Document ID: EPA-HQ-OPP-2005-0174-0249
Agency: epa
Document Type: Proposed Rule
Title: Proposed Order Granting Objections to Tolerances and Denying Requests for a Stay: Sulfuryl Fluoride; Second Request for Comment
Posted Date: 2012-05-01T04:00Z

[Federal Register Volume 77, Number 84 (Tuesday, May 1, 2012)]
[Proposed Rules]
[Pages 25661-25664]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10493]

[[Page 25661]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0174; FRL-9343-6]

Sulfuryl Fluoride; Second Request for Comment on Proposed Order 
Granting Objections to Tolerances and Denying Request for a Stay

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Order; request for comment.

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SUMMARY: In this notice, EPA is requesting comment on several issues 
that were raised in comments on EPA's proposed resolution of objections 
and a stay request with regard to sulfuryl fluoride and fluoride 
tolerances promulgated in 2004 and 2005 under section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is requesting that 
interested parties address various legal issues that were raised by 
several commenters as well as provide further documentation for 
submissions regarding the impacts of the withdrawal of the sulfuryl 
fluoride and fluoride tolerances.

DATES: Comments must be received on or before July 30, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2005-0174, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0174. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or 
email. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an email 
comment directly to EPA without going through regulations.gov, your 
email address will be automatically captured and included as part of 
the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Meredith Laws, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-7038; email address: laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, pesticide manufacturer, or 
consumer. Potentially affected entities may include, but are not 
limited to:
     Food manufacturing (NAICS code 311), e.g., grain and 
oilseed milling; animal food manufacturing; flour milling; bread and 
bakery product manufacturing; cookie, cracker, and pasta manufacturing; 
snack food manufacturing.
     Pesticide manufacturing (NAICS code 32532), e.g., 
pesticide manufacturers; commercial applicators.
     Community Food Services (NAICS code 624210), e.g., food 
banks.
     Farm Product Warehousing and Storage (NAICS code 493130), 
e.g., grain elevators, private and public food warehousing and storage.
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.

[[Page 25662]]

    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Request for Additional Comment

A. What action is the agency taking?

    In this notice, EPA is requesting additional comment on several 
issues that were raised in comments on EPA's proposed resolution of 
objections and a stay request with regard to sulfuryl fluoride and 
fluoride tolerances promulgated in 2004 and 2005 under section 408(d) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA). (January 19, 2011, 
76 FR 3422). In that notice, EPA proposed to grant the objections to 
the tolerances based on a conclusion that aggregate exposure to 
fluoride (from all sources including drinking water, dental products, 
and food) does not meet the safety standard in FFDCA section 408, 
although EPA notes that fluoride exposure that occurs as a result of 
sulfuryl fluoride use accounts for a relatively small portion of 
overall aggregate exposure (approximately 3 to 4 percent of total 
fluoride exposure). In the notice, EPA proposed to withdraw the 
sulfuryl fluoride and fluoride tolerances under an implementation 
schedule that would provide time for sulfuryl fluoride users to 
transition to new pest control alternatives. The notice also specified 
that the proposed tolerance withdrawal, if finalized, would become 
effective 60 days from the date of the final order, and would follow 
the implementation schedule detailed in the final order. EPA notes that 
during the pendency of the Agency's consideration of the objections to 
the sulfuryl fluoride and fluoride tolerances, the tolerances remain in 
effect. Neither the January 2011 proposed order nor this notice 
constitute final agency action.

B. What is the agency's authority for taking this action?

    The procedure for filing objections to tolerance actions and EPA's 
authority for acting on such objections is contained in section 408(g) 
of FFDCA (21 U.S.C. 346a(g) and regulations at 40 CFR part 178. That 
same authority governs hearing and stay requests.

C. On what matters is EPA requesting additional comment?

    EPA is seeking additional comment in two general areas. First, 
several commenters argued that, as a legal matter, EPA had a greater 
degree of discretion in how to interpret the standard in section 408(b) 
than indicated by EPA's proposal. EPA believes a fuller discussion of 
these arguments would aid its decision-making. Second, EPA has been 
contacted by several organizations regarding their comments bearing on 
the availability of alternatives to sulfuryl fluoride and the impacts 
of removal of the sulfuryl fluoride and fluoride tolerances. In 
discussions with these organizations, EPA noted that additional 
documentation was needed to support assertions made in the comments in 
question. In light of this, as well as due to the importance of this 
action, EPA has surveyed the comments and identified several issues 
related to availability of alternatives and impacts from withdrawal of 
the sulfuryl fluoride and fluoride tolerances that were raised by one 
or more commenters but were not always sufficiently documented. EPA is 
reopening the comment period to allow all commenters or others to 
provide additional information on the following issues.
    1. Legal issues. There are three legal issues that EPA believes 
warrant comment: whether the de minimis doctrine is applicable here 
given the limited fluoride exposure from pesticidal sources; whether 
EPA's aggregation of exposure to a pesticide and other related 
substances can include non-pesticidal substances, especially where 
pesticidal exposure is proportionally small compared to exposure to 
related substances; and whether EPA's obligations under other statutory 
authority should be considered in implementing FFDCA section 408.
    i. De minimis doctrine. Several commenters have asserted that EPA's 
proposed action would lead to absurd and undesirable consequences 
because removing the sulfuryl fluoride and fluoride tolerances will 
result in no greater than a minimal reduction in fluoride exposure but 
could have major impacts with regard to pest control for various stored 
commodities as well as complicating compliance by the United States 
with its obligations under the Montreal Protocol on Substances that 
Deplete the Ozone Layer (Montreal Protocol) and Title VI of the Clean 
Air Act (CAA) addressing Stratospheric Ozone Protection. In fact, Dow 
AgroSciences LLC argues that ``if sulfuryl fluoride were not in use as 
a fumigant, there would be no change in the number of children in the 
U.S. currently exposed to excessive levels of fluoride * * *.'' (EPA-
HQ-OPP-2005-0174-0228).
    In brief, these commenters are objecting to the fluoride exposures 
EPA has taken into account in assessing fluoride risk under FFDCA 
section 408. Under that provision, a pesticide tolerance may only be 
promulgated or left in effect by EPA if the tolerance is ``safe.'' (21 
U.S.C. 346a(b)(2)(A)(i)). ``Safe'' is defined by the statute 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.'' (21 U.S.C. 346a(b)(2)(A)(ii)). Other 
provisions in section 408 enlarge on the obligation to aggregate and 
cumulate exposures to the pesticide as well as other related 
substances. See 21 U.S.C. 346a(b)(2)(C)(i)(III) (requiring assessment 
of risk to infants and children based on cumulative effects of the 
pesticide and other substances that have a common mechanism of 
toxicity), 346a(b)(2)(D)(v) (requiring consideration of cumulative 
effects of the pesticide and other substances that have a common 
mechanism of toxicity), 346a(b)(2)(D)(vi) (requiring consideration of 
aggregate exposure to the pesticide and other related substances). In 
implementing this safety standard for the sulfuryl fluoride and 
fluoride tolerances, EPA has summed fluoride exposures from all 
sources, not just pesticidal sources, in evaluating the safety of the 
tolerances. The commenters have challenged this approach arguing that 
the de minimis doctrine would allow EPA to soften its approach to the 
aggregation of fluoride exposures and thus avoid potentially absurd 
consequences. As to absurd results, Dow AgroSciences LLC notes the 
``insignificant exposure profile [of sulfuryl fluoride], the adverse 
impacts on public health that would follow its elimination, and the de 
minimis treatment that EPA has afforded sources of similar amounts of 
fluoride exposure.''
    Under the de minimis doctrine, an agency need not apply the 
language of the statute in a literal manner if this leads to ``patently 
absurd results that will undermine Congress' broader purposes,'' Public 
Citizen v. FTC, 869

[[Page 25663]]

F.2d 1541, 1557 n. 33 (D.C. Cir. 1989), and the covered matter can 
``fairly be considered de minimis,'' Alabama Power Co. v. Costle, 636 
F.2d 323, 360 (D.C. Cir. 1979). Essential to exercise of a de minimis 
exception is that Congress cannot have been ``extraordinarily rigid,'' 
Alabama Power Co. v. Costle, 636 F.2d at 360; the exception cannot 
``thwart a statutory command; it must be interpreted with a view to 
`implementing the legislative design;' '' Public Citizen v. Young, 831 
F.2d 1108, 1113 (D.C. Cir. 1987) (quoting Alabama Power Co. v. Costle, 
636 F.2d at 360-61); and regulation under the terms of the statute must 
``yield a gain of trivial or no value,'' Alabama Power Co. v. Costle, 
636 F.2d at 360-61. See EDF v. EPA, 82 F.3d 451, 466-467 (D.C. Cir. 
1996); Ohio v. EPA, 997 F.2d 1520, 1534-35 (D.C. Cir. 1993).
    EPA seeks comment on how, if at all, the three elements of the de 
minimis doctrine would apply in the context of EPA's proposal to 
withdraw the sulfuryl fluoride and fluoride tolerances. First, has 
Congress imposed the aggregation requirement with extraordinary 
rigidity? In responding to this question it would be helpful if 
commenters would address the numerous references in FFDCA section 408 
to the aggregation and cumulation of exposures, including the multiple 
references to the aggregation and cumulation of exposures to pesticides 
and other substances. See 21 U.S.C. 346a(b)(2)(C)(i)(III), 
346a(b)(2)(D)(v), and 346a(b)(2)(D)(vi). Second, does not aggregating 
fluoride from pesticidal and non-pesticidal sources thwart or implement 
the statutory design? In other words, is the withdrawal of the sulfuryl 
fluoride and fluoride tolerances a ``patently absurd result[]'' that 
would thwart purposes of FFDCA section 408 or does it implement the 
statutory design? Finally, does fluoride exposure from pesticides truly 
amount to no greater than a de minimis risk? In approaching this 
question, it should be considered that EPA's risk assessments show that 
for the most highly exposed communities, total pesticidal fluoride 
amounts are approximately 3 to 4 percent of total fluoride exposure and 
2 to 8 percent of the fluoride reference dose (RfD), depending on the 
age groups considered. See Kentucky Waterways Alliance v. Johnson, 540 
F.3d 466, 492 (6th Cir. 2008). More broadly, any decision regarding 
whether fluoride exposure from pesticides is de minimis would 
potentially be precedential regarding other pesticides, and thus EPA 
requests comment generally on what factors should be considered in 
determining whether a pesticide's contribution to aggregate exposure is 
de minimis.
    ii. Exposure to other related substances. FIFRA section 
408(b)(1)(A)(ii) defines the safety finding for the establishment of 
tolerances as requiring a determination 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.'' 
FIFRA section 408(b)(2)(D)(vi) requires EPA in establishing tolerances 
to ``consider, among other relevant factors * * * available information 
concerning the aggregate exposure of consumers (and major identifiable 
subgroups of consumers) to the pesticide chemical and to other related 
substances * * *.'' Dow AgroSciences LLC argues (1) that the ``other 
related substances'' referenced in FIFRA section 408(b)(2)(D)(vi) are 
only other related pesticidal substances; and (2) that, even if the 
term ``other related substances'' includes non-pesticidal substances, 
aggregation of pesticide alone must have a ``meaningful impact on the 
end point of concern.'' EPA requests comment on whether such an 
interpretation is consistent with the language of these two provisions, 
as well as the other provisions of the statute that discuss aggregation 
and cumulation of pesticides and other related substances. See 21 
U.S.C. 346a(b)(2)(C)(i)(III), 346a(b)(2)(D)(v).
    iii. Reconciling all environmental statutes and treaty obligations. 
The Natural Resources Defense Council (NRDC) argues in its comments 
that EPA has an obligation to reconcile its action on sulfuryl fluoride 
under FFDCA section 408 with its duties under the Clean Air Act and the 
Montreal Protocol relating to the phase-out of methyl bromide. (EPA-HQ-
OPP-2005-0174-0150). Specifically, NRDC asserts that EPA must consider 
the ``full range of the health consequences of its actions'' under 
FFDCA section 408. EPA requests comment on whether the presence of 
other statutory duties would allow EPA to approve a pesticide tolerance 
that was otherwise unsafe under FFDCA section 408, if failing to 
approve the tolerance would lead to greater net damages to the 
environment. In responding to this question, commenters should address 
FFDCA section 408(b)(2)(B) that describes the circumstances under which 
EPA may take such health-health tradeoffs into account. Also, EPA 
requests comment on the question of what are the ``full range of the 
health consequences'' of withdrawing the sulfuryl fluoride and fluoride 
tolerances. If EPA were to accept NRDC's legal premise, the facts 
surrounding the ``range of health consequences'' would be important to 
any EPA decision.
    2. Alternatives and impacts. EPA has identified several issues 
related to availability of alternatives and impacts from withdrawal of 
the sulfuryl fluoride and fluoride tolerances that were raised by one 
or more commenters but were not always sufficiently documented. EPA 
would recommend commenters consider the following descriptions of the 
types of documentation that would aid EPA in compiling adequate record 
materials on the issues in question:
    i. Please provide complete and accurate references (i.e., peer-
reviewed articles, personal contacts, consultants, other) for any and 
all data and information included, mentioned, referred to, and/or cited 
in comments. For example, provide sources of information for costs of 
heat treatment, costs of construction, phosphine resistance, phosphine 
corrosion, efficacy of alternatives, etc. Any information relied on to 
make any inference, reach a conclusion, or derive a quantitative 
estimate should be accompanied by a complete and accurate reference. 
Some of the commenters already provided references for their 
information; others did not. Please note that without accurate 
references, the Agency may not be able to locate the information to 
update and/or revise impacts where appropriate.
    ii. If cost estimates for warehouse construction, fumigation 
chamber construction, or other types of construction were included in a 
comment, please provide the full details of the calculations and all 
assumptions used to derive the estimates, and please provide a contact 
name and number for the person or company that created the estimates, 
in case the Agency has further questions.
    iii. Regarding the corrosive effects of phosphine to equipment, 
what types of machines are damaged by phosphine, what is the nature of 
the damage, how many phosphine treatments does it take to damage them, 
how much does the equipment cost, and, if possible, how could the 
equipment be moved or retrofitted so that the damage does not occur?
    iv. Please provide complete and accurate references to any law or 
regulation on food safety cited in a comment. For example, some 
comments mentioned mandatory fumigation, pasteurization, etc. of food 
products. Please provide specific references to any

[[Page 25664]]

and all statutes and/or regulations that require such treatments.
    v. Several applicators mentioned that sulfuryl fluoride was safer 
than phosphine for applicators. Please explain why sulfuryl fluoride 
application is safer, using specific examples where possible.
    vi. Several comments mentioned the inability of heat to penetrate 
finished product. Please contrast this with the ability for fumigant 
gas to penetrate the products.
    vii. If any specific customer requests for fumigation to address a 
particular pest infestation are mentioned in a comment, please provide 
examples of those requests.
    viii. If any claims are made that sulfuryl fluoride is needed so 
that food can meet phytosanitary conditions in foreign markets, please 
provide examples of those requirements (e.g., import requirements of 
other countries), please explain why quarantine methyl bromide cannot 
be used to meet the requirements, and please provide details on the 
pounds of product fumigated with sulfuryl fluoride for export each year 
to countries with these requirements.
    ix. Many comments from groups that process and store commodities, 
such as nuts and dried fruit, noted that there was a need for fast 
turnaround times in fumigation to meet market demand. If the industry 
never requested a methyl bromide critical use exemption, please explain 
how fast fumigation was conducted prior to the introduction of sulfuryl 
fluoride, why the transition to sulfuryl fluoride occurred, and why it 
would now not be possible to switch back to previous methods. Several 
comments indicated that there would be human health concerns from lack 
of an effective fumigant. If available, please provide specific 
examples (with complete and accurate references) of public health 
issues caused by lack of fumigants.
    x. As to claims that there are commercially viable, chemical or 
non-chemical, alternatives for commodities and/or structures, please 
provide literature citations and/or personal contacts for the efficacy 
of these alternatives and the costs and technical feasibility of 
transition. In addition, please provide any available information on 
how using the alternatives is expected to affect the cost of the end 
product.
    xi. As to claims that pest problems for which U.S. industries 
currently employ sulfuryl fluoride are successfully controlled in 
countries where neither sulfuryl fluoride nor methyl bromide is used, 
please provide data, literature citations and/or personal contacts for 
the efficacy and costs of these chemical or non-chemical alternatives.
    xii. As to claims of economic or other types of impacts as a result 
of EPA's proposed order, recognizing that EPA has not yet issued a 
final order or taken final agency action, please provide specific 
information, data, and/or personal contacts to substantiate these 
claims.

X. Regulatory Assessment Requirements

    This notice seeks additional comment on the Agency's proposed order 
regarding objections filed under section 408 of FFDCA. The proposed 
order is part of an adjudication and not a rule. The regulatory 
assessment requirements imposed on rulemaking do not, therefore, apply 
to this notice.

XI. 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, does 
not apply to this notice because this is not a rule for purposes of 5 
U.S.C. 804(3).

List of Subjects in 40 CFR Part 180

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

    Dated: April 24, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2012-10493 Filed 4-30-12; 8:45 am]
BILLING CODE 6560-50-P