FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Sulfuryl Fluoride Index Page
Sulfuryl Fluoride (Dow AgroSciences).
February 7, 2002.
Final Rule. Federal Register.
Three-year Experimental Use Permit that allows Dow to use Sulfuryl fluoride
as a fumigant on Raisins and Walnuts. This
permit allows very high tolerances of inorganic fluoride: 30
ppm in or on raisins and 12 ppm
in or on walnuts.
http://www.epa.gov/fedrgstr/EPA-PEST/2002/February/Day-07/p2983.htm
[Federal Register: February 7, 2002 (Volume 67, Number 26)]
[Rules and Regulations]
[Page 5735-5740]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe02-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301166A; FRL-6823-4]
RIN 2070-AC18
Sulfuryl Fluoride; Temporary Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes temporary tolerances for residues
of sulfuryl fluoride and inorganic fluoride in or on walnuts and
raisins. The Agency is establishing these temporary tolerances under
the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996 to support an Experimental Use Permit
(EUP) that involves testing a possible alternative to methyl bromide in
the post-harvest fumigation of stored commodities. This experimental
use fumigant program is being proposed as a methyl bromide alternative
for the post-harvest fumigation of stored walnuts and raisins. These
temporary tolerances will support a 3-year EUP effective between March
1, 2002 through March 1, 2005 and allows 18 months for treated
commodities to clear commerce. The EUP will be conducted by Dow
AgroSciences entirely in the state of California. The temporary
tolerances expire on September 1, 2006. A detailed risk assessment for
the proposed use was published in the Federal Register on September 5,
2001 (66 FR 46415).
DATES: This regulation is effective February 7, 2002. Objections and
requests for hearings, identified by docket control number OPP-301166A,
must be received by EPA on or before April 8, 2002.
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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301166A 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, Ariel Rios Building, 1200 Pennsylvania Ave., NW.,
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:
------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
[[Page 5736]]
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_180/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-301166A. 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,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 5, 2001 (66 FR 46415) (FRL-
6799-6), 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 filing of a pesticide petition (PP) for tolerance by Dow
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. This
proposed rule included a risk assessment of the temporary tolerance
petition and EUP by the Agency.
The petition requested that 40 CFR part 180 be amended by
establishing temporary tolerances for residues of the insecticide
sulfuryl fluoride and its metabolite inorganic fluoride, in or on
walnuts and raisins at 2.0 parts per million (ppm) for sulfuryl
fluoride in or on walnuts; 0.004 ppm for sulfuryl fluoride in or on
raisins; and, 12 ppm for fluoride in or on walnuts.
[Note from FAN: The tolerance for inorganic fluoride on raisins is approved
for 30 ppm which accounts for the fluoride residues from the use of cryolite
on grapes. -See "Sec. 180.145" at the end - highlighted in red. EC]
The proposed temporary tolerances were first published in the Federal Register on
June 15, 2001 (66 FR 32618) (FRL-6788-2)(as the registrant's notice of
filing) and once again on September 5, 2001 (66 FR 46415) with a more
robust, Agency-written risk assessment for residues of sulfuryl
fluoride and the metabolite fluoride in or on walnuts and raisins.
These temporary tolerances will expire on September 1, 2006.
The registrant also submitted a request for an exemption from the
requirement of a tolerance for fluoride residues in or on raisins
resulting from the treatment with the insecticide sulfuryl fluoride
under the USEPA's Threshold of Regulation Policy - Deciding Whether a
Pesticide with a Food Use Pattern Needs a Tolerance. The Agency did not
accept this request for several reasons outlined in the September 5,
2001 proposed rule, the major reason being that current registered uses
of the insecticide cryolite on grapes can result in fluoride residues
in raisins.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Based on these risk assessments presented in the preamble to the
proposed rule, (66 FR 46415, September 15, 2001), and taking into
account the comments on the proposed rule discussed below, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to sulfuryl fluoride and inorganic fluoride residues.
III. Analytical Enforcement Method
Adequate methods of analysis for both sulfuryl fluoride and
fluoride anion are available. The methods are considered adequate as
tolerance enforcement methods for the purposes of these temporary
tolerances during the EUP. For a Section 3 registration, the registrant
will need to submit independent laboratory validations for both the
proposed sulfuryl fluoride and inorganic fluoride methods. For sulfuryl
fluoride, the method consists of blending the sample for 5 minutes in
an air-tight Eberbach blending device, equilibrating the sample for 5
minutes and analyzing 30 ml of headspace from the sample container by
gas chromatography. For fluoride anion, analysis is done by ion-
specific electrodes using a double standard addition procedure. Spike
and recovery data submitted with the request show acceptable recovery
for both sulfuryl fluoride and inorganic fluoride for raisins and
walnuts.
Adequate enforcement methodology is available to enforce the
tolerance expression. The methods may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone
[[Page 5737]]
number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.
IV. Response to Comments
The Agency received 86 written comments, and two individuals called
on the telephone objecting to the proposed tolerances. A few of the
comments were submitted by the same individual twice. Most of the
comments the Agency received concerning establishment of temporary
tolerances for sulfuryl fluoride concern the fluoride tolerances and
issues with fluoride exposure/toxicity. No scientific argument or
rationale related to sulfuryl fluoride exposure/toxicity was received.
A few individuals did state they did not want sulfuryl fluoride used on
food at all because it is a poison. A very large number of comments
came from organizations that have strong concerns about fluoridation of
the water. The debate on water fluoridation has a long history. It is
noteworthy, however, that the Centers for Disease Control and
Prevention lists fluoridation of the drinking water as one of the ten
great public health achievements in the 20th Century. The exposure to
fluoride as a result of the proposed tolerances in or on walnuts and
raisins is insignificant compared to the exposure to fluoride in
drinking water. In addition, tolerances already exist for residues of
fluoride in or on raisins at 7 ppm (expressed as Cryolite) as a result
of using Cryolite to treat grapes for insect control. The Agency
estimates that the proposed use will not significantly increase the
dietary levels of fluoride for the public as a result of consuming
raisins and/or walnuts treated under an EUP.
There have been numerous independent evaluations of the toxicity of
fluoride: U.S. Public Health Service (1991), EPA (1985), National
Academy of Science (NAS) (1998) and Agency for Toxic Substances and
Disease Registry (ASTDR) (1993, draft report 2001). All of these
reviews have indicated that the critical adverse effects, i.e., the
endpoints to regulate, from fluoride ingestion are the effects on bone
and teeth. In consideration of the proposed temporary tolerances for
walnuts and raisins, the Agency used the maximum concentration limit
goal (MCLG) of 4.0 ppm (0.114 mg/kg/day) for fluoride as the basis for
a maximum allowable exposure to inorganic fluoride (see the Cryolite
Reregistration Eligilibility Decision, 8/96, EPA-738-R-96-016). This
exposure was used as the chronic population adjusted dose for inorganic
fluoride in the risk assessment supporting the temporary tolerances.
The exposure to fluoride from this use is estimated to be insignificant
when compared to typical exposures from fluoridated water supplies. In
addition, fluoridation of water has been endorsed by the U.S. Surgeon
General.
Many parties commented on the proposed temporary tolerances
associated with the EUP. They included environmental and public
interest groups, private citizens, foreign nationals, and the
registrant. The comments ranged in specificity. Some commenters
prepared detailed arguments based on exposure and or toxicology. Other
commenters criticized the Agency for even considering establishing
tolerances for fluoride residues on food. These commenters did not seem
to be aware that there have been tolerances for fluoride residues in
food from cryolite use for many years.
Many of the commenters, presumably prompted by one public interest
group as all the letters read the same, requested a time extension to
allow additional time for comments on the proposed use. The Agency
published details concerning the proposed use in July and again in
September 2001. The individual who prompted the letter-writing campaign
requesting the time extension, subsequently stated in a telephone
conversation that the group would not be providing any new information
and that the request for the time extension was so that the Agency
would consider the cumulative exposure from fluoride.
[sic. Presumably that individual was me. While the latter part of this
last sentence is correct, the first part is not. I did provide new
information. I sent Jennifer Luke's PhD thesis on fluoride's impact
on the pineal gland to EPA's Dennis McNeilly to allow EPA scientists
to consider fluoride's potential for adverse impacts. - Ellen Connett]
The Agency already has sufficient information to conduct a risk assessment for
sulfuryl fluoride use on walnuts and raisins, including cumulative
exposures to fluoride, and therefore no additional time extension for
comments was granted.
The comments can be grouped into seven basic areas of concern and
each section below contains a summary of the commenters concerns
grouped by that general topic.
1. Issue #1. Several commenters raised concerns that the Agency had
not used all available data in making its safety finding. In
particular, one commenter discussed the results of a study published in
1998 that evaluated exposure to inorganic fluoride compounds and
suggested that the Agency utilize this information before issuing the
EUP for sulfuryl fluoride.
Agency response to issue #1. Most of the studies cited in the
comment were studies outlined in the Notice of Filing and the Proposed
Rule published on June 15, 2001 and September 5, 2001, respectively.
The Agency has included all of the results of these studies in its risk
assessment for the use of sulfuryl fluoride for post-harvest fumigation
of walnuts and raisins. The commenters raise concerns about the
toxicological findings in these studies. The Agency believes that it is
important to remember that the objective of the toxicological testing
is to define no observed adverse effect levels and lowest observed
adverse effect levels for the chemical being evaluated. The Agency has
taken all of these studies into account and believes that the
toxicological endpoints chosen by the Agency in its risk assessment are
sufficiently protective of human health.
The commenters do reference new information not considered as part
of the Agency's risk assessment. In particular, one commenter suggested
that the Agency incorporate the results of a study entitled ``Chronic
Administration of Aluminum-Fluoride or Sodium Fluoride to Rats in
Drinking Water: Alterations in Neuronal and Cerebrovascular
Integrity'', published in the publication Brain Research in 1998. One
of the co-authors of this study is an Agency employee who has indicated
that the experiment discussed was designed to explore a specific
hypothesis and that the results are not directly applicable to making
conclusions about effects of aluminum or fluoride on public health. In
addition, the study co-author has indicated that the results of the
study do not support a conclusion that aluminum or fluoride selectively
damage the brain or that these compounds cause Alzheimer's Disease.
Therefore, at this time, the results of this study are not considered
significant from the standpoint of establishing the tolerances proposed
in the Agency's September 5, 2001, proposed rulemaking.
The other health concerns raised by the commenters have already
been addressed by the Agency in other rulemakings or in responses to
Members of Congress concerning exposure to fluoride. Included in the
docket for this rulemaking is a copy of a letter, dated September 5,
2000, from J. Charles Fox, EPA Assistant Administrator, Office of
Water, to Congressman Ken Calvert, Chairman of the Subcommittee on
Energy and the Environment, Committee on Science. The Agency believes
that this letter addresses the remaining health effects issues raised
by the commenters.
2. Issue #2. Many commenters expressed concerns about the potential
for over exposure to fluoride, specifically to children. Commenters
mentioned exposures through dental product use, fluoridated water, and
fluoride exposures from the use of other pesticides.
Agency response to issue #2. A requirement of the FQPA is that the
[[Page 5738]]
Agency consider all non-occupational exposures to a pesticide or
substance when establishing new or reassessing tolerances for that
pesticide. In conducting its risk assessment, the Agency assumed that
all walnuts and raisins grown in the United States would be treated
with sulfuryl fluoride, even though the accompanying EUP would
significantly limit the use of sulfuryl fluoride to a small fraction of
the total U.S. walnut and raisin crops. The Agency believes that its
risk assessment accounts for the other concerns raised. The Dietary
Exposure Examination Model (DEEM) includes data evaluating the food
consumption patterns of children, including their consumption of
walnuts and raisins. The risk assessment also includes analysis that
neither raisins nor walnuts are typically washed before these foods are
eaten. Regarding exposure to fluoride via dental products, the Agency
believes that warning labels on these products provide explicit
direction on how to significantly limit dietary exposure to fluoride-
containing dental products for children. Regarding other exposures, the
Agency's risk assessment includes exposures from the ingestion of
fluoridated drinking water and fluoride exposures from the use of other
pesticides, specifically cryolite. The Agency discussed these
considerations at great length in its proposed rule of September 5,
2001.
3. Issue #3. One commenter expressed concern that the U.S. Food and
Drug Administration (FDA) has not approved the use of sulfuryl fluoride
on walnuts and raisins.
Agency response to issue #3. Both FDA and EPA share authority for
implementation of the FFDCA. However, in establishing tolerances for
pesticide residues on food, Congress explicitly delegated this
authority to EPA. FDA does not approve or evaluate pesticide uses. FDA
does have responsibility for monitoring the levels of pesticides
residues in the food supply, however.
4. Issue #4. A commenter raised concern that the proposed tolerance
did not include a discussion of the economic impacts of the proposed
tolerances. In particular, the commenter discussed a recent ruling by
the European Community regarding fluoride residues in wine grapes.
Agency response to issue #4. The FQPA of 1996 does not allow the
Agency to consider the economic impacts of its decisions when
establishing tolerances for pesticide residues. In this specific case,
however, the commenter raises issues associated with wine grapes that
are not the subject of this rulemaking.
5. Issue #5. Many commenters expressed concerns about drinking
water being treated with fluoride.
Agency response to issue #5. The Agency has evaluated these
concerns as part of its prior rulemakings setting the standard for the
level of fluoride in drinking water. The Agency's Office of Water has
taken these concerns into account. Furthermore, the Surgeon General has
also evaluated the Agency's drinking water standard and has determined
that the level of fluoride allowed in drinking water is safe. In
addition, the Agency's risk assessment for sulfuryl fluoride includes
exposures of fluoride resulting from the consumption of treated
drinking water and it, too, concludes that the level of exposure is
safe.
6. Issue #6. The registrant raised concerns about the need for a
developmental neurotoxicity study to evaluate certain effects
associated with exposure to sulfuryl fluoride.
Agency response to issue #6. The Agency has determined that this
study is not needed to evaluate potential risks associated with the
proposed EUP. However, as a requirement for unconditional registration
of this product under the Federal Insecticide, Fungicide, and
Rodenticide Act, the Agency believes that the developmental
neurotoxicity study is warranted. The Agency is requiring this study
because of the observation of treatment-related neurotoxic lesions in
rats, mice, dogs and rabbits.
V. 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-301166A 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 April 8,
2002.
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, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, 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
[[Page 5739]]
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, 1200 Pennsylvania Ave., NW.,
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, 1200 Pennsylvania
Ave., NW., 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 VI.A., 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. Mail your
copies, identified by docket control number OPP-301166A, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-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 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).
VI. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning RegulationsThat Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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 itrequire any 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). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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 onthe
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
thathave 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
growers, foodprocessors, 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). 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 withIndian 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 ofpower
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.
VII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801et seq., asadded by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
[[Page 5740]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 29, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.145 is amended by adding paragraph (a)(3) to read as
follows:
Sec. 180.145 Fluoride compounds; tolerances for residues.
(a) * * *
(3) Temporary tolerances are established for residues of fluoride
resulting from the post-harvest treatment with sulfuryl fluoride. The
tolerances are measured and expressed as ppm of fluoride. Total
residues of fluoride in or on raisins from the use of cryolite on
grapes, addressed in paragraph (a)(1) of this section, or sulfuryl
fluoride on raisins shall not exceed the tolerance list in the
following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Raisins.................... 30.0 9/1/06
Walnuts........................... 12.0 9/1/06
------------------------------------------------------------------------
* * * * *
3. Section 180.575 is added to read as follows:
Sec. 180.575 Sulfuryl fluoride; tolerances for residues.
(a) General. Temporary tolerances are established for residues of
sulfuryl fluoride from the post-harvest treatment with sulfuryl
fluoride on the following food commodities.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Raisins........................... 0.004 9/1/06
Walnuts........................... 2.0 9/1/06
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
[FR Doc. 02-2983 Filed 2-6-01; 8:45 am]
BILLING CODE 6560-50-S