[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Rules and Regulations]
[Pages 42776-42779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20391]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301152; FRL-6793-5]
RIN 2070-AB78


Revocation of Unlimited 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. These exemptions from 
the requirement of a tolerance can be revoked because they are 
duplications. In this direct final rule, the Agency is revoking 
tolerance exemptions for 10 inert ingredients. 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) 21 U.S.C. 346a(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. This regulatory action will 
count for one reassessment toward the August 2002 deadline.

DATES: If no relevant adverse comment is submitted on or before 
September 14, 2001, this action will become effective on November 13, 
2001. If adverse comment is received, EPA will publish a timely 
withdrawal.

ADDRESSES: Adverse 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

[[Page 42777]]

OPP-301152 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: 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; 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 are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       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_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-301152. 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 imperative that 
you identify docket control number OPP-301152 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-301152. Electronic comments may 
also be filed online at many Federal Depository Libraries.

II. Issuance of this Action 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 will not result in any adverse comments. If no 
relevant adverse comment is submitted within 30 days of publication, 
this action will become effective 90 days after publication without any 
further action by the Agency. If, however, a relevant adverse comment 
is received during the comment period, this direct final rule will be 
withdrawn and the public comments received will be addressed in a 
subsequent final rule, or EPA may request additional public comments.
    For the reasons set forth above, EPA believes that it is 
appropriate to issue this rule as a direct final rule. In addition, 
this rule also conforms with the ``good cause'' exemption under section 
553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(B)), 
which allows agencies to issue an action without additional notice and 
comment if further notice and comment would be unnecessary.

III. Background

A. What Action is the Agency Taking?

    On its own initiative, the Agency is amending 40 CFR 180.1001 and 
180.1026 by its intent to revoke exemptions from the requirement of a 
tolerance for 10 inert ingredients that are duplicates. No uses of 
these inert ingredients will be lost as a result of these tolerance 
exemption revocations.
    1. In 40 CFR 180.1026 there is an exemption from the requirement of 
a tolerance for N,N-diallydichloroacetamide (dichlormid) when used as 
an inert ingredient in formulations of the herbicides S-ethyl 
diisobutylthiocarbamate, S-ethyl dipropylthiocarbamate, and S-propyl 
dipropylthiocarbamete when applied to cornfields before the corn plants 
emerge from the soil. The Agency's records indicate that dichormid is 
no longer used with any of these aformentioned active ingredients in 
pesticide products. This action revokes these exemptions. However, 
should any uses remain, they would be covered under the existing

[[Page 42778]]

time-limited tolerances in 40 CFR 180.469 which the Agency established 
on March 27, 2000 (65 FR 16143) (6498-7). These time-limited tolerances 
are for residues of dichlormid (N,N-diallyldichloroacetamide (CAS Reg. 
No. 37764-25-3)) when used as an inert ingredient (safener) in 
pesticide formulations applied to corn commodities before the corn 
plants emerge from the soil in or on the following food commodities: 
corn, field, forage, 0.05 ppm; corn, field, grain, 0.05 ppm; corn, 
field, stover, 0.05 ppm; corn, pop, grain, 0.05 ppm; corn, pop, stover, 
0.05 ppm. These tolerances expire March 27, 2002.
    2. In 40 CFR 180.1001(c) there are two entries for poly(vinyl 
pyrrolidone). One has a molecular weight of 4,000 amu and the other has 
a molecular weight of 40,000 amu. In the Federal Register of August 31, 
1994 (59 FR 44956) (FRL-4906-1), the Agency issued a proposed rule 
which discussed pesticide petition (PP) 4E4308. This petition requested 
to amend 40 CFR 180.1001(c) by revising the then currently listed 
exemption from the requirement of a tolerance for residues of 
poly(vinylpyrrolidone) to lower the molecular weight from 40,000 amu to 
4,000 amu. In the final rule which was published in the Federal 
Register on November 2, 1994 (59 FR 54825) (FRL-4914-1), the Agency 
inadvertently established a new tolerance exemption for poly (vinyl 
pyrrolidone) with a molecular weight of 4,000 amu instead of amending 
the existing tolerance exemption for poly(vinylpyrrolidone) polymers. 
The lower molecular weight polymer tolerance exemption would include 
those with the higher molecular weights. For this reason, this action 
revokes the exemption for poly(vinyl pyrrlidone) of molecular weights 
greater than 40,000 since it is duplicative and therefore not 
necessary.
    3. In 40 CFR 180.1001(e) there are two entries for FD&C Blue No. 1. 
One is specified for use as a dye and the other is specified for use as 
a dye, coloring agent. Since the listing solely as a dye is covered by 
the other FD&C Blue No. 1 entry and is therefore a duplication, this 
action revokes the FD&C Blue No. 1 entry for use as a dye.
    4. An exemption from the requirement of a tolerance for calcium 
hypochlorite for use as a sanitizing and bleaching agent is currently 
listed in both 40 CFR 180.1001(c) and (d). Residues of the inert 
ingredients contained in 40 CFR 180.1001(c) are exempted from the 
requirement of a tolerance when used in pesticide formulations that are 
applied to growing crops or to raw agricultural commodities after 
harvest in accordance with good agricultural practices. 40 CFR 
180.1001(d) exempts residues of the inert ingredients when used in 
pesticide formulations that are applied to growing crops only. This 
action revokes the calcium hypochlorite tolerance exemption in 40 CFR 
180.1001(d), since 40 CFR 180.1001(d) is actually a subset of 40 CFR 
180.1001(c).
    5. There are two entries in 40 CFR 180.1001(d) for diethylene 
glycol. The first entry is limited to use as a ``deactivator for 
formulations used before the crop emerges from soil'' and the second 
entry is limited to use as a ``deactivator, adjuvant for formulations 
used before crop emerges from the soil.'' These entries are 
duplicative. Therefore, this action revokes the diethylene glycol entry 
limited to use as a deactivator for formulations used before crop 
emerges from the soil.
    6. There are duplicate exemptions from the requirement of a 
tolerance for 1,1,1-trichloroethane in 40 CFR 180.1001(e). One is 
limited to presence in formulations not to exceed 25% of the pesticide 
formulation while the other one does not have any limits. This action 
revokes the 1,1,1-trichloroethane exemption limited to exceed 25% of 
the pesticide formulation, since the unlimited tolerance exemption 
includes this limitation.
    7. Exemptions from the requirement of a tolerance for isopropyl 
alcohol are in 40 CFR 180.1001(c) and (d). This action revokes the 
exemption from a requirement of a tolerance in 40 CFR 180.1001(d) for 
isopropyl alcohol since as previously stated 40 CFR 180.1001(d) is a 
subset of 40 CFR 180.1001(c).
    8. There are duplicate exemptions from the requirement of a 
tolerance for n-propanol in 40 CFR 180.1001(c) and (d). The exemption 
from the requirement of a tolerance of n-propanol in 40 CFR 180.1001(c) 
is for use for a solvent and co-solvent. The exemption from the 
requirement of a tolerance for n-propanol in 40 CFR 180.1001(d) is for 
use as a solvent for blended emulsifiers. This action revokes the 
exemption in 40 CFR 180.1001(d) for n-propanol since this use is 
included in 40 CFR 180.1001(c).
    9. There are duplicate exemptions from the requirement of a 
tolerance for epoxidized soybean oil in 40 CFR 180.1001(e). One has the 
use as a stabilizer, while the other has the use as a ``stabilizer, 
plasticizer, component animal tag.'' This action revokes the exemption 
for epoxidized soybean oil with the use as a stabilizer since the use 
as a stabilizer is included in the epoxidized soybean oil exemption 
with uses as a ``stabilizer, plasticizer, and component of animal 
tag.''
    10. Exemptions from the requirement of a tolerance for sodium mono-
di-and tri-isopropyl napthalene sulfonate are in both 40 CFR 
180.1001(c) and (d). This action revokes the exemption from a 
requirement of a tolerance in 40 CFR 180.1001(d) for sodium mono-di-and 
tri-napthalene sulfonate since as previously stated 40 CFR 180.1001(d) 
is a subset of 40 CFR 180.1001(c).

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

    This direct final rule is issued pursuant to section 408(e) of 
FFDCA, 21 U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170). 
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)).

C. 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 direct 
final rule revokes 10 duplicative tolerance exemptions. Therefore, if 
there are no adverse comments, 90 days after publication of the direct 
final rule, one tolerance reassessment (for N,N 
diallydichloroacetamide) will be counted toward the August 2002 review 
deadline of FFDCA section 408(q), as amended by FQPA in 1996. The other 
revoked tolerance exemptions will be counted toward tolerance 
reassessment when the remaining associated tolerance exemption is 
reassessed.

III. Regulatory Assessment Requirements

    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).
    This direct final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et

[[Page 42779]]

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 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 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).
    Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), the Agency hereby certifies that these proposed 
actions to amend/revise Sec. 180.1001(c), (d), and (e) will not have a 
significant negative economic impact on a substantial number of small 
entities. This direct final rule will have no negative impact because 
it merely removes duplicative entries from the EPA regulations listing 
substances exempted from tolerances.
    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 direct final rule does not affect States 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).
    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 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.

IV. 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 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 the rule in the Federal Register. This 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: July 31, 2001.
James Jones,
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 371.

Sec. 180.1001 [Amended]

    2. Section 180.1001 is amended as follows:
    i. The table in paragraph (c) is amended by removing the entire 
entry for Poly (vinyl pyrrolidone); molecular weight (in amu) 40,000 or 
over.
    ii. The table in paragraph (d) is amended by removing the entire 
entry for Calcium hypochlorite; the entire second entry for Diethylene 
glycol; and the entire entries for Isopropyl alcohol; n-Propanol; and 
Sodium mono-, di-, and triisopropyl.
    iii. The table in paragraph (e) is amended by removing the entire 
first entry for Epoxidized soybean oil; the entire first entry for FD&C 
Blue No. 1; and the entire second entry for 1,1,1-trichloroethane.

Sec. 180.1026 [Removed]

    3. Section 180.1026 is removed.
[FR Doc. 01-20391 Filed 8-14-01; 8:45 am]
BILLING CODE 6560-50-S