Page 1 of 12 

## Cost and Small Business Analysis of Revisions to Minimum Risk Exemption

August 4 , 2015

1 Background

Under Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA ) 25(b)(2), EPA may exempt from the requirements of FIFRA any pesticide that is “of a character unnecessary to be subject to [FIFRA]”. Pursuant to this authority, in March 1996, EPA promulgated 40 CFR 152.25(g), which exempted from FIFRA any pesticide produ cts consisting solely of specified ingredients that EPA judged to pose minimum risk to humans and the environment (61 FR 8876, March 6, 1996). This provision was later redesignated as §152.25(f) (66 FR 64759, December 14, 2001).

Unlike producers of reg istered pesticides, producers of products exempted under 152.25(f) do not register their products with EPA, pay registration fees, or report production to EPA. Exempt products are required to provide certain information on their labels, including the name s of both the active and inert ingredients. However, the names found on labels are often the technical names, which are not known to consumers, and may not be known to all inspectors, which can lead to confusion and delays in

enforcement.

EPA is modifyin g the label requirements in the exemption to require the use of specific common chemical names in lists of ingredients on minimum risk pesticide product labels, which will facilitate enforcement, and to require producer contact

information on the label. EP A is also revising the exemption to more clearly specify the active and inert ingredients permitted in products eligible for the exemption from regulation for minimum risk pesticides (40 CFR 152.25(f)). EPA is reorganizing these lists and adding specific chemical identifiers to make it clearer to manufacturers; the public; and Federal, state, and tribal inspectors the specific ingredients that are permitted in minimum risk pesticide products.

The purpose of this analysis is to estimate the cost of label changes of this rulemaking , as separate and distinct from (i.e., incremental to) routine label changes that producers already undertake and assess the impacts on small entities

. The document is organized as follows. In section 2, the profile of affected industry is described, including the total number of minimum risk pesticide products currently on the market and the firms that produce these products. In section 3, the anticipated cost s of the final rule are estimated for three implementation periods: immediate, two years, and three years. The cost per label change and the total number of label changes anticipated from the final rule are estimated, from which the industry cost is derived. Using the cost est imates of section 3, the impacts on small businesses are analyzed in section 4. Based on thisPage 2 of 12

analysis, EPA concludes that there will not be a significant impact on substantial number

of small entities.



### 2 Profile of Affected Industry

In this section, the minimum risk pesticide industry that would be affected by the

final rule is delineated. Minimum risk pesticide products are identified in subsection 2.1 and the firms that produce these products are described in subsection 2.2.



### 2.1 Minimum Risk Pesticide Prod ucts

Table 1 shows the number and types of minimum risk pesticide products. The information in Table 1 is derived primarily from lists of products registered in 14 states (EPA, 2010) . A lthough minimum risk products are exempt from registration by EPA,

ap proximately 37 states require registration of these pesticide products. Many of these states provide their pesticide registration lists (including for minimum risk pesticides) online, and available to the public. In addition to the states’ registration l ists, the list of personal insect repellent products is also derived from the retail store scanner data (Nielsen, 2008) and on

- line searches.

Table 1. Minimum Risk Products

Type of Product Number

Antimicrobial 2

Deodorizer 1
Fungicide 9
Fungicide & Herbicide 2

Herbicide 62

Herbicide & Fertilizer 32

Rodenticide 6

Insecticide 149
Insecticide/Repellent 2
Repellent, Animals 141
Repellent, Insect for Animals 31
Repellent, Insect for Pets 20
Repellent, Insect 218
Repellent, Insect, Skin

- applied 74

Unknown 8

Total 757 Sources: State minimum risk product registrations (2010)

and AC Nielsen (2008).

Only the products that comply with 40 CFR 152.25(f) would be subject to the rule. Based on the Agency’s enforcement experience and review of minimum risk insect repellent labels, some products marketed under the minimum risk exemption are not in full compliance. They may, for example, include inert ingre dients that have not been approved for these products. When identified, these products must be registered with EPA or reformulated to comply with 40 CFR 152.25(f).Page 3 of 12 Since EPA may have incomplete information regarding the number of products out of compli ance, we assume that all 757 products in Table 1 are subject to the rule, which would result in an overestimation of the cost of the rule. On the other hand, since exempt products are not registered, Table 1 may n ot include all of the minimum risk pestici de products on the market

, leading to an underestimate of the cost of the rule

. The net effect of these two opposing factors cannot be determined due to the lack of data.



### 2.2 Firms Producing Minimum Risk Products

Table 2 summarizes the number of firms pro ducing the minimum risk pesticide products identified by EPA. A total of 216 firms were identified. Some of these firms (23) produce both skin

- applied insect repellents and other minimum risk pesticide products.

Table 2. Number of Minimum Risk Pesticide Product Firms by Product Type

Firms Producing Number of

Firms Products

Skin

- Applied Insect Repellents 34 74

Other Products 205 683

Both of the Above 23

All Products 216 757
Sources: State minimum risk product registrations (2010) and AC Nielsen (2008).

For the purpose of cost analysis, the firm data is needed for the highest level of

multi

- layered corporate organizations, called the parent firm. EPA used the Dun &

Bradstr eet (D&B) Market Spectrum database to obtain firm size and financial data, and to determine the parent firms (Dun & Bradstreet, 2009). D&B is a comprehensive source of financial information on entities, including firm locations, sales, and primary busines s classifications under North American Industrial Classification System code (NAICS). Based on a review of this data, 192 parent companies were identified (Table 3). Not all parent companies could be determined from the D&B database. Together, the 192 p arent companies account for 541 minimum risk products, or about 79 percent of those identified by EPA.

Table 3 shows the distribution of firms by NAICS code

. Most firms in the minimum risk pesticide industry belong to Chemical Manufacturing (NAICS code 325)

and Merchant Wholesalers, Nondurable Goods (NAICS code 424). Forty

- two firms are divided among 31 NAICS codes, including NAICS code s 311, 332, and 333, each with

four firms), NAICS code s 335 with 3 firms, NAICS codes 112, 115, 445, 453, 525, each

with two firms, and 17 NAICS codes with one firm in each.Page 4 of 12 Table 3. Producers of Minimum Risk Pesticides

3

- digit

NAICS Code NAICS Code Description Number of parent firms

325 Chemical Manufacturing 72

339 Miscellaneous Manufacturing 8

423 Merchant Wholesalers, Durable Goods 11

424 Merchant Wholesalers, Nondurable Goods 32

444 Building Material and Garden Equipment and Supplies Dealers 7

541 Professional, Scientific, and Technical Services 7

561 Administrative and Support Services 13

Others 42

Total with classification 192 Sources: State product registrations (2010), AC Nielsen retail store scanner data (2008).



### 3 Cost of Label Changes

In this section, the cost of the final rule is estimated. The cost of the rule consists

of a one

- time change in the design of the label to comply with the labeling requirement s. The incremental cost of the final rule depends on the extent to which the change is separate and distinct from the routine label changes firms undertake on regular basi s. The section is organized as follows: t he methodology for estimating the cost per label change is presented in subsection 3.1. In subsection 3.2, the total industry cost is estimated by multiplying the cost per label change by the total number of label changes

that result from the final rule

.



### 3.1 Cost per Label Change Methodology

In general, the cost of a label change depends on the size and type of packages for products, which determine types of graphics and printing methods. Also, the firm size

can influence the cost of labeling as smaller firms may choose setups that are less expensive (e.g., graphic designs with fewer colors). It is noted that firms change their labels on a routine basis to update or “refresh” their product labels even if not requ ired by government regulation and this is an important factor that determines the magnitude of

the cost of the rule

. The final rule will impose some cost to redesign the label to accommodate new EPA requirements. The expected cost of the label change wil l depend on the duration of the rule implementation period, which will determine the extent to which the EPA’s requirements can be incorporated into firms ’ routine relabeling operations.

To estimate the cost of the rule, EPA uses the Food and Drug Admin istration’s ( FD A) labeling cost model (FDA, 2003) developed for estimating the labeling cost for

food products. This is a reasonable model for minimum risk pesticide products because the package sizes and shapes of exempt pesticide products are similar to the packaging for many food products. According to th is model, firm’s labeling cost consists of:

1. Set up costs

a. Administrative costsPage 5 of 12 b. Graphic design

c. Printing setup

– prepress and engraving

2. Printing cost

Administrative costs include working with outside vendors to supply graphic design, prepress and engraving, market testing of redesigned graphics, and meeting EPA requirements (e.g., searching the common chemical names for the ingredients). Firms

often wo rk with a graphic design company to redesign their label graphics. Depending on the type of graphic designs (e.g., number of colors), costs vary. Prepress operations convert the design created by the designer into the film or files that are used to engra ve or etch the printing plates or cylinders (FDA, 2003). Estimates for these setup costs are described in the next subsection (Table 4).

Because firms have to print labels anyway, printing cost is not a cost of this rule unless firms would have to print labels before they used up their stock of printed labels.

Because firms will be allowed three years to change labels and will know in advance of

three years that label changes will be required, we assume that firms will be able to plan

in advance and not have any unused packaged product and label stock.

The cost of a firm’s routine label change is considered as the baseline in estimating

the incremental cost of the final rule, because the routine re

- labeling cost is part of the normal business operations in the absence of the rule.

In the next subsection the setup costs per label change are described.

3.1.1 Setup Costs per Label Change

– Baseline
In order to successfully market their product, producers label their product with the information that they want the public to know about the product. Thus, producers create labels, and update labels as a routine cost of doing business.

Table 4 below summarizes the setup costs per label change. Many products have more than one size or type of package. Each is r eferred to as a stock keeping unit ( SKU ) ( FDA, 2003 )

. Each SKU would have to be relabeled to comply with the new requirements . For each type of a label change (e.g. 1

- color), FDA has a low, medium, and high estimate. Table 4 shows the low estimate for a 1

- color change, the medium

estimate for a 2

- color change, and the high estimate for a full redesign with 6 colors, thus covering the range of cost estimates from the lowest to the highest . The last column

shows the simple average of all nine of FDA’s estimates. EPA assumes that the se average costs will apply to the industry as whole (both large and small firms). T he

average set up costs to re

- labe l range from $1, 282 to $14

, 76 2.Page 6 of 12

Table 4. Setup Cost to Re

- label per SKU (Stock Keeping Unit): Baseline

1

- color,

low 2

- color,

medium Full redesign,

high b Average c

Administrative $134 $504 $986 $504

Graphic design $336 $1,512 $3,360 $1,512

Prepress a $353 $765 $3,920 $1,389

Engraving a $459 $1,374 $6,496 $2,229

Total $1,282 $4,155 $14,762 $5,634
Source: FDA Labeling Cost Model (FDA, 2003) adjusted for inflation using Producer Price Index for printing of 1.12

a Average of flexography, offset lithograph, and rotogravure

b W ith 6 colors

c Average of all 9 of FDA estimates: 3 each of 1

- color, 2

- color, and full redesign.

Estimates in Table 4 represent the baseline costs of label change the firms routinely conduct as part o f normal business operation. In the next subsection, the costs

of the final rule under different compliance periods are estimated.

3.1.2 Cost of the Final Rule

The final rule will impose some cost to redesign the label to accommodate new EPA requirements. The expected cost of the label change will depend on the length of the rule implementation period, which determine the extent to which the new EPA requirements can be incorporated as part of firm’s routine relabeling operations. In a previous analysis (EPA, 2 005) , EPA determined that many pesticide labels routinely undergo changes every 1 to 3 years. Based on this information , for the current cost analysis, EPA assumes that firms will routinely re

- label every three years, although some firms may re

- label more or less frequently.

Also, the 2005 EPA analysis assumed that if the changes occurred during a routine label update, then one

- third of the artwork cost would be due to EPA’s mandate. Applying the same assumption, EPA assumes that if the firm’s routine re

- labeling operation falls within the rule compliance period (that is, if the rule requirements can be fully coordinated with the firm’s routine labeling change), the cost of the rule would

amount to one

- third of the baseline administrative and graphic desi gn costs only. This incremental cost is associated with complying with EPA requirements (adding common chemical names and company contact information, etc). This is the only cost of the label change due to the rule because the rest of relabeling costs wi ll be incurred as part of the firm’s normal business operations. In Table 5, the cost estimates for this scenario r ange from $157 to $1

, 449.

If the firm’s routine relabeling cycle falls outside the rule compliance period (that is, if the rule requirement s cannot be incorporated into the firm’s routine labeling change), then the firm must incur the full cost of label change estimated in the previous subsection (see Table 4) plus administrative and graphic design costs would be one

- third larger due to EPA’s mandate. In the first row of Table 5, the cost estimates for this scenario range from $1,439 to $16,210. These costs are calculated by adding the one

-Page 7 of 12

third extra administrative and design costs to the baseline costs of a routine label change

from Table 4. This extra cost is shown in the last row of Table 5 because EPA assumes that all labels would have been routinely changed within three years without the rule.

If the firm’s routine relabeling cycle overlaps with the rule implementation period, the cost of the rule would lie between the two cases described above. For example

, if the rule implementation period is two years

, two

- thirds of the labels are likely

to be relabeled during the rule implementation period , while one

- third of the labels are likely to be relabeled ahead of their routine label change schedule because of the rule mandate (FDA, 2003). In this case, the average cost per label is estimate d to range from $5 84 to $ 6,369 (Table 5). For example, the weighted averag e cost for a 1

- color change is computed as $1, 439 *(1/3) + $157*(2/3) = $5 84

.

The estimated costs of the rule under different rule compliance periods are shown

in Table 5.

Table 5

. Relabeling Cost per SKU (Stock Keeping Unit) under Three Rule Implem entation Periods

1

- color,

low 2

- color,

medium Full

redesign, high Average 1

Immediate relabeling 2 $1,439 $4,827 $16,210 $6,306

2

- year implementation $584 $2,057 $6,369 $2,550

3

- year implementation 3 $157 $672 $1,449 $672

Source: EPA calculations.

1 Average of all 9 of FDA estimates: 3 each of 1

- color, 2

- color, and full redesign.

2 Does not include additional printing costs due to discarding of label stocks.

3 Since 3 years sufficient time for routine label changes, this row represents the c ost attributable to rule if the firm would have relabeled anyway, which is 1/3 of admin istrative and design costs.

If firms are required to relabel their products, additional costs could be incurred in

terms of un used packaged product and label stock s that have to be discarded requiring additional printing costs to replace disca rded label stocks. However, EPA assume s that firms will be able to plan in advance and not have any unused inventory stock s, thus avoiding this cost with two or more years to comply with the label change requirements

. While these costs would occur with immediate relabeling, we have no information to estimate additional printing costs due to discarding of label stocks. For the above

reasons , we did not include this cost in our estimates.



### 3.2 Industry Cost

T o estimate the cost to industry of the final rule, t he average label setup cost per SKU is multiplied by the anticipated number of label changes (the total number of SKUs)

. For th e industry consisting of large and small firms, we use the average re

- label cost in the right hand column of Table 5. The total number of label changes is based on the number of exempt pesticide products in the industry and the average number of SKUsPage 8 of 12

per product, which depends on the number of package sizes and types per product. Since there is no data regarding the number of SKUs per product for the minimum risk pesticide industry, EPA uses 1 .5 3 SKUs per product from the FDA’s sunscreen rule (FDA, 2011). EPA believes that skin

- applied insect repellents (approximately 10% of the total number of minimum risk products identified in this study, see Table 1) are probably similar to sunscreen products in terms of multiple packaging since both are dermal applic ation products for humans and thus, 1.53 SKUs per product may be a reasonable estimate for these products. However, for the other products affected by the rule there are no data regarding the number of SKUs per product, and this is a source of uncertainty

in the estimation of the cost of the final rule. Since EPA did not receive information during the public comment period on the number of SKUs per product , EPA has proceeded to use this estimate for all minimum risk pesticide products

.

Using the average cost estimates from the last column of Table 5

, EPA estimate s the industry cost under three different rule implementation periods, assuming firms are o n a three

- year relabeling cycle: immediate relabeling, two years, and three years. To

estimate the cost of the rule under each implementation period, the number of SKUs per product (1.53) is multiplied by the total number of minimum risk pesticide products (757 from Table 1) to obtain the total number of SKUs (1,158), which is in turn multiplied by

the avera ge cost per SKU from the last column of Table 5. The results are displayed in

Table 6.

Table 6 : Industry Cost U nder Three Rule Implementation Periods

Immediate 2 years 3 years

Total number of SKUs a 1,158 1,158 1,158

Average cost per SKU labe l change (last column of Table 5 ) $6,306 $2,550 $672

Total cost to industry b $7,300,282 $2,952,097 $778,005

Source: (FDA, 2003 and 2011)

a The total number of SKUs is equal to the SKUs per product (1.53) times the number of products (757).

b The total cost to industry is equal to the total number of SKUs times the average cost per SKU.

Under an implementation period of two years, the estimated industry cost is about $ 3

million. As shown in Table 6

, with a three

- year compliance period, the cost of the rule is

reduced to a bout $780,000.



### 4 Small Firm Impact Analysis

The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requi res regulators to assess the effects of regulations on small entities, including businesses, non

- profit organizations, and governments. In some instances when significant economic impacts on a substantial number of small entities are expected, agencies ar e also required to examine regulatory alternatives that may reduce adverse economic effects on significantly impacted small

entities.Page 9 of 12 The RFA does not define the terms “significant” or “substantial” with regard s to the extent of the economic impact and nu mber of small entities affected. EPA has previously characterized annual incremental compliance costs of one percent of annual sales as not significant. If costs are likely to be greater than one percent of annual sales,

EPA considers both the number of affected firms and their proportion of all small firms to determine if a substantially higher number of firms will be impacted. If costs are likely to be greater than three percent of annual sales, a smaller number and proportion of

affected firms is cons idered substantial.



### 4.1 Profile of Small Businesses

Firms are classified as small or large by the Small Business Administration (SBA). SBA uses either the number of employee s or annual gross revenue as a threshold

to classify a company as small or large. F or example, the firms in the NAICS code 325: Chemical Manufacturing , the most common code for the firms producing minimum risk pesticide products are classified as small if the number of employees is less than 500, 750, or 1,000, depending on the more refi ned classification scheme (that is, the 6

- digit NAICS code) (see Table 3). The firms in the next most common NAICS code

– 424: Merchant Wholesalers, Nondurable Goods

– are classified as small if the number of employees is less than 100. The revenue thres hold is used for only a few firms in the industry. Using such SBA thresholds, it is determined that for the minimum risk pesticide industry, there are 97 small firms (out of the total 192, see Table 3), accounting for approximately 51% of the industry. T hey employ on average approximately 30 employees, with average annual revenue of approximately $2.8 million. 1 Base d on this information, EPA certif

ies that there will not be a significant impact on a substantial number of small entities (SISNOSE)

. This conclusion is based on our finding that the following criteria are met: Under a 3

- year implementation period, f ewer than 10 small businesses are likely to experience an economic impact of 1% or more of gross sales, and

less than 10 % of the small businesse s are likely to experience an economic impact of 1% or more of gross sales. No small firms are expected to experience an economic impact greater than or equal to 3% of annual gross sales

.



### 4.2 Estimation of Impacts on Small Businesses

As noted above, EPA evalu ates the impact of a rule on a small firm by comparing the cost to the firm with the firm’s annual sales. We first examine the likely impact to small firms on average before refining the analysis to consider those firms that may face higher than average i mpacts.

The average cost to a small firm is simply the average cost of a label change multiplied by the number of labels the average firm would have to modify. The number of labels that must be changed is estimated as the average number of products a firm markets times the average number of SKU per product.

1 The average revenue is based on 85 small parent firms for which revenue information is available in Dun & Bradstreet (2009) database.Page 10 of 12 T he average relabeling cost per SKU was estimated in the previous section and presented in the last column of Table 5 . The average cost may overestimate costs to small firms in the industry as sma ller firms may be more likely than large firms to use simpler labels with one or two colors. The 97 small firms identified in Section 4.1 market, on average, 3.8 products. The average number of products is multiplied by the estimate of 1.53 SKUs per prod uct (see the discussion in Section 3.2 above) to obtain the expected number of labels that the average small firm would change as a result of the rule: 5.75 labels per firm. Table 7 presents the estimated impact, given average revenues of $2.8 million/yea r, under different rule implementation periods. T he impacts of the

final rule on small firms are measured as the cost of the rule as a percent of the average

small business annual revenue ($2.8 million) . Thus, the impacts are approximately 1 .3%,

0.5 %, an d 0.1% of the average gross revenue of small firms, under each rule implementation period . This means that under a three

- year implementation period, for example, an average small firm is likely to experience the impact that is approximately

0. 1 % of average gross revenue. A similar interpretation is given for the other two implementation periods.

Table 7. Small Business Impacts

Rule implementation period Average cost per SKU Average cost

per firm a Impact (% of

gross revenue) b

Immediate $6,306 $36, 189 1.3%
With 2 years to change labels $2,550 $14,634 0.5%
With 3 years to change labels $672 $3,857 0.1%

a Cost per SKU times 5. 75 SKU s per firm (3.8 products per firm × 1.53 SKUs per product)

. b Given average revenue per small firm of $2.8 million.

Thus, for the two

- year and three

- year implementation periods, EPA concludes that the average small firm would not face significant impacts, based on the criteria above. The immediate label change sce nario might be a borderline case, but this scenario

was not considered for the implement ation period for the final rule

.

To better understand the distribution of impacts across firms, i n the next section, the small business impacts are analyzed in more detail by further delineating the SBA

defined small firms into “small” and “very small” firms.



### 4.3 Refined Analysis

The size of the company may influence the cost of label change s . In general, small firms might choose setup costs that are less expensive, compared to the large companies with more resources. Thus, EPA assumes that small firms would choose

either 1

- color or 2

- color label change schemes, and are unlikely to do a full color design

of their labels. Inspection of firm revenue data indicates that there are several small firms with very small annual revenue. To investigate the impacts of the final rule on these firms more closely

, EPA further classified the SBA

- defined s mall firms into “small” and “very small” firms as follows. Since the medium cost for a 2

- color label change is estimated to be $4,155 (see Table 4), which is approximately 1% of the gross revenue of a firm with gross revenue of $500,000, EPA assumes that small firms with annualPage 11 of 12

revenues of $500,000 or more would, on average, choose the medium 2

- color set up for

their labels . EPA also assumes that “ very small ” firms of less than $ 500 ,000 sales

revenue would choose the low 1

- color set up for their labels

.

Since the data on the number of products for each small firm is available, using the estimate of 1.53 SKUs per product for all small firms, EPA was able to estimate the total number of SKUs for each small firm. Then, EPA computed the cost of the rule for each small firm by multiplying the appropriate (i.e., the 1

- color low estimate for “very

“small” and 2

- color medium estimate for “small” firms) average relabeling cost per SKU from Table 5 by the total number of SKUs for each firm. These firm

- specific cos ts, as a percent of each firm’s annual revenue, are used as a measure of the impact of the final

rule on small businesses.

The impacts of the final rule on small businesses are reported in Table 8 . With a

three

- year compliance period, 7 small firms ( or 7 % of all small firms) are likely to experience an economic impact of 1% or more of gross sales, while no small firms are expected to incur impacts greater than or equal to 3% of gross sales. Therefore, based on

the criteri a described above, EPA concludes that there will be no significant impact on a

substantial number of small entities (SISNOSE) using the 3

- year implementation period

.

Because many of the firms are very small, even the modest set up cost (Table 4)

can result in a large impact on small firms. However, by allowing firms sufficient time to comply with the re

- label requirement s the impact on small firms can be reduced. For example, from Table 8, if given three years to comply over one or two years , the impact

on small businesses can be greatly reduced.

Table 8 . Small Business Impacts

– Refined Analysis

Rule implementation period Impact (% of annual gross revenue) a

≥ 1% ≥ 3%

Immediate 64% (62) 21% (21)

With 2 years to change labels 27 % (2 6 ) 9 % ( 9 )

With 3 years to change labels 7% (7) 0% (0)

a The estimates are the percent of the small firms impacted out of 97 small firms and the numbers in parentheses represent the number of firms impacted.



### References

Comments submitted by small businesses

. Docket EPA

- HQ

- OPP

- 20 10

- 0305

Dun and Bradstreet, 2009

. Market Spectrum Analysis.

EPA, 2005. “Economic Analysis of the Bulk Pesticide Container Design and Residue

Removal Standards.” Docket EPA

- HQ

- OPP

- 2005

- 0327. Document ID: EPA

- HQ

- OPP

2005

- 0327

- 0024Page 12 of 12

EPA, 2010. State registration lists: AL

, AK

, AZ

, CO

, IO

, LA

, MS

, NH

, NC

, OK

, RI

, SC

, SD

, and WA

. Docket EPA

- HQ

- OPP

- 20 10

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FDA, 2003. FDA Labeling Cost Model. Research Triangle Institute.

FDA, 2011. Labeling and Effectiveness Testing; Sunscreen D rug Products for Over

- the

Counter Human Use, Final Rule, June 17, 2011. Docket ID FDA

- 1978

- N

- 0018 (formerly

1978N

- 0038).

Nielsen Company. Scanner data on skin

- applied insect repellent products. 2008. Docket

EPA

- HQ

- OPP

- 20 10

- 0305

EPA. S tate minimum risk product registrations

. 2010

. Docket EPA

- HQ

- OPP

- 20 10

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