[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Proposed Rules]
[Pages 27943-27947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13056]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300868; FRL-6083-3]
RIN 2070-AC18


Formaldehyde; Proposed Revocation of Exemptions from the 
Requirement of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke exemptions from the 
requirement of tolerances for residues found in 40 CFR 180.1032 for 
formaldehyde or a mixture of methylene bispropionate and 
oxy(bismethylene) bispropionate in or on the grains of barley, corn, 
oats, sorghum, and wheat and the forages of alfalfa, bermuda grass, 
bluegrass, brome grass, clover, cowpea hay, fescue, lespedeza, lupines, 
orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan 
grass, timothy, and vetch from postharvest application use as a 
fungicide to treat animal feeds. This action is being taken because 
there are no registered uses for formaldehyde on these commodities. EPA 
expects to determine whether any individuals or groups want to support 
these exemptions. The regulatory actions in this proposal are part of 
the Agency's reregistration program under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment 
requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA). By 
law, EPA is required to reassess 33% of the tolerances in existence on 
August 2, 1996, by August 1999, or about 3,200 tolerances. The 
regulatory actions proposed in this document pertain to the proposed 
revocation of 22 exemptions, which would be counted among reassessments 
made toward the August 1999 review deadline of FFDCA section 408(q), as 
amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: Comments must be received on or before July 23, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit IV. of this proposal.

FOR FURTHER INFORMATION CONTACT: Phil Budig, Special Review Branch 
(7508C), Special Review and Reregistration Division, Office of 
Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location: Special Review Branch, CM 
#2, 6th floor, 1921 Jefferson Davis Hwy., Arlington, VA, Telephone: 
(703) 308-8029; e-mail: [email protected].
SUPPLEMENTARY INFORMATION:

I. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required to reassess 33% of the tolerances in 
existence on August 2, 1996, by August 1999, or about 3,200 tolerances. 
As of March 1999, EPA has reassessed over 2,400 tolerances. The 
regulatory actions proposed in this document pertain to the proposed 
revocation of 22 exemptions, which count toward the August 1999 review 
deadline of FFDCA section 408(q), as amended by the Food Quality 
Protection Act (FQPA) of 1996.

II. Does This Proposal Apply To Me?

    You may be affected by this proposal if you sell, distribute, 
manufacture, or use pesticides for agricultural applications, process 
food, distribute or sell food, or implement governmental pesticide 
regulations. Pesticide reregistration and other actions (see FIFRA 
section 4(g)(2)) include tolerance and exemption reassessment under 
FFDCA section 408. Potentially affected categories and entities may 
include, but are not limited to:

[[Page 27944]]



 
------------------------------------------------------------------------
                                               Examples of Potentially
                 Category                         Affected Entities
------------------------------------------------------------------------
Agricultural stakeholders                   Growers/agricultural
                                             workers, contractors
                                             (certified/commercial
                                             applicators, handlers,
                                             advisors, etc.), commercial
                                             processors, pesticide
                                             manufacturers, user groups,
                                             food consumers
------------------------------------------------------------------------
Food distributors                           Wholesale contractors,
                                             retail vendors, commercial
                                             traders/importers
------------------------------------------------------------------------
Intergovernmental stakeholders              State, Local, and/or Tribal
                                             government agencies
------------------------------------------------------------------------
Foreign entities                            Governments, growers, trade
                                             groups
------------------------------------------------------------------------

    This table 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. If you have any questions regarding the applicability of this 
action to a particular entity, you can consult with the person listed 
in the ``FOR FURTHER INFORMATION CONTACT'' section.

III. How Can I Get Additional Information or Copies of This or 
Other Support Documents?

A. Electronically

    You may obtain electronic copies of this document and various 
support documents from the EPA Internet Home Page at http://
www.epa.gov. On the Home Page, select ``Laws and Regulations,'' and 
then look up the entry for this document under ``Federal Register - 
Environmental Documents.'' You can also go directly to the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr.

B. In Person or by Phone

    If you have any questions or need additional information about this 
action, please contact the person identified in the ``FOR FURTHER 
INFORMATION CONTACT'' section. In addition, the official record for 
this notice, including the public version, has been established under 
docket control number OPP-300868, (including comments and data 
submitted electronically as described below). A public version of this 
record, including printed, paper versions of any electronic comments, 
which does not include any information claimed as CBI, is available for 
inspection in Room 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 Public Information and Records Integrity 
Branch telephone number is (703) 305-5805.

IV. How Can I Respond To This Notice?

A. How and To Whom Do I Submit Comments To?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number (i.e., ``OPP-300868'') in your correspondence.
    1. By mail. Submit written comments, identified by the docket 
control number, OPP-300868, to: Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 
M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments, identified by 
the docket control number, OPP-300868, to: Public Information and 
Records Integrity Branch, Office of Pesticide Programs, U.S. 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    3. Electronically. Submit your comments and/or data electronically 
by E-mail to: [email protected]. Do not submit any information 
electronically that you consider to be Confidential Business 
Information (CBI). Submit electronic comments in ASCII file format, 
avoiding the use of special characters and any form of encryption. 
Comment and data will also be accepted on standard computer disks in 
WordPerfect 5.1/6.1 or ASCII file format. All comments and data in 
electronic form must be identified by the appropriate docket control 
number, OPP-300868. You may also file electronic comments and data 
online at many Federal Depository Libraries.

B. How Should I Handle CBI Information In My Comments?

    You may claim information you submit 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. 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. If you have any questions about CBI 
or the procedures for claiming CBI, please consult with the person 
identified in the ``FOR FURTHER INFORMATION CONTACT'' section.

V. What Is A ``Tolerance''?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals in or on raw agricultural commodities and processed 
foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the 
FQPA of 1996, Public Law 104-170, authorizes the establishment of 
tolerances (maximum residue levels), 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 (21 U.S.C. 346(a)). Without a tolerance 
or 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 considered to be 
``adulterated,'' you cannot distribute the product in interstate 
commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be 
sold and distributed, the pesticide must not only have appropriate 
tolerances under the FFDCA, but also must be registered under section 3 
of FIFRA (7 U.S.C. et seq.). To retain these tolerances and exemptions, 
EPA must make a finding that the tolerances and exemptions are safe. To 
make this safety finding, EPA needs data and information indicating 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide residues covered by the tolerances 
and exemptions.
    Monitoring and enforcement of pesticide tolerances and exemptions 
are carried out by the U.S. Food and Drug Administration (FDA) and the 
U.S. Department of Agriculture (USDA). This includes monitoring for 
pesticide residues in or on commodities imported into the United 
States.

VI. Why Is EPA Proposing the Tolerance Actions Discussed Below?

    EPA is proposing to revoke exemptions from the requirement of 
tolerances for residues of formaldehyde on commodities listed in 40 CFR 
180.1032 because no active registrations exist for these uses. None of 
these commodities have been on an active formaldehyde label since 1994.
    It is EPA's general practice to propose revocation of tolerances 
and tolerance exemptions for residues of pesticide active ingredients 
on crop uses for

[[Page 27945]]

which FIFRA registrations no longer exist. EPA has historically 
expressed a concern that retention of tolerances and exemptions that 
are not necessary to cover residues in or on legally treated foods has 
the potential to encourage misuse of pesticides within the United 
States. However, in accordance with FFDCA section 408, EPA will not 
revoke any tolerance or exemption proposed for revocation if any person 
demonstrates a need for the retention of the tolerance, and if 
retention of the tolerance will meet the tolerance standard established 
under FQPA. Generally, interested parties support the retention of such 
tolerances and exemptions in order to permit treated commodities to be 
legally imported into the United States, since raw agricultural 
commodities or processed food or feed commodities containing pesticide 
residues not covered by a tolerance or exemption are considered to be 
adulterated.
    Tolerances and exemptions established for pesticide chemicals with 
FIFRA registrations cover residues in or on both domestic and imported 
commodities. To retain these tolerances and exemptions, EPA must make a 
finding that the tolerances and exemptions are safe. To make this 
safety finding, EPA needs data and information indicating that there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide residues covered by the tolerances and exemptions.
    To assure that all food marketed in the U.S. is safe, under FFDCA, 
EPA requires the same technical chemistry and toxicology data for such 
import tolerances (tolerances without related U.S. registrations) as 
are required to support U.S. food use registrations and any resulting 
tolerances. In addition, EPA requires residue chemistry data (crop 
field trials) that are representative of growing conditions in 
exporting countries in the same manner that EPA requires representative 
residue chemistry data from different U.S. regions to support domestic 
use of the pesticide and tolerance. Interested parties should contact 
EPA for written guidance on adapting U.S. residue chemistry data 
requirements to non-U.S. growing conditions in order to support an 
import tolerance.

VII. Which Pesticides Are Covered By This Action?

    Formaldehyde is an antimicrobial fungicide and germicide used as a 
non-food disinfect.

VIII. What Action Is Being Taken?

    EPA is proposing to revoke exemptions from the requirement of 
tolerances established under section 408 of FFDCA for residues of 
formaldehyde in or on the grains of barley, corn, oats, sorghum, and 
wheat, and the forages of alfalfa bermuda grass, bluegrass, brome 
grass, clover, cowpea hay, fescue, lespedeza, lupines, orchard grass, 
peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, 
and vetch from postharvest application of formaldehyde or a mixture of 
methylene bispropionate and oxy(bismethylene) bispropionate when used 
as a fungicide. These exemptions apply only to use of the exempted 
tolerances as animal feeds. The Agency is proposing to revoke the 
exemptions for formaldehyde by removing 40 CFR 180.1032.

IX. When Do These Actions Become Effective?

    EPA proposes that these actions become effective 90 days following 
publication of a final rule in the Federal Register. EPA is proposing 
the effective date because EPA believes that, by the date, all existing 
stocks of pesticide products labeled for uses associated with the 
tolerances proposed for revocation will have been exhausted for more 
than 1 year, giving ample time for any treated products to clear trade 
channels. None of these commodities have been on an active formaldehyde 
label since 1994. Therefore, EPA believes the effective date proposed 
in this document--90 days following publication of the final rule--
should be reasonable. However, if EPA is presented with information 
that there would be existing stocks still available for use after the 
expiration date and that the information is verified, EPA will consider 
extending the expiration date of the tolerance. If you have comments 
regarding existing stocks, please submit comments as described in Unit 
IV. of this proposal.
    Any commodities listed in this document that are treated with the 
pesticide subject to this proposal, and are in the channels of trade 
following the tolerance revocations, shall be subject to FFDCA section 
408(1)(5), as established by FQPA. Under this section, any residue of 
the pesticide in or on such food shall not render the food adulterated 
so long as it is shown to the satisfaction of FDA that, (1) the residue 
is present as the result of an application or use of the pesticide at a 
time and in a manner that was lawful under FIFRA, and (2) the residue 
does not exceed the level that was authorized at the time of the 
application or use to be present on the food under a tolerance or 
exemption from a tolerance. Evidence to show that food was lawfully 
treated may include records that verify the dates the pesticide was 
applied to such food.

X. What Can I Do If I Wish the Agency to Maintain a Tolerance that 
the Agency Proposes to Revoke?

    In addition to submitting comments in response to this proposal, 
you may also submit an objection. EPA subsequently issues a final rule 
after considering the comments that are submitted in response to this 
proposal. If you fail to file an objection to the final rule within the 
time period specified, you will have waived the right to raise any 
issues resolved in the final rule. After the specified time, issues 
resolved in the final rule cannot be raised again in any subsequent 
proceedings.
    This proposed rule provides a comment period of 60 days for any 
interested person to demonstrate a need for retaining a tolerance, if 
retention of the tolerance will meet the tolerance standard established 
under FQPA. If EPA receives a comment to that effect, EPA will not 
proceed to revoke the tolerance immediately. However, EPA will take 
steps to ensure the submission of any needed supporting data and will 
issue an order in the Federal Register under FFDCA section 408(f), if 
needed. The order would specify the data needed and time frames for its 
submission, and would require that within 90 days some person or 
persons notify EPA that they will submit the data. If the data are not 
submitted as required in the order, EPA will take appropriate action 
under FIFRA or FFDCA.

XI. How Do the Regulatory Assessment Requirements Apply to This 
Action?

A. Is This a Significant Regulatory Action Involving Health and Safety 
Risks To Children?

    No. Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action.'' The Office of Management and Budget 
(OMB) has determined that, in general, tolerance actions are not 
``significant'' unless the action involves the revocation of a 
tolerance that may result in a substantial adverse and material affect 
on the economy. In addition, this proposed action is not subject to 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997), because this action is not an economically significant 
regulatory action, as defined by Executive Order 12866. Nonetheless, 
environmental health and safety risks to children are

[[Page 27946]]

considered by the Agency when determining appropriate tolerances. Under 
FQPA, EPA is required to apply an additional 10-fold safety factor to 
risk assessments, in order to ensure protection of infants and 
children, unless reliable data support a different safety factor.

B. Does This Proposed Action Contain Any Reporting or Recordkeeping 
Requirements?

    No. This proposed action does not impose any information collection 
requirements, subject to OMB review or approval, pursuant to the 
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

C. Does This Proposed Action Involve Any ``Unfunded Mandates''?

    No. This proposed action does not impose any enforceable duty, or 
contain any ``unfunded mandates,'' as described in Title II of the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

D. Do Executive Orders 12875 and 13084 Require EPA to Consult With 
States and Indian Tribal Governments Prior To Taking the Action in This 
Proposed Document?

    No. Under Executive Order 12875, entitled Enhancing 
Intergovernmental Partnerships (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to the OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's proposed rule does not create an unfunded Federal mandate 
on State, local, or tribal governments. The proposed rule does not 
impose any enforceable duties on these entities. Accordingly, the 
requirements of section 1(a) of Executive Order 12875 do not apply to 
this proposed rule.
    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this proposed rule.

E. Does This Action Involve Any Environmental Justice Issues?

    No. This proposed rule does not involve special consideration of 
environmental justice-related issues pursuant to Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

F. Does This Proposed Action Have a Potentially Significant Impact on a 
Substantial Number of Small Entities?

    No. The Agency has certified that tolerance actions, including the 
proposed tolerance actions in this document, are not likely to result 
in a significant adverse economic impact on a substantial number of 
small entities. The factual basis for the Agency's determination, along 
with its generic certification under section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), appears at 63 FR 55565, 
October 16, 1998 (FRL-6035-7). This generic certification has been 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

G. Does this Proposed Action Involve Technical Standards?

    No. This proposed tolerance 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), Pubic Law 104-
113, Section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to 
use voluntary consensus standards in its regulatory activities, unless 
to do so would be inconsistent with applicable law or otherwise 
impractical. Voluntary consensus standards are technical standards 
(e.g., materials specifications, test methods, sampling procedures, 
business practices, etc.) that are developed or adopted by voluntary 
consensus standards bodies. The NTTAA requires EPA to provide Congress, 
through OMB, explanations when the Agency decides not to use available 
and applicable voluntary consensus standards. EPA invites public 
comment on this conclusion.

H. Are There Any International Trade Issues Raised By This Action?

    These proposed revocations will not become final if comments are 
received which demonstrate the need to maintain the tolerance to cover 
residues in or on imported commodities. However, data must be submitted 
supporting the continued tolerance. EPA is working to ensure that the 
U.S. tolerance reassessment program under FQPA does not disrupt 
international trade. EPA considers Codex Maximum Residue Limits (MRLs) 
in setting U.S. tolerances and in reassessing them. MRLs are 
established by the Codex Committee on Pesticide Residues, a committee 
within the Codex Alimentarius Commission, an international organization 
formed to promote the coordination of international food standards. 
When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain in a Federal 
Register document the reasons for departing from the Codex level. EPA's 
effort to harmonize with Codex MRLs is summarized in the tolerance 
reassessment section of individual REDs. EPA is developing a guidance 
concerning submissions for import tolerance support. This guidance will 
be made available to interested parties.

[[Page 27947]]

I. Is This Proposed Action Subject to Review Under the Congressional 
Review Act?

    No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) of 
the Administrative Procedure Act (APA), as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Title II of 
Public Law 104-121, 110 Stat. 847), only final rules must be submitted 
to the U.S. Senate, U.S. House of Representatives, and Comptroller 
General of the United States prior to publication in the Federal 
Register.

List of Subjects in 40 CFR Part 180

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

    Dated: May 18, 1999.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 be amended to read 
as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

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

Sec. 180.1032 [Removed]

    2. By removing Sec. 180.1032.

[FR Doc. 99-13056 Filed 5-21-99; 8:45 am]
BILLING CODE 6560-50-F