Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 38417 

§ 165.T13–148 Safety Zones; Multiple 

Firework Displays in Captain of the Port, 

Puget Sound Area of Responsibility, WA 

(a) Safety Zones. The following areas 

are designated as safety zones: 

(1) All waters of Boston Harbor 

encompassed within a 200 yard radius 

around position 47° 08.5′N, 122° 54.2′ 

W from 5 p.m. on July 3, 2010 until 1 

a.m. on July 4, 2010. 

(2) All waters of Boston Harbor 

encompassed within a 200 yard radius 

around position 47° 08.5′ N, 122° 54.2′ 

W from 5 p.m. on July 24, 2010 until 1 

a.m. on July 25, 2010. 

(3) All waters near Stuart Island 

encompassed within a 700 yard radius 

around position 48° 37.5′ N, 121° 12.0′ 

W from 5 p.m. on August 6, 2010 until 

1 a.m. on August 7, 2010. 

(b) Regulations. In accordance with 

the general regulations in § 165.23 of 

this Part, no person or vessel may enter, 

transit, moor, or anchor within the 

safety zones created in this section 

unless authorized by the Captain of the 

Port or his Designated Representative. 

(c) Authorization. All persons or 

vessels who desire to enter the safety 

zones created in this section must 

obtain permission from the Captain of 

the Port or his Designated 

Representative by contacting either the 

on-scene patrol craft on VHF Ch 13 or 

Ch 16 or the Coast Guard Sector Seattle 

Joint Harbor Operations Center (JHOC) 

via telephone at 206–217–6002. 

(d) Effective Period. The safety zones 

created in this section are effective on 

the dates and times noted in paragraph 

(a) unless canceled sooner by the 

Captain of the Port. 

Dated: June 22, 2010. 

S. W. Bornemann, 

Captain, U. S. Coast Guard, Captain of the 

Port, Puget Sound. 

[FR Doc. 2010–16118 Filed 7–1–10; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0801; FRL–8832–5] 

Carbaryl; Order Denying Washington 

Toxics Coalition Petition to Revoke 

Tolerances and Notice of Availability of 

Denial of Request to Cancel Uses 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order and Notice of 

Availability. 

SUMMARY: This order denies a petition 

requesting that EPA revoke all pesticide 

tolerances for carbaryl under section 

408(d) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA). The petition 

was filed on January 10, 2005 by the 

Washington Toxics Coalition (WTC). 

This order also informs the public of the 

availability of a response to WTC’s 

petition to cancel all uses of carbaryl. 

DATES: This Order is effective July 2, 

2010. Objections and requests for 

hearings must be received on or before 

August 31, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2006–0801. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert the 

docket ID number where indicated and 

select the ‘‘Submit’’ button. Follow the 

instructions on the regulations.gov 

website 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 

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 

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: 

Jacqueline Guerry, Pesticide Reevaluation Division (7508P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (215) 814– 

2184; e-mail address: 

guerry.jacqueline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general, and may be of interest to a 

wide range of stakeholders including 

environmental, human health, and 

agricultural advocates; the chemical 

industry; pesticide users; and members 

of the public interested in the sale, 

distribution, or use of pesticides. Since 

others also may be interested, the 

Agency has not attempted to describe all 

the specific entities that may be affected 

by this action. 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 http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://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 http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, any 

person may file an objection to any 

aspect of this order and may also 

request a hearing on those objections. 

You must file your objection or request 

a hearing on this order in accordance 

with the instructions provided in 40 

CFR part 178. To ensure proper receipt 

by EPA, you must identify docket ID 

number EPA–HQ–OPP–2006–0801 in 

the subject line on the first page of your 

submission. All requests must be in 

writing, and must be mailed or 

delivered to the Hearing Clerk as 

required by 40 CFR part 178 on or 

before August 31, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2006–0801, 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 


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38418 Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 

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’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. 

II. Introduction 

A. What Action Is the Agency Taking? 

The WTC filed a petition dated 

January 10, 2005 (WTC Petition) with 

EPA which, among other things, 

requested that EPA cancel all 

registrations for the pesticide carbaryl 

and revoke all carbaryl tolerances 

established under section 408 of the 

FFDCA, 21 U.S.C. 346a (Ref. 1). It 

should be noted that the WTC Petition 

generally raises a subset of identical 

issues raised by a petition submitted by 

the Natural Resources Defense Council 

(NRDC), which is also dated January 10, 

2005 (Ref. 2). Indeed, most of the WTC 

Petition is virtually a verbatim recitation 

of the NRDC petition. The primary 

difference is that the WTC Petition does 

not address any of the tolerance-related 

issues raised in the NRDC petition; there 

is nothing in the WTC Petition which 

supports the request to revoke 

tolerances. Nonetheless, to the extent 

that the WTC Petition can be construed 

to raise tolerance-related issues, this 

Order relies on EPA’s response to the 

NRDC petition and denies that portion 

of the WTC Petition that seeks the 

revocation of the carbaryl tolerances. 

This document also announces a notice 

of availability for EPA’s response to 

WTC’s Petition to cancel all uses of 

carbaryl, which may be found in docket 

number EPA–HQ–OPP–2006–0801. 

B. What Is the Agency’s Authority for 

Taking This Action? 

Under section 408(d)(4) of the 

FFDCA, EPA is authorized to respond to 

a section 408(d) petition to revoke 

tolerances either by issuing a final rule 

revoking the tolerances, issuing a 

proposed rule, or issuing an order 

denying the petition. (21 U.S.C. 

346a(d)(4)). 

III. Statutory and Regulatory 

Background 

A. FFDCA/FIFRA and Applicable 

Regulations 

1. In general. EPA establishes 

maximum residue limits, or 

‘‘tolerances,’’ for pesticide residues in 

food and feed commodities 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, 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 estrogenic substances 

screening program. (Public Law 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 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 or left in effect by 

EPA if the tolerance is ‘‘safe.’’ (21 U.S.C. 

346a(b)(2)(A)(i)). This standard applies 

both to petitions to establish and 

petitions to revoke tolerances. ‘‘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— ... 

(v) available information concerning the 

cumulative effects of such residues and other 

substances that have a common mechanism 

of toxicity; and 

(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 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) 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; and 

(III) available information concerning the 

cumulative effects on infants and children of 

such residues and other substances that have 

a common mechanism of toxicity.... 

(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 ‘‘in 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 


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Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 38419 

throughout this Order as the ‘‘FQPA 

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 the 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 establishing, amending, or 

revoking the tolerance or denying the 

petition, any party 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 is subject 

to judicial review. (21 U.S.C. 

346a(h)(1)). 

4. Tolerance reassessment and FIFRA 

reregistration. 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). 

Tolerance reassessment and 

reregistration decisions were generally 

combined in a Reregistration Eligibility 

Decision (‘‘RED’’) document. 

B. EPA’s Approach to Dietary Risk 

Assessment and Science Policy 

Considerations 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. In 

addition, EPA applies a number of 

policy considerations with respect to 

determining the appropriate children’s 

safety factor, cholinesterase inhibition 

as a regulatory endpoint, and the use of 

a bench mark dose approach. EPA has 

discussed these in great detail in its 

response to an earlier and virtually 

identical petition file by NRDC. EPA 

hereby incorporates and relies upon that 

discussion. See Carbaryl: Order Denying 

NRDC’s Petition to Revoke Tolerances, 

dated September 30, 2008 (October 29, 

2008, 73 FR 64229). 

IV. Carbaryl Tolerances 

A. Regulatory Background 

Carbaryl is a carbamate insecticide 

and molluscide that was first registered 

in 1959 for use on cotton. Carbaryl has 

many trade names, but is most 

commonly known as Sevin®. In 1980, 

the Agency published a position 

document summarizing its conclusions 

from a Special Review of carbaryl, and 

concluded that risk concerns, 

particularly those related to 

teratogenicity, did not warrant 

cancellation of the registration for 

carbaryl. A Registration Standard, 

issued for carbaryl in 1984 and revised 

in 1988, described the terms and 

conditions for continued registration of 

carbaryl. At the time carbaryl was 

assessed for purposes of reregistration, 

carbaryl was registered for use on over 

400 agricultural and non-agricultural 

use sites, and there were more than 140 

tolerances for carbaryl in the Code of 

Federal Regulations (40 CFR 180.169). 

For example, carbaryl was registered for 

domestic outdoor uses on lawns and 

gardens, and indoors in kennels and on 

pet sleeping quarters. It was also 

registered for direct application to cats 

and dogs (collar, powder, and dip) to 

control fleas and ticks. 

EPA completed an Interim 

Reregistration Eligibility Decision 

(IRED) for carbaryl on June 30, 2003 

(2003 IRED, Ref. 3). The Agency 

amended the IRED on October 22, 2004 

(2004 Amended IRED. Ref. 4), and 

published a formal Notice of 

Availability for the document which 

provided for a 60–day public comment 

period (69 FR 62663; docket EPA–HQ– 

OPP–2003–0376). EPA received 

numerous comments on the carbaryl 

IRED, including two nearly identical 

petitions from the WTC and the NRDC 

requesting that EPA cancel all carbaryl 

registrations and revoke all tolerances 

(Refs. 1 and 2). The Agency published 

a Notice of Availability for the WTC 

Petition in the Federal Register, which 

provided a public comment period. See 

‘‘Petition to Revoke or Modify 

Tolerances Established for Carbaryl; 

Notice of Availability,’’ October 13, 2006 

(71 FR 60511). 

The 2004 Amended IRED for carbaryl 

specified mitigation of risks from 

residential uses including the following: 

Canceling liquid broadcast applications 

to home lawns pending EPA review of 

pharmacokinetic data to refine post– 

application risk estimates; home garden/ 

ornamental dust products must be 

packaged in ready-to-use shaker can 

containers, with no more than 0.05 lbs. 

active ingredient per container; 

cancellation of the following uses and 

application methods: all pet uses (dusts 

and liquids) except collars, aerosol 

products for various uses, belly grinder 

applications of granular and bait 

products for lawns, hand applications of 

granular and bait products for 

ornamentals and gardens. 

On March 9, 2005, EPA issued a 

cancellation order for the liquid 

broadcast use of carbaryl on residential 

turf to address post-application risk to 

toddlers (Ref. 5). In March 2005, EPA 

also issued generic and product-specific 

data call-ins (DCIs) for carbaryl. The 

carbaryl generic DCI required several 

confirmatory studies of the active 

ingredient carbaryl, including 

additional toxicology, worker exposure 

monitoring, data to support the use of 

carbaryl in pet collars, and 

environmental fate data. The productspecific DCI required acute toxicity and 

product chemistry data for all pesticide 

products containing carbaryl; these data 

are being used for product labeling. EPA 

has received numerous studies in 

response to these DCIs, and, where 

appropriate, these studies were 

considered in the tolerance 

reassessment. 

In response to the DCIs, many 

carbaryl registrants chose to voluntarily 

cancel their carbaryl products, rather 

than revise their labels or conduct 

studies to support these products. EPA 

published a notice of receipt of these 

requests in the Federal Register on 

October 28, 2005 (70 FR 62112), 

followed by a cancellation order issued 

on July 3, 2006. One technical 

registrant, Burlington Scientific, chose 

to cancel its technical product, leaving 

Bayer CropScience (Bayer) as the sole 


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38420 Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 

technical registrant for carbaryl. 

Approximately two-thirds of all of the 

carbaryl products registered at the time 

of the 2003 IRED were canceled through 

this process. 

In addition, Bayer, the sole remaining 

technical registrant responsible for 

developing data, requested waivers of 

required exposure monitoring or residue 

studies because the following use 

scenarios were not on any Bayer 

technical or product labels or were to be 

deleted from Bayer labels: Carbaryl use 

in or on pea and bean, succulent shelled 

(subgroup 6B); millet; wheat; pre-plant 

root dip for sweet potato; pre-plant root 

dip/drench for nursery stocks, vegetable 

transplants, bedding plants, and foliage 

plants; use of granular formulations on 

leafy vegetables (except Brassica); ultra 

low volume (ULV) application for adult 

mosquito control; and dust applications 

in agriculture. 

Bayer subsequently requested that all 

of its carbaryl registrations bearing any 

of the uses just mentioned be amended 

to delete these uses. EPA notified all 

affected registrants that these uses and 

application methods must be deleted 

from their carbaryl product labels. EPA 

identified 34 product labels from 14 

registrants (other than Bayer) bearing 

these end uses. All of these registrants 

requested that their affected carbaryl 

product registrations be amended to 

delete these uses. EPA published 

Notices of receipt of these requests from 

Bayer and the other 14 registrants in the 

Federal Register on August 20, 2008 

and October 15, 2008. On March 18, 

2009, the Agency published an order 

granting the requests to delete uses (74 

FR 11553). 

Further, in November 2009, Bayer 

submitted a waiver request for the 

dermal and inhalation exposure studies 

required for aerial application of 

carbaryl bait used in the USDA 

Rangeland Grasshopper and Mormon 

Cricket Suppression Program due to a 

recent reduction in the maximum 

application rate, which eliminated 

remaining uncertainties associated with 

this use scenario. The Agency accepted 

the waiver request in January 2010. 

Carbaryl is a member of the N-methyl 

carbamate (NMC) class of pesticides, 

which share a common mechanism of 

toxicity by affecting the nervous system 

via cholinesterase inhibition. 

Specifically, carbaryl is a reversible 

inhibitor of Acetylcholinesterase 

(AChE). A cumulative risk assessment, 

which evaluates exposures based on a 

common mechanism of toxicity, was 

conducted to evaluate risk from food, 

drinking water, residential use, and 

other non-occupational exposures 

resulting from registered uses of NMC 

pesticides, including carbaryl. 

In June 2006, EPA determined that the 

uses associated with 120 of the existing 

carbaryl tolerances were not significant 

contributors to the overall NMC 

cumulative risk and, as a result, these 

tolerances would have no effect on the 

retention or revocation of other NMC 

tolerances. Therefore, EPA considered 

these 120 tolerances for carbaryl as 

reassessed on June 29, 2006, and posted 

this decision on the Agency’s internet 

site. (See http://www.epa.gov/ 

pesticides/cumulative/ 

carbamates_commodity.pdf). 

In late November 2006, EPA received 

data from a carbaryl comparative 

cholinesterase study conducted to 

determine the comparative sensitivity of 

adults and offspring to cholinesterase 

inhibition by carbaryl. These data were 

used to revise the FQPA Safety Factor 

for carbaryl for the NMC cumulative risk 

assessment and to select new toxicology 

endpoints or points of departure (PODs) 

for the risk assessment. The Agency 

determined that it was appropriate to 

use the new FQPA Safety Factor and 

revised PODs in both the NMC 

cumulative risk assessment and the 

carbaryl-specific human health risk 

assessment. Because this necessitated a 

revision of the carbaryl human health 

aggregate risk assessment, EPA also 

considered additional new data 

generated in response to the DCI, new 

methodologies, and other new 

information in performing its most 

recent assessment of carbaryl and in 

responding to this Petition. EPA has 

thus, in effect, revised the carbaryl 

single chemical assessment in response 

to the issues raised during the public 

comment process as well as based upon 

more recent data and analytical 

methods. 

On September 26, 2007, EPA issued 

the NMC cumulative risk assessment 

(Ref. 6). EPA concluded that the 

cumulative risks associated with the 

NMC pesticides meet the safety 

standard set forth in section 408(b)(2) of 

the FFDCA, provided that the mitigation 

specified in the NMC cumulative risk 

assessment is implemented. EPA has 

therefore terminated the tolerance 

reassessment process under 408(q) of 

the FFDCA. (See 72 FR 54656). In 

conjunction with the NMC cumulative 

risk assessment, EPA completed a 

Reregistration Eligibility Decision (RED) 

for carbaryl on September 24, 2007 (Ref. 

7) and issued this RED on October 17, 

2007 with a formal Notice of 

Availability in the Federal Register (72 

FR 58844). In addition to relying on the 

NMC cumulative risk assessment to 

determine that the cumulative effects 

from exposure to all NMC residues, 

including carbaryl, was safe, the 

carbaryl RED relied upon the revised 

assessments and the mitigation that had 

already been implemented (e.g., 

cancellation of pet uses except for 

collars). In addition, the RED included 

additional mitigation with respect to 

granular turf products for residential 

use; namely, that product labels direct 

users to water the product immediately 

after application. Subsequently, on 

August 25, 2008, EPA completed an 

addendum to the Carbaryl RED, 

incorporating the results of a revised 

occupational risk assessment and 

modified mitigation measures for the 

protection of workers (Ref. 8). 

Subsequent to the completion of the 

carbaryl RED addendum, EPA 

completed a revised master label table 

for carbaryl and a list of carbaryl uses 

eligible for reregistration. These 

materials, which summarized the 

changes necessary to implement the 

carbaryl RED and addendum, were sent 

to all carbaryl end-use registrants on 

March 25, 2009. (See docket entry: 

EPA–HQ–OPP–2007–0941–0088.) All 

carbaryl end-use registrants were 

required to submit revised labels to EPA 

by April 30, 2009. EPA has completed 

its review of these amended labels, and 

all acceptable carbaryl products are now 

reregistered. Once again, some 

registrants chose to cancel their carbaryl 

product registrations rather than submit 

revised labels that incorporate the final 

RED mitigation. EPA has received 

voluntary cancellation requests for 19 

additional carbaryl product 

registrations, and 7 Special Local Need 

registrations, from 8 registrants, 

including the last remaining carbaryl 

products registered for use on pets – 

carbaryl-treated dog and cat collars. The 

Agency has published Notice of Receipt 

of Requests for Cancellation and/or 

Cancellation Notice for all 26 carbaryl 

product registrations as per sec. 6(f) of 

FIFRA. The two carbaryl pet collar 

product registrations, specifically, will 

be canceled effective September 30, 

2010, with a reduced existing stock 

provision of 3 months (74 FR 66642). 

Finally, EPA completed a response to 

NRDC’s January 10, 2005 petition to 

cancel all uses of carbaryl in a letter 

dated September 30, 2008 (Ref. 9). The 

Agency’s response to NRDC’s petition to 

revoke carbaryl tolerances is in an Order 

also dated September 30, 2008 (Ref. 10). 

This Order Denying NRDC’s Petition to 

Revoke Tolerances was published in the 

Federal Register on October 29, 2008 

(73 FR 64229). 


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Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 38421 

B. FFDCA Tolerance Reassessment and 

FIFRA Pesticide Reregistration 

As required by the Food Quality 

Protection Act of 1996, EPA reassessed 

the safety of the carbaryl tolerances 

under the safety standard established in 

the FQPA. In the September 2007 RED 

for carbaryl, EPA evaluated the human 

health risks associated with all currently 

registered uses of carbaryl and 

determined that there is a reasonable 

certainty that no harm will result from 

aggregate, non-occupational exposure to 

the pesticide chemical residue. In 

making this determination, EPA 

considered dietary exposure from food 

and drinking water and all other nonoccupational sources of pesticide 

exposure for which there is reliable 

information. (Ref. 7). The Agency has 

concluded that with the adoption of the 

risk mitigation measures identified in 

the NMC cumulative risk assessment, all 

of the tolerances for carbaryl meet the 

safety standard as set forth in section 

408(b)(2)(D) of the FFDCA. Therefore, 

the tolerances established for residues of 

carbaryl in or on raw agricultural 

commodities were considered 

reassessed as safe under section 408(q) 

of FFDCA, as amended by FQPA, in 

September 2007. These findings 

satisfied EPA’s obligation to review the 

carbaryl tolerances under the FQPA 

safety standard. 

To implement the carbaryl tolerance 

reassessment, EPA commenced with 

rulemaking in 2008. The Agency 

published a Notice of proposed 

tolerance actions in the May 21, 2008 

Federal Register (73 FR 29456). This 

proposed rule provided for a 60–day 

public comment period. No comments 

relevant to carbaryl tolerances were 

received and EPA published a Notice of 

final tolerance actions in the September 

10, 2008 Federal Register (73 FR 

52607). This carbaryl tolerance rule is 

codified in 40 CFR 180.169. 

V. The Petition to Revoke Tolerances 

WTC filed a petition on January 10, 

2005, requesting, among other things, 

that EPA cancel all carbaryl registrations 

and revoke all carbaryl tolerances. This 

January 10, 2005 submission is in the 

form of comments on and requests for 

changes to the Carbaryl IRED published 

in the Federal Register on October 27, 

2004. (70 FR 62663) (Ref. 1). 

Nevertheless, in the introduction to the 

comments, WTC included a statement 

that it is also petitioning the Agency to 

revoke all carbaryl tolerances. It should 

be noted that the WTC petition 

primarily raises a subset of identical 

issues raised by a petition submitted by 

NRDC, which is also dated January 10, 

2005. Indeed, to the extent they address 

the same issues, most of the WTC’s 

petition is virtually a word-for-word 

copy of the NRDC petition. The primary 

difference is that the WTC petition does 

not address any of the tolerance-related 

issues raised in the NRDC petition. 

Nonetheless, to the extent that anything 

in the WTC Petition could be construed 

as raising a tolerance-related issue, EPA 

is relying on its response to the NRDC 

petition to revoke all carbaryl tolerances 

in denying the WTC Petition to revoke 

all carbaryl tolerances. 

The issues raised by the WTC Petition 

center around the ecological risk 

assessment that supported the 2004 

IRED decision. Again, most of these 

issues are identical to those raised by 

NRDC and have been addressed in a 

response denying the NRDC petition to 

cancel all carbaryl registrations, dated 

September 30, 2008. The ecological risk 

assessment issues that are unique to the 

WTC Petition are addressed in a 

separate response, dated June 18, 2010. 

EPA hereby announces the availability 

of this response in the public docket 

EPA–HQ–OPP–2006–0801. 

VI. Public Comment 

In response to the statement that the 

WTC Petition sought the revocation of 

the carbaryl tolerances, EPA published 

notice of the WTC Petition for comment 

on October 13, 2006 (71 FR 60511). EPA 

received 28 comments in response to 

the notice of availability for the WTC 

Petition. These comments may be found 

in their entirety in docket EPA–HQ– 

OPP–2006–0801. A number of 

commenters from land grant universities 

mentioned the importance of carbaryl in 

agriculture, especially in the production 

of grapes, small fruit, and pecans. 

Several commenters from the U.S. 

Forest Service and state departments of 

forestry commented on the importance 

of carbaryl in controlling bark beetle. In 

addition, the carbaryl registrant, Bayer 

CropScience, submitted comments 

opposing the claim by the WTC that 

carbaryl poses unreasonable risks to 

non–target organisms. In general, these 

comments focus on the importance and 

benefits of carbaryl, and are not specific 

to carbaryl tolerances and, therefore, are 

not relevant to the requested revocation 

of pesticide tolerances. EPA is 

responding to the WTC Petition insofar 

as it seeks cancellation of all carbaryl 

products separately, and, therefore, 

these comments are not directly relevant 

here. 

In addition, one comment from a 

private citizen supported WTC’s 

petition, asserting that all carbaryl 

tolerances should be revoked (but 

without, however, providing sufficient 

details to substantiate this position). 

Another commenter, Northwest 

Horticultural Council, submitted 

comments stating that WTC’s claims are 

often based on outdated information, 

such as carbaryl residue levels on 

apples and pears reported in a 1967 

monograph of the Food and Agricultural 

Organization (FAO) of the United 

Nations World Health Organization. The 

Northwest Horticultural Council states 

that the FAO Monograph is superseded 

by 2004 residue monitoring data from 

USDA’s Pesticide Data Program (PDP), 

which shows less than 10% of samples 

with detection, where carbaryl residues 

ranged from 0.0005 to 0.49 ppm. In any 

event, the comments as a whole 

(including these particular comments) 

did not add any new information 

pertaining to whether the tolerances 

were in compliance with the FFDCA. 

VII. Ruling on Petition 

This Order responds to the WTC 

Petition to revoke carbaryl tolerances. 

As noted above, this request was 

included as part of WTC’s comments on 

the carbaryl IRED. The WTC Petition 

contains a number of comments that do 

not provide a basis upon which to either 

cancel all carbaryl registrations or 

revoke all carbaryl tolerances. Moreover, 

the WTC Petition focuses solely on 

ecological issues. EPA is responding to 

WTC’s comments regarding the 

ecological assessment supporting the 

carbaryl RED in a separate response, 

which is available in docket EPA–HQ– 

2006–0801. However, EPA has not 

attempted to respond to every comment 

or suggestion for improvement made in 

the comments provided by the WTC. 

EPA hereby denies the WTC Petition 

to revoke all carbaryl tolerances. The 

WTC Petition has not demonstrated that 

carbaryl tolerances are unsafe. Again, 

the WTC Petition primarily raises a 

subset of identical issues that were 

raised in the NRDC petition, and does 

not provide any factual support for the 

proposition that the carbaryl tolerances 

do not meet the FFDCA safety standard. 

To the extent that the WTC Petition can 

be construed as raising any tolerancerelated issues, in denying the WTC 

Petition, EPA is relying on and hereby 

incorporates its response to the NRDC 

petition. (See 73 FR 64229). 

VIII. Regulatory Assessment 

Requirements 

As indicated previously, this action 

announces the Agency’s order denying 

a petition filed, in part, under section 

408(d) of FFDCA. As such, this action 

is an adjudication and not a rule. The 

regulatory assessment requirements 


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38422 Federal Register / Vol. 75, No. 127 / Friday, July 2, 2010 / Rules and Regulations 

imposed on rulemaking do not, 

therefore, apply to this action. 

IX. 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 

because this action is not a rule for 

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

X. References 

1. Washington Toxics Coalition 

Comments to Carbaryl IRED and 

petition to cancel registrations. January 

10, 2005. 

2. National Resources Defense 

Council (NRDC) Comments to Carbaryl 

IRED and petition to cancel 

registrations. January 10, 2005. 

3. U.S. EPA. Office of Pesticide 

Programs. 2003. Interim Reregistration 

Eligibility Decision for Carbaryl. June 

30, 2003. 

4. U.S. EPA. Office of Pesticide 

Programs. 2004. Amended Interim 

Reregistration Eligibility Decision for 

Carbaryl. October 22, 2004. 

5. U.S. EPA. Office of Pesticide 

Programs. 2005. Letter to Peg Cherney, 

Bayer CropScience, Final Cancellation 

Order for Carbaryl Liquid Broadcast 

Application to Lawns/Turf; EPA 

Registration Numbers 264–324, 264– 

325, and 264–328. March 9, 2005. 

6. U.S. EPA Office of Pesticide 

Programs. 2007. Revised N-methyl 

Carbamate Cumulative Risk Assessment. 

September 24, 2007. Docket EPA–HQ– 

OPP–2007–0935–0003. 

7. U.S. EPA. Office of Pesticide 

Programs. Reregistration Eligibility 

Decision (RED) for Carbaryl. September 

24, 2007. 

8. U.S. EPA. Office of Pesticide 

Programs. 2008. Amended 

Reregistration Eligibility Decision (RED) 

for Carbaryl. Revised August 24, 2008. 

9. U.S. EPA. Office of Pesticide 

Programs. 2008. Letter to Jennifer Sass, 

Natural Resources Defense Council, Re: 

NRDC’s comments on the Carbaryl IRED 

and petition to cancel registrations 

dated January 10, 2005 as well as 

petition to cancel carbaryl registrations 

dated November 26, 2007 and submitted 

as part of NRDC’s comments to Nmethyl carbamate cumulative. 

September 30, 2008. 

10. U.S. EPA. Office of Pesticide 

Programs. Carbaryl: Order Denying 

NRDC’s Petition to Revoke Tolerances. 

September 20, 2008. Docket EPA–HQ– 

OPP–2007–0941–0031. 

List of Subjects in 40 CFR Part 180 

Environmental protection, Carbaryl, 

Pesticides and pests. 

Dated: June 18, 2010. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

[FR Doc. 2010–15751 Filed 7–1–2010; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 40 

[Docket OST–2008–0088] 

RIN OST 2105–AD84 

Procedures for Transportation 

Workplace Drug and Alcohol Testing 

Programs 

AGENCY: Office of the Secretary, DOT. 

ACTION: Final rule. 

SUMMARY: The Department of 

Transportation published a final rule 

authorizing the use of an updated 

Alcohol Testing Form with a mandatory 

start date of August 1, 2010. The 

Department subsequently learned the 

industry might not use all the forms by 

that mandatory use date. To avoid 

wasting the forms, the Department is 

extending the mandatory use date to 

January 1, 2011. 

DATES: This rule is effective July 2, 

2010. 

FOR FURTHER INFORMATION CONTACT: For 

program issues, Bohdan Baczara, Office 

of Drug and Alcohol Policy and 

Compliance, 1200 New Jersey Avenue, 

SE., Washington, DC 20590; (202) 366– 

3784 (voice), (202) 366–3897 (fax), or 

bohdan.baczara@dot.gov (e-mail). 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On February 25, 2010, the Department 

published a final rule [75 FR 8528] 

updating the Alcohol Testing Form 

(ATF). The Department anticipated that 

employers and alcohol testing 

technicians could have a supply of old 

ATFs and, to avoid unnecessarily 

wasting these forms, the Department 

permitted the use of the old ATF until 

August 1, 2010. Employers were 

authorized to begin using the updated 

ATF immediately. 

Since the final rule was published, 

the Department became aware that some 

vendors of the ATF might not be able to 

deplete their current supply of the ATFs 

before the August 1, 2010 

implementation date. In light of this 

new information and to avoid wasting 

already printed forms, on May 11, 2010, 

the Department published a notice of 

proposed rulemaking [75 FR 26183] to 

propose to extend the implementation 

date to January 1, 2011. 

Discussion of Comments to the Docket 

There were fifteen commenters, 

including alcohol testing device 

manufacturers and suppliers, third party 

administrators, a medical facility, 

individuals and a trade association. The 

commenters unanimously agreed to 

extend the mandatory use date to 

January 1, 2011, citing that the extra 

time to use the old form will enable 

them to reduce their inventory of 

alcohol testing forms and give them the 

necessary time to design, print and 

distribute the new form. The 

commenters also appreciated the 

Department’s sensitivity to minimizing 

the unnecessary waste of paper and 

expense that would have been caused 

by throwing away forms that could no 

longer be used. One commenter 

suggested for the Department to permit 

the use of the old ATF past the 

proposed mandatory use date of January 

1, 2011. Two commenters asked for 

guidance on what would happen if an 

old ATF was used past the January 1, 

2011 mandatory use date. 

The Department agrees with the 

commenters that extending the 

mandatory use date from August 1, 2010 

to January 1, 2011 will enable regulated 

employers and their service agents to 

reduce their inventory of old alcohol 

testing forms and give them sufficient 

time to design, print, and distribute the 

new ATF. As such, the final rule will 

reflect this new date. Regarding the use 

of the old ATF past the January 1, 2011 

date, the Department expects that the 

ten month transition period from using 

the old ATF to the new ATF will be 

sufficient time for employers and TPAs 

to ensure the breath alcohol technicians 

(BATs) that service them are aware of 

the new form and have the new form for 

use by the January 1, 2011 date. The 

Department does not see the need to 

make a provision for use of the old ATF 

past the January 1, 2011. 

Regulatory Analyses and Notices 

The statutory authority for this 

proposed rule derives from the Omnibus 

Transportation Employee Testing Act of 

1991 (49 U.S.C. 102, 301, 322, 5331, 

20140, 31306, and 45101 et seq.) and the 

Department of Transportation Act (49 

U.S.C. 322). 

This proposed rule is a nonsignificant rule both for purposes of 

Executive Order 12886 and the 

Department of Transportation’s 

Regulatory Policies and Procedures. The 

Department certifies that it will not have 

a significant economic effect on a 

substantial number of small entities, for 


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