Title 7, parts 27 to 52, revised as of January 1, 2004, is being republished in its entirety. The earlier issuance inadvertently omitted Table III contained in § 52.1853 and subsequent sections 52.1854 through 52.1858, 52.3181 through 52.3188, and 52.3751 through 52.3764. The omitted table and text should immediately follow § 52.1853(c) on page 576.

The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56 through 319.56-8, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and spread of plant pests that are new to or not widely distributed within the United States.

On December 18, 2003, we published in the Federal Register (68 FR 70448-70463, Docket No. 02-106-1) a proposal to amend the regulations to list a number of fruits and vegetables from certain parts of the world as eligible, under specified conditions, for importation into the United States. We also proposed to recognize areas in Peru as free from the South American cucurbit fly.

We solicited comments concerning our proposal for 60 days ending February 17, 2004. We received five comments by that date. They were from representatives of State governments, an industry organization, and individuals. They are discussed below by topic.

One commenter stated that it is impossible to determine the efficacy of the proposed risk mitigation method for grapes from South Korea until a peer review of the supporting data is conducted. The commenter further stated that data on risk mitigation for Korean grapes should be published prior to rulemaking in order to increase the transparency of the regulation.

We do not agree that a peer review of the supporting data is necessary in order for the efficacy of the phytosanitary measures for grapes from South Korea to be determined. In the proposed rule, we cited the pests of concern identified in our risk assessment and described the phytosanitary measures that would be required to guard against the entry of those pests, but we did not explicitly link the role of each measure in addressing the risk presented by each identified pest of concern. We are providing those connections below.

The quarantine pests of concern for grapes grown in South Korea are yellow peach moth ( Conogethes punctiferalis ), grapevine moth ( Eupoecilia ambiguella ), leaf-rolling tortix ( Sparganothis pilleriana ), apple heliodinid ( Stathmopoda auriferella ), the plant pathogenic fungus Monilinia fructigena and the moth Nippoptilia vitis .

Each of these pests exhibits symptoms that are macroscopic and detectable upon visual inspection. Specifically:

• Yellow peach moth larvae bore into and tunnel the stems and fruits of host plants. Larvae on the fruit burrow into the green berries, causing them to split, shrivel, or fall off when damaged.

• Grapevine moth larvae feed on flowers and later on developing fruit. Larvae cause surface damage to leaves and fruit. Additionally, larvae may produce webbing on the flower buds and newly set fruit, which often causes affected parts to drop from the vine.

• Leaf-rolling tortix and Nippoptilia vitis larvae cause damage to the leaves, fruit, and stem.

• Apple heliodinid larvae cause webbing of the flower buds and newly set fruit, often causing affected plant parts to drop from the vine and burrow into the green berries, which may split, shrivel, or fall off when damaged.

• Monilinia fructigena causes raised light brown pustules on the fruit that often expand enclosing the fruit to form a dark, wrinkled, hard mummified fruit

There are three measures in our regulatory approach that individually and collectively mitigate the risk posed by each of the six pests. First, field inspections have proven effective since, as detailed above, the damage these pests cause makes their presence obvious. Second, fruit is bagged from the time the fruit sets until harvest. Since bagging is done when the fruit is very young, the risk of exposure to arthropods and diseases is reduced. Third, fruit is inspected and certified to be free of the pests of concern by South Korea's national plant protection organization (NPPO). In addition, an additional inspection of a sample of fruit from each consignment will be conducted upon its arrival in the United States.

These measures have proven to be effective in guarding against similar pests of concern on sandpears from South Korea and Japan (yellow peach moth and Monilinia fructigena , as well as two other moths and a leafroller). We have been importing Japanese and Korean sandpears under a similar systems approach for over 10 years with no significant phytosanitary problems.

Finally, we disagree with the commenter's statement that we should have published data on risk mitigation prior to publication of the proposed rule. On June 19, 2001, we published in the Federal Register (66 FR 32923-3928, Docket No. 00-082-1) a notice entitled “Procedures and Standards Governing the Consideration of Import Requests” wherein we established policies for the publication of risk documents, among other things. In that document we set out “routine” and “nonroutine” as the two categories of risk assessments. The terms “routine” and “nonroutine” do not necessarily connote different types of risk assessments, but nonroutine assessments are associated with issues that may require greater resources. In determining the type of risk assessment, we consider the following factors: Economic value of the affected crop(s), public interest, environmental and public health importance, level of uncertainty, local importance, and precedence ( i.e. , whether the commodity/origin combination in question, or a similar combination, has ever been addressed in previous risk assessments and/or whether the assessment will require the use of new or different methodologies). Only for nonroutine assessments do we make the risk assessments available for public review and comment in advance of rulemaking. Since the issues addressed in our proposed rule were determined to be routine, we did not make the risk documents prepared for this proposal available in advance of the proposed rule's publication.

A second commenter said that the term field needs to be defined. The commenter also objected to the fact that grapes from a field found to contain evidence of infestation may be reapproved for export following one negative inspection.

A definition for the term field can be found in the definitions portion of the regulations at § 319.56-1. Field is defined as a plot of land with defined boundaries within a place of production on which a commodity is grown.

We believe one negative inspection is enough to reapprove a field for export. Under the systems approach laid out in this document and in the proposed rule, if evidence of any of the pests of concern is detected during field inspection, the field will immediately be rejected, and exports from that field will be canceled until visual inspection of the vines shows that the infestation has been eradicated. There are a variety of measures growers may utilize to eliminate infestation on the leaves, stems, and fruits on the vine. These measures include contact pesticides in the case of insect infestation, fungicides in the case of fungal infestation, sanitation measures, weed removal, pruning, trapping, and/or bait stations. One or more of these measures would serve to eradicate the pests of concern. As expressed previously, evidence of the presence of all of the pests of concern is readily visible; thus we believe that a single inspection would be all that is necessary to determine whether a field could be reapproved for participation in the program.

One commenter stated that beets ( Beta vulgaris ) from Mexico and turnips ( Brassica spp.) from Peru should be removed from the list of commodities enterable subject to inspection in § 319.56-2t since they are both hosts of the potato pathotype of the false root-knot nematode ( Nacobbus aberrans ).

Of the two commodities cited by the commenter, only beets from Mexico are being added to the list in § 319.56-2t in this rulemaking. Turnips from Peru have been eligible for importation under the regulations for 11 years and were listed in the proposed rule only because we set out § 319.56-2t in its entirety due to our revision of that section's format. By International Plant Protection Convention (IPPC) standards, a quarantine pest is considered to be “a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled.” Since the potato pathotype of the false root-knot nematode is already present in the United States and not subject to an official control program, we do not consider it to be a quarantine pest, therefore we do not regulate imports to protect against entry of this pest.

Another commenter stated that snow peas ( Pisum sativum subsp. sativum ) from Columbia; cole and mustard crops, including cabbage, broccoli, cauliflower, turnips, mustards, and related varieties ( Brassica spp.) from Ecuador, Costa Rica, El Salvador, Peru, and Jamaica; Allium spp. from Israel, Mexico, Belgium, and the Netherlands; Swiss chard ( Beta vulgaris ) from Peru; beets ( Beta vulgaris ) from Mexico; and cucurbits ( Cucurbitaceae ) from Mexico should be removed from the list of commodities enterable subject to inspection found at § 319.56-2t since they are hosts of the pea leaf miner ( Liriomyza huidobrensis Blanchard), which does not occur in the United States. Another commenter stated that the regulations should specify which types of cucurbits are allowed entry into the United States from Mexico.

The only commodities listed by the commenter that are added in this rulemaking are Allium spp. from Mexico and beets from Mexico. The other commodities have been eligible for importation prior to this rulemaking and were listed in the proposed rule only because we set out § 319.56-2t in its entirety due to our revision of that section's format. Specifically, cucurbits from Mexico have been eligible for importation under the regulations for 30 years. With regard to Allium spp. and beets from Mexico, as above, our records indicate that the pea leaf miner is already present in the United States and not subject to an official control program, therefore, we do not consider it to be a quarantine pest.

The commenter additionally stated that the importation of watermelon from Korea is of concern because of the presence of the pumpkin fruit fly ( Bactrocera depressa ). The commenter asked APHIS to clarify the type of fruit fly trap required, as well as to provide evidence of its efficacy in trapping the pumpkin fruit fly.

We have considered the commenter's point and have modified the trapping procedure outlined in the proposed rule to specify that the fruit fly traps used must be McPhail traps or a similar type with a protein bait that has been shown to be efficacious in trapping the pumpkin fruit fly. APHIS has employed the McPhail trap for decades. It is a generalist trap with a food bait that catches all fruit feeding tephritids. We use these traps to catch a variety of fruit flies around the world such as various Bactrocera spp. that are not known to be attracted by a specific parapheromone lure.

One commenter stated that since the domestic Mexican fruit fly (Mexfly) regulations at 7 CFR 301.64-2 and the melon fruit fly regulations at 7 CFR 301.97-2 list Annona spp. as hosts to those flies, we should have included an analysis of the risk associated with importation of Annona spp. from Grenada based on the possible presence of Mexfly and melon fruit fly in that country.

Our research indicates that neither Mexfly nor melon fruit fly occur in Grenada. Since there is no scientific evidence of the existence of these pests in the area in question, there is no need for further analysis of the risks posed by those pests in this case.

Another commenter claimed that the mitigation methods described in the proposal with regard to cucurbits ( Cucurbitaceae ) from South Korea do not provide adequate protection against cucumber green mottle mosaic virus ( tobamovirus ).

Cucumber green mottle mosaic virus is seedborne with no known biological vectors; it can also be mechanically transmitted. Symptoms of infection are yellowed leaves and shriveled fruit. These are macroscopic and detectable upon inspection. Further, the commodities in question must meet the following conditions:

• The commodities in question must be grown within pest-proof greenhouses registered with Korea's NPPO.

• The NPPO must also inspect and regularly monitor those greenhouses and plants, including fruit, at intervals of no more than 2 weeks from the time of fruit set until the end of harvest.

• Each shipment must be accompanied by a phytosanitary certificate issued by the NPPO, with an additional declaration stating that the commodities were grown in a registered greenhouse.

Growing plants in registered greenhouses will result in additional scrutiny for symptoms and infected plants will most likely be discovered and removed. The risk of seed transmission is negligible since the cucurbits will be imported only for consumption. APHIS is confident that the inspection and certification measures will serve as sufficient mitigation against cucumber green mottle mosaic virus.

Another commenter stated that the recent discovery in certain parts of Mexico of a new phytoplasma related to but distinct from lethal yellowing disease, which affects coconuts, should be taken into consideration. The commenter claimed that this new phytoplasma on coconuts was not included in our risk assessment.

The Malayan dwarf and Maypan varieties of coconut resistant to the lethal yellowing phytoplasma are also resistant to the new phytoplasma of concern. Under the requirements set out in the rule portion of this document, coconut fruit with milk and husk must be accompanied by a phytosanitary certificate issued by Mexico that includes an additional declaration stating that the fruit is of the Malayan dwarf variety or Maypan variety based on verification of the parent stock. This requirement provides sufficient protection against the spread of mycoplasmalike organisms.

One commenter questioned whether roots and soil were included in our consideration of a whole plant imported specifically from Mexico.

The commodities that were listed in the proposed rule as enterable from Mexico as whole plants were Allium spp., asparagus, beets, carrots, eggplants, jicama, parsley, radishes, and tomatoes. All of these commodities have been previously allowed entry under permit. Their addition to the regulations is solely in order to improve transparency.

Currently, the only whole plants allowed importation from Mexico are Allium spp., beets, carrots, parsley, and radishes. These commodities are root crops and, as such, are enterable as whole plants intended for consumption. The other commodities listed enterable as whole plants in the proposed rule (asparagus, eggplants, jicama, and tomatoes) were listed as such in error. We have amended the listings in this final rule in order to correctly list the plant parts that, historically, have come in under permit. Soil is prohibited entry with any commodity listed at § 319.56-2t.

Another commenter claimed that the risk of pest contamination is greater in the case of commercial shipments since the amount of commodities is greater than that associated with non-commercial shipments.

Risk of pest dissemination associated with commercial shipments is generally lower since commercial growers are more likely to utilize proper phytosanitary practices, are aware of pest problems and the methods used to control them, and are generally more experienced in dealing with the importation of various commodities. By contrast, noncommercial shipments are principally comprised of commodities hand-carried into the United States by private citizens. There are far fewer safeguards and assurances associated with such commodities. By contrast, commercial shipments provide a far higher level of phytosanitary security.

One commenter stated that lack of funding at the ports of first arrival in the United States means that many shipments cannot be or are not inspected.

While the Department of Homeland Security (DHS) conducts a majority of inspections of agricultural commodities at the ports of first arrival, inspectors follow established and effective APHIS protocols regarding inspection rates and procedures. APHIS continues to work with DHS to ensure that the United States is protected against pests of concern from agricultural imports. Currently, DHS is sufficiently staffed at all ports and fully capable of providing the necessary inspection services.

One commenter observed that no statistics on the pest free status of commercial shipments were included in our risk assessments. The commenter stated that such information should be available prior to any approval granted for the importation of new commodities.

Pest risk assessments are prepared for those commodities that have not been imported previously into the United States. For that reason there are no pest interception data available to include in our risk assessments.

Another commenter cited the court decision on APHIS's rule authorizing the importation of citrus from Argentina ( Harlan Land Company, et al. vs. United States Department of Agriculture ) (referred to below as Harlan Land Co. ), and claimed that according to the decision in that case, APHIS must define what it considers to be a “negligible level of risk” in the context of a rule authorizing the importation of fruit from a disease and pest infested area. The commenter stated that APHIS must thus define what it considers to be an acceptable level of risk, and it must adequately explain that determination, and claimed that the proposed rule does not do so.

We disagree with this comment. In the court decision on APHIS's rule authorizing the importation of clementines from Spain ( Cactus Corner, LLC, et al. vs. United States Department of Agriculture ), the court concluded that, “[n]either law nor logic requires an agency to quantify a numeric threshold of ‘acceptable risk’ every time risk prevention is sought to be achieved by an agency rule.”

The commenter went on to advise that we should consider all types of pests, not just those pests that are known to be dangerous. He argued that pests that pose no danger in their countries of origin may prove harmful to domestic plants if they become established in the differing environment in the United States.

We do not regulate imports based on unknown or speculative risks. We regulate based on sound scientific evidence, consistent with our authority under the Plant Protection Act. We are confident that the mitigation measures detailed in the rule are sufficient to protect against the scientifically determined pests of concern.

The commenter cited our failure to consider appropriate monitoring as a mitigation against infestation and stated that the environmental assessment does not examine the necessity of monitoring at each stage of the importation process.

Monitoring, as described by the commenter, is not required in all cases. Program monitoring is required only when it is found to be necessary according to pest risk analysis. There is no need to examine the need for monitoring in the absence of an identified risk. In the case of this rule, we have determined that all risks are mitigated sufficiently by the measures described. Our risk assessments found the probability of artificial spread of pests via these commodities to be low. Therefore, monitoring at each stage of the import process as suggested by the commenter becomes unnecessary. We are confident that the mitigation measures, including port of entry inspection, described in the rule and considered in the environmental assessment are sufficient to protect against the quarantine pests of concern.

The commenter stated that a monitoring program must provide a system by which the public may review and respond to the findings of that monitoring.

Our Cooperative Agricultural Pest Survey (CAPS) reports finds and movements of damaging foreign organisms from all 50 States and U.S. territories. CAPS tracks more than 4,000 pests nationwide. The CAPS survey data collected each year are entered into the National Agricultural Pest Information System (NAPIS) database which is available on the Internet at http://www.aphis.usda.gov/ppq/.

Providing constant formal reports on the results of our monitoring efforts beyond what is available through CAPS/NAPIS would be costly and time-consuming. Our current rulemaking mechanism allows us to make or propose changes to the regulations that are based on our consideration of a variety of complex and changeable factors, including the findings of monitoring programs.

The commenter suggested that we alter our approach to importation by phasing in the approved fruit and vegetable imports from each country over successive years in order to ensure that any pests imported with the newly allowed commodities will not prove to be injurious once introduced into the United States.

As a signatory to the IPPC, the United States has agreed not to prescribe or adopt phytosanitary measures concerning the importation of plants, plant products, and other regulated articles unless such measures are made necessary by phytosanitary considerations and are technically justified. Based on the conclusions of our risk analyses, we do not believe that there is a technical justification for the phasing in of imports as suggested by the commenter.

One commenter raised issues regarding the environmental assessment that we prepared to document our review and analysis of the potential environmental impacts associated with the proposed rule. A detailed analysis of the issues raised by the commenter can be found later in this document under the heading “National Environmental Policy Act.”

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is set out below, regarding the economic effects of this rule on small entities.

We are amending the fruits and vegetables regulations to list a number of fruits and vegetables from certain parts of the world as eligible, under specified conditions, for importation into the United States. All of the fruits and vegetables, as a condition of entry, will be inspected and subject to treatment at the port of first arrival as may be required by an inspector. In addition, some of the fruits and vegetables will be required to meet other special conditions. We are also recognizing areas in Peru as free from the South American cucurbit fly. These actions will provide the United States with additional types and sources of fruits and vegetables while continuing to protect against the introduction of quarantine pests through imported fruits and vegetables.

We have used all available data to estimate the potential economic effects of allowing the fruits and vegetables specified in this rule to be imported into the United States. However, some of the data we believe would be helpful in making this determination have not been available. Specifically, data are not available on: (1) The quantity of certain fruits and vegetables produced domestically; (2) the quantity of potential imports; and (3) the degree to which imported fruits and vegetables will displace existing imported or domestic products. In our proposed rule, we asked the public to provide such data for specific commodities. In addition, we invited the public to comment on the potential effects of the proposed rule on small entities, in particular the number and kind of small entities that may incur benefits or costs from the implementation of the proposed rule. However, we did not receive any additional information or data in response to those requests.

Data on the number and size of U.S. producers of the various commodities that will be eligible for importation into the United States under this rule are not available. However, since most fruit and vegetable farms are small by Small Business Administration standards, it is likely that the majority of U.S. farms producing the commodities discussed below are small entities. The potential economic effects of this final rule are discussed below by commodity and country of origin.

African horned cucumber from Chile. We are to amending the regulations to allow the entry of African horned cucumber from Chile. African horned cucumber is a specialty crop that is grown in small quantities. Less than 20 acres of the fruit are cultivated in California, and less than 10 acres in Region V (Olmue) and Region X (Osorno) of Chile have been cultivated since 1996. Approximately 32,000 pounds of fruit are expected to be shipped to the United States annually from March to May. There is no reason to believe that allowing imports of African horned cucumber from Chile will have any significant economic impact on U.S. entities. In addition, we believe that U.S. consumers of African horned cucumber will benefit from the increase in its supply and availability.

Annona spp. from Grenada. We are amending the regulations to allow the entry of commercial shipments of cherimoya, soursop, custard apple, sugar apple, and atemoya, which are species of Annona, into the United States from Grenada. In the United States, Annona spp. are apparently a specialty crop produced on a small scale mainly in southern California; thus no data on the U.S. production of Annona spp. are available. Although no separate data are available on the production and trade of Annona spp. from Grenada, data may have been included with the production of all apples. From 2001 to 2003, Grenada produced an average of 533 metric tons of apples. In addition, Annona spp. exports may be included under the category of “apples, not elsewhere specified,” which includes wild apples. The 3-year average for exports of apples, not elsewhere specified, from Grenada is 5 metric tons. We believe that any exports to the United States will be minimal and will not have any significant economic effect on U.S. producers, whether small or large, or consumers. In addition, we believe that U.S. consumers of Annona spp. will benefit from the increase in their supply and availability.

Fruit and vegetables from Mexico. We are specifically listing Allium spp., asparagus, banana, beets, carrots, coconut fruit without husk, cucurbits, eggplant, grape, jicama, lemon, sour lime, parsley, pineapple, prickly pear pads, radish, tomato, and tuna as admissible fruits and vegetables from Mexico. Because these fruits and vegetables have been admissible into the United States from Mexico under permit, specifically listing these commodities in the regulations will not have any economic effect on U.S. producers, whether small or large, or consumers. While production and trade data are not available for jicama, prickly pear, and tuna from Mexico or the United States, data are shown for the other commodities, as available, in table 1. The data provided in table 1 are based on either a 2- or 3-year average. The averages presented for most U.S. and Mexican production and trade, as well as for tomato exports from Mexico, are for the 3-year period of 2000, 2001, and 2002. A 2-year average for 2000 and 2001 is given for exports from Mexico (except tomatoes), U.S. production of parsley and beets, and U.S. imports of parsley and cucurbits.

Coconut fruit with milk and husk from Mexico. Coconut fruit without husk have been admissible into the United States from Mexico under permit. In this final rule, we are amending the regulations to allow coconut fruit with milk and husk from Mexico to be imported into the United States. While the data on coconut production and trade do not differentiate between coconut fruit with or without husk and milk, it is possible that an increase in imports of coconuts into the United States from Mexico will occur, since coconut fruit with milk and husk have previously been inadmissible from Mexico. Because the U.S. production of coconut fruit with milk and husk is supplemented with imports in order to satisfy the domestic demand, we do not believe that allowing the importation of coconut fruit with milk and husk from Mexico will have a significant effect on either U.S. consumers or producers. In addition, we believe that U.S. consumers will benefit from the increase in the supply and availability of coconut fruit with milk and husk from Mexico.

Pitaya from Mexico. In the United States, pitaya are a specialty crop produced on a small scale; thus no data on the U.S. production of pitaya are available. Mexican production and trade data are also not available.

Melon and watermelon from Peru. We are amending the regulations to allow the entry of commercial shipments of watermelon and several varieties of melon ( Cucumis melo L. subsp. melo ) into the United States from Peru. The specific varieties of melons that will be considered for importation include cantaloupe, netted melon (muskmelon, nutmeg melon, and Persian melon), vegetable melon (snake melon and oriental pickling melon), and winter melon (honeydew and casaba melon). The melon and watermelon from Peru will be admissible from the Departments of Lima, Ica, Arequipa, Moquegua, and Tacna, which we recognize as free of the South American cucurbit fly.

From 2001 to 2003, the United States produced an average of almost 3 million metric tons of melon and watermelon and imported an average of 882,350 metric tons. For that same 3-year period, Peru produced an average of 72,337 metric tons of melon and watermelon. For the 2-year period of 2000 and 2001, Peru exported an average of 1,393 metric tons of melon and watermelon. Because the U.S. production of melon and watermelon is supplemented with imports in order to satisfy the domestic demand, we do not believe that allowing the importation of melon and watermelon from certain areas of Peru will have a significant effect on either U.S. consumers or producers. In addition, we believe that U.S. consumers of melon and watermelon will benefit from the increase in its supply and availability.

Watermelon, squash, cucumber, and oriental melon from the Republic of Korea. We are amending the regulations to allow watermelon, squash, cucumber, and oriental melon to be imported into the United States from the Republic of Korea (South Korea) under certain conditions. Table 2 shows the average U.S. and South Korean production and trade data available for the 3-year period of 2000, 2001, and 2002, with a 2-year average for 2000 and 2001 for exports from South Korea. Note that the data include a broader category than what is actually eligible to be imported; e.g. , we are allowing for the importation of cucumber, but the data are available under the broader category of cucumber and gherkins.

Grapes from South Korea. We are amending the regulations to allow the importation of grapes into the United States from South Korea under certain conditions. From 2001 to 2003, the United States produced an average of almost 6.5 million metric tons of grapes and imported an average of 987,124 metric tons. For that same 3-year period, South Korea produced an average of 461,198 metric tons of grapes (approximately 7 percent of the total U.S. production) with an average export of 101 metric tons. Because the U.S. production of grapes is supplemented with imports in order to satisfy the domestic demand, we do not believe that allowing the importation of grapes from South Korea will have a significant effect on either U.S. consumers or producers. In addition, we believe that U.S. consumers of grapes will benefit from the increase in its supply and availability.

This rule contains various recordkeeping requirements, which were described in our proposed rule, and which have been approved by the Office of Management and Budget ( see “Paperwork Reduction Act” below).

This final rule allows certain fruits and vegetables to be imported into the United States from certain parts of the world. State and local laws and regulations regarding the importation of fruits and vegetables under this rule will be preempted while the fruit is in foreign commerce. Fresh fruits and vegetables are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

We have prepared an environmental assessment for this rule. The environmental assessment, entitled “Rule for the 12th Periodic Amendment of the Fruits and Vegetables Regulations” (September 2004), analyzes alternatives to amending the regulations to allow the importation into the United States of a number of fruits and vegetables from various areas of the world under certain conditions. The environmental assessment may be accessed on the Internet at http://www.aphis.usda.gov/ppq/enviro_docs/. Copies of the environmental assessment are also available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 690-2817 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

The environmental assessment for this rule analyzes two alternatives, no action and amending the fruits and vegetables regulations. The no action alternative would be to leave the fruits and vegetables regulations unchanged. Under the no action alternative, (1) certain fruits and vegetables from Mexico ( i.e., Allium spp., asparagus, banana, beets, carrots, coconuts, cucurbits, eggplant, grape, jicama, lemon, sour lime, parsley, pineapple, prickly pear pads, radish, tomato, tuna, coconut [fruit without husk], and pitaya) would continue to be eligible for importation under permit, and (2) cucurbits and grapes from South Korea, melon from Peru, pitaya and coconut with milk and husk from Mexico, Annona spp. from Grenada, and African horned cucumber from Chile would not be approved for importation into the United States. Under the second alternative—amending the fruits and vegetables regulations—the previously named fruits and vegetables from Mexico that have been enterable under permit would be listed as enterable in the regulations, and the listed fruits and vegetables from South Korea, Peru, Mexico, Grenada, and Chile would become eligible for importation into the United States under certain phytosanitary conditions.

The environmental assessment describes the potential environmental effects associated with each alternative. The environmental assessment also describes the phytosanitary measures required for the importation of each commodity, including treatment, specified growing conditions, limits on dates of shipping, inspection and monitoring of growing areas by the plant protection organization of the country where grown, trapping in the growing areas, fruit cutting, safeguarding during transport, and/or permits and phytosanitary certificates. These measures have been designed to safeguard all potentially affected aspects of the human environment, including human health and safety, non-target species, and protected species and habitat.

We omitted one commodity, coconut with milk and husk of the Malayan Dwarf and Maypan hybrid varieties from Mexico, from the environmental assessment that was prepared for the proposed rule and made available to the public for comment. An analysis of this commodity has been added to the environmental assessment prepared for this final rule. Two quarantine pests of concern were identified in the proposed rule as being associated with this commodity, the red ring nematode and lethal yellowing disease. We have determined that the risk associated with red ring nematode is low since nuts on infected trees fall prematurely and would not be harvested. The risk of introduction of lethal yellowing disease would also be low since coconuts with husk and milk of the Malayan Dwarf and Maypan hybrids do not harbor lethal yellowing disease, including the new phytoplasma mentioned by one of the commenters and discussed earlier in this final rule.

As stated in the background section of this final rule, one commenter raised objections to the review and analysis of potential environmental impacts contained in the environmental assessment prepared for the proposed rule. The commenter raised several issues, which are discussed below.

The commenter stated that, under the Endangered Species Act, Federal agencies are required to consult with the U.S. Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) to ensure that their actions will not prove harmful to any listed species. He further stated that APHIS had not performed such consultations and asked that we do so.

Section 7(a)(2) of the Endangered Species Act of 1973 requires that Federal agencies ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. Consultation with FWS and/or NMFS is required only if the proposed action “may affect” listed species or critical habitat.

Prior to the publication of the proposed rule, APHIS prepared a biological assessment to consider the potential risks to federally listed threatened and endangered species and species proposed for listing that could be posed by the proposed importation of certain fruits and vegetables from Mexico, Chile, Grenada, South Korea, and Peru. Based upon the ability of the phytosanitary measures described in the proposed rule to eliminate risks from shipments of these fruits and vegetables, we determined that the importation of those commodities would not affect any endangered and threatened species or their habitats. This “no effect” determination is the appropriate conclusion when an agency determines that its proposed action will not affect listed species or designated critical habitats. Consultation with FWS and/or NMFS is not required if the agency has considered the effects of the proposed action on threatened, endangered, and proposed species and determined that it will have no effect on those species or their critical habitats.

The commenter asked that APHIS, in its environmental assessment, address the cumulative impacts of pesticides and pests on the commodities in question, the environment, and on humans. He additionally stated that it is necessary to investigate the infestation potential of pests when introduced into a new environment, to identify those undesirable qualities in pests that may be triggered by environmental factors, and to consider the possibility of destructive hybridization occurring between native and non-native pests.

Our environmental assessments are uniformly prepared subsequent to our consideration of the best and most up-to-date scientific data. No scientific evidence exists to support the commenter's requests. As stated previously, in the unlikely event of a non-native pest being introduced into the United States via an imported fruit or vegetable, we have the authority to immediately prohibit or further restrict the importation of that commodity. Such action would almost certainly be taken if a pest were to display new and destructive characteristics following its introduction into the United States.

APHIS has considered the potential effects of this final rule on the quality of the human environment. The exclusionary nature of the phytosanitary measures required by this rule will prevent entry of invasive species of concern that are associated with the fruits and vegetables, and this exclusion precludes any effects on native species or their habitats. Based on the analysis provided in the environmental assessment and our assessment of the comments submitted on the proposed rule and its accompanying environmental assessment, implementation of the rule will not significantly impact the quality of the human environment and an environmental impact statement does not need to be prepared.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0236.

The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

Background

The Inflation Adjustment Act (Act), 28 U.S.C. 2461 note, requires the OCC, as well as other Federal agencies with CMP authority, to publish regulations to adjust each CMP authorized by a law that the agency has jurisdiction to administer. The purpose of these adjustments is to maintain the deterrent effect of CMPs and to promote compliance with the law. The Act requires adjustments to be made at least once every four years following the initial adjustment. The OCC's prior adjustment to each CMP was published in the Federal Register on December 11, 2000, 65 FR 77250, and became effective that same day.

The Act requires that the adjustment reflect the percentage increase in the Consumer Price Index between June of the calendar year preceding the year in which the adjustment will be made and June of the calendar year in which the amount was last set or adjusted. The Act defines the Consumer Price Index as the Consumer Price Index for all urban consumers (CPI-U) published by the Department of Labor. 1 See 28 U.S.C. 2461 note. In addition, the Act provides rules for rounding off increases, 2 and requires that any increase in a CMP apply only to violations that occur after the date of the adjustment. Finally, section 2 of the Debt Collection Improvement Act, 28 U.S.C. 2461 note, limited the initial adjustment of a CMP pursuant to the Act to 10 percent of the amount set by statute.

This final rule adjusts the amount for each type of CMP that the OCC has jurisdiction to impose in accordance with the statutory requirements by revising the table contained in subpart O of 12 CFR part 19. The table identifies the statutes that provide the OCC with CMP authority, describes the different tiers of penalties provided in each statute (as applicable), and sets out the inflation-adjusted maximum penalty that the OCC may impose pursuant to each statutory provision.

The Act requires that we compute the inflation adjustment by comparing the CPI-U for June of the year in which the CMPs were last set or adjusted with the CPI-U for June of the calendar year preceding the adjustment. 28 U.S.C. 2461 note. For those CMPs that were adjusted in 2000, we compared the CPI-U for June 2003 (183.7) with the CPI-U for June 2000 (172.4). This resulted in an inflation adjustment of 6.6 percent. For those penalties that were last adjusted in 1997, we compared the CPI-U for June 1997 (160.3) to the CPI-U for June 2003 (183.7). This resulted in an inflation increase of 14.6 percent. The penalty for failure to require flood insurance or notify the borrower of lack of coverage, 42 U.S.C. 4012a(f)(5), has never been adjusted for inflation because of application of the rounding rules. For that penalty, we compared the CPI-U for June of the year of enactment, 1994  3 (148.0), with the CPI-U for June 2003 (183.7). This resulted in an inflation increase of 24.1 percent.

We multiplied the amount of each CMP by the appropriate percentage inflation adjustment and added that amount to the current penalty. We rounded the resulting dollar amount up or down according to the rounding requirements of the Act. In some cases, rounding resulted in no adjustment to the CMP. In the case of the flood insurance penalty, the increase was capped at 10 percent because this is the initial adjustment. The following table shows both the present CMPs and the inflation adjusted CMPs. The table published in § 19.240(a) is shorter and shows only the adjusted CMPs, not the calculations.

New § 19.240(b) states that the adjustments made in § 19.240(a) apply only to violations that occur after the effective date of this final rule.

The OCC will readjust these amounts in 2008 and every four years thereafter, assuming there are no further changes to the mandate imposed by the Act.

The OCC also is amending 12 CFR 19.240 to make a technical correction. When we issued subpart P (pertaining to the removal, suspension, and debarment of accountants from performing audit services) (68 FR 48265, Aug. 13, 2003), we inadvertently assigned a number—§ 19.241—that already appears in Subpart O. To correct this numbering overlap, the final rule amends subpart O by combining §§ 19.240 (prescribing the inflation-adjusted CMP amounts) and 19.241 (specifying when the inflation-adjusted CMP amounts apply) into § 19.240 and removes § 19.241 from subpart O. Revised § 19.240 is divided into paragraphs (a) and (b). Former § 19.240 becomes paragraph (a) and former § 19.241 becomes paragraph (b). Section 19.241 in subpart P is unchanged.

Under the Administrative Procedure Act (APA), an agency may dispense with public notice and an opportunity for comment if the agency finds, for good cause, that these procedural requirements are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The Act provides the OCC no discretion in calculating the amount of the civil penalty adjustment. The OCC, accordingly, cannot vary the amount of the adjustment to reflect any views or suggestions provided by commenters. In addition, combining §§ 19.240 and 19.241 is technical in nature. Therefore, notice and comment are unnecessary and delay in the form of notice and comment procedure is contrary to the public interest. Accordingly, good cause exists to dispense with this procedure.

The RCDRIA requires that the effective date of new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions shall be the first day of a calendar quarter that begins on or after the date the regulations are published in final form. See 12 U.S.C. 4802(b)(1). The RCDRIA does not apply to this final rule because the rule merely increases the amount of CMPs that already exist and does not impose any additional reporting, disclosures, or other new requirements.

The Regulatory Flexibility Act applies only to rules for which an agency publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). See 5 U.S.C. 601(2). Because the OCC has determined for good cause that the APA does not require public notice and comment on this final rule, we are not publishing a general notice of proposed rulemaking. Thus, the Regulatory Flexibility Act does not apply to this final rule.

The OCC has determined that this final rule is not a significant regulatory action under Executive Order 12866.

The OCC has determined that this final rule will not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, a budgetary impact statement is not required under section 202 of the Unfunded Mandates Reform Act of 1995.

The FAA published this direct final rule with a request for comments in the Federal Register on September 24, 2004 (69 FR 57170). The Federal Register subsequently published a correction to the direct final rule on October 4, 2004 (69 FR 59303). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on January 20, 2005. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The FAA published this direct final rule with a request for comments in the Federal Register on September 28, 2004 (69 FR 57839). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on January 20, 2005. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

This action is rulemaking on two revisions to the Wisconsin SIP for the control of NO X emissions from stationary sources as required by State rule NR 428. The rule applies to existing sources in eight of the counties in the Milwaukee-Racine area (Kenosha, Manitowoc, Milwaukee, Ozaukee, Racine, Sheboygan, Washington, and Waukesha counties), and to new sources in six of the eight counties (Kenosha, Milwaukee, Ozaukee, Racine, Washington, and Waukesha).

One revision modifies language to clarify which units are eligible for demonstrating compliance through emissions averaging. The emissions averaging provisions apply only to existing electric utility boilers in the Milwaukee-Racine ozone nonattainment area (Kenosha, Manitowoc, Milwaukee, Ozaukee, Racine, Sheboygan, Washington, and Waukesha counties). The second revision creates a new NO X categorical limit for newly installed combustion turbines burning biologically derived gaseous fuel. Sources affected by the new categorical NO X limit are landfill operations, wastewater treatment plants and digester facilities specifically designed to generate gaseous fuel. The new NO X categorical limit for newly installed combustion turbines burning biologically derived fuel applies only to new sources located in Kenosha, Milwaukee, Ozaukee, Racine, Washington, and Waukesha counties in southeastern Wisconsin. The revisions have been adopted into the state administrative code and became effective on January 1, 2004.

1. The Regional Office has established an official public rulemaking file for this action that is available both electronically and in hard copy form at the Regional office. The electronic public rulemaking file can be found under Regional Material in Edocket (RME) ID No. R05-OAR-2004-WI-0001. The official public file consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public rulemaking file does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The hard copy version of the official public rulemaking file is available for public viewing at the Air Programs Branch, Air and Radiation Division, EPA Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding federal holidays.

2. Electronic Access. You may access this Federal Register document electronically through the regulations.gov Web site located at http://www.regulations.gov , where you can find, review, and submit comments on federal rules that have been published in the Federal Register , the government's legal newspaper, and are open for comment.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at the EPA Regional Office in the format that EPA receives them, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in the official public rulemaking file. The entire printed comment, including the copyrighted material, will be available at the Regional Office for public inspection.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate rulemaking identification number by including the text “Public comment on proposed rulemaking Region 5 in Regional Material in Edocket “R05-OAR-2004-WI-0001” in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

For detailed instructions on submitting public comments and on what to consider as you prepare your comments see the ADDRESSES section and the section I General Information of the SUPPLEMENTARY INFORMATION section of the related proposed rule, which is published in the Proposed Rules section of this Federal Register .

EPA is approving, as part of the Wisconsin ozone SIP, certain sections of Wisconsin rule NR 428, Control of Nitrogen Oxide Emissions. These revisions refer to the addition of language to clarify which sources are eligible to participate in the emissions averaging program.

In addition EPA is approving language that creates a separate categorical emission limit for new combustion turbines burning biologically derived gaseous fuel.

The current version of NR 428 contained in the SIP allows utilities to demonstrate compliance with NO X emission limitations by averaging emissions over multiple units. The rule defines eligible units through the combination of two provisions. NR 428.06(2)(a), the introduction to the averaging program, specifies that a unit must be subject to emission limitations for existing units under NR 428.03. NR 428.06(2)(e)3 specifies that, to be eligible for the averaging program a unit must be allotted a portion of the total 15,912 tons of NO X emissions allocated by the department based on fuel consumption for 1995 through 1997. This mass of NO X emissions is the quantity determined by the Wisconsin Department of Natural Resources for electric utility units with emission limitations under NR 428.03 and which have operated in the ozone nonattainment area during the 1995 to 1997 time frame. Through these two provisions the affected sources are defined as 17 units at five facilities in the nonattainment area, owned by We-Energies, Alliant Energy, and Wisconsin Public Service.

Section NR 428.06(2)(a) is amended to specify that an eligible unit must be subject to the emission limitations for utility boilers under NR 428.03(a). The amendment eliminates the need to reference two provisions in determining eligible sources.

Eligible sources must still receive a proportion of the total 15,912 tons of NO X emissions as stated under the NR 428.06(2)(e)3. This revision does not change the population of the sources currently eligible under the existing SIP.

In this SIP revision, EPA is also approving a new categorical NO X emission limit for newly installed combustion turbines burning biologically derived gaseous fuel. This section of the rule applies to new sources installed after January 1, 2004, in six of the eight counties of the Milwaukee-Racine ozone nonattainment area: Kenosha, Milwaukee, Ozaukee, Racine, Washington, and Waukesha.

The Wisconsin Department of Natural Resources (DNR) created this new categorical NO X emission limit because sources looking to install new combustion turbines would not be able to comply with the limit for natural gas-fired units that would otherwise apply under the provision of NR 428.04(2)(g)(1)(c). Currently, a newly installed simple cycle combustion turbine with a maximum design output less than 40 megawatts and burning biologically derived gaseous fuel is subject to the SIP emission limitation of 25 parts per million (ppmdv) of NO X at 15 percent oxygen under NR 428.04(2)(g)(1)(c), which was established for burning any type of “gaseous fuel”. In the original development of NR 428, the Wisconsin DNR anticipated biologically derived gaseous fuels being combusted in reciprocating engines and not in a combustion turbine. Therefore, biologically derived gaseous fuels were not addressed in establishing the combustion turbine emission limit of 25 ppmdv of NO X at 15 percent oxygen. Instead, the emission limit was established based solely on the combustion of fossil gaseous fuels such as natural gas or propane.

The Wisconsin DNR has determined that a separate categorical standard of 35 ppmdv at 15 percent oxygen is appropriate for a combustion turbine burning landfill gas or any other biologically derived fuel. Comparable alternatives of controlling emissions from sources that generate biologically derived gaseous fuel, as currently allowed under the SIP, are likely to result in greater NO X emissions than the combustion turbine. Landfills and wastewater digester plants generate biologically derived gaseous fuel as a by-product. Instead of destroying the gas by flaring, these facilities prefer to generate electricity to drive their pumping and gas collection systems. The units capable of burning the biologically derived gaseous fuel and generating electricity are either a combustion turbine or spark ignition reciprocating engine. However, the actual NO X emission rate of the reciprocation engine is significantly higher than the new categorical limit of the combustion turbine.

The use of a combustion turbine's higher energy efficiency and lower overall emissions potentially results in further environmental benefit. First, the turbine generates energy more efficiently than a reciprocating engine or power boiler burning biologically derived fuel. Second, the additional generated electricity for the same unit of fuel can potentially offset emissions from traditional electricity sources. ( e.g. coal-fired utility plants).

Therefore, the Wisconsin DNR has concluded that implementation of a separate categorical limit is necessary for the continued or increased use of combustion turbines firing biologically derived gaseous fuel. In addition, this action is likely to result in lower NO X emissions than originally allowed in the ozone attainment demonstration submitted to EPA in December, 2000. See 66 FR 56931, November 13, 2001. The new categorical NO X limit is expressed for both a simple cycle and combined cycle combustion turbine configuration.

The limit is placed in the section of NO X emission limits for combustion turbines under provision NR 428.04(2)(g)4 as follows.

NR 428.04(2)(g)4. ‘Units fired by a biologically derived gaseous fuel.’ No person may cause, allow or permit nitrogen oxides to be emitted from a biologically derived gaseous fuel fired combustion turbine in amounts greater than those specified in this subdivision.

a. 35 parts per million dry volume (ppmdv), corrected to 15% oxygen, on a 30-day rolling average basis for a simple cycle combustion turbine.

b. 35 parts per million dry volume (ppmdv), corrected to 15% oxygen, on a 30-day rolling average basis for a combined cycle combustion turbine.

With the creation of the new categorical emission limit, this revision amends the introductory language under provision NR 428.04(2)(g)(1), to acknowledge that combustion turbines only burning biologically derived gaseous fuel are not subject to the more stringent general emission limitations for burning any type of “gaseous fuels”. The amended language references the newly created subparagraph 4 and reads:

Biologically derived gaseous fuel is defined under the newly created provision NR 428.02(1). The current provision of NR 428.02(1) is renumbered to NR 428.02(2). The newly created definition is as follows:

Units subject to the new categorical limit for combustion turbines burning biologically derived gaseous fuel must meet the same compliance, monitoring, and reporting requirements established for all other new sources. These requirements have already been determined appropriate for combustion turbines and approved by EPA in the Wisconsin SIP.

EPA's review of the revisions to Wisconsin's SIP regarding the control of NO X emissions is contained in a technical support document available from EPA Region 5, according to previously described procedures in “Section I.B.” of this notice.

EPA has concluded that the modification to Wisconsin's NO X SIP to clarify those units eligible for demonstrating compliance through emission averaging does not change the population of sources currently eligible under the existing SIP. The approval of the new categorical NO X emission limit will have no negative impact on the Wisconsin one-hour ozone attainment demonstration SIP. The new categorical standard will not result in any increase in overall NO X emissions. To the contrary, this action is anticipated to reduce NO X emission levels on a source-by-source basis below those allowed by the December 2000 SIP. The comparable alternative for burning biologically derived fuel is a spark ignition reciprocating engine with a higher NO X emission rate than the new categorical standard for combustion turbines. In addition, there is a general environmental benefit due to the use of combustion turbines, in most cases, generating energy (electricity and steam) more efficiently than reciprocating engines or power boilers.

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 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 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 January 10, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

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

EPA, on its own initiative, in accordance with sections 408(e) and 408(1)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of hexythiazox (trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or on corn, field, grain at 0.05 ppm; corn, field, forage at 2.0 ppm; and corn, field, stover at 2.0 ppm. These tolerances will expire and are revoked on December 31, 2007. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The applicant stated that the development of resistance in spider mite populations to the standard acaricide used to control mites has created an urgent and non-routine situation. EPA has authorized under FIFRA section 18 the use of hexythiazox on corn for control of Banks grass mite and two-spotted spider mite in Texas. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of hexythiazox in or on field corn grain, stover, and fodder. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances will expire and are revoked on December 31, 2007, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on field corn grain, stover, and fodder after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed levels that were authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether hexythiazox meets EPA's registration requirements for use on corn or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of hexythiazox by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Texas to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for hexythiazox, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of hexythiazox and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of hexythiazox (trans-5-(4-chlorophenyl)- N -cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide) and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or on corn, field, grain at 0.05 ppm; corn, field, forage at 2.0 ppm; and corn, field, stover at 2.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

The dose at which no observed adverse effect level (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the lowest observed adverse effect level (LOAEL)) is sometimes used for risk assessment if NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (aRfD or cRfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

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

• Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of August 18, 2004 (69 FR 51301) (FRL-7364-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0F6195, 1F6274, 2F6487, and 3F6570) by Monsanto Company, 600 13 th St., NW., Suite 660, Washington, DC 20005. The petition requested that 40 CFR 180.364 be amended by establishing a tolerance for residues of the herbicide glyphosate, N-(phosphonomethyl)glycine, in or on alfalfa seed at 0.5 parts per million (ppm) (PP 2F6487); increasing the current tolerance for cotton, gin byproducts from 100 ppm to 150 ppm (PP 3F6570); rice, bran at 30 ppm; rice, grain at 15 ppm; and rice, hulls at 25 ppm (PP 1F6274); wheat, forage at 10.0 ppm; wheat, hay at 10.0 ppm (PP 0F6195). Monsanto Company also proposed to revise the entry for grain, cereal group tolerance “except rice” to read as grain, cereal group 15 except barley, field corn, grain sorghum, oats, rice, and wheat at 0.1 ppm (PP 1F6274). Monsanto Company also amended PP 0F6195 to delete the proposal for wheat grain at 6 ppm that was announced in the Federal Register of April 17, 2002 (67 FR 18894) (FRL-6830-5). The notice stated that tolerances for alfalfa, rice, wheat, and cotton gin byproducts include both conventional and genetically altered crops.

The notice also proposed that the tolerances for alfalfa, forage at 175 ppm and alfalfa, hay at 400 ppm be deleted from § 180.364. Also proposed was to amend § 180.364 by replacing the current listing vegetable, legume, group 6 except soybean at 5.0 ppm with the current crop group pea and bean, dried and shelled, subgroup 6C at 5.0 ppm. That notice included a summary of the petition prepared by Monsanto Company, the registrant. One comment was received in response to the notice of filing from B. Sachau, 15 Elm St., Florham Park, NJ 07932. The commenter objected to allowing any tolerance, wavier, or exemption for glyphosate. The commenter also objected to animal testing and stated that a more reliable method of testing should be developed. This comment is discussed further in Unit V.

During the course of the review the Agency decided to correct the company address to read Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 20005. The Agency also determined the tolerance proposed for cotton, gin byproducts should be raised to 175 ppm and that the current tolerance for cotton, undelinted seed be increased to 35 ppm.

The Agency has determined that based on available data, the current tolerances for alfalfa, forage and alfalfa, hay are to be maintained and that the current listing for vegetable, legume, group 6 except soybean at 5 ppm is correct; therefore, these proposed changes are not made at this time. Also, even though the proposed tolerances for alfalfa, seed; rice, bran; rice, grain; rice, hulls; wheat, forage; and wheat, hay are included in the risk assessment discussed in Units III.C., D., and E., these tolerances are not being issued at this time.

The Agency is also correcting the proposed tolerance expression to agree with the current tolerance expression by including references to the salts. Therefore, the tolerance expression is corrected to read: Tolerances are established for residues of glyphosate, N-(phosophonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate in or on cotton, gin byproducts at 175 ppm and cotton, undelinted seed at 35 ppm.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of glyphosate, N-(phosophonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate on cotton, gin byproducts at 175 ppm and cotton, undelinted seed at 35 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by glyphosate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed are discussed in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2).

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or UFs may be used: “Traditional uncertainty factors;” the “special FQPA safety factor;” and the “default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional UFs used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children, primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 - 5 ), one in a million (1 X 10 - 6 ), or one in ten million (1 X 10 - 7 ). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

A summary of the toxicological endpoints for glyphosate used for human risk assessment is discussed in Unit V.B. of the final rule published in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.364) for the residues of glyphosate, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

A review of the toxicity database, including developmental toxicity studies in rats and rabbits, did not provide an endpoint that could be used to quantitate risk to the general population and to females 13-50 years old from a single-dose administration of glyphosate. Therefore, no acute dietary analysis was conducted for glyphosate.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues, DEEM default factors and 100% crop treated. PCT and/or anticipated residues were not used.

iii. Cancer . Glyphosate is classified as a Group E chemical, negative for carcinogenicity in humans, based on the absence of carcinogenicity in male and female rats as well as male and female mice.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for glyphosate in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of glyphosate.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentration and Ground Water (SCI-GROW) model, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs), which are the model estimates of a pesticide's concentration in water in quantitative risk assessments. EECs derived from these models are used to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to glyphosate they are further discussed in the aggregate risk sections, Unit III.E.

Based on the GENEEC, and SCI-GROW models, the EECs of glyphosate for acute exposures are estimated to be 21.0 parts per billion (ppb) for surface water and 0.0038 ppb for ground water. The EECs for chronic exposures are estimated to be 0.83 ppb for surface water. The EEC resulting from the registered use of direct glyphosate application to surface water is 230 ppb. Because the glyphosate water-application estimate is greater than the crop-application estimate, 230 ppb is the appropriate value to use in the chronic risk assessment. The EEC for chronic exposure in ground water is 0.0038 ppb.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

i. Non-occupational (recreational) exposures . Glyphosate is currently registered for use on the following residential non-dietary sites: Recreational areas, including parks and golf courses for control of broadleaf weeds and grasses, and lakes and pond, including reservoirs for control of nuisance aquatic weeds. Based on the registered uses, adult and child golfers are anticipated to have short-term post-application dermal exposure at golf courses. Swimmers (adults, children, and toddlers) are anticipated to have short-term post-application dermal and incidental ingestion exposures. However, since the Agency did not select dermal endpoints, no post-application dermal assessment was performed.

A post-application incidental ingestion exposure assessment for swimmers was performed. This assessment assumed 100% of applied concentration available at maximum application rate in the top one foot of water column; an ingestion rate of 0.05 Liter/hour (L/hr), and an exposure duration of 5 hrs/day (although a toddler is unlikely to be exposed for 5 hrs/day). Adult and toddler swimmers were included in this assessment as they are anticipated to represent the upper and lower bound of swimmer exposures. The respective body weights are 60 kilogram (kg) for adult-females (since NOAEL is based on developmental study) and 15 kg for toddlers. This exposure assessment is fully discussed in Unit V.C. of the final rule published in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2). MOEs for incidental exposure for incidental ingestion by swimmers were 7,600 for toddler and to 36,000 for adult females and therefore, do not exceed the Agency`s level of concern (LOC) for short-term non-occupational (recreational ) exposures (MOEs of less than 100).

ii. Residential exposures . Glyphosate is also registered for broadcast and spot treatments on home lawns and gardens by homeowners and by lawn care operators (LCOs). Based on the registered residential use pattern, there is a potential for short-term dermal and inhalation exposures to homeowners who apply products containing glyphosate (residential handlers). Additionally, based on the results of the environmental fate studies, there is a potential for incidental ingestion by toddlers. However, since the Agency did not select short- or intermediate-term dermal or inhalation endpoints, no residential handler or post-application dermal assessment was performed.

A post-application toddler assessment for incidental ingestion exposure assessment was performed. The SOPs For Residential Exposure Assessments , Draft, 17-DEC-1997 and Exposure Science Advisory Committee (ExpoSAC) Policy No. 11, 22-FEB-2001: Recommended Revisions to the SOPs for Residential Exposure were used to estimate post-application incidental ingestion exposures and risk estimates for toddlers. The following assumptions were used to assess exposures to toddlers after contact with treated lawns: Toddler body weight of 15 kg; toddler hand-surface area is 20 centimeter squared (cm) 2 , and a toddler performs 20 hand-to-mouth events per hr for short-term exposures; exposure duration of 2 hrs per day; 5% of application rate represents fraction of glyphosate available for transfer to hands and a 50% saliva extraction factor for hand-to-mouth exposures; surface area of a object (for toddler object-to-mouth exposures; surface area of an object (for toddler object-to-mouth exposures) is approximately 25 cm 2 ; 20% of application rate available as dislodgeable residues for object-to-mouth exposures; 100% of application rate is avaible in the top 1 cm of soil for soil ingestion exposures; and that a toddler can ingest 100 milligram (mg) soil/day. This risk assessment is fully discussed in Unit V.C. of the final rule published in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2). MOEs for toddler post-application incidental ingestion exposures were 7,200 for hand-to-mouth, 29,000 for object-to-mouth and greater than 10 6 for soil ingestion, and therefore, do not exceed the Agency`s level of concern for residential exposures (MOEs) less than 100.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to glyphosate and any other substances and glyphosate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that glyphosate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/ .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . Based on the acceptable developmental studies, the Agency has determined that there is no evidence of either a quantitative or qualitative increased susceptibility following in utero glyphosate exposure to rats or rabbits, or following prenatal/postnatal exposure in the 2-generation reproduction study in rats.

3. Conclusion . There is a complete toxicity database for glyphosate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The impact of glyphosate on the nervous system has not been specifically evaluated in neurotoxicity studies. However, there was no evidence of neurotoxicity seen in either acute, subchronic, chronic, or reproductive studies. and there are no concerns for potential developmental neurotoxicity. Therefore, neurotoxicity studies are not required for glyphosate. EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is removed because the toxicology database is complete; a developmental neurotoxicity study is not required; there is no evidence of quantitative or qualitative increased susceptibility of the young demonstrated in the prenatal developmental studies in rats or rabbits and pre-/postnatal reproduction study in rats; and the dietary (food and drinking water) exposure assessments will not underestimate the potential exposure for infants and children.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against EECs. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA's Office of Water are used to calculate DWLOCs: 2 L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Glyphosate is not expected to pose an acute risk because no toxicological endpoints attributable to a single exposure (dose), including maternal toxicity in developmental toxicity studies, were identified in the available data.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to glyphosate from food will utilize 2.2% of the cPAD for the U.S. population, 3.9% of the cPAD for all infants < 1 year old, and 5.4% of the cPAD for children 1-2 years old. Based the use pattern, chronic residential exposure to residues of glyphosate is not expected. In addition, there is potential for chronic dietary exposure to glyphosate in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 1 of this unit:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Glyphosate is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for glyphosate.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,800 for all infants < 1 year old, 1,500 for children 1-6 years old, and 2000 for children 7-12 years old. Because the incidental oral ingestion exposure estimates for toddlers from residential turf exposures exceeded the incidental oral exposure from post-application swimmer exposures, the Agency conducted this risk assessment using exposure estimates from the worst case situation. No attempt was made to combine exposures from swimmer and residential turf scenarios due to the low probability of both occurring. See Tables 5 and 6 from the final rule published in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2) for detailed discussion. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of glyphosate in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 2 of this unit:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Glyphosate is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for glyphosate.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,800 for all infants < 1 year old, 1,500 for children 1-6 years old, and 2,000 for children 7-12 years old. Because the incidental oral ingestion exposure estimates for toddlers from residential turf exposures exceeded the incidental oral exposure from post-application swimmer exposures, the Agency conducted this risk assessment using exposure estimates from the worst case situation. No attempt was made to combine exposures from swimmer and residential turf scenarios due to the low probability of both occurring. See Tables 5 and 6 from the final rule published in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2) for detailed discussion. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of glyphosate in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in Table 3 of this unit:

5. Aggregate cancer risk for U.S. population . Glyphosate has no carcinogenic potential.

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to glyphosate residues.

Adequate analytical methods are available for the enforcement of tolerances for glyphosate in plant and livestock commodities. These methods include gas liquid chromatography (GLC) ( Method I in Pesticides Analytical Manual (PAM II)) and High Performance Liquid Chromatography (HPLC) with fluorometric detection. Use of GLC is discouraged due to the lengthiness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion into PAM II. A Gas Chromatography Spectrometry (GC/MS) method for glyphosate in crops has also been validated by EPA.

These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

Codex and Mexican maximum residue levels (MRLS) are established for residues of glyphosate per se and Canadian MRLs are established for combined residues of glyphosate and aminomethylphosphonic acid (AMPA) in a variety of raw agricultural commodities. Codex MRLs exist for dry peas and dry beans at 5 ppm and 2 ppm, respectively. Canadian MRLs exist for peas, beans, and lentils at 5 ppm, 2 ppm, and 4 ppm, respectively. Mexican MRLs of 0.2 ppm exist for both peas and beans. Codex and Canadian MRLs for beans and lentils, and Mexican MRLs for peas and beans are lower then necessary to cover residues from the use patterns in the United States. The proposed U. S. tolerance for the crop group peas and beans, dried and shelled, except soybeans, is in agreement with the Codex and Canadian MRLs for dry peas and peas, respectively, and are necessary to cover use patterns in the United States.

Currently no Codex MRL for cotton, gin byproducts or cotton, undelinted seed are established.

There are no conditions of registration for the establishment of tolerances on cotton, gin byproducts or cotton, undelinted seed.

One comment was received in response to the notice of filing from B. Sachau, 15 Elm St., Florham Park, NJ 07932. The commenter objected to the allowance of any tolerances, waiver, or exemption from tolerance for glyphosate because there are bad effects from glyphosate. The commenter also objected to animal testing, because testing on rabbit or dog constitutes animal abuse, and stated that a more reliable method of testing should be developed.

The comment contained no scientific data or evidence to rebut the Agency`s conclusion that there is a reasonable certainty that no harm will result from aggregate expose to glyphosate, including all anticipated dietary exposure and all other exposures for which the is reliable information.

Health Effects Guidelines (Series 870) recommends that dog or rabbit be used for various acute, subchronic, and longer term chronic, carcinogenic, developmental, and reproductive studies. Information derived from these tests serve to indicate the presence of possible hazards likely to arise from exposure to the test substance. Currently, there are not in vitro studies that can address the questions these studies answer. The EPA is currently working with the Interagency Coordinating Committee on the Validation or Alternative Methods (ICCVAM) to investigate alternative in vitro methods.

Therefore, the tolerance is established for residues of glyphosate, N-(phosophonomethyl)glycine, resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate in or on cotton, gin byproducts at 175 ppm and cotton, undelinted seed at 35 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2004-0323 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before January 10, 2005.

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

Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14 th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES . Mail your copies, identified by docket ID number OPP-2004-0323, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES . You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dpap/dfars/transf.htm.

This final rule is a result of the DFARS Transformation initiative. The DFARS changes include—

• Deletion of text at DFARS 209.103, 209.103-70, and 252.209-7000 pertaining to obsolete Intermediate Range Nuclear Forces (INF) Treaty inspection requirements.

• Deletion of text at DFARS 209.106-1, 209.106-2, and 209.202 containing internal DoD procedures relating to requests for pre-award surveys and approval for use of product qualification requirements. This text has been relocated to the new DFARS companion resource, Procedures, Guidance, and Information (PGI), available at http://www.acq.osd.mil/dpap/dars/pgi.

• Deletion of unnecessary first article testing and approval requirements in DFARS subpart 209.3.

DoD published a proposed rule at 69 FR 8150 on February 23, 2004. DoD received no comments on the proposed rule. Therefore, DoD has adopted the proposed rule as a final rule. An additional change has been made at DFARS 209.202 to reflect the qualification requirements for aviation critical safety items added to the DFARS on September 17, 2004 (69 FR 55987).

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because the rule deletes DFARS text that is obsolete, unnecessary, or procedural, but makes no significant change to contracting policy.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dpap/dfars/transf.htm.

This final rule is a result of the DFARS Transformation initiative. The DFARS changes—

• Delete unnecessary text pertaining to structuring of contracts at DFARS 212.303; and

• Update a FAR reference at DFARS 212.503(c)(ii).

DoD published a proposed rule at 69 FR 31939 on June 8, 2004. DoD received no comments on the proposed rule. Therefore, DoD has adopted the proposed rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because the rule deletes unnecessary text and updates reference information, but makes no significant change to contracting policy.

The Paperwork Reduction Act does not apply, because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dpap/dfars/transf.htm.

This final rule is a result of the DFARS Transformation initiative. The DFARS changes include—

• Deletion of unnecessary text at DFARS 214.201-1, 214.407-3(h), and 214.5.

• Redesignation of DFARS 214.202-5(d) as 214.202-5(c) for consistency with the corresponding FAR text.

• Addition of the Defense Contract Management Agency General Counsel to the list of agency officials authorized to permit correction of mistakes in bid before award.

DoD published a proposed rule at 69 FR 8152 on February 23, 2004. DoD received no comments on the proposed rule. Therefore, DoD has adopted the proposed rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because the rule deletes unnecessary text and updates administrative information, but makes no significant change to contracting policy.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dpap/dfars/transf.htm.

This final rule is a result of the DFARS Transformation initiative. The rule deletes DFARS text in the areas addressed below. This text has been relocated to the new DFARS companion resource, Procedures, Guidance, and Information (PGI), available at http://www.acq.osd.mil/dpap/dars/pgi.

• DFARS 228.304, Risk-pooling arrangements. In the early 1950's, DoD teamed with the insurance industry to develop a program that would minimize the cost of workers' compensation and contractor liability charged to Government contracts. The objective was to provide an optional insurance plan to be used if it provided a better deal than what could be purchased on the open market. The team's solution was the National Defense Projects Rating Plan (NDPRP). The NDPRP defined premiums via a formula based upon average workers' compensation rates throughout the country and adjusted for experience pooled from Defense contractors. This produced premiums without loadings, e.g. , commissions, and eliminated the burden of negotiating premiums every year with insurance carriers. Today, there is little cost difference between the NDPRP and the states' workers' compensation program, because the states have adopted the same premium algorithm as the NDPRP and many contractors have adopted self-insurance. The text at DFARS 228.304 may be beneficial in the event of a prolonged surge in Defense contract activity, and should be retained as guidance. Accordingly, DoD has removed this text from the DFARS and relocated it to the new DFARS companion resource, PGI.

• DFARS 228.305, Overseas workers' compensation and war-hazard insurance. The Defense Base Act (42 U.S.C. 1651 et seq. ) extends the Longshoremen's and Harbor Workers' Compensation Act (33 U.S.C. 901) to various classes of employees working outside the United States. When the agency head recommends a waiver to the Secretary of Labor, the Secretary may waive the applicability of the Defense Base Act to any contract, subcontract, work location, or classification of employees. DFARS 228.305 provides the procedures within DoD for submitting such requests for waiver. DoD has removed this procedural text from the DFARS and relocated it to the new DFARS companion resource, PGI.

DoD published a proposed rule at 69 FR 8153 on February 23, 2004. DoD received no comments on the proposed rule. Therefore, DoD has adopted the proposed rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because the rule deletes DFARS text addressing procedural matters, but makes no significant change to contracting policy.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DFARS Transformation is a major DoD initiative to dramatically change the purpose and content of the DFARS. The objective is to improve the efficiency and effectiveness of the acquisition process, while allowing the acquisition workforce the flexibility to innovate. The transformed DFARS will contain only requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal operating procedures of DoD or a significant cost or administrative impact on contractors or offerors. Additional information on the DFARS Transformation initiative is available at http://www.acq.osd.mil/dpap/dfars/transf.htm.

This final rule is a result of the DFARS Transformation initiative. The DFARS changes include—

• Updating of a statutory reference at DFARS 235.006-70.

• Deletion of unnecessary text at DFARS 235.007 and 235.015.

• Deletion of text at DFARS 235.010 regarding DoD maintenance of scientific and technical reports. Text on this subject has been relocated to the new DFARS companion resource, Procedures, Guidance, and Information (PGI), available at http://www.acq.osd.mil/dpap/dars/pgi.

• Updating of administrative information at DFARS 235.017-1 and 252.235-7011.

DoD published a proposed rule at 69 FR 8158 on February 23, 2004. DoD received no comments on the proposed rule. Therefore, DoD has adopted the proposed rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because the rule updates administrative information, and deletes DFARS text that is unnecessary or procedural, but makes no significant change to contracting policy.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

The reef fish fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. Those regulations set the commercial quota for red grouper in the Gulf of Mexico at 5.31 million lb (2,413,636 kg) for the current fishing year, January 1 through December 31, 2004. Those regulations also require closure of the entire shallow-water grouper commercial fishery when either the red grouper quota or the shallow-water grouper quota is reached.

Under 50 CFR 622.43(a), NMFS is required to close the commercial fishery for a species or species group when the quota for that species or species group is reached, or is projected to be reached, by filing a notification to that effect in the Federal Register . Based on current statistics, NMFS has determined that the available commercial quota of 5.31 million lb (2,413,636 kg) for red grouper will be reached on or before November 15, 2004. Accordingly, NMFS is closing the commercial shallow-water grouper fishery in the Gulf of Mexico EEZ from 12:01 a.m., local time, on November 15, 2004, until 12:01 a.m., local time, on January 1, 2005. The operator of a vessel with a valid reef fish permit having shallow-water grouper aboard must have landed and bartered, traded, or sold such shallow-water grouper prior to 12:01 a.m., local time, November 15, 2004.

During the closure: the bag and possession limits specified in 50 CFR 622.39(b) apply to the harvest or possession of red grouper and shallow-water grouper in or from the Gulf of Mexico EEZ, and the sale or purchase of shallow-water grouper taken from the EEZ is prohibited. The prohibition on the sale or purchase does not apply to the sale or purchase of red grouper or shallow-water grouper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, November 15, 2004, and were held in cold storage by a dealer or processor.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds the need to immediately implement this action to close the fishery. Pursuant to 5 U.S.C. 553(b)(3)(B), there is good cause to waive provide prior notice and opportunity for public comment on this action, as notice and comment would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because it requires time during which harvest would likely exceed the quota.

There is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effective date. There is a need to implement this measure in a timely fashion to prevent an overage of the commercial quota of Gulf red grouper, given the capacity of the fishing fleet to exceed the quota quickly. Any delay in implementing this action would be impractical and contrary to the Magnuson-Stevens Act, the FMP, and the public interest. For these reasons, NMFS finds good cause that the implementation of this action cannot be delayed for 30 days.

This action is required by 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

The NMFS Regional Administrator (RA) adjusted the recreational salmon fishery in the area from the Queets River to Leadbetter Point, WA (Westport Subarea) to close at midnight on Monday, September 6, 2004. In addition, the recreational salmon fishery in the area from Leadbetter Point, WA, to Cape Falcon, OR (Columbia River Subarea) was modified to reopen the area between Cape Falcon and Tillamook Head (45°56′45″ N. lat.) effective Saturday, September 4, 2004. On September 2 the Regional Administrator had determined the available catch and effort data indicated that the adjusted quota of 10,000 coho salmon in the Westport Subarea would be reached by September 6, and that the small closed area in Columbia River Subarea could be reopened without exceeding conservation objectives established preseason.

All other restrictions remained in effect as announced for 2004 ocean salmon fisheries and previous inseason actions. These actions were necessary to conform to the 2004 management goals. Automatic season closures based on quotas are authorized by regulations at 50 CFR 660.409(a)(1). Modification of boundaries, including landing boundaries, and establishment of closed areas is authorized by regulations at 50 CFR 660.409(b)(1)(v).

In the 2004 annual management measures for ocean salmon fisheries (69 FR 25026, May 5, 2004), NMFS announced the recreational fishery in the area from the Queets River to Leadbetter Point, WA (Westport Subarea) would open June 27 through the earlier of September 19 or a 74,900-coho subarea quota, with a subarea guideline of 30,800 chinook; and the recreational fishery in the area from Leadbetter Point, WA to Cape Falcon, OR (Columbia River Subarea), would open June 27 through earlier of September 30 or 101,250 coho subarea quota with a subarea guideline of 8,000 chinook, and the area between Cape Falcon and Tillamook Head would be closed beginning August 1.

The recreational fishery in the area from the Queets River, WA, to Cape Falcon, OR (Westport and Columbia River Subareas) was modified by Inseason Action #7 to be open 7 days per week, with a modified daily bag limit of all salmon, two fish per day, and all retained coho must have a healed adipose fin clip, effective Friday, July 23, 2004, thus allowing for the retention of two chinook per day (69 FR 52448, August 26, 2004).

The recreational fisheries in the area from Cape Alava, WA, to Cape Falcon, OR (La Push, Westport, and Columbia River Subareas) were modified by Inseason Action #10 to have a minimum size limit for chinook of 24 inches (61.0 cm) total length; and for the area from Cape Alava to Queets River, WA (La Push Subarea) the daily bag limit was modified to: “all salmon, two fish per day, and all retained coho must have a healed adipose fin clip,” thus allowing for the retention of two chinook per day. In addition, 40,000 coho were reallocated from Queets River to Leadbetter Point, WA (Westport Subarea) quota, by transferring the coho on an impact neutral basis, to the coho quota in the subarea from the U.S.-Canada Border to Cape Alava, WA (Neah Bay Subarea), which increased the Neah Bay Subarea quota by 6,600 coho (69 FR 54047, September 7, 2004).

The recreational salmon fishery from the Queets River to Leadbetter Point, WA (Westport Subarea) was modified by Inseason Action #11, effective Sunday, August 29, 2004, to allow for the retention of all legal sized coho until the earlier of September 19 or a quota of 10,000 coho (69 FR 63332, November 1, 2004). Unmarked coho could only be possessed and landed in the Westport Subarea. In addition, 20,000 coho from the quota of the commercial fishery from the U.S.-Canada Border to Cape Falcon was traded for 5,000 chinook from the Westport Subarea quota.

The area from the U.S.-Canada Border to Cape Alava, WA (Neah Bay Subarea), was modified by Inseason Action #13 to close at midnight on Thursday, September 2, 2004 (69 FR 64501, November 5, 2004). To allow for the Neah Bay Subarea to remain open until September 2, 3,100 coho were transferred to the Neah Bay coho quota on an impact neutral basis from the Queets River to Leadbetter Point, WA (Westport Subarea), coho quota.

On September 2, 2004, the RA consulted with representatives of the Pacific Fishery Management Council, Washington Department of Fish and Wildlife, and Oregon Department of Fish and Wildlife by conference call. Information related to catch to date, the coho and chinook catch rates, and effort data indicated that it was likely that the revised Westport Subarea coho quota of 10,000 would be reached soon, and that the Columbia River Subarea catch was much lower than was predicted preseason. As a result, on September 2 the states recommended, and the RA concurred, that the recreational salmon fishery close in the Westport Subarea at midnight on Monday, September 6, 2004, and the recreational Columbia River Subarea be modified to reopen in the area between Tillamook Head and Cape Falcon effective Saturday, September 4, 2004. All other restrictions that apply to these fisheries remained in effect as announced in the 2004 annual management measures.

The RA determined that the best available information indicated that the catch and effort data, and projections, supported the above inseason actions recommended by the states. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice to fishers of the already described regulatory actions were given prior to the date the actions were effective, by telephone hotline number 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

These actions do not apply to other fisheries that may be operating in other areas.

Classification

The Assistant Administrator for Fisheries, NOAA (AA), finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory actions was provided to fishers through telephone hotline and radio notification. These actions comply with the requirements of the annual management measures for ocean salmon fisheries (69 FR 25026, May 5, 2004), the West Coast Salmon Plan, and regulations implementing the West Coast Salmon Plan 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies have insufficient time to provide for prior notice and the opportunity for public comment between the time the fishery catch and effort data are collected to determine the extent of the fisheries, and the time the fishery closure must be implemented to avoid exceeding the quota or the time an area must be reopened to allow access to fish when they are available. Because of the rate of harvest in this fishery, failure to close the fishery upon attainment of the quota would allow the quota to be exceeded, resulting in fewer spawning fish and possibly reduced yield of the stocks in the future. In addition, the action also relieved a restriction by reopening a closed area, thus providing additional harvest opportunity and was consistent with conservation and use objectives specified in the 2004 annual management measures. For the same reasons, the AA also finds good cause to waive the 30-day delay in effectiveness required under U.S.C. 553(d)(3).

These actions are authorized by 50 CFR 660.409 and 660.411 and are exempt from review under Executive Order 12866.