Waiver of Delay of Effective Date

Pursuant to 5 U.S.C. 553(d)(3), I find that good cause exists to waive the delay in effective date and make these regulations effective in less than 30 days. The delay in the effective date is being waived because the program changes do not mandate but will give agencies needed flexibilities to recruit, hire and retain high quality candidates quickly and effectively to respond to changing and critical mission requirements. The General Accounting Office has designated strategic human capital management as a Governmentwide high-risk area citing serious human capital shortfalls that erode the ability of agencies to “economically, efficiently and effectively perform their missions.” The President's Management Agenda calls for agencies to “flatten the Federal hierarchy, reduce the time to make decisions, and increase the number of employees that provide services to citizens. The reform also will pursue targeted civil service reforms, such as performance-based compensation and management flexibilities to recruit, retain, and reward a high-quality workforce.” With 50% of Federal employees eligible for retirement in the coming years, agencies must have contemporary, flexible tools for workforce management. Recent media articles have highlighted the public perception that getting a Federal job takes too long and is far too complicated. The Government needs the very best applicants; in turn applicants deserve a streamlined, understandable application process. These changes will accommodate that need.

None of the three flexibilities proposed by these regulations is new or untried. In fact, category rating has been used successfully by some agencies for a decade or more under demonstration authority and enabling legislation. Studies of category rating as implemented by the Department of Agriculture indicate that employment of veterans increases and diversity is not reduced. Private-sector companies routinely use tuition payment as a strategy to attract and retain high quality employees.

These flexibilities were proposed after broad consultation with a variety of stakeholders including employees, managers and the human resources community. They long have been advocated by numerous public and private groups including the Merit Systems Protection Board and the Partnership for Public Service as forward thinking, solid human capital strategies that should be available Governmentwide rather that to a few select agencies.

Direct hire, in particular, is critical if agencies are to respond effectively to the needs of the Nation. With a nationwide shortage of nurses and other healthcare workers, the Government must be able to move quickly and efficiently to hire excellent candidates—direct hire would provide that flexibility. Without it, the staffing to provide care to veterans and others in Federal medical facilities is diminished. Similarly, the critical need to hire talented, highly skilled workers to respond to a national crisis including an environmental threat such a raging wildfire can not be left to traditional hiring methods designed decades ago.

The alternatives provided by these regulations are not mandatory, but may be used strategically by agencies to improve the management of human capital, to meet mission requirements and to respond to the President's call for a Government that is citizen focus and results oriented. There is a compelling need to continue these flexibilities without delay.

This administrative rule is governed by the provisions of sections 556 and 557 of title 5 of the United States Code and, therefore, is excluded from the requirements of Executive Order 12866.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with the rule.

The Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may request modification or exemption from such order by filing with the Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with the law. A handler is afforded the opportunity for a hearing on the petition. After a hearing, the Department would rule on the petition. The Act provides that the District Court of the United States in any district in which the handler is an inhabitant, or has its principal place of business, has jurisdiction in equity to review the Department's ruling on the petition, provided a bill in equity is filed not later than 20 days after the date of the entry of the ruling.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Agricultural Marketing Service has considered the economic impact of this action on small entities and has certified that this rule will not have a significant economic impact on a substantial number of small entities. For the purpose of the Regulatory Flexibility Act, a dairy farm is considered a “small business” if it has an annual gross revenue of less than $750,000, and a dairy products manufacturer is a “small business” if it has fewer than 500 employees.

For the purposes of determining which dairy farms are “small businesses,” the $750,000 per year criterion was used to establish a production guideline of 500,000 pounds per month. Although this guideline does not factor in additional monies that may be received by dairy producers, it should be an inclusive standard for most “small” dairy farmers. For purposes of determining a handler's size, if the plant is part of a larger company operating multiple plants that collectively exceed the 500-employee limit, the plant will be considered a large business even if the local plant has fewer than 500 employees.

During June 2003, there were 897 producers pooled on, and 71 plants associated with, the Pacific Northwest order. Based on these criteria, 574 producers or 64 percent of producers and 37 plants or 52 percent of the associated plants would be considered small businesses. The adoption of the proposed pooling standards serves to revise established criteria that determine those producers, producer milk, and plants that have a reasonable association with, and are consistently serving the fluid needs of, the Pacific Northwest milk marketing. Criteria for pooling are established on the basis of performance levels that are considered adequate to meet the Class I fluid needs and, by doing so, determine those that are eligible to share in the revenue that arises from the classified pricing of milk. Criteria for pooling are established without regard to the size of any dairy industry organization or entity. The criteria established are applied in an equal fashion to both large and small businesses. Therefore, the amendments will not have a significant economic impact on a substantial number of small entities.

A review of reporting requirements was completed under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). It was determined that these amendments would have no impact on reporting, recordkeeping, or other compliance requirements because they would remain identical to the current requirements. No new forms are proposed and no additional reporting requirements would be necessary.

This action does not require additional information collection that requires clearance by the Office of Management and Budget (OMB) beyond currently approved information collection. The primary sources of data used to complete the forms are routinely used in most business transactions. Forms require only a minimal amount of information, which can be supplied without data processing equipment or a trained statistical staff. Thus, the information collection and reporting burden is relatively small. Requiring the same reports for all handlers does not significantly disadvantage any handler that is smaller than the industry average.

Prior documents in this proceeding:

Notice of Hearing: Issued November 14, 2001; published November 19 2001 (66 FR 57889).

Tentative Final Decision: Issued August 30 2002; published September 6, 2002 (67 FR 56942).

Interim Final Rule: Issued November 8 2002; published November 19, 2002 (67 FR 69668).

Final Decision: Issued April 5, 2004; published April 9, 2004 (69 FR 18834).

The findings and determinations hereinafter set forth supplement those that were made when the Pacific Northwest order was first issued and when it was amended. The previous findings and determinations are hereby ratified and confirmed, except where they may conflict with those set forth herein.

The following findings are hereby made with respect to the Pacific Northwest order:

(a) Findings upon the basis of the hearing record. Pursuant to the provisions of the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), and the applicable rules of practice and procedure governing the formulation of marketing agreements and marketing orders (7 CFR part 900), a public hearing was held upon certain proposed amendments to the tentative marketing agreement and to the order regulating the handling of milk in the Pacific Northwest marketing area.

Upon the basis of the evidence introduced at such hearing and the record thereof it is found that:

(1) The Pacific Northwest order, as hereby amended, and all of the terms and conditions thereof, will tend to effectuate the declared policy of the Act;

(2) The parity prices of milk, as determined pursuant to section 2 of the Act, are not reasonable in view of the price of feeds, available supplies of feeds, and other economic conditions which affect market supply and demand for milk in the marketing area, and the minimum prices specified in the order, as hereby amended, are such prices as will reflect the aforesaid factors, insure a sufficient quantity of pure and wholesome milk, and be in the public interest; and

(3) The Pacific Northwest order, as hereby amended, regulates the handling of milk in the same manner as, and is applicable only to persons in the respective classes of industrial and commercial activity specified in, a marketing agreement upon which a hearing has been held.

(b) Additional Findings. It is necessary in the public interest to make these amendments to the Pacific Northwest order effective July 1, 2004. Any delay beyond that date would tend to disrupt the orderly marketing of milk in the aforesaid marketing area.

The amendments to these orders are known to handlers. The final decision containing the proposed amendments to these orders was issued on April 5, 2004.

The changes that result from these amendments will not require extensive preparation or substantial alteration in the method of operation for handlers. In view of the foregoing, it is hereby found and determined that good cause exists for making these order amendments effective July 1, 2004. It would be contrary to the public interest to delay the effective date of these amendments for 30 days after their publication in the Federal Register . (Section 553(d), Administrative Procedure Act, 5 U.S.C. 551-559.)

(c) Determinations. It is hereby determined that:

(1) The refusal or failure of handlers (excluding cooperative associations specified in Sec. 8c(9) of the Act) of more than 50 percent of the milk that is marketed within the specified marketing area to sign a proposed marketing agreement tends to prevent the effectuation of the declared policy of the Act;

(2) The issuance of this order amending the Pacific Northwest order is the only practical means pursuant to the declared policy of the Act of advancing the interests of producers as defined in the order as hereby amended;

(3) The issuance of the order amending the Pacific Northwest order is favored by at least two-thirds of the producers who were engaged in the production of milk for sale in the marketing area.

Specifically, this final rule permanently adopts a “cooperative pool manufacturing plant” provision and continues system pooling for cooperative manufacturing plants. Additionally, this final rule permanently adopts a diversion limit of 80 percent of total producer receipts for a pool plant, continues the standard for the number of days during the month that the milk of a producer would need to be delivered to a pool plant in order for the rest of the milk of that producer to be eligible to be diverted to nonpool plants, and maintains the authority granted to the market administrator to adjust the touch-base standard.

Section 319.312 of FSIS regulations requires that the products labeled as “Beef with Barbecue Sauce” and “Pork with Barbecue Sauce” contain a minimum of 50 percent cooked meat of the species identified on the label, that the cooked meat be reduced by cooking to no more than 70 percent of the weight of the uncooked meat, and if uncooked meat is used to produce the product, the product contain at least 72 percent meat computed on the weight of the uncooked meat.

Some standards of identity have been promulgated with meat yield requirements, e.g. , “Hash” (§ 319.302), “Corned Beef Hash” (§ 319.303) and “Beef or Pork with Barbecue Sauce” (§ 319.312). Other meat and sauce products, such as “Meat Stews” (§ 319.304), “Beans with Frankfurters in Sauce, Sauerkraut with Wieners and Juice, and similar products' (§ 319.309), and “Beef with Gravy and Gravy with Beef” (§ 319.313), have minimum meat content requirements but do not require specific cooked or uncooked meat yields. There is no yield requirement for these mentioned products because the meat component used to make these latter products is typically pre-cooked and not cooked in the sauce.

FSIS was petitioned by the American Meat Institute to amend FSIS” regulations by removing a cooked meat yield requirement and a raw meat yield requirement for the food standards “Beef with Barbecue Sauce” and “Pork with Barbecue Sauce.” The petitioner stated that the food standard, promulgated in 1952, does not reflect the conditions of commercial marketability of beef or pork with barbecue sauce, and that given today's cooking methods and leaner meat cuts, a beef or pork item can be fully cooked at yields well above 70 percent. Further, these obsolete requirements place producers of these products at a competitive disadvantage with respect to manufacturers of similar products, such as “Beef with Gravy”, who do not have such requirements.

FSIS agrees with the petitioner's assertion that the subject standard of identity does not reflect the current conditions of commercial marketability of beef or pork with barbecue sauce. FSIS believes consumers are best served by promoting consistent standards among similar types of meat and poultry with sauce products. In this way, consumers can be assured that the same types of rules are applied to protect them from deceptive products so that they receive products with the essential components and the characteristics they expect.

Therefore, on September 3, 1997 (62 FR 46450), FSIS proposed to revise 9 CFR part 319 by removing the meat yield requirements for the beef and pork with barbecue sauce food standards. FSIS had not acted to remove the meat yield requirements sooner because of other, higher-priority regulatory initiatives.

In response to the proposed rule, FSIS received 7 comments. After carefully analyzing the comments, FSIS has decided to adopt the proposed rule.

FSIS received 7 comments from trade and professional organizations and food companies. Five commenters supported the revision and two opposed it. FSIS responses to the comments follow.

Comment: One commenter stated that 9 CFR 319.312 is outdated and does not accurately reflect cooking yields resulting from today's advanced cooking methods. This commenter also stated that a revision of the standard will encourage broader competition and will result in a wider variety of products of this type in the marketplace.

Response: FSIS agrees with this position. Revision of the regulation should promote the development of new and innovative products.

Comment: Three commenters expressed the opinion that the rule should be expanded to include other competitive products that require maximum cooking yields as part of the product's standards.

Response: FSIS does not agree with this comment. An expansion of this proposal to include other competitive products would not be within the scope of this rulemaking.

Comment: One commenter stated that FSIS should consider the potential impact of this rulemaking on manufacturers of standardized poultry products.

Response: This rulemaking will achieve consistency between the meat and poultry standards of identity in the regulations. The poultry standards do not include yield requirements.

Comment: Three commenters stated that this rulemaking would provide consistency with requirements for other meat with sauce products.

Response: FSIS agrees with this statement. The revision will eliminate the requirement for specific cooked meat yields for these two products and result in a standard that is consistent with requirements for other similar meat and poultry with sauce-type standardized products, e.g. , beef with gravy. Consumers can be assured that the same types of rules apply to protect them from deceptive meat and poultry sauce-type products so that they receive products with the essential characteristics they expect.

Comment: Two commenters who produce beef and pork with barbecue sauce were opposed to the revision of the regulation. They stated that such a revision would result in an economic hardship for their food companies given the large investments in equipment that they have made to facilitate manufacture of their product lines. These two commenters stated that the proposed revision would result in products containing less protein and more moisture and fat, resulting in economic adulteration.

Response: FSIS does not believe that an economic hardship would result from the proposed revision of the regulation. As explained in the section on the benefits of this final rule below, manufacturers will not need to purchase new equipment. They will modify their yield by altering cooking times and temperatures. FSIS also disagrees with the commenters' position that products containing less protein and more fat and moisture automatically constitute economic adulteration. Consumers can rely on the nutrition facts and ingredients statement that are required on the labels of meat and poultry products to be informed of the protein, fat, and other constituents of the products they purchase. They can use this information to make comparisons between products they wish to purchase.

This rule has been determined to be not significant and therefore has not been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

The current standard, 9 CFR 319.312, requires that products labeled as “Beef with Barbecue Sauce” and “Pork with Barbecue Sauce” must contain a minimum of 50 percent cooked meat of the species identified on the label, that the cooked meat must be reduced by cooking to no more than 70 percent of the weight of the uncooked meat, and that if uncooked meat is used to produce the product, the product must contain at least 72 percent meat computed on the weight of the uncooked meat. This final rule will provide consistency among meat and sauce food standards by removing the meat yield requirements for the food standard “Beef with Barbecue Sauce” and “Pork with Barbecue Sauce”. It will leave unchanged the minimum meat content requirement. Removal of the meat yield requirement will bring this food standard in line with other food standards for other meat and sauce products.

The standard for beef with barbecue sauce and pork with barbecue sauce requires the product be cooked and have not less than 50 percent beef or pork. Usually the beef or pork meat used in this product is derived from larger cuts of beef or pork. Mechanically separated pork may be used in accordance with 9 CFR 319.6 (FSIS has determined that mechanically separated beef is inedible and has prohibited its use for human food). Beef or pork with barbecue sauce is marketed in supermarkets and merchandise discount stores as either frozen or canned.

The industry is comprised of several hundred manufacturers who either conduct beef or pork slaughter and processing operations or only processing operations. Typically, these firms produce a broad range of processed products using beef, pork, or other meats. The majority of the manufacturers of beef with barbecue sauce or pork with barbecue sauce are located in the southeastern region of the United States and are considered small entities because they employ fewer than 500 employees. 1

The final rule will modernize the food standard for beef with barbecue sauce and pork with barbecue sauce to provide consistency with other meat and sauce food standards. Second, it will reflect the improvements in technology and the marketing of beef with barbecue sauce and pork with barbecue sauce products. Third, it will potentially reduce manufacturers highest component (meat) cost in producing beef or pork with barbecue sauce, and, therefore, it will result in savings that can be passed along to consumers through lower prices. Fourth, it will permit manufacturers to produce meat products with 70 percent or greater yield without requiring the purchase of new injection equipment.

Deleting the yield requirement in the food standard for beef or pork with barbecue sauce will allow manufacturers of these products to compete on an equitable basis with manufacturers who produce other meat with sauce products, because food standards for other meat with sauce products do not include a cooking yield requirement.

Current injection and tumbling technology permits manufacturers to produce cooked meat that will exceed 70 percent yield of the uncooked meat. The Agency believes that the current standard for beef or pork with barbecue sauce is outdated and does not reflect modern processing practices. 2

The current practice is to supply meat products with high cook yields. Because of the technology that produces pumped meat, manufacturers can now supply cuts of meat that are moist and tender, which consumers have grown to expect. When the current standard was promulgated in 1952, the vacuum tumbling technology did not exist, and therefore the resulting pumped products were not available to consumers. Consumer expectations and preferences have evolved since the introduction of the vacuum tumbling technology. This final rule will permit manufacturers to supply pumped beef with barbecue sauce and pumped pork with barbecue sauce, meeting consumers' demands and preferences for pumped products.

This final rule also will permit manufacturers to increase their least costly component (barbecue sauce), while reducing their highest cost component (the cooked meat portion). For example, a manufacturer processes 100 pounds of beef and cooks it to a yield of 70% (per the existing regulations) to 70 pounds. The manufacturer is then allowed to make a maximum of 140 pounds of beef with barbecue sauce in order to meet the requirement for a 50% minimum of cooked meat content. Under this final rule, the manufacturer is allowed to cook the same 100 pounds of beef until it yields 75%. The manufacturer is then allowed to make a maximum of 150 pounds of beef with barbecue sauce. Thus the additional 10 pounds of beef with barbecue sauce is made up of an extra 5 pounds of the least costly component of the product, barbecue sauce. 3 Because of the lower cost of production to process these products, manufacturers can pass these cost savings to consumers in the form of lower prices.

Manufacturers may continue to produce products of beef with barbecue sauce and pork with barbecue sauce with 70 percent or greater yield without purchasing new injection equipment by (1) shortening the present cooking time, and (2) changing the cooking temperature so that fewer of the juices are cooked out of the meat and, therefore, the meat will reach a higher yield. By not requiring a cook yield, the final rule will open new markets for manufacturers in which they may produce products that exceed the current cook yield requirement.

The final rule should not impose any new cost burden on manufacturers of beef with barbecue sauce and pork with barbecue sauce because these manufacturers are producing other products that meet the no meat yield requirement for cooked meat. All manufacturers who cook these products to meet the existing 70 percent yield requirement and those manufacturers who exceed the yield requirement will be in compliance.

FSIS has examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities. The agency has determined that the final rule will not have a significant impact on a substantial number of small entities.

Since the majority of the industry is comprised of small entities, and the final rule does not impose additional cost, these small entities will not suffer a significant adverse impact on their business operations and profits.

Small entities that are offering beef with barbecue sauce and pork with barbecue sauce products that do not exceed the 70 percent meat yield requirement when cooked will not be put at a disadvantage by the final rule. These small entities can continue to produce meat products that meet the 70 percent yield content.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 390.7 must be exhausted prior to any judicial challenge of the application of the provisions of this rule, if the challenge involves any decision of an FSIS employee relating to a denial of access of information.

There are no paperwork or recordkeeping requirements associated with this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities, are aware of this final rule, FSIS will announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov.

The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at http://www.regulations.gov.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

This amendment to 14 CFR 71 modifies the Class E surface area and the Class E airspace area extending upward from 700 feet AGL at Chadron, NE. An examination of controlled airspace for Chadron, NE revealed that neither airspace area is in compliance with FAA Orders 7400.2E, Procedures for Handling Airspace Matters, and 8260.19C, Flight Procedures and Airspace. The extension to the Class E surface area is redefined relative to the Whitney nondirectional radio beacon and the area is enlarged from a 4.2 to a 5.7-mile radius of Chadron Municipal Airport. The Class E airspace area extending upward from 700 feet AGL is increased from a 7.4 to a 10.7-mile radius of Chadron Municipal Airport in order to provide required airspace for diverse departures. The Chadron Municipal Airport ARP is corrected in the legal description. These modifications bring the legal descriptions of the Chadron, NW Class E airspace areas into compliance with FAA Orders 7400.2E and 8260.19C. Class E airspace areas designated as surface areas are published in Paragraph 6002 of FAA Order 7400.9L, Airspace Designations and Reporting Points, dated September 2, 2003, and effective September 16, 2003, which is incorporated by reference in 14 CFR 71.1. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of the same Order. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment, or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments re specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitting in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18012/Airspace Docket No. 04-ACE-41.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have 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. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295) and the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) established the requirement that a preamendments device that FDA has classified into class III is subject to premarket approval. A preamendments class III device may be commercially distributed without an approved PMA or a notice of completion of a PDP until 90 days after FDA issues a final rule requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the act, whichever is later. Also, a preamendments device subject to the rulemaking procedure under section 515(b) of the act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final rule requiring the submission of a PMA for the device. At that time, an IDE is required only if a PMA has not been submitted or a PDP completed.

When a rule to require premarket approval for a preamendments device is finalized, section 501(f)(2)(B) of the act (21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for any such device be filed within 90 days of the date of issuance of the final rule or 30 months after the final classification of the device under section 513 of the act, whichever is later. If a PMA or notice of completion of a PDP is not filed by the later of the two dates, commercial distribution of the device is required to cease.

The device may, however, be distributed for investigational use if the manufacturer, importer, or other sponsor of the device complies with the IDE regulations. If a PMA or notice of completion of a PDP is not filed by the later of the two dates, and no IDE is in effect, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the act, and subject to seizure and condemnation under section 304 of the act (21 U.S.C. 334) if its distribution continues. Shipment of devices in interstate commerce will be subject to injunction under section 302 of the act (21 U.S.C. 332), and the individuals responsible for such shipment will be subject to prosecution under section 303 of the act (21 U.S.C. 333). In the past, FDA has requested that manufacturers take action to prevent the further use of devices for which no PMA has been filed and may determine that such a request is appropriate for the class III devices that are the subjects of this regulation.

The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed. The House Report on the 1976 amendments states that:

In the Federal Register of November 18, 2003 (68 FR 65014) (the November 18, 2003, proposed rule), FDA issued a proposed rule to require the filing of a PMA or a notice of completion of a PDP for the indwelling blood oxyhemoglobin concentration analyzer, the cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. In accordance with section 515(b)(2)(A) of the act, FDA included in the preamble to the proposed rule the agency's proposed findings regarding the degree of risk of illness or injury intended to be eliminated or reduced by requiring the device to meet the statute's approval requirements as well as the benefits to the public from use of the device.

The November 18, 2003, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's proposed findings. In accordance with section 515(b)(2)(A) of the act, FDA also provided an opportunity for interested persons to request a change in the classification of the device based on new information relevant to its classification. Any petition requesting a change in the classification of these devices was required to be submitted by December 3, 2003. The comment period closed February 17, 2004.

FDA received no petitions requesting a change in the classification of any of the three devices. One comment was addressed to the docket of the proposed rule. This comment inquired as to when FDA would approve a certain device that was not one of the devices that were the subject of the November 18, 2003, proposed rule. The comment was irrelevant and FDA addressed it outside of the rulemaking process.

An indwelling blood oxyhemoglobin concentration analyzer is a photo electric device used to measure, in vivo, the oxygen carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.

An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).

Under section 515(b)(3) of the act, FDA is adopting the findings as published in the November 18, 2003, proposed rule. As required by section 515(b) of the act, FDA published its findings regarding the following information: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that these devices have an approved PMA or a declared completed PDP, and (2) the benefits to the public from the use of the device.

These findings are based on the reports and recommendations of the advisory committees (panels) for the classification of these devices along with any additional information that FDA has discovered. Additional information can be found in the following proposed and final rules published in the Federal Register on these dates: Anesthesiology devices, 21 CFR part 868 (44 FR 63292, November 2, 1979, and 47 FR 31130, July 16, 1982); cardiovascular devices, 21 CFR part 870 (44 FR 13284, March 9, 1979 and 45 FR 7903, February 5, 1980); and neurological devices, 21 CFR part 882 (43 FR 55639, November 28, 1978, and 44 FR 51725, September 4, 1979).

Under section 515(b)(3) of the act, FDA adopts the findings as published in the preamble of the November 18, 2003, proposed rule and issues this final rule to require premarket approval of the indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. This final rule revises parts 868, 870, and 882 (21 CFR parts 868, 870, and 882).

Under the final rule, a PMA or a notice of completion of a PDP is required to be filed within 90 days after date of publication of this rule in the Federal Register (see DATES ), for any indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, or ocular plethysmograph that was in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before that date. If a PMA or notice of completion of a PDP is filed for any such device within this time limit, the applicant will be permitted to continue marketing its device during FDA's review of its submission. Any other indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, or ocular plethysmograph that was not in commercial distribution before May 28, 1976, is required to have an approved PMA or a declared completed PDP in effect before it may be marketed.

If a PMA or a notice of completion of a PDP for an indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, or ocular plethysmograph is not filed on or before 90 days after date of publication of this rule in the Federal Register , that device is deemed adulterated under section 501(f)(1)(A) of the act, and commercial distribution of the device must cease immediately. The device may, however, be distributed for investigational use, if the requirements of the investigational device exemption (IDE) regulations (part 812) are met.

The exemptions in § 812.2(c)(1) and (c)(2) from the requirements of the IDE regulations for preamendments class III devices cease to apply to any indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, or ocular plethysmograph that is: (1) Not legally on the market 90 days after date of publication of this rule in the Federal Register ; or (2) legally on the market by, but for which a PMA or notice of completion of a PDP is not filed by 90 days after date of publication of this rule in the Federal Register , or for which PMA approval has been denied or withdrawn. FDA cautions that manufacturers who are not immediately planning to submit a PMA or notice of completion of a PDP should submit IDE applications to FDA by 60 days after date of publication of this rule in the Federal Register , to minimize the possibility of interrupting shipment of the device. At this time, FDA is not aware of any firm that is marketing these devices.

A PMA for these devices must include the information required by section 515(c)(1) of the act. Such a PMA should also include a detailed discussion of the risks identified previously, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on the following requirements: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

A PMA should include valid scientific evidence “obtained from well-controlled clinical studies, with detailed data,” in order to provide reasonable assurance of the safety and effectiveness of the device for its intended use. (See 21 CFR 860.7(c)(2)).)

Information about the premarket approval process is available from FDA's Center for Devices and Radiological Health (CDRH) on the Internet at http://www.fda.gov/cdrh/devadvice/pma/.

A PDP for any of these devices may be submitted in lieu of a PMA, and must follow the procedures outlined in section 515(f) of the act. A PDP should provide the following information: (1) A description of the device, (2) preclinical trial information (if any), (3) clinical trial information (if any), (4) a description of the manufacturing and processing of the devices, (5) the labeling of the device, and (6) all other relevant information about the device. In addition, the PDP must include progress reports and records of the trials conducted under the protocol on the safety and effectiveness of the device for which the completed PDP is sought.

Information about the PDP process is also available from CDRH on the on the Internet at http://www.fda.gov/cdrh/devadvice/pma/app_methods.html#product_dev.

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because there have been no premarket submissions for these devices in the past 5 years, and because FDA is not aware of any firms marketing these devices, the agency has concluded that there is little or no interest in marketing these devices. The agency, therefore, certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $110 million. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA). The burden hours required for § 884.5320(c), included in the collection entitled “Premarket Approval of Medical Devices—21 CFR Part 814,” are reported and approved under OMB control number 0910-0231. Therefore, clearance by OMB under the PRA is not required.

On May 26, 2004, the Department of Labor published final regulations on the notice provisions of part 6 of title I of ERISA. The regulations comprise four sections. Section 2590.606-1 establishes the time frames within which the general notice of continuation coverage must be provided and describes the specific information that the general notice must contain. Paragraph (d) of § 2590.606-1 permits delivery of a single notice addressed to a covered employee and the covered employee's spouse at their joint residence, provided that the plan's latest information indicates that both reside at that address. paragraph (d) states, on page 30097, that “nothing in this section shall be construed to create a requirement to provide a separate notice to dependent children who share a residence with a covered employer or a covered employee's spouse to whom notice is provided in accordance with this section.” The term “covered employer” in this sentence is an inadvertent error and should instead be “covered employee.”

In an appendix to § 2590.606-4, the Department also published a Model COBRA Continuation Coverage Election Notice for use by single-employer group health plans. The section of the model notice entitled “Important Information About Your COBRA Continuation Coverage Rights” states, on page 30108, that continuation coverage will be terminated before the end of the maximum period if, among other things, “a covered employee becomes entitled to Medicare benefits (under part A, Part B, or both) after electing continuation coverage.” The term “covered employee” on this page is an inadvertent error and should be changed “qualified beneficiary.”

This correction replaces two phrases with the correct terminology to prevent confusion and improve the clarity of the regulation and model notice.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard finds that this rule is exempt from notice and comment rulemaking requirements because some of these changes involve agency organization and practices, and good cause exists for not publishing an NPRM for all revisions in the rule because they are all non-substantive changes. This rule consists only of corrections and editorial, organizational, and conforming amendments. These changes will have no substantive effect on the public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

Each year title 33 of the Code of Federal Regulations is updated on July 1. This rule, which becomes effective June 30, 2004, corrects organization names and addresses, and makes other technical and editorial corrections throughout title 33. This rule does not create any substantive requirements.

Some of the revisions in this rule are not necessarily self-explanatory changes. For example, in § 4.02 we updated the listing of approved collections of information based on information requirements in Title 33. In parts 101 and 104, we replaced SOLAS “Chapter XI” references with “Chapter XI-1 or Chapter XI-2” to conform these chapter references to the Federal Register approved reference, used in the relevant incorporation by reference section, § 101.115(b). In §§ 118.3, 127.003, 140.7, 154.106, 164.03, 181.4, and 183.5, we changed references to material incorporated by reference as being “available for inspection” rather than merely “on file” to align these sections with other incorporation by reference sections.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. As this rule involves internal agency practices and procedures and non-substantive changes, it will not impose any costs on the public.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. 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. This rule does not require a general NPRM and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impact on small entities.

This rule will have no substantive effect on the regulated public. Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We note, however, that in 33 CFR 4.02, this rule updates the listing of approved collections of information based on information requirements contained in title 33.

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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 or more in any one year. Though this rule will not result in an expenditure of this magnitude, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraphs (34)(a) and (b), of the Instruction from further environmental documentation because this rule involves editorial, procedural, and internal agency functions. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

We did not publish a notice of rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

Temporary safety zones are necessary to ensure the safety of vessels and spectators from the hazards associated with fireworks displays. Based on recent accidents that have occurred in other Captain of the Port zones, and the explosive hazard of fireworks, the Captain of the Port Buffalo has determined fireworks launches in close proximity to watercraft pose significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the locations of the launch platforms will help ensure the safety of persons and property at these events and help minimize the associated risk.

The safety zone consists of all navigable waters of the St Lawrence River within a 300-yard radius of the fireworks display on Heart Island located in position 44°20′40″ N, 075°55′21″ W. All Geographic coordinates are North American Datum of 1983 (NAD 83). The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents.

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or his designated on-scene patrol representative. The designated on-scene patrol representative will be the patrol commander. Entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS).

This determination is based on the minimal time that vessels will be restricted from the zone, and therefore minor if any impacts to Mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant impact on a substantial number of small entities. 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.

This rule will affect the following entities, some of which might be small entities: The owners or operators of commercial vessels intending to transit a portion of an activated safety zone.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone is only in effect from 9:30 p.m. until 11:30 p.m. (local) on the day of the event.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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 so that they can better evaluate its effects and participate in the rulemaking process. 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 Marine Safety Office Buffalo ( see ADDRESSES. )

Small businesses may send comments on 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).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

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 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.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b) (2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard has analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. A written categorical exclusion determination is available in the docket for inspection or copying where indicated under ADDRESSES.

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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We did not publish a notice of rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this rule effective less than 30 days after publication in the Federal Register . The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

Temporary safety zones are necessary to ensure the safety of vessels and spectators from the hazards associated with fireworks displays. Based on recent accidents that have occurred in other Captain of the Port zones, and the explosive hazard of fireworks, the Captain of the Port Buffalo has determined fireworks launches in close proximity to watercraft pose significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the locations of the launch platforms will help ensure the safety of persons and property at these events and help minimize the associated risk.

The safety zone consists of all navigable waters of Lake Oneida within a 200-yard radius of the fireworks display around a barge located in position 43°14′15″ N, 076°08′03″ W. All Geographic coordinates are North American Datum of 1983 (NAD 83). The size of this proposed zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents.

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or his designated on-scene patrol representative. The designated on-scene patrol representative will be the patrol commander. Entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

This determination is based on the minimal time that vessels will be restricted from the zone, and therefore minor if any impacts to mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant impact on a substantial number of small entities. 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.

This rule will affect the following entities, some of which might be small entities: The owners or operators of commercial vessels intending to transit or anchor in the activated safety zone.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone is only in effect from 9:30 p.m. until 11:30 p.m. (local) on the day of the event.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule will economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects and participate in the rulemaking process. 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 Marine Safety Office Buffalo ( see ADDRESSES ).

Small businesses may send comments on 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).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

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 or more in any one year. Though this rule does not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference With Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard has analyzed this rule under Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

We have considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation. A written categorical exclusion determination is available in the docket for inspection or copying where indicated under ADDRESSES .

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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The Coast Guard did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM, and 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 . The permit application was not received in time to publish an NPRM followed by a final rule before the necessary effective date. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. The Coast Guard has not received any complaints or negative comments previously with regard to this event.

A temporary safety zone is necessary to ensure the safety of vessels and spectators from the hazards associated with fireworks displays. Based on accidents that have occurred in other Captain of the Port zones and the explosive hazard of fireworks, the Captain of the Port Detroit has determined fireworks launches in close proximity to watercraft pose significant risks to public safety and property.

The likely combination of large numbers of recreational vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at these events and help minimize the associated risks.

The safety zone will encompass all waters of Lake Huron within a 300-yard radius of the fireworks launch platform in approximate position 43°51′00″ N, 082°38′15″ W. The geographic coordinates are based upon North American Datum 1983 (NAD 83). The size of this zone was determined using the National Fire Prevention Association guidelines and local knowledge concerning wind, waves, and currents.

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene patrol representative. Entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Detroit or his designated on-scene representative. The designated on-scene representative will be the Patrol Commander. The Patrol Commander may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed this rule under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DHS is unnecessary. This determination is based on the minimal time that vessels will be restricted from the safety zone.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. 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 for the following reasons: This safety zone is only in effect from 8 p.m. until 11 p.m. on the day of the event and allows vessel traffic to pass outside of the safety zone. Before the effective period, the Coast Guard will issue maritime advisories widely available to users of Lake Huron by the Ninth Coast Guard District Local Notice to Mariners and Marine Information Broadcasts. Facsimile broadcasts may also be made.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment ( see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), small entities may be assisted in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction or if you have questions concerning its provisions or options for compliance, please contact Marine Safety Office Detroit ( see ADDRESSES ).

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).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132 if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. The coast Guard analyzed this rule under that Order and has determined that it does not have implications for federalism.

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 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.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

The Coast Guard has analyzed this rule under Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard has analyzed this rule under Commandant Instruction M16475.1D, which guides their compliance with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this rule that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

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.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

The Coast Guard has analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use, and has determined that it is not a “significant energy action” under that Order, because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

On October 1, 2003, the Postal Service published a general revision of its rules dealing with records and information (68 FR 56557). This revision updated terminology to reflect the Postal Service's current organizational structure, removed obsolete or duplicative provisions, and revised the fee schedule for disclosure of information where necessary. Further inspection of the affected provisions indicates that minor additional revisions are necessary to remedy oversights in the previous notice and avoid possible confusion. Accordingly, the Postal Service makes the following revisions effective immediately.

Throughout this document, wherever “we,” “us,” or “our” is used, we mean the EPA. Information is organized as follows:

On May 10, 2004, EPA published in the Federal Register , a proposal to approve the Anchorage, Alaska CO maintenance plan SIP revision and to redesignate the Anchorage CO nonattainment area to “attainment” for CO. See 69 FR 25869.

The action to redesignate the Anchorage, Alaska nonattainment area to attainment for CO is based on valid monitoring data and projections of ambient air quality made in the maintenance demonstration that accompanies the maintenance plan. Air quality data shows that it has not recorded a violation of the primary or secondary CO air quality standards since 1996. EPA believes the area will continue to meet the National Ambient Air Quality Standards (NAAQS or standards) for CO for at least 10 years beyond this redesignation, as required by the Act.

A detailed description of our action to approve the Anchorage, Alaska CO maintenance plan and redesignation request was published in a proposed rulemaking in the Federal Register on May 10, 2004 (69 FR 25869).

EPA provided a 30-day review and comment period and solicited comments on our proposal published in the May 10, 2004, Federal Register . No comments were received for the proposed rulemaking. EPA is now taking final action on the SIP revision consistent with the published proposal.

EPA is taking final action to approve the Anchorage CO Maintenance Plan and to redesignate the Anchorage CO nonattainment area to attainment. Alaska has demonstrated compliance with the requirements of section 107(d)(3)(E) based on information provided by the Municipality of Anchorage and contained in the Alaska SIP and Anchorage, Alaska CO maintenance plan. A Technical Support Document on file at the EPA Region 10 office contains a detailed analysis and rationale in support of the redesignation of Anchorage's CO nonattainment area to attainment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does 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).

This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. section 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 rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . 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. section 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 23, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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).)

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111), e.g., farmer.

• Animal production (NAICS 112), e.g., rancher.

• Food manufacturing (NAICS 311), e.g., restaurant.

• Pesticide manufacturing (NAICS 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

In the Federal Register of December 12, 2001 (66 FR 64251) (FRL-6809-8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1F6314) by 3M Corporation, 3M Center, St. Paul, MN 55144-1000. This notice included a summary of the petition prepared by the petitioner 3M Corporation. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of C8, C10, and C12 straight-chain fatty acid monoesters of glycerol and propylene glycol.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . . ” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The fatty acid monoesters of glycerol and propylene glycol are six closely-related monoesters of C8, C10, and C12 straight-chain fatty acids. There are three glycerol monoesters (glycerol monocaprylate, glycerol monocaprate, and glycerol monolaurate), and three propylene glycol monoesters (propylene glycol monocaprylate, propylene glycol monocaprate, and propylene glycol monolaurate).

In vertebrate organisms (including humans), glycerol fatty acid monoesters are formed naturally as part of the metabolism of triglycerides. They also occur naturally in vegetable oils (e.g., coconut and palm oils) and in saw palmetto leaves and berries. Glycerol fatty acid monoesters are, in addition, used as direct food additives. Propylene glycol fatty acid monoesters, also used as direct food additives, are naturally metabolized in vertebrate systems in an identical manner to the glycerol fatty acid monoesters.

Toxicity studies supporting this tolerance exemption are referenced below. More detailed analyses of these studies can be found in the specific Agency review of the studies (Ref. 1). Additional information relevant to toxicity also has been published and is cited in Ref. 2.

Acute toxicity studies were generated to support EPA registration of the C8, C10, and C12 straight-chain fatty acid monoesters of glycerol and propylene glycol as biochemical pesticides. In all studies, EPA limit doses were used, and the test compounds were found to be non-toxic at the limit dose, but all tests were not conducted on each of the six active ingredients. Instead, a full acute toxicity test battery (6 studies) was generated for the C8 propylene glycol monoester (propylene glycol monocaprylate) and for the C12 glycerol ester (glycerol monolaurate), thereby bounding the chemical structures of all six active ingredients. In addition, because all six active ingredients are known to be identical with respect to acute toxicity and metabolism, a 90-day rat oral toxicity study was conducted on propylene glycol monocaprylate only. The registrant requested and was granted waivers from toxicity testing for the additional monoesters (Ref. 3), since the metabolism and toxicity of the active ingredients have been well-documented for many years in the scientific literature. This represented all six active ingredients.

1. Acute oral toxicity for glycerol monolaurate (OPPTS Harmonized Guideline 870.1100; 152-10; MRID 45405505): Non-toxic . Fasted rats (three male and three female) received a single oral gavage of glycerol monolaurate formulated in corn oil and administered at a dose level of 5,000 milligrams/kilogram of body weight (mg/kg bwt). All rats survived and gained weight throughout the study with the exception of one female with a slight weight loss on the final day. Piloerection and increased salivation were observed in all rats within minutes of dosing. Normal salivation resumed shortly after dosing and piloerection resolved by day 3 in males and day 4 in females. No abnormalities were revealed in any rats at the macroscopic examination at study termination on day 15. The acute oral lethal dose (LD) 50 for rats was > 5,000 mg/kg. Classification: Acceptable; Toxicity Category IV (Ref. 4).

2. Acute oral toxicity for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.1100; 152-10; MRID 45428501): Non-toxic . Fasted rats (three males and three females) received a single oral gavage of propylene glycol monocaprylate administered at a dose of 5,000 mg/kg bwt. All rats survived and gained weight throughout the study. Piloerection (all rats) and increased salivation (one female only) were evident within a few minutes of dosing, with piloerection persisting for the remainder of day 1. Piloerection was resolved by day 2 in females and by day 4 in males. No abnormalities were revealed in any animal at the macroscopic examination at study termination on day 15. The acute oral LD 50 for rats was > 5,000 mg/kg. Classification: Acceptable; Toxicity Category IV (Ref. 5).

3. Acute dermal toxicity for glycerol monolaurate (OPPTS Harmonized Guideline 870.1200; 152-11; MRID 45428501): Non-toxic . Ten rats (five males and five females) received a single topical application of glycerol monolaurate formulated in corn oil and administered at a dose of 5,000 mg/kg bwt. All rats survived and had normal weight gains throughout the study, with the exception of two females with low or no weight gain during week 1. No clinical signs of reaction to treatment were observed in any animal throughout the study, and no macroscopic abnormalities were observed in any animal at study termination on day 15. The acute dermal LD 50 for rats was > 5,000 mg/kg. Classification: Acceptable; Toxicity Category IV (Ref. 6).

4. Acute dermal toxicity for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.1200; 152-11; MRID 45428503): Non-toxic . Ten rats (five males and five females) received a single topical application of propylene glycol monocaprylate at a dose of 5,000 mg/kg bwt. All rats survived and gained weight, with the exception of one female with a slight weight loss during week 2. No macroscopic abnormalities were observed in any animal at study termination on day 15. The acute dermal LD 50 for rats was > 5,000 mg/kg. Classification: Acceptable; Toxicity Category IV (Ref. 7).

5. Acute inhalation for glycerol monolaurate (OPPTS Harmonized Guideline 870.1300; 152-12; MRID 45405506): Harmless by inhalation . In all instances, the aerosol generator was blocked following the start of generation. The waxiness of glycerol monolaurate made it impossible to generate aerosols. Because respirable particles cannot be produced from such low-melting waxy materials, the test substance is considered harmless by the inhalation route of exposure under normal handling conditions. Classification: Acceptable; Toxicity Category IV (Ref. 8).

6. Acute inhalation for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.1300; 152-12; MRID 45405507): Non-toxic . Ten rats (five males and five females) were exposed for 4 hours to a droplet aerosol generated from propylene glycol monocaprylate at a target concentration of 5 mg/liter (L). Another group (five males and five females), exposed to clean dry air only, were controls. The mass median aerodynamic (MMAD) was 2.0 microns and was within the ideal range (1 micron to 4 microns) for an acute inhalation study. Approximately 88% of the particles were considered a respirable size (less than 7 microns in aerodynamic diameter). The lethal concentration (LC) 5O (4-hour inhalation) for propylene glycol monocaprylate was > 4.92 mg/L (4,920 ppm) in air. EPA's limit dose for this test is 2 mg/L. Classification: Acceptable; Toxicity Category IV (Ref. 9).

7. Eye irritation for glycerol monolaurate (OPPTS Harmonized Guideline 870.2400, 152-13, MRID 45405508): Slight irritant . Each of three rabbits was administered a single ocular dose of 0.1 milliliter (mL) (mean weight 60 mg) of glycerol monolaurate and observed for up to 7 days after instillation. The instillation in one animal elicited a corneal lesion and iritis (both Grade 1) 48 hours post-dose. All rabbits exhibited transient conjunctival inflammation (up to Grade 3). Resolution was complete in two instances within approximately 72 hours of dosing and, in one animal, 7 days after dosing. Glycerol monolaurate is considered a slight eye irritant. Classification: Acceptable; Toxicity Category III (Ref. 10).

8. Eye irritation for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.2400, 152-13, MRID 45405509): Slight irritant . Three rabbits were each administered a single ocular dose of 0.1 mL of propylene glycol monocaprylate and observed for up to 7 days after instillation. The test substance elicited a transient, slight to well-defined conjunctival irritation in two rabbits. Propylene glycol monocaprylate is not considered a major ocular irritant. Classification: Acceptable; Toxicity Category III (Ref. 11).

9. Skin irritation for glycerol monolaurate (OPPTS Harmonized Guideline 870.2500, 152-14, MRID 45405510): Non-Irritant. Each of three rabbits was administered a single dermal dose of 0.5 g of glycerol monolaurate under semi-occlusive conditions for 4 hours and observed for up to 7 days. The test material produced transient slight erythema in 2 animals that resolved by 72 hours; the third animal had well-defined erythema at 48 hours that resolved by day 7. Glycerol monolaurate is not considered a dermal irritant. Classification: Acceptable; Toxicity Category IV (Ref. 12).

10. Skin irritation for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.2500, 152-14, MRID 45405511): Non-irritant . Each of three rabbits was administered a single dermal dose of 0.5 mL of propylene glycol monocaprylate under semi-occlusive conditions for 4 hours and observed for up to 11 days. The test substance produced only slight erythema in all animals. Propylene glycol monocaprylate is not considered a dermal irritant. Classification: Acceptable; Toxicity Category IV (Ref. 13).

11. Skin sensitization for glycerol monolaurate (OPPTS Harmonized Guideline 870.2600, 152-15, MRID 45428504): Non-sensitizer . Guinea pigs (10 test and 5 control) were dosed by intradermal injection and topical application. Based on the results of a preliminary study, and in compliance with regulatory guidelines, the following dose levels were selected:

Intradermal injection: 2.5% w/v (weight/volume) in sterile water.

Topical application: 10% w/v in sterile water.

Challenge applications: 0.5% and 1% w/v in sterile water.

12. Skin sensitization for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.2600, 152-15, MRID 45448201): Potential sensitizer . The guinea pigs (10 test and 5 control) were dosed by intradermal injection and topical application. Based on the results of a preliminary study and in compliance with the regulatory guidelines, the following dose levels were selected:

Intradermal injection: 0.5% v/v in sterile water.

Topical application: as supplied.

Challenge application: 25% and 50% v/v in sterile water.

13. 28-Day oral for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.3050, MRID 45441101): Non-toxic . The effects of propylene glycol monocaprylate (T-7475.8) were assessed in rats (groups of five males and five females) by oral gavage administration once a day for 4 weeks, employing dose levels of 0, 500, 750, or 1,000 mg/kg/day. Doses up to 1,000 mg/kg/day were well tolerated with the only effects noted being higher protein and albumin values and a higher lung and liver weight, all in females. In the absence of histopathological examination, the toxicological importance of these findings is unclear. However, it was considered that 1,000 mg/kg/day was well tolerated and that it would be suitable for use as a high dose level in the subsequent 13-week toxicity study. Classification: Acceptable (Ref. 16).

14. 13-Week oral for propylene glycol monocaprylate (OPPTS Harmonized Guideline 870.3100 and 870.7800, MRID 45428505): Non-toxic . The systemic toxicity of propylene glycol monocaprylate (T-7475.8) was assessed in groups of rats (20 males and 20 females per group) by oral gavage administration at 0, 100, 500, or 1,000 mg/kg/day dose levels for 13 weeks. There were no unscheduled deaths in any of the groups and clinical observation, neurotoxicity, metabolic parameters, and organ histopathology indicated no changes of toxicological significance. It was concluded that a dosage of 1,000 mg/kg/day was considered to be a no observable adverse effect level (NOAEL) for either sex. Classification: Acceptable (Ref. 17).

15. Genotoxicity . Fatty acid monoesters of glycerol and propylene glycol in vertebrate systems are immediately metabolized to polyols and free fatty acids. Upon ingestion these compounds become indistinguishable from those in living systems. Polyols and free fatty acids in living systems are not genotoxic. Hence, waivers were requested and granted for all genotoxicity testing requirements on the basis that conducting such tests would not be of value to EPA in its evaluation of risks. The fatty acid monoesters of glycerol and propylene glycol are already known not to be genotoxic from a metabolic standpoint.

16. Reproductive and developmental toxicity . On their metabolic basis, fatty acid monoesters of glycerol and propylene glycol and their natural breakdown products are known not to be reproductive or developmental toxicants. Waivers therefore were requested and granted for all such testing requirements on the basis that conducting such tests would not be of value to EPA in its evaluation of risks (for both the registration action and this tolerance exemption action).

17. Scientific literature on toxicity and metabolism . Basic toxicity testing on mono- and diacylglycerols and saturated fatty acids was conducted in the 1930-1960 period and included intermediate-term and long-term studies. Less work has been published on propylene glycol saturated fatty acid esters, but the available data are adequate to demonstrate equivalence between propylene glycol esters and acylglycerols. Comprehensive reviews of these chemicals prepared by a number of sources including the Food and Drug Administration (FDA) and the Food and Agricultural Organization of the United Nations (FAO) and the World Health Organization (WHO) are available through the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The no observed adverse effect levels (NOAELs) for monoacylglycerols, regardless of the saturated fatty acid, are similar. Rats can be fed from 10-15% in the diet for a lifetime without ill effects, dose levels corresponding to 5 g/kg bwt/day. Rats fed propylene glycol monosuccinate and monostearate at levels up to 10% of the diet for 6 months showed no evidence of gross or histological pathology attributable to treatment. Dogs fed at the same levels for 6 months showed no signs of toxicity.

The fatty acid moiety in monoacylglycerols is of no consequence because vertebrate systems are capable of metabolizing each of the acids in the range of C8 to C18 with equal facility. In fact, oxidation of fatty acids is a primary source of energy in vertebrate systems. Fatty acids are supplied in the diet in the form of triacylglycerols (fats) which are hydrolyzed by pancreatic lipase enzymes to form free fatty acids, glycerol and monoacylglycerols. The glycerol monoester active ingredients are indistinguishable from the natural acylglycerols and fatty acids found in the intestine following ingestion of fats. Specificity of the pancreatic lipase enzyme is independent of the nature of the fatty acid. It is also not stereospecific in its action and glycerol esters and propylene glycol esters are hydrolyzed by it with equal facility. Studies with 14C-labeled propylene glycol show that it is readily absorbed from the gastrointestinal tract and rapidly converted in the liver to 14C-glycogen or 14CO2. Similarly, when 14C-glycerol is administered to rats, radiolabel appears in expired CO2, blood glucose, liver glycogen, liver fat and liver phosphatides within 15 minutes. Within 6 hours, 40% of the label is contained in expired CO2 and the remainder is distributed through the test animal. Very small amounts are excreted.

FDA has looked at metabolism of propylene glycol mono- and distearates as model compounds to represent propylene glycol fatty acids. In studies on radiolabeled propylene glycol distearate the rate-limiting factor in the metabolism was found to be hydrolysis of the ester, which is complete in about 3 hours. In 5 hours, 94% of the propylene glycol is absorbed and 94% of the absorbed material is found in expired CO2 in 72 hours. The fatty acid portion of the ester is absorbed and metabolized more slowly than the propylene glycol. Only 51% of the stearic acid label was expired as CO2 in the same period.

In addition, there is a long history of consumption by humans of fatty acids and their monoesters in food and the Agency knows of no instance where these have been associated with any toxic effects related to the consumption of food. Due to this knowledge of fatty acid monoesters' presence and function in the human system (Ref. 2) and the recent acute testing, EPA believes the fatty acid monoesters are unlikely to be carcinogenic or have other long-term toxic effects.

The data from the toxicity studies (Ref. 1) and the additional information from the scientific literature submitted by the registrant (Ref. 2) are sufficient to support the current waiver requests, and to demonstrate that no substantial risks to human health are expected from the use of glycerol or propylene glycol fatty acid monoesters, when used in accordance with good agricultural practices and in accordance with all relevant labeling.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Aggregate dietary exposure estimates were generated using EPA's Dietary Exposure Potential Model (DEPM) customarily used by the agency. The model is designed to generate dietary exposure estimates by combining food consumption and residue data. In this case, food consumption data came from the 10 th National Food Consumption Survey conducted during the 3-year period of 1994-1996 by the Agricultural Research Service of the U.S. Department of Agriculture. These data are also known as the Continuing Survey of Food Intake by Individuals, 1994-1996 (CSFII 1994-1996).

1. Food . Food residue estimates were generated for use in the DEPM analysis to simulate broad use of the fatty acid monoesters of glycerol and propylene glycol. Specifically, residue estimates were constructed for all food commodities corresponding to 18 raw agricultural commodities (RACs) for which residue data were generated for the following major food groups: Fruits; vegetables; beverages; and infant food. In keeping with the worst case nature of the analysis, residue data for a tested commodity was used also for similar commodities not tested (e.g., spinach values were used for other delicate greens; kale values were used for other heavy greens such as collard; peach values were used for apricots). It was also assumed residue levels are not changed by cooking and that fruit and vegetable mixtures contain 50% of one or more RAC, unless the composition of the mixture is specified. Total dietary exposure estimates were generated using the model for the U.S. population and 20 subpopulations, including non-nursing infants and children. The subpopulation groups were defined by age, gender, geographic location, ethnicity and income level. All calculations represented residue levels assuming treatment of 100% of every commodity consumed in the U.S. for which residue estimates could be generated, another severe worst-case assumption. The model produced data tables containing the consumption of each food, its assumed residue level and the calculated exposure from that consumption in μg/kg-bwt/day for each of the subpopulations. For all subpopulation groups, the commodity that contributed in the analysis the most to exposure was cooked green beans. This result reflects the fact that green beans absorbed an unexpectedly large amount of treatment solution in the experimental procedure used to generate RAC residue estimates. Based upon the worst-case data and assumptions described above, the model calculated the highest exposure of 0.5 mg/kg bwt/day for non-nursing infants. Dietary exposure for the total U.S. population was less than 0.2 mg/kg bwt/day. These levels are below the FDA approved dosage for addition to prepared foods, and the highest dose accepted as a chronic NOAEL for either sex was 5,000 times higher (Ref. 17).

2. Drinking water exposure . All anticipated or proposed uses of glycerol and propylene glycol fatty acid monoesters will be indoors and the compounds are not soluble in water. Hence, drinking water is not a feasible route of exposure.

Glycerol fatty acid monoesters are natural components of dietary fats and natural breakdown products from metabolism of fat (triacylglycerol) in all living systems. Additionally, fatty acid esters of both glycerol and propylene glycol occur as direct food additives.

1. Dermal exposure . Results of the acute dermal toxicity studies for glycerol monolaurate and propylene glycol monocaprylate indicated no toxicity (Toxicity Category IV) at the maximum dose tested (5,000 mg/kg) with no significant dermal irritation (Toxicity Category IV). Based on these results, the anticipated risks from dermal exposure are minimal. Dermal sensitization may occur with the propylene glycol monoesters as the caprylate is a potential sensitizer. This risk, however, is mitigated as long as the products are used according to the precautionary statements on the label, which advise washing thoroughly with soap and water after handling and that prolonged or frequently repeated skin contact may cause allergic reactions in some individuals.

2. Inhalation exposure . Because the inhalation toxicity study for propylene glycol monocaprylate showed no toxicity (Toxicity Category IV), and the glycerol fatty acid monoesters are waxy solids at room temperature (not present as respirable particles), the risks anticipated for this route of exposure are minimal.

Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when considering whether to establish, modify, or revoke a tolerance, to consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” These considerations include the possible cumulative effects of such residues on infants and children.

In assessing their cumulative effects, the fatty acid monoesters of glycerol and propylene glycol are members of a much larger class of compounds that are toxicologically and metabolically equivalent. All vertebrate systems deal with this class of compounds as food rather than toxicants. Glycerol fatty acid monoesters are natural components in dietary fats and natural breakdown products from metabolism of fat (triacylglycerol) in all living systems. Fatty acid esters of propylene glycol also occur as direct food additives in the human diet in substantial quantities. The use of fatty acid monoesters of glycerol and propylene glycol as pesticides will contribute a negligible amount (total U.S. population worst case estimate less than 0.2 mg/kg/day) to the existing cumulative exposure to the class of compounds when compared to natural levels of such compounds and their metabolites in tissue and foods (50-100 g/day in humans for glycerol esters), and to the levels permitted in food as direct additives (grams per day). Accordingly, exposure to these monoesters as a result of their label directed use as pesticides on raw agricultural food or feed commodities will result in a negligible increase in the cumulative exposure to this class of compounds over the present exposure, occurring as a result of daily consumption by the human population of this class of compounds from both naturally occurring sources and processed foods.

1. U.S. population . It is doubtful harm will result from aggregate exposure to residues of the fatty acid monoesters of glycerol or propylene glycol in the U.S. population. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the very low levels of mammalian toxicity (no toxicity at the maximum doses tested, Toxicity Category IV) associated with the fatty acid monoesters of glycerol and propylene glycol and the long history of their consumption.

2. Infants and children . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines a different margin of exposure will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty factors. The registrant used the NOAEL of 1,000 mg/kg bwt/day determined in the 90-day oral toxicity study in rats to calculate an estimated exposure of the active ingredients to the U.S. population of 0.13 mg/kg bwt/day and to non-nursing infants of 0.44 mg/kg bwt/day. The corresponding margins of exposure were calculated to be 7,690 for the U.S. population and 2,270 for non-nursing infants (Ref. 2).

In this instance, based on all the available information, the Agency concludes that the C8, C10, and C12 monoesters of glycerol and propylene glycol are virtually non-toxic to mammals, including infants and children. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. Since no toxic endpoints have been identified, any hazard is impossible to determine. As a result, EPA has not used a margin of exposure approach to assess the safety of the C8, C10, and C12 monoesters of glycerol and propylene glycol. Based on their abundance in nature and long history of use by humans without deleterious effects, there is reasonable certainty that no harm will result from aggregate exposure to the U.S. population, including infants and children, to residues of these glycerol and propylene glycol straight-chain fatty acid monoesters. This includes all anticipated dietary exposures and all other exposures for which there are reliable information. Thus, the Agency has determined that the additional margin of safety is not necessary to protect infants and children and that not adding any additional margin of safety will be safe for infants and children.

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate. Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

Based on the weight of the evidence of available data, no endocrine system-related effects are identified for the C8, C10, or C12 fatty acid monoesters of glycerol or propylene glycol and none is expected since they are natural components of vertebrate systems. Thus, there is no impact via endocrine-related effects on the Agency's safety finding set forth in this Final Rule for C8, C10, or C12 fatty acid monoesters of glycerol or propylene glycol.

The Agency proposes to establish an exemption from the requirement of a tolerance for the C8, C10, and C12 straight-chain fatty acid monoesters of glycerol and propylene glycol without any numerical limitation, based on their lack of mammalian toxicity. Their use will create only minuscule exposures ( < 1 mg/kg bwt/day) when compared to the natural levels of such compounds in living tissue and in foods (50-100 grams (g)/day), and compared to the levels permitted in food as direct additives (g/day). Based on this, the Agency has concluded that an analytical method is not required for enforcement purposes for the fatty acid monoesters of glycerol or propylene glycol.

There are no CODEX values for the C8, C10, and C12 straight-chain saturated fatty acid monoesters of glycerol or propylene glycol.

Based on the toxicology data submitted and other information available to the Agency, there is reasonable certainty no harm will result to the U.S. population, including infants and children, from aggregate exposure of residues of the C8, C10, and C12 straight-chain fatty acid monoesters of glycerol or propylene glycol when the product is used in accordance with good agricultural practices and in accordance with all relevant labeling. This includes all anticipated dietary exposures and all other exposures about which there is reliable information. As a result, EPA is establishing an exemption from tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of the C8, C10, and C12 straight-chain fatty acid monoesters of glycerol and propylene glycol in or on all food commodities.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object ” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0379 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 23, 2004.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees. ”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2004-0379, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

1. USEPA. Science Review in Support of the Registration of the Technical Grade Active Ingredient (TGAI) Product, VMX-42 Technology Propylene Glycol Monocaprylate, memo from Jones, Russell S., Ph.D., to Carol E. Frazer, Ph.D., April 4, 2003.

2. Dubeck, J.B., S.M. Price, and A.P. Jovanovich. Petition Proposing an Exemption from Tolerance for Pesticide Residues in or on Raw Agricultural Commodities and Processed Food. 3M, St. Paul, MN. April 13, 2001.

3. Jovanovich, A.P., Ph.D., MBA. Application for Pesticide Registration VWX-42 Technology. Request for Waivers. May 2, 2001.

4. Blanchard, Emma L., B.Sc. (Hons.). Acute oral toxicity study. MRID 45405505.

5. Coleman, David G., B.Sc. (Hons.). Acute oral toxicity study. MRID 45428501.

6. Coleman, David G., B.Sc. (Hons.). Acute dermal toxicity study. MRID 45428502.

7. Coleman, David G., B.Sc. (Hons.). Acute dermal toxicity study. MRID 45428503.

8. Paul, Graham R., B.Sc. (Hons.), M.Sc. Biol., M.I. Biol. Acute inhalation toxicity study. MRID 45405506.

9. Paul, Graham R., B.Sc. (Hons.), M.Sc. Biol., M.I. Biol. Acute inhalation toxicity study. MRID 45405507.

10. Blanchard, Emma L., B.Sc. (Hons.). Primary eye irritation study. MRID 45405508.

11. Blanchard, Emma L., B.Sc. (Hons.). Primary eye irritation study. MRID 45405509.

12. Blanchard, Emma L., B.Sc. (Hons.). Primary dermal irritation study. MRID 45405510.

13. Blanchard, Emma L., B.Sc. (Hons.). Primary dermal irritation study. MRID 45405511.

14. Coleman, David G., B.Sc. (Hons.). Dermal sensitization study. MRID 45428504.

15. Coleman, David G., B.Sc. (Hons.). Dermal Sensitization study. MRID 45448201.

16. Bottomley, Sarah M., B.Sc. (Hons.), M.Sc., C.Biol., M.I.Biol. 28-Day oral toxicity study in rats. MRID 45441101.

17. Bottomley, Sarah M., B.Sc. (Hons.), M.Sc., C.Biol., M.I.Biol. 90-Day oral toxicity study in rats. MRID 45428505.

This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications ” is defined in the Executive Order to include regulations that have “substantial direct effects 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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 rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule ” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET at (http://www.epa.gov/edocket/) , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR BetaSite Two at http://www.gpoaccess.gov/ecfr/ .

In the Federal Register of October 24, 2003 (68 FR 60987) (FRL-7330-6), EPA issued a notice pursuant to section 408(d)(3) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP OF6180) by PURAC America, Inc., 111 Barclay Blvd., Lincolnshire Corporate Center, Lincolnshire, IL 60069. This notice included a summary of the petition prepared by the petitioner PURAC America, Inc.

The petition requested that 40 CFR 180.950 be amended by establishing an exemption from the requirement of a tolerance for residues of n-propyl lactate, also known as lactic acid, n-propyl ester, (S) (CAS Reg. No. 53651-69-7). There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

In FR Doc. 04-9170 appearing on page 23155 in the issue of April 28, 2004, the effective date is corrected as set forth above, and in paragraph 18 of the preamble, the references to §§ 75.701(d)(2) and 75.701(d)(3) are corrected to read “25.701(d)(2)” and “25.701(d)(3)”.

This is a summary of the Media Bureau's Third Report and Order (“3 R&O ”) in MM Docket No. 98-204; FCC 04-103, adopted April 19, 2004, and released on June 4, 2004. The full text of this 3R&O is available for inspection and copying during regular business hours in the FCC Reference Center, 445 Twelfth Street, SW., Room CY-A257, Portals II, Washington, DC, 20554, and may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Room CY-B402, telephone (800) 378-3160, e-mail http://www.BCPIWEB.com . This document is available in alternative formats (computer diskette, large print, audio cassette and Braille). Persons who need documents in such formats may send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0531 (voice), 418-7365 (tty).

1. The Second Notice of Proposed Rulemaking (“ 2NPRM ”), 67 FR 1704, January 14, 2002, in this proceeding proposed and requested comment on new broadcast station and multichannel video programming distributor (“MVPD”) Equal Employment Opportunity (“EEO”) rules and new annual employment report forms to collect data on the race, ethnicity, and gender of the workforce of broadcast and MVPD employment units. In the Second Report and Order (“ 2R&O ”), 68 FR 670, January 7, 2003, and Third Notice of Proposed Rulemaking (“ 3NPRM ”), 67 FR 77374, December 17, 2002, in this proceeding, we adopted new broadcast and MVPD EEO rules, but deferred action on the issues relating to the Annual Employment Report forms. We now address those issues and adopt revised FCC Form 395-B, the broadcast station Annual Employment Report, and FCC Form 395-A, the multichannel video programming distributor Annual Employment Report. We also seek comment in the Fourth Notice of Proposed Rulemaking (“ 4NPRM ”) on the Commission's policies regarding public access to data contained in FCC Forms 395-A and 395-B.

2. In previously deferring action with respect to FCC Forms 395-A and 395-B, we stated that a deferral would permit us to coordinate these forms with new standards for classifying data on race, ethnicity, and job categories adopted by the Office of Management and Budget (OMB). OMB has responsibilities under the Paperwork Reduction Act of 1995 for coordinating data collection forms adopted by the Federal government. This deferral was also intended to provide additional time to address issues concerning the collection and processing of the forms. The Commission indicated that the data collected in the employment reports would be used to compile industry employment trend reports and reports to Congress and would not be used to determine compliance with the substantive EEO rules adopted.

3. The information provided by the annual employment reports is important in order to ascertain industry trends, report to Congress, and respond to inquiries from Congress. We note that Congress relied in part on media industry employment data in the 1992 Cable Act. The Commission has broad authority under the Communications Act to collect information and prepare reports. Collection of television broadcast and MVPD industry employment data is required by the Communications Act. Section 634(d)(3)(A) of the Communications Act requires the Commission to adopt rules requiring MVPDs with more than 5 full-time employees to “file with the Commission an annual statistical report identifying by race, sex, and job title the number of employees' in each of specifically identified full-time and part-time job categories. Section 334(a) of the Communications Act requires the Commission to maintain EEO rules for television broadcast station licensees and provides that “except as specifically provided in this section, the Commission shall not revise—* * * (2) the forms used by such licensees and permittees to report pertinent employment data to the Commission.” Section 334(b) authorizes the Commission to make non-substantive technical or clerical changes. We are directed by statute to require the submission of such reports by broadcast television stations and MVPDs. We have authority to require employment reports for all broadcasters and MVPDs and would exercise that authority even if not required by statute to do so.

4. We will adopt the requirement that broadcast and MVPD employment units file Forms 395-B and 395-A, respectively. As explained, the forms are being readopted and will be submitted to OMB for clearance for use in the year 2004 filing substantially in the same form as those previously used and will be revised in the future, as necessary, in coordination with OMB. The data collected in the employment reports will be used to compile industry employment trend reports and reports to Congress and will not be used to determine compliance with our EEO rules.

5. Several commenters urge the Commission to collect ethnicity and gender information in order to analyze industry employment trends.

6. Other commenters assert that collection of Form 395-B is prohibited by the decisions of the U.S. Court of Appeals for the District of Columbia Circuit in Lutheran Church—Missouri Synod v. FCC (“ Lutheran Church ”) and MD/DC/DE Broadcasters Association v. FCC (“ Association ”).

7. We do not agree that the decision of the U.S. Court of Appeals for the DC Circuit in Lutheran Church invalidated the data collection process. The court focused in that decision on the Commission's previous “processing guidelines disclosing the criteria it used to select stations for in-depth EEO review when their licenses came up for renewal.” It then made clear that “[i]f the regulations merely required stations to implement racially neutral recruiting and hiring programs, the equal protection guarantee would not be implicated.” And it reiterated in response to the government's rehearing petition that it had not held that a regulation “encouraging broad outreach to, as opposed to the actual hiring of, a particular race would necessarily trigger strict scrutiny.” The court did not conclude that the Commission lacks authority to collect statistical employment data for the purpose of analyzing industry employment trends or preparing annual employment trend reports, or that collecting employment data for those purposes would unconstitutionally pressure broadcasters to adopt race or gender-based hiring policies.

6. In Association , the court upheld the requirement for filing the Form 395-B and rejected the argument that this requirement was an arbitrary and capricious regulatory burden. Nothing in the court's decision suggested that the collection of Form 395-B data on the employees of stations for the purpose of compiling trend reports and reports to Congress was by itself subject to strict scrutiny or unconstitutional.

7. We stated in the 2R&O and 3NPRM that we would need to revise our Forms 395-A and 395-B to comply with new OMB racial classification standards. We have attempted to parallel our classification reporting with those adopted by the Equal Employment Opportunity Commission, which is in turn addressing the OMB classification issues. Our forms and reports conform to the existing EEO-1 racial and employment categories. Although the EEOC has proposed an updated EEO-1 to conform to the new OMB standards, the form has yet to be finalized. Therefore, to avoid any unnecessary confusion that might result from the use of different classification standards, we will continue to use the racial and employment categories in the Forms 395-A and 395-B adopted in 2000, which conform to the current EEO-1, until the new EEO-1 is released. At that time, we will review the annual employment reports to see what changes are needed to comply with the new OMB standards, and whether we can conform our forms to those standards consistent with sections 334 and 634 of the Act. Other than deleting EEO program information, now requested in the FCC Form 396-C, the only change we have made at this time is to delete the request for system community information in section II of the previous 395-A and replace it with a request for the employment unit's physical system identification number(s). This modification will reduce the paperwork burden for MVPD units.

8. Under the annual employment report filing requirements that we adopt, broadcasters with five or more full-time employees will be required to file Form 395-B by September 30 of each year. MVPD units with six or more full-time employees will be required to file Form 395-A by September 30 of each year. We will allow, this year only, a one-time filing grace period until a date to be determined in the Commission's Order addressing the issues raised in the 4NPRM . This grace period will give entities adequate time to collect the data needed to fulfill their filing requirements and will allow us to accommodate changes, if any, to the Forms 395-A and 395-B made necessary by the comments received in response to the 4NPRM . Regardless of what grace period deadline we ultimately set for filing the forms, they will be required to reflect any pay period from July, August, or September 2004, as provided for in the instructions to Form 395-B and § 76.77(a) of the Commission's rules, 47 CFR 76.77(a), for Form 395-A.

9. Final Regulatory Flexibility Analysis . As required by the Regulatory Flexibility Act (RFA), see 5 U.S.C. 603, an Initial Regulatory Flexibility Analysis (“IRFA”) was incorporated in the 2NPRM . The Commission sought written public comments on the possible significant economic impact of the proposed policies and rules on small entities in the 2NPRM , including comments on the IRFA. Pursuant to the RFA, see 5 U.S.C. 604, a Final Regulatory Flexibility Analysis (“FRFA”) is contained.

10. Paperwork Reduction Act of 1995 Analysis . This document contains modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public to comment on the information collection requirements contained in this Report and Order as required by the Paperwork Reduction Act of 1995, Pub. L. 104-13. Public and agency comments are due August 23, 2004.

11. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this 3R&O including the Final Regulatory Flexibility Analysis and the Initial Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

12. As required by the RFA, an IRFA was incorporated into the 2NPRM in this proceeding. The Commission sought written public comments on the possible significant economic impact of the proposed policies and rules on small entities in the 2NPRM , including comments on the IRFA. This FRFA conforms to the RFA.

13. This 3R&O adopts new rules and forms for broadcasters and MVPDs that enable the Commission to collect data on the race, ethnicity and gender of the workforce of broadcast and MVPD employment units.

14. One comment on annual employment reports was filed specifically in response to the IRFA. The American Cable Association (“ACA”) proposes that the Commission generally “streamline” FCC Form 395-A. The ACA also filed these same comments in response to the 2NPRM. The 3R&O considers ACA's comments, and determines that the Commission's annual employment reports must follow the standards issued by the Office of Management and Budget for classifying data on race and ethnicity.

15. This rulemaking adopts FCC Form 395-B, the broadcast Annual Employment Report, and FCC Form 395-A, the MVPD annual employment report. Forms 395-B and 395-A collect data on the ethnicity and gender of a reporting entity's workforce. Broadcasters with five or more full-time employees will be required to file Form 395-B by September 30 of each year. MVPD units with six or more full-time employees must file Form 395-A by September 30 of each year. Broadcast entities are not required to place copies of their annual employment reports in their public file. Generally, no special skills will be necessary to comply with the requirements.

16. The new rules would apply to broadcast stations and MVPDs. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted herein. Under the RFA, small entities may include small organizations, small businesses, and small governmental jurisdictions. The RFA, 5 U.S.C. 601(3), generally defines the term “small business” as having the same meaning as the term “small business concern” under the Small Business Act, 15 U.S.C. 632. A small business concern is one which: (1) is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

17. A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, there are approximately 1.6 million small organizations. Finally, “small governmental jurisdiction” generally means “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000.” As of 1992, there were approximately 85,006 such jurisdictions in the United States. This number includes 38,978 counties, cities, and towns; of these, 37,566, or 96 percent, have populations of fewer than 50,000. The United States Bureau of the Census (Census Bureau) estimates that this ratio is approximately accurate for all governmental entities. Thus, of the 85,006 governmental entities, we estimate that 81,600 (91 percent) are small entities.

18. In this context, the application of the statutory definition to television stations is of concern. An element of the definition of “small business” is that the entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television station is dominant in its field of operation. Accordingly, the estimates that follow of small businesses to which rules may apply do not exclude any television station from the definition of a small business on this basis and are therefore over-inclusive to that extent. An additional element of the definition of “small business” is that the entity must be independently owned and operated. We note that it is difficult at times to assess these criteria in the context of media entities and our estimates of small businesses to which they apply may be over-inclusive to this extent.

19. The Small Business Administration defines a television broadcasting station that has no more than $12 million in annual receipts as a small business. Business concerns included in this industry are those “primarily engaged in broadcasting images together with sound.” According to Commission staff review of the BIA Publications, Inc. Master Access Television Analyzer Database as of May 16, 2003, about 814 of the 1,220 commercial television stations in the United States have revenues of $12 million or less. We note, that, in assessing whether a business concern qualifies as small, business (control) affiliations must be included. Our estimates, therefore, likely overstates the number of small entities that might be affected by any changes to the ownership rules, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies.

20. The SBA defines a radio broadcast entity that has $6 million or less in annual receipts as a small business. Business concerns included in this industry are those “primarily engaged in broadcasting aural programs by radio to the public. According to Commission staff review of the BIA Publications, Inc., Master Access Radio Analyzer Database, as of May 16, 2003, about 10,427 of the 10,945 commercial radio stations in the United States have revenue of $6 million or less. We note, that many radio stations are affiliated with much larger corporations with much higher revenue, and that in assessing whether a business concern qualifies as small, such business (control) affiliations are included. Our estimate therefore likely overstates the number of small businesses that might be affected by any changes to the ownership rules.

21. The 3R&O also amends EEO rules applicable to MVPDs. SBA has developed a definition of a small entity for cable and other program distribution, which includes all such companies generating $12.5 million or less in annual receipts. This definition includes direct broadcast satellite services (DBS), multipoint distribution systems (MDS), and local multipoint distribution service (LMDS). According to Census Bureau data for 1997, there were 1,311 firms within the industry category Cable and Other Program Distribution, total, that operated for the entire year. Of this total, 1,180 firms had annual receipts of $9,999,999.00 or less, and an additional 52 firms had receipts of $10 million to $24,999,999.00.

22. Cable Systems: The Commission has developed, with SBA's approval, its own definition of small cable system operators. Under the Commission's rules, a “small cable company” is one serving fewer than 400,000 subscribers nationwide. Based on our most recent information, we estimate that there were 1,439 cable operators that qualified as small cable companies at the end of 1995. Since then, some of those companies may have grown to serve more than 400,000 subscribers, and others may have been involved in transactions that caused them to be combined with other cable operators. Consequently, we estimate that there are 1,439 or fewer small entity cable system operators that may be affected by the rules proposed herein.

23. The Communications Act also contains a definition of a small cable system operator, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1% of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenue in the aggregate exceeds $250,000,000.” The Commission has determined that there are 67,700,000 subscribers in the United States. We found that an operator serving fewer than 677,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all of its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that the number of cable operators serving 677,000 subscribers or less totals approximately 1,450. Since we do not request nor collect information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

24. MDS: MDS involves a variety of transmitters, which are used to relay programming to the home or office. The Commission has defined “small entity” for purposes of the 1996 auction of MDS as an entity that, together with its affiliates, has average gross annual revenues that are not more than $40 million for the preceding three calendar years. This definition of a small entity in the context of MDS auctions has been approved by the SBA. These stations were licensed prior to implementation of section 309(j) of the Communications Act of 1934, as amended. Licenses for new MDS facilities are now awarded to auction winners in Basic Trading Areas (BTAs) and BTA-like areas. The MDS auctions resulted in 67 successful bidders obtaining licensing opportunities for 493 BTAs. Of the 67 auction winners, 61 met the definition of a small business.

25. LMDS: The auction of the 1,030 LMDS licenses began on February 18, 1998, and closed on March 25, 1998. The Commission defined “small entity” for LMDS licenses as an entity that has average gross revenues of less than $40 million in the three previous calendar years. An additional classification for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. These regulations defining “small entity” in the context of LMDS auctions have been approved by the SBA. There were 93 winning bidders that qualified as small entities in the LMDS auctions. A total of 93 small and very small business bidders won approximately 277 A Block licenses and 387 B Block licenses. On March 27, 1999, the Commission reauctioned 161 licenses; there were 40 winning bidders. Based on this information, we conclude that the number of small LMDS licenses will include the 93 winning bidders in the first auction and the 40 winning bidders in the reauction, for a total of 133 small entity LMDS providers as defined by the SBA and the Commission's auction rules.

26. DBS: Because DBS provides subscription services, it falls within the SBA-recognized definition of “Cable and Other Program Distribution.” This definition provides that a small entity is one with $12.5 million or less in annual receipts. Currently, there are nine DBS authorizations, though there are only two DBS companies in operation at this time. We neither request nor collect annual revenue information for DBS services, and are unable to determine the number of DBS operators that would be considered a small business under the SBA definition.

27. An alternative way to classify small entities is by the number of employees. Based on available data, we estimate that in 1997 the total number of full-service broadcast stations with four or fewer employees was 5186, of which 340 were television stations. Similarly, we estimate that in 1997, 1900 cable employment units employed fewer than six full-time employees. Also, in 1997, 296 “MVPD” employment units employed fewer than six full-time employees. We also estimate that in 1997, the total number of full-service broadcast stations with five to ten employees was 2145, of which 200 were television stations. Similarly, we estimate that in 1997, 322 cable employment units employed six to ten full-time employees. Also, in 1997, approximately 65 MVPD employment units employed six to ten full-time employees.

28. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.

29. This 3R&O sets forth the Commission's new annual employment reports, and considers the significant alternatives presented in the comments. We have determined that our finalized rules fulfill our public interest goals while maintaining minimal regulatory burdens and ease and clarity of administration.

30. The 3R&O adopts relief for small entities. Broadcasters with fewer than five full-time employees will not be required to file Form 395-B. MVPD units with fewer than six full-time employees will not be required to file Form 395-A. The EEO Rule does not impose unreasonable burdens on small broadcasters or MVPDs. We provide this relief because entities with small staffs have limited personnel and financial resources. The exceptions for small business provides them with some relief of any recordkeeping and reporting costs.

31. As noted, the ACA asks for a generally “streamlined” FCC Form 395-A. As explained in the 3R&O, the Commission's annual employment reports must follow section 634 of the Act and the standards issued by the Office of Management and Budget for classifying data on race and ethnicity.

32. The Commission will send a copy of the 3R&O, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A). In addition, the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this 3R&O, including this FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the 3R&O and FRFA (or summaries thereof) will also be published in the Federal Register . See 5 U.S.C. 604(b).

33. Pursuant to the authority contained in sections 1, 4(i), 4(k), 303(r), 334, 403, and 634 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(k), 303(r), 334, 403, and 554, this 3R&O is adopted , and part 73 and 76 of the Commission's rules are amended.

34. The new rules and amendments set forth, and the information collection requirements contained in these rules, will be submitted to OMB for approval and are not effective until approved by OMB. The Commission will publish a notice in the Federal Register announcing the effective date following OMB approval.

On September 27, 1993, NHTSA published a Notice of Proposed Rulemaking (NPRM) proposing several amendments to its regulations (49 CFR parts 573 and 577) implementing the provisions of 49 U.S.C. chapter 301 concerning manufacturers' obligations to provide notification and remedy without charge for motor vehicles and items of motor vehicle equipment found to contain a defect related to motor vehicle safety or a noncompliance with a Federal motor vehicle safety standard (58 FR 50314). On April 5, 1995, we issued a final rule addressing most aspects of that NPRM (60 FR 17254), and on January 4, 1996, we amended several provisions of that final rule after receiving petitions for reconsideration (61 FR 274). However, we decided to delay issuance of the final rule on the subject of dealer notification because we had not resolved all the issues raised by the comments on that subject that were submitted in response to the NPRM. On May 19, 1999, we issued a supplemental notice of proposed rulemaking (SNPRM) in order to seek additional public comment on several significant proposed revisions to the proposal that we had originally set out in the NPRM (64 FR 27227).

We had originally proposed to require manufacturers to notify their dealers and distributors  1 of safety defects and noncompliances that had been determined to exist in their products within five days after notifying the agency of the determination pursuant to 49 CFR part 573. In the SNPRM, however, rather than specify a particular time period, we proposed to require manufacturers to notify dealers in accordance with a schedule that is to be submitted to the agency with the manufacturer's defect or noncompliance information report required by 49 CFR 573.6 (this section was codified as § 573.5 prior to August 9, 2002). Under the SNPRM, if the agency were to find that the public interest requires dealers to be notified at an earlier date than that proposed by the manufacturer, the manufacturer would have to notify its dealers in accordance with the agency's directive. The SNPRM also proposed to require that the dealer notification contain certain information (including language about manufacturer and dealer obligations under 49 U.S.C. 30116 and 30120(i)) and described the manner in which such notification is to be accomplished. We received comments on the SNPRM from the Alliance of Automobile Manufacturers (AAM)/Association of International Automobile Manufacturers (AIAM); Atwood Mobile Products (Atwood); Ford Motor Company (Ford); the Juvenile Products Manufacturers Association (JPMA); Meritor Automotive (Meritor); the Motor and Equipment Manufacturers Association (MEMA); the Motorcycle Industry Council (MIC); the National Automobile Dealers Association (NADA); the Recreational Vehicle Industry Association (RVIA); the Specialty Equipment Market Association (SEMA); and the Truck Manufacturer's Association (TMA).

We have fully considered the comments submitted in response to the SNPRM. In general, the commenters supported the revised approach taken in the SNPRM. We will discuss all relevant comments; however, to the extent that these comments repeated discussions of positions that we addressed in the SNPRM, we will not repeat our prior responses.

For the most part, the final rule adopted today follows the regulatory language proposed in the SNPRM and is based on the same rationale set forth in that Notice, which we incorporate here by reference. As described below, we have decided to make several revisions to the supplemental proposal on the basis of comments we received. We have also made a number of minor technical changes prompted by our own review, including changes to the “Scope” section of part 573. In addition, some of the section numbers have been changed to reflect other intervening amendments to parts 573 and 577.

The authority citations for part 573 and part 577 have been changed by adding a reference to 49 U.S.C. 30116 and by deleting the references to 49 U.S.C. 30112 and 30167.

Pursuant to 49 CFR part 573, manufacturers that have determined that a defect or noncompliance exists in their products must submit to NHTSA a report that contains certain specified information (part 573 report). Pursuant to § 573.6(c)(8)(ii), the part 573 report must include the estimated date on which the manufacturer will begin sending notifications to owners that a defect or noncompliance exists and that a remedy without charge will be available. Consistent with our revised approach to dealer notification, we are amending § 573.6(c)(8)(ii) to require manufacturers also to identify the date(s) on which they plan to notify their dealers and distributors of the defect or noncompliance. This will allow us to consider whether a manufacturer's proposed schedule for dealer notification is reasonable.

We are incorporating this requirement into paragraph (c)(8)(ii), rather than adding a new paragraph (c)(8)(iii) as we had proposed in the SNPRM, to avoid the need to add additional paragraphs addressing the duties of a manufacturer that files or plans to file a petition for an exemption from recall requirements on the basis that the defect or noncompliance is inconsequential to motor vehicle safety. Existing paragraphs (c)(8)(iii) and (iv) will apply to both owner and dealer notification.

As with other information required to be reported under part 573, if the manufacturer has not determined a schedule for dealer notification at the time that it submits its initial part 573 report, it must provide the information as soon as it is available. See § 573.6(b).

In their comments on the SNPRM, AAM/AIAM, MIC, and JPMA recommended that we specify that manufacturers must maintain a list of the names and addresses of dealers and distributors to which a defect or noncompliance notification is sent for five years from the date the manufacturer submits a defect and noncompliance information report to the agency. In fact, § 573.8(c), which is applicable to equipment manufacturers, already contains such a five-year retention requirement. To apply the same responsibility to vehicle manufacturers, we are revising § 573.8(a), which currently requires vehicle manufacturers to maintain lists owner names and addresses. Of course, vehicle manufacturers already maintain lists of their dealers, so this will not impose any additional burden upon them.

The time and manner of notification to dealers is addressed in a new paragraph (c) of § 577.7. As requested by AAM/AIAM, TMA, and Meritor, we revised proposed paragraph (c)(1) to require that the agency consider the views of the manufacturer when making a determination to require dealer notification on a specific date. The wording of this new requirement is comparable to that in subparagraph (a)(1) concerning notification of owners. Proposed subparagraph (c)(1) is also being modified to identify two additional factors that will be considered by the agency when deciding whether to require dealer notification on a specific date. These two factors are: (1) Availability of an interim remedial action by the owner and (2) the time frame in which the defect may manifest itself. AAM/AIAM recommended that these two factors, which were discussed in the preamble of the SNPRM, be included in the regulatory text.

We are revising proposed § 577.7(c)(2)(i) to identify examples of what will be considered to be verifiable electronic means of notification, such as receipts or logs from electronic mail or satellite distribution systems. AAM/AIAM and MIC recommended this change in order to clarify the meaning of verifiable electronic means. However, the examples referenced are not the only types of verifiable electronic means that would be permissible, since other technology that provides comparable information may become available.

Proposed § 577.7(c)(2)(ii) is being split into two subparagraphs, (c)(2)(ii) and (iii). The first sentence had proposed to require manufacturers of replacement equipment or tires to notify “all retailers, dealers, and purchasers of such equipment for purposes of re-sale.” SEMA and MEMA objected on the basis that this language indicated that manufacturers could be held responsible for assuring notification to each entity at every level of the distribution chain even though the manufacturer generally only has knowledge of the identity of its customers. These organizations also argued that such a requirement exceeded NHTSA's statutory authority. To address these concerns, new paragraph (c)(2)(ii) states that notification will only be required to dealers and distributors that are known to the manufacturer.

The second sentence of proposed paragraph (c)(2)(ii) (new paragraph (c)(2)(iii)) applies in those cases in which a manufacturer sold the recalled product to a central office of a retail network, such as an auto supply chain or a department store chain, which then distributed the product to its retail outlets. The new language, which will now apply to both vehicles and equipment, clarifies that the manufacturer will not have to notify each retail outlet individually, since notification to the central office will be deemed to be notice to all dealers and distributors within that group. It will be the responsibility of the purchaser (through its central purchasing office or otherwise) to assure that its retail outlets comply with all applicable statutory and regulatory requirements, such as the duty not to sell vehicles or items of equipment that are covered by a defect or noncompliance determination unless they have been remedied.

Several commenters objected to proposed § 577.7(c)(2)(iii), which addressed situations in which a manufacturer provides motor vehicles or motor vehicle equipment items to another entity, such as an independent distributor, which then provides them to independent dealers. The SNPRM proposed to allow the manufacturer to provide the required information to the distributors, “if those distributors agree to transmit it to all applicable retail dealers within five additional working days.” The proposed language expressly stated that the manufacturer would retain the legal responsibility for assuring that its dealers received the information in a timely manner.

AAM/AIAM, Atwood, JPMA, MEMA, and SEMA requested that the agency better define the extent to which the manufacturer is legally responsible for the actions of its dealers and distributors in this context. Several commenters were concerned that manufacturers might be held legally responsible for the actions of distributors at the third or fourth distribution stage that are independent entities over which the manufacturer has no effective control.

In recognition of these concerns, we are taking a somewhat different approach in this final rule. Under new § 577.7(c)(2)(iv), in cases in which a manufacturer sells or arranges for the delivery of vehicles or equipment to or through independent distributors that subsequently sell or arrange for the delivery of the vehicles or equipment items to independent retail outlets, the manufacturer will be required to provide the distributors with the required notification. However, in addition to the information included in standard notifications to dealers, the notification to such distributors must also instruct the distributors to provide copies of the notification to all entities further along the distribution chain within five working days of its receipt. (As a practical matter, this requirement would only affect equipment recalls, since vehicle manufacturers generally communicate directly with their dealers rather than through a distribution network.) We expect that the distributors will be able to verify that they transmitted the notifications to the appropriate entities with which they do business. However, manufacturers would not have the legal responsibility to assure that each lower tier, independent dealer is notified.

We recognize that under this approach it is possible that some lower tier, independent dealers may not receive notification of defects or noncompliances, particularly if there is more than one level of independent distributors. If we become aware of widespread inadequate notification to dealers by distributors, we may revisit this aspect of the regulation.

Proposed § 577.11, as revised, will now be designated as § 577.13 because of intervening amendments to part 577. We are revising proposed subsections (a) and (d) to clarify that the section applies to notifications to distributors as well as to dealers. This will conform this section to other sections of this final rule.

Proposed § 577.11(b) would have required language reminding dealers that they are prohibited (by 49 U.S.C. 30120(i)) from selling or leasing new motor vehicles or new motor vehicle equipment items until the defect or noncompliance is remedied. TMA and MEMA recommended that this language be changed to permit the sale or lease of recalled vehicles and motor vehicle equipment items, but prohibit the delivery of the vehicle or equipment item to the owner or lessee until the recall work has been completed. The agency is adopting this recommendation in new § 577.13(b), which is consistent with the language of section 30120(i).

We are making one additional minor change to this subsection to reflect 49 U.S.C. 30120(j), which was enacted as part of the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act in November 2000, after issuance of the SNPRM. Section 30120(j), which largely parallels, and in part overlaps, section 30120(i), prohibits the sale or lease of all motor vehicle equipment (including a tire) that has been determined to contain a defect or noncompliance under section 30118 unless the defect or noncompliance has been remedied before delivery under the sale or lease. See 49 CFR 577.12. Thus, the language required by § 577.13(b) will apply to all equipment (new and used), but only to new motor vehicles.

Proposed § 577.11(c) would have helped to implement 49 U.S.C. 30116 by requiring manufacturers to offer to repurchase defective or noncompliant motor vehicle equipment items that remained in a dealer's or a distributor's inventory under the terms specified in section 30116(a)(1). The proposal was not intended to prevent manufacturers from negotiating alternative repurchase terms with their dealers. In accordance with the recommendation of AAM/AIAM the agency is modifying this section by adding wording that would permit the negotiation of alternative, mutually agreeable repurchase terms, with the listed repurchase terms serving as a minimum requirement in the absence of negotiated alternative repurchase terms.

MEMA and SEMA argued that proposed subsection (c) was overly restrictive in that it required repurchase of recalled equipment items in dealer inventory and did not allow the items to be repaired or replaced. However, this language accurately tracks the language of 49 U.S.C. 30116(a)(1). Section 30116(a)(2) allows manufacturers of vehicles to provide parts needed to repair defective or noncompliant vehicles in dealer or distributor inventory, but this repair option is clearly limited to vehicles. (For the reasons discussed in more detail below, we have decided that there is no need to address section 30116(a)(2) or section 30116(b) in this final rule.)

We are aware that 49 U.S.C. 30120(a)(1)(B) authorizes equipment manufacturers to remedy defects or noncompliances “by repairing the equipment or replacing the equipment with identical or reasonably equivalent equipment.” However, the primary application of section 30120 is to the remedy of items in the hands of retail purchasers. Given the specific language of section 30116(a)(1), we do not agree with the commenters' contention that the remedies authorized by section 30120(a)(1)(B) apply to equipment that remains in dealer or distributor inventory.

As described below, we are not adopting several recommendations made by some commenters.

TMA and Meritor recommended that subparagraph (c)(1) of § 577.7, Time and manner of notification, be changed to specify a procedure for presenting the manufacturer's views concerning dealer notification on a specific date to the agency. Meritor also recommended that an appeal mechanism be established to challenge an adverse ruling by NHTSA concerning dealer notification. We do not believe that such a revision is needed. Based on past experience, we anticipate that there will be extraordinarily few occasions on which we will have to direct a manufacturer to accelerate its proposed schedule for dealer notification. In almost all previous cases in which we have concluded that dealer notification was warranted at a date earlier than originally planned by the manufacturer, the manufacturer has promptly agreed to immediately provide such notification to its dealers. However, in those rare cases in which there is a disagreement, we need the ability to act quickly without being encumbered by formalized procedures that would lengthen the process. The views of the manufacturer, if presented to the agency in a timely manner, will be fully considered.

MIC recommended that § 577.7(c)(2)(i) be changed to allow manufacturers to send notifications to dealers via first class mail. The statute (49 U.S.C. 30119(d)(4)) specifies that dealers are to be notified “by certified mail or quicker means if available.” While we have authorized the use of various means of notification, we have required that the manufacturer be able to verify that the notifications were sent to and received by each dealer. Since there is no way to verify receipt of first class mail, we have rejected this suggestion.

NADA recommended that proposed § 577.11(b) be expanded to include language informing dealers of the statutory right to reimbursement specified in 49 U.S.C. 30116(b). That provision requires that motor vehicle manufacturers reimburse motor vehicle dealers and distributors that install parts or equipment to remedy a defect or a noncompliance in a motor vehicle in dealer or distributor inventory for the reasonable value of the installation plus other amounts associated with delays in correcting the problem. As discussed above, new § 577.13 requires manufacturers of motor vehicle equipment to include language in the notification to their dealers that refers to the reimbursement provisions of section 30116(a)(1), primarily to assure that those dealers that might not be aware of their rights under that section (such as those dealers for whom motor vehicle equipment represents only a small portion of their retail sales) will be assured that they will not suffer any financial hardship by complying with the duty not to sell noncompliant or defective items. Otherwise, they might have a financial incentive to ignore their statutory obligations. We explained in the SNPRM that similar concerns do not apply to vehicle dealers, who are much more likely to be aware of their rights under section 30116. Moreover, with respect to the particular issue raised by NADA, all vehicle dealers are well aware of their right to be reimbursed by manufacturers for recall repair work.

Meritor offered four general criticisms of the SNPRM. Because each of these comments has previously been addressed in earlier rulemaking notices, our discussion of these comments will be brief. Meritor's first comment is that there is no need to regulate dealer notification, since the current system functions effectively. Meritor's second comment is that manufacturers are in a better position than NHTSA to determine the appropriate dealer notification date. We agree that in most cases the current dealer notification process has been effective and that the manufacturer is generally in the best position to determine an appropriate dealer notification date. However, there have been some instances in recent years in which safety considerations warranted immediate dealer notification and the recalling manufacturer would not cooperate with the agency. In such cases, we need the explicit authority to compel manufacturers to notify dealers on a specific date.

Meritor's third comment is that manufacturers and their dealers could be subject to severe financial hardships if NHTSA misjudges the need for early dealer notification. As previously stated, we intend to utilize our authority to accelerate dealer notification only in rare cases, and only after consultation with the manufacturer, so such “misjudgments” are unlikely. Meritor's fourth comment is that dealers may create their own home-made recall remedies to correct recalled vehicles in dealer inventory in order to be able to deliver these vehicles to a purchaser or lessee. We believe that this is highly unlikely. In general, dealers are not able to design remedies or to fabricate the necessary parts. And, if a dealer were to follow this course of action, it would face the possibility of manufacturer sanctions, as well as potential tort liability if the “remedy” did not function properly.

NHTSA has considered the impact of this rulemaking under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures, and determined that it is not a “significant regulatory action” within the meaning of Sec. 3 of E.O. 12866 and is not “significant” within the meaning of the Department of Transportation regulatory policies and procedures.

Manufacturers are currently required by statute to notify their dealers and distributors of safety defects and noncompliances. 49 U.S.C. 30116, 30118(b) and (c), and 30119(d)(4). Dealer notification must be within a “reasonable time.” 49 U.S.C. 30119(c)(2). This final rule restates that requirement, adding only that in the event that NHTSA disagrees with the manufacturer's assessment of what time period is reasonable, the agency's determination will control.

The agency anticipates, based on past experience, that there will be few disagreements on this issue. In any event, an agency directive requiring a manufacturer to accelerate its dealer notification will not impose any additional costs directly on the manufacturer, since the notification would eventually have to be made anyway.

NHTSA recognizes that an embargo on dealer deliveries of defective or noncompliant vehicles following the receipt of a notification from a manufacturer can impose costs, and that these costs could be relatively high if many vehicles are affected or if there is a significant delay in developing and implementing a remedy for the defect or noncompliance. (This would not apply in the context of recalled equipment, since that equipment must be repurchased pursuant to 49 U.S.C. 30116(a)(1).) However, these costs would ultimately be borne by the manufacturers, either through contractual provisions or pursuant to 49 U.S.C. 30116(b), which requires manufacturers to provide, among other things, “reasonable reimbursement of at least one percent a month of the price paid prorated from the date of notice of noncompliance or defect to the date the motor vehicle [is remedied].”

To the extent that agency actions pursuant to this rule impose additional costs, those costs would be outweighed by the safety benefit of ensuring that dealers do not deliver new motor vehicles or items of replacement equipment containing safety-related defects or noncompliances before the defect or noncompliance has been remedied, as required by 49 U.S.C. 30120(i) and (j). Moreover, any impacts are likely to be minimal, because manufacturers will have an incentive to develop and provide a remedy as soon as possible.

The agency has also considered the effects of this rulemaking action under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). I certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.

The new regulatory requirements would apply directly only to manufacturers of motor vehicles and items of motor vehicle equipment that conduct safety recalls, which for the most part are not small businesses. Moreover, manufacturers are already required by statute to notify their dealers of defects and noncompliances in their products. In rare cases, manufacturers may be required to send notification to dealers earlier than the manufacturer had proposed. Since manufacturers will generally have all of the required information at the time the notification is required, such a requirement will not impose a significant burden on manufacturers.

As noted above, a notification could have an adverse effect on dealers, most of whom are small businesses, in that the dealers would be prohibited from delivering defective or noncompliant new vehicles or equipment items in their inventory until they have been remedied. However, for the reasons described above, the costs associated with such a delay would almost certainly be borne by the manufacturer. In any event, such costs are the result of requirements imposed by 49 U.S.C. 30120(i) and (j), not this rule. Moreover, any impacts are likely to be minimal, because manufacturers will have an incentive to develop and provide a remedy as soon as possible. Finally, any such impacts would be offset by the safety benefits associated with preventing the delivery of defective or noncompliant vehicles or equipment items.

In accordance with the National Environmental Policy Act of 1969, the agency has analyzed the environmental impacts of this rulemaking action and determined that implementation of this action would not have a significant impact on the quality of the human environment. The new notification requirements will not introduce any new or harmful matter into the environment.

This rule contains provisions which are considered to be information collection requirements as that term is defined by the Office of Management and Budget (OMB) in 5 CFR part 1320.

Pursuant to the Paperwork Reduction Act of 1995 (PRA), and OMB's regulation at 5 CFR 1320.5(b)(2), NHTSA will seek approval from OMB for an amendment to a previously approved information collection requirement (OMB control number 2127-0004).

Pursuant to the OMB regulations, the agency had issued a notice seeking public comment on the PRA burdens of the requirements that had been proposed in the original NPRM. See 62 FR 63598 (December 1, 1997). Since many of the provisions of the final rule are significantly different from those in the original NPRM, we have prepared and sent to the Federal Register another notice seeking comments on PRA burdens associated with the revised provisions.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, and we have determined that the rulemaking does not have sufficient federalism implications under that order.

This rule will not impose any unfunded mandates under the Unfunded Mandates Reform Act of 1995 or under Executive Order 12875. It does not result in costs of $100 million or more to either State, local or tribal governments, in the aggregate, or to the private sector; and is the least burdensome alternative that achieves the objective of the proposed rule.

The proposed rule will not have a retroactive or preemptive effect. Judicial review of the proposed rule may be obtainable under 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Conservation and Management Act (16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among various domestic fishing categories.

Implementing regulations for the Atlantic tuna fisheries at § 635.23 set the daily retention limits for BFT and allow for adjustments to those limits in order to provide for maximum utilization of the quota over the longest period of time. NMFS may increase or decrease the retention limit for any size class BFT or change a vessel trip limit to an angler limit or vice versa. Such adjustments to the retention limits may be applied separately for persons aboard specific vessel types, such as private vessels, headboats and charter boats.

A recommendation of ICCAT requires that NMFS limit the catch of school BFT to no more than 8 percent by weight of the total domestic landings quota over each four-consecutive-year period. NMFS is implementing this ICCAT recommendation through annual and inseason adjustments to the school BFT retention limits, as necessary, and through the establishment of a school BFT reserve (64 FR 29090, May 28, 1999; 64 FR 29806, June 3, 1999).

The ICCAT recommendation allows for interannual adjustments for overharvests and underharvests, provided that the 8 percent landings limit is not exceeded over the applicable four consecutive-year period. The 2004 fishing year is the second year in the current accounting period. This multi-year block quota approach provides NMFS with the flexibility to enhance fishing opportunities and to collect information on a broad range of BFT size classes.

Regulations at 50 CFR 635.23(b) restrict vessels fishing under the BFT Angling category quota to one BFT per vessel per day/trip, which may be from the school, large school, or small medium category and, in addition, one large medium or giant BFT, 73 inches or greater (185 cm) CFL per vessel per year. Regulations at 50 CFR 635.23(b)(3) allow for the adjustment of these retention limits.

In 2003, NMFS increased the Angling category daily retention limit to one school, large school, or small medium BFT per person with a maximum of six BFT per vessel from June 15 through October 31, 2003, and then reduced it to one large school, or small medium BFT for November 1, 2003, through May 31, 2004 (68 FR 35822, June 17, 2003). During the development of the 2003 BFT quota specifications, it was initially determined that the Angling category had not harvested the available quota in 2002, thus the unharvested 2002 quota was carried over to the 2003 Angling category quota, and was the basis for liberalized retention limits. However, after publication of the final initial 2003 BFT quota specifications (68 FR 56783, October 2, 2004), revised estimates of 2002 fishing year Angling category landings indicated that the Angling category fishery actually overharvested its allocated quota in the 2002 fishing year. Therefore, NMFS closed the Angling category fishery in mid-November 2003 (68 FR 64990, November 18, 2003) for the remainder of the fishing year to avoid further overharvest in 2003.

As of June 1, 2004, additional quota is available to the United States, for the 2004 fishing year, pursuant to an ICCAT Recommendation. The 2002 and 2003 Angling category landings estimates are currently under review. However, based on preliminary landings information and information that recreational size class BFT are currently on the fishing grounds and that the current recreational retention limits are restricting any directed fishing trips for BFT, NMFS is making modest adjustments to the daily recreational retention limits at this time to provide recreational anglers a reasonable opportunity to pursue BFT.

Since June 1, 2004, the retention limit of one school, large school or small medium as specified at 50 CFR 635.23(b) has been in effect. Effective June 21 through July 21, 2004, inclusive, NMFS adjusts the daily retention limit for vessels permitted in the HMS Angling category, in all areas, to two BFT per vessel per day/trip, in any combination of the school, large school, or small medium size classes. Effective July 22, 2004, NMFS adjusts the daily retention limit for vessels permitted in the HMS Angling category, in all areas, to one BFT per vessel per day/trip, in any combination of the school, large school, or small medium size classes.

NMFS has also received public comments that a recreational retention limit of less than three or four BFT per vessel per day/trip does not provide reasonable fishing opportunities for charter/headboats, which carry multiple fee-paying passengers. Charter/Headboat operators have requested a modified recreational retention limit that recognizes a fee-paying client's willingness to book charters based on potential retention limits. On December 18, 2002, NMFS published a final rule that clarified the procedures to set differential BFT retention limits to provide equitable fishing opportunities for all types of fishing vessels (67 FR 77434). NMFS has determined, for economic reasons, that it is appropriate to implement an alternative recreational retention limit for vessels possessing a Atlantic HMS Charter/Headboat category permit.

Pursuant to 50 CFR 635.23(c), persons aboard a vessel issued an HMS Charter/Headboat permit may retain and land BFT under the daily limits and quotas applicable to the Angling category or the General category. The size category of the first BFT retained will determine the fishing category applicable to the vessel that day.

Since June 1, 2004, the retention limit of one school, large school or small medium as specified at 50 CFR 635.23(b) has been in effect. Effective June 21 through July 21, 2004, inclusive, NMFS adjusts the daily retention limit for vessels permitted in the HMS Charter/Headboat category, in all areas, to three BFT per vessel per day/trip, in any combination of the school, large school, or small medium size classes. Effective July 22, 2004, NMFS adjusts the daily retention limit for vessels permitted in the HMS Charter/Headboat category, in all areas, to one BFT per vessel per day/trip, in any combination of the school, large school, or small medium size classes.

NMFS selected the daily retention limits and the duration of the daily retention limit adjustments after examining past catch and effort rates. NMFS will continue to monitor the recreational BFT fishery closely through the Automated Landings Reporting System, the state harvest tagging programs in North Carolina and Maryland, and the Large Pelagics Survey. Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional retention limit adjustments are necessary to enhance scientific data collection from, and fishing opportunities in, all geographic areas. Additionally, NMFS may determine that an allocation from the school BFT reserve is warranted to further fishery management objectives.

Subsequent adjustments to the daily retention limit, if any, will be published in the Federal Register . In addition, anglers may call the Atlantic Tunas Information Line at (888) 872-8862 or (978) 281-9305 for updates on quota monitoring and retention limit adjustments. All recreational BFT landed under the Angling category quota must be reported within 24 hours of landing to the NMFS Automated Landings Reporting System via toll-free phone at (888) 872-8862; or the Internet at www.nmfspermits.com ; or, if landed in the states of North Carolina or Maryland, to a reporting station prior to offloading. Information about these state harvest tagging programs, including reporting station locations, can be obtained in North Carolina by calling (800) 338-7804, and in Maryland by calling (410) 213-1531.

The Assistant Administrator for Fisheries, NOAA (AA), finds good cause that providing prior notice and public comment for this action, as required under 5 U.S.C. 553(b)(B), is impracticable and contrary to the public interest. This action is intended to enhance recreational BFT fishing opportunities for all geographic areas without risking overharvest of the Angling category quota. NMFS has recently received information that recreational BFT are currently available on the fishing grounds and that the current recreational retention limits are restricting any directed fishing trips for BFT. The fishery is currently underway with a limited default recreational BFT retention limit and further delay in taking this action may have negative social and economic impacts on the recreational and charter/headboat communities.

NMFS provides prior notification of any adjustments by publishing them in the Federal Register , by faxing notification to individuals on the HMS FAX Network and to known fishery representatives, by announcing the notice on the Atlantic Tunas Information Line, and by posting the notice on the HMS Permitting website at www.nmfspermits.com .

For these reasons mentioned above and because this action relieves a restriction, the AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(1) and (3). This action is required under 50 CFR 635.28(a)(1) and is exempt from review under Executive Order 12866.