Terms used but not defined in this subpart have the meaning given them in the Clean Air Act and in subparts A, B, and Ec of this part. Standard Metropolitan Statistical Area or SMSA means any areas listed in OMB Bulletin No. 93-17 entitled “Revised Statistical Definitions for Metropolitan Areas” dated June 30, 1993 (incorporated by reference, see

(a) The provisions of this subpart are applicable to the following affected facilities used in phosphate rock plants which have a maximum plant production capacity greater than 3.6 megagrams per hour (4 tons/hr): dryers, calciners, grinders, and ground rock handling and storage facilities, except those facilities producing or preparing phosphate rock solely for consumption in elemental phosphorus production. (b) Any facility under

No source at a Department of Energy facility shall emit more than 20 picocuries per square meter per second (pCi/(m2-sec)) (1.9 pCi/(ft2-sec)) of radon-222 as an average for the entire source, into the air. This requirement will be part of any Federal Facilities Agreement reached between Environmental Protection Agency and Department of Energy. [54 FR 51701, Dec. 15, 1989

(a) Identification of plan. State of Kansas Implementation Plan for Control of Sulfuric Acid Mist from Existing Sulfuric Acid Plants. (b) The Plan was officially submitted on February 6, 1986. (c) Identification of sources. The Plan applies to existing facilities at the following existing sulfuric acid plant:

(a) Letter from the Kentucky Department for Environmental Protection submitted March 5, 2001, certifying that there are no small municipal waste combustion units subject to 40 CFR part 60, subpart BBBB. (b) Letter from Louisville, Kentucky, Air Pollution Control District submitted on February 11, 2010, certifying that there are no Small Municipal Waste Combustion units subject to 40 CFR part 60, subpart BBBB in its jurisdiction.

The 111(d)/129 plan for municipal waste combustors (MWC) units with a capacity greater than 250 tons per day (TPD) and the associated Pennsylvania Department of Environmental Protection operating permits that were submitted to EPA on April 27, 1998, and as amended on September 8, 1998, and July 7, 2000, including supplemental information dated August 15, 2000. All affected facilities must achieve full compliance with all 111(d)/129 plan requirements on or before

This part (40 CFR part 62) contains a list of State and Tribal areas with approved Clean Air Act section 111(d) and section 129 plans along with the effective dates for such plans. The list is published annually. If this part does not indicate that your State or Tribal area has an approved and effective plan, you should contact your State environmental agency's air director or your EPA Regional Office to determine if the EPA has approved a State plan covering your unit since publication of

Owners and operators that use a closed-vent system and a control device in accordance with the provisions of §63.962 shall prepare and submit to the Administrator the reports required for closed-vent systems and control devices in accordance with the requirements of §63.693

For each operating limit that you are required by §63.6000(b)(3) to monitor or each operating parameter that you are required by §63.6000(f) to monitor, you must install, operate, and maintain a continuous parameter monitoring system according to the provisions in

(a) You must meet each emission limit in Table 1 to this subpart that applies to you. (b) For each wet scrubber applied to meet any particulate matter, particulate matter less than 10 microns (PM10), chlorine, hydrochloric acid, or dioxins/furans emission limit in Table 1 to this subpart, you must maintain the hourly average pressure drop and scrubber liquid flow rate at or above

Within forty-five days after EPA has notified the owner or operator of a source of the final Agency decision that it is in violation of applicable legal requirements or is not entitled to an exemption, the owner or operator shall submit the information required by §66.13(a), including appropriate compliance and payment schedules and extra interest owed for the period of delay. The penalty shall

We may deny a petition requesting a waiver if the petition does not provide the information required under §1.918 (including the requirements of §10.30 of this chapter), or if we determine that the waiver could result in the transportation of food under conditions that would be unsafe for human or

(a) This subpart identifies postmarketing safety reporting requirements for combination product applicants and constituent part applicants. (b) This subpart does not apply to investigational combination products, combination products that have not received marketing authorization, or to persons other than combination product applicants and constituent part applicants. (c) This subpart supplements and

Register document confirming the effective date of the regulation may extend the time for compliance with the regulation.

(a) The provisions of 45 CFR part 73, establishing standards of conduct for all Department employees, are fully applicable to all Food and Drug Administration employees, except that such regulations shall be applicable to special government employees, i.e., consultants to the Food and Drug Administration, only to the extent stated in subpart L of 45 CFR part 73. (b) The provisions of 45 CFR part 73a supplement the Department standards

Marking records submitted to the Food and Drug Administration as confidential, or with any other similar term, raises no obligation by the Food and Drug Administration to regard such records as confidential, to return them to the person who has submitted them, to withhold them from disclosure to the public, or to advise the person submitting them when a request for their public disclosure is received or when they are in fact disclosed.

another Federal, State, or local government agency for any action that that agency determines to be appropriate.

(a) You must keep written records required by this part for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records. (b) Records must be kept as original records, as true copies (such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records), or as electronic records.

(a) Frozen orange juice is orange juice as defined in §146.135, except that it is frozen. (b) The name of the food is “Frozen orange juice”. Such name may be preceded on the label by the varietal name of the oranges used, and if the oranges grew in a single State, the name of such State may be included in the name, as for example

4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an antioxidant in articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive has a solidification point of 140°-141 °C. (b) The concentration of the additive and any other permitted antioxidants in the finished food-contact article does not

intended for transfusion are excluded from the restrictions in and the requirements of the Prescription Drug Marketing Act of 1987 and the Prescription Drug Amendments of 1992.

FDA's Office of Orphan Products Development will maintain and make publicly available a list of guidance documents that apply to the regulations in this part. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, rm. 5271, 10903 New

(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each of the general conditions established in §330.1. (b) References in this subpart to regulatory sections of the

(a) An over-the-counter antifungal drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in §330.1 of this chapter. (b) Reference in this subpart to regulatory sections of the

(a) An over-the-counter acne drug product in a form suitable for topical application is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in §330.1 of this chapter. (b) References in this subpart to regulatory sections of the Code of

(a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in §330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal

(a) An over-the-counter antiemetic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in §330.1. (b) References in this part to regulatory sections of the Code of Federal

(a) An over-the-counter nighttime sleep-aid drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in §330.1 of this chapter. (b) References in this part to regulatory sections of the Code of

(a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in §330.1. (b) References in this part to regulatory sections of the Code of Federal

The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient: (a) Ephedrine. (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. (e) Epinephrine bitartrate. (f) Racephedrine