[Federal Register Volume 67, Number 10 (Tuesday, January 15, 2002)]
[Proposed Rules]
[Pages 1925-1931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-699]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301189; FRL-6807-8]
RIN 2070-AC18


Pesticides; Tolerance Exemptions for Minimal Risk Active and 
Inert Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to list in 40 CFR part 180 the pesticide 
chemicals that are exempted from the requirement of a tolerance based 
on the Agency's determination that these chemicals are of ``minimal 
risk.'' The pesticide chemicals to be listed in 40 CFR 180.1001(g) 
include both active and inert ingredients and will be accomplished in 
several steps. As a first step, the existing tolerance exemptions for 
commonly consumed food commodities, animal feed items, and edible fats 
and oils will be recodified in the newly created paragraph (g) in a 
different format. Restructuring to this new format will provide greater 
clarification in defining a minimal risk pesticide chemical as well as 
increasing the number of substances that are currently considered to be 
minimal risk. In the future, EPA will propose other minimal risk 
pesticide chemicals for inclusion in paragraph (g). These regulatory 
actions are part of the tolerance reassessment requirements of the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended 
by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is 
required to reassess 66% of the tolerances in existence on August 2, 
1996, by August 2002, or about 6,400 tolerances. The regulatory actions 
proposed in this document, the proposed revocation of 39 tolerance 
exemptions, would be counted toward the August 2002 deadline.

DATES: Comments, identified by docket control number OPP-301189, must 
be received on or before March 18, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-301189 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
703-305-6304; fax number: 703-305-0599; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you formulate or 
market pesticide products. Potentially affected categories and entities 
may include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  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 table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes are provided to assist you and others in determining whether or 
not this action might apply to certain entities. If you have questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301189. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as Confidential Business Information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is

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imperative that you identify docket control number OPP-301189 in the 
subject line on the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-301189. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    The Agency is proposing to create a new paragraph (g) in 40 CFR 
180.1001, that specifies the pesticide chemicals that are exempt from 
the requirement of a tolerance under section 408 of Federal Food, Drug, 
and Cosmetic Act (``FFDCA''). This paragraph will contain a listing of 
pesticide chemicals that are considered to be of minimal risk. The 
tolerance exemption in 40 CFR 180.1164(d) (which was established post-
FQPA) as well as existing tolerance exemptions in 40 CFR 180.1001(c), 
(d) and (e) will be recodified in the newly established 40 CFR 
180.1001(g), albeit in a different format that will include additional 
clarification. The effect of these changes will be that all commonly 
consumed food items (as a reference, there is the Food and Feed 
Commodity Vocabulary on the Agency's website: see http://www.epa.gov/pesticides/foodfeed/), with the exception of the exclusions noted 
below, will be exempt from the requirement of a tolerance under the 
newly established 40 CFR 180.1001(g).
    The Agency is also proposing to establish in 40 CFR 180.1001(g) an 
exemption from the requirement of a tolerance for various animal feed 
items. The Agency is proposing that 40 CFR 180.1001 be amended by 
deleting the existing exemptions for various feed items, such as 
pomaces, corn cobs, peanuts shells, and oat hulls in 40 CFR 180.1001(c) 
and (d). These will be recodified in 40 CFR 180.1001(g) albeit in a 
different format that will include additional clarification. All feed 
items whether or not previously exempted from the requirement of a 
tolerance with the exception of the exclusions noted below, will be 
exempt from the requirement of a tolerance under the newly established 
40 CFR 180.1001(g).
    The Agency is proposing to place expiration dates on seven existing 
tolerance exemptions for known allergen-containing food commodities. At 
this time, the Agency cannot consolidate the overlapping and 
duplicative tolerance exemptions for allergen-containing commodities 
that currently exist in 40 CFR part 180.
    This proposed rule begins the process of harmonizing the regulation 
of certain pesticide chemicals whether used as inert or active 
ingredients. At the completion of this process there will be a single 
consistent approach for all food and feed commodities used as pesticide 
chemicals.

III. What is the Agency's Authority for Taking these Actions?

    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 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.

IV. Why is the Agency Proposing These Actions?

A. Why is a ``Minimal Risk'' Paragraph Being Created?

    The term ``minimal risk'' has been used by EPA for over 10 years, 
and has generally meant List 4A inert ingredient chemicals. On April 
22, 1987 (52 FR 13305), EPA created a series of four lists as part of 
an initiative to address the risks potentially posed by inert 
ingredients in pesticides. List 1 inert ingredients are ``inerts of 
toxicological concern''. List 1 inert ingredients are classified on the 
basis of peer reviewed studies which demonstrated carcinogenicity, 
adverse reproductive effects, neurotoxicity or other chronic effects, 
developmental toxicity (birth defects), ecological effects and the 
potential for bioaccumulation. List 2 inert ingredients are 
``potentially toxic inerts/high priority for testing.'' Many of these 
inert ingredients are structurally similar to chemicals known to be 
toxic; some have data suggesting a concern. List 3 inert ingredients 
are ``unknown

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toxicity.'' An inert ingredient was placed on List 3 if there was no 
basis for listing it on any of the other lists. At that time all List 4 
inert ingredients were classified as ``inerts of minimal concern''.
    The 4A Inert Ingredient List was created on November 22, 1989 (54 
FR 48314) by subdividing List 4 into Lists 4A and 4B. List 4B inert 
ingredients are ``inerts for which EPA has sufficient information to 
reasonably conclude that the current use pattern in pesticide products 
will not adversely affect public health or the environment.'' List 4A 
inert ingredients are ``minimal risk inert ingredients.'' Examples of 
List 4A inert ingredients are salt, and sugar.
    The September 28, 1994, Federal Register Notice (FRL 4872-5) was 
the last time that the Agency added new substances to and issued the 4A 
List. Classification as a List 4A inert ingredient is critical to those 
products that are exempted from Federal regulation under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) section 25(b). The 
substances on List 4A are the only inert ingredients that can be used 
in 25(b) deregulated products (see 40 CFR 152.25(g)(2)).
    Minimal risk does not imply no risk under any circumstances. Every 
substance, even for example water, presents some risk in certain 
circumstances. Minimal risk is used to indicate a substance for which 
there is no information to indicate that there is a basis for concern. 
Minimal risk or List 4A substances are mostly naturally occurring 
substances to which some refinement has occurred, such as beeswax, 
salt, sugar, limestone, and red cedar chips. The determination that a 
chemical is minimal risk would be based on a recognition of the overall 
safety of the chemical (such as very low toxicity or practically non-
toxic) considering the widely available information on the chemical's 
known properties, and a history of safe use under reasonable 
circumstances. Minimal risk (List 4A) substances are recognized as safe 
for use in all pesticide products subject only to good agricultural 
practices or good manufacturing practices. Classification as a List 4A, 
minimal risk, substance is a high standard to meet. As an example, 
substances of high acute toxicity are usually not considered for 
classification to List 4A. The critical distinction between List 4A 
minimal risk substances and other substances, is that the Agency does 
not define how, where, when or in what manner the substance can be 
used. Any reasonably foreseeable use of these substances is not 
expected to present a risk to humans. Accordingly, there should not be 
any unreasonable adverse effects from the inclusion of a List 4A 
substance in a pesticide product to the person applying a pesticide 
product in and around their home, to a child in a day-care center, or 
when ingesting a food commodity that has been treated. A List 4A 
substance used as an inert ingredient, incorporated into a 25(b) 
product (meeting all the appropriate exemption criteria) is subject to 
no Federal regulation. Therefore, unless a substance can meet and 
continues to meet this high standard, it will not be classified as 
minimal risk.

B. Why Are Uses as Both an Inert or Active Ingredient Being Included?

    Active ingredients are defined in 40 CFR 153.125 as having the 
capability at the proposed use dilution to function as a pesticide, 
that is to kill, repel, or mitigate the pest. Inert ingredients are 
defined as all ingredients that are not active ingredients. However, it 
is possible for a chemical to be an active ingredient in one pesticide 
product and an inert ingredient in another pesticide product. 
Determining whether an ingredient in a pesticide product is inert or 
active requires information on the purpose of the ingredient in the 
formulation. As an example, citric acid can be used as a disinfectant, 
sanitizer, and fungicide (an active ingredient). However, citric acid 
can also perform as a sequestration agent or to lower the pH, thus 
functioning as an inert ingredient. To determine whether an ingredient 
is inert or active requires an understanding of the purpose of the 
ingredient in the formulation.
    Thus, the toxicity of a chemical does not depend on whether it is 
used as either an inert ingredient or active ingredient, but on its 
impact to human health and the environment. Establishment of a 
tolerance exemption under 40 CFR 180.1001(g) indicates that the 
substance may be used as either an inert or an active ingredient (as 
appropriate, based on its use in the formulation) in pesticide 
formulations applied to food crops.

C. Why Are Commonly Consumed Foods Being Included in this New 
Paragraph?

    It is unlikely that a commonly consumed food commodity could be 
used to control a pest via a toxic mode of action. Generally, when used 
as an active ingredient, food commodities have been used to either 
attract or repel pests. Canola oil is a refined vegetable oil that can 
be used as an active ingredient to control insects in a wide variety of 
crops. Scientists believe that canola oil repels insects by altering 
the outer layer of the leaf surface or by acting as an insect irritant. 
Oils such as canola, however, can also be used as a surfactant in 
pesticide formulations. Surfactants are used to modify the nature of a 
surface, such as reducing the surface tension of water. Surfactants can 
be used as wetting agents, detergents, penetrants, and emulsifiers. 
When used in this capacity, canola oil would be an inert, rather than 
an active, ingredient. Other food commodities also are used as inert 
ingredients. For example, oats can be used as a carrier, i.e., the 
active ingredient is coated onto the oats, which is then consumed by 
the pest.
    In the September 28, 1994, Federal Register Notice titled ``Inert 
Ingredients in Pesticide Products; List of Minimal Risk Inerts'' the 
Agency established a policy of considering all commonly consumed foods 
as acceptable for use in all pesticide products. The Notice 
specifically stated that a specific exemption from tolerance would not 
be required for foods used as inert ingredients because foods were 
generally recognized as safe (GRAS). However, the above GRAS 
determination was superceded, on December 4, 1998, in the Federal 
Register (63 FR 37307) (FRL 6039-5) by EPA's establishment of a 
tolerance exemption for all edible food commodities. That exemption 
excepted certain foods known to have allergenic properties.

D. Why Are the Tolerance Exemptions for Known Food Allergens Being 
Time-Limited?

    As noted above, EPA has previously established an exemption from 
tolerance for all edible food commodities with the exception of 
peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat 
due to the allergenic properties of these foods. (40 CFR 180.1164(d)). 
The comment received by EPA in this 1998 rulemaking proceeding 
indicated a concern that the proposed exclusions for allergen-
containing food commodities were not sufficient, given that tolerance 
exemptions existed for some of the same commodities when used as inert 
ingredients.
    The following tolerance exemptions are currently listed in 40 CFR 
180.1071 and 40 CFR 180.1001(c), (d), and (e), for the eight known 
allergen food or food groups and their processed commodities:

------------------------------------------------------------------------
                  40 CFR                         Tolerance Exemption
------------------------------------------------------------------------
180.1001(c)...............................  casein
180.1001(c)...............................  fish meal
180.1001(c)...............................  soy protein, isolated

[[Page 1928]]

 
180.1001(c)...............................  soybean flour
180.1001(c)...............................  starch (potato, tapioca,
                                             wheat)
180.1001(c)...............................  wheat bran
180.1001(d)...............................  sodium caseinate
180.1001(d)...............................  wheat
180.1001(d)...............................  wheat flour
180.1001(e)...............................  soy protein, isolated
180.1001(e)...............................  wheat shorts
180.1071..................................  egg solids (whole)
------------------------------------------------------------------------

    The Agency has investigated the post-harvest uses of these eight 
allergen food or food groups, and has determined that such uses do 
exist. An example would be a formulation, that contains wheat as a 
carrier, which is then applied to stored grain other than wheat. Thus, 
some of the above tolerance exemptions are necessary to cover the use 
of these existing products. The 12 tolerance exemptions overlap to some 
degree and therefore EPA is proposing to amend them to reduce 
duplication. The result will be that the 12 tolerances will be reduced 
to 8.
    More importantly, the Agency is proposing to place 3-year 
expiration dates on the eight tolerance exemptions that will remain. 
This will give the Agency a period of 3 years to continue its 
examination of the uses of these food commodities, and discuss product 
re-formulation with affected registrants. The Agency recognizes that 
various factors such as restrictions on post-harvest applications or 
information on the environmental degradation/metabolism of the allergen 
may enable the Agency, at a future date, to (1) make a determination of 
safety, (2) reassess these tolerances, and (3) establish tolerance 
exemptions with limitations on the use pattern, that would not be time-
limited.

E. Why Are Animal Feed Exemptions Being Included in this New Paragraph?

    Like commonly-consumed human food, animal feed items are of minimal 
risk to humans who consume animal products (such as meat, milk, poultry 
or eggs), or to the animals. They are therefore being included in 
proposed 40 CFR 180.1001(g). Feed items are occasionally used as 
pesticides. For example, a feed item, such as corn cobs, can be used as 
a carrier. For such a use, the corn cobs would be ground, and then an 
active ingredient coated onto the ground feed item, is then consumed by 
the pest. Or a feed item could be used as a carrier for a lawn and 
garden product, with the added advantage of degrading over a period of 
time in the natural environment. Again, there is a long history of safe 
use of animals consuming these feed items, and then producing meat, 
milk, poultry, and eggs that are in turn consumed by humans.
    Feed items can also include items derived from known allergen-
containing foods, such as almond hulls and peanut shells. These by-
products of allergen-containing foods are not likely to cause an 
allergic reaction due to the separation of the hull or shell from the 
protein allergen.
    There are a large variety of feed items. Most agricultural crops 
and their corresponding raw agricultural and processed commodities can 
be, and are, fed to livestock. Due to differences in their metabolisms, 
animals can obtain nutrition from parts of plants that are not digested 
by humans such as hays, forages, seeds, leaves, hulls and shells, and 
stovers. Animals also consume plants, such as sorghum, that are not 
consumed by humans. As a reference, the significant feed items consumed 
by animals are contained in Table 1 (``Raw Agricultural and Processed 
Commodities and Feedstuffs Derived From Crops''), OPPTS Test 
Guidelines, Residue Chemistry, Guideline 860.1000, Background. (see 
http://www.epa.gov/docs/OPPTS_Harmonized/860_Residue_Chemistry_Test_Guidelines/Series/ ). There are also other feed items not listed 
in Table 1 such as pineapple forage and fodder, or sugarcane forage and 
fodder that are consumed by animals, but not in amounts considered to 
be significant feed items on a national basis.

F. Why Are Edible Fats and Oils Being Included in the New Paragraph?

    As previously explained on December 4, 1998, EPA established an 
exemption from tolerance for all edible food commodities with the 
exception of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, 
and wheat due to the allergenic properties of these foods. (40 CFR 
180.1164(d)) The exception included all processed forms of the 
allergen-containing food commodities including oils. EPA is proposing 
to no longer exclude highly refined edible oils derived from peanuts, 
tree nuts, soybeans, fish, crustacea, and wheat. Most oils are highly 
refined. The information available to the Agency does not indicate the 
presence of the protein allergens in the oils. The production process 
is generally believed to remove or destroy the allergen, which would 
cause the allergic reaction.

G. Why is Lactose Being Included?

    It is also proposed to include lactose (milk sugar) in the to-be-
established 40 CFR 180.1001(g) tolerance exemptions. Lactose 
intolerance occurs when the body does not produce a sufficient amount 
of lactase, the enzyme that digests lactose. The presence of undigested 
lactose in the large intestine can cause gas or diarrhea; however, this 
is not life-threatening, as allergic reactions can be. Many lactose-
intolerant individuals are capable of consuming small amounts of 
lactose with few or no symptoms. EPA can only regulate the use of 
lactose in pesticide formulations. Given the wide-spread nature of 
lactose in the food supply, the amount of lactose that can be applied 
to food as a result of its use in a pesticide product should not 
significantly increase the existing amounts in the food supply. 
Additionally, given the nature of plant metabolism it is unlikely that 
lactose would be directly absorbed or actually present in plant 
tissues. Lactose can be hydrolyzed to glucose, which is a natural plant 
compound and is, in fact, the sugar produced by photosynthesis. In 
plants, glucose is converted into starch or sucrose.

H. Conclusions

    All of the substances considered in this proposed rule for 
inclusion in 40 CFR 180.1001(g) can be grouped into and included in 
three major categories. These are: (1) Commonly consumed food 
commodities; (2) animal feed items; and (3) edible fats and oils. All 
of the revoked tolerances will be recodifed in 40 CFR 180.1001(g), 
albeit in a different format. In fact, the amendments and revisions to 
the tolerance exemptions will be beneficial to the regulated community 
by increasing the number of minimal risk inert ingredients for use in 
pesticide formulations.
    EPA believes that the proposed tolerance exemptions in 40 CFR 
180.1001(g) will be safe for humans including infants and children. EPA 
also is not aware of any data submitted pursuant to Section 6(a)2 of 
FIFRA showing significant adverse effects to humans from use of 
commonly consumed food commodities, animal feed items, or fats and 
oils. Because of the above, 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.

V. What is the Contribution to Tolerance Reassessment

    By law, EPA is required to reassess 66% or about 6,400 of the 
tolerances in existence on August 2, 1996, by August 2002. This 
proposed rule proposes to revoke 39 tolerance exemptions which will be 
counted toward the August 2002

[[Page 1929]]

review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

VI. Future Issues

    As previously stated, this proposed rule only considers commonly 
consumed foods, animal feed commodities, and refined, edible oils and 
fats. The Agency intends (in future proposed and final rules) to expand 
beyond these three categories and propose additional minimal risk 
chemicals for inclusion in 40 CFR 180.1001(g). Possible categories 
could include naturally occurring organic chemicals (such as fatty 
acids), common substances derived from weathered rocks and minerals, or 
some animal feed components.
    The eight allergen food or food groups tolerance exemptions 
mentioned earlier in this preamble cannot be reassessed at this time. 
The Agency will examine the use patterns of these eight and determine 
the appropriate actions that would allow the Agency to make the safety 
finding. As explained earlier, restrictions on post-harvest 
applications or information on the environmental degradation/metabolism 
of the allergen could enable the Agency, at a future date, to make a 
determination of safety. Since use restrictions will be necessary, 
these allergens will no longer meet the criteria of List 4A 
classification and therefore these eight food or food groups will be 
transferred from the Agency's 4A list to the 4B list.

VII. Regulatory Assessment Requirements

    The Agency is acting on its own initiative under FFDCA section 
408(e) in establishing new tolerance exemptions that will consolidate 
the existing, overlapping and duplicative tolerance exemptions. Under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993), this action is not a ``significant regulatory 
action'' subject to review by the Office of Management and Budget 
(OMB). Because the 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 104-4).
    Nor does it require any 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 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 proposed rule would establish a new paragraph in 40 CFR 
180.1001. Creating a new paragraph does not have a substantive effect 
and hence causes no impact. This proposed rule would place expiration 
dates on seven existing tolerance exemptions for various known 
allergen-containing food commodities. Currently, the Agency's 
regulatory approach as written in various CFR paragraphs and sections 
is inconsistent. This 3-year transition period will allow sufficient 
time to examine the uses of these food commodities, and discuss product 
re-formulation with affected registrants. At the completion of this 
process there will be a single consistent approach for all food 
commodities used as pesticide chemicals.
    This proposed rule would also revoke 39 tolerance exemptions, thus 
(1) revoking duplicative and overlapping tolerance exemptions for 
commonly consumed (non-allergen) food commodities, (2) revoking and 
consolidating the existing tolerance exemptions for animal feed items 
and allowing additional minimal risk animal feed items not previously 
exempted for use in pesticide products, and (3) establishing the use of 
edible oils derived from allergens since the available information 
indicates that the use of these oils is not of concern.
    Pursuant to the section 605(b) of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that these 
proposed actions will not have significant negative economic impact on 
a substantial number of small entities. By contrast, the amendments and 
revisions to the tolerance exemptions will be beneficial to the 
regulated community by increasing the number of minimal risk inert 
ingredients for use in pesticide formulations.
    Pursuant to the RFA the Agency previously assessed whether 
revocations of tolerances or tolerance exemptions might significantly 
impact a substantial number of small entities and concluded that, as a 
general matter, these actions do impose a significant economic impact 
on a substantial number of small entities. This analysis was published 
on December 17, 1997 (62 FR 66020) (FRL-5753-1), and was provided to 
the Chief Counsel for Advocacy of the Small Business Administration. 
Taking into account this analysis, the available information concerning 
the pesticide chemicals listed in this rule, the transition time for 
the known allergen containing commodities and considering that all of 
the to-be-revoked tolerance exemptions will be covered in the to-be-
established 40 CFR 180.1001(g), the Agency knows of no extraordinary 
circumstances that exist as to the present revocation that would change 
EPA's previous analysis.
    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 does not affect States directly, but 
does directly regulate 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 FFDCA section 408(n)(4).
    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

[[Page 1930]]

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.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practices and procedures, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: December 21, 2001.
James Jones,
Director, 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 would continue to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


Sec. 180.1001  [Amended]

    2. Section 180.1001 is amended as follows:
    A. In paragraph (c) remove the entries for: almond shells; apple 
pomace; citrus meal; cocoa shells; coconut oil; corn cobs; corn meal; 
corn oil; cornstarch; corn syrup; cottonseed oil; dextrose; fish oil; 
grape pomace, dried; lactose; lard; molasses; oatmeal; oats; orange 
pomace; peanut shells; rice bran; soybean, oil; starch (potato, 
tapioca, wheat); and sucrose.
    B. In paragraph (d) remove the entries for: cinnamon; clove; 
coffee; corn; corn gluten meal, hydrolized; fenugreek; low erucic acid 
rapeseed oil, conforming to 21 CFR 184.1555(c) (CAS Reg. No. none); oat 
hulls; wheat; and wheat flour.
    C. In paragraph (e) remove the entries for: corn syrup; dextrose; 
and sucrose.

    3. Section 180.1001 is further amended by revising the following 
entries in the tables to paragraphs (c), (d), and (e), by adding the 
entry ``wheat, including flour, bran, and starch'' to the table in 
paragraph (c), by adding and reserving paragraph (f) and by adding 
paragraph (g) to read as follows.


Sec. 180.1001  Exemptions from the requirement of a tolerance.

    (c) * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
          *      *      *          *      *      *      *
Casein..........................  expires [insert     Surfactant,
                                   date 3 years from   emulsifier,
                                   date of             wetting agent
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
Fish meal.......................  expires [insert     Solid diluent,
                                   date 3 years from   carrier
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
Soy protein, isolated...........  expires [insert     Adhesive
                                   date 3 years from
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
Soybean flour...................  expires [insert     Surfactant
                                   date 3 years from
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
Wheat, including flour, bran,     expires [insert     Solid diluent,
 and starch.                       date 3 years from   carrier,
                                   date of             attractant
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
------------------------------------------------------------------------

    (d) * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
           *      *      *        *      *      *      *
Sodium caseinate................  expires [insert     Suspending agent
                                   date 3 years from   and binder
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
------------------------------------------------------------------------

    (e) * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
           *      *      *        *      *      *      *
Soy protein, isolated...........  expires [insert     Adhesive
                                   date 3 years from
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
Wheat shorts....................  expires [insert     Solid diluent
                                   date 3 years from
                                   date of
                                   publication of
                                   the final rule in
                                   the Federal
                                   Register].
           *      *      *        *      *      *      *
------------------------------------------------------------------------

    (f) [Reserved]
    (g) Minimal risk substances. Unless specifically excluded, residues 
resulting from the use of the following substances as either an inert 
or an active ingredient in a pesticide chemical formulation, including 
antimicrobial pesticide chemicals, are exempted from the requirement of 
a tolerance under section

[[Page 1931]]

408 of the FFDCA if such use is in accordance with good agricultural or 
manufacturing practices.
    (1) Commonly-consumed food commodities.``Commonly-consumed food 
commodities'' means foods that are commonly consumed for their nutrient 
properties. The term ``commonly-consumed food commodities'' shall only 
apply to food commodities, whether a raw agricultural commodity or a 
processed commodity, in the form the commodity is sold or distributed 
to the public for consumption.
    (i) Included within the term ``commonly-consumed food commodities'' 
are:
    (A) Sugars such as sucrose, lactose, dextrose and fructose, and 
invert sugar and syrup.
    (B) Spices such as cinnamon, cloves, and red pepper.
    (C) Herbs such as basil, anise, or fenugreek.
    (ii) Excluded from the term ``commonly-consumed food commodities'' 
are:
    (A) Any food commodity that is adulterated under 21 U.S.C. 342.
    (B) Both the raw and processed forms of peanuts, tree nuts, milk, 
soybeans, eggs, fish, crustacea, and wheat.
    (C) Alcoholic beverages.
    (D) Dietary supplements.
    (2) Animal feed items. ``Animal feed items'' means all items 
derived from field crops that are fed to livestock, and meat meal. Meat 
meal is an animal feed composed of dried animal fat and protein that 
has been sterilized. Other than meat meal, the term ``animal feed 
item'' does not extend to any item designed to be fed to animals that 
contains, to any extent, components of animals.
    (i) Included within the term ``animal feed items'' are:
    (A) The hulls and shells of the commodities specified in paragraph 
(g)(1)(ii)(B) of this section, and cocoa beans.
    (B) Bird feed such as canary seed.
    (C) Any feed component of a medicated feed meeting the definition 
of an animal feed item.
    (ii) Excluded from the term animal feed item are both the raw and 
processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, 
crustacea, and wheat.
    (3) Edible fats and oils. Edible fats and oils means all edible 
(food or feed) fats and oils, derived from either plants or animals, 
whether or not commonly consumed, including products derived from 
hydrogenating (food or feed) oils, or liquefying (food or feed) fats. 
Excluded from the term edible fats and oils are plant oils used in the 
pesticide chemical formulation for their characteristic smell and/or 
taste and oils derived from the commodities specified in paragraph 
(g)(1)(ii)(B) of this section except to the extent such oils are highly 
refined.
    4. Section 180.1071 is revised to read as follows:


Sec. 180.1071  Egg solids (whole); exemption from the requirement of a 
tolerance.

    A time-limited tolerance exemption expiring [insert date 3 years 
from date of publication of the final rule in the Federal Register] is 
established for residues of whole egg solids (of at least feed grade 
quality) when used as an animal repellent in or on almonds and applied 
to the growing crop in accordance with good agricultural practices.


Sec. 180.1164  [Removed]

    5. Section 180.1164 is removed.


Sec. 180.1194  [Removed]

    6. Section 180.1194 is removed.
[FR Doc. 02-699 Filed 1-14-02; 8:45 a.m.]
BILLING CODE 6560-50-S