3422 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0174; FRL–8857–9] 

Sulfuryl Fluoride; Proposed Order 

Granting Objections to Tolerances and 

Denying Request for a Stay 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed Order. 

SUMMARY: In this document, EPA is 

making available its 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). 

The objections and stay request were 

filed by the Fluoride Action Network, 

the Environmental Working Group, and 

Beyond Pesticides. Notwithstanding the 

fact that this document is a proposed 

resolution, and regulatory assessment 

requirements do not apply, EPA is 

inviting public comment on all aspects 

of the proposed resolution of objections, 

including the underlying scientific 

evaluations. 

DATES: Comments must be received on 

or before April 19, 2011. 

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 

e-mail. 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 e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail 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; e-mail 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 e-mail. 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. 


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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. 

C. What are the acronyms used in this 

order? 

The following is a list of acronyms 

used in this order: 

CAA—Clean Air Act 

CAAA—Clean Air Act Amendments of 1990 

CSFII—Continuing Survey of Food Intakes by 

Individuals 

CUE—Critical Use Exemption 

EPA—Environmental Protection Agency 

FACA—Federal Advisory Committee Act 

FAN—Fluoride Action Network 

FDA—Food and Drug Administration 

FIFRA—Federal Insecticide, Fungicide, and 

Rodenticide Act 

FFDCA—Federal Food, Drug, and Cosmetic 

Act 

FQPA—Food Quality Protection Act of 1996 

IOM—Institute of Medicine 

L—liter 

LOAEL—Lowest Observed Adverse Effect 

Level 

MCL—Maximum contaminant level 

MCLG—Maximum contaminant level goal 

mg—milligram 

MOE—Margin of Exposure 

MRID—Master Record Identification 

NAS—National Academy of Sciences 

NOAEL—No Observed Adverse Effect Level 

NPDWR—National Public Drinking Water 

Regulations 

NRC—National Research Council 

NRDC—Natural Resources Defense Council 

OPP—EPA’s Office of Pesticide Programs 

OW—EPA’s Office of Water 

PAD—Population Adjusted Dose 

ppm—parts per million 

RED—Reregistration Eligibility Decision 

RfD—Reference Dose 

SDWA—Safe Drinking Water Act 

SMCL—Secondary maximum contaminant 

level 

SOP—Standard Operating Procedure 

USDA—United States Department of 

Agriculture 

II. Introduction 

A. What action is the agency taking? 

In this document, EPA is making 

available for comment a proposed order 

granting objections and denying a stay 

request with regard to tolerances 

established for sulfuryl fluoride and 

fluoride in 2004 (69 FR 3240, January 

23, 2004) (FRL–7342–1) and 2005 (70 

FR 40899, July 15, 2005) (FRL–7723–7) 

under FFDCA section 408 (21 U.S.C. 

346a). (See 40 CFR 180.145(c); 180.575). 

These objections were first filed by the 

Fluoride Action Network (FAN) and 

Beyond Pesticides/National Coalition 

Against the Misuse of Pesticides. (Ref. 

1). FAN and Beyond Pesticides also 

requested a hearing on their objections. 

At a later date, FAN and Beyond 

Pesticides were joined by the 

Environmental Working Group 

(hereinafter the three parties are referred 

to as ‘‘the Objectors’’) (Refs. 2 and 3). 

The Objectors argue that the sulfuryl 

fluoride and fluoride tolerances should 

not have been established by EPA 

because aggregate exposure to fluoride 

is unsafe under FFDCA section 408. The 

stay request as to the tolerances was 

filed by the Objectors in June, 2006, 

following release of a report by the 

National Research Council (NRC) of the 

National Academy of Sciences (NAS) 

concerning the risk of fluoride. (71 FR 

38125, July 5, 2006) (FRL–8075–6). 

After reviewing the objections and the 

NRC Report, EPA is proposing to grant 

the objections because it agrees that 

aggregate exposure to fluoride for 

certain major identifiable population 

subgroups does not meet the safety 

standard in FFDCA section 408. Because 

EPA is proposing to grant the Objectors’ 

objections a hearing is not warranted. 

Finally, EPA is proposing to deny the 

Objectors’ request for a stay because the 

risks from continued sulfuryl fluoride 

use in the short term is insignificant 

while the environmental and economic 

consequences from a sudden 

withdrawal of sulfuryl fluoride, a 

methyl bromide replacement, are 

considerable. 

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. 

III. Statutory and Regulatory 

Background 

In this Unit, EPA provides 

background on the relevant statutes and 

regulations governing the Objectors’ 

objections, requests for hearing, and 

request for a stay as well as on pertinent 

Agency policies and practices. 

Unit III.A. summarizes the 

requirements and procedures in section 

408 of FFDCA and applicable 

regulations pertaining to pesticide 

tolerances, including the procedures for 

objecting to EPA tolerance actions and 

the substantive standards for evaluating 

the safety of pesticide tolerances. This 

unit also discusses the closely-related 

statute under which EPA regulates the 

sale, distribution, and use of pesticides, 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) (7 U.S.C. 136 

et seq.). 

Unit III.B. provides an overview of the 

risk assessment process followed by 

EPA’s Office of Pesticide Programs 

(OPP). It contains an explanation of how 

EPA identifies the hazards posed by 

pesticides, how EPA determines the 

level of exposure to pesticides that pose 

a concern (level of concern), how EPA 

measures human exposure to pesticides, 

and how hazard, level of concern 

conclusions, and human exposure 

estimates are combined to evaluate risk. 

Further, this unit presents background 

information on two Agency policies 

with particular relevance to this action. 

Unit III.C. provides a brief overview of 

the Safe Drinking Water Act (SDWA) 

and 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. These 

statutory schemes and international 

treaty are relevant to this proceeding 

because EPA regulates fluoride, a 

sulfuryl fluoride degradate, under 

SDWA, and because sulfuryl fluoride 

has played an important role in the 

United States fulfilling its obligations 

under the Montreal Protocol and CAA. 

Specifically, sulfuryl fluoride is a 

substitute for the ozone-depleting 

pesticide, methyl bromide. 

A. FFDCA/FIFRA and Applicable 

Regulations 

1. In general. EPA establishes 

maximum residue limits, or 

‘‘tolerances,’’ for pesticide residues in 

food under section 408 of FFDCA. (21 

U.S.C. 346a). Without such a tolerance 

or an exemption from the requirement 

of a tolerance, a food containing a 

pesticide residue is ‘‘adulterated’’ under 

section 402 of FFDCA and may not be 

legally moved in interstate commerce. 

(21 U.S.C. 331, 342). Monitoring and 

enforcement of pesticide tolerances are 

carried out by the U.S. Food and Drug 

Administration (FDA) and the U.S. 

Department of Agriculture (USDA). 

Section 408 was substantially rewritten 

by the Food Quality Protection Act of 

1996 (FQPA), which added the 

provisions establishing a detailed safety 

standard for pesticides, additional 

protections for infants and children, and 

the estrogenic substances screening 


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program. (Pub. L. 104–170, 110 Stat. 

1489 (1996)). 

EPA also regulates pesticides under 

FIFRA (7 U.S.C. 136 et seq.). While 

FFDCA authorizes the establishment of 

legal limits for pesticide residues in 

food, FIFRA requires the approval of 

pesticides prior to their sale and 

distribution, (7 U.S.C. 136a(a)), and 

establishes a registration regime for 

regulating the use of pesticides. FIFRA 

regulates pesticide use in conjunction 

with its registration scheme by requiring 

EPA review and approval of pesticide 

labeling and specifying that use of a 

pesticide inconsistent with its labeling 

is a violation of Federal law. (7 U.S.C. 

136j(a)(2)(G)). In the FQPA, Congress 

integrated action under the two statutes 

by requiring that the safety standard 

under FFDCA be used as a criterion in 

FIFRA registration actions as to 

pesticide uses which result in dietary 

risk from residues in or on food, (7 

U.S.C. 136(bb)), and directing that EPA 

coordinate, to the extent practicable, 

revocations of tolerances with pesticide 

cancellations under FIFRA. (21 U.S.C. 

346a(l)(1)). 

2. Safety standard for pesticide 

tolerances. A pesticide tolerance may 

only be promulgated 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)). Section 408(b)(2)(D) 

directs EPA, in making a safety 

determination, to: 

Consider, among other relevant factors— 

* * * 

* * *available information concerning the 

aggregate exposure levels of consumers (and 

major identifiable subgroups of consumers) 

to the pesticide chemical residue and to other 

related substances, including dietary 

exposure under the tolerance and all other 

tolerances in effect for the pesticide chemical 

residue, and exposure from other nonoccupational sources.* * * 

(21 U.S.C. 346a(b)(2)(D)(v), (vi) and 

(viii)). EPA must also consider, in 

evaluating the safety of tolerances, 

‘‘safety factors which * * * are 

generally recognized as appropriate for 

the use of animal experimentation data.’’ 

(21 U.S.C. 346a(b)(2)(D)(ix). 

Risks to infants and children are given 

special consideration. Specifically, 

section 408(b)(2)(C)(i)(II) requires that 

EPA assess the risk to pesticides based 

on ‘‘available information concerning 

the special susceptibility of infants and 

children to the pesticide chemical 

residues, including neurological 

differences between infants and 

children and adults, and effects of in 

utero exposure to pesticide 

chemicals.* * * ’’ (21 U.S.C. 

346a(b)(2)(C)(i)(II)). This provision also 

creates a presumption that EPA will use 

an additional safety factor for the 

protection of infants and children. 

Specifically, it directs that ‘‘[i]n the case 

of threshold effects, * * * an 

additional tenfold margin of safety for 

the pesticide chemical residue and other 

sources of exposure shall be applied for 

infants and children to take into account 

potential pre- and post-natal toxicity 

and completeness of the data with 

respect to exposure and toxicity to 

infants and children.’’ (21 U.S.C. 

346a(b)(2)(C)). EPA is permitted to ‘‘use 

a different margin of safety for the 

pesticide chemical residue only if, on 

the basis of reliable data, such margin 

will be safe for infants and children.’’ 

(Id.). The additional safety margin for 

infants and children is referred to 

throughout this Order as the ‘‘children’s 

safety factor.’’ 

3. Procedures for establishing, 

amending, or revoking tolerances. 

Tolerances are established, amended, or 

revoked by rulemaking under the 

unique procedural framework set forth 

in FFDCA. Generally, a tolerance 

rulemaking is initiated by the party 

seeking to establish, amend, or revoke a 

tolerance by means of filing a petition 

with EPA. (See 21 U.S.C. 346a(d)(1)). 

EPA publishes in the Federal Register a 

notice of the petition filing and requests 

public comment. (21 U.S.C. 346a(d)(3)). 

After reviewing the petition, and any 

comments received on it, EPA may issue 

a final rule establishing, amending, or 

revoking the tolerance, issue a proposed 

rule to do the same, or deny the 

petition. (21 U.S.C. 346a(d)(4)). 

Once EPA takes final action on the 

petition by either establishing, 

amending, or revoking the tolerance or 

denying the petition, any person may 

file objections with EPA and seek an 

evidentiary hearing on those objections. 

(21 U.S.C. 346a(g)(2)). Objections and 

hearing requests must be filed within 60 

days. (Id.). The statute provides that 

EPA shall ‘‘hold a public evidentiary 

hearing if and to the extent the 

Administrator determines that such a 

public hearing is necessary to receive 

factual evidence relevant to material 

issues of fact raised by the objections.’’ 

(21 U.S.C. 346a(g)(2)(B)). EPA 

regulations make clear that hearings will 

only be granted where it is shown that 

there is ‘‘a genuine and substantial issue 

of fact,’’ the requestor has identified 

evidence ‘‘which, if established, resolve 

one or more of such issues in favor of 

the requestor,’’ and the issue is 

‘‘determinative’’ with regard to the relief 

requested. (40 CFR 178.32(b)). EPA’s 

final order on the objections and 

requests for hearing is subject to judicial 

review. (21 U.S.C. 346a(h)(1)). The 

statute directs that tolerance regulations 

shall take effect upon publication unless 

EPA specifies otherwise. (40 U.S.C. 

346a(g)(1)). EPA is authorized to stay 

the effectiveness of the tolerance if 

objections are filed. (Id.). 

B. EPA Risk Assessment for 

Tolerances—Policy and Practice 

1. The safety determination—risk 

assessment. To assess risk of a pesticide 

tolerance, EPA combines information on 

pesticide toxicity with information 

regarding the route, magnitude, and 

duration of exposure to the pesticide. 

The risk assessment process involves 

four distinct steps: 

(1) Identification of the toxicological 

hazards posed by a pesticide; 

(2) Determination of the ‘‘level of 

concern’’ with respect to human 

exposure to the pesticide; 

(3) Estimation of human exposure to 

the pesticide; and 

(4) Characterization of risk posed to 

humans by the pesticide based on 

comparison of human exposure to the 

level of concern. 

a. Hazard identification. In evaluating 

toxicity or hazard, EPA reviews toxicity 

data, typically from studies with 

laboratory animals, to identify any 

adverse effects on the test subjects. 

Where available and appropriate, EPA 

will also take into account studies 

involving humans, including human 

epidemiological studies. For most 

pesticides, the animal toxicity database 

usually consists of studies investigating 

a broad range of endpoints including 

gross and microscopic effects on organs 

and tissues, functional effects on bodily 

organs and systems, effects on blood 

parameters (such as red blood cell 

count, hemoglobin concentration, 

hematocrit, and a measure of clotting 

potential), effects on the concentrations 

of normal blood chemicals (including 

glucose, total cholesterol, urea nitrogen, 

creatinine, total protein, total bilirubin, 

albumin, hormones, and enzymes such 

as alkaline phosphatase, alanine 

aminotransfersase and cholinesterases), 

and behavioral or other gross effects 

identified through clinical observation 

and measurement. EPA examines 

whether adverse effects are caused by 

different durations of exposure ranging 

from short-term (acute) to long-term 

(chronic) pesticide exposure and 

different routes of exposure (oral, 

dermal, inhalation). Further, EPA 

evaluates potential adverse effects in 


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different age groups (adults as well as 

fetuses and juveniles). (Ref. 4 at 8–10). 

EPA also considers whether the 

adverse effect has a threshold—a level 

below which exposure has no 

appreciable chance of causing the 

adverse effect. For effects that have no 

threshold, EPA assumes that any 

exposure to the substance increases the 

risk that the adverse effect may occur. 

b. Level of concern/dose-response 

analysis. Once a pesticide’s potential 

hazards are identified, EPA determines 

a toxicological level of concern for 

evaluating the risk posed by human 

exposure to the pesticide. In this step of 

the risk assessment process, EPA 

essentially evaluates the levels of 

exposure to the pesticide at which 

effects might occur. An important aspect 

of this determination is assessing the 

relationship between exposure (dose) 

and response (often referred to as the 

dose-response analysis). EPA follows 

differing approaches to identifying a 

level of concern for threshold and nonthreshold hazards. 

i. Threshold effects. In examining the 

dose-response relationship for a 

pesticide’s threshold effects, EPA 

evaluates an array of toxicity studies on 

the pesticide. In each of these studies, 

EPA attempts to identify the lowest 

observed adverse effect level (LOAEL) 

and the no observed adverse effect level 

(NOAEL), which by definition is the 

next lower tested dose level below the 

LOAEL. Generally, EPA will use the 

lowest NOAEL from the available 

studies as a starting point (called ‘‘the 

Point of Departure’’) in estimating the 

level of concern for humans. (Ref. 4 at 

9 (The Point of Departure ‘‘is simply the 

toxic dose that serves as the ‘starting 

point’ in extrapolating a risk to the 

human population.’’)). At times, 

however, EPA will use a LOAEL from a 

study as the Point of Departure when no 

NOAEL is identified in that study and 

the LOAEL is close to, or lower than, 

other relevant NOAELs. The Point of 

Departure is in turn used in choosing a 

level of concern. EPA will make 

separate determinations as to the Points 

of Departure, and correspondingly 

levels of concern, for both short and 

long exposure periods as well as for the 

different routes of exposure (oral, 

dermal, and inhalation). 

In recent years, EPA has increasingly 

used a more scientifically sophisticated 

approach to choosing the Point of 

Departure. This approach, called a 

benchmark dose, or BMD, estimates a 

point along a dose-response curve that 

corresponds to a specific response level. 

(Ref. 5). For example, a BMD10

represents a 10% change from the 

background or typical value for the 

response of concern. In contrast to the 

NOAEL/LOAEL approach, a BMD is 

calculated using a range of dose 

response data and thus better accounts 

for the variability and uncertainty in the 

experimental results due to 

characteristics of the study design, such 

as dose selection, dose spacing, and 

sample size. In addition to a BMD, EPA 

generally also calculates a ‘‘confidence 

limit’’ in the BMD. Confidence limits 

express the uncertainty in a BMD that 

may be due to sampling and/or 

experimental error. The lower 

confidence limit on the dose used as the 

BMD is termed the BMDL, which the 

Agency often uses as the Point of 

Departure. Use of the BMDL for deriving 

the Point of Departure rewards better 

experimental design and procedures 

that provide more precise estimates of 

the BMD, resulting in tighter confidence 

intervals. It also provides a health 

protective conservative estimate of the 

safe dose. Numerous scientific peer 

review panels over the last decade have 

supported the Agency’s application of 

the BMD approach as a scientifically 

supportable method for deriving Points 

of Departure in human health risk 

assessment, and as an improvement 

over the historically applied approach 

of using NOAELs or LOAELs. (Refs. 6 

and 7). 

In estimating and describing the level 

of concern, the Point of Departure is at 

times used differently depending on 

whether the risk assessment addresses 

dietary or non-dietary exposures. For 

dietary risks, EPA uses the Point of 

Departure to calculate an acceptable 

level of exposure or reference dose 

(RfD). The RfD is calculated by dividing 

the Point of Departure by all applicable 

safety or uncertainty factors. Typically, 

EPA uses a baseline safety/uncertainty 

factor of 100X in assessing pesticide 

risk. That value includes a factor of 10 

(10X) where EPA is using data from 

laboratory animals to account for the 

possibility that humans potentially have 

greater sensitivity to the pesticide than 

animals and another factor of 10X to 

account for potential variations in 

sensitivity among members of the 

human population. Additional safety 

factors may be added to address data 

deficiencies or concerns raised by the 

existing data. Under the FQPA, an 

additional safety factor of 10X is 

presumptively applied to protect infants 

and children, unless reliable data 

support selection of a different factor. 

This FQPA additional safety factor 

largely replaces pre-FQPA EPA practice 

regarding additional safety factors. (Ref. 

8 at 4–11). 

In implementing FFDCA section 408, 

EPA’s Office of Pesticide Programs, also 

calculates a variant of the RfD referred 

to as a Population Adjusted Dose (PAD). 

APAD is the RfD divided by any portion 

of the FQPA safety factor that does not 

correspond to one of the traditional 

additional safety factors used in general 

Agency risk assessments. (Id. at 13–16). 

The reason for calculating PADs is so 

that other parts of the Agency, which 

are not governed by FFDCA section 408, 

can, when evaluating the same or 

similar substances, easily identify 

which aspects of a pesticide risk 

assessment are a function of the 

particular statutory commands in 

FFDCA section 408. Today, RfDs and 

PADs are generally calculated for both 

acute and chronic dietary risks although 

traditionally RfDs and PADs were only 

calculated for chronic risks. Throughout 

this document general references to 

OPP’s calculated safe dose are denoted 

as an RfD/PAD. 

For non-dietary, and combined 

dietary and non-dietary, risk 

assessments of threshold effects, the 

toxicological level of concern is not 

expressed as an RfD/PAD but rather in 

terms of an acceptable (or target) margin 

of exposure (MOE) between human 

exposure and the Point of Departure. 

The ‘‘margin’’ of interest is the ratio 

between human exposure and the Point 

of Departure which is calculated by 

dividing human exposure into the Point 

of Departure. An acceptable MOE is 

generally considered to be a margin at 

least as high as the product of all 

applicable safety factors for a pesticide. 

For example, if a pesticide needs a 10X 

factor to account for potential interspecies differences, 10X factor for 

potential intra-species differences, and 

10X factor for the FQPA children’s 

safety provision, the safe or target MOE 

would be a MOE of at least 1,000. What 

that means is that for the pesticide in 

the example to meet the safety standard, 

human exposure to the pesticide would 

generally have to be at least 1,000 times 

smaller than the Point of Departure. 

Like RfD/PADs, specific target MOEs are 

selected for exposures of different 

durations. For non-dietary exposures, 

EPA typically examines short-term, 

intermediate-term, and long-term 

exposures. Additionally, target MOEs 

may be selected based on both the 

duration of exposure and the various 

routes of non-dietary exposure—dermal, 

inhalation, and oral. 

ii. Non-threshold effects. For risk 

assessments for non-threshold effects, 

EPA does not use the RfD/PAD or MOE 

approach to choose a level of concern if 

quantification of the risk is deemed 

appropriate. Rather, EPA calculates the 

slope of the dose-response curve for the 

non-threshold effects from relevant 


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studies frequently using a linear, lowdose extrapolation model that assumes 

that any amount of exposure will lead 

to some degree of risk. This doseresponse analysis will be used in the 

risk characterization stage to estimate 

the risk to humans of the non-threshold 

effect. 

c. Estimating human exposure. Risk is 

a function of both hazard and exposure. 

Thus, equally important to the risk 

assessment process as determining the 

hazards posed by a pesticide and the 

toxicological level of concern for those 

hazards is estimating human exposure. 

Under FFDCA section 408, EPA is 

concerned not only with exposure to 

pesticide residues in food but also 

exposure resulting from pesticide 

contamination of drinking water 

supplies and from use of pesticides in 

the home or other non-occupational 

settings. (See 21 U.S.C. 

346a(b)(2)(D)(vi)). Additionally, EPA 

must take into account nonoccupational exposure from ‘‘other 

related substances.’’ (Id.). 

i. Exposure from food. There are two 

critical variables in estimating exposure 

in food: 

• The types and amount of food that 

is consumed; and 

• The residue level in that food. 

Consumption is estimated by EPA based 

on scientific surveys of individuals’ 

food consumption in the United States 

conducted by the USDA. (Ref. 4 at 12). 

Information on residue values comes 

from a range of sources including crop 

field trials, data on pesticide reduction 

(or concentration) due to processing, 

cooking, and other practices, 

information on the extent of usage of the 

pesticide, and monitoring of the food 

supply. (Id. at 17). 

In assessing exposure from pesticide 

residues in food, EPA, for efficiency’s 

sake, follows a tiered approach in which 

it, in the first instance, assesses 

exposure using the worst case 

assumptions that 100% of the crop or 

commodity in question is treated with, 

or exposed to, the pesticide and 100% 

of the food from that crop or commodity 

contains pesticide residues at the 

tolerance level. (Id. at 11). When such 

an assessment shows no risks of 

concern, a more complex risk 

assessment is unnecessary. By avoiding 

a more complex risk assessment, EPA’s 

resources are conserved and regulated 

parties are spared the cost of any 

additional studies that may be needed. 

If, however, a first tier assessment 

suggests there could be a risk of 

concern, EPA then attempts to refine its 

exposure assumptions to yield a more 

realistic picture of residue values 

through use of data on the percent of the 

crop or commodity actually treated 

with, or exposed to, the pesticide and 

data on the level of residues that may be 

present on the treated crop or 

commodity. These latter data are used to 

estimate what has been traditionally 

referred to by EPA as ‘‘anticipated 

residues.’’ 

Use of percent crop/commodity 

treated data and anticipated residue 

information is appropriate because 

EPA’s worst-case assumptions of 100% 

treatment and residues at tolerance 

value significantly overstate residue 

values. There are several reasons why 

this is true. First, all growers of a 

particular crop would rarely choose to 

apply the same pesticide to that crop 

(some may apply no pesticide; some 

may apply an alternative pesticide); 

generally, the proportion of the crop 

treated with a particular pesticide is 

significantly below 100%. (70 FR 46706, 

46731, August 10, 2005) (FRL–7727–4). 

This is true with food and structural 

fumigants such as sulfuryl fluoride as 

well, especially with regard to the 

structural fumigant use in food 

processing facilities because such use 

incurs infrequently and only potentially 

affects a small portion of the food 

processed in the facility. Second, the 

tolerance value represents a high end or 

worst case value. Tolerance values are 

chosen only after EPA has evaluated 

data from experimental trials in which 

the pesticide has been used in a manner, 

consistent with the draft FIFRA label, 

that is likely to produce the highest 

residue in the crop or food in question 

(e.g., maximum application rate, 

maximum number of applications, 

minimum pre-harvest interval between 

last pesticide application and harvest). 

(Refs. 4 and 9). These experimental 

trials are generally conducted in several 

locations and involve multiple samples. 

(Id. at 5, 7 and Tables 1 and 5). The 

results from such experimental trials 

invariably show that the residue levels 

for a given pesticide use will vary from 

as low as non-detectable to measurable 

values in the parts per million (ppm) 

range with the majority of the values 

falling at the lower part of the range. (70 

FR 46731) (FRL–7727–4). EPA uses a 

statistical procedure to analyze the 

experimental trial results and identify 

the upper bound of expected residue 

values. This upper bound value is 

typically used as the tolerance value. 

(Ref. 10). There may be some 

commodities from a treated crop or 

commodity that approach the tolerance 

value where the maximum label rates 

are followed, but most generally fall 

significantly below the tolerance value. 

If less than the maximum legal rate is 

applied, residues will be even lower. 

Third, residue values measured at the 

time of treatment do not take into 

account the lowering of residue values 

that frequently occurs as a result of 

degradation over time and through food 

processing and cooking. 

EPA uses several techniques to refine 

residue value estimates. (Ref. 4 at 17– 

28). First, where appropriate, EPA will 

take into account all the residue values 

reported in the experimental trials, 

either through use of an average or 

individually. Second, EPA will consider 

data showing what portion of the crop 

or commodity is not treated with, or 

exposed to, the pesticide. Third, data 

can be produced showing pesticide 

degradation and decline over time, and 

the effect of commercial and consumer 

food handling and processing practices. 

Finally, EPA can consult monitoring 

data gathered by the FDA, the USDA, or 

pesticide registrants, on pesticide levels 

in food at points in the food distribution 

chain distant from the farm, including 

retail food establishments. 

Another critical component of the 

exposure assessment is how data on 

consumption patterns are combined 

with data on pesticide residue levels in 

food. Traditionally, EPA has calculated 

exposure by simply multiplying average 

consumption by average residue values 

for estimating chronic risks and highend consumption by maximum residue 

values for estimating acute risks. Using 

average residues is a realistic approach 

for chronic risk assessment due to the 

fact that variations in residue levels and 

consumption amounts average out over 

time especially given the nationwide 

market for food in the United States. 

Using average values is inappropriate 

for acute risk assessments, however, 

because in assessing acute exposure 

situations it matters how much of each 

treated food a given consumer eats in 

the short-term and what the residue 

levels are in the particular foods 

consumed. Yet, using maximum residue 

values for acute risk assessment tends to 

greatly overstate exposure because it is 

unlikely that a person would consume 

at a single meal multiple food 

components bearing high-end residues. 

To take into account the variations in 

short-term consumption patterns and 

food residue values for acute risk 

assessments, EPA uses probabilistic 

modeling techniques for estimating 

exposure when more simplistic models 

appear to show risks of concerns. 

All of these refinements to the 

exposure assessment process, from use 

of food monitoring data through 

probabilistic modeling, can have 

dramatic effects on the level of exposure 


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predicted, typically reducing worst case 

estimates by at least 1 or 2 orders of 

magnitude. (Ref. 11 at 16–17; 70 FR 

46706, 46732, August 10, 2005) (FRL– 

7727–4). 

ii. Exposure from water. EPA may use 

either or both field monitoring data and 

mathematical water exposure models to 

generate pesticide exposure estimates in 

drinking water. Monitoring and 

modeling are both important tools for 

estimating pesticide concentrations in 

water and can provide different types of 

information. Monitoring data can 

provide estimates of pesticide 

concentrations in water that are 

representative of specific agricultural or 

residential pesticide practices and 

under environmental conditions 

associated with a sampling design. 

Although monitoring data can provide a 

direct measure of the concentration of a 

pesticide in water, it does not always 

provide a reliable estimate of exposure 

because sampling may not occur in 

areas with the highest pesticide use, 

and/or the sampling may not occur 

when the pesticides are being used. 

In estimating pesticide exposure 

levels in drinking water, EPA most 

frequently uses mathematical water 

exposure models. EPA’s models are 

based on extensive monitoring data and 

detailed information on soil properties, 

crop characteristics, and weather 

patterns. (69 FR 30042, 30058–30065, 

May 26, 2004) (FRL–7355–7). These 

models calculate estimated 

environmental concentrations of 

pesticides using laboratory data that 

describe how fast the pesticide breaks 

down to other chemicals and how it 

moves in the environment. These 

concentrations can be estimated 

continuously over long periods of time, 

and for places that are of most interest 

for any particular pesticide. Modeling is 

a useful tool for characterizing 

vulnerable sites, and can be used to 

estimate peak concentrations from 

infrequent, large storms. 

Unlike assessments of exposure to 

pesticides in food, assessments of 

exposure to pesticides in drinking water 

conducted under FIFRA and FFDCA 

section 408 do not assume there is a 

nationwide market for drinking water. A 

person’s source of drinking water is 

primarily local and often the pesticide 

use is quite localized as well. Thus, 

generally EPA assesses drinking water 

exposure to pesticides under FIFRA and 

FFDCA section 408 based on the most 

vulnerable watersheds and not on a 

national or even regional average. (See 

74 FR 59608, 59618–59619, 59658, 

November 18, 2009) (FRL–8797–6). 

Further, these assessments commonly 

use high-end residue estimates from 

models and assume average 

consumption levels. 

In the case of fluoride, however, the 

primary source of exposure is not from 

pesticide use. Additionally, as described 

in Unit V.A.2., EPA has an extensive 

monitoring database from across the 

United States on fluoride levels in 

drinking water. These factors have been 

taken into account in how EPA has 

conducted its FFDCA section 408 risk 

assessment for fluoride. 

d. Risk characterization. The final 

step in the risk assessment is risk 

characterization. In this step, EPA 

combines information from the first 

three steps (hazard identification, level 

of concern/dose-response analysis, and 

human exposure assessment) to 

quantitatively estimate the risks posed 

by a pesticide. Separate 

characterizations of risk are conducted 

for different durations of exposure. 

Additionally, separate and, where 

appropriate, aggregate characterizations 

of risk are conducted for the different 

routes of exposure (dietary and nondietary). 

For threshold risks, EPA estimates 

risk in one of two ways. Where EPA has 

calculated a RfD/PAD, risk is estimated 

by expressing human exposure as a 

percentage of the RfD/PAD. Exposures 

lower than 100% of the RfD/PAD are 

generally not of concern. Alternatively, 

EPA may express risk by comparing the 

MOE between estimated human 

exposure and the Point of Departure 

with the acceptable or target MOE. As 

described previously, the acceptable or 

target MOE is the product of all 

applicable safety factors. To calculate 

the actual MOE for a pesticide, 

estimated human exposure to the 

pesticide is divided into the Point of 

Departure. In contrast to the RfD/PAD 

approach, higher MOEs denote lower 

risk. Accordingly, if the target MOE for 

a pesticide is 100, MOEs equal to or 

exceeding 100 would generally not be of 

concern. 

As a conceptual matter, the RfD/PAD 

and MOE approaches are fundamentally 

equivalent. For a given risk and given 

exposure of a pesticide, if exposure to 

a pesticide were found to be acceptable 

under an RfD/PAD analysis it would 

also pass under the MOE approach, and 

vice-versa. However, for any specific 

pesticide, risk assessments for different 

exposure durations or routes may yield 

different results. This is a function not 

of the choice of the RfD/PAD or MOE 

approach but of the fact that the levels 

of concern and the levels of exposure 

may differ depending on the duration 

and route of exposure. 

For non-threshold risks (generally, 

cancer risks), EPA uses the slope of the 

dose-response curve for a pesticide in 

conjunction with an estimation of 

human exposure to that pesticide to 

estimate the probability of occurrence of 

additional adverse effects. Under 

FFDCA section 408, for non-threshold 

cancer risks, EPA generally considers 

cancer risk to be negligible if the 

probability of increased cancer cases 

falls within the range of 1 in 1 million. 

EPA describes this quantitative standard 

as a ‘‘range’’ because it does not want to 

impart a false precision to numerical 

cancer risk estimates. EPA seeks to 

identify risks differing significantly 

from a 1 in 1 million risk and that 

involves both a quantitative as well as 

qualitative assessment of what a risk 

estimate represents. 

2. EPA policy on the children’s safety 

factor. As the previous brief summary of 

EPA’s risk assessment practice 

indicates, the use of safety factors plays 

a critical role in the process. This is true 

for traditional 10X safety factors to 

account for potential differences 

between animals and humans when 

relying on studies in animals (interspecies safety factor) and potential 

differences among humans (intraspecies safety factor) as well as the 

FQPA’s additional 10X children’s safety 

factor. 

In applying the children’s safety 

factor provision, EPA has interpreted it 

as imposing a presumption in favor of 

applying an additional 10X safety factor. 

(Ref. 8 at 4, 11). Thus, EPA generally 

refers to the additional 10X factor as a 

presumptive or default 10X factor. EPA 

has also made clear, however, that this 

presumption or default in favor of the 

additional 10X is only a presumption. 

The presumption can be overcome if 

reliable data demonstrate that a different 

factor is safe for children. (Id.). In 

determining whether a different factor is 

safe for children, EPA focuses on the 

three factors listed in section 

408(b)(2)(C)—the completeness of the 

toxicity database, the completeness of 

the exposure database, and potential 

pre- and post-natal toxicity. In 

examining these factors, EPA strives to 

make sure that its choice of a safety 

factor, based on a weight-of-theevidence evaluation, does not 

understate the risk to children. (Id. at 

24–25, 35). 

C. SDWA and the Montreal Protocol/ 

CAA 

1. SDWA. SDWA (42 U.S.C. 300f et 

seq.) was enacted to assure that water 

supply systems serving the public meet 

minimum national standards for the 

protection of public health and to 

protect the underground sources of 

drinking water upon which the public 


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relies. (See generally A Legislative 

History of the Safe Drinking Water Act, 

Committee Print, 97th Cong., 2d Sess. 

(1982) at 533–541). Under SDWA, EPA 

is authorized to set ‘‘National primary 

drinking water regulations’’ (NPDWRs) 

governing contaminants which the 

Administrator determines may have an 

adverse effect on the health of persons. 

NPDWRs apply to ‘‘public water 

systems’’ nationwide and include 

monitoring and reporting requirements. 

(42 U.S.C. 300g–1). 

‘‘Public water systems’’ are defined as 

systems that provide water to the public 

through pipes or other constructed 

conveyances for human consumption 

and that have at least 15 service 

connections or regularly serve at least 

25 individuals. (42 U.S.C. 300f(4)(A)). 

By regulation, EPA has interpreted 

‘‘regularly serve at least 25 individuals’’ 

to mean providing water to an average 

of at least 25 individuals daily at least 

60 days of the year. (40 CFR 141.2). 

There are over 160,000 public water 

systems in the United States. The vast 

majority of these systems (95%) are 

small (i.e. serve populations of 3,300 

persons or less) and these systems only 

serve about 10% of the population. 

Many of these small systems rely on 

groundwater as a water source. The 

largest 2% of the public water systems 

serve 80% of the population and 

include the large metropolitan water 

systems such as in New York City, 

Washington, DC, Boston and Chicago. 

Most of these systems rely on surface 

waters as their primary water source. 

Public drinking water systems provide 

water to roughly 85 to 90% of the U.S. 

population. 

In promulgating a NPDWR for a 

contaminant, EPA must establish both a 

maximum contaminant level goal 

(MCLG) for that contaminant as well as 

either a maximum contaminant level 

(MCL) or a treatment technology 

requirement. (42 U.S.C. 300g–1(a)(3) 

and 300g–1(b)(4)(7)). MCLGs are not 

regulatory requirements and do not 

impose any obligations on public water 

systems. Rather, MCLGs are health goals 

that are to be set at a level at which, in 

the Administrator’s judgment, ‘‘no 

known or anticipated adverse effects on 

the health of persons occur and which 

allows for an adequate margin of safety.’’ 

(42 U.S.C. 300g–1(b)(4)(A)). 

A MCL sets a level of the contaminant 

not to be exceeded by public water 

systems and, with some exceptions is to 

be set as close to the MCLG as is 

‘‘feasible.’’ (42 U.S.C. 300g–1(b)(4)(B)). 

The Act defines feasible to mean 

‘‘feasible with the use of the best 

technology, treatment techniques or 

other means which the Administrator 

finds * * * are available (taking costs 

into consideration).’’ (42 U.S.C. 300g– 

(b)(4)(D)). The legislative history for this 

provision makes it clear that 

‘‘feasibility’’ is to be defined relative to 

‘‘what may reasonably be afforded by 

large metropolitan or regional public 

water systems.’’ (A Legislative History of 

the Safe Drinking Water Act, Committee 

Print, 97th Cong., 2d Sess. (1982) at 550. 

MCLs appear at 40 CFR part 141, 

subparts B and G). 

A treatment technique requirement 

imposes an obligation on public water 

systems to use an identified treatment 

technology and it must ‘‘prevent known 

or anticipated adverse effects on the 

health of persons to the extent feasible.’’ 

(42 U.S.C. 300g–1(b)(7)(A). EPA may 

establish treatment technique 

requirements in lieu of an MCL only if 

it is not economically or technologically 

feasible to ascertain the level of the 

contaminant. (Id.). 

SDWA also authorizes EPA to set 

‘‘secondary’’ drinking water standards or 

‘‘SMCLs.’’ Such standards specify levels 

which are necessary to protect ‘‘the 

public welfare,’’ (42 U.S.C. 300f(2)), but 

are not Federally enforceable (see A 

Legislative History of the Safe Drinking 

Water Act, Committee Print, 97th Cong., 

2d Sess. (1982) at 557). For example, 

such a contaminant level might be one 

which adversely affects the odor or 

appearance of water so that a large 

number of people discontinue using that 

source. SMCLs may vary by geography 

or other circumstances. EPA has 

established SMCLs for 15 contaminants, 

which are intended to be guidelines for 

the States. (40 CFR part 143). 

Every 6 years, EPA is required to 

review and revise ‘‘as appropriate’’ its 

existing drinking water standards. (42 

U.S.C. 300g–1(b)(9)). 

There is a long history of regulation 

of fluoride under SDWA. In 1975, EPA 

established a MCL for fluoride at a level 

varying between 1.4 milligrams (mg)/ 

liter (L) and 2.4 mg/L depending on 

annual ambient air temperature. (40 FR 

59566, December 24, 1975). These levels 

were set to prevent objectionable dental 

fluorosis. In 1981, South Carolina 

petitioned EPA to revoke the fluoride 

MCL arguing that dental fluorosis is 

merely a cosmetic effect not an adverse 

health effect. (See 50 FR 20164, May 14, 

1985). In response to that petition, EPA 

took a series of actions. First, in 1985, 

EPA established a MCLG for fluoride at 

4 mg/L. (50 FR 47142, November 14, 

1985) (At that time MCLGs were termed 

‘‘recommended maximum contaminant 

levels’’ (RMCLs) under SDWA.). The 

MCLG was set to protect against 

crippling skeletal fluorosis, an adverse 

health effect associated with high levels 

of fluoride exposure. EPA concluded 

that dental fluorosis, which had formed 

the basis for the earlier MCL, was not an 

adverse health effect under SDWA but 

only a cosmetic effect. Second, in 1986, 

EPA established a MCL for fluoride at 4 

mg/L, again based on the crippling 

skeletal fluorosis endpoint. (51 FR 

11396, April 2, 1986). Finally, also in 

1986, EPA established a SMCL for 

fluoride at 2 mg/L to protect against 

objectionable dental fluorosis. (Id.). 

Judicial review of the MCLG was sought 

by both the Natural Resources Defense 

Council (NRDC) and by South Carolina. 

(NRDC v. EPA, 812 F.2d 721 (DC Cir. 

1987)). NRDC argued that the level was 

too high because, among other reasons, 

the MCLG should have been set on 

dental fluorosis. Taking the opposite 

position, South Carolina claimed that no 

MCLG at all was appropriate because 

the evidence did not support that 

fluoride caused any adverse health 

effects. The DC Circuit upheld EPA’s 

regulation ruling that EPA had 

reasonably interpreted SDWA term 

adverse health effect to be limited to 

functional impairments and that EPA 

had reasonably concluded that effects of 

dental fluorosis were cosmetic in nature 

and did not result in functional 

impairment. South Carolina’s challenge 

was dismissed based on the court’s 

conclusion that EPA had made a 

‘‘permissible administrative judgment’’ 

based on the evidence before it. (Id. at 

725). 

Subsequent to these rulemakings, EPA 

has on two occasions asked NAS to 

reevaluate the potential risks of fluoride 

exposure in regard to the MCLG/MCL. 

The NRC Report on the second request 

is discussed extensively in Unit IV.D. 

2. The Montreal Protocol/CAA and 

methyl bromide. The Montreal Protocol 

is the international agreement aimed at 

reducing and eliminating the 

production and consumption of 

stratospheric ozone-depleting 

substances. The stratospheric ozone 

layer protects humans from 

overexposure to harmful ultraviolet 

radiation. The United States was one of 

the original signatories to the 1987 

Montreal Protocol and the United States 

ratified the Protocol in April, 1988. 

Congress then enacted the Clean Air Act 

Amendments (CAAA) of 1990 which 

included Title VI on Stratospheric 

Ozone Protection, codified as 42 U.S.C. 

Chapter 85, Subchapter VI, to ensure 

that the United States could satisfy its 

obligations under the Montreal Protocol. 

EPA issued regulations in 40 CFR part 

82 to implement this legislation and has 

since modified and updated the 

regulations as needed. In 2009, the 

Montreal Protocol became the first 


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universally ratified international 

environmental treaty. 

Methyl bromide was added to the 

Montreal Protocol as an ozone-depleting 

substance in 1992 through the 

Copenhagen Amendment to the 

Protocol. The Parties to the Montreal 

Protocol (Parties) agreed that each 

developed country’s level of methyl 

bromide production and consumption 

in 1991 should be the baseline for 

establishing a freeze. Under the 

Montreal Protocol and Title VI of the 

CAAA the term ‘‘consumption’’ is a 

calculated amount equal to production 

plus imports minus exports. EPA 

published a final rule in the Federal 

Register on December 10, 1993 (58 FR 

65018), listing methyl bromide as a 

Class I, Group VI controlled substance, 

freezing U.S. production and 

consumption at this 1991 baseline level 

of 25,528,270 kilograms, and setting 

forth the percentage of baseline 

allowances for methyl bromide granted 

to companies in each control period 

(each calendar year) until 2001, when 

the complete phase-out would occur. 

This phase-out date was established in 

response to a petition filed in 1991 

under sections 602(c)(3) and 606(b) of 

CAAA of 1990, requesting that EPA list 

methyl bromide as a Class I substance 

and phase out its production and 

consumption. This date was consistent 

with section 602(d) of CAAA of 1990, 

which, for newly listed Class I ozonedepleting substances, provides that ‘‘no 

extension [of the phase-out schedule in 

section 604] under this subsection may 

extend the date for termination of 

production of any class I substance to a 

date more than 7 years after January 1 

of the year after the year in which the 

substance is added to the list of class I 

substances.’’ 

At the Seventh Meeting of the Parties 

(MOP) in 1995, the Parties made 

adjustments to the methyl bromide 

control measures and agreed to 

reduction steps and a 2010 phase-out 

date for industrialized countries with 

exemptions permitted for critical uses. 

At that time, the United States 

continued to have a 2001 phase-out date 

in accordance with section 602(d) of 

CAAA of 1990. At the Ninth MOP in 

1997, the Parties agreed to further 

adjustments to the phase-out schedule 

for methyl bromide in industrialized 

countries, with reduction steps leading 

to a 2005 phase-out. 

In October 1998, the U.S. Congress 

amended CAA to conform the U.S. 

schedule to the schedule specified 

under the Protocol for developed 

countries by requiring EPA to move the 

date for ending production to January 1, 

2005 and authorizing EPA to provide 

certain exemptions. These amendments 

were contained in section 764 of the 

1999 Omnibus Consolidated and 

Emergency Supplemental 

Appropriations Act (Pub. L. 105–277, 

October 21, 1998) and were codified in 

section 604 of CAA. (42 U.S.C. 7671c). 

The amendment that specifically 

addresses the critical use exemption 

(CUE) appears at section 604(d)(6), 42 

U.S.C. 7671c(d)(6). EPA revised the 

phase-out schedule for methyl bromide 

production and consumption in a direct 

final rulemaking on November 28, 2000 

(65 FR 70795) (FRL–6906–4), which 

allowed for the phased reduction in 

methyl bromide consumption specified 

under the Protocol and extended the 

phase-out to 2005. EPA again amended 

the regulations to allow for an 

exemption for quarantine and 

preshipment purposes with an interim 

final rule on July 19, 2001 (66 FR 

37752)(FRL–7014–5) and with a final 

rule on January 2, 2003 (68 FR 

238)(FRL–7434–1). 

On December 23, 2004 (69 FR 

76982)(FRL–7850–8), EPA published a 

final rule that established the framework 

for the CUE; set forth a list of approved 

critical uses for 2005; and specified the 

amount of methyl bromide that could be 

supplied in 2005 from stocks and new 

production or import to meet the needs 

of approved critical uses. EPA 

subsequently published rules applying 

the CUE framework to the 2006, 2007, 

2008, 2009, and 2010 control periods. 

Since its introduction in 2004, 

sulfuryl fluoride has served as an 

alternative to methyl bromide with 

regard to methyl bromide’s use as a 

post-harvest commodity fumigant and 

fumigant for food processing 

warehouses and facilities. Introduction 

of sulfuryl fluoride has played a 

significant role in the United States’ 

reduction of the postharvest methyl 

bromide CUEs by almost 80% over the 

last 6 years. 

IV. Regulatory History of Sulfuryl 

Fluoride 

A. In General 

Sulfuryl fluoride is a fumigant that is 

used to kill insect pests, rodents, birds, 

and snakes. It is used both for the 

treatment of structures as well as stored 

food. Sulfuryl fluoride was initially 

registered under FIFRA as Vikane®, a 

fumigant to treat drywood termites and 

other wood boring insects in 1959. More 

recently, sulfuryl fluoride was identified 

as a potential alternative for uses of 

methyl bromide as a food fumigant and 

as a fumigant of food processing 

facilities. It was registered under the 

name of ProFume® by Dow 

AgroSciences for these uses in 2004 and 

2005. Sulfuryl fluoride has achieved 

significant penetration of several methyl 

bromide markets. EPA and Dow 

AgroSciences have concluded that 

sulfuryl fluoride is used in 

approximately 40% of mills and food 

processing facilities and is used on 

100% of cocoa beans. More recently, 

sulfuryl fluoride has been used 

extensively in fumigating walnuts and 

dried fruit other than raisins. 

Sulfuryl fluoride rapidly breaks down 

to form sulfate and the fluoride anion. 

B. 2004 Registration and Tolerances 

In 2004, EPA registered sulfuryl 

fluoride for use as a direct fumigant of 

various grains and dried fruits under 

FIFRA and established corresponding 

tolerances under FFDCA section 408. 

(69 FR 3240, January 23, 2004)(FRL– 

7342–1). Tolerances were established 

for both the parent chemical, sulfuryl 

fluoride, and the breakdown product, 

fluoride. (For convenience, both the 

sulfuryl fluoride and fluoride tolerances 

established in association with the use 

of sulfuryl fluoride are, hereinafter, 

referred to in this document as sulfuryl 

fluoride tolerances.) Separate risk 

assessments were conducted for sulfuryl 

fluoride and fluoride. 

In assessing the risk of fluoride, EPA 

relied on the MCLG that had been 

established under SDWA to establish a 

RfD-like value for fluoride. Established 

in 1986, the fluoride MCLG is 4 mg/L 

and is based on the adverse effect of 

crippling skeletal fluorosis. (40 CFR 

141.41). As was the case with the 

MCLG, EPA determined that dental 

fluorosis was not an adverse effect and 

thus was not an appropriate benchmark 

for evaluating the safety of fluoride 

under FFDCA. EPA also determined 

that, ‘‘given the wealth of reliable 

human data on fluoride,’’ the 

presumptive additional 10X children’s 

safety factor could be removed. (69 FR 

3253) (FRL–7342–1). Using the MCLG in 

combination with high-end water 

consumption information and body 

weights for age subgroups from infants 

through adults, EPA calculated safe 

fluoride levels on a milligram of 

fluoride per kilogram of body weight per 

day (mg/kg/day) basis. (69 FR 3248) 

(FRL–7342–1). These RfD-like values 

were compared to estimated aggregate 

exposure levels to fluoride from 

numerous sources: From use of the 

pesticides sulfuryl fluoride and cryolite 

on food; from natural and artificial 

levels of fluoride in drinking water; 

from background levels of fluoride in 

beverages, food, and ambient air; and 

from fluoride in dental products. 

Because aggregate exposure for each of 


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the age-based population subgroups fell 

below the calculated RfD-like values, 

EPA concluded that the tolerances were 

safe. 

Although FAN did not submit 

comments on the notice announcing 

Dow AgroSciences’ petition for 

tolerances, FAN had submitted 

objections to an earlier sulfuryl fluoride 

tolerance action. That earlier tolerance 

action was the establishment of 

temporary tolerances for sulfuryl 

fluoride on various grains and dried 

fruits in conjunction with an 

experimental use permit for sulfuryl 

fluoride under FIFRA section 5. (7 

U.S.C. 136c). Sulfuryl fluoride was 

never used under that experimental 

permit and the temporary tolerances 

were revoked with the establishment of 

the 2004 tolerances. However, EPA 

treated the FAN objections as comments 

on the petition for tolerances and 

responded to them in detail in 

promulgating the 2004 tolerances. (Refs. 

13, 14 and 15). Because EPA recognized 

that the NAS was undertaking a 

comprehensive evaluation of the latest 

data on fluoride, EPA noted that its 

review of the data submitted by FAN 

was preliminary and subject to 

reevaluation once the NRC Report was 

complete. (Ref. 14). 

On March 23, 2004, FAN, joined by 

Beyond Pesticides, filed objections to 

the 2004 tolerances and requested a 

hearing on those objections. (See Unit 

IV.D.). 

C. 2005 Registration and Tolerances 

In 2005, EPA registered sulfuryl 

fluoride for use as a direct fumigant on 

additional commodities and also as a 

structural fumigant for food processing 

facilities under FIFRA and established 

corresponding tolerances under FFDCA 

section 408. (70 FR 40899, July 15, 

2005) (FRL–7723–7). Again, EPA relied 

on the MCLG in assessing the aggregate 

risk to fluoride, taking into account the 

additional fluoride exposure from the 

new uses. (Id. at 40905). EPA also 

assessed fluoride risk using the Point of 

Departure suggested by NAS’ Institute of 

Medicine for evaluating the risk of 

crippling skeletal fluorosis. (Id. at 

40906). Under both approaches, EPA 

concluded that the tolerances were safe. 

FAN submitted comments on the 

notice announcing Dow AgroSciences’ 

petition for tolerances. EPA prepared a 

detailed response to these comments. 

(Ref. 16). 

On September 13, 2005, FAN, joined 

by Beyond Pesticides and the 

Environmental Working Group, filed 

objections to the 2005 tolerances and 

requested a hearing on those objections. 

(See Unit IV.D.). 

D. The 2006 NRC Report 

In 2003, EPA’s Office of Water (OW) 

asked the NRC to review new research 

on fluoride to determine whether the 

MCLG and SMCL for fluoride 

established under SDWA adequately 

protect the public health. (Ref. 17 at xii). 

Specifically, EPA asked NRC ‘‘to review 

toxicologic, epidemiologic, and clinical 

data on fluoride—particularly data 

published since NRC’s previous (1993) 

report—and exposure data on orally 

ingested fluoride from drinking water 

and other sources * * *, ’’ and ‘‘to 

evaluate independently the scientific 

basis of EPA’s MCLG of 4 mg/L and 

SMCL of 2 mg/L in drinking water and 

the adequacy of those guidelines to 

protect children and others from 

adverse health effects.’’ (Id. at 2). NRC 

was also asked to identify data gaps and 

to make recommendations for future 

research relevant to setting the MCLG 

and SMCL for fluoride.’’ (Id.). 

NRC completed its report in March 

2006. Its overall conclusions were that: 

(1) ‘‘EPA’s MCLG of 4 mg/L should be 

lowered;’’ (2) further study was needed 

to assess the protectiveness of the SMCL 

of 2 mg/L; and (3) ‘‘EPA should update 

the risk assessment of fluoride to 

include new data on health risks and 

better estimates of total exposure 

(relative source contribution) in 

individuals and to use current 

approaches to quantifying risk, 

considering susceptible subpopulations, 

and characterizing uncertainties and 

variability.’’ (Id. at 352). 

NRC’s decision as to the MCLG was 

driven by its concern regarding the 

fluoride exposure levels that produce 

the following effects: Severe enamel 

fluorosis (referred to in this document 

generally as severe dental fluorosis); 

clinical stage II skeletal fluorosis; and 

bone fractures. (Id.). Previously, all 

forms of dental fluorosis had been 

regarded merely as cosmetic effects and 

thus not properly considered in setting 

a MCLG. In the 2006 Report, NRC stated 

that: ‘‘The damage to teeth caused by 

severe enamel fluorosis is a toxic effect 

that the majority of the committee 

judged to be consistent with prevailing 

risk assessment definitions of adverse 

health effects.’’ (Id. at 127). NRC 

reasoned as follows: 

Severe enamel fluorosis is characterized by 

enamel loss and pitting. This damage 

compromises enamel’s protective barrier and 

can make the teeth more susceptible to 

environmental stresses and to caries 

formation because it allows bacteria, plaque, 

and food particles to become entrapped in 

the enamel. Caries is dental decay caused by 

bacterial infection. When the infection goes 

unchecked, cavities may form that can cause 

toothache and tooth sensitivity to 

temperature and sweets. If cavities are 

untreated, the infection can lead to abscess, 

destruction of bone, and spread of the 

infection to other parts of the body. While 

increased risk of caries has not been firmly 

established, the majority of the committee 

found that destruction of the enamel and the 

clinical practice of treating the condition 

even in the absence of caries provide 

additional lines of evidence for concluding 

that severe enamel fluorosis is an adverse 

health effect. 

(Id. at 346) (citation omitted). 

Two of the 12 members of the NRC 

committee ‘‘did not agree that severe 

enamel fluorosis should now be 

considered an adverse health effect’’ and 

would have characterized it as an 

‘‘adverse dental effect.’’ (Id.). 

Nonetheless, these two committee 

members concurred in the overall NRC 

conclusion that the MCLG should 

protect against this effect. Specifically, 

the Report stated: ‘‘Despite their 

disagreement on characterization of the 

condition, these two members 

concurred with the committee’s 

conclusion that the MCLG should 

prevent the occurrence of this unwanted 

condition.’’ (Id.). Turning to the level of 

exposure that can cause severe dental 

fluorosis, NRC concluded that such 

fluorosis occurs at an ‘‘appreciable 

frequency’’ in communities with water 

supplies containing at or near 4 mg/L 

but that ‘‘the prevalence of severe 

enamel fluorosis would be reduced to 

nearly zero by bringing the water 

fluoride levels in these communities 

down to below 2 mg/L.’’ (Id. at 127– 

128). 

As to skeletal fluorosis, NRC 

concluded that the MCLG should not be 

based solely on stage III (crippling) 

skeletal fluorosis but also take into 

account stage II skeletal fluorosis (the 

stage before mobility is significantly 

affected). Although the data on what 

level of fluoride exposure was need to 

cause stage II skeletal fluorosis was 

inconclusive, NRC ventured that the 

data ‘‘suggest[] that the MCLG might not 

protect all individuals from the adverse 

stages of the condition.’’ (Id. at 347). 

NRC advised that ‘‘more research is 

needed to clarify the relationship 

between fluoride ingestion, fluoride 

concentrations in bone, and stage of 

skeletal fluorosis.’’ (Id.). 

NRC found the evidence on the level 

of fluoride exposure which could lead 

to an increased risk of bone fracture to 

be somewhat more compelling. There 

was general agreement by NRC with the 

proposition ‘‘that there is scientific 

evidence that under certain conditions 

fluoride can weaken bone and increase 

the risk of fractures.’’ (Id. at 348). 

Further, ‘‘the majority of the committee 


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concluded that lifetime exposure to 

fluoride at drinking water 

concentrations of 4 mg/L or higher is 

likely to increase fracture rates in the 

population, compared with exposure to 

1 mg/L, particularly in some 

demographic subgroups that are prone 

to accumulate fluoride into their bones 

(e.g., people with renal disease).’’ (Id.). 

Three members of the NRC committee 

reached a more tempered conclusion 

suggesting that ‘‘the evidence only 

supported a conclusion that the MCLG 

might not be protective against bone 

fracture.’’ (Id.) (emphasis in original). 

Turning to the SMCL, NRC noted that, 

even if this standard now only 

addresses, at worst, moderate dental 

fluorosis, the 2 mg/L ‘‘SMCL does not 

completely prevent the occurrence of 

moderate enamel fluorosis.’’ (Id. at 352). 

Specifically, NRC found that ‘‘[p]ast 

evidence indicated an incidence range 

of 4% to 15% (50 FR 20164 [1985]).’’ 

(Ref. 17 at 130). NRC indicated that 

‘‘[t]he prevalence of moderate cases that 

would be classified as being of aesthetic 

concern (discoloration of the front teeth) 

is not known but would be lower than 

15%.’’ (Id.). In the end, NRC 

recommended further study of U.S. 

communities with drinking water 

fluoride levels of greater than 1 mg/L to 

better characterize the degree and 

consequences of moderate dental 

fluorosis and the levels at which these 

effects occur. (Id. at 352–353). 

NRC also examined in detail whether 

fluoride caused reproductive, 

developmental, neurotoxic, 

neurobehavioral, or cancer effects or 

had adverse effects on the endocrine, 

gastrointestinal, renal, hepatic, and 

immune systems. Although NRC 

recommended further study with regard 

to many of these effects, it did not 

conclude that any of these potential 

effects warranted a lowering of the 

MCLG. 

A substantial portion of the NRC 

Report is devoted to examining fluoride 

exposure in the United States. NRC 

considered exposures from drinking 

water; background levels in food, 

beverages, soil, and air; residues in food 

from pesticide usage; and dental 

products. Drinking water was generally 

the most significant source but certain 

age groups’ exposures from background 

levels in food and water and from dental 

products were not insubstantial. (Id. at 

60, Fig.2–1). NRC summarized the 

information on fluoride levels in water 

from public systems as follows: 

Of the 144 million people with fluoridated 

public water supplies in 1992, approximately 

10 million (7%) received naturally 

fluoridated water, the rest had artificially 

fluoridated water. Of the population with 

artificially fluoridated water in 1992, more 

than two-thirds had a water fluoride 

concentration of 1.0 mg/L, with almost onequarter having lower concentrations and 

about 5% having concentrations up to 1.2 

mg/L. 

Of the approximately 10 million people 

with naturally fluoridated public water 

supplies in 1992, approximately 67% had 

fluoride concentrations ≤ 1.2 mg/L. 

Approximately 14% had fluoride 

concentrations between 1.3 and 1.9 mg/L and 

another 14% had between 2.0 and 3.9 mg/L; 

2% (just over 200,000 persons) had natural 

fluoride concentrations equal to or exceeding 

4.0 mg/L. 

(Id. at 25) (citations omitted). 

As to persons who rely on private 

water sources, NRC noted: 

Little information is available on the 

fluoride content of private water sources, but 

the variability can reasonably be expected to 

be high and to depend on the region of the 

country. Fluoride measured in well water in 

one study in Iowa ranged from 0.06 to 7.22 

mg/L (mean, 0.45 mg/L); home-filtered well 

water contained 0.02–1.00 mg/L (mean, 0.32 

mg/L). Hudak (1999) determined median 

fluoride concentrations for 237 of 254 Texas 

counties (values were not determined for 

counties with fewer than five observations). 

Of the 237 counties, 84 have median 

groundwater fluoride concentrations 

exceeding 1 mg/L; of these, 25 counties 

exceed 2 mg/L and five exceed 4 mg/L. 

Residents in these areas (or similar areas in 

other States) who use groundwater from 

private wells are likely to exceed current 

guidelines for fluoride intake. 

(Id. at 25–26). 

E. The Objectors’ Objections and 

Hearing Requests 

1. Procedural history. The Objectors 

have filed several sets of objections and 

hearing requests on the 2004 and 2005 

tolerance actions as a result of various 

preliminary responses by EPA to FAN’s 

requests for hearing. As noted, the 

Objectors filed objections and hearing 

requests on March 23, 2004, as to the 

2004 tolerance action. On June 4, 2005, 

EPA responded by letter to the 

Objectors’ hearing request noting 

numerous potential flaws in the request 

and giving the Objectors 90 days to 

respond to the issues raised. On July 15, 

2005, EPA issued additional tolerances 

for sulfuryl fluoride/fluoride and on 

September 13, 2005, the Objectors 

submitted objections and hearing 

requests as to these tolerances. Then, on 

December 16, 2005, Objectors submitted 

a revised set of objections and hearing 

requests in response to EPA’s earlier 

letter. EPA responded to the December 

16, 2005 filing on February 13, 2006, 

seeking further clarification on several 

issues and giving the Objectors 90 days 

to respond. On November 6, 2006, the 

Objectors filed a second set of revised 

objections and hearing requests that 

consolidated their objections to both the 

2004 and 2005 tolerance actions. (Ref. 

3). 

The Objectors have made two 

additional filings with EPA. First, on 

June 1, 2006, the Objectors filed with 

EPA a motion for a stay of 2004 and 

2005 tolerance actions. (Ref. 2). This 

stay request was largely in response to 

the NRC Report on fluoride. Second, in 

February 2009, the Objectors filed a 

collection of 18 studies addressing 

potential effects of fluoride exposure on 

IQ levels in children. (Ref. 18). 

2. Consolidated objections and 

hearing requests. The Objectors’ 

consolidated objections and hearing 

requests filed in November, 2006, raise 

six main arguments: 

• The fluoride MCLG is not protective 

of the effects of fluoride on teeth and 

bones; 

• The fluoride MCLG is not protective 

of other neurotoxic, endocrine, and 

renal effects of fluoride; 

• EPA has not adequately protected 

children; 

• EPA cannot determine the safety of 

sulfuryl fluoride and fluoride in the 

absence of a developmental 

neurotoxicity study; 

• EPA has underestimated exposure 

to fluoride; and 

• EPA has committed procedural 

errors in violation of the Administrative 

Procedures Act (APA) (5 U.S.C. 551 et 

seq.). 

The Objectors argue that the 4 mg/L 

MCLG for fluoride does not provide 

adequate protection against severe 

dental fluorosis, pre-crippling skeletal 

fluorosis, and increased risk of bone 

fractures. The Objectors cite to 

government and literature studies 

documenting the significant 

consequences from severe dental 

fluorosis: ‘‘The enamel of the teeth 

become so porous that the teeth are 

‘prone to fracture and wear’ (ATSDR 

2003), ‘subject to extensive mechanical 

breakdown of the surface’ (Aoba & 

Fejerskov 2002), with a ‘friable enamel 

that can result in loss of dental function’ 

(Burt & Eklund 1999).’’ (Ref. 3 at 16). On 

pre-crippling skeletal fluorosis, the 

Objectors assert that pre-crippling 

skeletal fluorosis can be a painful 

condition for some people. (Id. at 19). 

Finally, the Objectors cite to many 

studies on the risk of increased bone 

fractures from fluoride exposure that 

allegedly show that these increased 

risks occur at fluoride exposure levels 

lower than those in communities with 

drinking water levels of 4 mg/L. (Id. at 

22–24). 

The Objectors also argue that the 4 

mg/L MCLG for fluoride does not 


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protect against fluoride’s effects on the 

brain, the endocrine system, and the 

kidneys. The Objectors cited a study in 

rats allegedly showing brain damage at 

a fluoride exposure level in water of 1 

ppm [1 mg/L] and epidemiological 

studies showing reductions in IQ levels 

in children at a fluoride exposure level 

of 0.9 ppm [0.9 mg/L] in iodinedeficient areas and 1.8 ppm [1.8 mg/L] 

in areas with sufficient iodine in the 

diet. (Id. at 25–26). As to the endocrine 

system, the Objectors reference the NRC 

Report’s conclusion that fluoride is an 

‘‘endocrine disruptor’’ and argue that 

fluoride can have adverse effects on 

insulin secretion and on the thyroid. (Id. 

at 31–35). The Objectors argue that 

fluoride can affect insulin secretion 

where drinking water contains 4 mg/L 

or less of fluoride, (Id. at 33), and that 

NRC has concluded that thyroid effects 

can occur at exposure levels as low as 

0.01–0.03 mg/kg/day for iodinedeficient humans, (Id. at 35). As to the 

kidneys, the Objectors claim that data 

show that adverse effects can occur 

when exposure levels in water are at the 

1 and 2 mg/L level. (Id. at 38–39). 

With regard to the safety of children, 

the Objectors assert that EPA, without 

basis or explanation, has applied a 

significantly less protective RfD to 

infants and children than the RfD 

applicable to adults. The Objectors note 

that prior to the promulgation of the 

2004 fluoride tolerances EPA had 

utilized a RfD of 0.114 mg/kg/day for all 

population age groups. (Id. at 59). The 

Objectors point out, however, that, in 

both the 2004 and 2005 tolerance 

actions, EPA increased the RfD for 

several of the infant and children age 

groups to levels that are allegedly as 

much as 10 times higher than the RfD 

for adults. This higher RfD for infants 

and children, the Objectors argue, is 

inconsistent with the statutory 

requirement for providing an additional 

margin of safety for infants and 

children, the basic toxicological 

principle that bodyweight affects the 

impact of a chemical, data showing 

adverse effects at levels below the RfD 

levels, and data showing that children’s 

bones are more sensitive to fluoride 

than adult’s bones. (Id. at 58–67). 

Further, the Objectors assert that EPA 

failed to take into account, in its 

decision on the safety of fluoride to 

infants and children, the uncertainty in 

the database concerning fluoride’s 

neurotoxic effects, and fluoride’s effects 

on the endocrine system. (Id. at 68–70). 

A developmental neurotoxicity study 

on sulfuryl fluoride, the Objectors 

claim, is critical to understanding the 

potential harmful effects of sulfuryl 

fluoride and fluoride. They argue that 

EPA’s reasons for waiving the study lack 

merit and that a developmental 

neurotoxicity study is mandated given 

NRC’s conclusion that fluoride is 

neurotoxic and that effects on the brain, 

including rare and severe effects, were 

seen in animal studies with sulfuryl 

fluoride. (Id. at 72–79). 

Turning to human exposure to 

fluoride, the Objectors argue that EPA 

has underestimated fluoride exposure 

and corrected fluoride values show that 

some people are exposed to unsafe 

levels of fluoride. The Objectors claim 

EPA made numerous errors in 

estimating fluoride exposure: (1) EPA 

underestimated average fluoride levels 

in water, (Id. at 81–82); (2) EPA 

considered only average water and food 

consumption levels instead of taking 

into account the full range of 

consumption amounts, (Id. at 82–84, 

105–106); (3) EPA underestimated 

fluoride exposures from toothpaste, (Id. 

at 88–91); and (4) EPA had insufficient 

data to estimate residues of fluoride on 

food from fumigation with sulfuryl 

fluoride (Id. at 106). The Objectors 

contend that a risk assessment using 

corrected exposure values will show 

that hundreds of thousands of people 

exceed the 0.114 mg/kg/day RfD and 

that millions of people would exceed a 

RfD set based on an endpoint of severe 

dental fluorosis. (Id. at 86, 94–95). 

Finally, the Objectors claim that EPA 

has made several procedural errors that 

violate the dictates of the APA. First, the 

Objectors argue that EPA has 

unreasonably delayed responding to 

their objections and hearing requests 

filed in March 2004. Second, the 

Objectors argue that EPA erred by not 

making its risk assessment available at 

the time of issuance of the 2005 

tolerance action. Third, EPA’s failure to 

place all requested documents in the 

record, according to the Objectors, has 

thwarted full public participation. 

Fourth, the Objectors assert it was a 

procedural error for EPA to issue 

sulfuryl fluoride tolerances without first 

obtaining the advice of NRC. 

The Objectors have also sought an 

adjudicatory hearing on each of these 

objections. In support of their hearing 

request, the Objectors have submitted 

all the data referenced in their 

consolidated objections. 

F. The Objectors’ Stay Request 

On June 1, 2006, the Objectors filed a 

motion with EPA seeking a stay of the 

effectiveness of the 2004 and 2005 final 

rules establishing sulfuryl fluoride 

tolerances. A stay of the effectiveness of 

these rules would essentially ban use of 

sulfuryl fluoride because if the 

tolerances are not effective then any 

sulfuryl fluoride or fluoride residue 

remaining in treated foods would render 

the food adulterated under FFDCA and 

subject to seizure. This stay request 

appears to have been triggered by the 

March 2006 release of the NRC Report 

on fluoride. (Ref. 2 at 4). The Objectors 

argued they were entitled to a stay 

because they had demonstrated (1) that 

they were likely to prevail on the merits 

of their objections; (2) the tolerances 

posed an imminent, substantial and 

irreparable harm; (3) no other parties 

would be substantially harmed by a 

stay; and (4) the public interest 

supported a stay. (Id. at 2). EPA held a 

30-day comment period on the stay 

request. (71 FR 38125, July 5, 2006) 

(FRL–8075–6). 

To support their likelihood of success 

on the merits argument, the Objectors 

make similar arguments to those 

contained in their consolidated 

objections. As to irreparable harm, the 

Objectors cite to the NRC Report 

claiming it linked fluoride not just to 

adverse effects on bones and teeth but 

also to interactive and synergistic toxic 

effects with other chemicals, cancer, 

and diabetes, as well as adverse effects 

on the brain, thyroid, pineal gland, 

kidney, liver, and the endocrine, 

immune, gastrointestinal, and 

reproduction systems. (Ref. 2 at 11, 13– 

15). Further, the Objectors cite to the 

‘‘high levels of fluoride from pesticides’’ 

arguing that ‘‘[a]s a result of these broadreaching, staggeringly high fluoride 

tolerances, EPA’s own data show that 

sulfuryl fluoride will become the second 

largest daily source of fluoride in the 

US.’’ (Id. at 3, 35). The Objectors assert 

that other parties, including Dow 

AgroSciences, will not be substantially 

harmed ‘‘in view of the overwhelming 

concern for public health at the heart of 

the statute.’’ (Id. at 36). Finally, the 

Objectors argue the public interest 

favors a stay because a stay would 

protect the public health. (Id. at 37). 

G. Comments of Dow AgroSciences 

Dow AgroSciences has filed two sets 

of comments on these matters. First, 

Dow AgroSciences filed comments on 

the Objectors’ request for a stay of the 

effectiveness of the sulfuryl fluoride 

tolerances during the public comment 

period during mid-2006. (Ref. 19). 

Second, in October 2006, Dow 

AgroSciences submitted a memorandum 

to EPA arguing that the Objectors’ were 

not entitled to a hearing on their 

objections. (Ref. 20). 

1. Comments on stay request. In its 

comments, Dow AgroSciences offered a 

series of reasons as to why a stay was 

not warranted. First, Dow AgroSciences 

argues that EPA should follow the 


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already-established process for how the 

sulfuryl fluoride/fluoride tolerances 

would be reviewed in light of the NRC 

Report. This process, according to Dow 

AgroSciences, involves an analysis of 

the NRC Report by EPA’s OW followed 

by a re-evaluation of the tolerances by 

EPA’s OPP. (Ref. 19 at 6–7). Dow 

AgroSciences asserts that ‘‘[a]bandoning 

now a process established by the 

Agency and relied upon by SF 

registrants and the scientific community 

would be arbitrary, unfair and 

unwarranted.’’ (Id. at 7). 

Second, Dow AgroSciences argues 

that the stay request is delinquent 

because it was not filed within 60 days 

of issuance of the final tolerance 

actions. (Id. at 8). Dow AgroSciences 

bases this claim on the statutory 

requirement that objections to a 

tolerance must be filed within 60 days 

of issuance. 

Third, Dow AgroSciences claims that 

a stay of the tolerance action is 

inappropriate because the stay request 

does not address ‘‘the underlying 

ProFume registration under FIFRA 

* * *.’’ (Id. at 10). According to Dow 

AgroSciences, ‘‘[b]ypassing the hearing 

rights and other procedural 

requirements provided by FIFRA would 

deny Dow AgroSciences and other 

adversely affected parties their due 

process rights under the U.S. 

Constitution.’’ (Id. at 9). 

Fourth, Dow AgroSciences argues that 

the NRC Report only indicates a concern 

for ‘‘that small, localized segment of the 

population exposed to high natural 

fluoride levels.’’ (Id. at 12). Such ‘‘an 

exceedingly small, isolated number of 

individuals,’’ Dow AgroSciences 

contends, would not constitute a ‘‘major 

identifiable’’ subgroup which is the 

regulatory focus under FFDCA section 

408. (Id.). 

Fifth, Dow AgroSciences challenged 

the Objectors’ claims that the NRC 

Report showed that there is a safety 

concern with fluoride. Dow 

AgroSciences noted that as to many 

potential health effects the NAS had 

either concluded that no risks were 

present from exposure in drinking water 

at 4 mg/L or there was insufficient data 

showing effects and more study was 

necessary. (Id. at 14). With regard to 

fluoride’s effects on the risk of bone 

fractures, Dow AgroSciences argues that 

EPA had previously dismissed the value 

of two studies on which NRC relied and 

implies that NRC did not give proper 

weight to a recent study from the 

University of Michigan. (Id. at 15–16). 

Further, Dow AgroSciences claims that 

NRC actually had little concern for a 

potential link between fluoride and 

stage II skeletal fluorosis. According to 

Dow AgroSciences, NRC emphasized 

insufficiency of data on this effect and 

merely called for more research. (Id. at 

18). Finally, Dow AgroSciences 

contends that NRC stepped beyond its 

competence in offering advice on the 

legal conclusion of whether severe 

dental fluorosis is an adverse health 

effect. (Id. at 19). Dow AgroSciences 

notes that a prior NRC panel had 

declined to make this ultimate 

conclusion and that a prior court ruling 

had indicated this was a question of 

statutory interpretation under SDWA. 

(Id. at 19–20). Switching tacks, Dow 

AgroSciences then argues there is a 

dispute within the scientific community 

as to whether severe dental fluorosis is 

an adverse effect. (Id. at 20). 

Sixth, Dow AgroSciences argues that 

EPA is not authorized to consider 

exposure to fluoride from artificial 

fluoridation of public water supplies in 

evaluating the safety of the sulfuryl 

fluoride/fluoride tolerances. (Id. at 21). 

Although acknowledging that FFDCA 

section 408 directs EPA to consider 

‘‘aggregate exposure’’ to both pesticides 

and other related substances, Dow 

AgroSciences contends that ‘‘[i]t is 

unnecessarily strained and 

counterintuitive to set tolerances for 

pesticides in or on food by looking at 

the therapeutic use of chemically 

related substances in humans.’’ (Id.). As 

support for this proposition, Dow 

AgroSciences asserts that the definition 

of ‘‘pesticide chemical residue’’ limits 

EPA to considering pesticide chemicals 

and their degradates and metabolites. 

Further, Dow AgroSciences claims that 

the most plausible reading of the term 

‘‘other related substances’’ is that this 

term covers other related ‘‘pesticidal’’ 

substances. (Id.at 22). 

Finally, Dow AgroSciences claims 

that EPA overestimated exposure to 

fluoride from use of sulfuryl fluoride. 

Specifically, Dow AgroSciences states 

that its records show that sulfuryl 

fluoride has been utilized less 

extensively than EPA projected and at 

lower rates than EPA expected. (Id. at 

34–35). When more realistic values are 

used in the exposure assessment, Dow 

AgroSciences contends that fluoride 

exposure from use of sulfuryl fluoride 

declines by over 80%. (Id. at 35). 

2. Comments on the hearing requests. 

In a memorandum submitted to EPA in 

October 2006, Dow AgroSciences 

offered several reasons as to why the 

Objectors were not entitled to a hearing 

on their claims. First, Dow 

AgroSciences argues that many of the 

issues raised by the Objectors fail to 

state a material issue of fact because 

they are contingent in nature or 

otherwise fail to raise a disputed matter. 

(Ref. 20 at 9). Second, Dow 

AgroSciences claims that a number of 

the Objectors’ issues dispute science 

policy determinations by EPA and thus 

do not constitute a matter of fact to be 

resolved at a hearing. (Id. at 11). For 

example, Dow AgroSciences identifies 

EPA conclusions regarding issues such 

as what constitutes a ‘‘conservative 

assumption,’’ a ‘‘significant 

subpopulation,’’ or an ‘‘adverse health 

effect’’ as decisions based on policy, as 

opposed to factual, reasons. Third, Dow 

AgroSciences asserts that the Objectors’ 

claim of procedural errors by EPA is a 

legal issue not appropriate for a hearing. 

Fourth, Dow AgroSciences argues that 

many of the Objectors’ claims are ‘‘no 

more than mere disagreements with 

Agency determinations made in earlier 

stages of the rulemaking process.’’ (Id. at 

12–13). According to Dow 

AgroSciences: 

In many instances, Objectors support their 

issues by citing to studies that have already 

been reviewed by EPA and have, either 

expressly or effectively, been found 

scientifically inadequate, procedurally 

flawed, or lacking in the requisite amount of 

empirical support. Objectors cite to these 

studies in spite of the clear edict that ‘‘[m]ere 

differences in the weight or credence given 

to particular scientific studies * * * are 

insufficient’’ to prompt EPA to hold a 

hearing. [citation omitted]. Clearly, Objectors 

disagree with EPA’s interpretations of these 

studies, but such disagreement is irrelevant 

in the Agency’s decision to grant a hearing 

on the objections submitted. 

(Id. at 13). 

Fifth, Dow AgroSciences contends 

that the Objectors have not submitted 

sufficient evidence in support of their 

claims based on Dow AgroSciences’ 

conclusion that the NRC Report, upon 

which the Objectors rely, does not in 

fact substantiate the Objectors’ position. 

(Id.) Finally, even where the NRC 

Report does support the Objectors’ 

claims, Dow AgroSciences asserts that a 

hearing is not appropriate because the 

NRC Report was performed under the 

aegis of SDWA to review the fluoride 

MCLG and SMCL and not the sulfuryl 

fluoride/fluoride tolerances and because 

the NRC Report did not generate new 

data but simply reviewed studies 

already examined by EPA. (Id. at 17– 

18). Dow AgroSciences concludes that 

the ‘‘NRC’s differences in opinion on the 

three issues detailed below [bone 

fracture, skeletal fluorosis, severe dental 

fluorosis] are just that—mere differences 

of opinion—and should be evaluated as 

such.’’ (Id. at 18). 

V. EPA’s Proposed Response to the 

Objections 

EPA is proposing to grant the 

objections to the establishment of the 


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sulfuryl fluoride/fluoride tolerances 

based on EPA’s agreement with the 

Objectors that (1) fluoride risks should 

be assessed based upon a more sensitive 

endpoint than crippling skeletal 

fluorosis; and (2) assessing fluoride risks 

on a more sensitive endpoint shows that 

aggregate exposure to fluoride for major 

identifiable subgroups does not meet the 

safety standard in FFDCA section 408. 

In reaching this conclusion, EPA has 

taken into account, in addition to the 

arguments and data submitted by the 

Objectors, the 2006 NRC Report on 

fluoride, the detailed analysis of that 

Report and followup peer-reviewed 

assessment of fluoride by EPA’s OW, 

and a revised risk assessment of fluoride 

performed by EPA’s OPP in light of the 

NRC Report, and usage information 

submitted by Dow AgroSciences. (All of 

these materials have been included in 

the docket for this action.). The 

conclusions of the NRC Report are 

described in Unit IV.D. In Units V.A. 

and V.B., EPA summarizes OW’s 

reassessment of fluoride risk undertaken 

on the recommendation of NRC, OPP’s 

revised fluoride risk assessment, and 

sets forth EPA’s proposed findings on 

the safety of the sulfuryl fluoride 

tolerances. Unit V.C. addresses 

comments from Dow AgroSciences 

pertaining to the safety of fluoride, and 

in particular, the conclusions of the 

NRC Report on fluoride safety. EPA is 

inviting public comment on all aspects 

of this proposal, including the 

underlying scientific documents 

discussed in Units V.A and V.B. 

A. OW’s Reassessment of Fluoride Risk 

One of the principal conclusions of 

the NRC Report was that EPA ‘‘should 

update the risk assessment of fluoride to 

include new data on health risks and 

better estimates of total exposure 

(relative source contribution) in 

individuals and to use current 

approaches to quantifying risk, 

considering susceptible subpopulations, 

and characterizing uncertainties and 

variability.’’ (Ref. 17 at 352). As the NRC 

Report was prepared in the context of 

evaluating the fluoride MCLG and 

SMCL for drinking water, EPA’s OW 

took the lead in preparing this revised 

fluoride risk assessment. OW’s risk 

assessment was broken into two parts: 

(1) A dose-response analysis directed at 

establishing a RfD for fluoride; and (2) 

an exposure and relative source 

contribution analysis that catalogued 

and estimated the various sources of 

fluoride exposure and characterized the 

risk of that exposure. EPA’s OPP 

contributed information on exposure to 

fluoride from use of the pesticides 

sulfuryl fluoride and cryolite (which 

also breaks down to fluoride). Both parts 

of the OW risk assessment were 

subjected to an external peer review by 

scientific experts. 

1. Dose-response analysis. OW’s doseresponse analysis focused on 

‘‘examining available dose-response data 

for the critical noncancer effects of 

fluoride on teeth and bone identified by 

NRC (2006) as adverse health effects.’’ 

(Ref. 21 at 1). For the most part, OW 

relied on the extensive database of 

epidemiological studies evaluating the 

relationship between the level of 

fluoride in drinking water and severe 

dental fluorosis, dental caries, and stage 

II skeletal fluorosis. OW noted a 

preference for older studies because 

determination of fluoride exposure 

levels in more recent studies is made 

more difficult by ‘‘the widespread use of 

fluoride-containing dentifrices and 

mouth rinses, the use of fluoride 

supplements in early childhood, and the 

potential presence of fluoride in 

processed foods and beverages (a result 

of the use of fluoridated water in the 

preparation of these products).’’ (Id. at 

9). 

a. Dental fluorosis. OW reviewed 

dozens of epidemiological studies 

bearing on the relationship of fluoride 

exposure to severe dental fluorosis. OW 

concluded that these studies supported 

the NRC Report conclusion that ‘‘the 

weight of evidence indicates that the 

threshold for severe dental fluorosis 

occurs at a water fluoride level of about 

2 mg/L.’’ (Id. at 35). OW also concluded 

that one study in particular, Dean 

(1942), provided the best data set for 

conducting a dose-response analysis. 

(Id.). In reaching this conclusion, OW 

undertook a detailed examination of the 

strengths and weaknesses of the study. 

OW summarized the strengths as 

follows: 

[The study was selected] due to its large 

size and geographic scale (22 U.S. 

communities in 10 States; 5824 children), 

range of fluoride concentrations evaluated 

(from 0.0 to 14.1 mg/L), and selection of an 

appropriate age class (school children 

primarily between the ages of 9 and 14; an 

age class in which a very high percentage of 

permanent teeth have erupted). In addition, 

every tooth per subject was examined using 

the same scoring protocol, and the 

community water supplies were tested for 

fluoride content by the same chemist. This 

dataset is sufficiently large and robust to 

support statistical analysis, the protocol is 

sound, and there were few alternate sources 

of commercially available fluoride (e.g., 

mouthwash, detrifrice, etc.) or fluoridated 

community water supplies to confound the 

dental fluorosis data collected by Dean (1942) 

at the time this study was conducted (late 

1930’s and early 1940’s). 

(Id. at 92) (citations and internal crossreferences omitted). Study weaknesses, 

identified by OW, included the lack of 

data on water intake amounts and 

fluoride exposure from food and the fact 

that the analytical method used for 

measuring fluoride was not as sensitive 

to fluoride and free from sensitivity to 

interfering substances as current 

fluoride methods. (Id. at 12–13). 

Additionally, although the time period 

of the study (late 1930’s through early 

1940’s) makes assessing fluoride 

exposure levels relatively easier than it 

is today, the time period also raises 

uncertainties due to differences between 

the late 1930’s/early 1940’s and today 

with regard to ‘‘dental hygiene, dietary 

intakes, body weights and puberty/ 

hormonal condition (e.g., age of 

menarche).’’ (Id. at 13). OW concluded 

that the lack of information relating to 

exposure from food and water could be 

overcome, to a large extent, by other 

data. (Id. at 103–105; Appendix C). As 

to the analytical method, OW found that 

it was ‘‘sensitive to small increments of 

fluoride over a range of 0.0 ppm to 3.0 

ppm, the critical range for assessing the 

threshold for severe [dental] fluorosis. 

*** ’’ (Id. at 13). A full discussion of 

the study can be found in the OW’s 

dose-response report. (Id. at 10–13, 87– 

94, 103–107). 

OW also reviewed a smaller set of 

studies examining the relationship 

between dental fluorosis and dental 

caries and the relationship between 

fluoride levels in drinking water and 

dental caries. These data were examined 

to assess whether ‘‘[t]he relationship 

between caries and fluoride exposure 

displays the U-shaped dose-response 

that characterizes many nutrients where 

there are adverse effects with intakes 

that are below those that confer a benefit 

and adverse effects with intakes that are 

greater than those with benefit.’’ (Id. at 

37). After closely examining all of the 

data, OW concluded: 

Although the data are supportive of NRC 

(2006) conclusions regarding enamel pitting 

they are moderately rather than strongly 

consistent with the hypothesis that the 

pitting of the enamel leads to an increased 

risk for caries. Socioeconomic status, 

availability of dental care, and personal 

dental hygiene habits are likely to confound 

the results from individual studies of the 

caries relationship. For this reason, OW has 

selected the pitting of the dental enamel as 

the critical effect for the dose-response 

analysis. EPA finding on the caries 

association is consistent with NRC (2006) 

that the ‘‘available evidence is mixed but 

generally supportive’’. 

(Id. at 64). 

b. Skeletal fluorosis. After reviewing 

the limited data available on the 


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relationship between fluoride exposure 

and stage II skeletal fluorosis, OW 

concluded that ‘‘the currently available 

data are not sufficiently robust to 

support a dose-response analysis of the 

effects of fluoride in drinking water on 

the skeletal fluorosis.’’ (Id. at 84). 

Specifically, OW found that the limited 

data ‘‘suggested that a daily fluoride 

dose in excess of 10 mg may be required 

to produce signs of stage II skeletal 

fluorosis (except possibly in the case of 

individuals with renal disease).’’ (Id. at 

83). OW also noted that the NRC Report 

called attention to the fact that a 

drinking water fluoride level of 4 mg/L 

can result in bone fluoride levels similar 

to those associated with stage II or III 

skeletal fluorosis; however, OW 

concluded that ‘‘because of 

inconsistencies in the entire data set, it 

is unlikely that bone fluoride 

concentration can be used in a doseresponse analysis of skeletal fluorosis.’’ 

(Id. at 65). 

c. Bone fractures. OW found that 

more data were available on fluoride’s 

potential effect on bone fractures than 

skeletal fluorosis. OW concluded that 

these data (1) ‘‘in general, support the 

conclusions of NRC that relative risk of 

fracture increases with increasing 

fluoride concentration * * *.’’ (Id. at 

84); and (2) ‘‘indicate[ ] that exposure 

to concentrations of fluoride in drinking 

water of 4 mg/L and above is suggestive 

of and appears to be positively 

associated with increased relative risk of 

bone fractures in susceptible 

populations when compared to 

populations exposed to 1 mg F/L.’’ (Id. 

at 86). Nonetheless, OW also 

determined that ‘‘there is no clear 

evidence that fluoride will cause * * * 

bone fractures at levels as low as those 

associated with severe dental fluorosis.’’ 

(Id. at 86). In a parallel to fluoride’s 

effect on the frequency of dental caries, 

OW noted that there are some data 

suggesting that there is a U-shaped doseresponse curve for fluoride’s effect on 

the risk of bone fracture. Agreeing with 

the NRC Report, OW stated that fluoride 

in drinking water at 1 mg/L may result 

in a reduction of bone fractures 

compared to either higher or lower 

fluoride exposures. (Id. at 84). 

d. Quantification of dose response. 

OW’s examination of the data on severe 

dental fluorosis, stage II skeletal 

fluorosis, and bone fractures led it to 

conclude that severe dental fluorosis 

was the adverse effect due to fluoride 

exposure likely to occur at the lowest 

exposure level. (Id. at 87). As indicated 

previously, OW also identified the 1942 

Dean study as presenting the most 

useful data for conducting a doseresponse assessment. (Id.). To confirm 

the appropriateness of using the data 

from the Dean study for a dose-response 

analysis, OW analyzed the data under a 

statistical procedure known as 

categorical analysis. That analysis 

showed that ‘‘fluoride concentration in 

this dataset is significantly and 

positively associated with severity of 

effect (c2 = 1101.86, p <0.0001).’’ (Id. at 

89). OW then used the Benchmark Dose 

approach to compute a benchmark dose 

(BMD) and a benchmark dose 

confidence limit (BMDL) for severe 

dental fluorosis at various severe dental 

fluorosis response rates. The lowest 

response rate of severe dental fluorosis 

within the range of probability that the 

dataset could support was severe dental 

fluorosis affecting at least 0.5% of the 

population exposed to fluoride at a 

particular level in drinking water. (Id. at 

90–91). At a severe dental fluorosis 

response rate of 0.5%, the BMD for the 

concentration of fluoride in drinking 

water was 2.14 mg/L and the BMDL was 

1.87 mg/L. OW ran various sensitivity 

analyses to confirm these results 

including comparing them to the 

NOAEL/LOAEL approach. These 

analyses supported the use of the BMDL 

from the Dean study data. 

To establish a RfD, it was necessary to 

convert the 1.87 mg/L fluoride 

concentration in drinking water into an 

exposure value in terms of milligram of 

exposure per kilogram of body weight 

per day (mg/kg/day) and to take into 

account any other sources of fluoride 

exposure (also in terms of mg/kg/day). 

Because the Dean study did not record 

drinking water intakes or body weight, 

OW converted the 1.87 mg/L level using 

more recent data on drinking water 

intake and body weight. OW calculated 

exposure values from consumption of 

drinking water containing 1.87 mg/L for 

different age groups of children and at 

different levels of water intake within 

those age groups. After examining the 

range of values produced by this 

exercise, OW chose the value of 0.07 

mg/kg/day as the contribution of 

drinking water to the fluoride RfD at the 

time of the Dean (1942) study (values 

ranged from 0.04 mg/kg/day to 0.19 mg/ 

kg/day). That value was chosen because 

it was the most protective value 

assuming average water intake that 

provided some margin of safety above 

the IOM’s minimum adequate intake 

level for fluoride of 0.05 mg/kg/day. (Id. 

at 101–102). OW concluded that the 

only other meaningful fluoride exposure 

at the time of the Dean study was from 

fluoride in food and OW estimated that 

exposure level to be 0.01 mg/kg/day 

based on data collected in the same time 

period of the Dean study. (Id. at 104). 

Combining these two values yields 0.08 

mg/kg/day. Because the 0.08 mg/kg/day 

value only marginally exceeds the 

adequate intake value of fluoride and 

the value was primarily derived from a 

human study with a large sample size, 

OW determined that no safety or 

uncertainty factors were needed in 

computing the RfD for fluoride. (Id. at 

105–106) Thus, 0.08 mg/kg/day was 

chosen as the fluoride RfD. Although 

the RfD is based on the endpoint of 

severe dental fluorosis in children, OW 

concluded that ‘‘the RfD is applicable to 

the entire population since it is 

protective for the endpoints of severe 

fluorosis of primary teeth, skeletal 

fluorosis and increased risk of bone 

fractures in adults.’’ (Id. at 107). 

OW described its confidence in the 

RfD as ‘‘medium.’’ (Id.). OW’s degree of 

confidence turned on its analysis of the 

data in the Dean study. On one hand, 

OW noted that the Dean study was: 

• Internally consistent as evidenced 

by the BMD stability when end points 

at the high and low end of the curve 

were removed, 

• Supported by later studies on some 

of the same water sources showing 

similar concentrations, 

• Used average concentration values 

from 12 consecutive months for all but 

the three systems with the highest 

prevalence of severe dental fluorosis, 

thereby compensating for potential 

individual and seasonal variation, 

• Based on water quality data from 

the same time period, and not likely to 

have been compromised by high levels 

of interfering substances. 

(Id. at 106–107) On the other hand, OW 

found that some uncertainty flowed 

from its reliance on the Dean study 

because of the difficulties encountered 

in converting the concentrationresponse data to dose estimates for the 

RfD derivation. (Id. at 107). 

2. Exposure assessment. In evaluating 

exposure to fluoride, OW focused on the 

following potentially significant 

sources: 

• Drinking water from public 

drinking water systems; 

• Solid foods and beverages such as 

milk and juices not from concentrate; 

• Residues from the use of sulfuryl 

fluoride; 

• Beverages prepared with 

commercial water which in some cases 

may have been fluoridated; 

• Infant formula made from 

powdered concentrate; 

• Toothpaste; and 

• Incidentally ingested soil. 

OW determined fluoride exposure from 

ambient air, dietary supplements, dental 

treatments, and pharmaceuticals was 


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minimal or too episodic to be of 

consideration for assessing long-term 

exposure. (Ref. 22). 

OW evaluated fluoride levels in 

drinking water based on the largest and 

most comprehensive set of drinking 

water compliance monitoring data ever 

compiled and analyzed by the Agency. 

The data include records from 

approximately 136,000 public drinking 

water systems, many of which include 

reports of fluoride concentrations. The 

data span 8 years (1998–2005), with up 

to quarterly sample analysis for fluoride, 

depending on the system and reporting 

requirements. This amounts to 

approximately 7,000 to 12,000 quarterly 

samples depicting fluoride residues. 

There was an increase in the number of 

States reporting for the subset of data 

from 2002–2005; therefore, OW focused 

on those data when estimating exposure 

to fluoride from drinking water. For that 

time period, the average of the quarterly 

means is 0.87 ppm and the average for 

the quarterly 90th percentile values is 

1.43 ppm. OW has also sub-sampled the 

monitoring data to focus on systems that 

had at least one detection equal to or 

greater than 2 ppm fluoride. Those 

systems represent 4.6 to 8.3% of the 

reporting systems, annually, during the 

2002–2005 time frame and, over the 

4-year reporting period, served 

approximately 10 million people. For 

water consumption information, OW 

relied on data from the CSFII for those 

consumers reporting consumption of 

drinking water. OW estimated fluoride 

exposure amounts for mean and 90th 

percentile consumers of drinking water 

from public systems considering both 

mean and 90th percentile fluoride 

levels. These values ranged from 0.26 

mg/day for infants (mean consumption 

(all consumers), mean fluoride value) to 

1.99 mg/day for adults (90th percentile 

consumption (consumers-only and 

mean fluoride level . (Ref. at 68–69, 

Tables 3–5 and 3–6). For 90th percentile 

consumers consuming mean fluoride 

levels, the values ranged from 0.63 mg/ 

day for children 1 to 3 years old to 1.74 

mg/day for adults. (Id. at 94, Table 6– 

3). 

For exposure to fluoride from food, 

milk, and non-concentrated juices, OW 

relied on market basket data, dietary 

surveys, and national food consumption 

data, for various age groups. OW 

estimated that fluoride exposure from 

these sources ranged from 0.25 mg/day 

for infants to 0.47 mg/day for teenagers. 

(Id. at 90, Table 6–1). 

Fluoride exposure from residues of 

sulfuryl fluoride in food was estimated 

by OPP based on usage data and residue 

data relevant to both sulfuryl fluoride’s 

use as a direct commodity fumigant and 

as a structural fumigant. Estimated 

exposure values ranged from 0.03 mg/ 

day for infants to 0.09 mg/day for 

children 7 to 10 years old. (Id. at 96, 

Table 6–5). 

OW estimated fluoride exposure from 

beverages other than milk and nonconcentrated juices from various studies 

and national consumption data, where 

appropriate. Fluoride exposure levels 

from beverages ranged from 0.36 mg/day 

for 1–<4 year olds to 0.60 mg/day for 7 

to 11 year olds. (Id. at 92, Table 6–2). 

Fluoride exposure from toothpaste 

was estimated by OW using studies that 

measure fluoride intake by subtracting 

the amount of toothpaste left on the 

toothbrush after brushing and the 

amount expectorated from the amount 

initially placed on the toothbrush. OW 

found a high level of uncertainty with 

these data because ‘‘the confidence 

bounds around the mean values are 

indicative of high inter-individual 

variability,’’ and because the studies 

were conducted not long after release of 

FDA recommendations ‘‘for children to 

use only a pea-sized amount of 

toothpaste when brushing.’’ (Id. at 94). 

OW also relied on data showing that 

generally young children only brushed 

their teeth once per day. Toothpaste 

label directions send different signals on 

this point, both recommending for 

children 2 years of age and older that 

teeth should be brushed ‘‘preferably 

after each meal or at least twice a day’’ 

and stating that for younger children a 

dentist or doctor should be consulted. 

21 CFR 355.50(d)(1). Estimated fluoride 

exposure values ranged from 0.07 mg/ 

day for 0.5 to 1 year olds to 0.34 mg/ 

day for 1 to 4 year olds. (Id. at 94, Table 

6–4). 

OW concluded that other sources of 

fluoride exposure (e.g., air, dental 

treatments) were insignificant with the 

exception of exposure to children 

through consumption of soil. Fluoride 

concentrations in the soil in the United 

States range from less than 10 ppm to 

70,000 ppm, with mean or typical levels 

in the 300–430 ppm range. (Id. at 86). 

Assuming mean levels of fluoride in the 

soil, OW estimated fluoride exposure for 

children less than 1 year old to be 0.02 

mg/day and for children in the 0–14 age 

group to be 0.04 mg/day. (Id. at 95). 

3. Risk characterization. In 

characterizing the risk from fluoride for 

the purpose of evaluating the fluoride 

MCLG, OW compared the revised 

fluoride RfD (0.08 mg/kg/day) to the 

significant sources of fluoride exposure 

described previously. OW used average 

exposure values as to all sources of 

exposure other than drinking water. For 

drinking water, OW, examined several 

different variations of concentration 

level and consumption level, but 

principally relied on the approach in 

long-held OW policy in establishing 

national drinking water standards that 

recommends use of average fluoride 

concentrations in water and 90th 

percentile consumption levels. (Id. at 

107–110). OW’s characterization of risk 

using these assumptions is shown in 

Figure 1. 


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(Id. at 105, Figure 8–1). 

OW explained the meaning of Figure 

1 in the following manner: 

When examining Figure [1] it is important 

to remember that the RfD represents an 

exposure that is estimated to provide the 

anticaries benefits from fluoride without 

causing severe dental fluorosis in 99.5% of 

the children who drink water with 0.87 

mg/L F at a 90th percentile intake level and 

have average intakes from other media during 

the period of secondary tooth formation. 

Based on the dose-response for severe dental 

fluorosis in EPA (2010a) only 0.5% or fewer 

of children consistently ingesting fluoride at 

a level equivalent to the RfD for a several 

month period would be at risk of 

experiencing severe dental fluorosis in two or 

more teeth. 

(Id. at 104–105). 

OW noted that the data show both 

that fluoride exposure has increased 

over time and that the incidence of all 

types of dental fluorosis has also 

increased. According to OW, ‘‘The 

prevalence of dental fluorosis has 

increased from 10–12% in the areas 

with about 1 mg/L in drinking water at 

the time of Dean to 23% in 1986/87 and 

to 32% in the 1999–2002 NHANES 

survey.’’ 

(Id. at 108) (citations omitted). 

OW summarized its overall 

conclusions as follows: 

• Some young children are being 

exposed to fluoride up to about age 7 at 

levels that increase the risk for severe 

dental fluorosis. 

• The contribution of residential tap 

water to total ingested fluoride is lower 

that it was in the past. 

• Use of fluoridated water for 

commercial beverage production has 

likely resulted in increased dietary 

fluoride in purchased beverages, adding 

to the risk for over-exposure. 

• The increase of fluoride in solid 

foods because of fluoridated commercial 

process water is more variable than that 

for beverages. 

• Incidental toothpaste ingestion is an 

important source of fluoride exposure in 

children up to about 4-years of age. 

However, use of fluoridated toothpaste 

is not recommended for children under 

age 2 according to FDA guidance and 

package labeling suggesting the need for 

greater parental awareness of the FDA 

(2009) recommendations. 

• Ambient air, soils, and sulfuryl 

fluoride residues in foods are minor 

contributions to total fluoride exposure. 

(Id. at 108–109). 

B. OPP’s Revised Fluoride Risk 

Assessment 

In light of the revised fluoride risk 

assessment by EPA’s OW, EPA’s OPP 

has conducted a revised aggregate 

assessment of fluoride exposure and risk 

under FFDCA section 408. (Ref. 23). 

EPA is inviting public comment on all 

aspects of the revised aggregate 

assessment. 

1. Hazard/dose-response assessment. 

OPP agrees with OW’s choice of severe 

dental fluorosis as the endpoint for 

assessing chronic risk from fluoride 

exposure. As noted, both OW and OPP 

had treated several dental fluorosis as a 

cosmetic effect and not an adverse 

health effect. Following the NRC Report 

and the re-examination of this issue by 

both OW and OPP, EPA has concluded 

that severe dental fluorosis is an adverse 

effect due to the fact that the pitting it 

causes in the permanent teeth is a 

structural defect to the teeth. As OW’s 

analysis explains: 

Pitting of the enamel is a structural defect 

that weakens the barrier between the oral 

environment and the dentin of the teeth. It 

is progressive in that the enamel can flake off 

from the sides of the pits allowing them to 

become progressively larger. Furthermore, 

the dentin of teeth with severe dental 


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fluorosis is hypomineralized and structurally 

variant increasing the importance of the 

enamel’s protective function. 

(Ref. 21 at 64) (citations omitted). 

OPP also agrees with OW’s choice of 

0.08 mg/kg/day as a NOAEL for severe 

dental fluorosis relying on the Dean 

study, and the use of that value as a 

Point of Departure for calculating the 

RfD. Further, OPP concurs that neither 

an inter- or intra-species safety factor 

should be used in the RfD calculation. 

An inter-species factor is unnecessary 

because the endpoint is from a human 

epidemiological study; an intra-species 

factor is not needed given the 

extensiveness of the data and the fact 

that it studied the subpopulations of 

concern, children of different ages. 

Given these findings, OPP concludes 

that the Objectors were correct in 

contesting the reliance on the endpoint 

of crippling skeletal fluorosis to set a 

RfD for fluoride. OPP agrees that the RfD 

should be based on a more sensitive 

endpoint—severe dental fluorosis. It 

follows that the Objectors were also 

correct to object to use of childrenspecific RfD values based on the 

endpoint of crippling skeletal fluorosis. 

A RfD based on the Dean study is 

appropriate for children, however, 

because such a RfD is derived from data 

on the effects of fluoride on children. 

2. Exposure assessment. OPP’s 

revised exposure analysis depends 

heavily on OW’s Relative Source 

Contribution Analysis. A brief 

description of how that data and 

analysis have been incorporated into a 

FFDCA section 408 risk assessment is 

provided in the following sections. 

a. Fluoride from sulfuryl fluoride. In 

the exposure assessments for the 2004 

and 2005 tolerance actions, EPA 

conducted a somewhat refined exposure 

assessment of fluoride exposure in food 

from use of sulfuryl fluoride as both a 

commodity fumigant and as a structural 

fumigant for food handling facilities. 

Taking into account comments OPP has 

received from Dow AgroSciences, OPP 

has further refined this aspect of the 

exposure assessment. (Ref. 24). The 

three main refinements are: 

(1) OPP used a regression analysis to 

estimate residue values of fluoride in 

food that occur from actual use rates 

rather than assuming residue values as 

measured under maximum application 

rates; 

(2) OPP used a probabilistic analysis 

to estimate residues resulting from 

possible sequential treatment of food 

(e.g., fumigation of raw commodity, 

incidental treatment during fumigation 

of structure, fumigation of the processed 

commodity) rather than conservatively 

assuming that 100% of food was 

sequentially treated; and 

(3) OPP used more extensive data on 

the percent of food treated with sulfuryl 

fluoride. EPA used methyl bromide 

usage as the basis for estimating the 

percent usage of sulfuryl fluoride 

because sulfuryl fluoride was 

introduced as a replacement for methyl 

bromide. The refinements to this aspect 

of the exposure assessment result in a 

reduction of estimated exposure values 

to fluoride from sulfuryl fluoride use of 

roughly an order of magnitude. 

Consistent with its well-established 

practice for chronic exposure 

assessments, OPP assessed exposure to 

fluoride residues in food based on 

average residue values and average food 

consumption values. Given the national 

food distribution patterns in the United 

States, exposure to foods with different 

residue levels average out over time. 

Further, because different people eat 

different foods in different amounts, it 

would dramatically overstate exposure 

to assume that a single person 

consumed all foods at a high end 

consumption value. The revised 

exposure values for fluoride from 

sulfuryl fluoride are presented in Table 

1. 

TABLE 1—SUMMARY OF SULFURYL FLUORIDE CONTRIBUTIONS TO DIETARY FLUORIDE EXPOSURE

Age range, years 

Average estimated exposure 

(mg/day) 

Average estimated exposure 

mg/kg/day 

SF structural a SF food b Total SF structural a SF food b Total 

0.5–<1 ............................ 0 .0087 0.021 0.030 0.0008 0.0019 0.0027 

1–<4 ............................... 0 .012 0.033 0.045 0.0008 0.0022 0.0030 

4–<7 ............................... 0 .015 0.047 0.062 0.0007 0.0022 0.0029 

7–<11 ............................. 0 .017 0.054 0.071 0.0005 0.0017 0.0022 

11–<14 ........................... 0 .018 0.068 0.086 0.0004 0.0014 0.0018 

14+ ................................. 0 .019 0.058 0.076 0.0003 0.0008 0.0011 

a Reflecting residues resulting from fumigation of structures that may contain human food products. 

b Reflecting residues resulting from intentional fumigation of human foods. 

(Ref. 23 at 10, Table 1). 

b. Fluoride from cryolite. Previously, 

OPP estimated fluoride exposure from 

use of the pesticide cryolite using 

residue data from cyrolite field trials 

and data on the percent of food treated 

with cryolite. Since cryolite has been in 

use for years, cryolite residues in food 

are captured by the monitoring data OW 

collected on fluoride data in food 

generally. As discussed in the next 

section, OPP is using this monitoring 

data in its exposure assessment and thus 

a separate assessment of fluoride from 

cryolite would result in doublecounting. 

c. Fluoride in food and beverages. 

OPP is relying on the comprehensive 

OW analysis of the extensive fluoride 

monitoring data in published literature 

in estimating fluoride exposure from 

foods and beverages. The food 

monitoring data predates sulfuryl 

fluoride use and thus does not capture 

those residue levels. Consistent with 

how it conducts chronic exposure 

assessments for pesticide residues in 

food, OPP has used central-tendency 

values in estimating exposure. Exposure 

estimates for fluoride from background 

levels in food (including cryolite 

residues) and in prepared beverages are 

presented in Table 2. 


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TABLE 2—SUMMARY OF ESTIMATED FLUORIDE EXPOSURES ATTRIBUTABLE TO BACKGROUND LEVELS IN FOOD AND

BEVERAGES

Age range, years Body weight, 

kg 

Estimated fluoride exposure 

(mg/day) 

Estimated fluoride exposure 

(mg/kg/day) 

Solid food *

 Beverages Total Solid food * Beverages Total 

0.5–<1 ...................... 9 0.26 * 0.26 0 .029 * 0.029 

1–<4 ......................... 14 0.16 0.36 0.52 0 .011 0 .026 0.037 

4–<7 ......................... 21 0.35 0.54 0.89 0 .017 0 .026 0.042 

7–<11 ....................... 32 0.41 0.60 1.01 0 .013 0 .019 0.032 

11–<14 ..................... 51 0.47 0.38 0.85 0 .0092 0 .0075 0.017 

14+ ........................... 70 0.38 0.59 0.97 0 .0054 0 .0084 0.014 

* Solid food includes milk as well as fruit and vegetable juices not made from concentrate. These are not categorized as beverages in the FDA 

Total Diet Study (Egan et al., 2007). For the age range 0.5–<1 year, all fluoride was considered to be from powdered formula and falls into the 

food category. 

(Ref. 23 at 15, Table 6). 

d. Fluoride from public drinking water 

systems. People are exposed to fluoride 

from public drinking water both by 

direct consumption of the water and 

from indirect consumption of the water 

after its use in the preparation of foods 

and beverages in the home. References 

in this section to drinking water 

exposure are intended to capture both of 

these types of exposure. Exposure to 

fluoride from water containing fluoride 

residues that is used in the commercial 

preparation of food and beverages is 

accounted for in the estimates of 

fluoride in food and beverages. (See 

Unit V.B.2.c). To estimate exposure, 

OPP has coupled average, per-capita 

consumption from the CSFII with the 

fluoride concentrations for the water 

systems described previously. The CSFII 

consumption estimates include drinking 

water (direct water) and water used for 

in-home preparation of foods and 

beverages (indirect water). 

In the earlier exposure assessments, 

OPP assumed that fluoride in drinking 

water was present at 2 mg/L. Extensive 

monitoring data on fluoride levels in 

drinking water, however, have now 

been collected and analyzed by OW in 

conducting its Relative Source Analysis 

in response to the NRC Report. OPP has 

relied on these data in estimating 

exposure. (Ref. 23 at 10–15). 

Generally, OPP estimates pesticide 

exposure from drinking water by 

focusing on watersheds that are likely to 

have high end residue levels. This 

approach is based on several factors. 

First, pesticide residues in watersheds 

can have widely different values based 

on their regional relationship with 

agricultural areas and environmental 

factors (e.g., soil type, rainfall amount). 

Second, consumption of drinking water, 

unlike food, is mainly a local 

phenomenon—i.e., tap water is not an 

amalgam from drinking water systems 

around the country. Thus, focusing on 

watersheds with high-end residue levels 

is critical to fulfilling EPA’s statutory 

obligation to consider aggregate 

exposure to ‘‘major identifiable 

subgroups of consumers * * *.’’ (21 

U.S.C. 346a(b)(2)(D)(vi)). Accordingly, 

in the first instance, OPP has used OW’s 

drinking water monitoring data to 

identify drinking water systems with 

high-end fluoride levels. OPP has 

focused on water systems that have had 

at least one measured fluoride value of 

greater than 2 mg/L, at least one 

measured value of greater than 3 mg/L, 

and at least one measured value of 

greater than 4 mg/L. These groupings of 

water systems were used because of the 

significant population groups served by 

these systems—from well over 1 million 

to roughly 10 million. OPP believes it is 

reasonable to use average monitoring 

values from these groups of water 

systems because of the relative stability 

of fluoride levels in water. Importantly, 

these average values bracket OPP’s prior 

assumption of 2 mg/L with the average 

values ranging from 1.76 mg/L to 2.58 

mg/L. 

Given the unusual circumstances of 

fluoride—not only are there multiple 

sources in addition to pesticidal sources 

but several sources are the result of 

intentional actions designed to result in 

wide-spread national exposure—OPP 

believes that OW’s approach to 

assessing fluoride exposure in its 

Relative Source Analysis under SDWA 

has relevance to its aggregate exposure 

analysis under FFDCA section 408. 

OW’s Relative Source Analysis focuses 

on high-end water consumers who are 

exposed to average exposures calculated 

on a national basis. Because the 

population concerned here is so large, 

roughly 300 million people, even 

looking at high-end consumers (OW’s 

traditional approach is to use the 90th 

percentile) represents consideration of a 

large population subgroup. 

Table 3 provides exposure estimates 

for fluoride in drinking water from both 

OPP and OW approaches. 

TABLE 3—FLUORIDE EXPOSURE ESTIMATES (MG/KG/DAY) FROM MUNICIPAL WATER 1

Age range, years 

Fluoride concentration in drinking water (mg/L); consumption percentile 

0.87 

90th 

1.76 

Average 

2.28 

Average 

2.59 

Average 

0.5–<1 .......................................................................................... 0.093 0.077 0 .10 0 .11 

1–<4 ............................................................................................. 0.045 0.040 0 .052 0 .059 

4–<7 ............................................................................................. 0.039 0.033 0 .043 0 .049 

7–<11 ........................................................................................... 0.027 0.024 0 .031 0 .035 

11–<14 ......................................................................................... 0.024 0.018 0 .024 0 .027 

14+ ............................................................................................... 0.025 0.026 0 .033 0 .038 

1 Includes drinking water as well as water for in-home preparation of foods and beverages. Estimates are based on 90th percentile consumer 

only or average per capita consumption, as indicated, and do not include fluoride from toothpaste, from soil, or from sulfuryl fluoride. 


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(Ref. 23 at 11, Table 3; 14, Table 5). 

e. Fluoride from toothpaste. OW has 

comprehensively reanalyzed the data on 

fluoride exposure from toothpaste 

taking into consideration all available 

studies. The results of that analysis are 

presented in Table 4. 

TABLE 4—SUMMARY OF ESTIMATED FLUORIDE EXPOSURES FROM INCIDENTAL INGESTION OF FLUORIDATED TOOTHPASTE

Age range, years 

Estimated fluoride exposure 

(mg/day) 

Estimated fluoride exposure 

(mg/kg/day*) 

1 brushing 

per day 

2 brushings 

per day 

1 brushing 

per day 

2 brushings 

per day 

0.5¥<1 ............................................................................................ 0 .07 0 .14 0 .0078 0 .016 

1¥<4 ............................................................................................... 0 .34 0 .68 0 .024 0 .049 

4¥<7 ............................................................................................... 0 .22 0 .44 0 .010 0 .021 

7¥<11 ............................................................................................. 0 .18 0 .36 0 .0056 0 .011 

11¥<14 ........................................................................................... 0 .2 0 .4 0 .0039 0 .0078 

14+* .................................................................................................. 0 .1 0 .2 0 .0014 0 .0029 

* No data were available for this age group. The exposure estimate is one half that of the 11 to 14 year group. 

(Ref. 23 at 16, Table 7). 

OW was also able to identify limited 

data on the frequency of teeth brushing 

by children. Those data are presented in 

Table 5. 

TABLE 5—NUMBER OF TOOTHBRUSHINGS PER DAY REPORTED FOR CHILDREN (SIX MONTHS TO FIVE YEARS OLD) 

Study N = Age (years) 

Percentages * 

1 time/day 2 times/day 3 times/day 

Simard et al., 1989 .............................................................................. 23 2 to 5 4 .8 71 .4 23 .8 

Simard et al., 1991 .............................................................................. 15 1 to 2 60 32 8 

Levy et al., 1997 .................................................................................. 899 0 .5 41 .2 16 .9 6 .3 

665 0 .75 33 .2 17 3 .1 

508 1 37 14 .7 3 .5 

Franzman et al., 2006 .......................................................................... 90 1 .3 48 14 4 

100 2 51 23 2 

100 3 51 24 1 

* Some studies also reported those brushing their teeth less than once per day and more than three times per day. In these cases the percentages do not add up to 100%. 

(Ref. 22 at 81, Table 4–10). Based on the 

fact that a substantial portion of 

children brush two or more times per 

day and that brushing twice per day is 

consistent with health care 

recommendations, OPP is assuming two 

brushings per day in its assessment. 

f. Fluoride from soil. Young children 

are exposed to fluoride from inadvertent 

consumption of soil. OPP estimated 

fluoride exposure from soil using 

standard EPA estimates on soil 

consumption and assuming average 

fluoride residues in soil. These 

estimates are presented in Table 6. 

TABLE 6—SUMMARY OF ESTIMATED

FLUORIDE EXPOSURES FROM INCIDENTAL INGESTION OF SOIL AND

OUTDOOR DUST

Age 

range, 

years 

Estimated fluoride exposure * 

(mg/day) 

Estimated fluoride exposure * 

(mg/kg/day) 

0.5–<1 ..... 0.02 0 .0022 

1–<4 ........ 0.04 0 .0029 

4–<7 ........ 0.04 0 .0019 

7–<11 ...... 0.04 0 .0013 

TABLE 6—SUMMARY OF ESTIMATED

FLUORIDE EXPOSURES FROM INCIDENTAL INGESTION OF SOIL AND

OUTDOOR DUST—Continued 

Age 

range, 

years 

Estimated fluoride exposure * 

(mg/day) 

Estimated fluoride exposure * 

(mg/kg/day) 

11–<14 .... 0.04 0 .00078 

14+ .......... 0.02 0 .00029 

* Assumes soil and dust contains 400 ppm 

fluoride. 

(Ref. 23 at 17, Table 8). 

g. Other sources of fluoride exposure. 

Although people are also potentially 

exposed to fluoride from fluoride in 

ambient air, fluoride dental treatments, 

and pharmaceuticals, among other 

things, OW concluded that these 

sources of exposure are insignificant 

compared to other sources of fluoride 

exposure. Accordingly, OPP is not 

including such exposures in its 

aggregate assessment. (Ref. 23 at 16). 

3. Children’s safety factor. In choosing 

a revised RfD for fluoride, OW did not 

apply any uncertainty or safety factors 

to the BMDL for severe dental fluorosis. 

OW reasoned that uncertainty factors 

were not warranted due to the extensive 

human epidemiological data on the 

effects of fluoride, including extensive 

data on children, the population of 

greatest concern. Decisions on pesticide 

tolerances, however, require OPP to 

apply special provisions for protection 

of children. Specifically, section 

408(b)(2)(C) of FFDCA provides that 

EPA shall apply an additional tenfold 

(10X) margin of safety for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines based on reliable 

data that a different margin of safety 

will be safe for infants and children. In 

making determinations on this 

children’s safety factor, OPP has focused 

on the statutory factors of data 

completeness with regard to toxicity 

and exposure and evidence bearing on 

pre- and post-natal toxicity. 

As with so many other aspects of the 

fluoride risk assessment, application of 


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the children’s safety factor provision to 

fluoride presents unique issues. OPP 

considered the following factors in 

determining whether reliable data show 

that an additional safety factor other 

than the default 10X value would be 

safe: 

a. Toxicity data. As a result of the 

decades-long water fluoridation 

program in the United States as well as 

the substantial areas with high natural 

levels of fluoride in drinking water, OPP 

has an epidemiological dataset for 

fluoride that is far more extensive than 

for any other pesticide. EPA also has an 

extensive set of animal data on sulfuryl 

fluoride and to the extent that sulfuryl 

fluoride breaks down to the fluoride 

anion during testing, these studies 

capture the effects of fluoride (dental 

fluorosis was observed in a number of 

studies). On the other hand, OPP has 

recently requested additional studies on 

sulfuryl fluoride, a developmental 

neurotoxicity study and an 

immunotoxicity study, and the NRC 

Report identified several areas, notably 

brain and endocrine effects, where 

further study would be useful. On the 

whole, however, OPP concludes that the 

completeness of the database with 

regard to fluoride exceeds what is 

generally available even on the most 

well-studied pesticides. 

b. Exposure data. OPP has an 

extremely extensive database on 

fluoride levels in drinking water due to 

the water monitoring data OW has 

collected. OPP also has reliable data on 

fluoride exposure from sulfuryl fluoride 

and on background levels of fluoride in 

food. To the extent sulfuryl fluoride has 

not replaced methyl bromide as a 

fumigant the fluoride estimate from 

sulfuryl fluoride overstates exposure. 

There is some uncertainty as to the 

amount of fluoride exposure from 

toothpaste. There are several factors 

here: Data on fluoride exposure from 

toothpaste are less extensive and are 

highly variable; the data may not reflect 

the latest recommendations on the 

amount of toothpaste children should 

use; label directions for adults and 

children 2 years old and above state that 

teeth should be brushed ‘‘thoroughly, 

preferably after each meal or at least 

twice a day;’’ and label directions for 

children below 2 years of age state that 

a dentist or doctor should be consulted. 

However, by assuming two brushings 

per day and relying on studies that may 

have used greater amounts of toothpaste 

than is used today as well as focusing 

on high-end exposure groups for 

drinking water, OPP believes it has 

addressed any uncertainties regarding 

fluoride exposure from toothpaste. 

c. Pre- and post-natal toxicity. Not 

only does OPP have extensive data 

identifying fluoride’s effects in humans 

and the dose at which those effects 

occur, but fluoride, unlike most 

pesticides or their metabolites, is 

considered a human nutrient. Fluoride’s 

classification as a nutrient—especially 

its role at certain doses in protecting 

teeth—cannot be ignored in the safety 

factor calculation. OPP is averse to 

choosing a safety factor that would 

result in the choice of a PAD that 

indicates that fluoride is harmful at 

levels below the adequate intake level 

for beneficial effects. The Objectors have 

raised concerns about potential other 

effects of fluoride—for example, brain, 

endocrine, kidney, and reproductive 

effects. Nonetheless, data on these 

effects generally either shows effects 

only at considerably higher levels than 

the levels causing severe dental 

fluorosis or are very equivocal. 

On balance, the extensiveness of the 

data on toxicity of fluoride and human 

exposure to it, the clear data defining 

the safe level for the effect of concern on 

children, and fluoride’s status as a 

human nutrient at levels only slightly 

below the level that is protective against 

severe dental fluorosis lead OPP to 

conclude that reliable data show that an 

additional safety factor for the 

protection of children is not necessary. 

Accordingly, OPP has not used an 

additional safety factor in its fluoride 

risk assessment. Hence, the PAD for 

fluoride is equivalent to the RfD (0.08 

mg/kg/day). (Ref. 23 at 9). 

4. Risk characterization. To 

characterize the risk of fluoride, OPP 

has aggregated exposure to fluoride from 

sulfuryl fluoride, background levels in 

food (including from cryolite), 

beverages, drinking water, toothpaste, 

and soil, and compared that aggregated 

exposure to the PAD. In evaluating 

exposure to major identifiable 

subgroups of consumers, OPP believes 

that for fluoride it is appropriate to 

consider the aggregate exposure of at 

least four different subgroups: 

a. Communities served by a water 

system with at least one sample 

showing fluoride levels greater than 2 

mg/L (2 mg/L communities); 

b. Communities served by a water 

system with at least one sample 

showing fluoride levels greater than 3 

mg/L (3 mg/L communities); 

c. Communities served by a water 

system with at least one sample 

showing fluoride levels greater than 4 

mg/L (4 mg/L communities); and 

d. High-end water consumers 

generally. 

The aggregate exposure of these 

subgroups relative to the RfD/PAD is 

shown in Table 7: 

TABLE 7—AGGREGATE EXPOSURE COMPARED TO RFD BY AGE GROUPS (MG/KG/DAY) 

Age groups RfD/PAD High-end water 

consumers 2 mg/L community 3 mg/L community 4 mg/L community 

0.5–<1 ...................................................... 0.08 0 .13 0 .13 0 .15 0 .16 

1–<4 ......................................................... 0.08 0 .11 0 .13 0 .14 0 .15 

4–<7 ......................................................... 0.08 0 .097 0 .10 0 .11 0 .12 

7–<11 ....................................................... 0.08 0 .068 0 .070 0 .077 0 .081 

11–<14 ..................................................... 0.08 0 .047 0 .045 0 .051 0 .054 

14+ ........................................................... 0.08 0 .042 0 .044 0 .051 0 .056 

(Ref. 23 at 21, Table 9). 

This risk assessment shows that 

aggregate fluoride exposure to young 

children exceeds the RfD/PAD under 

various different methods of identifying 

major population subgroups. In 

evaluating this assessment at least two 

other factors are relevant. First, the 

assessment of the 2–4 mg/L 

communities deviates from OPP’s 

traditional approach to assessing 

exposure in drinking water in that it 

averages exposures from systems that 

are surface water-based and systems that 

are groundwater-based. EPA generally 

assesses drinking water exposure on the 

higher value from surface water or 

groundwater because people get the 

majority of their drinking water 

exposure from one location. For 

fluoride, focusing only on groundwaterbased systems would modestly increase 

the exposure estimate. Second, this 

assessment does not take into account 

those people that depend on private 

drinking water wells and not public 

drinking water systems. Drinking water 


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wells in certain portions of the United 

States can have fluoride levels 

exceeding those used in the assessments 

discussed previously. 

Based on these assessments, EPA 

cannot conclude that there is a 

reasonable certainty of no harm for 

certain major identifiable groups of 

consumers from aggregate exposure to 

fluoride. Therefore, EPA cannot make 

the required finding that the sulfuryl 

fluoride and fluoride tolerances are 

‘‘safe’’ and is proposing to grant the 

Objectors’ objections to the 

establishment of the sulfuryl fluoride 

and fluoride tolerances promulgated on 

January 23, 2004, and July 15, 2005. 

C. Comments From Dow AgroSciences 

As noted previously, Dow 

AgroSciences has filed comments 

contesting the Objectors’ claims 

regarding the safety of fluoride. First, 

Dow AgroSciences argues that the 

Objectors have only potentially shown 

that small, localized groups of people 

are exposed to unsafe levels of fluoride 

and such small groups do not constitute 

a ‘‘major identifiable’’ subgroup under 

FFDCA. EPA disagrees with Dow 

AgroSciences that the groups of people 

exposed at levels that exceed the RfD 

are not major identifiable subgroups of 

consumers. As noted previously, the 

subgroups OPP relies upon include at 

least 1 million, and in some cases, many 

millions of people. Although the 

individuals within these subgroups 

facing unacceptable risks from aggregate 

fluoride exposure are limited to infants 

and children up to the age of 7, the 

persons at risk remain substantial. 

Second, Dow AgroSciences challenges 

whether the NRC Report showed that 

there is a more sensitive endpoint than 

crippling skeletal fluorosis. Dow 

AgroSciences’ comments on this issue 

focused on the endpoints of bone 

fracture, stage II skeletal fluorosis, and 

severe dental fluorosis. 

1. Bone fracture. Dow AgroSciences 

argued that the NRC Report did not 

place sufficient weight on a 2005 

observational study from the University 

of Michigan (Sowers) and placed too 

much weight on two other studies 

(Alarcon and Li) that were judged 

unreliable by OPP. OW undertook a 

comprehensive review of all of the 

available data. Like NRC, it found 

certain weaknesses in the 2005 Sowers 

study but overall considered it along 

with the Li study and several other 

studies to be one of the key studies for 

assessing the risk of bone fractures. The 

Alarcon study was given less weight. 

Also similar to the NRC Report, OW 

concluded that ‘‘the available data 

indicate that exposure to concentrations 

of fluoride in drinking water of 4 mg/ 

L and above is suggestive of and appears 

to be positively associated with 

increased relative risk of bone fractures 

in susceptible populations when 

compared to populations exposed to 1 

mg mg/L.’’ (Ref. 21 at 86). OW also 

noted, however, that ‘‘there are 

insufficient data to conclude that this 

increase in relative risk would also 

apply if comparisons were made to 

groups exposed to negligible fluoride 

concentrations or if comparisons were 

made based on total fluoride intake 

rather than on the basis of drinking 

water concentrations.’’ (Id.). Ultimately, 

OW concluded that the fluoride RfD 

should be based on severe dental 

fluorosis and that this endpoint was 

protective of any risk of bone fractures 

and thus a more definite resolution of 

this issue is unnecessary. 

2. Stage II skeletal fluorosis. Dow 

AgroSciences emphasized that the NRC 

Report’s finding on fluoride’s link to 

stage II skeletal fluorosis were 

equivocal. OW’s conclusions on stage II 

skeletal fluorosis were similar to those 

of NRC. OW found that ‘‘[t]he results of 

the limited epidemiological studies and 

case histories suggest that a daily 

fluoride dose in excess of 10 mg may be 

required to produce signs of stage II 

skeletal fluorosis (except possibly in the 

case of individuals with renal disease).’’ 

(Ref. 21 at 83). But OW concluded that 

‘‘the currently available data are not 

sufficiently robust to support a doseresponse analysis of the effects of 

fluoride in drinking water on skeletal 

fluorosis.’’ (Id.). As with risk of bone 

fractures, because OW determined that 

the fluoride RfD should be based on 

severe dental fluorosis and that this 

endpoint was protective of any risk of 

stage II skeletal fluorosis, a more 

definite resolution of this issue is 

unnecessary. 

3. Severe dental flurosis. Dow 

AgroSciences challenged the 

competency of NRC to make the legal 

conclusion that severe dental fluorosis 

is an adverse health effect and also 

argued that there is dispute within the 

scientific community regarding the 

adversity of severe dental fluorosis. 

Without question, it is EPA that is 

charged with interpreting SDWA and 

making legal findings in 

implementation of that Act. 

Nonetheless, EPA does not view NRC as 

stepping beyond its scientific advisory 

role in its report. OW has previously 

defined adverse health effects as 

involving functional impairment and 

NRC focused on whether the data 

showed functional impairment in 

reaching a conclusion on whether 

severe dental fluorosis is an adverse 

health effect. For example, the NRC 

Report states: 

One of the functions of tooth enamel is to 

protect the dentin and, ultimately, the pulp 

from decay and infection. Severe enamel 

fluorosis compromises this health-protective 

function by causing structural damage to the 

tooth. The damage to teeth caused by severe 

enamel fluorosis is a toxic effect that the 

majority of the committee judged to be 

consistent with prevailing risk assessment 

definitions of adverse health effects. 

(Ref. 17 at 127) (emphasis added). 

Finally, while there may be a dispute 

within the scientific community about 

how to characterize the adversity of 

severe dental fluorosis, there does not 

appear to be any significant dispute over 

the science question of whether severe 

dental fluorosis results in the pitting of 

dental enamel. As Dow AgroSciences 

has pointed out, it is EPA’s 

responsibility to make the legal 

determination of whether this effect 

should be categorized as an adverse 

health effect. 

Third, Dow AgroSciences argues that 

EPA is not authorized to aggregate 

fluoride added to drinking water for 

therapeutic purposes with fluoride from 

sulfuryl fluoride because fluoride from 

water fluoridation is neither a ‘‘pesticide 

chemical’’ under FFDCA nor an ‘‘other 

related substance.’’ Dow AgroSciences 

claims that FFDCA’s reference to ‘‘other 

related substances’’ means other related 

‘‘pesticidal’’ substances. EPA disagrees 

with Dow AgroSciences’ interpretation 

of FFDCA section 408 for several 

reasons. First, there is no exclusion from 

the aggregate exposure requirements for 

substances that have a therapeutic effect 

at certain levels. Second, there is no 

serious dispute that at certain levels 

exposure to fluoride is not therapeutic 

but harmful, and Dow AgroSciences 

cannot be contending that exposure to 

fluoride for water fluoridation does not 

aggregate within the body with fluoride 

from other exposures. Third, a 

significant portion of the U.S. 

population is exposed to fluoride in 

water that is naturally-occurring rather 

than added for therapeutic purposes. 

Finally, EPA has previously rejected 

attempts to limit the plain meaning of 

‘‘other related substances’’ and does not 

believe that Dow AgroSciences has 

offered any compelling legal, policy, or 

scientific reasoning for adopting an 

interpretation that would bar EPA from 

considering the full effects of aggregate 

exposure to a substance. (See 69 FR 

30042, 30073, May 26, 2004)(FRL– 

7355–7). 

Dow AgroSciences also claims that 

EPA overestimated exposure to fluoride 

from use of sulfuryl fluoride. EPA agrees 

with this comment and, as described 


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previously, EPA has incorporated 

information from Dow AgroSciences on 

sulfuryl fluoride usage in its sulfuryl 

fluoride/fluoride exposure assessment. 

VI. EPA’s Proposed Response to 

Requests for Hearing 

Because EPA is agreeing with the 

Objectors that the sulfuryl fluoride 

tolerances do not meet the safety 

standard and is proposing to grant their 

objections to the establishment of those 

tolerances, no further action is needed 

with regard to the Objectors’ hearing 

requests. At this point, there is no 

material dispute of fact with regard to 

the Objectors’ claims that warrants a 

hearing. 

VII. EPA’s Proposed Response to 

Request for a Stay and EPA’s Proposed 

Expiration Date for Tolerances 

Following release of the NRC Report, 

the Objectors filed a motion with EPA 

requesting a stay of the sulfuryl fluoride 

tolerances. (Ref. 2). In arguing for a stay, 

the Objectors relied on the four factors 

contained in Virginia Petroleum Jobbers 

Ass’n v. FPC, 259 F.2d 921 (DC Cir. 

1958): 

(1) Has the petitioner made a strong 

showing that it is likely to prevail on the 

merits; 

(2) Has the petitioner shown that 

without such relief it will be irreparably 

harmed; 

(3) Would issuance of the stay 

substantially harm other parties 

interested in the proceedings; 

(4) Wherein lies the public interest. 

In prior tolerance proceedings EPA 

has indicated it would consider the 

criteria in FDA’s regulations pertaining 

to stay requests. (See, e.g., 61 FR 39528, 

39540, July 29, 1996). Those regulations 

provide that a stay shall be granted if a 

petitioner can show all of the following: 

(1) The petitioner will otherwise 

suffer irreparable injury. 

(2) The petitioner’s case is not 

frivolous and is being pursued in good 

faith. 

(3) The petitioner has demonstrated 

sound public policy grounds supporting 

the stay. 

(4) The delay resulting from the stay 

is not outweighed by public health or 

other public interests. 

(21 CFR 10.35). 

The criteria under either approach are 

quite similar. Thus, in evaluating the 

stay request EPA will concentrate on an 

amalgam of the four factors: 

• What are the merits of the 

Objectors’ claims; 

• Have the Objectors’ shown that 

irreparable harm will occur in the 

absence of a stay; 

• Would a stay substantially harm 

other parties or cause other effects on 

the public health; and 

• Wherein lies the public interest. 

EPA also believes that these factors 

are relevant in choosing an effective 

date for its proposed grant of the 

objections. 

A. Merits of the Objectors’ Claims 

As indicated, EPA agrees with the 

Objectors that the sulfuryl fluoride 

tolerances do not meet the safety 

standard when aggregate fluoride 

exposure is considered and thus this 

factor supports granting the stay and 

making EPA’s proposed grant of the 

objections effective relatively quickly. 

B. Irreparable Harm to Objectors 

The Objectors argue that the public is 

irreparably harmed by the sulfuryl 

fluoride tolerances because aggregate 

exposure to fluoride poses a long litany 

of threats to health. According to the 

Objectors, the NRC Report linked 

fluoride not just to adverse effects on 

bones and teeth but also other effects 

ranging from neurological impacts to 

cancer. (Ref. 2 at 11, 13–15). The weight 

of this argument, however, is 

undermined by two factors. 

First, it is beyond dispute that NRC, 

after a comprehensive evaluation of all 

of the possible adverse effects of 

fluoride, recommended that OW lower 

the fluoride MCLG due to only three 

very specific health risks: severe dental 

fluorosis; stage II skeletal fluorosis; and 

bone fractures. (Ref. 17 at 345–346, 352). 

Although the NAS recommended 

further research on some of the other 

health risks cited by the Objectors, the 

NAS did not find sufficient evidence on 

any of them to support a lowering of the 

MCLG. 

Second, and more importantly, the 

threat that fluoride poses to teeth and 

bones is due to aggregate exposure to 

fluoride not the fluoride in food 

resulting from use of sulfuryl fluoride 

when viewed in isolation. Use of 

sulfuryl fluoride is responsible for a tiny 

fraction of aggregate fluoride exposure. 

For example, for the most highlyexposed age groups in the populations 

examined in the revised risk 

assessment, fluoride from sulfuryl 

fluoride accounts for about 2 to 3% of 

aggregate fluoride exposure. Given the 

aggregate level of fluoride exposure, 

termination of the use of sulfuryl 

fluoride would not change the fact that 

aggregate fluoride levels would still 

exceed the safe level for highly-exposed 

subpopulations. 

C. Harm to Others/Other Public Health 

Harms 

1. Overview. Immediate termination of 

sulfuryl fluoride tolerances will lead to 

some combination of the following 

negative consequences depending how 

food processors and distributors for the 

various affected commodities respond: 

an increase in the use of inventories of 

the stratospheric ozone-depleting 

pesticide, methyl bromide; a disruption 

in the amount and availability of certain 

commodities; an increase in 

contamination of commodities with 

insect parts and waste posing potential 

health risks; and/or increased short-term 

and long-term costs for food processors, 

distributors, and consumers. To the 

extent that methyl bromide cannot be 

obtained in sufficient quantities to fill 

the void left by the absence of sulfuryl 

fluoride, the other potential negative 

impacts will be heightened. 

In the following discussion, EPA first 

describes the likely effects that would 

occur in individual food markets if 

sulfuryl fluoride use is terminated. Then 

EPA presents more general information 

on the availability of methyl bromide, 

the potential disruption that can occur 

when food is contaminated with insect 

parts and waste, and potential health 

effects from such contamination. 

2. Likely effects in specific markets. 

OPP analyzed three uses of sulfuryl 

fluoride that provide a representative 

view of how the food industries relying 

on sulfuryl fluoride may respond to a 

loss of that pesticide and the impacts of 

that response: 

• Use of sulfuryl fluoride as a 

structural treatment in flour mills; 

• Use of sulfuryl fluoride as a food 

fumigant for cocoa beans; and 

• Use of sulfuryl fluoride as a food 

fumigant for walnuts. 

Each of these uses is discussed in more 

detail in the next section. (Refs. 25 and 

26). 

a. Flour mills. Generally, flour mills 

and other food processing facilities are 

fumigated two to three times per year to 

control insect populations (the primary 

pests are the red flour beetle and the 

confused flour beetle). In the absence of 

sulfuryl fluoride, there are potentially 

three possible alternative options whose 

costs and efficacy differ from sulfuryl 

fluoride: (1) Use of another chemical 

pesticide; (2) use of non-chemical 

controls; or (3) complete removal of all 

food from the facility during fumigation 

with sulfuryl fluoride. 

i. Chemical control. The only 

chemical alternative for use throughout 

food processing facilities is methyl 

bromide. As explained later in this 

document, mills and food processing 


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structures that do not have approved 

critical uses for a given year may not 

obtain methyl bromide produced under 

a critical use exemption. To the extent 

facilities have an approved critical use 

or can obtain methyl bromide from prephase-out inventories, mills will likely 

switch to methyl bromide if sulfuryl 

fluoride uses are immediately 

eliminated. Costs for use of methyl 

bromide and sulfuryl fluoride appear to 

be fairly similar at this time. No other 

chemical pesticides are a viable 

alternative. Phosphine is a commonlyused food fumigant that could be used 

in some portions of a flour mill; 

however, phosphine is highly corrosive 

to silver and copper metals and their 

alloys and thus cannot be used in the 

production areas of mills that contain 

electronic and electrical equipment 

which heavily rely on these metals. In 

terms of total area, the portion of a mill 

devoted to production is substantial and 

a failure to effectively dis-infest the 

production area would quickly result in 

re-infestation of the entire facility. Thus, 

phosphine is not an alternative to the 

use of sulfuryl fluoride. (Ref. 25 at 6–7). 

ii. Non-chemical control. The leading 

non-chemical control option for use in 

flour mills is temperature manipulation. 

Either heat or cold can be used to 

destroy insect pests. Use of cooling to 

control pests in flour mills, however, is 

unlikely because cold temperatures can 

damage electronic equipment in 

production areas. Use of heat is a more 

likely option. Temperatures of 120–130 

degrees Fahrenheit will kill most storedproduct insect pests. Heat, however, 

would not be appropriate for mills 

principally constructed of wood because 

heat at these levels will shrink, crack, 

and warp wood. This can result in 

structural damage to the facility and 

may also render the heat treatment 

ineffective due to leakage of heat from 

the facility. Approximately 25% of the 

total number of flour mills in the United 

States fall in this category. These tend 

to be the older and smaller mills and 

thus probably represent less than 25% 

of mill capacity. Newer mills are 

generally constructed primarily of 

concrete or similar materials which 

would be appropriate for use with heat 

disinfestation techniques. Initially, use 

of heat will involve higher costs due to 

capital investment in heaters and plant 

modifications. However, in the long run, 

use of heat may be less costly than 

chemical pesticides. Switching to heat 

will also require transition time for the 

industry. Not only will mills have to 

purchase (or rent) heaters but 

modifications may be necessary to the 

mill to insure that heat is evenly 

distributed. Individual mills will have 

to go through a trial and error process 

to determine how the heating technique 

can be effective in each unique facility. 

Because disinfestations are commonly 

needed only two to three times per year, 

mills are likely to need an extended 

transition time to implement the 

technology effectively. If chemical 

alternatives are not available during that 

timeframe, processed food contaminated 

with insect parts and waste due to 

failure of initial attempts at heat 

disinfestation will have to be destroyed. 

(Ref. 25 at 6). 

iii. Product removal. A third option 

that combines chemical and nonchemical control would be complete 

removal of all food from a facility before 

fumigation with sulfuryl fluoride. 

Currently, the sulfuryl fluoride label 

requires that food in facilities be 

minimized prior to fumigation. Only 

food that is not practical to remove may 

remain during the fumigation. Removal 

of food is also essential to the efficacy 

of sulfuryl fluoride. However, if all food 

is removed such that use of sulfuryl 

fluoride would not result in fluoride 

residues in food, no pesticide tolerance 

would be needed for this use and 

aggregate exposure to fluoride would 

not be increased. Currently, Canada has 

imposed restrictions on the use of 

sulfuryl fluoride for the fumigation of 

food processing facilities that are 

designed to insure that no residues 

result in food. Two obstacles remain, 

however, to adoption of this alternative. 

First, OPP’s analysis of this alternative 

indicates there may be substantial costs. 

Second, at this time, sulfuryl fluoride’s 

FIFRA label does not contain 

application instructions sufficient to 

eliminate residues on food. Thus, if the 

objections are granted as is proposed, 

EPA will pursue cancellation of all uses 

associated with the tolerances which are 

removed. Unless Dow AgroSciences, the 

registrant for sulfuryl fluoride, were to 

seek an amendment of its registration 

that imposes label restrictions insuring 

no residues in food, and OPP can 

determine that the proposed registration 

changes would achieve that result, this 

use would not be available to flour mills 

in the United States. (Ref. 25 at 10). 

b. Fumigation of cocoa and walnuts. 

Any food that is stored, processed, or 

packaged is subject to attack by insects, 

generally beetles or moths. Phosphine is 

the dominant fumigant in the 

commodity market for use against such 

pests because it is efficacious, costeffective, and easy to apply. However, 

phosphine fumigation takes 4 to 7 days 

to be effective. A fumigant that can work 

much more quickly, such as sulfuryl 

fluoride, is used when rapid fumigation 

is necessary. 

Fumigation of harvested walnuts to 

destroy pests is primarily used for inshell walnuts. Fumigation can kill pests 

in in-shell walnuts that are otherwise 

eliminated from shelled walnuts by 

shelling and processing of the nutmeat. 

The available data indicate that a high 

percentage of in-shell walnuts are 

fumigated one or more times. 

Fumigation is primarily not conducted 

with phosphine because, at peak harvest 

time, existing fumigation chambers do 

not have sufficient capacity to allow 

timely fumigation. Although historically 

most of this rapid fumigation was done 

with methyl bromide under a CUE, 

more recent information suggests that 

the industry is using sulfuryl fluoride 

almost entirely. (Ref. 26 at 4). 

For cocoa beans, rapid fumigation is 

necessary due to the circumstances 

where fumigation is conducted. Cocoa 

beans are imported to the United States 

from Africa and South America. Upon 

arrival, they are taken to a warehouse at 

the port and fumigated under 

tarpaulins. To minimize risk to port 

employees, fumigations typically occur 

over weekends when the ports and 

warehouses are closed. One hundred 

percent of cocoa beans are fumigated 

with sulfuryl fluoride. (Id. at 5). In 2009, 

approximately $1.2 billion worth of 

cocoa beans were imported to the 

United States. 

The primary chemical alternative to 

sulfuryl fluoride for walnuts and cocoa 

is phosphine. However, as indicated, 

there are insufficient fumigation 

chambers for walnuts at peak harvest 

time. For cocoa, existing facilities do not 

allow for use of phosphine because they 

are part of an ongoing port operation 

and cannot be shut down for more than 

2 days at a time and often contain other 

articles that may be affected by 

phosphine’s corrosive properties. Nonchemical alternatives either take too 

long (cold, modified atmosphere), may 

damage the stored commodity (heat), 

lack market acceptability (irradiation), 

or are largely untested for the 

commodities and pests in question 

(heat). Construction of fumigation 

chambers for walnuts and cocoa may 

take several years. (Id. at 5). 

EPA requests information on whether 

other commodities treated in the United 

States or other imported commodities 

would be affected by elimination of 

sulfuryl fluoride. 

3. Availability of methyl bromide. Due 

to the constraints of CAA and the 

Montreal Protocol, pesticide users 

would have very limited ability to use 

methyl bromide in lieu of sulfuryl 

fluoride if the sulfuryl fluoride 


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1Before U.S. production may legally occur, a 

specific use must receive a CUE through the 

authorization of the Parties to the Montreal Protocol 

and then through EPA’s regulations. The CUE 

process takes three years to complete for one 

control period (one calendar year). Methyl bromide 

users who wished to obtain a CUE to allow 

production in 2011 submitted their applications to 

EPA in 2008. The U.S. Government reviewed those 

applications and submitted a Critical Use 

Nomination to the United Nations Environment 

Programme Ozone Secretariat in early 2009. During 

2009, the Methyl Bromide Technical Options 

Committee (MBTOC) and the Technology and 

Economic Assessment Panel (TEAP), which are 

independent advisory bodies to the Parties to the 

Montreal Protocol, reviewed the Critical Use 

Nomination and made recommendations to the 

Parties. In the fall of 2009, the Parties met and 

approved CUEs for the following post-harvest uses 

in the U.S.: mills and food processing structures; 

country ham; dried fruit; and nuts. In 2010, EPA 

initiated notice-and-comment rulemaking to exempt 

the approved uses from its regulatory ban on methyl 

bromide production. The final rule will address 

what uses qualify for the exemption in 2011 and 

what amounts may be produced or imported for 

approved critical uses. 

tolerances were abruptly withdrawn. 

Methyl bromide is an ozone depleting 

substance whose production has been 

banned under the Clean Air Act for 

domestic use since 2005. Along with 

other developed countries, the United 

States is also subject to the methyl 

bromide production phase-out under 

the Montreal Protocol. Production of 

methyl bromide for U.S. use other than 

for quarantine and preshipment 

purposes is not allowed under the 

Montreal Protocol and EPA’s Clean Air 

Act implementing regulations unless the 

Parties to the Montreal Protocol agree to 

authorize additional new production for 

uses that have been demonstrated to be 

critical under the criteria adopted by the 

Parties. 

The criteria for critical use 

exemptions (CUEs) are demanding and 

not easily met. Under Decision IX/6 of 

the Parties to the Montreal Protocol ‘‘a 

use of methyl bromide should qualify as 

‘critical’ only if the nominating Party 

determines that: (i) The specific use is 

critical because the lack of availability 

of methyl bromide for that use would 

result in a significant market disruption; 

and (ii) there are no technically and 

economically feasible alternatives or 

substitutes available to the user that are 

acceptable from the standpoint of 

environment and public health and are 

suitable to the crops and circumstances 

of the nomination.’’ Decision IX/6 para. 

1(a). Additionally, Decision IX/6 

specifies that: 

[P]roduction and consumption, if any, of 

methyl bromide for critical uses should be 

permitted only if: 

(i) All technically and economically 

feasible steps have been taken to minimize 

the critical use and any associated emission 

of methyl bromide; 

(ii) Methyl bromide is not available in 

sufficient quantity and quality from existing 

stocks of banked or recycled methyl bromide, 

also bearing in mind the developing 

countries’ need for methyl bromide; 

(iii) It is demonstrated that an appropriate 

effort is being made to evaluate, 

commercialize and secure national regulatory 

approval of alternatives and 

substitutes.* * * 

Decision IX/6 para. 1(b). 

EPA’s stratospheric protection 

regulations contain essentially the same 

criteria (40 CFR 82.3). Decisions on 

these criteria are made following a 

careful review by both the United States 

and the Parties to the Montreal 

Protocol.1 Importantly, because the CUE 

process is an exception to the phase-out, 

it has been implemented in a manner 

that recognizes the importance of the 

technical substantiation of critical need 

relative to the criteria agreed upon by 

the Parties. Between the 2005 and 2011 

CUE Nominations, the United States 

post harvest CUE amount authorized by 

the Parties has declined by nearly 80% 

(784,936 kilograms (kg) to 161,394 kg). 

(Ref. 27). Given the potential availability 

of alternatives in a few years, taking into 

consideration the full suite of chemical 

and non-chemical pest control options 

for post harvest uses, technical and 

economic substantiation for methyl 

bromide would be limited under CUE 

criteria for uses that had transitioned to 

sulfuryl fluoride. Finally, the ability of any given user 

group to use methyl bromide will also 

be constrained in any given year by a 

number of other factors. First, it is 

impermissible for any person to sell 

critical use methyl bromide to an end 

user without receiving a certification 

that it will be used for an approved 

critical use. (40 CFR 82.4(p)(1)(i)). 

Second, although there is no legal 

restriction on a non-critical user 

purchasing and using pre-phase-out 

stocks (the quantity of stored methyl 

bromide produced prior to the U.S. 

phase-out in 2005), (75 FR 23167, 

23181, May 3, 2010) (FRL–9144–5), 

whether or not such stocks could be 

commercially obtained quickly given 

long-term contracting for stocks is 

another question. In any event, prephase-out inventory has declined 

substantially and it is unclear at this 

time how much of it could be purchased 

for use in the post-harvest market. Thus, in the short-term, production 

and import of methyl bromide is 

restricted with no opportunities for 

immediate change. In the longer term, 

given the historical trajectory of the 

critical use exemption under the 

Montreal Protocol, there likely will be 

less, not more, methyl bromide 

available. Current users of sulfuryl 

fluoride may attempt to purchase 

methyl bromide from pre-phase-out 

inventories if sulfuryl fluoride becomes 

unavailable; however, the feasibility of 

obtaining significant quantities from 

this source is uncertain. 

4. Disruption of the marketplace. 

Food containing insect parts and waste 

may be considered adulterated under 

FFDCA section 402(a)(4) and subject to 

seizure by FDA. (21 U.S.C. 342(a)(4); see 

21 CFR 110.110 (Defect Action Levels)). 

As the recent recall of the infant formula 

Similac shows, contamination with 

insect parts can result in extensive 

disruption of the market for consumers 

and significant costs for the food 

industry. (Ref. 28 (‘‘Worried parents 

have bombarded the maker of Similac 

with phone calls and peppered 

Facebook and Twitter pages over fears 

about insects in the top-selling baby 

formula after millions of cans were 

recalled.’’); Refs. 29 and 30 (reporting 

that recall involved ‘‘up to 5 million 

Similac-brand powder formulas’’ and 

‘‘Abbot expects to lose $100 million in 

connection with the recall.’’)). 

5. Harm to health. There is a real 

potential for adverse human health 

impacts if sulfuryl fluoride is not 

available for treatment of food 

commodities, food mills, and other food 

processing facilities where sulfuryl 

fluoride is used. Without sulfuryl 

fluoride, there would be re-infestation of 

those commodities or facilities if 

facilities are not able to find suitable 

alternatives and thus more 

contamination of food products by the 

pests controlled by sulfuryl fluoride. 

Contamination would include whole 

insects, insect body parts, and insect 

waste, mainly from various flour 

beetles, moths, and cockroaches. Some 

of these contaminants (e.g., from 

cockroaches) have been identified as 

allergens. (Ref. 31). Other beetles have 

been associated with gastrointestinal 

illness and discomfort. (Ref. 32 and 33). 

Contamination also could include foodborne pathogens that cause disease, 

such as E. coli or Salmonella, 

introduced by flies that would no longer 

be controlled by sulfuryl fluoride. (Id.) 

6. Conclusion. In the absence of 

sulfuryl fluoride tolerances, current 

sulfuryl fluoride users will, in the first 

instance, turn to methyl bromide if 

methyl bromide can be obtained. Users’ 

ability to obtain methyl bromide will 

depend on a complex mix of factors 

including: when a final decision is 

made on the sulfuryl fluoride 

tolerances; whether the use is an 

approved critical use for a given year 

and, if so, the amount of methyl 

bromide available either from new 


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production or from pre-phase-out 

inventory under the CUE Rule for that 

year; and whether users have access to 

pre-phase-out inventory sold for noncritical exemption uses. To the extent 

that methyl bromide is used as a 

sulfuryl fluoride replacement, such a 

reversion to a stratospheric-ozone 

depleting chemical is a negative public 

health impact because it will add to 

damage to the ozone layer and 

contribute to additional health effects 

caused by exposure to ultraviolet 

radiation, including skin cancers and 

cataracts. 

If both sulfuryl fluoride and methyl 

bromide are unavailable, or supplies are 

limited, there is likely to be some 

disruption of the food supply as to the 

affected commodities and/or there is a 

greater likelihood of contaminated food 

being released for public consumption. 

The extent of disruption and/or 

contamination varies based on the type 

of processing facility and the 

commodities involved. For newer flour 

mills and other food processing 

facilities (i.e., ones made principally of 

concrete), use of heat should eventually 

be a successful alternative to sulfuryl 

fluoride. In the interim, food may 

become contaminated with insect parts 

and waste as facility owners use trial 

and error in adapting heat technology to 

their individual facilities. 

Older processing facilities constructed 

mainly of wood may have no options 

other than to cease production unless 

Dow AgroSciences seeks and obtains a 

registration amendment for sulfuryl 

fluoride that insures that sulfuryl 

fluoride is used in a manner not 

resulting in residues in food. Even so, it 

is unknown whether use of sulfuryl 

fluoride under such an approach is 

economically feasible. EPA expects 

similar impacts on other food handling 

facilities that rely on sulfuryl fluoride or 

methyl bromide fumigation to control 

pests. 

As to cocoa, impacts are likely to be 

very substantial. Currently, 100% of the 

imported cocoa in the United States is 

disinfested using sulfuryl fluoride. The 

likelihood of switching to methyl 

bromide is quite low. As of June 29, 

2007 for the 2009 CUE control period, 

cocoa bean users of methyl bromide 

ceased seeking CUEs. Cocoa is not 

currently an approved critical use, and 

thus any methyl bromide produced 

under a CUE cannot be used on cocoa. 

Cocoa importers’ only avenue for using 

methyl bromide would be to purchase 

methyl bromide from the dwindling prephase-out inventories. Eventually, 

fumigation chambers for phosphine 

could be constructed for cocoa but it 

may be a matter of years before they are 

operational and phosphine use is not 

feasible at existing sulfuryl fluoride 

fumigation sites. In the absence of an 

alternative to sulfuryl fluoride for 

disinfestation of cocoa, cocoa imports 

(which in 2009 were valued at 

approximately $1.2 billion) would be 

lost due to either destruction or refusal 

of shipments by warehouse operators to 

comply with FDA regulations. Walnuts 

may also face significant impacts 

because of the need for rapid fumigation 

with either methyl bromide or sulfuryl 

fluoride. Without sulfuryl fluoride or 

methyl bromide, a significant portion of 

the crop may be lost simply due to 

insufficient fumigation capacity given 

the relatively long time needed for 

fumigation with phosphine. Other 

commodities facing a similar situation 

to walnuts include dried fruits other 

than raisins. 

D. The Public Interest 

Determining where the public interest 

lies in this matter involves a complex 

weighing of inter-related environmental 

and health impacts and cost effects 

upon commercial interests and 

consumers. OPP attempts to capture 

each of these impacts in the following 

summary, some of which have been 

described previously. Others are 

discussed for the first time because they 

do not neatly fit under factors discussed 

previously. 

1. Harm from fluoride exposure. 

Aggregate exposure to fluoride exceeds 

the safe level for several major 

identifiable population subgroups. Of 

principal concern here are children up 

to the age of 7. 

2. Sulfuryl fluoride’s contribution to 

fluoride exposure. Use of sulfuryl 

fluoride results in a minimal 

contribution to fluoride exposure. 

Elimination of sulfuryl fluoride does not 

solve, or even significantly decrease, the 

fluoride aggregate exposure problems 

identified earlier. 

3. Increase in the use of methyl 

bromide inventories. There is a 

worldwide consensus that the use of 

chemicals that deplete the stratospheric 

ozone, such as methyl bromide, should 

be eliminated. Termination of sulfuryl 

fluoride will increase demand for 

methyl bromide and may result in an 

increase of use of methyl bromide 

inventories. 

4. Impacts on the food supply. To the 

extent that neither methyl bromide nor 

sulfuryl fluoride is available, there are 

likely to be impacts on the food supply, 

either through disruption of food 

availability or contamination of food 

with insect parts and waste, because 

other feasible alternatives to sulfuryl 

fluoride and methyl bromide will not be 

immediately available. 

5. Other atmospheric effects of 

sulfuryl fluoride. EPA acknowledges 

that recent research has identified the 

potential for sulfuryl fluoride to 

contribute to the greenhouse effect; 

however there does not appear to be 

consensus yet in the scientific 

community on its global warming 

potential. 

6. International consequences. As 

explained previously, the United States 

agreed to end domestic production of 

methyl bromide in 2005, along with 

other developed countries that are 

Parties to the Montreal Protocol. Since 

2005, the United States has—along with 

a handful of other developed 

countries—been requesting limited 

continued amounts of methyl bromide 

to satisfy needs that Parties agree to be 

‘critical’. Also since 2005, U.S. requests 

for continued uses have been large, 

relative to those of other countries. At 

the beginning of the post-phase-out 

period, in 2005, 17 developed countries 

requested and obtained such 

exemptions; currently, the United States 

is one of only four developed countries 

that have not yet eliminated methyl 

bromide CUEs. (Ref. 27). The United 

States historically used a majority of the 

world’s methyl bromide; therefore, the 

challenge faced by U.S. agriculture in 

this transition has been formidable. 

Still, enormous progress has been made 

in adopting alternatives for all major 

uses, allowing the United States to 

substantially reduce the size and 

number of its CUE requests. Sulfuryl 

fluoride has been an important 

component to this process. A sudden 

reversal by the United States in its 

efforts to reduce the use of methyl 

bromide may have broad ramifications 

on the success of the treaty. U.S. 

authorizations have been reduced 

further by the Parties to the Montreal 

Protocol, based on recommendations 

from the relevant technical committees 

of the Montreal Protocol. Rapid 

termination of sulfuryl fluoride 

tolerances would be at odds with the 

careful, deliberate, and well-established 

CUE process. The process is protracted 

and the relevant criteria demand 

technical justifications that require time 

to develop and substantiate. In reality, 

the multi-step CUE process is not 

designed with the expectation that it 

would allow a Party to the Montreal 

Protocol requesting a CUE for a given 

year to rapidly adjust either to the 

introduction of a new alternative or to 

the withdrawal of an existing 

alternative. An additional international 

consequence is that the lack of sulfuryl 

fluoride to treat imported commodities 


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such as cocoa could lead to shipments 

of imported commodities being rejected 

and trade with some economically 

vulnerable countries may be negatively 

affected. 

E. Conclusion 

Taking all of these factors into 

account involves weighing EPA’s 

proposed conclusion that Objectors’ 

have meritorious objections and the 

potential beneficial impacts on the 

public interest if a stay was granted 

against the negative impacts on the 

public interest from a stay approval. The 

beneficial impacts from granting a stay 

would be a slight reduction in fluoride 

exposure and other potential 

atmospheric effects. On the other hand, 

granting a stay would potentially cause 

the following negative impacts: 

1. A possible increase in use of 

methyl bromide inventories, with 

attendant negative known atmospheric 

effects; 

2. An undermining of the substantial 

progress made in reducing methyl 

bromide critical use exemptions in the 

postharvest market and potential 

disruption in implementation of an 

important international treaty, and 

3. Significant impacts on several food 

industries and related effects on the 

public, including potential health 

effects on the public. 

Despite the health risks posed by overall 

aggregate fluoride exposure and the 

Objectors’ likelihood of success on the 

merits, OPP believes that each of the 

potential negative impacts on the public 

interest outweigh the beneficial public 

effects from a stay. Viewed in this light, 

EPA concludes that the public interest 

strongly, in fact overwhelmingly, 

supports denial of the Objectors’ stay 

request. 

VIII. Proposed Effective Date of Order 

EPA proposes to make this order 

effective 60 days following publication. 

However, EPA is also proposing a 

staggered implementation for 

withdrawal of the affected tolerances in 

40 CFR 180.145(c) and 180.575 taking 

into account the discussion in Unit VII. 

concerning the Objectors’ stay request. 

This staggered implementation is 

proposed to be accomplished by 

including an expiration/revocation date 

in 40 CFR 180.145(c) and 180.575 for 

each of the tolerances not proposed for 

withdrawal upon the effective date of 

the order. Given the potential disruption 

or contamination of some commodities 

in the food supply, severely limited 

availability of methyl bromide, and 

prospect of difficulties in implementing 

an important international treaty, EPA is 

proposing to withdraw tolerances under 

the following implementation or 

phaseout schedule: 

1. Tolerances for canceled uses: 

immediately. For uses that have been 

removed from the sulfuryl fluoride 

registration, there is no reason the 

proposed order should not take effect 

upon the effective date of the order. 

These tolerances are: Dried eggs; milk, 

powdered. 

2. Tolerances for commodities where 

there is little to no use of sulfuryl 

fluoride: 90 days. EPA’s analysis and 

information from Dow AgroSciences 

indicate that sulfuryl fluoride is not 

currently used in significant amounts, if 

at all, on numerous commodities for 

which direct fumigation is allowed 

under the sulfuryl fluoride registration. 

EPA is proposing a termination of 

tolerances associated with these uses 90 

days from the effective date of the order. 

Ninety days should be sufficient for all 

affected parties to come into compliance 

with the revised situation. Tolerances in 

this category are: barley, bran, 

postharvest; barley, flour, postharvest; 

barley, grain, postharvest; barley, 

pearled barley, postharvest; cattle, meat, 

dried; cheese; coconut, postharvest; 

coffee, bean, green, postharvest; corn, 

field, flour, postharvest; corn, field, 

grain, postharvest; corn, field, grits, 

postharvest; corn, field, meal, 

postharvest; corn, pop, grain, 

postharvest; cotton, undelinted seed, 

postharvest; ginger, postharvest; grain, 

aspirated fractions, postharvest; grape, 

raisin, postharvest; herbs and spices 

group 19, postharvest; hog, meat; millet, 

grain, postharvest; nut, pine, 

postharvest; nut, tree, Group 14, 

postharvest (revised to cover only 

walnuts, postharvest); oat, flour, 

postharvest; oat, grain, postharvest; oat, 

groat/rolled oats; peanut, postharvest; 

pistachio, postharvest; sorghum, grain, 

postharvest; triticale, grain, postharvest; 

vegetable, legume, group 6, postharvest; 

wheat, bran, postharvest; wheat, flour, 

postharvest; wheat, germ, postharvest; 

wheat, grain postharvest; wheat, milled 

byproducts, postharvest; wheat, shorts, 

postharvest. 

3. Tolerances for commodities directly 

treated where there is significant 

sulfuryl fluoride use and no readilyavailable alternative: 3 years. For 

several commodities, sulfuryl fluoride is 

used on all, or a substantial portion, of 

the crop and there is no readilyavailable alternative. These 

commodities are cocoa, walnuts, and 

dried fruits other than raisins. Although 

there is a feasible alternative available 

for sulfuryl fluoride in the long-term, 

phosphine, in the short-term that 

alternative is not available due to the 

lack of fumigation capacity. The 

situation for cocoa is perhaps the most 

dire in that 100% of the crop is treated, 

the space used for sulfuryl fluoride 

fumigation is not appropriate for 

phosphine use, and, given that cocoa is 

not currently an approved critical use, 

methyl bromide produced under a CUE 

may not be used on cocoa. While not 

facing quite such catastrophic 

consequences, walnuts are nonetheless 

in essentially the same situation because 

the only realistic treatment option in the 

near term (i.e., methyl bromide) can 

only be obtained, if at all, from prephase-out inventories or from 

production under the sharply-limited 

postharvest CUE, and another 

alternative will not be available until 

additional fumigation capacity is 

created. The situation appears similar 

for dried fruits other than raisins as 

well; however, EPA requests that 

information be submitted during the 

comment period documenting the 

amount of sulfuryl fluoride use on dried 

fruits and the availability of alternatives 

including the availability of capacity for 

alternative fumigations. EPA is 

proposing termination of tolerances 

associated with these uses 3 years from 

the effective date of the order. 

Construction of fumigation chambers 

may take several years. 

4. Tolerances for commodities 

receiving residues from incidental 

treatment during structural 

fumigation—3 years. The situation for 

foods requiring tolerances as a result of 

incidental treatment from structural 

fumigations is more complicated. 

Different types of facilities will face 

different hurdles in transitioning from 

sulfuryl fluoride to other methods of 

pest control. For most facilities, use of 

heat may prove an adequate pest control 

strategy. However, implementation of 

heat technology is not expected to be 

seamless and the availability of sulfuryl 

fluoride as a backup to avoid potential 

disruption or contamination is 

important. OPP expects that, after the 

first year, use of sulfuryl fluoride in 

these facilities will be the exception 

rather than the rule as the technology 

comes online and facility operators gain 

experience with it. In other words, 

sulfuryl fluoride would only be used 

when difficulties arise in perfecting the 

use of heat technology in individual 

facilities. Given the cost of sulfuryl 

fluoride treatment, facility operators, 

having invested in heat technology, will 

have a strong incentive to avoid use of 

sulfuryl fluoride unless absolutely 

necessary. A relatively short transition 

period may be appropriate for these 

facilities. For wooden structures, 

however, where heat is not an option, 


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3448 Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Proposed Rules 

no chemical or non-chemical alternative 

is immediately available. These 

facilities face an uncertain future with 

perhaps the best alternative being 

pursuit by Dow AgroSciences of 

restrictions on the sulfuryl fluoride 

registration that would eliminate the 

possibility of residues in food and thus 

permit continued use of sulfuryl 

fluoride as a structural fumigant in food 

handling facilities. Nonetheless, even 

this approach is in question due to 

feasibility issues. Thus, to some degree, 

owners of wooden food handling 

facilities face the most serious 

consequences of any producer group 

and, due to their relatively large share 

of the market, there could be similarly 

serious consequences for the public. For 

that reason, EPA is proposing 

termination of tolerances associated 

with these uses 3 years from the 

effective date of the order. To insure 

that this extended transition period will 

not encourage owners of concrete 

facilities to maintain the status quo, 

EPA plans to pursue registration 

modifications for sulfuryl fluoride that 

differentiate between sulfuryl fluoride 

use in concrete and wooden structures. 

EPA’s goal would be to allow sulfuryl 

fluoride use in concrete facilities for a 

period no longer than necessary to 

accomplish the transition to heat 

technology. 

EPA specifically requests comment on 

the potential impacts from the loss of 

sulfuryl fluoride including any available 

and additional information on pest 

control alternatives to sulfuryl fluoride. 

Such information is important to EPA’s 

decision on the proposed effective dates 

for this order. Further, EPA recognizes 

that sulfuryl fluoride is only one of 

many sources of exposure to fluoride. 

To the extent that new information 

indicates that overall fluoride exposure 

has decreased, including as a result of 

other government actions, EPA would 

consider revisiting the determinations 

in this proposed order. 

IX. Request for Public Comment 

EPA requests public comment on all 

aspects of this proposed order: Its 

hazard, exposure, and risk assessments 

of fluoride; its evaluation of the factors 

bearing on whether a stay should be 

granted; and its proposed effective dates 

for the order. 

X. Regulatory Assessment 

Requirements 

As indicated previously, this action 

announces the Agency’s proposed order 

regarding objections filed under section 

408 of FFDCA. As such, this action is an 

adjudication and not a rule. The 

regulatory assessment requirements 

imposed on rulemaking do not, 

therefore, apply to this action. 

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 order because this action is not a 

rule for purposes of 5 U.S.C. 804(3). 

XII. References 

As indicated under ADDRESSES, a 

docket has been established for this 

rulemaking under docket ID number 

EPA–HQ–OPP–2005–0174. The 

following is a listing of the documents 

that are specifically referenced in this 

document. The docket includes these 

documents and other information 

considered, including documents that 

are referenced within the documents 

that are included in the docket, even if 

the referenced document is not 

physically located in the docket. For 

assistance in locating these other 

documents, please consult the technical 

contact listed under FOR FURTHER

INFORMATION CONTACT. 

1. Fluoride Action Network and Beyond 

Pesticides/National Coalition Against the 

Misuse of Pesticides, Written Objections and 

Request for Hearing in the matter of: Sulfuryl 

Fluoride; Pesticide Tolerance; Final Rule. 

(March 23, 2004). 

2. Motion of Objectors for Stay of Final 

Rules Establishing Tolerances For Residues 

of Sulfuryl Fluoride and Fluoride Anion; 

(Docket Nos. OPP–2005–0174 and OPP– 

2003–0373) (June 1, 2006). 

3. Objectors’ Consolidated Objections to 

Final Rules Establishing Tolerances for 

Residues of Sulfuryl Fluoride and Fluoride 

Anion (November 6, 2006). 

4. USEPA, A User’s Guide to Available 

EPA Information on Assessing Exposure to 

Pesticides in Food (June 21, 2000). 

5. USEPA. Office of Research and 

Development. 2000. Benchmark Dose 

Technical Guidance Document. Draft report. 

Risk Assessment Forum, Office of Research 

and Development, U.S. Environmental 

Protection Agency. Washington, DC. EPA/ 

630/R–00/001. 

6. FIFRA Science Advisory Panel. 2002. 

Methods Used to Conduct a Preliminary 

Cumulative Risk Assessment for 

Organophosphate Pesticides. Final Report 

from the FIFRA Scientific Advisory Panel 

Meeting of February 5–7, 2002 (Report dated 

March 19, 2002). FIFRA Scientific Advisory 

Panel, Office of Science Coordination and 

Policy, Office of Prevention, Pesticides and 

Toxic Substances, U.S. Environmental 

Protection Agency. Washington, DC. SAP 

Report 2002–01. 

7. FIFRA Science Advisory Panel. 2005b. 

Final report on Preliminary N-Methyl 

Carbamate Cumulative Risk Assessment. 

Final Report from the FIFRA Scientific 

Advisory Panel Meeting of August 23–25, 

2005 (Report dated October 13, 2005). 

Available at: http://www.epa.gov/scipoly/ 

sap/2005/august/minutes.pdf. 

8. Office of Pesticide Programs, USEPA, 

Office of Pesticide Programs’ Policy on the 

Determination of the Appropriate FQPA 

Safety Factor(s) For Use in the Tolerance 

Setting Process (February 28, 2002). 

9. USEPA, Residue Chemistry Test 

Guidelines: OPPTS 860.1500 Crop Field 

Trials (August 1996). 

10. Office of Pesticide Programs, USEPA 

and Pest Regulatory Management Agency, 

Health Canada, NAFTA Guidance Document 

for Guidance for Setting Pesticide Tolerances 

Based on Field Trial Data (September 28, 

2005). 

11. Office of Pesticide Programs, USEPA, 

Choosing a Percentile of Acute Dietary 

Exposure as a Threshold of Regulatory 

Concern (March 16, 2000). 

12. Office of Pesticide Programs, USEPA, 

Standard Operating Procedures (SOPs) for 

Residential Exposure Assessments (Draft 

December 19, 1997). 

13. Office of Prevention, Pesticides, and 

Toxic Substances, USEPA, ‘‘Response To 

Public Comments Concerning The Use Of 

Sulfuryl Fluoride As A Post-Harvest 

Fumigant’’ (January 16, 2004). 

14. Baetcke et al., Office of Pesticide 

Programs, USEPA, ‘‘A Preliminary Evaluation 

of Articles Related to Fluoride Cited by the 

Fluoride Action Network (FAN) as 

Objections to the Sulfuryl Fluoride Pesticide 

Tolerance Rule’’ (November 18, 2003). 

15. Office of Prevention, Pesticides, and 

Toxic Substances, USEPA, Memorandum 

from Vicki L. Dellarco to Dennis McNeilly, 

Review of Five Recent Papers on Fluoride 

Submitted by the Fluoride Action Network 

(January 8, 2004). 

16. Office of Prevention, Pesticides, and 

Toxic Substances, USEPA, ‘‘Response to 

Public Comments Concerning the Use of 

Sulfuryl Fluoride In Food Handling 

Facilities’’ (July 14, 2005). 

17. National Research Council of the 

National Academies, ‘‘Fluoride in Drinking 

Water: A Scientific Review of EPA’s 

Standards’’ (March 2006). 

18. Objectors’ Submission to Docket: 18 IQ 

Studies (posted February 17, 2009). 

19. Dow AgroSciences LLC, ‘‘Response to 

Request for Public Comments; Sulfuryl 

Fluoride; Request for Stay of Tolerances; 

Public Docket Identification Numbers: EPA– 

HQ–OPP–2005–0174 and EPA–HQ–OPP– 

2003–0373 (August 4, 2006). 

20. Dow AgroSciences LLC, Memorandum, 

‘‘Standard for Granting a Hearing under the 

Federal Food, Drug, and Cosmetic Act 

Concerning Objections to Tolerances 

Established by EPA for Profume TM Gas 

Fumigant’’ (October 31, 2006). 

21. Health and Ecological Criteria Division, 

Office of Water, USEPA, ‘‘Fluoride: DoseResponse Analysis for Non-cancer Effects’’ 

(December 2010). 

22. Health and Ecological Criteria Division, 

Office of Water, USEPA, ‘‘Fluoride: Exposure 

and Relative Source Contribution Analysis’’ 

(December 2010). 

23. Office of Chemical Safety and Pollution 

Prevention, US EPA, Memorandum from 

Michael A. Doherty to Meredith Laws, 

‘‘Sulfuryl Fluoride—Revised Human Health 


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Risk Assessment for Fluoride to Incorporate 

New Hazard and Exposure Information’’ 

(January 7, 2011). 

24. Office of Prevention, Pesticides, and 

Toxic Substances, US EPA, Memorandum 

from Colwell A. Cook, Jonathan Becker, and 

Elisa Rim to Kable Davis/Venus Eagle and 

Michael Doherty/Christina Swartz, ‘‘Revised 

Assessment of Percent Commodity Treated 

Values used in the Registrant’s Dietary 

Exposure Assessment for Fluoride (DP# 

361041)’’ (May 1, 2009). 

25. Office of Chemical Safety and Pollution 

Prevention, US EPA, Memorandum from 

Michelle Ranville and Colwell Cook to 

Meredith Laws, ‘‘Assessment of Impacts on 

Flour Mills Operators of a Stay in Sulfuryl 

Fluoride Food Tolerances’’ (January 7, 2011). 

26. Office of Chemical Safety and Pollution 

Prevention, US EPA, Memorandum from 

Colwell Cook and Michelle Ranville to 

Meredith Laws, ‘‘Assessment of Impacts of a 

Stay of Food Tolerances for Sulfuryl Fluoride 

on Selected Post-Harvest Commodities’’ 

(January 7, 2011). 

27. Office of Chemical Safety and Pollution 

Prevention, US EPA, Memorandum from 

Colwell Cook and Michelle Ranville to 

Jonathan Fleuchaus, Post Harvest Methyl 

Bromide Grant to the United States by the 

Parties to the Montreal Protocol, 2005–2011 

(December 16, 2010). 

28. Washington Post, ‘‘Bugs in Baby 

Formula? Parents Worried About Recall’’ 

(September 24, 2010) (available at http:// 

www.washingtonpost.com/wp-dyn/content/ 

article/2010/09/24/ 

AR2010092402044.html?waporef=obinsite). 

29. U.S. FDA Consumer Update, ‘‘Abbott 

Recalls Some Similac Formulas (September 

23, 2010) (available at http://www.fda.gov/ 

ForConsumers/ConsumerUpdates/ 

ucm226941.htm). 

30. Washington Post, ‘‘Bug Contamination 

Sparks Baby Formula Recall’’ (September 23, 

2010) (available at http:// 

www.washingtonpost.com/wp-dyn/content/ 

article/2010/09/22/ 

AR2010092206070.html?waporef=obinsite). 

31. Olsen et al., Regulatory Action Criteria 

for Filth and Other Extraneous Materials, V. 

Strategy for Evaluating Hazardous and 

Nonhazardous Filth (Jan. 12, 2001). 

32. U.S. FDA Consumer Update, ‘‘Abbott 

Recalls Some Similac Formulas’’ (September 

23, 2010) (available at http://www.fda.gov/ 

ForConsumers/ConsumerUpdates/ 

ucm226941.htm). 

33. Olsen, Alan, FDA Teamwork Uncovers 

Insect Infestation, FDA Consumer, Vol. 25, 

Jul.–Aug. 1991). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 7, 2011. 

Steve Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2011–917 Filed 1–18–11; 8:45 am] 

BILLING CODE 6560–50–P 


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