[Federal Register Volume 70, Number 5 (Friday, January 7, 2005)]
[Rules and Regulations]
[Pages 1357-1360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-344]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0001; FRL-7694-5]


Peanuts, Tree Nuts, Milk, Soybeans, Eggs, Fish, Crustacea, and 
Wheat; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes 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. The Agency is acting on its own initiative.

DATES: This regulation is effective on January 7, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IV. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0001. 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 South 
Bell St., Arlington, VA., 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:

[[Page 1358]]

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 code 111), e.g., Crop production
     Industry (NAICS code 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/.

II. What is the Agency's Authority for Taking this Action?

    This final 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 and Statutory Findings

    In the Federal Register of July 21, 2004 (69 FR 43548) (FRL-7365-
5), EPA issued a proposed rule under section 408 (e) of the FFDCA, 21 
U.S.C. 346a, as amended by the FQPA (Public Law 104-170). The Agency 
proposed to establish in 40 CFR 180.1071 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 the use patterns specified by the Agency as being unlikely 
to result in residues of an allergen-containing material mixed-in with 
other (different) food commodities as a result of a pesticide 
application.
    One comment was received from a private citizen opposing the 
establishment of this exemption, particularly the animal feed-through 
use, but the commentor gave no reason for opposing the exemption other 
than a general objection to pesticides. The Agency recognizes that some 
individuals believe that pesticides should be banned completely. 
However, under the existing legal framework provided by section 408(e) 
of FFDCA, EPA can establish or modify pesticide tolerances or 
exemptions by demonstrating that the pesticide meets the safety 
standard imposed by that statute. The commentor has not provided the 
Agency with a specific rationale or additional information pertaining 
to the legal standards in FFDCA Section 408 for opposing the 
establishment of a tolerance exemption for residues of peanuts, tree 
nuts, milk, soybeans, eggs, fish, crustacea, and/or wheat. In the 
absence of any additional information of a factual nature, the Agency 
can not respond further to the commentor's disagreement with the 
Agency's decision.
    A late comment was received from the Monterey Chemical Company 
requesting that the use patterns specified in the proposed rule be 
changed to include the use on bearing citrus. The requester indicated 
their belief that because of the washing and waxing of the harvested 
crop that it would be ``unlikely that any residue of casein would 
remain on the harvested crop.'' The Agency has considered the 
commentor's request, but believes that additional information is 
needed. The casein is being intentionally used as a sticking agent, 
that is, the casein is formulated to stick to the surface of the 
developing citrus fruit. The Agency simply does not know if the casein 
would be degraded in the environment by sunlight or by microflora, or 
if the casein would still be present on the surface of the fruit after 
washing. If the Agency were in possession of data (for example, casein-
specific enzyme-linked immunosorbent assays (ELISA) wipe tests 
performed on citrus fruits as harvested, and as washed and waxed with 
detection levels of less than 10 ppm), then its ability to make a 
determination would increase.
    While not as a result of a public comment, the Agency is also 
formally including the term putrescent eggs within the definition of 
eggs, even though putrescent eggs would not be considered as a food 
commodity. It is a long-standing practice of the Pesticides Program to 
accept the use of the term putrescent eggs as being included under the 
descriptor egg solids (whole). In fact, putrescent whole egg solids are 
a minimum risk active ingredient per 40 CFR 152.25(f)(1).
    Based on the reasons set forth in the preamble to the proposed 
rule, and considering the comments received by the Agency in response 
to the proposed rule, EPA is establishing a tolerance exemption for 
residues of peanuts, tree nuts, milk (including casein), soybeans, eggs 
(including putrescent egg solids), fish, crustacea, and/or wheat when 
used according to the use patterns as specified by the Agency as being 
unlikely to result in residues of an allergen-containing material 
mixed-in with other (different) food commodities as a result of a 
pesticide application.


IV. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of 
the FFDCA. However, the period for filing objections is now 60 days, 
rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0001 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 on or before March 8, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the

[[Page 1359]]

grounds for the objections (40 CFR 178.25). If a hearing is requested, 
the objections must include a statement of the factual issues(s) on 
which a hearing is requested, the requestor's contentions on such 
issues, and a summary of any evidence relied upon by the objector (40 
CFR 178.27). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit XI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0001, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(e) of the FFDCA. The Office of Management 
and Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). Because this rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this rule is not subject to Executive Order 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded 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 final 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 final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this 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 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 rule.

[[Page 1360]]

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 the rule in the Federal Register. This 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 practices and procedures, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: December 29, 2004.
Betty Shackleford,
Acting 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 180.1071 is revised to read as follows:


Sec.  180.1071  Peanuts, Tree Nuts, Milk, Soybeans, Eggs, Fish, 
Crustacea, and Wheat; exemption from the requirement of a tolerance.

    (a) General. Residues resulting from the following uses of the food 
commodity forms of peanuts, tree nuts, milk, soybeans, eggs (including 
putrescent eggs), fish, crustacea, and wheat are exempted from the 
requirement of a tolerance in or on all food commodities 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 systems (via flood, drip, or 
furrow application with no overhead spray applications).
    (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, whether the plant fraction(s) intended for harvest are present 
or not, 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):

------------------------------------------------------------------------
                  Chemical Substance                        CAS No.
------------------------------------------------------------------------
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. 05-344 Filed 1-6-05; 8:45 am]
BILLING CODE 6560-50-S