corn gluten Tolerance Requirement Exemption 7/97
Federal Register Document
[Federal Register: July 18, 1997 (Volume 62, Number 138)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Corn Gluten; Proposed Exemption From the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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:
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
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
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
(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
(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
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
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
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
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:
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
Dated: July 7, 1997.
Janet L. Andersen.
Director, Biopesticides and Pollution Prevention Division, Office of
Therefore, 40 CFR Chapter I, part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1164 is amended by adding new paragraph (c) to read
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
[FR Doc. 97-18973 Filed 7-17-97; 8:45 am]
BILLING CODE 6560-50-F