30644 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Proposed Rules 

C. Trade Considerations 

The revocation of the existing 

tolerance exemption and establishment 

of tolerances for four commodities is a 

reduction in allowable residues of 

BLAD on food. Therefore, EPA intends 

to provide notice to the World Trade 

Organization (WTO) of this proposal in 

accordance with its obligations under 

the WTO’s Sanitary and Phytosanitary 

Measures Agreement. 

VI. Conclusion 

EPA proposes to revoke the existing 

tolerance exemption for residues of 

BLAD in or on all food commodities as 

established in the Federal Register of 

March 22, 2013 under section 408 of the 

FFDCA due to potential allergenicity 

concerns. In its stead, the Agency 

proposes to establish a tolerance for 

residues of BLAD in or on almonds, 

grapes, strawberries, and tomatoes at the 

level of detection of 0.005 ppm based on 

BLAD’s low toxicity profile, testing that 

indicated that BLAD is non-allergenic, 

and residue data that demonstrated a 

rapid decline of BLAD following 

application at an exaggerated rate. 

Therefore, EPA is proposing to establish 

a tolerance level at the limit of detection 

for the analytical method to prevent any 

exposure to sensitive individuals from 

potential residues of BLAD on the 

treated crops. 

VII. Statutory and Executive Order 

Reviews 

This proposed action would revoke an 

existing exemption from the 

requirement of a tolerance and establish 

new tolerances under FFDCA section 

408(e). The Office of Management and 

Budget (OMB) has exempted tolerance 

actions from review under Executive 

Orders 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993), and 13563, entitled 

Improving Regulation and Regulatory 

Review (76 FR 3821, January 21, 2011). 

As a result, this action is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). Nor does it require OMB 

review or any Agency action under 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.); require any special considerations 

under Executive Order 12898, entitled 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); and does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, but it does not regulate State 

or tribal governments. Nor does this 

action alter the relationships or 

distribution of power and 

responsibilities established in the 

preemption provisions of FFDCA 

section 408(n)(4). Therefore, the Agency 

has determined that Executive Orders 

13132, entitled Federalism (64 FR 

43255, August 10, 1999) and 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise significantly or uniquely 

affect small governments as described in 

the Unfunded Mandates Reform Act 

(UMRA) (2 U.S.C. 1501 et seq.). 

Under the Regulatory Flexibility Act 

(RFA) (5 U.S.C. 601 et seq.), I certify that 

this action will not have significant 

economic impact on a substantial 

number of small entities. In making this 

determination, the impact of concern is 

any significant adverse economic 

impact on small entities. An agency may 

certify that a rule will not have a 

significant economic impact on a 

substantial number of small entities if 

the action will not impose any 

requirements on small entities. There 

are not a substantial number of small 

entities affected by this rule. BLAD, 

which is currently manufactured only 

by CEV, is not being used as a pesticide 

on food at this time. Therefore, this 

action will not impose any requirements 

or have a significant impact on a 

substantial number of small entities. We 

have therefore concluded that this 

action will not impact small entities. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 13, 2015. 

Jack Housenger, 

Director, Office of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 3. Section 180.683 is added to read as 

follows: 

§ 180.683 Banda de Lupinus albus doce; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

banda de Lupinus albus doce (BLAD), 

including its metabolites and 

degradates, in or on the commodities in 

the table below as a result of the 

application of BLAD. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only BLAD 

in or on the following commodities. 

Commodity Parts per 

million 

Almonds ...................................... 0.005 

Grapes ........................................ 0.005 

Strawberries ................................ 0.005 

Tomatoes .................................... 0.005 

(a) Section 18 emergency exemptions. 

[Reserved] 

(b) Tolerances with regional 

registrations. [Reserved] 

(c) Indirect or inadvertent residues. 

[Reserved] 

§ 180.1319 [Removed and Reserved] 

■ 3. Remove and reserve § 180.1319. 

[FR Doc. 2015–12530 Filed 5–28–15; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Chapter I 

[EPA–HQ–OPP–2014–0818; FRL–9927–36] 

Proposal To Mitigate Exposure to Bees 

From Acutely Toxic Pesticide 

Products; Notice of Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA is seeking comment on a 

proposal to adopt mandatory pesticide 

label restrictions to protect managed 

bees under contract pollination services 

from foliar application of pesticides that 

are acutely toxic to bees on a contact 

exposure basis. These label restrictions 

would prohibit applications of pesticide 

products, which are acutely toxic to 

bees, during bloom when bees are 

known to be present under contract. 

EPA is also seeking comment on a 

proposal to rely on efforts made by 

states and tribes to reduce pesticide 


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Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Proposed Rules 30645 

exposures through development of 

locally-based measures, specifically 

through managed pollinator protection 

plans. These plans would include local 

and customizable mitigation measures 

to address certain scenarios that can 

result in exposure to pollinators. EPA 

intends to monitor the success of these 

plans in deciding whether further label 

restrictions are warranted. 

DATES: Comments must be received on 

or before June 29, 2015. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0818, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael Goodis, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; 

telephone number: (703) 308–8157; 

email address: goodis.michael@

epa.gov, or 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; 

telephone number: (703) 305–8578; 

email address: echeverria.marietta@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you produce an 

agricultural crop that is attractive to 

pollinators, if you are a beekeeper, or if 

you manufacture pesticides. In addition, 

state and tribal governments may be 

potentially affected by this action. The 

following list of North American 

Industrial Classification System 

(NAICS) codes is not intended to be 

exhaustive, but rather provides a guide 

to help readers determine whether this 

document applies to them. Potentially 

affected entities may include: 

• Pesticide and Other Agricultural 

Chemical Manufacturing (NAICS code 

325320), e.g., Insecticide and 

Herbicide Manufacturers 

• Apiculture (NAICS code 112910) 

• Crop Production (NAICS code 111) 

• Regulation of Agricultural Marketing 

and Commodities (NAICS code 

926140), e.g., Pest control programs, 

agriculture, government 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

http://www.epa.gov/dockets/

comments.html. 

C. How can I get copies of this 

document and other related 

information? 

A copy of EPA’s Proposal to Mitigate 

Exposure to Bees from Acutely Toxic 

Pesticide Products is available in the 

docket under docket identification (ID) 

number EPA–HQ–OPP–2014–0818. 

II. What action is the agency taking? 

EPA is proposing mandatory pesticide 

label restrictions to protect contracted 

managed bees, e.g., honey bee colonies 

that are under contract to provide 

pollination services, from foliar 

applications of pesticides that are 

acutely toxic to bees on a contact 

exposure basis, i.e., those pesticides 

with an acutely lethal dose to 50% of 

the bees tested of less than 11 

micrograms per bee, based on acute 

contact toxicity testing. Contracted 

pollination services result in a 

heightened risk potential where a large 

number of honey bee colonies are 

intentionally placed at a use site, and 

application of a toxic pesticide in this 

scenario is nearly certain to result in 

direct exposure to pollinators. Although 

the likely outcomes are counterproductive for both the beekeeper (loss 

of honey bee stock) and the grower 

(diminished pollination services), many 

beekeepers and growers seem not to 

have found ways to avoid such 

outcomes. Consequently, EPA believes 

that strong regulatory measures should 

be in place for the contracted service 

scenario to mitigate these potential 

problems. Therefore, EPA proposes to 

prohibit the foliar application of acutely 

toxic products during bloom for sites 

with bees on-site under contract, unless 

the application is made in accordance 

with a government-declared public 

health response. There would be no 

other exceptions to the bloom 

prohibition in the contracted-services 

scenario. Current neonicotinoid product 

labels include a 48-hr notification 

exception to the bloom prohibition. 

However, as part of this mitigation 

proposal, the 48-hr notification 

exception for crops under contracted 

pollination services during bloom for all 

neonicotinoid product labels would be 

removed. These restrictions are 

expected to reduce the likelihood of 

acute exposure and mortality to 

managed bees under contract. 

EPA believes that managed bees not 

under contracted services (and other 

unmanaged bees) may also be exposed 

to acutely toxic pesticides when they 

are within forage range of the 

application site. While pesticide 

exposure under this scenario is possible, 

it is less certain than in situations where 

a pesticide is applied to a site when 

large numbers of managed bees have 

intentionally been positioned at the site 

for the purposes of providing 

pollination services. EPA believes that 

the lower likelihood of exposure for 

large numbers of managed bees in this 

scenario may warrant a more flexible 

approach toward mitigation such as that 

afforded by state or tribal Managed 

Pollinator Protection Plans (MP3s). 

Accordingly, EPA intends to encourage 

states and tribes to develop MP3s that 

are effective in reducing the likelihood 

of bees being present in the treatment 

area at the time a pesticide application 

is to be made. EPA would monitor 

success of these MP3s in mitigating risk 

to bees from acutely toxic pesticides on 

an ongoing basis and determine whether 

additional EPA action is warranted. 

Therefore, for managed bees not under 

contract pollination services, EPA is not 

proposing to require any new language 


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30646 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Proposed Rules 

for pesticide labels. This does not alter 

EPA’s previous requirement for more 

specific restrictions on neonicotinoid 

pesticides for which EPA required 

language to address risks to bees not 

under contract for pollination services. 

EPA is seeking comment on both the 

approach of label restrictions on 

products used for bees under contract 

for pollinator services, and for the 

approach to rely on state and tribal 

pollinator protection plans to bees that 

are not under contract for pollination 

services. 

These actions are consistent with the 

Presidential directive issued in June 

2014 to reduce the effect of factors that 

have been associated with pollinator 

declines in general as well as the 

mandate to engage state and tribal 

partners in the development of 

pollinator protection plans. While the 

proposed mitigation focuses on 

managed bees, EPA believes that in 

protecting managed bees, these 

measures will also protect native 

solitary and social bees that are in and 

around treatment areas. The proposed 

mitigation is based on an acute toxicity 

threshold and is not intended to 

supersede more restrictive productspecific use prohibitions. EPA will 

continue to conduct chemical-specific 

risk assessments for bees and will 

consider additional product-specific 

mitigation as needed in the Office of 

Pesticide Program’s (OPP) registration 

and registration review programs. 

III. Areas of Feedback 

EPA is seeking comments on the 

proposed approach to mitigate exposure 

to bees from acutely toxic pesticide 

products under contract and noncontract pollination scenarios. In 

addition, EPA is specifically seeking 

comment on several issues described in 

the policy paper. 

A. Label Language for Applications to 

Sites With Bees Present Under 

Contracted Services 

EPA is proposing to prohibit the foliar 

application of acutely toxic products 

during bloom for sites with bees on-site 

under contract, unless the application is 

made in accordance with a governmentdeclared public health response. EPA 

encourages growers and beekeepers to 

include provisions in pollination 

service contracts that take into account 

the increased likelihood of bee colony 

exposure and ensure that colonies will 

be protected and pollination services 

secured. If EPA receives evidence 

during the public comment period and/ 

or through outreach at stakeholder 

meetings that such contract provisions 

are common or that there are other 

effective and mutually agreed upon 

stakeholder (i.e., beekeeper-to-grower) 

practices indicating that application of 

acutely toxic pesticides is not of risk 

concern for bees under contract, then 

EPA will consider this evidence in 

determining whether this scenario 

needs the mitigation indicated in the 

proposed language. Please comment on 

any factors that may allow EPA to 

reconsider the mitigation for this 

scenario, for example, if risks to bees are 

addressed through existing, and widely 

used, contract language. 

B. State and Tribal Managed Pollinator 

Protection Plans 

For sites not under contracted 

services, EPA believes that pollinator 

protection plans serve as examples of 

effective collaboration between 

stakeholders at the local level that can 

lead to reduced pesticide exposure and 

protection of managed bees while 

maintaining the flexibility needed by 

growers to protect crops. Based on 

feedback provided to EPA by state lead 

agencies that have developed such 

plans, beekeeper-to-grower 

communication has been enhanced and 

fewer bee kill incidents have been 

reported as a result of the plans. Across 

these diverse plans, the common 

element has been effective stakeholder 

engagement, and anecdotal reports from 

the stakeholder groups suggest that the 

plans are effective at increasing 

communication and cooperation. The 

development of pollinator protection 

plans is a voluntary way for states and 

tribes to address acute pesticide 

exposure to pollinators. EPA believes 

that a key factor for states and tribes to 

determine the effectiveness of managed 

pollinator protection plans will be to 

include mechanisms to measure the 

effectiveness and a process to 

periodically review and modify each 

plan. Please comment on EPA’s 

proposal to address risk to non-contract 

bees through reliance on state and tribal 

plans. Also, given the uncertainties with 

incident data, what kind of measures 

should be used to demonstrate that state 

and tribal pollinator protection plans 

are effective? 

C. Uncertainties 

EPA recognizes that there are a 

number of uncertainties that remain 

regarding chemicals and exposure 

scenarios that may not fall within the 

domain of the proposal. EPA is also 

interested in receiving feedback on 

these uncertainties, which are described 

in the proposal. 

Authority: 7 U.S.C. 136a. 

Dated: May 19, 2015. 

Jack E. Housenger, 

Director, Office of Pesticide Programs. 

[FR Doc. 2015–12989 Filed 5–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Part 162 

[CMS–0026–NC] 

Request for Information Regarding the 

Requirements for the Health Plan 

Identifier 

AGENCY: Office of the Secretary (HHS). 

ACTION: Request for information. 

SUMMARY: This request for information 

seeks public comment regarding the 

health plan identifier (HPID) including 

the requirements regarding health plan 

enumeration and the requirement, to 

use the HPID in electronic health care 

transactions. 

DATES: To be assured consideration, 

written or electronic comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

July 28, 2015. 

ADDRESSES: In commenting, refer to file 

code CMS–0026–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–0026–NC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–0026–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: a. For delivery in 


Lhorne on DSK2VPTVN1PROD with PROPOSALS