[Federal Register Volume 67, Number 65 (Thursday, April 4, 2002)]
[Rules and Regulations]
[Pages 16027-16030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8154]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0010; FRL-6833-3]
RIN 2070-AB78


Revocation of Certain Obsolete Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct Final rule.

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SUMMARY: EPA is amending 40 CFR part 180 subpart D to revoke various 
exemptions from the requirement of a tolerance for eight specific inert 
ingredients because those substances are no longer used in pesticide 
products, making these tolerance exemptions unnecessary. The Agency is 
acting on its own initiative. These regulatory actions are part of the 
tolerance reassessment requirements of section 408(q) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 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. This regulatory action will count for 10 
tolerance reassessments toward the August 2002 deadline.

DATES: This rule is effective on August 2, 2002 without further notice, 
unless EPA receives adverse comment by June 3, 2002. If EPA receives 
adverse comment, EPA will publish a timely withdrawal in the Federal 
Register informing the public that this rule will not take effect.

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. It is 
imperative that you identify docket control number OPP-2002-0010 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Treva C. Alston, Registration Division 
7505C], Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 308-8373; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. 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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been 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_00/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-2002-0010. The official 
record consists of the documents specifically referenced in this 
action, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the

[[Page 16028]]

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 imperative that 
you identify docket control number OPP-2002-0010 in the subject line on 
the first page of your response. EPA also encourages you to submit your 
comments electronically, if at all possible, which will facilitate 
timely receipt by the Agency and avoid potential delays associated with 
the processing of government mail.
    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-2002-0010. 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. Authority

A. What is the Agency's Authority for Taking this Action?

    This direct final rule is issued pursuant to section 408(e) of 
FFDCA, as amended by the FQPA (21 U.S.C. 346a(e)). Section 408 of FFDCA 
authorizes the establishment of tolerances, exemptions from the 
requirement of a tolerance, modifications in tolerances, and revocation 
of tolerances for residues of pesticide chemicals in or on raw 
agricultural commodities and processed foods. Without a tolerance or 
tolerance exemption, food containing pesticide residues is considered 
to be unsafe and therefore ``adulterated'' under section 402(a) of the 
FFDCA. If food containing pesticide residues is found to be 
adulterated, the food may not be distributed in interstate commerce (21 
U.S.C. 331(a) and 342 (a)).

B. Why is EPA Issuing this as a Direct Final Rule?

    EPA is issuing this action as a direct final rule without prior 
proposal because the Agency believes that this action is not 
controversial and is not likely to result in any adverse comments. This 
action removes various exemptions from the requirement of a tolerance 
for eight specific inert ingredients because those substances are no 
longer used in pesticide products. These tolerance exemptions are 
unnecessary.
    This rule is effective on August 2, 2002 without further notice, 
unless EPA receives adverse comment by June 3, 2002. If, however, EPA 
receives a relevant adverse comment during the comment period, then EPA 
will publish a timely withdrawal in the Federal Register informing the 
public that the rule will not take effect. EPA will also publish a 
notice of proposed rulemaking in a future edition of the Federal 
Register. EPA will address the comments on the direct final rule as 
part of that proposed rulemaking.

III. Background

A. What Action is the Agency Taking?

    In Federal Register Notices of November 22, 1989, (54 FR 58314) and 
June 24, 1998, (63 FR 34384)(FRL-5792-3) the Agency removed certain 
chemicals from its list of pesticide product inert ingredients that 
were no longer used as inert ingredients in registered pesticide 
products. At that time, the Agency indicated that future use of these 
chemcials as inert ingredients in pesticide products would not be 
permitted unless a petitioner or registrant satisfied all data 
requirements as identified by the Agency, and the Agency was able to 
make a determination that the use of the inert ingrediuent will not 
pose unreasonable risk to human health or the environment.
    On its own initiative, the Agency is amending 40 CFR 180.1001, 
180.1014, and 180.1046 by revoking exemptions from the requirement of a 
tolerance for eight inert ingredients that are no longer

[[Page 16029]]

used in pesticide products applied to food and feed commodities.

B. Which Tolerance Exemptions are Being Removed?

    1. On November 22, 1989, (54 FR 58314) the Agency removed benzene 
and formaldehyde from its list of chemicals currently used in pesticide 
products. These substances, both of which were initially classified as 
List 1 inert ingredients, were determined to no longer be in use as 
pesticide product inert ingredients and were therefore removed from all 
lists of inert ingredients. The exemptions from the requirement of a 
tolerance for the inert ingredient uses of benzene and formaldehyde are 
now being revoked.
    i. In 40 CFR 180.1001(d), there is an exemption from the 
requirement of a tolerance for benzene. This exemption is for its use 
as a solvent and cosolvent.
    ii. An exemption from the requirement of a tolerance for 
formaldehyde exists in 40 CFR 180.1001(d). This exemption is limited to 
not more than 1% of the pesticide formulation with a prescribed use as 
a preservative for the formulation.
    2. On June 24, 1998, (63 FR 34384) EPA removed certain chemicals 
from its list of pesticide product inert ingredients that are not 
currently used in pesticide products. Included among those removed 
inert ingredients were six substances for which exemptions from the 
requirement of a tolerance existed for their use as inert ingredients 
and for which the tolerance exemptions are now being revoked.
    i. In 40 CFR 180.1001(d) there are exemptions from the requirement 
of a tolerance for coal (derived only from anthracite and bituminous 
coals) and coke (from anthracite and bituminous coals only and 
petroleum). These two tolerance exemptions are limited to soil 
application and are for use as carriers and extenders.
    ii. An exemption from the requirement of a tolerance for dioxane is 
in 40 CFR 180.1001(d) for dioxane for use as a solvent and cosolvent. 
In the above cited Federal Register Notice, the Agency removed dioxane 
from its list of pesticide product inert ingredients that are currently 
used in pesticide products.
    iii. There are two tolerance exemptions for methylene chloride 
(dichloromethane) for use as a solvent currently in 40 CFR 180.1001(d) 
and (e). The exemption in 40 CFR 180.1001(d) is for a use as a solvent 
and co-solvent. The use in 40 CFR180.1001(e) is as a dispersing and 
wetting agent.
    iv. In 40 CFR 180.1014 there is an exemption from the requirement 
of a tolerance for pentane when used in accordance with good commercial 
practice as an adjuvant in liquid grain fumigants for the fumigation of 
the following grains; barley, corn, oats, popcorn, rice, rye, sorghum 
(milo), wheat.
    v. There are two exemptions from the requirement of a tolerance for 
dimethylformamide. In 40 CFR 180.1001(d), the exemption is for use as a 
solvent and cosolvent with its use limited to preemergence application 
prior to formation of edible parts of food plants, and seed and 
transplant treatment, and also as part of the U.S. Department of 
Agriculture witchweed quarantine program, postemergent application in 
field corn, after silking and tasseling of the corn. The second 
exemption from the requirement of a tolerance exists in 40 CFR 180.1046 
for dimethylformamide for the following two uses:
    a. When used in accordance with good agricultural practices in 
formulations with the fungicide triforine (N,N-[1,4-
piperazinediylbis(2,2,2,-trichloroethylidene)] bis [formamide]) if such 
formulations contain not more than 30 percent dimethylformamide in or 
on the following raw agricultural commodities: almonds, apples, 
apricots, bell peppers, blueberries, cantaloupes, cherries, 
cranberries, cucumbers, eggplants, hops, nectarines, peaches, plums, 
prunes (fresh), strawberries, and watermelons.
    b. When used by the U.S. Department of Interior, Fish and Wildlife 
Service as a solvent for the lamprecide sodium salt of alpha, alpha, 
alpha-trifluoro-4-nitro-meta-cresol or 4-nitro-3-(trifluoromethyl) 
phenol in the Great Lakes.

C. What is the Contribution to Tolerance Reassessment?

    Section 408(q) of FFDCA, as amended by FQPA requires EPA to 
reassess 66% or about 6,400 of the tolerances in existence on August 2, 
1996, by August 2002. This direct final rule revokes 10 tolerance 
exemptions. Therefore, if there are no adverse comments, 120 days after 
publication of the direct final rule, 10 tolerance reassessments will 
be counted toward the August 2002 deadline.

IV. Regulatory Assessment Requirements

    EPA is removing 10 tolerance exemptions that are no longer 
necessary. Since this direct final rule does not impose any new 
requirements, it is not subject to review by the Office of Management 
and Budget (OMB) under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993), Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997), or Executive Order 
13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).
    This direct final rule directly regulates food processors, food 
handlers, and food retailers, but does not affect States, local or 
Tribal governments directly. 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). 
This action will not have substantial direct effects on State or tribal 
governments, on the relationship between the Federal government and 
States or Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and States or Indian 
tribes. As a result, this action does not require any action under 
Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), or under Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Nor does it 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 special considerations under Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994); or Executive Order 12630, entitled Governmental Actions and 
Interference with Constitutionally Protected Property Rights (53 FR 
8859, March 15, 1988).
    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).
    Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), the Agency hereby certifies that these revocations 
will not have significant negative economic impact on a substantial 
number of small entities. The rationale supporting this conclusion is 
as follows. These chemical substances are no longer used in pesticide 
products applied to food and feed commodities. These

[[Page 16030]]

exemptions from the requirement for a tolerance are no longer 
necessary.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 28, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is 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), 346(a) and 374.


Sec. 180.1001  [Amended]

    2. In Sec. 180.1001 by:
    i. Removing from the table in paragraph (d) the entries for 
``benzene'', ``coal (derived only from anthracite and bituminous 
coals)'', ``coke (from anthracite and bituminous coals only and 
petroleum)'', ``dimethylformamide'', ``dioxane'', ``formaldehyde'', and 
``methylene chloride (dichloromethane)''.
    ii. Removing from the table in paragraph (e) the entry for 
``methylene chloride''.


Sec. 180.1014  [Removed]

    3. By removing Sec. 180.1014.


Sec. 180.1046  [Removed]

    4. By removing Sec. 180.1046
[FR Doc. 02-8154 Filed 4-3-02; 8:45 am]
BILLING CODE 6560-50-S