Carbofuran; Order Denying FMC's Objections and Requests for Hearing, 59608-59686 [E9-27261]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Rules and Regulations]
[Pages 59608-59686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27261]



[[Page 59607]]

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Part II





Environmental Protection Agency





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40 CFR Part 180



Carbofuran; Order Denying FMC's Objections and Requests for Hearing; 
Final Rule

Federal Register / Vol. 74 , No. 221 / Wednesday, November 18, 2009 / 
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0162; FRL-8797-6]


Carbofuran; Order Denying FMC's Objections and Requests for 
Hearing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Order.

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SUMMARY: In this order, EPA denies objections to, and requests for 
hearing on, a final rule revoking all pesticide tolerances for 
carbofuran under section 408(d) of the Federal Food, Drug, and Cosmetic 
Act (FFDCA). The objections and hearing requests were filed on June 30, 
2009, by the National Corn Growers Association, National Sunflower 
Association, National Potato Council, and FMC Corporation 
(``Petitioners'').

DATES: This final order is effective November 18, 2009.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0162. To access the 
electronic docket, go to https://www.regulations.gov, and search for the 
docket number. Follow the instructions on the regulations.gov Web site 
to view the docket index or access available documents. All documents 
in the docket are listed in the docket index available in 
regulations.gov. Although listed in the index, some information is not 
publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at https://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 Docket 
Facility is open 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: Jude Andreasen, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9342; e-mail 
address: andreasen.jude@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this Action Apply to Me?

    In this document EPA denies objections and hearing requests by the 
National Corn Growers Association, National Sunflower Association, 
National Potato Council, and FMC Corporation (``Petitioners'') 
concerning EPA's final rule revoking all pesticide tolerances for 
carbofuran. This action may also be of interest to agricultural 
producers, food manufacturers, or pesticide manufacturers. Potentially 
affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the Federal Register 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at https://www.gpoaccess.gov/ecfr.

C. Acronyms

    The following is a list of acronyms used in this order:

AChE--Acetylcholinesterase
aPAD--Acute Population Adjusted Dose
BMD--Bench Mark Dose
BMDL--Bench Mark Dose Level
CCA--Comparative Cholinesterase Assay
CNS--Central Nervous System
CRA--Cumulative Risk Assessment
CSFII--Continuing Survey of Food Intakes by Individuals
CWA--Clean Water Act
CWS--Community Water System
DEEM-FCID--Dietary Exposure Evaluation Model-Food Commodity Intake 
Database
ECG--Electrocardiogram
EDWC--Estimated Drinking Water Concentration
EPA--Environmental Protection Agency
FACA--Federal Advisory Committee Act
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
HSRB--Human Studies Review Board
HUC-8--8-digit hydrologic unit code
IRED--Interim Reregistration Eligibility Decision
LD50--Lethal Dose for 50% of a population
LOAEL--Lowest Observable Adverse Effect Level
NAWQA--National Water Quality Assessment Program
NHEERL--National Health and Environmental Effects Laboratory
NMC CRA--N-Methyl Carbamate Cumulative Risk Assessment
NOAEL--No Observable Adverse Effect Level
NOIC--Notice of Intent to Cancel
NRDC--National Resources Defense Council
OP--Organophosphate
ORD--Office of Research and Development
PAD--Population Adjusted Dose
PCA--Percent Cropped Area
PCT--Percent Crop Treated
PDP--Pesticide Data Program
PND--Post-Natal Day
PNS--Peripheral Nervous System
PoD--Point of Departure
ppb--parts per billion
ppm--parts per million
PRZM-EXAMS--Pesticide Root Zone Model-Exposure Analysis Model System
RBC--red blood cell
RED--Reregistration Eligibility Decision
RfD--Reference Dose
SAP--Scientific Advisory Panel
SDWA--Safe Drinking Water Act
USDA--United States Department of Agriculture
USGS--United States Geological Survey
WARP--Watershed Regression for Pesticides

II. Introduction

A. What Action Is the Agency Taking?

    Exposure to the pesticide carbofuran resulting from existing legal 
uses is unsafe--unsafe for the general

[[Page 59609]]

population, and particularly unsafe for infants and children. EPA 
reached this conclusion in 2006 after an exhaustive multi-year review 
of the data on carbofuran as part of its effort to determine whether 
carbofuran should be reregistered under the Federal Insecticide, 
Fungicide, and Rodenticide Act (``FIFRA''), and whether the tolerances 
allowing carbofuran residues on certain foods met the revised safety 
standard in section 408 of the FFDCA. This multi-year review included 
multiple opportunities for public participation, including no less than 
four formal public comment periods. Following EPA review of yet more 
carbofuran data submitted by FMC, the carbofuran registrant, and the 
review of EPA's science findings by the FIFRA Scientific Advisory Panel 
(SAP)--an independent scientific peer review panel--EPA again reached 
the same conclusion in its July 31, 2008 proposal to revoke the 
carbofuran tolerances (73 FR 44864 (July 31, 2008)). In response to 
this proposed revocation, FMC submitted comments challenging many of 
EPA's science findings and also requesting the cancellation of the 
registration of carbofuran on several crops and the restriction of 
where, and the manner in which, carbofuran could be used in the United 
States on its remaining registered crop sites. Finding FMC's science 
arguments to be flawed and its proposed amendments to the carbofuran 
registration to be insufficient, EPA finalized the rule revoking 
carbofuran tolerances on May 15, 2009 (74 FR 23046 (May 15, 2009)).
    Pursuant to the procedures of the FFDCA, on June 29, 2009 
objections to the final revocation rule were filed by the National Corn 
Growers Association, National Sunflower Association, National Potato 
Council, and FMC Corporation (``Petitioners''). The Petitioners also 
requested a hearing on their objections. Coupled with these objections, 
FMC filed on the same day yet another series of proposed amendments to 
its carbofuran registration. These proposed modifications contained new 
application and geographic restrictions as well as an unprecedented 
non-governmental scheme for preventing the use of carbofuran in any one 
area of the country above a small percentage of that area's 
agricultural acreage. The Petitioners relied on these proposed 
carbofuran registration amendments as central to, and inextricably 
intertwined with, their objection to EPA's prior determination in the 
final rule that carbofuran tolerances are unsafe. Specific challenges 
raised by the Petitioners involved EPA's decision on the appropriate 
level of the additional safety factor to protect infants and children, 
EPA's estimate of carbofuran levels in drinking water, EPA's 
consideration of the time needed to recover from exposure to 
carbofuran, and EPA's refusal to consider a human toxicity study 
conducted with carbofuran.
    Today's order denies all of the Petitioners' objections and 
requests for hearing. A principal flaw in the Petitioners' objections 
is that they have objected to EPA's determination in the final rule on 
the safety of carbofuran based on the FIFRA registration amendments 
that FMC filed with EPA 45 days after the safety determination was 
made. As such, the Petitioners' objections are irrelevant, and thus 
immaterial, to the determination EPA made in the final rule. FMC has 
the statutory right under FIFRA to request amendment of its carbofuran 
registration. What Petitioners may not do is prolong the FFDCA 
tolerance revocation process by challenging EPA's safety determination 
based on proposed FIFRA registration changes not before EPA at the time 
of its final revocation decision.
    It should be noted that EPA's decision on the carbofuran tolerances 
is not a determination on FMC's proposed registration amendments. FMC 
may continue to pursue these amendments and also the re-establishment 
of carbofuran tolerances in light of the amendments. Further, FMC may 
seek administrative review, and potentially an administrative hearing, 
with regard to any adverse decision issued by EPA on its proposed 
amendments. But that process must be played out in the future, a future 
in which any decision about the safety of carbofuran is made prior to 
the re-introduction of carbofuran residues in food and water, rather 
than concurrent with the continued exposure of infants and children to 
levels of carbofuran residues that EPA has found to be unsafe.
    Despite the fact that a central aspect of the Petitioners' 
objections is based on a flawed conception of the objection process 
(i.e., the notion that the objection process presents the opportunity 
for a complete reformulation of the matter in dispute, rather than a 
chance for a review of the accuracy of EPA's earlier determination), 
EPA has undertaken a comprehensive analysis of the merits of each of 
the Petitioners' objections and hearing requests. That analysis shows, 
as is exhaustively set out in Unit VI, that none of the Petitioners' 
requests for hearing meets the regulatory standard for granting a 
hearing and none of the Petitioners' objections has merit. There are 
numerous reasons for these conclusions, but two related themes running 
throughout EPA's analysis are the Petitioners' failure to timely raise 
issues or submit supporting documents during the public comment process 
on the proposed rule and the Petitioners' failure to object to how EPA, 
in the final rule, resolved the issues the Petitioners did raise in the 
comment process. EPA considers issues untimely raised to be waived--as 
EPA clearly warned at the proposal stage--and finds recycled comments 
on the proposed rule to be irrelevant to the detailed determinations 
made in the final rule. The rulemaking phase of the revocation process 
has a purpose, and parties treat it lightly at their peril. Finally, 
EPA notes that an additional problem with the Petitioners' objections 
is that once the newly proposed registration amendments are stripped 
from the objections, it is not at all clear that any remaining issues, 
even if concluded in the Petitioners' favor, would result in lowering 
carbofuran's estimated risks--which EPA has estimated as far exceeding 
the safety standard--to an acceptable level. For all of these reasons, 
the Petitioners' objections and hearing requests are denied.

B. What Is the Agency's Authority for Taking This Action?

    EPA is taking this action pursuant to the authority in FFDCA 
section 408(g)(2)(C), which requires the Agency to issue a final order 
resolving the objections to its final rule, issued pursuant to 
408(b)(1)(b), 408(b)(2)(A), and 408(e)(1)(A). 21 U.S.C. 346a(b)(1)(b), 
(b)(2)(A), (e)(1)(A), (g)(2)(C).)

III. Statutory and Regulatory Background

    In this Unit, EPA provides background on the relevant statutes and 
regulations governing the Petitioners' objections and requests for 
hearing as well as on pertinent Agency policies and practices.

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 the 
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 the FFDCA and may not be 
legally moved in interstate commerce (21 U.S.C. 331,

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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 discussed below establishing a detailed safety 
standard for pesticides, additional protections for infants and 
children, and the process for establishing or revoking tolerances (Pub. 
L. 104-170, 110 Stat. 1489 (1996)).
    EPA also regulates pesticides under the Federal Insecticide, 
Fungicide, and Rodenticide Act (``FIFRA'') (7 U.S.C. 136 et seq.). 
While the 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 labels and 
specifying that use of a pesticide inconsistent with its label 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 the FFDCA be used as a criterion in FIFRA 
registration actions as to pesticide uses that 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. Section 
408(b)(2)(A)(i) of the FFDCA requires EPA to modify or revoke a 
tolerance if EPA determines that the tolerance is not ``safe'' (21 
U.S.C. 346a(b)(2)(A)(ii)). Section 408(b)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(D) directs EPA, in 
making a safety determination, to:
    Consider, among other relevant factors--* * *
    (vi) 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 non-
occupational sources;

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) states that EPA:


    Shall assess the risk of the pesticide chemical based on--* * *
    (II) 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) and (III)). This provision also 
creates a presumptive 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 revoked by rulemaking under the unique procedural 
framework set forth in the FFDCA. Section 408(e) of the FFDCA, 21 
U.S.C. 346a(e), authorizes EPA to modify or revoke tolerances on its 
own initiative.
    In issuing a regulation on its own initiative, EPA must first 
publish a notice of proposed rulemaking, and must generally provide at 
least 60 days to allow the public to comment on the proposed 
regulation. After considering comments submitted during this comment 
period, EPA issues a final rule.
    Once EPA issues a final rule, any person may file objections with 
EPA and, if desired, request an evidentiary hearing on those objections 
(21 U.S.C. 346a(g)(2)). Objections must specify ``with particularity 
the provisions of the regulation * * * deemed objectionable and stating 
reasonable grounds therefore'' (21 U.S.C. 346a(g)(2)(A); 40 CFR 
178.25(a)). 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, will 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)). After consideration 
of any objections, EPA must issue a final order stating the action 
taken in response to each objection, including a determination as to 
whether any hearing is appropriate (21 U.S.C. 346a(g)(2)(C)). The final 
order also establishes any revisions to the final regulation EPA deems 
to be warranted based on the objections. Id. EPA's final order on the 
objections is subject to judicial review in the Court of Appeals, 
within 60 days of the publication of the order (21 U.S.C. 346a(h)(1)).
    4. Tolerance reassessment and FIFRA reregistration. EPA revoked the 
carbfuran tolerances to implement the Agency's findings made during the 
reregistration and tolerance reassessment processes.
    The FQPA required that EPA reassess the safety of all pesticide 
tolerances existing at the time of its enactment. (21 U.S.C. 346a(q)). 
EPA was given 10 years to reassess the approximately 10,000 tolerances 
in existence in 1996. In this reassessment, EPA was required to review 
existing pesticide tolerances under the new ``reasonable certainty that 
no harm will result'' standard set forth in section 408(b)(2)(A)(i). 
(21 U.S.C. 346a(b)(2)(A)(i)). This reassessment was substantially 
completed by the August 3, 2006 deadline. Tolerance reassessment was 
generally handled in conjunction with a similar program involving 
reregistration of pesticides under FIFRA. (7 U.S.C. 136a-1). 
Reassessment and reregistration decisions were generally combined in a 
document labeled a Reregistration Eligibility Decision (RED).

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B. EPA's Human Research Rule

    EPA decisions regarding the use of human studies in pesticide 
regulatory decisions are governed by the Protection for Subjects in 
Human Research final rule (``Human Research rule''), which 
significantly strengthened and expanded protections for subjects of 
human research (71 FR 6138 (February 6, 2006)). The framework of the 
Human Research rule rests on the basic principle that EPA will not, in 
its actions, rely on data derived from unethical research. The rule 
divides studies involving intentional dosing of human subjects into two 
groups: ``new'' studies--those initiated after April 7, 2006 (the 
effective date of the rule)--and ``old'' studies--those initiated 
before April 7, 2006. The Human Research Rule forbids EPA from relying 
on data from any ``new'' study, unless EPA has adequate information to 
determine that the research was conducted in substantial compliance 
with the ethical requirements contained therein (40 CFR 26.1705). These 
ethical rules are derived primarily from the ``Common Rule,'' (40 CFR 
part 26), a rule setting ethical parameters for studies conducted or 
supported by the federal government. In addition to requiring informed 
consent and protection of the safety of the subjects, among other 
things, the rule specifies that ``[r]isks to subjects [must be] 
reasonable in relation to * * * the importance of the knowledge that 
may reasonably be expected to result [from the study].'' (40 CFR 
26.1111(a)(2)). In other words, a study would be judged unethical if it 
did not have scientific value outweighing any risks to the test 
subjects.
    As to ``old'' studies, the Human Research Rule forbids EPA from 
relying on such data if there is clear and convincing evidence that the 
conduct of the research was fundamentally unethical or significantly 
deficient with respect to the ethical standards prevailing at the time 
the research was conducted (40 CFR 26.1704). EPA has indicated that in 
evaluating ``the ethical standards prevailing at the time the research 
was conducted'' it will consider the Nuremburg Code, various editions 
of the Declaration of Helsinki, the Belmont Report, and the Common 
Rule, as among the standards that may be applicable to any particular 
study (71 FR at 6161). Further, reflecting the concern that 
scientifically invalid data are ``always unethical,'' (71 FR at 6160), 
the rule limits the human research that can be relied upon by EPA to 
``scientifically valid and relevant data'' (40 CFR 26.1701).
    Whether the data are ``new'' or ``old,'' the Human Research rule 
forbids EPA from relying on data from any study involving intentional 
exposure of pregnant women, fetuses, or children subject to a very 
limited exception (40 CFR 26.1703, 1706).
    To aid EPA in making scientific and ethical determinations under 
the Human Research rule, the rule established an independent Human 
Studies Review Board (HSRB) to review both proposals for new research 
(new studies) and reports of completed human research (old studies) on 
which EPA proposes to rely (40 CFR 26.1603). The rule directs that the 
HSRB shall be comprised of non-EPA employees ``who have expertise in 
fields appropriate for the scientific and ethical review of human 
research, including research ethics, biostatistics, and human 
toxicology'' (40 CFR 26.1603(a)). If EPA decides to rely on the results 
from ``old'' research conducted to identify or measure a toxic effect, 
EPA must submit the results of its assessment to the HSRB for 
evaluation of the ethical and scientific merit of the research (40 CFR 
26.1602(b)(2)).
    EPA has established the HSRB as a federal advisory committee under 
the Federal Advisory Committee Act (FACA) to take advantage of ``the 
benefits of the transparency and opportunities for public 
participation'' that accompany a FACA committee (71 FR at 6156). The 
HSRB, as appointed by EPA, contains approximately 16 distinguished 
experts in the fields of bioethics, biostatistics, human health risk 
assessment and human toxicology, primarily from academia (Ref. 10).

IV. EPA's Approach to Dietary Risk Assessment

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. A short summary is provided 
below to aid the reader. For further discussion of the regulatory 
requirements of section 408 of the FFDCA and a complete description of 
the risk assessment process, see https://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-04/p34736.htm.
    To assess the 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 exposure ``level of concern'' for humans; (3) estimation of human 
exposure; and (4) characterization of human risk based on comparison of 
human exposure to the level of concern.

A. Hazard Identification and Selection of Toxicological Endpoint

    1. In General. Any risk assessment begins with an evaluation of a 
chemical's inherent properties, and whether those properties have the 
potential to cause adverse effects (i.e., hazard identification). EPA 
then evaluates the hazards to determine the most sensitive and 
appropriate adverse effect of concern, based on factors such as the 
effect's relevance to humans and the likely routes of exposure.
    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). In evaluating a chemical's 
dietary risks EPA uses a reference dose (RfD) approach, which involves 
a number of considerations including:
     A `point of departure' (PoD)--the value from a dose-
response curve that is at the low end of the observable data and that 
is the dose that serves as the `starting point' in extrapolating a risk 
to the human population;
     An uncertainty factor to address the potential for a 
difference in toxic response between humans and animals used in 
toxicity tests (i.e., interspecies extrapolation);
     An uncertainty factor to address the potential for 
differences in sensitivity in the toxic response across the human 
population (i.e., intraspecies variability); and
     The need for an additional safety factor to protect 
infants and children, as specified in FFDCA section 408(b)(2)(C).
    EPA uses the chosen PoD to calculate a safe dose or RfD. The RfD is 
calculated by dividing the chosen PoD by all applicable safety or 
uncertainty factors. Typically in EPA risk assessments, a combination 
of safety or uncertainty factors providing at least a hundredfold 
(100X) margin of safety is used: 10X to account for interspecies 
extrapolation and 10X to account for intraspecies variability. Further, 
as required by FFDCA section 408(b)(2)(C), in evaluating the dietary 
risks for pesticide chemicals, an additional safety factor of 10X is 
presumptively applied to protect infants and children, unless reliable 
data support selection of a different

[[Page 59612]]

factor. In implementing FFDCA section 408, EPA also calculates a 
variant of the RfD referred to as a Population Adjusted Dose (PAD). A 
PAD is the RfD divided by any portion of the children's safety factor 
that does not correspond to one of the traditional additional 
uncertainty/safety factors used in general Agency risk assessment. 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. For acute assessments, the risk is expressed as a 
percentage of a maximum acceptable dose or the acute PAD (i.e., the 
acute dose which EPA has concluded will be ``safe''). As discussed 
below in Unit V.C., dietary exposures greater than 100 percent of the 
acute PAD are generally cause for concern and would be considered 
``unsafe'' within the meaning of FFDCA section 408(b)(2)(B). Throughout 
this document general references to EPA's calculated safe dose are 
denoted as an acute PAD, or aPAD, because the relevant point of 
departure for carbofuran is based on an acute risk endpoint.
    2. Acetylcholinesterase Inhibition. Carbofuran is a member of the 
class of pesticides called N-methyl carbamates (NMCs). The primary 
toxic effect caused by NMCs, including carbofuran, is neurotoxicity 
resulting from inhibition of the enzyme acetylcholinesterase (AChE). 
The toxicity profile of these pesticides is characterized by rapid time 
to onset of effects followed by rapid recovery (minutes to hours). 
Consistent with its mechanism of action, toxicity data on AChE 
inhibition from laboratory rats provide the basis for deriving the PoD 
for carbofuran.
    AChE inhibition is a disruption of the normal process in the body 
by which the nervous system chemically communicates with muscles and 
glands. Communication between nerve cells and a target cell (i.e., 
another nerve cell, a muscle fiber, or a gland) is facilitated by the 
chemical, acetylcholine. When a nerve cell is stimulated it releases 
acetylcholine into the synapse (or space) between the nerve cell and 
the target cell. The released acetylcholine binds to receptors in the 
target cell, stimulating the target cell in turn. As EPA has explained, 
``the end result of the stimulation of cholinergic pathway(s) includes, 
for example, the contraction of smooth (e.g., in the gastrointestinal 
tract) or skeletal muscle, changes in heart rate or glandular secretion 
(e.g., sweat glands) or communication between nerve cells in the brain 
or in the autonomic ganglia of the peripheral nervous system.'' (Ref. 
78 at 10).
    AChE is an enzyme that breaks down acetylcholine and terminates its 
stimulating action in the synapse between nerve cells and target cells. 
When AChE is inhibited, acetylcholine builds up prolonging the 
stimulation of the target cell. This excessive stimulation potentially 
results in a broad range of adverse effects on many bodily functions 
including muscle cramping or paralysis, excessive glandular secretions, 
or effects on learning, memory, or other behavioral parameters. 
Depending on the degree of inhibition these effects can be serious, 
even fatal.
    EPA's cholinesterase inhibition policy statement explains EPA's 
approach to evaluating the risks posed by AChE-inhibiting pesticides 
such as carbofuran (Ref. 78 at 10). The policy focuses on three types 
of effects associated with AChE-inhibiting pesticides that may be 
assessed in animal and human toxicological studies: (1) Physiological 
and behavioral/functional effects; (2) AChE inhibition in the central 
and peripheral nervous system; and (3) AChE inhibition in red blood 
cells and blood plasma. The policy discusses how such data should be 
integrated in deriving an acceptable dose (RfD/PAD) for a AChE-
inhibiting pesticide.
    After clinical signs or symptoms, AChE inhibition in the nervous 
system provides the next most important endpoint for evaluating AChE-
inhibiting pesticides. Although AChE inhibition in the nervous system 
is not itself regarded as a direct adverse effect, it is ``generally 
accepted as a key component of the mechanism of toxicity leading to 
adverse cholinergic effects'' (Id. at 25). As such, the policy states 
that it should be treated as ``direct evidence of potential adverse 
effects'' and ``data showing this response provide valuable information 
in assessing potential hazards posed by antiAChE pesticides'' (Id.). 
Unfortunately, useful data measuring AChE inhibition in the peripheral 
nervous system tissues has only been relatively rarely captured by 
standard toxicology testing, particularly for the NMC compounds. For 
central nervous system effects, however, more recent neurotoxicity 
studies ``have sought to characterize the time course of inhibition in 
* * * [the] brain, including brain regions, after acute and 90-day 
exposures'' (Id. at 27).
    AChE inhibition in the blood is one step further removed from the 
direct harmful consequences of AChE-inhibiting pesticides. According to 
the policy, inhibition of blood AChEs ``is not an adverse effect, but 
may indicate a potential for adverse effects on the nervous system'' 
(Id. at 28). The policy states that ``[a]s a matter of science policy, 
blood AChE data are considered appropriate surrogate measures of 
potential effects on peripheral nervous system AChE activity in 
animals, for central nervous system (``CNS'') AChE activity in animals 
when CNS data are lacking and for both peripheral and central nervous 
system AChE in humans'' (Id. at 29). The policy notes that ``there is 
often a direct relationship between a greater magnitude of exposure [to 
a AChE-inhibiting pesticide] and an increase in incidence and severity 
of clinical signs and symptoms as well as blood AChE inhibition'' (Id. 
at 30). Thus, the policy regards blood AChE data as ``appropriate 
endpoints for derivation of reference doses or concentrations when 
considered in a weight-of-the-evidence analysis of the entire database 
* * *'' (Id. at 29). Between AChE inhibition measured in red blood cell 
(``RBC'') or blood plasma, the policy states a preference for reliance 
on RBC AChE measurements because plasma is composed of a mixture of 
acetylcholinesterase and butyrylcholinesterase, and inhibition of the 
latter is less clearly tied to inhibition of acetylcholinesterase in 
the nervous system (Id. at 29, 32).
    EPA has relied on a benchmark dose (BMD) approach for deriving the 
PoD from the available rat toxicity studies. A BMD is a point estimate 
along a dose-response curve that corresponds to a specific response 
level. For example, a BMD10 represents a 10% change from the 
background; 10% is often used as a typical value for the response of 
concern (Ref. 76). Generically, the direction of change from background 
can be an increase or a decrease depending on the biological parameter 
and the chemical of interest. In the case of carbofuran, inhibition of 
AChE is the toxic effect of concern. Following exposure to carbofuran, 
the normal biological activity of the AChE enzyme is decreased (i.e., 
the enzyme is inhibited). Thus, when evaluating BMDs for carbofuran, 
the Agency is interested in a decrease in AChE activity compared to 
normal activity levels, which are also termed ``background'' levels. 
Measurements of ``background'' AChE activity levels are usually 
obtained from animals in experimental studies that are not treated with 
the pesticide of interest (i.e., ``negative control'' animals).
    In addition to the BMD, a confidence limit was also calculated. 
Confidence limits express the uncertainty in a BMD that may be due to 
sampling and/or

[[Page 59613]]

experimental error. The lower confidence limit on the dose used as the 
BMD is termed the BMDL, which the Agency uses as the PoD. Use of the 
BMDL for deriving the PoD rewards better experimental design and 
procedures that provide more precise estimates of the BMD, resulting in 
tighter confidence intervals. Use of the BMDL also helps ensure with 
high confidence (e.g., 95% confidence) that the selected percentage of 
AChE inhibition is not exceeded. From the PoD, EPA calculates the RfD 
and aPAD. Specific to carbofuran and the other NMCs, EPA the FIFRA SAP 
has reviewed and supported the statistical methods used to derive the 
BMD and BMDLs on multiple occasions (Refs. 34, 35, 36).
    In the Agency's BMD analysis for carbofuran, EPA used a response 
level of 10% brain AChE inhibition; this value represents the estimated 
dose where AChE is inhibited by 10%, compared to untreated animals. For 
the last several years EPA has used the 10% value to regulate AChE 
inhibiting pesticides, including organophosphorous pesticides (OPs) and 
NMCs. For a variety of toxicological and statistical reasons, EPA chose 
10% brain AChE inhibition as the response level for use in BMD 
calculations. EPA analyses have demonstrated that 10% is a level that 
can be reliably measured in the majority of rat toxicity studies; is 
generally at or near the limit of sensitivity for discerning a 
statistically significant decrease in AChE activity across the brain 
compartment; and is a response level close to the background (Refs. 34, 
35).

B. Estimating Human Dietary Exposure Levels

    Pursuant to section 408(b) of the FFDCA, EPA has evaluated 
carbofuran's dietary risks based on ``aggregate exposure'' to 
carbofuran. By ``aggregate exposure,'' EPA is referring to exposure to 
carbofuran by multiple pathways of exposure. EPA uses available data 
and standard analytical methods, together with assumptions designed to 
be protective of public health, to produce separate estimates of 
exposure for a highly exposed subgroup of the general population, for 
each potential pathway and route of exposure. For acute risks, EPA then 
calculates potential aggregate exposure and risk by using probabalistic 
\1\ techniques to combine distributions of potential exposures in the 
population for each route or pathway. For dietary analyses, the 
relevant sources of potential exposure to carbofuran are from the 
ingestion of residues in food and drinking water. The Agency uses a 
combination of monitoring data and predictive models to evaluate 
environmental exposure of humans to carbofuran.
---------------------------------------------------------------------------

    \1\ Probabilistic analysis is used to predict the frequency with 
which variations of a given event will occur. By taking into account 
the actual distribution of possible consumption and pesticide 
residue values, probabilistic analysis for pesticide exposure 
assessments ``provides more accurate information on the range and 
probability of possible exposure and their associated risk values'' 
(Ref. 77). In capsule, a probabilistic pesticide exposure analysis 
constructs a distribution of potential exposures based on data on 
consumption patterns and residue levels and provides a ranking of 
the probability that each potential exposure will occur. People 
consume differing amounts of the same foods, including none at all, 
and a food will contain differing amounts of a pesticide residue, 
including none at all.
---------------------------------------------------------------------------

    1. Exposure from Food. The level of human exposure to pesticide 
residues in food is a function of both the pesticide residues in food 
and the amount of food consumed. Data on the residues of carbofuran in 
foods are available from a variety of sources. One of the primary 
sources of data comes from federally-conducted surveys, including the 
Pesticide Data Program (PDP) conducted by the USDA. Further, market 
basket surveys, which are typically performed by registrants, can 
provide additional residue data. These data generally provide a 
characterization of pesticide residues in or on foods consumed by the 
U.S. population that closely approximates real world exposures because 
they are sampled closer to the point of consumption in the chain of 
commerce than field trial data, which are generated to establish the 
maximum level of legal residues that could result from maximum 
permissible use of the pesticide. In certain circumstances, when EPA 
believes the information will provide more accurate exposure estimates, 
EPA will rely on field trial data (see below in Unit VI.E.1).
    EPA relies on USDA's Continuing Survey of Food Intake by 
Individuals (CSFII) for information on food consumption by the US 
population as well as 32 subgroups based on age, gender, ethnicity, and 
region. The latest CSFII was conducted in 1994-1996 and 1998. The 1998 
survey was a special survey required by the FQPA to supplement the 
number of children survey participants. DEEM-FCID also contains 
``recipes'' that convert foods as consumed (e.g., pizza) back into 
their component raw agricultural commodities (e.g., wheat from flour, 
or tomatoes from sauce, etc.). This is necessary because residue data 
are generally gathered on raw agricultural commodities rather than on 
finished ready-to-eat food. Data on residue values for a particular 
pesticide and the RfD or PADs for that pesticide are inputs to the 
DEEM-FCID computer program to estimate exposure and risk.
    The DEEM-FCID computer program estimates exposure by combining data 
on human consumption amounts with residue values in food commodities. 
DEEM-FCID also compares exposure estimates to appropriate RfD or PAD 
values to estimate risk. EPA uses DEEM-FCID to estimate exposure for 
the general U.S. population as well as for 32 subgroups based on age, 
sex, ethnicity, and region. DEEM-FCID allows EPA to process extensive 
volumes of data on human consumption amounts and residue levels in 
making risk estimates. Matching consumption and residue data, as well 
as managing the thousands of repeated analyses of the consumption 
database conducted under probabilistic risk assessment techniques, 
requires the use of a computer.
    For carbofuran's assessment, EPA used DEEM-FCID to calculate risk 
estimates based on a probabilistic distribution. DEEM-FCID combines the 
full range of residue values for each food with the full range of data 
on individual consumption amounts to create a distribution of exposure 
and risk levels. More specifically, DEEM-FCID creates this distribution 
by calculating an exposure value for each reported day of consumption 
per person (``person/day'') in CSFII, assuming that all foods 
potentially bearing the pesticide residue contain such residue at a 
value selected randomly from the exposure data sets. The exposure 
amounts for the thousands of person/days in the CSFII are then 
collected in a frequency distribution. EPA also uses DEEM-FCID to 
compute a distribution taking into account both the full range of data 
on consumption levels and the full range of data on potential residue 
levels in food. Combining consumption and residue levels into a 
distribution of potential exposures and risk requires use of 
probabilistic techniques.
    The probabilistic technique that DEEM-FCID uses to combine 
differing levels of consumption and residues involves the following 
steps:
    (1) Identification of any food(s) that could bear the residue in 
question for each person/day in the CSFII;
    (2) Calculation of an exposure level for each of the thousands of 
person/days in the CSFII database, based on the foods identified in 
Step 1 by randomly selecting residue values for the foods from 
the residue database;
    (3) Repetition of Step 2 one thousand times for each 
person/day; and

[[Page 59614]]

    (4) Collection of all of the hundreds of thousands of potential 
exposures estimated in Steps 2 and 3 in a frequency 
distribution.
    The resulting probabilistic assessment presents a range of 
exposure/risk estimates.
    2. Exposure from water. EPA may use field monitoring data and/or 
simulation water exposure models to generate pesticide concentration 
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 the 
specific agricultural or residential pesticide practices in specific 
locations, under the environmental conditions associated with a 
sampling design (i.e., the locations of sampling, the times of the year 
samples were taken, and the frequency by which samples were collected). 
Although monitoring data can provide a direct measure of the 
concentration of a pesticide in water, it does not always provide a 
reliable basis for estimating spatial and temporal variability in 
exposures because sampling may not occur in areas with the highest 
pesticide use, and/or when the pesticides are being used and/or at an 
appropriate sampling frequency to detect high concentrations of a 
pesticide that occur over the period of a day to several days.
    Because of the limitations in most monitoring studies, EPA's 
standard approach is to use simulation water exposure models as the 
primary means to estimate pesticide exposure levels in drinking water. 
Modeling is a useful tool for characterizing vulnerable sites, and can 
be used to estimate peak pesticide water concentrations from 
infrequent, large rain events. EPA's computer models use detailed 
information on soil properties, crop characteristics, and weather 
patterns to estimate water concentrations in vulnerable locations where 
the pesticide could be used according to its label (69 FR 30042, 30058-
30065 (May 26, 2004)). These models calculate estimated water 
concentrations of pesticides using laboratory data that describe how 
fast the pesticide breaks down to other chemicals and how it moves in 
the environment at these vulnerable locations. The modeling provides an 
estimate of pesticide concentrations in ground and surface water. 
Depending on the modeling algorithm (e.g., surface water modeling 
scenarios), daily concentrations can be estimated continuously over 
long periods of time, and for places that are of most interest for any 
particular pesticide.
    EPA relies on models it has developed for estimating pesticide 
concentrations in both surface water and ground water. Typically EPA 
uses a two-tiered approach to modeling pesticide concentrations in 
surface and ground water. If the first tier model suggests that 
pesticide levels in water may be unacceptably high, a more refined 
model is used as a second tier assessment. The second tier model for 
surface water is actually a combination of two models: The Pesticide 
Root Zone Model (PRZM) and the Exposure Analysis Model System (EXAMS). 
The second tier model for ground water uses PRZM alone.
    A detailed description of the models routinely used for exposure 
assessment is available from the EPA OPP Water Models Web site: https://www.epa.gov/oppefed1/models/water/index.htm. These models provide a 
means for EPA to estimate daily pesticide concentrations in surface 
water sources of drinking water (a reservoir) using local soil, site, 
hydrology, and weather characteristics along with pesticide application 
and agricultural management practices, and pesticide environmental fate 
and transport properties. Consistent with the recommendations of the 
FIFRA SAP, EPA also considers regional percent cropped area factors 
(PCA) which take into account the potential extent of cropped areas 
that could be treated with pesticides in a particular area. The PRZM 
and EXAMS models used by EPA were developed by EPA's Office of Research 
and Development (ORD), and are used by many international pesticide 
regulatory agencies to estimate pesticide exposure in surface water. 
EPA's use of the percent cropped area factors and the Index Reservoir 
scenario was reviewed and approved by the FIFRA SAP in 1999 and 1998, 
respectively (Refs. 30, 31).
    In modeling potential surface water concentrations, EPA attempts to 
model areas of the country that are vulnerable to surface water 
contamination rather than simply model ``typical'' concentrations 
occurring across the nation. Consequently, EPA models exposures 
occurring in small, highly agricultural watersheds in different growing 
areas throughout the country, over a 30-year period. The scenarios are 
designed to capture residue levels in drinking water from reservoirs 
with small watersheds with a large percentage of land use in 
agricultural production. EPA's models take into account that pesticide 
residues in water fluctuate daily, seasonally, and yearly as a result 
of the timing of pesticide applications, the vulnerability of the water 
supply to pesticide loading through runoff, spray drift and/or 
leaching, and changes in the weather. Concentrations are also affected 
by the method of application, the location and characteristics of the 
sites where a pesticide is used, the climate, and the type and degree 
of pest pressure.
    EPA uses the output of daily concentration values from tier two 
modeling as an input to DEEM-FCID, which combines water concentrations 
with drinking water consumption information in the daily diet to 
generate a distribution of exposures from consumption of drinking water 
contaminated with pesticides. These results are then used to calculate 
a probabilistic assessment of the aggregate human exposure and risk 
from residues in food and drinking water.
    3. Aggregate Exposure Analyses. Using probabilistic analyses, EPA 
combines the national food exposures with the exposures derived for 
individual region and crop-specific drinking water scenarios to derive 
estimates of aggregate exposure. Although food is distributed 
nationally, and exposures to pesticide residues are therefore not 
expected to vary substantially throughout the country, drinking water 
is locally derived and consumed and there can be significant variations 
in pesticide levels in local watersheds due to geographic, climatic, 
and other factors. To be protective of all population subgroups, EPA 
uses modeled estimates from vulnerable watersheds in calculating 
aggregate exposure.
    EPA's standard acute dietary exposure assessment calculates total 
dietary exposure over a 24-hour period; that is consumption over 24 
hours is summed and no account is taken of the fact that eating and 
drinking occasions may spread out exposures over a day. This total 
daily exposure generally provides reasonable estimates of the risks 
from acute dietary exposures, given the nature of most chemical 
endpoints. Due to the rapid recovery associated with carbofuran 
toxicity (AChE inhibition), 24-hour exposure periods may or may not be 
appropriate. To the extent that a day's eating or drinking occasions 
leading to high total daily exposure might be found close together in 
time, or to occur from a single eating event, minimal AChE recovery 
would occur between eating occasions (i.e., exposure events). In that 
case, the ``24-hour sum'' approach, which sums eating events over a 24-
hour period, would provide reasonable estimates of risk from food

[[Page 59615]]

and drinking water. Conversely, to the extent that eating occasions 
leading to high total daily exposures are widely separated in time 
(within one day) such that substantial AChE recovery occurs between 
eating occasions, then the estimated risks under any 24-hour sum 
approach may be overstated. In that case, a more sophisticated 
approach--one that accounts for intra-day eating and drinking patterns 
and the recovery of AChE between exposure events--may be more 
appropriate. This approach is referred to as the ``Eating Occasions 
Analysis'' and it takes into account the fact that the toxicological 
effect of a first dose may be reduced or tempered prior to a second (or 
subsequent) dose.
    Thus, rather than treating a full day's exposure as a one-time 
``bolus'' dose, as is typically done in the Agency's assessments, the 
Eating Occasion analysis uses the actual time of eating or drinking 
occasion, and amounts consumed as reported by individuals to the USDA 
CSFII. The actual CSFII-recorded time of each eating event is used to 
``separate out'' the exposures due to each eating occasion; in doing 
so, this ``separation'' allows the Agency to distinguish between each 
intake event and account for the fact that at least some partial 
recovery of AChE inhibition attributable to the first (earlier) 
exposure occurs before the second exposure event. For chemicals for 
which the toxic effect is rapidly reversible, the time between two (or 
more) exposure events permits partial to full recovery from the toxic 
effect from the first exposure and it is this ``partial recovery'' that 
is specifically accounted for by the Eating Occasion Analysis. More 
specifically, an estimated ``persisting dose'' from the first exposure 
event is added to the second exposure event to account for the partial 
recovery of AChE inhibition that occurs over the time between the first 
and second exposures. The `persisting dose' terminology, and this 
general approach were originally suggested by the FIFRA SAP in the 
context of assessing AChE inhibition from cumulative exposures to OP 
pesticides (Ref. 33).

C. Selection of Acute Dietary Exposure Level of Concern

    Because probabilistic assessments generally are based on a 
realistic range of residue values to which the population may be 
exposed, EPA's starting point for estimating exposure and risk for such 
aggregate assessments is the 99.9th percentile of the population under 
evaluation, which represents one person out of every 1000 persons. When 
using a probabilistic method of estimating acute dietary exposure, EPA 
typically assumes that, when the 99.9th percentile of acute exposure is 
equal to or less than the aPAD, the level of concern for acute risk has 
not been exceeded. By contrast, where the analysis indicates that 
estimated exposure at the 99.9th percentile exceeds the aPAD, EPA would 
generally conduct one or more sensitivity analyses to determine the 
extent to which the estimated exposures at the high-end percentiles may 
be affected by unusually high food consumption or residue values. To 
the extent that one or a few values seem to ``drive'' the exposure 
estimates at the high end of exposure, EPA would consider whether these 
values are reasonable and should be used as the primary basis for 
regulatory decision making (Ref. 77).

V. Carbofuran Background and Regulatory History

A. Tolerance Reassessment and Pesticide Reregistration

    In July 2006, EPA completed a refined acute probabilistic dietary 
risk assessment for carbofuran as part of the tolerance reassessment 
program under section 408(q) of the FFDCA and pesticide reregistration 
under section 4 of FIFRA. The assessment was conducted using Dietary 
Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCIDTM, Version 200-2.02), which incorporates consumption 
data from the United States Department of Agriculture's (USDA's) 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), 
1994-1996 and 1998, as well as carbofuran monitoring data from USDA's 
Pesticide Data Program \2\ (PDP), estimated percent crop treated 
information, and processing/cooking factors, where applicable. The 
assessment was conducted applying an additional 500-fold safety factor 
that included a 5X children's safety factor, pursuant to section 
408(b)(2)(C). That refined assessment showed acute dietary risks from 
carbofuran residues in food significantly above EPA's level of concern 
(Ref. 14). Based in part on the results of that assessment, EPA 
concluded that carbofuran failed to meet the revised safety standard in 
FFDCA section 408(b) and the standard for FIFRA reregistration.\3\
---------------------------------------------------------------------------

    \2\ USDA's Pesticide Data Program monitors for pesticides in 
certain foods at the distribution points just before release to 
supermarkets and grocery stores.
    \3\ Although not relevant to this proceeding, in addition to 
determining that use of carbofuran resulted in unacceptable dietary 
risks, EPA concluded that use of carbofuran did not meet the 
standard for FIFRA registration based on unacceptable occupational 
and ecological risks.
---------------------------------------------------------------------------

    The tolerance reassessment and FIFRA reregistration process for 
carbofuran contained numerous opportunities for public participation. 
These included public comment periods on the preliminary ecological 
risk assessment (June-August 2005), the preliminary human health risk 
assessment (September-November 2005), the revised combined risk 
assessment (March-May 2006), and the interim Registration Eligibility 
Document (RED) (August-November 2006). EPA received over 200 comments 
(plus a letter campaign supporting carbofuran with 2,896 signatories) 
to the 2006 RED. FMC submitted extensive comments throughout the 
process (including, but not limited to, a comment of 62 pages plus 13 
attachments totaling over 900 pages on August 23, 2005, a letter with 
20 attachments on November 11, 2005, 46 pages of comments on January 
26, 2006, 78 pages of comments on February 17, 2006, a 15-page letter 
with 8 attachments on May 22, 2006, over 200 pages on May 24, 2006, and 
other submissions. Following issuance of the RED in August 2006, FMC 
stated that they would be submitting new data to refute EPA's 
ecological and human health risk concerns, as well as EPA's benefits 
assessments. Twenty-three submissions with studies and analyses were 
submitted in 2007, all of which EPA reviewed. FMC submitted 175 pages 
of comments to the proposed tolerance revocations jointly with the NPC, 
NCGA, NCC, and NSA on 9/29/09. The Agency has also met numerous times 
with FMC, growers, and other stakeholders regarding carbofuran.
    One particular aspect of the risk assessment process that involved 
substantial public participation opportunities was EPA's review of the 
human toxicology studies performed with carbofuran. In making a 
determination on whether these studies met the standards of the Human 
Research rule, EPA, as required, sought the advice of the HSRB. The 
HSRB review process includes the opportunity for the public both to 
submit written comments and to make an oral presentation to the HSRB. 
FMC gave both written and oral comments at the HSRB meeting, which was 
held May 2-4, 2006. FMC also submitted written comments on the final 
HSRB report on the meeting.

[[Page 59616]]

B. Draft Notice of Intent to Cancel Carbofuran Registrations

    In January 2008, EPA published a draft Notice of Intent to Cancel 
(NOIC) all carbofuran registrations, based in part on carbofuran's 
dietary risks. As mandated by FIFRA, EPA solicited comments from the 
FIFRA Scientific Advisory Panel (SAP) on its draft NOIC.\4\ As part of 
that process, EPA presented its dietary risk assessment of carbofuran 
to the FIFRA SAP, and requested comment on key issues in the risk 
assessment: The Agency's approach to selecting the point of departure 
and the children's safety factor. FMC and the remaining Petitioners 
participated in this meeting, making substantial presentations to the 
SAP. As described in the proposal, the Agency believes that the Panel's 
responses unambiguously support the Agency's approach with regard to 
carbofuran's hazard identification and hazard characterization (73 FR 
44875 (July 31, 2008)). In addition, EPA believes that, on balance, the 
application of a 4X children's safety factor is consistent with the 
SAP's advice. Additional detail on the SAP's advice and EPA's responses 
can be found at Ref. 83.
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    \4\ The draft NOIC was based on all of carbofuran's combined 
risks--dietary, occupational, and ecological. Because some non-food 
use registrations remain, EPA anticipates issuing the NOIC 
subsequent to undertaking the activities required to revoke the 
carbofuran tolerances to cancel these remaining uses.
---------------------------------------------------------------------------

C. Proposed Revocation of Carbofuran Tolerances

    Having considered the comments from the SAP, EPA initiated the 
process to revoke all carbofuran tolerances, publishing a proposed 
revocation on July 31, 2008 (73 FR 44,864 (July 31, 2008) (FRL-8378-
8)). EPA proposed to revoke all of the existing tolerances for residues 
of carbofuran on the grounds that aggregate exposure from all uses of 
carbofuran fails to meet the FFDCA section 408 safety standard (Id). 
Based on the contribution from food alone, EPA calculated dietary 
exposures to carbofuran exceed EPA's level of concern for all of the 
more sensitive subpopulations of infants and children. At the 99.9th 
percentile, aggregate carbofuran dietary exposure from food and 
drinking water from contaminated ground water was estimated to range 
from 1100% of the aPAD for adults, to greater than 10,000% of the aPAD 
for infants, the population subgroup with the highest estimated dietary 
exposure (Ref. 12). Similarly, aggregate dietary exposures from food 
and drinking water from surface water, based on contamination from use 
on corn in Nebraska, ranged from 340% of the aPAD for adults, to 3,900% 
aPAD for infants. EPA also determined that, based on actual residue 
levels measured in food in commerce, individual children consuming 
typical amounts of a single food item received unsafe levels of 
carbofuran. For example, based on the level of residues detected on in 
the food supply, a child between 3-5 years, who consumed \1/2\ cup of 
cantaloupe, would receive a dose ranging between 180% and 7,200% of the 
aPAD. Finally, the proposal discussed a number of sensitivity analyses 
the Agency had calculated in order to further characterize the 
potential risks to children. Every one of these sensitivity analyses 
determined that estimated exposures significantly exceeded EPA's level 
of concern for children.
    EPA held a 60-day comment period on the proposed revocation rule. 
In the proposed rule, EPA made clear that if any person had concerns 
with EPA's proposed revocation, those concerns must be raised during 
the comment period to be preserved. Specifically, EPA stated:

    In addition to submitting comments in response to this proposal, 
you may also submit an objection at the time of the final rule. If 
you anticipate that you may wish to file objections to the final 
rule, you must raise those issues in your comments on this proposal. 
EPA will treat as waived, any issue not originally raised in 
comments on this proposal. Similarly, if you fail to file an 
objection to the final rule within the time period specified, you 
will have waived the right to raise any issues resolved in the final 
rule. After the specified time, issues resolved in the final rule 
cannot be raised again in any subsequent proceedings on this rule.

(73 FR at 44865).

D. Petitioners' Comments on the Proposed Rule

    The comment period for the proposed rule clos