[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Rules and Regulations]
[Pages 41815-41818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19783]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300868A; FRL-6097-1]
RIN 2070-AB78


Formaldehyde; Revocation of Exemptions from the Requirement of 
Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule announces the revocation of 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. The 
regulatory actions in this notice 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 and exemptions in existence 
on August 2, 1996, by August 1999, or about 3,200 tolerances and 
exemptions. This document revokes 22 exemptions, which will 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: This final rule becomes effective November 1, 1999. Objections 
and requests for hearings, identified by docket control number [OPP-
300868A] must be received by EPA on or before October 1, 1999.

ADDRESSES: Objections and hearing requests can be submitted by mail or 
in person. Please follow the detailed instructions provided in Unit V 
of the SUPPLEMENTARY INFORMATION section of this document. To ensure 
proper identification of your objection or hearing request, you must 
identify the docket control number [OPP-300868A] in the subject line on 
the first page of your request.

FOR FURTHER INFORMATION CONTACT:  For technical 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. 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 Potentially
              Categories                NAICS       Affected Entities
------------------------------------------------------------------------
Industry.............................      111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not exhaustive, but is a guide to entities likely 
to be regulated by this action. The North American Industrial 
Classification System (NAICS) codes will assist you in determining 
whether this action applies to you. If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

II. 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 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 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 technical 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-300868A] (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 Confidential Business 
Information (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.

III. What Action is being Taken?

     This final rule revokes FFDCA exemptions from the requirement of 
tolerances for residues of formaldehyde in or on certain specified 
commodities. EPA is revoking these exemptions from the requirement of 
tolerances because they are not necessary to cover residues of the 
relevant pesticides in or on domestically treated commodities or 
commodities treated outside but imported into the United States. This 
pesticide is no longer used on these commodities within the United 
States and no person has provided comment identifying a need for EPA to 
retain the exemptions to cover residues in or on imported foods. EPA 
has historically expressed a concern that retention of tolerances or 
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. Thus, it is EPA's policy to issue a final 
rule revoking those tolerances for residues of pesticide chemicals for 
which there are no active

[[Page 41816]]

registrations under FIFRA, unless any person, in comments on the 
proposal, demonstrates a need for the tolerance to cover residues in or 
on imported commodities or domestic commodities legally treated.
    In the Federal Register of May 24, 1999 (64 FR 27943) (FRL-6083-3), 
EPA issued a proposed rule announcing the proposed revocation of 
exemptions from the requirement of tolerances, in 40 CFR 180.1032, for 
residues found for formaldehyde. No comments were received by the 
Agency in response to the document published in the Federal Register of 
May 24, 1999.
    Therefore, EPA is revoking the exemptions from the requirement of 
tolerances found in 40 CFR 180.1032 for residues of 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.

IV. When Do these Actions Become Effective?

    These actions become effective 90 days following publication of 
this final rule in the Federal Register. EPA has delayed the 
effectiveness of these revocations for 90 days to ensure that all 
affected parties receive notice of EPA's action. Consequently, the 
effective date is November 1, 1999. For this particular final rule, the 
actions will affect uses which have been canceled for more than a year. 
Therefore, commodities should have cleared the channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticides subject to this notice, and that are in 
the channels of trade following the revocation of exemptions from the 
requirement of tolerances, shall be subject to FFDCA section 408(1)(5), 
as established by the Food Quality Protection Act (FQPA). Under this 
section, any residue of these pesticides 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 tolerance. Evidence to show 
that food was lawfully treated may include records that verify the 
dates that the pesticide was applied to such food.

V. Can I Submit Objections or Hearing Requests?

    Yes. Any person can file written objections to any aspect of this 
regulation and can also request a hearing on those objections. 
Objections and hearing requests are currently governed by the 
procedures in 40 CFR part 178, modified as needed to reflect the 
requirements of FFDCA section 408(g).

A. When and Where to Submit 

    Objections and hearing requests must be mailed or delivered to the 
Hearing Clerk no later than October 1, 1999. The address of the Hearing 
Clerk is: Hearing Clerk (1900), Environmental Protection Agency, Rm. 
M3708, 401 M St., SW, Washington, DC 20460.

B. Fees for Submission

    1. Each objection must be accompanied by a fee of $3,275 or a 
request for waiver of fees. Fees accompanying objections and hearing 
requests must be labeled ``Tolerance Petition Fees'' and forwarded to 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251.
    2. EPA may waive any fee when a waiver or refund is equitable and 
not contrary to the purposes of the Act. A request for a waiver of 
objection fees should be submitted to James Hollins, Information 
Resources and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW, Washington, D.C. 20460. 
The request for a waiver must be accompanied by a fee of $1,650, unless 
the objector has no financial interest in the matter. The fee, if 
required, must be submitted to the address in Unit V.B.1. of this 
document. For additional information on tolerance objection fee 
waivers, contact James Tompkins, Registration Division (7505C), at the 
same mailing address, or by phone at (703) 305-5697 or e-mail at 
[email protected].

 C. Information to be Submitted 

    Objections must specify the provisions of the regulation considered 
objectionable and the grounds for the objections. If a hearing is 
requested, the objections must include a statement of the factual 
issue(s) on which a hearing is requested, the requestor's contentions 
on such issues, and a summary of any evidence relied upon by the 
objector. You may claim information that you submit in response to this 
document as confidential 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.

D. Granting a Hearing Request

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following:
    1. There is a genuine and substantial issue of fact.
    2. There is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary.
    3. Resolution of the factual issue(s) in the manner sought by the 
requestor would be adequate to justify the action requested.

VI. How Do the Regulatory Assessment Requirements Apply to this 
Final Action?

A. Is this a ``Significant Regulatory Action''? 

    No. Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this final action is not a 
``significant regulatory action.'' The Office of Management and Budget 
(OMB) has determined that tolerance actions, in general, 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 final 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 final action is not an economically significant 
regulatory action, as defined by Executive Order 12866. Nonetheless, 
environmental health and safety risks to children are 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 the protection of infants and children, 
unless reliable data supports a different safety factor.

 B. Does this Final Action Contain Any Reporting or Recordkeeping 
Requirements? 

    No. This final 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.).

[[Page 41817]]

 C. Does this Final Action Involve Any ``Unfunded Mandates''? 

    No. This final 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 Final Action 
in this Document? 

    No. Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (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 Office of Management and Budget (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 final rule does not create an unfunded Federal mandate on 
State, local, or tribal governments. The 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 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 final rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This final 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 rule.

E. Does this Final Action Involve Any Environmental Justice Issues?

    No. This action does not involve special considerations 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 Final Action Have a Potentially Significant Impact on a 
Substantial Number of Small Entities?

    No. The Agency has certified that tolerance actions, including the 
tolerance final 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 Final Action Involve Technical Standards? 

    No. This tolerance final 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). 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.

 H. Are There Any International Trade Issues Raised by this Final 
Action? 

    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. The U.S. EPA has developed guidance concerning 
submissions for import tolerance support. This guidance will be made 
available to interested persons.

I. Is this Final Action Subject to Review under the Congressional 
Review Act? 

    Yes. The Congressional Review Act, 5 U.S.C. Sec. 801 et seq., as 
amended 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, 
U.S. House of Representatives, and Comptroller General of the United 
States, prior to publication of the rule in the Federal Register. This 
action 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,

[[Page 41818]]

Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 28, 1999.

Jack E. Housenger,

Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
    Therefore, 40 CFR, part 180, 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), 346a, and 371.


Sec. 180.1032   [Removed]

    2. By removing Sec. 180.1032.

[FR Doc. 99-19783 Filed 7-30-99; 8:45 am]
BILLING CODE 6560-50-F