2,4-D; Pesticide Tolerances, 55814-55817 [2011-22984]
Download as PDF
55814
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
(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.
Parts per
million
Commodity
*
*
*
*
Corn, sweet, forage ..................
Corn, sweet, kernel plus cob
with husks removed ..............
Corn, sweet, stover ..................
*
16
*
*
*
*
Food commodities and feed
commodities (other than
those covered by a higher
tolerance as a result of use
on growing crops) in food
and feed handling establishments ....................................
*
0.05
50
0.01
*
*
*
*
Goat, meat byproducts, except
kidney and liver .....................
*
11
*
*
*
*
Hog, meat byproducts, except
kidney and liver .....................
*
1.5
*
*
*
*
Horse, meat byproducts, except
kidney and liver .....................
Dated: August 26, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
11
*
*
*
*
Poultry, meat byproducts, except kidney and liver .............
Therefore, 40 CFR chapter I is
amended as follows:
*
*
*
*
*
Sheep, meat byproducts, except kidney and liver .............
*
7.0
*
11
*
*
*
*
*
I. General Information
BILLING CODE 6560–50–P
A. Does this action apply to me?
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.598, paragraph (a), is
amended as follows:
■ a. Revise the commodity entries for
‘‘cattle, meat byproducts, except kidney
and liver’’; ‘‘goat, meat byproducts,
except kidney and liver’’; ‘‘hog, meat
byproducts’’; ‘‘horse, meat byproducts,
except kidney and liver’’; ‘‘poultry, meat
byproducts’’; ‘‘sheep, meat byproducts,
except kidney and liver’’; and
■ b. Add, alphabetically, the
commodities for ‘‘corn, sweet, forage’’;
‘‘corn, sweet, kernel plus cob with
husks removed’’; ‘‘corn, sweet, stover’’;
and ‘‘food and feed commodities (other
than those covered by a higher tolerance
as a result of use on growing crops) in
food and feed handling establishments.’’
The revised and added text reads as
follows:
mstockstill on DSK4VPTVN1PROD with RULES
■
§ 180.598 Novaluron; tolerances for
residues.
(a) * * *
VerDate Mar<15>2010
16:30 Sep 08, 2011
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
[FR Doc. 2011–22981 Filed 9–8–11; 8:45 am]
1. The authority citation for part 180
continues to read as follows:
■
Cattle, meat byproducts, except
kidney and liver .....................
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
PART 180—[AMENDED]
Commodity
identification (ID) number EPA–HQ–
OPP–2010–0905. All documents in the
docket are listed in the docket index
available at https://www.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.
Parts per
million
11
Jkt 223001
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0905; FRL–8881–7]
2,4-D; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of 2,4-D in or on
teff, bran; teff, forage; teff, grain; and
teff, straw. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 9, 2011. Objections and
requests for hearings must be received
on or before November 8, 2011, 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
SUMMARY:
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
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).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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.
E:\FR\FM\09SER1.SGM
09SER1
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
mstockstill on DSK4VPTVN1PROD with RULES
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, 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–2010–0905 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 8, 2011. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0905, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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
Facility’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.
VerDate Mar<15>2010
16:30 Sep 08, 2011
Jkt 223001
II. Summary of Petitioned-For
Tolerance
In the Federal Register of February 4,
2011 (76 FR 6465) (FRL–8858–7), 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 0F7796) by IR–4,
500 College Road East, Suite 201W,
Princeton, NJ 08540. PP 0F7796 was
incorrectly reported and should have
read PP 0E7796, the correct petition
number. The petition requested that 40
CFR 180.142 be amended by
establishing a tolerance for residues of
the herbicide 2,4-D (2,4dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid,
in or on teff, bran at 4.0 parts per
million (ppm); teff, forage at 25.0 ppm;
teff, grain at 2.0 ppm; and teff, straw at
50.0 ppm. That notice referenced a
summary of the petition prepared on
behalf of IR–4 by Helena Chemical
Company, the registrant, which is
available in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance expression for all
established commodities to be
consistent with current Agency policy.
The reason for these changes is
explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
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
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 * * *.’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
55815
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 2,4-D including
exposure resulting from the tolerances
established by this action. EPA’s
assessment of exposures and risks
associated with 2,4-D follows.
In the Federal Register of July 27,
2005 (70 FR 43298) (FRL–7726–8), EPA
published a final reestablishing
tolerances for combined residues of the
herbicide 2,4-D (2,4dichlorophenoxyacetic acid), in or on
hops, wild rice, and soybeans, based on
upon EPA’s conclusion that aggregate
exposure to 2,4-D is safe for the general
population, including infants and
children. Since 2005, there have been
no additional tolerance actions for
2,4-D.
As noted in this unit, the current
action concerns a tolerance for 2,4-D on
teff. Teff is an intermediate grass that is
morphologically and taxonomically
similar to other cereal grains, including
wheat. It is used to make flour in a
manner similar to wheat and other
cereal grains. EPA recently assessed the
proposed use of 2,4-D on teff. In that
assessment, EPA determined that
aggregate 2,4-D exposures and risks will
not increase as a result of the addition
of the proposed teff uses to the uses
assessed as part of the 2005 rulemaking.
Teff is not included in the Continuing
Survey of Food Intakes by Individuals
(CSFII). However, because it is used to
make flour in a manner similar to wheat
and other cereal grains, it will likely
substitute in the diet for cereal grain
foods which will contain similar
residues of 2,4-D; therefore, a significant
increase in dietary exposure to residues
of 2,4-D from consumption of teffcontaining foods will not occur.
Furthermore, residues of 2,4-D in teff
livestock feeds will be similar to those
in other forages, hays, and silages for
which tolerances of 2,4-D are currently
established. As such, there would be no
increase in the livestock dietary burden
should teff be substituted in the
livestock diet for other hays and silages;
residues in meat, milk, poultry and eggs
will remain the same.
Further information about EPA’s risk
assessment and determination of safety
for this action can be found at https://
www.regulations.gov in document ‘‘2,4D and Dicamba: Petition for the
Establishment of Tolerances on Teff;
Request for Registration of Latigo (EPA
Reg. No. 5905–564) on Teff.’’ in docket
ID number EPA–HQ–OPP–2010–0905.
Except as supplemented by the
information described in this unit, EPA
E:\FR\FM\09SER1.SGM
09SER1
mstockstill on DSK4VPTVN1PROD with RULES
55816
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
is relying on the safety finding in the
2005 rulemaking and the risk
assessment underlying that action in
establishing tolerances for 2,4-D on teff,
bran; teff, forage; teff, grain; and teff,
straw. Further information regarding the
safety finding for the last rulemaking
can be found in the Federal Register of
July 27, 2005 (70 FR 43307) (FRL–7726–
8), at https://www.epa.gov/fedrgstr/EPAPEST/2005/July/Day-27/p14886.htm.
For the 2005 rulemaking, the 2,4-D
toxicity database was considered
complete except for the submission of a
developmental neurotoxicity study
(DNT) and a repeat 2-generation
reproduction study. The absence of
these studies led EPA to retain an
additional safety factor for the
protection of infants and children as
provided by FFDCA section
408(b)(2)(C). Additionally, recent
changes to 40 CFR part 158 imposed
new data requirements for
immunotoxicity testing (OPPTS
Guideline 870.7800) and acute and
subchronic neurotoxicity testing
(OPPTS Guideline 870.6200) for
pesticide registration. All of these data
requirements have now been met. The
toxicity database for 2,4-D includes
acceptable acute and subchronic
neurotoxicity studies; therefore, the
requirements for the neurotoxicity
screening battery have been met. To
address the other deficiencies, the
registrant submitted an F1-extended
1-generation toxicity study in rats. This
study has been reviewed and found
acceptable, and fulfills the outstanding
requirements for a DNT study, a repeat
2-generation reproduction study, and
immunotoxicity testing. After review of
these studies, EPA has concluded that
they do not affect EPA’s derivation of
2,4-D’s acute reference dose (aRfD) or
chronic reference dose (cRfD). It is
likely, however, that in the future EPA
will remove the additional safety factor
for the protection of infants and
children now that the 2,4-D database is
complete. Thus, once a full
reassessment of 2,4-D is completed,
estimated risks are likely to decline
substantially. However, because a full
reassessment of 2,4-D risk taking into
account the new studies has not been
formally conducted, EPA is relying
primarily on the 2005 rulemaking to
support this action. Therefore, the safety
finding for this action relies on the
additional margin of safety provided by
retaining the additional safety factor for
protection of infants and children. For
further information on EPA’s review of
these studies, information is available at
https://www.regulations.gov, in docket ID
number EPA–HQ–OPP–2010–0905.
VerDate Mar<15>2010
16:30 Sep 08, 2011
Jkt 223001
In the 2005 rulemaking, EPA relied
upon data showing the percent of crops
treated with 2,4-D in assessing chronic
risk. In evaluating the proposed teff
tolerances, EPA considered updated
data on percent crop treated and has
concluded that the updated data would
increase the chronic risk estimates from
the 2005 assessment for the general
population and children 1–6 years old
(the most sensitive subpopulation) by
2.2% and 3.1% of the cPAD,
respectively. Because the chronic risk
estimates for the 2005 assessment were
well below the level of concern, these
differences are considered insignificant.
Therefore, based upon the 2005
rulemaking and the other information
discussed in this unit, 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 2,4-D
residues. Refer to the July 27, 2005 (70
FR 43298) (FRL–7726–8) Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology,
a gas chromatography with electron
capture detection (GC/ECD) method,
designated as EN–CAS Method No.
ENC–2/93, 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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established MRLs
for 2,4-D in or on any commodities
associated with this action.
C. Response to Comments
EPA received one comment to the
Notice of Filing that made a general
objection to proposed new tolerances
and new tolerance exemptions for
several chemicals, including 2,4-D. The
commenter additionally noted that,
‘‘prior to approval of these or other
chemicals in the food system the EPA
must be confident that these will not
cause harm’’ and ‘‘only long term
studies can provide data on the health
impact of exposure to these chemicals.’’
The commenter stated that none of the
mentioned chemicals, including 2,4-D,
should be permitted in food.
The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that
certain pesticide chemicals should not
be permitted in our food. However, the
existing legal framework provided by
section 408 of the FFDCA states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. When new or amended
tolerances are requested for residues of
a pesticide in food or feed, the Agency,
as is required by section 408 of the
FFDCA, estimates the risk of the
potential exposure to these residues.
The Agency has concluded after this
assessment, which includes the
consideration of long-term animal
studies with 2,4-D, that there is a
reasonable certainty that no harm will
result from aggregate human exposure to
2,4-D and that, accordingly, the 2,4-D
tolerances on teff are ‘‘safe.’’
D. Revisions to Petitioned-For
Tolerances
The EPA has revised the tolerance
expression to clarify:
1. Tvided in FFDCA section 408(a)(3),
the tolerance covers metabolites and
degradates of 2,4-D not specifically
mentioned; and 2. Tcompliance with
the specified tolerance levels is to be
determined by measuring only the
specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established
for residues of 2,4-D (2,4dichlorophenoxyacetic acid), including
its metabolites and degradates, in or on
teff, bran at 4.0 ppm; teff, forage at 25.0
E:\FR\FM\09SER1.SGM
09SER1
55817
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
mstockstill on DSK4VPTVN1PROD with RULES
ppm; teff, grain at 2.0 ppm; and teff,
straw at 50.0 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 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
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 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
VerDate Mar<15>2010
16:30 Sep 08, 2011
Jkt 223001
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 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: August 31, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Parts per
million
Commodity
*
Teff,
Teff,
Teff,
Teff,
*
*
*
bran ....................................
forage .................................
grain ...................................
straw ...................................
*
*
*
*
*
4.0
25.0
2.0
50.0
*
*
*
*
*
*
(c) Tolerances with regional
registrations. Tolerances with regional
registration, as defined in § 180.1(l), are
established for residues of the herbicide,
plant regulator, and fungicide 2,4-D,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels is to be determined by
measuring residues of 2,4-D (2,4dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid,
in or on the follow commodities:
*
*
*
*
*
(d) Indirect or inadvertent residues.
Tolerances are established for indirect
or inadvertent residues of the herbicide,
plant regulator, and fungicide 2,4-D,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerances levels is to be determined by
measuring residues of 2,4-D (2,4dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid,
in or on the following commodities:
*
*
*
*
*
[FR Doc. 2011–22984 Filed 9–8–11; 8:45 am]
BILLING CODE 6560–50–P
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
FEDERAL COMMUNICATIONS
COMMISSION
1. The authority citation for part 180
continues to read as follows:
47 CFR Parts 1, 73 and 76
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.142 is amended by
revising the introductory text in
paragraphs (a), (c), and (d); and
alphabetically adding the following
commodities to the table in paragraph
(a) to read as follows:
■
§ 180.142
2,4-D; tolerances for residues.
(a) General. Tolerances are
established for residues of the herbicide,
plant regulator, and fungicide 2,4-D,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels is to be determined by
measuring residues of 2,4-D (2,4dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid,
in or on the following commodities:
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
[DA 11–1432]
Broadcast Applications and
Proceedings; Fairness Doctrine and
Digital Broadcast Television
Redistribution Control; Fairness
Doctrine, Personal Attacks, Political
Editorials and Complaints Regarding
Cable Programming Service Rates
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this document, the
Commission makes several
nonsubstantive, editorial revisions to
parts 1, 73 and 76 of the Commission’s
rules. The Commission removes rules
that are without current legal effect and
are obsolete. The deleted rules include
SUMMARY:
E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55814-55817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22984]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0905; FRL-8881-7]
2,4-D; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of 2,4-D
in or on teff, bran; teff, forage; teff, grain; and teff, straw.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 9, 2011. Objections and
requests for hearings must be received on or before November 8, 2011,
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-2010-0905. All documents in the
docket are listed in the docket index available at https://www.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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@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).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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.
[[Page 55815]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced in this document electronically,
please go https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2010-0905 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 8, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0905, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online 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 Facility'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. Summary of Petitioned-For Tolerance
In the Federal Register of February 4, 2011 (76 FR 6465) (FRL-8858-
7), 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
0F7796) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. PP 0F7796 was incorrectly reported and should have read PP
0E7796, the correct petition number. The petition requested that 40 CFR
180.142 be amended by establishing a tolerance for residues of the
herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), both free and
conjugated, determined as the acid, in or on teff, bran at 4.0 parts
per million (ppm); teff, forage at 25.0 ppm; teff, grain at 2.0 ppm;
and teff, straw at 50.0 ppm. That notice referenced a summary of the
petition prepared on behalf of IR-4 by Helena Chemical Company, the
registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the tolerance expression for all established commodities to be
consistent with current Agency policy. The reason for these changes is
explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
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 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 * *
*.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 2,4-D including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with 2,4-D follows.
In the Federal Register of July 27, 2005 (70 FR 43298) (FRL-7726-
8), EPA published a final reestablishing tolerances for combined
residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), in or
on hops, wild rice, and soybeans, based on upon EPA's conclusion that
aggregate exposure to 2,4-D is safe for the general population,
including infants and children. Since 2005, there have been no
additional tolerance actions for 2,4-D.
As noted in this unit, the current action concerns a tolerance for
2,4-D on teff. Teff is an intermediate grass that is morphologically
and taxonomically similar to other cereal grains, including wheat. It
is used to make flour in a manner similar to wheat and other cereal
grains. EPA recently assessed the proposed use of 2,4-D on teff. In
that assessment, EPA determined that aggregate 2,4-D exposures and
risks will not increase as a result of the addition of the proposed
teff uses to the uses assessed as part of the 2005 rulemaking. Teff is
not included in the Continuing Survey of Food Intakes by Individuals
(CSFII). However, because it is used to make flour in a manner similar
to wheat and other cereal grains, it will likely substitute in the diet
for cereal grain foods which will contain similar residues of 2,4-D;
therefore, a significant increase in dietary exposure to residues of
2,4-D from consumption of teff-containing foods will not occur.
Furthermore, residues of 2,4-D in teff livestock feeds will be similar
to those in other forages, hays, and silages for which tolerances of
2,4-D are currently established. As such, there would be no increase in
the livestock dietary burden should teff be substituted in the
livestock diet for other hays and silages; residues in meat, milk,
poultry and eggs will remain the same.
Further information about EPA's risk assessment and determination
of safety for this action can be found at https://www.regulations.gov in
document ``2,4-D and Dicamba: Petition for the Establishment of
Tolerances on Teff; Request for Registration of Latigo (EPA Reg. No.
5905-564) on Teff.'' in docket ID number EPA-HQ-OPP-2010-0905. Except
as supplemented by the information described in this unit, EPA
[[Page 55816]]
is relying on the safety finding in the 2005 rulemaking and the risk
assessment underlying that action in establishing tolerances for 2,4-D
on teff, bran; teff, forage; teff, grain; and teff, straw. Further
information regarding the safety finding for the last rulemaking can be
found in the Federal Register of July 27, 2005 (70 FR 43307) (FRL-7726-
8), at https://www.epa.gov/fedrgstr/EPA-PEST/2005/July/Day-27/p14886.htm.
For the 2005 rulemaking, the 2,4-D toxicity database was considered
complete except for the submission of a developmental neurotoxicity
study (DNT) and a repeat 2-generation reproduction study. The absence
of these studies led EPA to retain an additional safety factor for the
protection of infants and children as provided by FFDCA section
408(b)(2)(C). Additionally, recent changes to 40 CFR part 158 imposed
new data requirements for immunotoxicity testing (OPPTS Guideline
870.7800) and acute and subchronic neurotoxicity testing (OPPTS
Guideline 870.6200) for pesticide registration. All of these data
requirements have now been met. The toxicity database for 2,4-D
includes acceptable acute and subchronic neurotoxicity studies;
therefore, the requirements for the neurotoxicity screening battery
have been met. To address the other deficiencies, the registrant
submitted an F1-extended 1-generation toxicity study in rats. This
study has been reviewed and found acceptable, and fulfills the
outstanding requirements for a DNT study, a repeat 2-generation
reproduction study, and immunotoxicity testing. After review of these
studies, EPA has concluded that they do not affect EPA's derivation of
2,4-D's acute reference dose (aRfD) or chronic reference dose (cRfD).
It is likely, however, that in the future EPA will remove the
additional safety factor for the protection of infants and children now
that the 2,4-D database is complete. Thus, once a full reassessment of
2,4-D is completed, estimated risks are likely to decline
substantially. However, because a full reassessment of 2,4-D risk
taking into account the new studies has not been formally conducted,
EPA is relying primarily on the 2005 rulemaking to support this action.
Therefore, the safety finding for this action relies on the additional
margin of safety provided by retaining the additional safety factor for
protection of infants and children. For further information on EPA's
review of these studies, information is available at https://www.regulations.gov, in docket ID number EPA-HQ-OPP-2010-0905.
In the 2005 rulemaking, EPA relied upon data showing the percent of
crops treated with 2,4-D in assessing chronic risk. In evaluating the
proposed teff tolerances, EPA considered updated data on percent crop
treated and has concluded that the updated data would increase the
chronic risk estimates from the 2005 assessment for the general
population and children 1-6 years old (the most sensitive
subpopulation) by 2.2% and 3.1% of the cPAD, respectively. Because the
chronic risk estimates for the 2005 assessment were well below the
level of concern, these differences are considered insignificant.
Therefore, based upon the 2005 rulemaking and the other information
discussed in this unit, 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 2,4-D residues. Refer
to the July 27, 2005 (70 FR 43298) (FRL-7726-8) Federal Register
document, available at https://www.regulations.gov, for a detailed
discussion of the aggregate risk assessments and determination of
safety. EPA relies upon those risk assessments and the findings made in
the Federal Register document in support of this action.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, a gas chromatography with
electron capture detection (GC/ECD) method, designated as EN-CAS Method
No. ENC-2/93, 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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established MRLs for 2,4-D in or on any
commodities associated with this action.
C. Response to Comments
EPA received one comment to the Notice of Filing that made a
general objection to proposed new tolerances and new tolerance
exemptions for several chemicals, including 2,4-D. The commenter
additionally noted that, ``prior to approval of these or other
chemicals in the food system the EPA must be confident that these will
not cause harm'' and ``only long term studies can provide data on the
health impact of exposure to these chemicals.'' The commenter stated
that none of the mentioned chemicals, including 2,4-D, should be
permitted in food.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that certain pesticide chemicals should not be
permitted in our food. However, the existing legal framework provided
by section 408 of the FFDCA states that tolerances may be set when
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. When
new or amended tolerances are requested for residues of a pesticide in
food or feed, the Agency, as is required by section 408 of the FFDCA,
estimates the risk of the potential exposure to these residues. The
Agency has concluded after this assessment, which includes the
consideration of long-term animal studies with 2,4-D, that there is a
reasonable certainty that no harm will result from aggregate human
exposure to 2,4-D and that, accordingly, the 2,4-D tolerances on teff
are ``safe.''
D. Revisions to Petitioned-For Tolerances
The EPA has revised the tolerance expression to clarify:
1. Tvided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of 2,4-D not specifically mentioned; and 2.
Tcompliance with the specified tolerance levels is to be determined by
measuring only the specific compounds mentioned in the tolerance
expression.
V. Conclusion
Therefore, tolerances are established for residues of 2,4-D (2,4-
dichlorophenoxyacetic acid), including its metabolites and degradates,
in or on teff, bran at 4.0 ppm; teff, forage at 25.0
[[Page 55817]]
ppm; teff, grain at 2.0 ppm; and teff, straw at 50.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 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
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 9, 2000) do not apply to this final rule. In addition,
this final 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) (Pub. L. 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: August 31, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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 180.142 is amended by revising the introductory text in
paragraphs (a), (c), and (d); and alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:
Sec. 180.142 2,4-D; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide, plant regulator, and fungicide 2,4-D, including its
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels is to be determined by
measuring residues of 2,4-D (2,4-dichlorophenoxyacetic acid), both free
and conjugated, determined as the acid, in or on the following
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Teff, bran.................................................. 4.0
Teff, forage................................................ 25.0
Teff, grain................................................. 2.0
Teff, straw................................................. 50.0
* * * * *
------------------------------------------------------------------------
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec. 180.1(l), are established
for residues of the herbicide, plant regulator, and fungicide 2,4-D,
including its metabolites and degradates, in or on the commodities in
the table below. Compliance with the tolerance levels is to be
determined by measuring residues of 2,4-D (2,4-dichlorophenoxyacetic
acid), both free and conjugated, determined as the acid, in or on the
follow commodities:
* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for indirect or inadvertent residues of the herbicide, plant regulator,
and fungicide 2,4-D, including its metabolites and degradates, in or on
the commodities in the table below. Compliance with the tolerances
levels is to be determined by measuring residues of 2,4-D (2,4-
dichlorophenoxyacetic acid), both free and conjugated, determined as
the acid, in or on the following commodities:
* * * * *
[FR Doc. 2011-22984 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P