The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).

In an interim rule effective May 5, 2002, and published in the Federal Register on July 1, 2002 (67 FR 44016-44018, Docket No. 02-068-1), we amended the regulations in § 94.18(a)(1) by adding Poland to the list of regions where BSE exists. Poland had previously been listed in § 94.18(a)(2) as a region that presents an undue risk of introducing BSE into the United States. However, due to the detection of BSE in a native-born animal in that region, the interim rule was necessary to update the disease status of Poland regarding BSE.

Comments on the interim rule were required to be received on or before August 30, 2002. We received one comment by that date. The commenter fully supported the interim rule.

Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule.

This action also affirms the information contained in the interim rule concerning Executive Order 12866 and the Regulatory Flexibility Act, Executive Order 12988, and the Paperwork Reduction Act.

Further, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

In the Federal Register of March 10, 1997 (62 FR 10781), FDA published a proposal to establish a standard of identity for white chocolate. The proposal responded to petitions submitted separately by Hershey and by CMA. The petitions requested that FDA establish a standard of identity for “white chocolate.” Both Hershey and CMA described “white chocolate” as a food that deviates from the standardized cacao products in part 163 (21 CFR part 163) in that: (1) It is prepared without the nonfat components of the ground cacao nibs but contains the fat (cocoa butter) expressed from the ground cacao nibs; and (2) it may contain safe and suitable antioxidants. The petitioners further described “white chocolate” as the solid or semiplastic food prepared by mixing and grinding cocoa butter with one or more nutritive sweeteners and one or more of the optional dairy ingredients provided in part 163. The petitioners stated that “white chocolate” contains not less than 20 percent cocoa butter, not less than 14 percent of total milk solids, not less than 3.5 percent milkfat, and not more than 55 percent nutritive carbohydrate sweeteners.

The petitioners maintained that a standard of identity for “white chocolate” would provide several benefits: (1) Reducing economic deception and promoting honesty and fair dealing in the interest of consumers, (2) increasing the availability of products containing white chocolate by eliminating the requirement that firms receive temporary marketing permits (TMPs), and (3) enhancing the international marketability of white chocolate by establishing a standard consistent with international standards for white chocolate.

Based on FDA's review of the information provided in the petitions, we (FDA) tentatively concluded that it would be reasonable to establish a standard of identity for “white chocolate.” We tentatively concluded that use of the term would aid consumer recognition of the food and would promote honesty and fair dealing in the interest of consumers by eliminating the potential for economic fraud and consumer deception through the substitution of cheaper ingredients for cacao-derived ingredients. Furthermore, the agency tentatively concluded that: (1) Consumer confusion created by the use of alternative names for white chocolate-type confections would also be eliminated and (2) use of the standardized term “white chocolate” would enhance the international marketability of such products. Based on these tentative conclusions, FDA published a proposed rule to establish a standard of identity for “white chocolate,” consistent with the product described in the petitions (62 FR 10781 at 10786).

FDA received seven responses to the proposal, each containing one or more comments. Six responses were from companies that manufacture or market chocolate products, and the other was from a trade association. Most of the comments supported the establishment of a standard of identity for white chocolate. Other comments either opposed the establishment of a standard of identity for white chocolate or suggested modifications or revisions to various provisions of the proposed standard.

After considering the comments, FDA concludes that issuing a food standard for white chocolate will promote honesty and fair dealing in the interest of consumers. Specifically, a food standard for white chocolate will permit the sale of a product labeled “white chocolate” without TMPs and ensure that such products contain cacao-derived ingredients. The standard will distinguish white chocolate from the other standardized chocolate products, which contain chocolate liquor. Also, by eliminating requirements for TMPs, the standard will benefit consumers by allowing manufacturers to introduce white chocolate more quickly. Finally, the white chocolate food standard, which is consistent with the standards of Canada, the European Union (EU), and Codex Alimentarius Commission (Codex), will promote international harmonization.

(Comment 1) One comment opposed creating a standard of identity for white chocolate. The comment contended that a TMP is not required to sell white chocolate in the United States because the name “white chocolate” is sufficiently different from the names of standardized chocolate products. Thus, the comment contended, elimination of the TMP process is not a valid justification for the establishment of a standard of identity. The comment maintained that FDA is promoting the use of TMPs for all new products that may be perceived as variations of existing standardized products, no matter how easily distinguishable they may be, and even though there is no consumer confusion or deception. The comment further maintained that FDA could conserve agency resources by giving guidance that the TMP process will no longer be required for white chocolate products.

We disagree with the assertion that TMPs are not needed to market white chocolate products in the absence of a standard of identity. A product labeled as “white chocolate” contains the term “chocolate,” an alternative nomenclature for chocolate liquor that indicates the presence of cacao-derived ingredients. All existing chocolate standards include the cacao-derived ingredient chocolate liquor, which contains both the nonfat and the fat components of the cacao nibs. In contrast, the cacao-derived ingredient contained in products that consumers have come to know as “white chocolate” is cacao fat (i.e., cocoa butter), not chocolate liquor. Because the term “chocolate” implies that the product contains cacao-derived ingredients similar to those in standardized chocolate products, in the absence of a standard of identity or TMP, the product described in the proposed standard could not use the term “chocolate” on its labeling. Specifically, a product labeled “white chocolate” would purport to be chocolate, but it would not comply with the current food standards for cacao products in part 163. Therefore, the product would be misbranded under section 403(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343 (g)).

(Comment 2) The one comment that objected to the establishment of a standard of identity for white chocolate suggested that FDA should reconsider the need for a standard of identity and should regulate white chocolate like other nonstandardized products. The comment maintained that: (1) Only a few foods are currently governed by standards of identity; (2) most existing standards were adopted more than 25 years ago; (3) thousands of newly introduced foods have been regulated successfully under common or usual name regulations part 102 (21 CFR part 102) and under general misbranding provisions (section 403 of the act); and (4) standards do not play the same role in the regulatory scheme as they did many years ago when product names were the primary source of product information for consumers. The comment credited the success of using common or usual name regulations and general misbranding provisions to regulate nonstandardized foods to the additional ingredient and nutrition information now required on food labels. The comment pointed out that even though there is a standard for French dressing, there is no standard for ranch dressing. Analogously, the comment asserted that white chocolate is not inherently different from the thousands of other nonstandardized foods and, therefore, there is no need for a standard of identity for white chocolate.

FDA does not agree that a common or usual name regulation for white chocolate is sufficient to ensure honesty and fair dealing in the interest of consumers. First, FDA disagrees with the assertion that there are only a few standards of identity and that many more foods are regulated under common or usual name regulations. There are over 280 standards of identity, but there are only 16 common or usual name regulations.

When deciding whether it is appropriate to establish a standard of identity or a common or usual name regulation, FDA must consider which is more likely to ensure that consumers are not deceived or misled. Food standards are appropriate and necessary when there is a need to prescribe the entire compositional requirement for a food, in addition to the name of the food. In contrast, common or usual name regulations are appropriate if there is a need simply to establish a uniform and informative name for the food.

Because products bearing the name “chocolate” would be expected to contain some cacao-derived ingredients, we believe that it is necessary to ensure that “white chocolate” contains cacao-derived ingredients. If FDA establishes a common or usual name regulation for “white chocolate,” rather than a standard of identity, it would be necessary to include in the common or usual name a statement of the percentage of the characterizing ingredient, cacao fat, as provided in § 102.5(b). We disagree that establishing a common or usual name in this manner is the appropriate way to protect consumers' interests. The required additional labeling regarding the name and percentage of the characterizing ingredient, cacao fat, in the common or usual name might be confusing to consumers, especially because the amount of cacao fat would be disclosed differently than the amount of total fat in the nutrition label. A food standard eliminates the need for additional labeling. Therefore, FDA concludes that the appropriate way to ensure the composition of “white chocolate” and to protect consumers' interests is by establishing a standard of identity and not a common or usual name.

Moreover, at the time that they were established, one of the benefits of common or usual name provisions in part 102 was that names of new products could be established by regulation using “informal” notice and comment rulemaking, rather than the lengthy formal rulemaking procedures required for food standards. Since passage of the Nutrition Labeling and Education Act of 1990 (Public Law 101-35), which amended the act, FDA can establish new standards of identity for most foods by “informal” notice and comment rulemaking proceedings. In view of this change, FDA does not see any benefit to establishing a common or usual name regulation instead of a food standard to ensure that the product known as “white chocolate” contains cacao-derived ingredients.

Finally, FDA agrees that there are many products on the market that are regulated without standards of identity. However, we disagree with the comment's suggestion that requirements imposed after most of the food standards were created have rendered food standards unnecessary. The nutrition information that is required on the labels of standardized and nonstandardized foods gives consumers information on the levels of nutrients in products to assist them in making purchasing choices related to nutrient content. Nutrition information does not inform consumers of a product's formulation. In addition, ingredient labeling alone may be insufficient to differentiate two standardized products. For example, the ingredient lists for both milk chocolate and sweet chocolate may be identical (containing chocolate, nutritive carbohydrate sweeteners, and dairy products).

(Comment 3) The comment that opposed creation of a food standard further stated that, from a legal perspective, a standard of identity is not needed to authorize the sale of white chocolate in this country because: (1) White chocolate is an appropriately descriptive statement of identity, independent of existing standards; (2) the name “white chocolate” is sufficiently different from the names of other chocolate products; (3) white chocolate does not purport to be a standardized food; (4) the identity and fundamental positioning of white chocolate are predicated on the difference between white chocolate and chocolate; and (5) the appearance of white chocolate is in such stark contrast to traditional chocolate, which is brown in color, as to guarantee that no “passing-off” issue exists. The comment contended that FDA cited no evidence of consumer confusion with white chocolate, no evidence that consumer confusion would exist in the absence of a standard of identity for white chocolate, and no evidence of consumer confusion regarding the thousands of other nonstandardized foods on the market. The comment asserted that, in the absence of such evidence, FDA has no grounds for creating a standard of identity for white chocolate because the statutory threshold for regulation is not satisfied, i.e., that a standard of identity for white chocolate would promote honesty and fair dealing in the interest of consumers. The comment contended that FDA is maintaining and extending food standards without consideration of their actual utility or consumer benefit, and without regard to the labeling requirements now in effect. Therefore, the comment urged FDA to regulate white chocolate as a nonstandardized food and not to establish a standard of identity for white chocolate.

FDA disagrees with the comment's assertion that a standard of identity is not needed to sell a product bearing the name “white chocolate.” Our reasoning as to why a food standard or TMP is required to label a product as “white chocolate” is set forth in response to comment 1, section II of this document. In short, absent a food standard or TMP, a food labeled “white chocolate” purports to be chocolate, which is the subject of a food standard under § 163.111(c) requiring that the product be prepared by finely grinding cacao nibs (contains both the nonfat and fat components). The product is misbranded in violation of section 403(g) of the act because it does not conform to the definition and standard for chocolate in that it does not contain the nonfat portion of the cacao nibs.

Furthermore, we disagree with the comment that there is no legal basis on which to establish a food standard for white chocolate. The term “chocolate” has traditionally been used for standardized foods that contain cacao-derived ingredients, specifically chocolate liquor (§ 163.111). These standardized foods include sweet chocolate (§ 163.123), milk chocolate (§ 163.130), buttermilk chocolate (§ 163.135), skim milk chocolate (§ 163.140), mixed dairy product chocolate (§ 163.145), sweet chocolate and vegetable fat coating (§ 163.153), and milk chocolate and vegetable fat coating (§ 163.155). Because of this longstanding practice, consumers expect that products bearing names that include the term “chocolate” contain certain cacao-derived ingredients. While the product described in the proposed standard deviates from the other standardized chocolate products in that it contains only the cacao fat (i.e., cocoa butter) component of chocolate liquor, consumers' expectations that the food's basic component is derived from cacao are met by establishing a standard with that requirement.

Moreover, use of the term “white chocolate,” without an accompanying food standard, does not provide consumers with sufficient information as to the ingredients of the product. Historically, FDA has created separate standards of identity for different kinds of chocolate (e.g., milk chocolate, sweet chocolate). These standards ensure that consumers who purchase products labeled as “chocolate” receive a familiar product with a certain basic nature and composition. Neither the term “white” nor the white appearance of the product itself is sufficient to distinguish a white chocolate-type product that does not contain cacao-derived ingredients from a product that does contain cacao-derived ingredients. Use of the term “chocolate” in the name “white chocolate” implies that the product is cacao-derived. Thus, without a standard of identity prescribing that white chocolate be made from cocoa butter, manufacturers may produce products not containing cacao-derived ingredients and use the term “white chocolate” in a misleading manner.

(Comment 4) The one comment that objected to establishing a standard of identity for white chocolate stated that a standard of identity for white chocolate is not needed because white chocolate-type products made with ingredients not derived from cacao could be identified as “white chocolate-flavored” or “artificially flavored” to sufficiently distinguish them from white chocolate products derived from cacao. The comment further stated that consumers could look at the ingredient list to discover the substitution of less expensive ingredients not derived from cacao; thus, current regulations are sufficient to prevent economic deception.

FDA does not agree that identifying white chocolate products made from cheaper noncacao ingredients as “artificially flavored” or “white chocolate-flavored” would be sufficiently descriptive with regard to the composition of white chocolate. These terms refer to the characterizing flavor of a food, not its composition. The terms suggest products that are flavored to taste like white chocolate, but they do not provide guidance as to white chocolate's composition. Thus, use of such terms does not negate the need for a standard of identity, but rather further supports its need because, without a definition and standard for “white chocolate,” there is no way to define “white chocolate-flavored.” Moreover, FDA regulations governing use of the term “flavored” § 101.22(i)(1)(i) (21 CFR 101.22(i)(1)(i)) provide that a product that is expected to contain an ingredient, e.g., “white chocolate,” must bear the term “flavored” in the name of the food if the food contains natural flavor derived from that ingredient and either an amount of the ingredient insufficient to independently characterize the food or none of the ingredient. Therefore, unless a food contains the flavoring constituents derived from white chocolate, it cannot be named “white chocolate-flavored.”

Once a standard for white chocolate has been established, the term “white chocolate-flavored” could be used to describe a food that is commonly expected to contain the characterizing food ingredient, white chocolate, and which contains natural flavor derived from such an ingredient (i.e., cocoa butter or cacao fat) (§ 101.22(i)(1)(i)). The term “artificially-flavored white chocolate” could be used in cases where the food contains an artificial flavor that simulates, resembles, or reinforces the characterizing flavor (§ 101.22(i)(2)).

The only constituent in white chocolate that is derived from the cacao bean is cacao fat (i.e., cocoa butter); therefore, the agency assumes that if a cheaper ingredient that was not derived from cacao were used to replace the cacao-derived ingredient, the substitute ingredient would be some type of fat or oil used to replace the cacao fat. In this case, the agency would treat such products as substitute or imitation white chocolate products (21 CFR 101.3(e)) and would not regulate them by requiring that they be labeled “white chocolate-flavored.”

(Comment 5) The one comment that opposed issuing a standard of identity for white chocolate argued that food standards should be reformed. The comment stated that, in the advance notice of proposed rulemaking (ANPRM) (60 FR 67492, December 29, 1995) that responded to the Regulatory Reinvention Initiative, FDA acknowledged that existing food standards of identity are the types of regulations that need reform. The comment stated that there is no special circumstance that justifies a reversal of regulatory direction for white chocolate.

A few comments addressed the nature of the proposed standard of identity for white chocolate, objecting to its being prescriptive, recipe-based, and rigid. One of these comments, while supporting establishment of a standard of identity for white chocolate, made broader general statements about reforming food standards. In addition, several comments from manufacturers who support creating a standard for white chocolate supported FDA's intention to address all standards, including any new standard of identity for white chocolate, as a separate subject in accordance with the Regulatory Reinvention Initiative.

FDA stated in the ANPRM that standards of identity may need reform, and we are reviewing existing food standards in response to the Regulatory Reinvention Initiative. After deciding to establish a standard of identity for white chocolate, FDA considered whether to: (1) Continue the TMP process until all standards are reviewed in response to the Regulatory Reinvention Initiative and then establish a standard for white chocolate, (2) use different guiding principles to issue a standard, or (3) issue a standard consistent with the petitioners' requests and with existing standards. We concluded that the third approach was the most reasonable and efficient, considering our limited resources, industry's desire to establish a standard, and recognized consumer demand for the product. This approach avoids the time consuming task of reviewing and revising standards for a group of foods, e.g., chocolate products, in a piecemeal fashion, especially when no guiding principles have been published, and relieves industry and the agency from the burdensome TMP process. Therefore, FDA concludes that a standard for white chocolate should be issued that is generally consistent with current standards for U.S. chocolate products. FDA will address comments concerning the revision of the standard for white chocolate at such time as we consider revision of all chocolate standards.

FDA recognizes that the proposed standard of identity is prescriptive in nature. However, we believe that until all standards of identity are reviewed and decisions are made regarding whether to retain, revoke, or revise them, it is in the interest of consumers to establish a standard of identity for white chocolate that is generally consistent with other chocolate products in part 163. We also note that standards of identity for white chocolate established by Canada, Codex, and the EU are also prescriptive. Therefore, FDA finds that, at this time, it is appropriate to retain the recipe-like nature of the standard for white chocolate because it is consistent with current U.S. standards for other chocolates and with international standards of identity for white chocolate.

(Comment 6) Two comments suggested changes to the proposed standard to make the U.S. standard for white chocolate more consistent with international standards. One comment noted that the maximum level for emulsifiers in the proposed standard for white chocolate is adequate, but suggested that in the interest of international harmonization, FDA consider raising this level from 1 percent to 1.5 percent. The comment stated that if this were done, the proposed standard would then be consistent with those of Canada and Codex. The comment emphasized that it raised the issue solely in the interest of international harmonization, but did not want the issue to delay a prompt promulgation of the standard.

We agree that international harmonization should be taken into consideration in establishing standards and should be supported when such support promotes honesty and fair dealing in the interest of consumers, does not endanger the public health, and does not reduce the integrity of the standard. FDA believes that raising the level of permitted emulsifiers to 1.5 percent will not result in an inferior product, and the standard for white chocolate will still promote honesty and fair dealing in the interest of consumers. Therefore, the agency agrees that, to reduce barriers to trade, the level of emulsifiers should be changed to 1.5 percent.

The other comment recommended that FDA revise the proposed standard to permit the use of whey as an optional ingredient up to a level of 5 percent. The comment stated that whey should be listed in § 163.124(b)(6) as an optional ingredient so that it would not count toward the minimum milk solids content otherwise specified in the standard (§ 163.124(b)(2)). The comment contended that whey is a safe and suitable ingredient for use in chocolate and confectionery products.

The comment further stated that if the U.S. standard were adopted without permitting whey, it would be the only major white chocolate standard in the world that did not permit its use. According to the comment, Canada plans to issue a standard that expressly permits the addition of whey up to 5 percent. The comment stated that both the Codex and the EU standards permit the addition of whey in chocolate products. The comment asserted that the United States should include whey in its standard for white chocolate in the interest of international harmonization. Finally, the comment noted that delaying consideration of the use of whey until the generalized review of chocolate standards takes place would likely result in a delay of several years.

FDA agrees with the comment that whey should be permitted as an optional ingredient up to a level of 5 percent but should not count toward the minimum milk solids content otherwise specified in the standard. Listing whey as a separate ingredient, as suggested by the comment, permits the inclusion of whey in addition to, not in place of, the total milk solids specified in § 163.124(b)(2). FDA notes that since publication of our proposed rule to establish a standard for white chocolate, Canada has established a standard for white chocolate that permits as an optional ingredient less than 5 percent whey or whey products. Codex permits no more than 5 percent milk solids in its white chocolate standard, whereas the EU permits edible substances that do not exceed 40 percent of the total weight of the finished white chocolate product. Thus, FDA believes that the change to the proposed standard to permit whey as an optional ingredient would maintain the core ingredients required in the U.S. standard while promoting international harmonization and trade. Accordingly, FDA is modifying the proposed standard to include whey up to a level of 5 percent as a separate, optional ingredient in § 163.124(b)(6).

(Comment 7) One comment recommended deleting the requirement that white chocolate contain a minimum of 23.5 percent fat (20 percent cacao fat + 3.5 percent milkfat). The comment asserted that this high level of fat is inconsistent with current dietary guidelines and with FDA's stated goal to encourage the creation of products lower in fat and calories. The comment stated that it recognized that in order for the product to be designated as “chocolate,” it should contain some cacao-derived ingredients. However, the comment contended that the requirement to contain some minimum amount of cacao-derived ingredients could be met by having a minimum amount of cocoa solids. The comment argued that since milk chocolate must contain a minimum of 10 percent cocoa solids in the form of chocolate liquor, it would be consistent for white chocolate to contain a minimum of 10 percent cocoa solids, albeit in the form of cocoa butter. The resulting product, according to the comment, would contain a total of 13.5 percent fat (3.5 percent milkfat and 10 percent cacao fat).

FDA disagrees with changing the minimum level of fat required in white chocolate. The purpose of a standard of identity is to promote honesty and fair dealing in the interest of consumers. The product labeled “white chocolate” that has been marketed under TMPs for more than 10 years contains a minimum of 23.5 percent fat. We believe that consumers have come to know the product with this composition. This level is the same as that suggested by the petitioners and required by international standards for white chocolate. Accordingly, FDA has not been persuaded to change the minimum level of fat required.

We appreciate the comment's concern regarding dietary guidelines and note that manufacturers who wish to market products that are lower in fat relative to the standard product may develop lower fat white chocolate products in accordance with the provisions in 21 CFR 130.10.

In the proposed rule, FDA proposed that the effective date for a final rule for white chocolate be January 1, 1998 (62 FR 10781 and 10784). The only comment that addressed the proposed compliance date of January 1, 1998, stated that if FDA acted quickly in finalizing the proposal, the proposed compliance date would allow sufficient time for manufacturers to make label and formula changes. Further, the comment encouraged the FDA to state that compliance with the regulation could begin immediately after publication of the final rule issuing the standard.

Due to other agency priorities and to limited resources and staff, FDA is publishing this final rule later than it intended and after the proposed effective date. Consequently, we are revising the effective date of this regulation to the next uniform compliance date, i.e., January 1, 2004, to minimize costs associated with any necessary label changes. However, compliance with this final regulation may begin immediately. All affected products initially introduced or initially delivered for introduction into interstate commerce on or after January 1, 2004, shall fully comply.

There are many firms using TMPs to market products in the United States that are labeled “white chocolate” and that comply with the proposed standard. These products will not have to be relabeled. Other products that are labeled with descriptive names (e.g., “white confection”) will have to relabel their products in compliance with the new standard by the effective date of this rule.

FDA has examined the economic implications of this final rule as required by Executive Order 12866. 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 effects; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation also is considered a significant regulatory action under Executive Order 12866 if it raises novel legal or policy issues. FDA finds that this final rule is neither an economically significant rule nor a significant regulatory action as defined by Executive Order 12866.

The Unfunded Mandates Reform Act of 1995 (Public Law 104-4), requiring cost-benefit and other analyses, in section 1531(a) defines a significant rule as “a Federal mandate that may result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year.” FDA has determined that this rule does not constitute a significant rule under the Unfunded Mandates Reform Act.

FDA is establishing a standard of identity for white chocolate. This standard will provide for the use of the term “white chocolate” as the common or usual name of products made from cacao fat, milk solids, nutritive carbohydrate sweeteners, and other safe and suitable ingredients, but containing no nonfat cacao solids. In the benefit-cost analysis of the proposed rule, FDA considered three options:

1. Do not establish a standard and allow manufacturers to market products bearing the name “white chocolate” only with TMPs.

2. Establish a standard for white chocolate that is consistent with the standard described in the petitions where the levels of the ingredients are prescribed.

3. Establish a standard of identity for white chocolate with different criteria than those proposed in the petitions.

FDA received no comments that directly addressed the economic analysis of the proposed rule. Results of benefit-cost analysis suggest that the best choice for this proposed rule is the second option: Establish a standard for white chocolate consistent with the standard in the petitions where the levels of ingredients are prescribed. This option is the best choice for several reasons.

First, as stated in the comments that we received, the second option eliminates the time-consuming and burdensome task to manufacturers of applying for TMPs. By establishing a standard of identity for white chocolate and eliminating the need for TMPs, the proposed rule furthers a goal of the Paperwork Reduction Act by eliminating paperwork burden.

Second, while the standard of identity of white chocolate in the second option is somewhat prescriptive, the comments indicated that, at this time, the manufacturers favor a minimum of 23.5 percent total fat in white chocolate. This “prescriptive” standard of identity for white chocolate is similar to other published standards for chocolate and will prevent fraudulent or deceptive confections from being offered for sale as “white chocolate.”

Finally, the standard of identity for white chocolate proposed in the second option is in harmony with the white chocolate standards in use by Canada, Codex, and the EU. Comments on this rule supported the globalization of the white chocolate standard as an important market share-increasing tool.

We do not estimate benefits and costs for option 1, because it is the baseline. Although the benefits of options 2 and 3 are similar, we expect option 2 to generate higher benefits because it will lead to harmonization with international standards. The other benefits associated with option 2 would also be realized with option 3.

Currently, manufacturers must obtain TMPs if they want to use the term “chocolate” to market white chocolate products that meet the proposed standard. The TMPs are required because white chocolate products are considered to deviate from the existing standards of identity for chocolate products. In a recent year, FDA received more than one dozen requests for TMPs for white chocolate. Thus, one benefit of issuing a standard of identity for white chocolate is that it will eliminate a manufacturer's need to prepare and submit requests for TMPs in order to market products bearing the name “white chocolate.” This will reduce the paperwork burden to white chocolate manufacturers and reduce the burden to FDA of processing the TMPs.

Establishment of standards of identity for a product is thought to reduce consumer confusion and deception. Well-defined standards of identity, which establish consistent product names, can assist consumers in finding and comparing products by the name of the food. The standard of identity for white chocolate will establish a new product name that, according to the petitions, is consistent with the name that a majority of consumers are already using to describe this product. Comments to this rule indicated that the proposed standard of identity is compatible with not only the perception of United States consumers, but also aligns with the standard of identity for white chocolate as set by Canada, Codex, and the EU. This international harmonization of the white chocolate standard should make U.S.-produced white chocolate more competitive with internationally produced white chocolate, both at home and abroad.

Although we cannot estimate the total costs of this final rule, we expect that the costs of options 2 and 3 will be approximately the same.

The establishment of a standard of identity requires that all products that meet the standard bear the standardized name. If there are products that are formulated in accordance with the standard of identity but are not currently labeled as “white chocolate,” then those products will have to be relabeled.

Because “white chocolate” will need to appear on each product's principal display panel, the cost for label changes will depend on the number of products that must be relabeled and the amount of time manufacturers are given to complete the label changes. Many of the large chocolate manufacturers are already marketing their white chocolate products under TMPs and will not need to relabel their products.

There are approximately 250 firms that produce chocolate products in the United States, but the number of products whose formulation satisfies this new white chocolate standard of identity is unknown. To estimate the labeling change costs to chocolate producers as a result of the new white chocolate standard of identity, the “FDA Labeling Cost Model” (Ref. 1) is used. This model replaces the 1990 version of the model used in the white chocolate proposed rule estimates.

There are 9558 stock keeping units (SKUs) for products represented by the North American Industry Classification System (NAICS) code for Chocolate & Confectionery Products made from cacao beans. Using this SKU information, the “FDA Labeling Cost Model, Final Report” estimates the costs per product for a chocolate manufacturer to change the standard of identity on their principal display panel.

The actual cost of relabeling will be determined largely by the length of time between the date that the rule becomes final and date it becomes effective (the compliance period). Given that January 1, 2004, is the uniform compliance date for food labeling regulations that are issued between January 1, 2001, and December 31, 2002, the cost of relabeling per product for firms averages $4,300 for a minimum-allowed 12-month compliance period, $2,000 for a 24-month compliance period, and $120 for the maximum-allowed 36-month compliance period. Relabeling costs are comprised of administrative costs, printing costs, and costs of lost label inventory.

This final rule will not affect products that do not meet the standard, because they may continue to be produced and marketed as they currently are. FDA is not able to estimate the total cost of this final rule because we received no comments that supplied the additional information necessary.

FDA has examined the economic implications of this 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 agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA finds that this final rule will have a significant economic impact on a substantial number of small businesses.

This final rule will establish a standard of identity for white chocolate. Although the amount of the costs depend on the length of the compliance period, this final rule may impose significant compliance costs on industry, and there may be a significant impact of these provisions on a substantial number of small businesses.

FDA believes that the provision of this final rule most likely to have a significant impact on a substantial number of small businesses is the labeling requirement. There are approximately 250 firms that produce chocolate products (NAICS code 311320) in the United States. Almost all of these businesses have fewer than 500 employees, and thus are small businesses, as defined by the Small Business Administration, FDA has no data on the number of products that will meet the proposed standard and that, therefore, may need to be relabeled.

As discussed in section IV.C of this document, FDA has estimated the average relabeling costs per product for firms to be $4,300, $2,000, and $120, for a 12-month, 24-month, and 36-month compliance period, respectively. Using these average relabeling costs and the “Model for Estimating the Impacts of Regulatory Costs on the Survival of Small Businesses” (Ref. 2), the possibility of a small firm closing due to this standard of identity regulation can be estimated. If the compliance period is 12 months in length, the model predicts that approximately 6 firms with less than 500 employees are likely to go out of business. For the 24-month compliance period and the 36-month compliance period, it is expected that no firms are likely to go out of business.

FDA received no comments on the effects of the proposed rule on small businesses or on the length of the compliance period. Because so many small entities are in the industry, we believe that the final rule establishing a standard of identity will have a significant economic impact on a substantial number of small businesses.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism impact statement is not required.

FDA has previously considered the environmental effects of this rule, as announced in the proposed rule (62 FR 10781 at 10785, March 10, 1997). No new information or comments have been received that would affect our previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

In the proposal, FDA stated its tentative conclusion that the proposed rule contains no reporting, recordkeeping, labeling, or third party disclosure requirements and asked for comments on whether the proposed rule imposed any paperwork burden. No comments were received addressing the question of paperwork burden. FDA concludes that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Rather, the labeling statements are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320(c)(2)).

The following references have been placed on display at the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The Coast Guard is implementing the permanent safety zone in 33 CFR 165.909 (a)(29) (67 FR 44560, July 3, 2002) for fireworks displays in the Captain of the Port Milwaukee Zone during October 2002. The following safety zone is in effect for fireworks displays occurring in the month of October 2002:

Sheboygan South High School Fireworks—Sheboygan, WI. This safety zone will be enforced on October 3, 2002, from 7:50 p.m. until 8:40 p.m. In the event of inclement weather on October 3, 2002, the safety zone will be enforced from on October 4, 2002 from 7:50 p.m. until 8:40 p.m.

In order to ensure the safety of spectators and transiting vessels, this safety zone will be in effect for the duration of the event. Vessels may not enter the safety zone without permission from Captain of the Port Milwaukee Zone. Requests to transit the safety zone must be made in advance by contacting the person listed in FOR FURTHER INFORMATION CONTACT and must be approved by the Captain of the Port Milwaukee before transits will be authorized. Spectator vessels may anchor outside the safety zone but are cautioned not to block a navigable channel.

As part of the creation of the Office of Inspector General in 1996, certain functions were transferred from the Postal Inspection Service to the Postal Service Office of Inspector General. Part 962 is being revised to reflect that investigations under this part are now conducted by the Office of Inspector General. In addition, these rules of practice as well as the rules of practice in other proceedings before the Judicial Officer are being amended to correct typographical errors and omissions and make other technical changes.

These revisions are changes in agency rules of practice before the Judicial Officer and do not substantially affect any rights or obligations of private parties. Therefore, it is appropriate for their adoption by the Postal Service to become effective immediately.

This section is organized as follows:

EPA is approving VOC RACT plan approvals for four facilities in eastern Massachusetts. EPA is also approving Massachusetts' VOC RACT regulation 310 CMR 7.18 (17) as it applies to the Boston-Lawrence-Worcester (eastern Massachusetts) ozone nonattainment area. In addition, EPA is also approving negative declarations Massachusetts submitted for certain VOC source categories and is determining that Massachusetts has met the CAA VOC RACT requirements for the aerospace coating and wood furniture manufacturing source categories through a combination of measures that are already federally enforceable.

Sections 182(b)(2) and 184(b) of the Clean Air Act contain the requirements relevant to today's action. 42 U.S.C. sections 7511a(b)(2) and 7511c(b). Section 182(b)(2) requires states to adopt RACT rules for all areas designated nonattainment for ozone and classified as moderate or above. There are three parts to the section 182(b)(2) RACT requirement: (1) RACT for sources covered by an existing Control Techniques Guideline (CTG)— i.e. , a CTG issued prior to the enactment of the 1990 amendments to the CAA; (2) RACT for sources covered by a post-enactment CTG; and (3) all major sources not covered by a CTG, i.e. , non-CTG sources.

Pursuant to the CAA Amendments of 1990, all of Massachusetts was classified as serious nonattainment for ozone. Specifically, the following two areas were designated as serious ozone areas: the Boston-Lawrence-Worcester (or eastern Massachusetts) area; and the Springfield (or western Massachusetts) area. See 56 FR 56694 (Nov. 6, 1991). These areas were, thus, subject to the section 182(b)(2) RACT requirement.

In addition, Massachusetts is located in the Northeast Ozone Transport Region (OTR). The Commonwealth is, therefore, subject to section 184(b) of the CAA. Section 184(b) requires that RACT be implemented in the entire state for all VOC sources covered by a CTG issued before or after the enactment of the CAA Amendments of 1990 and for all major VOC sources (defined as 50 tons per year for sources in the OTR).

A CTG is a document EPA issues which establishes a “presumptive norm” for RACT for a specific VOC source category. Under the pre-amended CAA, EPA issued CTG documents for 29 categories of VOC sources. Section 183 of the CAA requires that EPA issue 13 new CTGs. Appendix E of the General Preamble of Title I (57 FR 18077) lists the categories for which EPA plans to issue new CTGs.

On November 15, 1993, EPA issued a CTG for Synthetic Organic Chemical Manufacturing Industry (SOCMI) Distillation Operations and Reactor Processes. Also, on August 27, 1996, EPA issued a CTG for shipbuilding and repair operations. On May 26, 1996, EPA issued a CTG for wood furniture finishing operations. Furthermore, on March 27, 1998, EPA issued a CTG for aerospace coating operations.

In response to the requirements to adopt RACT for all sources covered by a new CTG, Massachusetts submitted negative declarations to EPA for the shipbuilding and repair operations and the SOCMI reactor processes CTG categories. Through these negative declarations, Massachusetts is confirming that there are no sources in the Commonwealth that would be subject to a rule for these categories.

In addition, for the SOCMI distillation processes CTG category, Massachusetts stated in a letter, dated April 16, 1999, that Solutia Incorporated, in Springfield, is subject to this CTG. The letter also states that VOC emissions at this facility are currently controlled by a pollution control system with a required control efficiency of more than 85 percent and that this control requirement was determined to be best available control technology (BACT) in a federally enforceable plan approval issued pursuant to 310 CMR 7.02.

Furthermore, for the wood products CTG category, Massachusetts submitted a letter, dated July 24, 2002, stating that there are six facilities in Massachusetts that exceed the 25 ton per year (tpy) applicability threshold for the wood furniture CTG. Three of these facilities (Athol Table, Mark Richey Woodwork, and Adden Furniture) are subject to 310 CMR 7.18(23), “Wood Products Surface Coating.” This rule applies to 50 tpy facilities and was approved into the Massachusetts SIP on September 3, 1999 (64 FR 48297). In addition, one of the six facilities, Nichols and Stone, is subject to 310 CMR 7.18(17), “Reasonable Available Control Technology.” RACT was determined for this facility several years prior to the issuance of EPA's wood furniture CTG and was submitted to EPA as a single source SIP revision on July 19, 1993. EPA approved this SIP revision on January 6, 1995 (60 FR 2017). Also, Massachusetts has issued the remaining two wood furniture facilities (Saloom Furniture and Eureka Manufacturing) federally enforceable BACT plan approvals pursuant to 310 CMR 7.02. These BACT plan approvals contain the same emission limitations as those included in the wood furniture CTG.

Finally, for the aerospace CTG, Massachusetts submitted a letter, dated July 24, 2002, stating that there are two facilities in Massachusetts that exceed the 25 tpy applicability threshold of the aerospace CTG. They are General Electric in Lynn and Raytheon in Lowell. The coating operations at these two facilities are covered by Massachusetts' miscellaneous metal parts and products coating regulation, 310 CMR 7.18(11). Also, the degreasing emissions at these two facilities are covered by Massachusetts' degreasing regulation 310 CMR 7.18(8). Both 310 CMR 7.18(11) and 310 CMR 7.18(8) have been approved into the Massachusetts SIP. See 58 FR 34911 (June 30, 1993).

EPA is approving Massachusetts' negative declarations as meeting the CAA section 182(b)(2) and section 184(b) requirements, as applicable, for the shipbuilding and repair operations and SOCMI reactor processes CTG categories. However, if evidence is submitted by November 4, 2002 that there are existing sources within Massachusetts that would be covered by the CTGs for these same categories, 1 EPA would consider such comments adverse and we would withdraw this approval action on that negative declaration.

For the SOCMI reactor distillation operations CTG category, the only source in Massachusetts subject to this CTG is meeting an 85 percent control requirement which was determined to be BACT in a federally enforceable plan approval. EPA agrees that Massachusetts has met the VOC RACT requirements for this source category.

For the wood furniture and aerospace CTG categories, Massachusetts has imposed requirements on the six facilities that are subject to the wood furniture CTG and on the two facilities that are subject to the aerospace CTG through a combination of measures ( i.e. , VOC regulations and BACT and RACT plan approvals) that are already federally enforceable. EPA has evaluated these measures and has found that they are generally consistent with the applicable CTGs. Therefore, EPA is approving these measures as meeting RACT for the aerospace and wood furniture CTG categories. The specific requirements imposed on the aerospace and wood furniture facilities and EPA's evaluation of these requirements are detailed in a memorandum dated August 20, 2002, entitled “Technical Support Document—Massachusetts—VOC RACT” (TSD). The TSD, as well as the various plan approvals on which EPA is relying to enforce RACT, are available in the docket supporting this action.

On February 17, 1993, Massachusetts submitted 310 CMR 7.18(17) “Reasonable Available Control Technology.” In addition, Massachusetts subsequently submitted SIP revisions for the following four facilities which are subject to 310 CMR 7.18(17):

• Barnet Corporation of Peabody;

• Rex Finishing Incorporated of Peabody;

• Norton Company of Worcester; and

• Gillette Company's Andover Manufacturing Center.

Massachusetts' regulation and the plan approvals for the four facilities listed above are discussed in more detail below.

This regulation describes a process by which RACT can be defined, but does not specifically define RACT for each source applicable to the regulation. Therefore, in order to receive full approval, Massachusetts must define, and EPA must approve, RACT for all of the sources that are subject to 310 CMR 7.18(17). EPA previously approved this rule for the Springfield ozone nonattainment area. See 64 FR 48297 (September 3, 1999). In this rulemaking, EPA noted that there were sources in the eastern Massachusetts ozone nonattainment area for which EPA had not yet approved RACT plans and that EPA would address 310 CMR 7.18(17) for the eastern Massachusetts area in a separate rulemaking, along with the case-specific RACT determinations. Massachusetts has defined RACT for Barnet, Rex Finishing, Gillette, and Norton as described below.

On April 16, 1999, Massachusetts submitted VOC RACT plan approvals for Barnet and Rex Finishing to EPA as a SIP revision. At these facilities, VOCs are emitted from leather finishing operations. Massachusetts determined that implementing low VOC coatings and certain work practice and equipment standards represent RACT for Barnet and Rex Finishing. The plan approvals require these facilities to meet specific emission limitations and to maintain daily records in order to demonstrate compliance with these limits.

On October 7, 1999, Massachusetts submitted a VOC RACT plan approval for Gillette to EPA as a SIP revision. Gillette manufactures shaving cream and deodorants at its Andover, Massachusetts facility. The majority of VOC emissions from the facility are hydrocarbon propellants ( e.g. , isobutane) and ethanol solvents from aerosol propellant filling. The plan approval requires Gillette to use through the valve filling (TTV) for all products that can be successfully TTV-filled. TTV-filling is currently recognized as the lowest-emitting aerosol filling process available. The plan approval also caps VOC emissions to a maximum of 150 tons per rolling 12 month calendar period and 50 tons per month. Additionally, the plan approval requires Gillette to implement a leak detection and repair program. Finally, the plan approval also sets recordkeeping, reporting, and testing requirements.

On October 7, 1999, Massachusetts submitted a VOC RACT plan approval for Norton Company to EPA as a SIP revision. Norton is a manufacturer of abrasive products, ceramic grinding wheels, and high performance refractories. VOCs are emitted in the manufacture of these products. Norton has reduced its VOC emissions by using material substitution, reformulation, emission controls, good housekeeping and better operating practices. The plan approval requires Norton to meet several enforceable short and long term RACT limits which are specified and tracked by business unit or similar unit operation. In addition, the plan approval also sets the appropriate recordkeeping, reporting, and testing requirements in order to demonstrate compliance with these emission limits.

In addition to the SIP revisions submitted for the four facilities discussed above, Massachusetts also submitted documentation regarding two other facilities subject to 310 CMR 7.18(17), namely Polaroid of Waltham and Globe Manufacturing of Fall River. The VOC RACT plan approval submitted for Polaroid on April 16, 1999 was subsequently superseded by two federally enforceable BACT plan approvals that were issued to Polaroid on December 22, 1999 and September 15, 2000. When taken together, these two BACT plan approvals cover all of the processes that were included in the previously issued RACT plan approval. In addition, the BACT plan approvals require emission reductions above and beyond those required by the RACT plan. Therefore, in a letter dated July 24, 2002, the Massachusetts DEP withdrew its April 16, 1999 SIP revision request for Polaroid. In addition, Massachusetts submitted documentation showing that the three VOC emitting processes at Globe (the reaction spin process; the dry spin process; and the rubber fiber process) are subject to federally enforceable requirements contained in two BACT plan approvals issued to the facility on June 6, 1996 and November 24, 1997.

EPA has evaluated the plan approvals submitted for the facilities listed above and has found that these plan approvals are consistent with EPA guidance and impose RACT at these facilities. Therefore, EPA is approving the plan approvals for Barnet, Rex, Gillette, and Norton into the Massachusetts SIP. EPA has also evaluated Massachusetts 310 CMR 7.18(17) and has found that this regulation is generally consistent with EPA guidance, with the exception discussed above, and requires RACT to be developed at the facilities covered by the CAA. Since Massachusetts has, however, adequately addressed all of the applicable sources in the eastern Massachusetts serious ozone nonattainment area required to have RACT, EPA is approving this regulation as meeting the CAA requirements for this area. Finally, EPA has evaluated BACT plan approvals issued under 310 CMR 7.02 and has determined that they impose a level of control at least equivalent to RACT.

The specific requirements of the plan approvals and of Massachusetts 310 CMR 7.18(17) and EPA's evaluation of these requirements are detailed in the TSD.

Although EPA is not incorporating the BACT plan approvals issued under 310 CMR 7.02 into the SIP, because they are already federally enforceable under the SIP-approved section 7.02, these plan approvals are available for inspection in the docket supporting this action.

The EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should EPA receive relevant adverse comments. This action will be effective December 3, 2002 without further notice unless the EPA receives relevant adverse comments by November 4, 2002.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. EPA will then address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If EPA receives no such comments, the public is advised that this rule will be effective on December 3, 2002 and EPA will take no further action on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Final Action: EPA is approving the VOC RACT plan approvals for Barnet, Rex Finishing, Gillette Company, and Norton Company. EPA is also approving Massachusetts' VOC RACT regulation 310 CMR 7.18 (17) as it applies to the eastern Massachusetts ozone nonattainment area. In addition, EPA is approving Massachusetts' negative declarations for the shipbuilding and repair operations and SOCMI reactor processes CTG categories. EPA is also approving the Solutia BACT permit as meeting the CAA VOC RACT requirements for the SOCMI distillation reactors category. Finally, EPA is approving a combination of already federally enforceable measures (namely, the VOC RACT regulations and the RACT and BACT plan approvals discussed above) as meeting the CAA VOC RACT requirements for the aerospace and wood furniture manufacturing operations CTG categories.

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), because it 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 December 3, 2002. Interested parties should comment in response to the proposed rule rather than petition for judicial review, unless the objection arises after the comment period allowed for in the proposal. 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).

On July 25, 1990, the Commonwealth of Massachusetts submitted a formal revision to its State Implementation Plan (SIP). On October 1, 1990, Massachusetts submitted additional information and requested that all areas designated as nonattainment for Total Suspended Particulates (TSP) be redesignated to “Cannot be Classified.” The SIP revision consists of changes to Massachusetts Rules 310 CMR 6.04, 7.00, 8.02 and 8.03.

On July 1, 1987, EPA promulgated revised National Ambient Air Quality Standards (NAAQS) for particulate matter, based upon measurement of particles having a mean aerodynamic diameter of 10 microns or less (PM10) (52 FR 24634). The revised standards replace TSP as the national particulate standard. In 1990, Massachusetts submitted a SIP revision which adopted the PM10 standard and made other changes in their program to reflect the new PM10 NAAQS. Massachusetts submitted this change as part of a larger package which also contained changes to their New Source Review program. At that time, although some areas in Massachusetts were not in attainment for TSP, no exceedences of the PM10 standard were monitored. Massachusetts has also requested that EPA redesignate these areas to “cannot be classified.”

On July 25, 1990, Massachusetts submitted a formal request for a SIP Revision. This package revised four sections of 310 CMR, specifically 310 CMR 6.04, 7.00, 8.02 and 8.03. Some of these changes made PM10 the particulate standard. Other changes affected the New Source Review program, and EPA will consider them in a separate action. On October 1, 1990, Massachusetts also submitted a formal request to redesignate all TSP nonattainment areas to “cannot be classified.”

EPA is approving changes to these sections of the Code of Massachusetts Rules: 310 CMR 6.04 7.00, 8.02 and 8.03. Specifically, Massachusetts is changing Section 6.04(2) to make PM10 the standard for particulate matter. In Section 7.00, Massachusetts adds definitions of PM10 and PM10 emissions. In Section 8.02, Massachusetts adds a definition of PM10. In Section 8.03, Massachusetts makes PM10 the particulate criteria used to determine air pollution episode alerts and warnings.

These changes will make Massachusetts law consistent with the Federal NAAQS. They will eliminate the possibility of using TSP as an outdated ambient air quality standard for particulate matter.

40 CFR 81.322 lists some areas in Massachusetts as being “nonattainment” for TSP. Massachusetts requested to redesignate these areas from “nonattainment” to “cannot be classified.” Since TSP is no longer a criteria pollutant, this nonattainment designation is no longer meaningful. The areas cannot be redesignated to attainment, since TSP is no longer being measured. All of the areas are in attainment for PM10, but we cannot assume they are also in attainment for TSP. We encourage the states to designate these areas as “cannot be classified” to reflect this situation.

The redesignation will allow Massachusetts to issue permits to new and modified sources under the rules of an attainment area. This will give Massachusetts more flexibility in its New Source Review (NSR) permitting program.

There are multiple reasons for redesignating a “non-attainment” area to “cannot be classified” in this specific situation. First, Massachusetts no longer monitors for TSP. It has not monitored for TSP since 1989. The Commonwealth currently monitors for PM10 and there is evidence that all areas in the Commonwealth are in attainment for the PM10 NAAQS. Second, although Massachussetts no longer monitors for TSP, the last available TSP monitoring data indicated that Massachusetts was in attainment for TSP. However, in order to be able to redesignate an area to “attainment,” an attainment demonstration, which includes at least three years of data indicating that a state is in attainment, is required as part of the plan revision. Since the Commonwealth stopped monitoring for TSP it was never able to gather all the data required to substantiate the change. Therefore, Massachussetts is not able to meet the necessary requirements to redesignate the TSP nonattainment areas to attainment. Since the attainment designation is not an option, the Commonwealth is requesting that all the non-attainment areas be redesignated as “cannot be classified.”

Clean Air Act section 107(d)(3) sets out the requirements for redesignation of an area. 42 U.S.C. 7407(d)(3). For example, section 107(d)(3)(A) indicates the basis upon which EPA may initiate a redesignation and sections 107(d)(3)(A)-(D), among other things, specify the affected state's role in the designation process, including authority for the state to initiate process. Sections 107(d)(3)(E) and (F) set out restrictions which apply to redesignation of a nonattainment area. Section 107(d)(3)(E) prohibits redesignation of an area from nonattainment to attainment unless five specific conditions are met. As mentioned above, Massachusetts cannot meet these conditions. Section 107(d)(3)(F) of the Act prohibits redesignation of an area from nonattainment to unclassifiable.

Section 107(d)(4)(B) of the Act expressly provides that any designation for particulate matter (measured in terms of TSP) that the Administrator promulgated pursuant to section 107(d) prior to the date of enactment of the 1990 Amendments shall remain in effect for purposes of implementing the maximum allowable concentrations of particulate matter, until the Administrator determines that such designation is no longer necessary.

It is EPA's view that the purpose for the TSP designations found in section 107(d)(4) are based on a congressional intent which is largely different from the purpose for the redesignation requirements found in section 107(d)(3). Section 107(d)(4) indicates that Congress envisioned that EPA would keep the TSP designations for the narrow purpose of implementing the particulate matter increments measured in terms of TSP. Section 107(d)(3) is, in part, directed to limiting redesignations consistent with the the statute's air quality goals by ensuring, for example, that before a nonattainment area is redesignated attainment, the applicable SIP requirements have been implemented and the area attains the applicable NAAQS. These requirements make sense and have force where there are relevant NAAQS in place. However, there are no TSP NAAQS and there is no TSP-directed SIP program. While at this time EPA believes that a TSP designation may be necessary to implement the particulate matter increments, this narrow purpose can be fostered with any designation for TSP. Therefore, EPA believes that it is reasonable to conclude that TSP redesignations are not subject to the section 107(d)(3) requirements. Thus, among other things, an area could be redesignated from nonattainment to cannot be classified for TSP. Under these very limited circumstances, EPA has stated that on or after the date it approves a state's PM-10 SIP, it encourages and will approve state requests to redesignate TSP nonattainment areas to cannot be classified (52 FR 24670).

Since TSP was replaced by PM10 as a criteria pollutant, the redesignation of the specified areas will benefit Massachusetts as it continues to monitor criteria pollutants and issue permits to new and modified sources under the current federal standards. Ultimately, the redesignations will have a beneficial effect on the air quality of Massachusetts.

This action is not affected by the court's decision in American Trucking Assoc. v. U.S. EPA, 175 F.3d 1027 (D.C. Cir.1999) (“American Trucking”), recv'd on other grounds, 531 U.S. 457 (2001). This action is based on the original PM10 NAAQS promulgated in 1987. The American Trucking decision questions EPA's revised NAAQS introducing the PM2.5 (PM fine) standard. With regards to the relevant PM10 standard, the court stated that the record contains sufficient evidence to justify the Agency's decision to regulate coarse particle pollution: The relationship between PM 10 pollution and adverse health effects justifying the 1987 NAAQS is well established.

Massachusetts requested several changes to their New Source Review program at the same time they made this request. The EPA will address the other changes in another Federal Register package.

EPA is approving revisions to 310 CMR 6.04, 7.00, 8.02, and 8.03 and is redesignating all areas in Massachusetts currently designated as nonattainment for TSP to “Cannot be Classified.” The Agency has reviewed this request for revision of the federally-approved state implementation plan for conformance with the provisions of the 1990 amendments enacted on November 15, 1990. The Agency has determined that this action conforms with those requirements irrespective of the fact that the submittal preceded the date of enactment.

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comments be filed. This rule will be effective December 3, 2002, without further notice unless the Agency receives relevant adverse comments by November 4, 2002.

If the EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. Parties interested in commenting on the proposed rule should do so at this time. If EPA receives no such comments, the public is advised that this rule will be effective on December 3, 2002, and the Agency will take no further action on the proposed rule. Furthermore, please note that if EPA receives relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of a relevant adverse comment.

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), because it 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. 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. 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 December 3, 2002. Interested parties should comment in response to the proposed rule rather than petition for judicial review, unless the objection arises after the comment period allowed for in the proposal. 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).)

The Environmental Quality Improvement Act, as amended (Pub. L. 91-224, Title II, April 3, 1970; Pub. L. 97-258, September 13, 1982; and Pub. L. 98-581, October 30, 1984) establishes an Office of Environmental Quality Management Fund (OEQ Management Fund) to receive advance payments from other agencies or accounts that may be used solely to finance (1) study contracts that are jointly sponsored by the Office of Environmental Quality and one or more federal agencies and (2) federal interagency environmental projects (including task forces) in which the Office participates. 42 U.S.C. 4375. The Director of the Office of Environmental Quality (OEQ) is required to promulgate regulations setting forth policies and procedures for operation of the OEQ Management Fund. 42 U.S.C. 4375(c). The OEQ Director adopted policies and procedures for operation of the OEQ Management Fund in January of 1985. These policies and procedures have been revised to provide for the development and implementation of interagency agreements to assist the OEQ's oversight and administration of the Management Fund. In accordance with the Environmental Quality Improvement Act, these policies and procedures are hereby promulgated as regulations. Because these regulations are related solely to agency management, their promulgation is not subject to notice and comment in accordance with 5 U.S.C. 553(a)(2).

The OEQ considers this rule to be a procedural rule which is exempt from notice-and-comment under 5 U.S.C. 533(b)(3)(A).

This rule is not a significant rule and is not subject to review by the Office of Management and Budget under Executive Order 12866.

(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3) This rule does not alter the budgetary effects or entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(4) This rule does not raise novel legal or policy issues.

NASA is in the process of implementing a new Agency-wide Integrated Financial Management System. This implementation requires a minor change to the number of digits and sequence of characters used in the contract identification number. This final rule makes these administrative changes to the contract numbering scheme used for NASA contracts.

This final rule does not constitute a significant revision within the meaning of FAR 1.501 and Public Law 98-577, and publication for public comment is not required. However, NASA will consider comments from small entities concerning the affected NFS Part 1804 in accordance with 5 U.S.C. 610.

The Paperwork Reduction Act does not apply because the changes do not impose recordkeeping or information collection requirements which require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

After the terrorist attacks of September 11, 2001, the Federal Motor Carrier Safety Administration (FMCSA) and the Research and Special Programs Administration (RSPA) reviewed government and industry hazardous materials transportation safety and security programs with a view towards identifying areas where security should be enhanced. Over 800,000 shipments of hazardous materials occur each day in the United States. The overwhelming majority of these shipments—approximately 95 percent—are made by highway. Many of the hazardous materials transported by motor carriers potentially may be used as weapons of mass destruction or in the manufacture of such weapons. Since September 11, 2001, on several occasions, Federal law enforcement officials provided information indicating that terrorist organizations may be planning to use motor vehicles transporting certain hazardous materials for additional terrorist attacks on facilities in the United States.

Prior to 1975, the Secretary of Transportation regulated the transportation of hazardous materials by highway under the authority of the Motor Carrier Safety Act (MCSA). The authority to issue regulations under the MCSA is currently delegated to FMCSA. 49 CFR 1.73(g). In 1974, Congress passed the Hazardous Materials Transportation Act (HMTA). The HMTA gave the Secretary the authority to issue “regulations for the safe transportation in commerce of hazardous materials” applicable to “any person who transports, or causes to be transported or shipped, a hazardous material * * * .” Public Law 93-633; 88 Stat. 2156 (Jan. 3, 1975). The Secretary delegated this rulemaking authority to RSPA. 49 CFR 1.53(b).

Motor carriers that transport hazardous materials in interstate commerce must comply with both the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180), administered by RSPA, and the Federal Motor Carrier Safety Regulations (FMCSR; 49 CFR parts 390-397), administered by FMCSA. Motor carriers that transport hazardous materials in intrastate commerce must comply with the HMR, and the FMCSR to the extent that they apply (See 62 FR 1208, 1213 (January 8, 1997) and 49 CFR 177.804). As a result of a 1984 amendment to the MCSA and a 1990 amendment to the HMTA, RSPA is authorized to eliminate or amend regulations (other than highway routing regulations) that appear in part 397 of the FMCSR and that apply solely to the maintenance, equipment, loading, or operation of motor vehicles carrying hazardous materials. Therefore, we are issuing this final rule as a joint RSPA-FMCSA rulemaking.

Section 397.17 of the FMCSR requires periodic tire inspections for certain vehicles transporting hazardous materials. Drivers of vehicles with dual tires must stop every two hours or 100 miles to inspect the tires. When originally promulgated, this requirement was intended to prevent possible fires caused by overheated tube-type tires. With advancements in tire technology, fires caused by tire overheating occur much less frequently.

To require a vehicle transporting a hazardous material to stop at frequent regular intervals increases the security risk associated with such transportation. Any stop provides an opportunity for potential highjacking or theft of the vehicle and its cargo. Eliminating the tire check stop reduces this potential security risk. On July 16, 2002, we published a Notice of Proposed Rulemaking (NPRM) (67 FR 46624) proposing to eliminate this outdated requirement for certain motor vehicle operators to stop periodically to check their tires.

We received eight comments on the NPRM. Most commenters support the proposal to eliminate the requirement that certain motor vehicle operators periodically stop to check their tires. They agree with us that advancements in tire technology, specifically the elimination of inner-tubes, have largely eliminated the risk of fire caused by tire overheating. Hence, stopping every two hours or 100 miles to check the tires is no longer necessary. The commenters also support our position that frequent stops compromise the security of hazardous materials shipments and increase the vulnerability to theft and hijackings.

One commenter disagrees with the proposed changes, stating that a reduction in potential security risks for motor carriers should not come from the elimination of regulations that were established to promote carrier and public safety. As stated in the NPRM, we are not eliminating all tire checks. An operator of a motor vehicle transporting hazardous materials must still check each tire at the beginning of each trip and each time the vehicle is parked. Thus, we do not agree that elimination of the periodic 2 hour/100 mile tire check requirement reduces safety. This commenter also suggests that training for drivers that includes increased security awareness concerning hijackings and theft would be beneficial. In this regard, we note that in an NPRM published under Docket HM-232 on May 2, 2002 (67 FR 22030), we are proposing to add a provision to § 172.704 to require the training of hazmat employees to include a security component covering how to recognize and respond to possible security threats.

A commenter who supports the proposal notes that 49 CFR 392.9, Safe loading, requires drivers of trucks and truck tractors to stop periodically to examine the vehicle's cargo and its load-securing devices. The commenter suggests that we also analyze the risk and benefits related to periodic inspection of load-securing devices. The requirement for safe loading of cargo applies to all types of cargo and not just hazardous materials shipments, and therefore is outside the scope of this rulemaking.

The FMCSA has determined that this is not a significant regulatory action within the meaning of Executive Order 12866, or significant within the meaning of DOT regulatory policies and procedures (44 FR 11034).

Eliminating the periodic tire check requirement for motor vehicles transporting hazardous materials will not result in increased compliance costs on the industry. Instead, eliminating periodic stops to check tires will decrease costs for the industry by reducing en route shipment delays and, thus, improving overall delivery times. Because this final rule eliminates a requirement, preparation of a cost-benefit analysis is not warranted.

In compliance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the FMCSA evaluated the effects of this action on small entities. Accordingly, we certify that this action does not have a significant economic impact on a substantial number of small entities.

This action was analyzed in accordance with the principles and criteria contained in Executive Order 13132. It has been determined that this final action does not have a substantial direct effect on States, nor would it limit the policy-making discretion of the States. Nothing in this document preempts any State law or regulation.

This final rule has been analyzed under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments). Because this final rule does not significantly or uniquely affect the communities of the Indian tribal governments and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

This final rule does not impose an unfunded mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532 et seq. ) that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year.

This action does not contain an information collection requirement for the purposes of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

There are no significant environmental impacts associated with this final rule.

In consideration of the foregoing, FMCSA is amending chapter III, subchapter B, Title 49 of the Code of Federal Regulations, as follows:

The Fish and Wildlife Service published a proposed rule in the July 26, 2002 (67 FR 48855), Federal Register based upon information we obtained indicating that snakehead fishes are injurious to the wildlife and wildlife resources of the United States. The proposed rule invited comments for 30 days ending August 26, 2002. We received 453 written comments during this period. Of those 453 comments, 386 were nonrelevant or nonsignificant, one offered editorial suggestions on the proposed rule, 32 were opposed to adding snakeheads to the list of injurious fishes, and 34 stated their support for the proposed rule. Of the 386 nonrelevant or nonsignificant comments, 353 were electronic messages that were generated erroneously, 13 were electronic messages pertaining to investment scams, 8 were electronic messages pertaining to advertising, one comment offered a resume for employment opportunities, 2 were unknown, 2 offered suggestions/opinions on treating the ponds in Crofton, Maryland, and 7 provided information on sightings of snakeheads. Of the 67 comments that were considered relevant and significant, one came from a Federal agency, 12 from private organizations, 8 from State agencies, and 46 from private individuals.

We reviewed all comments received for substantive issues and new information regarding the injurious nature of snakehead fishes. Similar comments were grouped into issues; these issues and our responses to each are presented below:

Issue 1: One respondent stated that some readers may not understand that snakeheads are fishes until it's stated later in the proposed rule. The respondent suggested clarifying the rule by using the terms “snakehead fish” or “snakehead fishes” either early in the rule or throughout the rule.

Response: The Service agrees with the respondent's comments on this issue. The suggested changes to improve clarification are used in the final rule.

Issue 2: Twenty-one respondents requested that we not list the entire family of snakehead fishes (Channidae) as injurious, but that we list those species (up to five species) that are large and cold tolerant. The respondents stated that the small, temperature-sensitive species used in the aquarium hobby would not pose a threat in most of the United States because, if released, they would not survive the cold climates.

Response: We acknowledge that five of the 28 species recognized in the Channidae family at this time are considered large, approximately 6 are considered dwarf species, and the remaining species are considered medium-size snakehead fishes. As we presented in the proposed rule, the family Channidae contains 9 species that are strictly tropical, 4 can be considered tropical to subtropical, one is subtropical, 12 can tolerate tropical or subtropical to warm temperate conditions, one is warm temperate, and one is warm temperate to cold temperate.

The tropical species would survive in the warmest waters such as extreme southern Florida, perhaps parts of southern California, Hawaii, and certain thermal spring systems and their outflows in the American west. The tropical to subtropical species would have a similar potential range of distribution as for tropical species but with a greater likelihood of survival during cold winters and more northward limits. The tropical or subtropical to warm temperate species could survive in most southern States. The warm temperate, and warm temperate to cold temperate, species could survive in most areas of the United States.

Although the tropical to subtropical species of snakehead fishes are not likely to become established in the northern waters of the United States, all of the Channidae species, including the dwarf species, are aggressive and highly predatory. Should a species of snakehead fishes be accidentally or intentionally released into U.S. waters, the 131 taxa of threatened and endangered amphibians, fishes, and crustaceans could face additional threats. Additionally, because snakehead fishes are morphologically very similar, it would be very difficult for biologists, wildlife inspectors at entry ports, and law enforcement agents to differentiate among species of snakeheads.

Based upon the aggressive, predatory nature of all species of snakehead fishes, the fact that one or more species could become established in most waters of the United States, and the fact that it is very difficult to differentiate among the species of snakeheads, the Fish and Wildlife Service has determined that all 28 of the currently recognized species of snakehead fishes in the Channidae family should be listed as injurious fishes under the Lacey Act.

Issue 3: Six respondents indicated that most hobbyists and fish keepers are responsible and know that releasing exotic species into the environment is dangerous to the environment. The respondents indicated that the responsible hobbyists should not be punished and all species of snakehead fishes should not be listed as injurious. Additionally, most of these respondents stated that an educational campaign should be initiated to explain the hazards of releasing exotic species into the environment and encourage the proper disposition of unwanted pets.

Response: The Service appreciates that most hobbyists and fish keepers are responsible and properly dispose of unwanted pets. It is to the tremendous credit of hobbyists that snakehead fishes have been imported into the United States and only a small number have been found in the wild. This rule is not intended to punish hobbyists; it is based upon the scientific evidence that indicates that snakehead fishes are aggressive and highly predatory and therefore threaten the wildlife and wildlife resources of the United States. It is important to note that individuals or organizations who possessed snakeheads prior to the injurious wildlife listing in States where possession of snakeheads is legal will be able to continue to possess them; however, they will be prohibited from transporting them across State lines.

The Fish and Wildlife Service has initiated a national public awareness campaign known as Stop Aquatic Hitchhikers! This campaign targets aquatic recreation users to raise their awareness about the growing aquatic invasive species problem and to encourage them to become part of the solution in preventing the spread of harmful, nonnative species. While aquatic recreation users may not be responsible for bringing these species into the country, they may inadvertently transport them overland. The Service is working with State fish and wildlife agencies, conservation organizations, and the fishing and boating industries to address this issue. The campaign has a supporting web site with the address: http://www.protectyourwaters.net.

The Service is considering the development of a new campaign similar to Stop Aquatic Hitchhikers! that would target aquarium hobbyists. This campaign would be conducted in conjunction with the Pet Industry Joint Advisory Council, the largest trade association in the United States representing the pet industry in Washington, DC, and it would focus on raising awareness about aquatic invasive species, and encouraging aquarium hobbyists to adopt preventive actions to avoid having unwanted aquarium fish and plant species become part of our environment. The campaign would be a multi-layered, voluntary effort, and would encourage aquarium species importers, wholesalers, retailers and consumers to focus on how the aquarium industry is a responsible economic sector that collectively values the environment and seeks to protect it while simultaneously enjoying the benefits of the aquarium hobby.

Issue 4: Two respondents stated that they are opposed to the injurious wildlife listing because snakehead fishes are valuable food fish.

Response: The Service recognizes the value of snakehead fishes as a food source, just as we recognize their value to hobbyists. However, as stated above, the decision to list the Channidae family of snakehead fishes is based upon scientific data on the hazards that these fishes would present to the wildlife and wildlife resources of the United States. Dead or frozen snakehead fishes can continue to be imported and transported as an alternative to importing live snakeheads.

Issue 5: Two respondents stated that they consider the injurious wildlife listing of snakehead fishes to be racist against the Asian American community because it would prohibit the use of a valuable food source and protect the sport activity of European Americans. Additionally, the respondents indicated that the Service should consult with the Asian American community and that we should consider snakeheads as an economic resource and not a threat.

Response: The decision to list snakehead fishes as injurious under the Lacey Act is based solely on the biological characteristics of the fishes and the need to protect our native wildlife and wildlife resources, and is in no way based upon race or ethnicity, or preserving recreational opportunities for certain sectors of the population. We have substantial scientific data that describe the harm that snakehead fishes cause when introduced outside of their native range and are likely to cause if released into U.S. waters.

According to our Law Enforcement data, 372 individuals and 892 kilograms of snakehead fishes were imported into the United States in 1997; 1,488 individuals and 1,883 kilograms were imported in 1998; 6,044 individuals and 8,512 kilograms were imported in 1999; 8,650 individuals and 9,240 kilograms were imported in 2000; and 20,547 individuals were imported in 2001. We do not have information on how many of those imports contained young fishes destined for the aquarium trade and how many were larger individuals destined to be sold as live food fish. While the importations did increase between 1997 and 2001, the importation of snakehead fishes into the contiguous United States does not appear to represent a significant portion of live fish imports. We suggest that all persons who previously used live snakeheads as a food fish consider the use of dead or frozen fish as an alternative.

Issue 6: Two respondents indicated that the proposed listing of snakehead fishes was based more on hype than fact, and is an overreaction to media attention.

Response: As a result of the discovery of the bullseye snakeheads in south Florida, the U.S. Geological Survey and the Service began evaluating the risks associated with snakehead fishes in 2001. Consequently, the injurious wildlife listing was being developed within the Service before the recent media attention.

Outside of what is published in our official press releases, the Service has no control over what is published in the media. We agree that some of the facts have been exaggerated, and we have taken measures to correct misinformation that has appeared in the media.

Issue 7: Thirteen respondents stated that snakehead fishes threaten ecological harmony, present major risks to ecosystems and aquatic communities, and could eliminate some of our threatened and endangered species that are restricted in distribution. The respondents also stated that the United States has a well-documented history of adverse consequences to native species due to the introduction of other nonnative species.

Response: The Service agrees with the respondents' comments on these issues. The biological characteristics of snakehead fishes and their potential to be injurious to the wildlife and wildlife resources of the United States is the basis for our decision to add snakeheads to the list of injurious fishes under the Lacey Act.

Issue 8: Two respondents stated that the fines are too lenient compared to the potential ecological devastation caused by the potential establishment of snakeheads.

Response: The Secretary of the Interior has the authority under the Lacey Act to add species to the injurious wildlife list, but the Secretary does not have the authority to change the penalties. The penalties are established by statute and can be changed by an act of Congress.

Issue 9: Three respondents stated that the prohibition on importation and interstate transportation of snakehead fishes would not significantly impact the aquarium industry. They also stated that the humane disposition of snakeheads will be encouraged.

Response: The Service is pleased that this action will not result in significant financial losses to aquarium fish producers, wholesalers, and retailers. We are also encouraged that the respondents are willing to proactively promote the humane disposal of the fishes, thereby reducing the risk that they would be introduced into the environment.

Issue 10: Three respondents stated that they are opposed to listing the family Channidae by simply referring to “Channidae” because the taxonomy is not clear and not all people are conversant with scientific names. The respondents suggested we revise 50 CFR 16.13 to resemble a list instead of a paragraph, and that we include the genus, species, and common names of all currently recognized snakehead species, as well as the family name.

Response: We have accepted this suggestion and made the changes in this rule. We have also included synonyms for the Channa and Parachanna genera.

Issue 11: One respondent expressed concern that permits for importation and interstate transportation can be issued for medical purposes under the Lacey Act. The respondent indicated that permits should be granted only to accredited medical institutions.

Response: As described in 50 CFR 16.22, the Director of the Fish and Wildlife Service may issue permits for the importation and interstate transportation of injurious species only for scientific, medical, educational, or zoological purposes. Persons or institutions wishing to apply for a permit must meet the application requirements, additional permit conditions, and issuance criteria as set forth in 50 CFR 16.22. Permits are issued only to legitimate individuals and/or institutions for medical research, scientific, zoological, or educational purposes.

The regulations contained in 50 CFR part 16 implement the Lacey Act (18 U.S.C. 42) as amended. Under the terms of that law, the Secretary of the Interior is authorized to prohibit by regulation certain activities involving wild mammals, wild birds, fish (including mollusks and crustaceans), amphibians, reptiles, and the offspring or eggs of any of the foregoing that are injurious to human beings, to the interests of agriculture, horticulture, or forestry, or to the wildlife or wildlife resources of the United States. The lists of injurious wildlife species are at 50 CFR 16.11 to 16.15. By adding snakehead fishes to the list of injurious wildlife, their importation into, and transportation between, States, the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States by any means whatsoever is prohibited, except by permit for zoological, educational, medical, or scientific purposes (in accordance with permit regulations at 50 CFR 16.22), or by Federal agencies without a permit solely for their own use, upon filing a written declaration with the District Director of Customs and the U.S. Fish and Wildlife Service Inspector at the port of entry. No live snakehead fish, progeny thereof, or viable eggs imported or transported under a permit may be sold, donated, traded, loaned, or transferred to any other person or institution unless such person or institution has a permit issued by the Director of the U.S. Fish and Wildlife Service. The interstate transportation of any live snakehead fish or viable eggs currently held in the United States for any purpose is prohibited without a permit.

Two genera of snakehead fishes are currently recognized in the family Channidae. They are Channa (snakehead fishes of Asia, Malaysia, and Indonesia) and Parachanna (African snakeheads). Synonyms include Bostrychoides , Ophicephalus and its misspelled form Ophiocephalus , and Parophiocephalus . Although 86 species and 4 subspecies have been described (Eschmeyer, 1998), current taxonomy is in flux with approximately 28 species recognized as valid (Musikasinthorn, 2001; Table 1). Because their morphology is very similar, it is very difficult to differentiate among species of snakeheads. Juvenile and adult color patterns are often quite different (Day, 1875; Lee and Ng, 1991, 1994), and some are quite variable in size and color, and may represent species complexes. A taxonomic revision of the family, expected to be published within the next two years, will likely result in additional species being recognized as valid and perhaps new species described.

Snakehead fishes have distinctive morphological features as follows: Long, almost cylindrical body; long dorsal and anal fins, and all fins supported only by rays; most with large scales on head, somewhat similar to the large epidermal scales on the heads of snakes (hence the common name, snakeheads); eyes dorsolateral (back and side) and located on the anterior portion of the head; tubular, anterior nostrils; pectoral and caudal fin margins rounded; large mouth with protruding lower jaw; lower jaw always toothed, and prevomer and palatines often toothed; some lower jaw teeth canine-like, and canines present or absent on prevomer and palatines; most species with pelvic fins present; and ventral aorta typically divided into two portions, one serving the gills and the other the suprabranchial (above the gills) chambers. Suprabranchial chambers of Channa are non-labyrinthic (complex system of paths/tunnels), and made up of two plates, one formed by the first epibranchial (above the gills), the second from the hyomandibular; those of Parachanna consist of a single cavity with elements from the epibranchial of the first gill arch and hyomandibular absent.

Two larger snakehead species, Channa marulius and C. maruloides, superficially resemble the native bowfin, Amia calva, in that all three are elongated fishes, have long dorsal fins, tubular nostrils, and an ocellus (eyespot) at the base of the upper portion of the caudal fin. The bowfin, however, has its pelvic fins in a more abdominal rather than thoracic or anterior-abdominal position, and the anal fin is not elongated. Moreover, the bowfin does not have a rosette (circular arrangement) of enlarged scales on top of the head.

Species and species complexes of the genus Channa are native from southeastern Iran and eastern Afghanistan eastward through Pakistan, India, southern Nepal, Bangladesh, Myanmar (Burma), Thailand, Laos, Malaysia, Sumatra, Indonesia, and China northward into Siberia. Of the currently recognized 25 species of Channa, 9 species and representatives of 4 species complexes occur in peninsular Malaysia, Sumatra, and/or Indonesia. Of the same 25 species, 16 species and members of 5 species complexes are tropical to subtropical; members of three species complexes are temperate; and one species is temperate to boreal and can live beneath ice in the northern portion of its range. The three species of Parachanna are native to Africa and are tropical.

Snakeheads are considered as non-ostariophysan primary freshwater fishes (Mirza, 1975, 1995), meaning they have little or no tolerance for seawater. Habitat preferences vary by species or species complex, with a majority occurring in streams and rivers. Others occur in swamps, rice paddies, ponds, and ditches. All can tolerate hypoxic (low oxygen) conditions because they are airbreathers from late juvenile stages. Where known, pH range varies by species with one ( Channa bankanensis ) preferring highly acidic (pH 2.8-3.8) waters. At least three species are tolerant of a wide pH range; C. gachua, C. punctata, and C. striata survived for 72 hours at pH levels ranging from 4.25 to 9.4 (Varma, 1979).

Spawning seasons vary by species. While information on reproductive biology of many species is lacking, several conclusions can be drawn from those for which this information is available. Breeding in several species occurs primarily in summer months (June through August), and in at least two (the Channa striata species complex and C. punctata ), breeding pairs can be found throughout the year. Some species spawn twice each year. Okada (1960) reported that female northern snakeheads, C. argus, are capable of spawning five times per year. There are several reports that when snakeheads pair, the pair remains monogamous for a spawning season, perhaps longer, but a pair may not mate for life.

Snakehead fishes build nests by clearing a generally circular area in aquatic vegetation, often weaving the removed vegetation around the centrally cleared area. This results in a vertical column of water surrounded by vegetation. One species ( C. punctata ) prepares elaborate tunnels through vegetation leading into the nest column. At time of spawning, the male and female move upward into the central region of the nest column. The male entwines his body around that of the female, with some species appearing to “dance” in the water column as eggs are released and fertilized (Breder and Rosen, 1966; Ng and Lim, 1990). Eggs are buoyant, rising to the surface of the nest column, where they are vigorously guarded by one or both parents. Snakeheads in two species complexes ( C. gachua and C. orientalis ) are mouthbrooders, with the male being the mouthbrooder of fertilized eggs and, later, fry. Most snakehead fishes, however, are not mouthbrooders, but one or both parents guard their young vigorously; one species ( C. micropeltes ) reportedly attacked and in some instances killed humans who approached the mass of young (Kottelat, 1993). Thus, parental care, whether by mouthbrooding or guarding, is a behavioral characteristic of snakehead fishes. Successful spawning in the absence of vegetation has also been reported for three species of snakeheads (Parameswaran and Murgesan, 1976b).

Fecundity and early development: There is limited information on fecundity (capacity to produce offspring) except for those snakehead fishes of commercial importance. Nevertheless, that information shows a pattern that likely applies to the entire family Channidae. Smaller species, such as Channa gachua and C. orientalis, produce few oöcytes or unfertilized “eggs” (about 20 when sexual maturity is first reached and later up to 200; Lee and Ng, 1991, 1994). Both are considered to be “species complexes” and one or both “species” contain mouthbrooding adults; low fecundity is a general rule among mouthbrooding fishes (Breder and Rosen, 1966). Fecundity increases greatly in larger snakehead species and appears to follow increasing body length. For example, Quayyum and Quasim (1962) recorded fecundity ranging from 2,300 to 26,000 oöcytes for C. striata, increasing in number with increasing body length. The bullseye snakehead, C. marulius, the largest species of snakehead, has been reported to produce approximately 40,000 oöcytes (Jhingran, 1984). Frank (1970) reported that the northern snakehead, C. argus, produced approximately 50,000 oöcytes. Frank's data came from Nikol'skiy (1956) who recorded fecundity of 22,000 to 51,000 in northern snakehead from the Amur basin. Dukravets and Machulin (1978) gave fecundity rates of 28,600 to a high of 115,000 for northern snakehead (probably from Yangtze River stock) introduced to the Syr Dar'ya basin of Turkmenistan/Uzbekistan. They also noted that, although the growth of northern snakehead is slower than that reported for this species from the Amur basin, growth rates from both stocks become equal once sexual maturity is reached.

Oöcytes, when released from the female parent, are small, ranging from approximately 1 mm to slightly over 2 mm in diameter, depending on species. Fertilization takes place by the male releasing milt (sperm) on the oöcytes (or eggs) as they emerge from the female. Eggs contain an oil droplet within the yolk mass, which causes them to rise to the surface. Development time to hatching varies with water temperature and, to a lesser extent, with the species involved. For example, hatching occurred in 54 hours at 16-26°C and 30 hours at 28-33°C in Channa punctata (Khan, 1924). In the northern snakehead, C. argus, eggs hatch in 28 hours at 31°C, 45 hours at 25°C, and 120 hours at 18°C.

Early life history: In general, newly hatched fry, depending on species, are about 3.0—3.5 mm in length. Following yolk absorption, snakehead fry begin feeding on zooplankton. Fry typically remain together until they reach early juvenile stage, guarded by one or both adults, or until they can fend for themselves (Lee and Ng, 1994). Late juveniles of the giant snakehead, Channa micropeltes, school and feed in packs (Lee and Ng, 1991). Although there are few reports of early life history except for species of commercial importance, it appears that, as larval snakeheads mature to early juvenile stages, the diet changes to small crustaceans and insects, particularly insect larvae. Presence of phytoplankton, plant material, and detritus in the digestive system of young snakeheads, as well as adults, appears to occur from incidental ingestion.

Respiration and overland migrations: Snakeheads are highly evolved airbreathing teleostean (bony) fishes, and many are capable of overland migration by wriggling motions (Lee and Ng, 1991; Berra, 2001). They possess suprabranchial (above the gills) chambers for aerial respiration, and the ventral aorta is divided into two portions to permit bimodal (aquatic and aerial) respiration (Das and Saxena, 1956; Graham, 1997). The suprabranchial chambers become functional during the juvenile stage of growth (Graham, 1997), following which some species of snakehead fishes are obligate (limited, bound to a restricted environment) and others are facultative (optional, ability to live under varied conditions) airbreathers. In Channa, the chambers open into the pharynx through inhalent openings. The chamber lining contains respiratory “islets” with vascular papillae. The chambers can be filled with air or water. In addition, in C. striata, there are also vascular structures in the mouth and pharynx that can be utilized for respiration; these, however, can be retracted into depressions to prevent damage when feeding (Munshi and Hughes, 1992).

Some channids, perhaps all, have a circadian rhythm in oxygen uptake. Channa marulius, for example, showed a peak in oxygen uptake at night. C. striata and C. gachua peaked in early night hours, and C. punctata at dusk (Munshi and Hughes, 1992). Munshi and Hughes (1992) attributed these rhythms to evolution in swamp ecosystems ( i.e. , the rhythm is a property of the ecosystem).

It is unknown how many species of snakehead fishes are capable of overland migrations, but several are known to do so. These migrations from drying habitats in search of those with water are probably driven by instinctive behavior. Overland migrations likely apply to those species whose native range is subject to seasonal dry/wet (or monsoonal) conditions (encompassing much of western to southeastern Asia, where a majority of snakehead species exist).

Hypoxic survival: Snakehead fishes are either obligate or facultative airbreathers. Therefore, survival in hypoxic waters is not problematic to these fishes. When prevented from access to the surface, some adult snakeheads will drown due to lack of oxygen (Day, 1868, Lee and Ng, 1991). Moreover, snakeheads can remain out of water for considerable periods of time as long as they remain moist. Some snakeheads, especially Channa striata, can bury themselves in mud during times of drought (Smith, 1965). They are known to secrete mucus that helps to reduce desiccation and facilitates cutaneous breathing (Mittal and Banerji, 1975; Lee and Ng, 1991).

Fishers in Thailand are aware of this habit and, during drought periods, will slice into the mud until they locate the fish (Smith, 1965).

For larger species of snakeheads such as Channa marulius, young are facultative airbreathers and adults are obligate breathers (Wee, 1982), but all species are airbreathers.

Lifespan: No specific information on lifespan can be found in the literature. Nevertheless, one species ( C. marulius ) is reported to reach a total length of 1.8 meters in Maharashtra State, India (Talwar and Jhingran, 1992), indicating a relatively long lifespan. Smaller snakeheads, such as members of the C. gachua and C. orientalis species complexes, may not live for more than a few years. Most larger snakeheads are reported to reach sexual maturity in two years, after which growth slows but fecundity increases with increasing size.

Feeding habits: There are few studies of feeding habits of snakeheads. For those species studied, following yolk-sac absorption, snakehead fry feed mostly on zooplankton. As juveniles, they feed on insect larvae, small crustaceans, and fry of other fishes (Munshi and Hughes, 1992). What is universal in reports of adult feeding habits is that snakeheads are predators with many species showing a preference for other fishes, although they may also consume crustaceans, frogs, smaller reptiles, and larger species may sometimes consume birds and small mammals. Under conditions of food deprivation, snakeheads can become cannibalistic on their own young. The piscivorous (fish-eating) nature of snakeheads has led to the use of some species ( C. striata and C. micropeltes in particular) to control tilapia populations in aquaculture.

Associated diseases and parasites: Investigations of diseases and parasites of snakeheads concentrate on those species of importance in aquaculture. Bykhovskaya-Pavlovskaya et al. (1964) cited Channa argus as hosting 18 parasite species (Table 2). Two of the same parasites listed by Bykhovskaya-Pavlovskaya et al. (1964) were reported from the digestive tracts of northern snakehead from Kyungpook Province, Korea, from 115 specimens collected between 1995 and 1997. The trematode Azygia hwangtsinyi was found in 47% of the samples and the nematode Pingis sinensis in 73%.

Literature on parasites of snakeheads includes numerous descriptions of new species, not detailed herein, but indicates that most studies concentrate on cultured fishes such as Channa argus, C. punctata, and C. striata. The potential threat of these parasites to native North American fishes has yet to be examined.

A disease that received broad attention is epizootic ulcerative syndrome (EUS) that causes high mortality in snakeheads, particularly Channa striata and C. punctata under intensive culture. EUS involves several pathogens, including motile aeromonad bacteria ( e.g., Aeromonas hydrophila, A. caviae, Pseudomonas fluorescens; Prasad et al. , 1998; Qureshi et al. , 1999), a fungus Aphanomyces invadans (considered a primary pathogen; Mohan et al. , 1999; Miles et al. , 2001), and perhaps a rhabdovirus (Kanchanakhan et al. , 1999; Lio-Po et al. , 2000). Another bacterium, Aquaspirillum sp., has also been implicated in the disease (Lio-Po et al. , 1998). EUS may have originated in India in the 1980s, but has since been found in Pakistan, Thailand, and the Philippines with outbreaks reported from all these areas during the 1990s. Snakeheads are not the only fishes affected by this disease. It is also known to occur in airbreathing catfish ( Clarias ), the bagrid catfish genus Mystus, two cyprinid genera ( Cyprinus and Puntius ), mastacembalid eels ( Mastacembalus ), and the nandid genus Nandus in India (Mukherjee, 1998). In Thailand, it has been found in giant gourami ( Osphronemus gouramy ) and climbing perch ( Anabas testudineus ) during an outbreak in 1996-1997 (Kanchanakhan et al. , 1999).

History of introduction in the United States: Four species of snakeheads ( Channa argus, C. marulius, C. micropeltes, and C. striata ) have been recorded from open waters of the United States (California, Florida, Hawaii, Maine, Maryland, Massachusetts, and Rhode Island), and two have become established as reproducing populations. At least 16 States prohibit possession of live snakeheads (Alabama, Arkansas, California, Colorado, Florida, Georgia, Idaho, Kentucky, Mississippi, Nevada, North Carolina, Oregon, Pennsylvania, Texas, Utah, and Washington), and illegal activity, confiscations, citations, or investigations have occurred in six of those States within the past two years (Alabama, California, Florida, Kentucky, Texas, and Washington).

Florida: An established population of the bullseye snakehead, Channa marulius, was discovered in residential lakes and adjoining canals in Tamarac, Broward County, Florida, in 2001 (Florida Fish and Wildlife Conservation Commission, 2001). It is unknown how long this species has occupied these waters, perhaps several years, but both juveniles and adults have been collected, which indicates reproductive success. This species is the largest of snakeheads, with adults commonly reaching lengths of 120-122 cm (Talwar and Jhingran, 1992). Researchers have reported that in Maharashtra State, India, this species can reach a length of 1.8 m and a weight of 30 kg (Talwar and Jhingran, 1992). A length of 30 cm can be reached in one year (Talwar and Jhingran, 1992). The pathway of the introduction to Florida is unknown. The species may have escaped from a fish farm (although there are none known in Tamarac), been purposefully introduced to establish a food or aquarium fish resource, or they may have been introduced by aquarists. Tamarac is located just east of Water Conservation Area II, north of Everglades National Park, and interconnected canal systems lead into this area. Nevertheless, there are water control structures on canals leading into Water Conservation Area II that would have to be open to allow this snakehead access to that area. It is likely that C. marulius will expand its range in peninsular Florida as its native range includes tropical to temperate climates. The bullseye snakehead is considered predacious (Jhingran, 1984; Talwar and Jhingran, 1992), especially on other fishes (Schmidt, 2001).

The northern snakehead, Channa argus, is also reported from Florida waters. Two individuals were caught in the St. Johns River below Lake Harney, Seminole and Volusia counties, in 2000. Unconfirmed reports indicate three additional individuals having been caught nearby. An attempt to collect additional specimens by U.S. Geological Survey (USGS) personnel by electroshocking was unsuccessful, but will be repeated in 2002. Until reproduction has been confirmed, the species is considered present but not established. This species is not involved in the aquarium fish trade, but is sold in live food fish markets as a food fish. The most likely pathway is introduction of live food fish, perhaps to establish a local source. The northern snakehead is sold in live food fish markets and some restaurants in Boston and New York, where snakeheads are legal. Live C. argus were confiscated in Washington (100 individuals, alive on ice, destined for the international district of Seattle), a market in Houston, Texas (Howells et al. , 2002), markets in Miami and Plantation, southeastern Florida, in 2001, and in Orlando, Florida, in March 2002, all indications of the availability of this species in States where possession is illegal. Moreover, a few U.S. aquarium fish retailers sell snakeheads via the Internet. USGS scientists purchased three species from a reputable dealer in Rhode Island, who first requested a copy of the State permit that allowed USGS to possess the fish in Florida. Private purchases can also be made through several Internet “chat rooms” where possession of permits is not discussed.

California: California Department of Fish and Game personnel collected a snakehead while electrofishing in a reservoir, Silverwood Lake, in 1997. Silverwood Lake is in the Mohave River drainage, east-northeast of Los Angeles and north of San Bernardino in the San Bernardino Mountains. The specimen was subsequently frozen and later discarded (Camm Swift, pers. comm.). It was identified as Channa argus (John Sunada, pers. comm. to W.R. Courtenay, Jr.). It is believed that the fish got in the lake from the California Aqueduct that runs from the San Joaquin River south of Stockton into Lake Silverwood, one of several reservoirs that serves Los Angeles.

Hawaii: The chevron snakehead, ( Channa striata ) has been established on Oahu, Hawaii, since the late 1800s and was introduced from southern China (Herre, 1924). For whatever reasons, it does not appear to have been introduced to other waters of Hawaii and is confined to reservoirs on Oahu (Maciolek, 1984). In addition, the species is now being cultured as a food fish on Oahu. This species is regarded as carnivorous with a preference for other fishes (Moshin and Ambak, 1983; Conlu, 1986). Lee and Ng (1991) described it as a territorial ambush feeder. It is also used to control tilapia populations in the Philippines (Conlu, 1986).

Maryland: Two adults and eight juveniles of Channa argus were found in a pond in Crofton, Anne Arundel County, Maryland in late June and early July 2002. Maryland Department of Natural Resources personnel captured over 100 juveniles from the pond in July 2002. The adults are known to have over-wintered in the pond. The fish were purchased from a live food fish market in New York City, transported to Maryland, and kept in an aquarium, and two fish were released into the pond in 2000. This species appears to be the most common snakehead available in food markets and restaurants as a live food fish.

New England States: A specimen of the northern snakehead, Channa argus, was collected in October 2001 from Newton Pond, Sudbury, Worcester County, Massachusetts, by Massachusetts Department of Fish and Wildlife personnel. The likely source is from live food fish markets. It is capable of establishment in most fresh waters of the United States. Okada (1960) reported adults as voracious feeders, particularly on other fishes.

Specimens of the giant snakehead, Channa micropeltes, have been collected from open waters in Maine, Massachusetts, and Rhode Island (Courtenay et al, 1984; Fuller et al. , 1999). This tropical/subtropical species could not become established in those temperate waters. Juveniles of the species are cardinal red with two dark stripes on either side of the body, and sold by aquarium fish retailers as red or redline snakeheads. Aquarist-oriented web sites note that this species requires much animal food and that growth is rapid. These sites often advise that, once these fish reach approximately 15-20 cm in length, no more than one individual should be kept in a single aquarium because they are aggressive predators. The pathway into these New England States was likely aquarists who released their “pets” when they grew too large for their aquaria and/or because it was too costly to feed them. Releases of this species into subtropical waters in southern Florida or Hawaii could lead to establishment of this snakehead, regarded as the most predaceous channid and known to have attacked humans (Ng and Lim, 1990; Lee and Ng, 1991; Kottelat et al. , 1993).

Uses: According to U.S. Fish and Wildlife Service Law Enforcement data, 16,554 individuals or 20,527 kilograms of all species of snakeheads were imported into the United States between 1997 and 2000 at a declared value of $85,425 (records of imports report numbers of individual fish OR weight in kilograms). Importations of snakeheads into the United States do not appear to represent a significant portion of live fish imports at present. However, from the raw data, it is clear that the trend has been upward in recent years.

Snakeheads have been imported into the United States for two purposes: as aquarium fish and for use as food. In Southeast Asia, particularly in Thailand and Malaysia, and to a lesser extent in Japan, there are developing recreational fisheries for the larger snakehead species (see http://www.fishingasia.com as an example).

Several species of snakeheads are listed on aquarium fish websites. Some of these entries are for information purposes and a few others list fish for sale. The most popular species are, in order of importance and availability: Channa micropeltes, juveniles sold as red or redline snakehead; C. marulius, juveniles sold as cobra snakehead; C. bleheri, sold as rainbow snakehead; C. barca sold as barca or tiger snakehead; C. gachua sold under a variety of names; and Parachanna africana, juveniles sold as African snakehead. Some are cultured and others are captured from the wild. Rarely does one see listings for C. asiatica, C. orientalis, C. pleuropthalma, C. punctata, or C. stewartii. This is somewhat surprising because several are attractive aquarium fishes, and they can be purchased from dealers in southeast Asia via the Internet. Channa bleheri, C. gachua, and C. orientalis are small snakeheads, unlike C. micropeltes and C. marulius that grow quickly to large sizes. All but the smallest snakeheads are unsuitable for community tanks, and even they may kill other fishes in aquaria. Larger snakeheads require very large aquaria and must be kept alone. The number of aquarium hobbyists interested in keeping snakeheads appears to be small, and snakeheads represent a minor component in the aquarium fish industry (Marshall Myers, pers. comm. to J.D. Williams).

Conversely, use of snakeheads as food fishes is growing in the United States (Table 3). Live snakeheads of the larger species can be purchased in live food fish markets and in some restaurants in States where these fishes are not prohibited, but they are also appearing in markets in States where possession is prohibited (Howells et al. , 2002). Some restaurants display live snakeheads in aquaria, a common practice where these fishes are native, allowing customers to choose a fish to be prepared for a meal. This is reminiscent of many U.S. seafood restaurants where one can select a lobster to be cooked from an aquarium.

During FY 1999, the USDA Small Business Innovation Research Program funded a Phase II project to the Hawaii Fish Company of Waialua, Hawaii, to develop commercial culture of the chevron snakehead, Channa striata. It is now being cultured in Hawaii as a food fish.

Although several snakehead species may be found for sale alive in live food fish markets, the most available species is the northern snakehead, Channa argus. It is being sold in Boston and New York City, where snakeheads are legal. Through confiscation by State fish and game personnel in 2001, it has also been found in the live food fish trade of three States (Florida, Texas, and Washington) where possession of snakeheads is prohibited. The northern snakehead is able to tolerate a considerable temperature range, from warm temperate to boreal climates, where this species can live under ice. Additionally, its airbreathing capabilities enhance its transport and marketing. Marketing and customer preferences, however, are not synonymous. For example, persons of southeastern Asian descent prefer chevron snakehead, C. striata, above any other species. It is currently being cultured in much of southeastern Asia, the Philippines, and Hawaii.

Potential Range: Temperature is the most important environmental factor that would determine potential range of snakeheads in the United States. Because there are few data providing thermal tolerance ranges for snakeheads, potential range must be inferred from distribution within native ranges. The family Channidae contains nine species that are strictly tropical, and if introduced, would survive in the warmest waters such as extreme southern Florida, perhaps parts of southern California, Hawaii, and certain thermal spring systems and their outflows in the American west. Another four can be considered tropical to subtropical, indicating a similar potential range of distribution as for tropical species but with a greater likelihood of survival during cold winters and more northward limits. One is subtropical. Another 12 (4 of which appear to be species complexes) snakeheads can tolerate tropical or subtropical to warm temperate conditions, indicative of species that could survive in most southern States. One is warm temperate, and another warm temperate to cold temperate ( Channa argus with a temperature range of 0->30 °C).

In summary, there are few waters in the United States or territories of the United States that, based on temperature, would preclude some member(s) of the family Channidae from becoming established.

The likelihood of release or escape of snakeheads is high. One species, Channa striata , was released and became established in waters of Oahu, Hawaii, before 1900. It was likely introduced as a food fish. A second species, Channa marulius, is a recent introduction to southeastern Florida (Broward County) and has also become established. The pathway for this introduction was release of either food or aquarium fish. Two specimens of Channa argus were caught in the St. Johns River near Sanford, Florida, and three more are believed to have been caught at or near the same location. This species is available only through live food fish markets. The same species was captured from a pond in central Massachusetts in October 2001. The snakehead captured in Lake Silverwood, California, was also C. argus. Two adults and eight juveniles of C. argus were collected from a pond in Crofton, Maryland, in June and July 2002. Individual specimens of Channa micropeltes were caught in Maine, Massachusetts, and Rhode Island in past years, the source of which were most likely aquarium fish releases. The availability of 8 species of snakehead fishes in live food fish markets and the aquarium trade raises the probability that one or more species will be released into open water. As demonstrated by the documented discoveries of both aquarium and food fish species of snakeheads in the wild, there is a high likelihood that snakeheads would escape or be released.

If snakeheads escaped, or were released into the wild, the likelihood that they would survive and/or become established with or without reproduction is dependent upon the species of snakehead involved and the location of the release. The family Channidae contains 9 species that are strictly tropical, 4 can be considered tropical to subtropical, one is subtropical, 12 can tolerate tropical or subtropical to warm temperate conditions, one is warm temperate, and one is warm temperate to cold temperate. The tropical species would survive in the warmest waters such as extreme southern Florida, perhaps parts of southern California, Hawaii, and certain thermal spring systems and their outflows in the American west. The tropical to subtropical species would have a similar potential range of distribution as for tropical species but with a greater likelihood of survival during cold winters and more northward limits. The tropical or subtropical to warm temperate species could survive in most southern States. The warm temperate, and warm temperate to cold temperate, species could survive in most areas of the United States.

That Channa striata, a tropical to warm temperate species cultured for the live food trade, has been established for over a century in Hawaii and, more recently, C. marulius, a tropical to warm temperate species cultured for the aquarium trade, has become established as a reproducing population in southeastern Florida is indicative of the likelihood of survival and potential for establishment of snakehead fishes. Although C. striata is largely confined to reservoirs on Oahu, C. marulius has ample opportunity to expand its range in southeastern Florida through the large network of interconnected canals and Water Conservation Areas to the west of the metropolitan areas. The release of live food or aquarium fishes is a viable pathway for introduction of snakehead fishes and, depending on temperature, many species could become established from Florida to or above the U.S.-Canadian border and in many territories of the United States.

The likelihood and magnitude of spread would be high for all species within their thermal limits. Both the northern snakehead, Channa argus, and, to a somewhat lesser extent, the blotched snakehead, C. maculata, expanded their ranges of distribution from sites of initial introduction in Japan. Since introduction of the northern snakehead into the Aral Sea basin in the 1960s, there has been a dramatic range expansion in waters of Kazakhstan, Turkmenistan, and Uzbekistan. Range expansion also occurred in the Philippines following introduction of the chevron snakehead, C. striata.

Although there is limited information on the fecundity of snakeheads, scientific data indicate that fecundity increases greatly in larger snakeheads and follows increasing body length. According to Quayyum and Quasim (1962), fecundity for C. striata, a medium-sized snakehead species, ranges from 2,300 to 26,000 öcytes. Larger species, such as C. marulius and C. argus can produce 40,000 to 50,000 öcytes. Given that two individual northern snakeheads, C. argus, were reportedly released into the pond in Crofton, Maryland, and successfully reproduced two times in the summer of 2002, and that several species of snakeheads are known to have a high fecundity, there is a high likelihood that snakeheads would be capable of spreading within their thermal limits.

Several species of snakeheads, whose native ranges are subject to seasonal dry/wet conditions, are known to be capable of overland migrations. According to Peter Ng (pers. comm. to W.R. Courtenay, Jr.) some species can crawl sinuously on land, even dry land, from point to point. There are 2 main groups of snakeheads that are slow, but effective and directed, at overland migrations. One group, including C. striata, C. micropeltes, C. asiatica and C. gachua, has a more dorso-ventrally flattened body with a somewhat flatter belly and can crawl on land. The second group, including C. argus, C. maculata and C. lucius, has a more laterally compressed or rounded body and is not as successful at overland migrations. For those species that are not capable of overland migration, there is a high likelihood that they can be transferred to other water bodies through flooding if they are released into flood-prone areas. In summary, there are few waters in the United States or territories of the United States that, based on temperature, would preclude some member(s) of the family Channidae from becoming established and expanding their ranges through reproduction and/or overland migration.

At all life stages, snakeheads will compete for food with native species. As discussed above in the Biology section, snakehead fry feed on zooplankton; juveniles feed on insect larvae, small crustaceans, and fry of other fishes; and adults are predators, feeding on other fishes, crustaceans, frogs, smaller reptiles (snakes, lizards), and sometimes birds (particularly young waterfowl) and mammals. Native fish and wildlife populations that prey upon fishes, crustaceans, frogs, snakes, lizards, and young waterfowl would face reductions resulting from the loss of food sources.

Although the literature on snakeheads does not include specific information on feeding habits of every species, what is universal for those species that have been studied in this respect is that fishes are an important component of snakehead diets. This can range, for example, from approximately 20-30% ( e.g., Channa gachua ) of the diet to well over 90% ( e.g., C. argus, C. micropeltes, C. striata ). Next in line to fishes, crustaceans (particularly shrimp, etc.) form a substantial dietary component for snakeheads. Native fish populations in particular would likely be reduced through predation if snakeheads were introduced and became established in bodies of water. Through predation, ecosystem balance and predator-prey relationships could be modified drastically should snakeheads become established in waters with low diversity of native fishes and low abundance or absence of native predatory species. Therefore, the likelihood and magnitude of adverse impacts on native wildlife through competition for food and predation on native wildlife is high.

While the potential for snakeheads to transfer pathogens to native wildlife is largely unknown, all snakehead species examined are host to at least several species of parasites. At least two snakehead species, Channa punctata and C. striata, are susceptible to epizootic ulcerative syndrome (EUS), a disease believed to be caused by several species of bacteria, a fungus, and perhaps a retrovirus, under intensive culture conditions. EUS is not specific to snakeheads and has affected other fishes, such as clariid catfishes, bagrid catfishes, two cyprinid genera, mastacembalid eels, and a nandid fish in India; in Thailand, it has been found in giant gourami and climbing perch. Although there have been no studies undertaken to examine transfer of parasites or diseases from snakeheads to native North American fishes, there are numerous cases documented in the scientific literature where nonnative species have transferred diseases and pathogens to native species. Several of the parasites of northern snakeheads listed in Table 2 are known to affect salmonids, cyprinids, and percids. Therefore, there is a credible evidence on the potential for snakeheads to transfer pathogens to native fishes.

Due to the highly predatory nature of snakeheads, the likelihood and magnitude of effect on threatened and endangered species is high. Of all the taxa listed as endangered or threatened in U.S. aquatic habitats, 16 amphibians, 115 fishes, and 5 of the 21 crustaceans (the surface-dwelling crayfish and shrimp) would be the most likely to be affected. Based on habitat requirements and life history, fishes are more likely to be affected by introduced snakeheads than amphibians and the surface-dwelling crustaceans. Nonetheless, the possibility of an additional nonindigenous predator in the aquatic community with any listed amphibian or crustacean would constitute a threat.

In the western United States, habitat requirements of listed fishes range from steep-gradient, coldwater mountain streams, lower-gradient large desert rivers, to thermal (warm) springs in desert areas. Eastern fishes likewise occupy a variety of habitats, including springs, creeks, large rivers, and the Great Lakes. One or more species of snakeheads would be capable of living in any of the above habitats. Since all snakehead species prey on fish, to a greater or lesser extent, all of the fishes listed as endangered or threatened would be vulnerable to predation at some stage in their life history. The degree of threat would vary from extremely high for any species of snakeheads introduced in relatively small, isolated habitats, such as desert thermal springs and their outflows in the American southwest, to somewhat less in steep-gradient coldwater mountain streams. Based on the food habits and habitat preferences of snakeheads, it is likely to invade the habitat, feed on, and further threaten Federally listed freshwater fishes. Snakeheads are likely to also further threaten candidates for Federal protection.

The likelihood that one or more species may be placed in danger of extinction or become endangered within the foreseeable future as a result of introduction/establishment is high. The introduction of a small number of individuals (<5) into isolated spring habitats could result in the extinction of endemic spring-adapted fishes or crustaceans. The snakeheads would not have to establish a reproducing population to reduce or eliminate a fish or crustacean species confined to a small section of a stream or isolated spring habitat. Any snakehead that becomes established in a water body would represent a significant threat and could potentially push any listed amphibian, fish, or crustacean to extinction.

The likelihood and magnitude of ancillary wildlife resource damage due to control measures is high. Chemical control using rotenone or other similar toxins that work by preventing fish from removing oxygen from the water would likely be damaging to nontarget native organisms.

Only one species of snakehead, Channa micropeltes, a tropical/subtropical species, is reported to have attacked human beings. There have been reports of human deaths as a result. All such incidents apparently happened when humans approached a nest or group of young, and attacks were perpetrated by guarding adults. However, the likelihood and magnitude of direct impacts on human beings is low.

The ability to eradicate or control snakehead populations depends on where they are found. However, there is no known method of removing all snakeheads following introduction. If established in large lakes or river systems, eradication and/or control are expected to be nearly impossible, and snakeheads would likely become permanent members of the fish community. Control in smaller water bodies depends upon the amount of vegetation, the accessibility to the water body, and the effectiveness of the control methods. Piscicides work by preventing fish from removing oxygen from the water. Chemical control using rotenone and similar toxins would likely be ineffective to airbreathing snakeheads and damaging to nontarget organisms except in closed situations. Electrofishing and netting may provide some level of control of snakehead populations; however, eradication using these methods would be too selective on size classes to remove a population of snakeheads. When a population is discovered, it is typically too late for removal unless the population is isolated.

Since effective measures to eradicate, manage, or control the spread of snakeheads once they are established are not currently available, the ability to rehabilitate or recover ecosystems disturbed by the species is low. Re-establishment of extirpated populations of native amphibians, fishes, and crustaceans, if biologically possible, would be labor and cost intensive and would depend on eradication of snakeheads within those habitats.

Because several species of snakehead fishes are available through the aquarium, restaurant, and the live food fish trades, the likelihood that they would escape or be intentionally released into the wild is high. If they escape or are intentionally released, they are likely to survive or become established within their respective thermal limits. Because there are no known limiting factors, because some species have the ability to move across land, and because snakeheads have a fairly high reproductive potential, they are likely to spread once they are in the wild. Snakeheads fishes are likely to compete with native species for food, may transmit parasites to native species, and are likely to feed on native species, which will negatively affect native fishes, amphibians, crustaceans, birds, small reptiles, and small mammals. The air-breathing and mobile characteristics of snakeheads increase the difficulty in preventing, eradicating, managing, or controlling their spread. Because the successful removal of all individual snakeheads from a water body would be very difficult to accomplish, it will be very difficult rehabilitate or recover ecosystems disturbed by snakeheads. In conclusion, for the reasons stated above, the Service finds snakeheads to be injurious to the wildlife and wildlife resources of the United States.

We are making this rule effective upon publication. In accordance with the Administrative Procedure Act, we find good cause as required by 5 U.S.C. 553 (d)(3) to make this rule effective less than 30 days after publication in the Federal Register . Approximately 2.94 times more snakeheads were imported in July 2002 than in July 2001. Inspectors at ports of entry have noticed an increase in interest in importing snakeheads before the final rule becomes effective; some importers have told inspectors that they are trying to “beat the ban” and import as many snakeheads as possible before the prohibition on importation and interstate transportation is imposed. Because we have already documented a nearly three-fold increase in the importation of snakeheads from one year ago, and because of the increased interest in importing snakeheads before the final rule becomes effective, the Service believes that there will be a substantial and significant increase in the numbers of snakehead fishes imported and transported across State lines if this rule is effective 30 days after publication in the Federal Register . The increases in importations and interstate transportations during that 30-day period could result in a significant potential for damage to the wildlife and wildlife resources of the United States. As discussed previously in the preamble to this rule, snakehead fishes are highly predatory, are difficult to control, and are difficult to differentiate among species. Therefore, we believe that we have sufficient evidence and cause to take immediate action to prohibit further importation and interstate movement of the entire Channidae family of snakehead fishes.

This rule contains information collection activity for special use permits. The Fish and Wildlife Service has approval from OMB to collect information under OMB control number 1018-0093. This approval expires March 31, 2004. The Service may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In accordance with the criteria in Executive Order 12866, the Office of Management and Budget has determined that this rule is not a significant regulatory action.

(a) This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government. A cost-benefit and economic analysis is not required.

The net economic effect of prohibiting the importation and interstate transportation of snakeheads is difficult to determine because of the minimal amount of data available for a relatively new species to the aquarium, live fish markets, and restaurant trades. There is a trade-off between damage avoided by not letting snakeheads get into U.S. water bodies and the economic benefits received by fish markets and aquarium owners who want to own the species. Since only $85,000 worth of snakeheads were imported during the four-year period between 1997 and 2000, and the potential damage by snakeheads if they get into U.S. waters would be in the millions of dollars from the loss of native species, including threatened and endangered species, this rule will have a net positive benefit. The dollar amount of imported and traded value is not the net economic value of this fish, but the relatively small value compared to environmental damage avoided by prohibiting these species is convincing that this rule will not have a major negative economic effect.

(b) This rule will not create inconsistencies with other agencies. This rule pertains only to regulations promulgated by the Fish and Wildlife Service under the Lacey Act. No other agencies are involved in these regulations.

(c) This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights or obligations of their recipients. This rule does not affect entitlement programs. This rule is aimed at regulating the importation and movement of nonindigenous species that have the potential to cause significant economic and other impacts on natural resources.

(d) This rule does not raise novel legal or policy issues. No previous listings of wildlife as injurious have raised legal or policy concerns.

This rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). A Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. The rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule will not have an annual effect on the economy of $100 million or more, and does not have significant adverse effects on competition, employment, investment productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

No individual small industry within the United States will be significantly affected if snakehead importation and interstate transport are prohibited. Live food fish markets, restaurants, and aquarium hobbyists are the entities most likely to be affected by this rule. The number of aquarium hobbyists interested in keeping snakeheads appears to be small, and snakeheads represent a minor component in the aquarium fish industry (Marshall Myers, pers. comm.. to J.D. Williams). With only 16,554 individual snakeheads imported over four years and most of these going to markets and restaurants for human consumption, the number of entities engaging in selling and buying these fish is very small. There is no recreational fishery for these species. The number of entities involved in the trade of these species is not known, but it is assumed to be very small because of the small number of these fish imported. This rulemaking will have the indirect effect of protecting native fishes, amphibians, and crustaceans from the intentional or accidental introduction of snakeheads into U.S. water bodies. The snakeheads would likely devastate many native wildlife populations if introduced into a waterway. It is very unlikely that this rulemaking will affect a substantial number of small entities and those entities affected will not be significantly affected because of the very small numbers of these fish imported. This rulemaking, by protecting the environment from the spread of a nonnative species that would devastate native fishes, amphibians, and crustaceans, will indirectly work to sustain the economic benefits enjoyed by numerous small establishments engaged in the recreational fishing industry, among others.

This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This rulemaking will not affect costs or prices for any fish species other than snakeheads. Once this rule is published, and importation and interstate movement are prohibited, the maximum loss would be approximately $22,000 per year to the few entities that deal in these species.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), the rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. The Service has determined and certifies pursuant to the Unfunded Mandates Reform Act that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities; will not produce a Federal mandate of $100 million or greater in any year and therefore, is not a “significant regulatory action”.

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. This rule will not impose significant requirements or limitations on private property use.

In accordance with Executive Order 13132, the rule does not have significant Federalism effects. A Federalism assessment is not required. This rule will not have substantial direct effects on States, in the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, we determine that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order. The rule has been reviewed to eliminate drafting errors and ambiguity, was written to minimize litigation, provides a clear legal standard for affected conduct rather than a general standard, and promotes simplification and burden reduction.

We have reviewed this rule in accordance with the criteria of the National Environmental Policy Act and our Departmental Manual in 516 DM. This rule does not constitute a major Federal action significantly affecting the quality of the human environment. Since only 16,554 snakehead fishes were imported between 1997 and 2000 for a declared value of $85,000, the maximum annual loss to the few entities that deal in these species is estimated to be $22,000. Therefore, an environmental impact statement/assessment is not required. The action is categorically excluded under the Department's NEPA procedures (516 DM 2, Appendix 1.10), which apply to policies, directives, regulations, and guidelines of an administrative, legal, technical, or procedural nature; or the environmental effects of which are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will be subject later to the NEPA process, either collectively or on a case-by-case basis.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated potential effects on Federally recognized Indian tribes and have determined that there are no potential effects. This rule involves the importation and interstate movement of live snakeheads. We are unaware of trade in these species by Tribes.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. Because this rule is intended to prevent the accidental or intentional introduction of snakeheads and the possible subsequent establishment of populations of these fish in the wild, it is not a significant regulatory action under Executive Order 12866 and is not expected to affect energy supplies, distribution, and use. Therefore, this action is a not a significant energy action and no Statement of Energy Effects is required.

A complete list of all references cited in this rule is available upon request from the Division of Environmental Quality (see FOR FURTHER INFORMATION CONTACT section).

The Fish and Wildlife Service is issuing this final rule under the authority of the Lacey Act (18 U.S.C. 42).

This Federal Register document is available on the Government Printing Office's website at: http://www.access.gpo.gov /su_docs/ca/docs/aces/aces140.html. Background information and documents are available at the NMFS Northwest Region website at: http://www.nwr.noaa.gov/1sustfsh/gdfsh01.htm and at the Pacific Fishery Management Council's website at: http://www.pcouncil.org.

The Pacific Coast Groundfish FMP and its implementing regulations at 50 CFR part 660, subpart G, regulate fishing for over 80 species of groundfish off the coasts of Washington, Oregon, and California. Annual groundfish specifications and management measures are initially developed by the Pacific Fishery Management Council (Pacific Council), and are implemented by NMFS. The specifications and management measures for the current fishing year (January 1-December 31, 2002) were initially published in the Federal Register as an emergency rule for January 1-February 28, 2002 (67 FR 1540, January 11, 2002), as a proposed rule for all of 2002 (67 FR 1555, January 11, 2002), and as a final rule effective March 1, 2002 (67 FR 10490, March 7, 2002). The final rule was subsequently amended at 67 FR 15338, April 1, 2002, at 67 FR 18117, April 15, 2002, at 67 FR 30604, May 7, 2002, at 67 FR 40870, June 14, 2002, at 67 FR 44778, July 5, 2002, at 67 FR 48571, July 25, 2002, at 67 FR 50835, August 6, 2002, at 67 FR 55166, August 28, 2002, at 67 FR 56497, September 4, 2002, and at 67 FR 57973, September 13, 2002.

The following changes to current groundfish management measures were recommended by the Pacific Council, in consultation with Pacific Coast Treaty Tribes and the States of Washington, Oregon, and California, at its September 9-13, 2002, meeting in Portland, OR. Pacific Coast groundfish landings will be monitored throughout the year, and further adjustments will be made as necessary to allow achievement of or to avoid exceeding the 2002 OYs and allocations.

Beginning with the July 1, 2002, inseason action (67 FR 44778, July 5, 2002) the Pacific Council reinstated a management line at the 20-fm (37-m) depth contour south of 40° 0′ N. lat. The 20-fm (37-m) depth contour was used to implement management measures to protect bocaccio rockfish, an overfished species. Through an emergency rule (67 FR 57973, September 13, 2002) effective September 10, 2002, new depth-based management measures affecting the limited entry trawl fleet north of 40°10′ N. lat. were implemented to allow harvest of healthy groundfish stocks while protecting darkblotched rockfish, another overfished species. The emergency rule created a “no-trawl” zone between approximately 100 to 250 fm (183 to 457 m) north of 40°10′ N. lat. to the U.S.-Canada border, known as the DBCA. This inseason action will open up limited midwater trawl opportunities for widow and yellowtail rockfish in the DBCA, subject to the trip limits described below and a declaration process adopted by the States of Washington and Oregon.

When operating in areas with different trip limits north and south of a management line, the crossover provisions listed at paragraph IV.A.(12) in the 2002 annual specifications and management measures (67 FR 10490, March 7, 2002) apply. For the limited entry trawl flatfish fisheries north and south of the management line at 40°10′ N. lat., vessels are subject to the crossover provisions in paragraph IV.A.(12) when making landings that include any of the flatfish species specified at 50 CFR 660.302 in the flatfish fisheries.

At the Pacific Council's September meeting, public testimony reported a significant amount of adult sablefish discard in waters deeper than the bocaccio depth range with the 22-inch (56 cm) minimum sablefish size restriction that was imposed on July 1, 2002 (67 FR 44778, July 5, 2002 and subsequently amended at 67 FR 50835, August 6, 2002). Therefore, the Pacific Council recommended reducing the sablefish minimum size limit from 22 inches to 20 inches (56 cm-51 cm), beginning October 1, 2002, for limited entry fixed gear and open access vessels between 40°10′ N. lat. and 36° N. lat. and for limited entry trawl vessel south of 40°10′ N. lat. This reduction in the minimum sablefish size limit is intended to reduce the discard of smaller, mature sablefish while protecting bocaccio, an overfished species, by pushing fishing effort for sablefish into deeper waters.

North of 40°10′ N. lat., there continues to be no sablefish size limit because bocaccio do not generally occur north of 40°10′ N. lat. and the adult sablefish in that area tend to be larger. To the south of this area (i.e., south of 36° N. lat.), there continues to be no sablefish size limit for limited entry fixed gear or open access vessels because the adult sablefish, although small, generally occur outside of the bocaccio depth range. The 20-inch (51-cm) minimum sablefish size limit for the limited entry trawl gear sablefish sublimit will continue to extend south from 40°10′ N. lat. to the Mexico border.

“Other fish” are defined at 50 CFR 660.302 under the term groundfish, as those groundfish species or species groups for which there is no trip limit, size limit, quota, or harvest guideline. With this inseason action, the “other fish” category is added to the limited entry fixed gear and open access trip limit tables, in addition to the limited entry trawl table. For all gears north of 40°10′ N. lat., “other fish” are not limited, except that spiny dogfish is prohibited for all gears other than small footrope trawl. The fixed gear spiny dogfish fishery in the north has a history of yelloweye rockfish bycatch, especially off Washington. In order to protect yelloweye rockfish, an overfished species, spiny dogfish retention is prohibited for all gears except small footrope trawl in the north. For all gears south of 40°10′ N. lat., retention of “other fish” is prohibited in order to prevent incidental catch of bocaccio with the exception that retention of grenadiers is permitted. Grenadiers are a deep water species and can be targeted without intercepting overfished or depleted rockfish stocks.

At their September meeting, the Pacific Council decided to allow midwater trawl fisheries for widow and yellowtail rockfish inside the DBCA. The widow and yellowtail rockfish midwater fisheries had previously been closed in the north because these species primarily occur within the DBCA, an area closed to protect darkblotched rockfish. While midwater trawls for these species within the DBCA would not intercept darkblotched rockfish, the midwater fisheries were closed because of the enforcement difficulty in determining whether a vessel is conducting a midwater or pelagic trawl versus a small footrope bottom trawl, which would intercept darkblotched rockfish and is prohibited.

In order to allow midwater trawl opportunity for widow and yellowtail rockfish, the States of Washington and Oregon will implement a declaration process whereby vessels intending to fish with midwater trawl gear within the DBCA would be required to contact the State in advance of such fishing trips as a condition of landing in State ports. Washington and Oregon will implement a limited declaration process for the November-December period, while California will maintain an on-the-water enforcement presence. For November-December, the States of Washington and Oregon will handle all midwater trawl declarations for fishing in the DBCA. Due to limited State personnel resources to handle the declaration process, the frequency of trips landing either widow or yellowtail rockfish is being restricted in Federal regulations to no more than two trips per vessel per 2-month cumulative period (i.e., November-December).

The available trip limit for this midwater trawl opportunity was constrained to the November-December cumulative trip limit period. Historically, incidental catch of canary rockfish, an overfished species, in the widow rockfish midwater trawl fishery has been lower in the January-February, March-April and November-December cumulative trip limit periods. Because canary rockfish is approaching its OY, the widow and yellowtail midwater fisheries were re-opened only for the November-December trip limit period when the interception of canary rockfish is likely to be low.

For the November-December period, the 2-month cumulative limit for the widow rockfish midwater trawl fishery occurring north of 40°10′ N. lat. will be re-opened at 13,000 lb (5,897 kg) per 2 months, restricted to no more than 2 trips landing widow rockfish per vessel per 2-month period. For yellowtail rockfish, the November-December 2-month cumulative limit for the yellowtail rockfish midwater trawl fishery occurring north of 40°10′ N. lat. will be re-opened at 20,000 lb (9,072 kg) per 2 months, restricted to no more than 2 trips landing yellowtail rockfish per vessel per 2-month period.

The DTS complex north of 40°10′ N. lat. was previously scheduled to decrease for the November-December cumulative limit period. In addition, the September emergency rule (67 FR 57973, September 13, 2002) had split the November-December cumulative limit period from a 2-month to a monthly cumulative limit to allow more flexibility for possible future inseason adjustments. However, in doing so, the flexibility of the fishermen to plan their trips is further constrained and the likelihood of regulatory discards may increase. Because sufficient OY remains and the incidence of overfished rockfish species interception in the DTS fisheries is lower during November-December, the Pacific Council decided to increase the cumulative trip limits for the DTS complex during the November-December cumulative limit period and re-instate the 2-month cumulative limit.

In order to allow fishermen access to the remaining DTS OYs while still protecting darkblotched rockfish in all northern waters and canary rockfish in waters shoreward of the 100-fm (184 m) depth contour line, the Pacific Council increased the OY for all DTS complex species, but increased the Dover sole limit disproportionately between large and small footrope trawl gear. Small footrope trawl gear was assigned a lower Dover sole trip limit, 12,000 lbs (5,443 kg) per 2 months, because small footrope is the only bottom trawl gear allowed in waters shoreward of the 100 fm (183 m)depth contour where there is higher incidence of rockfish bycatch, including canary and darkblotched rockfish. Small footrope gear is allowed in waters inside of 100 fm (183 m) because it tends to have less incidental catch of canary rockfish since it cannot effectively fish in rocky seafloor habitat where canary rockfish are typically found. Conversely, the higher limit for Dover sole caught with large footrope trawl gear, 22,000 lb (9,979 kg) per 2 months, is intended to encourage vessels to operate seaward of the 250 fm (461 m) depth contour, outside the range of darkblotched and canary rockfish.

For the November-December period, the 2-month cumulative limit for the DTS trawl fishery north of 40°10′ N. lat. will be increased as follows: Dover sole will be increased from 7,000 lb (3,175 kg) per month to 22,000 lb (9,979 kg) per 2 months providing that only large footrope or midwater trawl gear is used to land any groundfish species during the entire cumulative limit period or 12,000 lb (5,443 kg) per 2 months if small footrope gear is used to land any groundfish species during the entire cumulative limit period; shortspine thornyhead will be increased from 750 lb (340 kg) per month to 2,200 lb (998 kg) per 2 months; longspine thornyhead will be increased from 1,000 lb (454 kg) per month to 8,000 lb (3,629 kg) per 2 months; and sablefish will be increased from 1,250 lb (567 kg) per month to 2,600 lb (1,179 kg) per 2 months.

As in the DTS fishery above, the September emergency rule had split the November-December cumulative limit period from a 2-month to a monthly cumulative limit to allow more flexibility for possible future inseason adjustments. However, in doing so, the flexibility of the fishermen to plan their trips is further constrained and the likelihood of regulatory discards may increase.

PacFIN landings estimates through September 7, 2002, report the limited entry slope rockfish catch in the north to be at 104 mt out of a 1,150 mt OY for 2002 (1,046 mt remaining) and at 275 mt out of a 497 mt OY (222 mt remaining) for the south. For splitnose rockfish in the Monterey and Conception management areas, PacFIN estimates report the limited entry and open access splitnose catch to be at 35 mt out of a 387 mt OY (352 mt remaining). Because sufficient OY remains and the incidence of overfished rockfish species interception is low, the Pacific Council decided to increase the cumulative trip limits for minor slope rockfish fisheries in the north during the November-December period and for the minor slope and splitnose rockfish fisheries south of 40°10′ N. lat. during the September-October and November-December cumulative limit periods, re-instating the 2-month cumulative limit.

For the September-October period, limited entry trawl fisheries for minor slope and splitnose rockfish south of 36° N. lat. will each be increased from 15,000 lb (6,804 kg) per 2 months to 25,000 lb (11,340 kg) per 2 months. For the November-December period, limited entry trawl fisheries for minor slope rockfish north of 36° N. lat. will be increased from 300 lb (136 kg) per month to 1,800 lb (816 kg) per 2 months; limited entry trawl fisheries for both minor slope and splitnose rockfish south of 36° N. lat. will be increased from 15,000 lb (6,804 kg) per 2 months to 40,000 lb (18,144 kg) per 2 months.

Previously, the Petrale sole trip limit south of 40°10′ N. lat. was included in the combined flatfish limit for rex sole, petrale sole, English sole, and arrowtooth flounder as an incidental catch allowance in the DTS fishery. South of 40°10′ N. lat., logbook and fish landing ticket data report that the limited entry trawl fishery for Petrale sole occurs primarily seaward of 180 fm (329 m) and has not shown any incidental catch of bocaccio. The overfished species bycatch for this fishery during November-December using a depth-based bycatch model projects that widow rockfish, lingcod, darkblotched rockfish may be intercepted in the Petrale sole fishery. However, incidental catch levels of these species are not projected to exceed their 2002 OYs. Therefore, Petrale sole was pulled out of the combined flatfish limit and given its own trip limit, 30,000 lb (13,608 kg) per 2 months, to provide targeted harvest opportunity on a healthy groundfish stock with minimal incidental catch of overfished rockfish species.

In addition, rex sole was pulled out of the combined flatfish limit and assigned a higher incidental catch allowance of 2,000 lb (907 kg) per trip. English sole and arrowtooth flounder retain a combined limit of 1,000 lb (454 kg) per trip as an incidental catch allowance in the DTS or petrale sole fisheries.

For the November-December period, limited entry trawl fisheries for flatfish south of 40°10′ N. lat. are closed with the following exceptions: petrale sole will have its own trip limit of 30,000 lb (13,608 kg) per 2 months, rex sole will have its own incidental catch allowance of 2,000 lb (907 kg) per trip, and English sole and arrowtooth flounder continue to have a combined incidental catch allowance of 1,000 lb (454 kg) per trip when landed with DTS or petrale sole. The amount of per-trip flatfish landings (rex sole, English sole, and arrowtooth flounder) must not exceed the amount of DTS and petrale sole landed. Landings may continue to be made with small or large footrope gear.

The limited entry fixed gear fisheries for minor slope and splitnose rockfish south of 36° N. lat. generally occur well outside of 250 fm (461 m). In addition to the fishery taking place in deeper waters beyond the range of bocaccio, the OY for limited entry slope rockfish in the south is estimated in PacFIN to be at 275 mt out of a 497 mt OY (222 mt remaining). For splitnose rockfish in the Monterey and Conception management areas, PacFIN estimates report the limited entry and open access splitnose catch to be at 35 mt out of a 387 mt OY (352 mt remaining). Because sufficient OY remains for both minor slope and splitnose rockfish and the likelihood of bocaccio interception in these fisheries during the remainder of 2002 is low, the cumulative limit for these fisheries will be increased.

For the September-October and November-December periods, the trip limits for both minor slope and splitnose rockfish will be increased south of 36° N. lat. from 15,000 lb (6,804 kg) per 2 months to 25,000 lb (11,340 kg) per 2 months.

PacFIN landings data estimates that the open access landings for sablefish in the north are at 1,032 mt out of a 1,780 mt OY for 2002 (748 mt remaining). Because sufficient OY remains for sablefish north of 36° N. lat., the limits in the sablefish daily trip limit fishery will be increased.

Beginning October 1, 2002, the limited entry fixed gear and open access daily trip limit fishery for sablefish north of 36° N. lat. will be increased from 300 lb (136 kg) per day, or 1 landing per week up to 800 lb (363 kg), not to exceed 2,400 lb (1,089 kg) per 2 months, to 300 lbs (136 kg) per day, or 1 landing per week up to 900 lb (408 kg), not to exceed 2,700 lb (1,225 kg) per 2 months.

PacFIN's landed catch estimates show the limited entry and open access nearshore rockfish catch north of 40°10′ N. lat. to be at 186 mt out of a 324 mt OY for 2002 (138 mt remaining). Because sufficient OY remains for nearshore rockfish, beginning October 1, 2002, the limited entry fixed gear and open access fisheries for minor nearshore rockfish north of 40°10′ N. lat. will be increased from 6,000 lb (2,722 kg) per 2 months, no more than 3,000 lb (1,361 kg) of which may be species other than black and blue rockfish, to 7,000 lb (3,175 kg) per 2 months, no more than 3,000 lb (1,361 kg) of which may be species other than black and blue rockfish.

Minor nearshore rockfish south of 40°10′ N. lat. are estimated to have exceeded the 2002 OY by 18 mt through September 7, 2002. Because nearshore rockfish and lingcod co-occur, the fishery for lingcod south of 40°10′ N. lat. will close one month earlier than previously scheduled to protect nearshore rockfish from continued overharvesting.

Previously, the limited entry fixed gear and open access fisheries for lingcod south of 40°10′ N. lat. were open only inside the 20 fm (37 m) contour with cumulative limits of 400 lb (181 kg) per month for limited entry fixed gear fisheries and 300 lb (136 kg) per month for open access fisheries. Beginning October 1, 2002, the limited entry fixed gear and open access fisheries south of 40°10′ N. lat. for lingcod will be closed.

The canary rockfish fishery was closed south of 40°10′ N. lat. with the July 1, 2002 trip limit adjustments (67 Fr 44778, July 5, 2002). The closure for the limited entry trawl fishery for canary rockfish starting October 1, 2002, was inadvertently removed during implementation of the September emergency rule (67 FR 56497, September 4, 2002). The limited entry trawl fishery for canary rockfish should be closed south of 40°10′ N. lat. for the remainder of 2002.

For the reasons stated herein, NMFS concurred with the Pacific Council's recommendations and hereby announces the following changes to the 2002 specifications and management measures (67 FR 10490, March 7, 2002, as amended at 67 FR 15338, April 1, 2002, 67 FR 18117, April 15, 2002, 67 FR 30604, May 1, 2002, 67 FR 40870, June 14, 2002, 67 FR 44778, July 5, 2002, 67 FR 48571, July 25, 2002, 67 FR 50835, August 6, 2002, 67 FR 55166, August 28, 2002, 67 FR 56497, September 4, 2002, and 67 FR 57973, September 13, 2002) to read as follows:

1. On page 10511, in column 1, section IV., under A. General Definitions and Provisions, paragraph (6)(d) is revised to read as follows:

Section 304(e) of the Magnuson-Stevens Act requires that, if the Secretary of Commerce (Secretary) determines that a fishery is overfished, the Secretary shall immediately notify the appropriate fishery management council and request that action be taken to end overfishing in the fishery and to implement conservation and management measures to rebuild affected stocks. The fishery management council has one year from the date of notification to prepare a plan to end overfishing in the fishery and to rebuild affected stocks.

On March 3, 1999, the Secretary approved Amendment 7 to the Fishery Management Plan for the Bering Sea/Aleutian Islands King and Tanner Crabs (FMP) (64 FR 11390, March 9, 1999). Pursuant to section 303(a)(10) of the Magnuson-Stevens Act, and the national standard guidelines (50 CFR part 600), the amendment revised the definitions of overfishing, maximum sustainable yield, and optimum yield for the king and Tanner crab stocks of the Bering Sea and Aleutian Islands.

A stock is considered overfished when the total spawning biomass is below the minimum stock size threshold (MSST) as defined in the FMP. The MSST for Pribilof Islands blue king crabs is 6.6 million lb (2,994 mt) of total mature biomass (TMB).

The Alaska Fisheries Science Center (AFSC) has determined that the stock has declined below its MSST. This determination is based on a joint NMFS and Alaska Department of Fish&Game (ADF&G) assessment of stock conditions, which incorporates the 2002 NMFS Eastern Bering Sea trawl survey data.

NMFS, as required by section 304(e), notified the Council by letter on September 23, 2002, that the Pribilof Islands blue king crab stock is overfished and that the Council must develop a rebuilding plan within one year. The time period for a rebuilding program must be as short as possible, but not exceed 10 years, unless the biology of the stock or other environmental conditions dictate otherwise.

According to the national standard guidelines at 50 CFR 600.310(d)(4)(ii) and (e)(3), the Council has two alternatives for remedial action. First, under the guidelines, if the stock is declining due to changes in environmental conditions that affect its long-term productivity, the Council must respecify the MSST. Second, if the stock or stock complex is overfished or if a threshold is being approached, the Council must take remedial action by preparing an FMP amendment designed to rebuild the stock to the maximum sustainable yield level within an appropriate time frame.

The situation with Pribilof Islands blue king crab is somewhat unusual in that NMFS is declaring the fishery overfished even though it has been closed since 1999, the stock is protected by existing Council, State of Alaska, and NMFS management measures, its habitat is protected by the Pribilof Islands habitat conservation area, and Pribilof Islands blue king crab are not caught as bycatch in any fishery.

Since 1980, when the harvest from this stock reached 11.0 million lb (4,990 mt), the Pribilof Islands blue king crab stock has declined substantially in abundance. The fishery was closed from 1988 to 1994 due to low stock abundance. Although this stock was estimated to be above the MSST during the early 1990s, abundance estimates of this stock were considered too unreliable to justify reopening the fishery. By 1995, the estimates had improved enough to open the fishery. However, from 1995 through 1998, harvests fell from 1.3 million lb (590 mt) to 0.5 million lb (227 mt). In 1999 the fishery was again closed due to several factors, including the declining abundance trend, low level of prerecruits, low precision of estimates, and poor fishery performance in the preceding two seasons.

Since 1999 the fishery has remained closed. Data from the 2001 NMFS Eastern Bering Sea trawl survey indicated that the stock was continuing its decline in abundance from mid-1990s levels. The stock's TMB for 2001 was estimated at 7.0 million lb (3,175 mt). Although that was above the MSST of 6.6 million lb (2,994 mt), the fishery remained closed because the abundance of mature males fell below the 0.77 million lb (349 mt) threshold level for mature males that the Alaska Department of Fish and Game (ADF&G) established under its harvest strategy for this stock. Furthermore, the stock level and trend raised concerns that the stock could fall below the MSST by 2002.

These concerns were borne out in 2002, when the stock's TMB was estimated to be below the MSST, at 4.5 million lb (2,041 mt). Mature male abundance for 2002 was estimated at 0.338 million lb (153 mt); this again was below the harvest strategy threshold for a fishery opening.

Although poor precision in abundance estimates makes year-to-year comparisons difficult, the trend in estimates since the mid-1990s indicates that this stock is depressed, in decline, and below MSST. Estimates of abundance for all male size classes are low and provide no suggestion of recruitment to the mature or legal component in the near future. A total of only 12 male blue king crabs were caught at six stations in the Pribilof District during the 2002 survey. Of these, only one was sub-legal size, and most of the rest were old-shell post recruit crabs.

ADF&G concurs with the results of the analysis of the 2002 NMFS trawl survey. The Council is aware of the results of the trawl survey and anticipated this determination. Industry has not been dependent on this fishery, which has been closed for several years.