[Congressional Record Volume 142, Number 110 (Wednesday, July 24, 1996)]
[Senate]
[Pages S8736-S8738]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      FOOD QUALITY PROTECTION ACT

  Mr. McCONNELL. I ask unanimous consent that the Senate proceed to the 
consideration of H.R. 1627 which was received from the House.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       A bill (H.R. 1627) to amend the Federal Insecticide, 
     Fungicide, and Rodenticide Act and the Federal Food, Drug, 
     and Cosmetic Act, and for other purposes.

  The PRESIDING OFFICER. Is there objection to the immediate 
consideration of the bill?

[[Page S8737]]

  There being no objection, the Senate proceeded to consider the bill.
  Mr. LUGAR. Today, the Senate takes final action on the Food Quality 
Protection Act. The legislation before us today passed the House on 
July 23 by a vote of 417 to 0.
  I commend our colleagues in the House for this bipartisan compromise 
to reform the Delaney clause. Chairman Bliley, Representative Dingell, 
and Representative Waxman are to be commended for their efforts. I also 
want to thank my counterparts on the House Agriculture Committee, 
Chairman Roberts and Representative de la Garza.
  This bill represents a carefully crafted compromise. A large list of 
consumer groups, environmental organizations, food industry 
organizations, and farm groups support the bill. The administration has 
indicated the President will sign the bill.
  The bill reforms the scientifically outdated Delaney clause enacted 
in 1958. The Delaney clause ignores the concept of risk. As science 
continues to develop new means of detecting even the smallest amount of 
substance in food, the Delaney clause would force more and more safe 
products off the market.
  The compromise bill sets a ``safe'' standard for both raw and 
processed food. Safe is defined as ``a reasonable certainty that no 
harm will result from aggregate exposure to pesticide chemical 
residue.''
  The bill also allows for the consideration of benefits when setting 
tolerances, but limits how much additional risk is acceptable as a 
tradeoff for benefits. As recommended by the National Academy of 
Sciences in 1993, EPA is required to give special consideration to 
infants and children when setting pesticide residue tolerances. For 
pesticides with threshold effects, an additional tenfold margin of 
safety shall be applied for infants and children, except EPA may use a 
different margin of safety on the basis of reliable data.
  National uniformity of tolerances is maintained with some exceptions. 
Uniformity does not apply to warning labels like Prop 65.
  The bill contains provisions to encourage development of new minor 
use pesticides without compromising food safety or adversely affecting 
the environment.
  The bill also addresses antimicrobial registrations by expediting 
registration procedures for antimicrobial pesticides.
  The bill extends EPA authorization to collect $14 million annually in 
reregistration fees--a provision strongly endorsed by the Environmental 
Protection Agency.
  Finally, I want to commend Senator Pryor for his efforts to reform 
the Delaney clause and his strong support for the legislation we 
introduced. Senator Kassebaum, chairman of the Labor and Human 
Resources Committee, has been a strong supporter of Delaney reform as 
an original cosponsor of S. 1166 and is supportive of our efforts to 
move forward. I also want to thank Senator Leahy for his support of 
this compromise and his willingness to work to move this bill through 
the Senate.
  I am pleased that we have a compromise bill before us that will 
reform the outdated Delaney clause and help ensure the continued 
availability of a safe, affordable and abundant food supply in our 
Nation. I urge my colleagues to support this important legislation.
  I ask unanimous consent to have printed in the Record three letters 
from Dr. Lynn Goldman, Assistant Administrator, Environmental 
Protection Agency.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:

                                                U.S. Environmental


                                            Protection Agency,

                                    Washington, DC, July 23, 1996.
     Hon. Richard Lugar,
     Chairman, Committee on Agriculture, Nutrition and Forestry, 
         U.S. Senate, Washington, DC.
       Dear Mr. Chairman: I am writing to clarify some questions 
     your staff has raised concerning certain provisions of H.R. 
     1627 as unanimously approved by the House of Representatives.
       The first issue relates to the tenfold additional margin of 
     safety when assessing risks to infants and children during 
     tolerance evaluations. We have clarified this issue through a 
     letter dated July 23, 1996 to Chairman Bliley (enclosed), and 
     would like to clarify one more point:
       Under this provision, as an uncertainty factor, we would 
     require an additional tenfold margin of safety if the Agency 
     does not have complete and reliable data to assess pre or 
     postnatal toxicity relating to infants and children, or if 
     the data indicate pre or postnatal effects of concern. When 
     the data are incomplete, we use an additional uncertainty 
     factor between three and ten based on how much information is 
     incomplete. The data EPA would consider include data 
     submitted in compliance with EPA testing requirements, 
     available data published in the scientific literature, and 
     any other data available to EPA and meeting general 
     scientific standards. Where reproductive and developmental 
     data have been found acceptable by EPA, and the data do not 
     indicate potential pre or postnatal effects of concern, the 
     additional tenfold margin of safety would not be applied.
       The second issue regards administrative hearings. With 
     respect to hearings under section 408 (g)(2)(B), EPA will 
     determine whether there are issues of material fact on which 
     a public hearing should be held. Issues of material fact may 
     include, for example, issues as to the magnitude of risk or 
     whether an effect is a threshold or non-threshold effect. 
     Where issues of material fact are raised, and relevant 
     factual information is at issue, the Administrator is 
     required to grant a request for a public hearing.
       The third issue regards the classification of certain 
     chemicals as threshold or non-threshold effects. For purposes 
     of the determination of safety under Section 408 
     (b)(2)(A)(ii), chemicals which currently are classified as 
     Category C carcinogens with no quantification of risk would 
     be treated under the standard applicable to threshold 
     effects.
       The Office of management and budget advises that there is 
     no objection to the presentation of these views from the 
     standpoint of the President's program.
           Sincerely,
                                            Lynn R. Goldman, M.D.,
     Assistant Administrator.
                                                                    ____

                                                U.S. Environmental


                                            Protection Agency,

                                    Washington, DC, July 23, 1996.
     Hon. Richard Lugar,
     Chairman, Committee on Agriculture, Nutrition, and Forestry, 
         U.S. Senate, Washington, DC.
       Dear Mr. Chairman: I am writing in response to your 
     question concerning the Agency's Special Review of the 
     pesticide atrazine. As you know, atrazine has been in Special 
     Review since November 1994, and currently we are reviewing 
     the additional information submitted by the registrant and 
     the public comments.
       Specifically, you have asked whether possible changes in 
     the Federal Food, Drug, and Cosmetic Act (FFDCA) might 
     obviate the need for completion of the atrazine Special 
     Review under the Federal Insecticide, Fungicide, and 
     Rodenticide Act (FIFRA).
       H.R. 1627 as enacted by the House of Representatives 
     contains numerous provisions changing the way we assess 
     tolerances for pesticide residues on food. However, should 
     the bill become law, the Special Review of atrazine would 
     continue as we assess the data submitted by the registrant 
     and others. Our plans for completion of the next step in the 
     Special Review process, the issuance of what we call 
     ``Position Document 2/3,'' remains unchanged. Completion of 
     this document is now planned for late 1997.
       We would not expect to examine the tolerances associated 
     with the current uses of atrazine until the later stages of 
     the Special Review process, that is at the ``Position 
     Document 4'' stage.
       Commonly, as part of our Special Review process, the Agency 
     discusses risk reduction measures on a continuing basis with 
     the registrant and affected grower community. These are often 
     a valuable part of the pesticide regulatory decision process. 
     Obviously, if the risk issues are resolved through this 
     process, we would terminate the Special Review.
       The Office of Management and Budget advises that there is 
     no objection to the presentation of these views from the 
     standpoint of the President's program.
           Sincerely,
                                            Lynn R. Goldman, M.D.,
     Assistant Administrator.
                                                                    ____

                                                U.S. Environmental


                                            Protection Agency,

                                    Washington, DC, July 23, 1996.
     Hon. Thomas Bliley,
     Chairman, Committee on Commerce, House of Representatives, 
         Washington, DC.
       Dear Mr. Chairman: We are writing to clarify questions 
     regarding the provision in H.R. 1627 as passed by the 
     Committee on Commerce concerning the ten-fold additional 
     margin of safety when assessing risks to infants and children 
     during tolerance evaluations. We believe that this language 
     when applied with the general safety standard, would provide 
     EPA with an important tool to implement the recommendations 
     found in the National Academy of Sciences' report, Pesticides 
     in the Diets of Infants and Children.
       We believe that this provision is consistent with the 
     recommendations found in that report (see attached), and 
     would allow the Agency to ensure that pesticide tolerances 
     are safe for children in those situations where an additional 
     margin of safety is necessary to account for inadequate or 
     otherwise incomplete data. This language provides the Agency 
     with discretion, based on

[[Page S8738]]

     sound science, to set the margin of safety at an appropriate 
     level to protect infants and children.
       This provision is consistent with current Agency risk 
     assessment practices. We have the been actively working to 
     implement the NAS recommendations, and are using the best 
     available science to assess risks to infants and children in 
     a manner consistent with those recommendations. In doing so, 
     EPA scientists exercise their best judgment, based on 
     reliable data, to determine whether studies accurately 
     reflect the risk to children or if an additional margin of 
     safety of up to ten is required. When the data are 
     incomplete, we use an additional uncertainty factor between 
     three and ten based on how much information is incomplete.
       We believe that the language passed by the Committee on 
     Commerce strikes the proper balance in setting a strong 
     standard to protect children while giving EPA the discretion 
     to use the best available science. We are pleased that the 
     children's standard will allow us to assure the public that 
     all foods are safe for children.
       The Office of Management and Budget advises that there is 
     no objection to the presentation of these views from the 
     standpoint of the President's program.
           Sincerely,
                                            Lynn R. Goldman, M.D.,
     Assistant Administrator.
                                                                    ____


            Pesticides in the Diets of Infants and Children

         (National Academy of Sciences Recommendations, page 9)

       Uncertainty factors.--For toxic effects other than cancer 
     or heritable mutation, uncertainty factors are widely used to 
     establish guidelines for human exposure on the basis of 
     animal testing results. This is often done by dividing the 
     no-observed-effect level (NOEL) found in animal tests by an 
     uncertainty factor of 100-fold. This factor comprises two 
     separate factors of 10-fold each; one allows for uncertainty 
     in extrapolating data from animals to humans; the other 
     accommodates variation within the human population. Although 
     the committee believes that the latter uncertainty factor 
     generally provides adequate protection for infants and 
     children, this population subgroup may be uniquely 
     susceptible to chemical exposures at particularly sensitive 
     stages of development.
       At the present, to provide added protection during early 
     development, a third uncertainty factor of 10 is applied to 
     the NOEL to develop the RfD. This third 10-fold factor has 
     been applied by the EPA and FDA whenever toxicity studies and 
     metabolic/disposition studies have shown fetal developmental 
     effects.
       Because there exist specific periods of vulnerability 
     during postnatal development, the committee recommends that 
     an uncertainty factor up to the 10-fold factor traditionally 
     used by EPA and FDA for fetal developmental toxicity should 
     also be considered when there is evidence of postnatal 
     developmental toxicity and when data from toxicity testing 
     relative to children are incomplete. The committee wishes to 
     emphasize that this is not a new, additional uncertainty 
     factor but, rather, an extended application of an uncertainty 
     factor now routinely used by the agencies for a narrower 
     purpose.
       In the absence of data to the contrary, there should be a 
     presumption of greater toxicity to infants and children. To 
     validate this presumption, the sensitivity of mature and 
     immature individuals should be studied systematically to 
     expand the current limited data base on relative sensitivity.

  Mr. PRYOR. Mr. President, today marks the conclusion of a monumental 
effort by numerous individuals and organizations to finally update food 
safety laws of this country. With the help of the Clinton 
administration, members of both the Agriculture and Labor Committees--
particularly Senator Lugar, the chief sponsor of the bill in the 
Senate--as well as our colleagues in the House, passage of the Food 
Quality Protection Act has finally become a reality.
  This legislation at long last updates the famed Delaney Clause which 
was first enacted in the 1950's, but became obsolete with the advances 
in science and technology. Although the provision served a very useful 
purpose in its day, we have recently found ourselves in a situation 
where the outdated law was working against the ability of the crop 
protection industry to find safer alternatives for our farmers and 
ranchers to use in the production of food and fiber.
  Again, Mr. President, I want to complement the Clinton administration 
for helping find a bipartisan solution to a problem that has plagued 
farmers and consumers for a number of years. The result is consumers 
continue to have a safe and abundant food supply and that farmers and 
agribusiness will be treated more fairly by government regulators. It 
is a clear victory for both farmers and consumers and proves once again 
that when we work in a bipartisan fashion we're all the better.


                     consumer right to know section

  Mr. SANTORUM. As we prepare to vote on H.R. 1627, I wish to seek 
clarification on the consumer right to know section if Chairman Lugar 
would be kind enough to respond.
  Mr. LUGAR. What clarification is the Senator seeking?
  Mr. SANTORUM. It is my understanding that under the consumer right to 
know section, the administrator of EPA in consultation with the 
Secretary of Agriculture and the Secretary of Health and Human Services 
will develop and distribute to large retail grocers information 
relating to the risks and benefits of pesticide residues in or on food 
items that are purchased by consumers.
  Mr. LUGAR. That is correct.
  Mr. SANTORUM. In turn, under this section, grocers are expected to 
display or make available this information in whatever manner best 
works for that retail store.
  Mr. LUGAR. Yes, the legislation makes this type of information 
available for display.
  Mr. SANTORUM. It is also my understanding under this section that a 
supermarket would not be held liable for any civil or criminal 
penalties in the event that the store were to be depleted of its supply 
of brochures or whatever information is provided by EPA, USDA, and FDA. 
Nor would a grocer be held liable or have products deemed misbranded if 
the information is not always available, or in the event the Government 
fails to provide the information to supermarkets.
  Mr. LUGAR. It is clearly not the intent of Congress to penalize 
supermarkets for failure to display the information. It is our intent, 
however, for grocery stores to serve as a conduit for the display and 
dissemination of this information to the greatest extent practical in a 
manner that will be determined by each store. In other words, we do not 
intend to impose an unfair burden on grocery stores that would subject 
them to fines or seizure of products simply because the information is 
not always available.
  Mr. SANTORUM. I appreciate this clarification on the consumer right 
to know section of the legislation.
  Mr. HEFLIN. Mr. President, it would be my understanding that with 
regard to the authority given the administrator to require a period of 
not less than 60 days for public comment after issuing a regulation 
under section 408(e)(1) of the Act that this would apply only to those 
tolerance petitions submitted after the effective date of the Act.
  Mr. LUGAR. The Senator from Alabama is correct.
  Mr. McCONNELL. Mr. President, I ask unanimous consent the bill be 
deemed read a third time, passed, the motion to reconsider be laid upon 
the table, and that any statements relating to this measure appear at 
this point in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The bill (H.R. 1627) was deemed read a third time, and passed.

                          ____________________