[Congressional Record Volume 144, Number 139 (Wednesday, October 7, 1998)]
[House]
[Pages H9898-H9900]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       ANTIMICROBIAL REGULATION TECHNICAL CORRECTIONS ACT OF 1998

  Mr. BLILEY. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 4679) to amend the Federal Food, Drug, and Cosmetic Act to 
clarify the circumstances in which a substance is considered to be a 
pesticide chemical for purposes of such Act, and for other purposes.
  The Clerk read as follows:

                               H.R. 4679

       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 ``Antimicrobial Regulation 
     Technical Corrections Act of 1998''.

     SEC. 2. DEFINITION OF PESTICIDE CHEMICAL UNDER FEDERAL FOOD, 
                   DRUG, AND COSMETIC ACT.

       (a) In General.--Section 201(q) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(q)) is amended by striking 
     ``(q)(1)'' and all that follows through the end of 
     subparagraph (1) and inserting the following:
       ``(q)(1)(A) Except as provided in clause (B), the term 
     `pesticide chemical' means any substance that is a pesticide 
     within the meaning of the Federal Insecticide, Fungicide, and 
     Rodenticide Act, including all active and inert ingredients 
     of such pesticide. Notwithstanding any other provision of 
     law, the term `pesticide' within such meaning includes 
     ethylene oxide and propylene oxide when such substances are 
     applied on food.
       ``(B) In the case of the use, with respect to food, of a 
     substance described in clause (A) to prevent, destroy, repel, 
     or mitigate microorganisms (including bacteria, viruses, 
     fungi, protozoa, algae, and slime), the following applies for 
     purposes of clause (A):
       ``(i) The definition in such clause for the term `pesticide 
     chemical' does not include the substance if the substance is 
     applied for such use on food, or the substance is included 
     for such use in water that comes into contact with the food, 
     in the preparing, packing, or holding of the food for 
     commercial purposes. The substance is not excluded under this 
     subclause from such definition if the substance is ethylene 
     oxide or propylene oxide, and is applied for such use on 
     food. The substance is not so excluded if the substance is 
     applied for such use on a raw agricultural commodity, or the 
     substance is included for such use in water that comes into 
     contact with the commodity, as follows:

[[Page H9899]]

       ``(I) The substance is applied in the field.
       ``(II) The substance is applied at a treatment facility 
     where raw agricultural commodities are the only food treated, 
     and the treatment is in a manner that does not change the 
     status of the food as a raw agricultural commodity (including 
     treatment through washing, waxing, fumigating, and packing 
     such commodities in such manner).
       ``(III) The substance is applied during the transportation 
     of such commodity between the field and such a treatment 
     facility.
       ``(ii) The definition in such clause for the term 
     `pesticide chemical' does not include the substance if the 
     substance is a food contact substance as defined in section 
     409(h)(6), and any of the following circumstances exist: The 
     substance is included for such use in an object that has a 
     food contact surface but is not intended to have an ongoing 
     effect on any portion of the object; the substance is 
     included for such use in an object that has a food contact 
     surface and is intended to have an ongoing effect on a 
     portion of the object but not on the food contact surface; or 
     the substance is included for such use in or is applied for 
     such use on food packaging (without regard to whether the 
     substance is intended to have an ongoing effect on any 
     portion of the packaging). The food contact substance is not 
     excluded under this subclause from such definition if any of 
     the following circumstances exist: The substance is applied 
     for such use on a semipermanent or permanent food contact 
     surface (other than being applied on food packaging); or the 
     substance is included for such use in an object that has a 
     semipermanent or permanent food contact surface (other than 
     being included in food packaging) and the substance is 
     intended to have an ongoing effect on the food contact 
     surface.
     With respect to the definition of the term `pesticide' that 
     is applicable to the Federal Insecticide, Fungicide, and 
     Rodenticide Act, this clause does not exclude any substance 
     from such definition.''.
       (b) Regulations.--Section 408(j) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 346a(j)) is amended by adding at 
     the end the following paragraph:
       ``(4) Certain substances.--With respect to a substance that 
     is not included in the definition of the term `pesticide 
     chemical' under section 201(q)(1) but was so included on the 
     day before the date of the enactment of the Antimicrobial 
     Regulation Technical Corrections Act of 1998, the following 
     applies as of such date of enactment:
       ``(A) Notwithstanding paragraph (2), any regulation 
     applying to the use of the substance that was in effect on 
     the day before such date, and was on such day deemed in such 
     paragraph to have been issued under this section, shall be 
     considered to have been issued under section 409.
       ``(B) Notwithstanding paragraph (3), any regulation 
     applying to the use of the substance that was in effect on 
     such day and was issued under this section (including any 
     such regulation issued before the date of the enactment of 
     the Food Quality Protection Act of 1996) is deemed to have 
     been issued under section 409.''.
       (c) Technical Amendment.--Section 201(q)(3) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 321(q)(3)) is amended 
     in the matter preceding clause (A) by striking ``paragraphs 
     (1) and (2)'' and inserting ``subparagraphs (1) and (2)''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Virginia (Mr. Bliley) and the gentleman from California (Mr. Brown) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Virginia (Mr. Bliley).


                             General Leave

  Mr. BLILEY. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
and to insert extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Virginia?
  There was no objection.
  Mr. BLILEY. Mr. Speaker, I yield myself 5 minutes.
  This bill, the Antimicrobial Regulation Technical Corrections Act of 
1998, corrects an unintended problem created by the Food Quality 
Protection Act of 1996.
  When we passed that legislation, we expanded the definition of 
``pesticide chemical.'' Unfortunately, that had the effect of 
transferring to the EPA jurisdiction over a small class of substances 
known as antimicrobials.
  Used in food contact applications, these products play an important 
role in the safety of our food supply. For example, food and drinks 
like milk are often packaged in paper containers. To make sure that 
this paper is free of contamination, we use antimicrobials.
  Before 1996, such substances were regulated by the FDA as food 
additives. That was right then, and it should be today. As a result, 
the bill before us today will return them once again to the FDA.
  This is strictly a technical corrections measure; it does not 
represent a change in FQPA policy, and it does not weaken any 
environmental safeguards. Indeed, one of the products blocked from the 
market by this problem actually won the President's Green Chemistry 
Award for its environmental benefits.
  Mr. Speaker, when we passed FDA reform last year, the conference 
report acknowledged this problem and urged the FDA and EPA to work with 
Congress to develop a bill that would correct it. This is that bill. It 
was developed jointly with EPA and FDA, the affected industries, and 
the environmental community. I think they all should be commended for 
their cooperation and effort.
  In closing, I would just like to inform my colleagues that the Senate 
is set to approve this measure tonight or tomorrow. It is being 
sponsored by Senators Durbin, Kennedy, Warner, Mikulski, and 
Hutchinson, among others.
  Mr. Speaker, H.R. 4679 will enable companies to bring beneficial 
antimicrobial products to market without further delay. I urge its 
immediate passage.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of California. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, it is my pleasure to support H.R. 4679 to amend the Food 
Quality Protection Act of 1996. The changes made to the Food Quality 
Protection Act mistakenly defined ``pesticide chemical'' in the Federal 
Food, Drug and Cosmetic Act. This definition unintentionally 
transferred regulatory authority of antimicrobials, which have 
traditionally been under the FDA to the EPA.
  This legislation would not change the Federal Insecticide, Fungicide 
and Rodenticide Act or remove any use of a substance from regulation as 
a pesticide under that act. FIFRA would continue to review these 
substances for registration and maintain the traditional FDA review for 
food additives.
  Antimicrobial food additive petitions have been delayed at the FDA 
since the enactment of FQPA. This legislation will shift regulatory 
jurisdiction from review and approval of petitions for specialty 
chemicals in food contact applications back to the FDA. This amendment 
would grant the FDA authority to regulate antimicrobial substances that 
may be used in food, come in contact with food, or be used in food 
packaging. This will facilitate consideration of petitions for new 
products.
  The Environmental Working Group, the Natural Resources Defense 
Council, and many other public interest groups have agreed not to 
oppose the legislation. At their request, language has been included to 
recognize that FQPA protective provisions have not been eliminated.
  These environmental groups and other organizations are right in their 
concern about food safety. This Congress has failed in the wake of 
NAFTA and other trade agreements to modernize our food safety laws and 
protect the public. Food imports, especially fruits and vegetables, 
have increased dramatically in the last 10 years in this country, 
especially since the passage of NAFTA, yet our inspection facilities 
are underfunded and unprepared, which unfortunately seems to be of 
little concern to this Congress.
  Nonetheless, Mr. Speaker, I support this bill and I urge my 
colleagues to do the same.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 1 minute to the gentlewoman 
from North Carolina (Mrs. Clayton).
  (Mrs. CLAYTON asked and was given permission to revise and extend her 
remarks.)
  Mrs. CLAYTON. Mr. Speaker, I thank the gentleman for yielding me this 
time.
  I am pleased to rise in support of H.R. 4679, and I am appreciative 
of the leadership who has brought this to the House. I want my 
colleagues to know this corrects a problem that will impact many 
workers in our areas. I know it was a mistake, but nevertheless, it 
would make a correction that does not lessen the quality of inspections 
of food, gives the same amount of regulation, and allows for this more 
worthy project to go forward.
  Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time, 
and I yield back the balance of my time.
  Mr. BLILEY. Mr. Speaker, I have no further requests for time, and I 
yield back the balance of my time.

[[Page H9900]]

  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Virginia (Mr. Bliley) that the House suspend the rules 
and pass the bill, H.R. 4679.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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