[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Rules and Regulations]
[Pages 5735-5740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2983]


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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: [email protected].

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 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. 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: [email protected].

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. 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 
[email protected], 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: [email protected]. 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