[Federal Register Volume 64, Number 249 (Wednesday, December 29, 1999)]
[Rules and Regulations]
[Pages 72947-72951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33332]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300961; FRL-6484-8]
RIN 2070-AB78
Phosphine; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Tolerances are being revised and consolidated for residues of
phosphine in or on certain agricultural commodities and animal feeds.
None of these tolerances are new, although the change will facilitate
new application methods. The Agency is merely changing the tolerance
expression to eliminate references concerning how the phosphine is
generated. The Agency published a detailed discussion of the change in
the tolerance expression, including a risk assessment, on June 9, 1999,
as a proposed rule.
DATES: This regulation is effective December 29, 1999. Objections and
requests for hearings, identified by docket control number OPP-300961,
must be received by EPA on or before February 28, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit III. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300961 in
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 308-6742; and e-mail address: McNeilly.Dennis@epa.gov.
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:
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Examples of
Categories NAICS Potentially
Affected Entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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 in the ``FOR FURTHER INFORMATION
CONTACT'' section.
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'' 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/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300961. 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 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,
[[Page 72948]]
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 9, 1999 (64 FR 30939) (FRL-6082-4),
EPA issued a proposed rule pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing
the revision of phosphine tolerances to eliminate references as to how
the gas is generated and consolidating the tolerances for phosphine in
40 CFR 180.225. The proposed rule included a detailed discussion of the
proposed change prepared by the Agency. The Agency completed the
Reregistration Eligibility Decision (RED) for Aluminum and Magnesium
Phosphide in December 1998 (EPA 738-R-98-017). That risk assessment
evaluated the acute and chronic risk from dietary exposure to phosphine
residues. For the reasons stated in the proposed rule, EPA concludes
that modifying the phosphine tolerance as described above will be safe.
EPA received several minor comments on the proposed rule and those
comments are addressed below. EPA has made minor changes to the
language in the tolerance regulation to clarify EPA's intent.
1. Comment. Several individuals pointed out a typographical error
in the listing of the tolerance for phosphine in or on animal feed. The
existing aluminum phosphide and magnesium phosphide tolerances for
animal feeds was incorrectly listed as 0.01 ppm rather than the actual
value of 0.1 ppm.
Response. The existing tolerances for residues of phosphine in or
on animal feeds from fumigation with aluminum phosphide or magnesium
phosphide is 0.1 ppm (40 CFR 186.200 and 40 CFR 186.3800). Tolerances
will be consolidated into a new 40 CFR 180.225, the tolerance level
published in this final rule remains unchanged, i.e., remains at the
0.1 ppm level. The Agency does note that the tolerance is associated
with the requirement to aerate fumigated finished feed for 48 hours
before use. The Agency is not modifing this restriction and it will
remain in effect unless data are provided indicating some other time
interval is more appropriate for any new products or new application
method. The 48-hour aeration interval is appropriate for all currently
registered products; however, in the future other products may apply
phosphine gas in a different manner from the existing technology and
any limitations or guidance to ensure that tolerances are not exceeded
will be provided on the products labels.
2. Comment. Legume vegetables (succulent or dried - excluding
soybeans) are listed in the proposed tolerances under raw agricultural
commodities (RACs). The present listing specifies vegetables, seed and
pod (except soybeans). Are these listings equivalent?
Response. The new listing ``Legume vegetables (succulent or dried -
excluding soybeans)'' is equivalent to the previous tolerance listing
with the exception that it does not include dill and okra. Therefore,
tolerances for these two commodities dill and okra are added to 40 CFR
180.225 to make the transition equivalent. The additional tolerances
for dill and okra do not change existing cultural practice or the
dietary exposure of the U.S. population or any population subgroup to
phosphine.
3. Comment. It has been suggested that residues from zinc phosphide
be included in this tolerance expression.
Response. The Agency considered this but decided that the use
patterns of this rodenticide is significantly different from the
fumigation uses of phosphine gas and therefore any residues from that
type of use are not specifically included in this tolerance document.
In addition, separate REDs were prepared for these very different
formulations and use patterns. Aluminum and magnesium phosphide were
also evaluated together in the same RED, while zinc phosphide was
evaluated in a separate RED.
4. Comment. Under RACs, the tolerance for coffee, bean, green is
listed as 0.1 ppm. What is the tolerance for roasted coffee beans? The
tolerance as presently written does not distinguish between the green
and roasted beans.
Response. The Agency revised tolerance nomenclature to avoid
ambiguity. The previous tolerance was for ``beans, coffee'' while the
new definition makes it clear that the tolerance is for ``Coffee,
beans, green.'' Unless processed commodities have different tolerances,
the established tolerance for the RAC applies, in this case 0.1 ppm. A
similar comment/question was also asked concerning cottonseed, i.e.
what is the tolerance for delinted cottonseed? The new listing is for
``cotton, seed, undelinted.'' Once again, unless a tolerance is
established for a processed commodity the tolerance for the commodity's
RAC applies, in this case the tolerance for ``cotton, seed,
undelinted'' which is 0.1 ppm. As stated in the summary, this rule
eliminates references as to how the phosphine gas is generated, no
tolerance levels are changed in this rule.
III. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300961 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before February
28, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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 (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed 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. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also
[[Page 72949]]
deliver your request to the Office of the Hearing Clerk in Room M3708,
Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the
Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Office of the
Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit III.A. of
this preamble, you should also send a copy of your request to the PIRIB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300961, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. of this preamble. You
may also send an electronic copy of your request via e-mail to: docket@epa.gov. Please use an ASCII file format and avoid the use of
special characters and any form of encryption. Copies of electronic
objections and hearing requests will also be accepted on disks in
WordPerfect 6.1/8.0 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; 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; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
IV. Regulatory Assessment Requirements
This final rule establishes a new tolerance expression for
phosphine under section 408(d) of the FFDCA. The Office of Management
and Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 13084, entitled
Consultation and Coordination with Indian Tribal Governments (63 FR
27655, May 19, 1998), or special consideration of environmental justice
related issues 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 require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note).
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 final rule directly regulates fumigators, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact entities and concluded, as
a generic matter, that there is no adverse economic impact. The factual
basis for the Agency's generic certification for tolerance actions
published on May 4, 1981 (46 FR 24950), and was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
V. 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 rule in the Federal Register. This rule is not
a ``major rule'' as defined by 5 U.S.C. 804(2).
[[Page 72950]]
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: December 17, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
b. Section 180.225 is revised to read as follows:
Sec. 180.225 Phosphine; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
phosphine in or on the following raw agricultural commodities (RACs)
resulting from post-harvest fumigation for the control of insects with
phosphine gas or phosphide compounds that produce phosphine gas.
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Commodity Parts per million
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Almond........................................................... 0.1
Avocado.......................................................... 0.01
Banana (includes Plantains)...................................... 0.01
Barley, grain.................................................... 0.1
Brazil nut....................................................... 0.1
Cabbage, Chinese................................................. 0.01
Cacao bean, dried bean........................................... 0.1
Cashew........................................................... 0.1
Citrus citron.................................................... 0.01
Coffee, bean, green.............................................. 0.1
Corn, field, grain............................................... 0.1
Corn, pop, grain................................................. 0.1
Cotton, undelinted seed.......................................... 0.1
Date, dried fruit................................................ 0.1
Dill, seed....................................................... 0.01
Eggplant......................................................... 0.01
Endive........................................................... 0.01
Filbert.......................................................... 0.1
Grapefruit....................................................... 0.01
Kumquat.......................................................... 0.01
Legume vegetables (succulent or dried group, excluding soybeans). 0.01
Lemon............................................................ 0.01
Lettuce.......................................................... 0.01
Lime............................................................. 0.01
Mango............................................................ 0.01
Millet, grain.................................................... 0.1
Mushroom......................................................... 0.01
Oat, grain....................................................... 0.1
Okra............................................................. 0.01
Orange........................................................... 0.01
Papaya........................................................... 0.01
Peanut........................................................... 0.1
Pecan............................................................ 0.1
Pepper........................................................... 0.01
Persimmon........................................................ 0.01
Pimento.......................................................... 0.01
Pistachio........................................................ 0.1
Rice, grain...................................................... 0.1
Rye, grain....................................................... 0.1
Safflower, seed.................................................. 0.1
Salsify tops..................................................... 0.01
Sesame, seed..................................................... 0.1
Sorghum, grain................................................... 0.1
Soybean, seed.................................................... 0.1
Sunflower, seed.................................................. 0.1
Sweet potato..................................................... 0.01
Tangelo.......................................................... 0.01
Tangerine........................................................ 0.01
Tomato........................................................... 0.01
Walnut........................................................... 0.1
Wheat, grain..................................................... 0.1
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[[Page 72951]]
(2) Tolerances are established for residues of the fumigant in or
on all RACs resulting from preharvest treatment of pest burrows in
agricultural and non-crop land areas.
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Commodity Parts per million
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All RACs resulting from preharvest treatment of pest 0.01
burrows.............................................
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(3) Residues resulting from fumigation of processed foods:
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Commodity Parts per million
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Processed foods...................................... 0.01
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(4) Residues resulting from fumigation of animal feeds:
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Commodity Parts per million
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Animal feeds......................................... 0.1
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(5) To assure safe use of this pesticide, it must be used in
compliance with the labeling conforming to that registered by the U.S.
Environmental Protection Agency (EPA) under FIFRA. Labeling shall bear
a restriction to aerate the finished food/feed for 48 hours before it
is offered to the consumer, unless EPA specifically determines that a
different time period is appropriate. Where appropriate, a warning
shall state that under no condition should any formulation containing
aluminum or magnesium phosphide be used so that it will come in contact
with any processed food, except processed brewer's rice, malt, and corn
grits stored in breweries for use in the manufacture of beer.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
Sec. 180.375 [Removed]
b. Section 180.375 is removed.
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.200 [Removed]
b. Section 185.200 is removed.
Sec. 185.3800 [Removed]
c. Section 185.3800 is removed.
PART 186--[AMENDED]
3. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 371.
Sec. 186.200 [Removed]
b. Section 186.200 is removed.
Sec. 186.3800 Removed
c. Section 186.3800 is removed.
[FR Doc. 99-33332 Filed 12-28-99; 8:45 am]
BILLING CODE 6560-50-F
