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 ECFR 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 email. 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 104170). 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) (FRL68348), the Agency placed an expiration date of May 24, 2005, on the following tolerance exemptions for allergencontaining commodities:
40 CFR Tolerance Exemption 180.910 formerly 180.1001(c) Casein
180.910 formerly 180.1001(c) Fish meal
180.910 formerly 180.1001(c) Soy protein, isolated 180.910 formerly 180.1001(c) Soybean flour
180.910 formerly 180.1001(c) Wheat, including flour, bran, and starch 180.920 formerly 180.1001(d) Sodium caseinate 180.930 formerly 180.1001(e) Soy protein, isolated 180.930 formerly 180.1001(e) Wheat shorts
180.1071 Egg solids (whole)

The 3year 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) (FRL68078) for additional information). Registrants would also have the same 3 years to consider their options and then carryout 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:

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EPA's intent is to establish exemptions from the requirement of a tolerance for these allergencontaining substances only for those uses which are unlikely to result in residues of an allergencontaining material mixedin 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 soildirected, 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 naturallyoccurring mechanisms would occur.

Animal feedthrough products are used to control flies in manure. Most animal feedthrough products contain an active ingredient that is coated on a small amount of an animal feed item. The animal feed item could be an allergencontaining 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 allergenicmaterials in food commodities.

Applications of gel and solid (nonliquid/nonspray) 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 mixedin with the nearby food commodities.

The Agency believes that aerial and ground applications, that are not soildirected, but take place when no aboveground 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 semispherical 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.

Postharvest applications of these allergencontaining 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 allergencontaining materials that are introduced via the application of a registered pesticide product. The existing timelimited 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 AllergenContaining 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 foodcommodity 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 commonlyunderstood terms.

As stated above, there are timelimited 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. 9005463). 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 foodcommodity types of chemical substances that could be termed casein, tolerance exemptions are proposed for: Caseins (CAS Reg. No. 9000719); caseins, ammonium complexes (CAS Reg. No. 9005429); caseins, hydrolyzates (CAS Reg. No. 65072006); and caseins, potassium complexes (CAS Reg. No. 68131544).
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
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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 allergencontaining material mixedin 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 allergencontaining material mixedin 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 allergencontaining material mixedin 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 1044). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 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 104113, 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 allergencontaining 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,
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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) Preplant and attransplant 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) Soildirected 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 aboveground harvestable food commodities are present (usually prebloom). (12) Application as part of an animal feedthrough product. (13) Applications as gel and solid (nonliquid/nonspray) 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:
Chemical Substance CAS No. Caseins........................................ 9000719 Caseins, ammonium complexes.................... 9005429 Caseins, hydrolyzates.......................... 65072006 Caseins, potassium complexes................... 68131544 Caseins, sodium complexes...................... 9005463 [FR Doc. 0416214 Filed 72004; 8:45 am]
BILLING CODE 656050S

FOR FURTHER INFORMATION CONTACT Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3056304; fax number: (703) 3050599; email address: boyle.kathryn@epa.gov.