[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The bill reforms the scientifically outdated Delaney clause enacted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.
____________________