Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Rules and Regulations 43847 

2U.S. Census Bureau, Language Use in the United 

States: 2007 (Apr. 2010), available at http:// 

www.census.gov/prod/2010pubs/acs-12.pdf. 

3 In fact, the FTC has challenged such a practice 

as deceptive under Section 5 of the FTC Act. See 

FTC v. Mortgages Para Hispanos.com Corp., No. 

4:06–cv19 (E.D. Tex. 2006) (alleging mortgage 

broker engaged in deceptive practices by orally 

offering Spanish-speaking customers one thing in 

Spanish and then delivering something else in loan 

documents written entirely in English). 

4See, e.g., FTC v. Cyberspace.com, LLC, 453 F.3d 

1196, 1200 (9th Cir. 2006); FTC v. Nat’l Urological 

Group, Inc., 645 F. Supp. 2d 1167, 1189 (N.D. Ga. 

2008), aff’d, 356 Fed. App’x (11th Cir. 2009). 

5See, e.g., Cyberspace.com, 453 F.3d at 1200. 

6 In 2008, the Board of Governors of the Federal 

Reserve System amended Regulation Z under the 

Truth in Lending Act to prohibit advertising certain 

information only in a foreign language while 

providing, in the same advertisement, other critical 

information in English. See Final Rule, Truth in 

Lending, 73 FR 44522, 44601 (Jul. 30, 2008) 

(codified at 12 CFR 226.24(i)(7)). This approach is 

consistent with longstanding FTC requirements that 

mandatory disclosures be made in the language of 

the target audience. See 16 CFR 14.9 (under FTC 

rules, cease-and-desist orders, and guides that 

require the ‘‘clear and conspicuous’’ disclosure of 

information, such disclosure must be made in the 

language of the target audience); 16 CFR 

610.4(a)(3)(ii) (in marketing free credit reports, 

mandatory disclosures must be made in the same 

language as that principally used in the 

advertisement); 16 CFR 429.1(a) (in door-to-door 

sales, failure to furnish a completed receipt or 

contract in the same language as the oral sales 

presentation is an unfair and deceptive act or 

practice); 16 CFR 455.5 (where used car sales 

pitches are conducted in Spanish, mandatory 

disclosures must be made in Spanish); 16 CFR 

308.3(a)(1) (mandatory disclosures about pay-percall services must be made in the same language as 

that principally used in the advertisement); see also 

FTC Final Rule, Free Annual File Disclosures, 75 

FR 9726, 9733 (Mar. 3, 2010) (noting ‘‘the 

Commission’s belief that a disclosure in a language 

different from that which is principally used in an 

advertisement would be deceptive’’). 

7The CFPB has begun testing draft prototype 

mortgage disclosure documents in English and 

Spanish in advance of a formal rulemaking process. 

See CFPB, Consumer Financial Protection Bureau 

Announces Initiative to Combine Mortgage Loan 

Disclosures (May 18, 2011), available at http:// 

www.consumerfinance.gov/pressrelease/consumerfinancial-protection-bureau-announces-initiativeto-combine-mortgage-loan-disclosures/. 

8See generally James M. Lacko & Janis K. 

Pappalardo, Federal Trade Commission Staff 

Report, Improving Consumer Mortgage Disclosures: 

An Empirical Assessment of Current And Prototype 

Mortgage Disclosure Forms (2007), available at 

http://www.ftc.gov/os/2007/06/P025505Mortgage

DisclosureReport.pdf. 

9Our colleague, Commissioner Rosch, expresses 

concern that we may be advancing an argument 

about mortgage disclosures that is not supported by 

the record before us. But far from prejudging the 

outcome of any work to be performed by the CFPB, 

we are simply highlighting some of the important 

consumer protection issues that may arise in 

connection with mortgage advertisements targeting 

consumers whose primary language is not English. 

As we noted above, the matters before the 

Commission in this rulemaking were narrow, and 

the evidence received on the issue of the use of 

multiple languages in advertising—a mere four 

comments—does not address the questions to be 

examined by the CFPB concerning improvements to 

mortgage disclosure documents. While this limited 

record does not purport to address such issues, we 

have no doubt that in considering this and other 

questions, the CFPB will develop a full and 

complete record that properly takes into account 

the impact on all stakeholders of any measure that 

is designed to ensure that consumers receive clear 

and accurate information to assist them in making 

sound decisions about mortgages. 

other than English at home.2 Marketers are 

well-aware of this trend, and today they often 

tout a wide array of products and services, 

including home loans, in languages other 

than English. 

It is essential that our consumer protection 

laws keep pace with such marketplace 

realities, and we are pleased that the MAP 

Rule broadly bans deception in commercial 

communications concerning residential 

mortgages regardless of the language or 

languages in which they are made. For 

example, under the MAP Rule it can be 

unlawful to offer a consumer one set of terms 

in her native language but then deliver 

different terms in loan documents written in 

English.3 In addition, because the ‘‘net 

impression’’ of an advertisement is the 

lynchpin of deception analysis,4 a fine print 

disclaimer or qualifying statement may be 

insufficient to cure an otherwise misleading 

advertisement.5 This principle, as applied to 

advertising that uses multiple languages, 

means that, in advertising that targets 

consumers in a language other than English, 

a disclaimer in English may be insufficient to 

cure misleading claims in another language.6

But there are many questions about the 

communication of mortgage loan terms that 

go beyond the scope of this rulemaking, 

among them whether mortgage disclosure 

documents should be provided to nonEnglish speakers in languages other than 

English.7 Congress has charged the Consumer 

Financial Protection Bureau with the longoverdue task of simplifying and clarifying 

mortgage disclosure documents,8 and has 

granted the new agency broad rulemaking 

authority with respect to the advertising and 

communication of mortgage loan terms. We 

look forward to the results of the CFPB’s 

work in this area, including its consideration 

of the needs of non-native English speaking 

consumers when carrying out that important 

mandate.9

More generally, given our country’s 

changing demographics, we believe that 

government and industry alike will need to 

pay greater attention to ensuring that 

consumers, no matter what language they 

speak, have access to important information 

regarding their purchases and are protected 

from unfair and deceptive practices. 

Appendix B—Response of Commissioner J. 

Thomas Rosch to the Concurring Statement 

of Commissioner Ramirez, in Which 

Chairman Leibowitz and Commissioner Brill 

Join 

Final Rule: Mortgage Acts and Practices— 

Advertising 

July 19, 2011 

I agree with the concurring statement of 

Commissioner Ramirez concerning the 

Mortgages Acts and Practices—Advertising 

Rule to the extent it reiterates the assertions 

of the Statement of Basis and Purpose that 

the ‘‘net impression’’ of an advertisement is 

a touchstone of FTC deception analysis 

regardless of the language or combination of 

languages. It is also axiomatic that 

government and industry need to be vigilant 

that all consumers, regardless of what 

language they speak, are not victims of unfair 

and deceptive practices. 

However, insofar as the concurring 

statement suggests that the Consumer 

Financial Protection Bureau should require 

that mortgage disclosure documents be 

provided to non-English speaking consumers 

in their native language, I disagree. There is 

no basis for making any recommendation to 

‘‘go beyond’’ the MAP Rule or Section 5 as 

respects requirements that lenders furnish 

‘‘non-English speakers’’ with disclosures that 

are not in English. See Concurring Statement 

at 3. Specifically, Census Bureau data 

showing that nearly 20 percent of people in 

the United States in 2007 ‘‘reported speaking 

a language other than English at home’’ (id. 

at 1) does not suggest that they could not 

read or understand English. Indeed, so far as 

the rulemaking record for the MAP Rule is 

concerned, it is my understanding that a 

majority of the comments received favored 

making disclosures only in English. Thus, 

there is currently no basis for the Federal 

government to burden this industry with 

disclosure requirements that would oblige 

the industry to make disclosures in a 

language other than English except when the 

‘‘net impression’’ left by not doing so would 

violate Section 5. 

[FR Doc. 2011–18605 Filed 7–20–11; 11:15 am] 

BILLING CODE 6750–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1700 

[CPSC Docket No. CPSC–2011–0007] 

Poison Prevention Packaging 

Requirements; Exemption of Powder 

Formulations of Colesevelam 

Hydrochloride and Sevelamer 

Carbonate 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC,’’ ‘‘Commission,’’ 

or ‘‘we’’) is amending its child-resistant 

packaging requirements to exempt 

powder formulations of two oral 

prescription drugs, colesevelam 

hydrochloride and sevelamer carbonate. 

Colesevelam hydrochloride, currently 

marketed as Welchol ®, is available in a 

powder formulation and is indicated to 

reduce elevated LDL cholesterol levels 

and improve glycemic control in adults 

with type 2 diabetes mellitus. Sevelamer 

carbonate, currently marketed as 

Renvela ®, is also available as a powder 

formulation and is indicated for the 

control of elevated serum phosphorus in 

chronic kidney disease patients on 

dialysis. The rule exempts these 


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prescription drug products on the basis 

that child-resistant packaging is not 

needed to protect young children from 

serious injury or illness from powder 

formulations of colesevelam 

hydrochloride and sevelamer carbonate 

because the products are not acutely 

toxic, lack adverse human experience 

associated with acute ingestion, and, in 

powder form, are not likely to be 

ingested in large quantities by children 

under 5 years of age. 

DATES: The rule becomes effective on 

July 22, 2011. 

FOR FURTHER INFORMATION CONTACT: John 

Boja, Office of Compliance, Consumer 

Product Safety Commission, Bethesda, 

MD 20814–4408; telephone (301) 504– 

7300; jboja@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

1. The Poison Prevention Packaging Act 

of 1970 and Implementing Regulations 

The Poison Prevention Packaging Act 

of 1970 (‘‘PPPA’’), 15 U.S.C. 1471–1476, 

gives the Commission authority to 

establish standards for the ‘‘special 

packaging’’ of household substances, 

such as drugs, when child-resistant 

(‘‘CR’’) packaging is necessary to protect 

children from serious personal injury or 

illness due to the substance and the 

special packaging is technically feasible, 

practicable, and appropriate for such 

substance. Accordingly, CPSC 

regulations require that oral prescription 

drugs be in CR packaging. 16 CFR 

1700.14(a)(10). The powder forms of 

cholestyramine and colestipol, two 

drugs that are chemically similar to 

colesevelam hydrochloride and 

sevelamer carbonate, currently are 

exempt from CR packaging. Id. 

1700.14(a)(10)(v) and (xv). 

CPSC regulations allow companies to 

petition the Commission for exemption 

from CR requirements. 16 CFR part 

1702. Among the possible grounds for 

granting an exemption are that: 

The degree or nature of the hazard to 

children in the availability of the substance, 

by reason of its packaging, is such that 

special packaging is not required to protect 

children from serious personal injury or 

serious illness resulting from handling, using 

or ingesting the substance. 

16 CFR 1702.17. 

2. The Products for Which Exemptions 

Are Sought 

a. Welchol ® (Colesevelam 

Hydrochloride) 

On February 24, 2009, Daiichi 

Sankyo, Inc. (‘‘Daiichi’’) petitioned the 

Commission to exempt the powdered 

form of colesevelam hydrochloride, 

which it markets as Welchol ®, from the 

special packaging requirements for oral 

prescription drugs. The petitioner stated 

that the exemption is justified because 

of lack of toxicity and lack of adverse 

human experience with the drug. 

Welchol ® has been marketed in tablet 

form and dispensed in CR packaging. 

On October 2, 2009, the U.S. Food and 

Drug Administration (‘‘FDA’’) approved 

a new powder formulation of the drug. 

The petition requested an exemption 

only for the powder dosage form of 

Welchol ®. The product, in tablet form, 

would continue to be in CR packaging. 

Welchol ® is a bile acid sequestrant 

indicated as an adjunct to: (1) Reduce 

elevated low-density lipoprotein 

cholesterol (LDL–C) levels; and (2) 

improve glycemic control in adults with 

type 2 diabetes mellitus. The new 

dosage form of Welchol ® provides 1.875 

g or 3.75 g of the powdered drug in unit 

dose packages to be mixed with water 

and taken orally as a suspension. (A 

unit dose package of Welchol ® is a 

pouch that contains an individual dose.) 

b. Renvela ® (Sevelamer Carbonate) 

On March 6, 2009, Genzyme 

Corporation (‘‘Genzyme’’) petitioned the 

Commission to exempt the powdered 

form of sevelamer carbonate, which it 

markets as Renvela, ® from the special 

packaging requirements for oral 

prescription drugs. The petitioner stated 

that the exemption is justified because 

of lack of toxicity and lack of adverse 

human experience with the drug. 

Renvela ® is a phosphate binder 

indicated for the control of serum 

phosphorus in patients with chronic 

kidney disease on dialysis. The tablets 

are marketed with a pill crusher for 

patients who have trouble swallowing 

the tablets. The company reformulated 

Renvela ® as a powder to be taken as an 

oral suspension, and the FDA approved 

this powder formulation on August 12, 

2009. The new dosage form of Renvela ®

provides either 0.8 g or 2.4 g of 

Renvela ® powder in unit dose packages 

to be mixed with 2 ounces of water. 

B. Proposed Rule 

On February 16, 2011, we published 

a notice of proposed rulemaking 

(‘‘NPR’’) proposing to exempt from 

special packaging the powder forms of 

colesevelam hydrochloride (Welchol ®) 

and sevelamer carbonate (Renvela ®). 76 

FR 8942. As explained in the preamble 

to the proposed rule, we considered the 

two exemption petitions together 

because Welchol ® and Renvela ® have 

similar chemical structures, biological 

properties, and powder formulations. 

C. Toxicity and Human Experience 

Data 

1. Summary of Data From Proposed 

Rule 

As noted in the preamble to the 

proposed rule (76 FR at 8943), the 

systemic toxicity of colesevelam 

hydrochloride and sevelamer carbonate 

is limited because they are not absorbed 

from the gastrointestinal (GI) tract. 

There is no data indicating that either 

drug is acutely toxic. Acute toxicity is 

the type of toxicity that is of concern 

when considering whether CR 

packaging is appropriate. Even in 

patients taking these drugs chronically, 

the adverse effects are mostly minor, 

such as diarrhea, nausea, constipation, 

flatulence, and dyspepsia. 

If a child were to ingest accidentally 

Welchol ® or Renvela ®, the potential for 

the occurrence of mild to moderate GI 

discomfort, such as indigestion, 

constipation, nausea, and vomiting does 

exist. However, a review of relevant data 

indicates that an acute ingestion of these 

drugs would not result in serious 

toxicity. 

CPSC’s CR packaging regulations 

exempt cholestyramine and colestipol 

in powder form, two bile acid 

sequestrants that are similar chemically 

to Welchol ® and Renvela.® We have not 

found any relevant articles in the 

medical literature describing toxic 

effects following the acute ingestion of 

either cholestyramine or colestipol from 

1975 through 2010. 

As discussed in the preamble to the 

proposed rule (76 FR at 8944), we 

searched the following databases for 

incidents related to Welchol ® and 

Renvela ® occurring between 2000 and 

2009: the Injury and Potential Injury 

Incident database (‘‘IPII’’), the National 

Electronic Injury Surveillance System 

database (‘‘NEISS’’), and the Death 

Certificates database (‘‘DTHS’’). We 

found one incident involving Welchol ®

in the NEISS database. In that incident, 

11-month-old twin boys were taken to 

the emergency room after they had been 

playing with their grandmother’s 

prescription medications. It is not clear 

how many, if any, pills the boys 

ingested, but the children were treated 

and released from the hospital. We also 

searched Poisindex,® Pub Med, and 

Google for Welchol,® Renvela,®

colestipol, and cholestyramine, and 

found no relevant incidents of acute 

poisoning in humans. 

Before publication of the proposed 

rule, and as noted therein, we also 

analyzed Medwatch reports obtained 

from the FDA. Medwatch is the FDA’s 

program for reporting a serious adverse 

event, product quality problem, product 


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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Rules and Regulations 43849 

use error, or therapeutic inequivalence/ 

failure that may be associated with the 

use of an FDA-regulated drug, biologic, 

medical device, dietary supplement, or 

cosmetic. (See http://www.fda.gov/

Safety/MedWatch/HowToReport/

default.htm.) There may be adverse 

events that have occurred and are not 

reported in the Medwatch database. 

Also, the existence of a report in the 

database does not mean necessarily that 

the product actually caused the adverse 

event. 

The FDA gave us 151 distinct 

incidents of adverse events associated 

with Welchol ® reported through the 

Medwatch system. We excluded 

incidents where other medications may 

have caused the adverse event reported, 

resulting in 22 adverse events. Most 

adverse events reported to Medwatch 

were gastrointestinal or involved muscle 

pain, which is to be expected 

considering the adverse effects reported 

from clinical trials of Welchol.®

We also received reports from the 

FDA of 40 distinct incidents of adverse 

events associated with Renvela.® We 

excluded incidents where other 

medications may have caused the 

adverse event reported, resulting in five 

in-scope incidents. Two of the five 

incidents were deaths, which most 

likely were related to the underlying 

disease and not treatment with 

Renvela.® One of the five incidents 

involved intestinal obstruction and 

perforation, which the patient’s 

physician thought were possibly related 

to the patient’s treatment with 

Renvela.® In the two remaining 

incidents, one patient experienced 

gastroenteritis, and the other (who had 

asthma and chronic obstructive 

pulmonary disease) suffered severe 

breathing problems while on Renvela.®

Neither of these two results likely was 

related to Renvela.®

2. Updated Injury Data 

We updated the injury data since 

publication of the proposed rule. We 

searched the IPII, NEISS, and death 

certificate databases from 2000 through 

2010, for incidents associated with 

Welchol,® Renvela,® and related drugs 

(i.e., cholestyramine (Questran ®) and 

colestipol (Colestid ®)). We did not 

identify any incidents related to 

Renvela,® Questran,® or Colestid,® and 

identifed only one new Welchol ®- 

related case. This incident occurred in 

July 2010, when a 19-month-old boy 

was found in his crib with an open 

Tylenol ® bottle. The bottle was 

previously used for carrying Welchol ®

and other drugs. It was not clear from 

the report if any Welchol ® tablets were 

in the bottle when the child accessed it. 

The child was taken to the emergency 

department, held overnight for 

observation, and then released the next 

day. 

Additionally, we searched 

Poisindex ® (a comprehensive database 

which identifies the toxicity of 

commercial, biological, and 

pharmaceutical products), and the 

medical literature for updated 

information on colesevelam 

hydrochloride and sevelamer carbonate 

colestipol, and cholestyramine. We 

found no incidents of acute poisoning in 

humans through this search. 

3. Powder Formulations Generally 

We also evaluated the likelihood of 

children younger than 5 years old 

ingesting powdered substances. The 

powdered form of these substances 

makes them more difficult to ingest than 

medicines in other forms and therefore, 

likely will keep children from ingesting 

significant quantities. It would be 

difficult for children under 5 years old 

to eat large amounts of powder quickly 

without aspirating or coughing. It also 

would be difficult for children to mix 

powder thoroughly in a liquid, and the 

resulting lumpy quality may be 

unappealing to children who try to 

drink it. Although children are likely to 

be able to tear open the non-childresistant packets used for Welchol ® and 

Renvela,® they are likely to spill much 

of the contents; therefore, they would 

have to open a number of packages to 

access a significant quantity of the drug. 

Most unintentional poisonings among 

children occur during short lapses in 

direct visual supervision. The difficulty 

posed by ingestion of powder 

introduces a delay in the poisoning 

scenario, and supervision is likely to 

resume before a child can take in a 

significant quantity. 

As noted in the preamble to the 

proposed rule (76 FR at 8944), the 

packages used with the powder 

formulations of Welchol ® and Renvela ®

also reduce the likelihood of child 

poisoning. Both drugs are provided in 

small, foil-lined packages containing 

individual doses. The Renvela ® package 

is easy to tear only at the notch. Because 

the package must be opened at a precise 

location, it is less accessible, especially 

to young children. The Welchol ®

package does not have a notch and has 

uniform resistance to tearing, which 

makes it more difficult to open than 

Renvela.® Although both packages tear 

easily enough to be opened by children 

under 5 years of age, the fine motor 

skills of children in this age group are 

still developing, and such children are 

likely to spill most of the powder. 

D. Response to Comments on the 

Proposed Rule 

We published a notice of proposed 

rulemaking in the Federal Register on 

February 16, 2011, to exempt 

colesevelam hydrochloride (Welchol ®) 

and sevelamer carbonate (Renvela ®) 

from the special packaging requirements 

of the PPPA. 76 FR 8942. The proposed 

rule would amend our existing 

regulations at 16 CFR § 1700.14 by 

adding a new paragraph (a)(10)(xxii) to 

exempt coleselam hydrochloride in 

powder form in packages containing not 

more than 3.75 grams of the drug. The 

proposed rule also would create a new 

paragraph (a)(10)(xxiii) to exempt 

sevelamer carbonate in powder form in 

packages containing not more than 2.4 

grams of the drug. We received 27 

comments, with 15 supporting the 

proposed rule. In general, the comments 

did not address the codified text; 

instead, they focused on issues relating 

to the drugs themselves. The comments 

are available at http:// 

www.regulations.gov/

#!docketDetail;rpp=50;po=0;D=CPSC– 

2011–0007. This section summarizes the 

issues raised by the comments and 

provides responses to those issues. Each 

summarized issue is identified below as 

a single comment, and the word 

‘‘Comment,’’ in parentheses, will appear 

before the summary description of all 

comments on that issue, and the word 

‘‘Response,’’ in parentheses, will appear 

before our response to the issue. We also 

have numbered each summarized issue 

as a separate comment to help 

distinguish between the different issues 

raised by the commenters and 

summarized by us. They are listed in no 

particular order. 

1. Concern About Possible Harm to 

Children 

(Comment 1)—Some commenters 

were concerned about what they felt 

was a lack of data, and they thought that 

these drugs could be harmful to 

children (e.g., cause bowel obstruction, 

electrolyte/serum glucose imbalance, 

and death), particularly if ingested in 

large amounts. One commenter also 

questioned the use of adverse effect data 

from adults and animals in predicting 

toxicity from accidental poisoning in 

children. 

(Response 1)—We typically consider 

all available data in toxicity 

assessments, with human data taking 

precedence over animal data. While 

limited data are available on the acute 

toxicity of Welchol ® and Renvela ® in 

children, the adverse effects reported 

are similar to those in adults. Because 

these drugs are not absorbed 


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systemically, acute adverse effects 

typically are limited to the GI tract and 

are unlikely to be serious. An extension 

of these effects would be expected in an 

overdose scenario. Notably, intestinal 

obstruction has only been observed 

during therapeutic use of these drugs in 

patients whose health has been 

compromised otherwise (e.g., low birth 

weight, chronic kidney disease, and 

adhesions). Cases have been 

documented in infants and one child 

following treatment with a similar drug, 

cholestyramine. In addition, a 45-yearold male developed an intestinal 

obstruction, perforation, and an 

abdominal fistula (abnormal opening in 

the stomach or bowel, which allows the 

contents to leak) after several months of 

treatment with Renvela.® Intestinal 

obstruction has occurred very rarely 

after treatment with Welchol.® In fact, 

Welchol ® has a greater specificity for 

bile acids than cholestyramine and 

colestipol and has been suggested to 

have greater gastrointestinal tolerance 

than the other two drugs. 

Based on all available information, an 

imbalance of electrolytes or glucose 

control is unlikely to occur following an 

acute exposure to Welchol ® or 

Renvela.® No unexpected laboratory 

tests were seen following chronic 

administration of 3.75 grams g/day of 

Welchol ® to pediatric subjects with 

heterozygous familial 

hypercholesteremia or 15 g/day of 

Renvela ® to normal volunteers. Chronic 

administration of Welchol ® decreased 

fasting glucose levels 3.9–15.9 mg/dl. 

Because a blood glucose goal is 100–180 

mg/dl for children, it is unlikely that 

acute administration of Welchol ®

would cause hypoglycemia (i.e., low 

blood sugar) in a child (less than 60 mg/ 

dl). 

Moreover, as discussed in section C of 

this preamble, there are no available 

poisoning data showing that these drugs 

cause serious toxicity following an acute 

exposure. 

2. Questions About Powder Form 

(Comment 2)—Some commenters 

argued that: (1) The powder may present 

a choking hazard to children; and (2) 

there is little support for claims that the 

powders are more difficult for children 

to ingest, access from the packet without 

spilling, and mix thoroughly in a liquid. 

(Response 2)—The low acute toxicity 

of Welchol® and Renvela® is a key 

factor for the exemptions. Additionally, 

CPSC’s Human Factors staff considered 

relevant data and medical literature to 

conclude that powders generally present 

a low risk because they are more 

difficult to ingest, particularly in large 

quantities. Generally, with the 

exception of caustics, the primary 

exposure risk associated with powders 

is aspiration. Notably, any potential 

choking hazard with these drugs could 

also occur with any non-pharmaceutical 

powder formulation available in the 

household, such as soaps, baby powder, 

drink mixes, and food products. 

We maintain that a child would have 

difficulty opening the packet of either of 

these drugs and mixing the powder with 

a liquid because of the lack of precision 

and control required. Moreover, there 

are no available poisoning data with 

these or similar drugs (colestipol or 

cholestyramine) to indicate otherwise. 

3. Mixing With Other Substances 

(Comment 3)—One commenter stated 

that he believes that ‘‘the drug can 

potentially be mixed with something to 

create an adverse reaction.’’ 

(Response 3)—The commenter 

provided no evidence to suggest that 

this is a likely event, and no information 

or examples of a substance that would 

cause an adverse reaction when mixed 

with Welchol® or Renvela®. Although it 

is possible that a child might mix the 

powder with a liquid in imitation of an 

adult, it is highly unlikely that a child 

would do so repeatedly because a small 

child can drink only a limited amount 

of liquid at one time. In addition, the 

consistency of incompletely mixed 

powder is likely to deter repetition. 

4. Benefits of the Exemptions 

(Comment 4)—Some commenters 

asserted that benefits from the CR 

exemptions are limited: increased 

profits for the manufacturers of the 

drugs; and ease of opening the package. 

(Response 4)—Exempting from CR 

requirements the powder forms of 

Welchol® and Renvela® may increase 

patient compliance. Poor adherence to 

medication regimens for chronic health 

issues is a well-established concern. 

Easier access to these drugs could 

benefit patients with minimal or no risk 

to children. 

E. Effective Date 

This rule exempts two drugs that 

otherwise would be subject to CR 

packaging requirements under the 

PPPA. Because the rule grants an 

exemption, it is not subject to the usual 

requirement under the Administrative 

Procedure Act (‘‘APA’’) that a rule must 

be published 30 days before it takes 

effect. 5 U.S.C. 553(d)(1). Therefore, it is 

appropriate for the rule to become 

effective upon publication in the 

Federal Register. 

F. Regulatory Flexibility Act 

Certification 

Under the Regulatory Flexibility Act 

(‘‘RFA’’), 5 U.S.C. 601 et seq., an agency 

that engages in rulemaking generally 

must prepare initial and final regulatory 

flexibility analyses describing the 

impact of the rule on small businesses 

and other small entities. Section 605 of 

the RFA provides that an agency is not 

required to prepare a regulatory 

flexibility analysis if the head of an 

agency certifies that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

As noted in the preamble to the 

proposed rule (76 FR at 8945), the 

Commission’s Directorate for Economic 

Analysis prepared a preliminary 

assessment of the impact of a rule to 

exempt powder formulations of 

Welchol® and Renvela® from special 

packaging requirements. Based on this 

assessment, we preliminarily concluded 

that the proposed amendment 

exempting powder formulations of 

Welchol® and Renvela® from special 

packaging requirements would not have 

a significant impact on a substantial 

number of small businesses or other 

small entities. We received no 

comments on this assessment or any 

additional information. Therefore, we 

conclude that exempting powder 

formulations of colesevelam 

hydrochloride (currently marketed as 

Welchol® and sevelamer carbonate 

(currently marketed as Renvela® from 

special packaging requirements would 

not have a significant impact on a 

substantial number of small businesses 

or other small entities. 

G. Environmental Considerations 

Pursuant to the National 

Environmental Policy Act, and in 

accordance with the Council on 

Environmental Quality regulations and 

CPSC procedures for environmental 

review, we have assessed the possible 

environmental effects associated with 

the proposed PPPA amendment. As 

discussed in the preamble to the 

proposed rule, CPSC regulations state 

that rules requiring special packaging 

for consumer products normally have 

little or no potential for affecting the 

human environment. 16 CFR 

1021.5(c)(3). Nothing in this rule alters 

that expectation. Therefore, because the 

rule would have no adverse effect on the 

environment, neither an environmental 

assessment nor an environmental 

impact statement is required. 

H. Executive Orders 

According to Executive Order 12988 

(February 5, 1996), agencies must state 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Rules and Regulations 43851 

1 75 FR 67258, November 2, 2010. Comments and 

ex parte communications list available at http:// 

comments.cftc.gov/PublicComments/ 

CommentList.aspx?id=889. 

2See 76 FR 4752, January 26, 2011. 

3Letter from Thomas W. Sexton, Senior Vice 

President and General Counsel, NFA, to David A. 

Stawick, Secretary, CFTC (December 2, 2010). 

in clear language the preemptive effect, 

if any, of new regulations. 

The PPPA provides that, generally, 

when a special packaging standard 

issued under the PPPA is in effect, ‘‘no 

State or political subdivision thereof 

shall have any authority either to 

establish or continue in effect, with 

respect to such household substance, 

any standard for special packaging (and 

any exemption therefrom and 

requirement related thereto) which is 

not identical to the [PPPA] standard.’’ 

15 U.S.C. 1476(a). A state or local 

standard may be excepted from this 

preemptive effect if: (1) the state or local 

standard provides a higher degree of 

protection from the risk of injury or 

illness than the PPPA standard; and (2) 

the state or political subdivision applies 

to the Commission for an exemption 

from the PPPA’s preemption clause and 

the Commission grants the exemption 

through a process specified at 16 CFR 

part 1061. 15 U.S.C. 1476(c)(1). In 

addition, the Federal government, or a 

state or local government, may establish 

and continue in effect a nonidentical 

special packaging requirement that 

provides a higher degree of protection 

than the PPPA requirement for a 

household substance for the Federal, 

state, or local government’s own use. 15 

U.S.C. 1476(b). 

Thus, with the exceptions noted 

above, the rule exempting powder 

formulations of Welchol® and Renvela®

from special packaging requirements 

preempts nonidentical state or local 

special packaging standards for the 

substances. 

List of Subjects in 16 CFR Part 1700 

Consumer protection, Drugs, Infants 

and children, Packaging and containers, 

Poison prevention, Toxic substances. 

For the reasons given above, the 

Commission amends 16 CFR part 1700 

as follows: 

PART 1700—[AMENDED] 

■ 1. The authority citation for part 1700 

continues to read as follows: 

Authority: 15 U.S.C. 1471–76. Secs. 

1700.1 and 1700.14 also issued under 15 

U.S.C. 2079(a). 

■ 2. Section 1700.14 is amended by 

adding paragraphs (a)(10)(xxii) and 

(xxiii) to read as follows: 

§ 1700.14 Substances requiring special 

packaging. 

(a) * * * 

(10) * * * 

(xxii) Colesevelam hydrochloride in 

powder form in packages containing not 

more than 3.75 grams of the drug. 

(xxiii) Sevelamer carbonate in powder 

form in packages containing not more 

than 2.4 grams of the drug. 

* * * * * 

Dated: July 18, 2011. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2011–18511 Filed 7–21–11; 8:45 am] 

BILLING CODE 6355–01–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Parts 15 and 20 

RIN 3038–AD17 

Large Trader Reporting for Physical 

Commodity Swaps 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Final rules. 

SUMMARY: The Commission is adopting 

reporting regulations (‘‘Reporting 

Rules’’) that require physical 

commodity swap and swaption (for ease 

of reference, collectively ‘‘swaps’’) 

reports. The new regulations require 

routine position reports from clearing 

organizations, clearing members and 

swap dealers and also apply to 

reportable swap trader positions. 

DATES: Effective Dates: This rulemaking 

shall become effective September 20, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Bruce Fekrat, Senior Special Counsel, 

Office of the Director, (202) 418–5578, 

bfekrat@cftc.gov, or Ali Hosseini, 

Attorney-Advisor, Office of the Director, 

(202) 418–6144, ahosseini@cftc.gov, 

Division of Market Oversight, 

Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street, NW., Washington, DC 

20581. 

SUPPLEMENTARY INFORMATION: 

I. Background and Summary of 

Comments 

A. Background 

On November 2, 2010, the 

Commission proposed Reporting Rules 

that, in addition to establishing 

recordkeeping requirements, require 

routine swaps position reports from 

clearing organizations, clearing 

members and swap dealers and apply 

non-routine reporting requirements to 

large swaps traders.1 The Reporting 

Rules, as finalized and adopted herein, 

will allow the Commission to 

administer its regulatory responsibilities 

under the Commodity Exchange Act 

(‘‘CEA or Act’’) by implementing and 

conducting effective surveillance of 

economically equivalent physical 

commodity futures, options and swaps. 

The Reporting Rules will directly 

support the Commission’s transparency 

initiatives such as its dissemination of 

Commitments of Traders and Index 

Investment Data Reports and will allow 

the Commission to monitor compliance 

with the trading requirements of the 

Act.2

The Commission currently receives 

and uses for market surveillance and 

enforcement purposes, data on large 

positions in all physical commodity 

futures and option contracts traded on 

designated contract markets (‘‘DCMs’’). 

Without the Reporting Rules, there 

would be no analogous reporting system 

in place for economically equivalent 

swaps, which until recently were largely 

unregulated financial contracts. The 

Reporting Rules, as discussed below, are 

reasonably necessary for the effective 

surveillance of economically equivalent 

futures and swaps. 

B. Proposed Reporting Rules Summary 

of Comments 

The Commission received 

approximately 130 comment letters, and 

engaged in several ex parte 

communications, for the proposed 

Reporting Rules. The Commission has 

carefully reviewed and considered the 

submitted comments. Substantive 

comments pertinent to specific 

provisions in the rulemaking are 

summarized and discussed below and 

in other sections of this notice. 

The National Futures Association 

(‘‘NFA’’) submitted a comment 3

suggesting that its issuance of trader 

identifications should be a part of the 

position reporting process. Although 

beyond the scope of this rulemaking as 

proposed, the Commission may review 

the feasibility of adopting such an 

approach as a part of its ongoing 

updating and revision of other 

transaction and position reporting 

requirements. 

The Air Transport Association 

(‘‘ATA’’), Better Markets Inc. (‘‘Better 

Markets’’), the Petroleum Marketers 

Association of America (‘‘PMAA’’) and 

New England Fuel Institute (‘‘NEFI’’), 

and Robert Pollin and James Heintz of 

the Political Economy Research Institute 


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