[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23890]
[Federal Register: September 28, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-36140B; FRL-4872-5]
Inert Ingredients in Pesticide Products; List of Minimal Risk
Inerts
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is issuing a list of inert ingredients considered to be of
minimal risk in pesticide products (List 4A). In addition, EPA is
announcing that substances commonly consumed as food will also be
considered minimal risk, List 4A, even if they have previously not been
used in pesticide products and are therefore not currently on the list.
Substances commonly consumed as foods will be considered acceptable for
use in all pesticide products, both food and nonfood use, and will not
require a specific exemption from tolerance.
EFFECTIVE DATE: September 28, 1994.
ADDRESSES: By mail, submit written comments identified by the document
control number [OPP-36140B] to: Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. In person, deliver comments to: Rm. 1132, Crystal Mall Bldg.
#2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part of all of that information as
``Confidential Business Information'' (CBI). Information so marked 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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the address given above, from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, Registration
Support Branch, Registration Division (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: 2800 Crystal Drive,
North Tower, Arlington, VA 22202, (703)-308-8393.
SUPPLEMENTARY INFORMATION: EPA announced its policy on toxic inert
ingredients in pesticide products in the Federal Register of April 22,
1987 (52 FR 13305). Through this policy, EPA encourages the use of the
least toxic inert ingredients available and requires the development of
data necessary to determine the conditions of safe use of products that
contain toxic inert ingredients. In developing this policy, EPA
categorized inert ingredients into the following four lists according
to toxicity:
List 1--Inerts of toxicological concern.
List 2--Potentially toxic inerts, with high priority for testing.
List 3--Inerts of unknown toxicity.
List 4--Inerts of minimal concern.
In the Federal Register of November 22, 1989 (58 FR 48314), EPA
issued a notice announcing some modifications to the previously
published Lists 1 and 2. In that notice, EPA also noted that List 4 was
being divided into two parts. The original List 4 became List 4A,
representing minimal risk inert ingredients. List 4B was created to
represent inert ingredients for which EPA has sufficient information to
conclude that their current use patterns in pesticide products will not
adversely affect public health and the environment. List 4B will be
developed as EPA works through the inerts strategy and reviews the
current inerts on Lists 2 and 3.
EPA is issuing List 4A to provide guidance to formulators of active
ingredients being proposed for deregulation under section 25(b) of the
Federal Insecticide, Fungicide and Rodenticide Act. The substances
included on List 4A can be added to such active ingredients without
jeopardizing their deregulated status. These minimum risk inert
ingredients are recognized as safe for use in pesticide products based
upon their known properties.
In reviewing List 4 inert ingredients for the proposed section
25(b) rule, many inerts on the original List 4 were moved from List 4A
to List 4B. In particular, acutely toxic inerts were moved to 4B
because, although the testing of products for acute toxicity ensures
low concern for these inerts in registered products, without such
regulatory oversight there may be unacceptable acute risks. In
addition, many of the inerts on the original List 4 received little
review for environmental fate and ecological effects. Those inerts have
been moved to List 4B while EPA further assess their environmental
risks. EPA also plans soon to move inert ingredients now on List 3 to
Lists 4A and 4B. The Food and Drug Administration has considered these
inerts for use as direct food additives and in pharmaceuticals, and
they are undergoing additional review by the FDA and the Office of
Water before final disposition.
Many of the inerts on List 4A are commonly consumed foods. There
may be other foods useful as inert ingredients in pesticide products
that are not included in this list because they have not been used in
pesticide products up to now. EPA is announcing a policy that, as a
general matter, it will consider all commonly consumed foods as List
4A, inerts of minimal concern. Although some commonly consumed foods
are currently exempted from the requirement of a tolerance by virtue of
their listing in the 40 CFR 180.1001, EPA generally will no longer list
common foods in this way. EPA generally considers substances that are
commonly consumed as food to fall into the category of ``generally
recognized as safe'' substances. EPA will not require a specific
listing for commonly consumed foods in this subpart unless specific
information suggests that categorization of ``generally recognized as
safe'' is inappropriate.
List 4A--Minimum Risk Inerts
Acetic acid
Agar
Alfalfa
Alfalfa meal
Almond hulls
Almond shells
Alpha cellulose
Apple pomace
Attapulgite-type clay
Beef fat
Beeswax
Beet powder
Bentonite
Bone meal
Bran
Bread crumbs
Calcareous shale
Calcite
Calcium carbonate
Canary seed
Cane syrup
Carbon dioxide
Cardboard
Carrageenan
Carrots
Casein
Cheese
Chlorophyll
Cinnamon
Citric acid
Citrus meal
Citrus pectin
Citrus pulp
Clam shells
Cloves
Cocoa
Cocoa shells
Coco shell flour
Cod liver oil
Coffee grounds
Cookies
Cork
Corn
Corn cobs
Corn flour
Corn meal
Corn oil
Cornstarch
Corn syrup
Cotton
Cottonseed meal
Cottonseed oil
Cracked oats
Cracked wheat
Dextrin
Dextrose
Dolomite
Douglas-fir bark, ground
Eggs
Egg shells
Edible fish meal
Edible fish oil
Flour
Fuller's earth
Gelatin
Glue, as depolymerized animal collagen
Glycerin
Granite
Grape pomace
Graphite
Ground oats
Guar gum
Gum arabic
Gum tragacanth
Gypsum
Hearts of corn flour
Hydrogenated vegetable oils
Honey
Invert sugar
Invert syrup
Kaolinite-type clay
Lactose
Lanolin
Lard
Latex
Lecithin
Lime
Limestone
Linseed oil
Malt flavor
Meat meal
Meal scraps
Medicated feed
Mica
Milk
Millet seed
Mineral oil, U.S.P.
Molasses
Montmorillonite-type clay
Nitrogen
Nutria meat
Nylon
Oatmeal
Oats
Olive oil
Onions
Orange pulp
Oyster shells
Paper
Paprika
Paraffin wax
Peanut butter
Peanut oil
Peanuts
Peanut shells
Peat moss
Pecan shell flour
Pectin
Polyethylene film
Polyethylene pellets
Potatoes
Pumice
Raisins
Red cedar chips
Red dog flour
Rice
Rice hulls
Rubber
Rye flour
Safflower oil
Sawdust
Seaweed, edible
Shale
Soapstone
Sodium bicarbonate
Sodium chloride
Sorbitol
Soybean hulls
Soybean meal
Soybean oil
Soy flour
Soy protein
Sucrose
Sugarbeet meal
Sunflower seeds
Tallow
Vanillin
Vermiculite
Vitamin C
Vitamin E
Walnut flour
Walnut shells
Water
Wheat
Wheat germ oil
Whey
Wintergreen oil
Wool
Xanthan gum
Yeast
List of Subjects
Environmental protection, Agricultural commodities, Administrative
practice and procedure, Pesticides and pests, Reporting and
recordkeeping requirements.
Authority: 7 U.S.C. 136a.
Dated: June 14, 1994.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 94-23890 Filed 9-27-94; 8:45 am]
BILLING CODE 6560-50-F