[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Rules and Regulations]
[Page 76048]
[FR Doc No: 2011-31136]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2011-0017; EPA-R05-OAR-2011-0106; FRL-9499-7]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio and Indiana; Redesignation of the Ohio and Indiana Portions
Cincinnati-Hamilton Area to Attainment of the 1997 Annual Standard for
Fine Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: Due to the receipt of an adverse comment, EPA is withdrawing
the October 19, 2011 (76 FR 64825), direct final rule approving Ohio's
and Indiana's requests to redesignate their respective portions of the
Cincinnati-Hamilton nonattainment area (for Ohio: Butler, Clermont,
Hamilton, and Warren Counties, Ohio; for Indiana: a portion of Dearborn
County) to attainment for the 1997 annual National Ambient Air Quality
Standard (NAAQS or standard) for fine particulate matter
(PM2.5). In the direct final rule, EPA stated that if
adverse comments were received by November 18, 2011, the rule would be
withdrawn and not take effect. On October 19, 2011, EPA received a
comment. EPA interprets this comment as adverse and, therefore, EPA is
withdrawing the direct final rule. EPA will address the comment in a
subsequent final action based upon the proposed rulemaking action, also
published on October 19, 2011 (76 FR 64880). EPA will not institute a
second comment period on this action.

DATES: The direct final rule published at 76 FR 64825 on October 19,
2011, is withdrawn as of December 6, 2011.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: November 23, 2011.
Susan Hedman,
Regional Administrator, Region 5.

PART 52--[AMENDED]

0
Accordingly, the amendments to 40 CFR 52.776 and 40 CFR 52.1880
published in the Federal Register on October 19, 2011 (76 FR 64825) on
page 64837 are withdrawn as of December 6, 2011.

PART 81--[AMENDED]

0
Accordingly, the amendments to 40 CFR 81.315 and 40 CFR 81.336
published in the Federal Register on October 19, 2011 (76 FR 64825) on
pages 64837-64838 are withdrawn as of December 6, 2011.

[FR Doc. 2011-31136 Filed 12-5-11; 8:45 am]
BILLING CODE 6560-50-P


Page 1 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 8, 2002 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Inert Ingredient Focus Group FROM: Peter Caulkins, Associate Director Registration Division TO: Jack Housenger, Associate Director Special Review and Reregistration Division The purpose of this document is to provide the Special Review and Reregistration Division ( SRRD) with an update on tolerance reassessment decisions.

Please find attached the April 8, 2002, memo which details the recommendations of the Inert Ingredient Focus Group and the rationale for the 25 tolerance reassessments of the plant and animal by products group.

If you have any comments or questions, please contact Kathryn Boyle at 703 305 6304.

Attachment Page 2 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 8, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: January 8, 2002 Meeting of the IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert ingredients associated with the " plant and animal byproducts" grouping. Page 3 of 15 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for the Plant and Animal By Product Grouping Chemical Name: Several, see below.

Category: Plant and Animal Byproducts CAS Reg. No.: Several, see below.

Introduction:

The meeting of the Inert Ingredient Focus Group ( IIFG) to discuss the " plant and animal byproducts" grouping was held on January 8, 2002. Focus Group members in attendance were: Kathryn Boyle ( RD), Kerry Leifer ( RD), Robert Forrest ( RD), Jeanie McAndrews ( RD), Steve Schaible ( RD), Harry Craven ( EFED), Diana Locke ( HED), Michael Doherty ( HED), Melba Morrow ( AD), Tom Brennan ( HED), Mark Perry ( SRRD), and Larry Schnaubelt ( SRRD). The presenters were: Mark Perry and Larry Schnaubelt ( SRRD). The Executive Secretaries for the meeting were Jeanie McAndrews and Steve Schaible ( RD). Also in attendance at the meeting were Marianne Lewis, Judy Loranger, and Ben Gregg, all of SRRD.

At this meeting, the available information on twenty five different plant and animal byproduct substances was discussed to determine if sufficient information was available to make tolerance reassessment decisions on the various materials and to make the determination as to whether the various materials should be classified as List 4A or List 4B substances. The 25 substances discussed do not represent the universe of plant and animal byproduct inert ingredients, but instead are a subset which have existing tolerance exemptions listed in 40 CFR Part 180 and can therefore be counted towards tolerance reassessment. The available information consisted of information retrieved from various websites such as TOXNET, FirstGov, and NTP, as specified in the methodology for lower toxicity chemicals. General Internet searches on the substance names and their toxicity were also used.

Information handed out at this meeting included: ( 1) a short summary dividing the substances into 25 groups for discussion purposes; ( 2) an animal toxicity data summary for linseed oil; and ( 3) a summary of developmental, reproductive, and chronic toxicity studies for gum arabic. Page 4 of 15 For purposes of evaluation in accordance with the newly developed inert ingredient methodology, many inert substances undergoing tolerance or tolerance exemption reassessment have been placed into groups based on possible common characteristics or potential similarity based on the fact that they are derived from materials that may generally be considered similar to each other. The term " plant and animal byproducts" is used by the Agency to describe a group of chemical substances that are derived from plant and animal sources. Some of the substances in this group, such as walnut shells or coconut shells, are only minimally processed from the direct plant material. This is usually a change only in the physical form of the substance, and is accomplished by activities such as grinding or chopping. Some, however, require more significant processing in order to generate the endproduct such as lecithin from oil, or glue from animal collagen. The plant and animal byproduct substances considered by the IIFG are used for a variety of purposes as inert ingredients. In pesticide products, these substances are used as surfactants, thickeners, carriers, emulsifiers, adhesive, dispersing agents, and many other uses.

Ecological Effects:

The substances in this group are derived from naturally occurring plant and animal materials and no adverse ecological effects were reported in the available literature. However, it was considered that three compounds ( guar gum, sodium alginate, and soap bark, which act as a foaming agent, foam stabilizer, and stabilizer/ thickener, respectively) could have ecological impacts. After consultation with OPPT and using Structural Activity Relationships ( SARs), the IIFG believes that these compounds are of low concern for ecotoxicity. The IIFG believes that no significant adverse ecological effects are anticipated from exposure to any of these substances.

Discussion A brief summation of the available information was given for each of the chemical substances. If available, the CAS Registry Number is given in parenthesis. Comments made during the discussion or after the meeting that pertained only to a specific group are in italics below. Current List classification is also in italics.

1. Animal Glue:

S manufactured from collagen derived from animal hides S glue may be slightly allergenic to individuals with sensitivity to certain proteins; allergic reactions are reversible.

Animal glue is a protein, and alien proteins may cause allergic reactions. However, these contact ( dermally induced) reactions are reversible and are generally not life threatening.

2. Coconut Shells, Douglas Fir Bark ( List 4A), Walnut Shells ( List 4A):

S coconut shells used to make activated charcoal ( carbon)

S Douglas fir bark commonly used as a landscaping mulch These compounds are minimally processed from their natural forms, in most cases being only Page 5 of 15 ground or shredded more finely. As these substances are in effect naturally occurring, it is not expected that pesticidal use of these substances will result in adverse exposure to humans or the environment.

3. Coffee Grounds: ( CAS: 68916 18 7) ( List 4A)

As the extract from ground coffee beans is widely consumed, it is unlikely that use of coffee grounds as an inert ingredient in a pesticide formulation will result in unacceptable risk to humans.

3. Licorice Root: ( CAS: 68916 18 7) ( List 3 " licorice extract")

S contains glycyrrhizinic acid which exhibits actions similar to natural mineralocorticoids of the adrenal cortex S licorice root is one of the most commonly used herbs in the world; licorice extracts are used as a food additive flavoring agent in mouthwash, root beer, chewing gum, candy, ice cream, baked goods, and as a pharmaceutical additive S licorice and licorice derivatives are on FDA's list of direct food substances affirmed as generally recognized as safe ( GRAS) ( 21 CFR 184.1408); maximum levels permitted in food are specified S according to ToxNet, licorice extract is characterized as being " slightly toxic" by the oral route; toxicity endpoints are as follows: LD50 rat oral = 14,200 mg/ kg, LD50 rat inter peritoneal = 1420 mg/ kg, LD50 rat subcutaneous = 4200 mg/ kg, LD50 mouse inter peritoneal = 1500 mg/ kg.

S cases of poisonings are mostly chronic in nature, not acute; chronic exposure longer than 4 6 weeks may cause hypokalemia ( low potassium levels), hypernatremia ( high sodium levels), hypertension, myopathy, and cardiac problems S " licorice extract" ( CAS: 97676 23 8) is classified as List 3; this CAS Number actually refers to " oils, licorice"

S no serious adverse reactions have been published about licorice root; single chemical extracts have caused serious adverse reactions on occasion when used in medicine or candy, but the whole root does not cause these serious reactions.

Exposure to licorice root from use as an inert ingredient in pesticidal products will be well below those levels of licorice extract already considered safe by other federal agencies.

4. Sperm Oil: ( CAS: 8002 24 2)

S liquid wax derived from sperm whale blubber.

S used as a lubricant for watches and other delicate instruments, in leather treatment products and soap making S sperm oil is a food additive permitted for direct application to food for human consumption ( 21 CFR 172.210) as well as an indirect food additive in adhesives, paper and paperboard components, and polymers ( 21 CFR Parts 175, 176, and 177)

Barring incidence data on adverse effects after exposure to sperm oil, this chemical should be added to List 4A. According to Jerome Blondell ( HED) and Norman Spurling, there are no records for sperm oil in the Incidence Data System database. Page 6 of 15 5. Wood Flour ( Wood Dust):.

S according to health and safety guidelines put out by the Occupational Safety and Health Administration ( OSHA), acute exposure to red cedar dust may result in irritation of the eyes, skin and respiratory tract. Chronic occupational exposure may result in dermatitis reactions, asthma, pneumonitis, bronchitis and nasal cancer.

S it is believed that toxicity is dependant on wood type, with nasal cancer and more severe respiratory effects being associated with exposure to dust from hardwoods such as beech, walnut, and oak S OSHA permissible exposure limit ( PEL) for red cedar dust is 15 mg/ m3 for total dust, and 5 mg/ m3 for respirable fractions ( nuisance dust)

S National Institute of Occupational Safety and Health ( NIOSH) recommended exposure limit ( REL) is 1 mg/ m3 ( as a time weighted average ( TWA) for up to 10 hour workday and a 40 hour work week), based on pulmonary dysfunction and other respiratory effects Exposure to wood dust or wood flour in a formulated pesticide product is likely to be well below the levels which result in chronic effects from daily occupational inhalation exposure to raw wood dust.

6. Camphor: ( CAS: 76 22 2) ( List 3)

S derived from the camphor tree, Cinnamomum camphora S Japanese white camphor oil ( CAS: 8008 51 3) and d camphor ( CAS: 464 49 3) permitted as a food additive permitted for direct addition to food for human consumption ( 21 CFR 172.510 and 172.515, respectively)

S reported uses include as an ingredient in non alcoholic beverages, baked goods, condiments, and in over the counter medications to relieve muscle aches, nasal congestion and cold sores; also used in the manufacture of plastics, lacquers/ varnishes, pyrotechnics and embalming fluid S currently present in approximately 950 non pesticidal products S ingredient in insecticides and moth and mildew preventatives S OSHA PEL: TWA 2 mg/ m3 S NIOSH REL: TWA 2 mg/ m3 S tolerance exemption specifies that camphor not compose more than 5% ( w/ w) of pesticide formulation.

Camphor is rapidly absorbed through the skin, respiratory and GI tracts. Camphor readily crosses the placenta and cases of fetal death after ingestion by mother have been reported. Ingestion of 0.7 to 1.0 g has proven fatal in children. Human fatalities have also been reported as a result of dermal and respiratory exposure. A Poisindex review of camphor ingestions ( estimated to exceed 2 mg/ kg) showed that 90% of patients remained asymptomatic, 4% developed minor symptoms and 6% developed major symptoms. Humans are considered more susceptible to the effects of camphor than other species. Camphor is irritating to skin, upper respiratory tract, and the gastrointestinal tract. It is toxic and reacts rapidly; exposure may result in dizziness, tension, hallucinations and mental confusion. Chronic camphor poisoning is uncommon due to its high toxicity and rapid action.

A developmental toxicity study in rabbits ( with d camphor) showed no fetal or maternal toxicity at 400 mg/ kg/ day, yet an associated range finding study found 60% maternal mortality at 500 Page 7 of 15 mg/ kg/ day. Another developmental toxicity study in rats ( d camphor) demonstrated that camphor does not affect fetal growth, viability or morphological development at doses which caused only minor maternal toxicity ( 800 mg/ kg/ day).

Camphor will be further evaluated using a more formal ( Tier 2) assessment process.

7. Mixed Phytosterols ( plant sterols):

S phytosterols ( e. g., campesterol, sitosterol, and stigmasterol) are ubiquitous compounds in plants similar to animal sterols but having an extra methyl or ethyl substituent in the side chain; plant sterols are found in plant cell walls and in plant oils; the content of sterols in plant oils range from hundreds of mg per 100 g to less than 10 mg S the tolerance exemption expression in 40 CFR180.1001( d) is for use in pesticide products of " mixed phytosterols ( consisting of campesterol, sitosterol, and stigmasterol, with minor amounts of associated plant sterols) derived from edible vegetable oils" as a surfactant S most information describes potential benefits derived from dietary consumption mixed phytosterols and phytosterol esters lower total blood cholesterol and LDL C; it is believed that phytosterols interfere with dietary and endogenous ( biliary) cholesterol absorption 8. Soapbark ( Quillaja Saponin): ( CAS: 1393 03 9) ( List 3)

S derived from soapbark tree S contains saponins which are natural detergents/ surfactants that have been used to make soap and used as a foaming agent in certain beverages ( like root beer)

S permitted as a food additive permitted for direct addition to food for human consumption ( 21 CFR 172.510)

S liquid solutions and dusts reported to cause reversible eye irritation and respiratory sensitization S no adverse effect on death rate or incidence of histopathological findings ( including tumors) were observed in mice ( both sexes) fed quillaja extract for 84 weeks; at high dose there was decreased body weight gain and differences in hematological examinations and in some absolute and relative organ weights of both sexes Soap bark may be associated with formulations of fire retardants which may have ecological impacts. After consultation with OPPT and using Structural Activity Relationships ( SARs) the IIFG believes that these compounds are of low concern for ecotoxicity. Therefore, the IIFG believes that no significant adverse ecological effects are anticipated from exposure to soapbark.

9. Wool Fat ( anhydrous lanolin): ( CAS: 8006 54 0) ( List 4A lanolin)

S lanolin is a greasy, yellow substance extracted from sheep wool; a mixture of cholesterol and the esters of several fatty acids S anhydrous lanolin refers to lanolin which contains less than 0.25% water S used as an ointment base in cosmetics and pharmaceuticals, as a lubricant, and in finishing and preserving leather; also a constituent of some varnishes and paint S lanolin is regulated by FDA as a food additive permitted for direct addition to food for human consumption ( 21 CFR 172.615), as well as an indirect food additive ( 21 CFR Parts 175 178) Page 8 of 15 S dermal sensitivity to lanolin has been reported, with a high incidence of lanolin allergy amongst eczema patients; ToxNet reports that lanolin should not be used in ointments intended for use by sensitive individuals S lanolin is considered practically non toxic by the oral route, according to ToxNet.

S pesticidal uses of lanolin as an active ingredient were canceled in 1998 as there were no active product registrations containing the substance S " lanolin" ( CAS: 8020 84 6) is classified as List 4A The focus group believes that this substance is not an allergen, but that there was individual sensitivity to the substance.

10. Castor oil: ( CAS: 8001 79 4) ( List 4B)

S a natural oil obtained from the seed of the castor bean; after the hulls are removed the seeds are cold pressed S medicinal castor oil is prepared from the yield of the first pressing; this is used as a purgative and laxative; oil from the second pressing is used as a lubricant for machinery, as a softening agent in making artificial leather, in the dressing of genuine leather, in brake fluids, and in paints and plastic materials S FDA direct food additive permitted in food for human consumption, as a releasing and antisticking agent, not to exceed 500 ppm in hard candy ( 21 CFR 172.876); as a natural flavoring substance or substance used in conjunction with flavors ( 172.510); and as an indirect food additive ( numerous citations in 21 CFR Parts 175 178); also used in cosmetics and pharmaceuticals S EPA FIFRA 25b active ingredient S Irritating to rabbit skin; slightly toxic by oral route. Another source considers castor oil to be " moderately toxic" by ingestion. Contraindicated for pregnant women; overdose has caused stillbirth and kidney damage.

As referenced on National Toxicology Program's ( NTP) web site, animal feeding studies ( up to 10% in diet for 13 wks.) in rats and mice resulted in no significant adverse effects. Genotoxicity studies were negative for mutation induction in Salmonella typhimurium, for induction of sister chromatid exchanges and for induction of micro nuclei in mice peripheral blood erythrocytes.

Dietary exposure to residues of castor oil from pesticidal use as an inert ingredient will not approach levels regulated by FDA as a direct or indirect food additive or ingredient in cosmetics.

11. Hydrogenated Castor Oil: ( CAS: 8001 78 3) ( List 3)

S manufactured by hydrogenation of castor oil in the presence of nickel catalyst with pressure and temperature; a hard, brittle wax that is extremely insoluble and is well suited for products needing resistance to water, oils, petroleum, and petroleum derivatives S mainly used in manufacturing greases, but also used in paper coatings for food packaging The tolerance exemption in 40 CFR 180.1036 for hydrogenated castor oil reads as follows: Page 9 of 15 " The adhesive hydrogenated castor oil is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cottonseed when used as an inert adhesive for formulations of the attractant gossyplure to disrupt the mating of the pink bollworm."

12. Boiled Linseed Oil: ( CAS: 8001 26 1) ( List 4A linseed oil)

S an amber colored, fatty oil extracted from the cotyledons and inner coats of the linseed, the seed of the flax plant ( Linum usitatissimum); also known as flaxseed oil S raw oil is pale in color and practically odorless and tasteless; boiled oil is darker and has a bitter taste and unpleasant odor S used as a drying agent in paints, varnishes, adhesives, inks and resins S linseed oil ( not boiled) is an EPA FIFRA 25b active ingredient S linseed oil ( not boiled) is an FDA prior sanctioned food ingredient; " substances classified as drying oils, when migrating from food packaging material ( as components of finished resins) shall include... linseed oil" ( 21 CFR 181.26)

S according to ToxNet, boiled linseed oil should not be taken internally, due to the addition of lead and other toxic element; the boiled oil may cause skin, eye and respiratory tract irritation through the inhalation route. Consumption of boiled linseed oil is contraindicated since lead, manganese and/ or cobalt is often added S rats fed boiled linseed oil during lactation and gestation had most offspring die within 3 days of birth: 6 month old Wistar rats were fed boiled linseed oil during gestation and lactation ( compared to a control group fed fresh linseed oil or peanut oil); mortality in the young was higher than normal, it was assumed cyclic monomers detected in the liver fatty acids were responsible for toxicity in the boiled oil S the fresh oil does not have the toxicity concerns that are associated with the boiled oil The tolerance exemption in 40 CFR 180.1056 for boiled linseed oil reads as follows:

" Boiled linseed oil ( containing no more than 0.33 percent manganese naphthenate and no more than 0.33 percent cobalt naphthenate) is exempt from the requirement of a tolerance when used as a coating agent for S ethyl hexahydro 1H azepine 1 carbothioate. No more than 15 percent of the pesticide formulation may consist of ` boiled linseed oil.' This exemption is limited to use on rice before edible parts form."

13. Carrageenan: ( CAS: 9000 07 1) ( List 4A)

S derived from red algae S used as a thickener/ stabilizer in foods such as chocolate, milk, ice cream, pudding, yogurt, frostings and cream soups S FDA direct food additive ( 21 CFR 172.620) and a substance generally recognized as safe by FDA ( 21 CFR 182.7255)

S natural carrageenan, which has a molecular weight between 100,000 and 1,000,000 can be chemically altered to form degraded carrageenan; degraded carrageenan has a molecular weight between 20,000 and 30,000, and has demonstrated significantly higher toxicity in animal studies, including malignancies in the gastrointestinal tract; degradation may occur in the human body Page 10 of 15 S considered to be a " water absorbing polymer"

S algin gum ( CAS: 9049 05 2), or calcium carrageenan, is included on List 3 Carrageenan will be further evaluated using a more formal ( Tier 2) assessment process.

14. Dextrin: ( CAS: 9004 53 9) ( List 4A), Corn Dextrin S natural polymer used clinically as a peritoneal dialysis solution and as a controlled drug delivery formulation; also used in distilleries, breweries, and the manufacture of cotton goods, rayon, paper products, adhesives, explosives and steel S acute toxicity includes skin irritation, as well as inhalation and ingestion hazard ( large amounts may cause gastro intestinal upset). Another source reported no adverse health effects expected from inhalation or skin contact however, dust may cause eye irritation ( mechanical). Negative in a series of 10 mutagenicity studies ( 1992) which tested " indigestible dextrin".

S direct food additive affirmed as GRAS ( 21 CFR 184.1277)

15. Furcelleran: ( CAS: 9000 21 9)

S extracted from Furcellaria fastigiata ( red seaweed) and used as an emulsifier, stabilizer, and thickener in foods S FDA direct food additive ( 21 CFR 172.655)

S a potential " water absorbing polymer"

Furcelleran will be further evaluated using a more formal ( Tier 2) assessment process due to its relationship to carrageenan.

16. Guar Gum: ( CAS: 9000 30 0) ( List 4A)

S used as a surfactant and related adjuvant of surfactant; also used as a stabilizer/ thickener in foods, as a binding and disintegrating agent in tablets, and in suspensions, emulsions, lotions, creams, and toothpaste S a direct food additive affirmed as GRAS by FDA, with maximum permitted usage levels in foods ( 21 CFR 184.1339)

S acute toxicity: LD 50 ( oral) rat  6770 mg/ kg, mouse  8100 mg/ kg, rabbit  7000 mg/ kg, hamster  6000 mg/ kg S guar dust may cause respiratory tract irritation and sensitization; and that some individuals may develop a respiratory allergic response, or persons with a history of respiratory allergies may have those conditions aggravated, by exposure to guar dust. Negative in a series of 15 mutagenicity studies ( 1992), as well as four 1982 studies, and one pre 1980 study. Negative in rat ( F344) and mouse ( B6C3F 1 ) in a National Cancer Institute ( NCI) carcinogenesis bioassay S considered to be a " water absorbing polymer"

S FDA has reportedly banned the use of guar gum as an active ingredient in drugs. Because this complex carbohydrate swells when wet it had been used in weight loss products to produce a feeling of fullness. One brand resulted in hospitalization of 10 patients and one death from a blood clot after surgery to remove a throat blockage. Guar gum can cause diarrhea, Page 11 of 15 vomiting, bloating, and intestinal blockages.

17. Gum Arabic ( Acacia): ( CAS: 9000 01 5) ( List 4A)

S A neutral, or slightly acidic, salt of a complex polysaccharide; derived from acacia tree sap S used in pharmaceuticals, adhesives, inks, textile printing, cosmetics, and as a thickening agent and colloidal in stabilizer in confectionary and food products; also used extensively in flavor emulsions S a direct food additive affirmed as GRAS by FDA ( 21 CFR 184.1330)

S gum arabic is considered to have low oral toxicity with LD50 values reported as follows: oral  > 16 g/ kg  rat; > 16 g/ kg  mouse; 8 g/ kg  rabbit; and > 18 g/ kg  hamster. Estimates of the probable oral lethal dose for humans are > 15,000 mg/ kg S gum arabic has been shown to be a severe allergen in the workplace and has led to skin lesions and sever asthmatic attacks in humans upon exposure to the dust S a 1971 study of 37 German printing workers exposed to gum arabic mist reported allergic reactions [" Printer's Asthma"], as well as well defined radiological findings in the lungs, with occasional chronic bronchitis and pulmonary congestion; hypersensitivity reactions upon dermal exposure to the dust have also been observed S two MSDS's reported eye irritation, one as severe with redness and pain S a potential " water absorbing polymer"

In a subchronic 13 week oral mouse study no compound related effects were observed. In a 13 week oral rat study no compound related effects were observed except for a reduction in feed consumption at the two highest dose in males and all doses in females, as compared with the control animals. The author reported NOAELs of 5,200 mg/ kg/ day and 13,800 mg/ kg/ day, respectively, for male and female rats. The date of this study was reported as 1982.

In an NTP cancer study, there were no statistically significant differences obtained from oral administration of gum arabic when control rates were compared to those observed in treated groups.

The IIFG believes that while there are no concerns for exposure via the oral route, there could be a contact or a mist problem for occupational exposure, based on the presented information.

18. Lecithin: ( CAS: 8002 43 5) ( List 4A)

S a naturally occurring mixture of the phosphatides of choline, ethanolamine, and inositol; isolated as a gum following hydration of solvent extracted soy, safflower, or corn oils.

S widely used in food and industrial applications; affirmed by FDA as GRAS, and used in foods with no limitations other than current good manufacturing practice ( 21 CFR 184.1400)

S in many products, lecithin is derived from soybean S acute toxicity: may cause transient eye irritation. Also, a 2 day study of mice exposed to aerosolized lecithin reported lungs showing focal endothelial cell swelling and interstitial edema Many products containing lecithin are derived from soy. While soybeans are considered to be allergens, the information available to the Agency indicates that the allergen invoking compound Page 12 of 15 is not carried over in the extraction process that produces highly refined soybean oil. Therefore there are no allergen concerns associated with lecithin even though it is processed from soybeans. Studies support that most soy allergic individuals can safely eat products containing soy lecithin without experiencing any allergic reaction.

Tolerance reassessment and list classification decisions will also apply to " lecithins, soya" ( CAS: 8030 76 0).

19. Sodium Alginate: ( CAS: 9005 38 3)

S the sodium salt of alginic acid; produced from brown algae ( Phaeophyceae) by processing to form alginic acid, then reacted with sodium hydroxide S a combustible, colorless or yellowish granular or powdery solid; insoluble in alcohol and ether; forms a viscous colloid in water S affirmed as GRAS by FDA, with maximum permitted usage levels in foods ( 21 CFR 184.1724)

S used as a foam stabilizer in brewing, a thickener and suspending agent in soft drinks, a binding agent in pharmaceutical tablets, and as a stabilizer in numerous food items S other than minor irritation of eyes and skin in some individuals, no other health effects are known to exist S according to ToxNet, practically non toxic S considered to be a " water absorbing polymer"

20. Xanthan Gum: ( CAS: 11138 66 2) ( List 4A)

S a water soluble, polysaccharide gum derived from Xanthomonas campestris; molecular weight between five and ten million S used in salad dressings and other products, and as a carrier for controlled release drugs S FDA direct food additive ( 21 CFR 172.695)

S a probable " water absorbing polymer", based on similar properties to the other gums in this group 21. Locust Bean Gum: ( CAS: 9000 40 2) ( List 4B)

S also known as carob gum; derived from the carob seed S affirmed GRAS by FDA ( 21 CFR 184.1343)

S used as a stabilizer, thickener, and binder in foods and cosmetics; a pharmaceutic agent; and in paints, textiles and paper manufacturing S acute oral LD50 values were reported as follows: 13 gm/ kg in rats and mice; 9100 mg/ kg in rabbits; and 10 gm/ kg in hamsters. When heated to decomposition this compound emits acrid smoke and fumes. Reported negative for both sexes of rats and mice in a NTP Carcinogenesis Bioassay. No further toxicity/ hazard information was reported.

S considered to be a " water absorbing polymer"

Discussion Page 13 of 15 Tolerance reassessment decisions for camphor, carrageenan, and furcelleran have been deferred until these substances can be further evaluated. For the remaining substances, there are no concerns for ecotoxicity, or for most dietary or dermal human exposures. Tolerance exemptions can be reassessed for these 25 substances.

While there is the potential for adverse effects to wood flour or wood dust from the inhalation route, individuals are not likely to be exposed at the levels described by OSHA from pesticidal application of products containing wood dust or wood flour as an inert ingredient. OSHA PELs reflect full time jobs, that may lead to daily exposures ( often indoors) over the course of many years; it is likely that these worker activities will create the possibility of respirable sized particles as a result of routine operations. By contrast, mixing/ loading and applying granular or dust pesticide products that have these same wood dust will not have the same level or types of exposures. The first major difference is the time and duration of exposure. For most cases the applicators will not be exposed on a daily basis. In fact, it is much more likely that pesticide handlers, both professional and homeowners, will only have short term exposures ( from 1day/ month to 1day/ year). Additionally, the exposure to the substance as an inert ingredient is likely to be significantly less than levels experienced through occupational exposure.

Several of the plant products used as thickeners have been identified as being water absorbing polymers. This term refers to substances which are able to absorb their weight in water, such as guar gum, sodium alginate, and locust bean gum. Other related substances such as xanthan gum and gum arabic are also likely to have this property based on similar characteristics. These chemicals have been identified as posing moderate concern for human health through the inhalation route if the particle size is sufficiently small to be inhaled into deep lungs (< 10 microns), and if the substance is sufficiently present in the formulation. However, in their use as thickeners in pesticide formulations, they will have already absorbed water and " swelled" to a larger particle size, and will therefore not be of toxicological concern through an inhalation route.

The CAS Registry Number on List 3 for " licorice extract" is 97676 23 8. The CAS Number for " licorice extract" referenced in both ToxNet and by FDA is 68916 18 7. Using the National Institutes of Health, National Library of Medicine's, ChemIDplus Locator webpage, the CAS Number 97676 23 8 refers to the term " licorice oils" and the proper CAS Number for licorice extract is 68916 18 7. Confusion around these terms will be cleared up by expanding the List classification term to include licorice and its derivatives.

Currently, boiled linseed oil is not included on any of the inert ingredient Lists, but has specific tolerance exemption language included in 180.1056; " linseed oil" ( presumably unboiled) is included in List 4A. It appears that the CAS number is the same regardless of whether the substance is boiled or unboiled.

IIFG Determinations By consensus there were no objections to the following: Page 14 of 15 All existing tolerance exemptions for the plant and animal byproduct substances listed below can be reassessed. In 40 CFR 180.1001( c): animal glue; coconut shells; coffee grounds; corn dextrin; dextrin; guar gum; gum arabic ( acacia); lecithin; licorice root; sodium alginate; sperm oil; walnut shells; wood flour; and xanthan gum. In 40 CFR 180.1001( d): Douglas fir bark, ground; locust bean gum; mixed phytosterols ( consisting of campesterol, sitosterol, and stigmasterol, with minor amounts of plant sterols) derived from edible vegetable oils; soapbark ( quillaja); and wool fat ( anhydrous lanolin). In 180.1001( e): castor oil, U. S. P.; dextrin; sodium alginate; and xanthan gum. In 180.1036 and 180.1056, hydrogenated castor oil and boiled linseed oil, respectively.

Terms to be expanded or consolidated as part of the tolerance reassessment decision are as follows:

1. " Wool fat ( anhydrous lanolin)" in 180.1001( d) shall become " lanolin ( including anhydrous lanolin)"

2. " Dextrin" and " corn dextrin" in 180.1001( c) ( both terms) and 180.1001( e) ( dextrin only) will be combined into the term " dextrin ( including corn dextrin)" and listed in both paragraphs.

3. The tolerance reassessment decision for " lecithin" will also apply to " lecithins, soya" and a tolerance exemption for this substance can be established.

By consensus the following List classifications have been determined:

1. Animal glue: Add to List 4A; contact allergenic reactions are likely to be reversible and the exposure levels and durations likely from use as an inert ingredient in pesticidal formulations do not justify classifying this substance as List 4B.

2. Coconut shells, walnut shells, and Douglas fir bark: List 4A based on the fact that these substances are naturally occurring and processing from their natural form is minimal for their use as inert ingredients.

3. Coffee grounds: List 4A, no concern expected to humans or the environment.

4. Licorice root: Reclassify " licorice extract" from List 3 to List 4B, and change the List classification term to " Licorice and licorice derivatives" such that licorice root, licorice oils, and licorice extract are all reflected. CAS numbers for both licorice extract and licorice oils should be listed. Licorice is widely used in foods and pharmaceuticals; toxicity data for licorice extract suggests some chronic effects at high doses ( doses not likely to be experienced through inert ingredient use in pesticide formulations).

5. Sperm oil: Classify as List 4A; derived from whale blubber, no incidence data exist in OPP's Incident Data System database for this substance.

6. Wood flour: Classify as List 4A; literature suggests potential chronic exposure concerns for wood dust from inhalation route in occupational setting. These exposure durations and levels Page 15 of 15 will not be realized from use of wood dust in a pesticide formulated product.

7. Mixed phytosterols: Classify as List 4A based on the fact that no concerns were identified.

8. Soapbark ( Quillaja Saponin): Reclassify from List 3 to List 4A; based on SAR, low concern for ecotoxicity, no concerns for human health.

9. Wool fat ( anhydrous lanolin): Currently the term " lanolin" is included on List 4A it should remain on list 4A but the term should be expanded to " lanolin ( including anhydrous lanolin)" and list both CAS numbers. There is no toxicologically significant difference between the two substances.

10. Castor oil: Reclassify from List 4B to List 4A.

11. Hydrogenated castor oil: Reclassify from List 3 to List 4B.

12. Boiled linseed oil: " Linseed oil, boiled" should be classified as List 4B. The existing " linseed oil" term in List 4A should remain on List 4A but be changed to specify " unboiled".

13. Dextrin and corn dextrin: Currently only dextrin in included in List 4A. Both should be reflected on List 4A under the term " dextrin ( including corn dextrin)".

14. Guar gum: Keep on List 4A.

15. Gum arabic ( Acacia): Reclassify from List 4A to List 4B, based on contact exposure concerns and occupational concerns with gum arabic mist.

16. Lecithin: Keep at List 4A; the pesticidal use of this substance is not expected to result in exposures near that from existing use of lecithin as a dietary supplement. " Lecithins, soya" ( CAS: 8030 76 0) should be added to List 4A.

17. Sodium Alginate: Add to List 4A; while this substance may be applied to water through use in fire retardant products, SAR analysis suggests that no significant adverse ecological effects are anticipated from exposure to this substance.

18. Xanthan gum: Keep on List 4A.

19. Locust Bean Gum: This substance is currently on List 4B, yet is added to all types of food. The group recommended that this compound be moved to List 4A.


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Rules and Regulations]
[Pages 13227-13230]
[FR Doc No: 2017-04781]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2016-0361; FRL-9959-10-Region 4]

Air Plan Approval and Designation of Areas; KY; Redesignation of
the Campbell County, 2010 1-Hour SO2 Nonattainment Area to
Attainment

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is approving two
separate but related submissions (one of which includes multiple
components) provided by the Commonwealth of Kentucky, through the
Kentucky Division of Air Quality (KDAQ), in relation to attainment of
the 2010 Sulfur Dioxide (SO2) national ambient air quality
standards (NAAQS) for the Kentucky portion of the Campbell-Clermont,
Kentucky-Ohio 2010 1-hour SO2 nonattainment area (hereafter
referred to as the ``Campbell-Clermont, KY-OH Area'' or ``Area''). On
March 31, 2015, KDAQ submitted a request for EPA to determine that the
Campbell-Clermont, KY-OH Area attained the 2010 1-hour SO2
NAAQS. Subsequently, on February 22, 2016, KDAQ submitted a request for
EPA to redesignate the Campbell County portion of Kentucky that is
within the Campbell-Clermont, KY-OH Area to attainment for the 2010 1-
hour SO2 NAAQS, and to approve a State Implementation Plan
(SIP) revision containing a maintenance plan, base year inventory, and
reasonably available control measures (RACM) determination for the
Kentucky portion of the Area. EPA is approving the Commonwealth's RACM
determination; the base year emissions inventory for the Kentucky
portion of the Area; the Commonwealth's request for a clean data
determination; and the Commonwealth's plan for maintaining attainment
of the 2010 1-hour SO2 NAAQS; and is redesignating the
Kentucky portion of the Area to attainment for the 2010 1-hour
SO2 NAAQS.

DATES: This rule will be effective March 10, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2016-0361. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to schedule your inspection. The
Regional Office's official hours of business are Monday through Friday
8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Steven Scofield, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, Region 4, U.S. Environmental
Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.
Mr. Scofield may be reached by phone at<PHONE_NUMBER> or via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background for Final Actions

    On June 2, 2010, EPA revised the primary SO2 NAAQS,
establishing a new 1-hour SO2 standard of 75 parts per
billion (ppb). See 75 FR 35520 (June 22, 2010). Under EPA's regulations
at 40 CFR part 50, the 2010 1-hour SO2 NAAQS is met at a
monitoring site when the 3-year average of the annual 99th percentile
of 1-hour daily maximum concentrations is less than or equal to 75 ppb
(based on the rounding convention in 40 CFR part 50, appendix T). See
40 CFR 50.17. Ambient air quality monitoring data for the 3-year period
must meet a data completeness requirement. A year meets data
completeness requirements when all four quarters are complete, and a
quarter is complete when at least 75 percent of the sampling days for
each quarter have complete data. A sampling day has complete data if 75
percent of the hourly concentration values, including state-flagged
data affected by exceptional events which have been approved for
exclusion by the Administrator, are reported.\1\
---------------------------------------------------------------------------

    \1\ 40 CFR part 50, appendix T, section 3(b).
---------------------------------------------------------------------------

    Upon promulgation of a new or revised NAAQS, the Clean Air Act (CAA
or Act) requires EPA to designate as nonattainment any area that does
not meet (or that contributes to ambient air quality in a nearby area
that does not meet) the NAAQS. At the time EPA conducted the initial
round of designations for the 2010 1-hour SO2 primary NAAQS,
Campbell County contained an SO2 monitor which registered
violations of the standard based on the three most recent years of
complete, quality assured, and certified ambient air quality data.
Using 2009-2011 ambient air quality data, EPA designated the Area as
nonattainment for the 2010 1-hour SO2 NAAQS on August 5,
2013 (78 FR 47191), which became effective on October 4, 2013. This
nonattainment designation established an attainment date five years
after the October 4, 2013, effective date for areas designated as
nonattainment for the 2010 1-hour SO2 NAAQS. Therefore, the
Campbell-Clermont, KY-OH Area's attainment date is October 4, 2018.
KDAQ was also required to submit a SIP to EPA that meets the
requirements of CAA sections 172(c) and 191-192 within 18 months
following the October 4, 2013, effective date of designation (i.e.,
April 4, 2015). As mentioned above, on March 31, 2015, KDAQ submitted a
request for EPA to determine that the Campbell-Clermont, KY-OH Area has
attained the 2010 1-hour SO2 NAAQS per EPA's ``Clean Data
Policy.'' Subsequently, on February 22, 2016, KDAQ submitted to EPA a
request for redesignation of the Campbell-Clermont, KY-OH Area to
attainment and a SIP revision containing a maintenance plan, base year
inventory, and RACM determination for the Kentucky portion of the Area.
In a notice of proposed rulemaking (NPRM) published on December 1,
2016, EPA proposed to take the following five separate but related
actions regarding Kentucky's aforementioned requests and SIP
submission: (1) To approve Kentucky's RACM determination for the
Kentucky portion of the Campbell-Clermont, KY-OH Area pursuant to CAA
section 172(c)(1) and incorporate it into the SIP; (2) to approve the
base year emissions inventory for the 2010 1-hour SO2 NAAQS
for the Kentucky portion of the Area pursuant to CAA section 172(c)(3)
and incorporate it into the SIP; (3) to approve the Commonwealth's
March 31, 2015, request for EPA to determine that the Area attained the
2010 1-hour SO2 NAAQS per EPA's ``Clean Data Policy;'' (4)
to approve Kentucky's plan for maintaining the 2010 1-hour
SO2 NAAQS (maintenance plan) in the Area and incorporate it
into the SIP; and (5) to redesignate the Kentucky portion of the
Campbell-Clermont, KY-OH Area to attainment for the 2010 1-hour
SO2 NAAQS.\2\ See 81 FR 86664. No comments were received on
the December 1, 2016, proposed rulemaking. The details of Kentucky's
submittal and the rationale for EPA's actions are further explained in
the NPRM. See 81 FR 86664 (December 1, 2016).
---------------------------------------------------------------------------

    \2\ On November 21, 2016, EPA published its final approval of
the redesignation request and maintenance plan for the Ohio portion
of the Area. See 81 FR 83158. As part of that final action, EPA
determined that the entire Area has attained the 2010 1-hour
SO2 NAAQS.
---------------------------------------------------------------------------

II. Effects of These Actions

    Approval of Kentucky's redesignation request changes the legal
designation of the portion of Campbell County that is within the
Campbell-Clermont, KY-OH Area, as found at 40 CFR 81.318, from
nonattainment to attainment for the 2010 1-hour SO2 NAAQS.
Approval of Kentucky's associated SIP revision also incorporates a plan
for maintaining the 2010 1-hour SO2 NAAQS in the Campbell-
Clermont, KY-OH Area through 2027 into the SIP as well as the State's
section 172(c)(1) RACM determination. This maintenance plan includes an
emissions inventory that satisfies the requirements of section
172(c)(3) and contingency measures to remedy any future violations of
the 2010 1-hour SO2 NAAQS.

III. Final Actions

    EPA is taking five separate but related actions regarding
Kentucky's aforementioned requests and SIP submission. First, EPA is
approving Kentucky's RACM determination for the Kentucky portion of the
Campbell-Clermont, KY-OH Area pursuant to CAA section 172(c)(1) and
incorporating it into the SIP.
    Second, EPA is approving the base year emissions inventory for the
2010 1-hour SO2 NAAQS for the Kentucky portion of the Area
pursuant to CAA section 172(c)(3) and incorporating it into the SIP.
    Third, EPA is approving the Commonwealth's March 31, 2015, request
for EPA to determine that the Area attained the 2010 1-hour
SO2 NAAQS per EPA's ``Clean Data Policy.''
    Fourth, EPA is approving Kentucky's plan for maintaining the 2010
1-hour SO2 NAAQS (maintenance plan) in the Area and
incorporating it into the SIP. The maintenance plan demonstrates that
the Area will continue to maintain the 2010 1-hour SO2 NAAQS
through 2027.
    Fifth, EPA is redesignating the Kentucky portion of the Campbell-
Clermont, KY-OH Area to attainment for the 2010 1-hour SO2
NAAQS.
    In accordance with 5 U.S.C. 553(d), EPA finds that there is good
cause for these actions to become effective immediately upon
publication. The immediate effective date for these actions is
authorized under 5 U.S.C. 553(d)(3), which allows an effective date
less than 30 days after publication as otherwise provided by the agency
for good cause found and published with the rule. The immediate
effective date for the redesignation action is also authorized under 5
U.S.C. 553(d)(1), which provides that rulemaking actions

may become effective less than 30 days after publication if the rule
grants or recognizes an exemption or relieves a restriction. The
purpose of the 30-day waiting period prescribed in section 553(d) is to
give affected parties a reasonable time to adjust their behavior and
prepare before the final rule takes effect. This rulemaking, however,
does not create any new regulatory requirements such that affected
parties would need time to prepare before the rules takes effect, and
the redesignation will relieve the Area from certain CAA requirements
that would otherwise apply to it. For these reasons, EPA finds good
cause under 5 U.S.C. 553(d) for these actions to become effective on
the date of publication of this action.

IV. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable federal regulations. See 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, these actions merely approve state law as meeting federal
requirements and do not impose additional requirements beyond those
imposed by state law. For these reasons, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA petitions for judicial review of
this action must be filed in the United States Court of Appeals for the
appropriate circuit by May 9, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control.

    Dated: January 20, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.

    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart S--Kentucky

0
2. Section 52.920(e) is amended by adding an entry for ``2010 1-hour
SO2 Maintenance Plan for the Kentucky Portion of the
Campbell-Clermont, KY-OH Area'' at the end of the table to read as
follows:

Sec.  52.920  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable           State
    Name of non-regulatory SIP        geographic or     submittal date/  EPA approval date       Explanations
            provision               nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2010 1-hour SO2 Maintenance Plan   Campbell County           2/22/2016  3/10/2017..........  This includes the
 for the Kentucky Portion of the    portion of                                                172(c)(1) RACM
 Campbell-Clermont, KY-OH Area.     Campbell-Clermont,                                        determination and
                                    KY-OH                                                     the 172(c)(3) base-
                                    Nonattainment Area.                                       year emissions
                                                                                inventory.
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
4. In Sec.  81.318, the table entitled ``Kentucky-2010 Sulfur Dioxide
NAAQS (Primary)'' is amended under ``Campbell-Clermont Counties, KY-
OH:'' by revising the entries for ``Campbell County (part)'' to read as
follows:

Sec.  81.318  Kentucky.

* * * * *

                   Kentucky--2010 Sulfur Dioxide NAAQS
                                [Primary]
------------------------------------------------------------------------
                                                Designation
         Designated area         ---------------------------------------
                                       Date                Type
------------------------------------------------------------------------
Campbell-Clermont Counties, KY-        3/10/2017  Attainment.
 OH: \1\.
    Campbell County (part).
        That portion of Campbell
         County which lies south
         and west of the Ohio
         River described as
         follows: Beginning at
         geographic coordinates
         38.9735 North Latitude,
         84.3017 West Longitude
         (NAD 1983) on the edge
         of the Ohio River
         running southwesterly
         to KY Highway 1566;
         thence continuing
         running southwesterly
         along KY Highway 1566
         to KY Highway 9 (AA
         Highway); thence
         running north westerly
         along KY Highway 9 (AA
         Highway) from Hwy 1566
         to Interstate 275;
         thence running
         northeasterly along
         Interstate 275 to
         Highway 2345 (John's
         Hill Road), Hwy 2345 to
         US-27, US-27 to I-275,
         I-275 to the Ohio
         River; thence running
         southeasterly along the
         Ohio River from
         Interstate 275 to
         geographic coordinates
         38.9735 North Latitude,
         84.3017 West Longitude
         (NAD 1983).

                              * * * * * * *
------------------------------------------------------------------------
\1\ Excludes Indian country located in each area, if any, unless
  otherwise specified.

* * * * *
[FR Doc. 2017-04781 Filed 3-9-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Rules and Regulations]
[Pages 39596-39598]
[FR Doc No: 2018-17222]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2018-0771]
RIN 1625-AA08

Special Local Regulation; Roanoke River, Plymouth, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a special local regulation on
the navigable waters of the Roanoke River in Plymouth, North Carolina.
This special local regulation is intended to restrict vessel traffic on
the Roanoke River during a high-speed boat race. The restriction of
vessel traffic movement in the regulated area is intended to protect
participants and spectators from the hazards posed by high-speed boat
races. Entry of vessels or persons into this regulated area is
prohibited unless specifically authorized by the Captain of the Port
(COTP) North Carolina or a designated representative.

DATES: This rule is effective from 11 a.m. on August 11, 2018, through
5 p.m. on August 12, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0771 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Matthew Tyson, Waterways Management
Division, U.S. Coast Guard Sector North Carolina, Wilmington, NC;
telephone:<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard was not notified of
the need for this rule until August 2, 2018, and it is impracticable
and contrary to the public interest to delay this action. Waiting for a
comment period to run would inhibit the Coast Guard's ability to
protect the public and participants from the dangers associated with
the high-speed boat race scheduled to start on August 11, 2018.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because immediate action is needed to protect the public and
participants from the dangers associated with the high-speed boat race
scheduled to start on August 11, 2018.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The COTP North Carolina has determined that potential hazards
associated with the Virginia Outlaw Drag Boat Association Rumble on the
Roanoke scheduled for 11 a.m. through 5 p.m. on August 11 and 12, 2018,
is a safety concern for mariners during the high-speed boat race on the
Roanoke River in Plymouth, North Carolina. This rule is necessary to
protect safety of life from the potential hazards associated with the
high-speed boat race.

IV. Discussion of the Rule

    This rule establishes a special local regulation on a portion of
the Roanoke River from 11 a.m. on August 11, through 5 p.m. on August
12, 2018. The rule will be enforced 11 a.m. through 5 p.m. each of
those days. The time of enforcement will be broadcast locally over VHF-
FM marine radio. The special local regulation will include all
navigable waters of the Roanoke River in Plymouth, North Carolina, from
approximate positions: Latitude 35[deg]52'25'' N, longitude
076[deg]44'33'' W, then northwest to latitude 35[deg]52'29'' N,
longitude 076[deg]44'37'' W, then southwest along the shoreline to
latitude 35[deg]52'00'' N, longitude 076[deg]45'31'' W, then south to
latitude 35[deg]51'56'' N, longitude 076[deg]45'30'' W, then northeast
along the shoreline to the point of origin, a length of approximately
one mile. The duration of this special local regulation is intended to
protect participants and spectators on the navigable waters of the
Roanoke River during the high-speed boat race. For safety reasons, no
public spectators will be allowed to view the event from the waterway.
Vessels may request permission to pass through the regulated area
between race heats. No vessel or person will be permitted to enter the
regulated area without obtaining permission from the COTP North
Carolina or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the special local regulation. Vessel traffic
will not be allowed to enter or transit a portion of the Roanoke River
from 11 a.m. through 5 p.m. on both August 11 and 12, 2018. The Coast
Guard will transmit a Broadcast Notice to Mariners via VHF-FM marine
channel 16 regarding the special local regulation. This portion of the
Roanoke River has been determined to be a low traffic area during this
time of the year. This rule allows vessels to request permission to
pass through the regulated area between race heats.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
special local regulation may be small entities, for the reasons stated
in section IV.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule will affect your small
business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In

particular, the Act addresses actions that may result in the
expenditure by a State, local, or tribal government, in the aggregate,
or by the private sector of $100,000,000 (adjusted for inflation) or
more in any one year. Though this rule will not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, which guides the Coast Guard in complying with the
National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves a special local regulation
lasting approximately six hours on two separate days that prohibits
entry into a portion of the Roanoke River. It is categorically excluded
from further review under paragraph L61 of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233; 33 CFR 1.05-1.

0
2. Add Sec.  100.35T05-0771 to read as follows:

Sec.  100.35T05-0771  Special Local Regulation, Roanoke River,
Plymouth, NC.

    (a) Location. The following area is a special local regulation: All
navigable waters of the Roanoke River in Plymouth, North Carolina, from
approximate positions: Latitude 35[deg]52'25'' N, longitude
076[deg]44'33'' W, then northwest to latitude 35[deg]52'29'' N,
longitude 076[deg]44'37'' W, then southwest along the shoreline to
latitude 35[deg]52'00'' N, longitude 076[deg]45'31'' W, then south to
latitude 35[deg]51'56'' N, longitude 076[deg]45'30'' W, then northeast
along the shoreline to the point of origin, a length of approximately
one mile.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, Sector North
Carolina.
    Official Patrol means any vessel assigned by the COTP North
Carolina with a commissioned, warrant, or petty officer on board and
displaying the Coast Guard ensign.
    Participants means persons and vessels involved in the high-speed
boat race.
    Patrol Commander means a Coast Guard commissioned, warrant, or
petty officer designated by the COTP North Carolina for the enforcement
of the special local regulation.
    (c) Regulations. (1) The requirements of Sec.  100.501(b) and
(c)(1) and (2) apply to the area described in paragraph (a) of this
section.
    (2) With the exception of participants, entry into or remaining in
this special local regulation is prohibited unless authorized by the
COTP North Carolina or the COTP North Carolina's Patrol Commander. All
other vessels must depart the special local regulation immediately upon
the start of enforcement.
    (3) To request permission transit through the special local
regulation, contact the COTP North Carolina or the COTP North
Carolina's Patrol Commander through the Coast Guard Sector North
Carolina Command Duty Officer, Wilmington, North Carolina, at telephone
number<PHONE_NUMBER> or on VHF-FM marine band radio channel 13 (165.65
MHz) or channel 16 (156.8 MHz).
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the special local regulation by Federal, State, and
local agencies.
    (e) Enforcement period. This regulation will be enforced from 11
a.m. through 5 p.m. on both August 11 and 12, 2018.

    Dated: August 6 2018.
Bion B. Stewart,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2018-17222 Filed 8-9-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Page 69548]
[FR Doc No: 2014-27602]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Aviation Rulemaking Advisory Committee; Meeting

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Aviation Rulemaking Advisory Committee (ARAC)
meeting.

-----------------------------------------------------------------------

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of the ARAC.

DATES: The meeting will be held on December 18, 2014, starting at 1:00
p.m. Eastern Standard Time. Arrange oral presentations by December 11,
2014.

ADDRESSES: The meeting will take place at the Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591, 5th
floor, 5A/B/C Conference Rooms.

FOR FURTHER INFORMATION CONTACT: Renee Pocius, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (5 U.S.C. App. 2), we are giving notice of a
meeting of the ARAC taking place on December 18, 2014, at the Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591.
    The Agenda includes:
    1. Request for Clarification:
    a. Avionics Systems Harmonization Working Group (TAE)--Phase 2 Low
Airspeed Alerting.
    2. Status Reports From Active Working Groups:
    a. AC 120-17A Maintenance Control by Reliability Methods (ARAC).
    b. Airman Certification Systems Working Group (ARAC).
    c. Airworthiness Assurance Working Group (TAE).
    d. Engine Harmonization Working Group (TAE).
    i. Engine Bird Ingestion.
    ii. Engine Endurance Testing Requirements--Revision of Section
33.87.
    e. Flight Test Harmonization Working Group (TAE)--Phase 2 Tasking.
    3. New Tasks:
    a. Transport Airplane Damage-Tolerance and Fatigue Evaluation
(TAE).
    b. Transport Airplane Crashworthiness and Ditching Evaluation
(TAE).
    c. Materials Flammability Working Group (TAE).
    d. Aircraft Systems Information Security Protection (ASISP) Working
Group.
    4. ARAC Bylaws:
    5. Status Report From the FAA:
Attendance is open to the interested public but limited to the space
available. Please confirm your attendance with the person listed in the
FOR FURTHER INFORMATION CONTACT section no later than December 11,
2014. Please provide the following information: Full legal name,
country of citizenship, and name of your industry association, or
applicable affiliation. If you are attending as a public citizen,
please indicate so.
    For persons participating by telephone, please contact the person
listed in the FOR FURTHER INFORMATION CONTACT section by email or phone
for the teleconference call-in number and passcode. Callers outside the
Washington metropolitan area are responsible for paying long-distance
charges.
    The public must arrange by December 11, 2014 to present oral
statements at the meeting. The public may present written statements to
the Aviation Rulemaking Advisory Committee by providing 25 copies to
the Designated Federal Officer, or by bringing the copies to the
meeting.
    If you are in need of assistance or require a reasonable
accommodation for this meeting, please contact the person listed under
the heading FOR FURTHER INFORMATION CONTACT. Sign and oral
interpretation, as well as a listening device, can be made available if
requested 10 calendar days before the meeting.

    Issued in Washington, DC, on November 18, 2014.
Lirio Liu,
Designated Federal Officer, Aviation Rulemaking Advisory Committee.
[FR Doc. 2014-27602 Filed 11-20-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Proposed Rules]
[Page 59353]
[FR Doc No: 2018-25532]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Parts 555, 571, and 591

[Docket No. NHTSA-2018-0092]
RIN 2127-AL99

Pilot Program for Collaborative Research on Motor Vehicles With
High or Full Driving Automation; Extension of Comment Period

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Advance notice of proposed rulemaking (ANPRM); extension of
comment period.

-----------------------------------------------------------------------

SUMMARY: In response to a request from the public, NHTSA is announcing
a two-week extension of the comment period on the ANPRM on a Pilot
Program for Collaborative Research on Motor Vehicles with High or Full
Driving Automation. The comment period for the ANPRM was originally
scheduled to end on November 26, 2018. It will now end on December 10,
2018.

DATES: The comment period for the ANPRM published on October 10, 2018
at 83 FR 50872 is extended. Written comments on the ANPRM must be
received on or before December 10, 2018 in order to be considered
timely.

ADDRESSES: Comments must be submitted by one of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m. Eastern
time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, they must include the
docket number identified in the heading of this notice.
    Note that all comments received, including any personal information
provided, will be posted without change to http://www.regulations.gov.
Please see the ``Privacy Act'' heading below.
    You may call the Docket Management Facility at<PHONE_NUMBER>.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. We will continue to file relevant information in
the docket as it becomes available.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its decision-making process.
DOT posts these comments, without edit, including any personal
information the commenter provides, to http://www.regulations.gov, as
described in the system of records notice (DOT/ALL-14 FDMS), which can
be reviewed at https://www.transportation.gov/privacy. Anyone can
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.).

FOR FURTHER INFORMATION CONTACT: For research and pilot program issues:
Dee Williams, Office of Vehicle Safety Research,<PHONE_NUMBER>,
[email protected], National Highway Traffic Safety Administration,
1200 New Jersey Avenue SE, Washington, DC 20590-0001.
    For legal issues: Stephen Wood, Assistant Chief Counsel, Vehicle
Rulemaking and Harmonization, Office of Chief Counsel,<PHONE_NUMBER>,
[email protected], at the same address.

SUPPLEMENTARY INFORMATION: On October 10, 2018, NHTSA published an
ANPRM to obtain public comments on the factors and structure that are
appropriate for the Agency to consider in designing a national pilot
program that will enable the Agency to facilitate, monitor and learn
from the testing and development of the emerging advanced vehicle
safety technologies and to assure the safety of those activities. The
ANPRM stated that the closing date for comments is November 26, 2018.
    On November 16, 2018, NHTSA received a request from the Uber
Technologies, Inc. for a two-week extension of the comment period. The
request can be found in the docket for the ANPRM listed above under
ADDRESSES. NHTSA has considered this request and believes that a 14-day
extension beyond the original due date is desirable to provide
additional time for the public to comment on the complex and novel
questions in the ANPRM. This is to notify the public that NHTSA is
extending the comment period on the ANPRM, and allowing it to remain
open until December 10, 2018.

    Issued in Washington, DC, pursuant to authority delegated in 49
CFR 1.81 and 1.95.
Heidi Renate King,
Deputy Administrator.
[FR Doc. 2018-25532 Filed 11-19-18; 4:15 pm]
BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2305-2307]
[FR Doc No: 2019-01253]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0208]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to exempt 14 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate

commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on December 28, 2018. The
exemptions expire on December 28, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>,fmcsamedical@dot.gov, FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0208, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On November 27, 2018, FMCSA published a notice announcing receipt
of applications from 14 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (83 FR 60954). The public comment period ended on December 27,
2018, and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received one comment in this proceeding. The commenter
acknowledged that each applicant has been examined by an
ophthalmologist or optometrist who has certified that, in the doctor's
opinion, the applicant has sufficient vision to perform all the tasks
necessary to operate a CMV. However, they also noted that the 14
individuals listed in this notice should be subject to frequent testing
to ensure that their driving abilities are not impacted by their
vision.
    FMCSA has evaluated the eligibility of each of these applicants and
determined that granting the exemptions would result in a level of
safety that is equal to, or greater than, that which would exist
without the exemptions. As discussed in Section IV of this notice:
Basis for Exemption Determination, each individual possesses a valid
license to operate a CMV, and each individual has demonstrated his or
her ability to safely operate a CMV in intrastate commerce for a three-
year period as part of the application process. In addition, each
applicant must continue to be physically examined every year by an
ophthalmologist or optometrist and a Certified Medical Examiner so that
they may continue to be qualified to operate a CMV in interstate
commerce.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for up to five years from the vision standard in 49 CFR 391.41(b)(10)
if the exemption is likely to achieve an equivalent or greater level of
safety than would be achieved without the exemption. The exemption
allows applicants to operate CMVs in interstate commerce. FMCSA grants
exemptions from the FMCSRs for a two-year period to align with the
maximum duration of a driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the November 27, 2018, Federal
Register notice (83 FR 60954) and will not be repeated in this notice.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 14
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, aphakia, cataract, chorioretinal scar,
complete loss of vision, corneal scar, diabetic retinopathy, glaucoma,
macular drusen, and retinal detachment. In most cases, their eye
conditions were not recently developed. Nine of the applicants were
either born with their vision impairments or have had them since
childhood. The five individuals that sustained their vision conditions
as adults have had it for a range of 3 to 13 years. Although each
applicant has one eye that does not meet the vision requirement in 49
CFR 391.41(b)(10), each has at least 20/40 corrected vision in the
other eye, and, in a doctor's opinion, has sufficient vision to perform
all the tasks necessary to operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These

conditions tax visual capacity and driver response just as intensely as
interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 3 to 59 years. In the past three years,
no drivers were involved in crashes, and no drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in 49 CFR 391.41(b)(10) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10) and
(b) by a certified Medical Examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) each driver
must provide a copy of the ophthalmologist's or optometrist's report to
the Medical Examiner at the time of the annual medical examination; and
(3) each driver must provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file, or
keep a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the exemption when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 14 exemption applications, FMCSA
exempts the following drivers from the vision requirement, 49 CFR
391.41(b)(10), subject to the requirements cited above:

Doyle L. Bowen (NM)
Guillermo Casio Gamero (WA)
William L. Cave (MD)
Marc C. Goss (NE)
Richard J. Hard (IN)
Dennis W. Johnson (MO)
Ken I. Johnson (GA)
Ibrahim F. Khashan (GA)
Shelby M. Kuehler (KS)
Kendall S. Lane (OK)
Leonard Morris (NJ)
Gale L. O'Neil (PA)
Michael L. Sheldon (NE)
Pedro T. Tellez Alvarez (CA)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136 and 31315.

    Issued on: January 30, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-01253 Filed 2-5-19; 8:45 am]
BILLING CODE 4910-EX-P