78748 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 

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). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

This action 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 of 1995 

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

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 19, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

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. 

§ 180.430 [Amended] 

■ 2. In § 180.430, in the table to 

paragraph (b), amend the entries for 

grass, forage and grass, hay by revising 

the expiration dates ‘‘12/31/13’’ to read 

‘‘12/31/16.’’ 

§ 180.434 [Amended] 

■ 3. In § 180.434, in the table to 

paragraph (b), amend the entry for 

avocado by revising the expiration date 

‘‘12/31/13’’ to read ‘‘12/31/16.’’ 

§ 180.517 [Amended] 

■ 4. In § 180.517, in the table to 

paragraph (b), amend the entries for 

rutabaga and turnip by revising the 

expiration dates ‘‘12/31/13’’ to read ‘‘12/ 

31/16.’’ 

§ 180.572 [Amended] 

■ 5. In § 180.572, in the table to 

paragraph (b), amend the entries for 

timothy, forage and timothy, hay by 

revising the expiration dates ‘‘12/31/13’’ 

to read ‘‘12/31/16.’’ 

[FR Doc. 2013–30877 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0540; FRL–9902–90] 

2,5-Furandione, polymer With 

ethenylbenzene, Reaction Products 

With polyethylene-polypropylene 

glycol 2-aminopropyl Me ether; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2,5-furandione, 

polymer with ethenylbenzene, reaction 

products with polyethylenepolypropylene glycol 2-aminopropyl Me 

ether; minimum number average 

molecular weight (in amu), 14,000 

(CASRN 162568–32–3); when used as 

an inert ingredient in a pesticide 

chemical formulation. Huntsman Corp. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether on food or feed 

commodities. 

DATES: This regulation is effective 

December 27, 2013. Objections and 

requests for hearings must be received 

on or before February 25, 2014, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0540, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. 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: 

• Crop production (NAICS code 111). 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78749 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. Can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

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–2013–0540 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before February 25, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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 (excluding 

any CBI) for inclusion in the public 

docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit the nonCBI copy of your objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2013–0540, 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. 

II. Background and Statutory Findings 

In the Federal Register of September 

12, 2013 (78 FR 56187) (FRL–9399–7), 

EPA issued a notice pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the receipt of a pesticide petition (IN– 

10607) filed by Huntsman Corp., 8600 

Gosling Rd., The Woodlands, TX 77381. 

The petition requested that 40 CFR 

180.960 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of 2,5-furandione, 

polymer with ethenylbenzene, reaction 

products with polyethylenepolypropylene glycol 2-aminopropyl Me 

ether. That notice included a summary 

of the petition prepared by the 

petitioner and solicited comments on 

the petitioner’s request. The Agency did 

not receive any comments. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of 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 

use in residential settings, but does not 

include occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing an 

exemption from the requirement of a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . .’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

III. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert in conjunction 

with possible exposure to residues of 

the inert ingredient through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether conforms to the 

definition of a polymer given in 40 CFR 

723.250(b) and meets the following 

criteria that are used to identify low-risk 

polymers. 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

7. The polymer does not contain 

certain perfluoroalkyl moieties 


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consisting of a CF3- or longer chain 

length as specified in 40 CFR 

723.250(d)(6). 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

8. The polymer’s number average MW 

is greater than or equal to 10,000 

daltons. The polymer contains less than 

2% oligomeric material below MW 500 

and less than 5% oligomeric material 

below MW 1,000. 

Thus, 2,5-furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether meets the criteria 

for a polymer to be considered low risk 

under 40 CFR 723.250. Based on its 

conformance to the criteria in this unit, 

no mammalian toxicity is anticipated 

from dietary, inhalation, or dermal 

exposure to 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether. 

IV. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that 2,5- 

furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether could be present 

in all raw and processed agricultural 

commodities and drinking water, and 

that non-occupational non-dietary 

exposure was possible. The number 

average MW of 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether is 14,000 

daltons. Generally, a polymer of this 

size would be poorly absorbed through 

the intact gastrointestinal tract or 

through intact human skin. Since 2,5- 

furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether conform to the 

criteria that identify a low-risk polymer, 

there are no concerns for risks 

associated with any potential exposure 

scenarios that are reasonably 

foreseeable. The Agency has determined 

that a tolerance is not necessary to 

protect the public health. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found 2,5-furandione, 

polymer with ethenylbenzene, reaction 

products with polyethylenepolypropylene glycol 2-aminopropyl Me 

ether to share a common mechanism of 

toxicity with any other substances, and 

2,5-furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base unless 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of 2,5-furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether, EPA has not 

used a safety factor analysis to assess 

the risk. For the same reasons the 

additional tenfold safety factor is 

unnecessary. 

VII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low-risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of 2,5-furandione, polymer 

with ethenylbenzene, reaction products 

with polyethylene-polypropylene glycol 

2-aminopropyl Me ether. 

VIII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for 2,5-furandione, polymer with 

ethenylbenzene, reaction products with 

polyethylene-polypropylene glycol 2- 

aminopropyl Me ether. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of 2,5-furandione, 

polymer with ethenylbenzene, reaction 

products with polyethylenepolypropylene glycol 2-aminopropyl Me 

ether from the requirement of a 

tolerance will be safe. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these rules 

from review under Executive Order 

12866, entitled ‘‘Regulatory Planning 

and Review’’ (58 FR 51735, October 4, 

1993). Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule 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) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it involve 

any technical standards that would 

require Agency consideration of 

voluntary consensus standards pursuant 


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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations 78751 

to section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA) (15 U.S.C. 272 

note). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes, or otherwise have any unique 

impacts on local governments. Thus, the 

Agency has determined that Executive 

Order 13132, entitled ‘‘Federalism’’ (64 

FR 43255, August 10, 1999) and 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

Although this action does not 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), EPA seeks to achieve 

environmental justice, the fair treatment 

and meaningful involvement of any 

group, including minority and/or lowincome populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 17, 2013. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

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. 

■ 2. In § 180.960, in the table, 

alphabetically add the following 

polymer before the entry for ‘‘Hexadecyl 

acrylate-acrylic acid copolymer * * *’’ 

to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

* * * * * 

2,5-Furandione, polymer with 

ethenylbenzene, reaction 

products with polyethylenepolypropylene glycol 2- 

aminopropyl Me ether; 

minimum number average 

molecular weight (in amu), 

14,000 ............................... 162568–32–3 

* * * * * 

[FR Doc. 2013–31108 Filed 12–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 411 

[CMS–1454–F] 

RIN 0938–AR70 

Medicare Program; Physicians’ 

Referrals to Health Care Entities With 

Which They Have Financial 

Relationships: Exception for Certain 

Electronic Health Records 

Arrangements 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

exception to the physician self-referral 

law that permits certain arrangements 

involving the donation of electronic 

health records items and services. 

Specifically, this final rule extends the 

expiration date of the exception to 

December 31, 2021, excludes laboratory 

companies from the types of entities 

that may donate electronic health 

records items and services, updates the 

provision under which electronic health 

records software is deemed 

interoperable, removes the electronic 

prescribing capability requirement, and 

clarifies the requirement prohibiting any 

action that limits or restricts the use, 

compatibility, or interoperability of 

donated items or services. 

DATES: With the exception of the 

amendment to § 411.357(w)(13), this 

regulation is effective on March 27, 

2014. The amendment to 

§ 411.357(w)(13) is effective on 

December 31, 2013. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Ohrin, (410) 786–8852. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Regulatory Action 

Section 1877 of the Social Security 

Act (the Act), codified at 42 U.S.C. 

1395nn, also known as the physician 

self-referral statute: (1) prohibits a 

physician from making referrals for 

certain designated health services (DHS) 

payable by Medicare to an entity with 

which he or she (or an immediate family 

member) has a financial relationship 

(ownership interest or compensation 

arrangement), unless the requirements 

of an exception are satisfied; and (2) 

prohibits the entity from submitting 

claims to Medicare for those referred 

services, unless the requirements of an 


tkelley on DSK3SPTVN1PROD with RULES