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(a) Each owner or operator of a bulk gasoline terminal or pipeline breakout station subject to the provisions of this subpart shall equip each gasoline storage vessel with a design capacity greater than or equal to 75 m3 according to the requirements in §60.112b(a) (1) through (4) of this chapter, except for the requirements in
treatment and controls as an agent for the industrial user. Group 1 POTW treatment plant is defined in §63.1595.
(b) Your POTW is a Group 2 POTW treatment plant if your POTW treats wastewater that is not subject to control by another NESHAP or the industrial user does not comply with its NESHAP by using the treatment and controls located at your POTW treatment plant. “Group
Compliance is determined using performance testing, collection system monitoring, continuous parameter monitoring, and other credible evidence. In addition, continuous parameter monitoring data collected under §63.1961(b)(1), (c)(1), and (d) are used to demonstrate compliance with the operating standards for control systems. If a deviation occurs, you have failed to
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For each . . .
During this time frame . . .
You must comply with the emission limitations in Table 1 to this subpart using the . . .
§63.5758. Keep records of the organic HAP content determination.
(b) For solvents containing more than 5 percent organic HAP by weight, comply with the requirements in paragraph (b)(1) or (b)(2), and paragraph (b)(3) of this section.
(1) If you are using an enclosed spray gun cleaner, visually inspect it at least once per month to ensure that covers are in place and the covers have no visible gaps when the cleaner is
(a) You must monitor and collect data according to this section.
(b) Before September 9, 2020, except for monitor malfunctions, associated repairs, and required quality assurance or control activities (including, as applicable, calibration checks and required zero and span adjustments), you must monitor continuously (or collect data at all required intervals) at all times that the affected source is operating including periods of
a reasonable basis in law and in fact for making the determination.
allowances allocated for the year after the year in which the source has excess emissions, from the source's compliance account on a first-in, first-out basis in accordance with §73.35(c)(2) of this chapter, equal to the amount of the source's excess emissions of sulfur dioxide.
[58 FR 3757, Jan. 11, 1993, as amended at 70 FR 25337, May 12, 2005]
(a) The Presiding Officer will review and evaluate the record, including the proposed findings and conclusions and any briefs filed by the parties, and issue a proposed decision on the factual, policy, and legal issues referred by the Environmental Appeals Board for decision under §78.6(b)(2)(ii) of this part, accompanied by findings of fact and proposed conclusions of
would be willing to review the record and discuss it with the individual.
(2) The availability of the record may be subject to any procedures for disclosure to an individual of medical records about himself under part 20 of this chapter, in addition to or in lieu of the procedures in paragraph (b)(1), that are not inconsistent with §21.41(f).
derived.
(b) For a given product or sector, the provisions contained in subparts A and B of this part shall apply in the first place, and the provisions of subpart C of this part in addition to those provisions. In the case of any inconsistency between the provisions of subpart A or B of this part and subpart C of this part, subpart A or B shall prevail, to the extent of that inconsistency.
(c) The agreement from which this part is
paragraph (a) of this section may be used as a color additive in contact lens in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization for this use shall not be construed as waiving any of the requirements of section 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color additive is used.
(c)
For the purposes of this part:
(a)-(f) [Reserved]
(g) The term alumina means a suspension in water of precipitated aluminum hydroxide.
(h) The term blanc fixe means a suspension in water of precipitated barium sulfate.
(i) The term
Director of the appropriate Food and Drug Administration district office. After normal business hours (8 a.m. to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-866-300-4374 shall be used. The manufacturer shall promptly send written confirmation of the notification to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., College Park, MD 20740, and to the
plant or animal used as the source; and
(iii) Any known toxicants that could be in the source;
(b) A description of the method of manufacture of the notified substance in sufficient detail to evaluate the safety of the notified substance as manufactured;
(c) Specifications for food-grade material; and
(d) When necessary to demonstrate safety, relevant data and
selenium, and 10 ppm zinc.
(c) The viable microbial content of the finished ingredient as a concentrate or dry material is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive Staphylococci
ingredient is based upon the following current good manufacturing practice conditions of use:
(1) The ingredient is used in the manufacture of paper and paperboard that contact food.
(2) The ingredient is used at levels not to exceed current good manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived.
As used in this subpart:
(a) Coal tar. The tar used for medicinal purposes that is obtained as a byproduct during the destructive distillation of bituminous coal at temperatures in the range of 900 °C to 1,100 °C. It may be further processed using either extraction with alcohol and suitable dispersing agents and maceration times or fractional distillation with or without the use of suitable
kittens—(1) Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
(2) Indications for use—(i) Dogs and puppies: Removal and control of intestinal roundworms (Toxocara canis and Toxascaris leonina) and hookworms (
(c) Conditions of use in dogs and cats—(1) Amount. 10 to 15 milligrams per pound of body weight every 6 to 8 hours.
(2) Indications for use. Treatment of respiratory, urogenital, skin and soft tissue infections and septicemia caused by pathogens susceptible to penicillin V potassium.
(3)
, every 4 hours.
(2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.
(3) Limitations
Certain other spices, seasonings, essential oils, oleoresins, and natural extracts that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows:
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Common name
applicants to submit specimens of the labels, enclosures, and containers, or to submit other final printed labeling. Submissions under this paragraph must be made in accordance with part 11 of this chapter except for the requirements of §11.10(a), (c) through (h), and (k), and the corresponding requirements of
(a) The following Massachusetts medical device requirements are enforceable notwithstanding section 521 of the act because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act:
(1) Massachusetts General Laws, Chapter 93, Section 72, to the extent that it requires a hearing test evaluation for a child under the age of 18.
(2) Massachusetts General Laws
maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the
Federal Register to make announcements about the standard development process of standard developers other than Federal agencies.
(c) Maintain records disclosing the course of development of the proposed standard, the comments and other information submitted by a person in connection with such development (including comments and information regarding the need for a standard), and such other information as may be required to evaluate the standard.
meningoencephalitis (inflammation of the brain and brain membranes) and is often fatal if untreated. A second form of human listeriosis is an intrauterine infection in pregnant women that results in a high mortality rate for infants before or after birth.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to
the patient. The special controls are as follows:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to
(a) Identification. An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an
with import control authorities under the Act or statutory authority other than the Controlled Substances Import and Export Act. The importer must maintain an official record of the import permit (available from the DEA Diversion Control Division secure network application after issuance) in accordance with part 1304 of this chapter as the record of authority for the importation and shall transmit an official record of the permit to the foreign exporter. If required by the foreign competent