[Federal Register Volume 69, Number 139 (Wednesday, July 21, 2004)]
[Proposed Rules]
[Pages 43548-43552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16214]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0191; FRL-7365-5]
Pesticides: Tolerance Exemptions for Crustacea, Eggs, Fish, Milk,
Peanuts, Soybeans, Tree Nuts, and Wheat
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of peanuts, tree nuts, milk,
soybeans, eggs, fish, crustacea, and/or wheat when used as inert or
active ingredients in pesticide products, for certain use patterns,
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: Comments, identified by docket ID number OPP-2004-0191, must be
received on or before September 20, 2004.
ADDRESSES: Submit your comments, identified by docket ID number OPP-
2004-0191, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/. Follow the
on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET, EPA's
electronic public docket and comment system, is EPA's preferred method
for receiving comments. Follow the on-line instructions for submitting
comments.
E-mail: Comments may be sent by e-mail to [email protected],
Attention: Docket ID Number OPP-2004-0191.
Mail: Public Information and Records Integrity Branch (PIRIB)
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001,
Attention: Docket ID Number OPP-2004-0191.
Hand delivery: Public Information and Records Integrity Branch
(PIRIB), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington,
VA, Attention: Docket ID Number OPP-2004-0191. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number OPP-2004-
0191. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some
information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; fax number: (703) 305-0599; e-mail address:
[email protected].
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:
Industry (NAICS 111), e.g., crop production.
[[Page 43549]]
Industry (NAICS 32532), e.g., pesticide manufacturing.
This listing is not intended to be exhaustive, but rather provides
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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. What is the Agency's Authority for Taking this Action?
This proposed rule is issued under section 408 of FFDCA, 21 U.S.C.
346a, as amended by the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to
establish, modify, or revoke tolerances, or exemptions from the
requirement of a tolerance for residues of pesticide chemicals in or on
raw agricultural commodities and processed foods.
III. Background
In the Federal Register of May 24, 2002 (67 FR 36534) (FRL-6834-8),
the Agency placed an expiration date of May 24, 2005, on the following
tolerance exemptions for allergen-containing commodities:
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40 CFR Tolerance Exemption
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180.910 formerly 180.1001(c) Casein
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180.910 formerly 180.1001(c) Fish meal
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180.910 formerly 180.1001(c) Soy protein, isolated
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180.910 formerly 180.1001(c) Soybean flour
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180.910 formerly 180.1001(c) Wheat, including flour,
bran, and starch
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180.920 formerly 180.1001(d) Sodium caseinate
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180.930 formerly 180.1001(e) Soy protein, isolated
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180.930 formerly 180.1001(e) Wheat shorts
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180.1071 Egg solids (whole)
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The 3-year expiration date was added to give the Agency time to
examine the use patterns of allergens used in pesticide products and
notify affected registrants of any concerns this examination disclosed
with use of these substances. (See the January 15, 2002, Federal
Register (67 FR 1925) (FRL-6807-8) for additional information).
Registrants would also have the same 3 years to consider their options
and then carry-out the actions needed to maintain their registrations.
IV. What Action is the Agency Taking?
Since placing the May 24, 2005, expiration date on the food
allergen tolerance exemptions, the Agency has completed its review of
the various ways that chemical substances such as food allergens are
used in pesticide products. In this proposed rule, the Agency is
proposing to establish tolerance exemptions for certain specified uses
of the raw and processed forms of crustacea, eggs, fish, milk, peanuts,
soybeans, tree nuts, and wheat.
The following types of uses are proposed:
When used in seed treatment products.
Nursery, potting and container uses.
Pre-plant and at-transplant applications.
Incorporation into seedling and planting beds.
Applications to cuttings and bare roots.
Applications that occur after the harvested crop has been
removed.
Soil-directed applications around and adjacent to all
plants.
Applications to rangelands, which is land, mostly
grasslands, whose plants can provide food (i.e., forage) for grazing or
browsing animals.
When used in chemigation and irrigation via flood, drip,
or furrow application.
Application as part of a dry fertilizer on which an active
ingredient is impregnated.
Aerial and ground applications that occur when no above-
ground harvestable food commodities are present (usually pre-bloom).
Application as part of an animal feed-through product.
Applications as gel and solid (non-liquid/non-spray) crack
and crevice treatments that place the gel or bait directly into or on
top of the cracks and crevices via a mechanism such as a syringe.
Applications to the same crop from which the food
commodity is derived, e.g., applications of peanut meal when applied to
peanut plants.
[[Page 43550]]
EPA's intent is to establish exemptions from the requirement of a
tolerance for these allergen-containing substances only for those uses
which are unlikely to result in residues of an allergen-containing
material mixed-in with other (different) food commodities as a result
of a pesticide application. With the exception of the last three uses,
the uses described above are soil-directed, or occur at a time that the
crop is not present. If these allergens are placed directly in/on the
soil (no matter the application method), then it could be expected that
degradation via naturally-occurring mechanisms would occur.
Animal feed-through products are used to control flies in manure.
Most animal feed-through products contain an active ingredient that is
coated on a small amount of an animal feed item. The animal feed item
could be an allergen-containing material such as wheat. This coated
animal feed item is then mixed in with the usual animal feed items. The
animal's consumption of small amounts of allergens as a result of this
tolerance exemption should not impact their production of meat, milk,
poultry and eggs for human consumption, and should not result in
residues of allergenic-materials in food commodities.
Applications of gel and solid (non-liquid/non-spray) crack and
crevice treatments that contain allergens are also not expected to
result in residues in food. Food commodities can play a critical role
in certain pesticide formulations used in food processing areas to
control rodent populations. The rodents are attracted to and then
consume the food which is coated with or contains within the active
pesticide ingredient. The Agency believes that these solid gel and bait
formulations that are not sprayed, but directly placed in cracks and
crevices would not be inadvertently mixed-in with the near-by food
commodities.
The Agency believes that aerial and ground applications, that are
not soil-directed, but take place when no above-ground harvestable food
is present are unlikely to result in residues in food. It is assumed
that some of the allergen could come in contact with the growing plant
and in certain cases the developing edible crop. EPA generally believes
that the allergenic material would not be taken up by the growing
plant, due to such factors as the large size of the molecules and the
difficulty of passing through the plant leaf cuticle layer, but no
definitive information is available. While it can be hypothesized that
the allergenic material would simply ``slide off'' certain developing
crops that have smooth surfaces and semi-spherical exteriors (e.g.,
apple, orange, banana, grape or tomato), the allergen might also be
enfolded in crops that do not have such characteristics such as lettuce
or spinach. The Agency would welcome additional information on these
issues during the comment period.
The intent of these tolerance exemptions is to protect those with
allergies from being unknowingly exposed to these most common allergens
via consumed foods. However, there are those who are not allergic and
willingly consume foods such as peanuts or wheat. Application of a
pesticide product containing wheat to stored wheat commodities does not
create concerns for those who are not allergic to wheat. Therefore,
applications to the same crop from which the food commodity is derived,
are proposed to be exempted because any residue from the allergen would
not present a different allergenic risk than the underlying food
commodity.
Post-harvest applications of these allergen-containing materials to
stored food commodities are not being proposed because those with
allergies need assurance that the foods that they consume do not
contain small amounts of allergen-containing materials that are
introduced via the application of a registered pesticide product. The
existing time-limited tolerance exemptions in 40 CFR 180.910, 180.920,
and 180.930 will expire on May 24, 2005. There is no plan to extend
these tolerance exemptions. Registrants of formulations with post-
harvest uses containing these eight allergens have been notified by
certified mail of the upcoming expiration date by the Agency.
V. What about Chemical Substances Whose Names Are Not Readily
Identified as an Allergen-Containing Commodity?
The relationship of the processed food commodity to the food
commodity from which it is derived may not always be apparent by the
name. For example, casein is milk protein. Currently, there are time-
limited exemptions for casein and sodium caseinate.
To improve communication and to avoid repeated questions on the
tolerance exemption status of the certain chemical substances, the
Agency intends to create within 40 CFR 180.1071, a paragraph (b) to
collect tolerance exemptions for food-commodity types of chemical
substances derived fromcrustacea, eggs, fish, milk, peanuts, soybeans,
tree nuts, or wheat that must also be avoided by those with certain
food allergies, and present them using commonly-understood terms.
As stated above, there are time-limited exemptions for casein and
sodium caseinate. The tolerance exemption for sodium caseinate is
easily understood to be the following chemical substance: Caseins,
sodium complexes (CAS Reg. No. 9005-46-3). However, the tolerance
exemption for casein has been used as a generalized term to hold
several casein chemical substances, which includes the ammonium and
potassium salts as well as the hydrolyzed form of casein. To provide
specificity on the food-commodity types of chemical substances that
could be termed casein, tolerance exemptions are proposed for: Caseins
(CAS Reg. No. 9000-71-9); caseins, ammonium complexes (CAS Reg. No.
9005-42-9); caseins, hydrolyzates (CAS Reg. No. 65072-00-6); and
caseins, potassium complexes (CAS Reg. No. 68131-54-4).
VI. Cumulative Effects from Substances with a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
The raw and processed forms of the eight most common food
allergens:crustacea, eggs, fish, milk, peanuts, soybeans, tree nuts,
and wheat do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that these chemical substances have a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
VII. Determination of Safety for U.S. Population, Infants and Children
The substances considered in this proposed rule are the food
commodities that most commonly can invoke an allergenic response. The
intent of these tolerance exemptions is to protect those with allergies
from being unknowingly
[[Page 43551]]
exposed to these most common allergens via consumed foods. The Agency
has selected for this proposal only those uses that are unlikely to
result in residues of an allergen-containing material mixed-in with
other (different) food commodities as a result of a pesticide
application. Those who are allergic to the eight most common food
allergens (crustacea, eggs, fish, milk, peanuts, soybeans, tree nuts,
and wheat) benefit by having greater surety that these substances will
not be present in the foods that they do consume. The amendments and
revisions to the existing tolerance exemptions will be beneficial to
the regulated community by providing detailed information on how these
allergenic food substances can be used in pesticide products.
As noted, the Agency is proposing only those uses which are
unlikely to result in residues of an allergen-containing material
mixed-in with other (different) food commodities as a result of a
pesticide application. Given this fact, EPA believes that the proposed
tolerance exemption will be safe for humans including infants and
children. Because these exemptions are not expected to contribute to
allergic individuals' exposure to allergens, EPA has not assessed the
risk of these substances using a safety factor approach. Accordingly,
application of an additional l0X safety factor analysis or quantitative
risk assessment is not necessary to protect infants and children.
VIII. Conclusion
Accordingly, EPA is proposing to establish an exemption from the
requirement for tolerance for peanuts, tree nuts, milk (including
caseins), soybeans, eggs, fish, crustacea, and/or wheat when used
according to those uses (as specified above) which are unlikely to
result in residues of an allergen-containing material mixed-in with
other (different) food commodities as a result of a pesticide
application.
IX. Statutory and Executive Order Reviews
The Agency is acting on its own initiative under FFDCA section
408(e) in establishing a tolerance exemption for the allergen-
containing commodities. 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 proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001). This proposed rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
This proposed rule establishes new tolerance exemptions in 40 CFR
180.1071. Establishing a new tolerance exemption permits expanded use
of pesticide products and thus has a positive economic impact. Under
section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency hereby certifies that the proposed action to
establish a new tolerance exemption for allergen-containing materials
will not have significant negative economic impact on a substantial
number of small entities.
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 6, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1071 is revised to read as follows:
Sec. 180.1071 Crustacea, Eggs, Fish, Milk, Peanuts, Soybeans, Tree
Nuts, and Wheat; exemption from the requirement of a tolerance.
(a) Residues resulting from the following uses of the food
commodity forms of crustacea, eggs, fish, milk,
[[Page 43552]]
peanuts, soybeans, tree nuts, and wheat are exempted from the
requirement of a tolerance under FFDCA section 408 (when used as either
an inert or an active ingredient in a pesticide formulation), if such
use is in accordance with good agricultural practices:
(1) Use in pesticide products intended to treat seeds.
(2) Use in nursery and greenhouse operations, as defined in 40 CFR
170.3, which includes seeding, potting and transplanting activities.
(3) Pre-plant and at-transplant applications.
(4) Incorporation into seedling and planting beds.
(5) Applications to cuttings and bare roots.
(6) Applications to the field that occur after the harvested crop
has been removed.
(7) Soil-directed applications around and adjacent to all plants.
(8) Applications to rangelands, which is land, mostly grasslands,
whose plants can provide food (i.e., forage) for grazing or browsing
animals.
(9) Use in chemigation and irrigation via flood, drip, or furrow
application.
(10) Application as part of a dry fertilizer on which an active
ingredient is impregnated.
(11) Aerial and ground applications that occur when no above-ground
harvestable food commodities are present (usually pre-bloom).
(12) Application as part of an animal feed-through product.
(13) Applications as gel and solid (non-liquid/non-spray) crack and
crevice treatments that place the gel or bait directly into or on top
of the cracks and crevices via a mechanism such as a syringe.
(14) Applications to the same crop from which the food commodity is
derived, e.g., applications of peanut meal when applied to peanut
plants.
(b) Specific chemical substances. Residues resulting from the use
of the following substances as either an inert or an active ingredient
in a pesticide formulation are exempted from the requirement of a
tolerance under FFDCA section 408, if such use is in accordance with
good agricultural practices and such use is included in paragraph (a)
of this section:
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Chemical Substance CAS No.
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Caseins........................................ 9000-71-9
Caseins, ammonium complexes.................... 9005-42-9
Caseins, hydrolyzates.......................... 65072-00-6
Caseins, potassium complexes................... 68131-54-4
Caseins, sodium complexes...................... 9005-46-3
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[FR Doc. 04-16214 Filed 7-20-04; 8:45 am]
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