Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12015 

stoichiometric equivalent of zoxamide 

in or on the raw agricultural commodity 

ginseng at 0.30 ppm and vegetable, 

tuberous and corm, subgroup 1C at 0.06 

ppm. In addition, tolerances are 

established for residues, determined by 

measuring only zoxamide (3,5-dichloroN-(3-chloro-1-ethyl-1-methyl-2- 

oxypropyl)-4-methylbenzamide, in or on 

raw agricultural commodity tomato 

subgroup 8–10A at 2.0 ppm and fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F at 5.0 ppm. 

Lastly, upon the establishment of the 

aforementioned tolerances, the 

established tolerances for grape at 3.0 

ppm; tomato at 2.0 ppm; and potato at 

0.060 ppm are removed as unnecessary. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, 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) or 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.), nor does it 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). 

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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

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

VII. 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: February 25, 2016. 

Susan Lewis, 

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 § 180.567: 

■ a. In the table in paragraph (a)(1): 

■ i. Add alphabetically entries for 

‘‘Fruit, small vine climbing’’ and 

‘‘Tomato subgroup 8–10A’’; and 

■ ii. Remove the entries for ‘‘Grape’’ and 

‘‘Tomato’’; and 

■ b. In the table in paragraph (a)(2): 

■ i. Add alphabetically entries for 

‘‘Ginseng’’ and ‘‘Vegetable, tuberous and 

corm’’; and 

■ ii. Remove the entry ‘‘Potato’’. 

The additions read as follows: 

§ 180.567 Zoxamide; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 5.0 

*****

Tomato subgroup 8–10A ............ 2.0 

*****

(2) * * * 

Commodity Parts per 

million 

Ginseng ...................................... 0.30 

*****

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.06 

* * * * * 

[FR Doc. 2016–04740 Filed 3–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0443; FRL–9943–21] 

Fluopyram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

amends, and deletes tolerances for 

residues of fluopyram in or on multiple 

commodities which are identified and 

discussed later in this document. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 8, 2016. Objections and requests 

for hearings must be received on or 

before May 9, 2016, 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) 


asabaliauskas on DSK3SPTVN1PROD with RULES
12016 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

number EPA–HQ–OPP–2015–0443, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main 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). 

• 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How 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–2015–0443 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 May 9, 2016. 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 Confidential Business Information 

(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 non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0443, 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 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. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 26, 

2015 (80 FR 51759) (FRL–9931–74), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 4F8284) by Bayer 

CropScience, 2 T. W. Alexander Drive, 

Research Triangle Park, North Carolina 

27709. The petition requested that 40 

CFR 180.661 be amended by 

establishing tolerances for residues of 

the fungicide fluopyram in or on the 

raw agricultural commodities artichoke, 

globe at 4.0 parts per million; aspirated 

grain fractions at 50.0 ppm; peanut hay 

at 40.0 ppm; hops at 60.0 ppm; root 

vegetables, except beet, sugar, root, crop 

subgroup 1B at 0.30 ppm; tuberous and 

corm vegetables, crop subgroup 1C at 

0.10 ppm; potato wet peel at 0.30 ppm; 

vegetables, leaves of root and tuber, crop 

group 2 at 30.0 ppm; bulb vegetables, 

bulb onion (crop subgroup 3–07A) at 

0.30 ppm; bulb vegetables, green onions 

(crop subgroup 3–07B) at 15.0 ppm; 

leafy greens (crop subgroup 4A), 

without spinach at 20.0 ppm; leafy 

greens (crop subgroup 4A) spinach at 

40.0 ppm; leafy petioles subgroup, 

celery (crop subgroup 4B) at 20.0 ppm; 

brassica leafy vegetables: Head and stem 

(crop subgroup 5A) at 4.0 ppm; brassica 

leafy vegetables: Leafy greens (crop 

subgroup 5B) at 50.0 ppm; soybean 

forage at 9.0 ppm; soybean hay at 30.0 

ppm; legume vegetables: Edible podded 

(crop subgroup 6A) at 4.0 ppm; legume 

vegetables: Succulent shelled peas and 

beans (crop subgroup 6B) at 0.20 ppm; 

legume vegetables: Dried shelled peas 

and beans (crop subgroup 6C) at 0.70 

ppm; vegetable, foliage of legume 

vegetables, forage, hay and vines, forage 

(crop group 7) at 90.0 ppm; fruiting 

vegetables, tomato subgroup (crop 

subgroup 8–10A) at 1.00 ppm; fruiting 

vegetables, pepper/eggplant subgroup 

(crop subgroup 8–10B) at 3.00 ppm; 

cucurbit vegetables (crop group 9A), 

melon subgroup at 0.90 ppm; cucurbit 

vegetables (crop group 9B), cucumber/

squash subgroup at 0.30 ppm; citrus 

fruits (crop group 10–10) at 0.90 ppm; 

citrus oil at 8.0 ppm; pome fruit (crop 

group 11–10) at 2.0 ppm; stone fruit 

(crop group 12–12A), cherry subgroup at 

2.00 ppm; stone fruit (crop group 12– 

12B), peach subgroup at 1.00 ppm; stone 

fruit (crop group 12–12C), plum 

subgroup at 0.50 ppm; berries and small 

fruit: Caneberry (crop subgroup 13–07A) 

at 5.0 ppm; berries and small fruit: 

Bushberry (crop subgroup 13–07B) at 

7.0 ppm; raisins at 4.0 ppm; berries and 

small fruit, small fruit vine climbing, 

except fuzzy kiwi (crop subgroup 13– 

07F) at 1.5 ppm; berries and small fruit: 

Low growing berry (crop subgroup 13– 

07G) at 2.0 ppm; sorghum, grain at 1.5 

ppm; wheat milled by-products at 2.0 

ppm; grass forage, fodder and hay: 

Forage (crop group 17) at 80.0 ppm; 

herb crop (crop subgroup 19A) at 70.0 

ppm; dill seed at 70.00 ppm; herbs, 

dried at 400 ppm; oilseeds, rapeseed, 

canola (crop subgroup 20A) at 0.70 

ppm; oilseeds, sunflower, seed (crop 

subgroup 20B) at 0.70 ppm; and 

oilseeds: Cottonseed (crop subgroup 

20C) at 0.80 ppm and in or on the 

animal commodities chicken, meat 

byproducts at 0.40 ppm; chicken, fat at 

0.15 ppm; chicken, meat at 0.10 ppm; 

goat, fat at 4.00 ppm; and goat, meat at 

4.00 ppm. Bayer CropScience also 

requests to establish a tolerance in 40 

CFR 180.661 for indirect or inadvertent 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12017 

residues of the fungicide fluopyram in 

or on the raw agricultural commodity 

sugarcane, cane at 0.08 ppm. The 

petition also requested to amend 

tolerances in 40 CFR 180.661 for 

residues of the fungicide fluopyram in 

or on the raw agricultural commodities 

peanut at 0.20 ppm; sugar beet, roots at 

0.09 ppm; soybean, seed at 0.30 ppm; 

soybean forage at 9.0 ppm; soybean hay 

at 30.0 ppm; tree nuts (crop group 14) 

at 0.04 ppm; almond hulls at 10.00 ppm; 

grain, cereal, except rice and sorghum 

(crop group 15) at 0.90 ppm; cereal 

grain, except rice, forage, fodder and 

straw (crop group 16) at 20.0 ppm; and 

cotton gin by-product at 30.00 ppm and 

in or on the animal commodities cattle, 

meat byproducts at 40.00 ppm; cattle, 

fat at 4.00 ppm; cattle, meat at 4.00 

ppm; milk, cattle at 2.00 ppm; eggs, 

chicken at 0.20 ppm; hog, meat 

byproducts at 0.40 ppm; hog, fat at 0.04 

ppm; hog, meat at 0.04 ppm; horse, meat 

byproducts at 40.00 ppm; horse, fat at 

4.00 ppm; horse, meat at 4.00 ppm; goat, 

meat byproducts at 40.00 ppm; sheep, 

meat byproducts at 40.00 ppm; sheep, 

fat at 4.00 ppm; and sheep, meat at 4.00 

ppm. Bayer CropScience also requests to 

delete tolerances in 40 CFR 180.661 for 

residues of the fungicide fluopyram in 

or on the raw agricultural commodities 

apple at 0.30 ppm; bean, dry at 0.09 

ppm; beet, sugar, roots at 0.04 ppm; 

apple wet pomace at 0.60 ppm; cherry 

at 0.60 ppm; grape, wine at 2.0 ppm; 

potato at 0.02 ppm; strawberry at 1.5 

ppm; and watermelon at 1.0 ppm. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA is issuing 

some tolerances that vary from the 

fluopyram tolerances as requested. The 

reasons for these changes are explained 

in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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 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 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 . . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fluopyram 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluopyram follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies 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. 

Decreased body weight and liver 

effects were the common and frequent 

findings in the fluopyram subchronic 

and chronic oral toxicity studies in rats, 

mice, and dogs, and they appeared to be 

the most sensitive effects. Liver effects 

were characterized by increased liver 

weight, hepatocellular hypertrophy, 

hepatocellular vacuolation, increased 

mitosis and hepatocellular necrosis. 

Thyroid effects were found at dose 

levels similar to those that produced 

liver effects in rats and mice; these 

effects consisted of follicular cell 

hypertrophy, increased thyroid weight, 

and hyperplasia at dose levels greater 

than or equal to 100 milligrams/

kilogram/day (mg/kg/day). Changes in 

thyroid hormone levels were also seen 

in a subchronic toxicity study. In male 

mice, there was an increased incidence 

of thyroid adenomas. 

Although increased liver tumors were 

observed in female rats in the 

carcinogenicity study, EPA has 

concluded that fluopyram is ‘‘Not Likely 

to be Carcinogenic to Humans’’ at doses 

that do not induce cellular proliferation 

in the liver or thyroid glands. This 

classification was based on convincing 

evidence that non-genotoxic modes of 

action for liver tumors in rats and 

thyroid tumors in mice have been 

established and that the carcinogenic 

effects have been demonstrated as a 

result of a mode of action dependent on 

activation of the CAR/PXR receptors. 

The Agency is using a point of 

departure for regulating fluopyram 

(NOAEL of 1.2 mg/kg/day) that is below 

the doses that cause cell proliferation in 

the liver (11 mg/kg/day) and subsequent 

liver tumor formation (89 mg/kg/day); 

therefore, the Agency concludes that 

exposure to fluopyram will not be 

carcinogenic. Moreover, fluopyram is 

not genotoxic or mutagenic. 

Fluopyram is not a developmental 

toxicant, nor did it adversely affect 

reproductive parameters. No evidence of 

qualitative or quantitative susceptibility 

was observed in developmental studies 

in rats and rabbits or in a 

multigeneration study in rats. 

In an acute neurotoxicity study, 

transient decreased motor activity was 

seen only on the day of treatment, but 

no other findings demonstrating 

neurotoxicity were observed. In 

addition, no neurotoxicity was observed 

in the subchronic neurotoxicity study in 

the presence of other systemic adverse 

effects. Fluopyram did not produce 

treatment-related effects on the immune 

system. 

Fluopyram has low acute toxicity via 

the oral, dermal, and inhalation routes 

of exposure. Fluopyram is not a skin or 

eye irritant or sensitizer under the 

conditions of the murine lymph node 

assay. Specific information on the 

studies received and the nature of the 

adverse effects caused by fluopyram as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

entitled: ‘‘Fluopyram: Human Health 

Risk Assessment for Proposed New Uses 

on Crop Subgroup 1B, Subgroup 1C, 

Crop Group 2, Subgroup 3–07A, 

Subgroup 3–07B, Subgroup 4A, 

Subgroup 4B, Subgroup 5A, Subgroup 

5B, Subgroup 6A, Subgroup 6B, Dried 

Beans, Soybean, Subgroup 8–10A, 

Subgroup 8–10B, Subgroup 9A, 

Subgroup 9B, Subgroup 10–10, Group 

11–10, Subgroup 12–12A, Subgroup 12– 

12B, Subgroup 12–12C, Subgroup 13– 

07A, Subgroup 13–07B, Subgroup 13– 

07F, Subgroup 13–07G, Crop Group 15 

(except corn and Rice), Crop Group 16, 

Subgroup 19A, Dill Seed, Subgroup 

20A, Subgroup 20B, Subgroup 20C, 

Artichoke (Globe), Hops, and Sugarcane 

(Rotated). Amended Tolerance Requests 

for the Registered Uses due to Crop 

Group/Subgroup Expansion Requests. 

Proposed New Uses on Turf Grass, 

Ornamentals, and Christmas trees, and 

as a seed treatment to Peanuts’’ in 


asabaliauskas on DSK3SPTVN1PROD with RULES
12018 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

docket ID number EPA–HQ–OPP–2015– 

0443. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

iaspub.epa.gov/apex/pesticides/

f?p=chemicalsearch:1. 

A summary of the toxicological 

endpoints for fluopyram used for 

human risk assessment is shown in 

Table 1. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUOPYRAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

NOAEL = 50 mg/kg/

day.

UFA = 10x 

UFH =10x 

FQPA SF = 1x 

Acute RfD = 0.50 

mg/kg/day.

aPAD = 0.50 mg/kg/

day.

Acute Neurotoxicity Study in Rats 

LOAEL = 100 mg/kg/day based on decreased motor and locomotor activity in females. The LOAEL in males was 125 mg/

kg/day. 

Acute dietary (Females 13–50 

years of age).

An endpoint attributable to a single dose exposure has not been identified for this subpopulation. 

Chronic dietary (All populations) NOAEL = 1.2 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.012 

mg/kg/day.

cPAD = 0.012 mg/

kg/day.

Combined Chronic/Carcinogenicity in Rats 

LOAEL = 6.0 mg/kg/day based on follicular cell hypertrophy in 

the thyroid, and increased liver weight with gross pathological and histopathological findings. 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 14.5 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Reproduction study in rats 

LOAEL = 82.8 mg/kg/day based on clinical pathology changes, 

decreased spleen and thymus weights, increased liver weight 

and centrilobular hypertrophy in parents, and decreased 

body weight and body weight gain with decreases in spleen 

and thymus weights and slight delay in preputial separation 

in offspring. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

NOAEL = 300 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

28-day dermal study in rats 

LOAEL = 1000 mg/kg/day based on increased cholesterol (F), 

increased prothrombin time (M). 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1–6 months).

NOAEL = 14.5 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

Reproduction study in rats 

LOAEL = 82.8 mg/kg/day based on clinical chemistry changes 

and increased kidney weight in parents, and decreased body 

weight and body weight gain with decreases in spleen and 

thymus weights in offspring. 

Cancer (Oral, dermal, inhalation).‘‘Not Likely to be Carcinogenic to Humans’’ at doses that do not induce cellular proliferation in the liver or thyroid glands. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. Mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluopyram, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluopyram tolerances in 40 CFR 

180.661. EPA assessed dietary 

exposures from fluopyram in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for fluopyram. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey/What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA included 

tolerance residue levels, the assumption 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12019 

of 100% crop treated, and processing 

factors (empirical and default). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/

WWEIA. As to residue levels in food, 

EPA included average residue levels, % 

crop treated, and processing factors 

(empirical and default). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluopyram does not pose 

a cancer risk to humans at doses that do 

not induce cellular proliferation in the 

liver or thyroid glands. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for the 

chronic dietary exposure assessment for 

existing uses as follows: 

Almonds 33%; apples 40%; 

blackberries 55%; blueberries 54%; 

broccoli 24%; cantaloupes 22%; celery 

60%; corn field 9%; corn, sweet 15%; 

cucumbers 41%; dry beans/peas 7%; 

fresh tomatoes 64%; grape wine 79% 

(used for grape, wine and sherry); head 

lettuce 67%; leaf lettuce 62%; oranges 

39%; peaches 56%; pears 43%; peanuts 

67%; potatoes 64%; processed tomatoes 

57%; pumpkins 45%; snap beans 44%; 

soybeans 17%; spinach 43%; squash 

47%; strawberries 75%; sugar beets 

48%; watermelons 54%; and wheat 17% 

(from spring wheat at 17% and winter 

wheat at 6%). 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fluopyram may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluopyram in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluopyram. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/

water/index.htm. 

Based on the Pesticide Root Zone 

Model Ground Water (PRZM GW) and 

the surface water concentration 

calculator (SWCC), the estimated 

drinking water concentrations (EDWCs) 

of fluopyram for acute exposures are 

estimated to be 50.6 parts per billion 

(ppb) for surface water and 97.6 ppb for 

ground water. The chronic exposures for 

non-cancer assessments are estimated to 

be 17.3 ppb for surface water and 90.5 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 97.6 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 90.5 ppb was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fluopyram is proposed for use that 

could result in residential exposures: 

golf course turf, residential lawns, fruit 

trees, nut trees, ornamentals and 

gardens. EPA assessed residential 

exposure using the following 

assumptions: short-term dermal, oral 

(derived from incidental oral hand to 

mouth post-application exposures to 

treated lawn in children), and 

inhalation exposures derived from 

treating lawns by hose-end sprayers 

(adults); residential post-application 

exposures: adults and children (1 to <2 

years old) dermal exposure to treated 

turf during high contact lawn activities; 

children (1 to <2 years old) incidental 

oral exposure as a result of contacting 

treated turf; adults and youths (11 to 

<16 yr old) dermal exposure to treated 

turf during mowing and golfing 

activities; children (6 to <11 years old) 

dermal exposure to treated turf during 

golfing activities; and adults and 


asabaliauskas on DSK3SPTVN1PROD with RULES
12020 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

children (6 to <11 years old) dermal 

exposure to treated gardens. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/

science/trac6a05.pdf. 

4. 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 fluopyram to share a common 

mechanism of toxicity with any other 

substances, and fluopyram does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

fluopyram 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. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The available developmental toxicity 

studies in rats and rabbits and the multigeneration reproduction in rats 

demonstrate no evidence of increased 

susceptibility in the developing or 

young animals which were exposed 

during pre- or post-natal periods. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for fluopyram 

is complete. 

ii. There is no indication that 

fluopyram is a neurotoxic chemical. 

Although transient decreases in motor 

and locomotor activities in the acute 

neurotoxicity study were seen on the 

day of treatment and limited use of 

hind-limbs and reduced motor activity 

was seen in the rat chronic/

carcinogenicity study, there were no 

other associated neurobehavioral or 

histopathology changes found in other 

studies in the fluopyram toxicity 

database. The effects seen in the 

chronic/carcinogenicity study were in 

the presence of increased mortality and 

morbidity such as general pallor and 

emaciated appearance. Therefore, the 

reduced motor activity and limited use 

of hind-limbs seen in these two studies 

were judged to be the consequence of 

the systemic effects and not direct 

neurotoxicity. Additionally there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

fluopyram results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary exposure assessment 

was performed using conservative 

exposure inputs, including tolerancelevel residues for all crops, whereas the 

chronic dietary assessment included 

average field-trial residue levels for all 

crops. The acute dietary assessment 

assumed 100 PCT, whereas the chronic 

dietary assessment utilized average 

percent crop treated numbers for several 

crops. Both acute and chronic dietary 

assessments incorporated empirical or 

default processing factors. The dietary 

exposure assessment also assumed that 

all drinking water will contain 

fluopyram at the highest EDWC levels 

modeled by the Agency for ground or 

surface water. Therefore, it can be 

concluded that the dietary exposure 

analysis does not underestimate risk 

from acute and chronic dietary exposure 

to fluopyram. While there is the 

potential for handler and postapplication residential exposure, the 

best data and approaches currently 

available were used in the fluopyram 

residential assessment. The Agency 

used the current conservative 

approaches for residential assessment, 

many of which include recent upgrades 

to the SOPs. The Agency believes that 

the calculated risks represent 

conservative estimates of exposure 

because maximum application rates are 

used to define residue levels upon 

which the calculations are based. 

Therefore, residential exposures are 

unlikely to be underestimated. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluopyram will occupy 35% of the aPAD 

for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluopyram from 

food and water will utilize 81% of the 

cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of fluopyram is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Fluopyram is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

fluopyram. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs from handler inhalation exposure 

(the most conservative risk estimate) of 

1,500 for adults. For children 1–2 years 

old, post-application incidental oral 

exposures aggregated with food and 

drinking water resulted in an MOE of 

1,500. Because EPA’s level of concern 

for fluopyram is a MOE of 100 or below, 

these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12021 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Intermediate-term residential exposure 

is not expected given the intermittent 

nature of applications in residential 

settings. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A, 

because the Agency is regulating 

exposure to fluopyram at doses lower 

than those that may induce cellular 

proliferation in the liver or thyroid 

glands, fluopyram is not expected to 

pose a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to fluopyram 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The German multiresidue method 

DFG Method S 19, a gas 

chromatography with mass selective 

detection (GC/MSD) method, is the 

method for the enforcement of 

tolerances for fluopyram residues in/on 

crop commodities and a high 

performance liquid chromatography 

method with tandem mass spectrometry 

detection (HPLC/MS/MS), Method 

01079, has been accepted for the 

enforcement of tolerances for residues of 

fluopyram and its metabolite, AE 

C656948-benzamide, in livestock 

commodities. The validated limit of 

quantitation (LOQ) is 0.01 ppm and the 

calculated limit of detection (LOD) is 

0.003 ppm for each analyte in each 

matrix. The method was adequately 

validated using cattle milk, fat, muscle, 

liver, and kidney, and hen whole egg 

fortified with fluopyram and AE 

C656948-benzamide, each at 0.01 and 

0.10 ppm. The method was subjected to 

ILV using samples of beef muscle, beef 

liver, eggs, and milk fortified with 

fluopyram and AE C656948-benzamide, 

each at 0.01 and 0.10 ppm. 

Adequate enforcement methodology 

DFG Method S 19 and Method 01079 

are available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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. 

There are Codex maximum residue 

levels MRLs established on berries 

(blackberry and raspberry 3 ppm), 

broccoli and Brussels sprouts (0.3 ppm), 

dry beans (0.07 ppm), head cabbage 

(0.15 ppm), carrot (0.4 ppm), 

cauliflower (0.09 ppm), cherry (0.7 

ppm), cucumber (0.5 ppm), dried grapes 

(currants, raisins and sultanas 5 ppm), 

grapes (2 ppm), leek (0.15 ppm), lettuce 

(head and leaf 15 ppm), onion bulb 

(0.07 ppm), peach subgroup (1 ppm), 

peanut (0.03 ppm), plums (0.5 ppm), 

pome fruits (0.5 ppm), potato (0.03 

ppm), rapeseed (1 ppm), strawberry (0.4 

ppm), sugar beet (0.04 ppm), tomato (0.4 

ppm), and tree nuts (0.04 ppm). 

The tolerance definitions are 

harmonized among the US, Canada, and 

Codex for all plant and livestock 

commodities. In addition, the U.S. 

tolerances for grape (within the fruit, 

small vine climbing, except fuzzy 

kiwifruit, subgroup 13–07F), peach 

(within the fruit, stone, peach subgroup 

12–12B), and plum (within the fruit, 

stone, plum subgroup 12–12C) are 

harmonized with the Codex MRLs for 

grape, peach, and plum. 

Harmonization with Codex MRLs for 

berries (blackberry and raspberry 3 

ppm), broccoli and Brussels sprouts (0.3 

ppm), dry beans (0.70 ppm), head 

cabbage (0.15 ppm), cauliflower (0.09 

ppm), cherry (0.7 ppm), cucumber (0.5 

ppm), leek (0.15 ppm), lettuce (head and 

leaf 15 ppm), onion bulb (0.07 ppm), 

peanut (0.03 ppm), pome fruits (0.5 

ppm), potato (0.03 ppm), rapeseed (1 

ppm), strawberry (0.4 ppm), sugar beet 

(0.04 ppm), tomato (0.4 ppm), and tree 

nuts (0.04 ppm) is not possible because 

the Codex MRLs are lower than the 

recommended U.S. tolerances. The U.S. 

tolerances cannot be harmonized 

because following the approved label 

directions could result in residues above 

the recommended tolerances. The U.S. 

tolerances for carrot and raisin are 

higher than the Codex MRLs. EPA is not 

harmonized with Codex in order to 

remain harmonized with Canada. 

The U.S. and Codex livestock MRLs 

are not harmonized due to different 

livestock dietary burdens. Fluopyram is 

approved for use on more livestock feed 

stuffs in the United States and thus 

contributes to a greater portion of the 

assessment of the livestock dietary 

burden in the United States than in the 

assessment of livestock dietary burden 

supporting the Codex MRLs. 

Harmonization could lead to tolerance 

exceedances when the pesticide is used 

legally in the United States. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioned-for tolerances differ 

from the tolerances that EPA is 

establishing for sugar beet roots, onion 

bulbs, leafy greens subgroup 4A, crop 

subgroup 6C, fruiting vegetables (8– 

10B), melon subgroup 9A, citrus, 

subgroup 13–07F, raisin, tree nuts, crop 

group 15, herb subgroup 19A, dill seed, 

and subgroup 20A. 

For citrus, crop group 15, fruiting 

vegetables (8–10B), onion bulbs, 

rapeseed subgroup 20A, and tree nuts, 

the Organization for Economic 

Cooperation and Development (OECD) 

statistical calculation procedures 

applied to the field trial residue data 

provided a different value than the 

petitioned-for tolerances. Also, for crop 

group 15 and subgroup 20A, the values 

petitioner requested were based on a 

data set that excluded a field trial (on 

sorghum and canola, respectively) as an 

outlier based on statistical tests. 

However, the trials could not be 

excluded by the Agency since there 

were no abnormal field conditions. 

While the petitioner requested a 

tolerance for crop group 15, except rice 

and sorghum, the Agency has 

determined that a crop group 15 

tolerance, except corn and rice is 

appropriate. This is due to the wide 

variation in residue levels from the 

available data. The minimum residues 

on sweet corn at 0.01 ppm and the 

maximum residues on sorghum 3.2 ppm 

differ by more than 5x; therefore, the 

tolerance level (1.5 ppm) is not 

appropriate to establish a crop group 

tolerance with all the representative 

crops. Rather, based on the available 

data, EPA is establishing tolerances on 

grain, cereal, except rice and corn, 

group 15 at 4.0 ppm; and individual 

tolerance on corn, field, grain at 0.02 

ppm; corn, pop, grain at 0.02 ppm; and 

corn, sweet, kernal plus cob with husks 

removed at 0.01 ppm. 


asabaliauskas on DSK3SPTVN1PROD with RULES
12022 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

Although the petitioner requested two 

separate tolerances for commodities of 

subgroup 4A, the available data support 

a tolerance of 40 ppm for residues of 

fluopyram in/on leafy greens subgroup 

4A and at 20 ppm on leaf petioles 

subgroup 4B. 

The petitioner requested two separate 

tolerances for herb subgroup 19A, fresh 

and herbs, dried. Because subgroup 19A 

covers both dried and fresh herbs, the 

Agency is establishing a tolerance on 

herb subgroup 19A at 40 ppm, based on 

available data. 

The petitioner has requested to 

establish tolerances on vegetables, 

legume; dried beans and peas, except 

soybeans (subgroup 6C) at 0.70 ppm. 

Because only data on dried beans is 

available, there is not sufficient data to 

support establishing a subgroup 

tolerance. Therefore, based on the 

available residue data for dried beans, 

the Agency is establishing an individual 

tolerance of 0.70 ppm on dried beans 

only. EPA is establishing dry bean 

tolerance at 0.70 ppm to harmonize with 

Canada. 

The petitioner had requested to 

establish tolerances on vegetables, 

cucurbit, cucumber/squash subgroup at 

0.30 ppm and fruit, pome at 1.0 ppm. 

Based on available data that reflect the 

proposed use pattern, EPA is 

establishing a tolerance on squash/

cucumber subgroup 9B at 0.60 ppm and 

fruit, pome, group 11–10 at 0.80 ppm. 

For harmonization purposes with 

Canada, tolerances being established for 

sugar beet, melon subgroup 9A, tree 

nuts, and subgroup 13–07F are slightly 

increased above the tolerance levels 

requested for those commodities. 

The requested grape, raisin tolerance 

of 4.0 ppm is being reduced to 3.0 ppm 

based on the highest average field trial 

(HAFT) (0.948 ppm) for grape and 

processing factor of 2.4. 

Because use of fluopyram is limited to 

Region 3 (Florida), the Agency is 

establishing a tolerance with a regional 

registration for inadvertent or indirect 

residues of fluopyram on sugarcane, 

cane (0.08 ppm) when sugarcane is used 

as a rotational crop. 

The requested tolerances for livestock 

commodities were based on some 

livestock feed stuffs that have been 

withdrawn from the list of crops to be 

treated with fluopyram. Based on a 

recalculation of the livestock dietary 

burden, the Agency is establishing 

tolerances for livestock commodities 

that are lower than requested. 

In addition, the Agency has revised 

several commodity terms to reflect the 

current commodity definitions used by 

the Agency and revised several 

tolerance level values to be consistent 

with EPA’s practice of extending 

tolerance values out to two significant 

figures. 

Although the petition requested a 

tolerance for nut tree group 14, the 

Agency is establishing a tolerance for 

nut, tree 14–12 consistent with its stated 

policy of not establishing tolerances for 

pre-existing crop groups. See 77 FR 

50617, 50619 (Aug. 22, 2012). 

Finally, the requests for tolerances 

were withdrawn for the following 

commodities: Crop group 7 at 90.0 ppm; 

crop group 17 at 80.0 ppm; peanut hay 

at 40.0 ppm, soybean forage at 9.0 ppm; 

and soybean hay at 30.0 ppm. A 

separate tolerance for wheat, milled 

byproducts is not needed as it is 

covered by the crop group 15 tolerance. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluopyram in or on 

almond, hulls at 10 ppm; artichoke, 

globe at 4.0 ppm, bean, dry at 0.70 ppm; 

beet, sugar at 0.10 ppm; berry, low 

growing, except cranberry, subgroup 

13–07G at 2.0 ppm; brassica, head and 

stem, subgroup 5A at 4.0 ppm; brassica, 

leafy greens, subgroup 5B at 50 ppm; 

bushberry subgroup 13–07B at 7.0 ppm; 

grain, aspirated grain fractions at 50 

ppm; caneberry subgroup 13–07A at 5.0 

ppm; cereal, forage, fodder and straw, 

group 16 at 20 ppm; cherry subgroup 

12–12A at 2.0 ppm; citrus, oil at 8.0 

ppm; corn, field, grain at 0.02 ppm; 

corn, pop, grain at 0.02 ppm; corn, 

sweet, kernel plus cob with husks 

removed 0.01 ppm; cotton, gin 

byproducts at 30 ppm; cottonseed 

subgroup 20C at 0.80 ppm; dill, seed at 

70 ppm; rapeseed subgroup 20A at 5.0 

ppm; fruit, citrus, group 10–10 at 1.0 

ppm; fruit, pome, group 11–10 at 0.80 

ppm; fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 2.0 

ppm; grape, raisin at 3.0 ppm; grain, 

cereal, group 15, except corn and rice at 

4.0 ppm; grain, herb subgroup 19A at 40 

ppm; hop, dried cones at 60 ppm; leaf 

petioles subgroup 4B at 20 ppm; leafy 

greens subgroup 4A at 40 ppm; melon 

subgroup 9A at 1.0 ppm; nut, tree, group 

14–12 at 0.05 ppm; onion, bulb, 

subgroup 3–07A at 0.40 ppm; onion, 

green, subgroup 3–07B at 15 ppm; pea 

and bean, succulent shelled, subgroup 

6B at 0.20 ppm; peach subgroup 12–12B 

at 1.0 ppm; peanut at 0.20 ppm; potato, 

wet peel at 0.30 ppm; pepper/eggplant 

subgroup 8–10B at 4.0 ppm; plum 

subgroup 12–12C at 0.50 ppm; soybean, 

seed at 0.30 ppm; squash/cucumber 

subgroup 9B at 0.60 ppm; sunflower 

subgroup 20B at 0.70 ppm; tomato 

subgroup 8–10A at 1.0 ppm; vegetable, 

leaves of root and tuber, group 2 at 30 

ppm; vegetable, legume, edible podded, 

subgroup 6A at 4.0 ppm; vegetable, root, 

except sugar beet, subgroup 1B at 0.30 

ppm; and vegetable, tuberous and corm, 

subgroup 1C at 0.10 ppm. 

Tolerances are also established for 

residues of fluopyram and its metabolite 

2-(trifluoromethyl)benzamide, 

expressed in parent equivalents for 

cattle, fat at 0.70 ppm; cattle, meat at 

0.80 ppm; cattle, meat byproducts at 7.5 

ppm; egg at 0.08 ppm; goat, fat at 0.70 

ppm; goat, meat at 0.80 ppm; goat, meat 

byproducts at 7.5 ppm; hog, meat 

byproducts at 0.20 ppm; horse, fat at 

0.70 ppm; horse, meat at 0.80 ppm; 

horse, meat byproducts at 7.5 ppm; milk 

at 0.40 ppm; poultry, fat at 0.04 ppm; 

poultry, meat at 0.04 ppm; poultry, meat 

byproducts at 0.16 ppm; sheep, fat at 

0.70 ppm; sheep, meat at 0.80 ppm; and 

sheep, meat byproducts at 7.5 ppm. 

In addition, the Agency is removing 

tolerances for almond, hull; apple, wet 

pomace; bean, dry; beet, sugar, root; 

canola seed; cotton, gin byproducts; 

cotton, undelinted seed; cherry; grape, 

wine; grain, cereal, except rice, group 

15; grain, cereal, forage, fodder, and 

straw, group 16; nut, tree, group 14; 

peanut; pistachio; potato; soybean 

forage; soybean hay; soybean, seed; 

strawberry; and watermelon because 

they are superseded by other tolerances 

being established in this action. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, 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) or 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.), nor does it 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). 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 12023 

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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

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

VII. 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: March 1, 2016. 

G. Jeffery Herndon, 

Acting 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. Section 180.661 is revised to read 

as follows: 

§ 180.661 Fluopyram; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

Fluopyram, N-[2-[3-chloro-5- 

(trifluoromethyl)-2-pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

fluopyram in or on the commodity. 

Commodity Parts per 

million 

Almond, hulls .............................. 10 

Artichoke, globe .......................... 4.0 

Banana 1 ..................................... 1.0 

Bean, dry .................................... 0.70 

Beet, sugar ................................. 0.10 

Berry, low growing, except cranberry, subgroup 13–07G ......... 2.0 

Brassica, head and stem, subgroup 5A ................................. 4.0 

Brassica, leafy greens, subgroup 

5B ............................................ 50 

Bushberry subgroup 13–07B ...... 7.0 

Caneberry subgroup 13–07A ..... 5.0 

Cherry subgroup 12–12A ........... 2.0 

Citrus, oil ..................................... 8.0 

Corn, field, grain ......................... 0.02 

Corn, pop, grain .......................... 0.02 

Corn, sweet, kernel plus cob 

with husks removed ................ 0.01 

Cotton, gin byproducts ............... 30 

Cottonseed subgroup 20C ......... 0.80 

Dill, seed ..................................... 70 

Fruit, citrus, group 10–10 ........... 1.0 

Fruit, pome, group 11–10 ........... 0.80 

Fruit, small vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F .......................................... 2.0 

Grain, aspirated grain fractions .. 50 

Grain, cereal, forage, fodder and 

straw, group 16 ....................... 20 

Grain, cereal, group 15, except 

corn and rice ........................... 4.0 

Grape, raisin ............................... 3.0 

Herb subgroup 19A .................... 40 

Hop, dried cones ........................ 60 

Leafy greens subgroup 4A ......... 40 

Leafy petioles subgroup 4B ........ 20 

Melon subgroup 9A .................... 1.0 

Nut, tree, group 14–12 ............... 0.05 

Onion, bulb, subgroup 3–07A .... 0.40 

Onion, green, subgroup 3–07B .. 15 

Commodity Parts per 

million 

Pea and bean, succulent 

shelled, subgroup 6B .............. 0.20 

Peach subgroup 12–12B ............ 1.0 

Peanut ........................................ 0.20 

Pepper/eggplant subgroup 8– 

10B .......................................... 4.0 

Plum subgroup 12–12C .............. 0.50 

Potato, wet peel .......................... 0.30 

Rapeseed subgroup 20A ............ 5.0 

Soybean, seed ............................ 0.30 

Squash/cucumber subgroup 9B 0.60 

Sunflower subgroup 20B ............ 0.70 

Tomato subgroup 8–10A ............ 1.0 

Vegetable, leaves of root and 

tuber, group 2 ......................... 30 

Vegetable, legume, edible podded, subgroup 6A ................... 4.0 

Vegetable, root, except sugar 

beet, subgroup 1B .................. 0.30 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.10 

1There are no U.S. registrations. 

(2) Tolerances are established for 

residues of the fungicide fluopyram, N- 

[2-[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates. 

Compliance with the tolerance levels 

specified in the table below is to be 

determined by measuring only the sum 

of fluopyram and its metabolite, 2- 

(trifluoromethyl)benzamide, calculated 

as the stoichiometric equivalent of 

fluopyram, in or on the commodity. 

Commodity Parts per 

million 

Cattle, fat .................................... 0.70 

Cattle, meat ................................ 0.80 

Cattle, meat byproducts ............. 7.5 

Egg ............................................. 0.08 

Goat, fat ...................................... 0.70 

Goat, meat .................................. 0.80 

Goat, meat byproducts ............... 7.5 

Hog, fat ....................................... 0.20 

Hog, meat ................................... 0.02 

Hog, meat byproducts ................ 0.20 

Horse, fat .................................... 0.70 

Horse, meat ................................ 0.80 

Horse, meat byproducts ............. 7.5 

Milk ............................................. 0.40 

Poultry, fat .................................. 0.04 

Poultry, meat .............................. 0.04 

Poultry, meat byproducts ............ 0.20 

Sheep, fat ................................... 0.70 

Sheep, meat ............................... 0.80 

Sheep, meat byproducts ............ 7.5 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration, as defined in § 180.1(1), are 

established for indirect or inadvertent 

residues of fungicide fluopyram, N-[2- 

[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 


asabaliauskas on DSK3SPTVN1PROD with RULES
12024 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

fluopyram in or on the commodity. 

Commodity Parts per 

million 

Sugarcane, cane ........................ 0.08 

(d) Indirect or inadvertent residues. It 

is recommended that tolerances be 

established for indirect or inadvertent 

residues of fungicide fluopyram, N-[2- 

[3-chloro-5-(trifluoromethyl)-2- 

pyridinyl]ethyl]-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only 

fluopyram in or on the commodity. 

Commodity Parts per 

million 

Alfalfa, forage ............................. 0.45 

Alfalfa, hay .................................. 1.1 

Soybean, seed ............................ 0.10 

[FR Doc. 2016–05025 Filed 3–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 405, 410, 411, 414, 425, 

and 495 

[CMS–1631–F2] 

RIN 0938–AS40 

Medicare Program; Revisions to 

Payment Policies Under the Physician 

Fee Schedule and Other Revisions to 

Part B for CY 2016; Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correcting 

amendment. 

SUMMARY: This document corrects 

technical and typographical errors that 

appeared in the final rule with comment 

period published in the November 16, 

2015 Federal Register (80 FR 70886 

through 71386) entitled ‘‘Medicare 

Program; Revisions to Payment Policies 

Under the Physician Fee Schedule and 

Other Revisions to Part B for CY 2016.’’ 

DATES: Effective date: This correcting 

document is effective March 7, 2016. 

Applicability date: The corrections 

indicated in this document are 

applicable beginning January 1, 2016. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Ohrin Wilson (410) 786–8852, or 

Matthew Edgar (410) 786–0698, for 

issues related to physician self-referral 

updates. Jessica Bruton, (410) 786–5991 

for all other issues. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2015–28005 (80 FR 70886 

through 71386), the final rule entitled 

‘‘Medicare Program; Revisions to 

Payment Policies Under the Physician 

Fee Schedule and Other Revisions to 

Part B for CY 2016’’ (hereinafter referred 

to as the CY 2016 PFS final rule with 

comment period), there were a number 

of technical and typographical errors 

that are identified and corrected in 

section IV., the Correction of Errors. The 

effective date for the rule was January 1, 

2016, except for the definition of 

‘‘ownership or investment interest’’ in 

§ 411.362(a), which has an effective date 

of January 1, 2017. These corrections are 

applicable as of January 1, 2016. We 

note that Addenda B and C to the CY 

2016 PFS final rule with comment 

period as corrected by this correcting 

amendment are available on the CMS 

Web site at http://www.cms.gov//

PhysicianFeeSched/. 

II. Summary of Errors 

A. Summary of Errors in the Preamble 

On page 70894, we inadvertently 

omitted a sentence from the first 

comment summary regarding applying 

the same overrides used for the MP RVU 

calculations to the PE calculations. 

On page 70894, we inadvertently 

omitted a clause from the response 

summary regarding the overrides that 

also apply to the MP RVU calculation in 

the development of PE RVUs. 

On page 70898, due to data errors 

made in the ratesetting process, many of 

the values contained in Table 4: 

Calculation of PE RVUs under 

Methodology for Selected Codes, are 

incorrect. 

On page 70953, we inadvertently 

included language regarding the 

application of the equipment utilization 

assumption. 

On page 70971, 

a. Due to a typographical error, the 

work RVU for CPT code 76945 was 

listed incorrectly. As a result, the work 

RVU for CPT code 76948 was also 

inadvertently listed incorrectly. 

b. Due to a typographical error, we 

inadvertently referred to CPT code 

76948 rather than CPT code 76945. 

On page 70992, due to a typographical 

error in Table 13—CY 2016 Actions on 

Codes with CY 2015 Interim Final 

RVUs, the CY 2016 work RVU for CPT 

code 76948 was incorrectly displayed. 

On page 71317, we inadvertently 

included language in our comment 

discussion on the issue regarding 

compensation arrangements. 

On page 71357, 

a. Due to data errors, we incorrectly 

stated the estimated CY 2016 net 

reduction in expenditures. 

b. Due to data errors, we incorrectly 

stated the reduction to the conversion 

factor. 

c. Due to data errors, we incorrectly 

stated the CY 2016 PFS conversion 

factors. As a result, many of the values 

in Table 60—Calculation of the CY 2016 

PFS Conversion Factor, are incorrect. 

d. Due to data errors, we incorrectly 

stated the CY 2016 PFS anesthesia 

conversion factors. As a result, many of 

the values in Table 61—Calculation of 

the CY 2016 PFS Anesthesia Conversion 

Factor, are incorrect. 

On pages 71358 through 71359, due to 

data errors, many of the values in Table 

62—CY 2016 PFS Estimated Impact On 

Total Allowed Charges By Specialty, are 

incorrect. 

On pages 71359 through 71360, due to 

data errors, many of the values in Table 

63— Impact on CY 2016 Payment for 

Selected Procedures, are incorrect. 

On page 71369, 

a. Due to data errors, we incorrectly 

stated the CY 2016 national payment 

amount in the nonfacility setting for 

CPT code 99203. 

b. Due to data errors, we incorrectly 

stated the CY 2016 proposed beneficiary 

coinsurance for CPT code 99203. 

B. Summary of Errors in Regulation Text 

On page 71375 of the CY 2016 PFS 

final rule with comment period, we 

made a typographical error in 

§ 411.357(d)(1)(iv). In this paragraph, we 

inadvertently included the word ‘‘for’’. 

On page 71377 of the CY 2016 PFS 

final rule with comment period, we 

made a typographical error in 

§ 411.357(x)(1)(vi)(A). In this paragraph, 

we inadvertently omitted the word 

‘‘directly’’. 

C. Summary and Correction of Errors in 

the Addenda on the CMS Web site 

Due to the errors identified and 

summarized in section II.A and B of this 

document, we are correcting errors in 

the work, PE or MP RVUs (or 

combinations of these RVUs) in 

Addendum B: CY 2016 Relative Value 

Units (RVUs) And Related Information 

Used In Determining Final Medicare 

Payments and Addendum C: CY 2016 


asabaliauskas on DSK3SPTVN1PROD with RULES