemed unsafe for the purposes of 
     section 501(a)(6) unless--
       ``(A) there is in effect an approval of an application 
     filed pursuant to subsection (b) of this section with respect 
     to such drug, as used in such animal feed,
       ``(B) such animal feed is manufactured at a site for which 
     there is in effect a license issued pursuant to subsection 
     (m)(1) of this section to manufacture such animal feed, and
       ``(C) such animal feed bears approved labeling, and such 
     use conforms to the conditions and indications of use 
     published pursuant to subsection (i) of this section.''
       (b) Section 512(m) (21 U.S.C. 360b(m)) is amended to read 
     as follows:
       ``(m) (1) Any person may file with the Secretary an 
     application for a license to manufacture animal feeds bearing 
     or containing new animal drugs. Such person shall submit to 
     the Secretary as part of the application (A) a full statement 
     of the business name and address of the specific facility at 
     which the manufacturing is to take place and the facility's 
     registration number, (B) the name and signature of the 
     responsible individual or individuals for that facility, (C) 
     a certification that the animal feeds bearing or containing 
     new animal drugs are manufactured and labeled in accordance 
     with the applicable regulations published pursuant to 
     subsection (i) of this section, and (D) a certification that 
     the methods used in, and the facilities and controls used 
     for, manufacturing, processing packaging, and holding such 
     animal feeds are in conformity with current good 
     manufacturing practice as described in section 501(a)(2)(B).
       ``(2) Within 90 days after the filing of an application 
     pursuant to subsection (m)(1), or such additional period as 
     may be agreed upon the Secretary and the applicant, the 
     Secretary shall either (A) issue an order approving the 
     application if the Secretary then finds that none of the 
     grounds for denying approval specified in paragraph (3) 
     applies, or (B) give the applicant notice of an opportunity 
     for a hearing before the Secretary under paragraph (3) on the 
     question whether such application is approvable. The 
     procedure governing such a hearing shall be the procedure set 
     forth in the last two sentences of subsection (c)(1).
       ``(3) If the Secretary, after due notice to the applicant 
     in accordance with paragraph (2) and giving the applicant an 
     opportunity for a hearing in accordance with such paragraph, 
     finds, on the basis of information submitted to the Secretary 
     as part of the application, on the basis of a preapproval 
     inspection, or on the basis of any other information before 
     the Secretary--
       ``(A) that the application is incomplete, false, or 
     misleading in any particular;
       ``(B) that the methods used in, and the facilities and 
     controls used for, the manufacture, processing, and packing 
     of such animal feed are inadequate to preserve the identity, 
     strength, quality, and purity of the new animal drug therein; 
     or
       ``(C) that the facility manufacturers animal feeds bearing 
     or containing new animal drugs in a manner that does not 
     accord with the specifications for manufacture, or labels 
     animal feeds bearing or containing new animal drugs in a 
     manner that does not accord with the conditions or 
     indications of use that are published pursuant to subsection 
     (i) of this section; the Secretary shall issue an order 
     refusing to approve the application. If, after such notice 
     and opportunity for hearing, the Secretary finds that 
     subparagraphs (A) through (C) do not apply, the Secretary 
     shall issue an order approving the application. An order 
     under this subsection approving an application for a 
     license to manufacture animal feeds bearing or containing 
     new animal drugs shall permit a facility to manufacture 
     only those animal feeds bearing or containing new animal 
     drugs for which there are in effect regulations pursuant 
     to subsection (i) of this section relating to the use of 
     such drugs in or on such animal feed.
       ``(4)(A) The Secretary shall, after due notice and 
     opportunity for hearing to the applicant, revoke a license to 
     manufacture animal feeds bearing or containing new animal 
     drugs under this subsection if the Secretary finds--
       ``(i) that the application contains any untrue statement of 
     a material fact; or
       ``(ii) that the applicant has made changes that would cause 
     the application to contain any untrue statements of material 
     fact or that would affect the safety or effectiveness of the 
     animal feeds manufactured at the facility unless the 
     applicant has supplemented the application by filing with the 
     Secretary adequate information respecting all such changes 
     and unless there is in effect an approval of the supplemental 
     application.
       If the Secretary (or in his absence the officer acting as 
     Secretary) finds that there is an imminent hazard to the 
     health of humans or of the animals for which such animal feed 
     is intended, the Secretary may suspend the license 
     immediately, and give the applicant prompt notice of the 
     action and afford the applicant the opportunity for an 
     expedited hearing under this subsection; but the authority 
     conferred by this sentence shall not be delegated.
       ``(B) The Secretary may also, after due notice and 
     opportunity for hearing to the applicant, revoke a license to 
     manufacture animal feed under this subsection if the 
     Secretary finds--
       ``(i) that the applicant has failed to establish a system 
     for maintaining required records, or has repeatedly or 
     deliberately failed to maintain such records or to make 
     required reports in accordance with a regulation or order 
     under paragraph (5)(A) of this subsection or section 
     504(a)(3)(A), or the applicant has refused to permit access 
     to, or copying or verification of, such records as required 
     by subparagraph (B) of such paragraph or section 
     504(a)(3)(B);
       ``(ii) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the methods used in, 
     or the facilities and controls used for, the manufacture, 
     processing, packing, and holding of such animal feed 
     are inadequate to assure and preserve the identity, 
     strength, quality, and purity of the new animal drug 
     therein, and were not made adequate within a reasonable 
     time after receipt of written notice from the Secretary, 
     specifying the matter complained of;
       ``(iii) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the labeling of any 
     animal feeds, based on a fair evaluation of all material 
     facts, is false or misleading in any particular and was not 
     corrected within a reasonable time after receipt of written 
     notice from the Secretary specifying the matter complained 
     of; or
       ``(iv) that on the basis of new information before the 
     Secretary, evaluated together with the evidence before the 
     Secretary when such license was issued, the facility has 
     manufactured, processed, packed, or held animal feed bearing 
     or containing a new animal drug adulterated under section 
     501(a)(6) and the facility did not discontinue the 
     manufacture, processing, packing, or holding of such animal 
     feed within a reasonable time after receipt of written notice 
     from the Secretary specifying the matter complained of.
       ``(C) The Secretary may also revoke a license to 
     manufacture animal feeds under this subsection if an 
     applicant gives notice to the Secretary of intention to 
     discontinue the manufacture of all animal feed covered under 
     this subsection, and waives an opportunity for a hearing on 
     the matter.
       ``(D) Any order under paragraph (4) of this subsection 
     shall state the findings upon which it is based.
       ``(5) When a license to manufacture animal feeds bearing or 
     containing new animal drugs has been issued:
       ``(A) the applicant shall establish and maintain such 
     records, and make such reports to the Secretary, or (at the 
     option of the Secretary) to the appropriate person or persons 
     holding an approved application filed under subsection (b), 
     as the Secretary may by general regulation, or by order with 
     respect to such application, prescribe on the basis of a 
     finding that such records and reports are necessary in order 
     to enable the Secretary to determine, or facilitate a 
     determination, whether there is or may be ground for invoking 
     subsection (e) or paragraph (4) of this subsection;
       ``(B) every person required under this subsection to 
     maintain records, and every person in charge or custody 
     thereof, shall, upon request of an officer or employee 
     designated by the Secretary, permit such officer or employee 
     at all reasonable times to have access to and copy and verify 
     such records.
       ``(6) To the extent consistent with the public health, the 
     Secretary may promulgate

[[Page S10614]]

     regulations for exempting from the operation of this 
     subsection facilities that manufacture, process, pack, or 
     hold animal feeds bearing or containing new animal drugs.''
       (c) Transitional Provision.--A person engaged in the 
     manufacture of animal feeds bearing or containing new animal 
     drugs who holds at least one approved medicated feed 
     application for an animal feed bearing or containing new 
     animal drugs, the manufacture of which was not otherwise 
     exempt from the requirement for an approved medicated feed 
     application at the time of enactment of this Act, shall be 
     deemed to hold a license for the manufacturing site 
     identified in the approved medicated feed application. The 
     revocation of license provisions of section 512(m)(4) of the 
     Federal Food, Drug, and Cosmetic Act, as amended by this Act, 
     shall apply to such licenses. Such license shall expire 
     within 18 months from the date of enactment of this Act 
     unless the person submits to the Secretary a completed 
     license application for the manufacturing site accompanied by 
     a copy of an approved medicated feed application for such 
     site, which license application shall be deemed to be 
     approved upon receipt by the Secretary.
                                 ______
                                 

                        WYDEN AMENDMENT NO. 5352

  Mr. WYDEN proposed an amendment to the bill, H.R. 3662, supra; as 
follows:

       At the appropriate place in title I, insert the following:

     SEC 10. WATERSHED RESTORATION AND ENHANCEMENT AGREEMENTS.

       (a) In General.--For fiscal year 1997 and each fiscal year 
     thereafter, appropriations made for the Bureau of Land 
     Management may be used by the Secretary of the Interior for 
     the purpose of entering into cooperative agreements with 
     willing private landowners for restoration and enhancement of 
     fish, wildlife, and other biotic resources on public or 
     private land or both that benefit these resources on public 
     lands within the watershed.
       (b) Direct and Indirect Watershed Agreements.--The 
     Secretary of the Interior may enter into a watershed 
     restoration and enhancement agreement--
       (1) directly with a willing private landowner: or
       (2) indirectly through an agreement with a State, local, or 
     tribal government or other public entity, educational 
     institution, or private nonprofit organization.
       (c) Terms and Conditions.--In order for the Secretary to 
     enter into a watershed restoration and enhancement 
     agreement--
       (1) the agreement shall--
       (A) include such terms and conditions mutually agreed to by 
     the Secretary and the landowner:
       (B) improve the viability of and otherwise benefit the 
     fish, wildlife, and other biotic resources on public land in 
     the watershed.
       (C) authorize the provision of technical assistance by the 
     Secretary in the planning of management activities that will 
     further the purposes of the agreement;
       (D) provide for the sharing of costs of implementing the 
     agreement among the Federal Government, the landowner, and 
     other entities, as mutually agreed on by the affected 
     interests: and
       (E) ensure that any expenditure by the Secretary pursuant 
     to the agreement is determined by the Secretary to be in the 
     public interest; and
       (2) the Secretary may require such other terms and 
     conditions as are necessary to protect the public investment 
     on private lands, provided such terms and conditions are 
     mutually agreed to by the Secretary and the landowner.
                                 ______
                                 

                BUMPERS (AND OTHERS) AMENDMENT NO. 5353

  Mr. BUMPERS (for himself, Mr. Gregg, and Mr. Kerry) proposed an 
amendment to the bill, H.R. 3662, supra; as follows:

       At the end of the pending committee amendment ending on 
     line 4 on page 25, add the following:

     SEC.   . GRAZING FEES.

       (a) Grazing Fee.--Notwithstanding any other provision of 
     law and subject to subsections (b) and (c), the Secretary of 
     the Interior and the Secretary of Agriculture shall charge a 
     fee for domestic livestock grazing on public rangelands as 
     provided for in section 6(a) of the Public Rangelands 
     Improvement Act of 1978 (43 U.S.C. 1905(a)) and Executive 
     Order 12548 (51 F.R. 5985).
       (b) Determination of Fee.--(1) Permittees or lessees, 
     including related persons, who own or control livestock 
     comprising less than 2,000 animal unit months on the public 
     rangelands pursuant to one or more grazing permits or leases 
     shall pay the fee as set forth in subsection (a).
       (2) Permittees or lessees, including related persons, who 
     own or control livestock comprising more than 2,000 animal 
     unit months or the public rangelands pursuant to one or more 
     grazing permits or leases shall pay the fee as set forth in 
     subsection (a) for the first 2,000 animal unit months. For 
     animal unit months in excess of 2,000, the fee shall be the 
     higher of either--
       (A) the average grazing fee (weighted by animal unit 
     months) charged by the State during the previous grazing year 
     for grazing on State lands in which the lands covered by the 
     permit or lease are located; or
       (B) the Federal grazing fee set forth in subsection (a), 
     plus 25 percent.
       (c) Definitions.--For the purposes of this section--
       (1) State lands shall include school, education department, 
     and State lands board lands;
       (2) individual members of a grazing association shall be 
     considered as individual permittees or lessees in determining 
     the appropriate grazing fee; and
       (3) related persons includes--
       (i) the spouse and dependent children (as defined in 
     section 152 of the Internal Revenue Code of 1986), of the 
     holder of the permit or lease; and
       (ii) a person controlled by, or controlling, or under 
     common control with the holder of the permit or lease.

                          ____________________