[Federal Register Volume 62, Number 138 (Friday, July 18, 1997)]
[Proposed Rules]
[Pages 38513-38514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18973]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300505; FRL-5717-8]


Corn Gluten; Proposed Exemption From the Requirement of a 
Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

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SUMMARY: EPA is proposing to establish an exemption from the 
requirement of a tolerance for residues of the biochemical pesticide 
corn gluten, also known as corn gluten meal, when used as a herbicide 
in or on various food commodities. The exemption from the requirement 
of a tolerance is being proposed by the Agency on its own initiative.
DATES: Comments, identified by the docket control number [OPP-300505], 
must be received on or before September 16, 1997.
ADDRESSES: By mail, submit written comments to: Information and Records 
Integrity Branch, Public Information and Services Divison (7506C), 
Office of Pesticides Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. In person bring comments to: Rm. 1132, 
CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment 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. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Freshteh Toghrol, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 5th Floor, Crystal Station 1, 2805 Crystal Drive, Arlington, 
VA; Telephone number (703) 308-7014, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to section 408(d) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) and 21 U.S.C. 346a(d), EPA 
proposes to amend 40 CFR 180.1164 by establishing an exemption from the 
requirement of a tolerance for residues of the biochemical pesticide 
corn gluten, also known as corn gluten meal, when applied in accordance 
with good agricultural practices in or on all food commodities. 
Pursuant to section 408(d)(2)(a)(i) of the FFDCA, as amended, the 
Agency is issuing this proposed exemption on its own initiative.

I. Corn Gluten

    Corn gluten is classified by Food and Drug Administration as GRAS 
(Direct Food Substances Affirmed As Generally Recognized As Safe, 21 
CFR 184.1321).

A. Proposed Use Practices

    Corn gluten, also known as corn gluten meal, is proposed to be used 
as an herbicide in or on all food commodities. The rate of application 
and number of applications will not be limited because corn gluten is a 
protein (food-by product) obtained from corn.

B. Product Identity/Chemistry

    1. Corn gluten. Corn gluten (Cas Reg. No. 66071-96-3), also known 
as corn gluten meal, is the principal protein component of corn 
endosperm. It consists mainly of zein and glutelin, and is a by-product 
of the wet milling of corn for starch. The gluten fraction is washed to 
remove residual water soluble proteins. Corn gluten is also produced as 
a by-product during the conversion of the starch in whole or various 
fractions of dry milled corn to corn syrups.
    a. The ingredient is used as a nutrient supplement as defined in 21 
CFR 170.3(o)(20) and a texturizer as defined in 21 CFR 170.3(o)(32).
    b. The ingredient is used in food at levels not to exceed current 
good manufacturing practice.
    c. Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.
    Corn gluten is also classified by EPA as a pesticide not requiring 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulation 
(Exemptions For Pesticides of a Character Not Requiring FIFRA 
Regulation, 40 CFR 152.25). Corn gluten is listed under 40 CFR 
152.25(g)(1):
    Sec. 152.25 Exemptions for pesticides of a character not 
requiring FIFRA regulation.
*    *    *    *    *
    (g) Minimum risk pesticides--(1) Exempted products. Products 
containing the following active ingredients are exempt from the 
requirements of FIFRA, alone or in combination with other substances 
listed in this paragraph, provided that all of the criteria of this 
section are met.
*    *    *    *    *
    (2) Permitted inerts. A pesticide product exempt under paragraph 
(g)(1) of this section may only include inert ingredients listed in 
the most current List 4A *  *  *.
    (3) Other conditions of exemption. All of the following 
conditions must be met for products to be exempted under this 
section:
    (i) Each product containing the substance must bear a label 
identifying the name and percentage (by weight) of each active 
ingredient and the name of each inert ingredient.
    (ii) The product must not bear claims either to control or 
mitigate microorganisms that pose a threat to human health, 
including but not limited to disease transmitting bacteria or 
viruses, or claim to control insects or rodents carrying specific 
diseases, including, but not limited to ticks that carry Lyme 
disease.
    (iii) The product must not include any false and misleading 
labeling statements, including those listed in 40 CFR 156.10 
(a)(5)(i) through (viii).

    Based upon the information provided above, EPA has found that when 
corn gluten is used in accordance with good agricultural practice, the 
ingredient is useful and a tolerance is not necessary to protect public 
health. Therefore, EPA proposes that an exemption from the requirement 
of a tolerance be established for residues of the herbicide corn 
gluten, when used as an active ingredient for end-use formulations.
    2. Magnitude of Residue. The Agency believes that corn gluten 
residues are non-toxic since corn gluten occurs naturally in food and 
the environment.
    3. Analytical method. The analytical method is not needed because 
corn gluten residues consist of proteins, which will not be 
distinguishable from those proteins present in the crop.

C. Mammalian Toxicological Profile

    Corn gluten is a protein found in food consumed by humans, and 
animals, and

[[Page 38514]]

is non-toxic to humans, and animals. The Agency therefore, supports the 
exemption from the requirement of a tolerance for corn gluten.

D. Aggregate Exposure

    1. Dietary exposure. Under this proposed tolerance exemption, oral 
exposure to crops containing corn gluten may occur; however, due to the 
product's lack of mammalian toxicity, such exposure will not be harmful 
to humans.
    2. Drinking water and non dietary exposure. Corn gluten is a food 
by-product and its use in residential, home garden, or lawn care 
situations, as well as other potential sources of dietary and non-
dietary exposure to the general population such as drinking water and 
non-occupational exposures, are not expected to be significant or 
harmful to human health.

E. Cumulative Effects

    Since corn gluten is not toxic to mammals, it is unlikely that it 
will have any cumulative toxic effects when used with other pesticides 
or substances.

F. Safety Determination

    1. Population in general. Corn gluten is a non-toxic protein, 
isolated from corn, a plant used as food by humans and as feed by 
animals. Corn has been used as food and feed as long as corn has been 
known to and used by humankind, with no reported adverse effects. Based 
on this, the Agency believes that the aggregate exposure to corn gluten 
over a lifetime will not pose appreciable risks to human health. The 
Agency also concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to corn gluten residues and that 
exempting corn gluten from the requirement of a tolerance is safe.
    2. Infants and children. Residues of corn gluten pose no potential 
toxicity to infants and children. Due to the lack of adverse effects 
and negligible exposure, the Agency concludes with reasonable 
certainty, that no harm will result to infants and children from 
aggregate exposure to corn gluten.

G. Existing Tolerances

    No tolerances or exemptions from requirements of tolerances have 
been issued in the United States or internationally for corn gluten.

II. Public Record

    The official record for this rulemaking, as well as the public 
version, has been established for this notice of filing under docket 
control number [OPP-300505] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the Virginia address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number [OPP-300505]. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries.

III. Regulatory Assessment Requirements

    This action proposes to establish an exemption from the tolerance 
requirement under FFDCA section 408(e). 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). In addition, 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) (Pub.L. 
104-4). Nor does it require any prior consultation as specified by 
Executive Order 12875, entitled Enhancing the Intergovernmental 
Partnership (58 FR 58093, October 28, 1993), or special considerations 
as required by Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require special OMB 
review in accordance with Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), the Agency previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

Dated: July 7, 1997.

Janet L. Andersen.

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR Chapter I, part 180 is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1164 is amended by adding new paragraph (c) to read 
as follows:


Sec. 180.1164  Food and food by-products; exemption from the 
requirement of a tolerance.

*    *    *    *    *
    (c) Corn gluten is exempt from the requirement of a tolerance on 
all food commodities when used as an herbicide in accordance with good 
agricultural practice.

[FR Doc. 97-18973 Filed 7-17-97; 8:45 am]
BILLING CODE 6560-50-F