Glufosinate-ammonium; Pesticide Tolerance, 72622-72626 [E7-24841]
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations
The provisions of § 52.21 except
paragraph (a)(1) are hereby incorporated
and made a part of the South Dakota
State implementation plan and are
applicable to proposed major stationary
sources or major modifications to be
located on Indian reservations.
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[FR Doc. E7–24717 Filed 12–20–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0029; FRL–8342–3]
I. General Information
Glufosinate-ammonium; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation modifies the
tolerances for the combined residues of
glufosinate-ammonium and its
metabolites expressed as butanoic acid
in or on raw agricultural commodities.
Bayer CropScience LLC requested this
revision under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 21, 2007. Objections and
requests for hearings must be received
on or before February 19, 2008 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0029. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
index, some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
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Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Kathryn V. Montague, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 305–1243; e-mail address:
montague.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
PO 00000
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https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, any
person may file an objection to any
aspect of this regulation and may also
request a hearing on those objections.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2007–0029 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before February 19, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2007–0029, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation 8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays. Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of February
28, 2007 (72 FR 9000) (FRL–8115–5),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 6F7161) by Bayer
CropScience LLC, 2 T.W. Alexander Dr.,
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Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.473
be amended by establishing a tolerance
for combined residues of the herbicide,
glufosinate-ammonium and its
metabolites expressed as butanoic acid,
2-amino-4-(hydroxymethylphosphinyl)-,
monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid
(expressed as glufosinate free acid
equivalents), in or on raw agricultural
commodities grain aspirated fractions at
25.0 parts per million (ppm); nontransgenic canola, meal at 1.1 ppm; nontransgenic canola, seed at 0.4 ppm; nontransgenic field corn, forage at 4.0 ppm;
non- transgenic field corn, grain at 0.2
ppm; non- transgenic field corn, stover
at 6.0 ppm; non- transgenic soybean, at
2.0 ppm; non-transgenic soybean, hulls
at 5.0 ppm. That notice referenced a
summary of the petition prepared by
Bayer CropScience LLC, the registrant,
which is available to the public in the
docket, https://www.regulations.gov.
In the Federal Register of June 27,
2007 (72 FR 35237) (FRL–8133–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the amendment
to existing tolerances by filing of a
pesticide petition (PP 6F7161) by Bayer
CropScience LLC, 2 T.W. Alexander Dr.,
Research Triangle Park, NC 27709. The
petition proposes to amend the
tolerances in 40 CFR 180.473(a) to
eliminate the reference to transgenic
crops tolerant to glufosinate ammonium
in §180.473(a)(2) such that the crop
tolerances listed under §180.473 (a)
General, support uses in all of the crops
listed to include both conventional and
transgenic crops and to delete §180.473
(a)(1) and (a)(2). This notice clarifies the
initial notice of filing published in the
Federal Register of February 28, 2007
(72 FR 9000) (FRL–8115–5). The
tolerances for glufosinate-ammonium
and its metabolites listed for the
commodities under both paragraphs
(a)(1) and paragraph (a)(2) are proposed
to be placed in §180.473 (a) General to
read as follows: Tolerances are
established for residues of glufosinateammonium (butanoic acid, 2-amino-4(hydroxymethylphosphinyl)monoammonium salt) and its
metabolites expressed as butanoic acid,
2-amino-4-(hydroxymethylphosphinyl)-,
monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid
expressed as glufosinate free acid
equivalents in or on the raw agricultural
commodities: Almond, hulls at 0.50
ppm; apple at 0.05 ppm; grain aspirated
fractions at 25.0 ppm; banana at 0.30
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ppm; banana, pulp at 0.20 ppm; beet,
sugar, molasses at 5.0 ppm; beet, sugar,
roots at 0.9 ppm; beet, sugar, tops at 1.5
ppm; bushberry subgroup 13B at 0.15
ppm; canola, meal at 1.1 ppm; canola,
seed at 0.4 at ppm; cattle, fat at 0.40
ppm; cattle, meat at 0.15 ppm; cattle,
meat byproducts at 6.0 ppm; corn, field
forage at 4.0 ppm; corn, field, grain at
0.2 ppm; corn, field, stover at 6.0 ppm;
cotton, gin byproducts at 15 ppm;
cotton, undelinted seed at 4.0 ppm; egg
at 0.15 ppm; goat, fat at 0.40 ppm; goat,
meat at 0.15 ppm; goat, meat byproducts
at 6.0 ppm; grape at 0.05 ppm; hog, fat
at 0.40 ppm; hog, meat at 0 .15; hog,
meat byproducts at 6.0 ppm; horse, fat
at 0.40 ppm; horse, meat at 0.15 ppm;
horse, meat byproducts at 6.0 ppm;
Juneberry 0.10 ppm; lingonberry at 0.10
ppm; milk at 0.15 ppm; nut, tree, group
14 at 0.10 ppm; potato at 0.80 ppm;
potato, chips at 1.60 ppm; potato
granules/flakes 2.00 ppm; poultry, fat
0.15 ppm; poultry, meat at 0.15 ppm;
poultry, meat byproducts 0.60 ppm;
rice, grain at 1.0 ppm; rice, hull at 2.0
ppm; rice, straw at 2.0 ppm; salal at 0.10
ppm; sheep, fat at 0.40 ppm; sheep,
meat at 0.15 ppm; sheep, meat
byproducts at 6.0 ppm; soybean at 2.0
ppm and soybean, hulls at 5.0 ppm.
Comments were received on the
notices of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Bayer’s petition asks EPA to
consolidate subsections (a)(1) and (a)(2)
of 40 CFR 180.473 which contains
tolerances for glufosinate on various
non-transgenic crops and transgenic
crops, respectively, and remove the
restriction as to transgenic crops. In part
this petition is related to Bayer’s
application to EPA to amend its
glufosinate registration under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) to allow preplant burn down application to both
transgenic and non-transgenic field
corn, canola, and soybean. Glufosinate
is currently registered foliar uses on the
transgenic forms of these crops. The
proposed registration amendment
would not alter existing seasonal
application amount limitations. There
are currently no FFDCA tolerances for
glufosinate on non-transgenic field corn,
canola, and soybean but FFDCA
tolerances are in place for the foliar use
on the transgenic form of these crops.
Consolidating subsections (a)(1) and
(a)(2) and removing the transgenic
restriction would address the lack of
tolerances for non-transgenic field corn,
canola, and soybean.
EPA initially concluded that two
tolerance expressions were appropriate
for plants: non-transgenic (40 CFR
180.473 (a)(1)) with glufosinate
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ammonium and 3-methylphosphinicopropionic acid and transgenic crops (40
CFR 180.473 (a)(2)) with glufosinate
ammonium, N-acetyl-glufosinate, and 3methylphosphinico-propionic acid.
Subsequent to this decision, based upon
a petition from Bayer, EPA modified the
tolerance expressions in subsections
(a)(1) and (a)(2) so that they are identical
for transgenic and non-transgenic crops.
68 FR 55833 (September 29, 2003). This
modification was done because EPA
concluded that a single tolerance
expression for both transgenic crops and
non-transgenic crops (i.e. glufosinate
ammonium, N-acetyl-glufosinate, and 3methylphosphinico-propionic acid) was
appropriate for the following reasons: 1)
Enforcement laboratories do not know if
a sample is derived from transgenic or
non-transgenic crop and 2) the
enforcement method quantifies
glufosinate ammonium and N-acetylglufosinate together (both are
devitalized to the same compound). As
a result of the decision, the tolerance
expression for 40 CFR 180.473 (a)(1)
was altered to include N-acetylglufosinate; however, the tolerances in
40 CFR 180.473 (a)(2) remains. EPA has
determined that consolidating the
existing glufosinate tolerances in
subsections (a)(1) and (a)(2) and
removing the transgenic crop restriction,
where applicable, is safe and is
appropriate. Tolerance levels will not
need to be increased with the addition
of a pre-plant burn down use because
the same seasonal amount limitations
are being retained. Given that foliar
applications would result in higher
residue levels than pre-plant burn
down, allocation of a portion of the
permitted application to the pre-plant
burn down use will not increase the
residue level that could be present.
III. Aggregate Risk Assessment and
Determination of Safty
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
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tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
proposal to place all the commodities
listed in 180.473 (a)(1) and 180.473
(a)(2) together in paragraph 180.473(a)
based on the rationale for having a
single tolerance expression is
appropriate. Tolerance levels for
combined residues of glufosinateammonium are unchanged. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
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A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by glufosinate-ammonium as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies.
Specific information on the studies
received and the nature of the toxic
effects caused by glufosinate ammonium
as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL)
from the toxicity studies are discussed
in the final rule published in the
Federal Register of September 29, 2003
(68 FR 55833) (FRL–7327–9).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects are observed
(the NOAEL) in the toxicology study
identified as appropriate for use in risk
assessment. However, if a NOAEL
cannot be determined, the lowest dose
at which adverse effects of concern are
identified (the LOAEL) is sometimes
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used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the LOC to take into
account uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic risks by comparing
aggregate exposure to the pesticide to
the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. Short-term,
intermediate-term, and long-term risks
are evaluated by comparing aggregate
exposure to the LOC to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for glufosinate ammonium
used for human risk assessment is
discussed in Unit III.B. of the final rule
published in the Federal Register of
September 29, 2003 (68 FR 55833)
(FRL–7327–9).
C. Exposure Assessment
EPA concludes that the tolerance
levels for combined residues of
Glufosinate-ammonium are unchanged.
The exposure assumptions discussed in
the final rule published in the Federal
Register of September 29, 2003 (68 FR
55833) (FRL–7327–9) remain the same.
D. Safety Factor for Infants and
Children
A summary of the safety factor for
infants and children for glufosinate
ammonium is discussed in Unit III.D. of
the final rule published in the Federal
Register of September 29, 2003 (68 FR
55833) (FRL–7327–9)
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable UFs. For linear cancer risks,
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EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-term, intermediateterm, and long-term risks are evaluated
by comparing aggregate exposure to the
LOC to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
section 408(b)(2)(D), EPA has reviewed
the available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure for
the petitioned-for revision in the
tolerance expressions for combined
residues of glufosinate-ammonium and
its metabolites. EPA’s assessment of
exposures and risks associated with
establishing the tolerance are discussed
in the Federal Register of September 29,
2003 (68 FR 55833) (FRL–7327–9).
Accordingly EPA concludes that there
is a reasonable certainty that no harm
will result to the general population and
to infants and children from aggregate
exposure to glufosinate-ammonium
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
gas chromatography is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
Since tolerances levels remain the
same and since there are no new
tolerances established, harmonization
with CODEX, Canada or Mexico’s MRLs
is impacted.
C. Response to Comments
Public comments were received from
B. Sachau who objected to the proposed
tolerances because of the amounts of
pesticides already consumed and
carried by the American population.
She further indicated that testing
conducted on animals have absolutely
no validity and are cruel to the test
animals. B. Sachau’s comments
contained no scientific data or evidence
to rebut the Agency’s conclusion that
there is a reasonable certainty that no
harm will result from aggregate
exposure to glufosinate ammonium,
including all anticipated dietary
exposures and all other exposures for
which there is reliable information. EPA
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has responded to B. Sachau’s
generalized comments on numerous
previous occasions. (January 7, 2005, 70
FR 1349) (October 29, 2004, 69 FR
63083).
V. Conclusion
Therefore, the tolerance regulation for
the combined residues of glufosinateammonium and its metabolites
expressed as butanoic acid, 2-amino-4(hydroxymethylphosphinyl)-,
monoammonium salt, 2-acetamido-4methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid
(expressed as glufosinate free acid
equivalents), are revised by placing all
the commodities listed §180.473 (a)(1)
and (a)(2) together in §180.473 (a).
VI. 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 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, 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) 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
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply
to this rule. In addition, This rule does
not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.473 is amended by
revising paragraph (a) to read as follows.
I
180.473 Glufosinate-ammonium;
tolerances for residues.
(a) General. Tolerances are
established for residues of the herbicide
glufosinate-ammonium (butanoic acid,
2-amino-4-(hydroxymethylphosphinyl)monoammonium salt) and its
metabolites, 2-acetamido-4methylphosphinico-butanoic acid and
3-methylphosphinico-propionic acid,
expressed as 2-amino-4(hydroxymethylphosphinyl)butanoic
acid equivalents, in or on the following
food commodities:
sroberts on PROD1PC70 with RULES
Commodity
Parts per million
Almond, hulls ...................................................................................................................................................
Apple ................................................................................................................................................................
Banana .............................................................................................................................................................
Banana, pulp ....................................................................................................................................................
Beet, sugar, molasses .....................................................................................................................................
Beet, sugar, roots ............................................................................................................................................
Beet, sugar, tops (leaves) ...............................................................................................................................
Bushberry subgroup 13B .................................................................................................................................
Canola, meal ....................................................................................................................................................
Canola, seed ....................................................................................................................................................
Cattle, fat .........................................................................................................................................................
Cattle, meat .....................................................................................................................................................
Cattle, meat byproducts ...................................................................................................................................
Corn, field forage .............................................................................................................................................
Corn, field, grain ..............................................................................................................................................
Corn, field, stover ............................................................................................................................................
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Federal Register / Vol. 72, No. 245 / Friday, December 21, 2007 / Rules and Regulations
Commodity
Parts per million
Cotton, gin byproducts .....................................................................................................................................
Cotton, undelinted seed ...................................................................................................................................
Egg ...................................................................................................................................................................
Goat, fat ...........................................................................................................................................................
Goat, meat .......................................................................................................................................................
Goat, meat byproducts ....................................................................................................................................
Grain aspirated fractions .................................................................................................................................
Grape ...............................................................................................................................................................
Hog, fat ............................................................................................................................................................
Hog, meat ........................................................................................................................................................
Hog, meat byproducts .....................................................................................................................................
Horse, fat .........................................................................................................................................................
Horse, meat .....................................................................................................................................................
Horse, meat byproducts ..................................................................................................................................
Juneberry .........................................................................................................................................................
Lingonberry ......................................................................................................................................................
Milk ...................................................................................................................................................................
Nut, tree, group 14 ..........................................................................................................................................
Pistachio ..........................................................................................................................................................
Potato ...............................................................................................................................................................
Potato, chips ....................................................................................................................................................
Potato granules/flakes .....................................................................................................................................
Poultry, fat ........................................................................................................................................................
Poultry, meat ....................................................................................................................................................
Poultry, meat byproducts .................................................................................................................................
Rice, grain ........................................................................................................................................................
Rice, hull ..........................................................................................................................................................
Rice, straw .......................................................................................................................................................
Salal .................................................................................................................................................................
Sheep, fat ........................................................................................................................................................
Sheep, meat ....................................................................................................................................................
Sheep, meat byproducts ..................................................................................................................................
Soybean ...........................................................................................................................................................
Soybean, hulls
*
*
*
*
*
FOR FURTHER INFORMATION CONTACT:
[FR Doc. E7–24841 Filed 12–20–07; 8:45 am]
BILLING CODE 6560–50–S
Robert Hayne, Media Bureau (202) 418–
2177.
This is a
synopsis of the letter from Peter H.
Doyle, Chief, Audio Division, Media
Bureau to Liberty Productions, a
Limited Partnership, et al., released
December 11, 2007, (DA 07–4945). The
full text of this letter is available for
inspection and copying during normal
business hours in the FCC Reference
Information Center at Portals l1, CY–
A257, 445 12th Street, SW.,
Washington, DC 20554. The complete
text of this decision may also be
purchased from the Commission’s copy
contractor, Best Copying and Printing,
Inc., 445 12th Street, SW., Room CY–
B402, Washington, DC 20554, telephone
1–800–378–3160 or https://
www.BCPIWEB.com. The Commission,
is, therefore, not required to submit a
copy of this Letter pursuant to the
Government Accountability Office,
pursuant to the Congressional Review
Act, see 5 U.S.C. 801 (a)(1)(A), because
the Petition for Reconsideration was
dismissed.
SUPPLEMENTARY INFORMATION:
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 07–4945; MB Docket No. 02–352; RM–
10602, RM–10776, RM–10777]
Radio Broadcasting Services; Clyde
and Glenville, NC, Tazewell, Tennessee
and Weaverville, NC
Federal Communications
Commission.
ACTION: Final rule; dismissal.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: This document approves a
Joint Request for Approval of Settlement
Agreement filed by Liberty Productions,
a Limited Partnership, Saga
Communications of North Carolina,
LLC, Ashville Radio Partners, LLC, and
Willsyr Communications, Limited
Partnership, requesting withdrawal of a
Petition for Reconsideration and all
pleadings filed in connection MB
Docket No. 02–352. With this action, the
proceeding is terminated.
VerDate Aug<31>2005
18:20 Dec 20, 2007
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0.15
0.60
1.0
2.0
2.0
0.10
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0.15
6.0
2.0
5.0
Federal Communications Commission.
John A. Karousos,
Assistant Chief, Audio Division, Media
Bureau.
[FR Doc. E7–24623 Filed 12–20–07; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 070817468–7715–02]
RIN 0648–AV91
Fisheries of the Northeastern United
States; Atlantic Sea Scallop Fishery;
Framework Adjustment 20
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final Rule.
AGENCY:
SUMMARY: NMFS issues this final rule to
approve and implement measures
contained in Framework Adjustment 20
(Framework 20) to the Atlantic Sea
Scallop Fishery Management Plan
(FMP). This action maintains the trip
E:\FR\FM\21DER1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 245 (Friday, December 21, 2007)]
[Rules and Regulations]
[Pages 72622-72626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24841]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0029; FRL-8342-3]
Glufosinate-ammonium; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation modifies the tolerances for the combined
residues of glufosinate-ammonium and its metabolites expressed as
butanoic acid in or on raw agricultural commodities. Bayer CropScience
LLC requested this revision under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective December 21, 2007. Objections and
requests for hearings must be received on or before February 19, 2008
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0029. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address:
montague.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0029 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before February 19, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0029, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of February 28, 2007 (72 FR 9000) (FRL-
8115-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7161) by Bayer CropScience LLC, 2 T.W. Alexander Dr.,
[[Page 72623]]
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.473 be amended by establishing a tolerance for combined residues of
the herbicide, glufosinate-ammonium and its metabolites expressed as
butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt,
2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid (expressed as glufosinate free acid equivalents), in or
on raw agricultural commodities grain aspirated fractions at 25.0 parts
per million (ppm); non- transgenic canola, meal at 1.1 ppm; non-
transgenic canola, seed at 0.4 ppm; non- transgenic field corn, forage
at 4.0 ppm; non- transgenic field corn, grain at 0.2 ppm; non-
transgenic field corn, stover at 6.0 ppm; non- transgenic soybean, at
2.0 ppm; non-transgenic soybean, hulls at 5.0 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience LLC,
the registrant, which is available to the public in the docket, https://
www.regulations.gov.
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the amendment to existing tolerances by
filing of a pesticide petition (PP 6F7161) by Bayer CropScience LLC, 2
T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition
proposes to amend the tolerances in 40 CFR 180.473(a) to eliminate the
reference to transgenic crops tolerant to glufosinate ammonium in
Sec. 180.473(a)(2) such that the crop tolerances listed under
Sec. 180.473 (a) General, support uses in all of the crops listed to
include both conventional and transgenic crops and to delete
Sec. 180.473 (a)(1) and (a)(2). This notice clarifies the initial
notice of filing published in the Federal Register of February 28, 2007
(72 FR 9000) (FRL-8115-5). The tolerances for glufosinate-ammonium and
its metabolites listed for the commodities under both paragraphs (a)(1)
and paragraph (a)(2) are proposed to be placed in Sec. 180.473 (a)
General to read as follows: Tolerances are established for residues of
glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites
expressed as butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-,
monoammonium salt, 2-acetamido-4-methylphosphinico-butanoic acid and 3-
methylphosphinico-propionic acid expressed as glufosinate free acid
equivalents in or on the raw agricultural commodities: Almond, hulls at
0.50 ppm; apple at 0.05 ppm; grain aspirated fractions at 25.0 ppm;
banana at 0.30 ppm; banana, pulp at 0.20 ppm; beet, sugar, molasses at
5.0 ppm; beet, sugar, roots at 0.9 ppm; beet, sugar, tops at 1.5 ppm;
bushberry subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola,
seed at 0.4 at ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm;
cattle, meat byproducts at 6.0 ppm; corn, field forage at 4.0 ppm;
corn, field, grain at 0.2 ppm; corn, field, stover at 6.0 ppm; cotton,
gin byproducts at 15 ppm; cotton, undelinted seed at 4.0 ppm; egg at
0.15 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat
byproducts at 6.0 ppm; grape at 0.05 ppm; hog, fat at 0.40 ppm; hog,
meat at 0 .15; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm;
horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; Juneberry
0.10 ppm; lingonberry at 0.10 ppm; milk at 0.15 ppm; nut, tree, group
14 at 0.10 ppm; potato at 0.80 ppm; potato, chips at 1.60 ppm; potato
granules/flakes 2.00 ppm; poultry, fat 0.15 ppm; poultry, meat at 0.15
ppm; poultry, meat byproducts 0.60 ppm; rice, grain at 1.0 ppm; rice,
hull at 2.0 ppm; rice, straw at 2.0 ppm; salal at 0.10 ppm; sheep, fat
at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0
ppm; soybean at 2.0 ppm and soybean, hulls at 5.0 ppm.
Comments were received on the notices of filing. EPA's response to
these comments is discussed in Unit IV.C.
Bayer's petition asks EPA to consolidate subsections (a)(1) and
(a)(2) of 40 CFR 180.473 which contains tolerances for glufosinate on
various non-transgenic crops and transgenic crops, respectively, and
remove the restriction as to transgenic crops. In part this petition is
related to Bayer's application to EPA to amend its glufosinate
registration under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) to allow pre-plant burn down application to both transgenic
and non-transgenic field corn, canola, and soybean. Glufosinate is
currently registered foliar uses on the transgenic forms of these
crops. The proposed registration amendment would not alter existing
seasonal application amount limitations. There are currently no FFDCA
tolerances for glufosinate on non-transgenic field corn, canola, and
soybean but FFDCA tolerances are in place for the foliar use on the
transgenic form of these crops. Consolidating subsections (a)(1) and
(a)(2) and removing the transgenic restriction would address the lack
of tolerances for non-transgenic field corn, canola, and soybean.
EPA initially concluded that two tolerance expressions were
appropriate for plants: non-transgenic (40 CFR 180.473 (a)(1)) with
glufosinate ammonium and 3-methylphosphinico-propionic acid and
transgenic crops (40 CFR 180.473 (a)(2)) with glufosinate ammonium, N-
acetyl-glufosinate, and 3-methylphosphinico-propionic acid. Subsequent
to this decision, based upon a petition from Bayer, EPA modified the
tolerance expressions in subsections (a)(1) and (a)(2) so that they are
identical for transgenic and non-transgenic crops. 68 FR 55833
(September 29, 2003). This modification was done because EPA concluded
that a single tolerance expression for both transgenic crops and non-
transgenic crops (i.e. glufosinate ammonium, N-acetyl-glufosinate, and
3-methylphosphinico-propionic acid) was appropriate for the following
reasons: 1) Enforcement laboratories do not know if a sample is derived
from transgenic or non-transgenic crop and 2) the enforcement method
quantifies glufosinate ammonium and N-acetyl-glufosinate together (both
are devitalized to the same compound). As a result of the decision, the
tolerance expression for 40 CFR 180.473 (a)(1) was altered to include
N-acetyl-glufosinate; however, the tolerances in 40 CFR 180.473 (a)(2)
remains. EPA has determined that consolidating the existing glufosinate
tolerances in subsections (a)(1) and (a)(2) and removing the transgenic
crop restriction, where applicable, is safe and is appropriate.
Tolerance levels will not need to be increased with the addition of a
pre-plant burn down use because the same seasonal amount limitations
are being retained. Given that foliar applications would result in
higher residue levels than pre-plant burn down, allocation of a portion
of the permitted application to the pre-plant burn down use will not
increase the residue level that could be present.
III. Aggregate Risk Assessment and Determination of Safty
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a
[[Page 72624]]
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .'' These provisions were added to
FFDCA by the Food Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for proposal to
place all the commodities listed in 180.473 (a)(1) and 180.473 (a)(2)
together in paragraph 180.473(a) based on the rationale for having a
single tolerance expression is appropriate. Tolerance levels for
combined residues of glufosinate-ammonium are unchanged. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by glufosinate-ammonium as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies.
Specific information on the studies received and the nature of the
toxic effects caused by glufosinate ammonium as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
final rule published in the Federal Register of September 29, 2003 (68
FR 55833) (FRL-7327-9).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for glufosinate ammonium
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of September 29, 2003 (68 FR
55833) (FRL-7327-9).
C. Exposure Assessment
EPA concludes that the tolerance levels for combined residues of
Glufosinate-ammonium are unchanged. The exposure assumptions discussed
in the final rule published in the Federal Register of September 29,
2003 (68 FR 55833) (FRL-7327-9) remain the same.
D. Safety Factor for Infants and Children
A summary of the safety factor for infants and children for
glufosinate ammonium is discussed in Unit III.D. of the final rule
published in the Federal Register of September 29, 2003 (68 FR 55833)
(FRL-7327-9)
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for revision in
the tolerance expressions for combined residues of glufosinate-ammonium
and its metabolites. EPA's assessment of exposures and risks associated
with establishing the tolerance are discussed in the Federal Register
of September 29, 2003 (68 FR 55833) (FRL-7327-9).
Accordingly EPA concludes that there is a reasonable certainty
that no harm will result to the general population and to infants and
children from aggregate exposure to glufosinate-ammonium residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology gas chromatography is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
Since tolerances levels remain the same and since there are no new
tolerances established, harmonization with CODEX, Canada or Mexico's
MRLs is impacted.
C. Response to Comments
Public comments were received from B. Sachau who objected to the
proposed tolerances because of the amounts of pesticides already
consumed and carried by the American population. She further indicated
that testing conducted on animals have absolutely no validity and are
cruel to the test animals. B. Sachau's comments contained no scientific
data or evidence to rebut the Agency's conclusion that there is a
reasonable certainty that no harm will result from aggregate exposure
to glufosinate ammonium, including all anticipated dietary exposures
and all other exposures for which there is reliable information. EPA
[[Page 72625]]
has responded to B. Sachau's generalized comments on numerous previous
occasions. (January 7, 2005, 70 FR 1349) (October 29, 2004, 69 FR
63083).
V. Conclusion
Therefore, the tolerance regulation for the combined residues of
glufosinate-ammonium and its metabolites expressed as butanoic acid, 2-
amino-4-(hydroxymethylphosphinyl)-, monoammonium salt, 2-acetamido-4-
methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid
(expressed as glufosinate free acid equivalents), are revised by
placing all the commodities listed Sec. 180.473 (a)(1) and (a)(2)
together in Sec. 180.473 (a).
VI. 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 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, 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) 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 information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.473 is amended by revising paragraph (a) to read as
follows.
180.473 Glufosinate-ammonium; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the
following food commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond, hulls....................... 0.50
Apple............................... 0.05
Banana.............................. 0.30
Banana, pulp........................ 0.20
Beet, sugar, molasses............... 5.0
Beet, sugar, roots.................. 0.9
Beet, sugar, tops (leaves).......... 1.5
Bushberry subgroup 13B.............. 0.15
Canola, meal........................ 1.1
Canola, seed........................ 0.40
Cattle, fat......................... 0.40
Cattle, meat........................ 0.15
Cattle, meat byproducts............. 6.0
Corn, field forage.................. 4.0
Corn, field, grain.................. 0.20
Corn, field, stover................. 6.0
[[Page 72626]]
Cotton, gin byproducts.............. 15
Cotton, undelinted seed............. 4.0
Egg................................. 0.15
Goat, fat........................... 0.40
Goat, meat.......................... 0.15
Goat, meat byproducts............... 6.0
Grain aspirated fractions........... 25
Grape............................... 0.05
Hog, fat............................ 0.40
Hog, meat........................... 0.15
Hog, meat byproducts................ 6.0
Horse, fat.......................... 0.40
Horse, meat......................... 0.15
Horse, meat byproducts.............. 6.0
Juneberry........................... 0.10
Lingonberry......................... 0.10
Milk................................ 0.15
Nut, tree, group 14................. 0.10
Pistachio........................... 0.10
Potato.............................. 0.80
Potato, chips....................... 1.6
Potato granules/flakes.............. 2.0
Poultry, fat........................ 0.15
Poultry, meat....................... 0.15
Poultry, meat byproducts............ 0.60
Rice, grain......................... 1.0
Rice, hull.......................... 2.0
Rice, straw......................... 2.0
Salal............................... 0.10
Sheep, fat.......................... 0.40
Sheep, meat......................... 0.15
Sheep, meat byproducts.............. 6.0
Soybean............................. 2.0
Soybean, hulls 5.0
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-24841 Filed 12-20-07; 8:45 am]
BILLING CODE 6560-50-S
