Federal Register, Volume 74, Number 46, March 11, 2009, Pages 10455-10672 Page: 10,500
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10500 Federal Register/Vol. 74, No. 46/Wednesday, March 11, 2009/Rules and Regulations
definition of a polymer given in 40 CFR
723.250(b) and meets the following
criteria that are used to identify low-risk
polymers.
1. The polymer is not a cationic
polymer nor is it reasonably anticipated
to become a cationic polymer in a
natural aquatic environment.
2. The polymer does contain as an
integral part of its composition the
atomic elements carbon, hydrogen, and
oxygen.
3. The polymer does not contain as an
integral part of its composition, except
as impurities, any element other than
those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed
nor can it be reasonably anticipated to
substantially degrade, decompose, or
depolymerize.
5. The polymer is manufactured or
imported from monomers and/or
reactants that are already included on
the TSCA Chemical Substance
Inventory or manufactured under an
applicable TSCA section 5 exemption.
6. The polymer is not a water
absorbing polymer with a number
average molecular weight (MW) greater
than or equal to 10,000 daltons.
Additionally, the polymer also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW
of 16,000 is greater than or equal to
10,000 daltons. The polymer contains
less than 2% oligomeric material below
MW 500 and less than 5% oligomeric
material below MW 1,000.
Thus, 2-propenoic acid, polymer with
a-[4-(ethenyloxy) butyl]-w-hydroxypoly
(oxy-1,2-ethanediyl) and 1,2-
propanediol mono-2-propenoate,
potassium sodium salt meets the criteria
for a polymer to be considered low risk
under 40 CFR 723.250. Based on its
conformance to the criteria in this unit,
no mammalian toxicity is anticipated
from dietary, inhalation, or dermal
exposure to 2-propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-w-
hydroxypoly (oxy-1,2-ethanediyl) and
1,2-propanediol mono-2-propenoate,
potassium sodium salt.
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that 2-
propenoic acid, polymer with a-[4-
(ethenyloxy) butyl]-a-hydroxypoly (oxy-
1,2-ethanediyl) and 1,2-propanediol
mono-2-propenoate, potassium sodium
salt could be present in all raw and
processed agricultural commodities and
drinking water, and that non-
occupational non-dietary exposure was
possible. The number average MW of 2-propenoic acid, polymer with a-[4-
(ethenyloxy) butyl]-w-hydroxypoly (oxy-
1,2-ethanediyl) and 1,2-propanediol
mono-2-propenoate, potassium sodium
salt is 16,000 daltons. Generally, a
polymer of this size would be poorly
absorbed through the intact
gastrointestinal tract or through intact
human skin. Since 2-propenoic acid,
polymer with a-[4-(ethenyloxy) butyl]-
w-hydroxypoly (oxy-1,2-ethanediyl) and
1,2-propanediol mono-2-propenoate,
potassium sodium salt conform to the
criteria that identify a low-risk polymer,
there are no concerns for risks
associated with any potential exposure
scenarios that are reasonably
foreseeable. The Agency has determined
that a tolerance is not necessary to
protect the public health.
V. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance or tolerance exemption, the
Agency consider "available
information" concerning the cumulative
effects of a particular chemical's
residues and "other substances that
have a common mechanism of toxicity."
For the purposes of this tolerance
action, EPA has not assumed that 2-
propenoic acid, polymer with a-[4-
(ethenyloxy) butyl]-w-hydroxypoly (oxy-
1,2-ethanediyl) and 1,2-propanediol
mono-2-propenoate, potassium sodium
salt has a common mechanism of
toxicity with other substances, based on
the anticipated absence of mammalian
toxicity. For information regarding
EPA's efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA's Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA's website at http://www.epa.gov/
pesticides/cumulative.
VI. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base unless
EPA concludes that a different margin of
safety will be safe for infants and
children. Due to the expected low
toxicity of 2-propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-a-
hydroxypoly (oxy-1,2-ethanediyl) and1,2-propanediol mono-2-propenoate,
potassium sodium salt, EPA has not
used a safety factor analysis to assess
the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
VII. Determination of Safety
Based on the conformance to the
criteria used to identify a low-risk
polymer, EPA concludes that there is a
reasonable certainty of no harm to the
U.S. population, including infants and
children, from aggregate exposure to
residues of 2-propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-w-
hydroxypoly (oxy-1,2-ethanediyl) and
1,2-propanediol mono-2-propenoate,
potassium sodium salt.
VIII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Tolerances
The Agency is not aware of any
country requiring a tolerance for 2-
propenoic acid, polymer with a-[4-
(ethenyloxy) butyl]-w-hydroxypoly (oxy-
1,2-ethanediyl) and 1,2-propanediol
mono-2-propenoate, potassium sodium
salt nor have any CODEX Maximum
Residue Levels (MRLs) been established
for any food crops at this time.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of 2-propenoic acid,
polymer with a-[4-(ethenyloxy) butyl]-
w-hydroxypoly (oxy-1,2-ethanediyl) and
1,2-propanediol mono-2-propenoate,
potassium sodium salt from the
requirement of a tolerance will be safe.
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these rules
from review under Executive Order
12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).This final rule does not contain any
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United States. Office of the Federal Register. Federal Register, Volume 74, Number 46, March 11, 2009, Pages 10455-10672, periodical, March 11, 2009; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc132908/m1/54/: accessed April 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.