Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564 Page: 9,366
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Federal Register/Vol. 74, No. 41/Wednesday, March 4, 2009/Rules and Regulations
III. Response to Comments
Comments were received in response
to the proposed rule from two United
States citizens. The comments and
EPA's response are presented below:
An anonymous citizen objected to the
presence of any pesticide residues on
crops and stated that EPA should set no
pesticide tolerance greater than zero.
The Agency understands the
commenter's concerns and recognizes
that some individuals believe that
pesticides should be banned
completely. However, the existing legal
framework provided by section 408 of
FFDCA contemplates that tolerances
greater than zero may be set when
persons seeking such tolerances or
exemptions have demonstrated that the
pesticide meets the safety standard
imposed by that statute. This citizen's
comment appears to be directed at the
underlying statute and not EPA's
implementation of it; the citizen has
made no contention that EPA has acted
in violation of the statutory framework.
A second citizen indicated her
support for the tolerances on lychee and
starfruit based on EPA's determination
that the proposed tolerance levels are
safe, but, at the same time, expressed
hope that all pesticide residues will
eventually be removed from food. The
commenter also expressed "great"
concern about the carcinogenicity of
chlorothalonil, notwithstanding EPA's
determination that the cancer risk is
below the level of concern; and voiced
concerns that EPA's risk assessment for
chlorothalonil did not adequately
address the risks of cancer from
"aggregate" residues of multiple
pesticides on food.
The Agency understands the
commenter's concerns about
establishing food tolerances for
pesticides that have the potential to
cause cancer. Prior to establishing such
tolerances, EPA conducts an aggregate
exposure assessment to evaluate cancer
risk to ensure that the tolerance meets
the safety standard of a "reasonable
certainty of no harm" established by
FFDCA. The cancer effect observed in
chlorothalonil animal studies is
believed to be a threshold effect
resulting from a non-linear mode of
action. In the case of a threshold effect
for a pesticide, EPA considers that a
tolerance will provide a "reasonable
certainty of no harm" if the aggregate
exposure to the pesticide residue is
lower by an ample margin of safety than
the level at which the pesticide will not
cause or contribute to any known or
anticipated harm to human health.
Aggregate exposures that are at least100-fold lower than the no observable
adverse effect level (NOAEL) are
considered to provide an ample margin
of safety when data are extrapolated
from animals. The aggregate exposure
assessment conducted to evaluate
cancer risk for chlorothalonil indicates
that aggregate exposures are more than
100-fold lower than the NOAEL for
chlorothalonil; therefore, EPA has
concluded that the proposed tolerances
are acceptable.
EPA disagrees with the comment that
the chlorothalonil risk assessment did
not adequately address cancer risk from
residues of multiple pesticides on food.
The Agency is required by section 408
of FFDCA to consider available
information concerning the cumulative
toxicological effects of the residues of a
pesticide and of other substances having
a common mechanism of toxicity with
it. This requirement applies to all types
of toxicological effects, including
cancer. At this time, EPA has not
identified any other substances having a
common mechanism of carcinogenicity
with chlorothalonil. Therefore, EPA did
evaluate potential cancer risk from
exposure to chlorothalonil and other
pesticides.
IV. Conclusion
Based on the information, analysis,
and conclusions in the December 3,
2008 proposal (73 FR 73632) (FRL-
8390-1), tolerances are established for
residues of chlorothalonil,
tetrachloroisophthalonitrile, and its
metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on
lychee at 15 ppm and starfruit at 3.0
ppm.
V. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA on
EPA's own initiaive. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted
from review under Executive Order
12866 due to its lack of significance,
this rule is not subject to Executive
Order 13211, Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001). This final rule
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded MandatesReform Act of 1995 (UMRA) (Public
Law 104-4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note). Pursuant to
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency hereby certifies that
this rule will not have significant
negative economic impact on a
substantial number of small entities.
Establishing a pesticide tolerance or an
exemption from the requirement of a
pesticide tolerance is, in effect, the
removal of a regulatory restriction on
pesticide residues in food, and thus
such an action will not have any
negative economic impact on any
entities, including small entities.
In addition, the Agency has
determined that this action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure "meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications." "Policies
that have federalism implications" is
defined in the Executive order to
include regulations that have
"substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government." This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this ruledoes not have any "tribal implications"
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United States. Office of the Federal Register. Federal Register, Volume 74, Number 41, March 4, 2009, Pages 9343-9564, periodical, March 4, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132903/m1/31/: accessed April 24, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.